Classification Changes of Origin Plants of Traditional Chinese Medicine Based on APG Ⅳ System / 中国实验方剂学杂志

ObjectiveThe angiosperm phylogeny group （APG） Ⅳ system is currently the latest angiosperm classification system. The APG system based on DNA sequence can more naturally reflect the phylogeny and evolution of plants， which has been widely recognized and applied in scientific research and teaching of plants in other countries. Through the comparison between the changes in the APG Ⅳ system and the traditional plant classification system， the changes in the taxonomic status of the original plants of traditional Chinese medicine （TCM） in the 2020 edition of Chinese Pharmacopoeia were reviewed. MethodBy referring to the literature in China and abroad， the changes in the taxonomic status of the original plants of TCM recorded in Chinese Pharmacopoeia were sorted out according to the basic groups of angiosperms in the APG Ⅳ system， including the basal group of ANA， the magnoliid and chloranthales， the basal groups of monocots and eudicots， the superrosids， and the superasterids. ResultThere are about 72 species of TCM in the 2020 edition of Chinese Pharmacopoeia. A total of 76 species of the original plants change in family grade according to the APG Ⅳ system. There are 22 species of TCM belonging to the dicotyledon class， involving 26 species of the original plants. It should be placed in front of the differentiation of monocotyledons and eudicotyledons according to the APG Ⅳ system. ConclusionThis paper largely clarifies the change in the taxonomic status of the original plants of TCM in Chinese Pharmacopoeia according to the APG Ⅳ system， which is helpful to the reviewing literature in China and abroad for the original plants of TCM and facilitates the international academic exchange for TCM. It provides a reference for the revision of textbooks such as Botany and Medicinal Botany in Chinese colleges and universities and will lay the foundation for updating the content of Chinese Pharmacopoeia in the future.

Historical Evolution and Modern Research Progress of Processing of Notoginseng Radix et Rhizoma / 中国实验方剂学杂志

By reviewing the relevant literature of ancient herbal works and modern codices， this paper sorted out the historical evolution and developmental venation of processing of Notoginseng Radix et Rhizoma. On this basis， the modern research of processed products of Notoginseng Radix et Rhizoma was used as the breakthrough point to analyze the literature in terms of processing technology， chemical composition changes and changes in pharmacological effects before and after processing. According to the research status of processing of Notoginseng Radix et Rhizoma， some existing problems were analyzed in this paper， such as not many ancient processing methods used in modern time， lack of standardized research on processing technology. And saponins， polysaccharides， amino acids， flavonoids and other chemical components in Notoginseng Radix et Rhizoma may change to different degrees before and after processing， which was the main reason for the difference of efficacy before and after processing. However， the current research on the pharmacological effects of Notoginseng Radix et Rhizoma mainly focuses on raw products， resulting in a lack of in-depth research on the transformation mechanism of Notoginseng Radix et Rhizoma in processing difference， and the scientific connotation of "Shengxiao Shubu" has not been clearly elaborated， which is not conducive to the standardized clinical use of drugs. Therefore， it is necessary to further analyze the material basis of Notoginseng Radix et Rhizoma and its processed products， and to explore the change rule of chemical components before and after processing and its correlation with pharmacodynamic activity， so as to clarify the processing mechanism for providing scientific basis for its standardized processing， quality control and clinical rational use.

Discussion on Current National Standards for Traditional Chinese Medicine Dispensing Granules / 中国实验方剂学杂志

Strengthening the standard formulation and quality management of traditional Chinese medicine（TCM） dispensing granules is an important part of the strategic planning for the development of TCM in China. In order to examine the clinical application and overall quality control of the existing national standards for TCM dispensing granules， this study classified and summarized the varieties in the existing standards， analyzed their clinical applicability， and discussed the characteristics of the test methods for identification， content determination and specific chromatogram/fingerprint. It was found that the coverage of the existing standards was inadequate in terms of quantity， and it was even weaker in the aspects of therapeutic efficacy， herb family， processing method and preparation method of TCM dispensing granules. It was concluded that the characteristics of national standards in test methods were summarized as follows：guided by clinical application， based on the reference system， taking specific chromatogram as a breakthrough， so as to improve the overall quality control of TCM dispensing granules. It is suggested that the coverage of national standards should be subsequently expanded to meet the needs of market development. In order to enhance clinical applicability， the content of national quality standards should be increased， including increasing variety diversity to meet the needs of clinical application， raising the standard requirements to improve the clinical medication experience， and strengthening effectiveness research to highlight clinical efficacy. At the same time， the accessibility of regulatory inspection is enhanced， the rules for the management of varieties without national standards are promulgated to lay the foundation for the healthy and orderly development of TCM dispening granule industry.

