基于UPLC指纹图谱结合化学模式识别的丹灯通脑软胶囊质量控制研究  

Quality control of Dandeng Tongnao Ruanjiaonang based on UPLC fingerprint combined with chemical pattern recognition

作　　者：周霖[1,2] 孙志 薛文华[1,2] 梁淑红 左莉华[1,2] 丁娟 赵灵灵[4] 姜晓芳 贾清泉[1,4] 韦花 刘克锋[1,2] 胡幼红 赵杰[1,2] ZHOU Lin,SUN Zhi,XUE Wen-hua,LIANG Shu-hong,ZUO Li-hua,DING Juan,ZHAO Ling-ling,JIANG Xiao-fang,JIA Qing-quan,WEI Hua,LIU Ke-feng,HU You-hong,ZHAO Jie(1.Department of Pharmacy,the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;2.Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China;3.Department of Quality Control,the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;4.Department of Chinese Medicine,the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;5.Medical College,Henan Polytechnic University, Jiaozuo 454000, China)

机构地区：[1]郑州大学第一附属医院药学部,河南郑州450052 [2]河南省精准临床药学重点实验室,河南郑州450052 [3]郑州大学第一附属医院质量控制管理处,河南郑州450052 [4]郑州大学第一附属医院中医药学部,河南郑州450052 [5]河南理工大学医学院,河南焦作454000

出　　处：《中国中药杂志》2018年第16期3279-3284,共6页China Journal of Chinese Materia Medica

基　　金：河南省重点研发与推广专项(182102310404);常州四药临床药学科研基金项目(CZSYJJ16030;CZSYJJ16015);河南省高等学校重点科研项目(17A320014)

摘　　要：采用UPLC建立丹灯通脑软胶囊的指纹图谱，并结合化学模式识别技术对其进行系统、全面和科学的质量评价。采用Waters UPLC超高效液相色谱仪,ACQUITY UPLC HSS T3 色谱柱，以乙腈-0．1％甲酸水为流动相进行梯度洗脱，检测波长256nm，建立10批次丹灯通脑软胶囊的指纹图谱；同时通过相似度分析并结合聚类分析（CA）、主成分分析（PCA）及正交偏最小二乘法-判别分析（OPLS-DA）等模式识别技术对丹灯通脑软胶囊的总体质量进行分析评价。结果显示，该研究建立的指纹图谱共标定77个共有峰，经对照品进行化学指认并鉴定了其中的15个色谱峰。lO批供试品的相似度均大于0．960，表明该药物总体质量较为稳定；但通过CA及PCA均发现不同批次药物质量之间仍然存在有微小差异，且主要分为两大类，最后进一步采用OPLS-DA筛选出了导致批次药物质量差异的6个共有峰。该分析方法科学、准确、可靠且简便易行，指纹图谱结合化学模式识别技术可更加系统、全面地评价丹灯通脑软胶囊的药物质量，同时为中药及其制剂的质量控制提供参考。To establish the ultra performance liquid chromatography （UPLC） fingerprint of Dandeng Tongnao Ruanjiaonang and conduct a systemic,comprehensive quality evaluation of the drug by combining with a chemical pattern recognition method. In this study, Waters UPLC uhra-high performance liquid chromatography instrument and ACQUITY UPLC HSS T3 chromatographic column were employed to perform the separation with acetonitrile-0,1% formic acid aqueous solution as the mobile phase for gradient elution; and the detection wavelength was set at 256 nm to establish the UPLC fingerprint of 10 batches of Dandeng Tongnao Ruanjiaonang.Then, the further quality assessment of the drug was carried out by similarity evaluation, Cluster Analysis （CA）, Principal Component Analysis （PCA） and orthogonal partial least squares discriminant analysis （OPLS-DA）. Finally, 77 peaks were recognised as common peaks in the fingerprint, and 15 peaks of them were identified using standard references. The similarity value of these 10 batches of drugs was all above 0.960, indicating a relatively stable quality. But minor differences were still discovered between the batches of the drug by CA and PCA. Finally, 6 common peaks were recognised as the quality makers using OPLS-DA method. The analysis method established in this study was scientific, accurate, reliable and simple ; fingerprint combined with chemical pattern recognition technique can be used to systematically and comprehensively evaluate the drug quality of Dandeng Tongnao Ruanjiaonang; what＇s more, it could also provide a reference for the quality control of traditional Chinese medicine and its preparations at the same time.

关 键 词：丹灯通脑软胶囊 指纹图谱 化学模式识别 质量控制 

分 类 号：R286.0[医药卫生—中药学]