双氯芬酸赖氨酸盐缓释片的制备及体外释放度

Preparation of diclofenac lysine extended release tablet and its drug release

目的：制备双氯芬酸赖氨酸盐缓释片,对其释放机制进行考察。方法：以羟丙基甲基纤维素(HPMC K4M)为主要辅料,制备水溶性骨架片,通过正交设计优化出双氯芬酸赖氨酸盐缓释片的处方,以进口双氯芬酸钠缓释片为对照,根据中国药典1995年版所载的溶出方法测定其释放度。结果：所制备的缓释片在12 h内呈现良好的零级释药特征。结论：以正交法优选的双氯芬酸赖氨酸盐缓释片处方合理,体外释放与进口双氯芬酸钠缓释片相比差异无显著性。

OBJECTIVE：To prepare diclofenac lysine(DAL) extended release tablets and to investigate the release mechanism in vitro.METHODS：The water-soluble matrix tablet was prepared by use of HPMC(K4M).The drug release was determined according to method of Chinese Pharmacopoeia(1995).The optimal formulation was obtained by orthogonal design and the imported diclofenac sodium extended release tablet was the controlled tablet.RESULTS：The release profile of the tablets in vitro was fitted well by zero-order release.CONCLUSIONS：The formulation is reasonable and tablets release in vitro showed no obvious difference to the controlled tablet.