中国药物警戒 ›› 2024, Vol. 21 ›› Issue (8): 841-846.
DOI: 10.19803/j.1672-8629.20240341

• 细菌内毒素检测技术与实践专栏 • 上一篇    下一篇

细菌内毒素检查微量凝胶法的研究

张晨雪1, 蔡彤1△, 陈晨1, 刘涛2, 李文龙1, 裴宇盛1,*   

  1. 1中国食品药品检定研究院化学药品检定所药理室,北京 102629;
    2中国科学院苏州生物医学工程技术研究所,中国科学院生物医学检验技术重点实验室,江苏 苏州 215163
  • 收稿日期:2024-05-24 出版日期:2024-08-15 发布日期:2024-08-21
  • 通讯作者: *裴宇盛,男,硕士,副研究员,药检药理。E-mail: pysh@nifdc.org.cn
  • 作者简介:张晨雪,女,硕士,药品质量控制。△为并列第一作者。
  • 基金资助:
    国家重点研发计划（2023YFC2606100）

Study of a microgel method for the examination of bacterial endotoxins

ZHANG Chenxue1, CAI Tong1△, CHEN Chen1, LIU Tao2, LI Wenlong1, PEI Yusheng1,*   

  1. 1Division of Pharmacology, Institute for Chemical Drug Control, National Institute for Food and Drug Control, Beijing 102629, China;
    2Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Key Laboratory of Biomedical Testing Technology, Chinese Academy of Sciences, Suzhou Jiangsu 215163, China
  • Received:2024-05-24 Online:2024-08-15 Published:2024-08-21

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摘要： 目的 通过研究微量凝胶法确定其能否满足《中华人民共和国药典》（2020年版）（简称“《中国药典》”）要求,作为现有细菌内毒素检查法的补充。方法 依据《中国药典》四部“9101 药品质量分析方法验证指导原则”规定,按照其项下“杂质测定”中“限度”项目具体要求,对微量凝胶法（5μL样品+50μL鲎试剂）进行专属性、检测限、耐用度3项内容进行验证,并采用凝胶法和微量凝胶法对85批样品进行品种适用性比较研究,对384批样品进行一致性比对研究。结果 经方法学验证,微量凝胶法符合《中国药典》对定性方法的要求,微量凝胶法与凝胶法相比,品种适用性与一致性比对具有等效结果。结论 微量凝胶法可以作为凝胶法的补充方法在我国推广。

关键词: 细菌内毒素, 鲎试剂, 微量凝胶法, 方法学验证, 品种适用性, 一致性评价, 补充方法

Abstract: Objective To determine whether the microgel method can meet the requirements of Chinese Pharmacopoeia, as a supplement to the existing bacterial endotoxin test method. Methods According to the provisions of “9101 Guidelines for the validation of pharmaceutical quality analysis methods” in Part IV of the Pharmacopoeia of the People’s Republic of China(2020 edition), the microgel method (5 μL samples+50 μL limulus ambocyte lysate) was analyzed for “specificity”, “limit of detection” and “durability” in the item of “Determination of impurities”. The gel method and microgel method were used to compare 85 batches of samples for variety applicability and 384 batches of samples for consistency comparison. Results The microgel method was methodologically validated and showed that it met the requirements of the Pharmacopoeia of the People’s Republic of China for the qualitative methods, and the microgel method was equivalent to the gel method for the comparison of the applicability and consistency of the varieties. Conclusion The microgel method can be promoted as a supplementary alternative to the gel method in China.

Key words: bacterial endotoxin, limulus ambocyte lysate (LAL), microgel method, methodological validation, variety suitability, consistency comparison, complementary and alternative method

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