中国药物警戒 ›› 2025, Vol. 22 ›› Issue (10): 1127-1131.
DOI: 10.19803/j.1672-8629.20250396

• 安全与合理用药 • 上一篇    下一篇

《中华人民共和国药典》（2025年版）细菌内毒素检查法应用指导原则修订解读

裴宇盛1, 高华1, 朱冉2, 刘涛3, 蔡彤1,*   

  1. 1中国食品药品检定研究院化学药品检定所,北京 102629;
    2国家药典委员会,北京 100061;
    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:2025-06-18 出版日期:2025-10-15 发布日期:2025-10-20
  • 通讯作者: *蔡彤,女,硕士,主任药师,药检与药理研究。E-mail: teddyct@163.com
  • 作者简介:裴宇盛,男,硕士,副研究员,药检与药理研究。
  • 基金资助:
    国家重点研发计划（2023YFC2606100）

Interpretations of Revised Guidelines for Bacterial Endotoxin Testing in Chinese Pharmacopoeia 2025

PEI Yusheng1, GAO Hua1, ZHU Ran2, LIU Tao3, CAI Tong1*   

  1. 1Institute for Chemical Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China;
    2Chinese Pharmacopoeia Commission, Beijing 100061, China;
    3Suzhou Institute of Biomedical Engineering and Technology Chinese Academy of Sciences, Suzhou Jiangsu 215163, China
  • Received:2025-06-18 Online:2025-10-15 Published:2025-10-20

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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）细菌内毒素检查法应用指导原则9251的修订内容,以提高细菌内毒素检查的科学性和可操作性。方法 系统分析《中国药典》（2025年版）中细菌内毒素检查法应用指导原则的修订变化,深入研究修订的背景及其实际应用意义。结果 修订内容主要包括：①新增眼科用药的内毒素限值规定;②完善原辅料和包材的限度制定要求;③增加常见干扰因素及排除措施;④详细描述难溶性样品和包材的前处理方法;⑤介绍低内毒素回收率现象;⑥明确重组C因子法作为补充方法。结论 本次修订体现我国药品质量控制水平的提升,为相关从业人员提供更加科学和实用的技术指导,对提高药品质量控制水平具有重要意义。

关键词: 中国药典, 细菌内毒素检查法, 应用指导原则, 修订, 低内毒素回收率现象, 美国药典

Abstract: Objective To interpret the revised guidelines for bacterial endotoxin testing (9251) in Chinese Pharmacopoeia 2025 in order to help make the related testing more precise and feasible. Methods The modifications in the guidelines for bacterial endotoxin testing specified in Chinese Pharmacopoeia 2025 were analyzed. The background for the revision and implications were studied in depth. Results The major revisions included① specifications of endotoxin limits for ophthalmic medications; ②refined limit-setting requirements for raw materials, excipients, and packaging materials; ③ common interferents and ways of removal; ④ detailed descriptions of pretreatment methods for poorly soluble samples and packaging materials; ⑤ descriptions of low endotoxin recovery; ⑥ the specification of the recombinant factor C method as a complementary approach. Conclusion These revisions reflect better standards for pharmaceutical quality control in China and provide more practical technical guidance for professionals, which are of vital importance for quality control of pharmaceuticals.

Key words: Chinese Pharmacopoeia, Bacterial Endotoxin Testing, Guidelines, Revision, Low Endotoxin Recovery, United States Pharmacopeia

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