中国药物警戒 ›› 2025, Vol. 22 ›› Issue (4): 372-376.
DOI: 10.19803/j.1672-8629.20240685

• 细菌内毒素检测技术研究专栏 • 上一篇    下一篇

重组促卵泡素β注射液使用凝胶法和重组C因子法检测细菌内毒素的方法学研究

陈晨1, 赵小燕2,△, 蔡彤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,北京 102629;
    2北京联馨药业有限公司,北京 102600
  • 收稿日期:2024-09-04 发布日期:2025-04-17
  • 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:陈晨,女,硕士,助理研究员,药检药理。△为并列第一作者。
  • 基金资助:
    中国食品药品检定研究院中青年发展研究基金课题（2023A1）

Detection of Bacterial Endotoxin in Recombinant Follicle-Stimulating Hormone β Injection Using Gel-Clot Method and Recombinant C-Factor Method

CHEN Chen1, ZHAO Xiaoyan2,△, CAI Tong1, PEI Yusheng1,*   

  1. 1Institute for Chemical Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China;
    2Beijing Lianxin Pharmaceutical Co., Ltd, Beijing 102600, China
  • Received:2024-09-04 Published:2025-04-17

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摘要： 目的 建立重组促卵泡素β注射液的细菌内毒素检测方法,为临床安全应用提供参考。方法 根据《中华人民共和国药典》（2020年版）相关要求,建立重组促卵泡素β注射液细菌内毒素的检测限度;分别使用凝胶法和国内外2家重组C因子试剂盒进行细菌内毒素检测的方法学研究,并对2种检测方法进行对比。结果 经过干扰试验筛选,在稀释80倍后凝胶法和重组C因子法干扰试验均符合规定,可排除干扰,且3批供试品的内毒素含量小于0.25 EU·IU-1,国内外2家重组C因子试剂盒与凝胶法试验结果一致。结论 本研究建立的凝胶法和重组C因子法均适用于重组促卵泡素β注射液的细菌内毒素检测。

关键词: 重组促卵泡素β注射液, 细菌内毒素, 凝胶法, 鲎试剂, 干扰试验, 重组C因子

Abstract: Objective To establish a method for detecting bacterial endotoxins in recombinant follicle-stimulating hormone β injection in order to ensure clinical safety. Methods As required by the pharmacopoeia, the detection limit of bacterial endotoxin for recombinant follicle stimulating hormone β injection was established. The methodology of bacterial endotoxin detection was studied by using the gel method and two recombinant C factor kits made at home and abroad respectively before the two detection methods were compared. Results Interference testing showed that after an 80-fold dilution, both the gel-clot method and the recombinant C-factor method met the specified criteria, with no interference detected. The endotoxin levels in three batches of the test samples were less than 0.25 EU·IU-1. Results from the two recombinant C-factor kits were consistent with those obtained using the gel-clot method. Conclusion Both the gel-clot method and the recombinant C-factor method established in this study are applicable to the detection of bacterial endotoxins in recombinant follicle-stimulating hormone β injection.

Key words: Recombinant Follicle Hormone β Injection, Bacterial Endotoxin, Gel Method, Limulus Amebocyte Lysate, Test for Interference, Recombinant Factor C

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