双氯芬酸钠缓释片的体外释放度研究

Researchon In-vitro Dissolution of Diclofenac Sodium Sustained-release Tablets

  • 摘要: 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.

     

    Abstract: 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,Td and 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.

     

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