新型佐剂疫苗药学研究的思考  

The CMC consideration of novel adjuvant vaccines

作　　者：郭舒杨 李敏 GUO Shu-yang;LI Min(Center for Drug Evaluation,Nation Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2020年第17期1939-1943,共5页Chinese Journal of New Drugs

摘　　要：新型佐剂以及新型佐剂疫苗逐渐成为疫苗研究领域的新热点,目前如采用新佐剂的人乳头状瘤病毒(HPV)疫苗、乙肝疫苗和带状疱疹疫苗等已通过临床研究证实具有较大突破,并获得全球多个国家批准上市。由于新型佐剂制备工艺及质量控制与传统的铝佐剂不同,因此对于新佐剂及新型佐剂疫苗的药学研究也存在一些特点。本文就新型佐剂疫苗的发展,结合各国监管机构的指导原则以及审评实践,对其药学研究共性问题进行了一些探索与思考。Novel adjuvants and novel adjuvant vaccines have gradually become a new hotspot in vaccine research area. At present, HPV vaccine, hepatitis B vaccine and herpes zoster vaccine with novel adjuvants have been proved a great breakthrough in clinical researches and have gained approval in many countries. Because of the differences of preparation process and quality control between novel adjuvants and traditional aluminum adjuvants, there are some characteristics in CMC research on novel adjuvants and new adjuvant vaccines. In this paper, combined with the guiding principles of national regulatory agencies and review practices, common problems in pharmaceutical research were explored and reflected with the development of novel adjuvant vaccines.

关 键 词：新型佐剂 新型佐剂疫苗 药学研究 佐剂系统 

分 类 号：R95[医药卫生—药学]