Analysis and suggestions on harvest period standards of plant medicinal materials in 2020 edition of Chinese Pharmacopoeia / 中国中药杂志

The improvement of the harvest period standards is critical in the quality control of Chinese medicinal materials. The present study statistically analyzed the harvest period standards of plant medicinal materials in the 2020 edition of Chinese Pharmacopoeia(Vol.Ⅰ) and put forward the existing problems and suggestions based on herbal records and modern research to provide references for the improvement of the standards. According to the statistical analysis, in 499 types of plant medicinal materials, harvest period standards are recorded under 486 types, accounting for 97.4%, and are lacking in the remaining. Only one medicinal material(Stellariae Radix) is recorded with the standard of the harvest year. The standards of the harvest season and phenological period are recorded under 233 types, accounting for 46.7%. For 237 types, only harvest season is specified, accounting for 47.5%, and for 15 types, only harvest phenological period is specified, accounting for 3.0%. Among 222 types mainly derived from cultivation and 51 types from wild resources and cultivation, only 11 types are recorded with harvest period of cultivated products. Only Stellariae Radix is recorded with the harvest period standards for the wild and cultivated products separately. The harvest period standards of plant medicinal materials with different medicinal parts have certain rules to follow. The main problems about the harvest period standards are discovered. Specifically, no harvest period standards are recorded under 13 types of plant medicinal materials. Almost all perennial cultivated medicinal materials are not recorded with harvest year standard. No phenological period standard is found under 250 types of plant medicinal materials. There is no clear distinction between the harvest period standards of cultivated and wild products. The evidence for harvest period standards of 26 types of plant medicinal materials that can be harvested all year round is insufficient. As a result, it is proposed to strengthen basic research in response to the above-mentioned problems and improve the harvest period standards as soon as possible to ensure the quality of Chinese medicinal materials.

Validation and applicability of an alternative method for dialysis water and dialysate quality analysis / Validação e aplicabilidade de um método alternativo para análise da qualidade da água e do dialisato em diálise

ABSTRACT Introduction: In hemodialysis, patients are exposed to a large volume of water, which may lead to fatal risks if not meeting quality standards. This study aimed to validate an alternative method for monitoring microbiological quality of treated water and assess its applicability in dialysis and dialysate analysis, to allow corrective actions in real-time. Methods: Validation and applicability were analyzed by conventional and alternative methods. For validation, E. coli standard endotoxin was diluted with apyrogenic water in five concentrations. For the applicability analysis, treated water for dialysis was collected from different points in the treatment system (reverse osmosis, drainage canalization at the storage tank bottom, reuse, and loop), and dialysate was collected from four machines located in different rooms in the hemodialysis sector. Results: The validation results were in accordance with the Brazilian Pharmacopoeia acceptance criteria, except for the last two concentrations analyzed. In addition, the ruggedness criterion performed under the US Pharmacopoeia was in agreement with the results. Discussion: A limiting factor in the applicability analysis was the absence of the endotoxin maximum permitted level in dialysate by the Brazilian legislation. When comparing the analysis time, the alternative method was more time-consuming than the conventional one. This suggests that the alternative method is effective in the case of few analyses, that is, real-time analyses, favoring corrective actions promptly. On the other hand, it does not support the implementation of the alternative method in a laboratory routine due to the high demand for analyses.