Characteristics of Menstruation-regulating Chinese Patent Medicines in 2020 Edition of Chinese Pharmacopoeia / 中国实验方剂学杂志

ObjectiveTo analyze the functions， formulae， dosage forms， and methods of administration of the menstruation-regulating Chinese patent medicines included in the 2020 edition of the Chinese Pharmacopoeia， so as to provide reference for rational clinical use. MethodThe relevant Chinese patent medicines were recorded one by one， and the efficacy， dosage forms， methods of administration， and contraindications were counted， classified， and summarized. Further， we analyzed the Chinese medicines used in these Chinese patent medicines， identified the high-frequency Chinese medicines for menstrual regulation， and analyzed their natures， tastes， meridian tropism， and functions， aiming to guide the clinical use. ResultA total of 142 Chinese patient medicines for menstrual disorders were included in this study. They were classified into 12 categories according to their efficacy， mainly for regulating menstruation and blood， tonifying， activating blood， and eliminating mass. The representative Chinese patent medicines were Bazhen Yimu pills， Shaofu Zhuyu pills， Lyujiao Buxue granules， and Guizhi Fuling pills， which are in line with the principles of moving Qi and blood and regulating liver and spleen. Menstruation-regulating Chinese patents medicines are mostly in pills and capsules and are mainly taken with yellow wine or ginger decoction. Pregnancy was the contraindication with the highest frequency， followed by menstruation and dietary precautions. The high-frequency Chinese medicines mainly had the functions of tonifying， activating blood， resolving stasis， and clearing heat， with the top three being Angelicae Sinensis Radix， Paeoniae Radix Alba， and Chuanxiong Rhizoma. These medicines mainly had warm nature， sweet， bitter， and pungent tastes， and tropism to liver and spleen meridians. ConclusionThe treatment of menstrual disorders should focus on nourishing and activating blood， regulating Qi， tonifying kidney， supporting spleen， nourishing liver， and harmonizing stomach. The appropriate dosage form should be selected according to the patient's specific conditions. The medicinal guide and the method of administration should be selected on the basis of syndrome differentiation with attention to the contraindications. In summary， the Chinese patient medicines for menstrual regulation should be chosen based on the patient’s syndrome under guidance of the theory of traditional Chinese medicine.

Reporting on antibiotic use patterns using the WHO Access, Watch, Reserve classification in the Caribbean / Presentación de informes sobre los patrones de consumo de antibióticos mediante la clasificación de acceso, control y reserva (AWaRe) de la OMS en el Caribe / Relatório sobre padrões de uso de antibióticos no Caribe usando a classificação Acesso, Vigilância e Reserva da OMS

ABSTRACT Objective. To assess antibiotic use in three hospitals in three Caribbean countries based on data from 2013 and 2018 using the World Health Organization Essential Medicines List "Access, Watch, Reserve" (AWaRe) classification. Methods. A retrospective observational study, which analyzed the World Health Organization Point Prevalence Survey data from three hospitals in three Caribbean countries, to examine proportional AWaRe group antibiotic use for the top ten inpatient indications. The Access-to-Watch ratio was calculated, and the top three antibiotics prescribed in each hospital were determined. Results. The final data set included 376 prescriptions for the top ten indications in 766 inpatients. The hospital antibiotic use point prevalence for Hospital 1 was 35.6%, Hospital 2 was 48.6%, and Hospital 3 was 47.1%. The Access-to-Watch ratio for the top ten indications was 2.45, 1.36, and 1.72 in the three hospitals. Access group prevalence was 71.0% in Hospital 1, 57.6% in Hospital 2, and 63.2% in Hospital 3. There were no Reserve antibiotics prescribed in any of the institutions. The most common indication for Watch prescription was skin and soft tissue infections in Hospital 1 and pneumonia in Hospital 2 and 3. Conclusions. This study draws urgent attention to evidence of a high proportion of Watch antibiotic prescribing and lack of Reserve group antibiotics in three Caribbean countries. This research provides data that may inform national formulary and antimicrobial stewardship policy-making across the settings analyzed and the wider region.

