复方黄根颗粒的质量标准研究

Quality Standard of Compound Huanggen Granule

目的:建立复方黄根颗粒的质量标准。方法:采用薄层色谱法对叶下珠进行定性鉴别;采用高效液相色谱-蒸发光散射检测法对制剂中人参皂苷Rg1、人参皂苷Rb1、黄芪甲苷进行含量测定。结果:定性鉴别法分离度好、专属性强;人参皂苷Rg1、人参皂苷Rb1和黄芪甲苷进样量分别在1.26～12.60、0.41～4.10和2.83～28.30μg范围内,其自然对数与各自峰面积的自然对数呈良好的线性关系(r>0.999 0),三者平均加样回收率分别为99.34%、100.80%和100.10%,RSD分别为1.2%、2.4%和1.2%(n=6)。结论:所建标准可有效控制复方黄根颗粒的质量。

OBJECTIVE：To establish the quality standard for Compound huanggen granule.METHODS：Phyllanthus urinaria of Compound huanggen granule were identified by TLC.Ginsenoside Rg1,ginsenoside Rb1 and astragaloside Ⅳ were determined by HPLC-ELSD.RESULTS：The qualitative identification was well-separated and specific.The linear ranges of ginsenoside Rg1,ginsenoside Rb1 and astragaloside Ⅳ were 1.26-12.60 μg,0.41-4.10 μg and 2.83-28.30 μg（r0.999 0）.The average recoveries of ginsenoside Rg1,ginsenoside Rb1 and astragaloside Ⅳ were 99.34%,100.80% and 100.10%,respectively.RSD were 1.2%,2.4% and 1.2%（n=6）.CONCLUSION：Established standard can be used for quality control of Compound huanggen granule effectively.