生脉注射液UPLC特征指纹图谱及11种成分定量分析  

Study on Fingerprint and Quantification of Eleven Components in Shengmai Injection

作　　者：柴瑞平[1] 路娟[1] 吕欣锴 俞月 赵颖 陈曦[1] CHAI Rui-Ping;LU Juan;LYU Xin-kai;YU Yue;ZHAO Ying;CHEN Xi(Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100193,China)

机构地区：[1]北京协和医学院中国医学科学院药用植物研究所,北京100193

出　　处：《中国现代中药》2019年第4期498-503,共6页Modern Chinese Medicine

基　　金：国家自然科学基金面上项目(81673667);中国医学科学院医学与健康科技创新工程经费资助(2016-I2M-3-015;2017-I2M-B&R-09);云南省中青年学术带头人后备人才项目(2013HB099)

摘　　要：目的:建立生脉注射液UPLC指纹图谱及多成分含量测定方法,测定人参皂苷Rb_1、麦冬皂苷D、五味子醇甲等11种活性成分的含量,为提升生脉注射液的质量标准提供实用可靠的方法。方法:采用超高效液相色谱-二极管阵列检测器(UPLC-DAD)法,使用Waters RP18色谱柱(100 mm×2.1 mm,1.7μm),以乙腈-水为流动相,梯度洗脱,流速为0.3 mL·min^(-1),柱温为40℃,全波长扫描(190～400 nm)。选取五味子醇甲为参照峰,并使用中药色谱指纹图谱相似度评价系统对指纹图谱进行相似性评价。结果:分析5厂家9批次生脉注射液指纹图谱,相似度均大于0.91,标定共有峰44个,对其中11个色谱峰进行了定性定量研究,各项方法学考察结果均符合测试要求。结论:所建立的UPLC指纹图谱分离效果良好,特征性强,方法稳定简单,基本能够反映生脉注射液的整体化学成分特征,结合多种活性成分同时测定的含量测定方法,更加客观全面地对该药进行质量控制,同时可为中药注射液安全性使用起一定的提示作用。Objective: To establish UPLC fingerprints and method for simultaneous determination of eleven components in Shengmai Injection,such as ginsenoside Rb1,Ophiopogon japonicus D,Schisandrin,and provide a practical and reliable method to improve the quality standard of Shengmai Injection. Methods: By the technology of UPLC-DAD,the analysis was carried out on a Waters RP18 column (100 mm×2.1 mm,1.7 μm )with gradient elution of acetonitrile (A )-water (B )at a flow rate of 0.3 mL · min^-1 with full- wavelength scanning (190-400 nm ).The column temperature was 40℃.Schisandrin was selected as the reference peak.The UPLC fingerprints were analyzed and the similarity was evaluated with Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine . Results: The fingerprints of 9 batches of Shengmai injections from 5 manufacturers were all more than 0.91,and 44 common peaks were calibrated.The 11 peaks were qualitatively and quantitatively studied.The methodological investigation results were all in accordance with the testing requirements. Conclusion: The UPLC fingerprints established have a good separation effect,with strong characteristics.The method is stable and simple.It can basically reflect the overall chemical composition of Shengmai Injection.Combined with the determination method of simultaneous quantification of various active ingredients,the UPLC fingerprint is more objective and comprehensive and can provide warnings for the safe use of Chinese medicine injections.

关 键 词：生脉注射液 指纹图谱 含量测定 红参 麦冬 五味子 

分 类 号：R286[医药卫生—中药学] R944.1[医药卫生—中医学]