基于高效液相色谱法多指标定量联合化学计量学及灰色关联度分析评价泻青丸综合质量  

Comprehensive evaluation of Xieqing Pills by HPLC multi-component quantitative combined with chemo-metrics and grey relational analysis

作　　者：金晓姣 徐磊 王玉莹 李志国 Jin Xiaojiao;Xu Lei;Wang Yuying;Li Zhiguo(Department of Pharmacy,Jinhua Central Hospital,Jinhua,Zhejiang 321000,China;Department of Pharmacy,Jinhua Hospital of Traditional Chinese Medicine,Jinhua,Zhejiang 321017,China;Department of Pharmacy,Yongkang Second People′s Hospital,Yongkang,Zhejiang,Zhejiang 321300,China;School of Pharmacy,Zhejiang Chinese Medical University,Hangzhou,Zhejiang 311402,China)

机构地区：[1]金华市中心医院药学部,浙江金华321000 [2]金华市中医医院药学部,浙江金华321017 [3]永康市第二人民医院药剂科,浙江永康321300 [4]浙江中医药大学药学院,浙江杭州311402

出　　处：《中国药物与临床》2024年第9期605-612,F0003,共9页Chinese Remedies & Clinics

基　　金：浙江省中医药科技计划项目(2023ZF016)。

摘　　要：目的建立泻青丸多指标成分定量方法,同时借助化学计量学及灰色关联度分析(GRA)评价其综合质量。方法采用高效液相色谱法(HPLC),以Venusil MP C18为色谱柱,乙腈-0.2%冰醋酸为流动相,同时测定泻青丸中獐牙菜苦苷、龙胆苦苷、獐牙菜苷、山栀子苷、羟异栀子苷、京尼平龙胆双糖苷、栀子苷、升麻素苷、升麻素、亥茅酚苷、洋川芎内酯H、洋川芎内酯I、洋川芎内酯A和藁本内酯含量。结合化学计量学挖掘影响泻青丸产品质量的差异标志物。以相对关联度为测度,对泻青丸综合质量进行评价。结果完成14个成分含量测定方法学验证,结果均符合中国药典要求。化学计量学分析显示栀子苷、龙胆苦苷、藁本内酯、京尼平龙胆双糖苷、洋川芎内酯A、升麻素苷和羟异栀子苷是影响泻青丸产品质量的主要因子。GRA结果显示相对关联度为0.385~0.584,可用于泻青丸质量优劣评价。结论HPLC多组分定量与化学计量学及GRA方法结合可综合评价泻青丸质量。Objective To establish a method for quantifying the multiple indicator components of Xieqing Pills,and to evaluate its comprehensive quality by chemometrics and grey relational analysis GRA methods.Methods Determined by HPLC,chromatographic column was Venusil MP C18 column,and acetonitrile-0.2%glacial acetic acid as the mobile phase.The contents of swertiamain,gentiopicrin,sweroside,shanzhiside,garypto-side,genipin 1-gentiobioside,geniposide,prim-O-glucosylcimifugin,cimifugin,sec-o-glucosylhamaudol,senkyuno-lide H,senkyunolide I,senkyunolide A and ligustilide of Xieqing Pills were determined.Chemometrics was used to explore differential markers affecting the product quality of Xieqing Pills.The relative correlation degree was used as the measure to analyze the comprehensive quality of Xieqing Pills.Results The methodological validation of the content determination of 14 components was completed,and the results met the requirements of Chinese Pharma-copoeia.The chemometric analysis showed that geniposide,gentiopicrin,ligustilide,genipin 1-gentiobioside,senkyunolide A,prim-O-glucosylcimifugin and gardenoside were the main potential markers affecting the quality of Xieqing Pills.The results of GRA showed that the relative correlation degree was between 0.385 and 0.584,which could be used to evaluate the quality of Xieqing Pills.Conclusion The quality of Xieqing Pills can be compre-hensively evaluated by combining HPLC multi-component quantification with chemometrics and GRA method.

关 键 词：泻青丸 色谱法 液相 化学计量 综合评价 

分 类 号：R286.0[医药卫生—中药学]