“Long-Dan”is an important traditional Chinese medicinal(TCM)herb used widely for the treatment of inflammation,hepatitis,rheumatism,cholecystitis,and tuberculosis.In the Chinese Pharmacopoeia,the roots and rhizomes ...“Long-Dan”is an important traditional Chinese medicinal(TCM)herb used widely for the treatment of inflammation,hepatitis,rheumatism,cholecystitis,and tuberculosis.In the Chinese Pharmacopoeia,the roots and rhizomes of four species from the genus Gentiana(Gentianaceae)are recorded as the original materials of“Long-Dan”,called Gentianae Radix et Rhizoma.The species included G.manshurica,G.scabra,G.triflora and G.rigescens,which are distributed in different areas of China.Though iridoid and secoiridoid glucosides were reported as the main constituents in“Long-Dan”,these four different species also resulted in different minor components,which may related to their pharmacological activities.Herein,we summarized the herbal textual study,distribution,chemical constituents,biological investigation and quality control of the recorded“Long-Dan”origins in Chinese Pharmacopoeia during the period 1960 to 2011.展开更多
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 w...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 requirements 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 technologies,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.展开更多
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 ...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 Ch P(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.展开更多
With sulphur-fumigated Chinese medicinal materials （Fritillaria thunbergii , Isatis #utigotica , Asparagus cochinchinensis and Poria cocos ） as the test materials, sulfur dioxide or sulfite residue was determined by...With sulphur-fumigated Chinese medicinal materials （Fritillaria thunbergii , Isatis #utigotica , Asparagus cochinchinensis and Poria cocos ） as the test materials, sulfur dioxide or sulfite residue was determined by the method in Chinese Pharmacopoeia （2015 edition） and titration-fluorescence spectrometry, respec- tively. The results showed that there were significant differences in measured value between titration-fluorescence spectrometry and phmmacopoeia method. The t result of titration-fluorescence spectrometry was much closer to the actual content of sulfur dioxide in Chinese medicinal materials. Thus, titration-fluo- rescence spectrometry had higher application value展开更多
Objective To provide reference for strengthening the management of preventing interest conflicts among pharmacopoeia members.Methods The procedures of the United States Pharmacopoeia (USP) Committee,and the actions ta...Objective To provide reference for strengthening the management of preventing interest conflicts among pharmacopoeia members.Methods The procedures of the United States Pharmacopoeia (USP) Committee,and the actions taken by members or experts of US food and drug administration to prevent interest conflicts were referred to analyze the problems in the management of preventing interest conflicts in China pharmacopoeia committee,and corresponding suggestions were put forward.Results and Conclusion Although the interest and risk avoidance system and dismissal measures were mentioned in the measures for the administration of Chinese pharmacopoeia commissioners,no detailed rules and specific procedures were formulated to prevent interest conflicts of Chinese pharmacopoeia commissioners.It is suggested that preventing the interest conflicts of pharmacopoeia members should be included into the drug formulation and revision system as soon as possible.In addition,the management measures for pharmacopoeia members should be further perfected to avoid the interest conflicts.The scope of publicity for the formulation and revision of drug standards should be expanded and the supervision and implementation must be strengthened.Therefore,the members of pharmacopoeia can participate in the formulation and revision of drug standards in a fair or just manner.展开更多
Compilation of the Pharmacopoeia of the People’s Republic of China (known as the Chinese Pharmacopoeia 2010) has been completed by the Ninth Chinese Pharmacopoeia Commission,which has been officially distributed in J...Compilation of the Pharmacopoeia of the People’s Republic of China (known as the Chinese Pharmacopoeia 2010) has been completed by the Ninth Chinese Pharmacopoeia Commission,which has been officially distributed in January 2010 and implemented展开更多
Objective: The Chinese Pharmacopoeia(2015) includes 584 plant medicines, of which 284 also contain high quality subsets, so called "Daodi" components, where Daodi denotes superior clinical properties compare...Objective: The Chinese Pharmacopoeia(2015) includes 584 plant medicines, of which 284 also contain high quality subsets, so called "Daodi" components, where Daodi denotes superior clinical properties compared to non-Daodi counterparts despite being sourced from the same species. Commercial and clinical drivers of selection for Daodi have been described elsewhere. Our objective is to investigate the overall composition of Daodi to determine in what ways medicines with Daodi as a whole differ from the other plants of the Chinese Pharmacopoeia. A further objective is to characterise the Chinese Pharmacopoeia and Daodi in terms of the plant species including their traits and distribution.Methods: We used trait analysis to identify whether Daodi species were significantly different from the remaining Chinese Pharmacopoeia plant species in any traits. We used biogeographic methods and an existing classification of Daodi into 10 regions to identify