胃内漂浮缓释制剂在复方左金和元胡止痛片中的应用研究

Application of Gastric Floating Sustained-release Tablets in Chinese Herbal Compound Zuojin and Yuanhuzhitong

目的:制备复方左金和元胡止痛的胃内缓控释片剂,评价其体外释药性能。方法:以羟丙基甲基纤维素(HPMC)为亲水性凝胶骨架,碳酸氢钠为起泡剂制备漂浮片,以释放度、漂浮性能以及外观作为考察指标,用正交设计法优化制剂配方。结果:最佳处方片剂能在人工胃液中立即起漂,体外漂浮时间达10h以上,其体外释放规律1～10h符合peppas方程。结论:所选定处方的复方胃内缓控释片剂具有起漂时间快、缓释效果明显的特点。

Objective：To prepare gastric floating sustained-release tablets of Chinese herbal compound Zuo jin and Yuanhuzhitong and evaluate its release characteristics in vitro. Methods：The sustained-release tablets were prepared with hydroxypropyl methyl cellulose （HPMC） as hydrophilic gel-matrix and sodium bicarbonate as the foaming agent. The best formulation and preparation routes of the tablets were optimized by orthogonal experiment design using floating capability and release profile in vitro as indicators. Results ：The investigation showed that the floating sustained-release tablets could quickly emerge on the artificial gastric fluid surface and maintained a sustained floating state for over 10 hours in vitro. The sustained-release property was good in vitro and the release profiles kept well with the equation of Peppas. Conclusion： The optimized tablets possess quick floating and ideal sustained-release characteristics in vitro.