HPLC指纹图谱结合化学模式识别评价祖师麻注射液的整体质量  

HPLC fingerprint combined with chemical pattern recognition for integral quality of Zushima Injection

作　　者：孙岩 吴晨光 韩群 黄胜阳 SUN Yan;WU Chen-guang;HAN Qun;HUANG Sheng-yang(Beijing Key Laboratory of Environmental and Viral Oncology,College of Life Science and Bioengineering,Beijing University of Technology,Beijing 100124,China)

机构地区：[1]北京工业大学生命科学与生物工程学院环境与病毒肿瘤学北京市重点实验室,北京100124

出　　处：《中草药》2020年第8期2170-2176,共7页Chinese Traditional and Herbal Drugs

基　　金：国家科技支撑计划项目(2015BAK44B00)。

摘　　要：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,5μm);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.

关 键 词：祖师麻注射液 HPLC 指纹图谱 化学模式识别 质量评价 一致性 聚类分析 主成分分析 正交偏最小二乘判别分析 质量标志物 祖师麻甲素 

分 类 号：R286.02[医药卫生—中药学]