葛黄颗粒的质量标准研究

Research on the quality standard of Gehuang Granules

目的建立葛黄颗粒的质量标准。方法采用薄层色谱法(TLC)对葛黄颗粒中的白芍、丹参、虎杖、党参进行定性鉴别;采用高效液相色谱法(HPLC)测定葛黄颗粒中射干苷含量:色谱柱为Shim-pack VPODS柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.2%磷酸溶液(15∶85),柱温为40℃,流速为1.0 ml/min,检测波长为265 nm,进样量为10μl。结果薄层色谱斑点清晰且阴性对照无干扰;射干苷在5.60~358.66μg/ml(r^(2)=0.9993,n=7)范围内线性关系良好,平均加样回收率为101.19%,RSD为1.5%(n=9)。结论本研究建立的质量标准具有良好的可靠性、稳定性、可行性,可以有效地控制葛黄颗粒的质量。

Objective To establish the quality standard of Gehuang Granules.Methods Thin-layer chromatography(TLC)was adopted to qualitatively identify radix paeoniae alba,radix salviae miltiorrhizae,rhizoma polygoni cuspidati and radix codonopsis in Gehuang Granules.The content of tectoridin in Gehuang Granules was determined by high performance liquid chromatography(HPLC),and the chromatographic column was Shim-pack VP-ODS column(4.6 mm×250 mm,5μm),the mobile phase was acetonitrile-0.2%phosphoric acid solution(15∶85),the column temperature was 40℃,the flow rate was 1.0 ml/min,the detection wavelength was 265 nm,and the sample volume was 10μl.Results TLC chromatographic spots were clear and negative control had no interference.The linear range of tectoridin was 5.60-358.66μg/ml(r^(2)=0.9993,n=7).The average recovery rate was 101.19%and RSD was 1.5%(n=9).Conclusion The quality standard established in this research has good reliability,stability and feasibility,and can effectively control the quality of Gehuang Granules.