A relic of medieval folklore: Corpus Christi Octave herbal wreaths in Poland and their relationship with the local pharmacopoeia.

PubMed

Łuczaj, Łukasz Jakub

2012-06-26

Herbal wreaths are blessed all over Poland on the eighth day of the Corpus Christi Octave (usually in June). They used to contain many species of aromatic and medicinal plants, both collected from the wild and cultivated. The aim of this study was to document the present composition of wreaths using photographs (etic perspective) and questionnaires (emic perspective) and compare it with the local pharmacopoeia, the composition of Assumption Day bouquets (blessed in August) and historical data on the composition of the wreaths. The study was carried out in SE Poland (near Krosno). Photographs of 245 wreaths were taken and 133 questionnaires concerning the blessed plants and their medical use were obtained. On average a photographed wreath contained over five species of plants and an average informant listed six species. The frequency of species in photos and questionnaires was similar. Several medicinal plants which used to be the key elements of the wreaths (e.g. Sedum acre, Asarum europaeum, Matricaria recutita, Thymus pulegioides, Alchemilla spp.) are now less frequently seen, mainly due to vegetation transformations. Nowadays only about a quarter of species in the wreaths are medicinal plants, the remaining are mainly ornamental flowers. Only a part of the local pharmacopoeia is represented in the blessed wreaths and bouquets. The wreaths were often used in fumigation practices (whole wreaths or single species taken out) for a whole continuum of purposes: from purely ritual to medicinal. Nowadays they serve a mainly apotropaic function, but help to preserve traditional ethnomedicinal knowledge. The blessing of herbal wreaths in Poland seems to be the last relic of a more widespread custom found in medieval times throughout northern and central Europe originally associated with summer solstice. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Bioprospecting: evolutionary implications from a post-olmec pharmacopoeia and the relevance of widespread taxa.

PubMed

Leonti, Marco; Cabras, Stefano; Castellanos, Maria Eugenia; Challenger, Antony; Gertsch, Jürg; Casu, Laura

2013-05-02

"Nothing in biology makes sense except in the light of evolution" The historical legacy and relevance of ethnopharmacology in drug discovery is undisputed. Here we connect the parameters influencing the selection of plant derived medicines by human culture with the concept of evolution. In the present contribution we compare global data with local data and try to answer the questions, to what extent are the taxonomic clades included in indigenous pharmacopoeias associated with certain ailment groups, and to what extent can ecology and phylogeny, which we consider a proxy for chemical relatedness and convergence, account for the observed bias? We use an approximated chi-square test (χ(2)) to check for associations between 12 ethnomedical use-categories and 15 taxonomical clades. With cluster analyses we test for correlations between phylogeny and use-categories. We compare the 67 drug-productive families identified by Zhu et al. with the medicinal flora of the Popoluca and the APG database and compare our results with the phylogenetic target classes evidenced by Zhu et al. Furthermore, we compare the medicinal flora of the Popoluca with the world's weeds (cf. Holm et al.) and discuss our results in relation to anthropological rationales for plant selection. The null-hypothesis "species from the 15 taxonomic clades are selected proportionally to their share in the treatment of the twelve organ- and symptom-defined use-categories" is rejected. The cluster dendrogram for the clades shows that the use patterns are to a certain extent associated with Angiosperm phylogeny. With the occurrence of 53 families the 67 drug-productive families are overrepresented in the regional flora of the Popoluca. The importance of these families in terms of their share is even more pronounced with the medicinal flora holding around 70% of all individual Popoluca informant responses. The overall phylogenetic use pattern is influenced by both the inherent pharmacological properties, which

Evaluation of an International Pharmacopoeia method for the analysis of nelfinavir mesilate by liquid chromatography.

PubMed

Yekkala, Raja Satyanarayana; Vandenwayenberg, Stephanie; Hoogmartens, Jos; Adams, Erwin

2006-11-17

A gradient LC method for the determination of related substances in nelfinavir mesilate (NFVM) has been recently published in the International Pharmacopoeia. The method uses a base deactivated reversed phase C18 column (25 cm x 4.6 mm I.D.), 5 microm kept at a temperature of 35 degrees C. The mobile phases consist of acetonitrile, methanol, phosphate buffer pH 3.4 and water. The flow rate is 1.0 ml/min. UV detection is performed at 225 nm. A system suitability test (SST) is described to govern the quality of the separation. The separation towards NFVM components was investigated on 18 C18 columns and correlation was made with the column classification system developed in our laboratory. The method was evaluated using a Hypersil BDS C18 column (25 cm x 4.6 mm I.D.), 5 microm. A two level fractional factorial design was applied to examine the robustness of the method. The method shows good selectivity, precision, linearity and sensitivity. Seven commercial samples were examined using this method.

The treatment of syphilis in Ferrara (Italy) in the 19th century: the example of the Ferrarese pharmacopoeia.

PubMed

Guidi, Enrica; Angelini, Lauretta; Mares, Donatella; Contini, Carlo; Vicentini, Chiara Beatrice

2010-03-01

The authors have taken the Italian city of Ferrara as an example of the remedies against syphilis, commonly used worldwide in the 1800s. After having identified the terminologies used to diagnose syphilis, they evidence the legislative behaviours of the government authorities in 19th century in Italy and, in particular, the social and sanitary measures taken in Ferrara to limit the spread of the syphilis epidemic. Historical sources permitted description of the remedies employed in Ferrara from the beginning to the end of that century, not only to treat conditions linked directly to the malady itself, but also its complications and secondary pathologies. The pharmacopoeia written for the apothecaries of Ferrara by Antonio Campana, a famous Professor of Pharmaceutical Chemistry and Botany, won a great reputation and distribution in the international medical world not only of the first half of the 1800s. His authoritative work was much appreciated in Italy and abroad.

Traditional medicine in Central Sahara: pharmacopoeia of Tassili N'ajjer.

PubMed

Hammiche, Victoria; Maiza, Khadra

2006-05-24

Further to the previously reported ethnobotanical surveys of North-Sahara and Ahaggar [Maiza, K., Brac de la Perrière, R.A., Bounaga, N., Hammiche, V., 1990. Usages traditionnels des plantes spontanées d'El Goléa. Actes du Colloque de l'Association. Française pour la Conservation des Espèces Végétales, Mulhouse; Maiza, K., Hammiche, V, Bounaga, N., Brac de la Perrière, R.A., 1992. Inventaire des plantes médicinales de trois régions d'Algérie. Actes du Colloque International hommage à Jean Pernès: Complexes d'espèces, flux de gènes, ressources génétiques des plantes. Paris, pp. 631-633; Maiza, K., Brac de la Perrière, R.A., Hammiche, V., 1993a. Traditional Saharian pharmacopoeia. Acta Horticulturae, I.S.H.S. 332, 37-42; Maiza, K., Brac de la Perrière, R.A., Hammiche, V., 1993b. Récents apports à l'ethnopharmacologie du Sahara algérien: Actes du 2ème Colloque Européen d'Ethnopharmacologie & 11ème Conférence Internationale d'Ethnomédecine. Heidelberg, pp. 169-171; Maiza, K., Brac de la Perrière, R.A., Hammiche, V., 1995. Pharmacopée traditionnelle saharienne. Revue de Médecines et Pharmacopées Africaines, 9 (No. 1), 71-75; Maiza, K., Smati, D., Brac de la Perrière, R.A., et Hammiche, V., 2005. Pharmacopée traditionnelle au Sahara Central: Pharmacopée de l'Ahaggar. Retenu pour publication. Revue de Médecines et Pharmacopées Africaines.], we have now moved our investigations on Tassili N'Ajjer, another distinct region of the Southern Algerian Sahara. Ethnobotanic research has been carried out through interviews with nomad populations and the traditional pratictionners of recognised competence. To date, 80 wild indigenous medicinal plants have been identified and are currently used by the local population for various illnesses. Information on their vernacular Tamahaq and Arabic names, their flowering distribution, the parts used, the modes of preparation and routes of administration are reported and discussed in this paper. This work

Possible alternative to European Pharmacopoeia's method of analysis Test for Fc Function of Immunoglobulin (2.7.9) by using tetanus toxoid as antigen.

PubMed

Perez-del-Pulgar, S; Lopez, M; Gensana, M; Jorquera, J I

2006-08-01

Preparations of intravenous immunoglobulins must keep functional integrity throughout the purification process. In order to assess Fc fragment functionality, the European Pharmacopoeia proposes the Test for Fc function of immunoglobulin (2.7.9), which is based on a rubella antigen of high titre. Sometimes, such antigen is difficult to obtain. In the present study, we develop the same assay using tetanus toxoid instead of rubella antigen, adapting the procedure for the use of tetanus toxoid. The comparison between rubella-based and tetanus-based assays showed that the slopes of the haemolysis curves were higher if red blood cells had been sensitised with the rubella antigen than with tetanus toxoid. Nonetheless, the tetanus-based assay gave satisfactory results and it could be a good alternative antigen target.

Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride.

PubMed

Marković, Bojan; Ignjatović, Janko; Vujadinović, Mirjana; Savić, Vedrana; Vladimirov, Sote; Karljiković-Rajić, Katarina

2015-01-01

Inter-laboratory verification of European pharmacopoeia (EP) monograph on derivative spectrophotometry (DS) method and its application for chitosan hydrochloride was carried out on two generation of instruments (earlier GBC Cintra 20 and current technology TS Evolution 300). Instruments operate with different versions of Savitzky-Golay algorithm and modes of generating digital derivative spectra. For resolution power parameter, defined as the amplitude ratio A/B in DS method EP monograph, comparable results were obtained only with algorithm's parameters smoothing points (SP) 7 and the 2nd degree polynomial and those provided corresponding data with other two modes on TS Evolution 300 Medium digital indirect and Medium digital direct. Using quoted algorithm's parameters, the differences in percentages between the amplitude ratio A/B averages, were within accepted criteria (±3%) for assay of drug product for method transfer. The deviation of 1.76% for the degree of deacetylation assessment of chitosan hydrochloride, determined on two instruments, (amplitude (1)D202; the 2nd degree polynomial and SP 9 in Savitzky-Golay algorithm), was acceptable, since it was within allowed criteria (±2%) for assay deviation of drug substance, for method transfer in pharmaceutical analyses. Copyright © 2015 Elsevier B.V. All rights reserved.

Collaborative study for establishment of the European Pharmacopoeia BRP batch 1 for diphtheria toxin.

PubMed

Sesardic, D; Prior, C; Daas, A; Buchheit, K H

2003-07-01

A stable liquid candidate Biological Reference Preparation (BRP) for diphtheria toxin was prepared in peptone buffer (nominal content of diphtheria toxin: 1 Lf/ml, 0.4 micro g/ml), filled in ampoules (filling volume: 1 ml) and characterised in a collaborative study. The toxin is to be used in the test "Absence of toxin and irreversibility of toxoid" as described in the current European Pharmacopoeia (Ph. Eur.) monograph Diphtheria Vaccine (Adsorbed) (2002:0443). Eleven laboratories assessed the specific activity of the preparation by in vivo and in vitro assays. The material is assumed to have satisfactory stability with a calculated predicted loss of activity of <1% per year at 4-8 degrees C. From the collaborative study, the specific activity was calculated as 77.6 (45-113) LD( 50)/ml (lethal challenge) and >75 000 Lr/Lf (intradermal challenge). The candidate BRP was successfully used in nine laboratories and confirmed suitable for use in the Vero cell test for "Absence of toxin and irreversibility of toxoid" as described in the Ph. Eur. monograph 2002:0443; i.e., concentrations of 5 x 10( -5) Lf/ml and below caused cytotoxic effects in the Vero cell test. Due to its liquid nature, the stability of the material will be monitored at regular intervals and preparation of a stable freeze-dried formulation will be considered for long-term use. Additional studies will be performed to confirm suitability of this BRP for other applications. The candidate BRP was adopted as the Ph. Eur. reference material for Diphtheria Toxin Batch 1 by the Ph. Eur. Commission at its session in March 2003.

Development and validation of a multiplex quantitative polymerase chain reaction assay for the detection of Mollicutes impurities in human cells, cultured under good manufacturing practice conditions, and following European Pharmacopoeia requirements and the International Conference on Harmonization guidelines.

PubMed

Vanni, Irene; Ugolotti, Elisabetta; Raso, Alessandro; Di Marco, Eddi; Melioli, Giovanni; Biassoni, Roberto

2012-07-01

The clinical applications of in vitro manipulated cultured cells and their precursors are often made use of in therapeutic trials. However, tissue cultures can be easily contaminated by the ubiquitous Mollicutes micro-organisms, which can cause various and severe alterations in cellular function. Thus methods able to detect and trace Mollicutes impurities contaminating cell cultures are required before starting any attempt to grow cells under good manufacturing practice (GMP) conditions. We developed a multiplex quantitative polymerase chain reaction (qPCR) assay specific for the 16S-23S rRNA intergenic spacer regions, for the Tuf and P1 cytoadhesin genes, able to detect contaminant Mollicutes species in a single tube reaction. The system was validated by analyzing different cell lines and the positive samples were confirmed by 16S and P1 cytoadhesin gene dideoxy sequencing. Our multiplex qPCR detection system was able to reach a sensitivity, specificity and robustness comparable with the culture and the indicator cell culture method, as required by the European Pharmacopoeia guidelines. We have developed a multiplex qPCR method, validated following International Conference on Harmonization (ICH) guidelines, as a qualitative limit test for impurities, assessing the validation characteristics of limit of detection and specificity. It also follows the European Pharmacopoeia guidelines and Food and Drug Administration (FDA) requirements.

Medicinal plants of the Achuar (Jivaro) of Amazonian Ecuador: ethnobotanical survey and comparison with other Amazonian pharmacopoeias.

PubMed

Giovannini, Peter

2015-04-22

This paper presents the first ethnobotanical survey conducted among the Achuar (Jivaro), indigenous people living in Amazonian Ecuador and Peru. The aims of this study are: (a) to present and discuss Achuar medicinal plant knowledge in the context of the epidemiology of this population (b) to compare the use of Achuar medicinal plants with the uses reported among the Shuar Jivaro and other Amazonian peoples. The author conducted field research in 9 indigenous villages in the region of Morona Santiago and Pastaza in Ecuador. Semi-structured interviews on local illnesses and herbal remedies were carried out with 82 informants and plant specimens were collected and later identified in Quito. A literature research was conducted on the medicinal species reported by Achuar people during this study. The most reported medicinal plants are species used by the Achuar to treat diarrhoea, parasites infection, fractures, wounds, and snakebites. Informants reported the use of 134 medicinal species for a total of 733 recorded use-reports. Of these 134 species, 44 are reported at least 3 times for one or more specific disease condition for a total of 56 uses. These species are considered a core kit of medicinal plants of the Achuar of Ecuador. Most of these medicinal species are widely used in the Amazon rainforest and in many other parts of Latin America. The author documented a core kit of 44 medicinal plants used among the Achuar of Ecuador and found that this core set of medicinal plants reflects local epidemiological concerns and the pharmacopoeias of the Shuar and other Amazonian groups. These findings suggest that inter-group diffusion of medicinal plant knowledge had a prominent role in the acquisition of current Achuar knowledge of medicinal plants. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

European Pharmacopoeia biological reference preparation for poliomyelitis vaccine (inactivated): collaborative study for the establishment of batch No. 3.

PubMed

Martin, J; Daas, A; Milne, C

2016-01-01

Inactivated poliomyelitis vaccines are an important part of the World Health Organization (WHO) control strategy to eradicate poliomyelitis. Requirements for the quality control of poliomyelitis vaccines (inactivated) include the use of an in vitro D antigen quantification assay for potency determination on the final lot as outlined in the European Pharmacopoeia (Ph. Eur.) monograph 0214. Performance of this assay requires a reference preparation calibrated in International Units (IU). A Ph. Eur. biological reference preparation (BRP) for poliomyelitis vaccine (inactivated) calibrated in IU has been established for this purpose. Due to the dwindling stocks of batch 2 of the BRP a collaborative study was run as part of the European Directorate for the Quality of Medicines & HealthCare (EDQM) Biological Standardisation Programme to establish BRP batch 3 (BRP3). Twelve laboratories including Official Medicines Control Laboratories (OMCLs) and manufacturers participated. The candidate BRP3 (cBRP3) was from the same source and had the same characteristics as BRP batch 2 (BRP2). During the study the candidate was calibrated against the 3 rd International Standard for inactivated poliomyelitis vaccine using in-house D antigen ELISA assays in line with the Ph. Eur. monograph 0214. The candidate was also compared to BRP2 to evaluate the continuity. Based on the results of the study, values of 320 DU/mL, 78 DU/mL and 288 DU/mL (D antigen units/mL) (IU) for poliovirus type 1, 2 and 3 respectively were assigned to the candidate. In June 2016, the Ph. Eur. Commission adopted the material as Ph. Eur. BRP for poliomyelitis vaccine (inactivated) batch 3.

Renewal of an old European Pharmacopoeia method for Terazosin using modeling with mass spectrometric peak tracking.

PubMed

Kormány, Róbert; Molnár, Imre; Fekete, Jenő

2017-02-20

An older method for terazosin was reworked in order to reduce the analysis time from 90min (2×45min) to below 5min. The method in European Pharmacopoeia (Ph.Eur.) investigates the specified impurities separately. The reason of the different methods is that the retention of two impurities is not adequate in reversed phase, not even with 100% water. Therefore ion-pair-chromatography has to be applied and since that two impurities absorb at low UV-wavelength they had to be analyzed by different method than the other specified impurities. In our new method we could improve the retention with pH elevation using a new type of stationary phases available for high pH applications. Also a detection wavelength could be selected that is appropriate for the detection and quantification of all impurities. The method development is the bottleneck of liquid chromatography even today, when more and more fast chromatographic systems are used. Expert knowledge with intelligent programs is available to reduce the time of method development and offer extra information about the robustness of the separation. Design of Experiments (DoE) for simultaneous optimization of gradient time (t G ), temperature (T) and ternary eluent composition (t C ) requires 12 experiments. A good alternative way to identify a certain peak in different chromatograms is the molecular mass of the compound, due to its high specificity. Liquid Chromatography-Mass Spectrometry (LC-MS) is now a routine technique and increasingly available in laboratories. In our experiment for the resolution- and retention modeling the DryLab4 method development software (Version 4.2) was used. In recent versions of the software the use of (m/z)-MS-data is possible along the UV-peak-area-tracking technology. The modelled and measured chromatograms showed excellent correlations. The average retention time deviations were ca. 0.5s and there was no difference between the predicted and measured R s,crit -values. Copyright © 2016

[Transition of Psychotropic Drugs in Japanese Pharmacopoeia (JP) (Part 16). Transitions in the Standards and Test Methods of Bromovalerylurea in JP V (1932) and JP X VI (2011), and Comparison with Deutsches Arzneibuch].

PubMed

Yanagisawa, Kiyohisa

2015-01-01

Soam discovered the drug Bromovalerylurea (or less BV) in 1907. After that, BV was imported in Japan in the latter part of the Meiji period as Western medicine. Under the influence of the First World War, in Japan, BV was domestic production. And BV are listed in JP V (1932), it is continued listing until the current JP X VI (2011). As a foreign pharmacopoeia which listed the BV, only in addition to the JP, there was a German Pharmacopoeia (DAB). During this time, the JP and DAB, the standards and test methods of BV, it was amended as shown in Table 1 and Table 2. The discrimination test and analysis test was defined based on the chemical properties of urea and isovaleric acid and bromine. Therefore, consistency was seen in the chemical criteria for test. From this it is understood that BV is Bromoisovalerateureido synthesized based on urea and isovaleric acid and bromine. This isovaleric acid is the active ingredient of Japanese Valerian and Valerian roots. BV is an organic synthetic urea derivative that was effectively improved organic synthesis isovaleric acid with respect to quality and efficacy surface. For this reason at the time that BV have been developed, it is an ideal new drug, it was described as a good medicine have no side effects. But to BV, there is a nature that it has tolerance, addictive, a dependency. In Japan after the Second World War, there was a lack of awareness about the nature of such BV. That it had become a system that masses can easily purchase the BV. Revision of the Pharmaceutical Affairs Law of 1960 against in this, selling regulation of BV is provided. However, for analgesic formulated with BV of dose observed in the Pharmaceutical Affairs Law, as generic drugs, selling is permitted, it is continuing until today. For this reason in recent years, long-term use of BV by self-judgment of the masses is frequent. And chronic bromine poisoning BV by this it have been a problem. Therefore regard to BV, always for their safety, including

Standardization of allergen products: 2. Detailed characterization of GMP-produced recombinant Phl p 5.0109 as European Pharmacopoeia reference standard.

PubMed

Himly, M; Nandy, A; Kahlert, H; Thilker, M; Steiner, M; Briza, P; Neubauer, A; Klysner, S; van Ree, R; Buchheit, K-H; Vieths, S; Ferreira, F

2016-04-01

The Biological Standardization Programme of the European Directorate for Quality of Medicines and Healthcare (EDQM) aims at the establishment of well-characterized reference standards based on recombinant allergens and validated assays for the quantification of major allergen content. The objective of this study was to examine the detailed physicochemical and immunological characterization of recombinant Phl p 5.0109, the second available allergen reference standard. Recombinant Phl p 5.0109 PP5ar06007 was produced under GMP conditions and analyzed by an array of physicochemical and immunological methods for identity, quantity, homogeneity, and folding stability in bulk solution, as well as thermal denaturation, aggregation state, and biological activity when formulated for long-time storage. PP5ar06007 revealed as a highly homogeneous, monomeric, well-folded preparation of rPhl p 5.0109, as documented by mass spectrometry, SDS-PAGE, isoelectric focusing, size-exclusion chromatography with light scattering, circular dichroism, and infrared spectroscopy. Upon storage at +4°C, PP5ar06007 retained the monomeric state for at least 2 months. A protein quantity of 1.56 ± 0.03 mg/ml was determined by amino acid analysis in PP5ar06007, and its biological activity was shown to be comparable to natural Phl p 5 in terms of basophil activation and T-cell reactivity. Recombinant Phl p 5.0109 PP5ar06007 was characterized extensively at the physicochemical and immunological level. It revealed to be a highly stable, monomeric, and immunologically equivalent of its natural counterpart. PP5ar06007 is now available as European Pharmacopoeia allergen reference standard for grass pollen products. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Ruggedness/robustness evaluation and system suitability test on United States Pharmacopoeia XXVI assay ginsenosides in Asian and American ginseng by high-performance liquid chromatography.

PubMed

Li, Yong-Guo; Chen, Ming; Chou, Gui-Xin; Wang, Zheng-Tao; Hu, Zhi-Bi

2004-09-03

The work of the ruggedness/robustness evaluation and system suitability tests was oriented to profound understand the practicability of using assay methods issued by United States Pharmacopoeia (USP XXVI and XXVII) for ginsenosides in Asian ginseng and American ginseng. The items chosen for the method validation included quantitative related items such as recovery of Rg(1) and Rb(1), respectively, and qualitative related items such as resolution, theoretical plate number, relative retention time of two critical-band-pairs, Rg(1)/Re and Rb(1) with its neighboring peak, respectively. Totally, 16 column types were used for comparison of different vendors, different packing materials, different size, etc. and five sets of LC systems and two laboratories were involved in comparing the data of both quantitative and qualitative items. The results showed that different packing materials of columns used might significantly alters separation. The column packing material Hypersil afforded the preferable separating for the ginsenosides. No significant difference was observed from the different instrumentations and inter-laboratories. Our results suggest a modification of the system suitability test as given in USP26-NF21 and the latest version of USP27-NF22, which was not suitable for most systems. Using resolutions of Rg(1)/Re and Rb(1) with its neighboring peak as critical parameters for the ginsenosides assay and omitting the relative retention time of both Rg(1)/Re and Rb(1) with its neighboring peak is our suggestion for a more reasonable, yet practicable system suitability. Six typical chromatograms gain from different columns were figured out as well.

Do ferns and lycophytes function as medicinal plants? A study of their low representation in traditional pharmacopoeias.

PubMed

Reinaldo, Rafael Corrêa Prota dos Santos; Santiago, Augusto César Pessôa; Medeiros, Patrícia Muniz; Albuquerque, Ulysses Paulino

2015-12-04

Ethnobotany is becoming an important tool for understanding how traditional medical systems are organized and which variables affect their structure and dynamics. However, some phenomena observed in ethnobotanical studies led us to question whether such phenomena are real or methodological artifacts. The small proportion of ferns and lycophytes in ethnobotanical surveys of medicinal plants is one such phenomenon, and its causes should be identified using different approach levels. The present study aimed to clarify the reasons for a low representation of these two groups in studies of medicinal plants. The present study considered the following hypotheses: 1) ferns and lycophytes are little represented in different ethnobotanical studies because of inadequate data collection methods to record these species; 2) ferns and lycophytes are little represented because of the local perception of their low therapeutic efficacy; and 3) species of ferns and lycophytes are represented in local pharmacopoeias in proportion to the size of their families. We chose rural communities from Chapada do Araripe, Northeast Brazil to test our hypotheses. Data on the medicinal plant repertoires of the communities and on the perceived therapeutic efficacy of ferns were obtained using two different methods, semi-structured interviews associated with free lists and a checklist interview, both applied to local specialists. The resulting data were analyzed differently for each test. In addition, data regarding the total flora x medicinal flora ratio were obtained with a floristic survey and accessing data banks from previous studies performed by our research team. All hypotheses were confirmed, showing that all three factors contributed to the low representation of these plant groups as medicinal resources. The present study showed that free-list interviews are not a good method to access traditional knowledge of medicinal ferns and lycophytes and that the use of visual stimuli can help the

Lead and traditional Moroccan pharmacopoeia.

PubMed

Lekouch, N; Sedki, A; Nejmeddine, A; Gamon, S

2001-12-03

The use of traditional cosmetics and remedies such as kohl and henna is very common in Morocco, especially among women, children and babies. Kohl is a dangerous eye cosmetic. It is usually mixed with other harmful substances, then applied on women's eyebrows and used in skin treatments for infants. Henna is another traditional product, with religious associations, which has been widely used over the centuries for cosmetic and medical purposes. Many people add various herbs or other substances to the henna in order to strengthen it or to give it a stronger colour. Our results were reassuring in that the concentrations of lead found in non-elaborate (henna only) samples of henna were low. However, when henna was mixed with other products (elaborate henna), these concentrations increased. Lead concentrations in kohl were very high however, unlike henna, were lower in mixed kohl as mixing with other products diluted the concentration of lead. Nevertheless, in both types of kohl, lead concentrations were very high and consequently constitute a risk for public health, particularly for children.

Effect of an orally formulated processed black cumin, from Iranian traditional medicine pharmacopoeia, in relieving symptoms of knee osteoarthritis: A prospective, randomized, double-blind and placebo-controlled clinical trial.

PubMed

Salimzadeh, Ahmad; Ghourchian, Anahita; Choopani, Rasool; Hajimehdipoor, Homa; Kamalinejad, Mohammad; Abolhasani, Maryam

2017-06-01

Osteoarthritis is a global health problem, especially for the elderly. A good replacement for non-surgical treatments is the use of traditional medicines. We selected a revere plant (Nigella sativa L.), a widely utilized medicinal herb for the treatment of inflammatory conditions, from the Iranian traditional medicine (ITM) pharmacopoeia with proven anti-inflammatory and analgesic actions. We performed a prospective, randomized, double-blind, and placebo-controlled clinical trial, in order to investigate whether the herb is useful in alleviating the symptoms of knee osteoarthritis. American College of Rheumatology clinical criteria were the basis of diagnosis, while the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire was considered as the main outcome measure. One hundred and ten eligible patients were assigned to receive a placebo or an active intervention (2 g/day of processed N. sativa seed powder in divided doses). Acetaminophen tablets were the rescue medicine. Finally, 40 patients in the placebo group and 37 patients in the active group completed the trial and were included in the statistical analysis. Both cohorts demonstrated statistically significant within-group differences (P < 0.05) in some subscales that were more prominent in the active group without any considerable adverse effects. Nevertheless, KOOS score results and the mean number of acetaminophen tablets used by patients showed no statistically significant between-group differences. It can be concluded that future programmed studies with larger sample sizes, longer follow-up periods, and other forms of N. sativa seeds as an active intervention is necessary to evaluate its efficacy in relieving the symptoms of knee osteoarthritis. © 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

Monographs for medicines on WHO's Model List of Essential Medicines.

PubMed

Roth, Lukas; Adler, Melissa; Jain, Tanvi; Bempong, Daniel

2018-06-01

To raise awareness about the importance of public pharmaceutical standards, identify if and, if so, where current pharmacopeias are falling short in the development of new and complete monographs and foster collaboration among the various pharmacopeias, to prioritize, develop and make available standards for those key medicines for which no complete monographs exist. In August 2017, we mined eight pharmacopeias to identify which of the 669 medicines in the 20th edition of the World Health Organization's Model List of Essential Medicines were covered by complete or incomplete monographs. The pharmacopeias we included were the Brazilian Pharmacopoeia, the British Pharmacopoeia, the Indian Pharmacopeia Commission, the International Pharmacopoeia, the Japanese Pharmacopoeia, the Mexican Pharmacopoeia, the Pharmacopeia of the People's Republic of China and the United States Pharmacopeia. For 99 (15%) of the medicines on the Model List, no monographs were available in any of the eight pharmacopeias investigated. Only 3% (1/30) of the cardiovascular medicines listed, but 28% (9/32) of the antiretroviral medicines and 23% (6/26) of the antimalarial medicines lacked monographs. There appear to be no public standards for many so-called essential medicines. To address this shortfall, a greater collaboration in the global health community is needed.

Monographs for medicines on WHO’s Model List of Essential Medicines

PubMed Central

Adler, Melissa; Jain, Tanvi; Bempong, Daniel

2018-01-01

Abstract Objective To raise awareness about the importance of public pharmaceutical standards, identify if and, if so, where current pharmacopeias are falling short in the development of new and complete monographs and foster collaboration among the various pharmacopeias, to prioritize, develop and make available standards for those key medicines for which no complete monographs exist. Methods In August 2017, we mined eight pharmacopeias to identify which of the 669 medicines in the 20th edition of the World Health Organization’s Model List of Essential Medicines were covered by complete or incomplete monographs. The pharmacopeias we included were the Brazilian Pharmacopoeia, the British Pharmacopoeia, the Indian Pharmacopeia Commission, the International Pharmacopoeia, the Japanese Pharmacopoeia, the Mexican Pharmacopoeia, the Pharmacopeia of the People’s Republic of China and the United States Pharmacopeia. Findings For 99 (15%) of the medicines on the Model List, no monographs were available in any of the eight pharmacopeias investigated. Only 3% (1/30) of the cardiovascular medicines listed, but 28% (9/32) of the antiretroviral medicines and 23% (6/26) of the antimalarial medicines lacked monographs. Conclusion There appear to be no public standards for many so-called essential medicines. To address this shortfall, a greater collaboration in the global health community is needed.

Pharming Pharmacopoeia: Living Apothecaries from the Sea

NASA Astrophysics Data System (ADS)

Baden, D. G.

2012-12-01

The quest for, and development of, new drugs to treat extant and emerging diseases is an interdisciplinary effort, often requiring isolation of pro-drugs from new organisms, environments, and species followed by activity measurement. Exploitation of cultivated microalgae from marine sources has produced some of the most potent natural biological agents known, with specific receptor-mediated activities in pulmonary medicine, toxicology, cancer chemotherapy, the cardiovascular system, central and peripheral nervous system, and in dermatology. Our recent discovery that one class of marine-derived molecule promotes trans-membrane transport, a second that enhances mucus secretion, and a third which is an inhibitor of inflammation--- all isolated from the same organism, highlights the increasingly broad potential for innovative exploitation of natural products that occur in marine microalgae. Approaches that include interdisciplinary teams, permanent innovation, and disruptive technologies all will be described in the context of discoveries made in the treatment of cystic fibrosis, in the improvement of drug efficacy, and in the development of multiple for translational sciences in the ocean and health arenas.

Detection and Analysis of the Quality of Ibuprofen Granules

NASA Astrophysics Data System (ADS)

Yu-bin, Ji; Xin, LI; Guo-song, Xin; Qin-bing, Xue

2017-12-01

The Ibuprofen Granules comprehensive quality testing to ensure that it is in accordance with the provisions of Chinese pharmacopoeia. With reference of Chinese pharmacopoeia, the Ibuprofen Granules is tested by UV, HPLC, in terms of grain size checking, volume deviation, weight loss on drying detection, dissolution rate detection, and quality evaluation. Results indicated that Ibuprofen Granules conform to the standards. The Ibuprofen Granules are qualified and should be permitted to be marketed.

Recent trends in the impurity profile of pharmaceuticals

PubMed Central

Pilaniya, Kavita; Chandrawanshi, Harish K.; Pilaniya, Urmila; Manchandani, Pooja; Jain, Pratishtha; Singh, Nitin

2010-01-01

Various regulatory authorities such as the International Conference on Harmonization (ICH), the United States Food and Drug administration (FDA), and the Canadian Drug and Health Agency (CDHA) are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredients (APIs). The various sources of impurity in pharmaceutical products are — reagents, heavy metals, ligands, catalysts, other materials like filter aids, charcoal, and the like, degraded end products obtained during \\ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, decarboxylation, enantiomeric impurity, and so on. The different pharmacopoeias such as the British Pharmacopoeia, United State Pharmacopoeia, and Indian Pharmacopoeia are slowly incorporating limits to allowable levels of impurities present in APIs or formulations. Various methods are used to isolate and characterize impurities in pharmaceuticals, such as, capillary electrophoresis, electron paramagnetic resonance, gas–liquid chromatography, gravimetric analysis, high performance liquid chromatography, solid-phase extraction methods, liquid–liquid extraction method, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction column chromatography, mass spectrometry, Nuclear magnetic resonance (NMR) spectroscopy, and RAMAN spectroscopy. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC)-Mass Spectroscopy (MS), LC-NMR, LC-NMR-MS, GC-MS, and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research. PMID:22247862

[Key-point investigation list of traditional Chinese medicinal materials for national survey of Chinese material medica resources].

PubMed

Zhang, Xiao-Bo; Guo, Lan-Ping; Zhang, Yan; Zhou, Liang-Yun; Huang, Lu-Qi

2014-04-01

Base on the traditional Chinese medicinal materials list that include Pharmacopoeia of the People's Republic of China, Dao-di Herbs, the common used herbs, endangered species, to analyze the key-point investigation traditional Chinese medicinal materials list was analysed. Results displayed that the variety number of traditional Chinese medicinal materials in Pharmacopoeia of the People's Republic of China is 894, the variety number of Dao-di Herbs is 495, the variety number of the common use is 326, the variety number of traditional Chinese medicinal materials from endangered species is 280, and during the third national survey of Chinese material medica resources the variety number of traditional Chinese medicinal materials that were analysed is 360. In the list of Dao-di Herbs and common used herbs over 85% are in the list of Pharmacopoeia of the People's Republic of China, in the list of the common used herbs over 80% are in the list of Dao-di Herbs, in the list of Pharmacopoeia of the People's Republic of China and Dao-di Herbs over 10% are in the list of endangered species. The key-point investigation traditional Chinese medicinal materials list includes three part, the first part includes 563 variery traditional Chinese medicinal materials that need to statistics quantity of resource by field investigation, the second part includes 457 variery that need to monitor the changing situation, the third part includes 280 variery that need to estimated endangered situation.

Development and evaluation of a PCR-based assay kit for authentication of Zaocys dhumnades in traditional Chinese medicine.

PubMed

Zhang, Xiaomei; Zhou, Tingting; Yu, Wenjing; Ai, Jinxia; Wang, Xuesong; Gao, Lijun; Yuan, Guangxin; Li, Mingcheng

2018-01-01

We developed a kind of Zaocys dhumnades DNA test kit and it's indexes including specificity, sensitivity and stability were evaluated and compared with the method recorded in Chinese Pharmacopoeia (2010 edition). The bioinformatics technology was used to design primers, sequencing and blast, in conjunction with PCR technology based on the characteristics of Z. dhumnades cytochrome b (Cyt b) gene. The efficiency of nucleic acid extraction by the kit was done in accordance with Pharmacopoeia method. The kit stability results proved effective after repeated freezing and thawing 20 times. The sensitivity results indicated that the lowest amount detected by the kit was 0. 025 g of each specimen. The specificity test of the kit was 100% specific. All repeatability tests indicated the same results when conducted three times. Compared with the method recorded in Chinese Pharmacopoeia, the PCR-based assay kit by our team developed is accurate, effective in identification of Z. dhumnades, it is simple and fast, demonstrating a broad prospect in quality inspection of Z. dhumnades in the future.

Modern European monographs for quality control of Chinese herbs.

PubMed

Bauer, Rudolf; Franz, Gerhard

2010-12-01

The actual concern about the safety and efficacy of herbal drugs originating from traditional Chinese medicine (TCM) is based on observations that these medicinal plants may have a high risk potential due to insufficient definitions, problems with identity, purity and falsifications. No uniform legal status for these groups of herbal drugs currently exists in the European Union. For quality control, monographs for TCM herbs can mainly be found in the Pharmacopoeia of the Peoples Republic of China. Based on these facts the Commission of the European Pharmacopoeia decided in 2005 to establish TCM-herbal drug monographs for the most important medicinal plants imported from Far East. These new monographs had to be established and evaluated on the basis of existing monographs in the Chinese Pharmacopoeia (ChP), English edition 2005. Due to important differences in the overall features of EP and ChP, a simple adapt/adopt procedure was not feasible. Therefore, specialist groups were mandated with a corresponding working programme. Some results and actual problems related to this working programme will be presented and discussed. © Georg Thieme Verlag KG Stuttgart · New York.

Identification and control of unspecified impurity in trimetazidine dihydrochloride tablet formulation

NASA Astrophysics Data System (ADS)

Jefri; Puspitasari, A. D.; Talpaneni, J. S. R.; Tjandrawinata, R. R.

2018-04-01

Trimetazidine dihydrochloride is an anti-ischemic metabolic agent which is used as drug for angina pectoris treatment. The drug substance monograph is available in European Pharmacopoeia and British Pharmacopoeia, while the drug product monograph is not available in any of the pharmacopoeias. During development of trimetazidine dihydrochloride tablet formulation, we found increase of an unspecified impurity during preliminary stability study. The unspecified impurity was identified by high performance liquid chromatography coupled with mass spectrometry (LC-MS) and the molecular weight obtained was matching with the molecular weight of N-formyl trimetazidine (m/z 295). Further experiments were performed to confirm the suspected result by injecting the impurity standard and spiking formic acid into the drug substance. The retention time of N-formyl trimetazidine was similar to the unspecified impurity in drug product. Even spiking of formic acid into drug substance showed that the suspected impurity increased with increasing concentration of formic acid. The proposed mechanism of impurity formation is via amidation of piperazine moiety of trimetazidine by formic acid which present as residual solvent in tablet binder used in the formulation. Subsequently, the impurity in our product was controlled by choosing the primary packaging which could minimize the formation of impurity.

The Enduring Legacy of 250 Years of Pharmacology in Edinburgh.

PubMed

Kelly, John S; Mackay, Angus V P

2018-01-06

In 1768, 250 years ago, the University of Edinburgh appointed Francis Home to the first chair of materia medica, the accumulated knowledge of materials used in healing. Francis Home and his colleagues were determined to improve the quality of medical training in Edinburgh by introducing a final examination and compiling a catalog of medicines validated by the Royal College of Physicians of Edinburgh. The catalog, known as the Edinburgh Pharmacopoeia, was a great success, partly due to the orderly nature of its contents, its routine editing to eliminate worthless entries, and the introduction of new treatments whose preparation was precisely documented. In a relatively short time, the worth of the Edinburgh Pharmacopoeia was recognized throughout Europe, America, and the British Empire. Today, the British and European Pharmacopoeias are catalogs of publicly available, legally enforceable standards for active pharmaceutical ingredients and finished dosage forms of pharmaceutical products and medical devices. Home and the many luminaries who succeeded him would surely take pleasure and pride in the fact that the mantra of today's medicines regulators worldwide is little different from that of these early visionaries: "To take better advantage of the best possible science in the service of the public health and our health-care systems" ( 1 , p. 492).

[Our medicinal preparations in the mid-19th century. Part I--Introduction and chemical preparations].

PubMed

Drábek, Pavel

2012-08-01

The paper deals with the development of the first editions of the Austrian Pharmacopoeia, Pharmacopoea Austriaca, since its origin in the year 1812. It demonstrates its gradual retardation in the period when nearly all medicinal substances had to be prepared only in pharmacies. The conception was changed as late as 1855 in the Fifth Edition, when it was allowed to buy many medicinal substances from producers or wholesalers. At the same time, requirements for organoleptic properties and chemical purity began to be introduced. The present communication also deals with the chemical drugs used in the mid-19th century and is based on a comparison of the pharmacopoeias of 1836 and 1855. It presents some typical examples, such as alkaloids and metal compounds.

Biological indicators, tools to verify the effect of sterilisation processes - position paper prepared on behalf of group 1 (biological methods and statistical analysis).

PubMed

Haberer, K; van Doorne, H

2011-11-01

Biological indicators (BIs) are test systems containing viable microorganisms (usually spores of bacteria) providing a defined challenge to a specified sterilisation process. General chapter 5.1.2 of the European Pharmacopoeia [1] (Ph. Eur.) sets specifications for BIs and gives some guidance for their use. As shown in this text, the approach followed by Ph. Eur. as well as by ISO standards is outdated and could create nowadays some confusion among the users of the pharmacopoeia. It is the objective of this paper to provide the theoretical background of BIs as tools for the design and qualification of reliable moist heat sterilisation processes. The principles laid down in this article will form the basis of a future draft on a revised chapter on BIs in Pharmeuropa.

Ethnobotanical study on traditional uses of wild medicinal plants in Prokletije Mountains (Montenegro).

PubMed

Menković, N; Savikin, K; Tasić, S; Zdunić, G; Stesević, D; Milosavljević, S; Vincek, D

2011-01-07

The main objectives were to collect information on the use of wild growing medicinal plants by local people living in high mountain region of Montenegro and conduct local botanical and ecological surveys. Active ingredients of plant species officinal in European Pharmacopoeia 6.0 (Ph. Eur. 6.0) were studied and we assessed possibilities for commercial exploitation for local economic development. The 75 people that were interviewed (40-82 years old) identified 94 species for treatment of various human ailments. For each named species, the following elements are provided: botanical name, family, part(s) used, medicinal use and perceived property, listing in published pharmacopoeias, the relative abundance of each species and locality where the plant was collected. Chemical analyses were done according to prescriptions of Ph. Eur. 6.0 in order to estimate potential commercial use of native plants. The most common in traditional usage were Rosaceae (11 species) making 11.7%, Asteraceae (10 species) 10.6% and Lamiaceae (7 species) 7.4%. From 94 species reported, 35 (37.2%) are officinal in Ph. Eur. 6.0 and 12 in national pharmacopoeias (12.8%). Aerial parts were mostly used (43.6%). The most frequently reported medicinal uses were for treating gastrointestinal (57.4%) and respiratory diseases (41.5%). Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Anglo-Saxon pharmacopoeia revisited: a potential treasure in drug discovery.

PubMed

Watkins, Frances; Pendry, Barbara; Corcoran, Olivia; Sanchez-Medina, Alberto

2011-12-01

Three of the four major Anglo-Saxon collections reporting medicinal formulations in England from the 10th century, the Old English Herbarium, Bald's Leechbook and the Lacnunga, could contain leads and insights into new medicinal uses. Previous pharmacological studies of medicinal plants mentioned in Anglo-Saxon medical texts suggested that some were effective and led to the identification and isolation of natural compounds. For example, matricin from yarrow Achillea millefolium L., is a proprionic acid analogue that yields chamazulene carboxylic acid with cyclooxygenase-2 activity similar to that of ibuprofen. As we discuss here, multidisciplinary projects could further explore historical texts to discover additional plant metabolites with potential pharmacological applications. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Moyse Charas, a typical master apothecary and physician for his time (1619-1698)].

PubMed

Bonnemain, Bruno

2016-09-01

The life of Moyse Charas has been very stormy, especially after 1680. One can consider three main periods in his carrier : a first one from his birth in Uzès (France), in 1619, to 1680 ; his exile from 1680 to 1689 in various European countries ; and finally, his return to Paris in 1690 until his death in 1698. He decided his return to Paris and confirmed his conversion to Catholicism the 1st of July 1691, being received by Louis XIV and elected as a member of the French Academy of Sciences in 1692. Charas dictated his one’s will the 12th of January 1698, a few days before his death. All along his very active life, Charas was noteworthy by two major achievements : his interest and works on viper and, as a consequence, on theriac ; and his book that became a reference for all apothecaries and physicians at the time, the Pharmacopée Royale galénique et chimique (the Galenic and Chemical Royal Pharmacopoeia). The present study examines specifically the influence of Charas’ pharmacopoeia to the Universal Pharmacopeia of Lémery, and the conceptual visible differences between the two authors. He decided his return to Paris and confirmed his conversion to Catholicism the 1st of July 1691, being received by Louis XIV and elected as a member of the French Academy of Sciences in 1692. Charas dictated his one’s will the 12th of January 1698, a few days before his death. All along his very active life, Charas was noteworthy by two major achievements : his interest and works on viper and, as a consequence, on theriac ; and his book that became a reference for all apothecaries and physicians at the time, the Pharmacopée Royale galénique et chimique (the Galenic and Chemical Royal Pharmacopoeia). The present study examines specifically the influence of Charas’ pharmacopoeia to the Universal Pharmacopeia of Lémery, and the conceptual visible differences between the two authors.

[Stability of disintegration in health food].

PubMed

Ma, Lan; Zhao, Xin; Zhou, Shuang; Yang, Dajin

2012-11-01

To study the change of disintegration of different formulation samples which stored in the artificial climate box or room temperature and provide the technical support for health food monitoring. According to the method of Chinese Pharmacopoeia and British Pharmacopoeia. Appendix XII A. Disintegration 2010. Disintegration of the non-accelerate, accelerated after 1, 2 and 3 months samples were determined by the disintegrator, respectively. Sample properties, the ingredients of the samples, the proportions of the capsule and treatment methods have some effect on the stability of the disintegration. The disintegration time of health food will be changed particularly after they were accelerated under the condition of (38 +/- 1) degrees C/75% RH. Especially the disintegration time of soft capsules were significantly prolonged. The composition and properties of samples were the main factors that affected the disintegration.

Determination of the Deacetylation Degree of Chitooligosaccharides

PubMed Central

Fu, Chuhan; Wu, Sihui; Liu, Guihua; Guo, Jiao; Su, Zhengquan

2017-01-01

The methods for determination of chitosan content recommended in the Chinese Pharmacopoeia and the European Pharmacopoeia are not applicable for evaluation of the extent of deacetylation (deacetylation degree, DD) in chitooligosaccharides (COS). This study explores two different methods for assessment of DD in COS having relatively high and low molecular weights: an acid-base titration with bromocresol green indicator and a first order derivative UV spectrophotometric method for assessment of DD in COS. The accuracy of both methods as a function of molecular weight was also investigated and compared to results obtained using 1H NMR spectroscopy. Our study demonstrates two simple, fast, widely adaptable, highly precise, accurate, and inexpensive methods for the effective determination of DD in COS, which have the potential for widespread commercial applications in developing country. PMID:29068401

[Study on suitable harvest time of Dendrobium officinale in Yunnan province].

PubMed

Zhang, Shan-bao; Zhou, Ke-jun; Zhang, Zhen; Lu, Rui-rui; Li, Xian; Li, Xiao-hua

2015-09-01

In order to determine the suitable harvest time of Dendrobium officinale from different regions in Yunnan province, the drying rate, mannose and glucose peak area ratio, extract, contents of polysaccharide and mannose of D. officinale samples collected from six producing areas in Ynnnan province were determined. The results indicate that drying rate and the contents of polysaccharide and mannose arrived the peak from January to April, extract reached a higher content from September to December, and mannose and glucose peak area ratio from October to February of the coming met the requirment of the Chinese Pharmacopoeia. Hence, the suitable harvesting time of D. officinale in Yunnan province is from December to February of the coming year,according to the experimental results and the request of the Chinese Pharmacopoeia.

Rubus rosaefolius extract as a natural preservative candidate in topical formulations.

PubMed

Ostrosky, Elissa Arantes; Marcondes, Elda Maria Cecilio; Nishikawa, Suzana de Oliveira; Lopes, Patricia Santos; Varca, Gustavo Henrique Costa; Pinto, Terezinha de Jesus Andreoli; Consiglieri, T Vladi Olga; Baby, Andre Rolim; Velasco, Maria Valéria Robles; Kaneko, Telma Mary

2011-06-01

Even though the synthetic preservatives may offer a high antimicrobial efficacy, they are commonly related to adverse reactions and regarded as having potentially harmful effects caused by chronic consumption. The development of natural preservatives provides a way of reducing the amount of synthetic preservatives normally used in pharmaceutical and cosmetic preparations. In addition, these agents have less toxic effects and represent a possible natural and safer alternative of the preservatives. The purpose of this research was to evaluate the Rubus rosaefolius Smith extract efficiency as a natural preservative in base formulations. Of the extract, 0.2% (w/w) was assayed for its effectiveness of antimicrobial protection in two different base formulations (emulsion and gel). The microbial challenge test was performed following the standard procedures proposed by The United States Pharmacopoeia 33nd, European Pharmacopoeia 6th, Japanese Pharmacopoeia 15th, and the Cosmetics, Toiletries, and Fragrance Association using standardized microorganisms. The results demonstrated that R. rosaefolius extract at the studied concentration reduced the bacterial inocula, satisfying the criterion in all formulations, even though it was not able to present an effective preservative behavior against fungi. Thus, the investigation of new natural substances with preservative properties that could be applied in pharmaceutical and cosmetic products is relevant due to the possibility of substituting or decreasing the concentration of synthetic preservatives, providing a way for the development of safer formulas for the use of consumers.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2014-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

The botulinum neurotoxin LD50 test - problems and solutions.

PubMed

Bitz, Silke

2010-01-01

Apart from the fact that the LD50 test is generally considered a procedure causing severe distress, which alone should result in its immediate deletion, it also conflicts with the EU wide ban on cosmetic testing in animals in the case of Botulinum Neurotoxin (BoNT) testing. The European Pharmacopoeia monograph allows for the use of three alternative methods provided they are validated. However these alternative assays are neither implemented by the manufactures of BoNT products nor are they enforced by the responsible authorities, e.g. by deleting the LD50 from the European Pharmacopoeia. The number of animals used for the testing of BoNT is not officially recorded. However, data from an undercover investigation allow the estimation that the number of mice used in LD50tests for BoNT products is greater than 600,000 per year worldwide.

Maya phytomedicine in Guatemala - Can cooperative research change ethnopharmacological paradigms?

PubMed

Hitziger, Martin; Heinrich, Michael; Edwards, Peter; Pöll, Elfriede; Lopez, Marissa; Krütli, Pius

2016-06-20

This paper presents one of the first large-scale collaborative research projects in ethnopharmacology, to bring together indigenous stakeholders and scientists both in project design and execution. This approach has often been recommended but rarely put into practice. The study was carried out in two key indigenous areas of Guatemala, for which very little ethnopharmacological fieldwork has been published. To document and characterize the ethno-pharmacopoeias of the Kaqchikel (highlands) and Q'eqchi' (lowlands) Maya in a transdisciplinary collaboration with the two groups Councils of Elders. The project is embedded in a larger collaboration with five Councils of Elders representing important indigenous groups in Guatemala, two of which participated in this study. These suggested healing experts reputed for their phytotherapeutic knowledge and skills. Ethnobotanical fieldwork was carried out over 20 months, accompanied by a joint steering process and validation workshops. The field data were complemented by literature research and were aggregated using a modified version of the International Classification of Diseases (ICD-10) and Trotter & Logan's consensus index. Similar numbers of species were collected in the two areas, with a combined total of 530 species. This total does not represent all of the species used for medicinal purposes. Remedies for the digestive system, the central nervous system & behavioral syndromes, and general tissue problems & infections were most frequent in both areas. Furthermore, remedies for the blood, immune & endocrine system are frequent in the Kaqchikel area, and remedies for the reproductive system are frequent in the Q'eqchi' area. Consensus factors are however low. The Kaqchikel, in contrast to the Q'eqchi', report more remedies for non-communicable illnesses. They also rely heavily on introduced species. The transdisciplinary research design facilitated scientifically rigorous and societally relevant large-scale fieldwork, which

Possible ambiguities when testing viscosity in compendial monographs - characterisation of grades of cellulose ethers.

PubMed

Doelker, E

2010-10-01

The European Pharmacopoeia (Ph. Eur.) monographs for the water-soluble cellulose ethers require viscosity determination, either in the "Tests" section or in the non-mandatory "Functionality-related characteristics" section. Although the derivatives are chemically closely related and used for similar applications, the viscosity tests strongly differ. Some monographs generically speak of the rotating viscometer method (2.2.10) and a fixed shear rate (e.g. 10 s-1), which would necessitate an absolute measuring system, while others recommend the capillary viscometer method for product grades of less than 600 mPa∙s and the rotating viscometer method and given operating conditions for grades of higher nominal viscosity. Viscometer methods also differ between the United States Pharmacopeia/National Formulary (USP/NF) and the Japanese Pharmacopoeia (JP) monographs. In addition, for some cellulose ethers the tests sometimes diverge from one pharmacopoeia to the other, although the three compendiums are in a harmonisation process. But the main issue is that the viscometer methods originally employed by the product manufacturers are often not those described in the corresponding monographs and generally vary from one manufacturer to the other. The aim of this study was therefore to investigate whether such a situation could invalidate the present pharmacopoeial requirements. 2 per cent solutions of several viscosity grades of hydroxyethylcellulose, hypromellose and methylcellulose were prepared and their (apparent) viscosity determined using both relative and absolute viscometer methods. The viscometer method used not only affects the measured viscosity but experimental values generally do not correspond to the product nominal viscosities. It emerges that, in contrast to Newtonian solutions (i.e. those of grades of up to ca. 50 mPa∙s nominal viscosity), some of the viscometer methods currently specified in the monographs are not able unambiguously to characterise the

[Identification of original species of Mantidis Oötheca (Sangpiaoxiao) based on DNA barcoding].

PubMed

Wang, Xi; Hou, Fei-xia; Wang, Yi-xuan; Wang, Yu-xian; Li, Jun-de; Yuan, Yuan; Peng, Cheng; Guo, Jin-lin

2015-10-01

Both market research and literature reports both found that the ootheca of mantodea was all used as medicine. However, Chinese Pharmacopoeia only records the ootheca of three mantis species. The clinical use of ootheca unrecorded in Chinese Pharmacopoeia, will pose potential risks to drug safety. It's urgent to identify the origin of Mantidis Oötheca. The current researches about original animal in Mantidis Oötheca are based on morphology and unanimous. DNA barcoding fill gaps of the traditional morphological identification, which is widely used in animal classification studies. This study first use DNA barcoding to analyze genetic distance among different Mantidis Oötheca types, align COI sequences between mantis and Mantidis Oötheca and construct the phylogeny tree. The result confirmed that Tenodera sinensis and Hierodula patellifera were the origin insects of Tuanpiaoxiao and Heipiaoxiao, respectively, and Statilia maculate and Mantis religiosa were the origin insects of Changpiaoxiao.

Microwave-assisted digestion using nitric acid for heavy metals and sulfated ash testing in active pharmaceutical ingredients.

PubMed

Pluhácek, T; Hanzal, J; Hendrych, J; Milde, D

2016-04-01

The monitoring of inorganic impurities in active pharmaceutical ingredients plays a crucial role in the quality control of the pharmaceutical production. The heavy metals and residue on ignition/sulfated ash methods employing microwave-assisted digestion with concentrated nitric acid have been demonstrated as alternatives to inappropriate compendial methods recommended in United States Pharmacopoeia (USP) and European Pharmacopoeia (Ph. Eur.). The recoveries using the heavy metals method ranged between 89% and 122% for nearly all USP and Ph. Eur. restricted elements as well as the recoveries of sodium sulfate spikes were around 100% in all tested matrices. The proposed microwave-assisted digestion method allowed simultaneous decomposition of 15 different active pharmaceutical ingredients with sample weigh up to 1 g. The heavy metals and sulfated ash procedures were successfully applied to the determination of heavy metals and residue on ignition/sulfated ash content in mycophenolate mofetil, nicergoline and silymarin.

Dissolution Studies of Papaverine Hydrochloride from Tablets in Three Pharmacopoeia Apparatuses.

PubMed

Polski, Andrzej; Kasperek, Regina; Rogowska, Magdalena; Iwaniak, Karol; Sobòtka-Polska, Karolina; Poleszak, Ewa

2015-01-01

In tablet production, the most important aspects are the physical properties of the tablets and their dissolution studies, which can be performed in four pharmacopoeial apparatuses. There are differences between them in construction and action, so differences in the results obtained are possible. The aim of the study was to compare the release of a model drug substance (papaverine hydrochloride) from tablets in three pharmacopoeial dissolution apparatus: a basket, a paddle (closed system) and flow-through cell (open system). The one series of tablets were produced by direct compression in a tablet press. The physical properties of the tablets (weight and size uniformity test, friability and hardness tests, disintegration time test), drug content and the release study of papaverine hydrochloride from tablets were studied in three dissolution apparatuses. The content of the active substance was studied spectrophotometrically. All tablets met the pharmacopoeic requirements. Over 80% of the model substance released from the tablets after 14 min in flow through the cell apparatus, while in the basket and paddle apparatuses after about 7 min 30 sec. After 20 min, the amount of the substance released in all apparatuses was over 90%. The release profiles of the drug substance in paddle and basket apparatuses were similar, while in the flow-through cell apparatus it was slightly slower. When the study conditions and composition of the tablets are the same, the release profile of the drug can be affected by the type of dissolution apparatus.

Liquid paraffin as new dilution medium for the analysis of high boiling point residual solvents with static headspace-gas chromatography.

PubMed

D'Autry, Ward; Zheng, Chao; Bugalama, John; Wolfs, Kris; Hoogmartens, Jos; Adams, Erwin; Wang, Bochu; Van Schepdael, Ann

2011-07-15

Residual solvents are volatile organic compounds which can be present in pharmaceutical substances. A generic static headspace-gas chromatography analysis method for the identification and control of residual solvents is described in the European Pharmacopoeia. Although this method is proved to be suitable for the majority of samples and residual solvents, the method may lack sensitivity for high boiling point residual solvents such as N,N-dimethylformamide, N,N-dimethylacetamide, dimethyl sulfoxide and benzyl alcohol. In this study, liquid paraffin was investigated as new dilution medium for the analysis of these residual solvents. The headspace-gas chromatography method was developed and optimized taking the official Pharmacopoeia method as a starting point. The optimized method was validated according to ICH criteria. It was found that the detection limits were below 1μg/vial for each compound, indicating a drastically increased sensitivity compared to the Pharmacopoeia method, which failed to detect the compounds at their respective limit concentrations. Linearity was evaluated based on the R(2) values, which were above 0.997 for all compounds, and inspection of residual plots. Instrument and method precision were examined by calculating the relative standard deviations (RSD) of repeated analyses within the linearity and accuracy experiments, respectively. It was found that all RSD values were below 10%. Accuracy was checked by a recovery experiment at three different levels. Mean recovery values were all in the range 95-105%. Finally, the optimized method was applied to residual DMSO analysis in four different Kollicoat(®) sample batches. Copyright © 2011 Elsevier B.V. All rights reserved.

75 FR 54153 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 11: Capillary... text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the...

75 FR 18509 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

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Disintegration Test of Health Food Products Containing Ginkgo Biloba L. or Vitex Agnus-Castus L. in the Japanese Market.

PubMed

Sato-Masumoto, Naoko; Masada, Sayaka; Takahashi, Satoshi; Terasaki, Sachiko; Yokota, Yoichi; Hakamatsuka, Takashi; Goda, Yukihiro

2015-04-23

For many years now, a number of Western herbs have been widely used in health food products in Japan and as pharmaceuticals in Europe. There are few or no mandated criteria concerning the quality of these herbal health food products, thus clarification is warranted. Here, we performed disintegration tests of 26 pharmaceutical and health food products containing the Western herbs ginkgo leaf and chaste tree fruit, in accord with the Japanese Pharmacopoeia. All eight pharmaceutical herbal products found in the European market completely disintegrated within the defined test time, and 11 of the 18 tested herbal products distributed as health foods in Japan disintegrated. Among the incompatible products identified in the Pharmacopoeia test, some products remained intact after incubation in water for 60 min. To ensure the efficacy of Western herbal products sold as health food in Japan, quality control, including disintegration, is therefore recommended, even though these products are not regulated under the Pharmaceutical Affairs Law.

[Rapid analysis of metronidazole tablets by optic-fiber sensing technologies and the similarity of ultraviolet spectra].

PubMed

Jin, Lu; Li, Li; Li, Xin-xia; Yang, Ting; Kong, Bin; Xu, Ping-ping

2011-02-01

The paper is to report the development of an optic-fiber sensing technology method to analyze metronidazole tablets rapidly. In this fiber-optic sensing system, the light from source delivering to probe can be dipped into simple-handling sample solution, absorbed by the solution and reflected to the fiber-optic and detected in the detection system at last. Then the drug content can be shown in the screen from the ultraviolet absorption spectra and the consistency between that obtained by this method and that in China Pharmacopoeia can be compared. With regard to data processing, a new method is explored to identify the authenticity of drugs using the similarity between the sample map and the standard pattern by full ultraviolet spectrum. The results indicate that ultraviolet spectra of tablets can be obtained from this technology and the determination results showed no significant difference as compared with the method in China Pharmacopoeia (P > 0.05), and the similarity can be a parameter to identify the authenticity of drugs.

Disintegration Test of Health Food Products Containing Ginkgo Biloba L. or Vitex Agnus-Castus L. in the Japanese Market

PubMed Central

Sato-Masumoto, Naoko; Masada, Sayaka; Takahashi, Satoshi; Terasaki, Sachiko; Yokota, Yoichi; Hakamatsuka, Takashi; Goda, Yukihiro

2015-01-01

For many years now, a number of Western herbs have been widely used in health food products in Japan and as pharmaceuticals in Europe. There are few or no mandated criteria concerning the quality of these herbal health food products, thus clarification is warranted. Here, we performed disintegration tests of 26 pharmaceutical and health food products containing the Western herbs ginkgo leaf and chaste tree fruit, in accord with the Japanese Pharmacopoeia. All eight pharmaceutical herbal products found in the European market completely disintegrated within the defined test time, and 11 of the 18 tested herbal products distributed as health foods in Japan disintegrated. Among the incompatible products identified in the Pharmacopoeia test, some products remained intact after incubation in water for 60 min. To ensure the efficacy of Western herbal products sold as health food in Japan, quality control, including disintegration, is therefore recommended, even though these products are not regulated under the Pharmaceutical Affairs Law. PMID:28930200

[Pharmaceutical research progress of rhynchophylla based on chemical stability].

PubMed

Hao, Bo; Yang, Xiu-Juan; Feng, Yi; Hong, Yan-Long

2014-12-01

Rhynchophylla is a Chinese herb commonly used in clinical practice. It's also the primary herb of some famous Chinese herbal compound such as Tianma Gouteng decoction, and Lingyang Gouteng decoction. According the record from many previous materia medica literatures, rhynchophylla should be added later during decoction. Pharmaceutical research showed that rhynchophylla alkaloids were not stable. Which has resulted in many problems in the research and its application. For example, there was not a quantitative determination method in "Chinese Pharmacopoeia" of past and present versions, which seriously impacted its quality control and product application. Firstly, records from previous materia medica literatures and "Chinese Pharmacopoeia" were systematically sorted based on the chemical stability of rhynchophylla. Secondly, pharmaceutical research including chemical compositions and their stability, pharmacological effects, extraction process and quality analysis, was reviewed after reference of literatures published at home and abroad in recent decades. Positive reference and evidence for further research and development of rhynchophylla will be provided in the article.

Determination of Interference During In Vitro Pyrogen Detection: Development and Characterization of a Cell-Based Assay.

PubMed

Palma, Linda; Rossetti, Francesca; Dominici, Sabrina; Buondelmonte, Costantina; Rocchi, Marco B L; Rizzardi, Gian P; Vallanti, Giuliana; Magnani, Mauro

Contamination of pharmaceutical products and medical devices with pyrogens such as endotoxins is the most common cause of systemic inflammation and, in worst cases, of septic shock. Thus, quantification of pyrogens is crucial. The limulus amebocyte lysate (LAL)-based assays are the reference tests for in vitro endotoxin detection, in association with the in vivo rabbit pyrogen test (RPT), according to European Pharmacopoeia (EP 2.6.14), and U.S. Pharmacopoeia (USP <85>). However, several substances interfere with LAL assay, while RPT is not accurate, not quantitative, and raises ethical limits. Biological assays, as monocyte activation tests, have been developed and included in European Pharmacopoeia (EP 7.0; 04/2010:20630) guidelines as an alternative to RPT and proved relevant to the febrile reaction in vivo. Because this reaction is carried out by endogenous mediators under the transcriptional control of nuclear factor-kappaB (NF-kappaB), we sought to determine whether a NF-kappaB reporter-gene assay, based on MonoMac-6 (MM6) cells, could reconcile the basic mechanism of innate immune response with the relevance of monocytoid cell lines to the organism reaction to endotoxins. This article describes both optimization and characterization of the reporter cells-based assay, which overall proved the linearity, accuracy, and precision of the test, and demonstrated the sensitivity of the assay to 0.24 EU/mL endotoxin, close to the pyrogenic threshold in humans. Moreover, the assay was experimentally compared to the LAL test in the evaluation of selected interfering samples. The good performance of the MM6 reporter test demonstrates the suitability of this assay to evaluate interfering or false-positive samples.

The apparency hypothesis applied to a local pharmacopoeia in the Brazilian northeast

PubMed Central

2014-01-01

Background Data from an ethnobotanical study were analyzed to see if they were in agreement with the biochemical basis of the apparency hypothesis based on an analysis of a pharmacopeia in a rural community adjacent to the Araripe National Forest (Floresta Nacional do Araripe - FLONA) in northeastern Brazil. The apparency hypothesis considers two groups of plants, apparent and non-apparent, that are characterized by conspicuity for herbivores (humans) and their chemical defenses. Methods This study involved 153 interviewees and used semi-structured interviews. The plants were grouped by habit and lignification to evaluate the behavior of these categories in terms of ethnospecies richness, use value and practical and commercial importance. Information about sites for collecting medicinal plants was also obtained. The salience of the ethnospecies was calculated. G-tests were used to test for differences in ethnospecies richness among collection sites and the Kruskal-Wallis test to identify differences in the use values of plants depending on habit and lignifications (e.g. plants were classes as woody or non-woody, the first group comprising trees, shrubs, and lignified climbers (vines) and the latter group comprising herbs and non-lignified climbers). Spearman’s correlation test was performed to relate salience to use value and these two factors with the commercial value of the plants. Results A total of 222 medicinal plants were cited. Herbaceous and woody plants exhibited the highest ethnospecies richness, the non-woody and herbaceous plants had the most practical value (current use), and anthropogenic areas were the main sources of woody and non-woody medicinal plants; herbs and trees were equally versatile in treating diseases and did not differ with regard to use value. Trees were highlighted as the most commercially important growth habit. Conclusions From the perspective of its biochemical fundamentals, the apparency hypothesis does not have predictive potential to explain the use value and commercial value of medicinal plants. In other hand, the herbaceous habit showed the highest ethnospecies richness in the community pharmacopeia, which is an expected prediction, corroborating the apparency hypothesis. PMID:24410756

[Fragments of an old west Nordic pharmacopoeia of the 13th century ].

PubMed

Schwabe, Fabian

2009-01-01

Only few medicine books in Norrøn language have survived till today. Concerning Norway and Iceland, just seven fragments of manuscripts are known to us. The oldest manuscript has been dated at about the 13th century, the youngest, which was found in Ireland, at about the time between 1500 and 1550. In medieval times, genuine Scandinavian medical literature did not exist. All seven manuscripts are connected with Continental European sources that are derived from monastic medicine and classical antiquity. The names of Galen, Hippocrates of Kos and Dioscorides are mentioned in some of the texts. Obviously, Norway and Iceland were the recipients of an intensive knowledge transfer from the South via Denmark to the North. Henrik Harpestraeng's book of herbs and the well-known 'Macer floridus' (11th century) are the main sources of the Norrøn manuscripts that are highly related to each other. The text and its variations was made use of during a long period of time and it was widely distributed. A diplomatic edition of the oldest fragment, manuscript AM 655 XXX, and a translation into modern German are the core of the article.

[Historical review of insulin and its preparations in pharmacopoeia (3). Fish insulins].

PubMed

Suehiro, M

1992-01-01

Existence of encapsulated glands situated in the mesentery of certain teleosti was reported by Brockmann (1846) and Stannius (1848), respectively. Thus the gland was named stannius corpuscle or Brockmann body. Later, as results of histological study, cells of stannius corpuscle tissues were constituted with Langerhans islet cells observed in mammalian pancreas by Diammare (1899) and Laguesse (1906). Thus, before the days of discovery of insulin by Banting and Best in 1921, stannius corpuscle has been interesting from the aspects of comparative anatomy and physiology. Rennie (1906) examined a large number of specimens in various species of teleosti and gave the term "principal islet" to easily recognizable stannius corpuscle. Osawa studied comparative anatomy in Freiburg and returned to Tokyo. He continued the study of comparative anatomy of Langerhans islet aand published a report on observation of "principal islet" of flatfish, limanda yokohamae Gth. in 1912 in Japanese. His report seemed to be a milestone of studies of fish insulin in Japan. Macleod attempted to demonstrate direct evidence on secretion of insulin from Langerhans islet cells. Experiments were made on extraction of "principal islet" of teleosti, angler Lophius) and sculpin (Myoxocephalus) to obtain insulin and demonstrated activity. No insulin activity was obtained from pancreatic tissues constituted with acinar cells of these fishes. In the case of elasmobranch, Langerhans islets are not separated, but potent insulin could be extracted from the pancreas. His report published in 1922 was the first report on fish insulin. Succeeding to Macleod's report, several reports on fish insulin were contnributed from Canada, England and U.S.A. until 1929. Dr. Kkumagai, Professor of Internal Medicine, Tohoku Imperial University (Sendai) also conducted the studies on extraction of active principle of pancreas since 1920, independently. But, a Toronto group reached the goal on discovery of insulin earlier than the Sendai group. The Sendai group also described extraction of active principle from the "principal islet" of teleosti. Especially, Ukai (1926) described morphological study on pancreas and stannius corpuscle for more than twenty species of fish. His report played an important role as the next milestone on the road of fish insulin development studies in Japan. In 1926, Dr. Sakaguchi who was a leading clinical diabetologist in Japan published a monograph entitled "Insulin" written in Japanese. He referred the report on fish insulins of McCormick and Noble and Dr. Kumagai's report, however, he commented that production of insulin from fish seemed to be less worthy due to requirements of laborious work to collect small stannius corpuscle from fish. Professor A. Ogata described a textbook entitled "Zoki-Yakuhin-Kagaku (chemistry of organotherapeutics): in 1931. In the first edition, papers of Macleod, McCormick, Dudley and Osawa were referred. In the revised fifth edition (1940) contained description of unpublished data of insulin content of various kinds of fish caught in Japan and supplied from his student Nagasawa. Under the circumstance of expanding tendency of the China Incident to World War II, shortage of importation and production of insulin preparations manufactured from domestic animals was anticipated. Development on manufacture of fish insulin became urgent. [Truncated

Determination of iodide with 1,3-dibromo-5,5-dimethylhydantoin (DBH) in comparison with the ICl-method. Analytical methods of pharmacopeias with DBH in respect to environmental and economical concern. Part 3.

PubMed

Hilp, M; Senjuk, S

2001-06-01

USP 1995 (The United States Pharmacopeia, 23rd Edit., (1995), potassium iodide p. 1265, sodium iodide p. 1424), PH. EUR. 1997 (European Pharmacopoeia, third ed., Council of Europe, Strasbourg, (1997), potassium iodide p. 1367, sodium iodide p. 1493) and JAP 1996 (The Japanes Pharmacopoeia, 13th ed. (1996), potassium iodide p. 578, sodium iodide p. 630) determine iodide with the ICl-method (J. Am. Chem. Soc. 25 (1903) 756-761; Z. Anorg. Chem. 36 (1903) 76-83; Fresenius Z. Anal. Chem. 106 (1936) 12-23; Arzneibuch-Kommentar, Wissenschaftliche Erläuterungen zum Europäischen Arzneibuch, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, Govi-Verlag - Pharmazeutischer Verlag GmbH, Eschborn, 12th suppl. (1999), K10 p. 2), using chloroform, which is toxic and hazardous to environment. Without the application of chlorinated hydrocarbons USP 2000 (The United State Pharmacopeia, 24th ed. (2000), potassium iodide p. 1368, sodium iodide p. 1535) and Brit 1999 (British Pharmacopoeia London, (1999), Appendix VIII C, p. A162) titrate iodide with the redox indicator amaranth. A titration with potentiometric indication giving two end-points at the step of I(2) and [ICl(2)](-) is described. Due to the high concentration of hydrochloric acid required for the ICl-method, the determination with DBH (1,3-dibromo-5,5-dimethylhydantoin; 1,3-dibromo-5,5-dimethyl-2,4-imidazolidinedione) can be recommended and is performed easily. Similarly, the iodide content of gallamine triethiodide may be analyzed with DBH by application of a visual two-phase titration in water and ethyl acetate or with potentiometric indication in a mixture of 2-propanol and water. During the removal of the excess of DBH 4-bromo-triethylgallamine (2,2',2"-[1-bromo-benzene-2,3,4-triyltris(oxy)]N,N,N-triethylethanium) is formed.

'You've got m@il: fluoxetine coming soon!': accessibility and quality of a prescription drug sold on the web.

PubMed

Gelatti, U; Pedrazzani, R; Marcantoni, C; Mascaretti, S; Repice, C; Filippucci, L; Zerbini, I; Dal Grande, M; Orizio, G; Feretti, D

2013-09-01

The increasing phenomenon of online pharmacies has potential for serious public health problems. This study aimed to evaluate the possibility of accessing a prescription drug in the absence of a prescription for an Italian purchaser. Fluoxetine pills were ordered from several online pharmacies. The study included website analysis, and the quality of the received product including packaging, chemical and microbiological analyses. Orders could be placed correctly on 61 of the 98 selected websites, and a sales transaction was concluded successfully on 17 websites. Thirteen drug samples were eventually received. In one case it was necessary to fill in a questionnaire before ordering the drugs. All websites displayed aggressive marketing strategies. There was wide variation in terms of domain registration, company base (when declared) and manufacturer's location (mostly India). All pills were delivered in sealed blister packs showing the lot number and manufacturer's details. A leaflet was enclosed in one case only. In three cases we received more pills than ordered, and in one case Viagra pills as a free gift. Pharmacopoeia microbiological requirements were satisfied. Chemical analysis revealed that the active principle was always present, although many samples did not meet the Pharmacopoeia "other impurities" or "total impurities" criteria. Heavy metals and solvents regulated by the Pharmacopoeia did not exceed the set limits; some of the non-regulated ones were also assessed, in some cases with a positive result (e.g. styrene). About 20% of purchase attempts resulted in delivery of the drugs, even in the absence of a medical prescription. Traceability was poor and drug quality was generally worse compared to conventional pharmacy-purchased products. Based on all these broad-spectrum results, user safety appears not to be globally guaranteed. Copyright © 2013 Elsevier B.V. All rights reserved.

Special forest products: integrating social, economic, and biological considerations into ecosystem management.

Treesearch

R. Molina; N. Vance; J.F. Weigand; D. Pilz; M.P. Amaranthus

1997-01-01

Throughout history, forests have provided a wealth of beneficial and essential products ranging from foods and medicines to building materials. Ancient pharmacopoeias list myriad forest plants and fungi for treating various ailments. Many of these ancient remedies have evolved and continue to evolve into the important drugs of modern medicine. Use of diverse forest...

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-ninth report.

PubMed

2015-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities.