RESUMO Introdução: Na hemodiálise, os pacientes são expostos a um grande volume de água, o que pode levar a riscos fatais se não cumprir com padrões de qualidade. Este estudo teve como objetivo validar um método alternativo para monitorar a qualidade microbiológica da água tratada e avaliar sua aplicabilidade em análises de diálise e dialisato, para permitir ações corretivas em tempo real. Métodos: A validação e aplicabilidade foram analisadas por métodos convencionais e alternativos. Para validação, a endotoxina padrão de E. coli foi diluída com água apirogênica em cinco concentrações. Para a análise de aplicabilidade, a água tratada para diálise foi coletada em diferentes pontos do sistema de tratamento (osmose reversa, canalização de drenagem no fundo do tanque de armazenamento, reutilização e circuito) e o dialisato foi coletado em quatro máquinas localizadas em diferentes salas do setor de hemodiálise. Resultados: Os resultados da validação obedeceram aos critérios de aceitação da Farmacopeia Brasileira, com exceção das duas últimas concentrações analisadas. Além disso, o critério de robustez realizado sob a Farmacopeia dos EUA estava de acordo com os resultados. Discussão: Um fator limitante na análise de aplicabilidade foi a ausência do nível máximo permitido de endotoxina no dialisato pela legislação brasileira. Ao comparar o tempo de análise, o método alternativo consumiu mais tempo que o convencional. Isso sugere que o método alternativo é eficaz no caso de poucas análises, ou seja, análises em tempo real, favorecendo ações corretivas imediatamente. Por outro lado, não suporta a implementação do método alternativo em uma rotina de laboratório devido à alta demanda por análises.

Los anfibios en la medicina popular española, la farmacopea de Plinio y el Dioscórides / Amphibians in Spanish popular medicine and the pharmacopoeia of Pliny and Dioscorides

Se presenta una lista de remedios médicos basados en el uso de anfibios en la medicina popular española y en el Mundo Clásico. Se ha llevado a cabo una revisión de la bibliografía relativa a estudios de folklore, trabajos etnográficos e investigaciones en antropología social o médica. Se documenta un total de 113 remedios y el uso de nueve especies de anfibios, dos pertenecientes a la familia de los caudados (urodelos) y siete anuros. La mayoría de los remedios se basa en la "preconcepción" popular sobre la influencia de los mismos y la sanación mediante la transmisión del mal a un ser vivo. Se destaca el uso tradicional de algunas especies amenazadas, dato a tener en cuenta a la hora de tomar decisiones en el campo de la biología de la conservación y la educación ambiental.

This article presents a list of medical remedies based on the use of amphibians in Spanish popular medicine and in the classical world. It provides an overview of bibliography relative to folklore studies, ethnographic work and research on social or medical anthropology. It documents a total of 113 remedies and the use of nine species of amphibians, two from the family of caudates (urodeles) and seven anurans. Most of these remedies are based on the popular "preconception" about the influence of amphibians and healing by transmitting an illness to a living creature. The traditional use of certain threatened species is emphasized, an issue to bear in mind in decision-making in the field of conservation biology and environmental education.

Estudo colaborativo nacional para o estabelecimento do material de referência de trabalho da vacina contra sarampo, caxumba e rubéola: evolução para a autossuficência na produção nacional da vacina tríplice viral / National collaborative study for establishing the working reference material of the vaccine against measles/mumps and rubella: evolution to the self-sufficiency in the national production of triple viral vaccine

A monografia farmacopeica da vacina tríplice viral (sarampo/caxumba/rubéola) exige a validação de desempenho do ensaio de potência utilizando-se apropriado material de referência (MR). Com o intuito de estabelecer o primeiro MR de trabalho (MRT) nacional para a vacina tríplice viral, foi realizado o estudo colaborativo nacional com a participação de duas únicas instituições que executam o ensaio de potência desta vacina, o Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos, produtor nacional) e o Instituto Nacional de Controle de Qualidade em Saúde.O material candidato (cMRTBio), preparado pelo produtor, foi avaliado pelos laboratórios participantes utilizando-se as respectivas metodologias in-house de determinação de potência. O cMRTBio foi considerado apropriado como MR in-house por estar em concordância com as especificações recomendadas nas normativas de compêndios, a saber: variações intra- (< 5 %), inter-ensaios (< 10 %) e entre laboratórios (< 10 %) abaixo dos limites aceitáveis; e potência estimada (log10 CCID50/DH) em 3,72 para sarampo, 4,80 para caxumba e 3,70 para rubéola. Este trabalho reflete o compromisso do único produtor nacional da vacina tríplice viral com a saúde pública, descrevendo-se a expansão da tecnologia, o cumprimento às diretrizes internacionais, o cuidado com o controle da qualidade e culminância para a autossuficiência nacional na produção de vacinas.

