双氯芬酸钠缓释片的体外释放度研究

以pH6.8磷酸盐为释放介质,通过测定最大吸收波长、绘制标准曲线、精密度实验、稳定性实验和加样回收率实验,建立双氯芬酸钠缓释片释放度的测定方法,对两个不同厂家的双氯芬酸钠缓释片的释放度进行测定,计算累积释放率,采用weibull方程计算释放参数T50、Td、m,并进行方差分析.结果表明,A厂家和B厂家双氯芬酸钠缓释片的释放速率有明显差别,两厂家药品释放参数存在显著差异(P0.01).不同厂家的双氯芬酸钠缓释片质量可能存在较大差异,临床用药应注意.

Research on In-vitro Dissolution of Diclofenac Sodium Sustained-release Tablets

To establish assaying measures of diclofenac sodium sustained-release tablets,a series of experiments were performed in phosphate release medium at pH 6.8,including determining maximum absorption wave,drawing standard curve,pricision test,stability test and recovery test.The dissolution of diclofenac sodium sustained-release tablets from two different pharmaceutical factories was tested.The cumulative dissolution ratio was calculated,and the release parameters T50,Tdand m were calculated by weibull equation and analyzed by variance analysis.The test result showed that the dissolution of diclofenac sodium sustained-release tablets from A factory was different from B factory,and the striking difference existed in the release parameters of sustained-release tablets from two different factories(P < 0.01).Therefore,it should be pay attention to that the quality of diclofenac sodium sustained-release tablets may vary greatly in different factories in clinical application.