脂质体体外释放行为评价方法研究进展  

Research Progress of Evaluation Methods of Liposomes Release Behavior in Vitro

作　　者：宋波 黄莺 郭盈杉 SONG Bo;HUANG Ying;GUO Yingshan(Center for Food and Drug Inspection of NMPA,Beijing 100044,China;Center for Drug Evaluation of Hebei,Shijiazhuang 050091,China)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100044 [2]河北省药品审评中心,石家庄050091

出　　处：《医药导报》2023年第3期384-389,共6页Herald of Medicine

摘　　要：活性药物只有从脂质体中释放出来才可能在体内进一步发挥治疗作用,脂质体释药过程可通过体外释放行为来模拟,因此,体外释放行为是脂质体重要质量控制指标。文献报道的常用脂质体释放行为评价方法有取样分离法、透析法、流通池法、Franz扩散池法、ussing chamber法以及一些改良优化的方法,每种评价方法都有特定的优势和应用局限性。《中华人民共和国药典》目前并没有明确脂质体体外释放评价方法,这在一定程度上阻碍了脂质体的应用,因此,研究建立重复性好、操作性强、标准化程度高的体外释放方法是脂质体开发过程中亟待解决的问题。该文概括了近年来脂质体体外释放行为评价方法的研究现状及应用情况,分析了每种释放方法的特点,以期为脂质体体外释放行为评价方法的发展和完善提供参考。The liposome drug could act its therapeutic effect in vivo only when released from liposome.The release process could be stimulated in vivo.The commonly used analysis methods of liposome release behavior reported in the literature include sampling separation method,dialysis method,flow cell method,Franz diffusion cell method,and other optimized methods.Each evaluation method has specific advantages and application limitations.However,the Chinese Pharmacopoeia does not contain the evaluation method of in vitro release of liposome,which hinders the application of liposome.Therefore,it is an urgent problem to establish an in vitro release method with good reproducibility,strong operability,and high standardization in the development of liposome.According to the inherent properties of liposome,the research status and practical application of in vitro release behavior analysis methods of liposome in recent years were summarized,and the characteristics of each release method were briefly analyzed.It provided a reference for developing and improving in vitro release behavior analysis methods of liposome.

关 键 词：脂质体 体外释放行为 评价方法 

分 类 号：R943[医药卫生—药剂学]