基于指纹图谱及多元统计分析评价藿香清胃片质量  

Quality Evaluation of Huoxiang Qingwei Tablets by HPLC Fingerprint and Multivariate Statistical Analysis

作　　者：苏建芬 Su Jianfen(Second Hospital of Yinzhou District in Ningbo,Zhejiang Ningbo 315100,China)

机构地区：[1]宁波市鄞州区第二医院,浙江宁波315100

出　　处：《中国药师》2022年第9期1661-1666,共6页China Pharmacist

摘　　要：目的:建立藿香清胃片的HPLC指纹图谱,为评价其质量提供依据。方法:采用CAPCELL PAK C_(18) MGⅡ色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈(A)-0.15%磷酸溶液(B),梯度洗脱,流速:0.95 ml·min^(-1),切换检测波长:210 nm(检测熊果酸)、240 nm(检测栀子苷、升麻素苷、5-O-甲基维斯阿米醇苷及甘草苷)、258 nm(检测栀槲皮素及香草酸)、309 nm(检测广藿香酮、藿香黄酮醇及毛蕊花糖苷),柱温:30℃,进样量:10μl。建立藿香清胃片的指纹图谱,根据相似度评价,结合化学计量学方法对藿香清胃片进行质量评价。结果:建立15批藿香清胃片的HPLC指纹图谱,共确定24个共有指纹峰,通过与对照品比对指认了10个成分;15批藿香清胃片的指纹图谱相似度为0.972~0.998,通过聚类分析(CA)、主成分分析(PCA)、偏最小二乘法-判别分析(PLS-DA),15批样品分成3类,分类结果与厂家呈相关性,并发现5个差异性标志物。结论:所建立的HPLC指纹图谱方法重复性好、专属性强,可为藿香清胃片的质量控制提供依据和参考。Objective:To establish the HPLC fingerprint of Huoxiang Qingwei tablets to provide reference for the quality evaluation.Methods:The determination was carried out on a CAPCELL PAK C_(18) MGⅡ(250 mm×4.6 mm,5μm)column with acetonitrile-0.15%phosphoric acid as the mobile phase with gradient elution at a flow rate of 0.95 ml·min^(-1),and the detection wavelength was set at 210 nm for ursolic acid,240 nm for geniposide,prim-O-glucosylcimifugin and 5-O-methylvisammioside,258 nm for quercetin and vanillic acid,and 309 nm for pogostone,pachypodol and verbascoside,the column temperature was 30℃and the sample volume was 10μl.According to the similarity evaluation,a chemometrics method was used to evaluate the quality of Huoxiang Qingwei tablets.Results:The HPLC fingerprint of Huoxiang Qingwei tablets was set up with 24 common peaks,and ten of them were identified by comparing with the standard references.The similarities of 15 batches of samples were 0.972-0.998.The fifteen batches of samples were classified into three clusters by CA,PCA and PLS-DA,and the classification results were correlated with the pharmaceutical manufacturers.Five differential markers were found.Conclusion:The established HPLC fingerprint method has good repeatability and specificity,which can be used for the quality control of Huoxiang Qingwei tablets.

关 键 词：藿香清胃片 高效液相指纹图谱 相似度 聚类分析 主成分分析 偏最小二乘法-判别分析 

分 类 号：TQ460.72[医药卫生—药物分析学]