山楂叶总黄酮双层缓释片的研制

Development of sustained release bilayer tablets of total flavonoids from hawthorn leaves

目的山楂叶总黄酮双层缓释片的制备研究。方法双层缓释片由速释层和缓释层两部分组成。以释放度为考察指标,考察不同种类的辅料及其用量,确定最佳处方。结果山楂叶总黄酮双层缓释片质量稳定,其最优处方为速释层:3.2%山楂叶提取物,22%MCC,1.1%c CMC-Na(内加),2.1%c CMC-Na(外加),11.2%淀粉,0.4%硬脂酸镁;缓释层:16%山楂叶提取物,24%HPMCK4M,3%CMC-Na,16.4%MCC,0.6%硬脂酸镁。结论山楂叶总黄酮双层缓释片处方合理,质量可控,是值得开发的产品。

Objective To screen the optimal formula for sustained release bilayer tablet of total flavonoids. Methods Sustained release bilayer tablet consists of a rapid release layer and a slow release layer. Different kinds of excipients in the formulation were selected and their dosage was optimized by examining the dissolution rate. Results The optimal formulation was as follows： the rapid release layer contained 3. 2% total flavonoid extracts of hawthorn leaves,22% of MCC,1. 1% of c CMC- Na（ add within）,2. 1% of c CMC- Na（ plus）,11. 2% of starch,and0. 6% of magnesium stearate,while the slow release layer contained16% of hawthorn leaves total flavonoids,24% of HPMCK4 M,3% of CMC- Na,16. 4% of MCC,and 0. 6% of magnesium stearate. Conclusion The as- prepared sustained release bilayer tablet is a promising formulation with reliable therapeutic effects.