人二倍体细胞乙型脑炎灭活疫苗毒种的质量评价
Quality evaluation of Japanese encephalitis inactivated vaccine strain in human diploid cells
徐宏山 1沈慧莉 2付瑞 1刘欣玉 1李玉华 1叶强1
作者信息
- 1. 中国食品药品检定研究院,北京 102629
- 2. 安徽智飞龙科马生物制药有限公司,合肥 230088
- 折叠
摘要
目的:对人二倍体细胞(ZFB-3)乙型脑炎灭活疫苗毒种进行质量评价.方法:通过鉴别试验对毒种进行鉴别,以鉴别是否为乙脑病毒;通过脑内滴定法对毒种进行病毒滴度检测,以评估其在人二倍体细胞(ZFB-3)上的适应性和增殖能力;对毒种进行无菌检查、支原体检查、外源病毒因子检查,以检测是否有外源性污染.结果:证明毒种为乙脑病毒,且具有较高的病毒滴度,在人二倍体细胞(ZFB-3)上已较好地适应,且无细菌、真菌、支原体、外源病毒因子污染.结论:人二倍体细胞(ZFB-3)乙型脑炎灭活疫苗毒种质量符合要求,可应用于疫苗的生产.
Abstract
Objective:To evaluate the quality of the Japanese encephalitis inactivated vaccine strain adapted in human diploid cells(ZFB-3).Methods:The virus strain was identified by identification test to determine whether it was Japanese encephalitis virus strain,the virus titer was tested in mice brain to evaluate the adaptabili-ty and proliferation ability of the virus seed on human diploid cells(ZFB-3),the sterility test,mycoplasma test,and external virus factor test was conducted for any external contamination.Results:The virus strain was proved as Japanese encephalitis virus and had been well adapted to human diploid cells(ZFB-3)with high virus titer.The virus strain was free from contamination by bacteria,fungi,mycoplasma or exogenous viral factors.Conclusion:The quality of Japanese encephalitis inactivated vaccine strain adapted in human diploid cells(ZFB-3)meets the requirements and can be applied to vaccine production.
关键词
乙型脑炎病毒/灭活疫苗/人二倍体细胞/毒种/质量评价Key words
Japanese encephalitis virus/inactivated vaccines/human diploid cells/virus strain/quality evaluation引用本文复制引用
出版年
2024
NETL
NSTL
万方数据