中国药科大学学报2026，Vol.57Issue(1)：108-114,7.DOI:10.11665/j.issn.1000-5048.2025111101
抗生素国家生物标准品概览
National biological standards for antibiotics:an overview
摘要
Abstract
National biological standards for antibiotics are critical components of the antibiotic quality control system and serve as reference materials for measuring and calibrating the biological activity of antibiotics.This article systematically reviews the classification,definition of potency units,and current research status of commercially available national antibiotic biological standards in China.At present,these standards can be categorized based on chemical structure,number of components,and development methods.The definition of potency units has evolved from an early"arbitrarily assigned unit"to"being represented by the mass of the antibiotic salt"and,more recently,to the current mainstream approach of"being represented by the mass of the active ingredient".This evolution reflects a shift in quality control philosophy from primarily biological analysis to a system dominated by chemical analysis supplemented by biological methods.Current research focuses on optimizing potency determination methods,studying the unification of content and potency,and implementing dual quality control of both the potency and the ratio/content of active components in multi-component antibiotics.For complex multi-component antibiotics,the microbiological assay based on biological activity remains irreplaceable in quality control.Future efforts should emphasize further method optimization,ensuring batch-to-batch consistency of standards,and advancing precision quality control as key research priorities for antibiotic biological standards.关键词
抗生素/生物标准品/效价单位/多组分抗生素Key words
antibiotics/biological standards/potency unit/multi-component antibiotics分类
医药卫生引用本文复制引用
马步芳,刘慧,金轩,冯艳春,李进..抗生素国家生物标准品概览[J].中国药科大学学报,2026,57(1):108-114,7.基金项目
This study was supported by the Project of National Key Laboratory of Drugs Regulatory Science(2025SKLDRS0309) 药品监管科学全国重点实验室课题(No.2025SKLDRS0309) （2025SKLDRS0309）
