综述

分枝杆菌检测在生物制品质量控制中的应用

  • 王静 孟丽 姚亚夫
展开
  • 610023 成都生物制品研究所有限责任公司质量检定室(王静)、质量保证部(孟丽)、所长办公室(姚亚夫)

网络出版日期: 2025-08-16

Application of mycobacteria detection in quality control of biological products

Expand
  • Quality Control Department, Chengdu Institute of Biological Products Co., Ltd., Chengdu, 610023, China

Online published: 2025-08-16

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。

本文引用格式

王静 孟丽 姚亚夫 . 分枝杆菌检测在生物制品质量控制中的应用[J]. 国际生物制品学杂志, 2013 , 36(3) : 141 -145 . DOI: 10.3760/cma.j.issn.1673-4211.2013.03.007

Abstract

 According to the latest requirements of World Health Organization and U.S. Food and Drug Administration for detecting mycobacteria in biological products, mycobacteria detection is first added to quality control of live attenuated Japanese encephalitis vaccine. This article reviews classification and characteristics of mycobacteria, pathogenicity of different kinds of mycobacteria and common technology for detecting mycobacteria, and introduces different methods for detecting mycobacteria 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.
文章导航

/