新型肠道病毒71型(EV71)疫苗质量控制和评价标准的研究  

Quality Control and Evaluation of New Enterovirus 71(EV71) Vaccines

作　　者：毛群颖[1] 姚昕[1] 梁争论[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2012年第12期1319-1321,1347,共4页Chinese Pharmaceutical Affairs

基　　金：国家科技支撑计划(编号2008BAI69B01);国家科技重大专项课题(编号2009ZX10004-804)

摘　　要：目的研究建立新型肠道病毒71型(EV71)疫苗质量控制标准和评价体系,为EV71疫苗研发提供基础。方法根据创新型疫苗研发的要求,充分发挥技术优势,开展EV71疫苗质控标准、标准品和评价方法研究。结果与结论建立EV71灭活疫苗的中和抗体和抗原定量测定标准品,统一不同企业疫苗的质控标准,规范疫苗的评价体系,为EV71疫苗的研发提供保障。Objective To establish quality control standards and evaluation system of new enterovirus 71（EV71） vaccines,thus providing a basis for research and development of the vaccine.Methods According to the requirements for the research and development of innovative vaccines,the quality control standards,reference standards and evaluation methods for EV71 vaccine were carried out by technological advantages.Results and Conclusion The quantitative standards of neutralizing antibody and antigen for EV71 inactivated vaccines were established,the quality control standards for EV71 inactivated vaccines from different companies were unified and the vaccine evaluation system was regulated,which all provided safeguard for the research and development of EV71vaccines.

关 键 词：肠道病毒71型(EV71) 疫苗 质量控制 

分 类 号：R392-33[医药卫生—免疫学] R926[医药卫生—基础医学]