目的 建立祖师麻注射液的HPLC指纹图谱和化学模式识别模型，为祖师麻注射液的质量一致性提供参考。方法 祖师麻注射液的分析采用Agilent C₁₈色谱柱（250 mm×4.6 mm，5 μm）；流动相为0.1%甲酸水溶液-乙腈，梯度洗脱；体积流量1.0 mL/min；检测波长300 nm和254 nm；柱温30℃。采用“中药色谱指纹图谱相似度评价系统”（2012版）考察15批祖师麻注射液的相似度，结合主成分分析（principal component analysis，PCA）、聚类分析（cluster analysis，CA）以及正交偏最小二乘判别分析（orthogonal partial least squares discriminant analysis，OPLS-DA）对祖师麻注射液进行整体质量评价。结果 祖师麻注射液的HPLC指纹图谱中15批样品相似度在0.882～0.998，通过PCA、CA、OPLS-DA分析，15批样品聚成3类，S1～S8来自同一厂家，聚为2类；S9～S14来自同一厂家聚为1类，并从12个共有峰中确定3个共有峰为祖师麻注射液质量标志物（Q-marker），分别为5、7（祖师麻甲素）、8号峰。结论 利用化学模式识别与指纹图谱相结合的方法可快速评定不同厂家不同批次祖师麻注射液的稳定性和一致性，适用于对祖师麻注射液整体质量的评价。

Objective To establish the HPLC fingerprint and chemical pattern recognition model of Zushima Injection (ZSMI) and provide reference for evaluating the quality consistency of ZSMI. Methods The analysis was performed on Agilent C₁₈ (250 mm×4.6 mm, 5 μm) column with acetonitrile-0.1% formic acid solution for gradient elution, the flow rate was 1.0 mL/min, the detection wavelength was 300 nm and 254 nm, and the column temperature was 30℃. "Similarity Evaluation System of Fingerprint of Traditional Chinese Medicine (2012 edition)" was adopted to investigate the similarity of 15 batches of ZSMI combined with principal component analysis (PCA), cluster analysis (CA), and orthogonal partial least squares discriminant analysis (OPLS-DA) to evaluate the overall quality of ZSMI. Results The similarity of 15 batches of samples was between 0.882 and 0.998. By PCA, CA, and OPLS-DA analysis, the 15 batches of samples were clustered into three types, of which S1-S8 were clustered into two types from the same manufacturer, S9-S14 were from the same manufacturer and clustered into group I. Three common peaks were identified from 12 common peaks as Q-marker of ZSMI, which were No. 5, 8, and 7 (daphnetin) peaks. Conclusion The method of combining chemical pattern recognition with fingerprint is simple with good reproducibility, which can quickly evaluate the stability and consistency of different batches of ZSMI from different manufacturers, and is suitable for the evaluation of the overall quality of ZSMI.

R286.02

国家科技支撑计划项目（2015BAK44B00）