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生脉注射液HPLC指纹图谱的建立
引用本文:郑笑为,汪祺,于建东,刘燕,戴忠,鲁静,林瑞超.生脉注射液HPLC指纹图谱的建立[J].药物分析杂志,2012(8):1471-1475.
作者姓名:郑笑为  汪祺  于建东  刘燕  戴忠  鲁静  林瑞超
作者单位:中国食品药品检定研究院
摘    要:目的:建立生脉注射液的HPLC指纹图谱。方法:采用Waters Symmetry ShieldTMRP18(4.6 mm×250 mm,5μm)色谱柱,以乙腈-水为流动相,梯度洗脱,流速为1 mL.min-1,检测波长203 nm,柱温30℃。结果:本色谱条件下生脉注射液各成分得到了良好分离,指纹图谱由23个特征峰组成。结论:所建立的指纹图谱分离效果好,信息量大,可作为生脉注射液的指纹图谱使用,以便更好地控制该产品的质量。

关 键 词:生脉注射液  特征成分指纹图谱  高效液相色谱  中药注射剂质量控制  人参皂苷  五味子原人参三醇  五味子甲素  五味子乙素  五味子醇甲  五味子酯甲

Establishment of HPLC fingerprint of Shengmai injection
ZHENG Xiao-wei,WANG Qi,YU Jian-dong,LIU Yan,DAI Zhong,LU Jing,LIN Rui-chao.Establishment of HPLC fingerprint of Shengmai injection[J].Chinese Journal of Pharmaceutical Analysis,2012(8):1471-1475.
Authors:ZHENG Xiao-wei  WANG Qi  YU Jian-dong  LIU Yan  DAI Zhong  LU Jing  LIN Rui-chao
Institution:(National Institutes for Food And Drug Control,Beijing 100050,China)
Abstract:Objective:To establish HPLC fingerprint of Shengmai injection.Methods:A Waters Symmetry ShieldTM RP18(4.6 mm×250 mm,5 μm)was adopted,acetonitrile-water(gradient elution) system was used as a mobile phase at flow rate of 1 mL·min-1,the detection wavelength was 203 nm,and colum temperature was set at 30 ℃.Results:According to the selected chromatographic conditions,standard fingerprint consisting of 23 communal peaks was obtained.Conclusion:The fingerprint established has the good separate effect and includes a lot message.It should be used as fingerprint,so that the quality of Shengmai injection can be controlled better.
Keywords:Shengmai injection  character compound fingerprint  HPLC  CTM injection quality control  ginsenoside  Fructus Schisandrae Chinensis protopanaxatriol  deoxyschizandrin  schisandrin B  schisandrin  Wuweizi ester A
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