多指标优化戊己胃内漂浮型缓释片制备工艺研究

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。

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

This study was aimed to screen out an optimal pharmaceutical formulation of Wuji Gastric Floating Sustained-release Tablets. With multicomponents of release for index, the extra-floating ability of the tablets was studied with the orthogonal test of four excipients, which were HPMC (K100M), PEG 6000, sodium bicarbonate and setanol. 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 requirements of formulation design. This preparation technique is with good maneuverability.