长效注射给药系统的体外释药评价

Evaluation of in vitro release from long-acting injectable system

近几年,长效注射给药系统作为一种新型的缓控释非胃肠道给药系统,因具有传统给药系统所不能比拟的优势,其在临床、科研领域都引起了颇多关注。在长效注射剂研发过程中,建立适当的体外释药方法是保证其质量、特性以及各批次间稳定性的关键步骤。本文对用于该系统的3种常见体外释药实验原理,3类典型释药新技术的体外常速释药及相关加速释药研究进行综述。

In recent years, long-acting injectable system as a novel controlled release parenteral drug deliv- ery system has attracted considerable attention in clinical and research fields because of its advantages compared with traditional drug delivery systems. In the process of long-acting injection development, the establishment of ap- propriate in vitro release methods is the key steps to guarantee the quality, features and stability of each batch. In this paper, three in vitro release experimental principles commonly used in the system, constant speed in vitro re- lease of three typical new release technologies and the related acceleration speed release studies were reviewed.