单核细胞活化检测法应用研究进展

doi:10.19803/j.1672-8629.20250672

摘要/Abstract

摘要： 目的针对传统热原检测方法存在的动物伦理问题、种属差异及检测范围局限等不足，开发并应用更灵敏、广谱且符合“3R”（减少、替代、优化）原则的非动物体外检测技术，以提升药品的热原安全性控制水平。方法通过查阅文献，综述单核细胞活化检测法（MAT）的特点、研究进展及发展趋势。结果 MAT技术具有效检测低浓度热原;既能识别内毒素，也能检测非内毒素热原;完全体外操作，符合“3R”原则等优势。结论 MAT作为新兴的非动物热原检测技术，凭借其高灵敏度、广谱性和伦理优势，能够为药品安全性及有效性提供有力保障。

关键词: 热原, 内毒素, 非内毒素, 单核细胞活化检测法, 药典

Abstract: Objective To develop a more sensitive, broad-spectrum, three-R (replacement, reduction and refinement) and non-animal in vitro platform in order to address ethical concerns, species-specific variations, and limited ranges of detection inherent in conventional methods for detection of pyrogens. Methods By reviewing the related literature, the characteristics, research progress and developments concerning the monocyte activation test (MAT) were summarized. Results The MAT technology proved capable of sensitive and broad-spectrum detection of endotoxins and non-endotoxin pyrogens (NEPs) In addition, this technology could be used entirely in vitro and without using any animal. Conclusion This study has validated the MAT as a robust and ethically-feasible technology for ensuring the safety and efficacy of drugs.

Key words: Pyrogen, Endotoxin, Non-Endotoxin, Monocyte Activation Test, Pharmacopoeia

中图分类号:

R927.1

吴昊, 贺庆, 蔡彤, 裴宇盛, 刘涛, 王冬梅. 单核细胞活化检测法应用研究进展[J]. 中国药物警戒, 2026, 23(2): 213-218.

WU Hao, HE Qing, CAI Tong, PEI Yusheng, LIU Tao, WANG Dongmei. Research Progress in Applications of MAT[J]. Chinese Journal of Pharmacovigilance, 2026, 23(2): 213-218.

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