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目的:研究不同厂家心安胶囊的HPLC指纹图谱,并用主成分分析和聚类分析建立其化学模式识别方法,以期为心安胶囊的质量控制提供参考。方法:色谱柱为Agilent ZORBAX SB-C_(18)(250 mm×4.6 mm,5μm);流动相为0.1%甲酸水溶液(A)-乙腈(B)-四氢呋喃(C)混合溶液,梯度洗脱,流速为1.0 ml·min~(-1);检测波长为350 nm,柱温为30℃。对15批心安胶囊进行检测,用《中药色谱指纹图谱相似度评价系统》2004A版对指纹图谱进行相似度计算,应用SPSS19.0统计学软件进行化学模式识别研究。结果:根据聚类分析和主成分分析结果筛选出10批心安胶囊样品,并建立了指纹图谱的共有模式。结论:该方法简便准确,灵敏度高,可以作为心安胶囊的质量控制方法。
OBJECTIVE: To study the HPLC fingerprints of Xinan Capsules from different manufacturers and to establish their chemical pattern recognition methods by principal component analysis and cluster analysis in order to provide reference for the quality control of Xinan Capsules. METHODS: The chromatographic column was Agilent ZORBAX SB-C 18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of 0.1% formic acid (A) -acetonitrile (B) -tetrahydrofuran (C) The flow rate was 1.0 ml · min -1. The detection wavelength was 350 nm and the column temperature was 30 ℃. Fifteen batches of Xinan Capsules were tested, and the similarity of fingerprints was calculated using the 2004A version of “Chinese Medicines Chromatographic Fingerprint Similarity Evaluation System”. The chemical pattern recognition was performed using SPSS19.0 statistical software. Results: According to the results of cluster analysis and principal component analysis, 10 batches of Xinan Capsules were screened and the common mode of fingerprinting was established. Conclusion: The method is simple, accurate and sensitive and can be used as a quality control method for Xinan capsule.