2025年版《中国药典》药用辅料新增品种标准解读  

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

作　　者：陈蕾[1] 陈英[2] 涂家生[3] 刘雁鸣 郑璐侠 张军[1] 马双成 CHEN Lei;CHEN Ying;TU Jiasheng;LIU Yanming;ZHENG Luxia;ZHANG Jun;MA Shuangcheng(Chinese Pharmacopoeia Commission,State Key Laboratory of Drug Regulatory Science,Beijing 100061,China;Guangdong Institute for Drug Control,Guangdong 510663,China;China Pharmaceutical University,Nanjing 210009,China;Hunan Institute of Drug Testing,Changsha 410001,China;Shanghai Institute of Food and Drug Testing,Shanghai 201203,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]广东省药品检验所,广东510663 [3]中国药科大学,南京210009 [4]湖南省药品检验研究院,长沙410001 [5]上海市食品药品检验研究院,上海201203

出　　处：《中国药品标准》2025年第1期58-66,共9页Drug Standards of China

基　　金：国家药品标准提高课题(2020Y025、2021Y008和2022Y006等50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。其中药用辅料新增品种标准52个,与2020年版相比增长15.5%,总数已达387个。本文着重介绍了2025年版《中国药典》中药用辅料新增品种标准的总体情况和主要特点,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。According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition,the Chinese Pharmacopoeia 2025 Edition has been completed.Among them,52 new pharmaceutical excipients monographs have been added,an increase of 15.5%compared with the 2020 Edition,and the total number has reached 387.This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition,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 新增 

分 类 号：R97[医药卫生—药品]