花生壳总黄酮滴丸的制备工艺及含量测定

Preparation and content determination of peanuthull extracted total flavonoids dropping pills

目的确立花生壳总黄酮滴丸的最佳制备工艺和含量测定方法。方法采用熔融法,将药物粉末分散于基质中,滴入冷却剂中收缩成丸;采用单因素试验考察载药量及辅料用量;结合实际条件,以丸重变异系数RSD为评价指标,正交试验设计筛选滴丸滴制条件。并用紫外分光光度法测定滴丸中总黄酮含量。结果花生壳总黄酮滴丸最佳成型工艺为:药液温度80℃,基质为聚乙二醇4000(polyethyleneglyco,PEG4000),载药质量分数为25%,滴距5cm,冷却剂为液体石蜡,冷却温度为0℃(冰水浴)。结论本法确定的花生壳总黄酮滴丸制备工艺稳定可行,含量测定结果准确可靠。

Objective To optimize the preparation condition of peanuthull extracted total flavonoids dropping pills and study its content determination method.Method The dropping pills were prepared by dispersing the total flavonoids from peanuthull extracts into the melted excipients and the molten suspension was dropped into the cooling liquid paraffin.Thereafter, the drops contracted, cooled and solidified into dropping pills .Using hardness, degree of sphericity and dissolution time as standards, the amount of extracts and excipients were selected via single factor experiment.Subsequently, the dropping condition was optimized on the basis of three factors and three levels orthogonal design by assessing weight variance of the pills.The content of total flavonoids from peanuthull was determined with UV.Result The optimized condition to prepare total flavonoids loaded dropping pills was as follows:processing temperature 80℃, excipient PEG4000, loading of the extract 25% , dropping distance:5cm above liquid level, cool aqueous phase was liquid paraffin and temperature of the cool aqueous phase was 0 ℃.Conclusion Total flavonoids loaded dropping pills could be produced with good quality and the content determination method was feasible and specific.