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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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Xi'an Jiaotong University
2021
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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. |
format | Online Article Text |
id | pubmed-8424356 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Xi'an Jiaotong University |
record_format | MEDLINE/PubMed |
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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