目的 2020年版《中国药典》药用辅料标准是《中国药典》的重要组成部分,受到业内高度关注,对2020年版《中国药典》药用辅料标准总体情况的分析有助于《中国药典》的使用者对药典标准的正确理解和运用。方法 笔者着重介绍了2020年版《中国药典》药用辅料标准编制的基本情况、形成机制的主要变化、标准体系的总体框架和各部分标准的主要特点等。结果 2020年版《中国药典》在标准数量、标准体系和标准形成机制上均有明显提升和完善。结论 《中国药典》将不断加强药用辅料标准体系建设,推动产业升级,助力监管提升。

OBJECTIVE To analyze the general situation of pharmaceutical excipients standard in Chinese Pharmacopoeia 2020 edition and understand the standards accurately. METHODSE This article focuses on the overall information of standard, the changes of working mechanism, the framework of the standard system and the characteristics of all pharmaceutical excipients standards in the 2020 edition of Chinese Pharmacopoeia. RESULTS It has significantly improved that the number of standards, the standard system and the standard formation mechanism of the 2020 edition of China Pharmacopoeia. CONCLUSION The Chinese Pharmacopoeia will continue to strengthen the construction of a standard system for pharmaceutical excipients, promote industrial upgrading and improve supervision efficiency.