正交试验优化盐酸帕洛诺司琼口腔崩解片的制备工艺

Preparation optimization of palonosetron hydrochloride oral disintegrating tablets by orthogonal test

目的研究并优化盐酸帕洛诺司琼口腔崩解片的制备工艺。方法采用粉末直接压片法制备盐酸帕洛诺司琼口腔崩解片,采用HPLC法测定其含量,以崩解时限为指标优化处方。结果以12%低取代羟丙甲基纤维素,甘露醇∶优化微晶纤维素为2∶1,2%硬脂酸镁,3%甜菊苷制备的盐酸帕洛诺司琼口腔崩解片(60mg/片)外观圆整光洁,口感良好,崩解时限为12s,硬度为3kg,4min溶出度为99%。结论该制剂制备简单,处方合理,崩解较快。

Objective To prepare optimization of palonosetron hydrochloride oral disintegrating tablets by orthogonal test. Methods Palonosetron hydrochloride oral disintegrating tablets were prepared with direct compression process. The content of pal- onosetron hydrochloride was determined by HPLC. The formulation was optimized with disintegration time as evaluation indices. Results The optimal formulation（60 rag/tablet） was as follows：L-HPC 12% ,mannitol . SMCC= 2 ： 1,magnesium stearate 2%, stevia glycosides 3 %. The oral disintegrating tablets showed dine appearance and tested better： the disintegration time was 12 sec- onds;the tablets featured a hardness of 3 kg;4 min dissolution rate was 99%. Conclusion The preparation method is simple and reasonable,and the tablets can disintegrate rapidly.