Application and Characteristics of Chinese Herbal Medicine Containing Schisandra

NASA Astrophysics Data System (ADS)

Zhao, Hui; Mao, Mingsan

2018-01-01

Schisandra is the dried and ripe fruit of Chinese magnoliavine, which has the functions of protecting the liver and gallbladder, lowering blood sugar, antibacterial and antiaging. Schisandra contains biological activity is very high. As a commonly used blind Chinese herbal medicine, Schisandra often appear in the treatment of vertigo, palpitations, insomnia in the proprietary Chinese medicine, play a nourishing liver and kidney, nourishing the nerves and so on. Chinese Pharmacopoeia contains a total of 102 kinds of Chinese medicine containing Schisandra, according to the dosage form will contain Schisandra proprietary Chinese medicine is divided into pills, tablets, granules and other 8 categories, according to the compatibility of Schisandra application, will contain Schisandra proprietary Chinese medicine functional Class 9. In this paper, the main clinical application of proprietary Chinese medicines containing Schisandra chinensis was analyzed by analyzing the classification and functional treatment of Chinese medicinal constituents containing Schisandra in pharmacopoeia, and then providing the basis for the analysis of Schisandra in proprietary Chinese medicine and The study is conducted to give guidance.

[Study on quality standard of Sophora flavescens root extract].

PubMed

Zhao, Feng-chun; Li, Hao; Chen, Liang-mian; Gao, Hui-min; Zhang, Qi-wei; Wang, Zhi-min; Wu, Pi-e

2015-01-01

As a part of the project for the Chinese Pharmacopoeia (2015 edition), the quality standard of Sophora flavescens root extract was investigated and established. According to the methods described in the Appendix of Chinese Pharmacopoeia (2010 edition), the water and ash inspections were carried out. The marker components trifolirhizin, sophoraflavanone G, oxymatrine and oxysophocarpine in the samples were identified by qualitative TLC. The determination of oxymatrine, matrine, oxysophocarpine and sophocarpine was conducted by HPLC and the total flavonoids were measured by ultraviolet spectrophotometry, using sophoraflavanone G as reference substance. The results indicated the spots on the plate were clear with good resolution and the contents of oxymatrine, matrine, oxysophocarpine and sophocarpine in the 13 batches of the samples were 3.87% - 11.1%, 0.970% - 4.33%, 1.30% - 2.59% and 0.260% - 1.14%, respectively. The total flavoids in the 13 batches of the samples were 3.88% - 7.93%. In the study, the validated methods were reproducible and the established quality standard was feasible, which could be used for the quality control of S. flavescens root extract and related preparations.

Analytical challenges in drug counterfeiting and falsification-The NMR approach.

PubMed

Holzgrabe, Ulrike; Malet-Martino, Myriam

2011-06-25

Counterfeiting of products is a global problem. As long as clothes, clocks, leather wear, etc. are faked there is no danger, but when it comes to drugs, counterfeiting can be life-threatening. In the last years sub-standard active pharmaceutical ingredients (APIs) were found more often even though the use of the quality-ensuring methods of international pharmacopoeias should have detected additional impurities and the low content of the API. Methods orthogonal to the separating methods used in the pharmacopoeias are necessary to find counterfeits. Beside Raman and NIR spectroscopies as well as powder X-ray analysis, NMR spectroscopy being a primary ratio method of measurement is highly suitable to identify and quantify a drug and its related substances as well as to recognize a drug of sub-standard quality. DOSY experiments are suitable to identify the ingredients of formulations and therefore to identify wrong and/or additional ingredients. This review gives an overview of the application of quantitative NMR spectroscopy and DOSY NMR in anticounterfeiting. Copyright © 2010 Elsevier B.V. All rights reserved.

[Standard prescriptions for extemporaneously produced medicinal preparations in pharmacies VI. Collection Neues Rezeptur-Formularium].

PubMed

Subert, Jan; Kolář, Jozef

2013-10-01

The paper deals with the content of the collection Neues Rezeptur-Formularium (NRF) and some prescriptions potentially usable in innovations and standardization of prescriptions for extemporaneously produced medicinal preparations in pharmacies in the Czech Republic. Another possible use of NRF in the Czech Republic consists in the revision of the National Section of the Czech Pharmacopoeia.

[Simultaneous separation and detection of principal component isomer and related substances of raw material drug of ammonium glycyrrhizinate by RP-HPLC and structure confirmation].

PubMed

Zhao, Yan-Yan; Liu, Li-Yan; Han, Yuan-Yuan; Li, Yue-Qiu; Wang, Yan; Shi, Min-Jian

2013-08-01

A simple, fast and sensitive analytical method for the simultaneous separation and detection of 18alpha-glycyrrhizinic acid, 18beta-glycyrrhizinic acid, related substance A and related substance B by RP-HPLC and drug quality standard was established. The structures of principal component isomer and related substances of raw material drug of ammonium glycyrrhizinate have been confirmed. Reference European Pharmacopoeia EP7.0 version, British Pharmacopoeia 2012 version, National Drug Standards of China (WS 1-XG-2002), domestic and international interrelated literature were referred to select the composition of mobile phase. The experimental parameters including salt concentration, pH, addition quantities of organic solvent, column temperature and flow rate were optimized. Finally, the assay was conducted on a Durashell-C18 column (250 mm x 4.6 mm, 5 microm) with 0.01 mol x mL(-1) ammonium perchlorate (add ammonia to adjust the pH value to 8.2) -methanol (48 : 52) as mobile phase at the flow rate of 0.8 mL x min(-1), and the detection wavelength was set at 254 nm. The column temperature was 50 degrees C and the injection volume was 10 microL. The MS, NMR, UV and RP-HPLC were used to confirm the structures of principal component isomer and related substances of raw material drug of ammonium glycyrrhizinate. Under the optimized separation conditions, the calibration curves of 18 alpha-glycyrrhizinic acid, 18beta-glycyrrhizinic acid, related substance A and related substance B showed good linearity within the concentration of 0.50-100 microg x mL(-1) (r = 0.999 9). The detection limits for 18alpha-glycyrrhizinic acid, 18beta-glycyrrhizinic acid, related substance A and related substance B were 0.15, 0.10, 0.10, 0.15 microg x mL(-1) respectively. The method is sensitive, reproducible and the results are accurate and reliable. It can be used for chiral resolution of 18alpha-glycyrrhizinic acid, 18Pbeta-glycyrrhizinic acid, and detection content of principal component and

Spirits and liqueurs in European traditional medicine: Their history and ethnobotany in Tuscany and Bologna (Italy).

PubMed

Egea, Teresa; Signorini, Maria Adele; Bruschi, Piero; Rivera, Diego; Obón, Concepción; Alcaraz, Francisco; Palazón, José Antonio

2015-12-04

Fermented drinks, often alcoholic, are relevant in many nutritional, medicinal, social, ritual and religious aspects of numerous traditional societies. The use of alcoholic drinks of herbal extracts is documented in classical pharmacy since the 1st century CE and it is often recorded in ethnobotanical studies in Europe, particularly in Italy, where are used for a wide range of medicinal purposes. Formulations and uses represent a singular tradition which responds to a wide range of environmental and cultural factors. This research has two overarching aims To determine how long ancient uses, recipes and formulas for medicinal liqueurs from the pharmacopoeias and herbals of the 18th century persisted in later periods and their role in present ethnobotanical knowledge in areas of Tuscany and Emilia-Romagna (Italy). To trace other possible relationships among ancient and recent recipes of alcoholic beverages, from both popular and 'classic' (learned) sources in N-C Italy and neighboring areas. The review of herbals and classical pharmacopoeias, and ethnobotanical field work in Alta Valle del Reno (Tuscany and Emilia Romagna, Italy) were followed of a systematic study of ingredients and medicinal uses with multivariate analysis techniques. The multivariate analysis clearly shows six different styles of preparing medicinal alcoholic beverages: 1. The medicinal wine formulae by Dioscorides (1st century CE). 2. The pharmacopoeias of Florence and Bologna in the 18th century CE. 3. The formularies of Santa Maria Novella and Castiglione (19th and early 20th centuries CE). 4. The ethnobotanical data from Appennino Tosco-Emiliano; home-made formulations based almost exclusively on the use of local resources. 5. Traditional recipes from NE Italy and Austria. 6. Traditional recipes from NW Italy, Emilia, and Provence (France). A total of 54 ingredients (29 fruits) from 48 species are used in different combinations and proportions in Alta Valle del Reno (Italy) to produce

C-glucosidic ellagitannins from Lythri herba (European Pharmacopoeia): chromatographic profile and structure determination.

PubMed

Piwowarski, Jakub P; Kiss, Anna K

2013-01-01

Lythri herba, a pharmacopoeial plant material (European Pharmacopoea), is obtained from flowering parts of purple loosestrife (Lythrum salicaria L.). Although extracts from this plant material have been proven to possess some interesting biological activities and its pharmacopoeial standardisation is based on total tannin content determination, the phytochemical characterisation of this main group of compounds has not yet been fully conducted. To isolate ellagitannins from Lythri herba, determine their structures and develop chromatographic methods for their qualitative analysis. Five C-glucosidic ellagitannins - monomeric- vescalagin and castalagin together with new dimeric structures - salicarinins A-C, composed of vescalagin and stachyurin, vescalagin and casuarinin, castalagin and casuarinin units connected via formation of valoneoyl group, were isolated using column chromatography and preparative HPLC. Structures were determined according to (1) H and (13) C-NMR (one- and two-dimensional), electrospray ionisation-time of flight (ESI-TOF), electrospray ionisation-ion trap (ESI-MS(n) ) and circular dichroism (CD) spectra, together with acidic hydrolysis products analysis. HPTLC on RP-18 modified plates and HPLC-DAD-MS(n) on RP-18 column methods were developed for separation of the five main ellagitannins. Copyright © 2012 John Wiley & Sons, Ltd.

Perchance to Dream: Pathology, Pharmacology, and Politics in a 24-Hour Economy.

PubMed

Brassington, Iain

2018-04-01

The lack of sleep is a significant problem in the modern world. The structure of the economy means that 24 hour working is required from some of us, sometimes because we are expected to be able to respond to share-price fluctuations on the other side of the planet, sometimes because we are expected to serve kebabs to people leaving nightclubs, and sometimes because lives depend on it. The immediate effect is that we feel groggy; but there may be much more sinister long-term effects of persistent sleep deprivation and disruption, the evidence for which is significant, and worth taking seriously. If sleeplessness has a serious impact on health, it represents a notable public health problem. In this article, I sketch that problem, and look at how exploiting the pharmacopoeia (or a possible future pharmacopoeia) might allow us to tackle it. I also suggest that using drugs to mitigate or militate against sleeplessness is potentially morally and politically fraught, with implications for social justice. Hence, whatever reasons we have to use drugs to deal with the problems of sleeplessness, we ought to be careful.

Oromucosal film preparations: points to consider for patient centricity and manufacturing processes.

PubMed

Krampe, Raphael; Visser, J Carolina; Frijlink, Henderik W; Breitkreutz, Jörg; Woerdenbag, Herman J; Preis, Maren

2016-01-01

According to the European Pharmacopoeia, oromucosal films comprise mucoadhesive buccal films and orodispersible films. Both oral dosage forms receive considerable interest in the recent years as commercially available pharmaceutical products and as small scale personalized extemporaneous preparations. In this review, technological issues such as viscosity of the casting liquid, mechanical properties of the film, upscaling and the stability of the casting solution and produced films will be discussed. Furthermore, patient-related problems like appearance, mucosal irritation, taste, drug load, safety and biopharmaceutics are described. Current knowledge and directions for solutions are summarized. The viscosity of the casting solution is a key factor for producing suitable films. This parameter is amongst others dependent on the polymer and active pharmaceutical ingredient, and the further excipients that are used. For optimal patient compliance, an acceptable taste and palatability are desirable. Safe and inert excipients should be used and appropriate packaging should be provided to produced films. Absorption through the oral mucosa will vary for each active compound, formulation and patient, which gives rise to pharmacokinetic questions. Finally, the European Pharmacopoeia needs to specify methods, requirement and definitions for oromucosal film preparations based on bio-relevant data.

[The properties of simple medicines according to Avicenna (980-1037): analysis of some sections of the Canon].

PubMed

Ayari-Lassueur, Sylvie

2012-01-01

Avicenna spoke on pharmacology in several works, and this article considers his discussions in the Canon, a vast synthesis of the greco-arabian medicine of his time. More precisely, it focuses on book II, which treats simple medicines. This text makes evident that the Persian physician's central preoccupation was the efficacy of the treatment, since it concentrates on the properties of medicines. In this context, the article examines their different classifications and related topics, such as the notion of temperament, central to Avicenna's thought, and the concrete effects medicines have on the body. Yet, these theoretical notions only have sense in practical application. For Avicenna, medicine is both a theoretical and a practical science. For this reason, the second book of the Canon ends with an imposing pharmacopoeia, where the properties described theoretically at the beginning of the book appear in the list of simple medicines, so that the physician can select them according to the intended treatment's goals. The article analyzes a plant from this pharmacopoeia as an example of this practical application, making evident the logic Avicenna uses in detailing the different properties of each simple medicine.

Development and validation of chromatographic methods (HPLC and GC) for the determination of the active components (benzocaine, tyrothricin and menthol) of a pharmaceutical preparation.

PubMed

Ortiz-Boyer, F; Tena, M T; Luque de Castro, M D; Valcárcel, M

1995-10-01

Methods are reported for the determination of tyrothricin and benzocaine by HPLC and menthol by GC in the analysis of throat lozenges (tablets) containing all three compounds. After optimization of the variables involved in both HPLC and GC the methods have been characterized and validated according to the guidelines of the Spanish Pharmacopoeia, and applied to both the monitoring of the manufacturing process and the quality control of the final product.

Adulteration of Ginkgo biloba products and a simple method to improve its detection.

PubMed

Wohlmuth, Hans; Savage, Kate; Dowell, Ashley; Mouatt, Peter

2014-05-15

Extracts of ginkgo (Ginkgo biloba) leaf are widely available worldwide in herbal medicinal products, dietary supplements, botanicals and complementary medicines, and several pharmacopoeias contain monographs for ginkgo leaf, leaf extract and finished products. Being a high-value botanical commodity, ginkgo extracts may be the subject of economically motivated adulteration. We analysed eight ginkgo leaf retail products purchased in Australia and Denmark and found compelling evidence of adulteration with flavonol aglycones in three of these. The same three products also contained genistein, an isoflavone that does not occur in ginkgo leaf. Although the United States Pharmacopeia - National Formulary (USP-NF) and the British and European Pharmacopoeias stipulate a required range for flavonol glycosides in ginkgo extract, the prescribed assays quantify flavonol aglycones. This means that these pharmacopoeial methods are not capable of detecting adulteration of ginkgo extract with free flavonol aglycones. We propose a simple modification of the USP-NF method that addresses this problem: by assaying for flavonol aglycones pre and post hydrolysis the content of flavonol glycosides can be accurately estimated via a simple calculation. We also recommend a maximum limit be set for free flavonol aglycones in ginkgo extract. Copyright © 2014 Elsevier GmbH. All rights reserved.

[Medication error management climate and perception for system use according to construction of medication error prevention system].

PubMed

Kim, Myoung Soo

2012-08-01

The purpose of this cross-sectional study was to examine current status of IT-based medication error prevention system construction and the relationships among system construction, medication error management climate and perception for system use. The participants were 124 patient safety chief managers working for 124 hospitals with over 300 beds in Korea. The characteristics of the participants, construction status and perception of systems (electric pharmacopoeia, electric drug dosage calculation system, computer-based patient safety reporting and bar-code system) and medication error management climate were measured in this study. The data were collected between June and August 2011. Descriptive statistics, partial Pearson correlation and MANCOVA were used for data analysis. Electric pharmacopoeia were constructed in 67.7% of participating hospitals, computer-based patient safety reporting systems were constructed in 50.8%, electric drug dosage calculation systems were in use in 32.3%. Bar-code systems showed up the lowest construction rate at 16.1% of Korean hospitals. Higher rates of construction of IT-based medication error prevention systems resulted in greater safety and a more positive error management climate prevailed. The supportive strategies for improving perception for use of IT-based systems would add to system construction, and positive error management climate would be more easily promoted.

In vitro analysis of rifampicin and its effect on quality control tests of rifampicin containing dosage forms.

PubMed

Agrawal, S; Panchagnula, R

2004-10-01

The chemical stability of rifampicin both in solid state and various media has widely been investigated. While rifampicin is appreciably stable in solid-state, its decomposition rate is very high in acidic as well as in alkaline medium and a variety of decomposition products were identified. The literature reports on highly variable rifampicin decomposition in acidic medium. Hence, the objective of this investigation was to study possible reasons responsible for this variability. For this purpose, filter validation and correlation between rifampicin and its degradation products were developed to account for the loss of rifampicin in acidic media. For analysis of rifampicin with or without the presence of isoniazid, a simple and accurate method was developed using high performance chromatography recommended in FDC monographs of the United States Pharmacopoeia. Using the equations developed in this investigation, the amount of rifampicin degraded in the acidic media was calculated from the area under curve of the degradation products. Further, it was proved that in a dissolution study, the colorimetric method of analysis recommended in the United States Pharmacopoeia provides accurate results regarding rifampicin release. Filter type, time of injection as well as interpretation of data are important factors that affect analysis results of rifampicin in in vitro studies and quality control.

Risk of Fungi Associated with Aflatoxin and Fumonisin in Medicinal Herbal Products in the Kenyan Market.

PubMed

Keter, Lucia; Too, Richard; Mwikwabe, Nicholas; Mutai, Charles; Orwa, Jennifer; Mwamburi, Lizzy; Ndwigah, Stanley; Bii, Christine; Korir, Richard

2017-01-01

Utilization of herbal products is a major concern due to the possibility of contamination by toxigenic fungi that are mycotoxin producers such as Aspergillus species during processing and packaging. Research was carried out to determine the presence of aflatoxins and fumonisins in herbal medicinal products sold in Eldoret and Mombasa towns in Kenya. The study employed both exploratory and laboratory experimental design. The herbal products were purchased from the market and transported to Kenya Medical Research Institute for processing and analysis. Fungal contaminants were determined according to Pharmacopoeia specifications. The toxins were quantified using ELISA based technique. The genus Aspergillus was the most dominant followed by Penicillium . Fungal counts ranged between 1 CFU/g and >1000 cfu/g. Analysis of variance showed that the rate of fungal contaminants for Eldoret and Mombasa samples had significant association ( p ≤ 0.001). Aflatoxin levels ranged from 1 to 24 ppb, while fumonisin levels ranged from 1 to >20 ppb. Only 31% of samples met the standards for microbial limits as specified in Pharmacopoeia. There is need for product microbial quality improvement through proper harvesting, processing, storage, and marketing. It is recommended that a policy be enacted to enable regulation of herbal products in Kenya.

[History of the therapeutic uses of the tinder polypore, Fomes fomentarius (L. : Fr].

PubMed

Roussel, Bertrand; Rapior, Sylvie; Charlot, Colette; Masson, Christian-Louis; Boutié, Paul

2002-01-01

This paper presents the major therapeutic uses of Fomes fomentarius (L. : Fr.) Fr., tinder polypore. The context of this fungus is a wooly and soft material so called amadou (tinder). During the XVIII and XIXth centuries, the fungal material was used as haemostatic dressing and bandage to keep the temperature and compress parts of the body. It was also used as cautery for moxibustion and was reported in several traditional pharmacopoeias (Hungarian, Chinese, Indian).

Validation of the Technological Process of the Preparation "Milk by Vidal".

PubMed

Savchenko, L P; Mishchenko, V A; Georgiyants, V A

2017-01-01

Validation was performed on the technological process of the compounded preparation "Milk by Vidal" in accordance with the requirements of the regulatory framework of Ukraine. Critical stages of formulation which can affect the quality of the finished preparation were considered during the research. The obtained results indicated that the quality of the finished preparation met the requirements of the State Pharmacopoeia of Ukraine. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Creation of reference DNA barcode library and authentication of medicinal plant raw drugs used in Ayurvedic medicine.

PubMed

Vassou, Sophie Lorraine; Nithaniyal, Stalin; Raju, Balaji; Parani, Madasamy

2016-07-18

Ayurveda is a system of traditional medicine that originated in ancient India, and it is still in practice. Medicinal plants are the backbone of Ayurveda, which heavily relies on the plant-derived therapeutics. While Ayurveda is becoming more popular in several countries throughout the World, lack of authenticated medicinal plant raw drugs is a growing concern. Our aim was to DNA barcode the medicinal plants that are listed in the Ayurvedic Pharmacopoeia of India (API) to create a reference DNA barcode library, and to use the same to authenticate the raw drugs that are sold in markets. We have DNA barcoded 347 medicinal plants using rbcL marker, and curated rbcL DNA barcodes for 27 medicinal plants from public databases. These sequences were used to create Ayurvedic Pharmacopoeia of India - Reference DNA Barcode Library (API-RDBL). This library was used to authenticate 100 medicinal plant raw drugs, which were in the form of powders (82) and seeds (18). Ayurvedic Pharmacopoeia of India - Reference DNA Barcode Library (API-RDBL) was created with high quality and authentic rbcL barcodes for 374 out of the 395 medicinal plants that are included in the API. The rbcL DNA barcode differentiated 319 species (85 %) with the pairwise divergence ranging between 0.2 and 29.9 %. PCR amplification and DNA sequencing success rate of rbcL marker was 100 % even for the poorly preserved medicinal plant raw drugs that were collected from local markets. DNA barcoding revealed that only 79 % raw drugs were authentic, and the remaining 21 % samples were adulterated. Further, adulteration was found to be much higher with powders (ca. 25 %) when compared to seeds (ca. 5 %). The present study demonstrated the utility of DNA barcoding in authenticating medicinal plant raw drugs, and found that approximately one fifth of the market samples were adulterated. Powdered raw drugs, which are very difficult to be identified by taxonomists as well as common people, seem to be the easy

Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions.

PubMed

Yin, Jian; Swartz, Trevor E; Zhang, Jian; Patapoff, Thomas W; Chen, Bartolo; Marhoul, Joseph; Shih, Norman; Kabakoff, Bruce; Rahimi, Kimia

2016-01-01

A quantitative spectral method has been developed to precisely measure the color of protein solutions. In this method, a spectrophotometer is utilized for capturing the visible absorption spectrum of a protein solution, which can then be converted to color values (L*a*b*) that represent human perception of color in a quantitative three-dimensional space. These quantitative values (L*a*b*) allow for calculating the best match of a sample's color to a European Pharmacopoeia reference color solution. In order to qualify this instrument and assay for use in clinical quality control, a technical assessment was conducted to evaluate the assay suitability and precision. Setting acceptance criteria for this study required development and implementation of a unique statistical method for assessing precision in 3-dimensional space. Different instruments, cuvettes, protein solutions, and analysts were compared in this study. The instrument accuracy, repeatability, and assay precision were determined. The instrument and assay are found suitable for use in assessing color of drug substances and drug products and is comparable to the current European Pharmacopoeia visual assessment method. In the biotechnology industry, a visual assessment is the most commonly used method for color characterization, batch release, and stability testing of liquid protein drug solutions. Using this method, an analyst visually determines the color of the sample by choosing the closest match to a standard color series. This visual method can be subjective because it requires an analyst to make a judgment of the best match of color of the sample to the standard color series, and it does not capture data on hue and chroma that would allow for improved product characterization and the ability to detect subtle differences between samples. To overcome these challenges, we developed a quantitative spectral method for color determination that greatly reduces the variability in measuring color and allows

Synthesis and Characterization of Compounds Related to Lisinopril

PubMed Central

Raghava Reddy, Ambati V.; Garaga, Srinivas; Takshinamoorthy, Chandiran; Naidu, Andra; Dandala, Ramesh

2016-01-01

Lisinopril is a drug of the angiotensin-converting enzyme (ACE) inhibitor class that is primarily used in the treatment of hypertension. During the scale-up of the lisinopril process, one unknown impurity was observed and is identified. The present work describes the origin, synthesis, characterization, and control of this impurity. This paper also describes the synthesis and characterization of three other impurities listed in the European Pharmacopoeia 8.4 (Impurity C, D, and F). PMID:27222603

Application of guar gum biopolymer in the prescription of tablets with sodium ibuprofen--quality tests and pharmaceutical availability in vitro.

PubMed

Berner-Strzelczyk, Aneta; Kołodziejska, Justyna; Zgoda, Marian Mikołaj

2006-01-01

The increasing interest of the technology of drug form in natural biopolymers has become the reason for undertaking investigations on the possibility of guar gum application in the prescription of oral solid form of a drug. Alternative compositions and technology of the production of tablets of regulated in time sodium ibuprofen release were worked out for children. Two series of tablets were prepared with guar gum (5 and 10% content) and a series without the biopolymer. The tablet mass in each case contained keryostatic sorbitol and bioadhesive polyvinylpyrrolidone. All tablets were tested as regards the quality of production, compliance with the requirements of Polish Pharmacopoeia VI and potential therapeutic usefulness, manifestation of which is pharmaceutical availability of the therapeutic agent (sodium ibuprofen). The tests demonstrated that the produced tablets with sodium ibuprofen have proper physicochemical properties, in compliance with Polish Pharmacopoeia VI requirements. Application of biopolymer of guar gum type as adjuvant substance contributes to the improvement of the tablet hardness parameters and prevents technological problems (lining mixture of powders to tableting machine punch). The designed tablets demonstrate proper pharmaceutical availability of over 80%. Introduction of guar gum into their prescription prolonged their disintegration time and the rate of sodium ibuprofen release, which predisposes the produced form of a drug to have the function of a tablet with slowed-down release.

[Use of Ancient texts in modern therapeutic research].

PubMed

Fabre, André

2003-01-01

Two main purposes were assigned to this study of medicinal prescription of spices at the time of the Roman Empire: analyze Roman pharmacopoeia of spices in reference to modern criteria and assess a new discipline, close to "ethno-botany" and "ethno-pharmacology", aiming to a new approach of drug research: "archeopharmacology". A brief overview is given of the Roman world of spices : all aromatic substances from Orient, India and Far-East held a major place which can only be compared to the role of petroleum in our modern times. The study is conducted on a thesaurus of 2600 quotations from twelve authors: Apicius, Caelius Aurelianus, Cassius Felix, Celsus, Dioscorides, Galen, Marcellus,(Anonymous) Mulonmedicina, Pelagorius, Pliny the Elder, Serenus Sammonicus and Scribonius Largus and a set of 33 medicinal spices among which: cyperus, ferulas (Asa foetida), frankincense, pepper, myrrh and saffron. Medicinal use of spices (mainly for pneumology, dermatology and gastroenterology) do not differ notably from the rest of Roman pharmacopoeia: the main criteria for prescription of spices is not their place of origin but a "therapeutic profile" which is clearly assigned to each substance by tradition. During the last decades, new methods of therapeutic research: ethno-botany and ethno-pharmacology have been used extensively to explore traditional medicines. A new discipline is ready to emerge: "archeo-pharmacology", aiming towards a drug research based on Ancient texts.

Chinese herbs for memory disorders: a review and systematic analysis of classical herbal literature.

PubMed

May, Brian H; Lu, Chuanjian; Lu, Yubo; Zhang, Anthony L; Xue, Charlie C L

2013-02-01

Text mining and other literature-based investigations can assist in identifying natural products for experimental and clinical research. This article details a method for systematically analyzing data derived from the classical Chinese medical literature. We present the results of electronic searches of Zhong Hua Yi Dian ("Encyclopaedia of Traditional Chinese Medicine"), a CD of 1000 premodern (before 1950) medical books, for single herbs, and other natural products used for dementia, memory disorders, and memory improvement. This review explores how the terminology for these disorders has changed over time and which herbs have been used more or less frequently, and compares the results from the premodern literature with the herbs indexed for memory disorders in a modern pharmacopoeia. The searches located 731 citations deriving from 127 different books written between ca. 188 ad and ca. 1920. Of the 110 different natural products identified, those most frequently cited for forgetfulness were yuan zhi (Polygala tenuifolia), fu shen (Poria cocos), and chang pu (Acorus spp.), all of which have been cited repeatedly over the past 1800 years and appear among the 31 herbs indexed in a modern pharmacopoeia. By providing a complete, hierarchically organized list of herbs for a specific disorder, this approach can assist researchers in selecting herbs for research. Copyright © 2013. Published by Elsevier B.V.

Endotoxin Detection in Pharmaceuticals and Medical Devices with Kinetic-QCL, a Kinetic-Quantitative Chromogenic Limulus Amebocyte Lysate Assay.

PubMed

Berzofsky, Ronald N.

1995-01-01

The observation that endotoxin caused gelation in extracts of Limulus amebocytes has been expanded to the development of an in vitro kinetic, quantitative chromogenic LAL assay (Kinetic-QCL) for the detection of endotoxin in aqueous fluids. Within the last 15 years, the use of Limulus amebocyte lysate to detect and control the presence of pyrogenic substances in pharmaceuticals and medical devices has gained wide international acceptance. Both the United States and European Pharmacopoeias contain descriptions of and requirements for the LAL Bacterial Endotoxin Test. Both pharmacopoeias have begun to remove the rabbit pyrogen test requirement in a majority of drug monographs and have substituted endotoxin limits to be determined by LAL. The use of LAL has proved invaluable in controlling the level of endotoxin in finished product. The endotoxin contribution of raw materials and packaging material can be monitored as well. In-process testing at critical production steps can identify additional sources of endotoxin contamination, and depyrogenation processes can be validated by quantitating the degradation of endotoxin challenges. The speed, reproducibility, sensitivity, and economics of the Kinetic-QCL assay, in conjunction with the ppropriate equipment and software, over both the in vivo rabbit pyrogen test and the more traditional LAL gel-clot assay allow a more in-depth approach to the control of endotoxin in pharmaceuticals and medical devices.

Investigation of the solid state properties of amoxicillin trihydrate and the effect of powder pH.

PubMed

Ghassempour, Alireza; Rafati, Hasan; Adlnasab, Laleh; Bashour, Yosef; Ebrahimzadeh, Homeira; Erfan, Mohammad

2007-11-09

The purpose of this research was to investigate some physicochemical and solid-state properties of amoxicillin trihydrate (AMT) with different powder pH within the pharmacopoeia-specified range. AMT batches prepared using Dane salt method with the pH values from 4.39 to 4.97 were subjected to further characterization studies. Optical and scanning electron microscopy showed that different batches of AMT powders were similar in crystal habit, but the length of the crystals increased as the pH increased. Further solid-state investigations using powder x-ray diffraction (PXRD) demonstrated the same PXRD pattern, but the intensity of the peaks raised by the powder pH, indicated increased crystallinity. Differential scanning calorimetry (DSC) studies further confirmed that as the powder pH increased, the crystallinity and, hence, thermal stability of AMT powders increased. Searching for the possible cause of the variations in the solid state properties, HPLC analysis showed that despite possessing the requirements of the United States Pharmacopoeia (USP) for purity/impurity profile, there was a direct relationship between the increase of the powder pH and the purity of AMT, and also decrease in the impurity I (alpha-Hydroxyphenylglycine) concentration in AMT powder. Recrystallization studies confirmed that the powder pH could be controlled by adjusting the pH of the crystallization.

Quality evaluation of medicinal products and health foods containing chaste berry (Vitex agnus-castus) in Japanese, European and American markets.

PubMed

Fukahori, Masahiro; Kobayashi, Shojiro; Naraki, Yoko; Sasaki, Takahiro; Oka, Hideki; Seki, Masaharu; Masada-Atsumi, Sayaka; Hakamatsuka, Takashi; Goda, Yukihiro

2014-01-01

The aim of present study was to evaluate the qualities of chaste berry (fruit of Vitex agnus-castus L.) preparations using HPLC fingerprint analysis. Seven medicinal products 1 from Japan and 6 from Europe, and 17 health foods, 6 from Japan and 11 from the United States were analyzed. HPLC profile and 26 authentic peaks were compared medicinal products and health foods. Whereas medicinal products had similar HPLC profiles, health foods had various profiles and each peak was also greatly different. The measured amounts of two markers in 5 traditional medicinal products, agnuside and casticin specified in the European Pharmacopoeia (EP), the U.S. Pharmacopoeia (USP) or the WHO monographs of chaste berry, were much lower than those in 2 medicinal products defined as "well-established use" by the European Medicines Agency. The amounts of two markers for 17 health foods differed in a great deal from 14-5054% and 3-1272%, respectively. Furthermore the amount ratios of two markers, agnuside/casticin, in about half of the health foods were remarkably larger than the standard crude drug and the ratios were closer to one of the related Chinese herbs, Vitex negundo L. It is concluded that a combination of HPLC fingerprints and the amount ratios of the marker compounds of chaste berry preparations serves as a useful tool to evaluate the qualities of these preparations.

[Research and investigation on original plants of medicinal Moutan].

PubMed

Peng, Hua-Sheng; Wang, De-Qun; Peng, Dai-Yin; Huang, Lu-Qi

2017-05-01

As a kind of famous ornamental flowers, Moutan, known as "the king of flower", mainly originates from various cultivars of Paeonia suffruticosa. Moutan Cortex, a common traditional Chinese medicine, has a long medicinal history for more than 2 000 years. At present, "Fengdanpi", which is the root bark of P. ostii mainly growing in Tongling, Anhui, is a sort of Dao-di herbs in traditional Chinese medicine. However,various editions of Chinese pharmacopoeia has been stipulating that Moutan Cortex originates from the bark root of P. suffruticosa. Textual researches on germplasm of ornamental and medicinal Moutan provided that, Xi'an, Luoyang, Pengcheng, Bozhou, Heze and some other famous cultivation centers had been formed throughout the history. In addition, medicinal practitioners in Song Dynasty had been fully aware of the medicinal differences between ornamental and wild Moutan, and preferred wild single flowers as medicinal Moutan. Moreover, none of cultivation centers of ornamental Moutan were recorded in producing areas of medicinal Moutan. So far, Fengdan and Dianjiang Moutan in Chongqing are single flowers, which is consistent with the ancient herbal books. Therefore, this paper believes that the medicinal and ornamental Moutan are two different germplasm since ancient times. And we proposethat Chinese pharmacopoeia should record P. ostii and the single-flower varieties of P. suffruticosa as the original plants of Moutan Cortex. Copyright© by the Chinese Pharmaceutical Association.

Modern industrial and pharmacological applications of indigo dye and its derivatives--a review.

PubMed

Stasiak, Natalia; Kukuła-Koch, Wirginia; Głowniak, Kazimierz

2014-01-01

Plant sources, chemical properties, bioactivities, as well as the synthesis of indigo dye and its derivatives, are reviewed in this paper. These compounds were chosen because of their significant benefits and scope of application as both coloring agents in the textile industry and as pharmacologically active natural products. Their use in traditional chinese medicine (TCM) has directed the attention of European researchers and medical doctors alike. The preparation of indigoferous plants--Indigo naturalis is currently about to be introduced into the European Pharmacopoeia.

From Materia Medica to the Pharmacopoeia: Challenges of Writing the History of Drugs in India

PubMed Central

2016-01-01

Abstract Historians of indigenous medicine in colonial India have looked more closely at the changes, reinventions and reformulations of institutions of Ayurveda and Unani than at the cognitive content of the drugs themselves. The few historians who have examined the changing content of indigenous medicines have conceptualised the creation of materia medica of Indian drugs through two tropes: one of circulation (of specific drugs) through epistemological and geographic boundaries and the second, of marginalisation of certain other drugs either through a lack of textual legitimacy or the lack of the newly discovered ‘active principles’ within each drug. While these approaches have been useful, there is a case to be made for understanding the creation of formularies of Indian drugs in 19th and 20th centuries through the prism of medical praxis in India. PMID:27570491

[PROFESSOR VLADIMIR V. NIKOLAEV AND RUSSIAN PHARMACOLOGY.

PubMed

Bondarchuk, N G; Fisenko, V P

2016-01-01

Various stages of scientific research activity of Prof. Vladimir V. Nikolaev are analyzed. The importance of Prof. Nikolaev's discovery of the two-neuron parasympathetic nervous system and some new methods of pharmacological substances evaluation is shown. Prof. Nikolaev is known as the editor of the first USSR Pharmacopoeia. Peculiarities of pharmacology teaching at the First Moscow Medical institute under conditions of changing social demands are described. Successful research of Prof. Nikolaev with colleagues in studying new mechanisms of drug action and developing original pharmacological substances is summarized.

Senna alata.

PubMed

Hennebelle, Thierry; Weniger, Bernard; Joseph, Henry; Sahpaz, Sevser; Bailleul, François

2009-10-01

A review is made of chemical, ethnopharmacological and pharmacological papers dealing with Senna alata (L.) Roxb., a plant that belongs to the Creole traditional system of medicine and that has recently been introduced in the French Pharmacopoeia. The proofs existing for its various usages are presented. The species is mainly used against constipation and skin diseases. The laxative activity is supported by scientific findings. In contrast the dermatologic use requires further investigation. The species can be considered as safe for short-term or topical use.

Pastes: what do they contain? How do they work?

PubMed

Juch, R D; Rufli, T; Surber, C

1994-01-01

Pastes are semisolid stiff preparations containing a high proportion of finely powdered material. Powders such as zinc oxide, titanium dioxide, starch, kaolin or talc are incorporated in high concentrations into a preferably lipophilic, greasy vehicle. A clinically distinctive feature which is generally attributed to pastes is the quality to absorb exudates by nature of the powder or other absorptive components. Reviewing the various pharmacopoeias serious doubts arise from the various formulas of pastes and their absorptive features. The zinc oxide pastes of the USP XXII, the DAB 10 and BP 88 (US, German and British pharmacopoeias). are composed of petrolatum, zinc oxide and starch. Petrolatum, a highly lipophilic, water-immiscible vehicle surrounds the powder particles preventing any absorption of water or exudates. The goal of our investigation was to test a simple experimental setting to characterize the clinically important absorptive feature of powders and pastes. The absorptive features of the powders were determined by the method of Enslin. The absorptive features of the paste preparations were calculated from the weight difference between the paste preparation before and after incubation with water using a simple standardized procedure. The absorptive features of titanium dioxide, zinc oxide, kaolin, corn starch and methylcellulose powder in pharmacopoeia quality were determined. Zinc oxide and kaolin powder showed the highest absorption of 1,000 mg water/g powder (100%). The water absorption of corn starch and titanium dioxide was 700 and 450 mg/g powder, respectively. The absorptive features of a series of paste preparations were studied in a simple experimental setting. The data show that two-phase pastes consisting of two immiscible components, one (the dispersed or inner phase; powder) being suspended in the other (the continuous or outer phase; lipophilic vehicle), have no absorptive features. In contrast, three-phase pastes consisting of a

Spectrum-Effect Relationships Between Chemical Fingerprints and Antibacterial Effects of Lonicerae Japonicae Flos and Lonicerae Flos Base on UPLC and Microcalorimetry

PubMed Central

Shi, Zhilong; Liu, Zhenjie; Liu, Chunsheng; Wu, Mingquan; Su, Haibin; Ma, Xiao; Zang, Yimei; Wang, Jiabo; Zhao, Yanling; Xiao, Xiaohe

2016-01-01

The traditional Chinese medicines Lonicerae Japonicae Flos (LJF, Jinyinhua in Chinese) and Lonicerae Flos (LF, Shanyinhua in Chinese) refer to the flower buds of five plants belonging to the Caprifoliaceae family. Until 2000, all of these were officially listed as a single item, LJF (Jinyinhua), in the Chinese Pharmacopoeia. However, there have recently been many academic controversies concerning the separation and combination of LJF and LF in administrative regulation. Till now there has been little work completed evaluating the relationships between biological activity and chemical properties among these drugs. Microcalorimetry and UPLC were used along with principal component analysis (PCA), hierarchical cluster analysis (HCA), and canonical correlation analysis (CCA) to investigate the relationships between the chemical ingredients and the antibacterial effects of LJF and LF. Using multivariate statistical analysis, LJF and LF could be initially separated according to their chemical fingerprints, and the antibacterial effects of the two herbal drugs were divided into two clusters. This result supports the disaggregation of LJF and LF by the Pharmacopoeia Committee. However, the sample of Lonicera fulvotomentosa Hsu et S. C. Cheng turned out to be an intermediate species, with similar antibacterial efficacy as LJF. The results of CCA indicated that chlorogenic acid and 3,4-Dicaffeoylquinic acid were the major components generating antibacterial effects. Furthermore, 3,4-Dicaffeoylquinic acid could be used as a new marker ingredient for quality control of LJF and LF. PMID:26869929

[Study on influence of different storage environments and packaging materials on quality of Citri Reticulatae Pericarpium].

PubMed

Luo, Jiao-Yang; Zhou, Wen-Ju; Li, Kun-Lun; Zhao, Ming; Yang, Mei-Hua

2018-03-01

Traditional Chinese herbs are readily contaminated by mold that produced mycotoxins which are closly related to the herbs' external factors and external environments during the storage process. In this study, Citri Reticulatae Pericarpium was used as example, and the characteristics of traits, water content, active components (naringin, hesperidin, sinensetin, naringin, tangeretin) and the accumulation of aflatoxins (AFs) were selected as the evaluation indexes. Citri Reticulatae Pericarpium was stored under different environments and packaging materials for 12 months, and then the quality changes and mildew of Citri Reticulatae Pericarpium were examined. The results showed that the color of Citri Reticulatae Pericarpium was deepened after storage, but without mildew phenomenon. Besides, the sample storage in kraft paper and woven bags had varying degrees of moth phenomenon after 12 months storage, and the water content exceeded the limit of Chinese Pharmacopoeia. In addition, the contents of the five active constituents obviously decreased, especially for hesperidin, which did not meet the pharmacopoeia standard after storage. AFs were not detected in any of the tested samples. According to the results, we conclude that low temperature and humidity environment is more suitable for the storage of Citri Reticulatae Pericarpium, and that packaging materials should be further investigated. This study is of great significance for preventing the mold to contaminate the traditional Chinese medicine and ensuring the quality, effectiveness and safety of TCMs. Copyright© by the Chinese Pharmaceutical Association.

Collaborative study for the calibration of replacement batches for the heparin low-molecular-mass for assay biological reference preparation.

PubMed

Terao, E; Daas, A

2016-01-01

The European Pharmacopoeia (Ph. Eur.) prescribes the control of the activity of low molecular mass heparins by assays for anti-Xa and anti-IIa activities (monograph 0828), using a reference standard calibrated in International Units (IU). An international collaborative study coded BSP133 was launched in the framework of the Biological Standardisation Programme (BSP) run under the aegis of the Council of Europe and the European Commission to calibrate replacement batches for the dwindling stocks of the Heparin low-molecular-mass for assay Biological Reference Preparation (BRP) batch 8. Thirteen official medicines control and manufacturers laboratories from European and non-European countries took part in this study to calibrate two freeze-dried candidate batches against the 3rd International Standard (IS) for heparin, low molecular weight (11/176; 3rd IS). The Heparin low-molecular-mass for assay BRP (batch 8) was also included in the test panel to check the continuity between subsequent BRP batches. Taking into account the stability data, the results of this collaborative study and on the basis of the central statistical analysis performed at the European Directorate for the Quality of Medicines & HealthCare (EDQM), the 2 candidate batches were officially adopted by the Commission of the European Pharmacopoeia as Heparin low-molecular-mass for assay BRP batches 9 and 10 with assigned anti-Xa activities of 102 and 100 IU/vial and anti-IIa activities of 34 and 33 IU/vial respectively.

[Penicher: an manuscript addendum to his pharmacopoeia of 1695 on the copy of Pharmacy College Library].

PubMed

Bonnemain, Bruno

2016-03-01

Penicher's pharmacopeia (1695) was part of the Library of the "College de Pharmacie". The inventory of this Library was done in 1780 and is kept by the Library of the BIU Santé, Paris-Descartes University in Paris that digitized it recently. This copy contains handwritten texts that complete the original edition. The first main addition, at the beginning of the document, is three recipes of drugs, in Latin, one of them being well known at the early 18th century, the vulnerary balm of Leonardo Fioraventi (1517-1588), that is also known as Fioraventi's alcoholate. This product will still be present in the French Codex until 1949. The Penicher' book also includes, at the end, three handwritten pages in French which represent the equipment of apothecaries. These drawings are very close to the ones of Charas' Pharmacopeia. One can think that these additions are from the second part of the 18th century, but before the gift of the pharmacopeia to the College de Pharmacie by Fourcy en 1765. The author is unknown but he is probably one of the predecessor of Fourcy in Pharmacie de l'Ours (Bear's pharmacy). This gift done by Fourcy when joining the Community of Parisians pharmacists did not prevent the fact that Fourcy was sentenced by his colleagues pharmacists, a few years later, for the sales of "Chinese specialties" that someone called Jean-Daniel Smith, a physician installed in Paris, asked him to prepare.

Traditional medicines and globalization: current and future perspectives in ethnopharmacology.

PubMed

Leonti, Marco; Casu, Laura

2013-01-01

The ethnopharmacological approach toward the understanding and appraisal of traditional and herbal medicines is characterized by the inclusions of the social as well as the natural sciences. Anthropological field-observations describing the local use of nature-derived medicines are the basis for ethnopharmacological enquiries. The multidisciplinary scientific validation of indigenous drugs is of relevance to modern societies at large and helps to sustain local health care practices. Especially with respect to therapies related to aging related, chronic and infectious diseases traditional medicines offer promising alternatives to biomedicine. Bioassays applied in ethnopharmacology represent the molecular characteristics and complexities of the disease or symptoms for which an indigenous drug is used in "traditional" medicine to variable depth and extent. One-dimensional in vitro approaches rarely cope with the complexity of human diseases and ignore the concept of polypharmacological synergies. The recent focus on holistic approaches and systems biology in medicinal plant research represents the trend toward the description and the understanding of complex multi-parameter systems. Ethnopharmacopoeias are non-static cultural constructs shaped by belief and knowledge systems. Intensified globalization and economic liberalism currently accelerates the interchange between local and global pharmacopoeias via international trade, television, the World Wide Web and print media. The increased infiltration of newly generated biomedical knowledge and introduction of "foreign" medicines into local pharmacopoeias leads to syncretic developments and generates a feedback loop. While modern and post-modern cultures and knowledge systems adapt and transform the global impact, they become more relevant for ethnopharmacology. Moreover, what is traditional, alternative or complementary medicine depends on the adopted historic-cultural perspective.

Modernization of Physical Appearance and Solution Color Tests Using Quantitative Tristimulus Colorimetry: Advantages, Harmonization, and Validation Strategies.

PubMed

Pack, Brian W; Montgomery, Laura L; Hetrick, Evan M

2015-10-01

Color measurements, including physical appearance, are important yet often misunderstood and underappreciated aspects of a control strategy for drug substances and drug products. From a patient safety perspective, color can be an important control point for detecting contamination, impurities, and degradation products, with human visual acuity often more sensitive for colored impurities than instrumental techniques such as HPLC. Physical appearance tests and solution color tests can also serve an important role in ensuring that appropriate steps are taken such that clinical trials do not become unblinded when the active material is compared with another product or a placebo. Despite the importance of color tests, compendial visual tests are not harmonized across the major pharmacopoeias, which results in ambiguous specifications of little value, difficult communication of true sample color, and significant extra work required for global registration. Some pharmacopoeias have not yet recognized or adopted technical advances in the instrumental measurement of color and appearance, whereas others begin to acknowledge the advantage of instrumental colorimetry, yet leave implementation of the technology ambiguous. This commentary will highlight the above-mentioned inconsistencies, provide an avenue toward harmonization and modernization, and outline a scientifically sound approach for implementing quantitative technologies for improved measurement, communication, and control of color and appearance for both solutions and solids. Importantly, this manuscript, for the first time, outlines a color method validation approach that is consistent with the International Conference on Harmonization's guidance on the topic of method validation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Vapours, gargles, darts and bougies: Victorian ENT treatments.

PubMed

Montgomery, J; Robertson, A

2012-11-01

Sir Morell Mackenzie (1837-1892), the pre-eminent early laryngologist in the UK, is nowadays perhaps better remembered for his role in the management of the Crown Prince of Germany in 1887, than for his major contribution to the development of laryngology as a specialty. In this article we focus upon his text The Pharmacopoeia of the Hospital for Diseases of the Throat (fourth edition), and attempt a comparison of Victorian ENT treatments with today's management of ENT diseases. Some of these Victorian treatments bear a resemblance to modern day practices. Others have not withstood the test of time, in particular: silver nitrate sticks for syphilitic ulcers of the larynx (not epistaxis); nebulised sulphuric acid, which was used as a stimulant; nasal bougies, including scotch pine and lead acetate; chloroform vapour for the treatment of hay fever; 'London paste', a non-surgical treatment for the reduction of the tonsils, (which was perhaps the Victorian equivalent of coblation); and zinc chloride darts, which were plunged into intractable goitres. Some of these remedies bear no resemblance to today's evidence-based practices, while other treatments (such as silver nitrate) are still in common use. In Victorian times, however, Mackenzie's books were widely read throughout Europe and were the standard references for a specialty in its infancy. The Pharmacopoeia was published in 1872, and major advances in medicine have been made since then. We have no way of knowing which treatments in today's British National Formulary will still be in use in 140 years.

Collaborative study for the establishment of replacement batches of heparin low- molecular-mass for assay biological reference preparations.

PubMed

Terao, E; Daas, A; Rautmann, G; Buchheit, K-H

2010-10-01

A collaborative study was run by the European Directorate for the Quality of Medicines & HealthCare (EDQM) in the context of the Biological Standardisation Programme (BSP), under the aegis of the Council of Europe and the European Commission, to establish replacement batches for the dwindling stocks of the Heparin low-molecular-mass for assay European Pharmacopoeia Biological Reference Preparation (BRP). The replacement batches of BRP are intended to be used in the assays for anti-Xa and anti-IIa activities, as described in the European Pharmacopoeia (Ph. Eur.) monograph Heparins, low-molecular-mass (0828). Three freeze-dried candidate batches were calibrated against the current International Standard (IS) for Heparin, lowmolecular- weight (2nd IS, 01/608). For the purpose of the continuity check between subsequent BRP batches, the current Heparin low-molecular-mass for assay BRP (batch 5) was also included in the test panel. Thirteen official medicines control and manufacturers laboratories from European and non-European countries contributed data. A central statistical analysis of the datasets was performed at the EDQM. On the basis of the results, the 3 candidate materials were assigned a potency of 104 IU/vial for the anti-Xa activity and 31 IU/vial for the anti-IIa activity. Taken into account the preliminary stability data and the results of this collaborative study, the 3 batches of candidate BRP were adopted in June 2010 by the Commission of the Ph. Eur. as Heparin low-molecular-mass for assay BRP batches 6, 7 and 8.

[Standardization of the sour orange flower and leaf].

PubMed

Carnat, A; Carnat, A P; Fraisse, D; Lamaison, J L

1999-09-01

Dried flowers (1 batch) and leaves (6 batches) of sour orange Citrus aurantium L. had a similar flavonoid pattern. But the flavonoid levels of flowers were higher than those of leaves. The mean levels of the principal flavonoid compounds were respectively: total flavonoids 12.35 and 1.06%, neohesperidin 5.44 and 0.08%, naringin 1.93 and 0.06%, eriocitrin 0.38 and 0.25%. 18 batches of commercial origine were also examined for a comparative study. Specifications were proposed for a revision of the monographs "Sour orange flower" and "Sour orange leaf" of the French Pharmacopoeia.

[Study on quality standards of decoction pieces of salt Alpinia].

PubMed

Li, Wenbing; Hu, Changjiang; Long, Lanyan; Huang, Qinwan; Xie, Xiuqiong

2010-12-01

To establish the quality criteria for decoction pieces of salt Alpinia. Decoction pieces of salt Alpinia were measured with moisture, total ash, acid-insoluble ash, water-extract and volatile oils according to the procedures recorded in the Chinese Pharmacopoeia 2010. The content of Nootkatone was determined by HPLC, and NaCl, by chloridion electrode method. We obtained results of total ash, acid-insoluble ash, water-extract and volatile oils of 10 batches of decoction pieces of salt Alpinia moisture; Meanwhile we set the HPLC and chloridion electrode method. This research established a fine quality standard for decoction pieces of salt Alpinia.

Antimicrobial properties of Honduran medicinal plants.

PubMed

Lentz, D L; Clark, A M; Hufford, C D; Meurer-Grimes, B; Passreiter, C M; Cordero, J; Ibrahimi, O; Okunade, A L

1998-12-01

Ninety-two plants used in the traditional pharmacopoeia of the Pech and neighboring Mestizo peoples of central Honduras are reported. The results of in vitro antimicrobial screens showed that 19 of the extracts from medicinal plants revealed signs of antifungal activity while 22 demonstrated a measurable inhibitory effect on one or more bacterial cultures. Bioassay-guided fractionation of extracts from Mikania micrantha, Neurolaena lobata and Piper aduncum produced weak to moderately active isolates. The broad spectrum of activity of the extracts helps to explain the widespread use of these plants for wound healing and other applications.

[Regulatory aspects and medicolegal considerations regarding clinical drug trials].

PubMed

Cammarano, Andrea; De Dominicis, Enrico; Marella, Gian Luca; Maurici, Massimo; Arcudi, Giovanni

2016-01-01

This article aims to explore the regulatory and medicolegal aspects of experimental drug trials. Firstly, the authors provide definitions of drug according to WHO, the European Community and our official Pharmacopoeia, and that of experimental studies. They then explain the distinction between pure or basic research and drug trials and explain the various phases of the latter. Besides providing definitions, and exploring doctrinal, theoretical but also practical aspects of drug trials, the authors also discuss and analyze legislative aspects, with particular reference to the Italian legislative framework, and medicolegal issues, including informed consent, effects on humans, and professional responsibility.

The treatment of scrofula in Ferrara (Italy) in the 19th century.

PubMed

Vicentini, Chiara Beatrice; Altieri, Lorenzo; Guidi, Enrica; Contini, Carlo; Manfredini, Stefano

2012-06-01

The therapeutic approaches used against scrofula in the 19th Century in Ferrara are discussed. In the manuscripts and treatises of the time treasured in the town's libraries, hygienic and dietetic rules and treatment of this illness were described. In particular, baths and mineral water spas (sulphurous, ferruginous and other mineral waters, such as a bromo-iodine-salt water) and the sea-bathing establishment were recommended. The remedies reported in Campana's Pharmacopoeia ferrarese and the efficacious treatments employed in St Anna Hospital are discussed. The Committee and its President, Marquis Giovanni Manfredini, decided to cure the scrofulous in bathing establishments.

Evaluation of the preservative properties of Thymus vulgaris essential oil in topically applied formulations under a challenge test.

PubMed

Manou, I; Bouillard, L; Devleeschouwer, M J; Barel, A O

1998-03-01

The preservative properties of thyme essential oil (3%) with a known composition were evaluated in two types of final formulations, suitable for use as pharmaceutical or cosmetic vehicles, by means of a standard challenge test proposed by the latest European Pharmacopoeia. The required preservation efficacy criteria were satisfied against the bacterial strains, against the yeast in one of the formulations, but not against the mould strain involved in this study. Interactions between the essential oil compounds and other factors present in the final formulation might have influenced the activity of this essential oil, leading to an incomplete satisfaction of the criteria.

The challenges of 'medical cannabis' and mental health: a clinical perspective.

PubMed

Newton-Howes, Giles

2018-06-20

The use of cannabis as a medicine has a long tradition in western medicine. It has been seen as a viable option for the treatment of various neurological and psychiatric conditions, and recently there is again interest in the place of cannabinoids in the pharmacopoeia. What has become increasingly clear, however, is these benefits need to be weighed carefully against the potential difficulty associated with herbal cannabis and cannabinoid compounds for an individual's mental health. This challenges the use of cannabis as a medication and the regulation of its prescription. This article is protected by copyright. All rights reserved.

The Quality of Medicines Used in Children and Supplied by Private Pharmaceutical Wholesalers in Kinshasa, Democratic Republic of Congo: A Prospective Survey.

PubMed

Schiavetti, Benedetta; Wynendaele, Evelien; De Spiegeleer, Bart; Mbinze, Geremie J; Kalenda, Nicodème; Marini, Roland; Melotte, Vera; Hasker, Epco; Meessen, Bruno; Ravinetto, Raffaella; Van der Elst, Josiane; Mutolo Ngeleka, Daniel

2018-03-01

Poor-quality medicines are a threat to public health in many low- and middle-income countries, and prospective surveys are needed to inform corrective actions. Therefore, we conducted a cross-sectional survey on a sample of products used for children and available in the private market in Kinshasa, Democratic Republic Congo: amoxicillin (AX) and artemether/lumefantrine (AL), powders for suspension, and paracetamol (PC) tablets 500 mg. Overall, 417 products were covertly purchased from 61 wholesalers. To obtain a representative sample, the products were weighted on their market shares and a subset of 239 samples was randomly extracted to undergo in-depth visual inspection locally, and they were chemically assessed at two accredited laboratories in Belgium. Samples were defined of "poor-quality" if they failed to comply with at least one specification of the International Pharmacopoeia (for AL) or United States Pharmacopoeia 37 (for AX and PC). Results are reported according to the Medicine Quality Assessment Reporting Guideline. The visual inspection detected nonconformities in the aspects of antimalarial powders for suspension, and poor-quality labels across all medicine types. According to chemical analysis, 27.2% samples were of poor quality and 59.5% of AL samples were underdosed in artemether. Poor quality was more frequent for locally manufactured antimalarials (83.3%, P = 0.021; 86.4%, P = 0.022) and PC (4.8%, P = 0.000). The poor quality of the surveyed products may decrease the treatment's efficacy and favor the development of resistances to antimalarials. It is hoped that these findings may guide the corrective actions of the Democratic Republic of Congo Regulatory Authority, which was the main partner in the research.

The Quality of Medicines Used in Children and Supplied by Private Pharmaceutical Wholesalers in Kinshasa, Democratic Republic of Congo: A Prospective Survey

PubMed Central

Schiavetti, Benedetta; Wynendaele, Evelien; De Spiegeleer, Bart; Mbinze, Geremie J.; Kalenda, Nicodème; Marini, Roland; Melotte, Vera; Hasker, Epco; Meessen, Bruno; Ravinetto, Raffaella; Van der Elst, Josiane; Mutolo Ngeleka, Daniel

2018-01-01

Abstract. Poor-quality medicines are a threat to public health in many low- and middle-income countries, and prospective surveys are needed to inform corrective actions. Therefore, we conducted a cross-sectional survey on a sample of products used for children and available in the private market in Kinshasa, Democratic Republic Congo: amoxicillin (AX) and artemether/lumefantrine (AL), powders for suspension, and paracetamol (PC) tablets 500 mg. Overall, 417 products were covertly purchased from 61 wholesalers. To obtain a representative sample, the products were weighted on their market shares and a subset of 239 samples was randomly extracted to undergo in-depth visual inspection locally, and they were chemically assessed at two accredited laboratories in Belgium. Samples were defined of “poor-quality” if they failed to comply with at least one specification of the International Pharmacopoeia (for AL) or United States Pharmacopoeia 37 (for AX and PC). Results are reported according to the Medicine Quality Assessment Reporting Guideline. The visual inspection detected nonconformities in the aspects of antimalarial powders for suspension, and poor-quality labels across all medicine types. According to chemical analysis, 27.2% samples were of poor quality and 59.5% of AL samples were underdosed in artemether. Poor quality was more frequent for locally manufactured antimalarials (83.3%, P = 0.021; 86.4%, P = 0.022) and PC (4.8%, P = 0.000). The poor quality of the surveyed products may decrease the treatment’s efficacy and favor the development of resistances to antimalarials. It is hoped that these findings may guide the corrective actions of the Democratic Republic of Congo Regulatory Authority, which was the main partner in the research. PMID:29313479

Traditional medicines and globalization: current and future perspectives in ethnopharmacology

PubMed Central

Leonti, Marco; Casu, Laura

2013-01-01

The ethnopharmacological approach toward the understanding and appraisal of traditional and herbal medicines is characterized by the inclusions of the social as well as the natural sciences. Anthropological field-observations describing the local use of nature-derived medicines are the basis for ethnopharmacological enquiries. The multidisciplinary scientific validation of indigenous drugs is of relevance to modern societies at large and helps to sustain local health care practices. Especially with respect to therapies related to aging related, chronic and infectious diseases traditional medicines offer promising alternatives to biomedicine. Bioassays applied in ethnopharmacology represent the molecular characteristics and complexities of the disease or symptoms for which an indigenous drug is used in “traditional” medicine to variable depth and extent. One-dimensional in vitro approaches rarely cope with the complexity of human diseases and ignore the concept of polypharmacological synergies. The recent focus on holistic approaches and systems biology in medicinal plant research represents the trend toward the description and the understanding of complex multi-parameter systems. Ethnopharmacopoeias are non-static cultural constructs shaped by belief and knowledge systems. Intensified globalization and economic liberalism currently accelerates the interchange between local and global pharmacopoeias via international trade, television, the World Wide Web and print media. The increased infiltration of newly generated biomedical knowledge and introduction of “foreign” medicines into local pharmacopoeias leads to syncretic developments and generates a feedback loop. While modern and post-modern cultures and knowledge systems adapt and transform the global impact, they become more relevant for ethnopharmacology. Moreover, what is traditional, alternative or complementary medicine depends on the adopted historic-cultural perspective. PMID:23898296

[Medicinal plants in France, between pharmacy and herb trade: historical and legislative aspects].

PubMed

Lehmann, H

2015-09-01

Medicinal plants are registered on the French Pharmacopoeia in its successive editions, the first dated 1818. The edition which is currently in force, the XIth (2012), comprises two plant lists drawn up by a working group of experts belonging to the ANSM: List A (medicinal plants traditionally used [365 plants]) and list B (medicinal plants with the ratio benefit/risk's evaluation negative [123 plants]). Moreover, a list of medicinal plants with non exclusive therapeutic use has been established. This last list is composed of 147 plants which are thus liberated from the pharmaceutical monopoly, in application of decrees n(o) 2008-839 and 2008-841 dated August 22nd 2008. Medicinal plants are a matter, in France, from pharmaceutical monopoly, which means that they can only be dispensed to public in pharmacy, according to article L. 4211-1/5° of the Public Health Code, except however for a certain number of plants "liberated" from this monopoly. Nevertheless, besides officinal pharmacists, herbalists who obtained their diploma as far as 1941, were habilitated to deliver medicinal plants, even non "liberated", on condition that they are not registered on a list of venomous substances nor classified among the stupefacients, according to the article L. 4211-7 of Public Health Code. Concerning plants for herbal teas, which should be differentiated from herbal teas classified among the herbal medicines, they can be delivered in mixtures form, which are considered as officinal preparations, according to the new French Pharmacopoeia monography of August 1st 2013. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Arbutin production via biotransformation of hydroquinone in in vitro cultures of Aronia melanocarpa (Michx.) Elliott.

PubMed

Kwiecień, Inga; Szopa, Agnieszka; Madej, Kornelia; Ekiert, Halina

2013-01-01

Arbutin (hydroquinone β-D-glucoside) is a compound of plant origin possessing valuable therapeutic (urinary tract disinfection) and cosmetic (skin whitening) properties, which can be obtained from in vitro cultures of plants belonging to different taxa via biotransformation of exogenously supplemented hydroquinone. Agitating cultures of Aronia melanocarpa were maintained on the Murashige and Skoog medium containing growth regulators: the cytokinin - BAP (6-benzylaminopurine), 2 mg/l and the auxin NAA (α-naphthaleneacetic acid), 2 mg/l. The biomass was cultured for 2 weeks and then hydroquinone was supplemented at the following doses: 96, 144, 192, 288 and 384 mg/l either undivided or divided into two or three portions added at 24-hour intervals. The content of the reaction product - arbutin, was determined using an HPLC method in methanolic extracts from biomass and lyophilized medium samples collected 24 hours after the addition of the last precursor dose. The total amounts of arbutin were very diverse, from 2.71 to 8.27 g/100g d.w. The production of arbutin rose with increasing hydroquinone concentration. The maximum content of the product was observed after hydroquinone addition at 384 mg/l divided into two portions. Biotransformation efficiency also varied widely, ranging from 37.04% do 73.80%. The identity of the product - arbutin, after its isolation and purification was confirmed by spectral analysis ((1)H-NMR spectrum). The maximum amount of arbutin obtained was higher than that required by the latest 9(th) Edition of the Polish Pharmacopoeia and by the newest 8th Edithion of European Pharmacopoeia for Uvae ursi folium (7.0 g/100g d.w.), and is interesting from practical point of view.

Indirect potentiometric titration of ascorbic acid in pharmaceutical preparations using copper based mercury film electrode.

PubMed

Abdul Kamal Nazer, Meeran Mohideen; Hameed, Abdul Rahman Shahul; Riyazuddin, Patel

2004-01-01

A simple and rapid potentiometric method for the estimation of ascorbic acid in pharmaceutical dosage forms has been developed. The method is based on treating ascorbic acid with iodine and titration of the iodide produced equivalent to ascorbic acid with silver nitrate using Copper Based Mercury Film Electrode (CBMFE) as an indicator electrode. Interference study was carried to check possible interference of usual excipients and other vitamins. The precision and accuracy of the method was assessed by the application of lack-of-fit test and other statistical methods. The results of the proposed method and British Pharmacopoeia method were compared using F and t-statistical tests of significance.

[Egyptian medicine at the time of Bonaparte's expeditionary force].

PubMed

Hutin, Jean-François

2014-01-01

When the civils of the Commission for Sciences and Arts and the doctors from Bonaparte's expeditionary forces under Desgenettes and Larrey's orders arrived in Egypt, they described richly the state of medecine and surgery, the therapeutical knowledges and the medical organisation of the conquered land. They were surprised at first and desappointed to see how poorly Herophile and Ibn-An-Nafis' "Art of Healing" was considered. However they quickly managed to extract its most original qualities - in particular in the pharmacopoeia--all the more because the loss of the hospital-ships and Aboukir's defeat forced them to stay in Egypt and to find there the remedies they were lacking of.

Properties of colour reference solutions of the European Pharmacopoea in CIE L*a*b* colour space.

PubMed

Subert, J; Farsa, O; Gajdosová, Z

2006-12-01

The coordinates of CIE L*a*b* uniform colour space have been acquired from the transmitance spectra of colour reference solutions of European Pharmacopoeia (Ph.Eur.). Calculation of colour differences of these solutions from purified water deltaE* gave their values in the range between 0.7 (B9 solution) to 36 (Y1 solution) CIE units. Excluding red colour reference soulutions, deltaE* values did not depend on concentrations of colour compounds linearly. Small deltaE* values founded by the brown and brownish-yellow colour reference solutions of the lowest concentrations can possibly cause some problems of visual examination of the degree of coloration of liquids according to Ph.Eur.

[Formulation and special investigations of innovative intraoral solid dosage forms.

PubMed

Kristo, K; kATONA, B; Piukovics, P; Olah, I; Sipos, B; Sipos, S E; Sovany, T; Hodi, K; Ifi Regdon, G

During our work, we summarized the types of solid dosage forms which were in the focus of attention in the last years because of their innovative pharmaceutical technology solution and simple use. The biopharmaceutics of solid dosage forms for intraoral use and the advantages of the use of these dosages forms were presented in general. However, these dosage forms cannot always be prepared with conventional pharmaceutical processes, therefore the special pharmaceutical solutions which can be applied for their preparation were presented. In addition to testing the European Pharmacopoeia dosage forms, the special tests which can be applied for the characterization of innovative solid dosage forms were highlighted.

[Extemporaneous magistral formulas for the topical treatment of pruritus : Proven and new options].

PubMed

Staubach, P; Weisshaar, E

2016-08-01

The treatment of pruritus, primarily chronic pruritus, is often difficult and must be treated simultaneously with the cause of pruritus and the individual demands of the skin. Due to the chronicity, a combination of systemic therapies, different active ingredients and basic formulas must be used in local therapies and adjusted during the course of the treatment. There are still therapeutic gaps, which can be closed by the use of extemporaneous preparations. Magistral formulas, which are already checked for plausibility, should be preferred over individual prescriptions. In the following, different therapeutic options in daily practice by using extemporaneous formulas from the NRF (New German Pharmacopoeia for compounded medications) are presented.

Availability, diversification and versatility explain human selection of introduced plants in Ecuadorian traditional medicine

PubMed Central

Gaoue, Orou G.; de la Torre, Lucía; Navarrete, Hugo; Muriel, Priscilla; Macía, Manuel J.; Balslev, Henrik; León-Yánez, Susana; Jørgensen, Peter; Duffy, David Cameron

2017-01-01

Globally, a majority of people use plants as a primary source of healthcare and introduced plants are increasingly discussed as medicine. Protecting this resource for human health depends upon understanding which plants are used and how use patterns will change over time. The increasing use of introduced plants in local pharmacopoeia has been explained by their greater abundance or accessibility (availability hypothesis), their ability to cure medical conditions that are not treated by native plants (diversification hypothesis), or as a result of the introduced plants’ having many different simultaneous roles (versatility hypothesis). In order to describe the role of introduced plants in Ecuador, and to test these three hypotheses, we asked if introduced plants are over-represented in the Ecuadorian pharmacopoeia, and if their use as medicine is best explained by the introduced plants’ greater availability, different therapeutic applications, or greater number of use categories. Drawing on 44,585 plant-use entries, and the checklist of >17,000 species found in Ecuador, we used multi-model inference to test if more introduced plants are used as medicines in Ecuador than expected by chance, and examine the support for each of the three hypotheses above. We find nuanced support for all hypotheses. More introduced plants are utilized than would be expected by chance, which can be explained by geographic distribution, their strong association with cultivation, diversification (except with regard to introduced diseases), and therapeutic versatility, but not versatility of use categories. Introduced plants make a disproportionately high contribution to plant medicine in Ecuador. The strong association of cultivation with introduced medicinal plant use highlights the importance of the maintenance of human-mediated environments such as homegardens and agroforests for the provisioning of healthcare services. PMID:28886104

[New idea of traditional Chinese medicine quality control based on "composition structure" theory].

PubMed

Liu, Dan; Jia, Xiaobin; Yu, Danhong

2012-03-01

On the road of the modern Chinese medicine developing internationally, there is a key issues that setting up a reasonable, accurate and be quantified quality evaluation system which is comply with the basic theory of Chinese medicine. Based on the overall understanding of the role of traditional Chinese medicine components, author suggested that the idea of "structural components" theory should be embedded into the system and thought the Chinese medicine play a multi-target, multi-channel pharmacodynamic effects founded on the specific microcosmic structural relationship between the components and the components within the group. At present, the way of Chinese pharmacopoeia checking the quality of Chinese medicine is mainly depends on controlling the single or multiple targets of ingredients. In fact, this way is out of the overall effectiveness of the Chinese medicine, so we can not thoroughly controlling the quality of Chinese medicine from the essence of the Chinese medicine. Secondly, it's only macro-structural quantity that the Chinese pharmacopoeia just controlling the less effective ingredients, this is not enough to reflect the internal microstructure of the integrity and systematic. In other words, this cannot reflect the structural components of the Chinese medicine (the essence of traditional Chinese medicine). In view of above mentioned reasons, the author propose the new idea on the quality control in the medicine that quantify the ratio structural relationship in component and the ingredients of the components, set the optimal controlling proportion between the components and ingredients. At the same time, author thought we should conduct the depth study in the micro-quantified the multi-component and multi-ingredient, in the process of studying the material basis of Chinese medicine. Therefore, it could establish a more rational basis for the Chinese medicine quality controlling system.

Excipients and their role in approved injectable products: current usage and future directions.

PubMed

Nema, Sandeep; Brendel, Ronald J

2011-01-01

This review article is a current survey of excipients used in approved injectable products. Information provided includes concentration ranges, function, frequency of use, and role in dosage form. This article is an update of a paper published more than a decade ago (reference 11). Since then many new products have been approved. Safety concerning excipients has evolved as the scientific community continues to learn about their usage. New excipients are being used in early phases of clinical trials to support novel therapeutic entities like RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving specific needs that traditional excipients are unable to provide and for which safety studies are necessary to support a novel excipient for marketing applications. Excipients are added to parenteral dosage forms to serve a variety of functions including stabilization and as vehicles. This review article is a survey of excipients used in approved injectable products. Information provided includes excipient concentrations, functional roles, and frequency of use. This article is an update of an article originally published over a decade ago. Since then new products have been approved and safety concerns have evolved as the scientific community has learned about the usage of excipients. In addition, new excipients are being used in early phases of clinical trials to support novel therapeutic entities such as RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving

Why do people use exotic plants in their local medical systems? A systematic review based on Brazilian local communities

PubMed Central

Ferreira Júnior, Washington Soares; Ramos, Marcelo Alves; da Silva, Taline Cristina; Ladio, Ana Haydée; Albuquerque, Ulysses Paulino

2017-01-01

Efforts have been made to understand the processes that lead to the introduction of exotic species into local pharmacopoeias. Among those efforts, the diversification hypothesis predicts that exotic plants are introduced in local medical systems to amplify the repertoire of knowledge related to the treatment of diseases, filling blanks that were not occupied by native species. Based on such hypothesis, this study aimed to contribute to this discussion using the context of local Brazilian populations. We performed a systematic review of Brazilian studies up to 2011 involving medicinal plants, excluding those studies that presented a high risk of bias (because of sampling or plant identification problems). An analysis of similarities (ANOSIM) was conducted in different scales to test for differences in the repertoire of therapeutic indications treated using native and exotic species. We have found that although there is some overlap between native and exotic plants regarding their therapeutic indications and the body systems (BSs) that they treat, there are clear gaps present, that is, there are therapeutic indications and BSs treated that are exclusive to exotic species. This scenario enables the postulation of two alternative unfoldings of the diversification hypothesis, namely, (1) exotic species are initially introduced to fill gaps and undergo subsequent expansion of their use for medical purposes already addressed using native species and (2) exotic species are initially introduced to address problems already addressed using native species to diversify the repertoire of medicinal plants and to increase the resilience of medical systems. The reasons why exotic species may have a competitive advantage over the native ones, the implications of the introduction of exotic species for the resilience of medical systems, and the contexts in which autochthonous plants can gain strength to remain in pharmacopoeias are also discussed. PMID:28953960

Why do people use exotic plants in their local medical systems? A systematic review based on Brazilian local communities.

PubMed

Medeiros, Patrícia Muniz de; Ferreira Júnior, Washington Soares; Ramos, Marcelo Alves; Silva, Taline Cristina da; Ladio, Ana Haydée; Albuquerque, Ulysses Paulino

2017-01-01

Efforts have been made to understand the processes that lead to the introduction of exotic species into local pharmacopoeias. Among those efforts, the diversification hypothesis predicts that exotic plants are introduced in local medical systems to amplify the repertoire of knowledge related to the treatment of diseases, filling blanks that were not occupied by native species. Based on such hypothesis, this study aimed to contribute to this discussion using the context of local Brazilian populations. We performed a systematic review of Brazilian studies up to 2011 involving medicinal plants, excluding those studies that presented a high risk of bias (because of sampling or plant identification problems). An analysis of similarities (ANOSIM) was conducted in different scales to test for differences in the repertoire of therapeutic indications treated using native and exotic species. We have found that although there is some overlap between native and exotic plants regarding their therapeutic indications and the body systems (BSs) that they treat, there are clear gaps present, that is, there are therapeutic indications and BSs treated that are exclusive to exotic species. This scenario enables the postulation of two alternative unfoldings of the diversification hypothesis, namely, (1) exotic species are initially introduced to fill gaps and undergo subsequent expansion of their use for medical purposes already addressed using native species and (2) exotic species are initially introduced to address problems already addressed using native species to diversify the repertoire of medicinal plants and to increase the resilience of medical systems. The reasons why exotic species may have a competitive advantage over the native ones, the implications of the introduction of exotic species for the resilience of medical systems, and the contexts in which autochthonous plants can gain strength to remain in pharmacopoeias are also discussed.

Plants used as food and medicine by Polish migrants in Misiones, Argentina.

PubMed

Kujawska, Monika; Pieroni, Andrea

2015-01-01

In this article we discuss the importance of food plants, both introduced and native, in the pharmacopoeia of the Polish community in Misiones, Argentina. Food species constitute a relevant portion of all botanicals used by Polish settlers in home therapies (41%), while introduced food species prevail among the continued herbal remedies used by the study group. We explain this pattern of use by food plant availability, their versatility as reflected in the number of medicinal applications, and also their importance in cross-cultural relations. Finally, we conclude that several food plants used by Polish migrants (e.g., Allium sativum, Mentha xpiperita, and Camellia sinensis) may have served to "strengthen" migrants' identity within the host country.

