复方金芩片的质量标准研究

Study on the Quality Standard of Fufang Jinqin Tablet

目的：建立复方金芩片的质量标准。方法：采用薄层色谱（TLC）法对制剂中黄柏、金银花进行定性鉴别。采用高效液相色谱法测定制剂中黄芩苷的含量：色谱柱为Zorbax Eclipse XDB-C18,流动相为甲醇-0.2%磷酸（40∶60,V/V）,流速为1.0 ml/min,检测波长为280 nm,柱温为35℃,进样量为10μl。结果：黄柏、金银花的TLC图斑点清晰,分离度好。黄芩苷检测进样量线性范围为0.533-4.264μg（r=0.999 9）;精密度、稳定性、重复性试验的RSD〈2%;加样回收率为96.95%-99.70%（RSD=1.18%,n=6）。结论：所建标准可用于复方金芩片的质量控制。

OBJECTIVE： To establish the quality standard of Fufang jinqin tablet. METHODS ： TLC was conducted for the qualitative identification of Cortex phellodendri and Lonicera japonica in the preparation. And HPLC was conducted for the content determination of baicalin; the column was Zorbax Eclipse XDB-C18 with mobile phase of methanol-0.2% phosphoric acid water （40： 60, V/V） at a flow rate of 1.0 ml/min, the detection wavelength was 280 nm, column temperature was 35 ℃ ,and the injection volume of 1μl. RESULTS： C. phellodendri and L. japonica of TLC showed clear spots and good separation. The linear range of baicalin was 0.533-4.264μg（r=0.999 9） ; RSDs of precision, stability and reproducibility tests were lower than 2% ; recovery was 96.95%-99.70% （RSD= 1.18% ,n=6）. CONCLUSIONS： The standard can be used for the quality control of Fufang jinqin tablet.