雷诺嗪缓释片的制备工艺筛选及其体外溶出度考察

目的:研究雷诺嗪缓释片的制备方法,筛选出最佳制备工艺条件。方法:采用正交设计,以羟丙基甲基纤维素邻苯二甲酸酯(HPMCP)、甲基纤维素(MC)和微晶纤维素(PH101)的用量及缓释片的硬度为因素进行试验,确定出最佳制备工艺条件;并对优化的试验结果进行验证,同时考察其体外释放效果。结果:最佳工艺条件HPMCP、MC、PH101用量分别为150、75、30mg,压片硬度10kg;所制备的雷诺嗪缓释片在2、6、12h的体外累积释放率分别为(29.33±1.05)%、(59.93±1.53)%、(95.60±1.31)%。结论:制备的雷诺嗪缓释片缓释效果与预测值基本吻合,工艺重现性好,体外累积释放率符合要求。

Optimization of Preparation Technology and In Vitro Dissolution Rate of Ranolazine Sustained Release Tablets

OBJECTIVE:To study the preparation method of ranolazine sustained release tablets and to optimize the preparation technology conditions for these preparations. METHODS: The preparation technology conditions were optimized by orthogonal design with the amounts of HPMCP, MC, PH101 and the hardness of ranolazine sustained release tablets as indexes. The optimized results were verified and the in vitro release of ranolazine sustained release tablets was determined. RESULTS: The optimum preparation technology conditions of ranolazine sustained release tablets were as follows: the amounts of HPMCP, MC, PH101 and the hardness were 150mg, 75mg, 30mg, and 10kg, respectively; and the in vitro release rates at 2, 6, and 12h were (29.33±1.05)%, (59.9±1.53)% and (95.60±1.31)%, respectively. CONCLUSION: The delayed release effect of ranolazine sustained release tablets coincided with the predictive value on the whole, and the preparation technology was reproducible. The in vitro accumulated drug release was in conformity with the requirements.