Quality of 99mTcO4- from 99Mo Produced by 100Mo(n,2n)99Mo

NASA Astrophysics Data System (ADS)

Nagai, Yasuki; Nakahara, Yuto; Kawabata, Masako; Hatsukawa, Yuichi; Hashimoto, Kazuyuki; Saeki, Hideya; Motoishi, Shoji; Ohta, Akio; Shiina, Takayuki; Kawauchi, Yukimasa

2017-05-01

The pharmaceutical quality of 99mTc pertechnetate solution obtained from 99Mo, the 100Mo(n,2n) reaction product, was investigated for the first time with an emphasis on the nonradioactive Mo content and endotoxin concentration. They were less than the tolerance dose given in international guidelines and the established upper limit in an international pharmacopoeia, respectively. Four other quality control tests commonly used for a commercially available 99mTc pertechnetate solution also demonstrated to meet the United States Pharmacopeia requirements. The results strongly support that the thermochromatographic separation method used to separate 99mTc from 99Mo can be a promising substitute for the fission product 99Mo.

Pharmacotherapy of Insomnia

PubMed Central

Neubauer, David N; Pandi-Perumal, Seithikurippu R; Spence, David Warren; Buttoo, Kenneth; Monti, Jaime M

2018-01-01

Insomnia remains a common clinical concern that is associated with negative daytime consequences for patients and represents a significant public health problem for our society. Although a variety of therapies may be employed to treat insomnia, the use of medications has been a dominant approach. Regulatory agencies have now classified insomnia medications into 4 distinct pharmacodynamics classes. Medications with indications approved for insomnia treatment include benzodiazepine receptor agonists, a melatonin receptor agonist, a selective histamine receptor antagonist, and a dual orexin/hypocretin receptor antagonist. Both pharmacodynamic and pharmacokinetic advances with hypnotic medications in recent years have expanded the pharmacopoeia to allow personalized treatment approaches for different patient populations and individual sleep disturbance patterns.

[Application of rapid PCR to authenticate medicinal snakes].

PubMed

Chen, Kang; Jiang, Chao; Yuan, Yuan; Huang, Lu-Qi; Li, Man

2014-10-01

To obtained an accurate, rapid and efficient method for authenticate medicinal snakes listed in Chinese Pharmacopoeia (Zaocysd humnades, Bungarus multicinctus, Agkistrodon acutus), a rapid PCR method for authenticate snakes and its adulterants was established based on the classic molecular authentication methods. DNA was extracted by alkaline lysis and the specific primers were amplified by two-steps PCR amplification method. The denatured and annealing temperature and cycle numbers were optimized. When 100 x SYBR Green I was added in the PCR product, strong green fluorescence was visualized under 365 nm UV whereas adulterants without. The whole process can complete in 30-45 minutes. The established method provides the technical support for authentication of the snakes on field.

Comparison of Acid Titration, Conductivity, Flame Photometry, ICP-MS, and Accelerated Lamellae Formation Techniques in Determining Glass Vial Quality.

PubMed

Fujimori, Kiyoshi; Lee, Hans; Sloey, Christopher; Ricci, Margaret S; Wen, Zai-Qing; Phillips, Joseph; Nashed-Samuel, Yasser

2016-01-01

Certain types of glass vials used as primary containers for liquid formulations of biopharmaceutical drug products have been observed with delamination that produced small glass like flakes termed lamellae under certain conditions during storage. The cause of this delamination is in part related to the glass surface defects, which renders the vials susceptible to flaking, and lamellae are formed during the high-temperature melting and annealing used for vial fabrication and shaping. The current European Pharmacopoeia method to assess glass vial quality utilizes acid titration of vial extract pools to determine hydrolytic resistance or alkalinity. Four alternative techniques with improved throughput, convenience, and/or comprehension were examined by subjecting seven lots of vials to analysis by all techniques. The first three new techniques of conductivity, flame photometry, and inductively coupled plasma mass spectrometry measured the same sample pools as acid titration. All three showed good correlation with alkalinity: conductivity (R(2) = 0.9951), flame photometry sodium (R(2) = 0.9895), and several elements by inductively coupled plasma mass spectrometry [(sodium (R(2) = 0.9869), boron (R(2) = 0.9796), silicon (R(2) = 0.9426), total (R(2) = 0.9639)]. The fourth technique processed the vials under conditions that promote delamination, termed accelerated lamellae formation, and then inspected those vials visually for lamellae. The visual inspection results without the lot with different processing condition correlated well with alkalinity (R(2) = 0.9474). Due to vial processing differences affecting alkalinity measurements and delamination propensity differently, the ratio of silicon and sodium measurements from inductively coupled plasma mass spectrometry was the most informative technique to assess overall vial quality and vial propensity for lamellae formation. The other techniques of conductivity, flame photometry, and accelerated lamellae formation

Potential protective immunogenicity of tetanus toxoid, diphtheria toxoid and Cross Reacting Material 197 (CRM197) when used as carrier proteins in glycoconjugates.

PubMed

Bröker, Michael

2016-03-03

When tetanus toxoid (TT), diphtheria toxoid (DT) or Cross Reacting Material 197 (CRM197), a non-toxic diphtheria toxin mutant protein, are used as carrier proteins in glycoconjugate vaccines, these carriers induce a protein specific antibody response as measured by in vitro assays. Here, it was evaluated whether or not glycoconjugates based on TT, DT or CRM197 can induce a protective immune response as measured by potency tests according to the European Pharmacopoeia. It could be shown, that the conjugate carriers TT and DT can induce a protective immune response against a lethal challenge by toxins in animals, while glycoconjugates based on CRM197 failed to induce a protective immune response. Opportunities for new applications of glycoconjugates are discussed.

Potential protective immunogenicity of tetanus toxoid, diphtheria toxoid and Cross Reacting Material 197 (CRM197) when used as carrier proteins in glycoconjugates

PubMed Central

Bröker, Michael

2016-01-01

abstract When tetanus toxoid (TT), diphtheria toxoid (DT) or Cross Reacting Material 197 (CRM197), a non-toxic diphtheria toxin mutant protein, are used as carrier proteins in glycoconjugate vaccines, these carriers induce a protein specific antibody response as measured by in vitro assays. Here, it was evaluated whether or not glycoconjugates based on TT, DT or CRM197 can induce a protective immune response as measured by potency tests according to the European Pharmacopoeia. It could be shown, that the conjugate carriers TT and DT can induce a protective immune response against a lethal challenge by toxins in animals, while glycoconjugates based on CRM197 failed to induce a protective immune response. Opportunities for new applications of glycoconjugates are discussed. PMID:26327602

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2012-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products--points to consider; Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients.

In vitro immunomodulatory activity of plants used by the Tacana ethnic group in Bolivia.

PubMed

Deharo, E; Baelmans, R; Gimenez, A; Quenevo, C; Bourdy, G

2004-09-01

One hundred and seventy-eight ethanolic plant extracts from the pharmacopoeia of the Tacana, an ethnic group from Bolivia, were screened for immunomodulatory activity using complement cascade inhibition and ADP-induced platelet aggregation inhibition assays. Six impaired both complement pathways (classical and alternative): stem bark from Astronium urundeuvea (Anacardiaceae), Cochlospermum vitifolium (Cochlospermaceae), Terminalia amazonica (Combretaceae), Triplaris americana (Polygonaceae), Uncaria tomentosa (Rubiaceae) and Euterpe precatoria (Arecaceae) roots. Inhibition of complement cascade was independent of essential ion complexation, and was not due to direct hemolytic activity on target red blood cells. For A. urundeuvea, C. vitifolium, and T. amazonica, anti-inflammatory activity relied on cyclo-oxygenase inhibition. Four of these species (A. urundeuva, T. americana, U. tomentosa and E. precatoria) are used traditionally to treat inflammatory processes.

Do Aloe vera and Ageratum conyzoides enhance the anti-microbial activity of traditional medicinal soft soaps (Osedudu)?

PubMed

Moody, J O; Adebiyi, O A; Adeniyi, B A

2004-05-01

The Nigerian traditional soft soaps prepared using varied locally sourced raw materials such as cocoa pod ash (Theobroma cacao) palm kernel shaft ash (Elaies guineensis) have been evaluated for their physico-chemical properties and anti-microbial activities using standard pharmacopoeia protocols and an in-vitro agar diffusion bioassay method. The anti-microbial evaluation was done with and without incorporation of Aloe vera and Ageratum conyzoides extractives into the soap samples. Results showed that the physico-chemical properties of the soaps are dependent on the raw materials utilised. The incorporated medicinal plants used in this study, however, did not show any significant effect on the anti-microbial activities exhibited by the various soaps against the bacterial and fungal test organisms. Copyright 2004 Elsevier Ireland Ltd.

[Determination of metal elements in Achyranthis bidentatae radix from various habitats].

PubMed

Tu, Wan-Qian; Zhang, Liu-Ji

2011-12-01

To establish an atomic absorption spectrometry method for determination of the contents of metal elements in Achyranthis Bidentatae Radix and analyze 21 batches of samples from different areas. Fe, Mn, Ca, Mg, K, Zn and Cu were detected by atomic absorption spectrometry with hydrogen flame detector, Pb, As and Cd were detected by graphite furnace atomic absorption, Hg was detected by cold atomic absorption. The heavy metal contents met the requirement of Chinese Pharmacopoeia. The contents of K, Mg, Cu and Mn in the samples of geo-authentic areas were higher,while the contents of Fe, Zn, Hg and Pb in the samples of non-authentic areas were higher. This method is sample, accurate, repeatable and could be used to evaluate the quality of Achyranthis Bidentatae Radix.

[Principles for molecular identification of traditional Chinese materia medica using DNA barcoding].

PubMed

Chen, Shi-Lin; Yao, Hui; Han, Jian-Ping; Xin, Tian-Yi; Pang, Xiao-Hui; Shi, Lin-Chun; Luo, Kun; Song, Jing-Yuan; Hou, Dian-Yun; Shi, Shang-Mei; Qian, Zhong-Zhi

2013-01-01

Since the research of molecular identification of Chinese Materia Medica (CMM) using DNA barcode is rapidly developing and popularizing, the principle of this method is approved to be listed in the Supplement of the Pharmacopoeia of the People's Republic of China. Based on the study on comprehensive samples, the DNA barcoding systems have been established to identify CMM, i.e. ITS2 as a core barcode and psbA-trnH as a complementary locus for identification of planta medica, and COI as a core barcode and ITS2 as a complementary locus for identification of animal medica. This article introduced the principle of molecular identification of CMM using DNA barcoding and its drafting instructions. Furthermore, its application perspective was discussed.

[Development and application of reference materials containing mixed degradation products of amoxicillin and ampicillin].

PubMed

Li, Wei; Zhang, Wei-Qing; Li, Xiang; Hu, Chang-Qin

2014-09-01

Reference materials containing mixed degradation products of amoxicillin and ampicillin were developed after optimization of preparation processes. The target impurities were obtained by controlled stress testing, and each major component was identified with HPLC-MS and compared with single traceable reference standard each. The developed reference materials were applied to system suitability test for verifying HPLC system performed in accordance with set forth in China Pharmacopeia and identification of major impurities in samples based on retention and spectra information, which have advantages over the methods put forth in foreign pharmacopoeias. The development and application of the reference materials offer an effective way for rapid identification of impurities in chromatograms, and provide references for analyzing source of impurities and evaluation of drug quality.

Advances in the analysis of steroid hormone drugs in pharmaceuticals and environmental samples (2004-2010).

PubMed

Görög, Sándor

2011-06-25

A critical review of the literature of the analysis of steroid hormone drugs is presented based on 213 publications published between 2004 and 2010. The state of the art of the assay and purity check of bulk drug materials is characterized on the basis of the principal pharmacopoeias supplemented by the literature dealing with their impurity profiling and solid state characterization. The determination of the active ingredients and impurities/degradants in pharmaceutical formulation by HPLC, other chromatographic, electrodriven, spectrophotometric and other methods is also summarized. A short section deals with the application of analytical methods in drug research. The literature of the determination of steroid hormones in environmental samples is summarized in tabulated form. Copyright © 2010 Elsevier B.V. All rights reserved.

Diagnostics are central for a truly holistic approach against intestinal parasitic diseases.

PubMed

Harhay, Michael O; Horton, John; Olliaro, Piero L; Utzinger, Jürg

2011-02-01

This is a perspectives piece on the central role of diagnostics for a truly holistic approach against gastrointestinal (GI) parasitic diseases. This article was motivated by a recent review in the International Journal of Infectious Diseases, where Absar Alum and colleagues (September 2010) reviewed the global burden, key transmission pathways, current tools and strategies, and provided their vision of a holistic approach to control GI protozoan and helminthic infections in humans. We argue that, as the success of multiple rounds of national deworming campaigns are actualized in various parts of the world, diagnostics become vital to achieve successful elimination and to aid pharmacovigilance against emerging pathogen resistance to the limited deworming pharmacopoeia. Copyright © 2010 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Organic solvents in the pharmaceutical industry.

PubMed

Grodowska, Katarzyna; Parczewski, Andrzej

2010-01-01

Organic solvents are commonly used in the pharmaceutical industry as reaction media, in separation and purification of synthesis products and also for cleaning of equipment. This paper presents some aspects of organic solvents utilization in an active pharmaceutical ingredient and a drug product manufacturing process. As residual solvents are not desirable substances in a final product, different methods for their removal may be used, provided they fulfill safety criteria. After the drying process, analyses need to be performed to check if amounts of solvents used at any step of the production do not exceed acceptable limits (taken from ICH Guideline or from pharmacopoeias). Also new solvents like supercritical fluids or ionic liquids are developed to replace "traditional" organic solvents in the pharmaceutical production processes.

The pharmaceutical death-ride of dihydroartemisinin

PubMed Central

2010-01-01

In the 2010 second edition of WHO's guidelines for the treatment of malaria, the relatively new fixed dose combination dihydroartemisinin-piperaquine is included as one of the recommended artemisinin combination therapies. However, experimental testing demonstrates that, due to its intrinsic chemical instability, dihydroartemisinin is not suitable to be used in pharmaceutical formulations. In addition, data show that the currently available dihydroartemisinin preparations fail to meet the internationally accepted stability requirements. At a time when many efforts aim to ban counterfeit and substandard drugs from the malaria market, the obvious question rises how WHO and public-private partnerships, such as Medicine for Malaria venture (MMV), can support the production and marketing of anti-malarial drugs that do not even meet the International Pharmacopoeia requirements? PMID:20649950

A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice.

PubMed

Soncin, Sabrina; Lo Cicero, Viviana; Astori, Giuseppe; Soldati, Gianni; Gola, Mauro; Sürder, Daniel; Moccetti, Tiziano

2009-09-08

Main scope of the EU and FDA regulations is to establish a classification criterion for advanced therapy medicinal products (ATMP). Regulations require that ATMPs must be prepared under good manufacturing practice (GMP). We have validated a commercial system for the determination of bacterial endotoxins in compliance with EU Pharmacopoeia 2.6.14, the sterility testing in compliance with EU Pharmacopoeia 2.6.1 and a potency assay in an ATMP constituted of mononucleated cells used in cardiac regeneration. For the potency assay, cells were placed in the upper part of a modified Boyden chamber containing Endocult Basal Medium with supplements and transmigrated cells were scored. The invasion index was expressed as the ratio between the numbers of invading cells relative to cell migration through a control insert membrane. For endotoxins, we used a commercially available system based on the kinetic chromogenic LAL-test. Validation of sterility was performed by direct inoculation of TSB and FTM media with the cell product following Eu Ph 2.6.1 guideline. The calculated MVD and endotoxin limit were 780x and 39 EU/ml respectively. The 1:10 and 1:100 dilutions were selected for the validation. For sterility, all the FTM cultures were positive after 3 days. For TSB cultures, Mycetes and B. subtilis were positive after 5 and 3 days respectively. The detection limit was 1-10 colonies. A total of four invasion assay were performed: the calculated invasion index was 28.89 +/- 16.82% (mean +/- SD). We have validated a strategy for endotoxin, sterility and potency testing in an ATMP used in cardiac regeneration. Unlike pharmaceutical products, many stem-cell-based products may originate in hospitals where personnel are unfamiliar with the applicable regulations. As new ATMPs are developed, the regulatory framework is likely to evolve. Meanwhile, existing regulations provide an appropriate structure for ensuring the safety and efficacy of the next generation of ATMPs. Personnel

Particle characteristics and lung deposition patterns in a human airway replica of a dry powder formulation of polylactic acid produced using supercritical fluid technology.

PubMed

Cheng, Y S; Yazzie, D; Gao, J; Muggli, D; Etter, J; Rosenthal, G J

2003-01-01

Polylactic acid (PLA) powders have been used as vector particles to carry pharmaceutical material. Drugs incorporated in the PLA powder can be retained in the lung for a longer period and may be more effective than free-form drugs. A new formulation of L-PLA dry powder, which was easy to disperse in the air, was produced by using a supercritical technology. The L-PLA powder was characterized in terms of physical particle size and aerodynamic size as generated with a Turbuhaler dry powder inhaler (DPI). Electron microscopy analysis of the particles indicated that they were individual particles in bulk form and became aggregate particles after generation by the Turbuhaler. Aerodynamic particle size analysis using both an Aerodynamic Particle Sizer (APS) aerosol spectrometer and Andersen impactor showed that the aerodynamic size decreased as the flow rate in the Turbuhaler increased from 28.3 to 90 L min(-1). Deposition patterns in the human respiratory tract were estimated using a realistic physical replica of human airways. Deposition of the L-PLA was high (80.8%) in the oral airway at 28.3 L min(-1) and an average of 73.4% at flow rates of 60 and 90 L min(-1). In the lung region, the deposition totaled 7.2% at 28.3 L min(-1), 18.3% at 60 L min(-1), and 17.6% at 90 L min(-1). These deposition patterns were consistent with aerodynamic size measurement, which showed 76 to 86% deposition in the USP/EP (US Pharmacopoeia/European Pharmacopoeia) induction port. As the flow rate increased, fewer aggregates were formed resulting in the smaller aerodynamic particles. As a result, more particles penetrated the oral airways and were available for deposition in the lung. Our results showed that L-PLA particles as manufactured by the supercritical technology could be used in a DPI that does not require the use of carrier particles to facilitate aerosol delivery.

[Analysis of commercial grades of Schisandrae Sphenantherae Fructus based on schisantherin].

PubMed

Wang, Zhen-Heng; Jin, Ling; Ma, Yi; Cui, Zhi-Jia; Li, Qian; Huang, De-Dong

2017-10-01

Schisandrae Sphenantherae Fructus, from different producing areas, were collected and divided into three grades. The moisture content and total ash were determined on the basis of the pharmacopoeia method, and schisantherin was determined by UPLC. The study is aimed to find the commercial specifications and grades of Schisandrae Sphenantherae Fructus based on schisantherin content. The results showed that the content of water, total ash and schisantherin of Schisandrae Sphenantherae Fructus from different producing areas qualified. There was no significant difference between different grades of schisandrin content, but the second-class were the highest, first-class and third-class were lower. It means that schisandrin content is not positive correlation to commercial grade. The study will be helpful to the production, management and clinical practice of Schisandrae Sphenantherae Fructus. Copyright© by the Chinese Pharmaceutical Association.

Portable system of programmable syringe pump with potentiometer for determination of promethazine in pharmaceutical applications.

PubMed

Saleh, Tawfik A; Abulkibash, A M; Ibrahim, Atta E

2012-04-01

A simple and fast-automated method was developed and validated for the assay of promethazine hydrochloride in pharmaceutical formulations, based on the oxidation of promethazine by cerium in an acidic medium. A portable system, consisting of a programmable syringe pump connected to a potentiometer, was constructed. The developed change in potential during promethazine oxidation was monitored. The related optimum working conditions, such as supporting electrolyte concentration, cerium(IV) concentration and flow rate were optimized. The proposed method was successfully applied to pharmaceutical samples as well as synthetic ones. The obtained results were realized by the official British pharmacopoeia (BP) method and comparable results were obtained. The obtained t-value indicates no significant differences between the results of the proposed and BP methods, with the advantages of the proposed method being simple, sensitive and cost effective.

Development of ITS sequence based molecular marker to distinguish, Tribulus terrestris L. (Zygophyllaceae) from its adulterants.

PubMed

Balasubramani, Subramani Paranthaman; Murugan, Ramar; Ravikumar, Kaliamoorthy; Venkatasubramanian, Padma

2010-09-01

Tribulus terrestris L. (Zygophyllaceae) is one of the highly traded raw drugs and also used as a stimulative food additive in Europe and USA. While, Ayurvedic Pharmacopoeia of India recognizes T. terrestris as Goksura, Tribulus lanuginosus and T. subramanyamii are also traded by the same name raising issues of quality control. The nuclear ribosomal RNA genes and ITS (internal transcribed spacer) sequence were used to develop species-specific DNA markers. The species-specific markers efficiently amplified 295bp for T. terrestris (TT1F and TT1R), 300bp for T. lanuginosus (TL1F and TL1R) and 214bp for T. subramanyamii (TS1F and TS1R). These DNA markers can be used to distinguish T. terrestris from its adulterants. Copyright (c) 2010 Elsevier B.V. All rights reserved.

[HPLC specific chromatogram of Dendrobium officinale].

PubMed

Yan, Mei-Qiu; Chen, Su-Hong; Lv, Gui-Yuan; Zhou, Gui-Fen; Liu, Xia

2013-02-01

To establish the method of specific chromatogram analysis of ether extract of Dendrobium officinale for identification of D. officinale. Chromatographic separation was carried out at 30 degrees C on an Ultimate C18 column (4.6 mm x 250 mm, 5 microm) eluted with methanol and water containing 0.2% phosphoric acid in a gradient elution at a flow rate of 1.0 mL x min(-1). The detection wavelength was set at 280 nm. The similarity evaluation system for chromatographic fingerprint of NPC (National Pharmacopoeia Committee) was adopted to specific chromatogram construction. The HPLC specific chromatogram of D. officinale was constructed with 6 common specific chromatographic peaks including naringenin as a reference peak. The method shows good precision and repeatability of relative retention time. It can be used to identify D. officinale.

Present and future drug treatment for Parkinson's disease

PubMed Central

Schapira, A

2005-01-01

Considerable advances made in defining the aetiology, pathogenesis, and pathology of Parkinson's disease (PD) have resulted in the development and rapid expansion of the pharmacopoeia available for treatment. Anticholinergics were used before the introduction of levodopa which is now the drug most commonly used. Dopamine agonists are effective when used alone or as an adjunct to levodopa, while monoamine oxidase B inhibitors improve motor function in early and advanced PD. However, treatment mainly addresses the dopaminergic features of the disease and leaves its progressive course unaffected; the drug treatment available for the management of non-motor symptoms is limited. This article seeks to set current treatment options in context, review emerging and novel drug treatments for PD, and assess the prospects for disease modification. Surgical therapies are not considered. PMID:16227533

Mobile computing in critical care.

PubMed

Lapinsky, Stephen E

2007-03-01

Handheld computing devices are increasingly used by health care workers, and offer a mobile platform for point-of-care information access. Improved technology, with larger memory capacity, higher screen resolution, faster processors, and wireless connectivity has broadened the potential roles for these devices in critical care. In addition to the personal information management functions, handheld computers have been used to access reference information, management guidelines and pharmacopoeias as well as to track the educational experience of trainees. They can act as an interface with a clinical information system, providing rapid access to patient information. Despite their popularity, these devices have limitations related to their small size, and acceptance by physicians has not been uniform. In the critical care environment, the risk of transmitting microorganisms by such a portable device should always be considered.

Dr Pugh: a poisoner?

PubMed

Paull, J D; Morris, G M

2012-07-01

On 16 February 1845 the Reverend W. H. Browne, rector of St John's Church in Launceston, Van Diemen's Land, wrote in his journal, "My dear Wife died very suddenly almost immediately after and in consequence of taking a preparation of Hyd. Cyan. Acid prepared & supplied by Dr Pugh". This journal entry raises a number of questions. Was Dr Pugh treating a condition which he thought merited that treatment or was it a ghastly mistake? Was Caroline Browne suffering from pulmonary tuberculosis? Was hydrocyanic acid an accepted treatment at that time? Did Mrs Browne take the wrong dose? Was an incorrect concentration of the drug prepared by Dr Pugh? Did he use the wrong pharmacopoeia in preparing the hydrocyanic acid? Why was there no inquest? Only some of these questions can be answered.

The Use of Medicinal Plants by Migrant People: Adaptation, Maintenance, and Replacement

PubMed Central

de Medeiros, Patrícia Muniz; Soldati, Gustavo Taboada; Alencar, Nélson Leal; Vandebroek, Ina; Pieroni, Andrea; Hanazaki, Natalia; de Albuquerque, Ulysses Paulino

2012-01-01

Given the importance of studying the knowledge, beliefs, and practices of migrant communities to understand the dynamics of plant resource use, we reviewed the scientific literature concerning the use of medicinal plants by migrant populations engaged in international or long-distance migrations. We considered the importance of two processes: (1) adaptation to the new flora of the host country (i.e., substitution and incorporation of plants in the pharmacopoeia) and (2) continued use and acquisition of the original flora from migrants' home countries (i.e., importation, cultivation, and/or continued use of plants that grow in both host and home environments). We suggest that, depending on the specific context and conditions of migration, different processes that determine the use and/or selection of plants as herbal medicines may become predominant. PMID:22110548

The application of HPLC ESI MS in the investigation of the flavonoids and flavonoid glycosides of a Caribbean Lamiaceae plant with potential for bioaccumulation.

PubMed

Peter, Sonia R; Peru, Kerry M; Fahlman, Brian; McMartin, Dena W; Headley, John V

2015-01-01

As part of an exchange technology program between the government of Barbados and Environment Canada, methanolic and aqueous extracts from the flavonoid-rich Lamiaceae family were characterized using negative-ion electrospray mass spectrometry. The species investigated is part of the Caribbean Pharmacopoeia, and is used for a variety of health issues, including colds, flu, diabetes, and hypertension. The extracts were investigated for structural elucidation of phenolics, identification of chemical taxonomic profile, and evidence of bio-accumulator potential. The methanolic and aqueous leaf extracts of Plectranthus amboinicus yielded rosmarinic acid, ladanein, cirsimaritin, and other methoxylated flavonoids. This genus also shows a tendency to form conjugates with monosaccharides, including glucose, galactose, and rhamnose. The aqueous extract yielded four isomeric rhamnosides. The formation of conjugates by Plectranthus amboinicus is thus evidence of high bioaccumulator significance.

An Ophthalmologic Summit for On-Orbit Care

NASA Technical Reports Server (NTRS)

Bacal, Kira; McCulley, Phyllis; Paul, Bonnie

2004-01-01

Ophthalmologic issues are a source of concern for NASA flight surgeons, due to the remote nature of the space station as well as the microg ravity environment. Methods: A panel of external consultants was conv ened to evaluate the adequacy of the current in-flight medical system for the diagnosis and treatment of ophthalmologic issues. Participants were acknowledged experts in their field who also had experience in operational medicine. Results: Nine extramural experts provided assi stance, and six of them participated in a face to face meeting held a t NASA-Johnson Space Center. Changes were recommended for the space s tation pharmacopoeia, and diagnostic, therapeutic, and deorbit criteria protocols for a variety of ocular conditions were developed. Discus sion: The results of the panel provide an evidence based approach to the diagnosis and care of ophthalmologic conditions on the International Space Station

Oral Solid Dosage Form Disintegration Testing - The Forgotten Test.

PubMed

Al-Gousous, Jozef; Langguth, Peter

2015-09-01

Since its inception in the 1930s, disintegration testing has become an important quality control (QC) test in pharmaceutical industry, and disintegration test procedures for various dosage forms have been described by the different pharmacopoeias, with harmonization among them still not quite complete. However, because of the fact that complete disintegration does not necessarily imply complete dissolution, much more research has been focused on dissolution rather than on disintegration testing. Nevertheless, owing to its simplicity, disintegration testing seems to be an attractive replacement to dissolution testing as recognized by the International Conference on Harmonization guidelines, in some cases. Therefore, with proper research being carried out to overcome the associated challenges, the full potential of disintegration testing could be tapped saving considerable efforts allocated to QC testing and quality assurance. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Analysis on the Application and Characteristics of Chinese Patent Medicines Containing Dried Rehmanniae Radix

NASA Astrophysics Data System (ADS)

Guo, Hui; Miao, Yanyan; Miao, mingsan

2018-01-01

Dried Rehmanniae Radix has sweet taste, and its drug property is cold.It acts on heart, liver and kidney.It has the effect of clearing heat and cooling blood, nourishing yin and promoting fluid production.The active constituents of dried Rehmanniae Radix are mainly iridoid glycosides, polysaccharides, oligosaccharides and so on.This article sorted and analyzed the application forms, efficacy, applicable symptomsh and the frequency of the use of single traditional Chinese medicine in the Chinese patent medicines containing dried Rehmanniae Radix in the Chinese Pharmacopoeia of 2015. This method provides a train of thought for the further study of the pharmacological constituents of dried Rehmanniae Radix, and supplements the pharmacodynamics of Chinese herbal medicine of dried Rehmanniae Radix. It also provides ideas for the improvement of dried Rehmanniae Radix prescription and the new usage of its old prescription.

[Drugs Bazar of Constantinople].

PubMed

Nicolas, Michèle

2009-02-01

A long while in The Egyptian Bazaar in Istanbul, which was one of the high place of oriental medicine and pharmacopoeia, were established the most famous apothecaries (aktar), herborists, manufacturers and merchants of perfumes, and so merchants of cotton. With that of Bursa, it was one of the greatest trade center for plants, drugs and exotic spices, uncommon and expensive. The products were landed along the southerly water-side of the Golden Horn. The travellers, who discovered with astonishment all the scents of Orient, the aromatic drugs, the mysterious perfumes, were charmed and most of them described particularly and in details this Drugs Bazar of Constantinople in their travelbooks. To day, the merchants of spices (baharatçi) who are in this place offer to their clients a large choice of aromatic products, homemade specialities and traditional medicines.

Portable system of programmable syringe pump with potentiometer for determination of promethazine in pharmaceutical applications

PubMed Central

Saleh, Tawfik A.; Abulkibash, A.M.; Ibrahim, Atta E.

2011-01-01

A simple and fast-automated method was developed and validated for the assay of promethazine hydrochloride in pharmaceutical formulations, based on the oxidation of promethazine by cerium in an acidic medium. A portable system, consisting of a programmable syringe pump connected to a potentiometer, was constructed. The developed change in potential during promethazine oxidation was monitored. The related optimum working conditions, such as supporting electrolyte concentration, cerium(IV) concentration and flow rate were optimized. The proposed method was successfully applied to pharmaceutical samples as well as synthetic ones. The obtained results were realized by the official British pharmacopoeia (BP) method and comparable results were obtained. The obtained t-value indicates no significant differences between the results of the proposed and BP methods, with the advantages of the proposed method being simple, sensitive and cost effective. PMID:23960787

Studies on separation and purification of fission (99)Mo from neutron activated uranium aluminum alloy.

PubMed

Rao, Ankita; Kumar Sharma, Abhishek; Kumar, Pradeep; Charyulu, M M; Tomar, B S; Ramakumar, K L

2014-07-01

A new method has been developed for separation and purification of fission (99)Mo from neutron activated uranium-aluminum alloy. Alkali dissolution of the irradiated target (100mg) results in aluminum along with (99)Mo and a few fission products passing into solution, while most of the fission products, activation products and uranium remain undissolved. Subsequent purification steps involve precipitation of aluminum as Al(OH)3, iodine as AgI/AgIO3 and molybdenum as Mo-α-benzoin oxime. Ruthenium is separated by volatilization as RuO4 and final purification of (99)Mo was carried out using anion exchange method. The radiochemical yield of fission (99)Mo was found to be >80% and the purity of the product was in conformity with the international pharmacopoeia standards. Copyright © 2014 Elsevier Ltd. All rights reserved.

Edinburgh doctors and their physic gardens.

PubMed

Doyle, D

2008-12-01

Edinburgh has had eight physic gardens on different sites since its first one was created by the Incorporation of Barbers and Surgeons in 1656. As the gardens grew in size, they evolved from herb gardens to botanic gardens with small herbaria for the supply of medical herbs. They were intended for the instruction of medical, surgical and apothecary students and, in the case of the physicians, to demonstrate the need for a physicians' college and a pharmacopoeia. Some of the doctors in charge of them were equally famous and influential in botany as in medicine, and while Edinburgh Town Council enjoyed the fame the gardens brought to the city it was parsimonious and slow to support its botanical pioneers. The gardens are celebrated today in the Sibbald Garden within the Royal College of Physicians of Edinburgh.

[Quality control of Maca (Lepidium meyenii)].

PubMed

Shu, Ji-cheng; Cui, Hang-qing; Huang, Ying-zheng; Huang, Xiao-ying; Yang, Ming

2015-12-01

To control the quality of Maca, the quality standard was established in this study. According to the methods recorded in the Appendix of Chinese Pharmacopoeia (2010 Edition), the water, extract, total ash, acid insoluble substance, and heavy metals inspections in Lepidium meyenii were carried out. N-benzyl-9Z, 12Z-octadecadienamide in L. meyenii was identified by TLC, and it was determined by HPLC. The results showed that the N-benzyl-9Z, 12Z-octadecadienamide identification of TLC was a strong mark and specificity. In content determination experiment, the linearity of N-benzyl-9Z, 12Z-octadecadienamide was in the range of 0.01-2 microg (r = 0.9998), and the average recovery (n=9) was 99.27% (RSD 2.0%). The methods were simple, accurate, with good reproducibility. It is suitable for quality control L. meyenii.

[Identification of two varieties of Citri Fructus by fingerprint and chemometrics].

PubMed

Su, Jing-hua; Zhang, Chao; Sun, Lei; Gu, Bing-ren; Ma, Shuang-cheng

2015-06-01

Citri Fructus identification by fingerprint and chemometrics was investigated in this paper. Twenty-three Citri Fructus samples were collected which referred to two varieties as Cirtus wilsonii and C. medica recorded in Chinese Pharmacopoeia. HPLC chromatograms were obtained. The components were partly identified by reference substances, and then common pattern was established for chemometrics analysis. Similarity analysis, principal component analysis (PCA) , partial least squares-discriminant analysis (PLS-DA) and hierarchical cluster analysis heatmap were applied. The results indicated that C. wilsonii and C. medica could be ideally classified with common pattern contained twenty-five characteristic peaks. Besides, preliminary pattern recognition had verified the chemometrics analytical results. Absolute peak area (APA) was used for relevant quantitative analysis, results showed the differences between two varieties and it was valuable for further quality control as selection of characteristic components.

Epilepsy in popular Medicine from the Classic Age to the Modern Age: a study on elk hoof as an original treatment.

PubMed

Tagarelli, Antonio; Piro, Anna

2018-04-12

European people believed that epilepsy was both a sacred and demoniac disease in the pre- and post-Hippocratic Age, and this belief continued into the Christian era. Epilepsy was wrapped in mystery. The present work shows an epileptic treatment using elk (Alces alces) hoof, which was better known among Northern European people, and explains its historical and popular origins that lead to its importance and success within the Official Medicine in the sixteenth and seventeenth centuries until its gradual decline as a specific treatment in the subsequent centuries. We study authors from both Antiquity and the Modern Age. The present work concludes by highlighting the relationship between epilepsy and its magic-religious inheritance. It could be considered a valid example showing how a popular treatment can earn honors in the Official Pharmacopoeia, but later be excluded.

Review of clinical studies of Polygonum multiflorum Thunb. and its isolated bioactive compounds

PubMed Central

Bounda, Guy-Armel; Feng, YU

2015-01-01

Polygonum multiflorum Thunb. (PMT), officially listed in the Chinese Pharmacopoeia, is one of the most popular perennial Chinese traditional medicines known as He shou wu in China and East Asia, and as Fo-ti in North America. Mounting pharmacological studies have stressed out its key benefice for the treatment of various diseases and medical conditions such as liver injury, cancer, diabetes, alopecia, atherosclerosis, and neurodegenerative diseases as well. International databases such as PubMed/Medline, Science citation Index and Google Scholar were searched for clinical studies recently published on P. multiflorum. Various clinical studies published articles were retrieved, providing information relevant to pharmacokinetics-pharmacodynamics analysis, sleep disorders, dyslipidemia treatment, and neurodegenerative diseases. This review is an effort to update the clinical picture of investigations ever carried on PMT and/or its isolated bio-compounds and to enlighten its therapeutic assessment. PMID:26130933

[Application of traditional Chinese medicine reference standards in quality control of Chinese herbal pieces].

PubMed

Lu, Tu-Lin; Li, Jin-Ci; Yu, Jiang-Yong; Cai, Bao-Chang; Mao, Chun-Qin; Yin, Fang-Zhou

2014-01-01

Traditional Chinese medicine (TCM) reference standards plays an important role in the quality control of Chinese herbal pieces. This paper overviewed the development of TCM reference standards. By analyzing the 2010 edition of Chinese pharmacopoeia, the application of TCM reference standards in the quality control of Chinese herbal pieces was summarized, and the problems exiting in the system were put forward. In the process of improving the quality control level of Chinese herbal pieces, various kinds of advanced methods and technology should be used to research the characteristic reference standards of Chinese herbal pieces, more and more reasonable reference standards should be introduced in the quality control system of Chinese herbal pieces. This article discussed the solutions in the aspect of TCM reference standards, and future development of quality control on Chinese herbal pieces is prospected.

Ethnobotanical survey of cosmetic plants used in Marquesas Islands (French Polynesia).

PubMed

Jost, Xénia; Ansel, Jean-Luc; Lecellier, Gaël; Raharivelomanana, Phila; Butaud, Jean-François

2016-11-29

Cosmetic plants and their uses have often been neglected in ethnobotanical surveys which focus mainly on plants with medicinal or food uses. Thus, this survey was carried out to specifically investigate cosmetics in a small community and to establish a cosmetopoeia, based on the model of pharmacopoeia for medicinal plants. The geographic spread of the survey covered the Marquesas Islands, one of the five archipelagos of French Polynesia (Pacific Ocean). This archipelago was also recently investigated for its pharmacopoeia. This survey is based on individual interviews of Marquesan informants on the islands of Tahiti (Society archipelago) and Nuku Hiva (Marquesas archipelago). The methodological approach was semi-directive with open-ended questions based on cosmetic criteria (application area, cosmetic use, plant). Before each interview, researchers and the informant signed a Prior Informed Consent (PIC). Quantitative analyses were performed using basic statistics and the indice of Fidelity Level (FL). Twenty-eight informants from five of the six inhabited Marquesan islands were interviewed and yielded more than 500 cosmetic recipes. Marquesan cosmetopoeia included 79 plant taxa, of which 5% are Marquesan endemics, 23% are indigenous, 28% are Polynesian introductions and 44% are modern introductions. Among the introduced species, half were cultivated whereas the other half were weedy species. Most of the plants were abundant and only eight species were considered rare, of which four were Marquesan endemics. Main cosmetic plants were identified through informant citations and fidelity levels, and included Calophyllum inophyllum, Cananga odorata, Citrus aurantiifolia, Cocos nucifera, Curcuma longa, Gardenia taitensis, Mentha spp., Ocimum basilicum, Rauvolfia nukuhivensis and Santalum insulare var. marchionense. The most referred application areas were skin, hair and private parts whereas the main cosmetic uses were perfume, hydration, medicinal care and healing

Effectiveness of ophthalmic solution preservatives: a comparison of latanoprost with 0.02% benzalkonium chloride and travoprost with the sofZia preservative system.

PubMed

Ryan, Gerard; Fain, Joel M; Lovelace, Cherie; Gelotte, Karl M

2011-04-21

Although in vitro and in vivo laboratory studies have suggested that benzalkonium chloride (BAK) in topical ophthalmic solutions may be detrimental to corneal epithelial cells, multiple short- and long-term clinical studies have provided evidence supporting the safety of BAK. Despite the conflicting evidence, BAK is the most commonly used preservative in ophthalmic products largely due to its proven antimicrobial efficacy. This study was designed to characterize the antimicrobial performance of two commonly used topical ocular hypotensive agents that employ different preservative systems: latanoprost 0.005% with 0.02% BAK and travoprost 0.004% with sofZia, a proprietary ionic buffer system. Each product was tested for antimicrobial effectiveness by European Pharmacopoeia A (EP-A) standards, the most stringent standards of the three major compendia, which specify two early sampling time points (6 and 24 hours) not required by the United States Pharmacopeia or Japanese Pharmacopoeia. Aliquots were inoculated with between 10(5) and 10(6) colony-forming units of the test organisms: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus brasiliensis. Sampling and enumeration were conducted at protocol-defined time points through 28 days. BAK-containing latanoprost met EP-A criteria by immediately reducing all bacterial challenge organisms to the test sensitivity and fungal challenges within the first six hours while the preservative activity of travoprost with sofZia did not. Complete bacterial reduction by travoprost with sofZia was not shown until seven days into the test, and fungal reduction never exceeded the requisite 2 logs during the 28-day test. Travoprost with sofZia also did not meet EP-B criteria due to its limited effectiveness against Staphylococcus aureus. Both products satisfied United States and Japanese pharmacopoeial criteria. Latanoprost with 0.02% BAK exhibited more effective microbial protection than

Effectiveness of ophthalmic solution preservatives: a comparison of latanoprost with 0.02% benzalkonium chloride and travoprost with the sofZia preservative system

PubMed Central

2011-01-01

Background Although in vitro and in vivo laboratory studies have suggested that benzalkonium chloride (BAK) in topical ophthalmic solutions may be detrimental to corneal epithelial cells, multiple short- and long-term clinical studies have provided evidence supporting the safety of BAK. Despite the conflicting evidence, BAK is the most commonly used preservative in ophthalmic products largely due to its proven antimicrobial efficacy. This study was designed to characterize the antimicrobial performance of two commonly used topical ocular hypotensive agents that employ different preservative systems: latanoprost 0.005% with 0.02% BAK and travoprost 0.004% with sofZia, a proprietary ionic buffer system. Methods Each product was tested for antimicrobial effectiveness by European Pharmacopoeia A (EP-A) standards, the most stringent standards of the three major compendia, which specify two early sampling time points (6 and 24 hours) not required by the United States Pharmacopeia or Japanese Pharmacopoeia. Aliquots were inoculated with between 105 and 106 colony-forming units of the test organisms: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus brasiliensis. Sampling and enumeration were conducted at protocol-defined time points through 28 days. Results BAK-containing latanoprost met EP-A criteria by immediately reducing all bacterial challenge organisms to the test sensitivity and fungal challenges within the first six hours while the preservative activity of travoprost with sofZia did not. Complete bacterial reduction by travoprost with sofZia was not shown until seven days into the test, and fungal reduction never exceeded the requisite 2 logs during the 28-day test. Travoprost with sofZia also did not meet EP-B criteria due to its limited effectiveness against Staphylococcus aureus. Both products satisfied United States and Japanese pharmacopoeial criteria. Conclusions Latanoprost with 0.02% BAK exhibited more

Disintegration of sublingual tablets: proposal for a validated test method and acceptance criterion.

PubMed

Weda, M; van Riet-Nales, D A; van Aalst, P; de Kaste, D; Lekkerkerker, J F F

2006-12-01

In the Netherlands the market share of isosorbide dinitrate 5 mg sublingual tablets is dominated by 2 products (A and B). In the last few years complaints have been received from health care professionals on product B. During patient use the disintegration of the tablet was reported to be slow and/or incomplete, and ineffectiveness was experienced. In the European Pharmacopoeia (Ph. Eur.) no requirement is present for the disintegration time of sublingual tablets. The purpose of this study was to compare the in vitro disintegration time of products A and B, and to establish a suitable test method and acceptance criterion. A and B were tested with the Ph. Eur. method described in the monograph on disintegration of tablets and capsules as well as with 3 modified tests using the same Ph. Eur. apparatus, but without movement of the basket-rack assembly. In modified test 1 and modified test 2 water was used as medium (900 ml and 50 ml respectively), whereas in modified test 3 artificial saliva was used (50 ml). In addition, disintegration was tested in Nessler tubes with 0.5 and 2 ml of water. Finally, the Ph. Eur. method was also applied to other sublingual tablets with other drug substances on the Dutch market. With modified test 3 no disintegration could be achieved within 20 min. With the Ph. Eur. method and modified tests 1 and 2 product A and B differed significantly (p < 0. 001), with product B having longer disintegration times. These 3 methods were capable of discriminating between products and between batches. The time measured with the Ph. Eur. method was significantly lower compared to modified tests 1 and 2 (p < 0.001) and correlated well with the Nessler tube results. It is concluded that the in vivo complaints on product B could be related to the in vitro data. Furthermore, it is proposed that for immediate release of sublingual tablets the disintegration time should be tested. The Ph. Eur. method is considered suitable for this test. In view of the

[Safety evaluation and risk control measures of Cassiae Semen].

PubMed

Zhao, Yi-Meng; Wu, Li; Zhang, Shuo; Zhang, Li; Gao, Xue-Min; Sun, Xiao-Bo; Wang, Chun

2017-11-01

In this study, the authors reviewed domestic and foreign literatures, conducted the textual research on origin and development of Cassia Semen, studied records in ancient books and ancient and modern literatures, clinical adverse reactions and relevant experimental studies in recent years, and summarized the clinical features and influencing factors related to the safety of Cassiae Semen. According to the findings,Cassia Semen's safety risks are mainly liver and kidney system damages, with the main clinical features of fatigue, anorexia, disgusting of oil, yellow urine and gray stool; digestive system injury, with the main clinical features of diarrhea, abdominal distension, nausea and loose stool; reproductive system damage, with the main clinical features of vaginal bleeding. Allergic reactions and clinical adverse events, with the main clinical features for numb mouth, itching skin, nausea and vomiting, diarrhea, wheezing and lip cyanosis were also reported. The toxicological studies on toxic components of Cassiae Semen obtusifolia were carried out through acute toxicity test, subacute toxicity test, subchronic toxicity test and chronic toxicity test. Risk factors might include patients, compatibility and physicians. Physicians should strictly abide by the medication requirements in the Pharmacopoeia, pay attention to rational compatibility, appropriate dosage,correct usage and appropriate processing, control the dosage below 15 g to avoid excessive intake, strictly control the course of treatment to avoid accumulated poisoning caused by long-term administration. At the same time, clinicians should pay attention to the latest research progress, update the knowledge structure, quickly find the latest and useful materials from clinical practice, scientific research and drug information and other literatures, make evaluation and judgment for the materials, establish a traditional Chinese medicine intelligence information library, and strengthen the control over

An assessment of the Bhutanese traditional medicine for its ethnopharmacology, ethnobotany and ethnoquality: Textual understanding and the current practices.

PubMed

Wangchuk, Phurpa; Pyne, Stephen G; Keller, Paul A

2013-06-21

: This study involves the assessment of the Bhutanese traditional medicine (BTM) which was integrated with the mainstream biomedicine in 1967 to provide primary health care services in the country. It caters to 20-30% of the daily out-patients within 49 traditional medicine units attached to 20 district modern hospitals and 29 Basic Health Units in the country. : This study presents the ethnopharmacological, ethnobotanical and the ethnoquality concepts in relation to mainstream Tibetan medicine and describes the current practices of BTM. : Experienced BTM practitioners (Drung-tshos and Smen-pas) were selected using a convenience sampling method and were interviewed using an open questionnaire followed by informal discussions. The corpus of BTM, Tibetan and scientific literature was obtained and the information on ethnopharmacological, ethnoquality and ethnobotanical concepts and current practices of BTM was extracted. : This study found that the BTM shares many similarities in terms of materia medica, pharmacopoeia and the principles and concepts of ethnopharmacology and ethnobotany with its mainstream Tibetan medicine. However, the resourceful Bhutanese Drung-tshos and Smen-pas have adapted this medical system based on the local language, culture, disease trend, health care needs and their familiarity with the locally available medicinal ingredients making it particular to the country. A number of notable distinctions observed in the current practices include a code of classification of diseases (only 79 of 404 types of disorders recognized), formulations (currently used only 103 of thousands formulation types), usage of medicinal plants (only 229 species of thousands described) and selected treatment procedures (golden needle and water therapy). This BTM was found to cater to 20-30% of daily out-patients visiting 49 modern hospitals and basic health units in the country. : The BTM has been evolved from the Tibetan medicine. While the pharmacopoeia

Application of a trap-free two-dimensional liquid chromatography combined with ion trap/time-of-flight mass spectrometry for separation and characterization of impurities and isomers in cefpiramide.

PubMed

Wang, Jian; Xu, Yu; Wen, Chunmei; Wang, Zhijian

2017-11-01

High-resolution mass spectrometry had been routinely used for structure identification of impurity. However, all LC-MS methods were based on a volatile mobile phase, and a non-volatile system is used in the official analytical method of United States Pharmacopoeia for cefpiramide which limited the use of mass spectrometry for structure characterization of the impurities. Here we presented the utilization of a trap-free two-dimensional liquid chromatography coupled to high resolution ion trap/time-of-flight mass spectrometry (2D LC-IT-TOF MS) with positive and negative modes of electrospray ionization for characterization of eight impurities in cefpiramide. Trap-free two-dimensional liquid chromatography and online desalting technique made it possible to characterize the impurity in cefpiramide in the condition of official standard, and the TIC chromatogram of LC-MS was in conformity with the LC chromatogram of the official analytical method in the peak sequence of impurities, which could further improve the method of official monographs in pharmacopoeias. Each peak separated by the non-volatile mobile phase was trapped by a 20 μL quantitative loop then transferred into a system with a volatile mobile phase connected to a MS detector. In the first dimension, the column was Kromasil C 8 analytical column (250 mm × 4.6 mm, 5 μm) with a non-volatile salt mobile phase at the flow rate of 0.8 mL min -1 . In the second dimension, the column was Shimadzu Shim-pack GISS C 18 (50 mm × 2.1 mm, 1.9 μm) with a volatile salt mobile phase at the flow rate of 0.3 mL min -1 . Through the multiple heart-cutting 2D-LC approach and online desalting technique, the problem of incompatibility between non-volatile salt mobile phase and mass spectrometry was solved completely. The fragmentation behavior of cefpiramide and its eight impurities were studied. The structures of eight impurities in cefpiramide drug substance were deduced based on the HPLC-MS n data, in

The future is written: impact of scripts on the cognition, selection, knowledge and transmission of medicinal plant use and its implications for ethnobotany and ethnopharmacology.

PubMed

Leonti, Marco

2011-04-12

Apart from empirically learned medicinal and pharmacological properties, the selection of medicinal plants is dependent on cognitive features, ecological factors and cultural history. In literate societies the transmission of medicinal plant knowledge through texts and, more recently, other media containing local as well as non-local knowledge has a more immediate and a more prolonged effect than oral transmission. Therefore, I try to visualize how field based studies in ethnobiology and especially medical ethnobotany and ethnopharmacology run the risk of repeating information and knowledge and illustrate the importance of differentiating and acknowledging the origin, transmission and rationale of plant use made by humans. Reviewing literature dealing with the traditional parameters (e.g. hot/cold dichotomy, organoleptic properties, doctrine of signatures) influencing the selection and transmission of plant use in a juxtaposition to our recent finding of causal influence of text on local plant use. Discussing the passing down of knowledge by text as a special case of oblique/one-to-many knowledge transmission. Historical texts on materia medica, popular books on plant use, clinical studies, and informants of ethnobotanical field studies generate a circle of information and knowledge, which progressively conditions the results of ethnobotanical field studies. While text reporting on phytotherapeutical trends may cause innovation through the introduction of "new" applications to local customs, persistently repeating well established folk remedies leads to the consolidation of such uses adding a conservative dimension to a local pharmacopoeia, which might not actually be there to that extent. Such a "shaping" of what might appear to be the results of a field investigation is clearly outside the ordinary principles of scientific enquiry. The traditional pillars of ethnobotanical field studies - that is, "input to drug discovery" and "conservation of cultural heritage

Simultaneous determination of Magnolol and Honokiol by amino acid ionic liquid synchronous fluorescence spectrometry

NASA Astrophysics Data System (ADS)

Liu, Wei; Zhu, Xiashi

2018-05-01

A novel method based on amino acid ionic liquids (AAILs) as an additive synchronous fluorescence spectrometry is proposed for simultaneous determination of magnolol (MN) and honokiol (HN) in traditional Chinese medicine Houpu. The overlapping fluorescence spectrum of MN and HN could be completely separated in the AAILs medium. Experiment parameters (the type and concentration of AAILs, pH values and temperature) were discussed. The detection limits of MN and HN reached 1.46 ng/mL, 0.92 ng/mL and the recovery rates ranged from 98.6%-100.7%, 99.7%-100.6%, respectively. This methods was successfully employed for simultaneously determination of MN and HN in real samples. No significant differences could be found in the results of this method and the pharmacopoeia of People's Republic of China 2015 (Ch.P.2015). The experiment mechanisms were discussed by the Gaussian simulation and fluorescence quantum yield.

Oromucosal film preparations: classification and characterization methods.

PubMed

Preis, Maren; Woertz, Christina; Kleinebudde, Peter; Breitkreutz, Jörg

2013-09-01

Recently, the regulatory authorities have enlarged the variety of 'oromucosal preparations' by buccal films and orodispersible films. Various film preparations have entered the market and pharmacopoeias. Due to the novelty of the official monographs, no standardized characterization methods and quality specifications are included. This review reports the methods of choice to characterize oromucosal film preparations with respect to biorelevant characterization and quality control. Commonly used dissolution tests for other dosage forms are not transferable for films in all cases. Alternatives and guidance on decision, which methods are favorable for film preparations are discussed. Furthermore, issues about requirements for film dosage forms are reflected. Oromucosal film preparations offer a wide spectrum of opportunities. There are a lot of suggestions in the literature on how to control the quality of these innovative products, but no standardized tests are available. Regulatory authorities need to define the standards and quality requirements more precisely.

Comparison of chiral electrophoretic separation methods for phenethylamines and application on impurity analysis.

PubMed

Borst, Claudia; Holzgrabe, Ulrike

2010-12-15

A chiral microemulsion electrokinetic chromatography method has been developed for the separation of the enantiomers of the phenethylamines ephedrine, N-methylephedrine, norephedrine, pseudoephedrine, adrenaline (epinephrine), 2-amino-1-phenylethanol, diethylnorephedrine, and 2-(dibutylamino)-1-phenyl-1-propanol, respectively. The separations were achieved using an oil-in-water microemulsion consisting of the oil-component ethyl acetate, the surfactant sodium dodecylsulfate, the cosurfactant 1-butanol, the organic modifier propan-2-ol and 20mM phosphate buffer pH 2.5 as aqueous phase. For enantioseparation sulfated beta-cyclodextrin was added. The method was compared to an already described CZE method, which made use of heptakis(2,3-di-O-diacetyl-6-O-sulfo)-beta-cyclodextrin (HDAS) as chiral selector. Additionally, the developed method was successfully applied to the related substances analysis of noradrenaline, adrenaline, dipivefrine, ephedrine and pseudoephedrine monographed in the European Pharmacopoeia 6. Copyright 2010 Elsevier B.V. All rights reserved.

Ultrahigh hydrostatic pressure extraction of flavonoids from Epimedium koreanum Nakai

NASA Astrophysics Data System (ADS)

Hou, Lili; Zhang, Shouqin; Dou, Jianpeng; Zhu, Junjie; Liang, Qing

2011-02-01

Herba Epimedii is one of the most famous Chinese herbal medicines listed in the Pharmacopoeia of the People's Republic of China, as one of the representatives of traditional Chinese herb, it has been widely applied in the field of invigorate the kidney and strengthen 'Yang'. The attention to Epimedium extract has more and more increased in recent years. In this work, a novel extraction technique, ultra-high hydrostatic pressure extraction (UPE) technology was applied to extract the total flavonoids of E. koreanum. Three factors (pressure, ethanol concentration and extraction time) were chosen as the variables of extraction experiments, and the optimum UPE conditions were pressure 350 MPa; ethanol concentration 50% (v/v); extraction time 5 min. Compared with Supercritical CO2 extraction, Reflux extraction and Ultrasonic-assisted extraction, UPE has excellent advantages (shorter extraction time, higher yield, better antioxidant activity, lower energy consumption and eco-friendly).

Antimicrobial activity of bark extracts of Syzygium jambos (L.) alston (Myrtaceae).

PubMed

Djipa, C D; Delmée, M; Quetin-Leclercq, J

2000-07-01

Syzygium jambos (L.) Alston (Myrtaceae) is a widespread medicinal plant traditionally used in sub-Saharan Africa to treat infectious diseases. Acetone and aqueous extracts from the bark of S. jambos were tested for antimicrobial activity in vitro by the agar dilution method in petri dishes. Both extracts showed some activity against the tested micro-organisms. They proved to be particularly effective on Staphylococcus aureus, Yersinia enterocolitica and coagulase negative staphylococci among which Staphylococcus hominis, Staphylococcus cohnii and Staphylococcus warneri. These properties seem to be related to the high tannin content of S. jambos extracts (77 and 83% for the aqueous and acetone extracts, respectively, determined according to the European Pharmacopoeia method) which were generally more active than Hamamelis virginiana, Krameria triandra, Alchemilla vulgaris and Rubus fruticosus extracts containing 48, 44, 46 and 28% tannins, respectively. Furthermore, elimination of tannins totally suppressed these antimicrobial activities.

Physicochemical characterization, fatty acid composition, and thermal analysis of Bertholletia excelsa HBK oil

PubMed Central

Pena Muniz, Marcos Antônio; Ferreira dos Santos, Marina Nídia; da Costa, Carlos Emmerson Ferreira; Morais, Luiz; Lamarão, Maria Louze Nobre; Ribeiro-Costa, Roseane Maria; Silva-Júnior, José Otávio Carréra

2015-01-01

The present study aimed at characterizing the oil extracted from Bertholletia excelsa H.B.K. almond, a native species from the Amazon region. Analytical methods used for oils and fats were employed through pharmacopoeia assays, AOCS (American Oil Chemists Society) standard methods as well as those recommended by ANVISA (National Health Surveillance Agency) such as acidity, peroxide value, saponification index, iodine value and refractive index, pH and relative density, and also thermoanalytical analyses (thermogravimetry, differential thermogravimetry and differential thermal analysis) as well as chromatographic analysis (gas chromatography). The characterization assessments of B. excelsa oil showed results indicating that the oil contains polyunsaturated fatty acids in large proportion. The termoanalytical tests indicated that B.excelsa oil showed thermal stability up to 220 °C, These results showed that the oil extracted from B. excelsa has acceptable characteristics and is of good quality. PMID:25709225

Polyphenolic profile and biological activity of Chinese hawthorn (Crataegus pinnatifida BUNGE) fruits.

PubMed

Jurikova, Tunde; Sochor, Jiri; Rop, Otakar; Mlcek, Jiri; Balla, Stefan; Szekeres, Ladislav; Adam, Vojtech; Kizek, Rene

2012-12-06

Chinese hawthorn (Crataegus pinnatifida Bge.) fruits are rich in polyphenols (e.g., epicatechin, procyanidin B2, procyanidin B5, procyanidin C1, hyperoside, isoquercitrin and chlorogenic acid)--active compounds that exert beneficial effects. This review summarizes all information available on polyphenolic content and methods for their quantification in Chinese hawthorn berries and the relationships between individual polyphenolic compounds as well. The influence of species or cultivars, the locality of cultivation, the stage of maturity, and extract preparation conditions on the polyphenolic content were discussed as well. Currently, only fruits of C. pinnatifida and C. pinnatifida var. major are included in the Chinese Pharmacopoeia. Recent trials have demonstrated the efficacy of Chinese hawthorn fruit in lowering blood cholesterol and the risk of cardiovascular diseases. The fruit has also demonstrated anti-inflammatory and anti-tumour activities. This review deals mainly with the biological activity of the fruit related to its antioxidant properties.

[Application of solid-phase extraction column for determination of matrine and oxymatrine in Sophora flavescens].

PubMed

Yang, Xia; Guo, Bao-Lin; Hu, Hong-Yu; Huang, Wen-Hua; Qiao, He-Ping; Fan, Sheng-Ci; Guan, Zha-Gen

2013-09-01

A Cleanert Alumina-N-SPE column (0.5 g/6 mL) chromatograpy with 5 mL of chloroform-methanol (7: 3) as eluent, instead of aluminum oxide column (100-200 mesh, 5 g, 1 cm) chromatograpy eluted successively with chloroform and the chloroform-methanol (7:3) (20 mL each), was applied to enrich matrine and oxymatrine in Sophora flavescens. Also, the optimization of the HPLC determination conditions with acetonitrile-ethanol absolute-3% phosphoric acid solution (84: 6: 10) as mobile phase, instead of acetonitrile-ethanol absolute -3% Phosphoric acid solution (80: 10: 10) recorded in Chinese Pharmacopoeia 2010 Edition, was more suitable for determination of matrine and oxymatrine in S. flavescens. This method has advantage of reducing sample handling time and solvent volume and increasing the accuracy and feasibility, which can simplify the procedure for determination of matrine and oxymatrine in S. flavescens.

[Functional targets of Chinese herbal medicine].

PubMed

Xiao, Bin; Wang, Yun

2010-12-01

In order to elucidate the mechanisms of Chinese herbal medicine, much work has been done based on chemical constituent-target in the molecular system. It cannot comply with the holistic efficacy of Chinese herbal medicine. Thus, the authors of this paper proposed to study the functional target adopted from Western medicine. The data of Chinese herbal function were collected from 2005 edition of The People's Republic of China Pharmacopoeia. A total of 135 functional targets were found, and a network about functional target and mode of action was built. The authors also explored the applications of functional target and the network combined with Sijunzi Decoction and Mahuang Decoction. The results, reflecting the feature of Chinese herbal medicine, will not only be helpful to elucidate the holistic mechanisms of Chinese herbal medicine, but also beneficial to studying the theory of Chinese formulas and developing new formulas.

[History of pharmaceutical packaging in modern Japan. II--Package size of pharmaceuticals].

PubMed

Hattori, Akira

2014-01-01

When planning pharmaceutical packaging, the package size for the product is important for determining the basic package concept. Initially, the sales unit for herbal medicines was the weight; however in 1868, around the early part of the Meiji era, Japanese and Western units were being used and the sales unit was confusing. Since the Edo era, the packing size for OTC medicines was adopted using weight, numbers, dosage or treatment period. These were devised in various ways in consideration of convenience for the consumer, but the concept was not simple. In 1887, from the time that the first edition of the Japanese Pharmacopoeia came out, use of the metric system began to spread in Japan. Its use spread gradually for use in the package size of pharmaceutical products. At the time, the number of pharmaceutical units (i.e., tablets), became the sales unit, which is easy to understand by the purchaser.

Comprehensive separation of secondary metabolites in natural products by high-speed counter-current chromatography using a three-phase solvent system.

PubMed

Yanagida, Akio; Yamakawa, Yutaka; Noji, Ryoko; Oda, Ako; Shindo, Heisaburo; Ito, Yoichiro; Shibusawa, Yoichi

2007-06-01

High-speed counter-current chromatography (HSCCC) using the three-phase solvent system n-hexane-methyl acetate-acetonitrile-water at a volume ratio of 4:4:3:4 was applied to the comprehensive separation of secondary metabolites in several natural product extracts. A wide variety of secondary metabolites in each natural product was effectively extracted with the three-phase solvent system, and the filtered extract was directly submitted to the HSCCC separation using the same three-phase system. In the HSCCC profiles of crude natural drugs listed in the Japanese Pharmacopoeia, several physiologically active compounds were clearly separated from other components in the extracts. The HSCCC profiles of several tea products, each manufactured by a different process, clearly showed their compositional difference in main compounds such as catechins, caffeine, and pigments. These HSCCC profiles also provide useful information about hydrophobic diversity of whole components present in each natural product.

Trends in active pharmaceutical ingredient salt selection based on analysis of the Orange Book database.

PubMed

Paulekuhn, G Steffen; Dressman, Jennifer B; Saal, Christoph

2007-12-27

The Orange Book database published by the U.S. Drug and Food Administration (FDA) was analyzed for the frequency of occurrence of different counterions used for the formation of pharmaceutical salts. The data obtained from the present analysis of the Orange Book are compared to reviews of the Cambridge Structural Database (CSD) and of the Martindale "The Extra Pharmacopoeia". As well as showing overall distributions of counterion usage, results are broken down into 5-year increments to identify trends in counterion selection. Chloride ions continue to be the most frequently utilized anionic counterions for the formation of salts as active pharmaceutical ingredients (APIs), while sodium ions are most widely utilized for the formation of salts starting from acidic molecules. A strong trend toward a wider variety of counterions over the past decade is observed. This trend can be explained by a stronger need to improve physical chemical properties of research and development compounds.

Consensus nomenclature rules for radiopharmaceutical chemistry — Setting the record straight

DOE PAGES

Coenen, Heinz H.; Gee, Antony D.; Adam, Michael; ...

2017-10-21

Over recent years, within the community of radiopharmaceutical sciences, there has been an increased incidence of incorrect usage of established scientific terms and conventions, and even the emergence of ‘self-invented’ terms. Here, in order to address these concerns, an international Working Group on ‘Nomenclature in Radiopharmaceutical Chemistry and related areas’ was established in 2015 to achieve clarification of terms and to generate consensus on the utilisation of a standardised nomenclature pertinent to the field. Upon open consultation, the following consensus guidelines were agreed, which aim to: Provide a reference source for nomenclature good practice in the radiopharma-ceutical sciences; Clarify themore » use of terms and rules concerning exclusively radiopharmaceutical terminology, i.e. nuclear- and radiochemical terms, symbols and expressions; Address gaps and inconsistencies in existing radiochemistry nomenclature rules; Provide source literature for further harmonisation beyond our immediate peer group (publishers, editors, IUPAC, pharmacopoeias, etc.).« less

'Bacoside B'--the need remains for establishing identity.

PubMed

Deepak, Mundkinajeddu; Amit, Agarwal

2013-06-01

Bacopa monnieri is fast gaining popularity for its beneficial effects on cognition and memory. The active constituents of the plant were putatively identified as 'bacosides A and B' in older publications. Subsequently 'bacoside A' was identified as a mixture of four saponins [bacoside A3 (1), bacopaside II (2), bacopasaponin C (3) and the jujobogenin isomer of the latter (4)] and was considered as part of major constituents of the herb along with bacopaside I (5). These major saponins now form part of analytical monographs in many Pharmacopoeia. However identity of 'bacoside B' still appears controversial with seemingly contradictory information available in the scientific literature. At the same time quality of many extracts and herbal products derived from the plant is still being determined based on the content of 'bacosides A and B'. We have elaborated these issues in this article along with our recommendations to move forward towards achieving scientific clarity on the subject. Copyright © 2013 Elsevier B.V. All rights reserved.

Simultaneous determination of phenylephrine hydrochloride, guaifenesin, and chlorpheniramine maleate in cough syrup by gradient liquid chromatography.

PubMed

Amer, Sawsan M; Abbas, Samah S; Shehata, Mostafa A; Ali, Nahed M

2008-01-01

A simple and reliable high-performance liquid chromatographic method was developed for the simultaneous determination of mixture of phenylephrine hydrochloride (PHENYL), guaifenesin (GUAIF), and chlorpheniramine maleate (CHLO) either in pure form or in the presence of methylparaben and propylparaben in a commercial cough syrup dosage form. Separation was achieved on a C8 column using 0.005 M heptane sulfonic acid sodium salt (pH 3.4 +/- 0.1) and acetonitrile as a mobile phase by gradient elution at different flow rates, and detection was done spectrophotometrically at 210 nm. A linear relationship in the range of 30-180, 120-1800, and 10-60 microg/mL was obtained for PHENYL, GUAIF, and CHLO, respectively. The results were statistically analyzed and compared with those obtained by applying the British Pharmacopoeia (2002) method and showed that the proposed method is precise, accurate, and can be easily applied for the determination of the drugs under investigation in pure form and in cough syrup formulations.

Composition of Indigo naturalis.

PubMed

Plitzko, Inken; Mohn, Tobias; Sedlacek, Natalie; Hamburger, Matthias

2009-06-01

A proposal for a European Pharmacopoeia monograph concerning Indigo naturalis has recently been published, whereby the indigo (1) and indirubin (2) content should be determined by HPLC-UV. This method was tested, but problems were seen with the dosage of indigo due to poor solubility. A quantitative assay for indigo based on (1)H-NMR was developed as an alternative. The HPLC and qNMR assays were compared with eight Indigo naturalis samples. The HPLC assay consistently gave much lower indigo concentrations because solubility was the limiting factor in sample preparation. In one sample, sucrose was identified by (1)H-NMR as an organic additive. Simple wet chemistry assays for undeclared additives such as sugars and starch were tested with artificially spiked Indigo naturalis samples to establish their limits of detection, and sulfate ash determinations were carried out in view of a better assessment of Indigo naturalis in a future European monograph.

Development of a novel and simple method to evaluate disintegration of rapidly disintegrating tablets.

PubMed

Hoashi, Yohei; Tozuka, Yuichi; Takeuchi, Hirofumi

2013-01-01

The purpose of this study was to develop and test a novel and simple method for evaluating the disintegration time of rapidly disintegrating tablets (RDTs) in vitro, since the conventional disintegration test described in the pharmacopoeia produces poor results due to the difference of its environmental conditions from those of an actual oral cavity. Six RDTs prepared in our laboratory and 5 types of commercial RDTs were used as model formulations. Using our original apparatus, a good correlation was observed between in vivo and in vitro disintegration times by adjusting the height from which the solution was dropped to 8 cm and the weight of the load to 10 or 20 g. Properties of RDTs, such as the pattern of their disintegrating process, can be assessed by verifying the load. These findings confirmed that our proposed method for an in vitro disintegration test apparatus is an excellent one for estimating disintegration time and the disintegration profile of RDTs.

Gravimetric method for the determination of diclofenac in pharmaceutical preparations.

PubMed

Tubino, Matthieu; De Souza, Rafael L

2005-01-01

A gravimetric method for the determination of diclofenac in pharmaceutical preparations was developed. Diclofenac is precipitated from aqueous solution with copper(II) acetate in pH 5.3 (acetic acid/acetate buffer). Sample aliquots had approximately the same quantity of the drug content in tablets (50 mg) or in ampules (75 mg). The observed standard deviation was about +/- 2 mg; therefore, the relative standard deviation (RSD) was approximately 4% for tablet and 3% for ampule preparations. The results were compared with those obtained with the liquid chromatography method recommended in the United States Pharmacopoeia using the statistical Student's t-test. Complete agreement was observed. It is possible to obtain more precise results using higher aliquots, for example 200 mg, in which case the RSD falls to 1%. This gravimetric method, contrary to what is expected for this kind of procedure, is relatively fast and simple to perform. The main advantage is the absolute character of the gravimetric analysis.

[Status and suggestions for adjuvant standard for Chinese materia medica processing in China].

PubMed

Yang, Chun-Yu; Cao, Hui; Wang, Xiao-Tao; Tu, Jia-Sheng; Qian, Zhong-Zhi; Yu, Zhi-Ling; Shang, Yue; Zhang, Bao-Xian

2017-04-01

In this paper, the status of adjuvant standard for Chinese materia medica processing in the Chinese Pharmacopoeia 2015 edition, the National Specification of Chinese Materia Medica Processing, and the 29 provincial specification of Chinese materia medica was summarized, and the the status including general requirements, specific requirements, and quality standard in the three grade official specifications was collected and analyzed according to the "medicine-adjuvant homology" and "food-adjuvant homology" features of adjuvants. This paper also introduced the research situation of adjuvant standard for Chinese materia medica processing in China; In addition, analyzed and discussed the problems existing in the standard system of adjuvant for Chinese materia medica processing, such as lack of general requirements, low level of standard, inconsistent standard references, and lack of research on the standard, and provided suggestions for the further establishment of the national standards system of adjuvant for Chinese materia medica processing. Copyright© by the Chinese Pharmaceutical Association.

Quantitative elemental analysis of an industrial mineral talc, using accelerator-based analytical technique

NASA Astrophysics Data System (ADS)

Olabanji, S. O.; Ige, A. O.; Mazzoli, C.; Ceccato, D.; Ajayi, E. O. B.; De Poli, M.; Moschini, G.

2005-10-01

Accelerator-based technique of PIXE was employed for the determination of the elemental concentration of an industrial mineral, talc. Talc is a very versatile mineral in industries with several applications. Due to this, there is a need to know its constituents to ensure that the workers are not exposed to health risks. Besides, microscopic tests on some talc samples in Nigeria confirm that they fall within the BP British Pharmacopoeia standard for tablet formation. However, for these samples to become a local source of raw material for pharmaceutical grade talc, the precise elemental compositions should be established which is the focus of this work. Proton beam produced by the 2.5 MV AN 2000 Van de Graaff accelerator at INFN, LNL, Legnaro, Padova, Italy was used for the PIXE measurements. The results which show the concentration of different elements in the talc samples, their health implications and metabolic roles are presented and discussed.

Evaluation of the botanical origin of black cohosh products by genetic and chemical analyses.

PubMed

Masada-Atsumi, Sayaka; Kumeta, Yukie; Takahashi, Yutaka; Hakamatsuka, Takashi; Goda, Yukihiro

2014-01-01

Despite the increasing sales of black cohosh (the dried rhizome and root of Cimicifuga racemosa L.) in the world herbal market, these products have continuous adulteration issues. The botanical authenticity of the black cohosh products is the first important step for ensuring their quality, safety and efficacy. In this study, we genetically identified the botanical sources of 10 black cohosh products and 5 Cimicifuga Rhizome crude drugs of Japanese Pharmacopoeia grade, and analyzed the metabolic profiling of 25 black cohosh products using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Consequently, we found that C. dahurica and possibly C. foetida are misused as sources of the black cohosh products and in some cases, the extracts of black cohosh were adulterated with the plant materials of C. dahurica. We demonstrated that these three species can be distinguished by three marker compounds in a specific mass range. These results must be helpful in establishing regulations for the safe use of the black cohosh products.

Automatic miniaturized fluorometric flow system for chemical and toxicological control of glibenclamide.

PubMed

Ribeiro, David S M; Prior, João A V; Taveira, Christian J M; Mendes, José M A F S; Santos, João L M

2011-06-15

In this work, and for the first time, it was developed an automatic and fast screening miniaturized flow system for the toxicological control of glibenclamide in beverages, with application in forensic laboratory investigations, and also, for the chemical control of commercially available pharmaceutical formulations. The automatic system exploited the multipumping flow (MPFS) concept and allowed the implementation of a new glibenclamide determination method based on the fluorometric monitoring of the drug in acidic medium (λ(ex)=301 nm; λ(em)=404 nm), in the presence of an anionic surfactant (SDS), promoting an organized micellar medium to enhance the fluorometric measurements. The developed approach assured good recoveries in the analysis of five spiked alcoholic beverages. Additionally, a good agreement was verified when comparing the results obtained in the determination of glibenclamide in five commercial pharmaceutical formulations by the proposed method and by the pharmacopoeia reference procedure. Copyright © 2011 Elsevier B.V. All rights reserved.

A sensible technique to detect mollicutes impurities in human cells cultured in GMP condition.

PubMed

Ugolotti, Elisabetta; Vanni, Irene

2014-01-01

In therapeutic trials the use of manipulated cell cultures for clinical applications is often required. Mollicutes microorganism contamination of tissue cultures is a major problem because it can determine various and severe alterations in cellular function. Thus methods able to detect and trace cell cultures with Mollicutes contamination are needed in the monitoring of cells grown under good manufacturing practice conditions, and cell lines in continuous culture must be tested at regular intervals. We here describe a multiplex quantitative polymerase chain reaction assay able to detect contaminant Mollicutes species in a single-tube reaction through analysis of 16S-23S rRNA intergenic spacer regions and Tuf and P1 cytoadhesin genes. The method shows a sensitivity, specificity, and robustness comparable with the culture and the indicator cell culture as required by the European Pharmacopoeia guidelines and was validated following International Conference on Harmonization guidelines and Food and Drug Administration requirements.