spatial patterns amongst the species. Regression and binomial analyses were used to test for over-and under-use of plant families and endemic species.Preferences for lineages were visualized using phylogenetic mapping.Results: We found that Daodi species(species with any Daodi subset) were more likely to be roots that are "hot" or "warm", and less likely to be "oxic", according to traditional Chinese medicine(TCM) concepts. Roots were over-represented in the Bei region, and whole plants over-represented in Guang. Both the Chinese Pharmacopoeia and Daodi indicated preferences for families not common in previously studied ethnopharmacopoeias, and fewer endemic species were represented than expected by chance.Conclusion: Using the phylogenetic and biogeographical methods, we highlighted patterns of plant use,and the biological characters of Daodi medicinal plants. Our study points towards cultural preferences in need of scientific explanation.展开更多
Genomic data have demonstrated considerable traction in accelerating contemporary studies in traditional medicine. However,the lack of a uniform format and dispersed storage limits the full potential of herb genomic d...Genomic data have demonstrated considerable traction in accelerating contemporary studies in traditional medicine. However,the lack of a uniform format and dispersed storage limits the full potential of herb genomic data. In this study, we developed a Global Pharmacopoeia Genome Database(GPGD). The database contains 34,346 records for 903 herb species from eight global pharmacopoeias(Brazilian, Egyptian, European, Indian, Japanese, Korean, the Pharmacopoeia of the People’s Republic of China, and U.S. Pharmacopoeia’s Herbal Medicines Compendium). In particular, the GPGD contains 21,872 DNA barcodes from 867 species, 2,203 organelle genomes from 674 species, 55 whole genomes from 49 species, 534 genomic sequencing datasets from 366 species, and 9,682 transcriptome datasets from 350 species. Among the organelle genomes, 534 genomes from 366 species were newly generated in this study. Whole genomes, organelle genomes, genomic fragments, transcriptomes, and DNA barcodes were uniformly formatted and arranged by species. The GPGD is publicly accessible at http://www.gpgenome.com and serves as an essential resource for species identification, decomposition of biosynthetic pathways, and molecular-assisted breeding analysis. Thus, the database is an invaluable resource for future studies on herbal medicine safety, drug discovery, and the protection and rational use of herbal resources.展开更多
Sankezhen(Berberidis Radix)is a traditional Chinese materia medica,cold in nature and bitter in taste,for treating syndromes of liver,stomach,and large intestinal meridians,in which berberine and berbamine are the maj...Sankezhen(Berberidis Radix)is a traditional Chinese materia medica,cold in nature and bitter in taste,for treating syndromes of liver,stomach,and large intestinal meridians,in which berberine and berbamine are the major pharmacological components.Sankezhen has been readmitted in Chinese Pharmacopoeia 2010 following the 1977 version as the roots of Berberis spp.e.g.B.soulieana,B.wilsonae,B.poiretii,B.vernae,etc.Recent studies showed that Berberis spp.were potential phytomedicines with multiple spectrums therapeutic effects and various pharmaceutical parts.Here we reviewed Sankezhen in traditional use and phytochemistry,and its major active components berberine and berbamine with potential bioactivities recently discovered,such as antitumor,antidiabetic, antihyperlipidemic,anti-arrhythmic,and neuro-protective activities.It is necessary to mature the quality assessment of Sankezhen as a new admission of Chinese Pharmacopoeia 2010.Other parts of Berberis spp.should be investigated to better develop this herb in medicinal usage.展开更多
In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Count...In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Countries which are signatories of the European Pharmacopoeia Convention. Consequently, new Ph Eur TCM herbal drug Monographs should be elaborated, based on preexisting Monographs in the Chinese Pharmacopoeia(Ch P) 2010.Such a program has been inaugurated in 2005 by the Ph Eur Groups of Experts 13 A and B(Phytochemistry). Since then good progress has been made, elaborating of about one third of the originally proposed 100 TCM herbals being identified as important monographs for the European Market. Taking into account the many challenges still laying ahead, the establishment of a specialized Working Party(WP) on TCM with specialists and experts from many EU Member States has been decided by the Ph Eur Commission in 2008 which is highly active ever since in the examination and elaboration of new TCM herbal drug monographs, primarily to assure the safety of the European patient and further to provide quality parameters extremely important for all registration and licensing procedures of the respective National Authorities all over Europe.This paper is a survey of results and difficulties obtained so far which has been encountered meanwhile in the elaboration process by the Ph Eur TCM WP of these monographs and will discuss these in detail. Moreover the role of Ph Eur TCM monographs in the European community is addressed.展开更多
基金supported by Science and Technology Planning Project of Yunnan Province(2010CD106)the 973 Program of Ministry of Science and Technology of China(2011CB915503)+1 种基金the State Key Laboratory of Phytochemistry and Plant Resources in West China,Chinese Academy of Sciences(P2010-ZZ03)The Fourteenth Candidates of the Young Academic Leaders of Yunnan Province(Min XU,2011CI044).
