单核细胞热原检测法的设计与应用要点分析  

Analysis on design and application of monocyte pyrogen assay

作　　者：贺庆(综述)[1] 高华(审校)[1] HE Qing;GAO Hua(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国生物制品学杂志》2020年第8期961-965,共5页Chinese Journal of Biologicals

摘　　要：热原检测技术是保证药品安全性的一项关键技术。随着各类新型生物技术药品的发展,家兔热原检查法及细菌内毒素检查法作为传统热原检测方法控制此类产品安全性的能力正面临严峻挑战,研究建立单核细胞热原检测法替代上述传统热原检测方法是该领域的整体发展趋势,《中国药典》四部(2020版)将收录该方法。本文主要就单核细胞热原检测法的选择、设计、材料、步骤、试验有效性及方法变异等方面对该方法的设计与应用要点进行分析,以期为准确应用该方法控制相关产品的质量提供参考。Pyrogen detection is a key technology to ensure drug safety.With the development of innovative biotechnological drugs,rabbit pyrogen test and bacterial endotoxin test as traditional pyrogen tests to control the safety of those products are facing severe challenges.It is a trend to develop monocyte pyrogen assay instead of the above-mentioned tests.The monocyte pyrogen assay will be included into the Chinese Pharmacopoeia(VolⅣ,2020 edition).This paper mainly introduces the design and application of monocyte pyrogen assay from the aspects of selection,design,materials,steps,test effectiveness and method variation,so as to provide a reference for the quality of relevant products by the method.

关 键 词：热原 家兔热原检查法 细菌内毒素检查法 单核细胞活化反应测定法 

分 类 号：R921.2[医药卫生—药学]