《中国药典》2020年版第一增补本药用辅料标准解读

Introduction on the standard of pharmaceutical excipientsin the first supplement of the Chinese Pharmacopoeia 2020

《中国药典》2020年版第一增补本自2024年3月12日起施行,它起着重要的承上启下的作用,其中药用辅料标准新增11个、修订46个。本次制修订药用辅料标准是基于风险管理理念和全过程管理理念,围绕保障药品临床安全性和有效性,在制定标准过程中突出对药用辅料关键质量属性的评估,增加了功能性相关指标、安全性指标,突出了标准国际协调和绿色环保标准理念,加强了标准规范性和可操作性。本文着重介绍了《中国药典》2020年版第一增补本中药用辅料新增和修订标准的总体思路和主要特点。以期对《中国药典》的使用者正确理解、执行或运用药典标准有所帮助。

The first supplement of the Pharmacopoeia of the People′s Republic of China 2020 Edition will be implemented on March 12,2024.It plays an important role in connecting link between the preceding and the following.Among them,11 new pharmaceutical excipients monographs have been added and 46 monographs have been revised.This formulation and revision of pharmaceutical excipients standards are based on the concept of risk management and the full lifecycle management and focuse on ensuring the clinical safety and effectiveness of drugs,the evaluation of critical quality attributes on pharmaceutical excipients is highlighted in the standard-making process,and functional-related characteristics(FRCs)and safety indicators are included.Moreover,the excipient standards have emphasized the concept of international pharmacopeia harmonization and green environmental protection and strengthened the standardization and operability.This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the first supplement of the Chinese Pharmacopoeia 2020,which can contribute to accurately understand and utilize the standards in the Chinese Pharmacopoeia.