盐酸托烷司琼口腔崩解片的制备

Preparation of Tropisetron hydrochloride orally disintegrating tablets

目的制备并评价盐酸托烷司琼口腔崩解片。方法选择辅料,以口腔中崩解时间为考察指标,综合运用效应面图和等高线图对口腔崩解片处方进行优化,直接压片法压片后,考察盐酸托烷司琼口腔崩解片的溶出度。结果所用处方为5 mg盐酸托烷司琼、78 mg微晶纤维素、95 mg甘露醇、20 mg交联羧甲基纤维素钠、1.6 mg草莓香精、0.4 mg硬脂酸镁。口腔中崩解时间为22.8 s,溶出度为97.4%。结论采用直接压片法制备的盐酸托烷司琼口腔崩解片崩解时间短、溶出速度快。

OBJECTIVE To prepare and evaluate Tropisetron hydrochloride orally disintegrating tablets.METHODS With the oral disintegration time as index,the formulation was optimized by response surface and contour plot.The tablets were prepared by a direct compression method and the dissolution was investigated.RESULTS The optimal formulation consisted of 5 mg tropisetron hydrochloride,78 mg MCC,95 mg Man,20 mg Ac-Di-Sol,1.6 mg strawberry essence,0.4 mg magnesium stearate.Disintegrating time of the tablets was 22.8 s,...