摘要
脂质纳米粒(lipid nanoparticle,LNP)作为一种新兴的药物递送系统,在先进疗法中展现出广阔的应用潜力。近年来,LNP在基因治疗、细胞治疗和疫苗等领域取得显著进展,尤其是在mRNA疫苗中的应用,为应对新型冠状病毒感染提供了有效的解决方案。综述LNP的组成、制备方法、作用机制及其在先进治疗药品中的应用,重点分析已上市的LNP产品及其临床应用情况,并总结国内外主要监管机构对LNP产品的相关监管要求,以期为该类药物的研究与评价提供参考。
As an emerging drug delivery system,lipid nanoparticle(LNP)has demonstrated potential of broad application in advanced therapies.In recent years,significant breakthroughs have been made with LNP in gene therapy,cell therapy and vaccines,particularly in the application of mRNA vaccines in providing an effective solution for combating the COVID-19 pandemic.This article reviews the composition,preparation methods,mechanisms of action of LNP,and its applications in advanced therapy medicinal products,focusing on the analysis of the marketed LNP products and their clinical applications,and the summary of the relevant regulatory requirements for LNP-based drugs from major regulatory agencies at home and abroad,aiming to provide some reference for the research and evaluation of such drugs.
作者
付淑军
朱含
陆惠平
龚婧如
卢懿
吴伟
黄芳华
FU Shujun;ZHU Han;LU Huiping;GONG Jingru;LU Yi;WU Wei;HUANG Fanghua(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Department of Pharmacy,Shanghai Pudong Hospital,Fudan University,Shanghai 201399,China;Ministry of Education Key Laboratory of Smart Drug Delivery,School of Pharmacy,Fudan University,Shanghai 201203,China)
出处
《药学进展》
2026年第2期115-124,共10页
Progress in Pharmaceutical Sciences
基金
复旦大学附属浦东医院院级课题(No.YJ2023-15)。
关键词
脂质纳米粒
药物递送系统
先进治疗药品
监管要求
lipid nanoparticle
drug delivery system
advanced therapy medicinal product
regulatory requirement
