复方软肝颗粒质量标准研究

Quality standard for Compound Ruangan Granules

目的:建立复方软肝颗粒(黄芪,丹参,灵芝,赤芍,柴胡,等)的质量标准。建立了复方软肝颗粒中丹参、灵芝、赤芍、柴胡的薄层鉴别方法及黄芪甲苷、丹酚酸B的含量测定方法。方法:采用薄层层析进行鉴别,用高效液相色谱-蒸发光散射检测法对黄芪甲苷、用高效液相色谱法对丹酚酸B进行含量测定。结果:本品中黄芪甲苷的平均含量为0.404mg/g,加样回收率为97.61%,RSD为1.27%,丹酚酸B的平均含量为5.76 mg/g,加样回收率为98.64%,RSD为0.90%。结论:该质量标准可较好的控制复方软肝颗粒的质量。

AIM： To establish the quality standard for Compound Ruangan Granule （Radix Astragali, Radix et Rhizoma Salviae multiorrhizae, Ganoderma, Radix Paeoniae rubra, Radix Bupleuri ） METHODS： The thin liquid chromatography was used to identify the four botanical drugs, the content of astragalosidelV in Compound Ruangan Granules was determined by HPLC-ELSD RESULTS： The average content of astragal and the content of salvianolic acid B was determined by HPLC. oside Ⅳ was 0.404 mg/g. The average recovery and relative standard deviation were 97.61% and 1.27%, respectively. The average content of salvianolic acid B was 5.76 mg/g. The average recovery and relative standard deviation were 98.64% and 0.90%, respec method can be adopted as a standard for the quality control of Compound Ruangan G tively. CONCLUSION ： The ranules.