益气止血丸的质量标准研究

Study on the Quality Standard of Yi Qi ZhiXue Pills

目的 建立益气止血丸的质量标准。方法 对益气止血丸全方进行显微鉴别;采用薄层色谱法(TLC)鉴别处方中党参、马齿苋、茜草炭、地榆炭;采用高效液相色谱法(HPLC)测定处方中黄芪甲苷含量。结果 经对处方中黄芪、续断、炒酸枣仁、三七粉、蒲黄、海螵蛸的显微特征鉴别进行验证,结果专属性较强、显微特征明显,方法可行;以TLC鉴别益气止血丸中党参阴性液无干扰,专属性较强;黄芪甲苷的质量浓度在0.426~5.325μg·mL^(-1)之间峰面积对数值与浓度对数间有良好的线性关系,样品所检测的黄芪甲苷含量平均值为0.16489(mg·g^(-1)),RSD%小于2.0%,重复性良好。结论 本试验所用方法可行、准确性高、重复性好,专属性强,可用于益气止血丸的质量控制。

OBJECTIVE To establish the quality standard of YiQi ZhiXue Pills.METHODS The whole formula of YiQi ZhiXue Pills was identified by microscopic method.Codonopsis pilosula, purslane, madder charcoal and burnet charcoal were identified by thin-layer chromatography(TLC) method.The content of astragaloside IV in the prescription was determined by high performance liquid chromatography(HPLC).RESULTS The identification of microscopic features of astragalus membranaceus, tzuduan, fried suanzaoren, panax notoginseng powder, puhuang and sea octopus in the prescription was verified, and the results were specific and obvious, and the method was feasible.The identification of codonopsis negative liquid in YiQi ZhiXue Pills by TLC had no interference and had strong specificity.The mass concentration of astragaloside IV was between 0.426 and 5.325 μg·mL^(-1),and there was a good linear relationship between the logarithm of the peak area and the logarithm of the concentration.The average content of astragaloside IV in the samples was 0.16489(mg·g^(-1)),the RSD% was less than 2.0%,and the repeatability was good.CONCLUSION The method used in this experiment is feasible, accurate, repeatable and specific, and can be used for the quality control of YiQi ZhiXue Pills.