2025年版《中国药典》药用辅料修订品种标准概况  

The introduction on the revised standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition

作　　者：陈蕾[1] 刘雁鸣 袁耀佐 陈英[4] 戴红 张军[1] 马双成 CHEN Lei;LUI Yanming;YUAN Yaozuo;CHEN Ying;DAI Hong;ZHANG Jun;MA Shuangcheng(Chinese Pharmacopoeia Commission,State Key Laboratory of Drug Regulatory Science,Beijing 100061,China;Hunan Institute of Drug Testing,Changsha 410001,China;Jiangsu Food and Drug Supervision and Inspection Institute,Nanjing 210008,China;Guangdong Institute for Drug Control,Guangdong 510663,China;Beijing Institute of Drug Testing,Beijing 100085,China)

机构地区：[1]国家药典委员会,药品监管科学全国重点实验室,北京100061 [2]湖南省药品检验研究院,长沙410001 [3]江苏省食品药品监督检验研究院,南京210008 [4]广东省药品检验所,广东510663 [5]北京市药品检验研究院,北京100085

出　　处：《中国药品标准》2025年第1期51-57,共7页Drug Standards of China

基　　金：国家药品标准提高课题(2020Y019、2021Y009和2022Y021等80余项)。

摘　　要：按照2025年版《中国药典》编制大纲确定的工作目标和任务,现已完成2025年版《中国药典》中药用辅料标准的制修订工作。本版药典共新增药用辅料品种标准52个,总数已达387个;修订品种标准245个,其中仅文字修订的109个,有实质性修订的136个。本文着重介绍2025年版《中国药典》中药用辅料品种标准修订主要特点,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。According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition,the Chinese Pharmacopoeia 2025 has been completed.Among them,52 new pharmaceutical excipients monographs have been added,and the total number has reached 387.245 pharmaceutical excipients monographs have been revised,of which 109 monographs have only textual revisions and 136 monographs have substantive revisions.This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025,which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.

关 键 词：中国药典 药用辅料 标准 修订 

分 类 号：R97[医药卫生—药品]