RESUMEN Objetivo. Evaluar el consumo de antibióticos en tres hospitales de tres países del Caribe según datos del período 2013-2018 mediante la clasificación de acceso, control y reserva (AWaRe, por su sigla en inglés) de la lista de medicamentos esenciales de la Organización Mundial de la Salud. Métodos. Se realizó un estudio observacional retrospectivo, que analizó los datos de la encuesta de prevalencia puntual de la Organización Mundial de la Salud de tres hospitales en tres países del Caribe, a fin de evaluar el consumo proporcional de antibióticos por grupo de la clasificación AWaRe para las diez principales indicaciones en pacientes hospitalizados. Se calculó la relación entre los grupos de acceso y de control y se determinó cuáles eran los tres principales antibióticos prescritos en cada hospital. Resultados. El conjunto final de datos incluyó 376 recetas para las diez indicaciones principales en 766 pacientes hospitalizados. La prevalencia puntual del consumo de antibióticos en el hospital 1 fue 35,6%, en el hospital 2 fue 48,6% y en el hospital 3 fue 47,1%. La relación entre los grupos de acceso y de control correspondientes a las diez principales indicaciones fue 2,45, 1,36 y 1,72 en los tres hospitales. La prevalencia del grupo de acceso fue 71,0% en el hospital 1, 57,6% en el hospital 2 y 63,2% en el hospital 3. No se prescribieron antibióticos del grupo de reserva en ninguna de las instituciones. La indicación más común para la prescripción de antibióticos en el grupo de control fue infecciones en la piel y los tejidos blandos en el hospital 1 y neumonía en los hospitales 2 y 3. Conclusiones. Este estudio busca llamar la atención urgentemente sobre la evidencia de una alta proporción de prescripción de antibióticos del grupo de control y la carencia de antibióticos del grupo de reserva en tres países del Caribe. Esta investigación proporciona datos que pueden fundamentar el formulario nacional y la elaboración de políticas para la optimización del uso de antimicrobianos en los entornos analizados y en la región en general.

RESUMO Objetivo. Avaliar o uso de antibióticos em três hospitais de três países do Caribe, com base em dados de 2013 e 2018, usando a classificação "Acesso, Vigilância e Reserva" (AWaRe) da Lista de Medicamentos Essenciais da Organização Mundial da Saúde. Métodos. Estudo observacional retrospectivo com análise de dados do Estudo de Prevalência Pontual da Organização Mundial da Saúde, coletados em três hospitais de três países do Caribe para examinar o uso proporcional de antibióticos dos grupos AWaRe para as dez indicações mais frequentes em pacientes internados. A razão entre os grupos Acesso e Vigilância foi calculada e determinou-se quais eram os três antibióticos mais prescritos em cada hospital. Resultados. O conjunto final de dados incluiu 376 medicamentos prescritos para as dez indicações mais frequentes em 766 pacientes internados. A prevalência pontual de uso de antibióticos foi de 35,6% no hospital 1, 48,6% no hospital 2 e 47,1% no hospital 3. A razão entre Acesso e Vigilância nas dez indicações mais frequentes foi 2,45, 1,36, e 1,72 nos três hospitais. A prevalência do grupo Acesso foi de 71,0% no hospital 1, 57,6% no hospital 2 e 63,2% no hospital 3. Nenhum antibiótico da categoria Reserva foi prescrito em nenhuma das instituições. A indicação mais comum dos medicamentos prescritos no grupo Vigilância foram infecções de pele e tecidos moles no hospital 1 e pneumonia nos hospitais 2 e 3. Conclusões. Este estudo chama urgentemente a atenção para evidências de uma grande proporção de antibióticos prescritos no grupo Vigilância e a carência de antibióticos do grupo Reserva em três países do Caribe. Esta pesquisa fornece dados que podem guiar a criação de políticas para o formulário terapêutico nacional e o uso racional de antimicrobianos nos cenários analisados e na região como um todo.

