基于一测多评(QAMS)法联合化学计量学的参贝止咳颗粒综合质量评价  

Comprehensive quality evaluation of Shenbei Zhike Granules based on HPLC-QAMS combined with chemometrics

作　　者：刘艳芬 段芳[1] 张翘[2] 邹敏 郭丹[1] LIU Yan-fen;DUAN Fang;ZHANG Qiao;ZOU Min;GUO Dan(Department of Pharmacy,Southern Hospital of Southern Medical University,Guangzhou 510515,China;College of Traditional Chinese Medicine,Guangdong Food and Drug Vocational College,Guangzhou 510520,China;College of Basic Medicine,Guangxi University of Chinese Medicine,Nangning 530200,China;Department of Pediatrics,International Zhuang Medicine Hospital Affiliated to Guangxi University of Chinese Medicine&Guangxi International Zhuang Medical Hospital,Nangning 530200,China)

机构地区：[1]南方医科大学南方医院药学部,广东广州510515 [2]广东食品药品职业学院中药学院,广东广州510520 [3]广西中医药大学基础医学院,广西南宁530200 [4]广西中医药大学附属国际壮医医院&广西国际壮医医院儿科,广西南宁530200

出　　处：《中草药》2022年第2期413-423,共11页Chinese Traditional and Herbal Drugs

基　　金：全国中药特色技术传承人才培训项目(国中医药人教函[2019]43号T20194828003);广西壮族自治区中医药管理局自筹经费科研课题(GZZC2020114);广西壮族自治区教育厅高校中青年教师基础能力提升项目(2018KY0302)。

摘　　要：目的建立参贝止咳颗粒中重楼皂苷Ⅶ、Ⅵ、Ⅰ及白花前胡甲素、白花前胡乙素、白花前胡素E、法卡林二醇、人参炔醇、柚皮芸香苷、橙皮苷、川陈皮素、橘红素的高效液相色谱(HPLC)一测多评(quantitative analysis of multi-components by single-marker,QAMS)方法,并结合聚类分析和主成分分析对参贝止咳颗粒进行综合质量评价。方法采用Venusil XBP C;色谱柱;乙腈-0.1%磷酸水溶液为流动相,梯度洗脱;检测波长分别为203 mm(检测重楼皂苷Ⅶ、Ⅵ、Ⅰ)、321 nm (检测白花前胡甲素、白花前胡乙素和白花前胡素E)、254 nm (检测法卡林二醇和人参炔醇)和283 nm (检测柚皮芸香苷、橙皮苷、川陈皮素和橘红素);以白花前胡甲素为内参物,建立重楼皂苷Ⅶ、Ⅵ、Ⅰ及白花前胡乙素、白花前胡素E、法卡林二醇、人参炔醇、柚皮芸香苷、橙皮苷、川陈皮素和橘红素的相对校正因子(relative correctionfactor,RCF),利用RCF计算各成分含量并与外标法实测值进行比较,验证所建立的HPLCQAMS法的准确性和可行性;并采用SPSS 26.0统计软件对12批参贝止咳颗粒中12种成分定量测定结果进行聚类分析和主成分分析。结果参贝止咳颗粒中12种成分线性范围良好(0.999 1≤r≤0.999 7);重楼皂苷Ⅶ、Ⅵ、Ⅰ及白花前胡乙素、白花前胡素E、法卡林二醇、人参炔醇、柚皮芸香苷、橙皮苷、川陈皮素和橘红素的RCF耐用性良好;QAMS法与外标法含量测定结果无显著性差异;聚类分析和主成分分析结果一致,12批参贝止咳颗粒聚为2类,主成分1~4是影响参贝止咳颗粒质量评价的主要因子。结论以白花前胡甲素为内参物,建立的HPLCQAMS法可用于参贝止咳颗粒中多指标成分定量控制和综合质量评价。Objective To establish a high performance liquid chromatography(HPLC)quantitative analysis of multi-components by single-marker(QAMS)method for the simultaneous determination of polyphyllinⅦ,Ⅵ,Ⅰ,praeruptorin A,B,E,falcarindiol,panaxynol,narirutin,hesperidin,nobiletin and tangeretin in Shenbei Zhike Granules(SZG,参贝止咳颗粒),and combine cluster analysis and principal component analysis to comprehensive evaluate the quality of SZG.Methods The chromatographic column was Venusil XBP C18 column.The mobile phase was composed of acetonitrile-0.1%phosphoric acid in gradient elution.The detection wavelength were set at 203 nm for polyphyllinⅦ,Ⅵ,andⅠ,321 nm for praeruptorin A,B and E,254 nm for falcarindiol and panaxynol,and 283 nm for narirutin,hesperidin,nobiletin and tangeretin.The relative correction factors(RCF)of polyphyllinⅦ,Ⅵ,Ⅰ,praeruptorin B,E,falcarindiol,panaxynol,narirutin,hesperidin,nobiletin and tangeretin were established by HPLC method with praeruptorin A as internal reference,which was used to calculate the content of various constituents.The external standard method(ESM)was used to determine the contents of twelve components.The results of the two methods were compared,and the accuracy and feasibility of the established HPLC QAMS method was verified.The cluster analysis and principal component analysis of twelve components in twelve batches of SZG were carried out by SPSS 26.0 statistical software.Results The results showed that the twelve components had good linear relationship(0.9991≤r≤0.9997).The RCF of polyphyllinⅦ,Ⅵ,Ⅰ,praeruptorin B,E,falcarindiol,panaxynol,narirutin,hesperidin,nobiletin and tangeretin had good durability.There was no significant difference between QAMS and ESM.The results of cluster analysis and principal component analysis were consistent.Twelve batches of samples were clustered into two categories,and the principal components 1—4 were the main factor affecting the quality evaluation of SZG.Conclusion The established HPLC QAMS method can be used

关 键 词：参贝止咳颗粒 多指标成分 高效液相色谱 一测多评法 相对校正因子 化学计量学 聚类分析 主成分分析 质量评价 重楼皂苷Ⅶ 重楼皂苷Ⅵ 重楼皂苷Ⅰ 白花前胡甲素 白花前胡乙素 白花前胡素E 法卡林二醇 人参炔醇 柚皮芸香苷 橙皮苷 川陈皮素 橘红素 

分 类 号：R283.6[医药卫生—中药学]