基于HPLC指纹图谱及定量测定的益气逐瘀利水方质量评价研究  

Quality evaluation of Yiqi Zhuyu Lishui Recipe based on HPLC fingerprints combined with content determination

作　　者：陈婷[1] 胡芳[1] 唐樑[1] 黄玉宇 沈夕坤[1] 成旭东[1] CHEN Ting;HU Fang;TANG Liang;HUANG Yu-yu;SHEN Xi-kun;CHENG Xu-dong(Department of Pharmacy,Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine,Jiangsu Suzhou 215009,China)

机构地区：[1]南京中医药大学附属苏州市中医医院药学部,江苏苏州215009

出　　处：《中国医院药学杂志》2022年第7期707-712,共6页Chinese Journal of Hospital Pharmacy

基　　金：苏州市科技项目(编号:SKJY2021130,SKJYD2021228,SYS2020184)。

摘　　要：目的:建立益气逐瘀利水方的HPLC指纹图谱,并测定4种成分含量,为益气逐瘀利水方产业化开发的质量控制提供参考。方法:采用Agilent ZORBAX Eclipse XDB-C_(18)色谱柱,乙腈-0.1%磷酸水为流动相,梯度洗脱,体积流量1.0 mL·min^(-1),柱温30℃,检测波长245 nm,建立10批益气逐瘀利水方指纹图谱。采用中药色谱指纹图谱相似度评价软件(2012年版)进行相似度评价,结合聚类分析(CA)、主成分分析(PCA)及正交偏最小二乘法-判别分析(OPLS-DA)模式识别技术进行质量评价,同时进行含量测定。结果:10批益气逐瘀利水方标准汤剂指纹图谱相似度均大于0.995,标定出共有峰24个,指认其中的4个共有峰(14号峰毛蕊异黄酮葡萄糖苷、15号峰阿魏酸、17号峰汉防己乙素、19号峰粉防己碱),CA、PCA及OPLS-DA将10批样品分成2类。定量分析方法学考察结果良好,10批样品中毛蕊异黄酮葡萄糖苷、阿魏酸、汉防己乙素、粉防己碱的定量结果分别为43.98~64.18、107.32~167.95、122.63~175.21、391.62~582.02μg·g^(-1)。结论:所建立的益气逐瘀利水方指纹图谱及定量测定方法稳定性好、重复性高,可更加全面系统地评价益气逐瘀利水方的质量。OBJECTIVE Establish the HPLC fingerprint of Yiqi Zhuyu Lishui Recipe and determine the contents of four components,so as to provide reference for the quality control of its industrial development.METHODS All samples were analyzed on an Agilent ZORBAX Eclipse XDB-C_(18) chromatographic column with gradient elution of acetonitrile and 0.1%phosphoric acid at a flow rate 1.0 mL·min^(-1).The column temperature was set at 30℃and the detection wavelength was 245 nm.The fingerprints of 10 batches of Yiqi Zhuyu Lishui Recipe were established and their similarity was evaluated by Similarity Evaluation System for Chromatographic Fingerprints of TCM(2012 Edition).Combined with cluster analysis(CA),principal component analysis(PCA)and orthogonal partial least squares-discriminant analysis(OPLS-DA),the quality evaluation of Yiqi Zhuyu Lishui Recipe standard decoction was carried out.At the same time,the contents of four components were determined.RESULTS The similarity of 10 batches of Yiqi Zhuyu Lishui Recipe standard decoction was more than 0.995,and 24 common peaks were demarcated,4 of which were identified(peak No 14 calycosin-7-glucoside,peak No 15 ferulic acid,peak No 17 Hanfangichin B,peak No 19 tetrandrine).CA,PCA and OPLS-DA were used to divide the 10 batches of samples into 2 categories.The results of the methodological investigation of the quantitative analysis were satisfactory.The contents of calycosin-7-glucoside,ferulic acid,Hanfangichin B and tetrandrine were within the ranges of 43.98~64.18,107.32~167.95,122.63~175.21 and 391.62~582.02μg·g^(-1),respectively.CONCLUSION The fingerprint combined with quantitative determination method has good stability and high repeatability,which can evaluate the quality of Yiqi Zhuyu Lishui Recipe more comprehensively and systematically.

关 键 词：益气逐瘀利水方 指纹图谱 聚类分析 主成分分析 正交偏最小二乘法-判别分析 

分 类 号：R284.1[医药卫生—中药学]