森林脑炎灭活疫苗效力试验国家参考品的研制  

Development of national reference materials for efficacy testing of the inactivated tick-borne encephalitis vaccine

作　　者：刘晶晶[1] 李景良 刘晓辉 姜崴 李玉华[1] LIU Jing-jing;LI Jing-liang;LIU Xiao-hui;JIANG Wei;LI Yu-hua(Department of Arbovirus Vaccine,National Institutes for Food and Drug Control,Beijing 102629,China;不详)

机构地区：[1]中国食品药品检定研究院虫媒病毒疫苗室,北京102629 [2]长春生物制品研究所有限责任公司疫苗三室,吉林长春130012

出　　处：《微生物学免疫学进展》2022年第3期15-18,共4页Progress In Microbiology and Immunology

摘　　要：目的研制森林脑炎灭活疫苗效力试验国家参考品,用于该疫苗的效力质量控制。方法该参考品系用森林脑炎病毒“森张”株感染原代地鼠肾细胞,经连续收获、浓缩、灭活、纯化后添加铝佐剂和稳定剂分装制成。采用小鼠体内效力试验方法对该参考品进行协作标定赋值。随机抽取15个标定样品,检测抗原含量,考察该参考品的均匀性和稳定性。结果经协作标定,该参考品的免疫保护指数为4.8×10^(7),参考范围为9.1×10^(6)~2.5×10^(8),均匀性和稳定性均良好。结论成功研制了森林脑炎灭活疫苗效力试验国家参考品,完善了效力试验的检测方法。Objective To improve the quality control of the inactivated tick-borne encephalitis vaccine,the first lot of national reference materials for efficacy testing was prepared.Methods The national reference vaccine was prepared by infecting the primary hamster kidney cell with tick-borne encephalitis virus(strain“Sen Zhang”),and then added aluminum adjuvant and stabilizer after virus harvesting,concentration,inactivation and purification.In vivo potency assay in mice was used for the collaborative calibration of the reference materials.Randomly take 15 samples to test the uniformity and stability of the reference products by measuring the antigen content.Results The value of the reference materials for efficacy testing was stated as 4.8×10^(7) according to collaborative calibration,ranged from 9.1×10^(6) to 2.5×10^(8),which showed that the reference vaccine had good uniformity and stability.Conclusion The national reference materials were successfully developed for assessing the efficacy of the inactivated tick-borne encephalitis vaccine.

关 键 词：森林脑炎灭活疫苗 效力试验 参考品 质量控制 

分 类 号：R373[医药卫生—病原生物学] TQ464.7[医药卫生—基础医学]