流行性感冒病毒灭活疫苗规模化生产工艺的建立  

Establishment of process to produce vaccine of influenza virus

作　　者：王辉[1] 李克寒[1] 乔建英[1] 胡文权 张振萍 张宏[1] 

机构地区：[1]兰州生物制品研究所,兰州730046

出　　处：《微生物学免疫学进展》2002年第1期23-27,共5页Progress In Microbiology and Immunology

摘　　要：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。Establishment of process to produce in activated vaccine of influenza virus in a large scale was reported in this paper.The embryonated hen eggs that was infected by three types of influenza virus,A 1,A 3,B,respectively were cultivated.Influenza virus was separated from the virus infected allantoic fluid and then,it was purified,formulated and measured.Many important steps,such as duration of culture,yield,separation,purification,,inactivation were compared and optimized.According to the results of experiment on which the most optimal process for vaccine preparation was set up,and safe,and high quality vaccine preparation was produced.

关 键 词：流感病毒 疫苗制剂 纯化工艺 规模化生产工艺 灭活疫苗 

分 类 号：R392-33[医药卫生—免疫学]