胃康灵胶囊中芍药苷及7种三萜皂苷类成分的含量测定与聚类分析

目的:建立HPLC波长切换法同时测定胃康灵胶囊中芍药苷、人参皂苷Rg1、人参皂苷Rb1、三七皂苷R1、人参皂苷Re、甘草苷、甘草次酸和甘草酸的含量,并进行聚类分析。方法:采用Sunfire ODS C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.05%磷酸溶液为流动相(梯度洗脱),流速为1.0 ml·min^-1,柱温为30℃。采用波长切换法:0~15 min为230 nm,检测芍药苷、甘草苷;15~60 min为203 nm,检测人参皂苷Rg1、人参皂苷Rb1、三七皂苷R1、人参皂苷Re;60~80 min为250 nm,检测甘草次酸、甘草酸。采用SPSS 22.0统计软件对含量测定结果进行聚类分析。结果:芍药苷、人参皂苷Rg1、人参皂苷Rb1、三七皂苷R1、人参皂苷Re、甘草苷、甘草次酸、甘草酸的质量浓度线性范围分别为12.51~625.30μg·ml^-1(r=0.9994)、3.25~162.30μg·ml^-1(r=0.9996)、2.66~133.20μg·ml^-1(r=0.9993)、2.19~109.70μg·ml^-1(r=0.9995)、2.12~105.90μg·ml^-1(r=0.9999)、7.37~368.30μg·ml^-1(r=0.9998)、3.81~190.60μg·ml^-1(r=0.9992)、6.11~305.30μg·ml^-1(r=0.9997);平均加样回收率分别为99.1%,101.4%,98.4%,97.9%,96.9%,97.6%,101.0%,99.0%,RSD均小于2.0%(n=9)。3个厂家9批样品聚为3类。结论:本方法操作简便,精密度、稳定性及重复性好,符合方法学验证要求,可用于胃康灵胶囊中上述8个成分含量的同时测定。

Content Determination and Cluster Analysis of Paeoniflorin and Seven Tritepenoid Saponins in Weikangling Capsules

Objective:To establish a method for the simultaneous determination of paeoniflorin,ginsenoside Rg1,ginsenoside Rb1,notoginsenoside R1,ginsenoside Re,lquiritin,glycyrrhetinic acid and glycyrrhizic acid in Weikangling capsules by HPLC with wavelength switching,and to conduct cluster analysis.Methods:The analysis was performed on a Sunfire ODS C18 column(250 mm×4.6 mm,5μm)with the mobile phase consisting of acetonitrile-0.05%phosphoric acid(gradient elution)at the flow rate of 1.0 ml·min^-1.The column temperature was set at 30℃.The detection wavelength was set at 230 nm for paeoniflorin and lquiritin in the first 15 min,203 nm for ginsenoside Rg1,ginsenoside Rb1,notoginsenoside R1 and ginsenoside Re during 15 and 60 min,and 250 nm for glycyrrhetinic acid and glycyrrhizic acid during 60 and 80 min.The cluster analysis was conducted for the results of content determination by SPSS 22.0 statistical software.Results:The linear range of paeoniflorin,ginsenoside Rg1,ginsenoside Rb1,notoginsenoside R1,ginsenoside Re,lquiritin,glycyrrhetinic acid and glycyrrhizic acid was 12.51-625.30μg·ml^-1(r=0.9994),3.25-162.30μg·ml^-1(r=0.9996),2.66-133.20μg·ml^-1(r=0.9993),2.19~109.70μg·ml^-1(r=0.9995),2.12-105.90μg·ml^-1(r=0.9999),7.37-368.30μg·ml^-1(r=0.9998),3.81-190.60μg·ml^-1(r=0.9992)and 6.11-305.30μg·ml^-1(r=0.9997),respectively.The average recovery of the above eight components was 99.1%,101.4%,98.4%,97.9%,96.9%,97.7%,101.0%and 99.0%,respectively,and the RSDs were all lower than 2.0%(n=9).The samples of 9 batches of Weikangling capsules could be divided into 3 categories.Conclusion:The method is simple,precise,stable and reproducible,and consistent with method validation requirements,therefore can be used for the simultaneous determination of eight components in Weikangling capsules.