The pharmacopoeia monograph for the measles/mumps and rubella (MMR) triple vaccine demands to perform the validation of the potency assay by using the suitable reference material (MR). Aiming at establishing the firstwork MR (MRT) for the MMR triple vaccine, a national collaborative study was performed with the participation of the two unique national institutions working on the vaccine potency evaluation test, the Imunobiological Technology Institute (Bio-Manguinhos, national manufacturer) and the National Institute for Quality Control in Health. The candidate product (cMRTBio) prepared by the manufacturer was evaluated by the participant laboratories by employing the respective in-house methodologies for determining the potency. The cMRTBio was considered suitable as in-house MR, according to the specifications based on the normative compendia, being the intra-assay (< 5 %), inter-assay(< 10 %) and between laboratories variations (< 10 %) below the acceptable limits, and the estimate potency(log10 CCID50/DH) in 3.72 for measles, 4.80 for mumps and 3.70 for rubella. This study reflects the commitment of the unique national MMR vaccine producer to the public health, describing the expansion of technology,the compliance with international guidelines and the careful quality control, leading to the national self-sufficiency in the vaccine production.

Guidelines and strategy of the International Conference of Harmonization (ICH) and its member states to overcome existing impurity control problems for antibiotics in China / 中国天然药物

In the present report, we review the technical guidelines and principles on impurity research and control for antibiotics established by various agencies, including the International Conference of Harmonization (ICH), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the China Food and Drug Administration (CFDA). Progresses with the US Pharmacopoeia (USP), the European Pharmacopoeia (EP) and the Chinese Pharmacopoeia (ChP) to control impurities in antibiotics are also presented. Next, our discussion is focused on analyzing the CFDA's requirements on impurity research and control for antibiotics, and the implementation of ICH, FDA and other technical guidelines for generic drugs impurity control in China. Existing problems are further reviewed, in order to improve the overall process for the control of antibiotic purity.

Discussion on efficacy of traditional Chinese medicine "Zi-hua Qianhu" in Chinese Pharmacopoeia (2010 Edition) / 中国中药杂志

To clarify the origin and application development of the traditional Chinese medicine " Zi-hua Qianhu" and " Qianhu", the medicinal literatures of past dynasties and modern researches were analysed. The plant Angelica decursivum was used as a substitute for traditional Chinese medicine "Angelica sinensis Radix" for a long historical period, it is used incorrectly for traditional Chinese medicine "Qianhu" due to origin research in modern times. The plant origin of "Qianhu" is Peucedanum praeruptorum. There are significant differences in clinical applications and chemical composition of the two drugs. The same efficacy description of "Zi-huaQianhu" and "Qianhu" could not stop "Zi-huaQianhu" used as "Qianhu" in practical application. Therefore, we need to further research for the plant A. decursivum, delimit its medicinal attribution.

Reliability of sulfur dioxide determination method documented in Chinese pharmacopoeia for evaluating Paeoniae Radix Alba / 中国中药杂志

The content of SO2 in Paeoniae Radix Alba (RPA) was determined by the method documented in Chinese Pharmacopoeia (CP) 2010 edition to validate the repeatability of the method for evaluating RPA, and the contents of paeoniflorin sulfonate in both the residual material and distilled solution of RPA were determined by HPLC to study the transformation of paeoniflorin sulfonate to SO2 by HCl. It was found that the repeatability of the method in CP for evaluating RPA is unacceptable, and paeoniflorin sulfonate was detectable in both the residual material and distilled solution of RPA even at "the end point" of SO2 determination, merely about 50% of paeoniflorin sulfonate was transformed to SO2 by HCl, indicating that the current SO2 determination method in CP is not able to accurately quantify SO2 in RPA. It is recommended that more special method for determining SO2 content in RPA should be developed regarding the chemical characteristics of sulfur-fumigated RPA.

