六味地黄浓缩丸HPLC指纹图谱研究  

HPLC fingerprint of Liuwei Dihuang condensed pills

作　　者：高新彪[1] 孙磊[2] 乔善义[2] 高松[3] 车彦忠[3] 张克荣 

机构地区：[1]沈阳药科大学中药学院基于靶点的药物设计与研究教育部重点实验室,辽宁沈阳110016 [2]军事医学科学院毒物药物研究所,北京100850 [3]河南宛西制药股份有限公司,河南南阳473000 [4]ABSCIEX公司亚太技术支持中心,上海200233

出　　处：《中国中药杂志》2012年第22期3411-3415,共5页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2011ZX09201-201-13;2009ZX09301002);国家科技支撑计划项目(2006BAI08B03-08)

摘　　要：目的:建立六味地黄浓缩丸的HPLC指纹图谱。方法:Dikma Diamonsil C18色谱柱(4.6 mm×250 mm,5μm);以乙腈(含0.05%磷酸)-水(含0.05%磷酸)为流动相梯度洗脱;柱温40℃;流速1.0 mL·min-1;检测波长276 nm(0～10min),236 nm(10～40 min),276 nm(40～60 min);进样量20μL。采用Q-TOF-MS-IDA-MS/MS进行色谱峰指认。结果:该方法精密度、稳定性、重复性良好。采用Q-TOF-MS-IDA-MS/MS对22个共有峰中的18个色谱峰进行了定性鉴别。采用该方法测定了10批六味地黄浓缩丸,其相似度均在0.96以上。结论:该研究为六味地黄浓缩丸的全面质量评价奠定了基础。Objective： To establish HPLC fingerprints of Liuwei Dihuang condensed pills. Method： Dikma Diamonsil C is eol- umn （4. 6 mm × 250 ram, 5 μm） was adopted, with acetonitrile （ containing 0. 05 % phosphoric） -water （ containing 0. 05 % phosphor- ic） as the mobile phase. The column temperature was set at 40 ℃, and the flow rate was 1.0 mL · min^-1. The detection wavelength was 276 nm （0-10 min） , 236 nm （ 10-40 min） and 276 nm （40-60 min）. The sample size was 20 μL. Chromatographic peaks were identified by Q-TOF-MS-IDA-MS/MS method. Result： Good precision, stability and repeatability were proved. Q-TOF-MS-IDA-MS/ MS method was adopted for qualitative determination of eighteen chromatographic peaks. Ten batches of Liuwei Dihuang condensed pills were determined with the method, and their similarities were above 0. 96. Conclusion ： The study lays a foundation for the overall quality evaluation of Liuwei Dihuang condensed pills.

关 键 词：六味地黄浓缩丸 HPLC 指纹图谱 质量评价 

分 类 号：R286.0[医药卫生—中药学]