目的 基于HPLC指纹图谱与多成分含量测定，并结合化学模式识别法评价紫丹活血片（ZHT）的质量。方法 采用ACE Neptune-C₁₈色谱柱（250 mm×4.6 mm，5 μm），以乙腈-0.1%磷酸水溶液为流动相，体积流量1.0 mL/min，检测波长275nm，柱温25℃，对18批ZHT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与主成分分析（PCA）对ZHT质量进行评价。结果 建立了ZHT HPLC指纹图谱，确定了26个共有峰，并指认了其中9个色谱峰（包含2号峰丹参素钠、8号峰迷迭香酸、9号峰紫草酸、10号峰丹酚酸B、12号峰丹酚酸A、21号峰二氢丹参酮I、22号峰隐丹参酮、23号峰丹参酮I、25号峰丹参酮II_A）；18批ZHT HPLC指纹图谱的相似度在0.93～1.00；聚类分析和PCA结果与相似度结果基本一致。多指标成分定量分析方法学考察结果表面，8个指标成分的加样回收率在98.27%～103.42%，RSD为0.86%～2.53%；18批ZHT中丹参素钠、迷迭香酸、紫草酸、丹酚酸B、二氢丹参酮I、隐丹参酮、丹参酮I及丹参酮II_A的质量分数分别为0.149%～0.218%、0.179%～0.225%、0.222%～0.286%、3.570%～6.399%、0.048%～0.136%、0.122%～0.309%、0.061%～0.215%、0.093%～0.413%。结论 不同批次ZHT存在一定的质量差异。通过指纹图谱与聚类分析、PCA等方法相结合可全面地评价ZHT的质量，此方法的建立可以为ZHT的质量控制及评价提供参考依据。

Objective To evaluate the quality of Zidan Huoxue Tablets (ZHT) based on HPLC fingerprint and multi-component content determination combined with chemical pattern recognition method. Methods ACE Neptune-C₁₈ column (250 mm×4.6 mm, 5 μm) was used with acetonitrile-0.1% phosphoric acid aqueous solution as mobile phase at a flow rate of 1.0 mL/min. The detection wavelength was 275 nm and the column temperature was 25℃. A total of 18 batches of ZHT was analyzed, and the quality of ZHT was evaluated by the similarity evaluation system of traditional Chinese medicine chromatographic fingerprints combined with cluster analysis and principal component analysis. Results The fingerprint of ZHT was established. Twenty-six common peaks were identified and nine of them were identified, including 2-sodium danshensu, 8-rosmarinic acid, 9-lithospermic acid, 10-salvianolic acid B, 12-salvianolic acid A, 21-dihydrotanshinone I, 22-cryptotanshinone, 23-tanshinone I, and 25-tanshinone II_A. The similarity of fingerprints of 18 batches of ZHT was between 0.93 and 1.00. The results of cluster analysis and principal component analysis were basically consistent with similarity results. After validating the multiple component quantitative analysis condition through methodology, the average recoveries were between 98.27% and 103.42%, and the RSD were in the range of 0.86%-2.53%. The content of sodium danshensu, rosmarinic acid, lithospermic acid, salvianolic acid B, dihydrotanshinone I, cryptotanshinone, tanshinone I, tanshinone II_A in 18 batches of ZHT were in the range of 0.149%-0.218%, 0.179%-0.225%, 0.222%-0.286%, 3.570%-6.399%, 0.048%-0.136%, 0.122%-0.309%, 0.061%-0.215%, 0.093%-0.413%, respectively. Conclusion There is a certain quality difference between different batches of ZHT. Through the combination of fingerprinting, cluster analysis and principal component analysis, the quality of ZHT can be comprehensively evaluated. The establishment of this method can provide reference for the quality control and evaluation of ZHT.

R286.02

云南省重大科技专项（2018ZF001）