中国中药杂志

2014, v.39(10) 1816-1821

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指纹图谱分析结合多指标成分定量用于六味五灵片的质量评价
Quality assessment of Liuwei Wuling tablet by HPLC fingerprint and quantitative analysis

刘宏明;徐楠楠;聂磊;
LIU Hong-ming;XU Nan-nan;NIE Lei;Zibo Institute for Food and Drug Control;School of Pharmacy,Shandong University;

摘要(Abstract):

采用反相高效液相色谱法-二极管阵列检测器,以乙腈-0.1%磷酸溶液梯度洗脱,对20批六味五灵片中的6种成分进行同时分析测定,并对其指纹图谱进行研究。结果表明6种成分(特女贞苷、连翘苷、五味子醇甲、五味子酯甲、五味子甲素、五味子乙素)分离良好,加样回收率在98.96%~100.5%,RSD小于2.0%;在特征指纹图谱研究中,以五味子酯甲为参照峰,共标定了25个共有峰,采用夹角余弦法、相关系数法、等权比率法对指纹图谱进行了相似度分析,分析的20批六味五灵片与共有模式之间具有良好的相似性,相似度均在0.95以上。G检验及聚类分析结果表明所建立的含量测定结合特征图谱分析方法可用于六味五灵片的质量控制。
Reversed phase high performance liquid chromatography with diode array detector was employed for simultaneous determination of six components and specific chromatograms analysis in Liuwei Wuling tablets with gradient elution of acetonitrile and water containing 0.1% phosphoric acid as mobile phase.The results showed that six components containing specnuezhenide,phillyrin,schisandrin,schisantherin A,schizandrin A and schizandrin B were separated well under the analytical condition.The average recoveries ranged from 98.96% to 100.5% with RSD less than 2.0%.Twenty-five common peaks were selected as the specific chromatograms of Liuwei Wuling tablets with schisantherin A as the reference peak.Similarities calculated by cosine of angle,correlation coefficient and peak area ratio similarity(PAR) were all above 0.95,indicating a good similarity between the reference and twenty batches of samples.Grubbs test and cluster analysis indicated that the established HPLC fingerprints and HPLC quantitative analysis can be used efficiently in the quality control of Liuwei Wuling tablets.

关键词(KeyWords): 六味五灵片;HPLC;指纹图谱;质量评价
Liuwei Wuling tablet;HPLC;fingerprint;quality analysis

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基金项目(Foundation): 山东省自然科学基金项目(ZR2011HM080)

作者(Author): 刘宏明;徐楠楠;聂磊;
LIU Hong-ming;XU Nan-nan;NIE Lei;Zibo Institute for Food and Drug Control;School of Pharmacy,Shandong University;

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