某院中成药药品说明书安全信息项标注情况分析  

Analysis on the Labelling of Safety Information Items in the Instructions of Chinese Patent Medicines

作　　者：李艳平 蒋婷婷 伍渊麟 张妮 彭丹 刘耀 LI Yanping;JIANG Tingting;WU Yuanlin;ZHANG Ni;PENG Dan;LIU Yao(Army Medical Center of the PLA,Chongqing,China 400042)

机构地区：[1]中国人民解放军陆军特色医学中心,重庆400042

出　　处：《中国药业》2025年第4期25-29,共5页China Pharmaceuticals

基　　金：军队中医药服务能力培育与提升专项[2023ZY014];重庆市临床药学重点专科建设项目[渝卫办发[2020]68号];重庆市中青年医学高端人才项目。

摘　　要：目的为完善中成药药品说明书的标注提供参考。方法以某院中成药药品目录为参考,通过国家药品监督管理局(以下简称国家药监局)药品审评中心、企业官方网站及药智网获取最新药品说明书,记录并分析信息项标注情况。结果共涉及中成药142种,其中处方药118种(83.10%),非处方药24种(16.90%);排名前3的剂型分别为胶囊剂(50种,35.21%),片剂(31种,21.83%)和颗粒剂(22种,15.49%)。【禁忌】、【不良反应】、【注意事项】(均为必须明确标注的安全事项),标注明确率分别为54.93%,55.63%,80.28%,标注“尚不明确”的比例分别为44.37%,44.37%,19.72%,【禁忌】项标注缺失的仅有1种(0.70%)中成药。【警示语】、【特殊人群用药】、【药物相互作用】、【药理毒理】、【临床试验】(其他安全事项),标注明确率分别为17.61%,4.93%,3.52%,40.14%,14.79%,“尚不明确”标注率分别为0,0.70%,15.49%,0,0,标注缺失率分别为82.39%,94.37%,80.99%,59.86%,85.21%。结论中成药药品说明书【禁忌】、【不良反应】、【注意事项】存在内容缺失、标注模糊、更新不及时的问题,其他安全事项标注缺失问题较严重。建议拓展中成药药品说明书信息来源,规范撰写并及时更新,同时构建完备的专业人才团队,促进中成药的安全、合理使用。Objective To provide a reference for improving the labeling of instructions of Chinese patent medicines.Methods Based on the Chinese patent medicines catalogue of a hospital,the latest information of the drug instructions was obtained from the official websites of the Center for Drug Evaluation,NMPA,enterprises and www.yaozh.com,and the information labeling was recorded and analyzed.Results There were 142 kinds of Chinese patent medicines involved,including 118 prescription drugs(83.10%)and 24 non-prescription drugs(16.90%).The top three dosage forms were capsules(50 types,35.21%),tablets(31 types,21.83%),and granules(22 types,15.49%).The safety items that must be clearly labeled according to the NMPA regulations included contraindications,adverse reactions and precautions,with the clear labeling rates of 54.93%,55.63%,80.28%respectively,the"not clear"labeling rates of 44.37%,44.37%,19.72%respectively;there was only one Chinese patent medicines(0.70%)with missing information of contraindication.Other safety items included warnings,use in special populations,drug interactions,pharmacology and toxicology,and clinical trials,with the clear labeling rates of 17.61%,4.93%,3.52%,40.14%,14.79%,respectively,the"not clear"labeling rates of 0,0.70%,15.49%,0,0,respectively,the missing labeling rates of 82.39%,94.37%,80.99%,59.86%,85.21%,respectively.Conclusion The contraindications,adverse reactions and precautions in the instructions of Chinese patent medicines have the problems of missing content,vague labeling and untimely updating,and the labeling of other safety items are missing seriously.It is suggested to expand the information source,standardize the writing and timely update the drug instructions,and construct a complete professional team to promote the safe and rational use of Chinese patent medicines.

关 键 词：中成药 药品说明书 安全信息项 不良反应 禁忌 注意事项 

分 类 号：R95[医药卫生—药学]