Consensus nomenclature rules for radiopharmaceutical chemistry — Setting the record straight

DOE Office of Scientific and Technical Information (OSTI.GOV)

Coenen, Heinz H.; Gee, Antony D.; Adam, Michael

Over recent years, within the community of radiopharmaceutical sciences, there has been an increased incidence of incorrect usage of established scientific terms and conventions, and even the emergence of ‘self-invented’ terms. Here, in order to address these concerns, an international Working Group on ‘Nomenclature in Radiopharmaceutical Chemistry and related areas’ was established in 2015 to achieve clarification of terms and to generate consensus on the utilisation of a standardised nomenclature pertinent to the field. Upon open consultation, the following consensus guidelines were agreed, which aim to: Provide a reference source for nomenclature good practice in the radiopharma-ceutical sciences; Clarify themore » use of terms and rules concerning exclusively radiopharmaceutical terminology, i.e. nuclear- and radiochemical terms, symbols and expressions; Address gaps and inconsistencies in existing radiochemistry nomenclature rules; Provide source literature for further harmonisation beyond our immediate peer group (publishers, editors, IUPAC, pharmacopoeias, etc.).« less

Expression of Clostridium perfringens epsilon-beta fusion toxin gene in E. coli and its immunologic studies in mouse.

PubMed

Pilehchian Langroudi, Reza; Shamsara, Mehdi; Aghaiypour, Khosrow

2013-07-11

Clostridium perfringens is an anaerobic spore-forming, pathogenic bacterium that is responsible for severe diseases in humans and livestock. In the present study, an epsilon-beta fusion toxin was expressed as a soluble protein in E. coli and the recombinant cell lysate was used for immunization studies in mouse. Potency of the toxin (as an antigen) induced 6 and 10IU/ml of epsilon and beta anti-toxin in rabbit, respectively. These titers were higher than the minimum level required by the European Pharmacopoeia for epsilon and beta toxins. Experimental challenge with the recombinant fusion toxoid revealed that it could protect mice against C. perfringens epsilon and beta toxins. Toxicity of the fusion toxin was studied by histopathological findings, which were the same as the native toxins. In conclusion, E. coli is a suitable expression host for immunogenic epsilon-beta fusion toxin of C. perfringens. Copyright © 2013 Elsevier Ltd. All rights reserved.

A comparative study on immunomodulatory activity of polysaccharides from two official species of Ganoderma (Lingzhi).

PubMed

Meng, Lan-Zhen; Xie, Jing; Lv, Guang-Ping; Hu, De-Jun; Zhao, Jing; Duan, Jin-Ao; Li, Shao-Ping

2014-01-01

Two Ganoderma species, G. lucidum and G. sinense, are listed as Lingzhi in Chinese Pharmacopoeia and they are considered to have the same therapeutic effects. Polysaccharides were the main immunomodulatory and anticancer components in Ganoderma. In this study, the chemical characters and the effects of polysaccharides from G. lucidum (GLPS) and G. sinense (GSPS) on macrophage functions were investigated and compared. Chemical studies showed that GLPS and GSPS were different, displaying various molecular weight distribution and ratio of monosaccharide components. In vitro pharmacological studies showed that both GLPS and GSPS had potent effects on macrophage functions, such as promoting macrophage phagocytosis, increasing their release of nitric oxide and cytokines interleukin (IL)-1α, IL-6, IL-10, and tumor necrosis factor-α. Generally, GLPS was more powerful than GSPS. This study is helpful to elucidate the active components and pharmacological variation between the 2 Ganoderma species. The structure-activity relationship of polysaccharides from Ganoderma needs further study.

Studies on an inactivated vaccine against rabies virus in domestic animals.

PubMed

Monaco, F; Franchi, P M; Lelli, R

2006-01-01

An inactivated vaccine against rabies virus was prepared from the attenuated ATCC PV-12 viral rabbit Pasteur strain. The virus was grown on Baby Hamster Kidney (BHK21) cells, and the supernatant was purified by filtration and inactivated with beta-propriolactone. The inactivated product was checked according to the NHI and European Pharmacopoeia methods. Part of the product was then lyophilised and the other part was adjuvanted with Al(OH)3. Both parts were used to vaccinate and boost groups of horses, cattle and sheep at different intervals. Their immunogenicity was compared with a similar commercial product. Blood samples were collected on a regular basis and the antibody titre was determined by the Fluorescence Antibody Virus Neutralisation (FAVN) test. No significant differences were found between species after both inoculations even though the immune response increased in intensity and duration after the booster dose in all the animals tested and was stronger and lasted longer with the adjuvanted aliquot.

In vitro evaluation of antioxidant activity of Cordia dichotoma (Forst f.) bark

PubMed Central

Nariya, Pankaj B.; Bhalodia, Nayan R.; Shukla, Vinay J.; Acharya, Rabinarayan; Nariya, Mukesh B.

2013-01-01

Cordia dichotoma Forst. f. bark, identified as botanical source of Shleshmataka in Ayurvedic pharmacopoeia. Present investigation was undertaken to evaluate possible antioxidant potential of methanolic and butanol extract of C. dichotoma bark. In vitro antioxidant activity of methanolic and butanol extract was determined by 1,1, diphenyl–2, picrylhydrazyl (DPPH) free radical scavenging assay. The extracts were also evaluated for their phenolic contents and antioxidant activity. Phenolic content was measured using Folin–Ciocalteu reagent and was calculated as Gallic acid equivalents. Antiradical activity of methanolic extract was measured by DPPH assay and was compared to ascorbic acid and ferric reducing power of the extract was evaluated by Oyaizu method. In the present study three in vitro models were used to evaluate antioxidant activity. The first two methods were for direct measurement of radical scavenging activity and remaining one method evaluated the reducing power. The present study revealed that the C. dichotoma bark has significant radical scavenging activity. PMID:24049418

In vitro evaluation of antioxidant activity of Cordia dichotoma (Forst f.) bark.

PubMed

Nariya, Pankaj B; Bhalodia, Nayan R; Shukla, Vinay J; Acharya, Rabinarayan; Nariya, Mukesh B

2013-01-01

Cordia dichotoma Forst. f. bark, identified as botanical source of Shleshmataka in Ayurvedic pharmacopoeia. Present investigation was undertaken to evaluate possible antioxidant potential of methanolic and butanol extract of C. dichotoma bark. In vitro antioxidant activity of methanolic and butanol extract was determined by 1,1, diphenyl-2, picrylhydrazyl (DPPH) free radical scavenging assay. The extracts were also evaluated for their phenolic contents and antioxidant activity. Phenolic content was measured using Folin-Ciocalteu reagent and was calculated as Gallic acid equivalents. Antiradical activity of methanolic extract was measured by DPPH assay and was compared to ascorbic acid and ferric reducing power of the extract was evaluated by Oyaizu method. In the present study three in vitro models were used to evaluate antioxidant activity. The first two methods were for direct measurement of radical scavenging activity and remaining one method evaluated the reducing power. The present study revealed that the C. dichotoma bark has significant radical scavenging activity.

Exploration of the frontiers of tradomedical practices: basis for development of alternative medical healthcare services in developing countries.

PubMed

Osujih, M

1993-08-01

The study is a brief exploration of the functions and roles of the traditional healers in the total health care delivery system as a basis for tapping the salient features of this age old art: for the purpose of refining, and establishing it as an alternative medical health-care service. The investigation is considered relevant particularly in the developing countries where, in addition to the dearth of orthodox medical services, institutions and personnel, it is relatively cheaper, socio-culturally accessible and acceptable. Refining and developing some aspects of the traditional healers' services will serve the interest of the health consumers whose main concern is with service and not the source. Furthermore, it is hoped that the study will stimulate purposeful discussions on the need for an unbiased examination of the materials, methods and techniques of the traditional healers including, eventually, compiling a native pharmacopoeia. A more comprehensive account of the traditional healers contributions to the battle against diseases and maintenance of health and well being is envisaged.

Surface-active agents from the group of polyoxyethylated glycerol esters of fatty acids. Part III. Surface activity and solubilizing properties of the products of oxyethylation of lard (Adeps suillus, F.P. VIII) in the equilibrium system in relation to lipophilic therapeutic agents (class II and III of BCS).

PubMed

Nachajski, Michał J; Piotrowska, Jowita B; Kołodziejczyk, Michał K; Lukosek, Marek; Zgoda, Marian M

2013-01-01

Research was conducted into the solubilization processes of diclofenac, ibuprofen, ketoprofen and naproxen in equilibrium conditions in the environment of aqueous solutions of oxyethylated lard's fractions (Adeps suillus, Polish Pharmacopoeia VIII). The determined thermodynamic (cmc, deltaGm(0)) and hydrodynamic (R0, R(obs), omega, M(eta)) parameters characterizing the micelle of the solubilizer and the adduct demonstrate that lipophilic therapeutic agents are adsorbed in a palisade structure of the micelle due to a topologically created so-called "lipophilic adsorption pocket". This shows that the hydrophilicity of the micelle and the adsorption layer decreases at the phase boundary, which is confirmed by the calculated values of coefficients A(m) and r x (a). The results obtained indicate the possibility of making use of the class of non-ionic surfactants which are not ksenobiotics for the modification of the profile of solid oral dosage forms with lipophilic therapeutic agents from the II class of Biopharmaceutics Classification System (BCS).

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2005-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products and related materials and draft guidelines for registration of fixed-dose combination medicinal products.

Validation of Milliflex® Quantum for Bioburden Testing of Pharmaceutical Products.

PubMed

Gordon, Oliver; Goverde, Marcel; Staerk, Alexandra; Roesti, David

2017-01-01

This article reports the validation strategy used to demonstrate that the Milliflex ® Quantum yielded non-inferior results to the traditional bioburden method. It was validated according to USP <1223>, European Pharmacopoeia 5.1.6, and Parenteral Drug Association Technical Report No. 33 and comprised the validation parameters robustness, ruggedness, repeatability, specificity, limit of detection and quantification, accuracy, precision, linearity, range, and equivalence in routine operation. For the validation, a combination of pharmacopeial ATCC strains as well as a broad selection of in-house isolates were used. In-house isolates were used in stressed state. Results were statistically evaluated regarding the pharmacopeial acceptance criterion of ≥70% recovery compared to the traditional method. Post-hoc test power calculations verified the appropriateness of the used sample size to detect such a difference. Furthermore, equivalence tests verified non-inferiority of the rapid method as compared to the traditional method. In conclusion, the rapid bioburden on basis of the Milliflex ® Quantum was successfully validated as alternative method to the traditional bioburden test. LAY ABSTRACT: Pharmaceutical drug products must fulfill specified quality criteria regarding their microbial content in order to ensure patient safety. Drugs that are delivered into the body via injection, infusion, or implantation must be sterile (i.e., devoid of living microorganisms). Bioburden testing measures the levels of microbes present in the bulk solution of a drug before sterilization, and thus it provides important information for manufacturing a safe product. In general, bioburden testing has to be performed using the methods described in the pharmacopoeias (membrane filtration or plate count). These methods are well established and validated regarding their effectiveness; however, the incubation time required to visually identify microbial colonies is long. Thus, alternative

A pilot study on quality of artesunate and amodiaquine tablets used in the fishing community of Tema, Ghana

PubMed Central

2013-01-01

Background The ineffectiveness of artesunate and amodiaquine tablets in malaria treatment remains a health burden to WHO and governments of malaria-endemic countries, including Ghana. The proliferation of illegitimate anti-malarial drugs and its use by patients is of primary concern to international and local drug regulatory agencies because such drugs are known to contribute to the development of the malaria-resistant parasites in humans. No data exist on quality of these drugs in the fishing village communities in Ghana although the villagers are likely users of such drugs. A pilot study on the quality of anti-malarial tablets in circulation during the major fishing season at a malarious fishing village located along the coast of Tema in southern Ghana was determined. Methods Blisterpacks of anti-malarial tablets were randomly sampled. The International Pharmacopoeia and Global Pharma Health Fund Minilab protocols were used to assess the quality of anti-malarial tablets per blisterpacks allegedly manufactured by Guilin Pharmaceutical Co Ltd, China (GPCL) and Letap Pharmaceuticals Ltd, Ghana (LPL) and sold in chemical sales outlets at Kpone-on–Sea. Ferric chloride and cobaltous thiocyanate tests confirmed the presence of active ingredients in the tablets. A confirmatory test for the active ingredient was achieved with artesunate (ICRS1409) and amodiaquine (ICRS0209) reference standards. A high performance liquid chromatography analysis confirmed the amount of artesunate found in tablets. Results Based on the International Pharmacopoeia acceptable range of 96/98 to 102% for genuine artesunate per tablet, 10% [relative standard deviation (RSD): 3.2%] of field-selected artesunate blisterpack per tablets manufactured by GPCL, and 50% (RSD: 5.1%) of a similar package per tablet by LPL, passed the titrimetric test. However, 100% (RSD: 2.2%) of amodiaquine blisterpack per tablet by GPCL were found to be within the International Pharmacopeia acceptable range of 90 to

Collaborative study for the establishment of the WHO 3(rd) International Standard for Endotoxin, the Ph. Eur. endotoxin biological reference preparation batch 5 and the USP Reference Standard for Endotoxin Lot H0K354.

PubMed

Findlay, L; Desai, T; Heath, A; Poole, S; Crivellone, M; Hauck, W; Ambrose, M; Morris, T; Daas, A; Rautmann, G; Buchheit, K H; Spieser, J M; Terao, E

2015-01-01

An international collaborative study was organised jointly by the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC), the United States Pharmacopeia (USP) and the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe) for the establishment of harmonised replacement endotoxin standards for these 3 organisations. Thirty-five laboratories worldwide, including Official Medicines Control Laboratories (OMCLs) and manufacturers enrolled in the study. Three candidate preparations (10/178, 10/190 and 10/196) were produced with the same material and same formulation as the current reference standards with the objective of generating a new (3(rd)) International Standard (IS) with the same potency (10 000 IU/vial) as the current (2(nd)) IS, as well as new European Pharmacopoeia (Ph. Eur.). and USP standards. The suitability of the candidate preparations to act as the reference standard in assays for endotoxin performed according to compendial methods was evaluated. Their potency was calibrated against the WHO 2(nd) IS for Endotoxin (94/580). Gelation and photometric methods produced similar results for each of the candidate preparations. The overall potency estimates for the 3 batches were comparable. Given the intrinsic assay precision, the observed differences between the batches may be considered unimportant for the intended use of these materials. Overall, these results were in line with those generated for the establishment of the current preparations of reference standards. Accelerated degradation testing of vials stored at elevated temperatures supported the long-term stability of the 3 candidate preparations. It was agreed between the 3 organisations that batch 10/178 be shared between WHO and EDQM and that batches 10/190 and 10/196 be allocated to USP, with a common assigned value of 10 000 IU/vial. This value maintains the continuity of the global harmonisation of reference materials and

Citri Reticulatae Pericarpium (Chenpi): Botany, ethnopharmacology, phytochemistry, and pharmacology of a frequently used traditional Chinese medicine.

PubMed

Yu, Xin; Sun, Shuang; Guo, Yuyan; Liu, Yan; Yang, Dayu; Li, Guoyu; Lü, Shaowa

2018-06-28

Citri Reticulatae Pericarpium (Rutaceae, CRP), commonly called as Chenpi () in Chinese, is most frequently used as a qi-regulating drug in thousands of Chinese medicine prescriptions. CRP is found mainly in major citrus-producing areas such as the Guangdong, Guangxi, Sichuan, Fujian, and Zhejiang Provinces of China. Since thousands of years in China, CRP has been used widely in clinical practice to treat nausea, vomiting, indigestion, anepithymia, diarrhea, cough, expectoration, and so on. Currently, CRP is listed in the Pharmacopoeia of the People's Republic of China. The present paper reviews the botany, ethnopharmacology, phytochemistry, pharmacology, quality control, and toxicology of CRP. Information on CRP was gathered from various sources including the books on traditional Chinese herbal medicine; scientific databases including Elsevier, PubMed, and ScienceDirect; Baidu Scholar; CNKI; and others and from different professional websites. Approximately 140 chemical compounds have been isolated and identified from CRP. Among them, volatile oils and flavonoids are generally considered as the main bioactive and characteristic ingredients. CRP possesses wide pharmacological effects such as having a beneficial effect on the cardiovascular, digestive, and respiratory systems, antitumor, antioxidant, and anti-inflammatory properties; and a protective effect on the liver and nerve. Moreover, hesperidin is chosen as an indicator in the quantitative determination of CRP, and the quantity of aflatoxin in CRP must not exceed the standard limit mentioned in the pharmacopoeia. In brief, CRP has a warming nature, and hence, it can be used in harmony with a lot of medicines. CRP not only exhibits its effects individually but also aids other medicines exhibit a better effect. CRP can be consumed with tea, food, alcohol, and medicine. Irrespective of the form it is being consumed, CRP not only shows a synergistic effect but also has strengths on its own. Modern pharmacological

Therapeutic Effects of Medicinal Plants on Cutaneous Wound Healing in Humans: A Systematic Review

PubMed Central

de Lara, Celia Eliane; Ferreira, Fabiana Borges Padilha; de Souza Terron Monich, Mariana; Mesquita da Silva, Claudinei; Felicetti Lordani, Claudia Regina; Giacomini Bueno, Fernanda; Vieira Teixeira, Jorge Juarez

2018-01-01

The pharmaceutical industry has made great strides in providing drugs that are able to stimulate the healing process, but only 1–3% of all drugs that are listed in Western pharmacopoeias are intended for use on the skin or cutaneous wounds. Of these, at least one-third are obtained from plants. We sought to review the therapeutic effects of medicinal plants on human skin lesions. For this systematic review, we searched the PubMed, Scopus, and Web of Science databases to identify clinical trials that were published from 1997 to 2017. We reviewed studies that described the use of medicinal plants for the treatment of skin lesions in humans. Ten studies were selected, eight of which were published from 2007 to 2016, with a total of 503 patients. Among the plant species that were used for the treatment of human skin lesions, 12 belonged to 11 families and were included in the analysis. All of the plant species that were studied presented high therapeutic potential for the treatment of cutaneous lesions. PMID:29805312

Micelle-mediated extraction and cloud point preconcentration for the analysis of aesculin and aesculetin in Cortex fraxini by HPLC.

PubMed

Shi, Zhihong; Zhu, Xiaomin; Zhang, Hongyi

2007-08-15

In this paper, a micelle-mediated extraction and cloud point preconcentration method was developed for the determination of less hydrophobic compounds aesculin and aesculetin in Cortex fraxini by HPLC. Non-ionic surfactant oligoethylene glycol monoalkyl ether (Genapol X-080) was employed as the extraction solvent. Various experimental conditions were investigated to optimize the extraction process. Under optimum conditions, i.e. 5% Genapol X-080 (w/v), pH 1.0, liquid/solid ratio of 400:1 (ml/g), ultrasonic-assisted extraction for 30 min, the extraction yield reached the highest value. For the preconcentration of aesculin and aesculetin by cloud point extraction (CPE), the solution was incubated in a thermostatic water bath at 55 degrees C for 30 min, and 20% NaCl (w/v) was added to the solution to facilitate the phase separation and increase the preconcentration factor during the CPE process. Compared with methanol, which was used in Chinese Pharmacopoeia (2005 edition) for the extraction of C. fraxini, the extraction efficiency of 5% Genapol X-080 reached higher value.

Development and stability of semisolid preparations based on a supercritical CO2 Arnica extract.

PubMed

Bilia, Anna Rita; Bergonzi, Maria Camilla; Mazzi, Giovanni; Vincieri, Franco Francesco

2006-05-03

Conventional herbal drug preparations (HDP) based on Arnica montana L. have a low content of the active principles, sesquiterpene lactones, which show poor stability and low physical compatibility in semisolid formulations. Recently, an innovative supercritical carbon dioxide (CO2) extract with high sesquiterpene content has been marketed. Development of six semisolid preparations (cetomacrogol, polysorbate 60, polawax, anphyphil, natrosol and sepigel) based on this innovative CO2 extract is discussed. Stability of these preparations was investigated according to ICH guidelines. The evaluation of in vitro release of active constituents was performed using the cell method reported in the European Pharmacopoeia. Preliminary data on in vivo permeation of three selected formulations is demonstrated using the "skin stripping" test, according to the FDA, in healthy subjects. Analysis of sesquiterpene lactones within the extract and in vitro and in vivo studies was performed by RP-HPLC-DAD-MS method. The cetomacrogol showed the best release profile in the in vitro test, while in the in vivo test the best preparation resulted polysorbate 60 and polawax.

Use of Innovative (Micro)Extraction Techniques to Characterise Harpagophytum procumbens Root and its Commercial Food Supplements.

PubMed

Diuzheva, Alina; Carradori, Simone; Andruch, Vasil; Locatelli, Marcello; De Luca, Elisa; Tiecco, Matteo; Germani, Raimondo; Menghini, Luigi; Nocentini, Alessio; Gratteri, Paola; Campestre, Cristina

2018-05-01

For the determination of harpagoside and the wide phenolic pattern in Harpagophytum procumbens root and its commercial food supplements, dispersive liquid-liquid microextraction (DLLME), ultrasound-assisted DLLME (UA-DLLME), and sugaring-out liquid-liquid extraction (SULLE) were tested and compared. In order to optimise the extraction efficiency, DLLME and UA-DLLME were performed in different solvents (water and aqueous solutions of glucose, β-cyclodextrin, (2-hydroxypropyl)-β-cyclodextrin, sodium chloride, natural deep eutectic solvent, and ionic liquid). The plant material was ground and sieved to obtain a uniform granulometry before extraction. Commercial food supplements, containing H. procumbens are commercially available in Italy. The most effective sodium chloride-aided-DLLME was then optimised and applied for analyses followed by HPLC-PDA. For comparison, microwave-assisted extraction was performed using the same solvents and the best results were obtained using 1% of β-cyclodextrin or 15% of sodium chloride. All commercial samples respected the European Pharmacopoeia monograph for this plant material, showing a harpagoside content ≥ 1.2%. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

A solvent-extraction module for cyclotron production of high-purity technetium-99m.

PubMed

Martini, Petra; Boschi, Alessandra; Cicoria, Gianfranco; Uccelli, Licia; Pasquali, Micòl; Duatti, Adriano; Pupillo, Gaia; Marengo, Mario; Loriggiola, Massimo; Esposito, Juan

2016-12-01

The design and fabrication of a fully-automated, remotely controlled module for the extraction and purification of technetium-99m (Tc-99m), produced by proton bombardment of enriched Mo-100 molybdenum metallic targets in a low-energy medical cyclotron, is here described. After dissolution of the irradiated solid target in hydrogen peroxide, Tc-99m was obtained under the chemical form of 99m TcO 4 - , in high radionuclidic and radiochemical purity, by solvent extraction with methyl ethyl ketone (MEK). The extraction process was accomplished inside a glass column-shaped vial especially designed to allow for an easy automation of the whole procedure. Recovery yields were always >90% of the loaded activity. The final pertechnetate saline solution Na 99m TcO 4 , purified using the automated module here described, is within the Pharmacopoeia quality control parameters and is therefore a valid alternative to generator-produced 99m Tc. The resulting automated module is cost-effective and easily replicable for in-house production of high-purity Tc-99m by cyclotrons. Copyright © 2016 Elsevier Ltd. All rights reserved.

Determination of propranolol hydrochloride in pharmaceutical preparations using near infrared spectrometry with fiber optic probe and multivariate calibration methods.

PubMed

Marques Junior, Jucelino Medeiros; Muller, Aline Lima Hermes; Foletto, Edson Luiz; da Costa, Adilson Ben; Bizzi, Cezar Augusto; Irineu Muller, Edson

2015-01-01

A method for determination of propranolol hydrochloride in pharmaceutical preparation using near infrared spectrometry with fiber optic probe (FTNIR/PROBE) and combined with chemometric methods was developed. Calibration models were developed using two variable selection models: interval partial least squares (iPLS) and synergy interval partial least squares (siPLS). The treatments based on the mean centered data and multiplicative scatter correction (MSC) were selected for models construction. A root mean square error of prediction (RMSEP) of 8.2 mg g(-1) was achieved using siPLS (s2i20PLS) algorithm with spectra divided into 20 intervals and combination of 2 intervals (8501 to 8801 and 5201 to 5501 cm(-1)). Results obtained by the proposed method were compared with those using the pharmacopoeia reference method and significant difference was not observed. Therefore, proposed method allowed a fast, precise, and accurate determination of propranolol hydrochloride in pharmaceutical preparations. Furthermore, it is possible to carry out on-line analysis of this active principle in pharmaceutical formulations with use of fiber optic probe.

Validation of Quantitative HPLC Method for Bacosides in KeenMind.

PubMed

Dowell, Ashley; Davidson, George; Ghosh, Dilip

2015-01-01

Brahmi (Bacopa monnieri) has been used by Ayurvedic medical practitioners in India for almost 3000 years. The pharmacological properties of Bacopa monnieri were studied extensively and the activities were attributed mainly due to the presence of characteristic saponins called "bacosides." Bacosides are complex mixture of structurally closely related compounds, glycosides of either jujubogenin or pseudojujubogenin. The popularity of herbal medicines and increasing clinical evidence to support associated health claims require standardisation of the phytochemical actives contained in these products. However, unlike allopathic medicines which typically contain a single active compound, herbal medicines are typically complex mixtures of various phytochemicals. The assay for bacosides in the British Pharmacopoeia monograph for Bacopa monnieri exemplifies that only a subset of bacosides present are included in the calculation of total bacosides. These results in calculated bacoside values are significantly lower than those attained for the same material using more inclusive techniques such as UV spectroscopy. This study illustrates some of the problems encountered when applying chemical analysis for standardisation of herbal medicines, particularly in relation to the new method development and validation of bacosides from KeenMind.

Pharmacognostical and physicochemical analysis of Tamarindus indica Linn. stem.

PubMed

Kodlady, Naveena; Patgiri, B J; Harisha, C R; Shukla, V J

2012-01-01

Tamarindus indica Linn. fruits (Chincha) are extensively used in culinary preparations in Indian civilization. Its vast medicinal uses are documented in Ayurvedic classics and it can be used singly or as a component of various formulations. Besides fruit, the Kasta (wood) of T. indica L. is also important and used to prepare Kshara (alkaline extract) an Ayurvedic dosage form. Pharmacognostical and physicochemical details of Chincha Kasta are not available in authentic literature including API (Ayurvedic Pharmacopoeia of India). The study is an attempt in this direction. T. indica L. stem with heartwood was selected and morphological, microscopic and physicochemical standardization characters along with TLC finger print, and fluorescence analysis were documented. Transverse section of stem showed important characters such as phelloderm, stone cells layer, fiber groups, calcium oxalate, crystal fibers, and tylosis in heartwood region. Four characteristic spots were observed under UV long wave, in thin layer chromatography with the solvent combination of toluene: ethyl acetate (8:2). The study can help correct identification and standardization of this plant material.

[Concern for children in family management texts].

PubMed

Kottek, Samuel S

2002-06-01

Hausväterliteratur designates works aimed at landlords and their wives in order to help them in the management of their estate. Among a wide-ranged list of topics tackled in these sizeable volumes, child welfare seldom fails to appear, though generally rather briefly. We consider in this paper a number of German works, most of them dating from the 17th century, though beginning with Johann Coler (1593) and winding up with Johann Joachim Becher (1714). These works include some advice on how to diagnose and manage the most common ailments, as well as some basic educational principles. A brief "pediatric" pharmacopoeia is often added. Although this review concerns only works in German, we have added references to a document taken from English literature, the diary of the clergyman and landlord Ralph Josselin. Dating from the same period (1643-1683), this document shows us how a landlord and his wife actually treated their sick children, thus shifting from theory to practice. "Hausväterliteratur" can be considered as an early stage of what was later termed "Domestic Medicine".

[Improvement of powder flowability and hygroscopicity of traditional Chinese medicine extract by surface coating modification technology].

PubMed

Zeng, Rong-Gui; Jiang, Qie-Ying; Liao, Zheng-Gen; Zhao, Guo-Wei; Luo, Yun; Luo, Juan; Lv, Dan

2016-06-01

To study the improvement of powder flowability and hygroscopicity of traditional Chinese medicine extract by surface coating modification technology. The 1% hydrophobic silica nanoparticles were used as surface modifier, and andrographis extract powder was taken as a model drug. Three different techniques were used for coating model drugs, with angle of repose, compressibility, flat angle and cohesion as the comprehensive evaluation indexes for the powder flowability. The powder particle size and the size distribution were measured by Mastersizer 2000. FEI scanning electron microscope was used to observe the surface morphology and structure of the powder. The percentage of Si element on the powder surface was measured by energy dispersive spectrometer. The hygroscopicity of powder was determined by Chinese pharmacopoeia method. All of the three techniques can improve the flowability of powder extract. In particular, hygroscopicity of extract powder can also be improved by dispersion and then high-speed mixing, which can produce a higher percentage of Si element on the powder surface. The improvement principle may be correlated with a modifier adhered to the powder surface. Copyright© by the Chinese Pharmaceutical Association.

Stability studies on diloxanide furoate: effect of pH, temperature, gastric and intestinal fluids.

PubMed

Gadkariem, E A; Belal, F; Abounassif, M A; El-Obeid, H A; E E Ibrahim, K

2004-04-01

The degradation of the amoebicide diloxanide furoate in alkaline medium at different temperatures was investigated using both a spectrophotometric and a developed HPLC method. In solutions, the drug was found to undergo decomposition, i.e., temperature and pH dependent. The pH-rate profile at pH between 7.6 and 9.6 indicated a first-order dependence of Kobs on [-OH]. Arrhenius plot obtained at pH 8 was linear between 40 and 63 degrees C. The estimated activation energy of hydrolysis was found to be 18.25 kcal degree.mol(-1). The effect of simulated gastric and intestinal fluids on the drug was also investigated. A new thin-layer chromatographic (TLC) procedure for the fractionation of the drug and its alkaline hydrolysis products has been developed and was found to compare favorably with that of the British Pharmacopoeia. Three hydrolysis products of a basic methanolic solution of the drug, namely furoic acid, diloxanide and methylfuroate could be identified by the use of TLC, HPLC, infrared and mass spectrometry.

Gene-Editing: Interpretation of Current Law and Legal Policy.

PubMed

Kim, Na-Kyoung

2017-09-01

With the development of the third-generation gene scissors, CRISPR-Cas9, concerns are being raised about ethical and social repercussions of the new gene-editing technology. In this situation, this article explores the legislation and interpretation of the positive laws in South Korea. The BioAct does not specify and regulate 'gene editing' itself. However, assuming that genetic editing is used in the process of research and treatment, we can look to the specific details of the regulations for research on humans as well as gene therapy research in order to see how genetic editing is regulated under the BioAct. BioAct differentiates the regulation between (born) humans and embryos etc. and the regulation differ entirely in the manner and scope. Moreover, due to the fact that gene therapy products are regarded as drugs, they fall under different regulations. The Korean Pharmacopoeia Act put stringent sanctions on clinical trials for gene therapy products and the official Notification "Approval and Examination Regulations for Biological Products, etc." by Food and Drug Safety Administration may be applied to gene editing for gene therapy purposes.

[Pharmacology in ancient Rome. First appearance, development, extension].

PubMed

Lehmann, Yves; Lehmann, Hélène

2015-01-01

The history of Roman pharmacology is ponctuated with ideological debates about relevance of this art. Thus, Hippocrates --a contemporary of Socrates who was teaching that "science of remedies and science of poisons are the same"--was given credit for favourable mood towards pharmaceuticals by Scribonius Largus on the basis of therapeutic complementarity. Among the Latin doctors of the late Roman Empire, Marcellus Empiricus and Caelius Aurelianus, Hippocrates appeared as an authority favourable towards medication, especially in a fictitious letter written by Marcellus to the Claudian emancipated slave Callistus. Likewise, popular philosophy has taken over the Socratic antinomy between remedia and uenena. Last but not least, Sextius Niger wrote a pharmacopoeia attested as an official source by Celsus and plentifully consulted by Pliny the Elder: the Naturalis historia allows to delimit Sextius' contribution to the recurring controversy about use of pharmaceuticals. In such a context, the antipharmaceutical argument entered by Asclepiades of Bithynia fulfils a provocative function, the historical impact of which needs to be assessed according to the present-day speculation about "useful, useless or dangerous medicines".

Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products.

PubMed

Velaga, Sitaram P; Djuris, Jelena; Cvijic, Sandra; Rozou, Stavroula; Russo, Paola; Colombo, Gaia; Rossi, Alessandra

2018-02-15

In vitro dissolution testing is routinely used in the development of pharmaceutical products. Whilst the dissolution testing methods are well established and standardized for oral dosage forms, i.e. tablets and capsules, there are no pharmacopoeia methods or regulatory requirements for testing the dissolution of orally inhaled powders. Despite this, a wide variety of dissolution testing methods for orally inhaled powders has been developed and their bio-relevance has been evaluated. This review provides an overview of the in vitro dissolution methodologies for dry inhalation products, with particular emphasis on dry powder inhalers, where the dissolution behavior of the respirable particles can have a role on duration and absorption of the drug. Dissolution mechanisms of respirable particles as well as kinetic models have been presented. A more recent biorelevant dissolution set-ups and media for studying inhalation biopharmaceutics were also reviewed. In addition, factors affecting interplay between dissolution and absorption of deposited particles in the context of biopharmaceutical considerations of inhalation products were examined. Copyright © 2017 Elsevier B.V. All rights reserved.

Direct high-performance liquid chromatographic determination of the enantiomeric purity of levodopa and methyldopa: comparison with pharmacopoeial polarimetric methods.

PubMed

Dolezalová, M; Tkaczyková, M

1999-03-01

Chiral high-performance liquid chromatography was employed for determination of the enantiomeric purity of levodopa and methyldopa. The determination of D-DOPA in levodopa was accomplished using a chiral ligand-exchange chromatograpy with an ordinary C18 column and a chiral mobile phase containing N,N-dimethyl-L-phenylalanine and Cu(II) acetate or by means of LC on a teicoplanin column in conjunction with ethanol-water (65:35, v/v). Both methods gave good performance, however, the latter was faster and more convenient and suitable for routine analyses. For the determination of D-methyldopa a LC method based on the use of a teicoplanin column in polar organic mode with methanol-acetic acid-triethylamine (1,000:0.05:0.05, v/v/v) mobile phase was developed. The precision, accuracy, linearity and selectivity were satisfactory. In comparison with pharmacopoeial polarimetric methods (according to the European Pharmacopoeia and the Pharmacopoea Bohemoslovaca), the LC methods proved to be much more sensitive giving detection limits 0.04% of D-DOPA and 0.3% of D-methyldopa.

[Treatment and remedies against smallpox outbreaks in Ferrara in the late nineteenth century].

PubMed

Vicentini, Chiara Beatrice; Manfredini, Stefano; Altieri, Lorenzo; Lupi, Silvia; Guidi, Enrica; Contini, Carlo

2013-09-01

Health interventions against smallpox during the two epidemics in the second half of the 19th century are outlined. The 1871 hospital health report and the medical report on smallpox patients treated at the hospital and poorhouse of Ferrara between January 1891 and January 1892, drawn up by Alessandro Bennati, provide both interesting data and insights into the treatments and remedies of the time. The treatment of this illness was - and indeed could be - nothing other than symptomatic, there being no real means to halt the spread of the disease. Rather, other remedies were found by alleviating pain and regaining energy during the various stages of the disease. A close relationship between vaccination and the incidence and gravity of the illness is underlined. When the practice of vaccination started to be widely employed at the end of the century, there were almost no cases of death due to smallpox. The pharmacopoeias of the time, Antonio Campana's Farmacopea ferrarese in particular, proved an essential guide in the analysis of each document.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2003-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, the report discusses activities related to the development of The International Pharmacopoeia and basic tests for pharmaceutical substances and dosage forms, as well as quality control of reference materials, good manufacturing practices (GMP), stability studies, inspection, hazard analysis, procurement, storage and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including recommendations on the risk of transmitting animal spongiform encephalopathy agents via medicinal products, guidelines on GMP for pharmaceutical products, a model certificate for GMP and guidance on a GMP inspection report. The final annexes provide guidance on the application of Hazard Analysis and Critical Control Point (HACCP) method to pharmaceuticals, good storage practices and a procedure for assessing acceptability of pharmaceutical products for purchase by United Nations agencies.

Evaluation of capillary zone electrophoresis for the determination of protein composition in therapeutic immunoglobulins and human albumins.

PubMed

Christians, Stefan; van Treel, Nadine Denise; Bieniara, Gabriele; Eulig-Wien, Annika; Hanschmann, Kay-Martin; Giess, Siegfried

2016-07-01

Capillary zone electrophoresis (CZE) provides an alternative means of separating native proteins on the basis of their inherent electrophoretic mobilities. The major advantage of CZE is the quantification by UV detection, circumventing the drawbacks of staining and densitometry in the case of gel electrophoresis methods. The data of this validation study showed that CZE is a reliable assay for the determination of protein composition in therapeutic preparations of human albumin and human polyclonal immunoglobulins. Data obtained by CZE are in line with "historical" data obtained by the compendial method, provided that peak integration is performed without time correction. The focus here was to establish a rapid and reliable test to substitute the current gel based zone electrophoresis techniques for the control of protein composition of human immunoglobulins or albumins in the European Pharmacopoeia. We believe that the more advanced and modern CZE method described here is a very good alternative to the procedures currently described in the relevant monographs. Copyright © 2016 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

PharmDB-K: Integrated Bio-Pharmacological Network Database for Traditional Korean Medicine

PubMed Central

Lee, Ji-Hyun; Park, Kyoung Mii; Han, Dong-Jin; Bang, Nam Young; Kim, Do-Hee; Na, Hyeongjin; Lim, Semi; Kim, Tae Bum; Kim, Dae Gyu; Kim, Hyun-Jung; Chung, Yeonseok; Sung, Sang Hyun; Surh, Young-Joon; Kim, Sunghoon; Han, Byung Woo

2015-01-01

Despite the growing attention given to Traditional Medicine (TM) worldwide, there is no well-known, publicly available, integrated bio-pharmacological Traditional Korean Medicine (TKM) database for researchers in drug discovery. In this study, we have constructed PharmDB-K, which offers comprehensive information relating to TKM-associated drugs (compound), disease indication, and protein relationships. To explore the underlying molecular interaction of TKM, we integrated fourteen different databases, six Pharmacopoeias, and literature, and established a massive bio-pharmacological network for TKM and experimentally validated some cases predicted from the PharmDB-K analyses. Currently, PharmDB-K contains information about 262 TKMs, 7,815 drugs, 3,721 diseases, 32,373 proteins, and 1,887 side effects. One of the unique sets of information in PharmDB-K includes 400 indicator compounds used for standardization of herbal medicine. Furthermore, we are operating PharmDB-K via phExplorer (a network visualization software) and BioMart (a data federation framework) for convenient search and analysis of the TKM network. Database URL: http://pharmdb-k.org, http://biomart.i-pharm.org. PMID:26555441

[Rationality of commodity criteria and traditional breeding of Polygala tenuifolia based on agronomic traits and determination of chemical components].

PubMed

Wang, Dan-Dan; Bai, Lu; Xu, Xiao-Shuang; Zhang, Fu-Sheng; Xing, Jie; Jia, Jin-Ping; Tian, Hong-Ling; Qin, Xue-Mei

2016-10-01

The agronomic traits (plant height, root diameter, root length, first lateral root height, lateral root amount, root weight) of 18 Polygala tenuifolia samples with different agronomic traits were analyzed, respectively. HPLC was used to analyze three main characteristic components including tenuifolin, polygalaxanthone Ⅲ, and 3,6'-disinapoyl sucrose. At last, the correlation between six agronomic traits and three main characteristic components were analyzed by scatter plot. We found no significant correlation between root diameter and three main characteristic components. There were no obvious correlations between tenuifolin and the remaining five agronomic traits. Short root length and first lateral root height as well as high lateral root amount resulted in high levels of polygalaxanthone Ⅲ in P. tenuifolia samples. High levels of 3,6'-disinapoyl sucrose were observed in P. tenuifolia samples with longer root. So, the current commodity criteria and traditional breeding of P. tenuifolia did not conform to pharmacopoeia standards, which excellent medicinal materials should have high contents of the main characteristic components. It was urgent to revise the current commodity criteria and breeding methods. Copyright© by the Chinese Pharmaceutical Association.

Validation of an ergonomic method to withdraw [99mTc] radiopharmaceuticals.

PubMed

Blondeel-Gomes, Sandy; Marie, Solène; Fouque, Julien; Loyeau, Sabrina; Madar, Olivier; Lokiec, François

2017-11-10

The main objective of the present work was to ensure quality of radiopharmaceuticals syringes withdrawn with a "Spinal needle/obturator In-Stopper" system. Methods: Visual examinations and physicochemical tests are performed at T0 and T+4h for [ 99m Tc]albumin nanocolloid and T+7h for [ 99m Tc]eluate, [ 99m Tc] HydroxyMethylene DiPhosphonate and [ 99m Tc]Human Serum Albumin. Microbiological validation was performed according to European pharmacopoeia. Fingertip radiation exposure was evaluated to confirm the safety of the system. Results: Results show stable visual and physicochemical properties. The integrity of the connector was not affected after 30 punctures (no cores). No microbiological contamination was found on tested syringes. Conclusion: The system could be used 30 times. The stability of syringes drawing with this method is guaranteed up to 4 hours for [ 99m Tc]albumin nanocolloid and 7 hours for [ 99m Tc]eluate, [ 99m Tc]HydroxyMethylene DisPhosphonate and [ 99m Tc]Human serum albumin. Copyright © 2017 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Analysis of refill liquids for electronic cigarettes.

PubMed

Etter, Jean-François; Zäther, Eva; Svensson, Sofie

2013-09-01

To assess levels of nicotine, nicotine degradation products and some specific impurities in commercial refill liquids for electronic cigarettes. We analyzed 20 models of 10 of the most popular brands of refill liquids, using gas and liquid chromatography. We assessed nicotine content, content of the known nicotine degradation products and impurities, and presence of ethylene glycol and diethylene glycol. The nicotine content in the bottles corresponded closely to the labels on the bottles. The levels of nicotine degradation products represented 0-4.4% of those for nicotine, but for most samples the level was 1-2%. Cis-N-oxide, trans-N-oxide, myosmine, anatabine and anabasine were the most common additional compounds found. Neither ethylene glycol nor diethylene glycol were detected. The nicotine content of electronic cigarette refill bottles is close to what is stated on the label. Impurities are detectable in several brands above the level set for nicotine products in the European Pharmacopoeia, but below the level where they would be likely to cause harm. © 2013 Society for the Study of Addiction.

From conventional towards new - natural surfactants in drug delivery systems design: current status and perspectives.

PubMed

Savić, Snezana; Tamburić, Slobodanka; Savić, Miroslav M

2010-03-01

Surfactants play an important role in the development of both conventional and advanced (colloidal) drug delivery systems. There are several commercial surfactants, but a proportionally small group of them is approved as pharmaceutical excipients, recognized in various pharmacopoeias and therefore widely accepted by the pharmaceutical industry. The review covers some of the main categories of natural, sugar-based surfactants (alkyl polyglucosides and sugar esters) as prospective pharmaceutical excipients. It provides analysis of the physicochemical characteristics of sugar-based surfactants and their possible roles in the design of conventional or advanced drug delivery systems for different routes of administration. Summary and analysis of recent data on functionality, applied concentrations and formulation improvements produced by alkyl polyglucosides and sugar esters in different conventional and advanced delivery systems could be of interest to researchers dealing with drug formulation. Recent FDA certification of an alkyl polyglucoside surfactant for topical formulation presents a significant step in the process of recognition of this relatively new group of surfactants. This could trigger further research into the potential benefits of naturally derived materials in both conventional and new drug delivery systems.

Experimental Study on Inactivation of Bacterial Endotoxin by Using Dielectric Barrier Discharge

NASA Astrophysics Data System (ADS)

Shi, Xingmin; Li, Yaxi; Zhang, Guanjun; Ma, Yue; Shao, Xianjun

2011-12-01

The low-temperature plasma (LTP) generated by dielectric barrier discharge (DBD) was used to sterilize the E.coli endotoxin, which is usually difficult to kill by traditional methods. Three different concentrations of bacterial endotoxin (1 EU/mL, 0.5 EU/mL and 0.25 EU/mL) were treated by LTP for different time (20 s, 40 s and 60 s). Tachypleus amebocyte lysate (TAL) method was employed to detect the concentration variation of bacterial endotoxin before and after the plasma treatment, and endotoxic shock mice model was used to evaluate the inactivation effects of LTP on endotoxin for further study. Experimental results demonstrated that, DBD plasma can inactivate the bacterial endotoxin quickly and effectively, and when the LTP treatment time was increased, the concentrations of bacterial endotoxin decreased gradually (after 60 s plasma treatment, its inactivation effect was beyond the Chinese pharmacopoeia standard), and the average survival time of mice gradually extended. The possible inactivation mechanisms are proposed to be related to reactive oxygen species (ROSs).

[Quality evaluation of American ginseng using UPLC coupled with multivariate analysis].

PubMed

Tang, Yan; Yan, Shu-Mo; Wang, Jing-Jing; Yuan, Yuan; Yang, Bin

2016-05-01

An ultra performance liquid chromatography (UPLC)method combined with multivariate data analysis was developed to evaluate the quality of American ginseng by simultaneously determining the concentrations of six ginsenosides (Rg₁, Re, Rb₁, Rc, Ro and Rd)in the samples. For UPLC, acetonitrile with 0.01% formic acid and water with 0.01% formic acid were used as the mobile phase with gradient elution. Under the established chromatographic conditions, the six ginsenosides could be well separated and the results of linearity, stability, precision, repeatability, and recovery rate all reached the requirement of quantification analysis, respectively. The total contents of Rg₁, Re, and Rb₁ in 57 samples all reached the requirement of the 2015 edition of Chinese Pharmacopoeia. At the same time, the experimental data were analyzed by principle component analysis (PCA) and partial least squares discriminant analysis (PLS-DA). The crude drugs and the decoction pieces can be discriminated by a PCA method and the samples with different age can be distinguished by a PLS-DA method. Copyright© by the Chinese Pharmaceutical Association.

Asymmetric flow field-flow fractionation (AF4) for the quantification of nanoparticle release from tablets during dissolution testing.

PubMed

Engel, A; Plöger, M; Mulac, D; Langer, K

2014-01-30

Nanoparticles composed of poly(DL-lactide-co-glycolide) (PLGA) represent promising colloidal drug carriers for improved drug targeting. Although most research activities are focused on intravenous application of these carriers the peroral administration is described to improve bioavailability of poorly soluble drugs. Based on these insights the manuscript describes a model tablet formulation for PLGA-nanoparticles and especially its analytical characterisation with regard to a nanosized drug carrier. Besides physico-chemical tablet characterisation according to pharmacopoeias the main goal of the study was the development of a suitable analytical method for the quantification of nanoparticle release from tablets. An analytical flow field-flow fractionation (AF4) method was established and validated which enables determination of nanoparticle content in solid dosage forms as well as quantification of particle release during dissolution testing. For particle detection a multi-angle light scattering (MALS) detector was coupled to the AF4-system. After dissolution testing, the presence of unaltered PLGA-nanoparticles was successfully proved by dynamic light scattering and scanning electron microscopy. Copyright © 2013 Elsevier B.V. All rights reserved.

Metabolomics study of Saw palmetto extracts based on 1H NMR spectroscopy.

PubMed

de Combarieu, Eric; Martinelli, Ernesto Marco; Pace, Roberto; Sardone, Nicola

2015-04-01

Preparations containing Saw palmetto extracts are used in traditional medicine to treat benign prostatic hyperplasia. According to the European and the American Pharmacopoeias, the extract is obtained from comminuted Saw palmetto berries by a suitable extracting procedure using ethanol or supercritical carbon dioxide or a mixture of n-hexane and methylpentanes. In the present study an approach to metabolomics profiling using nuclear magnetic resonance (NMR) has been used as a finger-printing tool to assess the overall composition of the extracts. The phytochemical analysis coupled with principal component analysis (PCA) showed the same composition of the Saw palmetto extracts obtained with carbon dioxide and hexane with minor not significant differences for extracts obtained with ethanol. In fact these differences are anyhow lower than the batch-to-batch variability ascribable to the natural-occurring variability in the Saw palmetto fruits' phytochemical composition. The fingerprinting analysis combined with chemometric method, is a technique, which would provide a tool to comprehensively assess the quality control of Saw palmetto extracts. Copyright © 2015 Elsevier B.V. All rights reserved.

Repeatability Assessment by ISO 11843-7 in Quantitative HPLC for Herbal Medicines.

PubMed

Chen, Liangmian; Kotani, Akira; Hakamata, Hideki; Tsutsumi, Risa; Hayashi, Yuzuru; Wang, Zhimin; Kusu, Fumiyo

2015-01-01

We have proposed an assessment methods to estimate the measurement relative standard deviation (RSD) of chromatographic peaks in quantitative HPLC for herbal medicines by the methodology of ISO 11843 Part 7 (ISO 11843-7:2012), which provides detection limits stochastically. In quantitative HPLC with UV detection (HPLC-UV) of Scutellaria Radix for the determination of baicalin, the measurement RSD of baicalin by ISO 11843-7:2012 stochastically was within a 95% confidence interval of the statistically obtained RSD by repetitive measurements (n = 6). Thus, our findings show that it is applicable for estimating of the repeatability of HPLC-UV for determining baicalin without repeated measurements. In addition, the allowable limit of the "System repeatability" in "Liquid Chromatography" regulated in a pharmacopoeia can be obtained by the present assessment method. Moreover, the present assessment method was also successfully applied to estimate the measurement RSDs of quantitative three-channel liquid chromatography with electrochemical detection (LC-3ECD) of Chrysanthemi Flos for determining caffeoylquinic acids and flavonoids. By the present repeatability assessment method, reliable measurement RSD was obtained stochastically, and the experimental time was remarkably reduced.

Efficiency of Calamintha officinalis essential oil as preservative in two topical product types.

PubMed

Nostro, A; Cannatelli, M A; Morelli, I; Musolino, A D; Scuderi, F; Pizzimenti, F; Alonzo, V

2004-01-01

To verify the efficiency of Calamintha officinalis essential oil as natural preservative in two current formulations. The 1.0 and 2.0% (v/v) C. officinalis essential oil was assayed for its preservative activity in two product types (cream and shampoo). The microbial challenge test was performed following the standards proposed by the European Pharmacopoeia Commission (E.P.) concerning topical preparations using standard micro-organisms and in addition wild strains, either in single or mixed cultures were used. The results clearly demonstrated that the C. officinalis essential oil at 2.0% concentration reduced the microbial inoculum satisfying the criterion A of the E.P. in the cream formulation and the criterion B in the shampoo formulation. Standard and wild strains showed a behaviour similar, both in cream and in shampoo formulation, with no significant difference (gerarchic variance, P > 0.05). C. officinalis essential oil confirmed its preservative properties but at higher concentration than that shown in previous studies on cetomacrogol cream. The nature of the formulation in which an essential oil is incorporated as preservative could have considerable effect on its efficacy.

Capillary zone electrophoresis for the determination of amodiaquine and three of its synthetic impurities in pharmaceutical formulations.

PubMed

Mufusama, Jean-Pierre; Hoellein, Ludwig; Feineis, Doris; Holzgrabe, Ulrike; Bringmann, Gerhard

2018-05-29

A simple and robust CZE method was developed for the separation and quantification of the antimalarial compound amodiaquine as well as three of its synthetic impurities at a concentration equal to or lower than 0.5%. For capillary electrophoresis, a fused-silica capillary, a background electrolyte of 100 mM sodium phosphate buffer at a pH value of 6.2, a voltage of +20 kV, and a detection wavelength of 220 nm were used, allowing the determination of the analytes within 20 minutes. The method was validated according to the guideline Q2(R1) of the International Council for Harmonization with respect to linearity, precision, accuracy, limit of detection and limit of quantification, and was successfully applied to evaluate the quality of drug samples collected in the Democratic Republic of the Congo. Quantitative analysis results obtained by the CZE method were compared to those obtained with the contemporary HPLC method described in The International Pharmacopoeia. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Antimicrobial and antifungal activities of Cordia dichotoma (Forster F.) bark extracts

PubMed Central

Nariya, Pankaj B.; Bhalodia, Nayan R.; Shukla, V. J.; Acharya, R. N.

2011-01-01

Cordia dichotoma Forst.f. bark, identified as botanical source of Shlesmataka in Ayurvedic pharmacopoeias. Present study was carried out with an objective to investigate the antibacterial and antifungal potentials of Cordia dichotoma bark. Antibacterial activity of methanol and butanol extracts of the bark was carried out against two gram negative bacteria (Escherichia coli, and Pseudomonas aeruginosa) and two Gram positive bacteria (St. pyogenes and Staphylococcus aureus). The antifungal activity of the extracts was carried out against three common pathogenic fungi (Aspergillus niger, A.clavatus, and Candida albicans). Zone of inhibition of extracts was compared with that of different standards like Amplicilline, Ciprofloxacin, Norfloxacin and Chloramphenicol for antibacterial activity and Nystain and Greseofulvin for antifungal activity. The extracts showed remarkable inhibition of zone of bacterial growth and fungal growth and the results obtained were comparable with that of standards drugs against the organisms tested. The activity of extracts increased linearly with increase in concentration of extract (mg/ml). The results showed the antibacterial and antifungal activity against the organisms tested. PMID:22661859

Antimicrobial and antifungal activities of Cordia dichotoma (Forster F.) bark extracts.

PubMed

Nariya, Pankaj B; Bhalodia, Nayan R; Shukla, V J; Acharya, R N

2011-10-01

Cordia dichotoma Forst.f. bark, identified as botanical source of Shlesmataka in Ayurvedic pharmacopoeias. Present study was carried out with an objective to investigate the antibacterial and antifungal potentials of Cordia dichotoma bark. Antibacterial activity of methanol and butanol extracts of the bark was carried out against two gram negative bacteria (Escherichia coli, and Pseudomonas aeruginosa) and two Gram positive bacteria (St. pyogenes and Staphylococcus aureus). The antifungal activity of the extracts was carried out against three common pathogenic fungi (Aspergillus niger, A.clavatus, and Candida albicans). Zone of inhibition of extracts was compared with that of different standards like Amplicilline, Ciprofloxacin, Norfloxacin and Chloramphenicol for antibacterial activity and Nystain and Greseofulvin for antifungal activity. The extracts showed remarkable inhibition of zone of bacterial growth and fungal growth and the results obtained were comparable with that of standards drugs against the organisms tested. The activity of extracts increased linearly with increase in concentration of extract (mg/ml). The results showed the antibacterial and antifungal activity against the organisms tested.

Effect of the aqueous extract of Senecio biafrae (Oliv. & Hiern) J. Moore on some fertility parameters in immature female rat.

PubMed

Lienou, L L; Telefo, P B; Njimou, J R; Nangue, C; Bayala, B R; Goka, S C; Biapa, P; Yemele, M D; Donfack, N J; Mbemya, J T; Tagne, S R; Rodrigues, A P R

2015-02-23

Senecio biafrae is a plant from the huge family of Asteraceae used in the African pharmacopoeia for the treatment of many ailments among which is infertility. The aqueous extract, which was primarily subjected to polyphenol analysis, has been administered to immature female rats for 20 days at 8, 32, 64 and 128 mg/kg of body weight. The day following the treatment, the animals were sacrificed; their serum, ovary and uterus were retained respectively for reproductive hormones, ovarian and uterine proteins, and ovarian cholesterol assays. Light body weight gain variation of treated animals was observed during the experimental period. A significant increase (p ˂ 0.05) in serum estradiol and proteins as well as in uterine weight (p ˂ 0.01) of all Senecio biafrae treated animals was noted. No significant variation was noticed in the ovarian weight and follicle numbers. The various biochemical and physiological parameters of fertility were significantly improved with the aqueous extract of Senecio biafrae, thus attesting some of its traditional usage. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Haemovigilance: A Current Update in Indian Perspective

PubMed Central

Mukherjee, Somnath

2016-01-01

Haemovigilance is an organised scheme of monitoring, identifying, reporting, investigating and analysing adverse events and reactions pertinent to transfusion and manufacturing blood products. This system is also an elemental part of quality control in a blood system, bringing about corrective and preventive measures, and for the perpetual advancement of the quality and safety of blood products and the transfusion process. Nowadays haemovigilance setups have been enforced throughout the globe in most developed countries, to monitor the adverse reactions and episodes associated with blood donations and transfusions. Indian Pharmacopoeia Commission has started a Haemovigilance Program of India (HvPI) in 2012 under its Pharmacovigilance Program of India (PvPI) in collaboration with National Institute of Biologicals, Noida, Uttar Pradesh, under Ministry of Health and Family welfare, Government of India with a primary objective to track adverse reactions/events and incidences associated with blood transfusion and blood product administration and to identify trends, recommend best practices and interventions required to improve patient care and safety. This review article is a detail update of current scenario of haemovigilance in India. PMID:28050389

Factor analysis in optimization of formulation of high content uniformity tablets containing low dose active substance.

PubMed

Lukášová, Ivana; Muselík, Jan; Franc, Aleš; Goněc, Roman; Mika, Filip; Vetchý, David

2017-11-15

Warfarin is intensively discussed drug with narrow therapeutic range. There have been cases of bleeding attributed to varying content or altered quality of the active substance. Factor analysis is useful for finding suitable technological parameters leading to high content uniformity of tablets containing low amount of active substance. The composition of tabletting blend and technological procedure were set with respect to factor analysis of previously published results. The correctness of set parameters was checked by manufacturing and evaluation of tablets containing 1-10mg of warfarin sodium. The robustness of suggested technology was checked by using "worst case scenario" and statistical evaluation of European Pharmacopoeia (EP) content uniformity limits with respect to Bergum division and process capability index (Cpk). To evaluate the quality of active substance and tablets, dissolution method was developed (water; EP apparatus II; 25rpm), allowing for statistical comparison of dissolution profiles. Obtained results prove the suitability of factor analysis to optimize the composition with respect to batches manufactured previously and thus the use of metaanalysis under industrial conditions is feasible. Copyright © 2017 Elsevier B.V. All rights reserved.

Development of Conductivity Method as an Alternative to Titration for Hydrolytic Resistance Testing Used for Evaluation of Glass Vials Used in Pharmaceutical Industry.

PubMed

Fujimori, Kiyoshi; Lee, Hans; Phillips, Joseph; Nashed-Samuel, Yasser

The European Pharmacopeia surface test to analyze the hydrolytic resistance is a common industrial method to understand and ensure the quality of produced glass vials. Hydrolytic resistance is evaluated by calculating the alkalinity of water extract from autoclaved vials by titration. As an alternative to this titration technique, a conductivity technique was assessed, which directly measures the ions in the water extract. A conductivity meter with a 12 mm diameter electrode was calibrated with a 100 μS/cm conductivity standard and carryover minimized by rinsing the probe in a water beaker per analysis. The limit of quantification at 1 μS/cm was determined as having a signal-to-noise ratio of 3 compared with the water blank. The conductivity method was selective for glass-composing elements (boron, sodium, aluminum, silicon, potassium, and calcium) within the vial extract. Accuracies of spiked conductivity standard within the range of 1 to 100 μS/cm were ±7% and had linearity with coefficient of determination (R 2 ) of ≥0.9999. Intraday precision had a relative standard deviation (RSD) (n = 5) of ≤6% for spiked conductivity standard within the range of 1 to 100 μS/cm. Interday precision had a RSD (n = 4) of ≤6% for 10 vials from three glass vial lots. Conductivity of water extracts from nine sets of seven lots of glass vials had a precise linear relationship [R 2 = 0.9876, RSD = 1% (n = 9)] with titration volumes of the same lots. Conductivity results in μS/cm could be converted to titration volumes in milliliters by a conversion factor of 0.0275. The simplicity, sample stability, and individual vial analysis of the conductivity technique were more advantageous than the current titration technique. The quality of glass vials used as primary containers in the pharmaceutical industry is of concern due to recent observations of glass flake-like delamination, or lamellae, under specific storage conditions. The current European Pharmacopoeia method to assess

An efficient HPLC method for the analysis of isomeric purity of technetium-99m-exametazime and identity confirmation using LC-MS.

PubMed

Vanderghinste, D; Van Eeckhoudt, M; Terwinghe, C; Mortelmans, L; Bormans, G M; Verbruggen, A M; Vanbilloen, H P

2003-08-08

99mTc-exametazime (99mTc-d,l-HMPAO, 99mTc-d,l-hexamethylpropyleneamine oxime) is a neutral rather unstable complex of short-lived 99mTc (t(1/2)=6 h) with the d,l-isomer (mixture of D,D- and L,L-isomers) of a bis-amine bis-oxime tetraligand. It is widely used for measurement of regional cerebral perfusion in nuclear medicine. The meso-isomer (D,L-form) should not be present in a preparation as it is not retained in brain and thus does not provide clinically useful information. Meso-HMPAO is removed from the ligand during the synthesis procedure by repeated recrystallization, but can still be present as impurity in d,l-isomer. Due to the lack of a suitable chromatographic method for analysis of the isomeric purity of 99mTc-exametazime preparations, United States Pharmacopoeia 25 (USP 25) prescribes a biological test in rats for quality control purpose. In this study, we developed a suitable high-performance liquid chromatography (HPLC) method which allows to demonstrate the relative amounts of d,l- and meso-isomer in 99mTc-exametazime and so obviates the need for a biodistribution test in animals as part of the quality control. Due to the low concentrations in which 99mTc-d,l-HMPAO is obtained (typically 2-6 ng/ml), confirmation of the identity of 99mTc-d,l-HMPAO in the monograph of the European Pharmacopoeia is now performed only indirectly by TLC and assessment of its retention time on RP-HPLC. To investigate the potential of radio-LC-MS for assessment of the identity of 99mTc-exametazime, 99mTc-d,l-HMPAO and 99mTc-meso-HMPAO prepared using a Tc-rich eluate were analyzed using a radio-LC-MS system equipped with a time-of-flight mass spectrometer with electrospray ionization. The main peak in the radiometric channel coincided with the molecular ion mass of 99mTc-d,l-HMPAO in the mass spectrometer channel and the measured accurate mass differed only by 0.26 ppm from the theoretical mass. The identity of 99mTc-meso-HMPAO was also confirmed. Thus, radio-LC-MS allowed

‘Herbals she peruseth’: reading medicine in early modern England

PubMed Central

Leong, Elaine

2014-01-01

In 1631, Richard Brathwaite penned a conduct manual for ‘English Gentlewomen’. In Brathwaite's mind, the ideal English gentlewoman was not only chaste, modest and honourable but also an avid reader. In fact, Brathwaite specifically recommends English gentlewomen to first peruse herbals and then to deepen their medical knowledge via conference. Centred on the manuscript notebooks of two late seventeenth-century women, Margaret Boscawen (d. 1688) and Elizabeth Freke (1642–1714), this article explores women and ‘medical reading’ in early modern England. It first demonstrates that whilst both women consulted herbals by contemporary authors such as John Gerard and Nicholas Culpeper, their modes of reading could not be more different. Where Freke ruminated, digested and abstracted from Gerard's large tome, Boscawen made practical lists from Culpeper's The English Physitian. Secondly, the article shows that both supplemented their herbal reading with a range of other vernacular medical texts including printed medical recipe books, contemporary pharmacopoeia and surgical handbooks. Early modern English women's medical reading, I argue, was nuanced, sophisticated and diverse. Furthermore, I contend that well-informed readers like Boscawen and Freke made smart medical consumers and formidable negotiators in their medical encounters. PMID:25821333

Development and validation of a dissolution test for lodenafil carbonate based on in vivo data.

PubMed

Codevilla, Cristiane Franco; Castilhos, Tamara dos Santos; Cirne, Carolina Araújo; Froehlich, Pedro Eduardo; Bergold, Ana Maria

2014-04-01

Lodenafil carbonate is a phosphodiesterase type 5 inhibitor used for the treatment of erectile dysfunction. Currently, there is no dissolution test reported for lodenafil carbonate and this drug is not listed in any pharmacopoeia. The present study focused on the development and validation of a dissolution test for lodenafil carbonate tablets, using a simulated absorption profile based on in vivo data. The appropriate conditions were determined after testing sink conditions. Different conditions as medium, surfactant concentration and rotation speed were evaluated. The percentage of dose absorbed was calculated by deconvolution, using the Wagner-Nelson method. According to the obtained results, the use of 0.1 M HCl + 1.5% SLS (900 mL, at 37 + 0.5 °C) as the dissolution medium, paddles at 25 rpm were considered adequate. The samples were quantified by UV spectroscopy at 295 nm and the validation was performed according to international guidelines. The method showed specificity, linearity, accuracy and precision, within the acceptable range. Kinetics of drug release was better described by the first-order model. The proposed dissolution test can be used for the routine quality control of lodenafil carbonate in tablets.

Venetian treacle and the foundation of medicines regulation

PubMed Central

Griffin, J P

2004-01-01

Mithridatium and the related product Theriac were both regarded from the time of their original formulations in the 2nd Century BC and the 1st Century AD respectively, until the mid 18th Century as universal panaceas. Any failure of these products to achieve the desired therapeutic result was attributed to defective composition or manufacture. As a result measures were introduced to ensure the quality of ingredients used in these products composition, the establishment of standard formulations and assurance of the competence of the manufacturer. Manufacture frequently was required to take place in public. Doubts about the efficacy of these panaceas arose in the mid 18th century and concerns of the adverse nature of interactions between the numerous ingredients surfaced in Heberden's treatise of 1745, as result of which these products disappeared from Editions of The London Pharmacopoeia after 1746. Subsequently, arising from these concerns for safety and efficacy, a call was made in 1799 for the establishment of a Public Committee of eminent physicians to scrutinise all new products prior to their launch to an gullible public. The concepts developed in the history of Mithridatium form the basis of modern medicines regulation. PMID:15327592

Validation of Quantitative HPLC Method for Bacosides in KeenMind

PubMed Central

Dowell, Ashley; Davidson, George; Ghosh, Dilip

2015-01-01

Brahmi (Bacopa monnieri) has been used by Ayurvedic medical practitioners in India for almost 3000 years. The pharmacological properties of Bacopa monnieri were studied extensively and the activities were attributed mainly due to the presence of characteristic saponins called “bacosides.” Bacosides are complex mixture of structurally closely related compounds, glycosides of either jujubogenin or pseudojujubogenin. The popularity of herbal medicines and increasing clinical evidence to support associated health claims require standardisation of the phytochemical actives contained in these products. However, unlike allopathic medicines which typically contain a single active compound, herbal medicines are typically complex mixtures of various phytochemicals. The assay for bacosides in the British Pharmacopoeia monograph for Bacopa monnieri exemplifies that only a subset of bacosides present are included in the calculation of total bacosides. These results in calculated bacoside values are significantly lower than those attained for the same material using more inclusive techniques such as UV spectroscopy. This study illustrates some of the problems encountered when applying chemical analysis for standardisation of herbal medicines, particularly in relation to the new method development and validation of bacosides from KeenMind. PMID:26448776

Video approach to chemiluminescence detection using a low-cost complementary metal oxide semiconductor (CMOS)-based camera: determination of paracetamol in pharmaceutical formulations.

PubMed

Lahuerta-Zamora, Luis; Mellado-Romero, Ana M

2017-06-01

A new system for continuous flow chemiluminescence detection, based on the use of a simple and low-priced lens-free digital camera (with complementary metal oxide semiconductor technology) as a detector, is proposed for the quantitative determination of paracetamol in commercial pharmaceutical formulations. Through the camera software, AVI video files of the chemiluminescence emission are captured and then, using friendly ImageJ public domain software (from National Institutes for Health), properly processed in order to extract the analytical information. The calibration graph was found to be linear over the range 0.01-0.10 mg L -1 and over the range 1.0-100.0 mg L -1 of paracetamol, the limit of detection being 10 μg L -1 . No significative interferences were found. Paracetamol was determined in three different pharmaceutical formulations: Termalgin®, Efferalgan® and Gelocatil®. The obtained results compared well with those declared on the formulation label and with those obtained through the official analytical method of British Pharmacopoeia. Graphical abstract Abbreviated scheme of the new chemiluminescence detection system proposed in this paper.

[Research and pharmaceutical development on the subject of communicable diseases in the intertropical region].

PubMed

Trouiller, P

1996-01-01

The development of the antimalarial drugs mefloquine and halofantrine in 1988 by American military research teams marked a start in the decline in investment in tropical disease research and drug development. The globalization of the market, increased clinical costs, and constraints on public health spending caused the pharmaceutical industry to concentrate on more profitable market segments (cardiovascular drugs, antineoplastics, anti-infection drugs, etc.). The market in developing countries represents a large volume, but a very low return because the added value is small, generic drugs are used and the state of the populations is impoverished. The ten or so drugs that have been developed recently result from chance (eflornithine), veterinary research (ivermectin), fortuitous analysis of traditional pharmacopoeia (artemether) or reevaluations of former drugs (amopyroquine). The deficiency of research and drug development for diseases of the intertropical zone has a direct negative effect on public health and also reveals health policy inconsistencies, particularly the incompatibility of the pharmaceutical industry's interests and international health priorities. The problem is also aggravated by the closed approach of external health assistance (official development aid) which aims to minimize costs by favoring primary health care.

Applicability of two automated disintegration apparatuses for rapidly disintegrating (mini)tablets.

PubMed

Sieber, Daniel; Lazzari, Alessia; Quodbach, Julian; Pein, Miriam

2017-03-01

Orally disintegrating (mini)tablets (OD(M)Ts) are of interest in the field of pharmaceutics. Their orodispersible character is defined by the disintegration time, which is measured with a basket apparatus according to the European Pharmacopoeia. This method, however, lacks applicability for ODTs and especially ODMTs. New disintegration apparatuses have been described in literature, but a qualification to assess the applicability has not been described. A qualification procedure for two automated disintegration apparatuses, OD-mate and Hermes apparatus, is introduced. Aspects of the operational qualification as well as precision and accuracy regarding a performance qualification were evaluated for both apparatuses analog to the ICH guideline Q2. While the OQ study is performed separately for each apparatus, accuracy and precision were performed following the same protocol for both testers. Small RSDs (16.9% OD-mate; 15.2% Hermes compared to 32.3% for the pharmacopeial method) were found despite very fast disintegration times (1.5 s for both apparatuses). By comparing these RSDs to practical examples, the authors propose threshold values for repeatability depending on the mean disintegration time. Obtained results from the qualification were used to assess the applicability of both apparatuses.

Using SSR-HRM to Identify Closely Related Species in Herbal Medicine Products: A Case Study on Licorice.

PubMed

Li, Jingjian; Xiong, Chao; He, Xia; Lu, Zhaocen; Zhang, Xin; Chen, Xiaoyang; Sun, Wei

2018-01-01

Traditional herbal medicines have played important roles in the ways of life of people around the world since ancient times. Despite the advanced medical technology of the modern world, herbal medicines are still used as popular alternatives to synthetic drugs. Due to the increasing demand for herbal medicines, plant species identification has become an important tool to prevent substitution and adulteration. Here we propose a method for biological assessment of the quality of prescribed species in the Chinese Pharmacopoeia by use of high resolution melting (HRM) analysis of microsatellite loci. We tested this method on licorice, a traditional herbal medicine with a long history. Results showed that nine simple sequence repeat (SSR) markers produced distinct melting curve profiles for the five licorice species investigated using HRM analysis. These results were validated by capillary electrophoresis. We applied this protocol to commercially available licorice products, thus enabling the consistent identification of 11 labels with non-declared Glycyrrhiza species. This novel strategy may thus facilitate DNA barcoding as a method of identification of closely related species in herbal medicine products. Based on this study, a brief operating procedure for using the SSR-HRM protocol for herbal authentication is provided.

Identification of Furosemide Photodegradation Products in Water-Acetonitrile Mixture.

PubMed

Katsura, Shinji; Yamada, Nobuo; Nakashima, Atsushi; Shiraishi, Sumihiro; Furuishi, Takayuki; Ueda, Haruhisa

2015-01-01

The aim of this study was to identify the chemical structure of the photodegradation products of furosemide in a water-acetonitrile mixture (1 : 1). Furosemide solution was irradiated with a D65 fluorescent lamp and the products were isolated by preparative HPLC. The fractions were evaporated to dryness in vacuo. The purity of the photodegradation products was measured by HPLC. The purity of products 1, 3, and 4 was greater than 90%, whereas that of product 2 was 13%, therefore, photodegradation product 2 was unstable. We identified photodegradation products 1 and 3 as 4-chloro-5-sulfamoylanthranilic acid and 4-hydroxy-N-furfuryl-5-sulfamoylanthranilic acid, respectively, by LC/MS and NMR. Additionally, we assumed that photodegradation product 4 was methyl 2-((furan-2-ylmethyl)amino)-4-hydroxy-3-(methyleneamino)-5-sulfamoylbenzoate by LC/MS and NMR. This showed that furosemide underwent hydrolysis and substitution, and reacted with the acetonitrile under the light of a D65 fluorescent lamp. We were furthermore able to determine the elution times of the photodegradation products of furosemide by applying the Japanese Pharmacopoeia chromatographic method for related substances to the isolated products.

Using SSR-HRM to Identify Closely Related Species in Herbal Medicine Products: A Case Study on Licorice

PubMed Central

Li, Jingjian; Xiong, Chao; He, Xia; Lu, Zhaocen; Zhang, Xin; Chen, Xiaoyang; Sun, Wei

2018-01-01

Traditional herbal medicines have played important roles in the ways of life of people around the world since ancient times. Despite the advanced medical technology of the modern world, herbal medicines are still used as popular alternatives to synthetic drugs. Due to the increasing demand for herbal medicines, plant species identification has become an important tool to prevent substitution and adulteration. Here we propose a method for biological assessment of the quality of prescribed species in the Chinese Pharmacopoeia by use of high resolution melting (HRM) analysis of microsatellite loci. We tested this method on licorice, a traditional herbal medicine with a long history. Results showed that nine simple sequence repeat (SSR) markers produced distinct melting curve profiles for the five licorice species investigated using HRM analysis. These results were validated by capillary electrophoresis. We applied this protocol to commercially available licorice products, thus enabling the consistent identification of 11 labels with non-declared Glycyrrhiza species. This novel strategy may thus facilitate DNA barcoding as a method of identification of closely related species in herbal medicine products. Based on this study, a brief operating procedure for using the SSR-HRM protocol for herbal authentication is provided. PMID:29740326

Rapid discrimination of sea buckthorn berries from different H. rhamnoides subspecies by multi-step IR spectroscopy coupled with multivariate data analysis

NASA Astrophysics Data System (ADS)

Liu, Yue; Zhang, Ying; Zhang, Jing; Fan, Gang; Tu, Ya; Sun, Suqin; Shen, Xudong; Li, Qingzhu; Zhang, Yi

2018-03-01

As an important ethnic medicine, sea buckthorn was widely used to prevent and treat various diseases due to its nutritional and medicinal properties. According to the Chinese Pharmacopoeia, sea buckthorn was originated from H. rhamnoides, which includes five subspecies distributed in China. Confusion and misidentification usually occurred due to their similar morphology, especially in dried and powdered forms. Additionally, these five subspecies have vital differences in quality and physiological efficacy. This paper focused on the quick classification and identification method of sea buckthorn berry powders from five H. rhamnoides subspecies using multi-step IR spectroscopy coupled with multivariate data analysis. The holistic chemical compositions revealed by the FT-IR spectra demonstrated that flavonoids, fatty acids and sugars were the main chemical components. Further, the differences in FT-IR spectra regarding their peaks, positions and intensities were used to identify H. rhamnoides subspecies samples. The discrimination was achieved using principal component analysis (PCA) and partial least square-discriminant analysis (PLS-DA). The results showed that the combination of multi-step IR spectroscopy and chemometric analysis offered a simple, fast and reliable method for the classification and identification of the sea buckthorn berry powders from different H. rhamnoides subspecies.

Development of a Suitable Dissolution Method for the Combined Tablet Formulation of Atorvastatin and Ezetimibe by RP-LC Method.

PubMed

Ozkan Cansel, Kose; Ozgur, Esim; Sevinc, Kurbanoglu; Ayhan, Savaser; Ozkan, Sibel A; Yalcin, Ozkan

2016-01-01

Pharmaceutical preparations of ezetimibe and atorvastatin are generally used to regulate the lipid level in blood. It decreases the secondary events for patients with high cholesterol and clinical cardiovascular disease such as non-fatal or fatal heart attack. There is no any pharmacopoeia method available for the dissolution testing recommended by the FDA. Development of dissolution tests method is very critical parameter especially for the pharmaceutical preparations that contain Class II drugs (slightly soluble, good permeable). In the proposed method, the effects of pH and surfactant on the dissolution of poorly water soluble combined drug therapy with a different pKa values in an in vitro environment is investigated. The content of our study was designed to answer these open-ended questions. The optimized test conditions achieved under sink conditions with USP apparatus 2 at a paddle rotation speed of 75 rpm and 900 ml in 0.01 M Acetate buffer (pH= 6.8) containing 0.45% SDS as a dissolution medium. Quantification of dissolution samples were analyzed with a new fully validated RP-LC method with UV detection at 242 nm.