Use of biorelevant dissolution media in dissolution tests as a predictive method of oral bioavailability

Abstract Dissolution is a key step in the uptake of oral drugs. In order to compare the behaviour of the dissolution of two formulations, the dissolution profile test was used. This assay must be discriminative and should mimic in vivo conditions. Many dissolution media described in pharmacopoeias are not predictive of bioavailability. Due to this, biorelevant media are used as an alternative to solve this problem. The objective of this work is to evaluate the relevance of biorelevant dissolution media to predict in vivo drug dissolution. For this, a bibliographic search was carried out in scientific databases. The search was first performed for articles verifying the physicochemical properties of human gastrointestinal fluids. Subsequently, a comparison was made between the properties of gastrointestinal fluids and those of biorelevant and pharmacopoeial media. Finally, the results of bioequivalence studies and dissolution profile tests in biorelevant media described in the literature were compared. The results revealed that there are a few publications that have analysed some physicochemical properties of gastrointestinal fluids. In addition, high variability was observed for some properties. Regarding the comparison of these properties with pharmacopoeial media and biorelevant media, the analysis showed that the biorelevant media are more similar to gastrointestinal fluids than the pharmacopoeial media. Finally, the in vitro dissolution profile results were similar to the results obtained in vivo. Thus, biorelevant media may be useful for analysing dissolution profiles.

Mutual Information Entropy Analysis of Compatibility of Traditional Chinese Patent Medicines Against Liver Diseases in Chinese Pharmacopoeia（2020 Edition） / 中国实验方剂学杂志

ObjectiveTo investigate the compatibility rule of traditional Chinese patent medicines （TCPMs） against liver diseases through network analysis. MethodWith “liver” as the search term， TCPMs against liver diseases were retrieved from volume Ⅰ of Chinese Pharmacopoeia （2020 edition）， and the basic information of them was collected. TCPMs with same Chinese medicinal materials （CMMs）， usage， and indications， but different dosage forms， were unified as one formula. Mutual information entropy （MIE） of CMM couples was calculated to quantify the relationship between them， and the top 25% CMM pairs in MIE were used to construct the compatibility network， with CMM as node and the relationship between CMM pairs as the edge. Key CMM and frequently used CMM combinations were identified based on node centrality and cluster analysis， respectively. The indications of TCPMs related to the CMMs in clusters were recorded. Cytoscape 3.6.1 was employed for visualization and topology analysis of the compatibility network. ResultA total of 179 TCPMs， involving 428 CMMs， were retrieved. Angelicae Sinensis Radix， Paeoniae Radix Alba， and Glycyrrhizae Radix et Rhizoma were identified as key CMMs with high frequency， and Cuscutae Semen-Lycii Fructus， Citri Reticulatae Pericarpium-Cyperi Rhizoma， and Ecliptae Herba-Ligustri Lucidi Fructus combinations had high MIE. Furthermore， the CMMs were clustered into ten groups corresponding to different diseases which， however， all belonged to digestive diseases. ConclusionThis study unveils potential CMM pairs and common CMM combinations against liver diseases， which can serve as a reference for revealing compatibility rules of CMMs and research and development of Chinese medicine.

Processing Methods and Quality Evaluation of Pinelliae Rhizoma： A Review / 中国实验方剂学杂志

In this paper， by consulting the historical herbs and medical classics coupled with related literature in modern research， the historical edition of Chinese Pharmacopoeia and local chronicles of traditional Chinese medicine （TCM） along with the ancient historical evolution of the processing methods of Pinelliae Rhizoma origin as well as the related processing methods of Pinelliae Rhizoma origin from 1959 to 2020 were systematically collated and summarized. It was found that the main processing methods of Pinelliae Rhizoma origin were peeling， decoction washing， lime wrapping and sun-drying. However， stacking， peeling， sun-drying or oven-drying are the primary methods in modern local chronicles of TCM. Meanwhile， washing， peeling， removing fibrous roots and sun-drying are the main methods in Chinese Pharmacopoeia. In addition， there were some changes in the quality evaluation of Pinelliae Rhizoma in different historical periods. Round and white were the best in the quality evaluation of Pinelliae Rhizoma in ancient times， while the evaluation indexes were further refined to size， color， texture， powder property， purity and evenness in modern herbal works. In modern studies， the quality of Pinelliae Rhizoma was mostly evaluated by the chemical components such as alkaloids， total organic acids， polysaccharides， nucleosides， fingerprint and pharmacodynamics. At present， the purification and drying stages of Pinelliae Rhizoma are in the transitional stage between the traditional manual peeling and natural drying methods as well as the modern mechanized and large-scale production. Therefore， a reasonable and feasible modern processing methods and guiding standards of Pinelliae Rhizoma are developed urgently to normalize the processing of Pinelliae Rhizoma and ensure the quality of medicinal materials.

