基于UPLC指纹图谱结合化学计量学的小儿咳喘灵颗粒质量评价  

Quality Evaluation of XiaoEr KeChuanLing Granules Based on Combinative Method of UPLC Fingerprints and Chemometrics

作　　者：陆林玲 钱叶飞 张华锋 周坚 LU Lin-ling;QIAN Ye-fei;ZHANG Hua-feng;ZHOU Jian(Suzhou Institute for Drug Control,Suzhou 215104,China)

机构地区：[1]苏州市药品检验检测研究中心,江苏苏州215104

出　　处：《海峡药学》2022年第1期57-60,共4页Strait Pharmaceutical Journal

基　　金：苏州市科技计划项目(SYSD2018218)。

摘　　要：目的建立UPLC指纹图谱结合化学计量学的小儿咳喘灵颗粒质量评价方法。方法采用UPLC法,以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,建立36批小儿咳喘灵颗粒的指纹图谱,并利用对照品对其特征峰进行指认;同时采用Chempattern化学计量学软件结合主成分分析(PCA)、聚类分析(CA)对数据进行处理,对不同厂家生产的小儿咳喘灵颗粒进行质量评价。结果建立的小儿咳喘灵颗粒的UPLC指纹图谱有18个共有峰,并指认了8个成分((R,S)-告依春、绿原酸、隐绿原酸、木樨草苷、甘草苷、异绿原酸A、异绿原酸C、甘草酸);36批样品与对照指纹图谱的相似度均高于0.88;不同厂家及批次的小儿咳喘灵颗粒存在较大的差异。结论所建立的指纹图谱能为小儿咳喘灵颗粒的质量控制提供更全面的参考。OBJECTIVE This study aims to establish a combinative method based on UPLC fingerprint and chemometrics for quality evaluation of XiaoEr KeChuanLing Granules.METHODS Fingerprints of 36 batches of XiaoEr KeChuanLing Granules were established by UPLC and acetonitrile-0.1%phosphoric acid solution was used as the mobile phase with the gradient elution.The common peaks were identified by comparison with the reference standards.At the same time,Chemometrics software Chempattern was employed to analyze the data.Through cluster analysis and principal component analysis,different preparations from different manufacturers and different batches from the same manufacturer were classified.RESULTS The XiaoEr KeChuanLing Granules fingerprint with 18 common peaks was established to confirm and identify eight characteristic peaks,namely,(R,S)-goitrin,chlorogenic acid,cryptochlorogenic acid,liquiritin;luteoloside,Isochlorogenic acid A,Isochlorogenic acid C,glycyrrhetic acid.The similarities between 36 batches of samples were over 0.88.There were certain differences in the XiaoEr KeChuanLing Granules of various batches and manufacturers.CONCLUSION The proposed specific UPLC characteristic chromatogram for XiaoEr KeChuanLing Granules offered more comprehensive reference for quality control of the crude drug.

关 键 词：小儿咳喘灵颗粒 超高效液相色谱法 指纹图谱 主成分分析 聚类分析 

分 类 号：R927[医药卫生—药学]