Page 114 - 《中国药科大学学报》2026年第1期

学报
108 Journal of China Pharmaceutical University 2026, 57(1): 108 − 114

·综 述·

抗生素国家生物标准品概览

马步芳，刘 慧，金 轩，冯艳春 ，李 进 **
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（中国食品药品检定研究院, 北京 102629）

摘 要 抗生素国家生物标准品是抗生素质量控制体系中的重要组成部分，是衡量和校准抗生素生物活性的基础物质。本
文系统梳理了我国在售抗生素国家生物标准品的分类、效价单位定义及研究现状。目前，标准品可根据化学结构、组分数量
及研制方式进行分类；其效价单位的定义经历了从早期“人为指定单位”到“以抗生素盐的质量表征”，发展为当前主流的“以
活性成分质量表征”，体现了质量控制理念从生物学分析向化学分析为主、生物学分析为辅的转变。当前工作主要聚焦于效
价测定方法优化、量效统一化研究及多组分抗生素的效价和活性组分的比例/含量双重质控等方面。对于成分复杂的多组分
抗生素而言，基于生物活性的微生物检定法在质控中仍具不可替代性。未来，进一步关注方法优化、确保标准品批次间的稳
定性并推进精准质控，将是抗生素生物标准品的重要研究课题。
关键词 抗生素；生物标准品；效价单位；多组分抗生素
中图分类号 R978.1;R927 文献标志码 A 文章编号 1000−5048(2026)01−0108−07
doi：10.11665/j.issn.1000−5048.2025111101

引用本文 马步芳，刘慧，金轩，等. 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.

Cite this article as: MA Bufang, LIU Hui, JIN Xuan, et al. National biological standards for antibiotics: an overview[J]. J China Pharm Univ,
2026, 57(1): 108-114.

National biological standards for antibiotics: an overview
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MA Bufang, LIU Hui, JIN Xuan, FENG Yanchun , LI Jin **
National Institutes for Food and Drug Control, Beijing 102629, China

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.
Key words antibiotics; biological standards; potency unit; multi-component antibiotics

This study was supported by the Project of National Key Laboratory of Drugs Regulatory Science (2025SKLDRS0309)

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收稿日期 2025-11-11 通信作者 E-mail：fyc@nifdc.org.cn
**
E-mail：medjinli@126.com
基金项目 药品监管科学全国重点实验室课题（No.2025SKLDRS0309）