消癌平分散片的研制

Preparation of Xiaoaiping dispersible tablets

目的优选消癌平分散片的成型工艺。方法以崩解时间为考察指标,考察不同种类的辅料及其用量,设计确定最佳处方。结果最佳处方组成为乌骨藤1 500 g、甘露醇100 g、微晶纤维素100 g、低取代羟丙基纤维素125 g、交联聚乙烯吡咯烷酮45 g、阿斯帕坦2.5 g、硬脂酸镁5 g。按该处方压片,崩解时间小于3 min,崩解迅速且完全。对三批中试样品按质量标准进行检验,结果均符合要求。结论所选处方合理,工艺可行。

Objective To optimize the molding process of Xiaoaiping dispersible tablets.Methods With disintegration time as an index,different kinds of excipients and their dosages in the prescription were optimized.Results Optimum formulation was composed of Marsdenia tenacissima 1 500 g,mannitol 100 g,microcrystalline cellulose 100g,L-hyprolose 125 g,crospovidone 45 g,aspartame 2.5 g,magnesium stearate 5 g.According to this prescription,the disintegration time was less than 3 min,and this tablet was disintegrated quickly and completely.The test results for three batches of samples were consistent with the requirements.Conclusion This optimized formulation is reasonable and feasible.