HPLC多指标成分联合PCA、OPLS-DA及灰色关联度法的宫瘤消胶囊综合质量评价  

Quality Control Study of Gongliuxiao Capsule(宫瘤消胶囊)Based on HPLC Multi-Component Quantitative Combined with PCA,OPLS-DA and Grey Relational Analysis

作　　者：张希冉 贡磊磊 李轶凡[1] 秦春雨 王志军 ZHANG Xiran;GONG Leilei;LI Yifan;QIN Chunyu;WANG Zhijun(Beijing Obstetrics and Gynecology Hospital,Capital Medical University/Beijing Maternal and Child Health Care Hospital,Beijing 100026,China;School of Pharmacy,Hebei University of Chinese Medicine,Shijiazhuang Hebei 050200,China)

机构地区：[1]首都医科大学附属北京妇产医院/北京妇幼保健院,北京100026 [2]河北中医学院药学院,河北石家庄050200

出　　处：《中医药导报》2024年第3期43-49,55,共8页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：河北省医学科学研究课题计划项目(20200128)。

摘　　要：目的:采用HPLC法同时检测宫瘤消胶囊(GLX)中13种成分含量,并联合化学计量学及灰色关联度分析(GRA)对GLX质量进行综合评价。方法:以Dikmatech Diamonsil Plus C18为色谱柱,乙腈-0.1%磷酸为流动相,同时测定GLX中党参炔苷、紫丁香苷、鸡矢藤次苷甲酯、车叶草苷酸、车叶草苷、氧化芍药苷、芍药苷、丹皮酚、香附烯酮、圆柚酮、α-香附酮、莪术二酮和莪术醇的含量。采用化学计量学挖掘影响GLX产品质量的主要标记物。基于灰色关联度法分析不同批次GLX各指标成分数据,以相对关联度为测度,对GLX综合质量进行评价。结果:13种成分在各自范围内线性关系良好(r>0.999),平均加样回收率(n=9)在96.81%~100.19%之间(RSD<2.0%)。化学计量学分析显示莪术二酮、香附烯酮、丹皮酚、车叶草苷、党参炔苷、鸡矢藤次苷甲酯、芍药苷和氧化芍药苷是影响GLX产品质量的主要潜在标志物。灰色关联度分析相对关联度0.3302~0.6068,GLX存在一定批间差异。结论:所建立的HPLC多组分定量联合化学计量学及灰色关联度分析方法,操作便捷、结果准确、全面客观,可用于GLX质量的综合评价,为该制剂质量控制提供参考。Objective:To establish an HPLC method for simultaneous determination of 13 components in Gongliuxiao Capsule(GLX),and to comprehensive evaluation the quality of GLX by chemometrics and grey relational analysis(GRA).Methods:Dikmatech Diamonsil Plus C18 column was used as the chromatographic column,and acetonitrile-0.1%phosphoric acid was used as the mobile phase.The contents of lobetyolin,syringin,feretoside,asperulosidic acid,asperuloside,oxypaeoniflorin,paeoniflorin,paeonol,cyperenone,nootkatone,α-cyperone,curdione and curcumol of GLX were determined.Chemometrics was used to mine differential markers affecting the product quality of GLX.The relative correlation degree was used to analyze the data of each index component of different batches of GLX,and the comprehensive quality of GLX was evaluated by GRA.Results:The 13 components showed good linear relationships within their respective ranges(r>0.999),and the average recovery rate(n=9)were 96.81%-100.19%(RSD<2.0%).Chemometric analysis showed that curdione,cyperenone,paeonol,asperuloside,lobetyolin,feretoside,paeoniflorin and oxypaeoniflorin were the main potential markers affecting the quality of GLX.The relative correlation degree of GRA were 0.3302-0.6068,and there was a certain difference between batches of GLX.Conclusion:The established HPLC multi-component quantitative combined chemometrics and GRA method is convenient,accurate,comprehensive and objective.It can be used for the quality comprehensive evaluation and provide reference for the quality control of GLX.

关 键 词：宫瘤消胶囊 高效液相色谱法 多组分 主成分分析 正交偏最小二乘法-判别分析 灰色关联度分析 综合评价 

分 类 号：R284.1[医药卫生—中药学]