中文摘要：

体外释放度是评价纳米制剂质量的重要指标,但是目前并没有关于纳米制剂体外释放度评价方法的药典标准存在,这严重制约了纳米制剂安全性的提高及其产品研发的进展。目前纳米制剂体外释放度评价方法主要有取样分离法、流通池法、透析法、弗朗茨扩散池法和结合法,以及电化学法、非电化学法和微渗析法等新方法。本文结合纳米制剂自身的特殊性,主要综述了近年来纳米制剂体外释放度评价方法的研究现状及各自的优缺点,以期为纳米制剂体外释放度评价方法的完善与发展提供参考依据。

英文摘要：

In vitro release is an important index to evaluate the quality of nano preparation, but there is no pharmacopoeia standard of in vitro release evaluation methods of nano preparation exists at present, it seriously restricts the safety improvement of nano preparation and the progress of its product development. The main in vitro release evaluation methods of nano preparation at present are sample and separate method, flow through cell method, dialysis method, franz diffusion cell method, combination methods, and the new methods of electrochemical method, nonelectrochemical method and microdialysis method. With the aim to optimize the improvement and development of in vitro release evaluation methods of nano preparation, this paper combined with the special properties of nano preparation and provided mainly the research status of in vitro release evaluation methods of nano preparation in recent years and their strengths and shortcomings.