我国生物制品生产用细胞外源因子污染情况检测  

Test for Contamination with Adventitious Agents in Cells Used for Production of Biologics in China

作　　者：孟淑芳[1] 李修兰[1] 冯建平[1] 林林[1] 郎淑惠 王佑春[1] 李德富[1] 

机构地区：[1]中国药品生物制品检定所细胞室,北京100050 [2]国家药品安全评价中心,北京100176

出　　处：《中国生物制品学杂志》2006年第6期627-629,632,共4页Chinese Journal of Biologicals

基　　金："自然科技资源共享描述标准整合试点研究与验证完善"资助项目(课题号:2004DKA30360-09).

摘　　要：目的 对我国目前生物制品生产用细胞外源因子污染情况进行检测。方法 按照《中国生物制品规程》2000版规定的细胞外源因子检测方法，对我国生物制品生产用细胞进行细菌、真菌、支原体及一般外源病毒污染检测。结果 自2003—2006年3月间共检测了用于生物制品生产用细胞库细胞79株。结果显示，被检测的79株细胞中，支原体污染细胞10株，污染阳性率为12．7％；外源病毒污染细胞5株，污染率为6．3％；这5株外源病毒污染的细胞中，2株293细胞体外接种至人二倍体细胞后，致细胞形态明显异常；2株Vero细胞接种鸡胚后，致鸡胚全部死亡；1株Vero细胞接种乳鼠及成鼠后第7天，致接种动物全部死亡，组织病理学检查结果显示，接种待检细胞组小鼠脑组织有不同程度的病变。结论 目前我国生物制品生产用细胞存在一定程度的外源因子污染。Objective To test the contamination with adventitious agents in the cells used for production of biologies in China. Methods Test the bacteria,fungi, mycoplasma and common adventitious viruses in the cells used for production of biologies according to the requirements in Chinese Pharmacopocia（ Volume Ⅲ ,2005 ）. Results A total of 79 cell lines from the cell bank for production of biologics were tested from 2003 to March 2006,of which 10 lines（ 12.7% ） were contaminated with myeoplasma and 5 lines（6. 3% ） with adventitious viruses. Of the 5 cell lines contaminated with adventitious viruses,two 293 cell lines caused the abnormal morphology of human diploid cells inoculated, two Vero cell strains caused the deaths of all the embryonated eggs inoculated, and the other one Vero cell strain caused the deaths of all the suckling or adult mice on the 7th day after inoculation. Histopathological examination proved the pathological changes at various degrees in the brain tissues of mice inoculated. Conclusion The cells for production of biologies in China are contaminated with adventitious agents at a certain degree.

关 键 词：生产用细胞 外源因子 污染 

分 类 号：R392[医药卫生—免疫学]