保元抗疲咀嚼片HPLC-ELSD特征图谱研究及4种功效成分的含量测定

Content determination of 4 effective ingredients in Baoyuan Kangpi chewable tablets by HPLC-ELSD

目的建立保元抗疲咀嚼片HPLC-ELSD特征图谱和4种代表性功效成分的含量测定方法。方法采用HPLC-ELSD法,色谱柱为Agilent 5 HC C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%甲酸水溶液,梯度洗脱,柱温25℃,流速1.0 mL·min^(-1),蒸发光散射检测器(ELSD)蒸发温度为120℃,气体流量为1.6 SLM。结果建立了保元抗疲咀嚼片HPLCELSD特征图谱,标定了11个特征峰,并鉴定出甘草苷、人参皂苷Rg_(1)、人参皂苷Re、人参皂苷Rb_(1)、甘草酸铵5个成分,15批样品特征图谱的相似度均>0.920。建立了保元抗疲咀嚼片中4种功效成分的含量测定方法,人参皂苷Rg_(1)、人参皂苷Re、人参皂苷Rb_(1)、甘草酸的含量分别为1.01~1.09 mg·g^(-1)、0.85~0.96 mg·g^(-1)、1.42~1.70 mg·g^(-1)、1.53~1.84mg·g^(-1)。结论采用HPLC-ELSD特征图谱结合多功效成分含量测定,可全面评价与控制保元抗疲咀嚼片的质量。

Objective To establish HPLC-ELSD characteristic chromatograms of Baoyuan Kangpi chewable tablets and determinate the content of 4 representative components.Methods An Agilent 5 HC C_(18)chromatographic column(250 mm×4.6 mm,5μm)was used.The mobile phase was acetonitrile-0.1%formic acid aqueous solution with gradient elution.The column temperature was 25℃and the flow rate was 1.0 mL·min^(-1).The evaporation temperature of the evaporative light scattering detector(ELSD)was 120℃.The gas flow rate was 1.6 SLM.Results The HPLC-ELSD characteristic chromatograms of Baoyuan Kangpi chewable tablets was established,and 11 characteristic peaks were calibrated.Totally 5 chromatographic peaks were identified,namely glycyrrhizin,ginsenoside Rg_(1),ginsenoside Re,ginsenoside Rb_(1)and ammonium glycyrrhizinate.The similarity of the characteristic chromatogram of 15 batches of samples was>0.920.The content of 4 effective components in Baoyuan Kangpi chewable tablets was determinated.The content of ginsenoside Rg_(1),ginsenoside Re,ginsenoside Rb_(1)and glycyrrhizic acid was 1.01~1.09 mg·g^(-1),0.85~0.96 mg·g^(-1),1.42~1.70 mg·g^(-1),and 1.53~1.84 mg·g^(-1),respectively.Conclusion HPLC-ELSD characteristic chromatogram combined with multi-functional component content determination can comprehensively evaluate and control the quality of Baoyuan Kangpi chewable tablets.