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Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review

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 Ch...

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Autores principales: Xu, Xinyi, Xu, Huayu, Shang, Yue, Zhu, Ran, Hong, Xiaoxu, Song, Zonghua, Yang, Zhaopeng
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Xi'an Jiaotong University 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424356/
https://www.ncbi.nlm.nih.gov/pubmed/34513116
http://dx.doi.org/10.1016/j.jpha.2021.05.001
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author Xu, Xinyi
Xu, Huayu
Shang, Yue
Zhu, Ran
Hong, Xiaoxu
Song, Zonghua
Yang, Zhaopeng
author_facet Xu, Xinyi
Xu, Huayu
Shang, Yue
Zhu, Ran
Hong, Xiaoxu
Song, Zonghua
Yang, Zhaopeng
author_sort Xu, Xinyi
collection PubMed
description 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.
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spelling pubmed-84243562021-09-10 Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review Xu, Xinyi Xu, Huayu Shang, Yue Zhu, Ran Hong, Xiaoxu Song, Zonghua Yang, Zhaopeng J Pharm Anal Review Paper 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. Xi'an Jiaotong University 2021-08 2021-05-20 /pmc/articles/PMC8424356/ /pubmed/34513116 http://dx.doi.org/10.1016/j.jpha.2021.05.001 Text en © 2021 Xi'an Jiaotong University. Production and hosting by Elsevier B.V. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Review Paper
Xu, Xinyi
Xu, Huayu
Shang, Yue
Zhu, Ran
Hong, Xiaoxu
Song, Zonghua
Yang, Zhaopeng
Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review
title Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review
title_full Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review
title_fullStr Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review
title_full_unstemmed Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review
title_short Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review
title_sort development of the general chapters of the chinese pharmacopoeia 2020 edition: a review
topic Review Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424356/
https://www.ncbi.nlm.nih.gov/pubmed/34513116
http://dx.doi.org/10.1016/j.jpha.2021.05.001
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