文摘“Long-Dan”is an important traditional Chinese medicinal(TCM)herb used widely for the treatment of inflammation,hepatitis,rheumatism,cholecystitis,and tuberculosis.In the Chinese Pharmacopoeia,the roots and rhizomes of four species from the genus Gentiana(Gentianaceae)are recorded as the original materials of“Long-Dan”,called Gentianae Radix et Rhizoma.The species included G.manshurica,G.scabra,G.triflora and G.rigescens,which are distributed in different areas of China.Though iridoid and secoiridoid glucosides were reported as the main constituents in“Long-Dan”,these four different species also resulted in different minor components,which may related to their pharmacological activities.Herein,we summarized the herbal textual study,distribution,chemical constituents,biological investigation and quality control of the recorded“Long-Dan”origins in Chinese Pharmacopoeia during the period 1960 to 2011.
基金financial support from the Chinese Pharmacopoeia Commission Drug Standard Promoting Funds and Comprehensive Reform of the Chinese Drug and Medical Device Review and Approval System Funds(2015e2020)。
文摘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 requirements 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 technologies,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.
文摘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 Ch P(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.
基金Supported by Key Technology R&D Program of Hebei Department of Science and Technology(15272506)Scientific Research Project of Hebei Administration of Traditional Chinese Medicine(2015080,2017105)+1 种基金Chinese Medicinal Material Innovation Team Project of Hebei Agricultural Industry Research System(7000120081)National Key Laboratory of Genuine Regional Drug and Significant Increase or Decrease Project of Central Level Project(2060302)
文摘With sulphur-fumigated Chinese medicinal materials （Fritillaria thunbergii , Isatis #utigotica , Asparagus cochinchinensis and Poria cocos ） as the test materials, sulfur dioxide or sulfite residue was determined by the method in Chinese Pharmacopoeia （2015 edition） and titration-fluorescence spectrometry, respec- tively. The results showed that there were significant differences in measured value between titration-fluorescence spectrometry and phmmacopoeia method. The t result of titration-fluorescence spectrometry was much closer to the actual content of sulfur dioxide in Chinese medicinal materials. Thus, titration-fluo- rescence spectrometry had higher application value
文摘Objective To provide reference for strengthening the management of preventing interest conflicts among pharmacopoeia members.Methods The procedures of the United States Pharmacopoeia (USP) Committee,and the actions taken by members or experts of US food and drug administration to prevent interest conflicts were referred to analyze the problems in the management of preventing interest conflicts in China pharmacopoeia committee,and corresponding suggestions were put forward.Results and Conclusion Although the interest and risk avoidance system and dismissal measures were mentioned in the measures for the administration of Chinese pharmacopoeia commissioners,no detailed rules and specific procedures were formulated to prevent interest conflicts of Chinese pharmacopoeia commissioners.It is suggested that preventing the interest conflicts of pharmacopoeia members should be included into the drug formulation and revision system as soon as possible.In addition,the management measures for pharmacopoeia members should be further perfected to avoid the interest conflicts.The scope of publicity for the formulation and revision of drug standards should be expanded and the supervision and implementation must be strengthened.Therefore,the members of pharmacopoeia can participate in the formulation and revision of drug standards in a fair or just manner.
文摘Compilation of the Pharmacopoeia of the People’s Republic of China (known as the Chinese Pharmacopoeia 2010) has been completed by the Ninth Chinese Pharmacopoeia Commission,which has been officially distributed in January 2010 and implemented
基金supported by grants from the National Natural Science Foundation of China(81473315)Public welfare scientific research project of State Administration of traditional Chinese Medicine(201507004-2-1)CAMS Innovation Fund for Medical Sciences(CIFMS)(No.2016-I2M-3-015)
文摘Objective: The Chinese Pharmacopoeia(2015) includes 584 plant medicines, of which 284 also contain high quality subsets, so called "Daodi" components, where Daodi denotes superior clinical properties compared to non-Daodi counterparts despite being sourced from the same species. Commercial and clinical drivers of selection for Daodi have been described elsewhere. Our objective is to investigate the overall composition of Daodi to determine in what ways medicines with Daodi as a whole differ from the other plants of the Chinese Pharmacopoeia. A further objective is to characterise the Chinese Pharmacopoeia and Daodi in terms of the plant species including their traits and distribution.Methods: We used trait analysis to identify whether Daodi species were significantly different from the remaining Chinese Pharmacopoeia plant species in any traits. We used biogeographic methods and an existing classification of Daodi into 10 regions to identify spatial patterns amongst the species. Regression and binomial analyses were used to test for over-and under-use of plant families and endemic species.Preferences for lineages were visualized using phylogenetic mapping.Results: We found that Daodi species(species with any Daodi subset) were more likely to be roots that are "hot" or "warm", and less likely to be "oxic", according to traditional Chinese medicine(TCM) concepts. Roots were over-represented in the Bei region, and whole plants over-represented in Guang. Both the Chinese Pharmacopoeia and Daodi indicated preferences for families not common in previously studied ethnopharmacopoeias, and fewer endemic species were represented than expected by chance.Conclusion: Using the phylogenetic and biogeographical methods, we highlighted patterns of plant use,and the biological characters of Daodi medicinal plants. Our study points towards cultural preferences in need of scientific explanation.