Processing Methods and Quality Evaluation of Pinelliae Rhizoma： A Review / 中国实验方剂学杂志

In this paper， by consulting the historical herbs and medical classics coupled with related literature in modern research， the historical edition of Chinese Pharmacopoeia and local chronicles of traditional Chinese medicine （TCM） along with the ancient historical evolution of the processing methods of Pinelliae Rhizoma origin as well as the related processing methods of Pinelliae Rhizoma origin from 1959 to 2020 were systematically collated and summarized. It was found that the main processing methods of Pinelliae Rhizoma origin were peeling， decoction washing， lime wrapping and sun-drying. However， stacking， peeling， sun-drying or oven-drying are the primary methods in modern local chronicles of TCM. Meanwhile， washing， peeling， removing fibrous roots and sun-drying are the main methods in Chinese Pharmacopoeia. In addition， there were some changes in the quality evaluation of Pinelliae Rhizoma in different historical periods. Round and white were the best in the quality evaluation of Pinelliae Rhizoma in ancient times， while the evaluation indexes were further refined to size， color， texture， powder property， purity and evenness in modern herbal works. In modern studies， the quality of Pinelliae Rhizoma was mostly evaluated by the chemical components such as alkaloids， total organic acids， polysaccharides， nucleosides， fingerprint and pharmacodynamics. At present， the purification and drying stages of Pinelliae Rhizoma are in the transitional stage between the traditional manual peeling and natural drying methods as well as the modern mechanized and large-scale production. Therefore， a reasonable and feasible modern processing methods and guiding standards of Pinelliae Rhizoma are developed urgently to normalize the processing of Pinelliae Rhizoma and ensure the quality of medicinal materials.

The standard specification of microscopic identification of Chinese Pharmacopoeia 2020 edition / 药学实践杂志

Objective To improve the standardization and legitimacy of the quality control for traditional Chinese medicine (TCM) by analyzing the microscopic identification quality standard of TCM in Chinese Pharmacopoeia 2020 edition (Volume 1). Methods Through the analysis of the standard items of microscopic identification in Chinese Pharmacopoeia 2020 edition (Volume1), the problems in the standard was summarized and classified , and suggestions for revision were provided. Results The standardization and consistency have the room to improve in TCM microscopic identification standard in Chinese Pharmacopoeia 2020 (Volume 1). Conclusion The TCM microscopic identification standard needs to be improved, and the formulation for the standard should be more specific and practical.

The historical evolution of processed mirabilite in the formulation of Zixue san and its processing method / 中国药房

Zixue san is a preparation in Chinese Pharmacopoeia ，and is a commonly used representative formula in Liangkai formulation. In the previous editions of Chinese Pharmacopoeia ，for the item of the formulation and preparation method of Zixue san，“mirabilite”“mirabilite（prepare）”“Xuanming powder ”and other different descriptions have been repeatedly modified and amended；the methods of preparation of mirabilite in the processing specifications of different provinces and cities are also different，causing effects in actual production. Therefore ，the author has researched the historical evolution of Zixue ，the formulation and preparation method of Zixue san in the previous editions of Chinese P harmacopoeia，and has expounded the change process of mirabilite，mirabilite（prepare），Xuanming powder in the item of formulation and preparation method of Zixue san. In addition ，the author compares Chinese Pharmacopoeia with the processing methods of mirabilite in the national and provincial processing specifications ，in order to provide a basis for the processing of mirabilite in the formulation of Zixue san.

Evaluation and optimization of content determination method of Chrysanthemi Flos in Chinese Pharmacopoeia / 中国中药杂志

