| 摘要: |
| 目的：优化苦参配方颗粒中苦参碱和氧化苦参碱含量的测定方法。方法：采用HPLC法，色谱柱为Agilent ZORBAX NH2色谱柱(250 mm×4.6 mm，5 μm)，流动相：乙腈-无水乙醇-3%磷酸溶液（80∶10∶10）；流速：1 ml/min;检测波长：220 nm;柱温：30℃，进样量：5μl。结果：苦参碱在73.620～736.200 ng范围内线性关系良好，回归方程为y=548.2629x-1200.6932，R=0.9999。氧化苦参碱在79.511～795.110 ng范围内线性关系良好，回归方程为y=533.4244x-560.8712，R=0.9999。精密度、重复性、稳定性试验RSD均<2%;苦参配方颗粒中苦参碱加样回收率在98%～103%之间，RSD为1.52%，氧化苦参碱加样回收率在99%～103%之间，RSD为1.17%。结论：该方法简便快捷，准确度高，重复性好，可为相关测定方法的改进提供参考。 |
| 关键词: 苦参 HPLC 苦参碱 氧化苦参碱 |
| DOI： |
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| Optimization of high-performance liquid chromatography for content determination of Radix Sophorae Flavescentis formula granules |
| LI Dingfa,DENG Congyou,ZHANG Jianxiang |
| (Guangdong Yifang Pharmaceutical Co.，Ltd.，Foshan 528244，Guangdong，China) |
| Abstract: |
| Objective：To optimize the method for content determination of matrine and oxymatrine in Radix Sophorae Flavescentis formula granules.Methods：High-performance liquid chromatography was performed on an Agilent ZORBAX NH2 column (250 mm × 4.6 mm，5 μm) with a mobile phase of acetonitrile-anhydrous ethanol-3% phosphoric acid (80∶10∶10) at a flow rate of 1 ml/min，a detection wavelength of 220 nm，a column temperature of 30℃，and a sample size of 5 μl.Results：Matrine showed a good linear relationship within the range of 73.620～736.200 ng，with a regression equation of y=548.2629x-1200.6932 (r=0.9999).Oxymatrine showed a good linear relationship within the range of 79.511～795.110 ng，with a regression equation of y=533.4244x-560.8712 (r=0.9999).Relative standard deviation (RSD) was <2% for accuracy，repeatability，and stability tests.In Radix Sophorae Flavescentis formula granules，matrine had a recovery rate of 98%～103% (RSD=1.52%)，and oxymatrine had a recovery rate of 99%～103% (RSD=1.17%).Conclusion：This method is simple and convenient，with high accuracy and good repeatability，which provide a reference for improving related determination methods. |
| Key words: Radix Sophorae Flavescentis high-performance liquid chromatography matrine oxymatrine |
