疏肝利胆片质控方法研究

目的：建立疏肝利胆片质量标准。方法：采用薄层色谱（TLC）法对处方中大黄、黄芩和金钱草进行定性鉴别；黄芩素HPLC测定采用Kromasil C18柱，以乙腈-0．6％磷酸（45：55）为流动相，流速为0．8ml／min，检测波长为274nm；大黄素HPLC测定采用Kromasil C18柱，以甲醇-0．1％磷酸（85：15）为流动相，流速0．8ml／min，检测波长275nm，柱温25℃。结果：在TLC色谱中，大黄、黄芩和金钱草均能检出；HPLC测定中黄芩素在1-3μg／ml内呈现良好的线性关系（r=-0．9997）；大黄素在18～42μg／mJ范围内呈现良好的线性关系（r=0．9999），平均回收率100．49％。结论：该方法简单、准确、专属性强，可作为疏肝利胆片质量控制方法。

Study on quality control of Shuganlidan Tablets

Objective： To establish a quality standard of Shuganlidan tablets. Metheds： TLC was used to identify Rhubarb, Radix scutellariae and Christina Loosestrife Herb;Baicalein was measured by HPLC method on Kromasil C18 column with a mixture of acetonitrile-0.6%HaPO4 （85：15） as mobile phase at a flow rate of 0.8 ml/min,under the wavelength of 274 nm at the column temperature of 25 ℃. Emodin was measured by HPLC method on Kromasil C18 column with a mixture of methanol-0.1% H3PO4 （45：55） as mobile phase at a flow rate of 0.8 ml/min,under the wavelength of 275 nm at the column temperature of 25 ℃. Results： Rhubarb, Radix scutellariae and Christina Loosestrife Herb could be examined by TLC. Baicalein had a good linear relationship in the range of 1-3 μg/ml, the linear equation was Y=210 127X-20 730, r=0.999 7. Emodin had a good linear relationship in the range of 18-42 μg/ml, the linear equation was Y= 11 284X＋14 616, r=0.999 9. The average recovery rate was 100.49%. Conclusion： This method was accurate and specific, which could be used for quality control of Shuganlidan tablets.