基于^(1)H-NMR技术的参麦注射液指纹图谱研究  

Fingerprint of Shenmai Injection based on^(1)H-NMR technique

作　　者：李文竹 杨嘉誉 赵芳[1,2,3] 潘坚扬[1,2] 瞿海斌 LI Wen-zhu;YANG Jia-yu;ZHAO Fang;PAN Jian-yang;QU Hai-bin(Pharmaceutical Informatics Institute,College of Pharmaceutical Sciences,Zhejiang University,Hangzhou 310058,China;Innovation Center in Zhejiang University,State Key Laboratory of Component-Based Chinese Medicine,Hangzhou 310058,China;Hisun Biopharmaceutical Co.,Ltd.,Hangzhou 311400,China)

机构地区：[1]浙江大学药学院药物信息学研究所,浙江杭州310058 [2]组分中药国家重点实验室浙江大学交叉创新中心,浙江杭州310058 [3]海正生物制药有限公司,浙江杭州311400

出　　处：《中国中药杂志》2022年第3期581-586,共6页China Journal of Chinese Materia Medica

基　　金：国家“重大新药创制”科技重大专项(2018ZX09201011-002)。

摘　　要：参麦注射液由中药红参和麦冬制得,在心血管疾病的治疗和辅助治疗中具有广泛的应用。氢核磁共振(^(1)H-NMR)技术具有样品预处理简单且无损,分析速度快,可以获得丰富的化学信息,可定量且无需随行标准曲线等优点,在中药、临床血样和尿样等复杂混合物的分析和研究中具有优势。为提高参麦注射液质量控制水平,该研究建立了参麦注射液的^(1)H-NMR指纹图谱,并对指纹图谱采集及数据处理方法进行了方法学考察,各考察项目均有良好结果。对参麦注射液^(1)H-NMR指纹图谱进行了信号峰指认,归属出32种化学成分,包括7种氨基酸、8种小分子有机酸、1种生物碱、4种糖、2种核苷、7种皂苷和3种其他成分。在此基础上,分别通过Pearson相关系数法和主成分分析与层次聚类分析结合的多变量分析方法,从全面化学成分的角度研究了82批参麦注射液的质量一致性,结果显示这82批参麦注射液具有较高的质量一致性。该研究表明^(1)H-NMR指纹图谱方法在中药注射剂质量控制应用中具有较大潜力。Shenmai Injection is a Chinese medicinal injection prepared from Ginseng Radix et Rhizoma Rubra and Ophiopogonis Radix,which is widely used in clinical practice for the treatment and adjuvant therapy of cardiovascular diseases with significant pharmacological effects.Proton nuclear magnetic resonance spectroscopy(^(1)H-NMR) has the advantages of simple and nondestructive sample pretreatment,fast analysis,abundant chemical information,quantification and no need to follow the standard curve.It is widely used in the analysis and research of complex mixtures of traditional Chinese medicine,clinical blood and urine samples.In this study,the^(1)H-NMR fingerprint of Shenmai Injection was established.Thirty-two chemical components were identified,including seven amino acids,eight small molecular organic acids,one alkaloid,four sugars,two nucleosides,seven saponins,and three other components.Pearson′s correlation coefficient and multivariate analysis of variance(principal component analysis combined with hierarchical cluster analysis) were applied based on the^(1)H-NMR fingerprint to evaluate the quality consistency.The results showed high-quality consistency of 82 batches of Shenmai Injection.This study confirms that the^(1)H-NMR fingerprint has great potential in the application of quality control of Chinese medicinal injection.

关 键 词：参麦注射液^(1)H-NMR 指纹图谱 中药注射液 一致性评价 

分 类 号：R284.1[医药卫生—中药学]