脂质体制剂制备工艺及质量控制研究进展  

Research progress of preparation technology and quality control of liposome formulation

作　　者：郭文娣 彭玉帅 许卉[1] 陈华[2] GUO Wen-di;PENG Yu-shuai;XU Hui;CHEN Hua(Yantai University,Yantai 264000,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]烟台大学,烟台264000 [2]中国食品药品检定研究院,北京102629

出　　处：《药物分析杂志》2023年第1期61-69,共9页Chinese Journal of Pharmaceutical Analysis

摘　　要：脂质体是成功转化为临床应用的药物递送系统。在过去的几十年里,脂质体作为载药系统在治疗领域中开展了广泛和深入的研究,国内外已有多种脂质体药物的上市产品,但目前针对其系统的质量检测与评价的方法报道较少。本文结合国内外文献资料及相关技术指导原则,对脂质体药物的制备工艺及系统的质量评价方法等进行综述,为脂质体给药技术的开发和评价提供参考。Liposome is a drug delivery system which has been successfully transformed for clinical application. In the past few decades, liposome as a drug delivery system has been extensively and deeply studied in the field of therapy. A variety of liposome drugs have been marketed at home and abroad, but there are few reports on the systematic quality detection and evaluation methods. In this paper, the preparation technology and systematic quality evaluation methods of liposome drugs were reviewed based on domestic and foreign literature and relevant technical guidelines, so as to provide reference for the development and evaluation of liposome drug delivery technology.

关 键 词：脂质体 药物递送系统 制备工艺 质量控制 释放度 

分 类 号：R917[医药卫生—药物分析学]