含苦杏仁中成药说明书的安全性内容分析与提升建议  

Safety Content Analysis and Suggestions for Enhancement of Chinese Medicines Containing Bitter Almond

作　　者：韩晶晶 豆妮娜 金锐 HAN Jingjing;DOU Nina;JIN Rui(Department of Pharmacy,Hebei Petro China Central Hospital,Langfang 065000,China;Department of Pharmacy,Xiyuan Hospital,Chinese Academy of Chinese Medical Sciences,Beijing 100091,China)

机构地区：[1]河北中石油中心医院药学部,廊坊065000 [2]中国中医科学院西苑医院药学部,北京100091

出　　处：《医药导报》2025年第5期738-743,共6页Herald of Medicine

基　　金：首都卫生发展科研专项(首发2020-2-2081)。

摘　　要：目的探讨含有苦杏仁的中成药说明书安全性内容存在的问题并提出建议。方法通过检索用药助手、药智数据平台《国家基本医疗保险、工伤保险和生育保险药品目录(2022年)》中含苦杏仁的中成药,整理其功能主治、组成、不良反应、用药禁忌、警示语、注意事项等,将收集到的信息录入Excel 2021版,对汇总的数据进行分析,并根据统计的结果对含苦杏仁中成药说明书安全性警示信息提出建议。结果在《国家基本医疗保险、工伤保险和生育保险药品目录(2022年)》中的1381种中成药中,含苦杏仁的品种共有67种,收集到的说明书存在安全性内容缺失情况。其中,明确标注警示语具体内容的仅有5种,明确标注不良反应的有17种,明确标注禁忌证的有24种,明确标明注意事项的有58种。从苦杏仁含量和处方占比看,67种含苦杏仁中成药中每日最大用量超过《中华人民共和国药典》用量有2种,有14种中成药处方占比超过10%;从组方配伍看,67种含苦杏仁中成药中配伍了其他毒性中药有25种,上述药品均具有安全风险。结论含苦杏仁中成药说明书关于安全性相关警示内容不够全面,建议根据《已上市中药说明书安全信息项内容修订技术指导原则(试行)》,加强药品全生命周期的管理,增加1级高风险品种的警示语,完善不良反应、禁忌证及注意事项等。Objective To explore the problems arising from the safety content in the instructions of Chinese patent medicines containing bitter almonds and to make suggestions.Methods By searching the Chinese patent medicines containing bitter almonds in the"National Basic Medical Insurance,Work Injury Insurance and Maternity Insurance Drug List(2022)"of the Medication Assistant and Yaozhi Online,the article collated their primary functions,composition,adverse reactions,contraindications to medication,warnings,and precautions.The article entered the collected information into the Excel 2021 version,analyzed the summarized data,and made suggestions for the safety warning information in the instructions of Chinese patent medicines containing bitter almonds based on the results of the statistics.Results Among the 1381 kinds of patent medicines listed in the"National Basic Medical Insurance,Work Injury Insurance,and Maternity Insurance Drug List(2022)",there are 67 varieties of Chinese patent medicines containing bitter almonds,and there were missing safety contents in the collected instructions.Among them,only five types were clearly labeled with specific contents of warnings,17 types were clearly labeled with adverse reactions,24 types were clearly labeled with contraindications,and 58 types were clearly labeled with precautions.However,in terms of the content of bitter almonds and prescription ratio,the maximum daily dosage of 2 out of 67 Chinese patent medicines containing bitter almonds exceeded the dosage of the Chinese Pharmacopoeia,and the prescription ratio of 14 Chinese patent medicines exceeded 10%;in terms of the combination and dosing,25 out of 67 Chinese patent medicines containing bitter almond were dosed with other poisonous traditional Chinese medicines,and the above medicines have high safety risks.The information on their safety should be increased,and their safety information should be increased.Conclusions The safety-related warnings in the instructions for Chinese patent medicines containing bitter almonds

关 键 词：苦杏仁 中成药 说明书 安全性 警示内容 

分 类 号：R286[医药卫生—中药学] R969.3[医药卫生—中医学]