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
“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
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
To improve the relevant methods of the quality control standards of tumor Positron Emission Computed Tomography(PET)radiopharmaceuticals and to reduce the clinical application risks of such drugs,this article compares...To improve the relevant methods of the quality control standards of tumor Positron Emission Computed Tomography(PET)radiopharmaceuticals and to reduce the clinical application risks of such drugs,this article compares and analyzes the similarities and differences of the quality control standards of tumor PET radiopharmaceuticals in the Pharmacopoeia of People’s Republic of China(ChP2020),European Pharmacopoeia(EP8.0)and United States Pharmacopoeia(USP39),focusing on comparing and analyzing the identification(identification method),inspection(pH,residual solvent,bacterial endotoxin,sterility,and impurities),and content determination(radionuclear purity,radiochemical purity,and radioactive concentration)of tumor PET radiopharmaceuticals.The quality control standards of ChP2020 for tumor PET radiopharmaceuticals are relatively equivalent to the quality control standards of USP39 but are not as stringent as those of EP8.0.In general,EP8.0 has the most comprehensive and strict quality control standards for tumor PET radiopharmaceuticals.The quality control standards of tumor PET radiopharmaceuticals in the Chinese Pharmacopoeia can be improved by referring to international standards,especially the European Pharmacopoeia.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
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.
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.
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
基金National Key Research and Development Plan(Grant No.2017YFC0113305).
文摘To improve the relevant methods of the quality control standards of tumor Positron Emission Computed Tomography(PET)radiopharmaceuticals and to reduce the clinical application risks of such drugs,this article compares and analyzes the similarities and differences of the quality control standards of tumor PET radiopharmaceuticals in the Pharmacopoeia of People’s Republic of China(ChP2020),European Pharmacopoeia(EP8.0)and United States Pharmacopoeia(USP39),focusing on comparing and analyzing the identification(identification method),inspection(pH,residual solvent,bacterial endotoxin,sterility,and impurities),and content determination(radionuclear purity,radiochemical purity,and radioactive concentration)of tumor PET radiopharmaceuticals.The quality control standards of ChP2020 for tumor PET radiopharmaceuticals are relatively equivalent to the quality control standards of USP39 but are not as stringent as those of EP8.0.In general,EP8.0 has the most comprehensive and strict quality control standards for tumor PET radiopharmaceuticals.The quality control standards of tumor PET radiopharmaceuticals in the Chinese Pharmacopoeia can be improved by referring to international standards,especially the European Pharmacopoeia.
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.
