国内外药典试药通则比较  

Comparison of reagents in domestic and foreign pharmacopoeias

作　　者：武建卓[1] 彭洁[1] 洪建文[1] 罗卓雅[1] WU Jianzhuo;PENG Jie;HONG Jianwen;LUO Zhuoya(Guangdong Institute for Drug Control,NMPA Key Laboratory for Rapid Testing Technology of Drugs,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所,国家药品监督管理局药品快速检验技术重点实验室,广州510663

出　　处：《中国药品标准》2021年第2期129-134,共6页Drug Standards of China

基　　金：国家药典委员会标准提高项目(编号2020Y01)。

摘　　要：目的:通过对国内外药典的试药通则进行全面比较,探讨如何修订完善《中国药典》试药通则。方法:对中、日、英、美四国药典及欧洲药典从试药通则的通用要求,体例格式,具体品种的分类分级以及关键指标的限度和方法等方面分别进行对比和讨论。结果与结论:《中国药典》试药标准应与国家化学试剂标准相协调,通用技术要求应丰富,试药品种的关键质量要求及其检测方法需增加,以使试药通则切实起到对药品检测的指导作用。Objective:The paper compared the general principles of reagents in domestic and foreign pharmacopoeias,and discussed how to revise and improve the general principles of reagents in the Chinese Pharmacopoeia.Methods:The Pharmacopoeias of China,Japan,Britain,the United States and Europe were compared and discussed in terms of general technical requirements,style and format,classification of substances in monographs,limits and assays of key indicators.Results and Conclusion:The general principles of reagents in the Chinese Pharmacopoeia should be consistent with the national chemical reagent standards,enrich the general technical requirements,and increase the key quality requirements and assays of reagents,so that the general principles of reagents can play a guiding role in drug testing.

关 键 词：试药 中国药典 日本药局方 英国药典 美国药典 欧洲药典 

分 类 号：R921.2[医药卫生—药学]