多指标优化戊己胃内漂浮型缓释片制备工艺研究

Optimization on Preparation Techniques of Wuji Gastric Floating Sustained-release Tablets by Multicomponent Indicator

目的:优选戊己胃漂浮缓释片制剂的最优处方配比。方法:以多个组分释放度为评价指标,选择辅料HPMC(K100M)、PEG 6000、NaHCO3、十六醇等4个因素,建立正交试验进行考察,干粉压片,优化制剂体外释药及漂浮性能。结果:选择以35%HPMC、5%PEG 6000、10%NaHCO3、15%十六醇、10%MCC及25%的主药,作为戊己胃漂浮缓释片处方的最优制剂配方。结论:所制备的戊己胃内漂浮型缓释片具有缓释、漂浮时间长的优点,制备工艺具有良好的可操作性。

This study was aimed to screen out an optimal pharmaceutical formulation of Wuji Gastric Floating Sus-tained-release Tablets. With multicomponents of release for index, the extra-floating ability of the tablets was stud-ied with the orthogonal test of four excipients, which were HPMC （K100M）, PEG 6000, sodium bicarbonate and se-tanol. The results showed that the combined optimal pharmaceutical formulation was 35% HPMC, 5% PEG 6000, 10% sodium bicarbonate, 15% setanol, 10% MCC and 25% main drug. It was concluded that Wuji Gastric Floating Sustained-release Tablets had the characteristics of slow-release and long floating duration which comply with re-quirements of formulation design. This preparation technique is with good maneuverability.