清热解毒颗粒的HPLC指纹图谱建立及聚类分析  

Establishment of HPLC Fingerprint of Qingre Jiedu Granules and Cluster Analysis

作　　者：洪挺 张昆艳 许妍 王栋 杨毅生 HONG Ting;ZHANG Kunyan;XU Yan;WANG Dong;YANG Yisheng(Jiangxi Institute for Drug Control,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,Nanchang 330029,China;Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China;Jiangxi Provincial Institute for Food Control,Jiangxi National Fruit and Vegetable Products and Processed Food Quality Supervision and Inspection Center,Nanchang 330001,China)

机构地区：[1]江西省药品检验检测研究院,江西省药品与医疗器械质量工程技术研究中心,南昌330029 [2]江西中医药大学,南昌330004 [3]江西省食品检验检测研究院,江西国家果蔬产品及加工食品质量监督检验中心,南昌330001

出　　处：《中国现代应用药学》2019年第24期3056-3060,共5页Chinese Journal of Modern Applied Pharmacy

基　　金：江西省食品药品监督管理局科研项目(2017YX04);国家药典委员会2017年国家药品标准提高项目(488);江西省2018年度研究生创新专项资金项目(YC2018-S286)

摘　　要：目的建立清热解毒颗粒的HPLC指纹图谱,并进行聚类分析。方法色谱柱为Phenomenex C18(250 mm×4.6 mm,5μm),以甲醇-0.1%磷酸溶液为流动相梯度洗脱,流速为1.0 mL·min^-1,柱温为30℃,检测波长为325 nm。采用"中药色谱指纹图谱相似度评价系统"(2012版)进行相似度评价,采用SPSS 21.0软件对15批样品进行聚类分析。结果建立了清热解毒颗粒的HPLC指纹图谱,确定了22个共有峰,指认了4个峰,相似度均≥0.916。15批样品可聚为3大类,S1~S7聚为Ⅰ类、S8~S10聚为Ⅱ类,S11~S15聚为Ⅲ类。结论采用HPLC建立的指纹图谱方法简单,重复性好,可用于清热解毒颗粒的质量控制和工艺评价。OBJECTIVE To establish the HPLC fingerprint chromatogram of Qingre Jiedu granules, and to conduct cluster analysis. METHODS HPLC was performed on Phenomenex C18 column(250 mm×4.6 mm, 5 μm) with the mobile phase consisted of methanol-0.1% phosphoric acid solution in gradient mode. The flow rate was 1.0 mL·min^-1 under the temperature of 30 ℃, with a detection wavelength of 325 nm. The similarity evaluation was carried out by Similarity Evaluation System for TCM Chromatographic Fingerprint(2012 Edition). Cluster analysis was carried out by using SPSS 21.0 statistical software. RESULTS The HPLC fingerprint of Qingre Jiedu granules with 22 commons peaks, and four of them were identified by comparing with reference substances. The similarity was ≥0.916. Fifteen batches of samples were divided into 3 categories. S1-S7 could be grouped into category Ⅰ;S8-S10 could be grouped into category Ⅱ;S11?S15 could be grouped into category Ⅲ. CONCLUSION The established method is simple and reproducible. The fingerprint and cluster analysis results can be used for the quality control and process evaluation.

关 键 词：清热解毒颗粒 高效液相色谱法 指纹图谱 聚类分析 

分 类 号：R284.1[医药卫生—中药学]