苦参降血糖活性部位分散片剂型研究

Study on dispersible tablets from antidiabetic extract of Sophora flavescens

目的对具有显著降糖活性的苦参乙酸乙酯部位进行分散片处方工艺研究,为工业化生产和临床应用奠定基础。方法以分散片硬度、崩解度为考察指标,通过正交试验确定最佳处方工艺。采用转篮法测定溶出度,并计算累积溶出度百分率。结果最佳处方工艺为主药量25%,1.0%阿斯巴甜作为矫味剂,1.4~1.6 mL/100 g浓度的蒸馏水作为润湿剂,0.5%硬脂酸镁作为润滑剂,2.0%PVPP作为崩解剂,MCC-预胶化淀粉(3︰1)作为填充剂。苦参分散片的累积溶出度平均值为82.65%。结论苦参分散片处方工艺合理可行,可用于苦参分散片的制备及质量控制。

Objective To investigate the dispersible tablets of the ethylacetate extract of Sophoraflavescens Ait., which will be laying the basic foundation for its industrial production and clinical study. Methods The orthogonal experiment design was performed to determine the optimized formulation with hardness and disintegration as examine indexes. The rotation basket was applied to determine the dissolution, and the accumulative dissolution percentage was calculated. Results The optimized formulation was shown as follows： the content of extracts in tablets was 25%, 1.0% aspartame was used as sweetener, 1.4-1.6 mL/100 g of distilled water was used as wetting agent, 0.5% magnesium stearate was used as lubricant, 2.0% PVPP was used as disintegrant, and MCC-pregelatinized starch （3：1） was used as filler. The average value of accumulative dissolution percentage was 82.65%. Conclusion The preparation is reasonable and fea- sible, which can be used in the preparation and the quality control of Sophora flavescens dispersible tablets.