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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 study the preparation of the total flavonoids of hawthorn leaf double sustained release tablets. Methods double sustained-release tablets from the immediate release layer and sustained release layer composed of two parts. Taking the release degree as the index of investigation, we investigated the different kinds of excipients and their dosage to determine the best prescription. Results The hawthorn leaf flavonoids sustained-release tablets were of stable quality. The best prescription was immediate release layer: 3.2% hawthorn leaf extract, 22% MCC, 1.1% c CMC-Na (Applied), 11.2% starch, 0.4% magnesium stearate; sustained-release layer: 16% hawthorn leaf extract, 24% HPMCK4M, 3% CMC-Na, 16.4% MCC, 0.6% Magnesium Stearate. Conclusion Hawthorn leaves flavonoids double-layered sustained-release tablets prescription is reasonable and quality control, is worth developing products.