复方黄獐软肝颗粒的质量标准研究

Quality Standard of Compound Huangzhang Ruangan Granule

目的:建立复方黄獐软肝颗粒的质量标准。方法:采用薄层色谱(TLC)法对制剂中黄芪、余甘子、肉豆蔻进行定性鉴别;采用高效液相色谱-蒸发光散射检测法测定黄芪中有效成分黄芪甲苷的含量。结果:TLC特征明显、专属性强;黄芪甲苷进样量在1.014～5.070μg范围内与峰面积积分值呈良好的线性关系(r=0.9991),平均回收率为97.96%,RSD=1.91%(n=6)。结论:所建标准可用于复方黄獐软肝颗粒的质量控制。

OBJECTIVE： To establish the quality standard of Compound huangzhang ruangan granule. METHODS： Astragali Radix, Phyllanthus emblica, Myristica fragrans in Compound huangzhang ruangan granule were identified by TLC, and the content of astragaloside in Compound huangzhang ruangan granule was determined by HPLC-ELSD. RESULTS： The TLC characteris- tics were distinctive and specific. The linear range of astragaloside was 1.01445.070 pg（r=0.999 1） with an average recovery of 99.29 % （RSD=1.91%, n= 6）. CONCLUSION： The established standard can be used for the quality control of Compound huangzhang ruangan granule.