肾康注射液指纹图谱的研究
投稿时间:2018-11-14  修订日期:2019-11-05  点此下载全文
引用本文:孙小萌,笔雪艳,曲范娜,张清波,杨会兵,张雪,周楠.肾康注射液指纹图谱的研究[J].药学实践杂志,2019,37(6):543~547,576
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作者单位E-mail
孙小萌 黑龙江中医药大学药学院, 黑龙江 哈尔滨 150040  
笔雪艳 黑龙江省食品药品检验检测所, 黑龙江 哈尔滨 150088 hljbixueyan@sina.com 
曲范娜 黑龙江省食品药品检验检测所, 黑龙江 哈尔滨 150088  
张清波 黑龙江省食品药品监督管理局, 黑龙江 哈尔滨 150001  
杨会兵 西安世纪盛康药业有限公司, 陕西 西安 710300  
张雪 西安世纪盛康药业有限公司, 陕西 西安 710300  
周楠 黑龙江中医药大学药学院, 黑龙江 哈尔滨 150040  
中文摘要:目的 建立肾康注射液的超高效液相色谱(UPLC)指纹图谱,并对肾康注射液指纹图谱共有峰进行鉴定。方法 采用超高效液相色谱条件法,色谱柱ACQUITY UPLC® CSH-C18(2.1mm×100mm,1.7μm),甲醇(A)-0.1%甲酸溶液(B)二元梯度洗脱,流速0.4 ml/min,检测波长280 nm,进样量2 μl,柱温30℃,使用飞行时间质谱仪,负离子模式扫描。结果 建立了肾康注射液UPLC指纹图谱,采用UPLC/ESI-Q-TOF MS技术共鉴定了26个共有峰。采用《中药指纹图谱相似度评价系统(2012.130723版)》评价了20批肾康注射液,指纹图谱相似度均大于0.90。结论 本方法所建立的肾康注射液指纹图谱灵敏度高,稳定可靠,为肾康注射液的质量控制提供了科学依据。
中文关键词:肾康注射液  指纹图谱  液相色谱-质谱联用技术
 
Studies on fingerprint of Shenkang injection
Abstract:Objective To establish an ultra-high performance liquid chromatography (UPLC) fingerprint of Shenkang injection and identify the common peaks of Shenkang injection fingerprint.Methods The UPLC method was established by employing ACQUITY UPLC® CSH-C18 column(2.1 mm×100 mm,1.7 μm) with methanol(A) -0.1% formic acid(B) aqueous solution as mobile phase in gradient elution.The detection wavelength was 280 nm.The flow rate was 0.4ml/min.The injection volume was 2 μl and the column temperature was 30℃.Time of flight mass spectrometer was used with negative ion mode scanning.Results The UPLC chromatographic fingerprint of Shenkang injection was established.26 common peaks of shenkang injection were identified by UPLC/ESI-Q-TOF MS.The similarity of 20 batches of shenkang injection was over 0.90,which was evaluated by similarity evaluation system for chromatographic fingerprint of TCM(Version 2012.130723).Conclusion This method is highly sensitive,stable and reliable,and can be used for the quality control of shenkang injection.
keywords:Shenkang injection  fingerprint  UPLC/ESI-Q-TOF MS
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