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研究鸢尾苷元胃内漂浮型缓释片的制备工艺及释放机制。采用羟丙基甲基纤维素(HPMC_(K15M))、交联聚乙烯吡咯烷酮(PVPP)、十八醇、碳酸氢钠为辅料,湿法制粒压片,以体外漂浮性能和体外释放性能为考察指标,采用正交实验设计对处方进行筛选与优化。优化的处方为鸢尾苷元33.3%、HPMCK15 M16.7%、PVPP 20.0%、十八醇13.3%、碳酸氢钠5%、预胶化淀粉10.7%。制得的片剂在人工胃液中10 s内起漂,体外持续漂浮时间>12 h;10 h累积释放度在70%以上。Ritger-Peppas方程拟合分析表明,该缓释片有药物扩散和骨架溶蚀双重作用。鸢尾苷元胃内漂浮型缓释片外观与可压性良好,且具有良好的漂浮性能和释药特征。
To study the preparation technology and release mechanism of tectorigenin intragastric floating sustained-release tablets. Hydroxypropyl methylcellulose (HPMC K15M), cross-linked polyvinylpyrrolidone (PVPP), octadecanol and sodium bicarbonate were used as excipients to wet-granulate the tablets. The in vitro floating performance and in vitro release performance were investigated Indicators, using orthogonal experimental design to filter and optimize the prescription. The optimized formulations were as follows: tectorigenin 33.3%, HPMCK15 M16.7%, PVPP 20.0%, stearyl alcohol 13.3%, sodium bicarbonate 5% and pregelatinized starch 10.7%. The prepared tablets began to bleach within 10 s in artificial gastric juice and persisted for more than 12 h in vitro. The cumulative release was above 70% after 10 h. Ritger-Peppas equation fitting analysis showed that the sustained-release tablets have the dual role of drug diffusion and skeleton erosion. The tectorigenin intragastric floating sustained-release tablets have good appearance and compressibility, and have good floating properties and drug release characteristics.