中国食品药品监管Issue(5)：14-25,12.DOI:10.3969/j.issn.1673-5390.2025.05.002
2025年版《中国药典》药用辅料标准增修订情况解析与启示
Interpretation and Insights into the Additions and Revisions of Pharmaceutical Excipient Standards in the 2025 Edition of the Chinese Pharmacopoeia
罗小凤 1乐鋆 1李贞桢 1夏文萍 1叶子瑜 2李小敏 1孙春萌 3涂家生3
作者信息
- 1. 中国药科大学国际医药商学院
- 2. 澳门大学中华医药研究院
- 3. 中国药科大学药学院
- 折叠
摘要
Abstract
The standard system for pharmaceutical excipients is a critical component of the Chinese Pharmacopoeia(ChP),comprising the general notices,general technical requirements and guidelines,and monographs for individual pharmaceutical excipients.In the 2025 edition of the ChP,the revision and formulation of excipient standards have been completed,including the addition of 52 new excipient monographs.Notably,General Guideline 9601,Guidelines on Functionality-Related Characteristics of Pharmaceutical Excipients,has been revised.The number of functional categories for excipients has increased from 19 in the 2020 edition of the ChP to 25 in the 2025 edition,and four new testing methods for functionality-related characteristics have been introduced,further enhancing general requirements for the characterization of excipient functionalities.This paper reviews and compares the content and revisions of Guideline 9601 in the 2015,2020,and 2025 editions of the ChP,as well as the related section<1059>in the 2025 United States Pharmacopeia(USP),in order to analyze the significance of these updates for strengthening China's scientific drug regulation and promoting the advancement of pharmaceutical formulation development.关键词
中国药典/药用辅料/功能性相关指标/检查法/科学监管Key words
Chinese Pharmacopoeia/pharmaceutical excipients/functionality-related characteristics(FRCs)/testing methods/scientific regulation分类
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罗小凤,乐鋆,李贞桢,夏文萍,叶子瑜,李小敏,孙春萌,涂家生..2025年版《中国药典》药用辅料标准增修订情况解析与启示[J].中国食品药品监管,2025,(5):14-25,12.
