缓控释非胃肠道给药系统的体外加速释放方法综述

A Summary of in vitro Accelerated Approaches for Controlled Release Parenteral Drug Delivery System

近年来,长效缓控释非胃肠道给药系统由于具有减少给药频率、提高药效、降低药物副作用和增加患者的顺应性等传统给药系统不能比拟的优势,在科学研究和临床应用中引起广泛关注和应用。对于缓控释非胃肠道给药系统的研发生产和质量控制来说,监测其体外的实时释放需要耗费数周乃至数月的时间,因此建立适当的体外加速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。文章对缓控释非胃肠道给药系统的体外加速释放的不同方法,如温度、pH值、添加有机溶剂或表面活性剂等进行了综述。

In recent years,long-term controlled release parenteral drug delivery system has attracted considerable attention in clinical and research fields because of its advantages compared with traditional drug delivery systems,including reducing dosing frequency,increasing drug efficacy,decreasing adverse side effects,and enhancing patient compliance.In the process of product development and quality control,real-time in vitro release tests for these dosage forms are often run over periods of weeks and months which are time consuming.Hence,the establishment of appropriate accelerated in vitro release methods is the key step to guarantee the quality,features and stability of each batch.In this paper,various of methods related to acceleration in vitro release studies include temperature,pH value,addictive of organic solvent or surfactant etc.are reviewed.