秦皮配方颗粒质量控制研究

目的：建立秦皮配方颗粒的质量控制方法.方法：采用薄层色谱法对秦皮配方颗粒进行定性鉴别;采用高效液相色谱法建立秦皮配方颗粒的指纹图谱,色谱柱：Waters Xbridge C18柱（250 mm×4.6 mm,5 μm）;甲醇-0.4%醋酸溶液为流动相梯度洗脱;检测波长340 nm;流速1.0 ml·min^-1;柱温30℃;进样体积10 μl.结果：薄层鉴别方法斑点清晰,分离度好;建立了秦皮配方颗粒的指纹图谱,确定了19个共有峰,各秦皮配方颗粒样品指纹图谱与对照指纹图谱相似度均在0.85以上,可以用于秦皮配方颗粒的质量控制.结论：所建立的方法简单、准确、专属性、重复性好,为秦皮配方颗粒的质量控制提供了有效可靠的方法.

Study on Quality Control of Cortex Fraxini Formula Granules

Objective： To establish a method quality control for cortex fraxini formula granules. Methods： Cortex fraxini formula granules were identified by TLC. The chromatographic fingerprints were obtained by HPLC. A Waters Xbridge C18 column（250 mm ×4.6 mm,5 μm） was used with the gradient elution solvent system composed of methanol-0.4% acetic acid, the wavelength was set at 340nm, the flow rate was 1.0 ml ·min^-1 , the column temperature was maintained at 30℃ and the injection volume was 10 μl. Re- sults： The spots on TLC plates were clear and the resolution was good. Nineteen common peaks were selected as the fingerprint peaks of cortex fraxini formula granules and good similarities with correlation coefficients higher than 0.85 were found in the fingerprints be- tween the different samples of cortex fraxini formula granules and the standard fingerprints. Conclusion： The method with good repro- ducibility is simple and accurate, and can be used as a quality control method for cortex fraxini formula granules.