Grupo de Investigación en Química Analítica y Bioanalítica (GABIO), Universidad de los Andes, Cra. 1 No. 18ª-10, Bogotá D.C., Colombia.
Drug Test Anal. 2014 Jun;6(6):568-77. doi: 10.1002/dta.1582. Epub 2013 Nov 20.
New bioanalytical assays were developed, validated, and applied in a clinical study for quantitative measurement of acetaminophen concentrations in blood and plasma samples. Furthermore, after validation, the bioanalytical assays were used for determination of pharmacokinetics within a group of six healthy male human volunteers after admission of a single oral dose of 500 mg of acetaminophen. Quantitative analyses were done by means of liquid chromatography-high resolution mass spectrometry and blood samples were collected at various sampling time points using different peripheral blood microsampling techniques. Post-dose peripheral collected blood samples were applied for the preparation of dry blood spots, dried matrix on paper discs, and peripheral plasma. Pharmacokinetic parameters determined were clearance (Cl), area under the curve (AUC), volume of distribution (Vd ), peak concentration (Cmax ), time of occurrence of peak concentration (Tmax ) and half-life time (T½ ). Observed pharmacokinetic values were not statistically (ANOVA) different compared to in literature reported values based on venous blood collection. The present pilot study demonstrated the feasibility of peripheral blood microsampling techniques in combination with quantitative liquid chromatography-high resolution mass spectrometry analysis for the determination of pharmacokinetics in clinical studies.
新的生物分析测定法已经开发、验证，并应用于一项临床研究中，用于定量测量血液和血浆样本中的对乙酰氨基酚浓度。此外，在验证后，这些生物分析测定法用于在一组 6 名健康男性人体志愿者单次口服 500 毫克对乙酰氨基酚后，确定其体内药代动力学。定量分析采用液相色谱-高分辨质谱法进行，使用不同的外周血微采样技术在不同的采样时间点采集血样。在给药后采集外周血样本，用于制备干血斑、纸碟上的干燥基质和外周血浆。确定的药代动力学参数包括清除率（Cl）、曲线下面积（AUC）、分布容积（Vd）、峰浓度（Cmax）、峰浓度出现时间（Tmax）和半衰期（T½）。与基于静脉血采集的文献报道值相比，观察到的药代动力学值在统计学上（方差分析）没有差异。本初步研究表明，外周血微采样技术与定量液相色谱-高分辨质谱分析相结合，可用于临床研究中确定药代动力学。
