降脂灵颗粒质量标准研究

Studies on quality Standard of Jiangzhiling Pellets

目的建立降脂灵颗粒质量标准。方法采用TLC法对处方中枸杞子、黄精、山楂、决明子进行定性鉴别;并采用HPLC法测定山楂中熊果酸的含量。结果薄层色谱均检出枸杞子、黄精、山楂、决明子;熊果酸在0.000262～0.003144μg范围呈良好的线性关系,r=0.9996;平均加样回收率为100.6%,RSD=1.41%。结论定性定量方法简便、准确、重现性好。提高后质量标准能更有效地控制该药品内在质量。

OBJECTIVE To determine the quality standard of Jiangzhiling Pellets.METHODS Fruit of Barbary wolfberry,Polygonatum sibiricum,Crataegus pinnatifida,Catsia tora linn in Jinagzhiling Pellets were identified by TLC.The content of Ursolic Acid was determined by HPLC.RESULTS The qualitative identification with TLC were specific.The linn rang of Ursolic Acid was 0.000262～0.003144μg（r=0.9996）;the recovery was 100.6%（RSD=1.41%）.CONCLUSION The method is simple,accurate and well reproducible.This method can be used for the quality control of Jiangzhiling Pellets.