香芍胃舒康颗粒的质量标准研究

目的:建立香芍胃舒康颗粒的质量标准。方法:采用薄层色谱法对香芍胃舒康颗粒中木香、山楂、决明子进行定性鉴别,并采用高效液相色谱法对方中芍药苷和芍药内酯苷进行含量测定。色谱柱:Eclipse XDB-C18柱(4.6 mm×150 mm,5μm);流动相:乙腈-0.1%磷酸(14∶86);检测波长为230 nm;流速:1.0 ml/min;柱温:35℃。结果:薄层色谱斑点清晰,阴性无干扰;芍药苷在3.44-27.48μg/ml范围内呈良好的线性关系,r=0.999 0,平均加样回收率为98.51%,RSD=1.54%(n=6);芍药内酯苷在3.22-25.76μg/ml范围内呈良好的线性关系,r=0.999 1,平均加样回收率为98.80%,RSD=1.58%(n=6)。结论:该方法简便、准确、可靠,可作为香芍胃舒康颗粒的质量控制方法。

Studies on the Quality Standard of Xiangshaoweishukang Granule

Objective： To establish quality standards for Xiangshaoweishukang granule.Methods： TLC method was used to distinguish RADIX AUCKLANDIAE,FRUCTUS CRATAEGI and SEMEN CASSIAE.HPLC method was used for the content determination of paeoniflorin.The column was Eclipse XDB-C18 column（4.6 mm×150 mm,5 μm）;mobile phase were acetonitrile-0.1%H3PO4（14∶86）;the detection wavelength was at 230 nm;flow rate at 1.0ml·min-1 and column temperature at 35 ℃ respectively.Results： The TLC spots were clear and negative sample has non-interference;paeoniflorin show a good linear relationship in the range of 3.44-27.48 μg/ml,r = 0.999 0,the average recovery was 98.51% with RSD=1.54%（n = 6）;Alibiflorin show a good linear relationship in the range of 3.22-25.76 μg/ml,r = 0.999 1,the average recovery was 98.80% with RSD = 1.58%（n = 6）;Conclusion： The method is simple,accurate,reliable and can be used as quality control for Xiangshaoweishukang granule.