Proposal for standardized authors' name citing in original plant Latin name listed in the Chinese Pharmacopoeia / 中国中药杂志

In 2010, Chinese Pharmacopoeia Committee officially enacted Chinese Pharmacopoeia (2010 edition). The Volume 1 of the pharmacopoeia is comprised of the medicinal materials and the decoction pieces, the essential oils and extracts of medicinal plants, prescription preparations and single preparation, etc., which not only provides Latin names of Chinese medicinal materials, also provided Latin names of the original medicinal plants to effectively control the quality of Chinese medicinal materials. In order to raise awareness of correctly citation and maintain the authority and standardization of Chinese Pharmacopoeia, this paper briefly describes abbreviations rules of authors' name of plant scientific name according to the 'International Code of Botanical Nomenclature, ICBN'. Through comparing with the rules of ICBN, 'Flora of China' (Chinese edition and English edition), and authority international plant catalogue databases, the authors made statistic and analysis of the non-standard cited authors' names phenomena of the original plant scientific names recorded in the Chinese Pharmacopoeia (2010 edition), and the revision suggestions are proposed.

Application of reference extracts in quality control of traditional Chinese medicines / 中国中药杂志

The essay summarizes the current development and application of reference extracts from traditional Chinese medicines (TCMs). Through the analysis on problems in the quality control of TCMs, and on the basis of the current application of reference extracts in Chinese Pharmacopoeia, it investigates reference extracts from TCMs and forecasts the study orientation on TCM quality standards. Despite a wide prospect for the application of reference extracts in quality control of TCMs, there remain problems in varieties and standards. It is of great significance for the TCM understanding to further promote the development of reference extracts.

Circulação e produção de saberes e práticas científicas na América meridional no século XVIII: uma análise do manuscrito Materia medica misionera de Pedro Montenegro (1710) / Circulation and production of knowledge and scientific practices in southern America in the eighteenth century: an analysis of Materia medica misionera, a manuscript by Pedro Montenegro (1710)

Analisa uma versão manuscrita de 1790, do livro escrito originalmente em 1710 pelo jesuíta Pedro Montenegro, Materia medica misionera. Além da persistência de saberes mágico-religiosos e dos exóticos ingredientes para as receitas, encontram-se na obra a inconfundível presença das concepções hipocráticas e galênicas e o crescente empirismo que marca as transformações científicas do século XVIII. Sua análise permite, ainda, a reflexão sobre difusão, circulação e produção de conhecimentos farmacológicos e médicos na primeira metade do século XVIII, no âmbito das reduções e dos colégios instalados na região Província Jesuítica do Paraguai, na América meridional.

The article analyzes a 1790 manuscript copy of Materia medica misionera, a book written in 1710 by a Jesuit, Pedro Montenegro. Alongside knowledge of a magical or religious nature, and exotic ingredients for the recipes, this work also contains the unmistakable presence of Hippocratic and Galenic conceptions and a growing empiricism, characteristic of the scientific transformations seen in the eighteenth century. The analysis of this work also prompts reflections about the diffusion, circulation and production of pharmacological and medical knowledge in the first half of the eighteenth century within the missions and colleges installed in the area that was the Jesuit Province of Paraguay, southern America.

Medicamentos potencialmente inapropriados para idosos / Potentially inappropriate medications in elderly