Use of the psbA-trnH region to authenticate medicinal species of Fabaceae.

PubMed

Gao, Ting; Ma, Xinye; Zhu, Xunzhi

2013-01-01

Fabaceae is a huge family that contains a large number of medicinal plants, many of which are commonly used in Chinese traditional medicine. However, traditional taxonomy has not been able to meet the complicated demands of species discrimination within Fabaceae. Thus, we employed a famous DNA barcode, the psbA-trnH region, to discriminate commonly used medicinal species of the family Fabaceae. Here, the psbA-trnH regions derived from 152 samples were amplified. These samples represented 104 Fabaceae medicinal species from 60 genera, including 25 authentic Fabaceae species listed in the Chinese pharmacopoeia and common adulterant species. The results indicate that the psbA-trnH region performed well in terms of its universality and high variability in length and composition. Species discriminative power analysis of the psbA-trnH region showed that 91.3% of species could be identified successfully by the BLAST1 method in conjunction with the nearest distance method. And, the species resolution rate of the TaxonGap method exceeded 93%. The results provide support for the use of the psbA-trnH plastid region as a sensitive marker to the authentication of Fabaceae medicinal plants.

The treatment of tuberculosis in Ferrara (Italy) in the 19th century.

PubMed

Vicentini, Chiara Beatrice; Mares, Donatella; Guidi, Enrica; Angelini, Lauretta; Contini, Carlo; Manfredini, Stefano

2010-12-01

The present work is a review of the remedies in use in Ferrara against tuberculosis in the 1800s. The work started from the discovery of accounts describing methods and remedies. These remedies were also in use world wide. Of particular interest is the work by Antonio Campana, a famous professor of Pharmaceutical Chemistry and Botany in Ferrara, who wrote a pharmacopoeia which had several editions between 1797 and 1841. The Farmacopea Ferrarese was addressed to the apothecaries of Ferrara. Nevertheless, due to its great reputation it had an international distribution. It provided us with an exhaustive view about the medical field in Ferrara in the early 1800s. The remedies adopted in the city in the second half of the century were in line with those present abroad. The work was also supported by the discovery of statistical accounts of the Sant'Anna hospital from 1871. The manuscript written by Alessandro Bennati enabled elucidation of the methods used to treat tuberculosis in the second half of the century. Bennati's work is an historical document completed by the work of the physician Cesare Minerbi.

Substrate prediction of Ixodes ricinus salivary lipocalins differentially expressed during Borrelia afzelii infection

NASA Astrophysics Data System (ADS)

Valdés, James J.; Cabezas-Cruz, Alejandro; Sima, Radek; Butterill, Philip T.; Růžek, Daniel; Nuttall, Patricia A.

2016-09-01

Evolution has provided ticks with an arsenal of bioactive saliva molecules that counteract host defense mechanisms. This salivary pharmacopoeia enables blood-feeding while enabling pathogen transmission. High-throughput sequencing of tick salivary glands has thus become a major focus, revealing large expansion within protein encoding gene families. Among these are lipocalins, ubiquitous barrel-shaped proteins that sequester small, typically hydrophobic molecules. This study was initiated by mining the Ixodes ricinus salivary gland transcriptome for specific, uncharacterized lipocalins: three were identified. Differential expression of these I. ricinus lipocalins during feeding at distinct developmental stages and in response to Borrelia afzelii infection suggests a role in transmission of this Lyme disease spirochete. A phylogenetic analysis using 803 sequences places the three I. ricinus lipocalins with tick lipocalins that sequester monoamines, leukotrienes and fatty acids. Both structural analysis and biophysical simulations generated robust predictions showing these I. ricinus lipocalins have the potential to bind monoamines similar to other tick species previously reported. The multidisciplinary approach employed in this study characterized unique lipocalins that play a role in tick blood-feeding and transmission of the most important tick-borne pathogen in North America and Eurasia.

Quantitative determination and validation of octreotide acetate using 1 H-NMR spectroscopy with internal standard method.

PubMed

Yu, Chen; Zhang, Qian; Xu, Peng-Yao; Bai, Yin; Shen, Wen-Bin; Di, Bin; Su, Meng-Xiang

2018-01-01

Quantitative nuclear magnetic resonance (qNMR) is a well-established technique in quantitative analysis. We presented a validated 1 H-qNMR method for assay of octreotide acetate, a kind of cyclic octopeptide. Deuterium oxide was used to remove the undesired exchangeable peaks, which was referred to as proton exchange, in order to make the quantitative signals isolated in the crowded spectrum of the peptide and ensure precise quantitative analysis. Gemcitabine hydrochloride was chosen as the suitable internal standard. Experimental conditions, including relaxation delay time, the numbers of scans, and pulse angle, were optimized first. Then method validation was carried out in terms of selectivity, stability, linearity, precision, and robustness. The assay result was compared with that by means of high performance liquid chromatography, which is provided by Chinese Pharmacopoeia. The statistical F test, Student's t test, and nonparametric test at 95% confidence level indicate that there was no significant difference between these two methods. qNMR is a simple and accurate quantitative tool with no need for specific corresponding reference standards. It has the potential of the quantitative analysis of other peptide drugs and standardization of the corresponding reference standards. Copyright © 2017 John Wiley & Sons, Ltd.

[Selected adjuvants as carriers of a dry extract of common ivy (Hedera helix L.)].

PubMed

Marczyński, Zbigniew; Zgoda, Marian Mikołaj; Bodek, Kazimiera Henryka

2011-01-01

The usefulness was tested of selected adjuvants: Vivapur 112, Carmellose calcium, Calcium carbonate CA 740, Calcium carbonate CA 800, Hypromellose as carriers of a dry extract of common ivy (Hedera helix L.) leaves in the process of direct tableting. The quality of the produced tablets was determined by examining their appearance, diameter, thickness, mass resistance to abrasion, crushing and disintegration time. Furthermore, the rate of release of biologically active components from the produced drug form to acceptor fluid was tested in accordance with the requirements of Polish Pharmacopoeia VII (PPVII). An attempt was made to estimate the effect of the used adjuvants on the course of this process. The applied adjuvants and acceptor fluid osmolarity decide significantly about the pharmaceutical availability of the therapeutic agents contained in the extract. The obtained model tablets are characterized by controlled release of biologically active substances, in majority of batches they fulfil the requirements as regards physicochemical properties. The formulation composition of the first batch (Extr. Hederae helices e fol.spir. sicc., Vivapur 112, Carmellose calcium, Sodium Stearyl Fumarate) appeared to be the most effective. The worked out method is optimal and provides technological reproducibility and high durability of the drug form.

Bioavailability and stability of erythromycin delayed release tablets.

PubMed

Ogwal, S; Xide, T U

2001-12-01

Erythromycin is available as the free base, ethylsuccinate, estolate, stearate, gluceptate, and lactobionate derivatives. When given orally erythromycin and its derivatives except the estolate are inactivated to some extent by the gastric acid and poor absorption may result. To establish whether delayed release erythromycin tablets meet the bioequivalent requirement for the market. Sectrophotometric analysis was used to determine the dissolution percentage of the tablets in vitro. High performance liquid chromatography and IBM/XT microcomputer was used to determine the bioavailability and pharmacokinetic parameters in vivo. Dissolution percentage in thirty minutes reached 28.9% and in sixty minutes erythromycin was completely released. The parameters of the delayed release tablets were Tlag 2.3 hr, Tmax.4.5 hr, and Cmax 2.123 g/ml Ka 0.38048 hr(-1) T (1/2) 1.8 hr, V*C/F 49.721 AUC 12.9155. The relative bioavailability of erythromycin delayed release tablet to erythromycin capsules was 105.31% The content, appearance, and dissolution bioavailability of delayed release erythromycin tablets conforms to the United States pharmacopoeia standards. The tablets should be stored in a cool and dry place in airtight containers and the shelf life is temporarily assigned two years.

The practice and clinical implications of tablet splitting in international health

PubMed Central

Elliott, Ivo; Mayxay, Mayfong; Yeuichaixong, Sengchanh; Lee, Sue J; Newton, Paul N

2014-01-01

Objective Tablet splitting is frequently performed to facilitate correct dosing, but the practice and implications in low-income settings have rarely been discussed. Methods We selected eight drugs, with narrow therapeutic indices or critical dosages, frequently divided in the Lao PDR (Laos). These were split, by common techniques used in Laos, by four nurses and four laypersons. The mean percentage deviation from the theoretical expected weight and weight loss of divided tablets/capsules were recorded. Results Five of eight study drugs failed, on splitting, to meet European Pharmacopoeia recommendations for tablet weight deviation from the expected weight of tablet/capsule halves with 10% deviating by more than 25%. There was a significant difference in splitting accuracy between nurses and laypersons (P = 0.027). Coated and unscored tablets were less accurately split than uncoated (P = 0.03 and 0.0019 for each half) and scored (0.0001 for both halves) tablets. Conclusion These findings have potential clinical implications on treatment outcome and the development of antimicrobial resistance. Investment by drug companies in a wider range of dosage units, particularly for narrow therapeutic index and critical dosage medicines, is strongly recommended. PMID:24702766

Informal Trade of Psychoactive Herbal Products in the City of Diadema, SP, Brazil: Quality and Potential Risks

PubMed Central

Soares Neto, Julino Assunção Rodrigues; Kato, Edna Myiake; Galduróz, José Carlos F.; Marques, Luis Carlos; Macrini, Thiago; Rodrigues, Eliana

2013-01-01

The present study aimed to assess the quality and risks involved in the consumption of psychoactive herbal products (PHs) that are available through informal commerce in the city of Diadema, SP, Brazil. Methods of ethnography were used to conduct the fieldwork during which four dealers were selected to record the collection, handling, packaging, types of PHs marketed, and their therapeutic purposes. In addition, lots of the PHs selected were purchased from the dealers and analyzed using microbiology and pharmacognosy techniques. 217 PHs were recorded and categorized into two main groups: stimulants (67%) and depressants (27%) of the central nervous system; sixteen of them were selected, and their 52 lots were acquired. The deficiencies observed in handling and packaging these lots by dealers were confirmed by microbiological analysis; 80.8% of them presented risk according to the indicators defined by the Brazilian Pharmacopoeia. The pharmacognostic analysis confirmed the authenticity of only 9 to 16 PHs analyzed. In addition, descriptions of contraindications, adverse reactions, and drug interactions were found in the literature for the PHs. The results of this study allow the observation of the priorities for the sanitary adequacy of the popular trade of herbs. PMID:23818934

Detection of endotoxins and other pyrogens using human whole blood.

PubMed

Fennrich, S; Fischer, M; Hartung, T; Lexa, P; Montag-Lessing, T; Sonntag, H G; Weigandt, M; Wendel, A

1999-01-01

When cells of the immune system, i.e. primarily blood monocytes and macrophages, come into contact with pyrogens (fever-inducing contaminations) they release mediators transmitting the fever reaction through the organism to the thermoregulatory centres of the brain. The new test discussed here exploits this reaction for the detection of pyrogens: human whole blood taken from healthy volunteers is incubated in the presence of the test sample. If there is pyrogen contamination, the endogenous pyrogen interleukin-1 is released, which is then determined by ELISA. According to the pharmacopoeia, the rabbit pyrogen test determines the fever reaction following injection of a test sample. In comparison, the new whole blood assay is more sensitive, less expensive and determines the reaction of the targeted species. Compared to the well established in vitro alternative, i.e. the limulus amebocyte lysate assay (LAL), the new blood assay is not restricted to endotoxins of gram-negative bacteria, it is not affected by endotoxin-binding blood proteins and it reflects the potency of different endotoxin preparations in mammals. Here, interim results of the ongoing optimization and pre-validation are reported and the present state of the evaluation for biological and pharmaceutical drugs are presented.

[Biopharmaceutics classification and absorption mechanisms primary study on four kinds of flavonoids].

PubMed

Li, Hui-Fang; Zhang, Dong; Qu, Wen-Jun; Wang, Hai-Lin; Liu, Yang; Borjigdai, Almaz; Cui, Jian; Dong, Zheng-Qi

2016-04-01

The solubility and permeability on four kinds of flavonoids (kaempferol, hesperidin, apigenin, genistein) were test according to the theory of biopharmaceutics classification system (BCS), and their absorption mechanism. The solubility was investigated by the method in determination of solubility of "Chinese Pharmacopoeia 2010". To detect appearance permeability of compounds mentioned above, the appropriate concentrations were selected by the MTT method in cell transfer experiments in Caco-2 cell model, which established by in vitro cell culture method. Therefore, these compounds were classified with BCS according to solubility and permeability. In addition, to explore absorption mechanisms, the experiments in three different concentrations of compounds in high, medium and low in bidirectional transformation methods in Caco-2 cell model contacted. The study indicated that all of kaempferol, hesperidin, apigenin, genistein have the characteristics in low solubility and high permeability, which belong to BCSⅡ, and the absorption mechanism of kaempferol was active transportation. Whereas, hesperidin, apigenin, genistein were passive transportation. In this study, it carried out initial explorations on establishment of determination for solubility and permeability in flavonoids, and provided theoretical reference for further research on BCS in traditional Chinese medicine. Copyright© by the Chinese Pharmaceutical Association.

An innovative approach to the analysis of 3-[4-(2-methylpropyl)phenyl]propanoic acid as an impurity of ibuprofen on a carbon-coated zirconia stationary phase.

PubMed

Kalafut, P; Kucera, R; Klimes, J; Sochor, J

2009-07-12

3-[4-(2-Methylpropyl)phenyl]propanoic acid has been introduced as impurity F to the European Pharmacopoeia in its Supplement 4.2. In contrast to other impurities, which are evaluated by HPLC, the content of impurity F is determined by gas chromatography after previous derivatization. Thus a novel reversed-phase HPLC method was developed to simplify the evaluation of pharmacopoeial impurity F of ibuprofen. Favourable properties of zirconia stationary phases were employed for this purpose. The HPLC separation was achieved on a Zr-CARB column (150 mm x 4.6mm i.d., 5 microm) using the mobile phase acetonitrile-phosphate buffer (pH 3.5, 25 mM) (38:62, v/v), temperature 80 degrees C and the flow rate 1.2 ml min(-1). The fluorescence detection was employed to enhance the sensitivity of the method. Optimal detection parameters were chosen on the basis of fluorescence spectra of the analytes. The excitation and emission wavelengths were 220 nm and 285 nm, respectively. The analysis was completed within 25 min. The subsequent validation of the method confirmed the applicability of method for the analytical assay of impurity F.

Thermoanalytical Investigation of Some Sulfone-Containing Drugs

PubMed Central

Salama, Nahla N.; El Ries, Mohammed A.; Toubar, Safaa; Abd El Hamid, Maha; Walash, Mohammed I.

2012-01-01

The thermal behavior of some sulfone-containing drugs, namely, dapsone (DDS), dimethylsulfone (MSM), and topiramate (TOP) in drug substances, and products were investigated using different thermal techniques. These include thermogravimetry (TGA), derivative thermogravimetry (DTG), differential thermal analysis (DTA), and differential scanning calorimetry (DSC). The thermogravimetric data allowed the determination of the kinetic parameters: activation energy (E a), frequency factor (A), and reaction order (n). The thermal degradation of dapsone and topiramate was followed a first-order kinetic behavior. The calculated data evidenced a zero-order kinetic for dimethylsulfone. The relative thermal stabilities of the studied drugs have been evaluated and follow the order DDS > TOP > MSM. The purity was determined using DSC for the studied compounds, in drug substances and products. The results were in agreement with the recommended pharmacopoeia and manufacturer methods. DSC curves obtained from the tablets suggest compatibility between the drugs, excipients and/or coformulated drugs. The fragmentation pathway of dapsone with mass spectrometry was taken as example, to correlate the thermal decomposition with the resulted MS-EI. The decomposition modes were investigated, and the possible fragmentation pathways were suggested by mass spectrometry. PMID:22792516

Thermoanalytical investigation of some sulfone-containing drugs.

PubMed

Salama, Nahla N; El Ries, Mohammed A; Toubar, Safaa; Abd El Hamid, Maha; Walash, Mohammed I

2012-01-01

The thermal behavior of some sulfone-containing drugs, namely, dapsone (DDS), dimethylsulfone (MSM), and topiramate (TOP) in drug substances, and products were investigated using different thermal techniques. These include thermogravimetry (TGA), derivative thermogravimetry (DTG), differential thermal analysis (DTA), and differential scanning calorimetry (DSC). The thermogravimetric data allowed the determination of the kinetic parameters: activation energy (E(a)), frequency factor (A), and reaction order (n). The thermal degradation of dapsone and topiramate was followed a first-order kinetic behavior. The calculated data evidenced a zero-order kinetic for dimethylsulfone. The relative thermal stabilities of the studied drugs have been evaluated and follow the order DDS > TOP > MSM. The purity was determined using DSC for the studied compounds, in drug substances and products. The results were in agreement with the recommended pharmacopoeia and manufacturer methods. DSC curves obtained from the tablets suggest compatibility between the drugs, excipients and/or coformulated drugs. The fragmentation pathway of dapsone with mass spectrometry was taken as example, to correlate the thermal decomposition with the resulted MS-EI. The decomposition modes were investigated, and the possible fragmentation pathways were suggested by mass spectrometry.

Optimisation and validation of a rapid and efficient microemulsion liquid chromatographic (MELC) method for the determination of paracetamol (acetaminophen) content in a suppository formulation.

PubMed

McEvoy, Eamon; Donegan, Sheila; Power, Joe; Altria, Kevin

2007-05-09

A rapid and efficient oil-in-water microemulsion liquid chromatographic method has been optimised and validated for the analysis of paracetamol in a suppository formulation. Excellent linearity, accuracy, precision and assay results were obtained. Lengthy sample pre-treatment/extraction procedures were eliminated due to the solubilising power of the microemulsion and rapid analysis times were achieved. The method was optimised to achieve rapid analysis time and relatively high peak efficiencies. A standard microemulsion composition of 33 g SDS, 66 g butan-1-ol, 8 g n-octane in 1l of 0.05% TFA modified with acetonitrile has been shown to be suitable for the rapid analysis of paracetamol in highly hydrophobic preparations under isocratic conditions. Validated assay results and overall analysis time of the optimised method was compared to British Pharmacopoeia reference methods. Sample preparation and analysis times for the MELC analysis of paracetamol in a suppository were extremely rapid compared to the reference method and similar assay results were achieved. A gradient MELC method using the same microemulsion has been optimised for the resolution of paracetamol and five of its related substances in approximately 7 min.

The dispersion releaser technology is an effective method for testing drug release from nanosized drug carriers.

PubMed

Janas, Christine; Mast, Marc-Phillip; Kirsamer, Li; Angioni, Carlo; Gao, Fiona; Mäntele, Werner; Dressman, Jennifer; Wacker, Matthias G

2017-06-01

The dispersion releaser (DR) is a dialysis-based setup for the analysis of the drug release from nanosized drug carriers. It is mounted into dissolution apparatus2 of the United States Pharmacopoeia. The present study evaluated the DR technique investigating the drug release of the model compound flurbiprofen from drug solution and from nanoformulations composed of the drug and the polymer materials poly (lactic acid), poly (lactic-co-glycolic acid) or Eudragit®RSPO. The drug loaded nanocarriers ranged in size between 185.9 and 273.6nm and were characterized by a monomodal size distribution (PDI<0.1). The membrane permeability constants of flurbiprofen were calculated and mathematical modeling was applied to obtain the normalized drug release profiles. For comparing the sensitivities of the DR and the dialysis bag technique, the differences in the membrane permeation rates were calculated. Finally, different formulation designs of flurbiprofen were sensitively discriminated using the DR technology. The mechanism of drug release from the nanosized carriers was analyzed by applying two mathematical models described previously, the reciprocal powered time model and the three parameter model. Copyright © 2017 Elsevier B.V. All rights reserved.

In vitro assessment of anticytotoxic and antigenotoxic effects of CANOVA(®).

PubMed

do Nascimento, Henrique Fonseca Sousa; Cardoso, Plínio Cerqueira Dos Santos; Ribeiro, Helem Ferreira; Mota, Tatiane Cristina; Gomes, Lorena Monteiro; Khayat, André Salim; Guimarães, Adriana Costa; Amorim, Marucia Irena Medeiros; Burbano, Rommel Rodriguéz; Bahia, Marcelo de Oliveira

2016-08-01

CANOVA(®) (CA) is a homeopathic immunomodulator. It contains several homeopathic medicines prepares according to the Brazilian Pharmacopoeia. CA is indicated in clinical conditions in which the immune system is impaired and against tumors. N-methyl-N-nitrosourea (NMU) is an N-nitroso compound, with genotoxic/mutagenic properties. Although several studies have shown promising results in the use of CA, there are no studies reporting possible antigenotoxic effects. This study evaluated the in vitro antigenotoxic and anticytotoxic effects of CA in human lymphocytes exposed to NMU. Samples of human lymphocytes that were subjected to different concentrations of a mixture containing CA and NMU were used. The genotoxicity/antigenotoxicity of CA was evaluated by the comet assay, anticytotoxicity was assessed by quantification of apoptosis and necrosis using acridine orange/ethidium bromide. CA significantly reduced DNA damage induced by NMU and reduced significantly the frequency of NMU-induced apoptosis after 24 h of treatment. CA has an important cytoprotective effect significantly reducing the DNA damage and apoptosis induced by the carcinogen NMU. Copyright © 2016 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Evaluation of the disintegration time of rapidly disintegrating tablets via a novel method utilizing a CCD camera.

PubMed

Morita, Yutaka; Tsushima, Yuki; Yasui, Masanobu; Termoz, Ryoji; Ajioka, Junko; Takayama, Kozo

2002-09-01

Many kinds of rapidly disintegrating or oral disintegrating tablets (RDT) have been developed to improve the ease of tablet administration, especially for elderly and pediatric patients. In these cases, knowledge regarding disintegration behavior appears important with respect to the development of such a novel tablet. Ordinary disintegration testing, such as the Japanese Pharmacopoeia (JP) method, faces limitations with respect to the evaluation of rapid disintegration due to strong agitation. Therefore, we have developed a novel apparatus and method to determine the dissolution of the RDT. The novel device consists of a disintegrating bath and CCD camera interfaced with a personal computer equipped with motion capture and image analysis software. A newly developed RDT containing various types of binder was evaluated with this protocol. In this method, disintegration occurs in a mildly agitated medium, which allows differentiation of minor distinctions among RDTs of different formulations. Simultaneously, we were also able to detect qualitative information, i.e., morphological changes in the tablet during disintegration. This method is useful for the evaluation of the disintegration of RDT during pharmaceutical development, and also for quality control during production.

Orodispersible films in individualized pharmacotherapy: The development of a formulation for pharmacy preparations.

PubMed

Visser, J Carolina; Woerdenbag, Herman J; Crediet, Stefan; Gerrits, Edwin; Lesschen, Marjan A; Hinrichs, Wouter L J; Breitkreutz, Jörg; Frijlink, Henderik W

2015-01-15

Orodispersible films (ODFs) are promising drug delivery systems for customized small scale pharmacy preparations. The aim of the present study was to develop a versatile casting solution suitable for the extemporaneous production of ODFs to which active pharmaceutical ingredients (APIs) can be added. Different combinations of film forming agents and other excipients and different casting heights were tested for their suitability for production of ODFs. The best suitable casting solution contained hypromellose, carbomer, glycerol, disodium EDTA and trometamol. This casting solution was used to prepare ODFs containing water-soluble APIs (enalapril maleate and prednisolone disodium phosphate) and a poorly water-soluble API (diazepam) for which ethanol 96% was used as co-solvent.The water-soluble APIs as well as ethanol influenced the viscosity of the casting solution, mechanical properties and disintegration time of the ODFs. All ODFs containing API met the requirements on uniformity of mass and uniformity of content set by the European Pharmacopoeia (2014) (Ph. Eur.) 8th edition. In conclusion, ODFs of good pharmaceutical quality can be prepared on small scale. Hereby opening the perspective of using ODFs for individualized pharmacotherapy. Copyright © 2014 Elsevier B.V. All rights reserved.

Accelerated in vitro release testing methods for extended release parenteral dosage forms

PubMed Central

Shen, Jie; Burgess, Diane J.

2012-01-01

Objectives This review highlights current methods and strategies for accelerated in vitro drug release testing of extended release parenteral dosage forms such as polymeric microparticulate systems, lipid microparticulate systems, in situ depot-forming systems, and implants. Key findings Extended release parenteral dosage forms are typically designed to maintain the effective drug concentration over periods of weeks, months or even years. Consequently, “real-time” in vitro release tests for these dosage forms are often run over a long time period. Accelerated in vitro release methods can provide rapid evaluation and therefore are desirable for quality control purposes. To this end, different accelerated in vitro release methods using United States Pharmacopoeia (USP) apparatus have been developed. Different mechanisms of accelerating drug release from extended release parenteral dosage forms, along with the accelerated in vitro release testing methods currently employed are discussed. Conclusions Accelerated in vitro release testing methods with good discriminatory ability are critical for quality control of extended release parenteral products. Methods that can be used in the development of in vitro-in vivo correlation (IVIVC) are desirable, however for complex parenteral products this may not always be achievable. PMID:22686344

[Establishment and application of "multi-dimensional structure and process dynamic quality control technology system" in preparation products of traditional Chinese medicine (I)].

PubMed

Gu, Jun-Fei; Feng, Liang; Zhang, Ming-Hua; Wu, Chan; Jia, Xiao-Bin

2013-11-01

Safety is an important component of the quality control of traditional Chinese medicine (TCM) preparation products, as well as an important guarantee for clinical application. Currently, the quality control of TCMs in Chinese Pharmacopoeia mostly focuses on indicative compounds for TCM efficacy. TCM preparations are associated with multiple links, from raw materials to products, and each procedure may have impacts on the safety of preparation. We make a summary and analysis on the factors impacting safety during the preparation of TCM products, and then expound the important role of the "multi-dimensional structure and process dynamic quality control technology system" in the quality safety of TCM preparations. Because the product quality of TCM preparation is closely related to the safety, the control over safety-related material basis is an important component of the product quality control of TCM preparations. The implementation of the quality control over the dynamic process of TCM preparations from raw materials to products, and the improvement of the TCM quality safety control at the microcosmic level help lay a firm foundation for the development of the modernization process of TCM preparations.

Local and traditional uses, phytochemistry, and pharmacology of Sophora japonica L.: A review.

PubMed

He, Xirui; Bai, Yajun; Zhao, Zefeng; Wang, Xiaoxiao; Fang, Jiacheng; Huang, Linhong; Zeng, Min; Zhang, Qiang; Zhang, Yajun; Zheng, Xiaohui

2016-07-01

Sophora japonica (Fabaceae), also known as Huai (Chinese: ), is a medium-sized deciduous tree commonly found in China, Japan, Korea, Vietnam, and other countries. The use of this plant has been recorded in classical medicinal treatises of ancient China, and it is currently recorded in both the Chinese Pharmacopoeia and European Pharmacopoeia. The flower buds and fruits of S. japonica, also known as Flos Sophorae Immaturus and Fructus Sophorae in China, are most commonly used in Asia (especially in China) to treat hemorrhoids, hematochezia, hematuria, hematemesis, hemorrhinia, uterine or intestinal hemorrhage, arteriosclerosis, headache, hypertension, dysentery, dizziness, and pyoderma. To discuss feasible trends for further research on S. japonica, this review highlights the botany, ethnopharmacology, phytochemistry, biological activities, and toxicology of S. japonica based on studies published in the last six decades. Information on the S. japonica was collected from major scientific databases (SciFinder, PubMed, Elsevier, SpringerLink, Web of Science, Google Scholar, Medline Plus, China Knowledge Resource Integrated (CNKI), and "Da Yi Yi Xue Sou Suo (http://www.dayi100.com/login.jsp)" for publications between 1957 and 2015 on S. japonica. Information was also obtained from local classic herbal literature, government reports, conference papers, as well as PhD and MSc dissertations. Approximately 153 chemical compounds, including flavonoids, isoflavonoids, triterpenes, alkaloids, polysaccharides, amino acids, and other compounds, have been isolated from the leaves, branches, flowers, buds, pericarps, and/or fruits of S. japonica. Among these compounds, several flavonoids and isoflavonoids comprise the active constituents of S. japonica, which exhibit a wide range of biological activities in vitro and in vivo such as anti-inflammatory, antibacterial, antiviral, anti-osteoporotic, antioxidant, radical scavenging, antihyperglycemic, antiobesity, antitumor, and

Could the gut microbiota reconcile the oral bioavailability conundrum of traditional herbs?

PubMed

Chen, Feng; Wen, Qi; Jiang, Jun; Li, Hai-Long; Tan, Yin-Feng; Li, Yong-Hui; Zeng, Nian-Kai

2016-02-17

A wealth of information is emerging about the impact of gut microbiota on human health and diseases such as cardiovascular diseases, obesity and diabetes. As we learn more, we find out the gut microbiota has the potential as new territory for drug targeting. Some novel therapeutic approaches could be developed through reshaping the commensal microbial structure using combinations of different agents. The gut microbiota also affects drug metabolism, directly and indirectly, particularly towards the orally administered drugs. Herbal products have become the basis of traditional medicines such as traditional Chinese medicine and also been being considered valuable materials in modern drug discovery. Of note, low oral bioavailability but high bioactivity is a conundrum not yet solved for some herbs. Since most of herbal products are orally administered, the herbs' constituents are inevitably exposed to the intestinal microbiota and the interplays between herbal constituents and gut microbiota are expected. Emerging explorations of herb-microbiota interactions have an opportunity to revolutionize the way we view herbal therapeutics. The present review aims to provide information regarding the health promotion and/or disease prevention by the interplay between traditional herbs with low bioavailability and gut microbiota through gut microbiota via two different types of mechanisms: (1) influencing the composition of gut microbiota by herbs and (2) metabolic reactions of herbal constituents by gut microbiota. The major data bases (PubMed and Web of Science) were searched using "gut microbiota", "intestinal microbiota", "gut flora", "intestinal flora", "gut microflora", "intestinal microflora", "herb", "Chinese medicine", "traditional medicine", or "herbal medicine" as keywords to find out studies regarding herb-microbiota interactions. The Chinese Pharmacopoeia (2010 edition, Volume I) was also used to collect the data of commonly used medicinal herbs and their quality

A New Test Unit for Disintegration End-Point Determination of Orodispersible Films.

PubMed

Low, Ariana; Kok, Si Ling; Khong, Yuet Mei; Chan, Sui Yung; Gokhale, Rajeev

2015-11-01

No standard time or pharmacopoeia disintegration test method for orodispersible films (ODFs) exists. The USP disintegration test for tablets and capsules poses significant challenges for end-point determination when used for ODFs. We tested a newly developed disintegration test unit (DTU) against the USP disintegration test. The DTU is an accessory to the USP disintegration apparatus. It holds the ODF in a horizontal position, allowing top-view of the ODF during testing. A Gauge R&R study was conducted to assign relative contributions of the total variability from the operator, sample or the experimental set-up. Precision was compared using commercial ODF products in different media. Agreement between the two measurement methods was analysed. The DTU showed improved repeatability and reproducibility compared to the USP disintegration system with tighter standard deviations regardless of operator or medium. There is good agreement between the two methods, with the USP disintegration test giving generally longer disintegration times possibly due to difficulty in end-point determination. The DTU provided clear end-point determination and is suitable for quality control of ODFs during product developmental stage or manufacturing. This may facilitate the development of a standardized methodology for disintegration time determination of ODFs. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

[Identification of antler powder components based on DNA barcoding technology].

PubMed

Jia, Jing; Shi, Lin-chun; Xu, Zhi-chao; Xin, Tian-yi; Song, Jing-yuan; Chen Shi, Lin

2015-10-01

In order to authenticate the components of antler powder in the market, DNA barcoding technology coupled with cloning method were used. Cytochrome c oxidase subunit I (COI) sequences were obtained according to the DNA barcoding standard operation procedure (SOP). For antler powder with possible mixed components, the cloning method was used to get each COI sequence. 65 COI sequences were successfully obtained from commercial antler powders via sequencing PCR products. The results indicates that only 38% of these samples were derived from Cervus nippon Temminck or Cervus elaphus Linnaeus which is recorded in the 2010 edition of "Chinese Pharmacopoeia", while 62% of them were derived from other species. Rangifer tarandus Linnaeus was the most frequent species among the adulterants. Further analysis showed that some samples collected from different regions, companies and prices, contained adulterants. Analysis of 36 COI sequences obtained by the cloning method showed that C. elaphus and C. nippon were main components. In addition, some samples were marked clearly as antler powder on the label, however, C. elaphus or R. tarandus were their main components. In summary, DNA barcoding can accurately and efficiently distinguish the exact content in the commercial antler powder, which provides a new technique to ensure clinical safety and improve quality control of Chinese traditional medicine

Search for the effect of E-beam irradiation on some steroids

NASA Astrophysics Data System (ADS)

Marciniec, B.; Ogrodowczyk, M.; Dettlaff, K.

2005-03-01

Seven steroid derivatives (hydrocortisone, hydrocortisone acetate, prednisolone, prednisolone acetate, methylprednisolone acetate, dexamethasone and fludrocortisone acetate) irradiated in the solid phase 10 MeV electrons, were studied by chromatographic methods (TLC and HPLC). Before the irradiation the derivatives contained different amounts of the following impurities: cortisone, cortisone acetate, prednisolone, prednisolone acetate and prednisone. After irradiation with a dose of upto 200 kGy radiolytic products were identified: cortisone, cortisone acetate, prednisone, prednisolone and methylprednisone acetate. All the identified radiolytic products were formed as a result of oxidation of the substituent at C 11, and in some cases the oxidation was accompanied by cleavage of the ester bond. The content of impurities before irradiation did not exceed 0.8%, while after the irradiation the content of the products of radiolysis depended on the kind of the derivative and the dose, and varied from 0.6% for a dose of 25 kGy to 4.03% for a dose of 200 kGy. For some derivatives, a linear relationship was found between the loss of a given steroid content and the dose. The studied steroid derivatives are characterised by high radiochemical stability and their sterilisation by irradiation does not lead to loss of the active substance below 97%, i.e. the lower limit admissible by the pharmacopoeias.

The Combination of Scopolamine and Psychostimulants for the Prevention of Severe Motion Sickness.

PubMed

Zhang, Li-Li; Liu, Hong-Qi; Yu, Xu-Hong; Zhang, Ying; Tian, Jia-Sheng; Song, Xu-Rui; Han, Bing; Liu, Ai-Jun

2016-08-01

Severe motion sickness is a huge obstacle for people conducting precise aviation, marine or emergency service tasks. The combination of scopolamine and d-amphetamine is most effective in preventing severe motion sickness. However, this combination is not included in any present pharmacopoeia due to the abuse liability of d-amphetamine. We wanted to find a combination to replace it for the treatment of severe motion sickness. We compared the efficacy of scopolamine, diphenhydramine, and granisetron (representing three classes of drugs) with different doses, and found that scopolamine was the most effective one. We also found scopolamine inhibited central nervous system at therapeutic doses and caused anxiety. Then, we combined it with different doses of psychostimulants (d-amphetamine, modafinil, caffeine) to find the best combination for motion sickness. The efficacy of scopolamine with modafinil (1 + 10 mg/kg) was equivalent to that of scopolamine with d-amphetamine (1 + 1 mg/kg); This combination also excited central nervous system and abolished the anxiety caused by scopolamine. The optimal dose ratio of scopolamine and modafinil is 1:10. This combination is beneficial for motion sickness and can abolish the side effects of scopolamine. So, it might be a good replacement of scopolamine and d-amphetamine for severe motion sickness. © 2016 John Wiley & Sons Ltd.

Bathe the baby to make it strong and healthy: plant use and child care among Saramaccan Maroons in Suriname.

PubMed

Ruysschaert, Sofie; van Andel, Tinde; Van de Putte, Kobeke; Van Damme, Patrick

2009-01-12

Young children are vulnerable to a range of illnesses and evil forces. Ethnobotanical folk remedies often play a major role in combating these afflictions. Here we show that plant use is highly valued and practiced within the Saramaccan Maroon Society in Suriname to maintain the general health and well-being of children. To assess the plant use importance in child care, we (1) quantified diversity and current status of herbal pharmacopoeia used in child care and (2) elucidated the reasons why care takers (mostly mothers) use these plants. We collected botanical vouchers of plants used in child care, carried out an ethnobotanical household survey with 105 women and interviewed 19 key informants. A total of 178 plant species were used in child care for different purposes. Preventive practices were preferred over curing remedies and plants were most frequently used to keep young children strong and healthy. Child care had a strong magical connotation. Bathing proved to be the most important type of application, often combined with drinking small amounts of the bath water. Plants play an important role in child care, but more research is needed on how Maroon plant use reflects actual health problems in young children in the Surinamese interior.

Effect of Herbal Therapy to Intensity Chemotherapy-Induced Nausea and Vomiting in Cancer Patients.

PubMed Central

Montazeri, Akram Sadat; Raei, Mehdi; Ghanbari, Atefeh; Dadgari, Ali; Montazeri, Azam Sadat; Hamidzadeh, Azam

2013-01-01

Background: Chemotherapy-induced nausea and vomiting are the most important complications for cancer patients as its prevalence has been reported to be about 54-96 percent. ginger has been used for medicinal purposes including nausea and vomiting in traditional Persian, Chinese and Indian pharmacopoeia. Objectives: The objective of this study was to evaluate the efficacy of complimentary ginger among cancer patients experiencing nausea and vomiting. Material and Methods: A randomized cross-over clinical trial was carried out on patients under chemotherapy treatment for at least 2 episodes of chemotherapy and at least 2 episodes of previous experience of nausea and vomiting. Subjects of this study received 2 different complementary regimes with 250mg ginger capsule in regime A and placebo capsule in regime B. subjects of the study were crossed over to receive the other regime during the two cycles of chemotherapy. Results: Findings of the study indicated that subjects receiving ginger showed significant reduction in frequency and intensity of nausea and vomiting compared to placebo receiving subjects. Conclusions: According to finding of this study, in accordance to most of other researches, ginger is an effective agent to reduce chemotherapy-induced nausea and vomiting. However, there are some researches supporting ginger as a moderate antiemetic agent among cancerous patients under chemotherapy. PMID:24693415

Ethnopharmacological survey of Samburu district, Kenya

PubMed Central

Nanyingi, Mark O; Mbaria, James M; Lanyasunya, Adamson L; Wagate, Cyrus G; Koros, Kipsengeret B; Kaburia, Humphrey F; Munenge, Rahab W; Ogara, William O

2008-01-01

Background Ethnobotanical pharmacopoeia is confidently used in disease intervention and there is need for documentation and preservation of traditional medical knowledge to bolster the discovery of novel drugs. The objective of the present study was to document the indigenous medicinal plant utilization, management and their extinction threats in Samburu District, Kenya. Methods Field research was conducted in six divisions of Samburu District in Kenya. We randomly sampled 100 consented interviewees stratified by age, gender, occupation and level of education. We collected plant use data through semi-structured questionnaires; transect walks, oral interviews and focus groups discussions. Voucher specimens of all cited botanic species were collected and deposited at University of Nairobi's botany herbarium. Results Data on plant use from the informants yielded 990 citations on 56 medicinal plant species, which are used to treat 54 different animal and human diseases including; malaria, digestive disorders, respiratory syndromes and ectoparasites. Conclusion The ethnomedicinal use of plant species was documented in the study area for treatment of both human and veterinary diseases. The local population has high ethnobotanical knowledge and has adopted sound management conservation practices. The major threatening factors reported were anthropogenic and natural. Ethnomedical documentation and sustainable plant utilization can support drug discovery efforts in developing countries. PMID:18498665

Saffron: An Old Medicinal Plant and a Potential Novel Functional Food.

PubMed

José Bagur, María; Alonso Salinas, Gonzalo Luis; Jiménez-Monreal, Antonia M; Chaouqi, Soukaina; Llorens, Silvia; Martínez-Tomé, Magdalena; Alonso, Gonzalo L

2017-12-23

The spice saffron is made from the dried stigmas of the plant Crocus sativus L. The main use of saffron is in cooking, due to its ability to impart colour, flavour and aroma to foods and beverages. However, from time immemorial it has also been considered a medicinal plant because it possesses therapeutic properties, as illustrated in paintings found on the island of Santorini, dated 1627 BC. It is included in Catalogues of Medicinal Plants and in the European Pharmacopoeias, being part of a great number of compounded formulas from the 16th to the 20th centuries. The medicinal and pharmaceutical uses of this plant largely disappeared with the advent of synthetic chemistry-produced drugs. However, in recent years there has been growing interest in demonstrating saffron's already known bioactivity, which is attributed to the main components-crocetin and its glycosidic esters, called crocins, and safranal-and to the synergy between the compounds present in the spice. The objective of this work was to provide an updated and critical review of the research on the therapeutic properties of saffron, including activity on the nervous and cardiovascular systems, in the liver, its antidepressant, anxiolytic and antineoplastic properties, as well as its potential use as a functional food or nutraceutical.

Pineal peptides restore the age-related disturbances in hormonal functions of the pineal gland and the pancreas.

PubMed

Goncharova, N D; Vengerin, A A; Khavinson, V Kh; Lapin, B A

2005-01-01

The purpose of this research was to study age-related changes in functioning of pineal and pancreatic glands of non-human primates, rhesus monkeys, and to elucidate the possibility of their corrections with the help of epitalon, a synthetic analogue of the pharmacopoeia drug epithalamin. In old (20-27 years) animals, the basal plasma levels of glucose and insulin were found to be higher, while the night melatonin level was lower in comparison with (6-8 years) young animals. After the glucose administration to old monkeys, a larger area under the curve of the plasma glucose response, a reduced glucose 'disappearance' rate, and a reduced insulin peak (5 min after the glucose administration) were observed in comparison with young animals in similar experiments. The epitalon administration to old monkeys caused the decrease in the basal levels of glucose and insulin and the increase in the basal night melatonin level. Additionally, in the case of old monkeys, epitalon decreased the area under the plasma glucose response curve, markedly increased the glucose 'disappearance' rate and normalized the plasma insulin dynamics in response to glucose administration. Yet, it has not affected the hormonal and metabolic changes in young animals. Thus, epitalon is a promising factor for restoring the age-related endocrine dysfunctions of primates.

Computational Fluid Dynamics Simulation of Hydrodynamics and Stresses in the PhEur/USP Disintegration Tester Under Fed and Fasted Fluid Characteristics.

PubMed

Kindgen, Sarah; Wachtel, Herbert; Abrahamsson, Bertil; Langguth, Peter

2015-09-01

Disintegration of oral solid dosage forms is a prerequisite for drug dissolution and absorption and is to a large extent dependent on the pressures and hydrodynamic conditions in the solution that the dosage form is exposed to. In this work, the hydrodynamics in the PhEur/USP disintegration tester were investigated using computational fluid dynamics (CFD). Particle image velocimetry was used to validate the CFD predictions. The CFD simulations were performed with different Newtonian and non-Newtonian fluids, representing fasted and fed states. The results indicate that the current design and operating conditions of the disintegration test device, given by the pharmacopoeias, are not reproducing the in vivo situation. This holds true for the hydrodynamics in the disintegration tester that generates Reynolds numbers dissimilar to the reported in vivo situation. Also, when using homogenized US FDA meal, representing the fed state, too high viscosities and relative pressures are generated. The forces acting on the dosage form are too small for all fluids compared to the in vivo situation. The lack of peristaltic contractions, which generate hydrodynamics and shear stress in vivo, might be the major drawback of the compendial device resulting in the observed differences between predicted and in vivo measured hydrodynamics. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Regionalization of Chinese Material Medical Quality Based on Maximum Entropy Model: A case study of Atractylodes lancea

NASA Astrophysics Data System (ADS)

Shoudong, Zhu; Huasheng, Peng; Lanping, Guo; Tongren, Xu; Yan, Zhang; Meilan, Chen; Qingxiu, Hao; Liping, Kang; Luqi, Huang

2017-02-01

Atractylodes is an East-Asiatic endemic genera that distributed in China, Japan and Russian Far Eastern. As an important resource of medicinal plant, atractylodes has long been used as herbal medicine. To example the significant features in its trueborn quality and geographical distribution, we explored the relationships between medicine quality and habitat suitability in two classifications-lower atractylodin content than the standard of Chinese Pharmacopoeia (2010) and the other has higher content. We found that the atractylodin content is negatively related to the habitat suitability for atractylodes with lower atractylodin, while the atractylodin content is positively related to the habitat suitability for those with higher atractylodin. By analyzing the distribution of atractylodeswith lower atractylodin content than the standard of Pharmacopeia, we discovered that the main ecological factors that could inhibit the accumulation of atractylodin were soil type (39.7%), soil clay content (26.7%), mean temperature in December (22.3%), Cation-exchange capacity (6%), etc. And these ecological factors promoted the accumulation of atractylodin for the atractylodes with higher atractylodin. By integrating the two classifications, we finally predicted the distribution of atractylodin content in China.Our results realized the query of atractylodes quality in arbitrary coordinates, and satisfied the actually cultivation demands of “Planting area based on atractylodin quality”.

Botanical features for identification of Gymnosporia arenicola dried leaf.

PubMed

Da Silva, Gustavo; Serrano, Rita; Gomes, Elsa Teixeira; Silva, Olga

2015-11-01

Gymnosporia arenicola Jordaan (Celastraceae) is a shrub or small tree, which naturally occurs in coastal sand dunes of Southern Mozambique and South Africa. Its dried leaf is often used in traditional medicine for the treatment of infectious and inflammatory diseases. Hereby, we present results of studies carried out according to the pharmacopoeia standards for the identification of herbal drugs, in the whole, fragmented, and powdered plant material. These results were complemented with scanning electron microscopy and histochemical techniques. The leaf microscopic analysis revealed a typical dorsiventral mesophyll with a corresponding spongy parenchyma-palisade parenchyma ratio of 0.60, anomocytic and paracytic stomata, papillate cells with a diameter of 4.00 ± 0.40 µm, multicellular uniseriate nonglandular trichomes with a length of 27.00 ± 4.10 µm and cristalliferous idioblasts containing calcium oxalate cluster crystals with a diameter of 23.04 ± 5.84 µm. The present findings demonstrate that the G. arenicola leaf has both nonglandular trichomes and hypoderm, features not previously described in the corresponding botanical section (Gymnosporia sect. Buxifoliae Jordaan). The establishment of these new botanical markers for the identification of G. arenicola leaf is essential for quality, safety and efficacy reasons. © 2015 Wiley Periodicals, Inc.

From rustics to savants: indigenous materia medica in eighteenth-century Mexico.

PubMed

Achim, Miruna

2011-09-01

This essay explores how indigenous knowledge about plant and animal remedies was gathered, classified, tested, and circulated across wide networks of exchange for natural knowledge between Europe and the Americas. There has been much recent interest in the "bioprospecting" of local natural resources-medical and otherwise-by Europeans in the early modern world and the strategies employed by European travellers, missionaries, or naturalists have been well documented. By contrast, less is known about the role played by indigenous and Creole intermediaries in this process. And yet, the transmission of knowledge between indigenous communities and the European cabinet was neither transparent nor natural, and often involved epistemological, linguistic, and religious obstacles. Drawing on printed and manuscript collections of indigenous remedies, written in colonial Mexico between the sixteenth and the eighteenth centuries, I focus on how local intermediaries, like creoles scholars, sought to overcome such obstacles by observing indigenous uses of remedies, by studying indigenous languages and by producing natural histories and pharmacopoeias in indigenous languages. Ultimately, behind the Creole participation in the transmission of indigenous remedies, one can point to political and cultural interests and to inclusive definitions of knowledge, which cut across oppositions between science and superstition, cabinet and field, centre and periphery. Copyright © 2011 Elsevier Ltd. All rights reserved.

Emerging importance of geographical indications and designations of origin - authenticating geo-authentic botanicals and implications for phytotherapy.

PubMed

Brinckmann, J A

2013-11-01

Pharmacopoeial monographs providing specifications for composition, identity, purity, quality, and strength of a botanical are developed based on analysis of presumably authenticated botanical reference materials. The specimens should represent the quality traditionally specified for the intended use, which may require different standards for medicinal versus food use. Development of quality standards monographs may occur through collaboration between a sponsor company or industry association and a pharmacopoeial expert committee. The sponsor may base proposed standards and methods on their own preferred botanical supply which may, or may not, be geo-authentic and/or correspond to qualities defined in traditional medicine formularies and pharmacopoeias. Geo-authentic botanicals are those with specific germplasm, cultivated or collected in their traditional production regions, of a specified biological age at maturity, with specific production techniques and processing methods. Consequences of developing new monographs that specify characteristics of an 'introduced' cultivated species or of a material obtained from one unique origin could lead to exclusion of geo-authentic herbs and may have therapeutic implications for clinical practice. In this review, specifications of selected medicinal plants with either a geo-authentic or geographical indication designation are discussed and compared against official pharmacopoeial standards for same genus and species regardless of origin. Copyright © 2012 John Wiley & Sons, Ltd.

Why the dim light melatonin onset (DLMO) should be measured before treatment of patients with circadian rhythm sleep disorders.

PubMed

Keijzer, Henry; Smits, Marcel G; Duffy, Jeanne F; Curfs, Leopold M G

2014-08-01

Treatment of circadian rhythm sleep disorders (CRSD) may include light therapy, chronotherapy and melatonin. Exogenous melatonin is increasingly being used in patients with insomnia or CRSD. Although pharmacopoeias and the European food safety authority (EFSA) recommend administering melatonin 1-2 h before desired bedtime, several studies have shown that melatonin is not always effective if administered according to that recommendation. Crucial for optimal treatment of CRSD, melatonin and other treatments should be administered at a time related to individual circadian timing (typically assessed using the dim light melatonin onset (DLMO)). If not administered according to the individual patient's circadian timing, melatonin and other treatments may not only be ineffective, they may even result in contrary effects. Endogenous melatonin levels can be measured reliably in saliva collected at the patient's home. A clinically reliably DLMO can be calculated using a fixed threshold. Diary and polysomnographic sleep-onset time do not reliably predict DLMO or circadian timing in patients with CRSD. Knowing the patient's individual circadian timing by assessing DLMO can improve diagnosis and treatment of CRSD with melatonin as well as other therapies such as light or chronotherapy, and optimizing treatment timing will shorten the time required to achieve results. Copyright © 2013 Elsevier Ltd. All rights reserved.

Drug target identification in protozoan parasites.

PubMed

Müller, Joachim; Hemphill, Andrew

2016-08-01

Despite the fact that diseases caused by protozoan parasites represent serious challenges for public health, animal production and welfare, only a limited panel of drugs has been marketed for clinical applications. Herein, the authors investigate two strategies, namely whole organism screening and target-based drug design. The present pharmacopoeia has resulted from whole organism screening, and the mode of action and targets of selected drugs are discussed. However, the more recent extensive genome sequencing efforts and the development of dry and wet lab genomics and proteomics that allow high-throughput screening of interactions between micromolecules and recombinant proteins has resulted in target-based drug design as the predominant focus in anti-parasitic drug development. Selected examples of target-based drug design studies are presented, and calcium-dependent protein kinases, important drug targets in apicomplexan parasites, are discussed in more detail. Despite the enormous efforts in target-based drug development, this approach has not yet generated market-ready antiprotozoal drugs. However, whole-organism screening approaches, comprising of both in vitro and in vivo investigations, should not be disregarded. The repurposing of already approved and marketed drugs could be a suitable strategy to avoid fastidious approval procedures, especially in the case of neglected or veterinary parasitoses.

Molecular cloning and expression of epsilon toxin from Clostridium perfringens type D and tests of animal immunization.

PubMed

Souza, A M; Reis, J K P; Assis, R A; Horta, C C; Siqueira, F F; Facchin, S; Alvarenga, E R; Castro, C S; Salvarani, F M; Silva, R O S; Pires, P S; Contigli, C; Lobato, F C F; Kalapothakis, E

2010-02-18

Epsilon toxin produced by Clostridium perfringens types B and D causes enterotoxemia in sheep, goats and calves. Enterotoxemia can cause acute or superacute disease, with sudden death of the affected animal. It provokes huge economic losses when large numbers of livestock are affected. Therapeutic intervention is challenging, because the disease progresses very rapidly. However, it can be prevented by immunization with specific immunogenic vaccines. We cloned the etx gene, encoding epsilon toxin, into vector pET-11a; recombinant epsilon toxin (rec-epsilon) was expressed in inclusion bodies and was used for animal immunization. Serum protection was evaluated and cross-serum neutralization tests were used to characterize the recombinant toxin. To analyze the potency of the toxin (as an antigen), rabbits were immunized with 50, 100 or 200 microg recombinant toxin, using aluminum hydroxide gel as an adjuvant. Titers of 10, 30 and 40 IU/mL were obtained, respectively. These titers were higher than the minimum level required by the European Pharmacopoeia (5 IU/mL) and by the USA Code of Federal Regulation (2 IU/mL). This rec-epsilon is a good candidate for vaccine production against enterotoxemia caused by epsilon toxin of C. perfringens type D.

Intercultural Usage of Mori Folium: Comparison Review from a Korean Medical Perspective

PubMed Central

Joh, Byungjin; Jeon, Eun Sang; Lim, Su Hye; Park, Yu Lee; Park, Wansu

2015-01-01

Objectives. A review on studies related to the use of Mori folium, the leaves of Morus alba, was conducted with the goal of identifying new clinical applications in Korean medicine. Methods. Global literature search was conducted using three electronic databases up to January 2015 with the term Morus alba and its Korean terms. KM literatures including textbooks and standard pharmacopoeia were separately hand-searched and reviewed to provide comparison. Data were extracted according to predetermined criteria, and clinical uses were standardized with ICD-10 categories. Results. 159 potentially relevant studies were identified, and 18 articles including 12 ethnopharmacologic and 6 clinical studies were finally included in this analysis. Ethnopharmacologic studies from 8 countries provided 17 clinical uses. We found that five out of six clinical trials were related to diabetes and suggested a moderate short-term to mild long-term effect. And 43 Korean texts also provided 156 clinical uses in 35 categories including ocular and respiratory disorders. Discussion and Conclusions. Though majority of the clinical uses were also found in Korean medicine literature, treatment of infertility, jaundice, cognitive disorder, and hyperpigmentation was found to be effective and diabetes with Morus alba was recognized to have clinical importance. PMID:26539223

Distinguishing the Chinese materia medica Tiepishihu from similar Dendrobium species of the same genus using histological and microscopic method.

PubMed

Yu, Kun-Zi; Yan, Hua; Tai, Hai-Chuan; Zhang, Nan-Ping; Cheng, Xian-Long; Guo, Zeng-Xi; Ma, Shuang-Cheng; Wei, Feng

2017-07-01

The Chinese Materia Medica, Tiepishihu, used as a tonic for over one thousand years, is a well-known precious medicine in China. According to the Chinese Pharmacopoeia, its source is the species Dendrobium officinale Kimura et Migo, which is distinguished from other species in Dendrobium genus. However, these species from the same genus are similar with Tiepishihu and caused confusion in the market. To find a quick and simple method to distinguish Tiepishihu from other similar species, histologic and microscopic methods were combined together to investigate the transverse section of stem of Tiepishihu and other similar species. Phloroglucinol test solution with hydrochloric acid was used to reveal the lignified tissue by staining the transverse section of Tiepishihu and similar species. Results revealed the unique identification characteristics to distinguish Tiepishihu from similar species, which were difficult to distinguish by other methods. The identification characteristics of Tiepishihu include the cells of vascular bundle sheath were stained red, parenchyma cells were not stained red. What's more, other species can be distinguished from each other with microscopic and histological characteristics. These characteristics proved stable and can be easily observed by normal light microscopic examination. This method is rapid, accurate, stable, and inexpensive. © 2017 Wiley Periodicals, Inc.

Effects of Pump Pulsation on Hydrodynamic Properties and Dissolution Profiles in Flow-Through Dissolution Systems (USP 4).

PubMed

Yoshida, Hiroyuki; Kuwana, Akemi; Shibata, Hiroko; Izutsu, Ken-Ichi; Goda, Yukihiro

2016-06-01

To clarify the effects of pump pulsation and flow-through cell (FTC) dissolution system settings on the hydrodynamic properties and dissolution profiles of model formulations. Two FTC systems with different cell temperature control mechanisms were used. Particle image velocimetry (PIV) was used to analyze the hydrodynamic properties of test solutions in the flow-through dissolution test cell. Two pulsation pumps (semi-sine, full-sine) and a non-pulsatile pump were used to study the effects of varied flows on the dissolution profiles of United States Pharmacopeia standard tablets. PIV analysis showed periodic changes in the aligned upward fluid flow throughout the dissolution cell that was designed to reduce the temperature gradient during pump pulsation (0.5 s/pulse). The maximum instantaneous flow from the semi-sine pump was higher than that of the full-sine pump under all conditions. The flow from the semi-sine wave pump showed faster dissolution of salicylic acid and prednisone tablets than those from other pumps. The semi-sine wave pump flow showed similar dissolution profiles in the two FTC systems. Variations in instantaneous fluid flow caused by pump pulsation that meets the requirements of pharmacopoeias are a factor that affects the dissolution profiles of tablets in FTC systems.

[Two books printed in Strasburg during the 16th century present in the inventory of the Paris College of Pharmacy Library].

PubMed

Lafont, Olivier

2017-03-01

The catalogue of the College of Pharmacy Library, written in 1780, mentioned two books printed in Strasburg during the 16th century. The first one was a Latin edition of PΠερι Υλης Ιατριχης of Dioscorides. The drop caps are enriched by the figuration of episodes from the Bible. The principal interest of this book comes from the identity of his donator, Ioannes Du Boys, apothecary of the Duke of Alençon, the brother of King Henry III. This apothecary was also the author of a pharmacopoeia entitled Methodus Miscendorum Medicamentorum. The second one was a compendium of various titles, which had, most of them, in common to have been written by Valerius Cordus. It contains many illustrations and some of them are especially expressive. Its main interest is nevertheless to be a part of a gift made by a group of Parisian apothecaries, in 1570. This gift is considered as the birth of apothecaries’ library, the direct ancestor of actual “BIU Santé pole Pharmacy”. The presence of these two books in the library constitutes a testimony of the importance of printers from Strasburg in history.

European Materia Medica in Historical Texts: Longevity of a Tradition and Implications for Future Use

PubMed Central

De Vos, Paula

2010-01-01

Recent research in the area of new drug discovery has shown the continued promise of looking to natural products for bioactive compounds. Researchers have thus turned to traditional medicine, which is still used widely throughout the world and increasingly in industrialized countries as well, to provide clues as to which products to investigate. The oral traditions on which much of this medical knowledge rests, however, are unstable, prompting researchers to turn to textual sources for potential drugs. This study uses Mediterranean/European medical texts from the 5th century BC to the 19th century A.D. to compile a list of the most commonly used “simples” – or single action drug substances – used in therapeutics in traditional European medicine. It finds that traditional European materia medica was based on a Dioscordean tradition that lasted through the 19th century with remarkably little variation, but is significantly different from the present-day herbal pharmacopoeia as represented by the National Institutes of Health. The most prominent simples of that tradition can thus provide clues to further bioactive compounds that have not as of yet been fully exploited for their potential, but were clearly of great use in the past. PMID:20561577

Synthesis, isolation and purification of [11C]-choline

PubMed Central

Jadwiński, Michał; Chmura, Agnieszka; Gorczewski, Kamil; Sokół, Maria

2016-01-01

[11C]-choline is an effective PET tracer used for imaging of neoplastic lesions and metastases of the prostate cancer. However, its production can be a challenge for manufacturers, as it has not yet been described in Polish or European pharmacopoeia. In this study the technical aspects of [11C]-choline production are described and detailed process parameters are provided. The quality control procedures for releasing [11C]-choline as solutio iniectabilis are also presented. The purity and quality of the radiopharmaceutical obtained according to the proposed method were find to be high enough to safely administrate the radiopharmaceutical to patients. Application of an automated synthesizer makes it possible to carry out the entire process of [11C]-choline production, isolation and purification within 20 minutes. It is crucial to maintain all aspects of the process as short as possible, since the decay half-time of carbon-11 is 20.4 minutes. The resulting radiopharmaceutical is sterile and pyrogen-free and of a high chemical, radiochemical, and radionuclide purity proved by chromatographic techniques. The yield of the process is up to 20%. [11C]-choline PET scanning can be used as accurate and effective diagnostic tool in all centers equipped with [11C]-target containing cyclotron. PMID:27660552

Peptide Nucleic Acid Based Molecular Authentication for Identification of Four Medicinal Paeonia Species Using Melting Array Analysis of the Internal Transcribed Spacer 2 Region.

PubMed

Kim, Wook Jin; Yang, Sungyu; Choi, Goya; Moon, Byeong Cheol

2017-11-07

Accurate taxonomic identification of plant materials in herbal medicines is important for product quality control. The genus Paeonia (Saxifragales) is the source of the herbal preparations Paeoniae Radix (Paeoniae Radix Alba and Paeoniae Radix Rubra) and Moutan Radicis Cotex. However, confusion has arisen regarding their contents due to linguistic and taxonomic ambiguities, similar morphologies and different definitions of Paeoniae Radix in the Korean and Chinese national pharmacopoeias, leading to the distribution of adulterated products. To develop a method for identifying the four Paeonia species used in these medicines, three fluorescently-labeled peptide nucleic acid (PNA) probes were designed against ITS2 sequences containing single nucleotide polymorphisms (SNPs) and used in a real-time PCR melting curve assay. Each of the four Paeonia species was accurately identified using this analysis. The accuracy and analytical stability of the PNA melting curve assay was confirmed using commercially available samples of the four Paeonia species. This assay is a reliable genetic tool to distinguish between different Paeonia -derived herbal medicines and identify the botanical origins of Paeoniae Radix and Moutan Radicis Cortex. This technique may also contribute to quality control and standardization of herbal medicines by providing a reliable authentication tool and preventing the distribution of inauthentic adulterants.

Methylene blue inhibits the asexual development of vivax malaria parasites from a region of increasing chloroquine resistance

PubMed Central

Suwanarusk, Rossarin; Russell, Bruce; Ong, Alice; Sriprawat, Kanlaya; Chu, Cindy S.; PyaePhyo, Aung; Malleret, Benoit; Nosten, François; Renia, Laurent

2015-01-01

Objectives Methylene blue, once discarded due to its unsettling yet mild side effects, has now found a renewed place in the pharmacopoeia of modern medicine. The continued spread of drug-resistant Plasmodium vivax and Plasmodium falciparum has also led to a recent re-examination of methylene blue's potent antimalarial properties. Here we examine the ex vivo susceptibility profile of Plasmodium spp. isolates to methylene blue; the isolates were from a region on the Thai–Myanmar border where there are increasing rates of failure when treating vivax malaria with chloroquine. Methods To do this we used a newly developed ex vivo susceptibility assay utilizing flow cytometry and a portable flow cytometer with a near-UV laser. Results P. vivax (median methylene blue IC50 3.1 nM, IQR 1.7–4.3 nM) and P. falciparum (median methylene blue IC50 1.8 nM, IQR 1.6–2.3 nM) are susceptible to methylene blue treatment at physiologically relevant levels. Unfortunately, the addition of chloroquine to combination treatments with methylene blue significantly reduces the ex vivo effectiveness of this molecule. Conclusions Our data support further efforts to employ methylene blue as a safe, low-cost antimalarial to treat drug-resistant malaria. PMID:25150147

Production of GMP-grade radioactive holmium loaded poly(L-lactic acid) microspheres for clinical application.

PubMed

Zielhuis, S W; Nijsen, J F W; de Roos, R; Krijger, G C; van Rijk, P P; Hennink, W E; van het Schip, A D

2006-03-27

Radioactive holmium-166 loaded poly(L-lactic acid) microspheres are promising systems for the treatment of liver malignancies. The microspheres are loaded with holmium acetylacetonate (HoAcAc) and prepared by a solvent evaporation method. After preparation, the microspheres (Ho-PLLA-MS) are activated by neutron irradiation in a nuclear reactor. In this paper, the aspects of the production of a (relatively) large-scale GMP batch (4 g, suitable for treatment of 5-10 patients) of Ho-PLLA-MS are described. The critical steps of the Ho-PLLA-MS production process (sieving procedure, temperature control during evaporation and raw materials) were considered and the pharmaceutical quality of the microspheres was evaluated. The pharmaceutical characteristics (residual solvents, possible bacterial contaminations and endotoxins) of the produced Ho-PLLA-MS batches were in compliance with the requirements of the European Pharmacopoeia. Moreover, neutron irradiated Ho-PLLA-MS retained their morphological integrity and the holmium remained stably associated with the microspheres; it was observed that after 270h (10 times the half-life of Ho-166) only 0.3+/-0.1% of the loading was released from the microspheres in an aqueous solution. In conclusion, Ho-PLLA-MS which are produced as described in this paper, can be clinically applied, with respect to their pharmaceutical quality.

[Immunogenicity of sabin inactivated poliovirus vaccine induced by diphtheria-tetanus-acellular pertussis and Sabin inactivated poliovirus combined vaccine].

PubMed

Ma, Yan; Qin, Min; Hu, Hui-Qiong; Ji, Guang; Feng, Ling; Gao, Na; Gu, Jie; Xie, Bing-Feng; He, Ji-Hong; Sun, Ming-Bo

2011-06-01

In order to search the preparation process and optimazing dosage ratio of adsorbed diphtheria-tetanus-acellular pertussis and sabin inactivated poliovirus combined vaccine (DTaP-sIPV), the neutralizing antibody titers of IPV induced by different concentration of DTaP-sIPV were investigated on rats. Two batches of DTaP-sLPV were produced using different concentration of sIPV and the quality control was carried. Together with sabin-IPV and DTaP-wIPV ( boostrix-polio, GSK, Belgium) as control group, the DTaP-sIPV were administrated on three-dose schedule at 0, 1, 2 month on rats. Serum sample were collected 30 days after each dose and neutralizing antibody titers against three types poliovirus were determined using micro-neutralization test. Two batches of prepared DTaP-sIPV and control sLPV were according to the requirement of Chinese Pharmacopoeia (Volume III, 2005 edition) and showed good stability. The seropositivity rates were 100% for sabin inactivated poliovirus antigen in all groups. The GMTs (Geometric mean titers) of neutralizing antibodies against three types poliovirus increased. The prepared DTaP-sIPV was safe, stable and effective and could induced high level neutralizing antibody against poliovirus on rats.

The Globalization of Traditional Medicine in Northern Peru: From Shamanism to Molecules

PubMed Central

Bussmann, Rainer W.

2013-01-01

Northern Peru represents the center of the Andean “health axis,” with roots going back to traditional practices of Cupisnique culture (1000 BC). For more than a decade of research, semistructured interviews were conducted with healers, collectors, and sellers of medicinal plants. In addition, bioassays were carried out to evaluate the efficacy and toxicity of plants found. Most of the 510 species encountered were native to Peru (83%). Fifty percent of the plants used in colonial times have disappeared from the pharmacopoeia. Market vendors specialized either on common and exotic plants, plants for common ailments, and plants only used by healers or on plants with magical purposes. Over 974 preparations with up to 29 different ingredients were used to treat 164 health conditions. Almost 65% of the medicinal plants were applied in these mixtures. Antibacterial activity was confirmed in most plants used for infections. Twenty-four percent of the aqueous extracts and 76% of the ethanolic extracts showed toxicity. Traditional preparation methods take this into account when choosing the appropriate solvent for the preparation of a remedy. The increasing demand for medicinal species did not increase the cultivation of medicinal plants. Most species are wild collected, causing doubts about the sustainability of trade. PMID:24454490

Determination of surface energies of hot-melt extruded sugar-starch pellets.

PubMed

Yeung, Chi-Wah; Rein, Hubert

2018-02-01

Hot-melt extruded sugar-starch pellets are an alternative for commercial sugar spheres, but their coating properties remain to be studied. Both the European Pharmcopoeia 8.6 and the United States Pharmacopoeia 40 specify the composition of sugar-starch pellets without giving requirements for the manufacturing process. Due to various fabrication techniques, the physicochemical properties of pellets may differ. Therefore, the adhesion energies of three coating dispersions (sustained, enteric and immediate release) on different types of pellets were investigated. In this context, the surface energies of various kinds of corn starch (normal, waxy, high-amylose) and sucrose pellets were analyzed using the sessile drop method, whereas the surface tensions of the coating dispersions were examined using the pendant drop method. The adhesion forces were calculated from the results of these studies. Furthermore, sugar spheres were characterized in terms of particle size distribution, porosity and specific surface area. An increase of the pellets' sucrose content leads to a more porous surface structure, which gives them an enhanced wetting behavior with coating dispersions. The adhesion energies of extruded sugar-starch pellets are similar to those of commercial sugar spheres, which comply with pharmacopeial requirements. Both types of pellets are equally suited for coating.

Pyrogen detection methods: Comparison of bovine whole blood assay (bWBA) and monocyte activation test (MAT)

PubMed Central

2014-01-01

Background Pyrogen detection is of utmost importance in pharmaceutical industry, laboratories and health care institutions. As an alternative to the animal-consuming rabbit pyrogen test or Limulus amoebocyte lysate test, the monocyte activation test was introduced as a gold standard method in the European Pharmacopoeia. However, the monocyte activation test has not gained wide acceptance in practice. Methods We stimulated bovine whole blood with different endotoxin preparations (lipopolysaccharide E.coli 0127:B8 and 0113:H10), as well as the non-endotoxin pyrogens peptidoglycan and lipoteichoic acid. Prostaglandin E2 (PGE2) served as read out. Results Employing PGE2 as read out enabled detection limits of 0.04 EU/ml for lipopolysaccharide 0127:B8, 0.25 EU/ml for lipopolysaccharide 0113:H10 and 10 μg/ml of lipoteichoic acid as well as peptidoglycan. To evaluate the bWBA test system as a possible alternative to the MAT we performed a peer-to-peer comparison of the two methods and confirmed similar sensitivities. Conclusions In conclusion, the bovine whole blood assay (bWBA) reproducibly enabled sensitive detection of endotoxin and non-endotoxin pyrogens and may thus become a viable alternative for pyrogen testing. PMID:25209100

Pharmacological evaluation of sedative and hypnotic effects of schizandrin through the modification of pentobarbital-induced sleep behaviors in mice.

PubMed

Zhang, Chenning; Zhao, Xu; Mao, Xin; Liu, Aijing; Liu, Zhi; Li, Xiaolong; Bi, Kaishun; Jia, Ying

2014-12-05

The fruits of Schisandra chinensis have been recorded as an effective somnificant for the treatment of insomnia in some oriental countries pharmacopoeias. However, the mechanism of sedative and hypnotic effects of this kind of herb is still unclear. In the present study, schizandrin, which is the main component of Schisandra chinensis, was selected as a target compound to investigate possible mechanisms through behavioral pharmacology methods. The results showed that schizandrin possessed dose-dependent (5-45 mg/kg, i.p.) sedative effects on locomotion activity in normal mice, and produced a dose-dependent decrease in sleep latency and an increase in sleep duration in pentobarbital-treated mice; thus, itself did not induce sleep at higher dose which was used in this experiment (45 mg/kg, i.p.). It also can reverse the rodent models of insomnia induced by p-chlorophenylalanine (PCPA) and caffeine, which could exhibit a syne with 5-hydroxytryptophan (5-HTP) as well; therefore, the hypnotic effects of schizandrin were not inhibited by flumazenil (a specific gamma aminobutyric acid (GABA)-A-BZD receptor antagonist). Altogether, these results indicated that schizandrin produces beneficial sedative and hypnotic bioactivity, which might be mediated by the modification of the serotonergic system. Copyright © 2014 Elsevier B.V. All rights reserved.

Comparison of core-shell and totally porous ultra high performance liquid chromatographic stationary phases based on their selectivity towards alfuzosin compounds.

PubMed

Szulfer, Jarosław; Plenis, Alina; Bączek, Tomasz

2014-06-13

This paper focuses on the application of a column classification system based on the Katholieke Universiteit Leuven for the characterization of physicochemical properties of core-shell and ultra-high performance liquid chromatographic stationary phases, followed by the verification of the reliability of the obtained column classification in pharmaceutical practice. In the study, 7 stationary phases produced in core-shell technology and 18 ultra-high performance liquid chromatographic columns were chromatographically tested, and ranking lists were built on the FKUL-values calculated against two selected reference columns. In the column performance test, an analysis of alfuzosin in the presence of related substances was carried out using the brands of the stationary phases with the highest ranking positions. Next, a system suitability test as described by the European Pharmacopoeia monograph was performed. Moreover, a study was also performed to achieve a purposeful shortening of the analysis time of the compounds of interest using the selected stationary phases. Finally, it was checked whether methods using core-shell and ultra-high performance liquid chromatographic columns can be an interesting alternative to the high-performance liquid chromatographic method for the analysis of alfuzosin in pharmaceutical practice. Copyright © 2014 Elsevier B.V. All rights reserved.

Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of herbal medicinal products in the European union.

PubMed

Vlietinck, Arnold; Pieters, Luc; Apers, Sandra

2009-06-01

In the European Union (EU) herbal medicinal products have become increasingly important. This is, for instance, underlined by the recent introduction of a simplified procedure in the Member States of the EU allowing the registration of herbal medicinal products which fulfill the criteria of a traditional herbal medicinal product, i.e., sufficient evidence of its medicinal use throughout a period of at least 30 years for products in the EU and at least 15 years within the EU and 15 years elsewhere for products outside the EU. With regard to the manufacturing of these products and their quality, applications of traditional herbal medicinal products have to fulfil the same requirements as applications for a marketing authorization. The quality of herbal substances as well as herbal preparations will be determined by the availability of modern science-based public monographs in the European Pharmacopoeia and their equivalents developed by the pharmaceutical industry. The standards put forward in these monographs must allow us not only to define the quality of these products, but also to eliminate dangerous counterfeit, substandard, adulterated and contaminated (traditional) herbal medicinal products. The usefulness of these monographs to implement the criteria on quality and specifications put forward for these products in the different guidelines of the European Medicines Agency (EMEA) is discussed.

Characterization and discrimination of raw and vinegar-baked Bupleuri radix based on UHPLC-Q-TOF-MS coupled with multivariate statistical analysis.

PubMed

Lei, Tianli; Chen, Shifeng; Wang, Kai; Zhang, Dandan; Dong, Lin; Lv, Chongning; Wang, Jing; Lu, Jincai

2018-02-01

Bupleuri Radix is a commonly used herb in clinic, and raw and vinegar-baked Bupleuri Radix are both documented in the Pharmacopoeia of People's Republic of China. According to the theories of traditional Chinese medicine, Bupleuri Radix possesses different therapeutic effects before and after processing. However, the chemical mechanism of this processing is still unknown. In this study, ultra-high-performance liquid chromatography with quadruple time-of-flight mass spectrometry coupled with multivariate statistical analysis including principal component analysis and orthogonal partial least square-discriminant analysis was developed to holistically compare the difference between raw and vinegar-baked Bupleuri Radix for the first time. As a result, 50 peaks in raw and processed Bupleuri Radix were detected, respectively, and a total of 49 peak chemical compounds were identified. Saikosaponin a, saikosaponin d, saikosaponin b 3 , saikosaponin e, saikosaponin c, saikosaponin b 2 , saikosaponin b 1 , 4''-O-acetyl-saikosaponin d, hyperoside and 3',4'-dimethoxy quercetin were explored as potential markers of raw and vinegar-baked Bupleuri Radix. This study has been successfully applied for global analysis of raw and vinegar-processed samples. Furthermore, the underlying hepatoprotective mechanism of Bupleuri Radix was predicted, which was related to the changes of chemical profiling. Copyright © 2017 John Wiley & Sons, Ltd.

The role of various surfactants on the release of salbutamol from suppositories.

