抗生素质量分析研究的新进展

Advances in quality analysis of antimicrobial agents

介绍了中国药典2005年版中收载抗生素品种的特点以及新技术、新方法在新版药典中的应用情况;并对人用药品注册技术要求国际协调会ICH最新增加的指导原则做了介绍;指出现在国内抗生素品种研发存在的几个主要误区;同时简要介绍抗生素分析方法的最新动态。

This paper revieued as follows： （1） the characteristics of antimicroblal agents monograplas and the application of new techniques and methods used in the Chinese Pharmacopoeia 2005 edition; （2） the recent relevant additional guidelines issued by International Conference on Harmonization（ICH）; （3） the key domain mistakes of consciousness found in the research and development of antimicrobial agents in domestic market; （4）the recent advances in quality analysis of antimicrobial agents.