中国药物警戒 ›› 2023, Vol. 20 ›› Issue (11): 1217-1220.
DOI: 10.19803/j.1672-8629.20230410

• 国家药品标准物质研究专栏 • 上一篇    下一篇

首批单核细胞活化反应检查法专用细菌内毒素国家标准品的建立与应用

裴宇盛, 陈晨, 宁霄, 蔡彤*   

  1. 中国食品药品检定研究院化学药品检定所,北京 102629
  • 收稿日期:2023-06-28 出版日期:2023-11-15 发布日期:2023-11-13
  • 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:裴宇盛,男,硕士,副研究员,药品质量控制。
  • 基金资助:
    国家重点研发计划（2021YFC2401103）

Establishment and application of the first batch of national standards for bacterial endotoxin for monocyte activation reaction tests

PEI Yusheng, CHEN Chen, NING Xiao, CAI Tong*   

  1. Institute for Chemical Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2023-06-28 Online:2023-11-15 Published:2023-11-13

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摘要： 目的 为《中华人民共和国药典》（2020年版）9301单核细胞活化反应检查法建立专用的细菌内毒素国家标准品,保障注射剂的质量安全。方法 通过生产制备、协作标定、均匀性考察等研究,建立了首批细菌内毒素国家标准品（单核细胞活化反应检查法专用）。结果 全国5家药品检验所使用3种方法进行协作标定,标定结果间经方差分析无显著性差异,加权平均值为每支152.0 EU,95%置信区间为每支136.2~169.5.0 EU,可信限率为10.96%。均匀性研究符合规定。待标品使用单核细胞活化反应检查法检测结果平均值为每支144.6 EU。最终确定待标品为细菌内毒素国家标准品（单核细胞活化反应测定用）,效价为每支150 EU。结论 建立了首批细菌内毒素国家标准品（单核细胞活化反应检查法用,批号：150608-202101）。

关键词: 细菌内毒素, 标准品, 鲎试剂, 单核细胞活化反应检查法, 协作标定, 安全性

Abstract: Objective To establish a specific national standard for bacterial endotoxins for 9301 monocyte activation reaction tests specified in the Chinese Pharmacopoeia, and to ensure the quality and safety of injections. Methods The first batch of national standards for bacterial endotoxins (for monocyte activation reaction tests) was established through production preparation, collaborative calibration, uniformity inspection and other studies. Results Five institutes of drug control were invited to use three methods for collaborative calibration. The calibration results showed no significant difference as evidenced by analysis of variance. The weighted average of the candidate products was 152.0 EU per vial, with a 95% confidence interval of 136.2~169.5.0 EU per vial, and the confidence limit rate was 10.96%. The result of uniformity study met the requirements. The average value of the test result of the candidate using the monocyte activation reaction test method was 144.6 EU per vial. Finally, the candidate was determined to be the national standard for bacterial endotoxin (for monocyte activation reaction tests), and the potency was 150 EU per vial. Conclusion The first batch of national standard for bacterial endotoxin (for monocyte activation reaction tests) has been established (batch number: 150608-202101).

Key words: bacterial endotoxins, standard products, tachypleus amebocyte lysate/limulus amebocyte lysate, monocyte activation test, collaborative calibration, safety

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