中成药说明书安全性内容“尚不明确”问题分析及建议  

Analysis and Suggestions on the Problem of the Unclear Part of the Safety Content Section of Chinese Patent Medicines

作　　者：李敏 周敏华 吴惠妃 LI Min;ZHOU Minhua;WU Huifei(Department of Pharmacy,Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine,Zhongshan 528400,China;Department of Pharmacy,Guangdong Hospital of Traditional Chinese and Western Medicine,Foshan 528200,China)

机构地区：[1]广州中医药大学附属中山中医院药学部,中山528400 [2]广东省中西医结合医院药学部,佛山528200

出　　处：《医药导报》2025年第5期727-731,共5页Herald of Medicine

摘　　要：目的对中成药说明书中有关安全性内容“尚不明确”问题进行分析,为提高中成药安全性、有效性提供参考。方法检索《中华人民共和国药典》《国家基本药物目录》《临床各科中成药精选手册》《现代中成药手册》,根据中成药功效、剂型的不同进行随机抽样,收集基本信息完整并且版本最新的药品说明书共105份,提取各药品说明书中的安全项信息,录入Excel 2019,并对其标注情况进行汇总,逐一统计分析。结果大部分说明书都有标注[不良反应][禁忌][药理毒理]等安全项信息,但各项内容的详尽程度有较大差异,普遍存在术语描述不规范、内容“避重就轻,一笔带过”或内容与标注不相符、临床资料研究不足等问题。结论中成药说明书研究性内容缺失严重,需进一步加强药物作用机制的探讨与研究,以修订和完善说明书安全项信息,保证临床用药安全。Objective The content of the relevant safety items in the instructions of Chinese patent medicines is"Not Clear"to provide a reliable reference for improving the safety and effectiveness of Chinese patent medicines.Methods Search the Chinese Pharmacopoeia 2020,National Essential Medicines List,Handbook of Selected Chinese Patent Drugs in Various Clinical Subjects,and Handbook of Modern Chinese Patent Drugs.Conduct random sampling according to Chinese patent medicines'different efficacy and dosage forms and collect complete basic information and versions.There are a total of 105 latest drug instructions.The safety information in each drug instruction is extracted and entered into Excel 2019.The annotations are summarized and statistically analyzed one by one.Results After summarizing,most instructions are marked with safety item information such as adverse events,contraindications,pharmacology,and toxicology.However,the degree of detail of each content varies greatly.Common problems include non-standard terminology description,content"avoiding the important and light,passing it off"or inconsistent content with the labeling,and insufficient clinical data research.Conclusions There is a severe lack of research content in the package insert of Chinese patent medicines,and it is still necessary to further strengthen the discussion and research on the mechanism of action of medicines to revise and improve the safety information of the instructions and ensure the safety of clinical use.

关 键 词：中成药 说明书 安全性 

分 类 号：R286[医药卫生—中药学] R288[医药卫生—中医学]