一测多评法测定补心气口服液中7种成分的含量

Determination of 7 components in Buxinqi Oral Liquid by QAMS

目的建立一测多评法(QAMS)同时测定补心气口服液中人参皂苷Rg 1、人参皂苷Re、毛蕊异黄酮葡萄糖苷、毛蕊异黄酮、芒柄花素、β-细辛醚和α-细辛醚的含量。方法色谱柱为Agilent Extend-C 18(250 mm×4.6 mm,5μm),以乙腈-1 mL·L^-1磷酸为流动相,梯度洗脱,流速为1.0 mL·min^-1,检测波长分别为203 nm(检测人参皂苷Rg 1和人参皂苷Re),257 nm(检测毛蕊异黄酮葡萄糖苷、毛蕊异黄酮、芒柄花素、β-细辛醚和α-细辛醚),柱温为25℃。以毛蕊异黄酮葡萄糖苷为内参物,建立其与人参皂苷Rg 1、人参皂苷Re、毛蕊异黄酮、芒柄花素、β-细辛醚和α-细辛醚的相对校正因子,并计算各成分含量,计算结果与外标法(ESM)实测值进行比较。结果7种成分分别在0.81~20.25(r 1=0.9993),1.59~39.75(r 2=0.9996),3.73~93.25(r 3=0.9991),1.86~46.50(r 4=0.9992),6.47~161.75(r 5=0.9995),14.78~369.50(r 6=0.9994),4.89~122.25μg·mL^-1(r 7=0.9991)范围内线性关系良好;平均回收率(RSD值)分别为97.44%(1.14%),99.80%(0.75%),100.05%(0.68%),96.98%(0.90%),98.87%(1.35%),99.88%(0.73%),97.91%(1.49%);QAMS法计算结果与ESM法实测值无明显差异。结论所建立的QAMS法操作便捷、结果准确,可用于补心气口服液的质量控制。

Objective To establish a quantitative analysis of multi-components by single-marker(QAMS)method for the determination of ginsenoside Rg 1,ginsenoside Re,calycosin7-O-β-D-glucopyranoside,calycosin,formononetin,β-asarone andα-asarone in Buxinqi Oral Liquid.Methods The samples were separated on an Agilent Extend-C 18(250 mm×4.6 mm,5μm)column at 25℃.The mobile phase was acetonitrile-1 mL·L^-1 phosphoric acid by gradient elution,and the flow rate was 1.0 mL·min^-1.The detection wavelengths were set at 203 nm for ginsenoside Rg 1 and ginsenoside Re,and 257 nm for calycosin 7-O-β-D-glucopyranoside,calycosin,formononetin,β-asarone andα-asarone.Calycosin7-O-β-D-glucopyranoside was used as an internal standard to calculate the relative correction factors for ginsenoside Rg 1,ginsenoside Re,calycosin,formononetin,β-asarone andα-asarone.The obtained results were then compared with the external standard method(ESM)results.Results 7 components showed good linear relationships within the ranges of 0.81-20.25(r 1=0.9993),1.59-39.75(r 2=0.9996),3.73-93.25(r 3=0.9991),1.86-46.50(r 4=0.9992),6.47-161.75(r 5=0.9995),14.78-369.50(r 6=0.9994)and 4.89-122.25μg·mL^-1(r 7=0.9991),whose average recoveries(RSDs)were 97.44%(1.14%),99.80%(0.75%),100.05%(0.68%),96.98%(0.90%),98.87%(1.35%),99.88%(0.73%)and 97.91%(1.49%),respectively.No significant difference of quantitative results was observed between ESM and QAMS method.Conclusion The established QAMS method is simple and accurate,which can be used for the quality control of Buxinqi Oral Liquid.