广东省医疗机构制剂化学药品通用名称命名存在问题及对策  

Problems and Solutions for the Naming of Generic Names for Chemical Drug Preparations in Medical Institutions of Guangdong Province

作　　者：陈家润 沈波 沈小莉[2] 张一凡 王晓英 Chen Jiarun;Shen Bo;Shen Xiaoli;Zhang Yifan;Wang Xiaoying(Center for Evaluation and Certifi cation,Guangdong Medical Products Administration,Guangzhou 510080,China;Guangdong Food and Drug Vocational College,Guangzhou 510520,China)

机构地区：[1]广东省药品监督管理局审评认证中心,广州510080 [2]广东食品药品职业学院,广州510520

出　　处：《中国药事》2022年第10期1117-1121,共5页Chinese Pharmaceutical Affairs

基　　金：广东省食品药品监督管理局定向委托课题项目(编号2016许药01);广东省食品药品监督管理局科技创新项目(编号2018TDZ10)。

摘　　要：目的:分析广东省医疗机构化学药制剂通用名称命名存在的问题,为进一步加强广东省医疗机构化学药制剂通用名称命名的规范化、科学化提供参考。方法:通过对2019-2021年医疗机构制剂再注册技术审评中执行质量标准为《中国医院制剂规范》的广东省医疗机构化学药制剂通用名称、处方、用法与用量等资料进行梳理、归纳,从技术角度阐述医疗机构化学药制剂通用名称命名存在的不足。结果与结论:经过技术审评,有61%执行《中国医院制剂规范》质量标准的化学药制剂品种的通用名称命名存在问题,存在问题主要有以下方面:剂型不规范、滥用和未使用“复方”字眼、以辅料命名、以适应症命名、处方组分相同但处方量比例不同使用同一通用名称。建议国家药品监督管理部门授权相关省级药品监督管理局对执行质量标准为《中国医院制剂规范》的医疗机构化学药制剂通用名称开展规范工作,以促进其通用名称的规范化和科学化。Objective:To analyze the existing problems on the naming of generic names for chemical drug preparations in medical institutions of Guangdong Province,and provide references for further strengthening the standardization and scientization of generic names for chemical drug preparations in medical institutions of Guangdong Province.Methods:The data of the generic names,prescriptions,usage and dosage of chemical drug preparations in medical institutions of Guangdong Province from 2019 to 2021 after technical review by the quality standards in the"Chinese Standard for Hospital Preparations"were combed and summarized.The shortcomings of the naming of generic names for chemical drug preparations in medical institutions were elaborated from the technical point of view.Results and Conclusion:Through technical reviews,sixty-one percent of the chemical pharmaceutical preparations that implemented the quality standards of the"Chinese Standard for Hospital Preparations"had problems with the naming of generic names,which existed mainly in the following aspects:non-standard dosage forms,abuse and non-use of the word"compound",the naming of excipients,the naming of indications,the use of the same generic names with the same prescription components but with diff erent prescription proportions.It is suggested that the National Medical Products Administration authorize relevant provincial medical products administrations to standardize the generic names of chemical pharmaceutical preparations in medical institutions with the quality standard of"Chinese Standard for Hospital Preparations",so as to promote the standardization and scientization of the generic names.

关 键 词：医疗机构制剂(医院制剂) 通用名称 命名原则 药品名称 药品监管 

分 类 号：R95[医药卫生—药学]