活血软肝丸的制备及质量控制

Preparation and Quality Control of Huoxueruangan Pill

目的研制活血软肝丸并制定质量控制方法。方法将柴胡、郁金、牡丹皮、血竭等药材粉碎成细粉,泛制成水丸。采用显微鉴别、薄层色谱法定性鉴别及高效液相色谱法测定主要成分柴胡皂苷a的含量。结果制备的丸剂均匀、崩解好,显微鉴别专属性强,薄层色谱鉴别无干扰,柴胡皂苷a线性范围为0.1～1.6μg,平均回收率为98.5%,RSD为0.49%,n=6。结论制备方法简便,质量控制准确快速,能较好控制本品质量。

Objective To prepare the Huoxueruangan Pill and make the quality control protocol.Methods Bupleurum,Turmeric,Dan,Blood and other herbs were crushed into powder and made into water pills.Determine the content of saikosaponin-a by microscopic identification,TLC and HPLC.Results The pills were uniform,good collapse,specificity for microscopic identification,TLC without interference,a linear range of saikosaponin 0.1-1.6μg,the average recovery was 98.5%,RSD 0.49%,n=6.Conclusion The preparation method was simple,fast and accurate quality control and can better control the product quality.