口服缓控释制剂体外释放评价方法研究进展

Recent advances in the in vitro release study of oral sustained-release systems

口服缓控释制剂在胃肠道中停留转运的时间显著长于普通制剂,更易受胃肠道生理因素的影响。因此,研究和建立与体内相关的体外释放评价方法,对于保证口服缓控释制剂的内在质量非常重要。文中从装置、释放介质pH、表面活性剂、食物、乙醇等方面综述了近几年口服缓控释制剂体外释放的最新进展。

Since the oral sustained-release systems stay in the gastrointestinal tract （GIT） much longer, the drug release from the oral sustained-release systems is influenced easier by the physiological conditions of the GIT than that from the conventional preparations. For the quality control of the oral sustained-release systems, it is very important to study and establish in vitro release methods with a good in vivo and in vitro correlation. Based on relevant literature, improvements on the release conditions such as release apparatus, the pH value of release medi- um, surfactant, food and alcohol for in vitro release of oral sustained-release systems were reviewed.