高效液相色谱指纹图谱法结合化学模式识别评价脑安胶囊整体质量  

Evaluation of Overall Quality of Naoan Capsules by HPLC Fingerprint Combined with Chemical Pattern Recognition

作　　者：魏培 曹春泉 朱瑞娟 钱淼 孙新堂 WEI Pei;CAO Chunquan;ZHU Ruijuan;QIAN Miao;SUN Xintang(Department of Food and Drug Technology,Shandong Vocational Animal Science and Veterinary College,Weifang,Shandong,China 261061;School of Pharmacy,Heze University,Heze,Shandong,China 274000)

机构地区：[1]山东畜牧兽医职业学院食品与药品科技系,山东潍坊261061 [2]菏泽学院药学院,山东菏泽274000

出　　处：《中国药业》2023年第3期67-72,共6页China Pharmaceuticals

摘　　要：目的评价脑安胶囊的整体质量。方法建立测定制剂中阿魏酸、川芎嗪、藁本内酯、羟基红花黄色素A、山柰素、人参皂苷Rg_(1)、人参皂苷Re和人参皂苷Rb_(1)8个化合物含量的高效液相色谱法,建立19批脑安胶囊的指纹图谱,运用中药色谱指纹图谱相似度评价系统2012A版软件进行相似度评价,并通过聚类分析(CA)和偏最小二乘-判别分析(PLS-DA)法进行化学模式分析。结果共标定21个共有峰。指认8个化合物,分别为羟基红花黄色素A、川芎嗪、阿魏酸、藁本内酯、人参皂苷Rg_(1)、人参皂苷Re、人参皂苷Rb_(1)、山柰素;19批样品相似度为0.911~0.996;CA和PLS-DA结果显示,可将19批样品按生产厂家的不同聚成两类,并确定7个差异标志物。结论高效液相色谱指纹图谱结合化学模式识别可客观评价脑安胶囊的质量。Objective To evaluate the overall quality of Naoan Capsules.Methods The high-performance liquid chromatography(HPLC)method was established for the determination of eight compounds including ferulic acid,tetramethylpyrazine,ligustilide,hydroxysafflor yellow A,kaempferol,ginsenoside Rg1,ginsenoside Re and ginsenoside Rb1in the preparation.The fingerprint of 19 batches of Naoan Capsules was established,the similarity was evaluated by the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(2012A),and the chemical pattern recognition was performed by the cluster analysis(CA)and partial least squares-discriminant analysis(PLS-DA).Results A total of 21 common peaks were obtained,and eight compounds were identified,including hydroxysafflor yellow A,tetramethylpyrazine,ferulic acid,ligustilide,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1and kaempferol.The similarity of 19 batches of samples was in the range of 0.911-0.996.The results of CA and PLS-DA showed that 19 batches of samples could be classified into two groups according to different manufacturers,and seven different markers was identified.Conclusion HPLC fingerprint combined with chemical pattern recognition can objectively evaluate the quality of Naoan Capsules.

关 键 词：脑安胶囊 高效液相色谱法 指纹图谱 化学模式识别 聚类分析 偏最小二乘-判别分析法 质量评价 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学] R286.0