华蟾素胶囊HPLC指纹图谱研究与化学模式识别  

HPLC fingerprint and chemical pattern recognition of cinobufagin capsules

作　　者：吴娟萍[1] 薛涛[1] 郭璐[1] 张雁 WU Juan-ping;XUE Tao;GUO Lu;ZHANG Yan(The Pharmacy Department of Huzhou First People’s Hospital,Huzhou 313000,China;Hunan Xiangtan Institute for Food and Drug Control,Xiangtan 411100,China)

机构地区：[1]湖州市第一人民医院药剂科,湖州313000 [2]湖南省湘潭市食品药品检验所,湘潭411100

出　　处：《药物分析杂志》2020年第11期1977-1985,共9页Chinese Journal of Pharmaceutical Analysis

基　　金：浙江省自然科学基金(LQ15H310004)。

摘　　要：目的:采用高效液相色谱法(HPLC)建立华蟾素胶囊的指纹图谱,并结合化学模式识别技术对其分析评价。方法:采用Kromasil C18(250 mm×4.6 mm,5μm)色谱柱;以乙腈-0.5%磷酸二氢钾水溶液为流动相进行梯度洗脱;体积流量0.9 mL·min-1;检测波长296 nm;建立华蟾素胶囊的HPLC指纹图谱。通过相似度评价,结合聚类分析(CA)及偏最小二乘法-判别分析(PLS-DA)对20批华蟾素胶囊的指纹图谱进行分析评价。结果:建立的华蟾素胶囊指纹图谱共标定23个共有峰,经与化学对照品比对鉴定出其中的7个色谱峰;20批样品相似度均大于0.971,通过CA和PLS-DA,20批样品聚成2类,分类结果与生产厂家呈相关性,并发现10个差异性标志物。结论:所建立的HPLC指纹图谱稳定可行,专属性强,可用于华蟾素胶囊的定性定量分析。Objective:To establish the high performance liquid chromatography(HPLC)fingerprint of cinobufagin capsules and to evaluate the drug by combining with chemical pattern recognition.Methods:The analysis was performed on a Kromasil C18(250 mm×4.6 mm,5μm)column with mobile phase consisting of acetonitrile and 0.5%potassium dihydrogen solution(gradient elution)at a flow rate of 0.9 mL·min-1.The detection wavelength was set at 296 nm to establish the HPLC fingerprint of cinobufagin capsules.Then the further assessment of 20 batches of samples was carried out by similarity evaluation,cluster analysis(CA)and discriminant analysis of partial least squares(PLS-DA).Results:HPLC fingerprint of cinobufagin capsules was set up with 23 common peaks,and 12 of them were identified by comparing with standard references.The similarities of 20 batches of samples were all above 0.971.20 batches of samples were classified into two clusters by CA and PLS-DA,and the classification results were correlated with the pharmaceutical manufacturers.Ten differential markers were found.Conclusion:The proposed fingerprint method is stable,feasible and specific,which can be used for qualitative and quantitative analysis of cinobufagin capsules.

关 键 词：华蟾素胶囊 高效液相色谱法 指纹图谱 聚类分析 偏最小二乘法-判别分析 化学模式识别 

分 类 号：R917[医药卫生—药物分析学]