保肾片超高效液相色谱指纹图谱的建立及化学模式识别分析  

UPLC fingerprints and recognition of chemical patterns of Baoshen tablets

作　　者：陆崟 李金慈 盛华 唐安福 苏华 汤淏 LU Yin;LI Jin-ci;SHENG Hua;TANG An-fu;SU Hua;TANG Hao(Department of Pharmacy,General Hospital of Eastern Theater Command,Nanjing 210002)

机构地区：[1]东部战区总医院药剂科,南京210002

出　　处：《中南药学》2022年第2期394-399,共6页Central South Pharmacy

基　　金：军队医疗机构制剂标准提高科研专项课题(编号:14ZJZ08)。

摘　　要：目的建立保肾片超高效液相色谱(UPLC)指纹图谱,结合聚类分析(CA)和偏最小二乘法-判别分析(OPLS-DA)。方法采用Agilent Poroshell 120 EC-C_(18)(2.7μm,4.6 mm×50 mm)型色谱柱,以甲醇-0.2%冰醋酸水溶液进行梯度洗脱,流速0.8 mL·min^(-1),检测波长260 nm,柱温30℃,建立16批保肾片的UPLC指纹图谱并进行共有模式和相似度评价。采用SPSS进行CA分析、SIMCA软件进行OPLS-DA分析,对其进行整体质量评价。结果建立了保肾片的UPLC指纹图谱,确定了12个共有峰,通过对照品比对指认出5个成分,分别为1号峰没食子酸、9号峰芦荟大黄素、10号峰大黄素、11号峰大黄酚、12号峰大黄素甲醚。16批保肾片相似度为0.860~0.997,CA分析发现样品聚成两类,表明不同批次的保肾片尚存在一定差异,通过OPLS-DA得出批次间显著性差异成分为11号峰、4号峰和3号峰。结论建立的保肾片指纹图谱和化学模式识别方法稳定可靠、简便易行、高效快速,可更加全面系统地提供保肾片化学成分信息,为综合评价制剂质量的稳定性和均一性提供参考。Objective To establish the UPLC fingerprints and chemical pattern recognition model of Baoshen tablets.Methods The chromatographic separation was conducted on an Agilent Poroshell 120 EC-C_(18)(2.7μm,4.6 mm×50 mm)column at 30℃ by gradient elution with methanol-0.2% acetic acid solution as the mobile phase at 0.8 mL·min^(-1).The similarity of the 16 batches Baoshen tablets fingerprints,the cluster analysis(A)and partial least squares-discriminant analysis(OPLSDA)were performed by the corresponding softwares respectively.Results The UPLC fingerprints of Baoshen tablets were established.Twelve common peaks were marked in the fingerprint,and five of them were identified as gallic acid(peak 1),aloe-emodin(peak 9),emodin(peak 10),chrysophanol(peak 11)and physcion(peak 12).The similarity of the 16 batches of samples was 0.860~0.997,indicating difference in different batches of Baoshen tablets.The samples were clustered into 2 groups by CA,and the main different components were peak 11,peak 4 and peak 3 screened by OPLS-DA.Conclusion The UPLC fingerprint and chemical pattern recognition are stable,efficient and rapid,which can provide comprehensive and systematic chemical information of Baoshen tablets the quality control and overall evaluation.

关 键 词：保肾片 超高效液相色谱 指纹图谱 相似度分析 化学模式识别 质量控制 

分 类 号：R284[医药卫生—中药学]