同时测定丹红注射液中21个化学成分含量的NMR方法研究  

NMR method for simultaneous determination of 21 chemical components in Danhong Injection

作　　者：李文竹 谢欣媛 杨嘉誉 赵芳[1,2,3] 潘坚扬[1,2] 瞿海斌 LI Wen-zhu;XIE Xin-yuan;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23期6399-6408,共10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：丹红注射液是由丹参和红花制备得到的一种复方中药注射剂,临床上用于冠心病、脑血栓、心肌梗死、心绞痛等心脑血管疾病的治疗。丹红注射液化学成分复杂,目前报道的相关化学成分分析方法多为高专属性方法,其全面化学成分并未得到充分研究,可能给用药安全带来隐患。该研究基于^(1)H-qNMR技术开发了一种丹红注射液中多类成分的定量方法,以氘代水配制样品,以TSP为内标,选择合适的定量峰,优化了分析参数,并进行了方法学验证,结果证明方法学指标均较好。该方法可同时对丹红注射液中的21个化学成分进行含量测定,包括6种氨基酸、4种小分子有机酸、5种糖及其衍生物、1种核苷和5种芳香化合物,其含量总和占总固体质量分数约85%,体现出^(1)H-qNMR在中药注射液分析中的较大优势。该研究开发的丹红注射液多类成分^(1)H-qNMR方法操作简单、分析时间短、分析范围广,对丹红注射液的质量评价具有实际意义,为中药注射液质量控制方法的开发提供借鉴。Danhong Injection,a compound Chinese medicine injection prepared from Salviae Miltiorrhizae Radix et Rhizoma and Carthami Flos,is used in the clinical treatment of coronary heart disease,cerebral thrombosis,myocardial infarction,angina pectoris and other cardiovascular and cerebrovascular diseases.In this study,a quantitative method for simultaneous determination of multiple components in Danhong Injection was developed based on^(1)H-qNMR technology and then methodological verification was carried out.The results showed that the established method had good methodological indexes.This method can simultaneously determine the content of 21 chemical components including 6 amino acids,4 small molecular organic acids,5 sugars and their derivatives,1 nucleoside,and 5 aromatic compounds in Danhong Injection.The total content accounted for about 85%of the total solid mass,which reflected the great advantage of^(1)H-qNMR method in the analysis of Chinese medicine injections.The^(1)H-qNMR method for simultaneous determination of multiple components in Danhong Injection developed in this study has simple operation,short analysis time,and wide application range,which has practical significance for the quality evaluation of Danhong Injection and provides reference for the development of quality control methods for Chinese medicine injections.

关 键 词：核磁共振 ^(1)H-qNMR 定量方法 多类成分 丹红注射液 

分 类 号：R284.1[医药卫生—中药学]