六味地黄浓缩丸中药材的鉴别及熊果酸的含量测定

The quality standard of Liuwei Dihuang pills

目的建立六味地黄浓缩丸质量控制的方法。方法采用薄层色谱法（TLC）对制剂中的牡丹皮、茯苓、山茱萸分别进行鉴别；采用HPLC测定熊果酸的含量。结果熊果酸进样量在0．112～2．240μg范围内，峰面积与进样量呈良好的线性关系（r=0．9998，n=5）。回归方程为：Y；6．480×10^5X-1．414×10^4，平均加样回收率为98．85％，RSD=1．01％。结论该方法准确，快速、灵敏、重复性好，可作为该制剂的质量控制方法。

OBJECTIVE To establish a quality control method of Liuwei Dihuang pills.METHODS Cortex Moutan, Poria, Fructus Corni was identified by TLC, respectively. Ursolic acid in Liuwei Dihuang pills was determined by HPLC. RESULTS The Cortex Moutan, Poria, Fructus Corni could be identified by TLC; Ursolic acid showed a good linear relation in the range of 0. 112 - 2.240μg（ r = 0.9998, n = 5）, the average recovery was 98.85 % with RSD of 1.01%. CONCLUSION The method is simple, sensitive and reproducible, and it can be used to control the quality of Liuwei Dihuang pills.