基于HPLC-QAMS多指标成分定量测定联合化学计量学的甘露消渴胶囊质量评价  

Quality Evaluation of Ganlu Xiaoke Capsule(甘露消渴胶囊)Based on HPLC-QAMS Multi-Index Component Quantitative Control Combined with Chemometrics

作　　者：钟亚芹 王晓明 杜建华 ZHONG Yaqin;WANG Xiaoming;DU Jianhua(Department of Pharmacy,The Second Hospital of Tianjin Medicine University,Tianjin 300211,China;School of Pharmacy,Hebei University of Chinese Medicine,Shijiazhuang 050200,Hebei,China)

机构地区：[1]天津医科大学第二医院药学部,天津300211 [2]河北中医学院药学院,河北石家庄050200

出　　处：《辽宁中医杂志》2024年第3期132-138,I0006,共8页Liaoning Journal of Traditional Chinese Medicine

基　　金：河北省医学科学研究课题计划项目(20200130)。

摘　　要：目的建立高效液相一测多评法(high performance liquid chromatography-quantitative analysis of multi-components by single marker,HPLC-QAMS)定量测定甘露消渴胶囊中毛蕊花糖苷、焦地黄苯乙醇苷B_(1)、东莨菪素、东莨菪苷、莫诺苷、马钱苷、山茱萸新苷、泽泻醇F、泽泻醇A、24-乙酰泽泻醇A、23-乙酰泽泻醇B的含量,并结合化学计量学对3个厂家的产品质量进行评价。方法采用高效液相色谱仪,流动相选择乙腈-0.2%磷酸,色谱柱为Ultimate XB-C_(18)(250 mm×4.6 mm,5μm)进行梯度洗脱。检测波长分别为330 nm(检测毛蕊花糖苷、焦地黄苯乙醇苷B_(1)、东莨菪素、东莨菪苷)、240 nm(检测莫诺苷、马钱苷、山茱萸新苷)和208 nm(检测泽泻醇F、泽泻醇A、24-乙酰泽泻醇A、23-乙酰泽泻醇B)。以马钱苷为内参物,建立其他10种成分的相对校正因子,并计算各成分含量。采用SPSS 26.0统计软件对甘露消渴胶囊中11种成分含量测定结果进行聚类分析和主成分分析。结果毛蕊花糖苷、焦地黄苯乙醇苷B_(1)、东莨菪素、东莨菪苷、莫诺苷、马钱苷、山茱萸新苷、泽泻醇F、泽泻醇A、24-乙酰泽泻醇A、23-乙酰泽泻醇B分别在7.51~375.50、3.37~168.50、0.46~23.00、1.08~54.00、9.60~480.00、4.77~238.50、1.64~82.00、0.76~38.00、1.95~97.50、0.93~46.50和6.69~334.50μg·mL^(-1)范围内线性关系良好,相关系数(r=0.9991~0.9995),加样回收率及相应的RSD依次为99.11%(1.24%)、98.66%(1.45%)、97.71%(1.60%)、96.98%(0.93%)、100.20%(0.65%)、98.54%(1.18%)、97.90%(1.34%)、96.95%(1.07%)、98.47%(0.94%)、99.10%(0.89%)和100.08%(0.59%)。15批甘露消渴胶囊聚为3类,经主成分分析得4个主成分的累积贡献率达到85.338%。结论所建立的HPLC-QAMS法结合化学计量学可综合评价甘露消渴胶囊的质量。Objective To establish a high performance liquid chromatography-quantitative analysis of multi-components by single marker(HPLC-QAMS)method for simultaneously detecting the contents of verbascoside,jionoside B_(1),scopoletin,scopolin,morroniside,loganin,cornuside,alisol F,alisol A,24-acetate alisol A and 23-acetate alisol B in Ganlu Xiaoke Capsule(甘露消渴胶囊)and evaluate the product quality of three factories by chemometrics.Methods The gradient elution was performed on a Ultimate XB-C_(18)(250 mm×4.6 mm,5μm)column with acetonitrile-0.2%phosphoric acid as the mobile phase using HPLC.The detection wavelength were set at 330 nm for verbascoside,jionoside B_(1),scopoletin and scopolin,240 nm for morroniside,loganin and cornuside,and 208 nm for alisol F,alisol A,24-acetate alisol A and 23-acetate alisol B.Using loganin as an internal standard,the relative correction factor of the other ten components was established and the contents of each component were calculated.The cluster analysis and principal component analysis were conducted for the content results of 11 constituents in Ganlu Xiaoke Capsule by SPSS 26.0 statistical software.Results Verbascoside,jionoside B_(1),scopoletin,scopolin,morroniside,loganin,cornuside,alisol F,alisol A,24-acetate alisol A and 23-acetate alisol B showed good linear relationshiPwithin 7.51-375.50,3.37-168.50,0.46-23.00,1.08-54.00,9.60-480.00,4.77-238.50,1.64-82.00,0.76-38.00,1.95-97.50,0.93-46.50 and 6.69-334.50μg·mL^(-1)(r=0.9991-0.9995),whose average recoveries(RSD)were 99.11%(1.24%),98.66%(1.45%),97.71%(1.60%),96.98%(0.93%),100.20%(0.65%),98.54%(1.18%),97.90%(1.34%),96.95%(1.07%),98.47%(0.94%),99.10%(0.89%)and 100.08%(0.59%).Fifteen batches of Ganlu Xiaoke Capsule were clustered into 3 categories,and the cumulative contribution rate of the 4 principal components reached 85.338%.Conclusion The method for simultaneous determination of 11 components of Ganlu Xiaoke Capsule by HPLC-QAMS combined with chemometrics can comprehensively evaluate the quality of Ganlu Xiaoke Capsu

关 键 词：甘露消渴胶囊 高效液相一测多评法 多指标成分 化学计量学 相对校正因子 质量评价 主成分分析 聚类分析 

分 类 号：R284[医药卫生—中药学]