热原与细菌内毒素检测法研究进展

doi:10.19803/j.1672-8629.20240821

摘要/Abstract

摘要： 目的介绍各类热原与细菌内毒素检测方法,为建立其标准化检测体系提供参考。方法通过查阅文献,综述体内热原检测法、体外热原检测法以及其他检测法的特点、研究进展及发展趋势。结果全球正逐步淘汰家兔热原检测法,积极推进非动物源性热原与细菌内毒素检测法的发展,但各体外方法仍存在技术局限性。结论鉴于各体外检测方法存在的局限性,需进行深入研究,以保障非肠道用药及机体接触的医疗器械安全。

关键词: 热原, 细菌内毒素, 鲎试剂, 家兔热原检测法, 细胞法, 重组C因子, 检测方法, 替代方法

Abstract: Objective To introduce the detection methods of pyrogen and bacterial endotoxin in order to provide a reference for establishing a standardized detection system. Methods The characteristics, research progress and developments related to pyrogen detection in vivo, pyrogen detection in vitro and other detection methods were outlined based on related literature. Results The rabbit pyrogen method was being phased out globally while non-animal pyrogen and bacterial endotoxin detection methods became more popular. However, each in vivo method had its own technical limitations. Conclusion The limitations of each in vivo detection method make it necessary to ensure the safety of drugs for injection and medical devices.

Key words: Pyrogen, Bacterial Endotoxin, Limulus Reagent, Rabbit Pyrogen Test, Cellular Method, Recombinant Factor C, Detection Method, Alternative Method

中图分类号:

R927
R994.11

刘思含, 裴宇盛, 谭德讲, 孙会敏, 张横, 刘涛, 王冬梅, 贺庆. 热原与细菌内毒素检测法研究进展[J]. 中国药物警戒, 2025, 22(4): 361-367.

LIU Sihan, PEI Yusheng, TAN Dejiang, SUN Huimin, ZHANG Heng, LIU Tao, WANG Dongmei, HE Qing. Research Progress in Detection Methods of Pyrogen and Bacterial Endotoxin[J]. Chinese Journal of Pharmacovigilance, 2025, 22(4): 361-367.

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https://zgywjj.magtechjournal.com/CN/Y2025/V22/I4/361

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