摘要
目的采用一测多评(QAMS)法同时检测人参固本丸中莫诺苷、马钱苷、山茱萸新苷、梓醇、地黄苷D、益母草苷、人参皂苷Rg_(1)、人参皂苷Re、人参皂苷Rb_(1)、泽泻醇A、24-乙酰泽泻醇A、23-乙酰泽泻醇B含量,建立多元统计分析模型对18批样品进行质量评价。方法采用HPLC法,以地黄苷D为内参物,计算各成分相对校正因子及含量,与外标法实测值对比验证QAMS法可行性;采用多元统计分析法对含量数据进行分析,挖掘人参固本丸质量差异标志物。结果建立的相对校正因子可用于定量分析,且耐用性良好;一测多评法与外标法结果无显著差异;18批样品聚为3类,人参皂苷Rb_(1)、人参皂苷Re、莫诺苷、梓醇、23-乙酰泽泻醇B和马钱苷为人参固本丸质量差异标志物。结论多指标定量、多元统计分析模型可用于人参固本丸质量综合评价。
Objective To simultaneously determine morroniside,loganin,cornuside,catalpol,rehmannioside D,ajugol,ginsenoside Rg_(1),ginsenoside Re,ginsenoside Rb_(1),alisol A,24-acetate alisol A,23-acetate alisol B in Renshen Guben pills by QAMS,and to establish a model of multivariate statistical analysis for evaluate the quality of 18 batches of samples.Methods HPLC method was used to calculate the relative correction factor and content of each component with rehmannioside D as internal reference,and the feasibility of QAMS method was verified by comparing with the measured value of external standard method(ESM).The content results were analyzed by multivariate statistical analysis to explore the quality difference markers of Renshen Guben pills.Results The established relative correction factor could be used for quantitative analysis and had good durability.There was no significant difference between the results of QAMS and ESM.The 18 batches of samples were clustered into three categories.Ginsenoside Rb_(1),ginsenoside Re,morroniside,catalpol,23-acetate alisol B and loganin were the quality difference markers of Renshen Guben pills.Conclusion The multi-index quantitative and multivariate statistical analysis model can be used for the comprehensive evaluation of the quality of Renshen Guben pills.
作者
马美玲
李晓
陈玉洁
许伟
MA Meiling;LI Xiao;CHEN Yujie;XU Wei(Department of Drug Testing,Dongying Institute for Food and Drug Control,Dongying 257091,China;Department of Quality and Technical Support,Dongying Institute for Food and Drug Control,Dongying 257091,China;School of Pharmacy,Shandong University of Traditional Chinese Medicine,Jinan 250355,China)
出处
《现代中药研究与实践》
2024年第6期47-53,共7页
Research and Practice on Chinese Medicines
基金
山东省中医药科技发展计划项目(2019-0033)
关键词
人参固本丸
多指标定量
一测多评法
多元统计分析
质量评价
Renshen Guben pills
multi-index quantitative
QAMS
multivariate statistical analysis
quality evaluation
