National biological standards for antibiotics: an overview
10.11665/j.issn.1000-5048.2025111101
- VernacularTitle:抗生素国家生物标准品概览
- Author:
Bufang MA
1
;
Hui LIU
;
Xuan JIN
;
Yanchun FENG
;
Jin LI
Author Information
1. 中国食品药品检定研究院, 北京 102629
- Publication Type:Journal Article 期刊文章
- Keywords:
antibiotics;
biological standards;
potency unit;
multi-component antibiotics
- From:
Journal of China Pharmaceutical University
2026;57(1):108-114
- CountryChina
- Language:Chinese
-
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.
