中成药说明书功能表述现状及建议  

Current Descriptions of Functions in Package Inserts of Chinese Herbal Patent Medicines

作　　者：张美微 李可千 姚克宇 朱彦[2] ZHANG Meiwei;LI Keqian;YAO Keyu;ZHU Yan(School of Medical Information,Changchun University of Traditional Chinese Medicine,Changchun Jilin 130117,China;Institute of Traditional Chinese Medicine Information,Chinese Academy of Traditional Chinese Medicine,Beijing 100700,China)

机构地区：[1]长春中医药大学医药信息学院,吉林长春130117 [2]中国中医科学院中医药信息研究所,北京100700

出　　处：《中国药物警戒》2025年第2期193-196,共4页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(82174534);中国中医科学院科技创新工程项目资助(CI2021A05306);中央级公益性科研院所基本科研业务费专项资金资助(ZZ13-YQ-126);中央级公益性科研院所基本科研业务费(ZZ160311)。

摘　　要：目的梳理中成药说明书功能表述现状,分析并提出相应的建议,为药品上市许可持有人(Marketing Authorization Holder,MAH)进行药品研发、说明书撰写提供参考。方法分析国家药品监督管理局网站、《中华人民共和国药典》(2020年版)、国内各级药品标准收集的中成药说明书信息,建立中成药说明书功能表述判定标准与功能术语提取标准,并对提取结果开展人工审核。结果与讨论大部分中成药说明书【功能主治】项内容的表述与现有既定要求相符,展现出了较高的规范化水平,但在表述规范性、与主治范畴一致性方面仍有待进一步优化。需要通过术语规范化工作的持续深入和积极落实相关主体责任等途径,实现功能规范表述,推动中成药说明书撰写的规范化进程。Objective To analyze the current descriptions of functions in package inserts of Chinese herbal patent medicines and propose corresponding countermeasures in order to provide a reference for marketing authorization holders(MAHs).Methods The information about package inserts of Chinese herbal patent medicines was retrieved from the official website of the National Medical Products Administration,the Pharmacopoeia of the People’s Republic of China(2020 edition),and from standards for pharmaceuticals at each level.A standard for determining descriptions of functions and retrieving terms of functions was established before a manual review and analysis of the results of retrieval were conducted.Results and Conclusion The descriptions of functions and indications in most of the package inserts of Chinese herbal patent medicines meet the current standards.However,the descriptions should be standardized and made more consistent with the targeted indications.

关 键 词：中成药 说明书 功能表述 规范化 现状分析 

分 类 号：R994.11[医药卫生—毒理学]