和肝利胆颗粒的质量标准研究

目的:建立和肝利胆颗粒的质量标准。方法:采用薄层色谱(TLC)法对方中黄芩、五味子、茵陈、栀子进行定性鉴别;采用高效液相色谱法对黄芩中的黄芩苷进行含量测定:色谱柱为Welchrom C18(200 mm×4.6 mm,5μm),流动相为甲醇-水-磷酸(42∶58∶0.2,V/V/V),流速为1.0 ml/min,检测波长为280 nm。结果:TLC图中的斑点清晰、分离较好,阴性对照无干扰;黄芩苷的质量浓度在1⁴0μg/ml范围内与峰面积积分值呈良好的线性关系(r=0.999 7),平均加样回收率为99.78%,RSD=2.68%(n=6)。结论:所建标准可用于和肝利胆颗粒的质量控制。

Study on Quality Standard of Hegan Lidan Granules

OBJECTIVE：To establish the quality standard of Hegan lidan granules. METHODS：TLC method was used for the qualitative identification of Scutellaria baicalensis,Schisandra chinensis,Artemisia capillaris and Gardenia jasminoides. HPLC was used to determine the content of baicalin. The determination was performed on Welchrom C18（200 mm×4.6 mm,5 μm）column with mobile phase consisted of methanol-water-phosphoric acid（42∶58∶0.2,V/V/V）at the flow rate of 1.0 ml/min. The detection wavelength was set at 280 nm. RESULTS：TLC spots were clear and well-separated without interference from negative sample. The linear range of baicalin was 1-40 μg/ml（r=0.999 7）with an average recovery of 99.78%（RSD=2.68%,n=6）. CONCLUSIONS：The method is simple,specific,accurate and reliable. It can be used for the quality control of Hegan lidan granules.