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.
出处
《中华医学杂志》
CAS
CSCD
北大核心
1998年第4期261-262,共2页
National Medical Journal of China
基金
"八五"攻关课题
