渗透泵给药系统设计原理、关键技术与发展动态

渗透泵控释制剂作为缓控释制剂的典型代表，是以渗透压为释药动力、以零级释放动力学为特征的一种制剂技术。由于其释药行为不受介质环境pH和食物等因素的影响,以及体内外释药相关性较好等特点，引起了国内外学者的广泛关注。经过多年的发展，渗透泵制剂的机制不断创新，结构不断完善，并已有多个产品上市。本文概述了渗透泵系统的发展历程及控释原理，并从药物溶解度、渗透压、释药孔及包衣膜4个方面，重点阐述影响渗透泵控释制剂药物释放速率的关键因素和国内外研发新进展。

The mechanism, critical technology and progress of osmotic drug delivery systems

As the typical example of controlled release preparation, osmotic pump-controlled release preparation is a new technique of preparation characterized by zero order release kinetics. Osmotic pressure is the motivation for releasing drug. The release behavior of osmotically controlled release systems is independent of external pH and food, and the in vivo-in vitro correlation is good, so they have attracted wide attention at home and abroad. After years of development, with the constant innovation of the mechanism, the structure of the osmotic pump has been continuously improved, and many products have been marketed. In this article, the development history and the mechanism of osmotic pump-controlled release preparation are briefly reviewed. Based on solubility, osmotic pressure, the delivery orifice and the coating membrane, the critical factors affecting the release rate and the research progress on osmotic pump controlled release preparation are mainly discussed.