参麦注射液中人参总皂苷的^(1)H-qNMR定量方法研究  

H-qNMR quantification of total ginsenosides in Shenmai Injection

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587-592,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：参麦注射液是由红参和麦冬制备得到的一种复方中药注射剂,临床上广泛用于冠心病、心肌梗死、心力衰竭等心血管疾病的治疗及辅助治疗。该研究以参麦注射液为例,利用人参皂苷类成分共有的^(1)H-NMR特征峰开发了基于^(1)H-qNMR技术的人参总皂苷含量测定方法。以氘代甲醇为溶剂,以对苯二甲酸二甲酯为内标,选择位于δ 8.11的峰用作内标峰,选择δ 1.68、0.79处的峰为人参总皂苷的定量峰,优化了分析参数,开发了人参总皂苷含量的^(1)H-qNMR测定方法,并进行了方法学验证。结果证明方法学指标均较好,应用该方法在0.167 6~3.091 1 mmol·L^(-1)可准确测定参麦注射液中的人参总皂苷。该研究开发的人参总皂苷定量方法操作简单、分析时间短、专属性强、不依赖随行标准曲线、取样量小,为参麦注射液的质量控制提供了可靠手段,为人参总皂苷定量方法开发提供了新思路。A content determination method based on^(1)H-qNMR was developed for the determination of total ginsenosides in Shenmai Injection.The parameters were optimized with CD;OD as the solvent,dimethyl terephthalate as the internal standard,the peak at δ 8.11 as the internal standard peak,and the peaks at δ 1.68 and δ 0.79 as quantitative peaks of total ginsenosides.The developed^(1)H-qNMR-based method was validated methodologically.The results showed that the method could achieve accurate measurement of total ginsenosides in Shenmai Injection in the range of 0.167 6-3.091 1 mmol·L^(-1).The developed^(1)H-qNMR-based method for total ginsenosides is simple in operation,short in analysis time,strong in specificity,independent of accompanying standard curve,and small in sample volume,which can serve as a reliable mean for the quality control of Shenmai Injection.This study is expected to provide new ideas for the development of quantification methods of total ginsenosides.

关 键 词：人参总皂苷 核磁共振^(1)H-qNMR 定量方法 参麦注射液 

分 类 号：R284.1[医药卫生—中药学]