This study discovered that the resolution of 3,5-O-dicaffeoylquinic acid(isochlorogenic acid A) in the content determination method of Chrysanthemi Flos in Chinese Pharmacopoeia(ChP)(2020 edition) was poor, which affected accurate quantification. We tested the method in ChP with chromatographic columns of seven brands to clarify the problems in the existing method, optimized the chromatographic conditions by adjusting the mobile phase composition and elution ratio and replacing the chromatographic column packing, and carried out the reproducibility assay for the new method. The two methods were compared for the content determination results of Chrysanthemi Flos prepared from six different varieties. As evaluated by the resolution based on different chromatographic columns of seven brands, the existing method failed to separate isochlorogenic acid A and isochlorogenic acid D well. The peaks of the two components were not completely separated on three chromatographic columns, and isochlorogenic acid A and isochlorogenic acid D generated a co-effluent peak in the other four columns. Isochlorogenic acid A and isochlorogenic acid D could be completely separated under the optimized chromatographic conditions. The difference in the peak areas of isochlorogenic acid A+isochlorogenic acid D obtained by the optimized method and the method in ChP was not significant, with deviation less than 3.0%, which further proved that the result measured by the method in ChP was the co-effluent of isochlorogenic acid A and isochlorogenic acid D. The optimized method can ensure the accurate quantification of isochlorogenic acid A. The existing content determination method of Chrysanthemi Flos has the problem of poor resolution. It is recommended to revise the chromatographic conditions for the content determination method of Chrysanthemi Flos to improve the resolution of isochlorogenic acid A and ensure its accurate quantification.

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.

Progress and prospect of application of traditional Chinese medicine fingerprint (specific chromatogram) in Chinese Pharmacopoeia (2010-2020) / 南方医科大学学报

The Chinese Pharmacopoeia began to apply fingerprints (specific chromatogram) to quality control of traditional Chinese medicine in its 2010 edition, and in its 2015 and 2020 editions, new fingerprints (specific chromatogram) were added for improvement of the Pharmacopoeia-based national standards for drugs. This review analyzes the traditional Chinese medicine fingerprints (specific chromatogram) in Chinese Pharmacopoeia (2010-2020) in terms of the number of varieties listed, application of fingerprints (specific chromatogram), selection of evaluation method, determination method, the selection of extraction or preparation solvents of the test samples. With the expansion of the application of fingerprints (specific chromatogram), the evaluation indicators are constantly improving. The future development of the fingerprints (specific chromatogram) is also discussed in light of the selection of appropriate extraction or preparation solvents to obtain effective substances, which is the basis for the establishment of the fingerprints; multiple fingerprints for one drug based on different functional indications or basic sources, which expands the application of the fingerprints; addition of technical guidelines for traditional Chinese medicine fingerprints to standardize the use of the fingerprints; and the regular revision, update and application expansion of the fingerprints to ensure its essential role in quality control of traditional Chinese medicine.

Comparison of the Names and Origins of Crude Drugs Used in Ethical Kampo Extract Formulation and Listed in the Western Pharmacopoeias with Those in the Pharmacopoeias of East Asian Countries / 日本東洋医学雑誌

Following the Chinese-led global standardization of Chinese medicine, the 9 th edition of the European Pharmacopoeia, published in 2016, listed 66 kinds of crude drugs that are used in traditional Chinese medicine. By the spread of dietary supplements in the United States, the number of herbal medicines listed in United States Pharmacopoeia is tended to be increasing. In this article, we compare the names and origins of crude drugs listed in the European and American Pharmacopoeias and used in ethical Kampo extract formulation with those described in the pharmacopoeias of Japan, China, Taiwan, and South Korea. There were 4 crude drugs that had the same origins and names in the pharmacopoeia of these 6 countries, but only Coix Seed had the same English name. The pharmacopoeia of the 5 countries except the United States had 19 crude drugs with the same origin, but only Platycodon Root and Eucommia Bark had the same English and Latin names. For other crude drugs, the names and origins in the pharmacopoeia of each country were different. When scientists in each country disseminate the information about crude drugs used in their own countries to the world, it is necessary for them to describe the original plant scientific names and their medicinal parts that are unified by International Code of Nomenclature for plants instead of English or Latin names of crude drugs.

Development of the general chapters of the Chinese Pharmacopoeia 2020 edition:A review / 药物分析学报

The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People's Republic of China in July 2020.The current edition was officially implemented on December 30,2020.The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines,which are the common re-quirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia.Owing to adherence to the principles of scientificity,versatility,operability,and sustainable development,there is an improvement in the general chapters of the 2020 edition over those of the previous editions.Further,the application of advanced and mature analytical techniques has expanded,the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened,and technical requirements are now better harmonized with international standards.The updated edition provides technical and methodological support to ensure safety,effectiveness,and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technolo-gies,improving the quality control of medicines,and strengthening the means of drug regulation in China.This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.

