基于UPLC指纹图谱及化学模式识别分析的四季三黄片质量一致性评价  

Quality Consistency Evaluation of Siji Sanhuang Tablets Based on UPLC Fingerprint and Chemical Pattern Recognition

作　　者：雷蓉 周亚楠 白洁 苏建 刘永利 LEI Rong;ZHOU Ya-nan;BAI Jie;SU Jian;LIU Yong-li(Hebei Key Laboratory of Traditional Chinese Medicine Quality Evaluation and Standard Researchof,Hebei Institute for Drug and Medical Device Control,Shijiazhuang 050027,China)

机构地区：[1]河北省药品医疗器械检验研究院河北省中药质量评价与标准研究重点实验室,河北石家庄050227

出　　处：《中国现代中药》2022年第10期1988-1994,共7页Modern Chinese Medicine

基　　金：河北省重点研发计划项目(21372502D)。

摘　　要：目的:建立四季三黄片超高效液相色谱法指纹图谱,并结合化学识别模式对其质量一致性进行评价。方法:ShimadzuShim-packgistC_(18)色谱柱(100 mm×2.1mm,2μm),以乙腈-0.1%三氟乙酸水溶液为流动相,梯度洗脱,体积流量为0.3 mL·min^(-1),柱温为30℃,检测波长为254 nm。采用相似度评价、聚类分析、主成分分析和偏最小二乘法-判别分析等模式识别技术对四季三黄片批次间质量差异进行分析。结果:指纹图谱有21个共有峰。4家生产企业的23批样品相似度为0.442~0.999,筛选出了影响质量的11个差异性标志物,结果表明不同企业样品质量存在较大差异,3家企业内批间一致性较好,1家企业内批间一致性较差。结论:建立的方法简便可行,具有良好的准确性、稳定性和专属性,能科学评价四季三黄片质量一致性,可为四季三黄片的质量控制提供参考。Objective:To establish the ultra-performance liquid chromatography(UPLC)fingerprint of Siji Sanhuang Tablets,and evaluate its quality consistency by combining the chemical pattern recognition.Methods:Chromatographic separation was performed on a Shimadzu Shim-pack gist C_(18)(100 mm×2.1 mm,2µm)with a gradient elution of acetonitrile0.1%trifluoroacetic acid at the flow rate of 0.3 mL·min^(-1).The column temperature was 30℃,and the detection wavelength was 254 nm.The similarity evaluation,hierarchical cluster analysis(HCA),principal component analysis(PCA)and partial least squares discriminant analysis(PLS-DA)were conducted to evaluate the differences between batches of Siji Sanhuang Tablets.Results:The fingerprints were established with 21 common peaks.The similarity of 23 batches of samples from four manufacturers was 0.442-0.999,and eleven differential markers that caused quality differences were found.The analysis results showed that there were some differences among the samples from different manufacturers,and the inter-batch consistency of three manufacturers was good,except for one manufacture.Conclusion:The established method was simple,reproducible,stable and specific,and could evaluate the quality consistency of the samples comprehensively and systematically.This study provided reference for the overall quality evaluation of Siji Sanhuang Tablets.

关 键 词：四季三黄片 指纹图谱 一致性评价 模式识别 聚类分析 主成分分析 偏最小二乘法-判别分析 

分 类 号：R286[医药卫生—中药学]