《中华人民共和国药典》（2025年版）体外热原检查法解读

doi:10.19803/j.1672-8629.20260140

中国药物警戒 ›› 2026, Vol. 23 ›› Issue (6): 663-666.
DOI: 10.19803/j.1672-8629.20260140

《中华人民共和国药典》（2025年版）体外热原检查法解读

李甜甜¹, 裴宇盛^1Δ, 刘涛³, 王灿^1#, 贺庆^2,*

¹上海市药品检验研究院生物制品检验研究所,上海市创新生物制品质量检验检测中心,上海 201203;
²中国食品药品检定研究院化学药品检定所,北京 102629;
³中国科学院苏州生物医学工程技术研究所,江苏苏州 215163

收稿日期:2026-02-12 出版日期:2026-06-15 发布日期:2026-06-18
通讯作者: ^*贺庆,男,博士,研究员,新型体外热原检测技术。E-mail: heqing@nifdc.org.cn。^#为共同通信作者。
作者简介:李甜甜,女,硕士,主管药师,药物分析与药理学。^△为并列第一作者。
基金资助:
国家重点研发计划（2023YFC2606100）; 基于全生命周期理念的生物技术药物生物活性检测技术国家标准体系的构建与应用（24DZ2201000）

In Vitro Tests for Pyrogens in the Pharmacopoeia of the People’s Republic of China (2025 Edition)

LI Tiantian¹, PEI Yusheng^1Δ, LIU Tao³, WANG Can^1#, HE Qing^2,*

¹Institute of Biological Product Inspection and Research, Shanghai Institute for Drug Control, Shanghai Quality Inspection and Testing Center for Innovative Biological Products, Shanghai 201203, China;
²Institute for Chemical Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China;
³Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou Jiangsu 215163, China

Received:2026-02-12 Online:2026-06-15 Published:2026-06-18

摘要/Abstract

摘要： 目的解读《中华人民共和国药典》（以下简称《中国药典》）（2025年版）新增通则3309体外热原检查法（报告基因法）,为热原检查方法的应用提供指导和参考。方法通过查阅国内外药典及文献,对收载于《中国药典》（2025年版）、欧洲药典（12.2）和美国药典（USPNF 2026 Issue2）中的热原检查方法进行梳理比较,并对《中国药典》新增的体外热原检查法（报告基因法）适用范围、干扰试验、样品测定注意事项以及试验有效标准等进行解析。结果《中国药典》（2025年版）收载的体外热原检查法（报告基因法）是国内外药典首次收载,填补了基于报告基因技术的热原检查法在法定标准体系中的空白。结论体外热原检查法（报告基因法）操作简单、实验周期短（3~6 h）、可检测的热原种类较多,但该方法仍需结合国际进展与国内实践持续修订。

关键词: 中华人民共和国药典, 中国药典, 热原检查法, 报告基因法, 通则3309, 干扰试验

Abstract: Objective To interpret General Requirement 3309 In Vitro Pyrogen Test (a Reporter Gene Assay) in the Pharmacopoeia of the People’s Republic of China (Chinese Pharmacopoeia, ChP) (2025 Edition) so as to provide guidance and references for the application of pyrogen testing methods. Methods By reviewing pharmacopoeias and literature at home and abroad, pyrogen testing methods included in the Chinese Pharmacopoeia (2025 Edition), the European Pharmacopoeia (Ph. Eur. 12.2), and the United States Pharmacopeia (USP-NF 2026 Issue 2) were compared. Furthermore, the scope of application, interference testing, considerations for sample measurement, and system suitability testing specified in General Requirement 3309 In Vitro Pyrogen Test (a Reporter Gene Assay) of the Chinese Pharmacopoeia (2025 Edition) were analyzed. Results The In Vitro Pyrogen Test (a Reporter Gene Assay) stipulated in the Chinese Pharmacopoeia (2025 Edition) was the first to be included in a pharmacopoeia worldwide. The In Vitro Pyrogen Test (a Reporter Gene Assay) filled the gap in reporter gene-based pyrogen testing methods within the regulatory standard system. Conclusion In Vitro Pyrogen Test (a Reporter Gene Assay) is simple to operate, short in experimental cycles (3-6 hours), and able to detect a wide range of pyrogens.However, this method needs to be constantly revised in light of advancements across the globe and domestic practices.

Key words: Pharmacopoeia of the People's Republic of China, Chinese Pharmacopoeia, Pyrogen Test, Reporter Gene Method, General Requirement 3309, Interference Testing

中图分类号:

R954
R917

李甜甜, 裴宇盛, 刘涛, 王灿, 贺庆. 《中华人民共和国药典》（2025年版）体外热原检查法解读[J]. 中国药物警戒, 2026, 23(6): 663-666.

LI Tiantian, PEI Yusheng, LIU Tao, WANG Can, HE Qing. In Vitro Tests for Pyrogens in the Pharmacopoeia of the People’s Republic of China (2025 Edition)[J]. Chinese Journal of Pharmacovigilance, 2026, 23(6): 663-666.

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《中华人民共和国药典》（2025年版）体外热原检查法解读

In Vitro Tests for Pyrogens in the Pharmacopoeia of the People’s Republic of China (2025 Edition)

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