2018年版《国家基本药物目录》收载的中成药品种存在的问题分析  

Analysis of Existing Problems of Proprietary Chinese Medicines in 2018 Edition of the National Essential Medicines List

作　　者：付智慧 施亚敏 张晓川 周政 贾文瑞[1] 朱春胜[1] 聂安政 Fu Zhihui;Shi Yamin;Zhang Xiaochuan;Zhou Zheng;Jia Wenrui;Zhu Chunsheng;Nie Anzheng(Department of Traditional Chinese Medicine,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院中医药学部,郑州450052

出　　处：《中国药事》2021年第8期892-898,共7页Chinese Pharmaceutical Affairs

基　　金：河南省科技发展计划项目(编号212102310346);河南省高等学校重点科研项目计划(编号21A360026)。

摘　　要：目的:通过整理2018年版《国家基本药物目录》收载的中成药品种存在的问题,以期为从事药品相关工作及临床医务人员提供参考。方法:查阅2018年版及2012年版《国家基本药物临床应用指南(中成药)》、2020年版《中华人民共和国药典》、2015年版《中华人民共和国临床用药须知中药成方制剂卷》等权威书籍,以及厂家药品说明书、相关期刊文献,对存在的问题进行深入分析、分类整理。结果:2018年版《国家基本药物目录》收载的中成药品种与2012年版一样,存在"同名异方"问题;除此之外,还存在西黄丸(胶囊)"同方异效"问题、六神丸(胶囊、凝胶)功能表述不一致问题、生脉饮(颗粒、胶囊)党参方是否属国家基本药物问题、通窍耳聋丸的药物组成厂家说明书与权威书籍收录不一致问题。结论:国家基本药物(中成药)存在的这些问题,可能会造成使用单位和使用人员的困惑,影响中成药的合理、安全、有效使用,本研究可为相关人员提供借鉴和参考。Objective:To collate the problems existing in Proprietary Chinese medicines in the National Essential Medicines List(2018 edition),and to provide references for people who are engaged in drug-related work and clinical medical staff.Methods:Authoritative books,including the 2018 and 2012 editions of the National Guidelines for Clinical Application of Essential Medicines(Chinese Patent Medicine),the 2020 edition of the Pharmacopoeia of the People’s Republic of China,and the 2015 edition of the People’s Republic of China Guidelines for Clinical Drug Use of Chinese Traditional Medicine Preparation Volume,drug instructions of the manufacturer and relevant literature were reviewed.The existing problems were analyzed deeply and classificated.Results:The issues of same name with different prescriptions were found in the collections of the 2018 version of the National Essential Medicines List,as it was with the 2012 version.In addition,there are also problems such as same prescription with different effects for Xi Huang pellets(capsules),inconsistency of function expressions for Liushen pills(capsules,gel),the problem of whether Shengmai oral liquid(granules,capsules)with Codonopsis Pilosula is a national essential medicine or not,and inconsistency of drug composition in the instructions and authoritative books for Tongqiao Erlong pills.Conclusion:The existing issues in national essential medicines may result in confusion to the users,which in turn will affect the rational,safe and effective use of proprietary Chinese medicines.This study could provide references for relevant personnel.

关 键 词：国家基本药物 中成药 问题 同名异方 同方异效 

分 类 号：R95[医药卫生—药学]