重组戊型肝炎疫苗质量控制和评价研究  

Quality control and evaluation of recombinant hepatitis E vaccine

作　　者：吴星[1] 陈盼[1] 梁争论[1] 

机构地区：[1]中国食品药品检定研究院肝炎病毒疫苗室,北京100050

出　　处：《微生物学免疫学进展》2017年第1期69-73,共5页Progress In Microbiology and Immunology

摘　　要：2012年全球首个戊型肝炎(简称戊肝)疫苗获准在中国上市,为防控戊型肝炎的流行提供了有效办法。提升戊肝疫苗的质量控制和评价标准不但对保证疫苗的质量,推动戊肝疫苗走向世界起着至关重要的作用;而且对今后同类重组疫苗的研究开发具有指导意义。本文就重组戊肝疫苗的质量控制和评价研究作一综述。The global first recombinant hepatitis E vaccine was licensed in China in 2012 and offered an effective way to protect people from hepatitis E virus infection. Efforts to improve quality control and evaluation standards of recombinant hepatitis E vaccine would not only guarantee the quality of vaccine products, but also promote its entry into global drug market ; ultimately, it will provide instructive directions on the development of similar recombinant vaccines. Here we fucus on current status of quality control and evaluation standards on hepatitis E vaccine.

关 键 词：戊型肝炎病毒 疫苗 质量控制 评价 标准 

分 类 号：R392-33[医药卫生—免疫学]