基金supported by the National Key Research and Development Program of China (2019YFC1711100)the National Natural Science Foundation of China and Karst Science Research Center of Guizhou Province (U1812403-1)+4 种基金the Special Foundation for National Science and Technology Basic Research Program of China (2018FY100701)the Fundamental Research Funds for the Central Public Welfare Research Institutes (ZXKT17027, ZXKT18014)the Open Research Fund of Chengdu University of Traditional Chinese Medicine Key Laboratory of Systematic Research of Distinctive Chinese Medicine Resources in Southwest China (2020GZ2011016)the Funds for Fostering Outstanding Scholars in Science and Technology (Innovation) (ZZ13-YQ-047)Innovation Fund of China Academy of Chinese Medical Sciences
文摘Genomic data have demonstrated considerable traction in accelerating contemporary studies in traditional medicine. However,the lack of a uniform format and dispersed storage limits the full potential of herb genomic data. In this study, we developed a Global Pharmacopoeia Genome Database(GPGD). The database contains 34,346 records for 903 herb species from eight global pharmacopoeias(Brazilian, Egyptian, European, Indian, Japanese, Korean, the Pharmacopoeia of the People’s Republic of China, and U.S. Pharmacopoeia’s Herbal Medicines Compendium). In particular, the GPGD contains 21,872 DNA barcodes from 867 species, 2,203 organelle genomes from 674 species, 55 whole genomes from 49 species, 534 genomic sequencing datasets from 366 species, and 9,682 transcriptome datasets from 350 species. Among the organelle genomes, 534 genomes from 366 species were newly generated in this study. Whole genomes, organelle genomes, genomic fragments, transcriptomes, and DNA barcodes were uniformly formatted and arranged by species. The GPGD is publicly accessible at http://www.gpgenome.com and serves as an essential resource for species identification, decomposition of biosynthetic pathways, and molecular-assisted breeding analysis. Thus, the database is an invaluable resource for future studies on herbal medicine safety, drug discovery, and the protection and rational use of herbal resources.
文摘Sankezhen(Berberidis Radix)is a traditional Chinese materia medica,cold in nature and bitter in taste,for treating syndromes of liver,stomach,and large intestinal meridians,in which berberine and berbamine are the major pharmacological components.Sankezhen has been readmitted in Chinese Pharmacopoeia 2010 following the 1977 version as the roots of Berberis spp.e.g.B.soulieana,B.wilsonae,B.poiretii,B.vernae,etc.Recent studies showed that Berberis spp.were potential phytomedicines with multiple spectrums therapeutic effects and various pharmaceutical parts.Here we reviewed Sankezhen in traditional use and phytochemistry,and its major active components berberine and berbamine with potential bioactivities recently discovered,such as antitumor,antidiabetic, antihyperlipidemic,anti-arrhythmic,and neuro-protective activities.It is necessary to mature the quality assessment of Sankezhen as a new admission of Chinese Pharmacopoeia 2010.Other parts of Berberis spp.should be investigated to better develop this herb in medicinal usage.
文摘In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Countries which are signatories of the European Pharmacopoeia Convention. Consequently, new Ph Eur TCM herbal drug Monographs should be elaborated, based on preexisting Monographs in the Chinese Pharmacopoeia(Ch P) 2010.Such a program has been inaugurated in 2005 by the Ph Eur Groups of Experts 13 A and B(Phytochemistry). Since then good progress has been made, elaborating of about one third of the originally proposed 100 TCM herbals being identified as important monographs for the European Market. Taking into account the many challenges still laying ahead, the establishment of a specialized Working Party(WP) on TCM with specialists and experts from many EU Member States has been decided by the Ph Eur Commission in 2008 which is highly active ever since in the examination and elaboration of new TCM herbal drug monographs, primarily to assure the safety of the European patient and further to provide quality parameters extremely important for all registration and licensing procedures of the respective National Authorities all over Europe.This paper is a survey of results and difficulties obtained so far which has been encountered meanwhile in the elaboration process by the Ph Eur TCM WP of these monographs and will discuss these in detail. Moreover the role of Ph Eur TCM monographs in the European community is addressed.
