双氯芬酸赖氨酸盐缓释片制备工艺的研究

The Preparation of Diclofenac Acid Lysinel Slow Release Tablets

目的 :以HPMC为主要材料 ,制备水溶性骨架片。方法 :经单因素考察 ,通过正交设计优化出双氯芬酸赖氨酸盐缓释片处方 ,按中国药典 1995年版所载 ,溶出方法的第二法测其释放度。结果 :所制备的缓释片在 12h内呈现良好的零级释放特征。结论 :经正交设计优化的双氯芬酸赖氨酸盐缓释片处方为最优处方 。

Aim The water-soluble matrix tablets were prepared by using of HPMC (K4M).Methods After the single factor was checked,the optimal formulation of Diclofenac acid lysinel(DAL) slow release tablets were obtained by employing orthogonal design.The degree of drug release was determined according to the method given in Chinese Pharmacopoeia (1995).Result The release profile of the DAL slow release tablets in vitro was governed well by zero order mechanism in 12h.Conclusion The formulation of DAL slow release tablet is optimal.The release in vitro showed no obvious difference between DAL and the controlled tablets.