中国药典2020年版化学药品标准增修订概述

Updates and Revisions of the Specifications of Chemical Drugs in Chinese Pharmacopoeia 2020 Edition

目的介绍中国药典2020年版化学药品标准主要增修订情况,使读者更好地理解和执行中国药典2020年版。方法从中国药典2020年版化学药的品种遴选、通用名规范及正文品种标准增修订情况等方面进行介绍,并相应举例说明。结果中国药典2020年版化学药标准制定更加严谨,品种遴选更加合理,与国际标准更加协调,标准形成机制更加科学。结论中国药典2020年版将为促进化学药品质量提升、保障公众用药安全有效发挥积极作用。

OBJECTIVE To introduce the major updates and revisions of the specifications of chemical drugs in Chinese Pharmacopoeia 2020 Edition(ChP 2020),and help the readers to understand and implement the ChP 2020.METHODS To give an introduction of the selection of the chemical drug monograph,standardization of drug generic names and mainly revisions of the specifications of chemical drugs,a numerical example was also given to illustrate the revisions.RESULTS The ChP 2020 had developed more rigorous standards for chemical drugs,variety selection was more reasonable,it had a better coordination with international drug standards,and the standard formation mechanism was more scientific.CONCLUSION ChP 2020 will play an important role on strengthening the quality and ensure the safety and effectiveness of public medication of the chemical drugs.