OBJETIVO: Comparar PRISCUS com Beers-Fick na detecção de medicamentos potencialmente inapropriados (MPI) para idosos à primeira consulta ambulatorial geriátrica. MÉTODOS: Análise retrospectiva de prontuários por PRISCUS e Beers-Fick adaptados à farmacopeia brasileira, comparando-se o encontro de MPI à primeira consulta ambulatorial geriátrica pelos dois critérios. RESULTADOS: Idade média de 77,4 ± 7,7 anos, 64 mulheres e 36 homens, consumo médio de 3,9 ± 2,5 fármacos. Este estudo encontrou significância estatística no número de mulheres em uso de benzodiazepínicos e de homens quanto a salicilatos. Média de 0,5 ± 0,7 MPI/paciente por Beers-Fick e 0,7 ± 0,8 MPI/paciente pela PRISCUS. Medicamentos de Beers-Fick mais referidos: benzodiazepínicos, metildopa e derivados do ergot. Medicamentos de PRISCUS mais referidos: benzodiazepínicos, anti-hipertensivos e antidepressivos tricíclicos. Não houve significância estatística comparando-se o número de idosos com MPI pelos dois critérios. Constatou-se significância estatística (PRISCUS versus Beers-Fick) no consumo de benzodiazepínicos de longa ação e laxantes. Ambos não incluem fármacos como vitaminas, fitoterápicos e colírios, relatados por percentual da casuística. CONCLUSÃO: Os dois critérios são úteis para a prevenção de MPI em idosos, sendo PRISCUS mais atualizada e abrangente, mas não são completos para a realidade ambulatorial brasileira.

OBJECTIVE: To compare PRISCUS with Beers-Fick in detecting potentially inappropriate medication (PIMs) in elderly at their first outpatient geriatric visit. METHODS: Retrospective medical record analysis by PRISCUS and Beers-Fick adapted to Brazilian pharmacopoeia, comparing the finding of PIMs at the first outpatient geriatric visit by both criteria. RESULTS: Cases had mean age of 77.4 ± 7.7 years (64 females and 36 males), and mean consumption of 3.9 ± 2.5 drugs. This study found statistical significance for the numbers of women using benzodiazepines and men using salicylates. The mean was 0.5 ± 0.7 PIMs/patient by Beers-Fick criteria and 0.7 ± 0.8 PIMs/patient by PRISCUS. Medications most often reported by Beers-Fick criteria were: benzodiazepines, methyldopa and ergot-derived drugs. Medications most often reported by PRISCUS criteria were: benzodiazepines, antihypertensive drugs, and tricyclic antidepressants. No statistical significance was found when the number of elderly patients with PIMs was compared between both criteria. Statistical significance was found (PRISCUS versus Beers-Fick) for the consumption of long acting benzodiazepines and laxatives. Both criteria do not include drugs such as vitamins, herbal medications, and eye drops, reported by a percentage of cases. CONCLUSION: Both criteria are useful to prevent PIMs in the elderly, with PRISCUS being more updated and comprehensive, but they are not complete for the Brazilian outpatient reality.

Essencialidade e assistência farmacêutica: considerações sobre o acesso a medicamentos mediante ações judiciais no Brasil / Essential drugs and pharmaceutical care: reflection on the access to drugs through lawsuits in Brazil

A garantia do direito à assistência farmacêutica no ordenamento jurídico brasileiro a partir da Constituição de 1988 deu vazão a um aumento das demandas judiciais para efetivação desse direito. Esse fenômeno vem sendo chamado de judicialização da assistência farmacêutica. Estudos sobre o tema têm revelado tanto deficiências no acesso dos usuários do Sistema Único de Saúde aos medicamentos das listas oficiais de assistência farmacêutica como dificuldades do sistema de justiça e do próprio procedimento judicial para lidar com a temática. Este artigo discute essas questões considerando o arcabouço conceitual que informa a política de medicamentos e a política de assistência farmacêutica brasileiras, sobretudo os conceitos de medicamentos essenciais e de alocação de recursos escassos.

The guarantee of pharmaceutical care as a legal right established by the Brazilian federal constitution of 1988 led to an increase in lawsuits to put that right into practice. This phenomenon has been dubbed the judicialization of pharmaceutical care. Studies on this topic have revealed, on the one hand, deficiencies in the access of Unified Health Care (SUS) users to drugs included in Ministry of Health pharmaceutical care lists, and, on the other hand, limitations of the legal system to deal with the situation. The present article addresses these issues in the context of the conceptual framework that supports the Brazilian drug policy and pharmaceutical care policy, especially the notions of essential drugs and allocation of scarce resources.

