基于星点设计-响应面法的红景天提取物冻干口崩片制备工艺研究

Preparation of oral disintegrating tablets of rhodiola extract based on central composite design and response surface methodology

目的通过优化工艺制备出合格的冻干型红景天提取物口崩片。方法以口崩片的外观性状和崩解时间为主要评价指标,设置综合评分表,采用单因素考察和星点设计-响应面法对口崩片的处方进行优化研究。结果红景天提取物口崩片最佳处方条件为:红景天提取物50.00 mg/片、普鲁兰多糖14.88 mg/片、甘露醇17.69 mg/片、黄原胶0.48 mg/片。所得口崩片片形饱满、表面光洁、颜色均匀、崩解迅速。结论红景天提取物口崩片制备工艺简单,稳定可靠,可用于大规模生产。

Objective To obtain qualified oral disintegrating tablets of rhodiola extract by optimizing the preparation technology.Methods The appearance characteristics and disintegration time of the tablets were used as the main evaluation indexes,to set up a comprehensive rating scale.The formulation of the tablets was optimized by single factor investigation and central composite design and response surface methodology.Results The optimal conditions of the oral disintegrating tablets were as follows:rhodiola extract 50.00 mg/tablet,pullulan polysaccharide 14.88 mg/tablet,mannitol 17.69 mg/tablet and xanthan gum 0.48 mg/tablet.The oral disintegrating tablets were prepared with good appearance and fast disintegration.Conclusion The optimized preparationprocess of rhodiola extract oral disintegrating tablets is stable and reliable,which can be used in mass production.