垂盆草护肝颗粒的质量标准研究

Study on quality standard of Chuipencao Hugan Granules(垂盆草护肝颗粒)

目的建立垂盆草护肝颗粒的质量标准。方法采用薄层色谱(TLC)法定性鉴别垂盆草护肝颗粒中垂盆草、佛手、栀子、黄连药材,高效液相色谱(HPLC)法测定垂盆草护肝颗粒中五味子醇甲、栀子苷含量,色谱柱为C_(18)柱(250.0 mm×4.6 mm,5μm),流速1.0 mL/min,柱温30℃,进样量10μL。五味子醇甲流动相为甲醇-水(65∶35),检测波长250 nm;栀子苷流动相为乙腈-0.2%磷酸水溶液(10∶90),检测波长238 nm。结果TLC斑点清晰、分离好,且阴性无干扰;五味子醇甲和栀子苷分别在0.63~31.60,5.86~58.63μg范围内线性关系良好,平均加样回收率分别为98.02%,98.19%,RSD分别为1.00%,0.99%;五味子醇甲、栀子苷的含量分别为0.051,1.249 mg/g。结论所建立的定性、定量鉴别方法准确、可靠,重复性好、专属性强,可为垂盆草护肝颗粒质量标准的制定提供依据。

Objective To establish the quality standard of Chuipencao Hugan Granules(垂盆草护肝颗粒).Methods Thin layer chromatography(TLC)was used to qualitatively identify Sedum Sarmentosum Bunge,Fructus Citri Sarcodactylis,Gardeniae Fructus,And Coptidis Rhizoma in Chuipencao Hugan Granules.High performance liquid chromatography(HPLC)was used to determine the contents of schisandrin and jasminoidin in Chuipencao Hugan Granules.The determination was performed on a C_(18)column(250.0 mm×4.6 mm,5μm)at the flow rate of 1.0 mL/min.The column temperature was 30℃,and the sample size was 10μL.The mobile phase of schisandrin was methanol-water(65∶35),and the detection wavelength was 250 nm.The mobile phase of jasminoidin was acetonitrile -0.2% phosphoric acid aqueous solution(10∶90),and the detection wavelength was 238 nm.Results The TLC spots were clear,well separated and negative without interference.The linear relationships of schisandrin and jasminoidin were good in the range of 0.63-31.60 and 5.86-58.63μg,respectively.The average recoveries were 98.02% and 98.19%,and RSD were 1.00% and 0.99%,respectively.The contents of schisandrin and jasminoidin were 0.051 and 1.249 mg/g,respectively.Conclusion The established qualitative and quantitative identification methods are accurate,reliable,reproducible and specific,and can provide a basis for the formulation of quality standards for Chuipencao Hugan Granules.