中国药物警戒 ›› 2024, Vol. 21 ›› Issue (8): 847-851.
DOI: 10.19803/j.1672-8629.20240267

• 细菌内毒素检测技术与实践专栏 • 上一篇    下一篇

检验用鲎试剂及重组试剂的现状与思考

杨宇希1, 裴宇盛2△, 刘涛3, 高华2, 蔡彤2,*   

  1. 1国家药品监督管理局医疗器械技术审评中心,北京 100081;
    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生物医学工程,江苏 苏州 215163
  • 收稿日期:2024-04-28 出版日期:2024-08-15 发布日期:2024-08-21
  • 通讯作者: *蔡彤,女,硕士,主任药师,药品质量控制。E-mail: teddyct@163.com
  • 作者简介:杨宇希,女,硕士,助理研究员,医疗器械技术审评。△为并列第一作者。
  • 基金资助:
    国家重点研发计划（2023YFC2606100）

Current situation and reflection on limulus amebocyte lysate and recombinant reagents for testing

YANG Yuxi1, PEI Yusheng2△, LIU Tao3, GAO Hua2, CAI Tong2,*   

  1. 1 Center for Medical Device Evaluation, NMPA, Beijing 100081, China;
    2 National Institute for Food and Drug Control Institute for Chemical Drug Control, Beijing 102629, China;
    3 Suzhou Institute of Biomedical Engineering and Technology Chinese Academy of Sciences Biomedical Engineering, Suzhou Jiangsu 215163, China
  • Received:2024-04-28 Online:2024-08-15 Published:2024-08-21

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摘要： 目的 通过研究检验用鲎试剂及重组试剂的使用及管理现状,为细菌内毒素检测和鲎试剂使用的科学有序发展提供参考。方法 结合日常医疗产品检测和管理工作实践,梳理检测用鲎试剂的相关历史沿革和国内外监管现状,分析在鲎资源短缺情况下,细菌内毒素检测主要替代方法及其所用重组试剂的基本情况。结果与结论 对目前在无菌医疗产品细菌内毒素检测领域可能面临的原材料短缺、监管方式有待进一步完善等主要问题进行总结,建议明确鲎试剂的管理归属、对医疗产品检验用鲎试剂的质量标准开展标准提高及生产质量管理的研究工作、加强鲎试剂检测替代方法相关试剂的监管等。

关键词: 鲎试剂, 中国鲎, 检测试剂, 细菌内毒素检查法, 替代方法, 重组试剂, 监督, 管理

Abstract: Objective To provide support for the scientific and orderly development of endotoxin detection and the use of limulus amebocyte lysate by studying the current status of the use and management of limulus amebocyte lysate and recombinant reagents for testing. Methods The relevant historical evolution and domestic and international regulatory status of limulus amebocyte lysate for testing were sorted out, and the basic situation of the main alternative methods for endotoxin testing and the recombinant reagents used in the context of horseshoe crab resource shortage was analyzed, combined with daily medical product testing and management practices. Results and Conclusion Summarize and sort out the main problems that may be faced in the field of endotoxin testing for sterile medical products, such as raw material shortages and outdated regulatory methods. Propose suggestions for clarifying the management of limulus amebocyte lysate, conducting research on improving the quality standards and production quality management of limulus amebocyte lysate used in medical product testing, and strengthening the supervision of reagents related to alternative methods for limulus amebocyte lysate testing.

Key words: limulus amebocyte lysate, Chinese horseshoe crab, testing reagent, bacterial endotoxin test method, alternative methods, recombinant reagents, supervision, management

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