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作 者:黄真[1] 周洪雷[1] 李运伦[2] 蒋海强[1] 郑德[1] 史玉霞[1] 仙云霞 齐冬梅[1]
机构地区:[1]山东中医药大学药学院,山东济南250355 [2]山东中医药大学附属医院,山东济南250011
出 处:《辽宁中医杂志》2014年第6期1251-1253,共3页Liaoning Journal of Traditional Chinese Medicine
基 金:山东省科技发展计划项目(2008GG2NS02011);国家科技重大专项-"重大新药创制"-"山东省重大新药创制中心建设"(2009ZX09301-013);山东省自然科学基金项目(ZR2010HM017);山东省教育厅科技计划项目(J105LL05)
摘 要:目的:以聚类分析、主成分分析等方法,结合含量测定,建立并完善藤菔降压片评价体系。方法:流动相为乙腈-0.01 mol/L-1磷酸二氢钠水溶液梯度洗脱,检测波长224 nm。对10批次不同时间制备的藤菔降压片进行测定,建立了藤菔降压片标准指纹谱,并计算各批次的相似度;对所得指纹图谱数据进行聚类分析及主成分分析。结果:方法精密度、重复性与稳定性良好。将藤菔降压片聚类为1类,确定21个共有峰,样品相似度>0.95,主成分分析显示10批藤菔降压片无明显分类。结论:建立的HPLC指纹图谱、聚类分析和主成分分析方法有助于完善藤菔降压片质量评价体系。Objective: To establish the method of HPLC fingerprints of Tengfu-Antihypertensive Tablets by using hierarchical cluster analysis,principal component analysis and determination of content. Methods: 10 batches were analyzed by HPLC. Acetonitrile and 0. 01 mmol /L-1sodium dihydrogen phosphate buffer were used as mobile phase by gradient eluting. Detection wavelength was set at 224 nm. By the similarity evaluation system forchromatographic fingerprint of traditional Chinese medicine( Version2004A),mean chromatogram was generated as the representative standard fingerprint. Data was analyzed by the method of hierarchical cluster analysis and principal component analysis. Results: 21 main marker peaks were selected in the standard fingerprint,and the similarity was over 〉0. 95. The method has high sensitivity and good reproducibility and the Tengfu-Antihypertensive Tablets could be divided into 1 grade,principal component analysis shows that the quality of 10 batches of Tengfu-Antihypertensive Tablets are stable. Conclusion: The fingerprints study,hierarchical cluster analysis and principal component analysis method can be used for the quality control of Tengfu-Antihypertensive Tablets.
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