基于聚类分析的牛黄清感胶囊HPLC指纹图谱研究

HPLC Fingerprint of Niuhuang Qinggan Capsules Based on Cluster Analysis

目的:建立牛黄清感胶囊的指纹图谱,采用相似度计算和聚类分析的方法评价牛黄清感胶囊的质量,为其真伪鉴别及质量控制提供依据。方法:采用HPLC法。色谱柱为Waters Sunfire ODS C18(250 mm×4.6 mm,5μm),以乙腈(A)-0.1%磷酸水溶液(B)为流动相,梯度洗脱;检测波长:210 nm,柱温:30℃,进样量:10μl,对15批牛黄清感胶囊样品进行分析,采用中药色谱指纹图谱相似度评价系统结合聚类分析对其质量进行评价。结果:建立了牛黄清感胶囊的指纹图谱,确定了19个共有峰,指认了其中5个色谱峰,15批牛黄清感胶囊与对照图谱的相似度为0.924~0.999,聚类分析可将不同生产时间段的牛黄清感胶囊很好的分为3类,且分类结果与相似度结果一致。结论:所建立的牛黄清感胶囊指纹图谱分析方法全面、准确、稳定,结合聚类分析研究可有助于牛黄清感胶囊的整体质量评价,同时为其质量评价提供一种有效手段。

Objective:To establish the common HPLC fingerprint of Niuhuang Qinggan capsules and evaluate the quality through similarity calculation and cluster analysis to provide basis for the authenticity identification and quality evaluation.Methods:An HPLC method was adopted.A Waters Sunfire ODS C18(250 mm×4.6 mm,5μm)column was used,acetonitrile-0.1%phosphoric acid was the mobile phase with gradient elution,the flow rate of 1.0 ml·min-1,the detection wavelength was 210 nm,the column temperature was 30℃,and the sample size was 10μl.Totally 15 batches of samples were analyzed and evaluated by the similarity evaluation system for chromatographic fingerprint of traditional Chinese medicine and cluster analysis.Results:The HPLC fingerprint pattern of Niuhuang Qinggan capsules was established,and 19 common peaks were recognized,and among them,5 peaks were identified.The similarity of the 15 batches of Niuhuang Qinggan capsules were 0.924-0.999.The samples were clearly classified into three groups by cluster analysis,and the classification results were consistent with the similarity results.Conclusion:The HPLC fingerprint detection method of Niuhuang Qinggan capsules is accurate,comprehensive and reliable,which contributes to the overall quality control,and can be applied as an effective method for the quality evaluation of Niuhuang Qinggan capsules.