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目的:建立健康人血浆淫羊藿苷的LC-MS/MS分析方法,探索淫羊藿提取物临床药动学特点。方法:色谱柱为Agilent ZORBAXSB-C18(2.1 mm×30 mm,3.5μm);流动相为乙腈:水(含0.1%甲酸)=22:78;流速0.3 mL/min;ESI离子源;定量离子对淫羊藿苷m/z:677.3→369.0,内标非那西丁m/z:180.1→110.0。健康受试者2例,单次口服含淫羊藿苷40.16 mg的淫羊藿提取物片剂制剂12片,分别于给药前和给药后0.5,1、1.5、2、2.5、3、3.5、4、5、6、7、8、10、12、24 h采血,检测血浆中淫羊藿苷。结果:血浆中内源性物质不干扰样品的测定,定量下限为0.05μg/L,方法符合生物样品分析要求。在本试验血浆浓度线性范围0.05~21.48μg/L内,人血浆中未测到淫羊藿苷原型。
Objective: To establish a LC-MS / MS method for the determination of icariin in healthy human and explore the clinical pharmacokinetics of Epimedium extract. Methods: The column was Agilent ZORBAXSB-C18 (2.1 mm × 30 mm, 3.5 μm). The mobile phase consisted of acetonitrile: water with 0.1% formic acid = 22:78, flow rate of 0.3 mL / min, ESI ion source, Icariin m / z: 677.3 → 369.0, internal standard phenacetin m / z: 180.1 → 110.0. Healthy subjects in 2 cases, a single oral administration of icariin 40.16 mg of epimedium extract tablet formulations 12, respectively, before and after administration of 0.5,1,1.5,2,2.5,3, 3.5,4,5,6,7,8,10,12,24 h blood collection, detection of icariin in plasma. Results: The endogenous substances in plasma did not interfere with the determination of the sample, and the lower limit of quantification was 0.05 μg / L. The method met the requirements of biological sample analysis. In this test, the plasma concentration of linear range of 0.05 ~ 21.48μg / L, not detected in human plasma icariin prototype.