预防用mRNA疫苗脂质纳米颗粒质量研究及质量控制药学评价的考虑  

Considerations on pharmaceutical quality assessment and control of lipid nanoparticles of prophylactic mRNA vaccines

作　　者：杨丹 赵欣 李小静 李敏[1] YANG Dan;ZHAO Xin;LI Xiao-jing;LI Min(Center for Drug Evaluation,National Medical Products Administration,Beijing 100038,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2023年第24期2452-2456,共5页Chinese Journal of New Drugs

摘　　要：随着预防用mRNA疫苗研究不断深入,发现了脂质纳米颗粒结构/形态等新问题。根据ICH Q6B理念,从药学评价角度对脂质纳米颗粒的结构特点、变化趋势等进行初步探讨,对其结构特征表征需要额外开展的研究工作也进行了一些探索与思考,以期为预防用mRNA疫苗质量研究及质量控制提供参考。As the continuous in-depth research on prophylactic mRNA vaccines,new questions have been raised about lipid nanoparticles in aspects of structures and morphologies.Based on the principle of ICH Q6B,the characteristics and changes of the structures of lipid nanoparticles were preliminarily discussed from the perspective of pharmaceutical evaluation,and the additional study for the structural characteristics were also addressed for providing a reference for the quality assessment and control of prophylactic mRNA vaccines.

关 键 词：mRNA疫苗 脂质纳米颗粒 粒径 形态 工艺控制 质量研究 

分 类 号：R95[医药卫生—药学]