利培酮口腔崩解片的研制

Preparation of risperidone orally disintegrating tablets

目的研究利培酮口腔崩解片的最佳处方和制备工艺。方法选用微晶纤维素和交联羧甲基纤维素钠作为崩解剂,通过湿法制粒压片制备,以体外崩解时间为指标,正交试验优化处方,并测定体外崩解时间及口感等质量评价指标。结果优选处方的口腔崩解片的体外崩解时间为(18.26±0.1)s,口感佳。结论本研究所得的处方可以制备性能优良的利培酮口腔崩解片。

Objective To develop the optimal formula and preparation for Risperidone orally disintegrating tablets. Methods CCMCrNa were employed as disintegrants, the wet process compression method was used for preparation, and the optimal formula was obtained by orthogonal test according to disintegrating time in vitro. The properties of the tablets, such as disintegrating time in vitro was determined. Results Disintegrating time both in vitro was （ 18.26 ± 0.1） s. Conclusion The preparation methods of risperidone orally disintegrating tablets is suitable.