平消片HPLC指纹图谱研究及化学模式识别分析  

HPLC Fingerprint and Chemical Pattern Recognition of Pingxiao Tablets

作　　者：柯海姑 盛敏慧 Ke Haigu;Sheng Minhui(Pharmacy Department of Hangzhou Cancer Hospital,Hangzhou 310000,China)

机构地区：[1]杭州市肿瘤医院药剂科,杭州310000

出　　处：《中国药师》2020年第11期2174-2179,2242,共7页China Pharmacist

摘　　要：目的:建立平消片的HPLC指纹图谱,为评价其质量提供依据。方法:采用Agilent SB-C18色谱柱(250 mm×4.6 mm,5μm);流动相乙腈(A)-0.05%磷酸水溶液(B)梯度洗脱;体积流量:1.0 ml·min^-1;分段变波长测定214,278 nm;柱温:40℃;进样量:10μl。根据相似度评价,结合化学计量学方法对平消片进行质量评价。结果:建立12批平消片的HPLC指纹图谱,共确定20个共有指纹峰,通过与对照品指认了9个成分;12批样品指纹图谱相似度均大于0.9,通过聚类分析(CA)可将12批样品聚成3类,结合主成分分析(PCA)、偏最小二乘法-判别分析(PLS-DA)发现8个成分是造成不同批次样品差异性的主要标记物。结论:所建立的HPLC指纹图谱方法稳定可行,可为平消片的质量控制提供参考。Objective:To establish the HPLC fingerprint of Pingxiao tablets to provide reference for the quality evaluation.Methods:The separation was performed on an Agilent SB-C18 column(250 mm×4.6 mm,5μm)with the mobile phase of acetonitrile and 0.05%phosphoric acid solution with gradient elution at a flow rate of 1.0 ml·min^-1;wavelength switching technology was used at 214 and 278 nm;the column temperature was at 40℃,and the sample volume was 10μl.According to the similarity evalutation,the chemometrics method was used to evaluate the quality of Pingxiao tablets.Results:The fingerprints of 12 batches of Pingxiao tablets were established,and 20 common peaks were found,and 9 of which were identified according to the reference substances.The samples were classified into three groups by hierarchical cluster analysis combined with principal component analysis(PCA)and discriminant analysis of partial least squares(PLS-DA),and 8 components were the main markers causing the differences in the various batches of samples.Conclusion:The established HPLC fingerprint method is stable and feasible,and can provide reference for the quality control of Pingxiao tablets.

关 键 词：平消片 指纹图谱 相似度 主成分分析 偏最小二乘法-判别分析 聚类分析 

分 类 号：TQ460.72[医药卫生—药物分析学]