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

作　　者：徐宏山[1] 沈慧莉 付瑞[1] 刘欣玉[1] 李玉华[1] 叶强[1] XU Hong-shan;SHEN Hui-li;FU Rui;LIU Xin-yu;LI Yu-hua;YE Qiang(National Institutes for Food and Drug Control,Beijing 102629,China;Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,Hefei 230088,China)

机构地区：[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

出　　处：《药物分析杂志》2024年第3期542-546,共5页Chinese Journal of Pharmaceutical Analysis

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。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 adaptability 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 

分 类 号：R917[医药卫生—药物分析学]