Overview of Compilation and Research of Lao Herbal Pharmacopoeia / 中国实验方剂学杂志

In order to promote the standardization of traditional medicines in Laos， China and Laos jointly formed a census team to conduct resource survey， market survey， species identification and others of medicinal plants in Laos. According to the principles of nationality， tradition， effectiveness and commonness， 160 medicinal materials and 40 prescriptions were selected and collected into Lao Herbal Pharmacopoeia after recommendation， examination of experts and review by the established expert committee. Moreover， quality standards of traditional medicine and scientific and clear translation methods were formulated in line with the national conditions of Laos， and the contents were finally compiled according to the 2010 edition of Chinese Pharmacopoeia. The promulgation and implementation of Lao Herbal Pharmacopoeia is a successful example of cooperation in the field of health care between China and Laos， which is conducive to promoting mutually beneficial cooperation between China and Association of Southeast Asian Nations （ASEAN） countries in the field of traditional medicine， and making traditional medicine play a greater role in the medical and health services of ASEAN countries.

Study of pharmacopoeia of root of Caryopteris Mongolica Bge / Монголын эм зүй, эм судлал

Introduction@#The main goal of the modern national drug manufacturer is to develop highly biological active, low-side effects and no toxicity pharmaceutical products that can replace synthetic drugs with natural animal, plant and mineral raw materials. We conducted this study in aim to develop the standard of pharmacopoeia of root of <i>Caryopteris mongolica</i> which an antibacterial activity plant that grows in Mongolia. The study included experiments to determine the appearance of the plant, to determine its anatomical structure, to determine the quantitative analysis of pharmacognosy and to determine the microbiological analysis.@*Method@#We defined the appearance of plant by sensory method, anatomical structure of plant by light microscopy method. And we experimented the quantitative analysis of pharmacognosy and microbiological analysis of plant according to the methodology specified in the general requirements for medicinal plant raw material of the National Pharmacopoeia of Mongolia.@*Conclusion@#As a result of the study, the appearance of plant was brown, woody thick, has many branched roots, odorless and bitter. The quantitative analysis of pharmacognosy of plant met the general requirements for medicinal plant raw material. For microbiological analysis, plant met the all requirements.

Development of chromatographic technologies for the quality control of Traditional Chinese Medicine in the Chinese Pharmacopoeia / 药物分析学报

As an important branch of medicine,Traditional Chinese Medicine(TCM)has been applied for the treatment of diseases for thousands of years in China and other countries in East Asia.The Chinese Pharmacopoeia(ChP)is a drug code formulated by the Chinese government,and it includes a special volume for the monographs of TCM,which plays an important role in ensuring the quality of drugs.The use of quality control technology has always been a complex and important factor in TCM.Owing to the chemical diversity of TCM,chromatography technology has been proven to be a comprehensive strategy for the assessment of the overall quality of TCM and has become the main analytical method in the ChP.This article provides an overview of the classical and modern chromatographic technologies applied in the ChP,and summarizes the advantages and disadvantages of each technique in the TCM monographs.In 2020,the new edition of the ChP(the 2020 edition)has been implemented at the end of 2020.This paper also contains a brief introduction about the application of chromatographic technologies in the new edition of the ChP.

Research on revision of origins to Chinese medicinal materials in 2020 edition of Chinese pharmacopoeia / 中国中药杂志

The origins of 9 species of the Chinese medicinal materials in the 2015 edition of the Chinese pharmacopoeia(ChP) has revised in the 2020 edition of ChP. The revision is based on the investigation and textual research on the problems found after screening the original plants, animals or minerals of all the Chinese medicinal materials in the 2015 edition. Among them the Chinese names of Alismatis Rhizoma, Cassiae Semen, Coicis Semen, Corydalis Bungeanae Herba and Echinopsis Radix all do not match to the Latin scientific names, and also do not match the name of the actual medicinal origins. In addition, Alismatis Rhizoma has the omission of original plant. There is confusion about the Chinese name and the family name of the original insect of Cera Chinensis. The original mineral of Gypsum Fibrosum has the wrong group names. Alumstone and melanterite, the original mineral of Alumen and Melanteritum respectively, of which the group names are missing. To solve these problems, field survey and literature research were conducted on the medicinal materials and their origins. The source of these problems are explored. The correct origins and the Chinese names or Latin names are all determined according to the research results to the situation, in which the Chinese and Latin names of the original plants of the medicinal materials do not match. The correct family name and group name are obtained through textual research by taxonomy if the names are confused or mis-sing. The scientific evidence and correct results of revision in the 2020 edition of ChP are determined at last.