PubMed

Hanaee, J; Javadzadeh, Y; Taftachi, S; Farid, D; Nokhodchi, A

2004-11-01

Salbutamol is a selective beta(2)-adrenoreceptor agonist with different pharmacological effects. In this research because of the simplicity of suppository application in elderly and its higher plasma concentration than tablets as well as its particular indication in premature labour, salbutamol suppositories were prepared. The suppositories were formulated containing 10 mg of the drug and Witepsol H15, the oleaginous soluble base using melting method. To optimize the release rate of drug, different surfactants namely, sodium lauryl sulphate (SLS) as an ionic surfactant and Tween 80 as well as Arlacel 60 as non-ionic surfactants with different HLBs were chosen. The effect of surfactant concentration on the release rate of salbutamol from suppositories were also investigated. All prepared formulations fulfilled the specifications set down in British Pharmacopoeia. The results showed that Tween 80 (2%w/w) and SLS (0.75%w/w) caused an increase in dissolution rate of salbutamol from suppositories. As anionic surfactants, such as SLS, cause greater damage on mucosa than non-ionic surfactant, such as Tween 80, this study recommended that Tween 80 could be added in suppository formulation in order to increase the dissolution rate of salbutamol. It was also shown that the release rate of salbutamol altered linearly with the amount of Tween 80 in suppository formulations.

Study of formulation of mild pharmaceutical forms of paracetamol in medical practice.

PubMed

Abdullahu, Bedri; Morina, Naim; Islami, Hilmi

2012-01-01

Paracetamol is one of the most used antipyretic- analgesic preparation, which can be found in different pharmaceutical forms and in different doses. Due to its wide utilization in the clinical practice, determination of paracetamol in pharmaceutical formulation is of a great importance since that over dosage with paracetamol may cause the hepatic fulminant necroses and other toxic effects. Study has included two formulations of paracetamol suppositories with doses of 125 mg widely used in the paediatric practice. Suppositories prepared according to these two formulations by the melting method and spilling into forms was subject to the quality control by implementing a series of trials and analyses for that aim, such are: reactions of identification, average mass, disintegration time, and homogeneity whilst quantitative determination was performed by applying two methods of instrumental analyze: spectrophotometry in UV zone and cromatography in liquid phase with high pressure. Results of these analyses, performed immediately following the preparation and 3 months after the preparation, showed that content of paracetamol in both of two formulations is within the norms of Pharmacopoeia. Suppositories of paracetamol in doses of 125 mg prepared as per formulation 1 are to be considered as more appropriate because it contains semi synthetic glycerides as excipient which has better features than other suppository excipients.

Drug target identification in protozoan parasites

PubMed Central

Müller, Joachim; Hemphill, Andrew

2016-01-01

Introduction Despite the fact that diseases caused by protozoan parasites represent serious challenges for public health, animal production and welfare, only a limited panel of drugs has been marketed for clinical applications. Areas covered Herein, the authors investigate two strategies, namely whole organism screening and target-based drug design. The present pharmacopoeia has resulted from whole organism screening, and the mode of action and targets of selected drugs are discussed. However, the more recent extensive genome sequencing efforts and the development of dry and wet lab genomics and proteomics that allow high-throughput screening of interactions between micromolecules and recombinant proteins has resulted in target-based drug design as the predominant focus in anti-parasitic drug development. Selected examples of target-based drug design studies are presented, and calcium-dependent protein kinases, important drug targets in apicomplexan parasites, are discussed in more detail. Expert opinion Despite the enormous efforts in target-based drug development, this approach has not yet generated market-ready antiprotozoal drugs. However, whole-organism screening approaches, comprising of both in vitro and in vivo investigations, should not be disregarded. The repurposing of already approved and marketed drugs could be a suitable strategy to avoid fastidious approval procedures, especially in the case of neglected or veterinary parasitoses. PMID:27238605

Influence of Prosolv and Prosolv:Mannitol 200 direct compression fillers on the physicomechanical properties of atorvastatin oral dispersible tablets.

PubMed

Gowda, Veeran; Pabari, Ritesh M; Kelly, John G; Ramtoola, Zebunnissa

2015-06-01

The objective of the present study was to evaluate the influence of Prosolv® and Prosolv®: Mannitol 200 direct compression (DC) fillers on the physicomechanical characteristics of oral dispersible tablets (ODTs) of crystalline atorvastatin calcium. ODTs were formulated by DC and were analyzed for weight uniformity, hardness, friability, drug content, disintegration and dissolution. Three disintegration time (DT) test methods; European Pharmacopoeia (EP) method for conventional tablets (Method 1), a modification of this method (Method 2) and the EP method for oral lyophilisates (Method 3) were compared as part of this study. All ODTs showed low weight variation of <2.5%. Prosolv® only ODTs showed the highest tablet hardness of ∼ 73 N, hardness decreased with increasing mannitol content. Friability of all formulations was <1% although friability of Prosolv®:Mannitol ODTs was higher than for pure Prosolv®. DT of all ODTs was <30 s. Method 2 showed the fastest DT. Method 3 was non-discriminatory giving a DT of 13-15 s for all formulations. Atorvastatin dissolution from all ODTs was >60% within 5 min despite the drug being crystalline. Prosolv® and Prosolv®:Mannitol-based ODTs are suitable for ODT formulations by DC to give ODTs with high mechanical strength, rapid disintegration and dissolution.

Evaluation of Antioxidant and DNA Damage Protection Activity of the Hydroalcoholic Extract of Desmostachya bipinnata L. Stapf

PubMed Central

Bhimathati, Solomon Sunder Raj

2014-01-01

Desmostachya bipinnata Stapf (Poaceae/Gramineae) is an official drug of ayurvedic pharmacopoeia. Various parts of this plant were used extensively in traditional and folklore medicine to cure various human ailments. The present study was aimed to evaluate the antioxidant and DNA damage protection activity of hydroalcoholic extract of Desmostachya bipinnata both in vitro and in vivo, to provide scientific basis for traditional usage of this plant. The extract showed significant antioxidant activity in a dose-dependent manner with an IC50 value of 264.18 ± 3.47 μg/mL in H2O2 scavenging assay and prevented the oxidative damage to DNA in presence of DNA damaging agent (Fenton's reagent) at a concentration of 50 μg/mL. Also, the presence of extract protected yeast cells in a dose-dependent manner against DNA damaging agent (Hydroxyurea) in spot assay. Moreover, the presence of extract exhibited significant antioxidant activity in vivo by protecting yeast cells against oxidative stressing agent (H2O2). Altogether, the results of current study revealed that Desmostachya bipinnata is a potential source of antioxidants and lends pharmacological credence to the ethnomedical use of this plant in traditional system of medicine, justifying its therapeutic application for free-radical-induced diseases. PMID:24574873

Evaluation of antioxidant and DNA damage protection activity of the hydroalcoholic extract of Desmostachya bipinnata L. Stapf.

PubMed

Golla, Upendarrao; Bhimathati, Solomon Sunder Raj

2014-01-01

Desmostachya bipinnata Stapf (Poaceae/Gramineae) is an official drug of ayurvedic pharmacopoeia. Various parts of this plant were used extensively in traditional and folklore medicine to cure various human ailments. The present study was aimed to evaluate the antioxidant and DNA damage protection activity of hydroalcoholic extract of Desmostachya bipinnata both in vitro and in vivo, to provide scientific basis for traditional usage of this plant. The extract showed significant antioxidant activity in a dose-dependent manner with an IC50 value of 264.18±3.47  μg/mL in H2O2 scavenging assay and prevented the oxidative damage to DNA in presence of DNA damaging agent (Fenton's reagent) at a concentration of 50  μg/mL. Also, the presence of extract protected yeast cells in a dose-dependent manner against DNA damaging agent (Hydroxyurea) in spot assay. Moreover, the presence of extract exhibited significant antioxidant activity in vivo by protecting yeast cells against oxidative stressing agent (H2O2). Altogether, the results of current study revealed that Desmostachya bipinnata is a potential source of antioxidants and lends pharmacological credence to the ethnomedical use of this plant in traditional system of medicine, justifying its therapeutic application for free-radical-induced diseases.

Dapsone for topical use in extemporaneous preparations.

PubMed

Wohlrab, Johannes; Michael, Julia

2018-01-01

The sulfone dapsone has an established role in systemic therapy. Its pharmacological and toxicological properties are well known. Topically, dapsone is used in a gel formulation for the treatment of acne vulgaris. In addition, there have been individual case reports on the efficacy of topical dapsone preparations in the treatment of various neutrophilic dermatoses. To date, no finished medicinal product for topical use has been available in Germany. Against this background, we set out to develop extemporaneous preparations containing dapsone (5 %) that meet the quality requirements of the European Pharmacopoeia as well as the manufacturing requirements of the German Ordinance on the Operation of Pharmacies (ApBetrO). These formulations included the incorporation of dapsone in a hydrophobic cream base ("hydrophobe Basiscreme DAC") as well as in methylprednisolone aceponate 0.1 % ointment (alternatively, in the latter's cream base without active ingredient). Tests aimed at investigating the physical, chemical, and microbiological stability of these formulations showed them to meet the aforementioned quality requirements. The extemporaneous formulations presented herein broaden the therapeutic options for topical treatment, in particular for patients with chronic inflammatory dermatoses associated with a neutrophilic pathogenesis. © 2017 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

Development of a highly sensitive PCR/DNA chip method to detect mycoplasmas in a veterinary modified live vaccine.

PubMed

Mbelo, Sylvie; Gay, Virginie; Blanchard, Stephanie; Abachin, Eric; Falque, Stephanie; Lechenet, Jacques; Poulet, Hervé; de Saint-Vis, Blandine

2018-05-09

Mycoplasmas are potential contaminants that introduce undesirable changes in mammalian cell cultures. They frequently contaminate cell substrates and other starting materials used for manufacturing cell-derived biologics, such as vaccines and pharmaceutical products. Mycoplasma purity testing of live vaccines, active ingredients, raw material, and seed lots is required during vaccine production. Previously, testing using a time-consuming, costly 28-day culture assay, which lacks sensitivity for species that do not grow in culture, was required in the European Pharmacopoeia (Ph. Eur). But now nucleic acid amplification techniques (NATs) can be used. NATs provide rapid results and are sensitive. We evaluated the sensitivity and specificity of a commercially-available NAT to detect individual mycoplasma DNA in a veterinary modified live vaccine using five reference strains recommended by the Ph. Eur. Our results showed that this NAT-based method can be used to detect mycoplasma in spiked live vaccine, without interference from the vaccine components, with a limit of detection of 10 CFU/mL, as required by the Ph. Eur. Its specificity was demonstrated since no mycoplasmas were detected in non-spiked vaccine. This method is undergoing validation as a replacement for the conventional culture method in the production of veterinary live vaccines. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Nano drug delivery systems and gamma radiation sterilization.

PubMed

Sakar, F; Özer, A Y; Erdogan, S; Ekizoglu, M; Kart, D; Özalp, M; Colak, S; Zencir, Y

2017-09-01

In recent years, drug delivery systems such as liposomes and microparticles have been used in clinic for the treatment of different diseases and from a regulatory point of view, a parenterally applied drug and drug delivery systems must be sterile and pyrogen free. Radiation sterilization is a method recognized by pharmacopoeias to achieve sterility criteria of parenterals. It has the ability to kill microorganisms in therapeutic products. The ability of, however, irradiation might also affect the performance of drug delivery systems. One of the most critical points is irradiation dose, because certain undesirable chemical and physical changes may accompany with the irradiation, especially with the traditionally applied dose of 25 kGy. Its ionizing property may cause fragmentation of covalent bond. The care must be paid to the applied dose. In this research, the effects of gamma irradiation on different drug delivery systems such as chitosan microparticles, liposomes, niosomes and sphingosomes were investigated. According to the experimental data, it can be concluded that gamma irradiation can be a suitable sterilization technique for liposome, niosome and sphingosome dispersions. When all irradiated drug carrier systems were taken into consideration, chitosan glutamate microparticles were found as the most radioresistant drug delivery system among the others.

Rapid analysis of Aurantii Fructus Immaturus (Zhishi) using paper spray ionization mass spectrometry.

PubMed

Liu, Xuemei; Gu, Zhixin; Guo, Yuan; Liu, Jingjing; Ma, Ming; Chen, Bo; Wang, Liping

2017-04-15

Paper spray-mass spectrometry (PS-MS) is a rapid, solvent-efficient, and high-throughput analytical method for analyzing complex samples. In this study, a PS-MS method was developed to obtain MS profiles of Aurantii Fructus Immaturus (aka Zhishi in Chinese) in positive and negative ion modes. In combination with multivariate analyses, including principal component analysis and cluster analysis, the PS-MS profiles of 25 batches of Zhishi were discriminated in 25 batches of Citri Reticulatae Pericarpium Viride (aka Qingpi in Chinese; an adulterant of Zhishi). Moreover, a rapid quantitative analysis of synephrine, a prescriptive quality control component of Zhishi listed in the Chinese Pharmacopoeia, was conducted with PS-MS using synephrine-d2 as an internal standard (IS). The linearity range was 1.68-16.8μg/mL (R 2 =0.9985), the limit of quantitation was 0.5μg/mL. Relative standard deviations in the intra- and inter-day precision of the MS were 4.87 and 4.90%, respectively. Compared with HPLC results, there was no significant difference in the quantitation of synephrine. This study demonstrated that the PS-MS method is useful for the rapid discrimination and quality control of Zhishi samples. Copyright © 2017 Elsevier B.V. All rights reserved.

[City-hospital network and quality control of officinal preparations].

PubMed

Curti, C; Gallice, S; Lamy, E; Rathelot, P; Vanelle, P

2018-05-01

In a hospital environment, the quality control of the hospital preparations allows to release homogeneous batches in a secure way. These controls are totally integrated into the process of production and can also, in certain cases, be realized for high-alert magistral preparations. In community pharmacy, these controls were not required, but the Agence régionale de santé (ARS) recently incited compounding community pharmacies to realize this type of analyses. This decision motivated the creation of a collaboration between the pharmacy department of a French teaching hospital and a society including around thirty community pharmacies having a preparatory. Twenty community pharmacies distributed on all the territory have submitted one of their pediatric preparation, capsules of captopril 2mg, to the pharmacopoeia controls usually realized in the industry or hospital. All the analyzed batches were in agreement with European Pharmacopeia specifications. We shall present the rational of this work, the results as well as the numerous perspectives offered by this new type of collaboration joining completely the logic of a network city-hospital allowing the improvement of security of the medication circuit in France. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

A simple method for HPLC retention time prediction: linear calibration using two reference substances.

PubMed

Sun, Lei; Jin, Hong-Yu; Tian, Run-Tao; Wang, Ming-Juan; Liu, Li-Na; Ye, Liu-Ping; Zuo, Tian-Tian; Ma, Shuang-Cheng

2017-01-01

Analysis of related substances in pharmaceutical chemicals and multi-components in traditional Chinese medicines needs bulk of reference substances to identify the chromatographic peaks accurately. But the reference substances are costly. Thus, the relative retention (RR) method has been widely adopted in pharmacopoeias and literatures for characterizing HPLC behaviors of those reference substances unavailable. The problem is it is difficult to reproduce the RR on different columns due to the error between measured retention time (t R ) and predicted t R in some cases. Therefore, it is useful to develop an alternative and simple method for prediction of t R accurately. In the present study, based on the thermodynamic theory of HPLC, a method named linear calibration using two reference substances (LCTRS) was proposed. The method includes three steps, procedure of two points prediction, procedure of validation by multiple points regression and sequential matching. The t R of compounds on a HPLC column can be calculated by standard retention time and linear relationship. The method was validated in two medicines on 30 columns. It was demonstrated that, LCTRS method is simple, but more accurate and more robust on different HPLC columns than RR method. Hence quality standards using LCTRS method are easy to reproduce in different laboratories with lower cost of reference substances.

Chemical Composition of Juniperus communis L. Cone Essential Oil and Its Variability among Wild Populations in Kosovo.

PubMed

Hajdari, Avni; Mustafa, Behxhet; Nebija, Dashnor; Miftari, Elheme; Quave, Cassandra L; Novak, Johannes

2015-11-01

Ripe cones of Juniperus communis L. (Cupressaceae) were collected from five wild populations in Kosovo, with the aim of investigating the chemical composition and natural variation of essential oils between and within wild populations. Ripe cones were collected, air dried, crushed, and the essential oils obtained by hydrodistillation. The essential-oil constituents were identified by GC-FID and GC/MS analyses. The yield of essential oil differed depending on the population origins and ranged from 0.4 to 3.8% (v/w, based on the dry weight). In total, 42 compounds were identified in the essential oils of all populations. The principal components of the cone-essential oils were α-pinene, followed by β-myrcene, sabinene, and D-limonene. Taking into consideration the yield and chemical composition, the essential oil originating from various collection sites in Kosovo fulfilled the minimum requirements for J. communis essential oils of the European Pharmacopoeia. Hierarchical cluster analysis (HCA) and principal component analysis (PCA) were used to determine the influence of the geographical variations on the essential-oil composition. These statistical analyses suggested that the clustering of populations was not related to their geographic location, but rather appeared to be linked to local selective forces acting on the chemotype diversity. Copyright © 2015 Verlag Helvetica Chimica Acta AG, Zürich.

Application of quantitative 1H NMR for the calibration of protoberberine alkaloid reference standards.

PubMed

Wu, Yan; He, Yi; He, Wenyi; Zhang, Yumei; Lu, Jing; Dai, Zhong; Ma, Shuangcheng; Lin, Ruichao

2014-03-01

Quantitative nuclear magnetic resonance spectroscopy (qNMR) has been developed into an important tool in the drug analysis, biomacromolecule detection, and metabolism study. Compared with mass balance method, qNMR method bears some advantages in the calibration of reference standard (RS): it determines the absolute amount of a sample; other chemical compound and its certified reference material (CRM) can be used as internal standard (IS) to obtain the purity of the sample. Protoberberine alkaloids have many biological activities and have been used as reference standards for the control of many herbal drugs. In present study, the qNMR methods were developed for the calibration of berberine hydrochloride, palmatine hydrochloride, tetrahydropalmatine, and phellodendrine hydrochloride with potassium hydrogen phthalate as IS. Method validation was carried out according to the guidelines for the method validation of Chinese Pharmacopoeia. The results of qNMR were compared with those of mass balance method and the differences between the results of two methods were acceptable based on the analysis of estimated measurement uncertainties. Therefore, qNMR is an effective and reliable analysis method for the calibration of RS and can be used as a good complementarity to the mass balance method. Copyright © 2013 Elsevier B.V. All rights reserved.

Herbal medicine in the Marquesas Islands.

PubMed

Girardi, Cynthia; Butaud, Jean François; Ollier, Corinne; Ingert, Nicolas; Weniger, Bernard; Raharivelomanana, Phila; Moretti, Christian

2015-02-23

verified in focus groups involving both scientists and Marquesan language specialists from the "Académie des Marquises". 40 plant species showed a high frequency of citation for a given affliction (RF>20). Despite the complex nosology the ICF to Marquesan traditional illness categories showed generally high ICF values, suggesting their strong coherence. An overview of the Marquesan pharmacopoeia, linked with ethnomedicinal practices, is presented in this paper. Marquesan traditional medicine survived until now despite the culture shock faced by the Marquesan population switching to numerous introduced plants commonly found in their close environment and easily gathered. Marquesan herbal medicine appears to draw its inspiration from a common Polynesian root. However further investigations on Marquesan nosologies are necessary to appreciate the originality of the Marquesan pharmacopoeia. Finally, the crossing of ICF and RF indices shows that 36 species have at least one significant use (frequencies>20%) with high ICF value (>0.5). This suggests that some key phytochemical ingredients may be present in these plants which require further phytopharmacological studies to a better knowledge of their medicinal properties. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Pharmaceutics, Drug Delivery and Pharmaceutical Technology: A New Test Unit for Disintegration End-Point Determination of Orodispersible Films.

PubMed

Low, Ariana; Kok, Si Ling; Khong, Yuetmei; Chan, Sui Yung; Gokhale, Rajeev

2015-11-01

No standard time or pharmacopoeia disintegration test method for orodispersible films (ODFs) exists. The USP disintegration test for tablets and capsules poses significant challenges for end-point determination when used for ODFs. We tested a newly developed disintegration test unit (DTU) against the USP disintegration test. The DTU is an accessory to the USP disintegration apparatus. It holds the ODF in a horizontal position, allowing top-view of the ODF during testing. A Gauge R&R study was conducted to assign relative contributions of the total variability from the operator, sample or the experimental set-up. Precision was compared using commercial ODF products in different media. Agreement between the two measurement methods was analysed. The DTU showed improved repeatability and reproducibility compared to the USP disintegration system with tighter standard deviations regardless of operator or medium. There is good agreement between the two methods, with the USP disintegration test giving generally longer disintegration times possibly due to difficulty in end-point determination. The DTU provided clear end-point determination and is suitable for quality control of ODFs during product developmental stage or manufacturing. This may facilitate the development of a standardized methodology for disintegration time determination of ODFs. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3893-3903, 2015. Copyright © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Validation of a thin-layer chromatography for the determination of hydrocortisone acetate and lidocaine in a pharmaceutical preparation.

PubMed

Dołowy, Małgorzata; Kulpińska-Kucia, Katarzyna; Pyka, Alina

2014-01-01

A new specific, precise, accurate, and robust TLC-densitometry has been developed for the simultaneous determination of hydrocortisone acetate and lidocaine hydrochloride in combined pharmaceutical formulation. The chromatographic analysis was carried out using a mobile phase consisting of chloroform+acetone+ammonia (25%) in volume composition 8:2:0.1 and silica gel 60F254 plates. Densitometric detection was performed in UV at wavelengths 200 nm and 250 nm, respectively, for lidocaine hydrochloride and hydrocortisone acetate. The validation of the proposed method was performed in terms of specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), precision, accuracy, and robustness. The applied TLC procedure is linear in hydrocortisone acetate concentration range of 3.75÷12.50  μg·spot(-1), and from 1.00÷2.50  μg·spot(-1) for lidocaine hydrochloride. The developed method was found to be accurate (the value of the coefficient of variation CV [%] is less than 3%), precise (CV [%] is less than 2%), specific, and robust. LOQ of hydrocortisone acetate is 0.198  μg·spot(-1) and LOD is 0.066  μg·spot(-1). LOQ and LOD values for lidocaine hydrochloride are 0.270 and 0.090  μg·spot(-1), respectively. The assay value of both bioactive substances is consistent with the limits recommended by Pharmacopoeia.

Identification of an exposure risk to heavy metals from pharmaceutical-grade rubber stoppers.

PubMed

Li, Xianghui; Qian, Pingping

2017-07-01

Exposure to low concentrations of heavy metals and metalloids represents a well-documented risk to animal and human health. However, current standards (European Pharmacopeia [EP], United States Pharmacopoeia [USP], International Organization for Standardization [ISO], YBB concerned with rubber closures) only require testing for Zn in pharmaceutical-grade rubber stoppers and then using only pure water as a solvent. We extracted and quantified heavy metals and trace elements from pharmaceutical-grade rubber stoppers under conditions that might occur during the preparation of drugs. Pure water, saline, 10% glucose, 3% acetic acid (w/v), 0.1 mol/L hydrochloric acid, and diethylenetriaminepentaacetic acid (4 mg/mL, 0.4 mg/mL, and 0.04 mg/mL) were used as extraction agents. We quantified the extracted arsenic, lead, antimony, iron, magnesium, aluminum, and zinc using inductively coupled plasma mass spectrometry. The concentration of extracted metals varied depending on the different extraction solutions used and between the different rubber stopper manufacturers. Rubber stoppers are ubiquitously used in the pharmaceutical industry for the storage and preparation of drugs. Extraction of heavy metals during the manufacturing and preparation of drugs represents a significant risk, suggesting a need for industry standards to focus on heavy metal migration from rubber stoppers. Copyright © 2016. Published by Elsevier B.V.

Review of the neurological benefits of phytocannabinoids.

PubMed

Maroon, Joseph; Bost, Jeff

2018-01-01

Numerous physical, psychological, and emotional benefits have been attributed to marijuana since its first reported use in 2,600 BC in a Chinese pharmacopoeia. The phytocannabinoids, cannabidiol (CBD), and delta-9-tetrahydrocannabinol (Δ9-THC) are the most studied extracts from cannabis sativa subspecies hemp and marijuana. CBD and Δ9-THC interact uniquely with the endocannabinoid system (ECS). Through direct and indirect actions, intrinsic endocannabinoids and plant-based phytocannabinoids modulate and influence a variety of physiological systems influenced by the ECS. In 1980, Cunha et al . reported anticonvulsant benefits in 7/8 subjects with medically uncontrolled epilepsy using marijuana extracts in a phase I clinical trial. Since then neurological applications have been the major focus of renewed research using medical marijuana and phytocannabinoid extracts. Recent neurological uses include adjunctive treatment for malignant brain tumors, Parkinson's disease, Alzheimer's disease, multiple sclerosis, neuropathic pain, and the childhood seizure disorders Lennox-Gastaut and Dravet syndromes. In addition, psychiatric and mood disorders, such as schizophrenia, anxiety, depression, addiction, postconcussion syndrome, and posttraumatic stress disorders are being studied using phytocannabinoids. In this review we will provide animal and human research data on the current clinical neurological uses for CBD individually and in combination with Δ9-THC. We will emphasize the neuroprotective, antiinflammatory, and immunomodulatory benefits of phytocannabinoids and their applications in various clinical syndromes.

In Silico Analysis of the Association Relationship between Neuroprotection and Flavors of Traditional Chinese Medicine Based on the mGluRs

PubMed Central

Qiao, Liansheng; Chen, Yankun; Zhao, Bowen; Gu, Yu; Huo, Xiaoqian; Zhang, Yanling; Li, Gongyu

2018-01-01

The metabotropic glutamate receptors (mGluRs) are known as both synaptic receptors and taste receptors. This feature is highly similar to the Property and Flavor theory of Traditional Chinese medicine (TCM), which has the pharmacological effect and flavor. In this study, six ligand based pharmacophore (LBP) models, seven homology modeling models, and fourteen molecular docking models of mGluRs were built based on orthosteric and allosteric sites to screening potential compounds from Traditional Chinese Medicine Database (TCMD). Based on the Pharmacopoeia of the People’s Republic of China, TCMs of compounds and their flavors were traced and listed. According to the tracing result, we found that the TCMs of the compounds which bound to orthosteric sites of mGluRs are highly correlated to a sweet flavor, while the allosteric site corresponds to a bitter flavor. Meanwhile, the pharmacological effects of TCMs with highly frequent flavors were further analyzed. We found that those TCMs play a neuroprotective role through the efficiencies of detumescence, promoting blood circulation, analgesic effect, and so on. This study provides a guide for developing new neuroprotective drugs from TCMs which target mGluRs. Moreover, it is the first study to present a novel approach to discuss the association relationship between flavor and the neuroprotective mechanism of TCM based on mGluRs. PMID:29320397

Collaborative study for the validation of alternative in vitro potency assays for human tetanus immunoglobulins.

PubMed

Gross, S; Janssen, S W J; de Vries, B; Terao, E; Daas, A; Buchheit, K-H

2010-07-01

An international collaborative study to validate 2 alternative in vitro methods for the potency testing of human tetanus immunoglobulin products was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM). The study, run in the framework of the Biological Standardisation Programme (BSP) under the aegis of the European Commission and the Council of Europe, involved 21 official medicines control and industry laboratories from 15 countries. Both methods, an enzyme-linked immunoassay (EIA) and a toxoid inhibition assay (TIA), showed good reproducibility, repeatability and precision. EIA and TIA discriminated between low, medium and high potency samples. Potency estimates correlated well and both values were in close agreement with those obtained by in vivo methods. Moreover, these alternative methods allowed to resolve discrepant results between laboratories that were due to product potency loss and reporting errors. The study demonstrated that EIA and TIA are suitable quality control methods for tetanus immunoglobulin, which can be standardised in a control laboratory using a quality assurance system. Consequently, the Group of Experts on Human Blood and Blood Products of the European Pharmacopoeia revised the monograph on human tetanus immunoglobulins to include both the methods as compendial alternatives to the in vivo mouse challenge assay. 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

Development of Lingzhi or Reishi medicinal mushroom, Ganoderma lucidum (Higher Basidiomycetes) polysaccharides injection formulation.

PubMed

Jiang, Yuji; He, Anle; Liu, Yanhong; Xie, Baogui; Li, Ye; Deng, Youjin; Liu, Xinrui; Liu, Qichao

2014-01-01

Biochemical and pharmacological research has demonstrated that Lingzhi or Reishi medicinal mushroom Ganoderma lucidum polysaccharides (GLPS) have significant anticancer, antitumor, and antioxidant activities. To investigate the effect of injecting GLPS into hosts for clinical studies, aqueous polysaccharide extracts from G. lucidum fruit bodies were purified by deproteinization using the Sevage method, anion-exchange chromatography elution (cellulose DEAE-52 chromatography), dialysis, ethanol precipitation, and active carbon and millipore membrane filtration techniques. The purified GLPS were used for injection in mice. Polysaccharide indexes, protein, tannin, heavy metal, arsenic salt, oxalate, potassium ion, resin, pH, ignition residue measurements, evaluation criterion for allergic reactions, and total solids content of the GLPS injection were all performed using the reference methods in the Chinese Pharmacopoeia. Our results showed that polysaccharide was the key component of injection mixtures. The ignition residue and total solids content in the injection mixture were 1.4% and 2.4%, respectively. The other indices were all within the expected safety ranges. Furthermore, studies from mice functional assays showed that the injection mixture improved the antifatigue capacity of mice without any effect on weight loss/gain. In addition, the injection mixture was safe, which was confirmed by allergy testing in guinea pigs. The development of a GLPS injection offers a novel approach for future medicinal mushroom utilization and holds great commercial promise.

Simultaneous determination of pyrroquinazoline alkaloids and flavonoids in Adhatoda beddomei and Adhatoda vasica and their marketed herbal formulations using ultra-high-performance liquid chromatography coupled with triple quadrupole linear ion trap mass spectrometry.

PubMed

Singh, Awantika; Kumar, Sunil; Bajpai, Vikas; Kumar, Brijesh

2017-03-01

Adhatoda beddomei and Adhatoda vasica leaf, known as 'Vasaka' and/or 'Vasa' in Ayurveda and 'Malabar nut' in English, is an official drug in the Indian Pharmacopoeia. The medicinal properties of these plants are due to the presence of pyrroquinazoline alkaloids. An UHPLC-ESI/MS/MS method in both positive and negative electrospray ionization in multiple-reaction-monitoring mode was developed and validated for the estimation of alkaloids and flavonoids in Adhatoda species and their marketed herbal formulations. Chromatographic separation was achieved on an Acquity UPLC® BEH C 18 -column using a gradient elution with 0.1% formic acid in water and methanol. The developed method was validated as per International Conference on Harmonization guidelines and found to be accurate with overall recovery in the range 94.2-105.0% (RSD ≤ 1.71%), precise (RSD ≤ 3.44%) and linear (R 2  ≥ 0.9992) over the concentration range of 0.5-1000 ng/mL. The total content of alkaloids and flavonoids were highest in the chloroform and aqueous fraction of A. vasica leaf, respectively. The results indicated that the developed method was simple, rapid, sensitive, selective and accurate for the estimation of multiple bioactive constituents in crude mixture, and therefore could make a contribution to the quality control of Adhatoda species and its derived herbal formulations. Copyright © 2016 John Wiley & Sons, Ltd.

Transdermal delivery of alprazolam from a monolithic patch: formulation based on in vitro characterization.

PubMed

Soler, L I; Boix, A; Lauroba, J; Colom, H; Domenech, J

2012-10-01

Alprazolam, a benzodiazepine widely used for the treatment of psychiatric disorders, has been aimed to be formulated in a transdermal delivery system (TDS) prototype. A series of TDS prototypes dosed in all cases at 0.35 mg·cm(-2) of alprazolam were prepared as a monolithic drug in adhesive matrix using acrylic pressure-sensitive adhesives (PSA) of acrylate vinyl acetate (Duro-tack(®)). The effects of several permeation enhancers as azone, transcutol, propylene glycol, dodecyl alcohol, decyl alcohol, diethanolamine, N-methyl pyrrolidone and lauric acid were studied. Prototypes have been characterized based on adhesion parameters (peel adhesion and shear adhesion), in vitro human skin permeation and in vitro drug release according to European Pharmacopoeia for the selected prototype. Best results show that a combination of permeation enhancers from different chemical groups is able to provide almost a 33 fold increase in the transdermal alprazolam flux of an aqueous saturated dispersion (from 0.054 ± 0.019 to 1.76 ± 0.21 μg h.cm(-2)). Based on these in vitro flux data, a predictive simulation of the achievable plasmatic levels was performed assuming a constant systemic infusion of drug. In summary, it is possible to obtain a prototype of a TDS of alprazolam with adequate adhesive properties (peel adhesion and shear adhesion) and able to predict sustained therapeutic plasmatic levels.

Optimising concentrations of antimicrobial agents in pharmaceutical preparations: Case of an oral solution of glycerol and an ophthalmic solution containing cysteamine.

PubMed

Chan Hew Wai, A; Becasse, P; Tworski, S; Pradeau, D; Planas, V

2014-11-01

In the context of current distrust of antimicrobial preservatives, the quantities of these substances in two pharmaceutical formulas were studied: an ophthalmic solution of cysteamine preserved benzalkonium chloride at 1mg/5mL and Glycerotone(®) preserved with sorbic acid at 0.1g/100g. The purpose of this work was to verify that a reduction of the quantities of preservative continues to fulfil the requirements for antimicrobial preservation. The Test of efficacy of antimicrobial preservation, section 5.1.3 of the 8th edition of the European Pharmacopoeia, was carried out on each formulation prepared with decreasing quantities of preservative. The results show that formulations whose preservative concentration was reduced by a factor of four remained compliant with standards. It is to be noted that in formulas without preservative, fungal growth was observed in both the solution of Glycerotone(®) and the ophthalmic solution containing cysteamine. Although there is no question that an antimicrobial preservative is necessary, the quantity of preservative can be reduced without deteriorating the quality of the pharmaceutical product but the minimal effective concentration remains to be determined. The formulations of many pharmaceutical products should therefore be examined in order to limit the quantities of preservative while continuing to guarantee patient's safety. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Automated Synthesis of 68Ga-DOTA-TOC: Methodological Aspects and Suitable Technical Solutions for a Cationic Purification System.

PubMed

Uccelli, Licia; Boschi, Alessandra; Cittanti, Corrado; Martini, Petra; Lodi, Luca; Zappaterra, Elisa; Romani, Simona; Zaccaria, Samanta; Cecconi, Davide; Rambaldi, Ilaria; Santi, Ivan; Panareo, Stefano; Giganti, Melchiore; Bartolomei, Mirco

2018-05-08

The PET Gallium-68 isotope has the advantage of being produced from a generator, so it is also available in nuclear medicine departments without a cyclotron. The preparation of Ga-68 DOTA-labelled compounds is actually performed by remotely controlled automated systems developed in order to assure production efficiency, reproducibility of the results, guarantee fast reaction time, to facilitate the synthesis and minimize the radiation exposure. Many automatic synthesis systems are available on the radiopharmaceutical market, and each of these requires the realization of some technical adaptations for routine use. We reported the Ga-68 DOTATOC production by automated cassette-based theranostic synthesizer system used in combination with a disposable GMP grade cassette system for cationic purification. The synthesizer is integrated with the 68Ge/68Ga generator systems and it allows to perform elution, eluate purification and radiolabeling in about 38 minutes. We have performed between January 2016 and January 2017 over 100 [68Ga]Ga-DOTA-TOC preparation and of these only three have failed. The average synthesis yield of radiopharmaceutical production was 54.4 ± 2.3 % and the average radiochemical purity was 96.94 ± 0.74 %. The methodology and the technical solutions adopted have allowed to obtain a high quality radiopharmaceutical product as required by the European Pharmacopoeia. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Desktop 3D printing of controlled release pharmaceutical bilayer tablets.

PubMed

Khaled, Shaban A; Burley, Jonathan C; Alexander, Morgan R; Roberts, Clive J

2014-01-30

Three dimensional (3D) printing was used as a novel medicine formulation technique for production of viable tablets capable of satisfying regulatory tests and matching the release of standard commercial tablets. Hydroxypropyl methylcellulose (HPMC 2208) (Methocel™ K100M Premium) and poly(acrylic acid) (PAA) (Carbopol(®) 974P NF) were used as a hydrophilic matrix for a sustained release (SR) layer. Hypromellose(®) (HPMC 2910) was used as a binder while microcrystalline cellulose (MCC) (Pharmacel(®) 102) and sodium starch glycolate (SSG) (Primojel(®)) were used as disintegrants for an immediate release (IR) layer. Commercial guaifenesin bi-layer tablets (GBT) were used as a model drug (Mucinex(®)) for this study. There was a favourable comparison of release of the active guaifenesin from the printed hydrophilic matrix compared with the commercially available GBT. The printed formulations were also evaluated for physical and mechanical properties such as weight variation, friability, hardness and thickness as a comparison to the commercial tablet and were within acceptable range as defined by the international standards stated in the United States Pharmacopoeia (USP). All formulations (standard tablets and 3D printed tablets) showed Korsmeyer-Peppas n values between 0.27 and 0.44 which indicates Fickian diffusion drug release through a hydrated HPMC gel layer. Copyright © 2013 Elsevier B.V. All rights reserved.

Development and Validation of Discriminating and Biorelevant Dissolution Test for Lornoxicam Tablets

PubMed Central

Anumolu, P. D.; Sunitha, G.; Bindu, S. Hima; Satheshbabu, P. R.; Subrahmanyam, C. V. S.

2015-01-01

The establishment of biorelevant and discriminating dissolution procedure for drug products with limited water solubility is a useful technique for qualitative forecasting of the in vivo behavior of formulations. It also characterizes the drug product performance in pharmaceutical development. Lornoxicam, a BCS class-II drug is a nonsteroidal antiinflammatory drug of the oxicam class, has no official dissolution media available in the literature. The objective of present work was to develop and validate a discriminating and biorelevant dissolution test for lornoxicam tablet dosage forms. To quantify the lornoxicam in dissolution samples, UV spectrophotometric method was developed using 0.01M sodium hydroxide solution as solvent at λma×376 nm. After evaluation of saturation solubility, dissolution, sink conditions and stability of lornoxicam bulk drug in different pH solutions and biorelevant media, the dissolution method was optimized using USP paddle type apparatus at 50 rpm rotation speed and 500 ml simulated intestinal fluid as discriminating and biorelevant dissolution medium. The similarity factor (f2) were investigated for formulations with changes in composition and manufacturing variations, values revealed that dissolution method having discriminating power and method was validated as per standard guidelines. The proposed dissolution method can be effectively applied for routine quality control in vitro dissolution studies of lornoxicam in tablets and helpful to pharmacopoeias. PMID:26180277

[Research progress on standards of commodity classes of Chinese materia medica and discussion on several key problems].

PubMed

Yang, Guang; Zeng, Yan; Guo, Lan-Ping; Huang, Lu-Qi; Jin, Yan; Zheng, Yu-Guang; Wang, Yong-Yan

2014-05-01

Standards of commodity classes of Chinese materia medica is an important way to solve the "Lemons Problem" of traditional Chinese medicine market. Standards of commodity classes are also helpful to rebuild market mechanisms for "high price for good quality". The previous edition of commodity classes standards of Chinese materia medica was made 30 years ago. It is no longer adapted to the market demand. This article researched progress on standards of commodity classes of Chinese materia medica. It considered that biological activity is a better choice than chemical constituents for standards of commodity classes of Chinese materia medica. It is also considered that the key point to set standards of commodity classes is finding the influencing factors between "good quality" and "bad quality". The article also discussed the range of commodity classes of Chinese materia medica, and how to coordinate standards of pharmacopoeia and commodity classes. According to different demands, diversiform standards can be used in commodity classes of Chinese materia medica, but efficacy is considered the most important index of commodity standard. Decoction pieces can be included in standards of commodity classes of Chinese materia medica. The authors also formulated the standards of commodity classes of Notoginseng Radix as an example, and hope this study can make a positive and promotion effect on traditional Chinese medicine market related research.

The use of thiolated polymers as carrier matrix in oral peptide delivery--proof of concept.

PubMed

Bernkop-Schnürch, Andreas; Pinter, Yvonne; Guggi, Davide; Kahlbacher, Hermann; Schöffmann, Gudrun; Schuh, Maximilian; Schmerold, Ivo; Del Curto, Maria Dorly; D'Antonio, Mauro; Esposito, Pierandrea; Huck, Christian

2005-08-18

It was the aim of this study to develop an oral delivery system for the peptide drug antide. The stability of the therapeutic peptide towards gastrointestinal peptidases was evaluated. The therapeutic agent and the permeation mediator glutathione were embedded in the thiolated polymer chitosan-4-thio-butylamidine conjugate (chitosan-TBA conjugate) and compressed to tablets. Drug release studies were performed in the dissolution test apparatus according to the Pharmacopoeia Europea using the paddle method and demineralized water as release medium. In order to avoid mucoadhesion of these delivery systems already in the oral cavity and oesophagus tablets were coated with a triglyceride. These tablets were orally given to pigs (weight: 50+/-2 kg; Edelschwein Pietrain). Moreover, antide was administered intravenously, subcutaneously and orally in solution. Results showed stability of antide towards pepsin, trypsin and chymotrypsin. In contrast, antide was rapidly degraded by elastase. Consequently a stomach-targeted delivery system was designed. Drug release studies demonstrated an almost zero-order controlled release of antide over 8 h. In vivo studies demonstrated a relative bioavailability of 34.4% for the subcutaneous administration. Oral administration of antide in solution led to no detectable concentrations of the drug in plasma at all. In contrast, administering antide being incorporated in the thiolated polymer resulted in a significant uptake of the peptide. The absolute and relative bioavailability was determined to be 1.1% and 3.2%, respectively.

UHPLC-Q-TOF-MS-based metabolomics approach to compare the saponin compositions of Xueshuantong injection and Xuesaitong injection.

PubMed

Yao, Changliang; Yang, Wenzhi; Zhang, Jingxian; Qiu, Shi; Chen, Ming; Shi, Xiaojian; Pan, Huiqin; Wu, Wanying; Guo, Dean

2017-02-01

Various traditional Chinese medicine preparations developed from Notoginseng total saponins, including Xueshuantong injection and Xuesaitong injection, are extensively used in China to treat cardiocerebrovascular diseases. However, the difference of their saponin compositions remains unknown. An ultra high performance liquid chromatography with quadrupole time-of-flight mass spectrometry based metabolomics approach was developed to probe the saponin discrimination between Xueshuantong and Xuesaitong and the related factors by large sample analysis. A highly efficient chromatographic separation was achieved on an HSS T3 column within 20 min with the holistic metabolites information recorded in the negative MS E mode. A six-step data pretreatment procedure mainly based on Progenesis QI and mass defect filtering was established. Pattern recognition chemometrics was used to discover the potential saponin markers. The saponin composition of Wuzhou Xueshuantong showed distinct discrimination from the other products. Wuzhou Xueshuantong contains more abundant protopanaxatriol-type noto-R 1 , Rg 1 , Re, and protopanaxadiol-type Rb 1 , but less Rd and other low-polarity protopanaxadiol-type ginsenosides. These differences could not directly correlate to the use of different parts of Panax notoginseng, but possibly to the different preparation techniques employed by different manufacturers. These results are beneficial to the establishment of pharmacopoeia standards and the assessment of the efficacy and adverse drug reactions for these homologous products. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Identification and evaluation of the chemical similarity of Yindan xinnaotong samples by ultra high performance liquid chromatography with quadrupole time-of-flight mass spectrometry fingerprinting.

PubMed

Gong, Leilei; Haiyu, Xu; Wang, Lan; Xiaojie, Yin; Huijun, Yuan; Songsong, Wang; Cheng, Long; Ma, Xiaojing; Gao, Shuangrong; Liang, Rixin; Yang, Hongjun

2016-02-01

Yindan xinnaotong, a compound preparation used in traditional Chinese medicine, is composed of eight herbs: Ginkgo biloba leaf (yinxingye), Salvia miltiorrhizae (danshen), Herba gynostemmatis (jiaogulan), Erigerontis herba (dengzhanxixin), Allii sativi bulbus (dasuan), Notoginseng radixe rhizoma (sanqi), Crataegi fructus (shanzha), and Borneolum (tianranbingpian). Yindan xinnaotong is primarily used to treat cardiovascular and cerebrovascular diseases. However, to date, no scientific methods have been established to assess the quality of Yindan xinnaotong. Therefore, a combinatorial method was developed based on chemical constituent identification and fingerprint analysis to assess the consistency of Yindan xinnaotong quality. In this study, ultra high performance liquid chromatography coupled with time-of-flight mass spectrometry was used to identify the chemical components of Yindan xinnaotong soft capsules. Approximately 74 components were detected, of which 70, including flavonoids, ginkgolide, phenolic acid, diterpenoid tanshinones, and ginsenoside, were tentatively identified. A fingerprint analysis was also conducted to evaluate the uniformity of the quality of Yindan xinnaotong soft capsules. Ten batches of Yindan xinnaotong soft capsules were analyzed. All of the resulting chromatograms were imported into the "Similarity Evaluation System for Chromatographic Fingerprints of TCM" (Chinese Pharmacopoeia Commission, version 2004A). The similarity scores of common peaks from these samples ranged from 0.903-1.000, indicating that samples from different batches were highly correlated. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Ethnomedicine in Himalaya: a case study from Dolpa, Humla, Jumla and Mustang districts of Nepal

PubMed Central

Kunwar, Ripu M; Nepal, Bal K; Kshhetri, Hari B; Rai, Sanjeev K; Bussmann, Rainer W

2006-01-01

Traditional plant use in Nepal has been documented for millennia. The importance of plants as medicine has not diminished in any way in recent times, and traditional medicines are still the most important health care source for the vast majority of the population. This paper examines the ethnobotany and traditional use of plants extracted from the vulnerable alpine zone in the Dolpa, Humla, Jumla and Mustang districts of Nepal. The results of this ethnobotanical study indicate that a very large number of plant species is used as traditional medicines. There were 107, 59, 44 and 166 species of ethnomedicinal importance in surveyed areas of Dolpa, Humla, Jumla and Mustang district respectively. Of these, 84 common species, used at least in two districts, were selected to enumerate their ethnomedicinal properties. The 84 species belonged to 75 genera and 39 families. The commonest species in this pharmacopoeia were: Allium wallichii, Cordyceps sinensis, Dactylorhiza hatagirea, and Rheum australe. A total of 21 species were most common in three districts and 59 in two districts. The genera Aconitum, Allium, Arisaema, Berberis, Corydalis, Gentiana, Hippophae, Juniperus and Rhododendron each possessed two species with ethnomedicinal use. Labiatae was the most medicinally important family with five species used, followed by Araceae, Compositae, Liliaceae, Polygonaceae, Ranunculaceae, Scrophulariaceae and Umbelliferae, each contributing four species. PMID:16749924

LC-MS/MS method for simultaneous determination of thalidomide, lenalidomide, cyclophosphamide, bortezomib, dexamethasone and adriamycin in serum of multiple myeloma patients.

PubMed

Shu, Chang; Zeng, Tianmei; Gao, Shouhong; Xia, Tianyi; Huang, Lifeng; Zhang, Feng; Chen, Wansheng

2016-08-15

Multiple myeloma (MM), a malignant neoplastic serum-cell disorder, has been a serious threat to human health. The determination of 6 commonly used drug concentrations, including thalidomide, lenalidomide, cyclophosphamide, bortezomib, dexamethasone and adriamycin, in MM patients was of great clinical interest. Herein, we reported a method for the rapid and simultaneous measurement of the above therapeutics by liquid chromatography-tandem mass spectroscopy (LC-MS/MS) method with solid phase extraction. Analysis was performed on a Waters XBridge(®) BEH C18 column (2.5μm, 2.1 mm×50mm), with formic acid aqueous solution and acetonitrile as the mobile phase at flow rate 0.3mL/min. All analytes showed good correlation coefficients (r>0.996), and LLOQ of thalidomide, lenalidomide, cyclophosphamide, bortezomib, dexamethasone and adriamycin were 4, 2, 2, 2, 2 and 2ng/mL, respectively. The inter- and intra-day precisions and stability were expressed as variation coefficients within 15% and relative error less than 15%. Dilution effect, carryover and incurred sample reanalysis were investigated according to the 2015 edition Chinese Pharmacopoeia guidelines, as US FDA (2013, revision 1) required. The LC-MS/MS based assay described in this article may improve future clinical studies evaluating common therapeutics for MM treatment. Copyright © 2016 Elsevier B.V. All rights reserved.

Methylene blue inhibits the asexual development of vivax malaria parasites from a region of increasing chloroquine resistance.

PubMed

Suwanarusk, Rossarin; Russell, Bruce; Ong, Alice; Sriprawat, Kanlaya; Chu, Cindy S; PyaePhyo, Aung; Malleret, Benoit; Nosten, François; Renia, Laurent

2015-01-01

Methylene blue, once discarded due to its unsettling yet mild side effects, has now found a renewed place in the pharmacopoeia of modern medicine. The continued spread of drug-resistant Plasmodium vivax and Plasmodium falciparum has also led to a recent re-examination of methylene blue's potent antimalarial properties. Here we examine the ex vivo susceptibility profile of Plasmodium spp. isolates to methylene blue; the isolates were from a region on the Thai-Myanmar border where there are increasing rates of failure when treating vivax malaria with chloroquine. To do this we used a newly developed ex vivo susceptibility assay utilizing flow cytometry and a portable flow cytometer with a near-UV laser. P. vivax (median methylene blue IC50 3.1 nM, IQR 1.7-4.3 nM) and P. falciparum (median methylene blue IC50 1.8 nM, IQR 1.6-2.3 nM) are susceptible to methylene blue treatment at physiologically relevant levels. Unfortunately, the addition of chloroquine to combination treatments with methylene blue significantly reduces the ex vivo effectiveness of this molecule. Our data support further efforts to employ methylene blue as a safe, low-cost antimalarial to treat drug-resistant malaria. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

[Trace analysis of aristolochic acid A].

PubMed

Liu, Yalin; Gao, Huimin; Wang, Zhimin; Zhang, Qiwei

2010-12-01

A HPLC method for limit detection of aristolochic acid A in the Chinese herbs containing aristolochic acid or suspected-containing aristolochic acid and their preparations was established. The samples were analyzed on an Alltima C18 column eluted with methanol-water-acetic acid (68:32:1.5) as the mobile phase. Flow rate was at 1.0 mL x min(-1) and the detection wavelength was at 390 nm. The calibration curve was linear over the range from 0.016 to 0.51 g (r = 0.9993) and LOD was 4 ng. The average recovery was 101.2% with RSD of 2.01%. The procedures of sample preparation were systematically investigated. The contents of aristolochic acid A in Radix et Rhizoma Asari bought from market or drugstore were fluctuated from 3.1 to 26.6 microg x g(-1) and 3 of 11 samples accorded with the quality requirement of current Chinese Pharmacopoeia. Among 15 batches samples of Chinese medicaments, only one sample was found to contain aristolochic acid A. The present investigation shows that the method is sensitive and repeatable and it could be used for the limit detection of aristolochic acid A in the Chinese herbal medicines containing trace amount of aristolochic acid A or suspected-containing aristolochic acid A and their preparations.

Suspensions as a Valuable Alternative to Extemporaneously Compounded Capsules.

PubMed

Dijkers, Eli; Nanhekhan, Valerie; Thorissen, Astrid; Polonini, Hudson

2017-01-01

The objective of this study was to determine the variation in content of 74 different active pharmaceutical ingredients (APIs) and compare it with what is known in the literature for the content uniformity of extemporaneous prepared capsules. Active pharmaceutical ingredients quantification was performed by high-performance liquid chromatography, via a stability-indicating method. Samples for all active pharmaceutical ingredients were taken throughout a 90-day period and the content was determined. In total, 5,190 different samples were analyzed for 74 different active pharmaceutical ingredients at room (15°C to 25°C) or controlled refrigerated temperature (2°C to 8°C). Each of these datasets was analyzed according to the United States Pharmacopeia Content Uniformity monograph, corrected for the sample number. The mean acceptance values were well within specifications. In addition, all suspensions complied with the criteria defined by the British Pharmacopoeia monograph for Content Uniformity of Liquid Dispersions for both room and controlled refrigerated temperature. In previous studies, it was found that a routine weight variation check is often not sufficient for quality assurance of extemporaneous prepared capsules. Compounded oral liquids show little variation in content for 74 different active pharmaceutical ingredients; therefore, compounded oral liquids are a suitable alternative when compounding individualized medications for patients. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Diagnostic Accuracy of Global Pharma Health Fund Minilab™ in Assessing Pharmacopoeial Quality of Antimicrobials.

PubMed

Pan, Hui; Ba-Thein, William

2018-01-01

Global Pharma Health Fund (GPHF) Minilab™, a semi-quantitative thin-layer chromatography (TLC)-based commercially available test kit, is widely used in drug quality surveillance globally, but its diagnostic accuracy is unclear. We investigated the diagnostic accuracy of Minilab system for antimicrobials, using high-performance liquid chromatography (HPLC) as reference standard. Following the Minilab protocols and the Pharmacopoeia of the People's Republic of China protocols, Minilab-TLC and HPLC were used to test five common antimicrobials (506 batches) for relative concentration of active pharmaceutical ingredients. The prevalence of poor-quality antimicrobials determined, respectively, by Minilab TLC and HPLC was amoxicillin (0% versus 14.9%), azithromycin (0% versus 17.4%), cefuroxime axetil (14.3% versus 0%), levofloxacin (0% versus 3.0%), and metronidazole (0% versus 38.0%). The Minilab TLC had false-positive and false-negative detection rates of 2.6% (13/506) and 15.2% (77/506) accordingly, resulting in the following test characteristics: sensitivity 0%, specificity 97.0%, positive predictive value 0, negative predictive value 0.8, positive likelihood ratio 0, negative likelihood ratio 1.0, diagnostic odds ratio 0, and adjusted diagnostic odds ratio 0.2. This study demonstrates unsatisfying diagnostic accuracy of Minilab system in screening poor-quality antimicrobials of common use. Using Minilab as a stand-alone system for monitoring drug quality should be reconsidered.

Investigation into mixing capability and solid dispersion preparation using the DSM Xplore Pharma Micro Extruder.

PubMed

Sakai, Toshiro; Thommes, Markus

2014-02-01

The goal of this investigation was to qualify the DSM Xplore Pharma Micro Extruder as a formulation screening tool for early-stage hot-melt extrusion. Dispersive and distributive mixing was investigated using soluplus, copovidone or basic butylated methacrylate copolymer with sodium chloride (NaCl) in a batch size of 5 g. Eleven types of solid dispersions were prepared using various drugs and carriers in batches of 5 g in accordance with the literature. The dispersive mixing was a function of screw speed and recirculation time and the particle size was remarkably reduced after 1 min of processing, regardless of the polymers. An inverse relationship between the particle size and specific mechanical energy (SME) was also found. The SME values were higher than those in large-scale extruders. After 1 min recirculation at 200 rpm, the uniformity of NaCl content met the criteria of the European Pharmacopoeia, indicating that distributive mixing was achieved in this time. For the solid dispersions preparations, the results from different scanning calorimetry, powder X-ray diffractometry and in-vitro dissolution tests confirmed that all solid-dispersion systems were successfully prepared. These findings demonstrated that the extruder is a useful tool to screen solid-dispersion formulations and their material properties on a small scale. © 2013 Royal Pharmaceutical Society.

The load and release characteristics on a strong cationic ion-exchange fiber: kinetics, thermodynamics, and influences.

PubMed

Yuan, Jing; Gao, Yanan; Wang, Xinyu; Liu, Hongzhuo; Che, Xin; Xu, Lu; Yang, Yang; Wang, Qifang; Wang, Yan; Li, Sanming

2014-01-01

Ion-exchange fibers were different from conventional ion-exchange resins in their non-cross-linked structure. The exchange was located on the surface of the framework, and the transport resistance reduced significantly, which might mean that the exchange is controlled by an ionic reaction instead of diffusion. Therefore, this work aimed to investigate the load and release characteristics of five model drugs with the strong cationic ion-exchange fiber ZB-1. Drugs were loaded using a batch process and released in United States Pharmacopoeia (USP) dissolution apparatus 2. Opposing exchange kinetics, suitable for the special structure of the fiber, were developed for describing the exchange process with the help of thermodynamics, which illustrated that the load was controlled by an ionic reaction. The molecular weight was the most important factor to influence the drug load and release rate. Strong alkalinity and rings in the molecular structures made the affinity between the drug and fiber strong, while logP did not cause any profound differences. The drug-fiber complexes exhibited sustained release. Different kinds and concentrations of counter ions or different amounts of drug-fiber complexes in the release medium affected the release behavior, while the pH value was independent of it. The groundwork for in-depth exploration and further application of ion-exchange fibers has been laid.

Compendia and anticancer therapy under Medicare.

PubMed

Tillman, Katherine; Burton, Brijet; Jacques, Louis B; Phurrough, Steve E

2009-03-03

In 1993, Congress directed the Medicare program to refer to 3 existing published compendia, American Medical Association Drug Evaluations (AMA-DE), United States Pharmacopoeia Drug Information for the Health Professional (USP-DI), and American Hospital Formulary Service Drug Information (AHFS-DI), to identify unlabeled but medically accepted uses of drugs and biologicals in anticancer chemotherapy regimens. Public discussion during the preceding years had centered on whether to designate unlabeled uses of anticancer treatments as experimental and thus outside the scope of Medicare benefits. American Medical Association Drug Evaluations and USP-DI subsequently ceased publication, and the Medicare program faced increasing calls to revise the list of acceptable compendia, as authorized in the statute. In 2007, the Centers for Medicare & Medicaid Services used its regulatory authority to establish a publicly transparent process to revise the list. The Centers for Medicare & Medicaid Services considered 5 requests in 2008 and added National Comprehensive Cancer Network Drugs and Biologics Compendium, DRUGDEX, and Clinical Pharmacology to the list of compendia. DrugPoints was not added, and AMA-DE was removed. Because of the potential for conflicts of interest to lead to biased judgments, the 2008 Medicare Improvements for Patients and Providers Act has a provision that explicitly prohibits inclusion of compendia that do not have a publicly transparent process for evaluating therapies and identifying potential conflicts of interest.

Review of the neurological benefits of phytocannabinoids

PubMed Central

Maroon, Joseph; Bost, Jeff

2018-01-01

Background: Numerous physical, psychological, and emotional benefits have been attributed to marijuana since its first reported use in 2,600 BC in a Chinese pharmacopoeia. The phytocannabinoids, cannabidiol (CBD), and delta-9-tetrahydrocannabinol (Δ9-THC) are the most studied extracts from cannabis sativa subspecies hemp and marijuana. CBD and Δ9-THC interact uniquely with the endocannabinoid system (ECS). Through direct and indirect actions, intrinsic endocannabinoids and plant-based phytocannabinoids modulate and influence a variety of physiological systems influenced by the ECS. Methods: In 1980, Cunha et al. reported anticonvulsant benefits in 7/8 subjects with medically uncontrolled epilepsy using marijuana extracts in a phase I clinical trial. Since then neurological applications have been the major focus of renewed research using medical marijuana and phytocannabinoid extracts. Results: Recent neurological uses include adjunctive treatment for malignant brain tumors, Parkinson's disease, Alzheimer's disease, multiple sclerosis, neuropathic pain, and the childhood seizure disorders Lennox-Gastaut and Dravet syndromes. In addition, psychiatric and mood disorders, such as schizophrenia, anxiety, depression, addiction, postconcussion syndrome, and posttraumatic stress disorders are being studied using phytocannabinoids. Conclusions: In this review we will provide animal and human research data on the current clinical neurological uses for CBD individually and in combination with Δ9-THC. We will emphasize the neuroprotective, antiinflammatory, and immunomodulatory benefits of phytocannabinoids and their applications in various clinical syndromes. PMID:29770251

Modern science for better quality control of medicinal products "Towards global harmonization of 3Rs in biologicals": The report of an EPAA workshop.

PubMed

Schutte, Katrin; Szczepanska, Anna; Halder, Marlies; Cussler, Klaus; Sauer, Ursula G; Stirling, Catrina; Uhlrich, Sylvie; Wilk-Zasadna, Iwona; John, David; Bopst, Martin; Garbe, Joerg; Glansbeek, Harrie L; Levis, Robin; Serreyn, Pieter-Jan; Smith, Dean; Stickings, Paul

2017-07-01

This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations). To facilitate the global regulatory acceptance of non-animal methods for the potency testing of, e.g., human diphtheria and tetanus vaccines and veterinary swine erysipelas vaccines, international convergence on the scientific principles of the use of appropriately validated in vitro assays for replacing in vivo methods was identified as an overarching goal. The establishment of scientific requirements for new assays was recognized as a further means to unify regulatory approaches in different jurisdictions. It was recommended to include key regulators and manufacturers early in the corresponding discussions. Manufacturers and responsible expert groups, e.g. at the European Directorate for the Quality of Medicines and Health Care of the Council of Europe or the European Medicines Agency, were invited to consider leadership for international collaboration. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

[Determination of trace heavy metal elements in cortex Phellodendron chinense by ICP-MS after microwave-assisted digestion].

PubMed

Kou, Xing-Ming; Xu, Min; Gu, Yong-Zuo

2007-06-01

An inductively coupled plasma mass spectrometry (ICP-MS) for determination of the contents of 8 trace heavy metal elements in cortex Phellodendron chinense after microwave-assisted digestion of the sample has been developed. The accuracy of the method was evaluated by the analysis of corresponding trace heavy metal elements in standard reference materials (GBW 07604 and GBW 07605). By applying the proposed method, the contents of 8 trace heavy metal elements in cortex Phellodendron chinense cultivated in different areas (in Bazhong, Yibin and Yingjing, respectively) of Sichuan and different growth period (6, 8 and 10 years of samples from Yingjing) were determined. The relative standard deviation (RSD) is in the range of 3.2%-17.8% and the recoveries of standard addition are in the range of 70%-120%. The results of the study indicate that the proposed method has the advantages of simplicity, speediness and sensitivity. It is suitable for the determination of the contents of 8 trace heavy metal elements in cortex Phellodendron chinense. The results also show that the concentrations of 4 harmful trace heavy metal elements As, Cd, Hg and Pb in cortex Phellodendron chinense are all lower than the limits of Chinese Pharmacopoeia and Green Trade Standard for Importing and Exporting Medicinal Plant and Preparation. Therefore, the cortex Phellodendron chinense is fit for use as medicine and export.

Development and Validation of Discriminating and Biorelevant Dissolution Test for Lornoxicam Tablets.

PubMed

Anumolu, P D; Sunitha, G; Bindu, S Hima; Satheshbabu, P R; Subrahmanyam, C V S

2015-01-01

The establishment of biorelevant and discriminating dissolution procedure for drug products with limited water solubility is a useful technique for qualitative forecasting of the in vivo behavior of formulations. It also characterizes the drug product performance in pharmaceutical development. Lornoxicam, a BCS class-II drug is a nonsteroidal antiinflammatory drug of the oxicam class, has no official dissolution media available in the literature. The objective of present work was to develop and validate a discriminating and biorelevant dissolution test for lornoxicam tablet dosage forms. To quantify the lornoxicam in dissolution samples, UV spectrophotometric method was developed using 0.01M sodium hydroxide solution as solvent at λma×376 nm. After evaluation of saturation solubility, dissolution, sink conditions and stability of lornoxicam bulk drug in different pH solutions and biorelevant media, the dissolution method was optimized using USP paddle type apparatus at 50 rpm rotation speed and 500 ml simulated intestinal fluid as discriminating and biorelevant dissolution medium. The similarity factor (f2) were investigated for formulations with changes in composition and manufacturing variations, values revealed that dissolution method having discriminating power and method was validated as per standard guidelines. The proposed dissolution method can be effectively applied for routine quality control in vitro dissolution studies of lornoxicam in tablets and helpful to pharmacopoeias.

Fast simultaneous determination of trimethoprim and sulfamethoxazole by capillary zone electrophoresis with capacitively coupled contactless conductivity detection.

PubMed

da Silva, Iranaldo Santos; Vidal, Denis Tadeu Rajh; do Lago, Claudimir Lucio; Angnes, Lúcio

2013-04-01

The association of trimethoprim and sulfamethoxazole is a very effective with antibiotic properties, and commonly used in the treatment of a variety of infections. Due to the importance in diseases treatment of humans and also of animals, the development of methods for their quantification in commercial formulations is highly desirable. In the present study, a rapid method for simultaneous determination of these compounds using CE with capacitively coupled contactless conductivity detection was developed. A favorable working region for both analytes was from 12.5 to 200 μmol/L (linear responses with R > 0.999 for N = 5). Other parameters calculated were sensitivity (1.28 ± 0.10/1.45 ± 0.11) min/(μmol L), RSD (4.5%/2.0%), and LOD (1.1/3.3) μmol/L for trimethoprim and sulfamethoxazole, respectively. Under this condition, the total run time was only 2.6 min. The proposed method was applied to the determination of trimethoprim and sulfamethoxazole in commercial samples and the results were compared to those obtained by using a HPLC pharmacopoeia method. This new method is advantageous for quality-control analyses of trimethoprim and sulfamethoxazole in pharmaceuticals samples, because it is rapid and precise. Moreover, it is less laborious and demands minimum amounts of reagents in comparison to the recommended method. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Optimization of a reversed-phase-high-performance thin-layer chromatography method for the separation of isoniazid, ethambutol, rifampicin and pyrazinamide in fixed-dose combination antituberculosis tablets.

PubMed

Shewiyo, D H; Kaale, E; Risha, P G; Dejaegher, B; Smeyers-Verbeke, J; Vander Heyden, Y

2012-10-19

This paper presents the development of a new RP-HPTLC method for the separation of pyrazinamide, isoniazid, rifampicin and ethambutol in a four fixed-dose combination (4 FDC) tablet formulation. It is a single method with two steps in which after plate development pyrazinamide, isoniazid and rifampicin are detected at an UV wavelength of 280 nm. Then ethambutol is derivatized and detected at a VIS wavelength of 450 nm. Methanol, ethanol and propan-1-ol were evaluated modifiers to form alcohol-water mobile phases. Systematic optimization of the composition of each alcohol in the mobile phase was carried out using the window diagramming concept to obtain the best separation. Examination of the Rf distribution of the separated compounds showed that separation of the compounds with the mobile phase containing ethanol at the optimal fraction was almost situated within the optimal Rf-values region of 0.20-0.80. Therefore, ethanol was selected as organic modifier and the optimal mobile phase composition was found to be ethanol, water, glacial acetic acid (>99% acetic acid) and 37% ammonia solution (70/30/5/1, v/v/v/v). The method is new, quick and cheap compared to the actual method in the International Pharmacopoeia for the assay of the 4 FDC tablets, which involves the use of two separate HPLC methods. Copyright © 2012 Elsevier B.V. All rights reserved.

High-throughput screening using pseudotyped lentiviral particles: a strategy for the identification of HIV-1 inhibitors in a cell-based assay.

PubMed

Garcia, Jean-Michel; Gao, Anhui; He, Pei-Lan; Choi, Joyce; Tang, Wei; Bruzzone, Roberto; Schwartz, Olivier; Naya, Hugo; Nan, Fa-Jun; Li, Jia; Altmeyer, Ralf; Zuo, Jian-Ping

2009-03-01

Two decades after its discovery the human immunodeficiency virus (HIV) is still spreading worldwide and killing millions. There are 25 drugs formally approved for HIV currently on the market, but side effects as well as the emergence of HIV strains showing single or multiple resistances to current drug-therapy are causes for concern. Furthermore, these drugs target only 4 steps of the viral cycle, hence the urgent need for new drugs and also new targets. In order to tackle this problem, we have devised a cell-based assay using lentiviral particles to look for post-entry inhibitors of HIV-1. We report here the assay development, validation as well as confirmation of the hits using both wild-type and drug-resistant HIV-1 viruses. The screening was performed on an original library, rich in natural compounds and pure molecules from Traditional Chinese Medicine pharmacopoeia, which had never been screened for anti-HIV activity. The identified hits belong to four chemical sub-families that appear to be all non-nucleoside reverse transcriptase inhibitors (NNRTIs). Secondary tests with live viruses showed that there was good agreement with pseudotyped particles, confirming the validity of this approach for high-throughput drug screens. This assay will be a useful tool that can be easily adapted to screen for inhibitors of viral entry.

Comparative study of the introduction of modern botany in Japan and China.

PubMed

Métailié, Georges

2002-03-01

Prior to the eighteenth-century, a similar approach towards the vegetable kingdom, mainly influenced by the tradition of the Chinese pharmacopoeias, could be observed in China and Japan. During the eighteenth-century, the interest for "Dutch learning" led some Japanese physicians and interpreters to be more and more interested in Western knowledge about medicinal plants. At the beginning of the nineteenth-century, a few scholars, through direct contact with foreigners or with foreign books, realised that there was a specific scientific field called "botany" and began to introduce the Japanese scholarly community to this new science which became one of the subjects taught at the "University of Tokyo" in 1877. In China, up to the middle of the nineteenth-century, no trace of modern botany can be found in any published document. In the second half of the century, a few botanical treatises were published, all being adaptations or translations of Western books, done by foreign-Chinese teams of translators. This situation began to change when Chinese students had the opportunity to go and study abroad, mainly to Japan, at the beginning of the twentieth-century, and, actually, it is between 20 and 30 years later that botany became a real scientific practice in China. We will analyse these two processes, their specificities and their interactions.

Abietic acid isolated from pine resin (Resina Pini) enhances angiogenesis in HUVECs and accelerates cutaneous wound healing in mice.

PubMed

Park, Jun Yeon; Lee, Yun Kyung; Lee, Dong-Soo; Yoo, Jeong-Eun; Shin, Myoung-Sook; Yamabe, Noriko; Kim, Su-Nam; Lee, Seulah; Kim, Ki Hyun; Lee, Hae-Jeung; Roh, Seok Sun; Kang, Ki Sung

2017-05-05

Resin known as Resina Pini is listed in the Korean and Japanese pharmacopoeias and has been used for treating skin wounds and inflammation. Resin is composed of more than 50% abietic acid and 10% neutral substances. In the present study, the wound-healing effects of abietic acid and the possible underlying mechanism of action were investigated in various in vitro and in vivo models. The effects of abietic acid on tube formation and migration were measured in human umbilical vein vascular endothelial cells (HUVECs). Protein expression of mitogen-activated protein kinase (MAPK) activation was evaluated via Western blotting analysis. The wound-healing effects of abietic acid were assessed using a mouse model of cutaneous wounds. The results showed that abietic acid enhanced cell migration and tube formation in HUVECs. Abietic acid induced significant angiogenic potential, which is associated with upregulation of extracellular signal-regulated kinase (ERK) and p38 expression. Additionally, 0.8μM abietic acid-treated groups showed accelerated wound closure compared to the controls in a mouse model of cutaneous wounds. The current data indicate that abietic acid treatment elevated cell migration and tube formation in HUVECs by the activation of ERK and p38 MAPKs. We suggest that abietic acid can be developed as a wound-healing agent. Copyright © 2017 Elsevier Ltd. All rights reserved.

Elemental Impurities in Pharmaceutical Excipients.

PubMed

Li, Gang; Schoneker, Dave; Ulman, Katherine L; Sturm, Jason J; Thackery, Lisa M; Kauffman, John F

2015-12-01

Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by a lack of publically available information on elemental impurity levels in common pharmaceutical excipients. This paper summarizes a recent survey of elemental impurity levels in common pharmaceutical excipients as well as some drug substances. A widely applicable analytical procedure was developed and was shown to be suitable for analysis of elements that are subject to United States Pharmacopoeia Chapter <232> and International Conference on Harmonization's Q3D Guideline on Elemental Impurities. The procedure utilizes microwave-assisted digestion of pharmaceutical materials and inductively coupled plasma mass spectrometry for quantitative analysis of these elements. The procedure was applied to 190 samples from 31 different excipients and 15 samples from eight drug substances provided through the International Pharmaceutical Excipient Council of the Americas. The results of the survey indicate that, for the materials included in the study, relatively low levels of elemental impurities are present. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association.

Patterns of medicinal plant use: an examination of the Ecuadorian Shuar medicinal flora using contingency table and binomial analyses.

PubMed

Bennett, Bradley C; Husby, Chad E

2008-03-28

Botanical pharmacopoeias are non-random subsets of floras, with some taxonomic groups over- or under-represented. Moerman [Moerman, D.E., 1979. Symbols and selectivity: a statistical analysis of Native American medical ethnobotany, Journal of Ethnopharmacology 1, 111-119] introduced linear regression/residual analysis to examine these patterns. However, regression, the commonly-employed analysis, suffers from several statistical flaws. We use contingency table and binomial analyses to examine patterns of Shuar medicinal plant use (from Amazonian Ecuador). We first analyzed the Shuar data using Moerman's approach, modified to better meet requirements of linear regression analysis. Second, we assessed the exact randomization contingency table test for goodness of fit. Third, we developed a binomial model to test for non-random selection of plants in individual families. Modified regression models (which accommodated assumptions of linear regression) reduced R(2) to from 0.59 to 0.38, but did not eliminate all problems associated with regression analyses. Contingency table analyses revealed that the entire flora departs from the null model of equal proportions of medicinal plants in all families. In the binomial analysis, only 10 angiosperm families (of 115) differed significantly from the null model. These 10 families are largely responsible for patterns seen at higher taxonomic levels. Contingency table and binomial analyses offer an easy and statistically valid alternative to the regression approach.

Stability of medicines after repackaging into multicompartment compliance aids: eight criteria for detection of visual alteration.

PubMed

Albert, Valerie; Lanz, Michael; Imanidis, Georgios; Hersberger, Kurt E; Arnet, Isabelle

2017-01-01

Multicompartment compliance aids (MCA) are widely used by patients. They support the management of medication and reduce unintentional nonadherence. MCA are filled with medicines unpacked from their original packaging. Swiss pharmacists currently provide MCA for 1-2 weeks, although little and controversial information exists on the stability of repackaged medicines. We aimed to validate the usefulness of a simple screening method capable of detecting visual stability problems with repackaged medicines. We selected eight criteria for solid formulations from The International Pharmacopoeia : (1) rough surface, (2) chipping, (3) cracking, (4) capping, (5) mottling, (6) discoloration, (7) swelling, and (8) crushing. A selection of 24 critical medicines was repackaged in three different MCA (Pharmis ® , SureMed™, and self-produced blister) and stored at room temperature for 4 weeks. Pharmis ® was additionally stored at accelerated conditions. Appearance was scored weekly. Six alterations (rough surface, cracking, mottling, discoloration, swelling, and crushing) were observed at accelerated conditions. No alteration was observed at room temperature, except for the chipping of tablets that had been stuck to cold seal glue. The eight criteria can detect alterations of the appearance of oral solid medicines repackaged in MCA. In the absence of specific guidelines, they can serve as a simple screening method in community pharmacies for identifying medicines unsuitable for repackaging.

[Theriac: medicine and antidote].

PubMed

Parojcic, Dusanka; Stupar, Dragan; Mirica, Milica

2003-06-01

Theriac was an ancient multi-ingredient preparation; originating as a cure for the bites of serpents, mad dogs and wild beasts, it later became an antidote to all known poisons. The name theriac (treacle), (Greek theriake, Latin theriaca, French thériaque) was derived from the Greek for wild beast - theriakos. The first formula was created by Mithridates Vl, King of Pontus, a skillful ruler but a monster of cruelty, who, living in such a fear of being poisoned, took a great interest in toxicology. In the 1st century AD, Nero's personal physician Andromachus improved the formula of Antidotum Mithridatium by adding flesh of vipers, which was commonly believed to be the best antidote against snakebite, and by increasing the proportion of opium. It became known as Theriac of Andromachus, and contained 64 ingredients including various minerals, herbals, poisons and animal flesh and blood, all combined with honey in the form of electuarium. Later it became the cure-all medicine which, accumulating all the simples into one form, was supposed to be a universal panacea against all diseases. In the Middle Ages this famous electuarium become a patent medicine and entered official dispensaries and pharmacopoeias. The most famous and expensive Theriac in Europe was that of Venice. It was not until the l8th century that it was excluded from medical use.