Pyrrolizidine alkaloids-containing Chinese medicines in the Chinese pharmacopoeia and related safety concerns / 药学学报

It has been well-known that many medicinal plants used in traditional Chinese medicine contain hepatotoxic pyrrolizidine alkaloids (HPAs), and some even have been recorded in many editions of the Chinese Pharmacopoeia (ChP). In order to clarify the current status of these PAs-containing Chinese materia medica and proprietary Chinese formulae, the ChP 2010, the newest version, and the related safety issues were thoroughly investigated and analyzed on the current advances in research. Total nine crude drugs (not including the processed slices) were found to contain HPAs, which may be present in tens of Chinese proprietary drugs prepared with these crude drugs. Because of the lack of the alkaloid limitation in most monographs, their potential threats to human health may be underestimated. For this reason, attention should be drawn to the importance of the issue. The key point is to conduct the basic studies immediately on these PA-containing herbal plants or products, whose possible hazards need to be carefully assessed. Further efforts should also be made to elevate the criteria for quality control and ensure the drugs' safety in clinic for human health.

Reseach on changes of varieties of ancient and modern Chinese herbs / 中国中药杂志

Because of many reasons, big changes occur in the varieties of ancient and modern Chinese herbs. Besides a significant increase in the number, there are many other features, such as significant differences among mainstream varieties, partly resolving the chaotic situation of uncoincidence of different herb names, increasing proportion of plant herbs, and herbal multi-polarization, etc.

[Comparative study for the analytical performance of potassium clavulanate assay methods in the United States, British, and Japanese pharmacopoeias]

A comparative study was conducted to verify the performance parameters of the compendial methods utilized for the assay of potassium clavulanate in the United States [USP], British [BP], and Japanese [JP] pharmacopoeias. The aim of the study was to find out the degree of accordance between the methods in terms of accuracy, precision, and linearity in the range 50-150% of the sample solution concentration provided in the monograph. The stability-indicating power of each method was verified in order to determine their suitability for use in stability studies in addition to the approximate cost of each method

Origin of some medicinal materials from animals in Chinese pharmacopoeia 2010 edition 1 / 中国中药杂志

<p><b>OBJECTIVE</b>Enable to make the origin of some medicinal materials from animals-national-standard Chinese Pharmacopoeia subdivision 1 more complete, to protect and utilize the wild medicinal animal resources, and to improve the quality of traditional Chinese medicines materials materials.</p><p><b>METHOD</b>In accordance with author's over two decades of studies in medicinal material from animals and medicinal animals, combining with modern animal classification findings, comparing the contents of medicinal material origin from animals in Pharmacopoeia new edition.</p><p><b>RESULT</b>Give amendment advices on gallnut, concha arcae, zaocys dhumnade, gadfly, and so forth the fifteen kinds of medicinal material origin from animals' taxonomic status, Chinese names and their Latin scientific names.</p><p><b>CONCLUSION</b>The origin of accuracy of medicinal material origin from animals is critical to ensure the quality of traditional Chinese medicine. As a national-level traditional Chinese medicine code of laws, it should advance with times, actively absorb and adopt the latest achievements in scientific research. Meanwhile, modern molecular biology techniques should be used to develop the research of conventional medicinal material origin from animals in a planned and systematic manner.</p>

Discussion and analysis on determination term of medicinal materials and decotion pieces in Chinese pharmacopoeia (2010 edition, volume I ) / 中国中药杂志

Term of medicinal materials and decoction pieces in Chinese pharmacopoeia (2010 edition, Volume I) have been analyzed and d. 374 among 593 medicinal materials in Chinese pharmacopoeia has determination term including 461 determination indexes, 323 compositions and 9 s; 417 kinds of decoction pieces among 822 in Chinese pharmacopoeia has determination term. Eight kinds of decoction pieces with limit requirements were found with no determination term. Content and style of term of and cutting crude drugs were inconsistent. Suggestions related have also been given for pharmacopoeia revision.