中成药说明书用药禁忌调查分析  

Contraindications in package inserts of Chinese patent medicine

作　　者：肖望重[1] 林聪 黄莉[1] 戴冰[1] 高元峰 XIAO Wangzhong;LIN Cong;HUANG Li;DAI Bing;GAO Yuanfeng(Department of Pharmacy,The First Hospital of Hunan University of Chinese Medicine,Changsha Hunan 410007,China;Department of Neurology,Hunan Second People's Hospital,Changsha Hunan 410007,China)

机构地区：[1]湖南中医药大学第一附属医院药剂科,湖南长沙410007 [2]湖南省第二人民医院神经内科,湖南长沙410007

出　　处：《中国药物警戒》2022年第4期400-403,407,共5页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(81803641);湖南省自然基金面上项目(2020JJ4069);第四批湖南省老中医药专家学术经验继承项目(湘中医药函[2020]37号)。

摘　　要：目的为中成药说明书的规范提供建议。方法收集湖南中医药大学第一附属医院2020年1月1日至2020年6月30日所使用的203种中成药说明书,参考《中华人民共和国药典》(2020年版)(简称“《中国药典》”)用药禁忌标注,对比分析药品说明书用药禁忌标注存在的问题。结果仅1种中成药说明书有配伍禁忌标注,7种中成药成分中含反药药对;共23种中成药说明书有证候禁忌标注,其中5种中成药证候禁忌标注与《中国药典》不一致;共57种中成药说明书有妊娠禁忌标注,其中8种中成药妊娠禁忌标注与《中国药典》不一致;共22种中成药说明书有饮食禁忌标注,其中13种中成药饮食禁忌标注与《中国药典》不一致。结论部分中成药说明书用药禁忌标注欠规范,与《中国药典》一致性较差,建议及时补充修订;同时建议《中国药典》加大对中成药用药禁忌研究,完善中成药用药禁忌范围,使中成药应用更合理安全。Objective To provide reference for the standardization of specifications in package inserts of Chinese patent medicine(CPM).Methods The package inserts of two hundred and three types of CPM which were prescribed in the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine between January 1,and June 30,in 2020 were collected.The problems with labeling of those package inserts were compared and analyzed according to the People's Republic of China(2020 edition)(ChP).Results Among the two hundred and three specifications of CPM,only one mentioned the incompatibility of drugs and seven presented antagonistic ingredients.The package inserts of twenty-three specifications mentioned syndrome type contraindications,five of which were inconsistent with the ChP.Fifty-seven specifications contained pregnancy contraindication labels,which were inconsistent with the ChP in five cases.In addition,there were twenty-two specifications that contained diet taboos,thirteen of which differed from those of the ChP.Conclusion Some package inserts of CPM have substandard labels of contraindications that show poor consistency with the ChP.Drug regulatory departments should continue to strengthen supervision and management.Meanwhile,it is necessary to enhance the quality of prescriptions and to improve the contents of the(ChP).

关 键 词：中成药 药品说明书 用药禁忌 中华人民共和国药典 

分 类 号：R994.11[医药卫生—毒理学]