双氯芬酸钠缓释制剂的释放度考察

Investigation on the dissolution of diclofenac sodium sustained release preparations

目的 :考察双氯芬酸钠缓释制剂的体外释放度。方法 :采用转篮法和 pH6 .8的人工肠液对市售 4个厂家的双氯芬酸钠缓释片和缓释胶囊的释放度进行了测定 ,并对释放度数据进行方程拟合及t检验。结果 :A、C厂家产品的释放规律较符合Weibull方程 ,而B、D厂家产品的释放规律较符合Higuchi方程。各厂家产品的释放度在1h ,6h时差异有显著性 ,在 1 2h时差异无显著性。结论 :不同厂家双氯芬酸钠缓释制剂的释放度差异存在显著性。

OBJECTIVE To compare the dissolution of diclofenac sodium sustained release preparations.METHODS The dissolution of diclofenac sodium sustained release tablets and its sustained release capsules from four pharmaceutical factories were determined with rotating basket method and pH 6.8 media .The dissolution data were simulated and t tested. RESULTS The dissolution rules of factories A and C were accorded with Weibull equation, but those of B and D were accorded with Higuchi equation. Statistical analysis showed that the dissolution data were significantly different in 1 h and 6 h ,but not significant difference in 12 h . CONCLUSIONS The dissolution data of diclofenac sodium sustained release preparations of the four products are significantly different.