中国药业2025，Vol.34Issue(4)：25-29,5.DOI:10.3969/j.issn.1006-4931.2025.04.007
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
摘要
Abstract
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Key words
Chinese patent medicines/drug instruction/safety information item/adverse reaction/contraindication/precaution分类
医药卫生引用本文复制引用
李艳平,蒋婷婷,伍渊麟,张妮,彭丹,刘耀..某院中成药药品说明书安全信息项标注情况分析[J].中国药业,2025,34(4):25-29,5.基金项目
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. （）
