山楂叶总黄酮分散片的研制

Preparation of Hawthorn Leaves Total Flavonoids Dispersible Tablets

目的:筛选山楂叶总黄酮分散片的制剂处方。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,采用正交试验设计确定最佳处方。结果:分散片最优处方为16%山楂叶提取物,55%MCC,8%cCMC-Na,18%淀粉,1%硬脂酸镁,其崩解时间为(66±5)s。结论:研制的山楂叶总黄酮分散片处方合理,体外溶出度明显优于市售普通片剂,是值得开发的产品。

Objective：To screen the optimal formula for total flavonoids dispersible tablets of hawthorn leaves.Method：Different kinds of excipients in the prescription were selected and their amount was optimized by using disintegration time as parameters.The optimal composition of the prescription was determined by orthogonal design experiment.Result：The optimal formulation was as follows：16% total flavonoids extracts of hawthorn leaves,55% MCC,8% cCMC-Na,18% starch and 1% magnesium stearate.The disintegration time of dispersible tablet was（66±5）s.Conclusion：The dispersible tablet had reasonable prescription and its dissolution rate was much better than the common tablet of hawthorn leaves total flavonoids in the market.It would be a product worthy of exploitation and utilization.