分枝杆菌检测在生物制品质量控制中的应用  

Application of mycobacteria detection in quality control of biological products

作　　者：王静(综述)[1] 孟丽(综述)[2] 姚亚夫(审校)[3] 

机构地区：[1]成都生物制品研究所有限责任公司质量检定室,610023 [2]成都生物制品研究所有限责任公司质量保证部,610023 [3]成都生物制品研究所有限责任公司所长办公室,610023

出　　处：《国际生物制品学杂志》2013年第3期141-145,共5页International Journal of Biologicals

摘　　要：根据世界卫生组织和美国食品药品管理局对生物制品中分枝杆菌检测的最新要求，乙型脑炎减毒活疫苗质量控制中首次增加了分枝杆菌检测项目。此文概述了分枝杆菌的特性和分类、不同种类分枝杆菌的致病性以及分枝杆菌检测的常用技术，并介绍了在乙型脑炎减毒活疫苗质量控制中检测分枝杆菌的不同方法。核酸扩增法检测分枝杆菌是我国首次用于生物制品质量控制。According to the latest requirements of World Health Organization and U. S. Food and Drug Administration for detecting mycobacteria in biological products, mycobaeteria detection is first added to quality control of live attenuated Japanese encephalitis vaccine. This article reviews classification and characteristics of myeobacteria, pathogenicity of different kinds of myeobacteria and common technology for detecting myeobaeteria, and introduces different methods for detecting mycobaeteria in quality control of Japanese encephalitis vaccine. Nucleic acid amplification assay for detecting mycobacteria is first applied to quality control of biological products in our country.

关 键 词：分枝杆菌 生物制品 质量控制 日本脑炎疫苗 

分 类 号：R[医药卫生]