论文部分内容阅读
本文报告了流行性感冒病毒疫苗规模化生产工艺的建立及结果。用鸡胚分别接种A1,A3 ,和B型病毒株 ,培养后进行了纯化、配苗及检定。对培养时间、收获量、离心分离及纯化、灭活、脱糖等重要步骤进行了优化比较。结果表明 ,培养 66小时病毒滴度及收获量达到最高 ;采用蔗糖密度梯度离心可收到理想的分离效果 ;超滤脱糖优于透析法 ;β 丙内酯在生产中是一种理想的灭活剂。并依此筛选出最优化工艺配置 ,建立了切实可行的疫苗规模生产工艺 ,成功制备了质量稳定、安全可靠的疫苗制剂。
This article reports the establishment and results of scale production of influenza virus vaccine. Chicken embryos were inoculated with A1, A3, and B virus strains, respectively, after being purified, sprouted and tested. The important steps such as cultivation time, yield, centrifugation, purification, inactivation and sugar removal were optimized and compared. The results showed that the virus titer and the yield reached the maximum after 66 hours of cultivation. The sucrose density gradient centrifugation could receive the ideal separation effect. The ultrafiltration desalination was better than the dialysis method. Β-propiolactone was an ideal Activator. Based on this, the optimal process configuration was screened out and a practical vaccine scale production process was established. The vaccine preparation with stable quality, safety and reliability was successfully prepared.