The load and release characteristics on a strong cationic ion-exchange fiber: kinetics, thermodynamics, and influences

PubMed Central

Yuan, Jing; Gao, Yanan; Wang, Xinyu; Liu, Hongzhuo; Che, Xin; Xu, Lu; Yang, Yang; Wang, Qifang; Wang, Yan; Li, Sanming

2014-01-01

Ion-exchange fibers were different from conventional ion-exchange resins in their non-cross-linked structure. The exchange was located on the surface of the framework, and the transport resistance reduced significantly, which might mean that the exchange is controlled by an ionic reaction instead of diffusion. Therefore, this work aimed to investigate the load and release characteristics of five model drugs with the strong cationic ion-exchange fiber ZB-1. Drugs were loaded using a batch process and released in United States Pharmacopoeia (USP) dissolution apparatus 2. Opposing exchange kinetics, suitable for the special structure of the fiber, were developed for describing the exchange process with the help of thermodynamics, which illustrated that the load was controlled by an ionic reaction. The molecular weight was the most important factor to influence the drug load and release rate. Strong alkalinity and rings in the molecular structures made the affinity between the drug and fiber strong, while logP did not cause any profound differences. The drug–fiber complexes exhibited sustained release. Different kinds and concentrations of counter ions or different amounts of drug–fiber complexes in the release medium affected the release behavior, while the pH value was independent of it. The groundwork for in-depth exploration and further application of ion-exchange fibers has been laid. PMID:25114504

[From ancient pot collections to the modern medicines. Menier's pot collection-19th century].

PubMed

Demouy, Isabelle

2012-02-01

At the beginning of the 19th century in 1816, Jean Antoine Brutus Menier founded the "Maison Centrale de Droguerie Menier". It supplied most of the pharmacies in France with drugs of animal, plant and mineral origin for the pharmaceutical preparations recommended at that time. The company provided training for many chemists and pharmacists, and as such, had a collection of pots containing over seven hundred drugs that is currently held at the head office of the Council of the College of Pharmacists in Paris. After having described the pot collection, set it against the 19th century background which experienced a real revolution within this profession, and after retracing its history, a study was then carried out in order to compare the former uses with the modern uses for each of the drugs. Thanks to this detailed, comparative analysis it is now possible to evaluate the relevance of the therapeutic range of drugs in the first half of the 19th century, before the significant rise in chemistry. The Germinal Law changed the pharmacist's profession, and with the birth of chemistry, the art of the pharmacy was revolutionised. However, the drugs, and particularly those of plant origin, have managed to keep a dominant position in today's pharmaceutical domain and in the French or European Pharmacopoeia.

Development of SCAR (sequence-characterized amplified region) markers as a complementary tool for identification of ginger (Zingiber officinale Roscoe) from crude drugs and multicomponent formulations.

PubMed

Chavan, Preeti; Warude, Dnyaneshwar; Joshi, Kalpana; Patwardhan, Bhushan

2008-05-01

Zingiber officinale Roscoe (common or culinary ginger) is an official drug in Ayurvedic, Indian herbal, Chinese, Japanese, African and British Pharmacopoeias. The objective of the present study was to develop DNA-based markers that can be applied for the identification and differentiation of the commercially important plant Z. officinale Roscoe from the closely related species Zingiber zerumbet (pinecone, bitter or 'shampoo' ginger) and Zingiber cassumunar [cassumunar or plai (Thai) ginger]. The rhizomes of the other two Zingiber species used in the present study are morphologically similar to that of Z. officinale Roscoe and can be used as its adulterants or contaminants. Various methods, including macroscopy, microscopy and chemoprofiling, have been reported for the quality control of crude ginger and its products. These methods are reported to have limitations in distinguishing Z. officinale from closely related species. Hence, newer complementary methods for correct identification of ginger are useful. In the present study, RAPD (random amplification of polymorphic DNA) analysis was used to identify putative species-specific amplicons for Z. officinale. These were further cloned and sequenced to develop SCAR (sequence-characterized amplified region) markers. The developed SCAR markers were tested in several non-Zingiber species commonly used in ginger-containing formulations. One of the markers, P3, was found to be specific for Z. officinale and was successfully applied for detection of Z. officinale from Trikatu, a multicomponent formulation.

Establishment of the Ph. Eur. erythropoietin chemical reference substance batch 1.

PubMed

Burns, C; Bristow, A F; Buchheit, K H; Daas, A; Wierer, M; Costanzo, A

2015-01-01

The Erythropoietin (EPO) European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) batch 3 was calibrated in 2006 by in vivo bioassay and was used as a reference preparation for these assays as well as for the physicochemical methods in the Ph. Eur. monograph Erythropoietin concentrated solution (1316). In order to avoid the frequent replacement of this standard and thus reduce the use of animals, a new EPO Chemical Reference Substance (CRS) was established to be used solely for the physicochemical methods. Here we report the outcome of a collaborative study aimed at demonstrating the suitability of the candidate CRS (cCRS) as a reference for the physicochemical methods in the Ph. Eur. monograph. Results from the study demonstrated that for the physicochemical methods currently required in the monograph (capillary zone electrophoresis (CZE), polyacrylamide gel electrophoresis (PAGE)/immunoblotting and peptide mapping), the cCRS is essentially identical to the existing BRP. However, data also indicated that, for the physicochemical methods under consideration for inclusion in a revised monograph (test for oxidised forms and glycan mapping), the suitability of the cCRS as a reference needs to be confirmed with additional work. Further to completion of the study, the Ph. Eur. Commission adopted the cCRS as "Erythropoietin for physicochemical tests CRS batch 1" to be used for CZE, PAGE/immunoblotting and peptide mapping.

Determination of Verapamil HCl in Pharmaceutical Preparations by a Fluorescent Nano Probe Based on CdTe/CdS/ZnS Quantum Dots

PubMed Central

Muhammad, Sohail; Xu, Guanhong; Wei, Fangdi; Ma, Yujie; Ma, Yunsu; Song, Yueyue; Shi, Menglan; Xu, Xiaoman; Cen, Yao; Hu, Qin

2017-01-01

An analytical technique based on fluorescence quenching of CdTe/CdS/ZnS quantum dots (QDs) was developed to quantify verapamil in commercially available preparations. Various reaction parameters were optimized and the method developed was validated. One way analysis of variance (ANOVA) and post hoc tests at a 5% significance level were performed to justify the significance of the variation in observations. The linear range of the verapamil concentration was 0.25–5 µg/mL while the limit of detection was 20 µg/mL. Recovery and relative standard deviations were not more than ±10% of the actual amount and <5.9%, respectively. Foreign materials, common metal ions and pharmaceutical excipients of dosage forms caused little interference. To verify the application of the analytical method, the quantity of verapamil in commercially available dosage forms was measured. Verapamil content in the tablets and injections was not more than ±10% of the stated amount and it conformed to the specifications of both the British and the United States pharmacopoeias. In the case of statistical analysis, p-value was <0.05 in almost all levels of all parameters except for the optimized level of system. It can be concluded from the results that the designed method is simple, reliable, cost effective, selective, rapid and sensitive enough to be used for quantitative measurement of the verapamil HCl in dosage forms for quality control purposes. PMID:29084166

Discrimination of Schisandrae Chinensis Fructus and Schisandrae Sphenantherae Fructus based on fingerprint profiles of hydrophilic components by high-performance liquid chromatography with ultraviolet detection.

PubMed

Oshima, Ryusei; Kotani, Akira; Kuroda, Minpei; Yamamoto, Kazuhiro; Mimaki, Yoshihiro; Hakamata, Hideki

2018-03-01

High-performance liquid chromatography with ultraviolet detection (HPLC-UV) using 20 mM phosphate mobile phase and an octadecylsilyl column (Triart C18, 150 × 3.0 mm i.d., 3 μm) has been developed for the analysis of hydrophilic compounds in the water extract of Schisandrae Fructus samples. The present HPLC-UV method permits the accurate and precise determination of malic, citric, and protocatechuic acids in the Japanese Pharmacopoeia (JP) Schisandrae Fructus, Schisandrae Chinensis Fructus and Schisandrae Sphenantherae Fructus. The JP Schisandrae Fructus studied contains 27.98 mg/g malic, 107.08 mg/g citric, and 0.42 mg/g protocatechuic acids, with a relative standard deviation (RSD) of repeatability of <0.9% (n = 6). The content of malic acids in Schisandrae Chinensis Fructus is approximately ten times that in Schisandrae Sphenantherae Fructus. To examine whether the HPLC-UV method is applicable to the fingerprint-based discrimination of Schisandrae Fructus samples obtained from Chinese markets, principal component analysis (PCA) was performed using the determined contents of organic acids and the ratio of six characteristic unknown peaks derived from hydrophilic components to internal standard peak areas. On the score plots, Schisandrae Chinensis Fructus and Schisandrae Sphenantherae Fructus samples are clearly discriminated. Therefore, the HPLC-UV method for the analysis of hydrophilic components coupled with PCA has been shown to be practical and useful in the quality control of Schisandrae Fructus.

Berberis vulgaris L. effects on oxidative stress and liver injury in lead-intoxicated mice.

PubMed

Laamech, Jawhar; El-Hilaly, Jaouad; Fetoui, Hamadi; Chtourou, Yassine; Gouitaa, Hanane; Tahraoui, Adel; Lyoussi, Badiaa

2017-03-01

Background Berberis vulgaris L. (BV), commonly known as "Aghriss" in Moroccan pharmacopoeia, is used to cure liver disorders and other diseases. The present study aimed to investigate the protective effect of BV aqueous extract against lead-induced toxicity in mice liver. Methods Sixty IOPS mice were divided into six groups and were treated as follows: group 1 (normal control) received double distilled water; group 2 (toxic control) received lead acetate (5 mg/kg body weight/day) in double distilled water for 40 days; groups 3-6 received BV aqueous extract at doses of 25, 50, 100 and 150 mg/kg body weight , respectively, once daily for 30 days from 11 day after beginning of lead acetate exposure to the end of the experiment. Results Toxic control group showed a significant alteration of serum alanine-aminotransferase (ALT), aspartate-aminotransferase (AST), total cholesterol (TC), total bilirubin (TB), catalase (CAT), superoxide dismutase (SOD), glutathione peroxidase (GPx) and reduced glutathione (GSH). Histological assessment of lead-intoxicated mice liver revealed alterations in hepatocytes and focal necrosis. BV treatment significantly prevented lead accumulation, increased ALT, AST, TC, and TB, inhibited lipid peroxidation and protein carbonyls(PCO) formation. Additionally, BV extract normalized the antioxidant enzymes (CAT, SOD and GPx), GSH and architecture of liver tissues. Conclusions BV aqueous extract exerts significant hepatoprotective effects against lead-induced oxidative stress and liver dysfunction. The BV effect may be mediated through the enhancement of antioxidant status, lead-chelating abilities and free radicals quenching.

Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical Preparation

PubMed Central

Dołowy, Małgorzata; Kulpińska-Kucia, Katarzyna; Pyka, Alina

2014-01-01

A new specific, precise, accurate, and robust TLC-densitometry has been developed for the simultaneous determination of hydrocortisone acetate and lidocaine hydrochloride in combined pharmaceutical formulation. The chromatographic analysis was carried out using a mobile phase consisting of chloroform + acetone + ammonia (25%) in volume composition 8 : 2 : 0.1 and silica gel 60F254 plates. Densitometric detection was performed in UV at wavelengths 200 nm and 250 nm, respectively, for lidocaine hydrochloride and hydrocortisone acetate. The validation of the proposed method was performed in terms of specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), precision, accuracy, and robustness. The applied TLC procedure is linear in hydrocortisone acetate concentration range of 3.75 ÷ 12.50 μg·spot−1, and from 1.00 ÷ 2.50 μg·spot−1 for lidocaine hydrochloride. The developed method was found to be accurate (the value of the coefficient of variation CV [%] is less than 3%), precise (CV [%] is less than 2%), specific, and robust. LOQ of hydrocortisone acetate is 0.198 μg·spot−1 and LOD is 0.066 μg·spot−1. LOQ and LOD values for lidocaine hydrochloride are 0.270 and 0.090 μg·spot−1, respectively. The assay value of both bioactive substances is consistent with the limits recommended by Pharmacopoeia. PMID:24526880

Methods for the practical determination of the mechanical strength of tablets--from empiricism to science.

PubMed

Podczeck, Fridrun

2012-10-15

This review aims to awake an interest in the determination of the tensile strength of tablets of various shapes using a variety of direct and indirect test methods. The United States Pharmacopoeia monograph 1217 (USP35/NF30, 2011) has provided a very good approach to the experimental determination of and standards for the mechanical strength of tablets. Building on this monograph, it is hoped that the detailed account of the various methods provided in this review will encourage industrial and academic scientists involved in the development and manufacture of tablet formulations to take a step forward and determine the tensile strength of tablets, even if these are not simply flat disc-shaped or rectangular. To date there are a considerable number of valid test configurations and stress equations available, catering for many of the various shapes of tablets on the market. The determination of the tensile strength of tablets should hence replace the sole determination of a breaking force, because tensile strength values are more comparable and suggestions for minimum and/or maximum values are available. The review also identifies the gaps that require urgent filling. There is also a need for further analysis using, for example, Finite Element Method, to provide correct stress solutions for tablets of differing shapes, but this also requires practical experiments to find the best loading conditions, and theoretical stress solutions should be verified with practical experiments. Copyright © 2012 Elsevier B.V. All rights reserved.

Traditional medicinal plant use in Northern Peru: tracking two thousand years of healing culture

PubMed Central

Bussmann, Rainer W; Sharon, Douglas

2006-01-01

This paper examines the traditional use of medicinal plants in Northern Peru, with special focus on the Departments of Piura, Lambayeque, La Libertad, Cajamarca, and San Martin. Northern Peru represents the center of the old Central Andean "Health Axis," stretching from Ecuador to Bolivia. The roots of traditional healing practices in this region go at least as far back as the Moche period (AC 100–800). Although about 50% of the plants in use reported in the colonial period have disappeared from the popular pharmacopoeia, the plant knowledge of the population is much more extensive than in other parts of the Andean region. 510 plant species used for medicinal purposes were collected, identified and their vernacular names, traditional uses and applications recorded. The families best represented were Asteraceae with 69 species, Fabaceae (35), Lamiaceae (25), and Solanaceae (21). Euphorbiaceae had twelve species, and Apiaceae and Poaceae 11 species. The highest number of species was used for the treatment of "magical/ritual" ailments (207 species), followed by respiratory disorders (95), problems of the urinary tract (85), infections of female organs (66), liver ailments (61), inflammations (59), stomach problems (51) and rheumatism (45). Most of the plants used (83%) were native to Peru. Fresh plants, often collected wild, were used in two thirds of all cases, and the most common applications included the ingestion of herb decoctions or the application of plant material as poultices. PMID:17090303

Continuous direct tablet compression: effects of impeller rotation rate, total feed rate and drug content on the tablet properties and drug release.

PubMed

Järvinen, Maiju A; Paaso, Janne; Paavola, Marko; Leiviskä, Kauko; Juuti, Mikko; Muzzio, Fernando; Järvinen, Kristiina

2013-11-01

Continuous processing is becoming popular in the pharmaceutical industry for its cost and quality advantages. This study evaluated the mechanical properties, uniformity of dosage units and drug release from the tablets prepared by continuous direct compression process. The tablet formulations consisted of acetaminophen (3-30% (w/w)) pre-blended with 0.25% (w/w) colloidal silicon dioxide, microcrystalline cellulose (69-96% (w/w)) and magnesium stearate (1% (w/w)). The continuous tableting line consisted of three loss-in-weight feeders and a convective continuous mixer and a rotary tablet press. The process continued for 8 min and steady state was reached within 5 min. The effects of acetaminophen content, impeller rotation rate (39-254 rpm) and total feed rate (15 and 20 kg/h) on tablet properties were examined. All the tablets complied with the friability requirements of European Pharmacopoeia and rapidly released acetaminophen. However, the relative standard deviation of acetaminophen content (10% (w/w)) increased with an increase in impeller rotation rate at a constant total feed rate (20 kg/h). A compression force of 12 kN tended to result in greater tablet hardness and subsequently a slower initial acetaminophen release from tablets when compared with those made with the compression force of about 8 kN. In conclusion, tablets could be successfully prepared by a continuous direct compression process and process conditions affected to some extent tablet properties.

Reducing animal experimentation in foot-and-mouth disease vaccine potency tests.

PubMed

Reeve, Richard; Cox, Sarah; Smitsaart, Eliana; Beascoechea, Claudia Perez; Haas, Bernd; Maradei, Eduardo; Haydon, Daniel T; Barnett, Paul

2011-07-26

The World Organisation for Animal Health (OIE) Terrestrial Manual and the European Pharmacopoeia (EP) still prescribe live challenge experiments for foot-and-mouth disease virus (FMDV) immunogenicity and vaccine potency tests. However, the EP allows for other validated tests for the latter, and specifically in vitro tests if a "satisfactory pass level" has been determined; serological replacements are also currently in use in South America. Much research has therefore focused on validating both ex vivo and in vitro tests to replace live challenge. However, insufficient attention has been given to the sensitivity and specificity of the "gold standard"in vivo test being replaced, despite this information being critical to determining what should be required of its replacement. This paper aims to redress this imbalance by examining the current live challenge tests and their associated statistics and determining the confidence that we can have in them, thereby setting a standard for candidate replacements. It determines that the statistics associated with the current EP PD(50) test are inappropriate given our domain knowledge, but that the OIE test statistics are satisfactory. However, it has also identified a new set of live animal challenge test regimes that provide similar sensitivity and specificity to all of the currently used OIE tests using fewer animals (16 including controls), and can also provide further savings in live animal experiments in exchange for small reductions in sensitivity and specificity. Copyright © 2011 Elsevier Ltd. All rights reserved.

A WOUND CARE AND INTRAVENOUS ACCESS SUMMIT FOR ON-ORBIT CARE

NASA Technical Reports Server (NTRS)

Scheuring, R.; Paul, B.; Gillis, D.; Bacal, K.; McCulley, P.; Polk, J.; Johnson-Throop, K.

2005-01-01

Wound care issues and the ability to establish intravenous (IV) access among injured or ill crew members are a source of concern for NASA flight surgeons. Indeed, the microgravity environment and the remote nature of the International Space Station (ISS) pose unique challenges in diagnosing and treating an injured astronaut. Therefore, it is necessary to identify and adapt the best evidence based terrestrial practices regarding wound care, hemostasis, and IV access for use on the ISS. Methods: A panel of consultants was convened to evaluate the adequacy of the current ISS in-flight medical system for diagnosis and treatment of wounds and establishing IV access by a nonclinician crew medical officer. Participants were acknowledged experts in terrestrial wound care and/or operational medicine. Prior to the meeting, each panelist was encouraged to participate in a pre-summit online forum. Results: Eight external experts participated in a face-to-face meeting held at NASA-Johnson Space Center. Recommendations were made to augment the space station pharmacopoeia, as well as current wound care diagnostic, therapeutic, and deorbit criteria protocols. Additionally, suggestions were offered regarding IV access techniques and devices for use in the microgravity environment. Discussion: The results of the expert panel provide an evidence-based approach to the diagnosis and care of wounds in an injured astronaut on aboard the ISS. The results of the panel underscored the need for further research in wound therapy and IV access devices.

Identification of New Diterpenes as Putative Marker Compounds Distinguishing Agnus Castus Fruit (Chaste Tree) from Shrub Chaste Tree Fruit (Viticis Fructus).

PubMed

Oshima, Naohiro; Masada, Sayaka; Suzuki, Ryuta; Yagi, Kanae; Matsufuji, Hiroshi; Suenaga, Emi; Takahashi, Yutaka; Yahagi, Tadahiro; Watanabe, Masato; Yahara, Shoji; Iida, Osamu; Kawahara, Nobuo; Maruyama, Takuro; Goda, Yukihiro; Hakamatsuka, Takashi

2016-01-01

Agnus Castus Fruit is defined in the European Pharmacopoeia as the dried ripe fruit of Vitex agnus-castus. In Europe it is used as a medicine targeting premenstrual syndrome and climacteric disorder. In Japan, Agnus Castus Fruit is becoming popular as a raw material for over-the-counter drugs and health food products, though its congenic species, Vitex rotundifolia and Vitex trifolia, have been used as Shrub Chaste Tree Fruit in traditional medicines. Therefore, it is important to discriminate these Vitex plants from the viewpoint of regulatory science. Here we tried to identify putative marker compounds that distinguish between Agnus Castus Fruit and Shrub Chaste Tree Fruit. We analyzed extracts of each crude drug by liquid chromatography-mass spectrometry, and performed differential analysis by comparison of each chromatogram to find one or more peaks characteristic of Agnus Castus Fruit. A peak was isolated and identified as an equilibrium mixture of new compounds named chastol (1) and epichastol (1a). The planar structures of 1 and 1a were determined spectroscopically. Their relative configurations were revealed by nuclear Overhauser effect spectroscopy and differential nuclear Overhauser effect-NMR data. Since avoiding contamination from closely related species is needed for the quality control of natural pharmaceuticals, this information will be valuable to establish a method for the quality control of both, Agnus Castus Fruit and Shrub Chaste Tree Fruit products. Georg Thieme Verlag KG Stuttgart · New York.

Potential use of local and systemic humoral immune response parameters to forecast Mycoplasma hyopneumoniae associated lung lesions.

PubMed

Garcia-Morante, Beatriz; Segalés, Joaquim; Fraile, Lorenzo; Llardén, Gemma; Coll, Teresa; Sibila, Marina

2017-01-01

Immunopathological events are key for the development of enzootic pneumonia (EP), which is macroscopically observed as cranioventral pulmonary consolidation (CVPC). This study aimed to investigate the putative association between the humoral immune response against Mycoplasma hyopneumoniae (M. hyopneumoniae) and prevalence and extension of CVPC in 1) experimentally infected pigs, 2) slaughtered pigs and 3) sequentially necropsied pigs in a longitudinal study. CVPC was scored by means of the European Pharmacopoeia recommended methodology. Specific IgG, IgG1 and IgG2 antibodies were assessed in serum. In addition, mucosal IgG and IgA antibodies were analyzed in broncho-alveolar lavage fluid (BALF) from experimentally challenged pigs. The systemic humoral immune response in experimentally infected pigs was delayed in onset whereas humoral respiratory mucosal immune response appeared more rapidly but declined earlier. Although low, BALF IgG antibodies showed the highest correlation with CVPC scores (r = 0.49, p<0.05). In slaughter-aged pigs, both percentage of lungs with CVPC and mean lung lesion score were significantly higher in M. hyopneumoniae seropositive farms compared to the seronegative ones (p<0.001). Similarly, seropositive sequentially necropsied pigs showed more severe CVPC than seronegative ones. Overall, mean serological values might help to forecast prevalence and severity of EP-like lung lesions using a population based approach. Remarkably, the specific systemic humoral immune response was found to be predominated by the IgG2 subclass, suggesting a dominant Th1-mediated immune response to M. hyopneumoniae.

Traditional Medicine Collection Tracking System (TM-CTS): a database for ethnobotanically driven drug-discovery programs.

PubMed

Harris, Eric S J; Erickson, Sean D; Tolopko, Andrew N; Cao, Shugeng; Craycroft, Jane A; Scholten, Robert; Fu, Yanling; Wang, Wenquan; Liu, Yong; Zhao, Zhongzhen; Clardy, Jon; Shamu, Caroline E; Eisenberg, David M

2011-05-17

Ethnobotanically driven drug-discovery programs include data related to many aspects of the preparation of botanical medicines, from initial plant collection to chemical extraction and fractionation. The Traditional Medicine Collection Tracking System (TM-CTS) was created to organize and store data of this type for an international collaborative project involving the systematic evaluation of commonly used Traditional Chinese Medicinal plants. The system was developed using domain-driven design techniques, and is implemented using Java, Hibernate, PostgreSQL, Business Intelligence and Reporting Tools (BIRT), and Apache Tomcat. The TM-CTS relational database schema contains over 70 data types, comprising over 500 data fields. The system incorporates a number of unique features that are useful in the context of ethnobotanical projects such as support for information about botanical collection, method of processing, quality tests for plants with existing pharmacopoeia standards, chemical extraction and fractionation, and historical uses of the plants. The database also accommodates data provided in multiple languages and integration with a database system built to support high throughput screening based drug discovery efforts. It is accessed via a web-based application that provides extensive, multi-format reporting capabilities. This new database system was designed to support a project evaluating the bioactivity of Chinese medicinal plants. The software used to create the database is open source, freely available, and could potentially be applied to other ethnobotanically driven natural product collection and drug-discovery programs. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Traditional Medicine Collection Tracking System (TM-CTS): A Database for Ethnobotanically-Driven Drug-Discovery Programs

PubMed Central

Harris, Eric S. J.; Erickson, Sean D.; Tolopko, Andrew N.; Cao, Shugeng; Craycroft, Jane A.; Scholten, Robert; Fu, Yanling; Wang, Wenquan; Liu, Yong; Zhao, Zhongzhen; Clardy, Jon; Shamu, Caroline E.; Eisenberg, David M.

2011-01-01

Aim of the study. Ethnobotanically-driven drug-discovery programs include data related to many aspects of the preparation of botanical medicines, from initial plant collection to chemical extraction and fractionation. The Traditional Medicine-Collection Tracking System (TM-CTS) was created to organize and store data of this type for an international collaborative project involving the systematic evaluation of commonly used Traditional Chinese Medicinal plants. Materials and Methods. The system was developed using domain-driven design techniques, and is implemented using Java, Hibernate, PostgreSQL, Business Intelligence and Reporting Tools (BIRT), and Apache Tomcat. Results. The TM-CTS relational database schema contains over 70 data types, comprising over 500 data fields. The system incorporates a number of unique features that are useful in the context of ethnobotanical projects such as support for information about botanical collection, method of processing, quality tests for plants with existing pharmacopoeia standards, chemical extraction and fractionation, and historical uses of the plants. The database also accommodates data provided in multiple languages and integration with a database system built to support high throughput screening based drug discovery efforts. It is accessed via a web-based application that provides extensive, multi-format reporting capabilities. Conclusions. This new database system was designed to support a project evaluating the bioactivity of Chinese medicinal plants. The software used to create the database is open source, freely available, and could potentially be applied to other ethnobotanically-driven natural product collection and drug-discovery programs. PMID:21420479

Ultraviolet-B and photosynthetically active radiation interactively affect yield and pattern of monoterpenes in leaves of peppermint (Mentha x piperita L.).

PubMed

Behn, Helen; Albert, Andreas; Marx, Friedhelm; Noga, Georg; Ulbrich, Andreas

2010-06-23

Solar radiation is a key environmental signal in regulation of plant secondary metabolism. Since metabolic responses to light and ultraviolet (UV) radiation exposure are known to depend on the ratio of spectral ranges (e.g., UV-B/PAR), we examined effects of different UV-B radiation (280-315 nm) and photosynthetically active radiation (PAR, 400-700 nm) levels and ratios on yield and pattern of monoterpenoid essential oil of peppermint. Experiments were performed in exposure chambers, technically equipped for realistic simulation of natural climate and radiation. The experimental design comprised four irradiation regimes created by the combination of two PAR levels including or excluding UV-B radiation. During flowering, the highest essential oil yield was achieved at high PAR (1150 micromol m(-2) s(-1)) and approximate ambient UV-B radiation (0.6 W m(-2)). Regarding the monoterpene pattern, low PAR (550 micromol m(-2) s(-1)) and the absence of UV-B radiation led to reduced menthol and increased menthone contents and thereby to a substantial decrease in oil quality. Essential oil yield could not be correlated with density or diameter of peltate glandular trichomes, the epidermal structures specialized on biosynthesis, and the accumulation of monoterpenes. The present results lead to the conclusion that production of high quality oils (fulfilling the requirements of the Pharmacopoeia Europaea) requires high levels of natural sunlight. In protected cultivation, the use of UV-B transmitting covering materials is therefore highly recommended.

Metabolic fate of cardiac glycosides and flavonoids upon fermentation of aqueous sea squill (Drimia maritima L.) extracts.

PubMed

Knittel, Diana N; Stintzing, Florian C; Kammerer, Dietmar R

2015-06-10

Sea squill (Drimia maritima L.) extracts have been used for centuries for the medical treatment of heart diseases. A procedure for the preparation of Drimia extracts applied for such purposes comprising a fermentation step is described in the German Homoeopathic Pharmacopoeia (GHP). However, little is known about the secondary metabolite profile of such extracts and the fate of these components upon processing and storage. Thus, in the present study sea squill extracts were monitored during fermentation and storage by HPLC-DAD-MS(n) and GC-MS to characterise and quantitate individual cardiac glycosides and phenolic compounds. For this purpose, a previously established HPLC method for the separation and quantitation of pharmacologically relevant cardiac glycosides (bufadienolides) was validated. Within 12 months of storage, total bufadienolide contents decreased by about 50%, which was attributed to microbial and plant enzyme activities. The metabolisation and degradation rates of individual bufadienolide glycosides significantly differed, which was attributed to differing structures of the aglycones. Further degradation of bufadienolide aglycones was also observed. Besides reactions well known from human metabolism studies, dehydration of individual compounds was monitored. Quantitatively predominating flavonoids were also metabolised throughout the fermentation process. The present study provides valuable information about the profile and stability of individual cardiac glycosides and phenolic compounds in fermented Drimia extracts prepared for medical applications, and expands the knowledge of cardiac glycoside conversion upon microbial fermentation. Copyright © 2015 Elsevier B.V. All rights reserved.

Procedures for the GMP-Compliant Production and Quality Control of [18F]PSMA-1007: A Next Generation Radiofluorinated Tracer for the Detection of Prostate Cancer

PubMed Central

Cardinale, Jens; Martin, René; Remde, Yvonne; Schäfer, Martin; Hienzsch, Antje; Hübner, Sandra; Zerges, Anna-Maria; Marx, Heike; Hesse, Ronny; Weber, Klaus; Smits, Rene; Hoepping, Alexander; Müller, Marco; Neels, Oliver C.; Kopka, Klaus

2017-01-01

Radiolabeled tracers targeting the prostate-specific membrane antigen (PSMA) have become important radiopharmaceuticals for the PET-imaging of prostate cancer. In this connection, we recently developed the fluorine-18-labelled PSMA-ligand [18F]PSMA-1007 as the next generation radiofluorinated Glu-ureido PSMA inhibitor after [18F]DCFPyL and [18F]DCFBC. Since radiosynthesis so far has been suffering from rather poor yields, novel procedures for the automated radiosyntheses of [18F]PSMA-1007 have been developed. We herein report on both the two-step and the novel one-step procedures, which have been performed on different commonly-used radiosynthesisers. Using the novel one-step procedure, the [18F]PSMA-1007 was produced in good radiochemical yields ranging from 25 to 80% and synthesis times of less than 55 min. Furthermore, upscaling to product activities up to 50 GBq per batch was successfully conducted. All batches passed quality control according to European Pharmacopoeia standards. Therefore, we were able to disclose a new, simple and, at the same time, high yielding production pathway for the next generation PSMA radioligand [18F]PSMA-1007. Actually, it turned out that the radiosynthesis is as easily realised as the well-known [18F]FDG synthesis and, thus, transferable to all currently-available radiosynthesisers. Using the new procedures, the clinical daily routine can be sustainably supported in-house even in larger hospitals by a single production batch. PMID:28953234

[Optimization of benzalkonium chloride concentration in 0.0015% tafluprost ophthalmic solution from the points of ocular surface safety and preservative efficacy].

PubMed

Asada, Hiroyuki; Takaoka-Shichijo, Yuko; Nakamura, Masatsugu; Kimura, Akio

2010-06-01

Optimization of benzalkonium chloride (alkyl dimethylbenzylammonium chloride: BAK) concentration as preservative in 0.0015% tafluprost ophthalmic solution (Tapros 0.0015% ophthalmic solution), an anti-glaucoma medicine, was examined from the points of ocular surface safety and preservative efficacy. BAKC(12), which is dodecyl dimethylbenzylammonium chloride, and BAKmix, which is the mixture of dodecyl, tetradecyl and hexadecyl dimethylbenzylammonium chloride were used in this study. The effects of BAKC(12) concentrations and the BAK types, BAKC(12) and BAKmix, in tafluprost ophthalmic solution on ocular surface safety were evaluated using the in vitro SV 40-immobilized human corneal epithelium cell line (HCE-T). Following treatments of Tafluprost ophthalmic solutions with BAKC(12), its concentration dependency was observed on cell viability of HCE-T. The cell viability of HCE-T after treatment of these solutions with 0.001% to 0.003% BAKC(12) for 5 minutes were the same level as that after treatment of the solution without BAK. Tafluprost ophthalmic solution with 0.01% BAKC(12) was safer for the ocular surface than the same solution with 0.01% BAKmix. Preservatives-effectiveness tests of tafluprost ophthalmic solutions with various concentrations of BAKC(12) were performed according to the Japanese Pharmacopoeia (JP), and solutions with more than 0.0005% BAKC(12) conformed to JP criteria. It was concluded that 0.0005% to 0.003% of BAKC(12) in tafluprost ophthalmic solution was optimal, namely, well-balanced from the points of ocular surface safety and preservative efficacy.

Determination of 20 trace elements and arsenic species for a realgar-containing traditional Chinese medicine Niuhuang Jiedu tablets by direct inductively coupled plasma-mass spectrometry and high performance liquid chromatography-inductively coupled plasma-mass spectrometry.

PubMed

Jin, Pengfei; Liang, Xiaoli; Xia, Lufeng; Jahouh, Farid; Wang, Rong; Kuang, Yongmei; Hu, Xin

2016-01-01

Niuhuang Jiedu tablet (NHJDT) is a realgar-containing traditional Chinese medicine. A direct inductively coupled plasma-mass spectrometry (ICP-MS) method for the simultaneous determination of 20 trace elements (Mg, K, Ca, Na, Fe, As, Zn, Sr, Ba, Cu, Mn, Ni, Pb, V, Cr, Se, Co, Mo, Cd, Hg) in NHJDT, as well as in water, gastric fluid and intestinal fluid was established. Meanwhile, a high performance liquid chromatography-inductively coupled plasma-mass spectrometry (HPLC-ICP-MS) method was developed for the determination of arsenite (As(III)), arsenate (As(V)), monomethylarsonic acid (MMA), dimethylarsinic acid (DMA) and for the identification of arsenobetaine (AsB) and arsenocholine (AsC) in these extracts. Both methods were fully validated in the respect of linearity, sensitivity, precision, stability and accuracy. The reliability of the ICP-MS method was further evaluated using a certified standard reference material prepared from dried tomato leaves (NIST, SRM 1572a). The analysis showed that some manufacturers formulated lower amount of realgar than required in the Chinese Pharmacopoeia (ChP) in their preparations. In addition, almost same extraction profiles for total As and inorganic As were found in water and in gastrointestinal fluids, while higher extraction rates for other 19 elements were observed in gastrointestinal fluids. Our findings show that the toxicities of Hg, Cu, Cd and Pb in NHJDP are low, while the real As toxicity in NHJDT should be deeply investigated. Copyright © 2015 Elsevier GmbH. All rights reserved.

Diffusion of counterfeit drugs in developing countries and stability of galenics stored for months under different conditions of temperature and relative humidity.

PubMed

Baratta, Francesca; Germano, Antonio; Brusa, Paola

2012-04-01

To investigate the diffusion of counterfeit medicines in developing countries and to verify the stability of galenic dosage forms to determine the stability of galenics prepared and stored in developing countries. We purchased 221 pharmaceutical samples belonging to different therapeutic classes both in authorized and illegal pharmacies and subjected them to European Pharmacopoeia, 7th ed. quality tests. An UV-visible spectrophotometric assay was used to determine the galenics stability under different conditions of temperature (T) and relative humidity (RH). A substantial percentage of samples was substandard (52%) and thus had to be considered as counterfeit. Stability tests for galenics showed that the tested dosage forms were stable for 24 months under "standard" (t=25±2°C, RH=50±5%) conditions. Under "accelerated" (t=40±2°C, RH=50±5%) conditions, samples were stable for 3 months provided that they were stored in glass containers. Stability results of samples stored in "accelerated" conditions were similar to those obtained by on site in tropical countries and could so supply precious information on the expected stability of galenics in tropical countries. This study gives useful information about the presence of counterfeit medicinal products in the pharmacies of many developing countries. This should serve as an alarm bell and an input for the production of galenics. We recommend setting up of galenic laboratories in developing countries around the globe.

Taxonomic examination of longgu (Fossilia Ossis Mastodi, "dragon bone") and a related crude drug, longchi (Dens Draconis, "dragon tooth"), from Japanese and Chinese crude drug markets.

PubMed

Oguri, Kazuki; Nishioka, Yuichiro; Kobayashi, Yoshitsugu; Takahashi, Kyoko

2017-07-01

Longgu ("dragon bone," Ryu-kotsu, Fossilia Ossis Mastodi, or Os Draconis) is the only fossil crude drug listed in the Japanese Pharmacopoeia. All longgu in the current Japanese market is imported from China, where its resources are being depleted. Therefore, effective countermeasures are urgently needed to prevent resource depletion. One possible solution is the development of a substitute made from bones of contemporary animals that are closely related to the original animal source of the current longgu. However, no research has been conducted on the original animal source of longgu, except for a report on the longgu specimens present in the Shosoin Repository. Taxonomic examination was performed on the fossil specimens related to longgu which are owned by the Museum of Osaka University, Japan. In total, 20,939 fossil fragments were examined, of which 20,886 were mammalian fossils, and 246 of these fossils were classified into nine families. The longgu specimens from the Japanese market belonged to a relatively smaller variety of taxa than those from the Chinese market. Despite the variety of taxa in longgu, medical doctors using Kampo preparations with longgu have not reported any problems due to the presence of impurities in the original animal source. These results suggest that the effect of longgu is independent of its origin as long as it is closely related to the origin of the current longgu. Thus, despite the considerable effects of fossilization, our results could help in developing an optimal substitute for longgu.

Comparison of in vivo immunomodulatory effects of 5-hydroxymethylfurfural and 5, 5'-oxydimethylenebis (2-furfural).

PubMed

Lin, Ni; Liu, Tiantian; Lin, Lin; Lin, Sheng; Zang, Qingce; He, Jiuming; Abliz, Zeper; Li, Chao; Wang, Aiping; Jin, Hongtao

2016-11-01

The standard of 5-Hydroxymethylfurfural (5-HMF) existed in dextrose injection as an inevitable by-product during high-temperature setrilization has been included in pharmacopoeias considering its hazardous effects on human health. We found that the concentrations of 5-HMF in some traditional Chinese medicine injections (TCMIs) far exceeded its limit in dextrose injection. Besides, we detected 5, 5'-Oxydimethylenebis (2-furfural) (OMBF) in those TCMIs containing high concentrations of 5-HMF. We investigated the in vivo immunomodulatory effects of 5-HMF and OMBF at three dose levels using the reporter antigen popliteal lymph node assay (RA-PLNA), which allows the straightforward examination and mechanistic study of immunotoxicity of low molecular weight compounds. We found that 5-HMF increased the production of IgG 2a and IFN-γ when co-injected with TNP-OVA, indicating its capability of providing a co-stimulatory signal to evoke a typical type-1 immune response. Compared with the 5-HMF, OMBF elevated the production of IgG 1 , IgG 2 , IL-4 and IFN-γ in response to both reporter antigens, suggesting that OMBF can act as a neo-antigen or neo-epitope to elicit a mixed type-1 and type-2 immune response. It indicates that both 5-HMF and OMBF have immunosensitizing potential with different mechanisms, and exposure to 5-HMF and OMBF may represent a safety concern for humans. Copyright © 2016 Elsevier Inc. All rights reserved.

Food allergen extracts to diagnose food-induced allergic diseases: How they are made.

PubMed

David, Natalie A; Penumarti, Anusha; Burks, A Wesley; Slater, Jay E

2017-08-01

To review the manufacturing procedures of food allergen extracts and applicable regulatory requirements from government agencies, potential approaches to standardization, and clinical application of these products. The effects of thermal processing on allergenicity of common food allergens are also considered. A broad literature review was conducted on the natural history of food allergy, the manufacture of allergen extracts, and the allergenicity of heated food. Regulations, guidance documents, and pharmacopoeias related to food allergen extracts from the United States and Europe were also reviewed. Authoritative and peer-reviewed research articles relevant to the topic were chosen for review. Selected regulations and guidance documents are current and relevant to food allergen extracts. Preparation of a food allergen extract may require careful selection and identification of source materials, grinding, defatting, extraction, clarification, sterilization, and product testing. Although extractions for all products licensed in the United States are performed using raw source materials, many foods are not consumed in their raw form. Heating foods may change their allergenicity, and doing so before extraction may change their allergenicity and the composition of the final product. The manufacture of food allergen extracts requires many considerations to achieve the maximal quality of the final product. Allergen extracts for a select number of foods may be inconsistent between manufacturers or unreliable in a clinical setting, indicating a potential area for future improvement. Copyright © 2016 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

A Validated Method for the Quality Control of Andrographis paniculata Preparations.

PubMed

Karioti, Anastasia; Timoteo, Patricia; Bergonzi, Maria Camilla; Bilia, Anna Rita

2017-10-01

Andrographis paniculata is a herbal drug of Asian traditional medicine largely employed for the treatment of several diseases. Recently, it has been introduced in Europe for the prophylactic and symptomatic treatment of common cold and as an ingredient of dietary supplements. The active principles are diterpenes with andrographolide as the main representative. In the present study, an analytical protocol was developed for the determination of the main constituents in the herb and preparations of A. paniculata . Three different extraction protocols (methanol extraction using a modified Soxhlet procedure, maceration under ultrasonication, and decoction) were tested. Ultrasonication achieved the highest content of analytes. HPLC conditions were optimized in terms of solvent mixtures, time course, and temperature. A reversed phase C18 column eluted with a gradient system consisting of acetonitrile and acidified water and including an isocratic step at 30 °C was used. The HPLC method was validated for linearity, limits of quantitation and detection, repeatability, precision, and accuracy. The overall method was validated for precision and accuracy over at least three different concentration levels. Relative standard deviation was less than 1.13%, whereas recovery was between 95.50% and 97.19%. The method also proved to be suitable for the determination of a large number of commercial samples and was proposed to the European Pharmacopoeia for the quality control of Andrographidis herba. Georg Thieme Verlag KG Stuttgart · New York.

Characteristics and Application Analysis of Traditional Chinese Medicine Containing Sophora Japonica

NASA Astrophysics Data System (ADS)

Wei, Zhenzhen; Feng, Suxiang; Fang, Xiaoyan; Miao, Mingsan

2018-01-01

Purposes: To sum up the characteristics of Chinese medicine with Sophora Japonica and provide reference for the research, development and utilization of the Chinese medicine of Sophora japonica in the future. Methods: The author sums up the forms, functions, indications, usage, dosage and contraindications of the proprietary Chinese medicine containing Sophora Japonica in the Chinese Pharmacopoeia and the Ministerial standards. In addition, we will inquire about the clinical application of proprietary Chinese medicine containing Sophora japonica in the China National Knowledge Infrastructure (CNKI). Results: The proprietary Chinese medicine containing Sophora Japonica was widely used in the treatment of various diseases in clinic, but it was taken orally and without any external use of Chinese patent medicine. Moreover, in most of the proprietary Chinese medicine, Sophora japonica was used as a supplement; In addition, the causes of adverse reactions were not analyzed, and the safety of the drugs needed to be further analyzed. Conclusions: To make clear the role of Sophora japonica in proprietary Chinese medicine, we can develop the Chinese medicine new dosage forms of Sophora japonica; The Chinese medicine is made up of a variety of single herbs, some are toxic drugs, when an adverse reaction occurs, We should analyze the specific causes and avoid the occurrence of adverse reactions. In addition, Sophora japonica is a traditional herbal medicine and food in China; we can expand the application in other areas and explore the pharmacological and toxicological pathology.

Pharmacokinetic profile of phytoconstituent(s) isolated from medicinal plants—A comprehensive review

PubMed Central

Mehta, Piyush; Shah, Rishi; Lohidasan, Sathiyanarayanan; Mahadik, K.R.

2015-01-01

Herbal medicine, the backbone of traditional medicine, has played an important role in human health and welfare for a long period. Traditional therapeutic approaches of regional significance are found in Africa, South and Central America, China, India, Tibet, Indonesia, and the Pacific Islands. The considerable scientific significance and commercial potential of traditional medicines have resulted in increased international attention and global market demands for herbal medicines, especially Chinese herbal medicines. Herbal medicines currently are the primary form of health care for the poor in the developing countries, and also are widely used as a supplement or substitute for conventional drugs in developed countries. These traditional medicines have a pivotal role in the treatment of various ailments and more than 50% of drugs used in Western pharmacopoeia are isolated from herbs or derived from modifications of chemicals found in plants. Herbal medicines usually contain a complex mixture of various bioactive molecules, which make its standardization complicated, and there is little information about all compounds responsible for pharmacological activity. Several research papers have been published that claim pharmacological activity of herbal medicines but few are discussing the role of the exact phytoconstituent. Understanding the pharmacokinetic profile of such phytoconstituents is essential. Although there are research papers that deal with pharmacokinetic properties of phytoconstituents, there are a number of phytoconstituents yet to be explored for their kinetic properties. This article reviews the pharmacokinetic profile of 50 different therapeutically effective traditional medicinal plants from the year 2003 onward. PMID:26587392

Establishment of the Ph. Eur. Hepatitis A virus RNA for NAT testing BRP batch 1.

PubMed

Chudy, M; Nübling, C M; Blümel, J; Daas, A; Costanzo, A

2017-01-01

Detection of viral contamination in plasma donations is critical to prevent transmission of infectious diseases. The European Pharmacopoeia (Ph. Eur.) monograph 1646 'Human plasma (pooled and treated for virus inactivation)', requires that plasma pools used for the manufacture of this product be tested, among others, for the presence of hepatitis A virus RNA by nucleic acid testing (NAT) using a positive control containing 100 International Units (IU) of hepatitis A virus (HAV) RNA per mL. To this end, the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) organised an international collaborative study under the aegis of the Biological Standardisation Programme, for the establishment of the 1 st Biological Reference Preparation (BRP) for HAV RNA for NAT testing. A freeze-dried candidate material was thus prepared and calibrated against the WHO 2 nd International Standard for HAV for NAT (00/562) in a study in which thirteen European and North American laboratories including Official Medicines Control Laboratories (OMCLs), manufacturers of plasma-derived products, producers of in vitro diagnostic kits and a blood transfusion centre participated. Based on the outcome of the study, an HAV RNA content of 40 000 IU/vial (corresponding approximately to 4.6 log 10 IU/vial) was assigned to the BRP, which was adopted by the Ph. Eur. Commission in March 2016 as Ph. Eur. hepatitis A virus RNA for NAT testing BRP batch 1.

Identification of medicinal plants in the family Fabaceae using a potential DNA barcode ITS2.

PubMed

Gao, Ting; Yao, Hui; Song, Jingyuan; Liu, Chang; Zhu, Yingjie; Ma, Xinye; Pang, Xiaohui; Xu, Hongxi; Chen, Shilin

2010-07-06

To test whether the ITS2 region is an effective marker for use in authenticating of the family Fabaceae which contains many important medicinal plants. The ITS2 regions of 114 samples in Fabaceae were amplified. Sequence assembly was assembled by CodonCode Aligner V3.0. In combination with sequences from public database, the sequences were aligned by Clustal W, and genetic distances were computed using MEGA V4.0. The intra- vs. inter-specific variations were assessed by six metrics, wilcoxon two-sample tests and "barcoding gaps". Species identification was accomplished using TaxonGAP V2.4, BLAST1 and the nearest distance method. ITS2 sequences had considerable variation at the genus and species level. The intra-specific divergence ranged from 0% to 14.4%, with an average of 1.7%, and the inter-specific divergence ranged from 0% to 63.0%, with an average of 8.6%. Twenty-four species found in the Chinese Pharmacopoeia, along with another 66 species including their adulterants, were successfully identified based on ITS2 sequences. In addition, ITS2 worked well, with over 80.0% of species and 100% of genera being correctly differentiated for the 1507 sequences derived from 1126 species belonging to 196 genera. Our findings support the notion that ITS2 can be used as an efficient and powerful marker and a potential barcode to distinguish various species in Fabaceae. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

Cytochrome C oxidase subunit I barcodes provide an efficient tool for Jinqian Baihua She (Bungarus parvus) authentication

PubMed Central

Chao, Zhi; Liao, Jing; Liang, Zhenbiao; Huang, Suhua; Zhang, Liang; Li, Junde

2014-01-01

Objective: To test the feasibility of DNA barcoding for accurate identification of Jinqian Baihua She and its adulterants. Materials and Methods: Standard cytochrome C oxidase subunit I (COI) gene fragments were sequenced for DNA barcoding of 39 samples from 9 snake species, including Bungarus multicinctus, the officially recognized origin animal by Chinese Pharmacopoeia, and other 8 adulterate species. The aligned sequences, 658 base pairs in length, were analyzed for divergence using the Kimura-2-parameter (K2P) distance model with MEGA5.0. Results: The mean intraspecific K2P distance was 0.0103 and the average interspecific genetic distance was 0.2178 in B. multicinctus, far greater than the minimal interspecific genetic distance of 0.027 recommended for species identification. A neighbor-joining (NJ) tree was constructed, in which each species formed a monophyletic clade with bootstrap supports of 100%. All the data were submitted to Barcode of Life Data system version 3.0 (BOLD, http://www.barcodinglife.org) under the project title “DNA barcoding Bungarus multicinctus and its adulterants”. Ten samples of commercially available crude drugs of JBS were identified using the identification engine provided by BOLD. All the samples were clearly identified at the species level, among which five were found to be the adulterants and identified as Dinodon rufozonatum. Conclusion: DNA barcoding using the standard COI gene fragments provides an effective and accurate means for JBS identification and authentication. PMID:25422545

Comparison of Polyphenol Profile and Antimutagenic and Antioxidant Activities in Two Species Used as Source of Solidaginis herba - Goldenrod.

PubMed

Woźniak, Dorota; Ślusarczyk, Sylwester; Domaradzki, Krzysztof; Dryś, Andrzej; Matkowski, Adam

2018-04-01

European Pharmacopoeia accepts two equivalent species Solidago canadensis L. and S. gigantea Aiton as goldenrod (Solidaginis herba). We compared phytochemical profile of both species from invasive populations in Poland. Further, we compared in vitro antimutagenic and antioxidant activities of solvent extracts from aerial (AP) and underground parts (UP). In S. gigantea, flavonoid profile was dominated by quercetin glycosides, with quercitrin as the major compound. In S. canadensis, quercetin and kaempferol rutinosides were two major constituents. Caffeoylquinic acids (CQAs) were less diverse with 5-CQA as a main compound. In UP, over 20 putative diterpenoids were detected, mostly unidentified. Several CQAs were present in higher amounts than in AP. Antioxidant and antimutagenic activities were different between species and organs, with the strongest inhibition of lipid peroxidation by Et 2 O and AcOEt fractions from AP of both species (IC 50 13.33 - 16.89 μg/mL) and BuOH fraction from S. gigantea UP (IC 50  = 13.32 μg/mL). Chemical mutagenesis was completely inhibited by non-polar fractions, but oxidative mutagenesis was inhibited up to 35% only by S. canadensis. No clear relationship was found between chemical profiles and antimutagenic activity. In conclusion, both species have diverse activity and their phytochemical profiles should be considered in quality evaluation. UP of these weeds can also provide potential chemopreventive substances for further studies. © 2018 Wiley-VHCA AG, Zurich, Switzerland.

Rapid quality assessment of Radix Aconiti Preparata using direct analysis in real time mass spectrometry.

PubMed

Zhu, Hongbin; Wang, Chunyan; Qi, Yao; Song, Fengrui; Liu, Zhiqiang; Liu, Shuying

2012-11-08

This study presents a novel and rapid method to identify chemical markers for the quality control of Radix Aconiti Preparata, a world widely used traditional herbal medicine. In the method, the samples with a fast extraction procedure were analyzed using direct analysis in real time mass spectrometry (DART MS) combined with multivariate data analysis. At present, the quality assessment approach of Radix Aconiti Preparata was based on the two processing methods recorded in Chinese Pharmacopoeia for the purpose of reducing the toxicity of Radix Aconiti and ensuring its clinical therapeutic efficacy. In order to ensure the safety and effectivity in clinical use, the processing degree of Radix Aconiti should be well controlled and assessed. In the paper, hierarchical cluster analysis and principal component analysis were performed to evaluate the DART MS data of Radix Aconiti Preparata samples in different processing times. The results showed that the well processed Radix Aconiti Preparata, unqualified processed and the raw Radix Aconiti could be clustered reasonably corresponding to their constituents. The loading plot shows that the main chemical markers having the most influence on the discrimination amongst the qualified and unqualified samples were mainly some monoester diterpenoid aconitines and diester diterpenoid aconitines, i.e. benzoylmesaconine, hypaconitine, mesaconitine, neoline, benzoylhypaconine, benzoylaconine, fuziline, aconitine and 10-OH-mesaconitine. The established DART MS approach in combination with multivariate data analysis provides a very flexible and reliable method for quality assessment of toxic herbal medicine. Copyright © 2012 Elsevier B.V. All rights reserved.

Qianliguang (Senecio scandens) safety dilemma: dose is the key?

PubMed

Lin, Ge; Li, Song-Lin; Li, Mi; Li, Na; Sun-Kin Chan, Sunny; Chan, Wood-Yee; Zhao, Zhong-Zhen

2009-08-01

Qianliguang ( SENECIO SCANDENS) is a common Chinese medicinal herb. Qianliguang-containing herbal proprietary products are registered as over-the-counter remedies in China and exported to Western countries. The safety of using Qianliguang and its products has raised general concerns because of a potential risk of the presence of hepatotoxic pyrrolizidine alkaloids (PAs). A systematic toxicological study is thus required to verify this public concern. In the present article, we report, for the first time, that S. SCANDENS contains nine hepatotoxic PAs with a content of 6.95-7.19 microg/g. At a dose equivalent to the daily intake recommended by the Pharmacopoeia of China, the total content of toxic PAs in Qianliguang was determined to be 3.48 microg/kg/day, which is far below the lowest dose to cause hepatotoxicity (15 microg/kg/day) suggested by the International Program on Chemical Safety. No significant hepatotoxic effects were observed in rats fed with the extract at this human-equivalent dose for 14 consecutive days. However, a single overdose of the herbal water extract (6 g/kg), which was about 8-fold higher than the recommended dose, produced typical PA-induced hepatotoxicity in rats. Therefore, appropriate dosage guidelines should be implemented for the herbal industry, for export/import retailers, and for herbal medicine practitioners to ensure the safe and beneficial use of these herbal medicines. Georg Thieme Verlag KG Stuttgart.New York.

Medicinal plants used in Northern Peru for reproductive problems and female health

PubMed Central

2010-01-01

Infections of the reproductive tract, complications after childbirth, and reproductive problems continue to be a major health challenge worldwide. An impressive number of plant species is traditionally used to remedy such afflictions, and some have been investigated for their efficacy with positive results. A total of 105 plant species belonging to 91 genera and 62 families were documented and identified as herbal remedies for reproductive problems in Northern Peru. Most species used were Asteraceae (9.52%), followed by Lamiaceae and Fabaceae (8.57% and 6.67%). The most important families are clearly represented very similarly to their overall importance in the local pharmacopoeia. The majority of herbal preparations for reproductive afflictions were prepared from the leaves of plants (22.72%), the whole plant (21.97%), and stems (21.21%), while other plant parts were used less frequently. More than 60% of the cases fresh plant material was used to prepare remedies. Over 70% of the remedies were applied orally, while the remaining ones were applied topically. Many remedies were prepared as mixtures of multiple ingredients. Little scientific evidence exists to prove the efficacy of the species employed as reproductive disorder remedies in Northern Peru. Only 34% of the plants found or their congeners have been studied at all for their medicinal properties. The information gained on frequently used traditional remedies might give some leads for future targets for further analysis in order to develop new drugs. PMID:21040536

[Determination of chlorogenic acid, caffeic acid and linarin in Flos Chrysanthemi Indici from different places by RP-hPLC].

PubMed

Guo, Qiaosheng; Fang, Hailing; Shen, Haijin

2010-05-01

To evaluate the quality of Flos Chrysanthemi Indici which produced in twenty-two different producing places. Chlorogenic acid and caffeic acid were analyzed on a Shim-pack C8 colunm (4.6 mm x 250 mm, 5 microm) eluted with the mobile phase consisted of acetonitrile-0.5% phosphoric acid( 19:81). The detection wavelength was set at 326 nm. Linarin were eluted with the mobile phase consisted of methanol-water-acetic acid(26: 23: 1). The detection wavelength was set at 334 nm. The column temperature was 25 degrees C. The flow rate was 1.0 mL x min . The linear response ranged within 2.5-50 microg for chlorogenic acid (r = 0.998), 2.5-25 microg for caffeic acid (r = 0.998) and 4.97-41.47 microg for linarin (r = 0.999), respectively. Recoveries were 100.8% with RSD 2.1% for chlorogenic acid, 96.2% with RSD 2.3% for caffeic acid and 103.7% with RSD 1.8% for linarin. There was a significant difference in the content of chlorogenic acid, caffeic acid, linarin among the samples. The content of chlorogenic in the sample from Fengdou Chongqing city was the highest in those from other places. The content of caffeic acid in the all samples is very low. The content of linarin in the samples from Jiangsu province and Anhui province almost reached the national standard in pharmacopoeia.

Production and characterization of spray-dried theophylline powders prepared from fresh milk for potential use in paediatrics.

PubMed

Aguiar, João P; Fernandes, Tânia A P; Nese, Carlotta; Fernandes, Ana I; Pinto, João F

2017-05-01

This work evaluates the potential of using fresh milk to deliver theophylline to children. Theophylline-fresh milk systems were prepared using different solids ratios (0 : 1-1 : 0) and three fat contents in commercial milks (low, medium and high), which were spray-dried at different inlet air temperatures (T inlet - 105, 130 and 150 °C). The process was evaluated for yield and the resulting powders for moisture content (MC), particle size and shape, density and wettability. Theophylline-milk potential interactions (differential scanning calorimetry (DSC) and FT-IR) and chemical (theophylline content) and microbiological stability of powders (shelf and in-use) were also evaluated. The production yield (13.6-76.0%), MC (0.0-10.3%) and contact angles in water (77.29-93.51°) were significantly (P < 0.05) affected by T inlet , but no differences were found concerning the mean particle size (3.0-4.3 μm) of the different powders. The milk fat content significantly (P < 0.05) impacted on the density (1.244-1.552 g/cm 3 ). Theophylline content remained stable after 6 months of storage, before extemporaneous reconstitution. After reconstitution in water, low-fat milk samples (stored at 4 °C) met the microbial pharmacopoeia criteria for up to 7 days. No theophylline-milk components interaction was observed. Spray-dried milk-composed powders may be used as vehicles for theophylline delivery in paediatrics following further characterization and in-vivo evaluation. © 2016 Royal Pharmaceutical Society.

Using color histograms and SPA-LDA to classify bacteria.

PubMed

de Almeida, Valber Elias; da Costa, Gean Bezerra; de Sousa Fernandes, David Douglas; Gonçalves Dias Diniz, Paulo Henrique; Brandão, Deysiane; de Medeiros, Ana Claudia Dantas; Véras, Germano

2014-09-01

In this work, a new approach is proposed to verify the differentiating characteristics of five bacteria (Escherichia coli, Enterococcus faecalis, Streptococcus salivarius, Streptococcus oralis, and Staphylococcus aureus) by using digital images obtained with a simple webcam and variable selection by the Successive Projections Algorithm associated with Linear Discriminant Analysis (SPA-LDA). In this sense, color histograms in the red-green-blue (RGB), hue-saturation-value (HSV), and grayscale channels and their combinations were used as input data, and statistically evaluated by using different multivariate classifiers (Soft Independent Modeling by Class Analogy (SIMCA), Principal Component Analysis-Linear Discriminant Analysis (PCA-LDA), Partial Least Squares Discriminant Analysis (PLS-DA) and Successive Projections Algorithm-Linear Discriminant Analysis (SPA-LDA)). The bacteria strains were cultivated in a nutritive blood agar base layer for 24 h by following the Brazilian Pharmacopoeia, maintaining the status of cell growth and the nature of nutrient solutions under the same conditions. The best result in classification was obtained by using RGB and SPA-LDA, which reached 94 and 100 % of classification accuracy in the training and test sets, respectively. This result is extremely positive from the viewpoint of routine clinical analyses, because it avoids bacterial identification based on phenotypic identification of the causative organism using Gram staining, culture, and biochemical proofs. Therefore, the proposed method presents inherent advantages, promoting a simpler, faster, and low-cost alternative for bacterial identification.

Comparison of a specific HPLC determination of toxic aconite alkaloids in processed Radix aconiti with a titration method of total alkaloids.

PubMed

Csupor, Dezso; Borcsa, Botond; Heydel, Barbara; Hohmann, Judit; Zupkó, István; Ma, Yan; Widowitz, Ute; Bauer, Rudolf

2011-10-01

In traditional Chinese medicine, Aconitum (Ranunculaceae) roots are only applied after processing. Nevertheless, several cases of poisoning by improperly processed aconite roots have been reported. The aim of this study was to develop a reliable analytical method to assess the amount of toxic aconite alkaloids in commercial aconite roots, and to compare this method with the commonly used total alkaloid content determination by titration. The content of mesaconitine, aconitine, and hypaconitine in 16 commercial samples of processed aconite roots was determined by an HPLC method and the total alkaloid content by indirect titration. Five samples were selected for in vivo toxicological investigation. In most of the commercial samples, toxic alkaloids were not detectable, or only traces were found. In four samples, we could detect >0.04% toxic aconite alkaloids, the highest with a content of 0.16%. The results of HPLC analysis were compared with the results obtained by titration, and no correlation was found between the two methods. The in vivo results reassured the validity of the HPLC determination. Samples with mesaconitine, aconitine, and hypaconitine content below the HPLC detection limit still contained up to 0.2% alkaloids determined by titration. Since titration of alkaloids gives no information selectively on the aconitine-type alkaloid content and toxicity of aconite roots this method is not appropriate for safety assessment. The HPLC method developed by us provides a quick and reliable assessment of toxicity and should be considered as a purity test in pharmacopoeia monographs.

A rapid method for sensitive profiling of bioactive triterpene and flavonoid from Astragalus mongholicus and Astragalus membranaceus by ultra-pressure liquid chromatography with tandem mass spectrometry.

PubMed

Liu, Yang; Liu, Jia; Wu, Ke-Xin; Guo, Xiao-Rui; Tang, Zhong-Hua

2018-05-15

Astragalus is one of the most popular Chinese herbal. Control of Astragalus quantity is most important, since that various varieties and ages largely affect bioactive metabolites and different pharmacological effects. Astragalus mongholicus and Astragalus membranaceus are both major sources of Astragalus according to the provisions in the Chinese Pharmacopoeia. Thus, a sensitive and rapid UPLC-MS/MS method for the simultaneous determination of l-Phenylalanine, Isoliquiritigenin, Liquiritigenin, Daidzein, Formononetin, Ononin, Calycosin, Calycosin-7-glucoside, Cycloastragenol, Astragaloside I, Astragaloside II, Astragaloside III and Astragaloside IV was established in this study. The detection was accomplished by MRM scanning in the positive ionization mode. Calibration curves offered linear ranges with r 2  > 0.999. The method was successfully validated for the linearity, intra-day and inter day precisions, accuracy, recovery, matrix effect and stability. Then this method was successfully applied to detect the contents of 13 target flavonoids and triterpenoids metabolites in different organs and ages of A. mongholicus and A. membranaceus. Significant organs-, ages- and varieties- specificity of the 13 target metabolites were observed and discussed. The results provided basis and support for further exploration of the distribution of bioactive metabolites, namely flavonoids and triterpenoids, in different organs and ages of two Astragalus varieties. This method should be applicable to various Astragalus matrices for the quantitative analysis of the target flavonoids and triterpenoids. Copyright © 2018 Elsevier B.V. All rights reserved.

Impurities in Tc-99m radiopharmaceutical solution obtained from Mo-100 in cyclotron.

PubMed

Tymiński, Zbigniew; Saganowski, Paweł; Kołakowska, Ewa; Listkowska, Anna; Ziemek, Tomasz; Cacko, Daniel; Dziel, Tomasz

2018-04-01

The gamma emitting impurities in 99m Tc solution obtained from enriched molybdenum 100 Mo metallic target after its irradiation in a cyclotron were measured using a high-purity germanium (HPGe) detector. The radioactivity range of tested samples of 99m Tc was rather low, in the range from 0.34 to 2.39 MBq, thus creating a challenge to investigate the standard measurement HPGe system for impurity detection and quantification. In the process of 99m Tc separation from irradiated target the AnaLig® Tc-02 resin, Dionex H + and Alumina A columns were used. Fractions of eluates from various steps of separation process were taken and measured for radionuclidic purity. The overall measurement sensitivity of gamma emitters in terms of minimum detectable activity (MDA) was found at the level of 14-70Bq with emission lines in range of 36 - 1836keV resulting in impurity content range of 6.7 × 10 -4 to 3.4 × 10 -3 % for 93 Tc, 93m Tc, 94 Tc, 94m Tc, 95 Tc, 95m Tc, 96 Tc 96 Nb, 97 Nb, 99 Mo contaminants and 9.4 × 10 -3 % for 97m Tc. The usefulness of the chosen measurement conditions and the method applied to testing the potential contaminators was proved by reaching satisfactory results of MDAs less than the criteria of impurity concentration of all nuclides specified in the European Pharmacopoeia. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Correlation between four properties of traditional Chinese medicine and function of reversing multidrug resistance of tumor cells].

PubMed

Tang, Tao; Liao, Zheng-Gen; Dong, Wei; Zhang, Jing; Zhao, Guo-Wei; Guan, Xue-Jing; Liang, Xin-Li

2017-02-01

To study the correlation of four properties of traditional Chinese medicine and the function of reversing multidrug resistance (MDR) of tumor cells, with 580 herbs in Chinese Pharmacopoeia 2015 version as the research objects. CNKI, CBA, Wanfang, VIP, and PubMed were searched to screen the documents related to the reversal of MDR for collection, summarizing and analysis. The results of the research showed that a total of 114 species Chinese herbs had been reported to be associated with reversal of MDR in tumor cells. Among 15 Chinese herbs with heat nature, 7 herbs had the function of reversing MDR in tumor cells, accounting for 46.7%. Among the 48 herbs with cool nature, 12 herbs had the function of reversing MDR, accounting for 25%. Among the 211 herbs with cold nature, 46 herbs had the function of reversing MDR, accounting for 21.8%. Among the 179 herbs with warm nature, 34 herbs had the function of reversing MDR, accounting for 19%. Among the 127 herbs with neutral nature, 15 herbs had the function of reversing MDR, accounting for 11.8%. Through the analysis on the relationship between four properties of 114 kinds of traditional Chinese medicines and reversing multidrug resistance of tumor cells, this paper speculated that there was a certain correlation between four properties of traditional Chinese medicine and the function of reversing multidrug resistance of tumor cells. Copyright© by the Chinese Pharmaceutical Association.

Spectrophotometric and spectrofluorimetric determination of indacaterol maleate in pure form and pharmaceutical preparations: application to content uniformity.

PubMed

El-Ashry, S M; El-Wasseef, D R; El-Sherbiny, D T; Salem, Y A

2015-09-01

Two simple, rapid, sensitive and precise spectrophotometric and spectrofluorimetric methods were developed for the determination of indacaterol maleate in bulk powder and capsules. Both methods were based on the direct measurement of the drug in methanol. In the spectrophotometric method (Method I) the absorbance was measured at 259 nm. The absorbance-concentration plot was rectilinear over the range 1.0-10.0 µg mL(-1) with a lower detection limit (LOD) of 0.078 µg mL(-1) and lower quantification limit (LOQ) of 0.238 µg mL(-1). Meanwhile in the spectrofluorimetric method (Method II) the native fluorescence was measured at 358 nm after excitation at 258 nm. The fluorescence-concentration plot was rectilinear over the range of 1.0-40.0 ng mL(-1) with an LOD of 0.075 ng mL(-1) and an LOQ of 0.226 ng mL(-1). The proposed methods were successfully applied to the determination of indacaterol maleate in capsules with average percent recoveries ± RSD% of 99.94 ± 0.96 for Method I and 99.97 ± 0.81 for Method II. In addition, the proposed methods were extended to a content uniformity test according to the United States Pharmacopoeia (USP) guidelines and were accurate, precise for the capsules studied with acceptance value 3.98 for Method I and 2.616 for Method II. Copyright © 2015 John Wiley & Sons, Ltd.

Assessment of the quality of simvastatin capsules from compounding pharmacies.

PubMed

Markman, Blanca Elena Ortega; Rosa, Paulo César Pires; Koschtschak, Maria Regina Walter

2010-12-01

To validate a method for determining the simvastatin content of compounded capsules, using high performance liquid chromatography. Eighteen samples of simvastatin 40 mg capsules from compounding pharmacies in the cities of São Paulo, Guarulhos, São Bernardo do Campo and Campinas, Southeastern Brazil, prescribed for fictitious patients were assessed. The analyses were based on the Brazilian Pharmacopoeia and on the high performance liquid chromatography method, optimized and validated in accordance with national and international standards for identification and quantification tests on compounded capsules. The mean weight of the capsules ranged from 70 mg to 316 mg; four samples presented weight variation outside of the specification. The simvastatin content in the capsules was within the specification in 11 samples. In six, the content ranged from 4% to 87% of the declared quantity, thereby not complying with the content requirements for the active agent. For one sample, no content or uniformity determinations were performed. In the content uniformity test, 15 samples presented indices of less than 85%, with relative standard deviations greater than 6%. Three pharmacies had met the specification in this test. In the dissolution test, eight samples presented unsatisfactory results in the first stage of the test, while the remainder presented inconclusive results. The method used was shown to be suitable for application to quality control, and it revealed the poor quality of the simvastatin capsules produced by some compounding pharmacies.

Homeopathic potencies of Arnica montana L. change gene expression in a Tamm-Horsfall protein-1 cell line in vitro model: the role of ethanol as a possible confounder and statistical bias.

PubMed

Chirumbolo, Salvatore; Bjørklund, Geir

2017-07-01

Marzotto et al. showed that homeopathic preparations of Arnica montana L. acted directly on gene expression of Tamm-Horsfall protein-1 (THP-1) monocyte/macrophage cell lines activated with phorbol12-myristate13-acetate and interleukin-4 (IL-4). A. montana homeopathic dilutions are used in complementary and alternative medicine to treat inflammation disorders and post-traumatic events as well as for wound repair. The French Pharmacopoeia of these remedies uses 0.3% ethanol in each centesimal dilution. In this paper, we discuss how ethanol-containing A. montana homeopathic centesimal dilutions can change gene expression in IL-4-treated monocyte/macrophage THP-1. We assessed the role of ethanol in the Arnica homeopathic dilutions containing this alcohol by investigating its action on gene expression of THP-1 cell. Evidence would strongly suggest that the presence of ethanol in these remedies might play a fundamental role in the dilutions ability to affect gene expression, particularly for doses from 5c to 15c. Where, rather than playing a major role in the mesoscopic structure of water, the ethanol might have a chemical-physical role in the induction of THP-1 gene expression, apoptosis, and deoxyribonucleic acid function. This evidence generates a debate about the suggestion that the use of a binary-mixed solvent in homeopathic chemistry, used by Hahnemann since 1810, may be fundamental to explain the activity of homeopathy on cell models.

[Dendrobium officinale stereoscopic cultivation method].

PubMed

Si, Jin-Ping; Dong, Hong-Xiu; Liao, Xin-Yan; Zhu, Yu-Qiu; Li, Hui

2014-12-01

The study is aimed to make the most of available space of Dendrobium officinale cultivation facility, reveal the yield and functional components variation of stereoscopic cultivated D. officinale, and improve quality, yield and efficiency. The agronomic traits and yield variation of stereoscopic cultivated D. officinale were studied by operating field experiment. The content of polysaccharide and extractum were determined by using phenol-sulfuric acid method and 2010 edition of "Chinese Pharmacopoeia" Appendix X A. The results showed that the land utilization of stereoscopic cultivated D. officinale increased 2.74 times, the stems, leaves and their total fresh or dry weight in unit area of stereoscopic cultivated D. officinale were all heavier than those of the ground cultivated ones. There was no significant difference in polysaccharide content between stereoscopic cultivation and ground cultivation. But the extractum content and total content of polysaccharide and extractum were significantly higher than those of the ground cultivated ones. In additional, the polysaccharide content and total content of polysaccharide and extractum from the top two levels of stereoscopic culture matrix were significantly higher than that of the ones from the other levels and ground cultivation. Steroscopic cultivation can effectively improves the utilization of space and yield, while the total content of polysaccharides and extractum were significantly higher than that of the ground cultivated ones. The significant difference in Dendrobium polysaccharides among the plants from different height of stereo- scopic culture matrix may be associated with light factor.

Simultaneous Quantitative Determination of 12 Active Components in Yuanhu Zhitong Prescription by RP-HPLC Coupled with Photodiode Array Detection

PubMed Central

Zhang, Xiaokai; Zhang, Song; Yang, Qian; Cao, Wei; Xie, Yanhua; Qiu, Pengcheng; Wang, Siwang

2015-01-01

Background: Yuanhu Zhitong prescription (YZP) is a famous traditional Chinese medicine formula, which is officially recorded in Chinese Pharmacopoeia for the treatment of stomach pain, hypochondriac pain, headache and dysmenorrhea caused by qi-stagnancy and blood stasis. It is the first report for the simultaneous determination of 12 active components in YZP. Objective: A newly, simple, accurate and reliable method for the separation and determination of 12 active components (protopine, α-allocryptopine, coptisine, xanthotol, palmatine, dehydrocorydaline, glaucine, tetrahydropalmatine, tetrahydroberberine, imperatorin, corydaline, isoimperatorin) in YZP was developed and validated using HPLC-PAD. Materials and Methods: The analytes were performed on a Phenomenex Luna-C18 (2) column (250×4.6 mm, 5.0 μm) with a gradient elution program using a mixture of acetonitrile and 0.1% phosphoric acid water solution (adjusted with triethylamine to pH 5.6) as mobile phase. Analytes were performed at 30°C with a flow rate of 1.0 mL/min. Results: The validated method was applied to analyze four major dosage forms of YZP coming from different manufacturers with good linearity (r2, 0.9981~0.9999), precision (RSD, 0.24~2.89%), repeatability (RSD, 0.15~3.34%), stability (RSD, 0.14~3.35%), recovery (91.13~110.81%) of the 12 components. Conclusion: The proposed method enables the separation and determination of 12 active components in a single run for the quality control of YZP. PMID:25709212

Ethnobotanical survey of medicinal plants in northeastern of Algeria.

PubMed

Bouasla, Asma; Bouasla, Ihcène

2017-12-01

In order to document medicinal uses of plants in the northeastern of Algeria, preserve traditional heritage and highlighted the risks of excessive human exploitation on flora and biodiversity of the region, an inventory of medicinal species existed in the traditional pharmacopoeia in Skikda region (north-east of Algeria) was made. The survey was carried out during the year (2015-2016), through face to face interviews, using pre-prepared questionnaire. The form contains: sociodemorgaphic profile of each respondent (sex, age, educational level and monthly income), local name of medicinal species used, uses, used parts and methods of preparations. A total of 90 species belonging to 42 botanical families, were listed. The analysis of the obtained results showed that the frequency of use of medicinal plants is related to the age, sex, educational level and monthly income of our respondents. It was recorded that the majority of remedies are prepared in the form of a decoctate from the leaves of the different species, in order to treat a wide range of diseases especially those of the digestive tract. Local population has a rich indigenous knowledge, but is always stays not adequately documented. It should be noted that some listed species are suffering from surexploitation which can subjects to the disappearance of the most vulnerable species. It will be urgent and essential to adopt a sustainable management strategy to avoid the degradation of biodiversity of the region. Copyright © 2017 Elsevier GmbH. All rights reserved.

Performance indicators for carrier-based DPIs: Carrier surface properties for capsule filling and API properties for in vitro aerosolisation.

