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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软胶囊批次间稳定性的重点化学成分。方法采用聚类分析、主成分分析及偏最小二乘法模型对不同批次清开灵软胶囊的高效液相色谱法指纹图谱进行整体观察和评价,找出可能与相似度强相关的标志物。结果通过系统聚类分析及主成分分析表明剔除黄芩苷色谱峰后的相似度计算结果更符合实际情况;经偏最小二乘法分析得到3个化学成分与相似度密切相关,该3个化合物可作为控制清开灵软胶囊批次间稳定性的重点化学成分。结论该中药指纹图谱-化学模式识别方法用于中药不同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 soft capsule batch based on the fingerprint of Chinese traditional medicine combined with chemical pattern recognition. Methods The cluster analysis, principal component analysis and partial least squares model were used to observe and evaluate the HPLC fingerprints of Qingkailing soft capsules in different batches. The markers that may be highly correlated with the similarity were found out. Results The results of cluster analysis and principal component analysis showed that the similarity of baicalin peaks was more in line with the actual situation. The three chemical components were closely related to the similarity by partial least squares analysis. The three compounds could be used as Control Qingkailing soft capsule batch stability between the key chemical composition. Conclusion The fingerprint of traditional Chinese medicine - chemical pattern recognition method for the stability control of different batches of traditional Chinese medicine is feasible.