低细菌内毒素回收现象及其缓解方式研究

doi:10.19803/j.1672-8629.20240502

中国药物警戒 ›› 2025, Vol. 22 ›› Issue (1): 72-75.
DOI: 10.19803/j.1672-8629.20240502

低细菌内毒素回收现象及其缓解方式研究

裴宇盛¹, 徐琳^2,∆, 赵雨歆^1,3, 蔡彤^1#, 华晓东^2,*

¹中国食品药品检定研究院化学药品检定所,北京 102629;
²天津市药品检验研究院药理室,天津 300070;
³沈阳药科大学药学院,辽宁沈阳 117004

收稿日期:2024-07-26 出版日期:2025-01-15 发布日期:2025-01-22
通讯作者: ^*华晓东,男,硕士,研究员,药检药理。E-mail: Hxd720527@126.com^#为共同通信作者。
作者简介:裴宇盛,男,硕士,副研究员,药品质量控制研究。^△为并列第一作者。
基金资助:
国家重点研发计划（2023YFC2606100）

Low Endotoxin Recovery and Mitigation Strategies

PEI Yusheng¹, XU Lin^2,∆, ZHAO Yuxin^1,3, CAI Tong^1#, HUA Xiaodong^2,*

¹Institute for Chemical Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China;
²Division of Pharmacology, Tianjin Institutes for Drug Control, Tianjin 300070, China;
³School of Pharmacy, Shenyang Pharmaceutical University, Shenyang Liaoning 117004, China

Received:2024-07-26 Online:2025-01-15 Published:2025-01-22

摘要/Abstract

摘要： 目的研究药品生产过程中低细菌内毒素回收现象的发生机制,降低药品生产放行环节中潜在的内毒素污染风险,防止具有致热性的药品流向市场危及患者用药安全。方法从低内毒素回收的定义、产生机制、其与其他干扰因素的区别及缓解措施等角度,探讨该现象的发生原因。结果和结论 通过采取的纠正低内毒素回收现象的方法,消除该风险,以期达到对药品生产过程的质量控制,最终实现对药品质量的监管,保障用药安全。

关键词: 低内毒素回收, 内毒素掩蔽, 形成机制, 细菌内毒素检测, 缓解措施, 质量控制

Abstract: Objective To investigate the mechanism of low endotoxin recovery (LER) in the process of manufacturing pharmaceuticals, reduce potential endotoxin contamination risks during product release, and prevent pyrogenic products from entering the market that may compromise patient safety. Methods The causes of LER were explored in terms of definitions, mechanisms, differences from other interferences, and mitigation strategies. Results and Conclusion By taking corrective measures for LER, the associated risks can be eliminated, quality control exercised throughout the manufacture, and drug quality supervision and medication safety ensured.

Key words: Low Endotoxin Recovery, Endotoxin Masking, Potential Mechanism, Bacterial Endotoxin Test, Strategies for Mitigation of LER, Quality Control

中图分类号:

R927

裴宇盛, 徐琳, 赵雨歆, 蔡彤, 华晓东. 低细菌内毒素回收现象及其缓解方式研究[J]. 中国药物警戒, 2025, 22(1): 72-75.

PEI Yusheng, XU Lin, ZHAO Yuxin, CAI Tong, HUA Xiaodong. Low Endotoxin Recovery and Mitigation Strategies[J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 72-75.

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低细菌内毒素回收现象及其缓解方式研究

Low Endotoxin Recovery and Mitigation Strategies

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