PubMed

Faulhammer, E; Zellnitz, S; Wutscher, T; Stranzinger, S; Zimmer, A; Paudel, A

2018-01-30

This study investigates engineered carrier, as well as engineered API particles, and shows that there are distinct performance indicators of particle engineering for carrier-based dry powder inhalers (DPIs). Spray dried (SDSS) and jet-milled (JMSS) salbutamol sulphate (SS) was blended with untreated α-lactose monohydrate (LAC_R) and α-lactose monohydrate engineered (LAC_E). Subsequent capsule filling was performed with different process settings on a dosator nozzle capsule filling machine in order to reach a target fill weight of 20-25 mg. To evaluate the performance of the different mixtures, in vitro lung deposition experiments were carried out with a next generation impactor, the emitted dose (ED) and fine particle fraction (FPF) were calculated based on the specification of the European pharmacopoeia. The FPF of micronised powder blends is significantly higher (20%) compared to the FPF of spray dried blends (5%). Compared to API engineering, carrier engineering had a positive effect on the capsule filling performance (weight variability and mean fill weight) at lower compression ratios (setting 1). Results further showed that higher compression ratios appear to be beneficial in terms of capsule filling performance (higher fill weight and less fill weight variation). Concluding, it can be stated that the carrier engineering, or generally carrier properties, govern downstream processing, whereas the API engineering and API properties govern the aerosolisation performance and thereby significantly affect the dose delivery to the lungs. Copyright © 2017 Elsevier B.V. All rights reserved.

[Effect of transplantation on growth and oxymatrine content of Sophora flavescens].

PubMed

Liu, Long-Yuan; Pan, Hai-Yun; Li, Shu-Yuan; Li, Hua-Shou; He, Hong-Zhi

2013-10-01

To study the effect of transplantation on the growth and oxymatrine content of Sophora flavescens and provide foundation for popularization and cultivation of Sophora flavescens in South China. Sophora flavescens which was usually planted in North China and Northwest China was planted in a non-traditional location, Zhongshan city, Guangdong Province in South China to test its adaptability. The growth characters, such as plant height, leaf area, dry weight of root, diameter and length of root and so on were measured from 2010 to 2012. The oxymatrine content of one-year old and two-year old root of Sophora flavescens were determined by HPLC. Nine major growth indexes for one-year old Sophora flavescens were comprehensively analyzed and evaluated by the methods of weighted gray relational and hierarchy evaluation of fuzzy mathematics. The weighted relevancy of introduced and reference cultivars was 0.8545. The introduced cultivar was rather adaptable to the geography environment in Zhongshan. Its quality was very close to the reference cultivars. Oxymatrine content of root of one-year old and two-year old Sophora flavescens was 13.2784 mg/g (as much as origin) and 16.4779 mg/g (less than origin 28.67%), respectively. These were 10.65% and 37.32% higher than the quality standard which were set up in the Chinese Pharmacopoeia (2010 edition). Sophora flavescens performs quite well in the newly introducing region. It is suitable to be cultivated and extended in South China.

Separation and characterization of unknown impurities and isomers in flomoxef sodium by LC-IT-TOF MS and study of their negative-ion fragmentation regularities.

PubMed

Yu, Xu; Wang, Fan; Li, Jiani; Shan, Weiguang; Zhu, Bingqi; Wang, Jian

2017-06-05

Thirteen unknown impurities in flomoxef sodium were separated and characterized by liquid chromatography coupled with high resolution ion trap/time-of-flight mass spectrometry (LC-IT-TOF MS)with positive and negative modes of electrospray ionization method for further improvement of official monographs in pharmacopoeias. The fragmentation patterns of impurities in flomoxef in the negative ion mode were studied in detail, and new negative-ion fragmentation regularities were discovered. Chromatographic separation was performed on a Kromasil C18 column (250mm×4.6mm, 5μm). The mobile phase consisted of (A) ammonium formate aqueous solution (10mM)-methanol (84:16, v/v) and (B) ammonium formate aqueous solution (10mM)-methanol (47:53, v/v). In order to determine the m/z values of the molecular ions and formulas of all detected impurities, full scan LC-MS in both positive and negative ion modes was firstly executed to obtain the m/z value of the molecules. Then LC-MS 2 and LC-MS 3 were carried out on target compounds to obtain as much structural information as possible. Complete fragmentation patterns of impurities were studied and used to obtain information about the structures of these impurities. Structures of thirteen unknown degradation products in flomoxef sodium were deduced based on the high resolution MS n data with both positive and negative modes. The forming mechanisms of degradation products in flomoxef sodium were also studied. Copyright © 2017. Published by Elsevier B.V.

Discrimination and chemical phylogenetic study of seven species of Dendrobium using infrared spectroscopy combined with cluster analysis

NASA Astrophysics Data System (ADS)

Luo, Congpei; He, Tao; Chun, Ze

2013-04-01

Dendrobium is a commonly used and precious herb in Traditional Chinese Medicine. The high biodiversity of Dendrobium and the therapeutic needs require tools for the correct and fast discrimination of different Dendrobium species. This study investigates Fourier transform infrared spectroscopy followed by cluster analysis for discrimination and chemical phylogenetic study of seven Dendrobium species. Despite the general pattern of the IR spectra, different intensities, shapes, peak positions were found in the IR spectra of these samples, especially in the range of 1800-800 cm-1. The second derivative transformation and alcoholic extracting procedure obviously enlarged the tiny spectral differences among these samples. The results indicated each Dendrobium species had a characteristic IR spectra profile, which could be used to discriminate them. The similarity coefficients among the samples were analyzed based on their second derivative IR spectra, which ranged from 0.7632 to 0.9700, among the seven Dendrobium species, and from 0.5163 to 0.9615, among the ethanol extracts. A dendrogram was constructed based on cluster analysis the IR spectra for studying the chemical phylogenetic relationships among the samples. The results indicated that D. denneanum and D. crepidatum could be the alternative resources to substitute D. chrysotoxum, D. officinale and D. nobile which were officially recorded in Chinese Pharmacopoeia. In conclusion, with the advantages of high resolution, speediness and convenience, the experimental approach can successfully discriminate and construct the chemical phylogenetic relationships of the seven Dendrobium species.

Comparative study on "long-dan", "qin-jiao" and their adulterants by HPLC analysis.

PubMed

Liu, Fang-Fang; Wang, Yan-Ming; Zhu, Hong-Tao; Wang, Dong; Yang, Chong-Ren; Xu, Min; Zhang, Ying-Jun

2014-10-01

"Long-Dan" and "Qin-Jiao" are two important TCM herbs since ancient times in China. In the Chinese Pharmacopoeia, the dried roots and rhizomes of four species from the genus Gentiana, e.g. Gentiana manshurica, G. scabra, G. triflora and G. rigescens, are recorded under the name of Gentianae Radix et Rhizoma ("Long-Dan" in Chinese), while the other four species from the same genus including G. macrophylla, G. crassicaulis, G. straminea and G. duhurica are recorded and used as the raw materials of Gentianae Macrophyllae Radix ("Qin-Jiao" in Chinese). On the basis of the establishment of a validated HPLC-UV method for quantifying simultaneously, five iridoid glycosides, e.g. loganic acid (1), swertiamarinin (2), gentiopicroside (3), sweroside (4) and 2'-(o,m-dihydroxybenzyl)sweroside (5) have been used successfully as chemical markers for the comparison of the species used as "Long-Dan", "Qin-Jiao" and their adulterants in the present study. The results suggested that four iridoid glycosides 1-4 commonly existed in both "Long-Dan" and "Qin-Jiao", while 2'-(o,m-dihydroxybenzyl)sweroside (5) also existed as one of the major components in "Dian-Long-Dan" species. Moreover, the contents of compounds 1-5 were various in different "Long-Dan" and "Qin-Jiao" species. Herein, we profiled and compared three "Long-Dan" species, four "Qin-Jiao" species and five adulterants by applying multivariate statistical techniques to their HPLC data sets to establish the differences and/or similarities.

Lavender, tea tree and lemon oils as antimicrobials in washing liquids and soft body balms.

PubMed

Kunicka-Styczyńska, A; Sikora, M; Kalemba, D

2011-02-01

The aim of this study was to evaluate the antimicrobial activity of commercial essential oils: lavender, tea tree and lemon, antimicrobials in washing liquid and O/W soft body balm. The inhibition efficacy of essential oils in washing liquid (1% alone or in mixtures), in soft body balm (0.5% alone), as well as combined with the synthetic preservative DMDM hydantoin and 3-iodo-2-propynyl butyl carbamate mixture (0.1 and 0.3%), was tested against S. aureus ATCC 6538, P. aeruginosa ATCC 9027, Candida sp. ŁOCK 0008 and A. niger ATCC 16404 in compliance with the European Pharmacopoeia standards. The components of the system preserving soft body balm were supplemented with a solubilizer. Washing liquids containing only essential oils met Criterion A E.P. only for S. aureus, Candida sp. and A. niger. In soft body balm formulations, oils at a concentration of 0.5% did not reveal any preserving activity. The introduction of a solubilizer to a system containing 0.5% tea tree oil led to a substantial increase in the bacteriostatic activity of the formulation, but did not significantly affect its fungistatic properties. A combination of 0.5% tea tree oil, 5% solubilizer and 0.3% synthetic preservative ensured the microbiological stability of soft body balm in accordance with Criterion A E.P. © 2010 The Authors. Journal compilation. © 2010 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

Study of quality and stability of ursodeoxycholic acid formulations for oral pediatric administration.

PubMed

Santoveña, A; Sánchez-Negrín, E; Charola, L; Llabrés, M; Fariña, J B

2014-12-30

This paper describes a rational method of characterizing the biopharmaceutical stability of two oral suspensions of ursodeoxycholic acid (UDCA) used in pediatrics. Because there is no commercial presentation of UDCA that can administer appropriate doses for infants and children, an active pharmaceutical ingredient (API) formulation is required. Due to its very low solubility and low dose in the formula (1.5%), two different suspensions with minimal use of excipients were studied, avoiding the use of complex additives and those not recommended by the European Medicines Agency (EMA). Adherence to Standard Operating Procedure (SOP) allows the preparation of formulations with appropriately sized and stable particles, and suitable rheological behavior in withdrawing the dose after stirring. Dose uniformity, expressed as mass and content variability, was determined using the criteria of the European and the United States Pharmacopoeia. Additionally, dose content variation of every mass determined was studied. A rational method was developed for determining the dose uniformity of UDCA in suspensions, whether freshly prepared or after storage under different conditions for 30 and 60 days. This method permits detection of differences between doses taken at different heights in the vessel at various times and storage conditions. UDCA was stable under all conditions studied, requiring the presence of glycerol in the formulation to obtain the declared API value after stirring. Storage of UDCA suspensions in a refrigerator increased variability between doses. Copyright © 2014 Elsevier B.V. All rights reserved.

Formulation and characterization of a 0.1% rapamycin cream for the treatment of Tuberous Sclerosis Complex-related angiofibromas.

PubMed

Bouguéon, Guillaume; Lagarce, Frédéric; Martin, Ludovic; Pailhoriès, Hélène; Bastiat, Guillaume; Vrignaud, Sandy

2016-07-25

Medicines for the treatment of rare diseases frequently do not attract the interest of the pharmaceutical industry, and hospital pharmacists are thus often requested by physicians to prepare personalized medicines. Tuberous Sclerosis Complex (TSC) is a rare disease that causes disfiguring lesions named facial angiofibromas. Various topical formulations of rapamycin (=sirolimus) have been proved effective in treating these changes in small case series. The present study provides for the first time characterization of a 0.1% rapamycin cream formulation presenting good rapamycin solubilisation. The first step of the formulation is solubilisation of rapamycin in Transcutol(®), and the second step is the incorporation of the mixture in an oil-in-water cream. A HPLC stability-indicating method was developed. Rapamycin concentration in the cream was tested by HPLC and confirmed that it remained above 95% of the initial concentration for at least 85days, without characteristic degradation peaks. The preparation met European Pharmacopoeia microbial specifications throughout storage in aluminum tubes, including when patient use was simulated. Odour, appearance and colour of the preparation were assessed and no change was evidenced during storage. The rheological properties of the cream also remained stable throughout storage. To conclude, we report preparation of a novel cream formulation presenting satisfactory rapamycin solubilisation for the treatment of TSC cutaneous manifestations, with stability data. The cream is currently being used by our patients. Efficacy and tolerance will be reported later. Copyright © 2016 Elsevier B.V. All rights reserved.

[Aseptic process validation and stability study of an injectable preparation of fructose (5%)-glycerol (10%) as part of a hospital clinical research program on endoscopic curative treatment for early epithelial neoplastic lesions of the gastrointestinal tract].

PubMed

Tall, M L; Salmon, D; Diouf, E; Drai, J; Filali, S; Lépilliez, V; Pioche, M; Laleye, D; Dhelens, C; Ponchon, T; Pivot, C; Pirot, F

2015-03-01

As part of a hospital clinical research program on endoscopic curative treatment for early epithelial neoplastic lesions of the gastrointestinal tract, a new hospital sterile and non-pyrogenic preparation of fructose (5%)-glycerol (10%) was realized. Under pharmaceutical legislation, the provision of this hospital preparation involves of aseptic process validation and achieve a stability study. After the aseptic process validation with Mediafill Test, the preparation was made under aseptic conditions associated with a sterilizing filtration according to the good practices preparation. Prepared flexible bags (100mL of solution) were stored for one year in a climatic chamber (25±2°C). To assess stability, the physicochemical controls (fructose concentration, glycerol concentration, hydroxy-methyl-5 furfural [5-HMF] concentration, sodium concentration, pH measure, osmolality and sub-visible particles count) and microbiological (bioburden, bacterial endotoxin and sterility) were performed at regular intervals for one year. Neither significant decrease of fructose concentration, glycerol concentration and sodium concentration nor pH, 5-HMF, osmolality variations out of specifications were observed for one year. The sub-visible particles count, the bacterial endotoxin and sterility were in accordance with the European pharmacopoeia attesting limpidity, apyrogenicity and sterility of this injectable preparation. The hospital preparation was stable over one year at 25±2°C, ensuring safe administration in humans within the framework of this clinical research. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

[Optimization of extraction technology from Paeoniae Radix Alba using response surface methodology].

PubMed

Jin, Lin; Zhao, Wan-shun; Guo, Qiao-sheng; Zhang, Wen-sheng; Ye, Zheng-liang

2015-08-01

To ensure the stability of chemistry components and the convenience of operation, ultrasound method was chosen to study in this investigation. As the total common peaks area in chromatograms was set to be evaluation index, the influence on the technology caused by extraction time, ethanol concentration and liquid-to-solid ratio was studied by using single factor methodology, and the extraction technology of Paeoniae Radix Alba was optimized by using response surface methodology. The results showed that the extracting results were most affected by ethanol concentration; liquid-to-solid ratio came the second and extraction time thirdly. The optimum ultrasonic-assisted extraction conditions were as follow: the ultrasonic extraction time was 20.06 min, the ethanol concentration in solvent was 72.04%, and the liquid-to-solid ratio was 53.38 mL · g(-1), the predicted value of total common peaks area was 2.1608 x 10(8). Under the extraction conditions after optimization, the total common peaks area was 2.1422 x 10(8), and the relative deviation between the measured and predicted value was 0.86%, so the optimized extraction technology for Paeoniae Radix Alba is suitable and feasible. Besides, for the purpose of extracting more sufficiently and completely, the optimized extraction technology had more advantages than the extraction method recorded in the monogragh of Paeoniae Radix Alba in Chinese Pharmacopoeia, which will come true the assessment and utilization comprehensively.

Anthocyanins in perilla plants and dried leaves.

PubMed

Fujiwara, Yumi; Kono, Miya; Ito, Airi; Ito, Michiho

2018-03-01

High-quality perilla leaves are purple on upper and lower surfaces and have a good aroma. The Japanese Pharmacopoeia specifies the content of essential oils in perilla leaves but not that of anthocyanins. Several reports have described the chemical species of anthocyanins in red perilla, but a complete analysis of anthocyanins in perilla has not been reported. In this study, the anthocyanins in the leaves of cultivated and wild species of perilla and those in commercially available perilla herbs were studied. Red perilla and most P. citriodora strains accumulate cyanidin derivatives that differ in the acyl group on the glucose moiety at the 3-O- and 5-O-positions of the anthocyanins. Several strains of P. citriodora contain cyanidin derivatives that are different from those in red perilla and most P. citriodora species. Green perilla and wild species other than P. citriodora do not contain foliar anthocyanins. The anthocyanins in commercially available perilla herbs and natural dyes made from red perilla were in agreement with those in fresh red perilla leaves and most P. citriodora samples. The amounts and types of anthocyanins were not associated with place of cultivation, although some changes occurred due to degradation during storage. These results provide clues regarding the biosynthesis of anthocyanins in perilla and the evolution of red perilla. The characteristics and stability of anthocyanins are discussed. Copyright © 2018 Elsevier Ltd. All rights reserved.

Chemical composition and antibacterial activity of Pinus halepensis Miller growing in West Northern of Algeria

PubMed Central

Fekih, Nadia; Allali, Hocine; Merghache, Salima; Chaïb, Faïza; Merghache, Djamila; El Amine, Mohamed; Djabou, Nassim; Muselli, Alain; Tabti, Boufeldja; Costa, Jean

2014-01-01

Objective To find new bioactive natural products, the chemical composition and to sudy the antibacterial activity of essential oil components extracted from the aerial parts of the Algerian aromatic plant Pinus halepensis Miller (P. halepensis) (needles, twigs and buds). Methods The essential oil used in this study was isolated by hydrodistillation using a Clevenger-type apparatus according to the European Pharmacopoeia. The chemical composition was investigated using GC-retention indices (RI) and GC-MS. Results Forty-nine compounds, representing 97.9% of the total collective oil, were identified. Essential oil was dominated by hydrocarbon compounds (80.6%) especially monoterpenes (65.5%). The major compounds from ten oils stations were: myrcene (15.2%-32.0%), α-pinene (12.2%-24.5%), E-β-caryophyllene (7.0%-17.1%), terpinolene (1.8%-13.3%), 2-phenyl ethyl isovalerate (4.8%-10.9%), terpinene-4-ol (1.0%-8.2 %) and sabinene (1.5%-6.3%). The intra-species variations of the chemical compositions of P. halepensis aerial parts essential oils from ten Algerian sample locations were investigated using statistical analysis. Essential oil samples were clustered in 2 groups by hierarchical cluster analysis, according to their chemical composition. The essential oil revealed an interesting antimicrobial effect against Lysteria monocytogenes, Enterococcus faecalis, Pseudomonas aeruginosa, Acinetobacter baumanii, Citrobacter freundii and Klebsiella pneumoniae. Conclusions These results suggest that the essential oil from P. halepensis may be a new potential source as natural antimicrobial applied in pharmaceutical and food industries.

Species-specific AFLP markers for identification of Zingiber officinale, Z. montanum and Z. zerumbet (Zingiberaceae).

PubMed

Ghosh, S; Majumder, P B; Sen Mandi, S

2011-02-08

The Zingiber genus, which includes the herbs known as gingers, commonly used in cooking, is well known for its medicinal properties, as described in the Indian pharmacopoeia. Different members of this genus, although somewhat similar in morphology, differ widely in their pharmacological and therapeutic properties. The most important species of this genus, with maximal therapeutic properties, is Zingiber officinale (garden ginger), which is often adulterated with other less-potent Zingiber sp. There is an existing demand in the herbal drug industry for an authentication system for the Zingiber sp in order to facilitate their commercial use as genuine phytoceuticals. To this end, we used amplified fragment length polymorphism (AFLP) to produce DNA fingerprints for three Zingiber species. Sixteen collections (six of Z. officinale, five of Z. montanum, and five of Z. zerumbet) were used in the study. Seven selective primer pairs were found to be useful for all the accessions. A total of 837 fragments were produced by these primer pairs. Species-specific markers were identified for all three Zingiber species (91 for Z. officinale, 82 for Z. montanum, and 55 for Z. zerumbet). The dendogram analysis generated from AFLP patterns showed that Z. montanum and Z. zerumbet are phylogenetically closer to each other than to Z. officinale. The AFLP fingerprints of the Zingiber species could be used to authenticate Zingiber sp-derived drugs and to resolve adulteration-related problems faced by the commercial users of these herbs.

Sensitive spectrophotometric determination of aceclofenac following azo dye formation with 4-carboxyl-2,6-dinitrobenzene diazonium ion.

PubMed

Aderibigbe, Segun A; Adegoke, Olajire A; Idowu, Olakunle S; Olaleye, Sefiu O

2012-01-01

The study is a description of a sensitive spectrophotometric determination of aceclofenac following azo dye formation with 4-carboxyl-2,6-dinitrobenzenediazonium ion (CDNBD). Spot test and thin layer chromatography revealed the formation of a new compound distinct from CDNBD and aceclofenac. Optimization studies established a reaction time of 5 min at 30 degrees C after vortex mixing the drug/CDNBD for 10 s. An absorption maximum of 430 nm was selected as analytical wavelength. A linear response was observed over 1.2-4.8 μg/mL of aceclofenac with a correlation coefficient of 0.9983 and the drug combined with CDNBD at stoichiometric ratio of 2 : 1. The method has a limit of detection of 0.403 μg/mL, limit of quantitation of 1.22 μg/mL and is reproducible over a three day assessment. The method gave Sandell's sensitivity of 3.279 ng/cm2. Intra- and inter-day accuracies (in terms of errors) were less than 6% while precisions were of the order of 0.03-1.89% (RSD). The developed spectrophotometric method is of equivalent accuracy (p > 0.05) with British Pharmacopoeia, 2010 potentiometric method. It has the advantages of speed, simplicity, sensitivity and more affordable instrumentation and could found application as a rapid and sensitive analytical method of aceclofenac. It is the first described method by azo dye derivatization for the analysis of aceclofenac in bulk samples and dosage forms.

Dereplication-guided isolation of a new indole alkaloid triglycoside from the hooks of Uncaria rhynchophylla by LC with ion trap time-of-flight MS.

PubMed

Zhang, Jian-Gang; Huang, Xiao-Yan; Ma, Yun-Bao; Zhang, Xue-Mei; Chen, Ji-Jun; Geng, Chang-An

2018-04-01

Uncaria rhynchophylla (Gou-Teng) as the monarch herb of many formulae (Fufang), e.g. "Tian-Ma-Gou-Teng-Yin," "Ling-Jiao-Gou-Teng-Yin," and "Yi-Gan-San", is a famous traditional Chinese medicine documented in the Chinese pharmacopoeia for mental and cardiovascular diseases. In the traditional Chinese medicine system, only the hook-bearing stems are used as the crude materials for Gou-Teng, and the hooks are always considered more effective than the stems. Focusing on the mono-herb and its active constituents from combinatorial formulae is the core idea of reductionism of traditional Chinese medicine theory. Detailed liquid chromatography with mass spectrometry analysis on the hooks of U. rhynchophylla was performed to profile the chemical constituents based on tandem mass spectrometry fragmentation and UV absorption. Under the guidance of liquid chromatography with ion trap/time-of-flight mass spectrometry, one new indole alkaloid triglycoside (1), together with five known compounds 2-6 as the main constituents, were isolated from the hooks of U. rhynchophylla by various column chromatography methods. Compound 1 showed moderate activity on MT 1 and MT 2 melatonin receptors with agonistic rates of 79.6 and 46.3% at the concentration of 1 mM. This dereplication strategy can be equally applicable to rapidly disclose the active constituents of other Chinese herbs through targeted purification. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Chemical and biological comparison of different sections of Uncaria rhynchophylla (Gou-Teng).

PubMed

Zhang, Jian-Gang; Geng, Chang-An; Huang, Xiao-Yan; Chen, Xing-Long; Ma, Yun-Bao; Zhang, Xue-Mei; Chen, Ji-Jun

2017-02-01

Uncaria rhynchophylla (Gou-Teng in Chinese) is officially documented in Chinese pharmacopoeia as one of the authentic sources for the crude drug of Gou-Teng which has long been used for mental and cardiovascular diseases. Indole alkaloids are the characteristic constituents responsible for the desired hypotensive effect; however, the psychiatric active constituents of Gou-Teng are still unclear. According to traditional Chinese medicine theory, only the hook-bearing stems of U. rhynchophylla are used as the crude materials for Gou-Teng, while its leaves and fruits are scarcely used. The present study aimed to compare the metabolic fingerprints of different parts (hooks, stems, leaves and fruits) of U. rhynchophylla by LC-DAD-MS/MS analysis and further evaluate their psychiatric activities on HEK293 cell line in vitro. A total of 38 constituents including 26 alkaloids, six flavonoids, two triterpenoids, two chlorogenic acid analogs and two other compounds were characterized. The different parts of U. rhynchophylla can be well differentiated from their chemical profiles. Leaves displayed the most potent activity on both MT 1 and MT 2 receptors, with agonistic rates of 39.7% and 97.6%. For 5-HT 1A and 5-HT 2C receptors, hooks showed the strongest activity with agonistic rates of 92.6% and 83.1%, respectively. This investigation provided valuable information for understanding the chemical divergence between different parts of U. rhynchophylla, and their substantial bases for psychiatric purposes.

Hepatoprotective standardized EtOH-water extract from the seeds of Fraxinus rhynchophylla Hance.

PubMed

Guo, Sen; Guo, Tiantian; Cheng, Ni; Liu, Qingchao; Zhang, Yunting; Bai, Lu; Zhang, Li; Cao, Wei; Ho, Chi-Tang; Bai, Naisheng

2017-04-01

Fraxinus rhynchophylla Hance (Oleaceae), its stem barks are known as Cortex fraxini ( qín pí) listed in Chinese Pharmacopoeia. Phytochemical study has indicated that methanol extracts from Qinpi has protective effect on acute liver injury. The present study investigates the hepatoprotective activity of EtOH-water extract from the seeds of F. rhynchophylla Hance against carbon tetrachloride-induced liver injury in mice. The EtOH-water extract significantly alleviated liver damage as indicated by the decreased levels of serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST), the malondialdehyde (MDA) content, and increased the levels of superoxide dismutase (SOD), glutathione (GSH) and glutathione peroxidase (GSH-Px), and reduced the pathological tissue injury induced by CCl 4 . Quantitative analysis of seven major constituents ( 1-7 ) in EtOH-water extract (EWE) was developed by high performance liquid chromatography-diode-array detector (HPLC-DAD). The current research indicates that the EWE from the seeds of F. rhynchophylla Hance decreased liver index, inhibited the increase of serum aminotransferase induced by CCl 4 , and decreased hepatic MDA content, SOD and GSH-Px activities. These results suggested that the pretreatment with EWE protected mice against CCl 4 -induced liver injuries. Based on the results, the EtOH-water extract from the seeds of F. rhynchophylla Hance is efficacious for prevention and treatment of CCl 4 -induced hepatic injury in mice. Secoiridoid and tyrosol glucosides might be the active ingredients responsible for the biological and pharmacological activities of hepatoprotection.

Establishment of hepatitis A detection antibodies set BRR batch 3 for antigen content determination by ELISA.

PubMed

Morgeaux, S; Manniam, I; Variot, P; Daas, A; Costanzo, A

2015-01-01

The current batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Reagents (BRRs) used for the in vitro potency assay of hepatitis A vaccines (HAV) by ELISA (enzymelinked immunosorbent assay) was established in 2012 for use in conjunction with Ph. Eur. general chapter 2.7.14 Assay of hepatitis A vaccine. It is composed of a coating reagent and a set of detection antibodies. As stocks of the latter are running low, the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised a collaborative study to qualify replacement batches. The candidate BRR antibodies (primary monoclonal antibody and labelled secondary antibody) were prepared under appropriate conditions from starting materials similar to those used for the current batches. The new batches of antibodies were tested alongside previous batches of BRRs to ensure continuity, and the results confirmed that they were suitable for use in the potency assay of hepatitis A vaccines by ELISA using the standard method referenced in Ph. Eur. general chapter 2.7.14 at the same final concentrations as the previous batches, i.e. 1:500 for the primary monoclonal antibody and 1:400 for the secondary conjugated antibody. The outcome of the study allowed their establishment by the Ph. Eur. Commission in March 2015 as anti-hepatitis A virus primary detection antibody BRR batch 3 and conjugated secondary detection antibody BRR batch 3 respectively. They are available from the EDQM as hepatitis A vaccine ELISA detection antibodies set BRR batch 3.

Establishment of hepatitis A vaccine (inactivated, non-adsorbed) BRP batches 2 and 3.

PubMed

Morgeaux, S; Manniam, I; Variot, P; Buchheit, K H; Daas, A; Wierer, M; Costanzo, A

2015-01-01

The current hepatitis A vaccine (HAV), inactivated, non-adsorbed, European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) is used for the in vitro potency assay of HAV as prescribed by the Ph. Eur. general chapter 2.7.14 Assay of hepatitis A vaccine. This reference preparation was calibrated in 2008 through an international collaborative study and was assigned a potency of 12 IU/mL. During use of this BRP it appeared to be inapplicable in certain cases due to a low nominal antigen content. Consequently, the European Directorate for the Quality of Medicines and HealthCare (EDQM) established replacement batches for this BRP, calibrated against the 1(st) WHO International Standard (IS) for HAV (inactivated), using the standard in vitro ELISA (enzyme-linked immunosorbent assay) method validated previously. The results of the study showed that the candidate BRPs were suitable for the intended purpose, and following completion of the study, they were adopted in November 2014 by the Ph. Eur. Commission as HAV (inactivated, non-adsorbed) BRP batches 2 and 3, with an assigned potency of 1350 IU/mL, for in vitro antigen content determination by ELISA. As the amount of material in each vial largely exceeds the amount required for the performance of a single assay, the BRPs are to be aliquoted by users as single-use aliquots and refrozen below -50 °C prior to their use as reference preparations.

Collaborative study for the establishment of the Ph. Eur. Hepatitis E virus RNA for NAT testing biological reference preparation batch 1.

PubMed

Baylis, S A; Terao, E; Blümel, J; Hanschmann, K-M O

2017-01-01

A new European Pharmacopoeia (Ph. Eur.) biological reference preparation (BRP) had to be established further to the decision to include nucleic acid testing (NAT) for the detection of hepatitis E virus (HEV) RNA in the monograph Human plasma (pooled and treated for virus inactivation) (1646). To this purpose, an international collaborative study was launched in the framework of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Commission of the European Union (EU). The study was run in conjunction with the establishment of the 1 st World Health Organization (WHO) international reference panel (IRP) for hepatitis E virus RNA genotypes (8578/13). Twenty-three laboratories used in-house developed and commercially available assays to calibrate a lyophilised candidate BRP prepared from a HEV 3f strain positive human plasma against the 1 st WHO International Standard (IS) for HEV RNA (6329/10). Results from quantitative and qualitative assays were in good agreement and were combined to calculate an assigned potency. Real-time stability studies indicated that the candidate BRP is very stable at lower temperatures and is thus suitable for long-term use. Based on these results, in February 2016, the Ph. Eur. Commission adopted the candidate material as the hepatitis E virus RNA for NAT testing BRP batch 1, with an assigned unitage of 2.1 × 10 4 IU/vial (4.32 log 10 IU/vial).

Potency determination of factor VIII and factor IX for new product labelling and postinfusion testing: challenges for caregivers and regulators.

PubMed

Dodt, J; Hubbard, A R; Wicks, S J; Gray, E; Neugebauer, B; Charton, E; Silvester, G

2015-07-01

A workshop organized by the European Medicines Agency and the European Directorate for the Quality of Medicines and HealthCare was held in London, UK on November 28-29, 2013, to provide an overview of the current knowledge of the characterization of new factor VIII (FVIII) and factor IX (FIX) concentrates with respect to potency assays and testing of postinfusion material. The objective was to set the basis for regulatory authorities' discussion on the most appropriate potency assay for the individual products, and European Pharmacopoeia (Ph. Eur.) discussion on whether to propose revision of the Ph. Eur. monographs with respect to potency assays in the light of information on new FVIII and FIX concentrates. The workshop showed that for all products valid assays vs. the international concentrate standards were obtained and potency could be expressed in International Units. The Ph. Eur. chromogenic potency assay gave valid assay results which correlate with in vivo functionality of rFVIII products. For some modified rFVIII products and all modified rFIX products, one-stage clotting assay methods result in different potencies depending on the activated partial thromboplastin time reagent. As a consequence, monitoring of patients' postinfusion levels is challenging but it was pointed out that manufacturers are responsible for providing the users with appropriate information for use and laboratory testing of their product. Strategies to avoid misleading determination of patents' plasma levels, e.g. information on suitable assays, laboratory standards or correction factors were discussed. © 2015 John Wiley & Sons Ltd.

Molecular identification and phylogenetic analysis of important medicinal plant species in genus Paeonia based on rDNA-ITS, matK, and rbcL DNA barcode sequences.

PubMed

Kim, W J; Ji, Y; Choi, G; Kang, Y M; Yang, S; Moon, B C

2016-08-05

This study was performed to identify and analyze the phylogenetic relationship among four herbaceous species of the genus Paeonia, P. lactiflora, P. japonica, P. veitchii, and P. suffruticosa, using DNA barcodes. These four species, which are commonly used in traditional medicine as Paeoniae Radix and Moutan Radicis Cortex, are pharmaceutically defined in different ways in the national pharmacopoeias in Korea, Japan, and China. To authenticate the different species used in these medicines, we evaluated rDNA-internal transcribed spacers (ITS), matK and rbcL regions, which provide information capable of effectively distinguishing each species from one another. Seventeen samples were collected from different geographic regions in Korea and China, and DNA barcode regions were amplified using universal primers. Comparative analyses of these DNA barcode sequences revealed species-specific nucleotide sequences capable of discriminating the four Paeonia species. Among the entire sequences of three barcodes, marker nucleotides were identified at three positions in P. lactiflora, eleven in P. japonica, five in P. veitchii, and 25 in P. suffruticosa. Phylogenetic analyses also revealed four distinct clusters showing homogeneous clades with high resolution at the species level. The results demonstrate that the analysis of these three DNA barcode sequences is a reliable method for identifying the four Paeonia species and can be used to authenticate Paeoniae Radix and Moutan Radicis Cortex at the species level. Furthermore, based on the assessment of amplicon sizes, inter/intra-specific distances, marker nucleotides, and phylogenetic analysis, rDNA-ITS was the most suitable DNA barcode for identification of these species.

PVC Membrane Sensors for Potentiometric Determination of Acebutolol

PubMed Central

Mostafa, Gamal Abdel-Hafiz; Hefnawy, Mohamed Mahmoud; Al-Majed, Abdulrahman

2007-01-01

The construction and general performance characteristics of two novel potentiometric membrane sensors responsive to the acebutolol are described. The sensors are based on the use of ion-association complexes of acebutolol (AC) with tetraphenylborate(TPB) (I) and phosphomolybdate(PM) (II) as exchange sites in a PVC matrix. The sensors show a fast, stable and near- Nernstian for the mono charge cation of AC over the concentration range 1×10-3 - ∼10-6 M at 25 °C over the pH range 2.0 - 6.0 with cationic slope of 51.5 ± 0.5 and 53.0 ± 0.5 per concentration decade for AC-I and AC-II sensors respectively. The lower detection limit is 6×10-6 M and 4×0-6 M with the response time 20-30 s in the same order of both sensors. Selectivity coefficients of AC related to a number of interfering cation and some organic compounds were investigated. There are negligible interferences are caused by most of the investigated species. The direct determination of 3 - 370 μg/ml of AC shows an average recovery of 99.4 and 99.5% and a mean relative standard deviation of 1.5% at 100.0 μg/ml for sensor I and II respectively. The results obtained by determination of AC in tablets using the proposed sensors which comparable favorably with those obtained by the British pharmacopoeia method. In the present investigation the electrodes have been utilized as end point indicator for some precipitation titration reactions. PMID:28903293

Comprehensive Quantitative Analysis of 32 Chemical Ingredients of a Chinese Patented Drug Sanhuang Tablet.

PubMed

Fung, Hau-Yee; Lang, Yan; Ho, Hing-Man; Wong, Tin-Long; Ma, Dik-Lung; Leung, Chung-Hang; Han, Quan-Bin

2017-01-12

Sanhuang Tablet (SHT) is a Chinese patented drug commonly used for the treatment of inflammations of the respiratory tract, gastrointestinal tract, and skin. It contains a special medicinal composition including the single compound berberine hydrochloride, extracts of Scutellariae Radix and Rhei Radix et Rhizoma, as well as the powder of Rhei Radix et Rhizoma. Despite advances in analytical techniques, quantitative evaluation of a Chinese patented drug like SHT remains a challenge due to the complexity of its chemical profile. In this study, ultra-high performance liquid chromatography coupled with quadrupole-time-of-flight mass spectrometry (UHPLC-Q-TOF-MS) was used to simultaneously quantify 29 non-sugar small molecule components of SHT (11 flavonoids, two isoflavonoids, one flavanone, five anthraquinones, two dianthranones, five alkaloids, two organic acids and one stilbene). Three major saccharide components, namely fructose, glucose, and sucrose, were also quantitatively determined using high performance liquid chromatography-charged aerosol detector (HPLC-CAD) on an Asahipak NH₂P-50 4E amino column. The established methods were validated in terms of linearity, sensitivity, precision, accuracy, and stability, and then successfully applied to analyze 27 batches of commercial SHT products. A total of up to 57.61% ( w / w ) of SHT could be quantified, in which the contents of the determined non-saccharide small molecules varied from 5.91% to 16.83% ( w / w ) and three saccharides accounted for 4.41% to 48.05% ( w / w ). The results showed that the quality of the commercial products was inconsistent, and only four of those met Chinese Pharmacopoeia criteria.

A sensitive and rapid assay for 4-aminophenol in paracetamol drug and tablet formulation, by flow injection analysis with spectrophotometric detection.

PubMed

Bloomfield, M S

2002-12-06

4-Aminophenol (4AP) is the primary degradation product of paracetamol which is limited at a low level (50 ppm or 0.005% w/w) in the drug substance by the European, United States, British and German Pharmacopoeias, employing a manual colourimetric limit test. The 4AP limit is widened to 1000 ppm or 0.1% w/w for the tablet product monographs, which quote the use of a less sensitive automated HPLC method. The lower drug substance specification limit is applied to our products, (50 ppm, equivalent to 25 mug 4AP in a tablet containing 500-mg paracetamol) and the pharmacopoeial HPLC assay was not suitable at this low level due to matrix interference. For routine analysis a rapid, automated assay was required. This paper presents a highly sensitive, precise and automated method employing the technique of Flow Injection (FI) analysis to quantitatively assay low levels of this degradant. A solution of the drug substance, or an extract of the tablets, containing 4AP and paracetamol is injected into a solvent carrier stream and merged on-line with alkaline sodium nitroprusside reagent, to form a specific blue derivative which is detected spectrophotometrically at 710 nm. Standard HPLC equipment is used throughout. The procedure is fully quantitative and has been optimised for sensitivity and robustness using a multivariate experimental design (multi-level 'Central Composite' response surface) model. The method has been fully validated and is linear down to 0.01 mug ml(-1). The approach should be applicable to a range of paracetamol products.

Diffusion of counterfeit drugs in developing countries and stability of galenics stored for months under different conditions of temperature and relative humidity

PubMed Central

Baratta, Francesca; Germano, Antonio; Brusa, Paola

2012-01-01

Aim To investigate the diffusion of counterfeit medicines in developing countries and to verify the stability of galenic dosage forms to determine the stability of galenics prepared and stored in developing countries. Methods We purchased 221 pharmaceutical samples belonging to different therapeutic classes both in authorized and illegal pharmacies and subjected them to European Pharmacopoeia, 7th ed. quality tests. An UV-visible spectrophotometric assay was used to determine the galenics stability under different conditions of temperature (T) and relative humidity (RH). Results A substantial percentage of samples was substandard (52%) and thus had to be considered as counterfeit. Stability tests for galenics showed that the tested dosage forms were stable for 24 months under “standard” (t = 25 ± 2°C, RH = 50 ± 5%) conditions. Under “accelerated” (t = 40 ± 2°C, RH = 50 ± 5%) conditions, samples were stable for 3 months provided that they were stored in glass containers. Stability results of samples stored in “accelerated” conditions were similar to those obtained by on site in tropical countries and could so supply precious information on the expected stability of galenics in tropical countries. Conclusion This study gives useful information about the presence of counterfeit medicinal products in the pharmacies of many developing countries. This should serve as an alarm bell and an input for the production of galenics. We recommend setting up of galenic laboratories in developing countries around the globe. PMID:22522996

[Al-Biruni--a universal scientist].

PubMed

Kujundzić, E; Masić, I

1999-01-01

Al-Biruni's was of Persian descent. He was born in Horesmiya and had studied mathematics, history and medicine. Acquiring knowledge from these sciences, he wrote an outstanding work on chronology of several nations and devoted it to Ziyarit ruler Kabus. He made a chronological overview of calendars from many nations, including Persians, Greeks, Egyptians, Jews, Melkitian and Nestorian Christians, Sabeyaans as well as the old Arabs. Data presented in the work, according to the later authors, were taken from very reliable sources. He was contemporary of Ibn-Sina, and thanks to their friendship, they have discussed very much miscellaneous topics. He belonged to the group of scholars, taken by Gaznevian Soultan Mahmud to a long journey to India. Afterwards Al-Biruni wrote and published detailed work "Description of India"--a work on cultural history of India. Due to excellent abilities of Al-Biruni as a philosopher and scholar, there are still significant and reliable notes about buddhistic philosophy, structure of castes and Brahmans' life style. In this Al-Biruni's masterpiece, there are many comparative analysis of Suffism and certain Indian philosophical methods. Al-Biruni's most important work is "Pharmacopoeia"--"Kitab al-saydala", which brilliantly describes all medicaments. This work has been published in many languages. He also wrote few works on astronomy and astrology. In those works he has explained some astrological events through scientific approach in a such peculiar way that nobody has ever explained before. He was also interested in sciences like geology, mineralology, geography, mathematics, psychology and many others.

Differentiation of Herba Cistanches by fingerprint with high-performance liquid chromatography-diode array detection-mass spectrometry.

PubMed

Jiang, Y; Li, S P; Wang, Y T; Chen, X J; Tu, P F

2009-03-13

Herba Cistanche (Rou Cong Rong in Chinese), dried succulent stems of Cistanche deserticola or C. tubulosa, is a famous Chinese herbal medicine and has been recorded in the Chinese Pharmacopoeia. In recent years, another two non-official species, C. salsa and C. sinensis have also been used as Herba Cistanche in some regions of China. To investigate the possibility of using these two non-official species as alternatives to the official species, a high-performance liquid chromatography-diode array detection-mass spectrometry (HPLC-DAD-MS) fingerprint method was developed to comparatively analyze the crude herbs of these four species. The fingerprint of C. deserticola, a historically certified species of Herba Cistanche, serves as 'standard pattern' for comparing the similarities with the other species by means of similarity and Principle Component Analysis. Additionally, 18 characteristic peaks in the fingerprints were identified by comparing their retention times, UV spectra and ESI-MS data with those of the reference substances and/or the data in the literatures. The comparative results demonstrate that the fingerprints of C. tubulosa and C. salsa possess high similarity to the standard pattern, suggesting that these two species may be used as alternative species; while that of C. sinensis has low similarity (0.053 correlation coefficient) to the standard pattern, indicating that it cannot be used as the substitute of the official herb. However, the varying fingerprint patterns among the samples of C. deserticola collected from various habitats illustrate that the quality consistency of crude herbs is still a problem worthy of serious concern.

Quality transitivity and traceability system of herbal medicine products based on quality markers.

PubMed

Liu, Changxiao; Guo, De-An; Liu, Liang

2018-05-15

Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

Effects of gamma ray and electron beam irradiation on reduction of microbial load and antioxidant properties of Chum-Hed-Thet (Cassia alata (L.) Roxb.)

NASA Astrophysics Data System (ADS)

Prakhongsil, P.; Pewlong, W.; Sajjabut, S.; Chookaew, S.

2017-06-01

Considering the growing demands of herbal medicines, Cassia alata (L.) Roxb. has been reported to have various phytochemical activities. It has also been called in Thai as Chum-Hed-Thet. In this study, C. alata (L.) Roxb. powder were exposed to gamma and electron beam irradiation at doses of 0, 5, 10, 15 and 20 kGy. At the dose of 10 kGy, both of gamma and electron beam irradiation were sufficient in reducing microbial load of irradiated samples as specified in Thai pharmacopoeia (2005). These include the total aerobic microbial count of < 5.0x105 CFU/g, total fungi count of < 5.0x104 CFU/g, bile tolerant gram negative bacteria of < 104 (per g). In addition, pathogenic Clostridium spp. (per 10 g), Salmonella spp. (per 10 g), S. aureus (per 1g) and E.coli (per 1g) were absence. In terms of the bioactive molecules, the total phenolic content, DPPH free radical scavenging activity and ferric reducing antioxidant potential of unirradiated and irradiated samples were 19.32-22.44 mg gallic acid equivalent/g, 5.20-7.82 mg ascorbic acid equivalent/g and 69.46-82.06 μmol FeSO4/g, respectively. However, there were no significant differences between unirradiated and irradiated samples (p>0.05). Therefore, both of radiation by gamma ray or electron beam at 10 kGy was sufficient in elimination of microbial flora and did not significantly affected the total phenolic content and antioxidant activities of C. alata (L.) Roxb.

Evaluation of the degree of mixing of combinations of dry syrup, powder, and fine granule products in consideration of particle size distribution using near infrared spectrometry.

PubMed

Yamamoto, Yoshihisa; Suzuki, Toyofumi; Matsumoto, Mika; Ohtani, Michiteru; Hayano, Shuichi; Fukami, Toshiro; Tomono, Kazuo

2012-01-01

We used near infrared (NIR) spectroscopy to evaluate the degree of mixing of blended dry syrup (DS) products whose particle sizes are not specified in the Revised 16th Edition of the Japanese Pharmacopoeia, and also evaluated the degree of mixing when powder products or fine granule products were added to DS products. The data obtained were used to investigate the relationship between the particle size distributions of the products studied and the degree of mixing. We found that the particle size distribution characteristics of the 15 DS products studied can be broadly classified into 5 types. Combinations of frequently prescribed products were selected to represent 4 of the 5 particle size distribution types and were blended with a mortar and pestle. The coefficient of variation (CV) decreased as the percent mass of Asverin® Dry Syrup 2% (Asverin-DS) increased in blends of Periactin® Powder 1% (Periactin) and Asverin-DS, indicating an improved degree of mixing (uniformity). In contrast, in blends of Periactin and Mucodyne® DS 33.3%, mixing a combination at a 1:1 mass ratio 40 times resulted in a CV of 20%. Other mixing frequencies and mass ratios resulted in a CV by 50% to 70%, indicating a very poor degree of mixing (poor uniformity). These results suggest that when combining different DSs, or a DS with a powder or fine granule product, the blending obtained with a mortar and pestle improves as the particle size distributions of the components approach each other and as the ranges of the distributions narrow.

Formulation, stability testing, and analytical characterization of melatonin-based preparation for clinical trial.

PubMed

Filali, Samira; Bergamelli, Charlotte; Lamine Tall, Mamadou; Salmon, Damien; Laleye, Diane; Dhelens, Carole; Diouf, Elhadji; Pivot, Christine; Pirot, Fabrice

2017-08-01

A new institutional clinical trial assessed the improvement of sleep disorders in 40 children with autism treated by immediate-release melatonin formulation in different regimens (0.5 mg, 2 mg, and 6 mg daily) for one month. The objectives of present study were to (i) prepare low-dose melatonin hard capsules for pediatric use controlled by two complementary methods and (ii) carry out a stability study in order to determine a use-by-date. Validation of preparation process was claimed as ascertained by mass uniformity of hard capsules. Multicomponent analysis by attenuated total reflectance Fourier transformed infrared (ATR-FTIR) of melatonin/microcrystalline cellulose mixture allowed to identify and quantify relative content of active pharmaceutical ingredients and excipients. Absolute melatonin content analysis by high performance liquid chromatography in 0.5 mg and 6 mg melatonin capsules was 93.6%±4.1% and 98.7%±6.9% of theoretical value, respectively. Forced degradation study showed a good separation of melatonin and its degradation products. The capability of the method was 15, confirming a risk of false negative <0.01%. Stability test and dissolution test were compliant over 18 months of storage with European Pharmacopoeia. Preparation of melatonin hard capsules was completed manually and melatonin in hard capsules was stable for 18 months, in spite of low doses of active ingredient. ATR-FTIR offers a real alternative to HPLC for quality control of high-dose melatonin hard capsules before the release of clinical batches.

Frog skin opioid peptides: a case for environmental mimicry.

PubMed Central

Lazarus, L H; Bryant, S D; Attila, M; Salvadori, S

1994-01-01

Naturally occurring environmental substances often mimic endogenous substances found in mammals and are capable of interacting with specific proteins, such as receptors, with a high degree of fidelity and selectivity. Narcotic alkaloids and amphibian skin secretions, introduced into human society through close association with plants and animals through folk medicine and religious divination practices, were incorporated into the armamentarium of the early pharmacopoeia. These skin secretions contain a myriad of potent bioactive substances, including alkaloids, biogenic amines, peptides, enzymes, mucus, and toxins (noxious compounds notwithstanding); each class exhibits a broad range of characteristic properties. One specific group of peptides, the opioids, containing the dermorphins (dermal morphinelike substances) and the deltorphins (delta-selective opioids), display remarkable analgesic properties and include an amino acid with the rare (in a mammalian context) D-enantiomer in lieu of the normal L-isomer. Synthesis of numerous stereospecific analogues and conformational analyses of these peptides provided essential insights into the tertiary composition and microenvironment of the receptor "pocket" and the optimal interactions between receptor and ligand that trigger a biological response; new advances in the synthesis and receptor-binding properties of the deltorphins are discussed in detail. These receptor-specific opioid peptides act as more than mimics of endogenous opioids: their high selectivity for either the mu or delta receptor makes them formidable environmentally derived agents in the search for new antagonists for treating opiate addiction and in the treatment of a wide variety of human disorders. Images p648-a Figure 2. Figure 3. PMID:7895704

Marketing Approval of Ethical Kampo Medicines.

PubMed

Hakamatsuka, Takashi

2017-01-01

Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

Application of high-performance liquid chromatography for research of salicin in bark of different varieties of Salix.

PubMed

Kenstaviciene, Palmyra; Nenortiene, Palma; Kiliuviene, Guoda; Zevzikovas, Andrejus; Lukosius, Audronis; Kazlauskiene, Daiva

2009-01-01

Willow (Salix L.) species are widely spread in Lithuanian natural dendroflora. Willow bark contains active substances known for anti-inflammatory properties and is known as a phytotherapeutic precursor of aspirin. Bark extracts are components of analgesic and antirheumatic preparations. Therapeutic effectiveness is associated with salicin (2-(hydroxymethyl)phenyl-beta-D-glucopyranoside), which turns into salicylic acid. Increasing attention to natural preparations gives primary importance to research of plants. This study focused on 12 willow taxa and employed routine pharmacopoeia methods. High-performance liquid chromatography method was applied for the analysis of bark extractions. The investigation revealed that not all willow species accumulated a therapeutically sufficient amount of salicin. Bark samples were investigated after 1- and 2-year growth in autumn and spring. Salicin content ranged from 0.08 to 12.6%. Higher contents of active materials were determined in autumn and in 2-year-old willows. Certain willow taxa (Salix alba L., Salix mollissima L., Salix triandra L., Salix viminalis "Americana", Salix dasyclados L.) possessed extremely low salicin amounts. In the second year, analysis covered 32 willow species. Results indicated striking differences in salicin amounts (from 0.04% in Salix viminalis "Americana" to 12.06% in Salix acutifolia). Willow species, plant age, and season should be considered when collecting medicinal plant material. The amount of salicylates in 2-year-old willow bark collected in autumn exceeded by 25% that in 1-year-old willow bark collected in spring. Bark of some analyzed willow species contained the amount of salicylates too low for using as anti-inflammatory or antipyretic remedy.

Human LH and hCG stimulate differently the early signalling pathways but result in equal testosterone synthesis in mouse Leydig cells in vitro.

PubMed

Riccetti, Laura; De Pascali, Francesco; Gilioli, Lisa; Potì, Francesco; Giva, Lavinia Beatrice; Marino, Marco; Tagliavini, Simonetta; Trenti, Tommaso; Fanelli, Flaminia; Mezzullo, Marco; Pagotto, Uberto; Simoni, Manuela; Casarini, Livio

2017-01-05

Human luteinizing hormone (LH) and chorionic gonadotropin (hCG) are glycoprotein hormones regulating development and reproductive functions by acting on the same receptor (LHCGR). We compared the LH and hCG activity in gonadal cells from male mouse in vitro, i.e. primary Leydig cells, which is a common tool used for gonadotropin bioassay. Murine Leydig cells are naturally expressing the murine LH receptor (mLhr), which binds human LH/hCG. Cultured Leydig cells were treated by increasing doses of recombinant LH and hCG, and cell signaling, gene expression and steroid synthesis were evaluated. We found that hCG is about 10-fold more potent than LH in cAMP recruitment, and slightly but significantly more potent on cAMP-dependent Erk1/2 phosphorylation. However, no significant differences occur between LH and hCG treatments, measured as activation of downstream signals, such as Creb phosphorylation, Stard1 gene expression and testosterone synthesis. These data demonstrate that the responses to human LH/hCG are only quantitatively and not qualitatively different in murine cells, at least in terms of cAMP and Erk1/2 activation, and equal in activating downstream steroidogenic events. This is at odds with what we previously described in human primary granulosa cells, where LHCGR mediates a different pattern of signaling cascades, depending on the natural ligand. This finding is relevant for gonadotropin quantification used in the official pharmacopoeia, which are based on murine, in vivo bioassay and rely on the evaluation of long-term, testosterone-dependent effects mediated by rodent receptor.

Evaluation of directly observed treatment short courses at a secondary health institution in Ibadan, Oyo State, Southwestern Nigeria.

PubMed

Adegoke, Olajire A; Orokotan, Olalekan A

2013-12-01

To evaluate the success rate of tuberculosis intervention programme at a specialist hospital in Ibadan, Nigeria through a retrospective study as well as carry out physicochemical evaluation of anti-tuberculous agents as a way of eliminating drug-related failure. The retrospective study involved the use of quarterly tuberculosis central register at the Government Chest Hospital, Ibadan between 1st quarter (2003) to 4th quarter (2009). Relevant data were extracted from these register with the aid of data collection forms. The basic physicochemical analyses of the drugs given to the patients were also carried out using the International Pharmacopoeia methods. All the drugs examined for their physicochemical properties passed the International Pharmacopeia recommended tests. A total number of 1 260 patients enrolled at the hospital were assessed through case notes. This comprises of 59.4% males of which 69.23% new cases were also males. There was a significant (P<0.05) patient enrollment across the quarters for the seven years. An overall 80.24% cure rate over the 7-period was obtained which is less than the WHO target of 85%. Cure rates were better in females than males. Failure treatment outcomes such as positive (1.51%), deaths (8.73%), defaulted (3.33%) and transferred out (5.95%) were recorded though not statistically significant (P>0.05). Failure rates in all categories were higher in males than females (P>0.05). More enlightenment and counseling is still required to meet up with the target for TB control. Copyright © 2013 Hainan Medical College. Published by Elsevier B.V. All rights reserved.

Traditional Chinese medicine and sports drug testing: identification of natural steroid administration in doping control urine samples resulting from musk (pod) extracts.

PubMed

Thevis, Mario; Schänzer, Wilhelm; Geyer, Hans; Thieme, Detlef; Grosse, Joachim; Rautenberg, Claudia; Flenker, Ulrich; Beuck, Simon; Thomas, Andreas; Holland, Ruben; Dvorak, Jiri

2013-01-01

The administration of musk extract, that is, ingredients obtained by extraction of the liquid secreted from the preputial gland or resulting grains of the male musk deer (eg, Moschus moschiferus), has been recommended in Traditional Chinese Medicine (TCM) applications and was listed in the Japanese pharmacopoeia for various indications requiring cardiovascular stimulation, anti-inflammatory medication or androgenic hormone therapy. Numerous steroidal components including cholesterol, 5α-androstane-3,17-dione, 5β-androstane-3,17-dione, androsterone, etiocholanolone, epiandrosterone, 3β-hydroxy-androst-5-en-17-one, androst-4-ene-3,17-dione and the corresponding urea adduct 3α-ureido-androst-4-en-17-one were characterised as natural ingredients of musk over several decades, implicating an issue concerning doping controls if used for the treatment of elite athletes. In the present study, the impact of musk extract administration on sports drug testing results of five females competing in an international sporting event is reported. In the course of routine doping controls, adverse analytical findings concerning the athletes' steroid profile, corroborated by isotope-ratio mass spectrometry (IRMS) data, were obtained. The athletes' medical advisors admitted the prescription of TCM-based musk pod preparations and provided musk pod samples for comparison purposes to clarify the antidoping rule violation. Steroid profiles, IRMS results, literature data and a musk sample obtained from a living musk deer of a local zoo conclusively demonstrated the use of musk pod extracts in all cases which, however, represented a doping offence as prohibited anabolic-androgenic steroids were administered.

[The elixir of doctor Garrus. Drug or liquor? Original formula or imitation?].

PubMed

Labrude, P

2010-04-01

Elixirs were formerly very used drugs or drinks. They are alcoholized and sugared, often offered as liquors, pleasant to drink, and contain drugs or not. Many are uncommon now, but Garrus elixir has passed through the centuries. Digestive stimulative, tonic, flavour of potions, aperitive and liquor, it is obtained by maceration of aloes, saffron, myrrh, clove, cinnamon and nutmeg in alcohol before distillation, then addition of vanilla, maiden-hair, orangeflower water and sugar. It seems to have been discovered at the end of the 17th century or the beginning of 18th century by Joseph Garrus, medicine doctor, living in Paris. When he died, in 1722, the elixir was already well known. During the Regency, it was administered to Duchess of Berry, who died nevertheless, and to some important members of the royal Court. During all the 18th century, it was considered as a panacea with many useful properties, inscribed in some pharmacopoeias and disposable in the drugstores. However, Garrus was acused of having simply improved the formula of the "élixir de propriété" of Paracelsius, also called tincture of aloes, myrrh and saffron. Taking in account the great number of formulas containing these same drugs and plants, it is difficult today to elucidate their origins and to discover who was imitated by another. The elixir of Doctor Garrus is also known in literature since its name is used in Madame Bovary and Tartarin sur les Alpes. At the beginning of our 21st century, some of us consider it as one of the best aperitive liquors.

A PEGylated fluorescent turn-on sensor for detecting fluoride ions in totally aqueous media and its imaging in live cells.

PubMed

Zheng, Fangyuan; Zeng, Fang; Yu, Changmin; Hou, Xianfeng; Wu, Shuizhu

2013-01-14

Owing to the considerable significance of fluoride anions for health and environmental issues, it is of great importance to develop methods that can rapidly, sensitively and selectively detect the fluoride anion in aqueous media and biological samples. Herein, we demonstrate a robust fluorescent turn-on sensor for detecting the fluoride ion in a totally aqueous solution. In this study, a biocompatible hydrophilic polymer poly(ethylene glycol) (PEG) is incorporated into the sensing system to ensure water solubility and to enhance biocompatibility. tert-Butyldiphenylsilyl (TBDPS) groups were then covalently introduced onto the fluorescein moiety, which effectively quenched the fluorescence of the sensor. Upon addition of fluoride ion, the selective fluoride-mediated cleavage of the Si-O bond leads to the recovery of the fluorescein moiety, resulting in a dramatic increase in fluorescence intensity under visible light excitation. The sensor is responsive and highly selective for the fluoride anion over other common anions; it also exhibits a very low detection limit of 19 ppb. In addition, this sensor is operative in some real samples such as running water, urine, and serum and can accurately detect fluoride ions in these samples. The cytotoxicity of the sensor was determined to be Grade I toxicity according to United States Pharmacopoeia and ISO 10993-5, suggesting the very low cytotoxicity of the sensor. Moreover, it was found that the senor could be readily internalized by both HeLa and L929 cells and the sensor could be utilized to track fluoride level changes inside the cells. Copyright © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Optimization of simultaneous microwave/ultrasonic-assisted extraction of phenolic compounds from walnut flour using response surface methodology.

PubMed

Luo, Yan; Wu, Wanxing; Chen, Dan; Lin, Yuping; Ma, Yage; Chen, Chaoyin; Zhao, Shenglan

2017-12-01

Walnut is a traditional food as well as a traditional medicine recorded in the Chinese Pharmacopoeia; however, the large amounts of walnut flour (WF) generated in walnut oil production have not been well utilized. This study maximized the total polyphenolic yield (TPY) from the walnut flour (WF) by optimizing simultaneous ultrasound/microwave-assisted hydroalcoholic extraction (SUMAE). Response surface methodology was used to optimize the processing parameters for the TPY, including microwave power (20-140 W), ultrasonic power (75-525 W), extraction temperature (25-55 °C), and time (0.5-9.5 min). The polyphenol components were analysed by LC-MS. A second-order polynomial model satisfactorily fit the experimental TPY data (R 2  = 0.9932, P < 0.0001 and R adj 2     = 0.9868). The optimized quick extraction conditions were microwave power 294.38 W, ultrasonic power 93.5 W, temperature 43.38 °C and time 4.33 min, with a maximum TPY of 34.91 mg GAE/g, which was a rapid extraction. The major phenolic components in the WF extracts were glansreginin A, ellagic acid, and gallic acid with peak areas of 22.15%, 14.99% and 10.96%, respectively, which might be used as functional components for health food, cosmetics and medicines. The results indicated that walnut flour, a waste product from the oil industry, was a rich source of polyphenolic compounds and thus could be used as a high-value functional food ingredient.

[Not Available].

PubMed

Demaeyer, Ph

2016-01-01

Medicine owes many to Hippocrate, but pneumology traces its origin back to antiquity, from Mesopotamia to ancient Rome. Regarding prehistory: if viscera of this period have not been kept, some bones were. Since Neanderthals, it is then possible to study osteoarticular pathologies (often chronic arthrosis). But no evidence of tuberculosis was found (all thoracic kyphosis are not tuberculosis). Tuberculosis probably appears during the Neolithic age, because of high concentration of population. In ancient times, pneumology was of course not a real medical specialty. However, respiratory illness already constituted a big part of antique medical practice. The purpose of the physician in antiquity was to establish a diagnosis, a prognostic and to propose a treatment. Prognostic revealed to be of great importance in ancient times, since therapeutic efficacy was limited. Contemporary physicians often neglect this part of their practice. In ancient times, physicians also tried to gradually eliminate magic-religious aspects in taking care of the patients. This review will propose a journey from Mesopotamia to ancient Egypt (and its medical papyrus). Very few sources are available concerning medicine in pre-Columbian cultures. However, it is well known that shamans had, besides their religious competences, a great pharmacopoeia. Because of these very few sources, this topic will not be added to this article. Little is known in Europa about chinese medicine before the Jesuit mission in China during the 17th and 18th centuries. Yet, chinese medicine grew in parallel with European's one. Some relevant elements of this medicine will hereafter be shown.

Pharmaceutical quality of generic isotretinoin products, compared with Roaccutane.

PubMed

Taylor, Peter W; Keenan, Michael H J

2006-03-01

Isotretinoin is the drug of choice for the management of severe recalcitrant nodular acne. Several generic products are available. However, their pharmaceutical quality, in particular particle size distribution, which may affect safety and efficacy is unknown. Hence, prescribing of some generic products may be problematic. To assess the pharmaceutical quality of 14 generic isotretinoin products compared with Roaccutane (F. Hoffmann-La Roche Ltd). Tests were performed according to Roche standard procedures, European and US pharmacopoeia specifications. Tests included isotretinoin content, identity and amount of impurities and degradation products, effect of accelerated shelf-life studies on stability, particle size distribution and composition of non-active ingredients. The 14 isotretinoin products differed by 30-fold in median particle size and showed variation in their non-active ingredients. The average isotretinoin content of Acnotin and Acne-Tretin fell outside the 95-105% Roche specifications. Following accelerated shelf-life tests, only four products retained isotretinoin content within Roche specifications, whilst Acne-Tretin (the only powder formulation) lost 72.5% isotretinoin content. Two generic products exceeded the +/- 2% specification (Ph. Eur.) and a further three exceeded the +/- 1% (USP) for tretinoin content, eight exceeded the 2.54% specification for total impurities and six contained >or= 5 unknown impurities. Isotretinoin-5.6-epoxide content exceeded the 1.04% specification in five generic products. Thirteen generic products failed to match Roaccutane in one or more tests and 11 failed in three or more tests. It cannot be assumed that all generic isotretinoin products are as therapeutically effective or safe as Roaccutane.

Comprehensive HPTLC Fingerprinting for Quality Control of an Herbal Drug - The Case of Angelica gigas Root.

PubMed

Frommenwiler, Débora Arruda; Kim, Jonghwan; Yook, Chang-Soo; Tran, Thi Thu Trang; Cañigueral, Salvador; Reich, Eike

2018-04-01

The quality of herbal drugs is usually controlled using several tests recommended in a monograph. HPTLC is the method of choice for identification in many pharmacopoeias. If combined with a suitable reference material for comparison, HPTLC can provide information beyond identification and thus may simplify quality control. This paper describes, as a proof of concept, how HPTLC can be applied to define specifications for an herbal reference material and to control the quality of an herbal drug according to these specifications. Based on multiple batches of cultivated Angelica gigas root, a specific HPTLC method for identification was optimized. This method can distinguish 27 related species. It also can detect the presence of mixtures of A. gigas with two other Angelica species traded as "Dang gui" and is suitable as well for quantitative assessment of samples in a test for minimum content of the sum of decursin and decursinol angelate. The new concept of "comprehensive HPTLC fingerprinting" is proposed: HPTLC fingerprints (images), which are used for identification, are converted into peak profiles and the intensities of selected zones are quantitatively compared to those of the corresponding zones of the reference material. Following a collaborative trial involving three laboratories in three countries, the method was applied to check the quality of further candidates for establishing an appropriate reference material. In conclusion, this case demonstrates that a single HPTLC analysis can provide information about identity, purity, and minimum content of markers of an herbal drug. Georg Thieme Verlag KG Stuttgart · New York.

Quality assessment of marketed chamomile tea products by a validated HPTLC method combined with multivariate analysis.

PubMed

Guzelmeric, Etil; Ristivojević, Petar; Vovk, Irena; Milojković-Opsenica, Dušanka; Yesilada, Erdem

2017-01-05

Chamomile tea composed of dried flower heads of Matricaria recutita L. (Asteraceae) is one of the most popular single ingredient herbal teas. Tea industries, spice shops or public bazaars are mostly supplied chamomile as a raw material via cultivation or through nature-picking. However, one of the drawbacks of nature-picking is adulteration. This could be either due to false authentication of the plant materials by ingenuous pickers or intentional/unintentional substitution with other flowers resembling to chamomile in appearance during harvesting. Therefore, quality control of raw chamomile materials before marketing should be carefully considered not only by quantification of apigenin 7-O-glucoside (active marker) but also by fingerprinting of chemical composition. This work presents both quantification of apigenin 7-O-glucoside and chemical fingerprinting of commercial chamomile tea products obtained from different food stores and spice shops by a validated HPTLC method. In addition, HPTLC profiles of investigated chamomile tea samples were compared with HPLC method stated in the European Pharmacopoeia and it was found that HPTLC method was superior to HPLC method in the field of adulteration confirmation. Therefore, fingerprint profiles performed on the silica gel 60 NH 2 F 254 s HPTLC plates combined with pattern recognition techniques of these marketed products were comparatively evaluated with wild and cultivar chamomile samples and also chamomile-like species from Asteraceae. Consequently, not chamomile tea bags but crude flowers sold on market were found to be adulterated with other plant materials. Copyright © 2016 Elsevier B.V. All rights reserved.

Fingerprint analysis of Radix Aconiti using ultra-performance liquid chromatography-electrospray ionization/ tandem mass spectrometry (UPLC-ESI/MS n) combined with stoichiometry.

PubMed

Zhu, Hongbin; Wang, Chunyan; Qi, Yao; Song, Fengrui; Liu, Zhiqiang; Liu, Shuying

2013-01-15

A fingerprinting approach was developed by means of UPLC-ESI/MS(n) (ultra-performance liquid chromatography-electrospray ionization/mass spectrometry) for the quality control of processed Radix Aconiti, a widely used toxic traditional herbal medicine. The present fingerprinting approach was based on the two processing methods recorded in Chinese Pharmacopoeia for the purpose of reducing the toxicity and ensuring the clinical therapeutic efficacy. Similarity evaluation, hierarchical cluster analysis and principal component analysis were performed to evaluate the similarity and variation of the samples. The results showed that the well processed, unqualified processed and the raw Radix Aconiti could be clustered reasonably corresponding to the contents of their constituents. The loading plot shows that the main chemical markers having the most influence on the discrimination amongst the qualified and unqualified samples were mainly some monoester diterpenoid aconitines and diester diterpenoid aconitines. Finally, the UPLC-UV and UPLC-ESI/MS(n) characteristic fingerprints were established according to the well processed and purchased qualified samples. At the same time, a complementary quantification method of six Aconitine-type alkaloids was developed using UPLC-UV and UPLC-ESI/MS. The average recovery of the monoester diterpenoid aconitines was 95.4-99.1% and the average recovery of the diester diterpenoid aconitines was 103-112%. The proposed combined quantification method by UPLC-UV and UPLC-ESI/MS allows the samples analyzed in a wide concentration range. Therefore, the established fingerprinting approach in combination with chemometric analysis provides a flexible and reliable method for quality assessment of toxic herbal medicine. Copyright © 2012 Elsevier B.V. All rights reserved.

Compounding pharmacy conundrum: "we cannot live without them but we cannot live with them" according to the present paradigm.

PubMed

Guharoy, Roy; Noviasky, John; Haydar, Ziad; Fakih, Mohamad G; Hartman, Christian

2013-04-01

Compounding pharmacies serve a critical role in modern health care to meet special patient care needs. Although the US Food and Drug Administration (FDA) has clearly delineated jurisdiction over drug companies and products manufactured under Good Manufacturing Practice (GMP) regulations to ensure quality, potency, and purity, compounding pharmacies are regulated by the State Boards and are not registered by the FDA. In recent years, some compounding pharmacies acted like a manufacturer, preparing large amounts of injectable drugs with interstate activities. Multiple outbreaks have been linked to compounding pharmacies, including a recent outbreak of fungal meningitis related to contaminated methylprednisolone, exposing > 14,000 patients in multiple states. This tragedy underscores the urgency of addressing safety related to compounding pharmacies. There is a call for action at the federal and state levels to set minimum production standards, impose new labeling conditions on compounded drugs, and require large-scale compounders be regulated by the FDA. "Industrial" compounding must come under FDA oversight, require those pharmacies to meet GMP standards, and ensure quality and safe products for patient use. Moreover, compliance with the Institute for Safe Medication Practices 2011 recommendations that any type of sterile compounding must be in compliance with the United States Pharmacopoeia chapter 797 guidelines will reduce the risk of patient harm from microbial contamination. Finally, other critical factors that require close attention include addressing injectable products compounded in hospitals and other outpatient health-care centers. The FDA and State Boards of Pharmacy must be adequately funded to exercise the oversight effectively.

Resolving Identification Issues of Saraca asoca from Its Adulterant and Commercial Samples Using Phytochemical Markers

PubMed Central

Hegde, Satisha; Hegde, Harsha Vasudev; Jalalpure, Sunil Satyappa; Peram, Malleswara Rao; Pai, Sandeep Ramachandra; Roy, Subarna

2017-01-01

Saraca asoca (Roxb.) De Wilde (Ashoka) is a highly valued endangered medicinal tree species from Western Ghats of India. Besides treating cardiac and circulatory problems, S. asoca provides immense relief in gynecological disorders. Higher price and demand, in contrast to the smaller population size of the plant, have motivated adulteration with other plants such as Polyalthia longifolia (Sonnerat) Thwaites. The fundamental concerns in quality control of S. asoca arise due to its part of medicinal value (Bark) and the chemical composition. Phytochemical fingerprinting with proper selection of analytical markers is a promising method in addressing quality control issues. In the present study, high-performance liquid chromatography of phenolic compounds (gallic acid, catechin, and epicatechin) coupled to multivariate analysis was used. Five samples each of S. asoca, P. longifolia from two localities alongside five commercial market samples showed evidence of adulteration. Subsequently, multivariate hierarchical cluster analysis and principal component analysis was established to discriminate the adulterants of S. asoca. The proposed method ascertains identification of S. asoca from its putative adulterant P. longifolia and commercial market samples. The data generated may also serve as baseline data to form a quality standard for pharmacopoeias. SUMMARY Simultaneous quantification of gallic acid, catechin, epicatechin from Saraca asoca by high-performance liquid chromatographyDetection of S. asoca from adulterant and commercial samplesUse of analytical method along with a statistical tool for addressing quality issues. Abbreviations used: HPLC: High Performance Liquid Chromatography; RP-HPLC: Reverse Phase High Performance Liquid Chromatography; CAT: Catechin; EPI: Epicatechin; GA: Gallic acid; PCA: Principal Component Analysis. PMID:28808391

Nanoscale Delivery Systems: Actual and Potential Applications in the Natural Products Industry.

PubMed

Simona, Antal Diana; Florina, Ardelean; Rodica, Chis Aimee; Evelyne, Ollivier; Maria-Corina, Serban

2017-01-01

Compounds and extracts derived from natural sources continue to stand in the spotlight of drug design owing to their versatile interaction with enzymes, receptors and metabolic pathways. Nanomedicine offers an operative tool for the efficient delivery of natural products, in terms of increased bioavailability, targeting, and controlled release while protecting active constituents against physico-chemical alterations. The interest of the scientific community in the field of nanosized delivery of natural compounds is demonstrated by the exponential growth of the publications in this field. Beyond the presentation of successful examples of nanoscale delivery systems containing natural products, the scope of this review is to point out the yet underexplored capacities of this field with relevance for the pharmaceutical and nutraceutical market. Departing from a short presentation of plant-derived natural products and strategies to obtain nanoformulations, the current work discusses nanoparticulate drug delivery systems targeting diseases of various organs and systems: skin, central nervous system, skeletal tissue, cardiovascular apparatus, and diabetes. While notable progress has been achieved in the preparation of nanomedicines containing selected dietary polyphenols, works dealing with crude extracts or standardized fractions are much less frequent. In fact, most of the plants with solidly documented therapeutic properties and registered in pharmacopoeias still wait to benefit from advances in the field of nanotechnology. At least for some of them, adequate nanoformulation shall contribute to their removal from the group of dietary supplements and pharmaceutical preparations with suboptimal bioavailability and efficacy. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

A new multivalent (DHPPi/L4R) canine combination vaccine prevents infection, shedding and clinical signs following experimental challenge with four Leptospira serovars.

PubMed

Wilson, Stephen; Stirling, Catrina; Thomas, Anne; King, Vickie; Plevová, Edita; Chromá, Ludmila; Siedek, Elisabeth; Illambas, Joanna; Salt, Jeremy; Sture, Gordon

2013-06-28

Although effective vaccines have been developed against the common Leptospira serovars, they are still reported in clinical cases, while others are increasingly prevalent. The results from four challenge studies following vaccination of dogs with a new combination vaccine (DHPPi/L4R) containing inactivated L. serovars, L. canicola, L. icterohaemorrhagiae, L. bratislava and L. grippotyphosa conducted to satisfy the requirements of the European Pharmacopoeia monograph (01/2008:0447), are reported. Six week old dogs received two vaccinations, three weeks apart, and were challenged 25 days later with different isolates of the L. serovars. Clinical observations were recorded, and blood, urine and tissue samples were collected for analysis. Following challenge, non-vaccinated dogs demonstrated various clinical signs, while no vaccinated dogs were affected; significant differences in mean clinical scores were observed. Measurable antibody titres to each Leptospira antigen were seen in vaccinated dogs 21 days following the first vaccination, with further increases in antibody titres observed following challenge with the respective Leptospira strain. Non-vaccinated dogs remained seronegative until challenge. Leptospira were re-isolated from the blood, urine, kidney and liver of all non-vaccinated dogs following challenge. In contrast no vaccinated dogs had Leptospira re-isolated from the same tissues. Significant differences were seen in number of days with positive isolation (blood and urine) and in number of dogs with positive samples (kidney and liver). In conclusion, vaccination of dogs with the new vaccine induces protective immunity 25 days after second vaccination with protection against infection, renal infection and clinical signs following challenge. Copyright © 2013 Elsevier Ltd. All rights reserved.