摘要
目的:建立野菊花配方颗粒的HPLC指纹图谱和化学模式识别模型,为野菊花配方颗粒的质量一致性研究提供参考。方法:采用Agilent C18色谱柱(4.6 mm×250 mm,5μm),流动相为乙腈~0.1%磷酸水溶液,梯度洗脱,体积流量1.0 m L·min^(-1),检测波长330 nm,柱温30℃;采用"中药色谱指纹图谱相似度评价系统"(2012版)建立对照指纹图谱,考察12批野菊花配方颗粒相似度,结合主成分分析、聚类分析以及对不同厂家不同批次野菊花配方颗粒进行整体质量评价。结果:4个厂家野菊花配方颗粒的HPLC指纹图谱样品相似度在0.857~0.998,主成分分析12批样品聚成4类,与样品颗粒厂家来源信息一致,聚类分析结果与主成分分析结果一致,并从22个共有峰中确定10个共有峰为野菊花配方颗粒特征峰。结论:利用化学模式识别与指纹图谱相结合的方法简便、可靠,可快速评定不同厂家不同批次野菊花配方颗粒的稳定性和一致性,适用于野菊花配方颗粒整体质量的评价。
Objective:To establish an HPLC fingerprint and chemical pattern recognition model of Yejuhua formula granules,providing reference for quality evaluation of Yejuhua formula granules.Methods:Analysis was performed on an Agilent C18(4.6 mm×250 mm,5μm)column with acetonitrile-0.1%phosphoric acid for gradient elution.The flow rate was 1.0 mL·min^(-1),the detection wavelength was 300 nm,and the column temperature was 30℃."Similarity Evaluation System of Fingerprint of Traditional Chinese Medicine(2012 edition)"was adopted to establish reference fingerprint and to calculate the similarities of 12 batches of Yejuhua formula granules.Combining with principal component analysis(PCA)and cluster analysis(CA),the overall quality of Yejuhua formula granules was evaluated.Results:Similarities of 12 batches of samples from 4 manufacturers were between 0.857 and 0.998.Samples were clustered into 4 types by PCA,which consistented with the source information of the sample.Cluster analysis result was consistent with that of principal component analysis.10 characteristic peaks were selected and identified from 22 common peaks.Conclusion:The method combining chemical pattern recognition with HPLC fingerprint is simple and reliable,which can quickly evaluate the stability and consistency of different batches of Yejuhua formula granules from different manufacturers,and is suitable for the evaluation of the overall quality evaluation of Yejuhua formula granules.
作者
张丽先
范毅
李飞飞
李智宁
李自红
ZHANG Li-xian;FAN Yi;LI Fei-fei;LI Zhi-ning;LI Zi-hong(Henan Natural Product Biotechnology Co.Ltd.,Zhengzhou 450002,China;Key Laboratory of Natural Products,Henan Academy of Sciences,Zhengzhou 450002,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2021年第5期913-918,共6页
Chinese Journal of Pharmaceutical Analysis
基金
河南省科学院科研开发项目(200613060)。
