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目的:基于中药指纹图谱结合化学模式识别方法寻找影响清开灵硬胶囊批次间稳定性的重点化学成分。方法:采用聚类分析、主成分分析(PCA)对清开灵硬胶囊HPLC指纹图谱数据进行分析,对其批次间稳定性进行评价;采用偏最小二乘法(PLS)寻找影响硬胶囊批次间相似度的标志物。结果:系统聚类分析及PCA分析结果显示,不同批次的硬胶囊存在一定的差异性,与剔除黄芩苷后经指纹图谱相似度评价软件所得评价结果接近;PLS分析显示,该硬胶囊中存在2个化学成分对产品批次间的稳定性具有重要影响。结论:将指纹图谱-化学模式识别方法用于中成药生产中批次间稳定性控制研究是可行的。
OBJECTIVE: To find out the key chemical components that affect the stability of Qingkailing capsules based on the fingerprints of traditional Chinese medicine and chemical pattern recognition. Methods: The data of HPLC fingerprints of Qingkailing hard capsule were analyzed by cluster analysis and principal component analysis (PCA), and the stability among the batches was evaluated. Partial least squares (PLS) Markers of similarity. Results: The result of cluster analysis and PCA analysis showed that there were some differences between the hard capsules of different batches and the results of similarity evaluation software of fingerprints obtained after removing baicalin. PLS analysis showed that there were Two chemicals have a significant impact on the stability between product lots. Conclusion: It is feasible to apply the fingerprint-chemical pattern recognition method to batch stability control in the production of proprietary Chinese medicines.