[关键词]
[摘要]
目的 建立舒筋活血制剂(舒筋活血胶囊、舒筋活血片)HPLC指纹图谱的方法,为其整体质量评价提供参考。方法 色谱柱为Agilent Poroshell 120 SB-C18(150 mm×4.6 mm,2.7 μm),以乙腈-0.2%甲酸水溶液为流动相,进行梯度洗脱;体积流量0.5 mL/min,检测波长277 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23批舒筋活血制剂的相似度,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)对舒筋活血制剂进行整体质量评价。结果 舒筋活血制剂的HPLC指纹图谱中18批样品(S1~S17和S23)的相似度>0.900,通过PCA、CA和OPLS-DA,23批样品聚成3类,S1~S16来自同一厂家为一类;S23和S17为一类;S18~S22为一类,并从10个共有峰中确定差异较大的4个共有峰,分别为1、3(5-羟甲基糠醛)、6(苯乙酸)和10(4-甲氧基水杨醛)号峰。结论 所建立的指纹图谱结合化学模式识别方法稳定、简单,可用于评价舒筋活血制剂质量。
[Key word]
[Abstract]
Objective To establish the fingerprint chromatography of Shujin Huoxue products (Shujin Huoxue Capsule and Shujin Huoxue Tablet) and provide a reference for its overall quality evaluation. Methods The analysis was performed on Agilent Poroshell 120 SB-C18 (150 mm×4.6 mm, 2.7 μm) column with acetonitrile-0.2% formic acid solution for gradient elution, the flow rate was 0.5 mL/min, the detection wavelength was 277 nm, and the column temperature was 30℃. HPLC of 23 batches of Shujin Huoxue products were analyzed by the software "Similarity Evaluation System for Chromatographic Fingerprint of TCM (2012 edition)" combined with principal component analysis (PCA), cluster analysis (CA), and orthogonal partial least squares discriminant analysis (OPLS-DA). Results The similarity of 18 batches (S1-S17 and S23) of samples was more than 0.900, 23 batches of samples could be clustered into three groups by PCA, CA, and OPLS-DA analysis. Among these, S1-S16 were clustered into group I, S23 and S17 could be divided into group II, and S18-S22 were clustered into group III. Four common peaks with larger differences were determined from 10 common peaks, including peaks 1, 3 (5-hydroxymethylfurfural), 6 (phenylacetic acid), and 10 (4-methoxy salicylaldehyde). Conclusion Fingerprint chromatography combined with chemical pattern recognition technique was stable and simple, which could be used to evaluate the quality of Shujin Huoxue products systematically and comprehensively.
[中图分类号]
[基金项目]
国家自然科学基金资助项目(81603249);中国博士后科学基金面上资助(2018M632507)