复方五藤散的质量标准研究

Study on Quality Standard of Compound Wuteng Poder

目的建立复方五藤散质量标准。方法采用薄层色谱法对复方中大血藤、鸡血藤、首乌藤进行定性鉴别。HPLC同时测定制剂中雷公藤甲素和杠柳毒苷含量,色谱柱:Welch Ultimate X 8-C 18(250 mm×4.6 mm,5μm);流动相:乙腈-0.05%磷酸溶液,梯度洗脱;检测波长为210 nm;流速:0.8 mL/min;进样量:10μL。结果薄层色谱斑点清晰且阴性样品无干扰。雷公藤甲素和杠柳毒苷分别在0.084~0.392μg/mL、10.2~47.6μg/mL内线性关系良好,加样回收率分别为99.53%~100.94%(RSD=0.62%,n=6)、99.39%~102.12%(RSD=2.04%,n=6)。结论本研究建立的质量标准方法准确、简便,可用于复方五藤散的质量控制,且所建立的大血藤、鸡血藤、首乌藤薄层鉴别方法可供其他的复方标准建立作参考。

Objective To establish the quality standard of Compound Wuteng Poder.Methods TLC was used to identify the Sargentodoxae Caulis,Spatholobi Caulis and Polygoni Multiflori Caulisqualitatively in Compound Wuteng Poder.HPLC was used to measure the content of Triptolide and Periplocin in Compound Wuteng Poder.The determination was performed on Welch Ultimate X8-C18(250×4.6 mm,5μm)column with mobile phase consisted of acetonitrile-0.05%phosphoric acid solution By gradient elution.Detection Wavelength Was 260 nm,Flow Rate 0.8 mL/min,Injection volume was 10μL.Results chromatograms of Sargentodoxae Caulis,Spatholobi Caulis and Polygoni Multiflori Caulis had clear spots and no same spot from negative samples.The linear range of Triptolide was 0.084~0.392μg/mL,The linear range of Periploside was 10.2~47.6μg/mL.The recovery rates of Triptolide were 99.53%~100.94%(RSD=0.62%,n=6);The recovery rates of Periploside were 99.39%~102.12%(RSD=2.04%,n=6).Conclusion stablished method is accurate and simple,and canbe used for the quality control of Compound Wuteng Poder.And the TLC method of he Sargentodoxae Caulis,Spatholobi Caulis and Polygoni Multiflori Caulis can be used as a reference for the establishment of other compound standards.