中国药典2020年版抑菌效力检查法修订介绍

目的 介绍中国药典（Chinese Pharmacopoeia，ChP）2020年版抑菌效力检查法修订情况。方法 对比ChP 2020年版与ChP 2015年版抑菌效力检查法内容的主要差异，同时分析ChP、美国药典（USP）、欧洲药典（EP）、英国药典（BP）、日本药局方（JP）等主要药典相关内容的区别与联系。结果 ChP 2020年版抑菌效力检查法在培养体系、测试菌种等方面都做了修订，更适合指导药物制剂中抑菌剂的筛选和抑菌体系的建立。结论 ChP 2020年版抑菌效力检查法进一步获得提高，成为更加完善的方法，既可用于指导药品研发阶段抑菌剂的筛选，也可用于上市药品抑菌剂添加是否科学合理的评价，有利于保证药品安全有效。

Introduction to the Revision of the Antimicrobial Effectiveness Testing of Chinese Pharmacopoeia 2020 Edition

OBJECTIVE To introduce the main revision situation about antimicrobial effectiveness testing of the Chinese Pharmacopoeia(ChP) 2020 Edition. METHODS Compared antimicrobial effectiveness testing of ChP 2020 Edition to the relevant content of the ChP 2015 Edition, the differences and links between the main pharmacopoeias such as ChP, US Pharmacopoeia(USP), European Pharmacopoeia(EP), British Pharmacopoeia(BP), and Japanese Pharmacopoeia(JP) were analyzed at the same time. RESULTS The antimicrobial effectiveness testing of ChP 2020 Edition had been revised in the culture system, test strains, and so on, it was more suitable to guide the screening of antibacterial agents and the establishment of antibacterial systems in the pharmaceutical preparations. CONCLUSION The antimicrobial effectiveness testing has been further improved to become a more complete method, which can be used to guide the screening of bacteriostatic agents in the drug development stage, and can also be used for the scientific and reasonable evaluation of the addition of bacteriostatic agents for listed drugs, which is conducive to ensuring drug safety and effective.