市售尼莫地平缓释胶囊的释放度考察

Investigation on the dissolution of Nimodipine sustained release capsules

目的:考察尼莫地平缓释胶囊的体外释放度。方法:采用转篮法,溶出介质为0.55%的十二烷基硫酸钠水溶液,对市售4个厂家的尼莫地平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12h时差异无显著性。结论:不同厂家尼莫地平缓释胶囊的释放度差异存在显著性。

Objective ： To compare the dissolution of Nimodipine sustained release capsules. Methods ： The dissolution of Nimodipine sustained release capsules from four pharmaceutical factories were determined with rotating basket method and the dissolvent solution was 0. 55 % water solution of sodium dodecyl sulphate. 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 Nimodipine sustained release capsules of the four products are significantly different.