国内外药典试药通则比较

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...

Comparison of reagents in domestic and foreign pharmacopoeias

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.