建立我国百日咳组分纯化疫苗质量标准的探讨  

Discussion on development of quality standard for pertussis component vaccine isolated and purified in China

作　　者：骆鹏[1] 马霄[1] 侯启明[1] 

机构地区：[1]中国食品药品检定研究院卫生部生物技术产品检定方法及其标准化重点实验室,北京100050

出　　处：《中国生物制品学杂志》2013年第9期1351-1354,共4页Chinese Journal of Biologicals

基　　金：国家高技术研究发展计划(863计划)课题疫苗效果和质量评价新技术研究(2012AA02A402)

摘　　要：百日咳组分纯化疫苗相对于共纯化疫苗,成分明确,更安全有效,更利于质量监管。我国的百日咳组分纯化疫苗已研制成功并开始应用,旧的共纯化苗质量标准已不适用,国际上尚无统一的组分苗质量标准。本文借鉴国内外研究,从疫苗有效成分(组分抗原)、安全性和有效性检测方面,对建立我国百日咳组分纯化疫苗的质量标准进行探讨。Compared with co-purified pertussis vaccine, purified pertussis component vaccine with definite component is more safe and more effective, which is beneficial to quality monitoring and management, and has been developed and applied in China. Because of the inapplicability and the disunity of the quality standard for co-purified vaccine, and there is no unique international quality standard for pertussis, the standard for control the pertussis component vaccine in China is in lack. Based on the researches on tests for active component （component antigen）, safety and efficacy ofpertussis component vaccine in China and abroad, this paper reviews and discusses the development of quality standard for the vaccine in China.

关 键 词：百日咳 组分疫苗 质量标准 

分 类 号：R378.996[医药卫生—病原生物学] R392-33[医药卫生—基础医学]