转瓶培养非洲绿猴肾传代细胞生产纯化流行性乙型脑炎疫苗的研究  

Production of purified Japanes encephalitis vaccine from Vero cells with roller bottles

作　　者：丁志芬[1] 石慧颖[1] 庞成华[1] 常振彦[1] 赵敏[1] 李荆[1] 杨抗抗[1] 刘培生[1] 

机构地区：[1]卫生部北京生物制品研究所

出　　处：《中华医学杂志》1998年第4期261-262,共2页National Medical Journal of China

基　　金："八五"攻关课题

摘　　要：目的研究用１５Ｌ转瓶培养非洲绿猴肾传代细胞（Ｖｅｒｏ细胞）生产纯化流行性乙型脑炎（以下简称乙脑）疫苗的工艺，提高乙脑疫苗的质量。方法用１５Ｌ转瓶培养Ｖｅｒｏ细胞和扩增乙脑病毒，病毒经过灭活、浓缩、硫酸鱼精蛋白处理、蔗糖密度梯度区带离心纯化，制备成冻干疫苗。结果建立了一套１５Ｌ转瓶培养Ｖｅｒｏ细胞生产纯化乙脑疫苗的工艺，用此工艺制备三批冻干疫苗，经检定疫苗质量达到同类产品的国际水平，已通过新药审评，人体安全性和效果观察正在进行中。结论转瓶培养Ｖｅｒｏ细胞生产纯化乙脑疫苗是可行的。Objective To study the production process of purified Japanese encephalitis (JE) vaccine from Vero cells cultivated in roller bottles to improve the quality of JE vaccine. [WT5”HZ〗Methods The 15L roller bottles were used for propagation of Vero cells and JE virus,then the virus was inactivated,concentrated,treated by protamine sulphate,purified by sucrose gradient density centrifugation and lyophylized as final product. Results Three batches of high quality lyophylized vaccine were produced and the quality control tests of vaccine for human use had been passed. Conclusion Using roller bottles to cultivate continuous cell line Vero cells for JE vaccine production is feasible.

关 键 词：流行性乙型脑炎 疫苗 纯化 生产 VERO细胞 

分 类 号：R392－33[医药卫生—免疫学] R512.320.3[医药卫生—基础医学]