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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Pharmacokinetic analysis of 14C-ursodiol in newborn infants using accelerator mass spectrometry
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Pharmacokinetic analysis of 14C-ursodiol in newborn infants using accelerator mass spectrometry

机译：促进剂质谱法用新生儿14℃-Ursodiol的药代动力学分析

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摘要

Pharmacokinetic studies in the neonatal population are often limited by the small volume of blood that can be collected. The high sensitivity of 14C-accelerator mass spectrometry (AMS) enables pharmacokinetic studies to be conducted with greatly reduced sample volumes. We demonstrated the utility of AMS in infants by studying the plasma pharmacokinetic behavior of nanogram doses of 14C-ursodiol administered as a non-perturbing microdose or as a microtracer with therapeutic doses of non-labeled ursodiol in infants. Five non-cholestatic infants were administered 3 consecutive oral microdoses of 14C-ursodiol: 8ng (1.0nCi), 26ng (3.3nCi), and 80ng (10nCi) 48hours apart. Three additional infants with cholestasis were administered a single 80ng (10.0nCi) oral dose of 14C-ursodiol together with a therapeutic dose of 40mg/kg of non-labeled ursodiol. A pharmacokinetic model describing ursodiol concentrations was developed using nonlinear mixed-effects modeling. The pharmacokinetics of ursodiol in this pilot study were best described by a two-compartment model with first-order elimination. This study demonstrates the feasibility and utility of microdose and microtrace methodology in pediatric research.
机译：新生儿群体的药代动力学研究通常受到可以收集的少量血液的限制。 14C-Accelerator质谱（AMS）的高灵敏度使得药代动力学研究能够大大降低的样品体积进行。我们通过研究纳米 - 熊二醇的血浆药代动力学行为作为非扰动微曲面的血浆药代动力学，或作为婴儿的治疗剂量的未标记尿苷中的微量反射剂，证明了AMS在婴儿的效用。将五个非胆汁淤积婴儿进行3℃-Ursodiol 3连续的口服微倍数：8ng（1.0NCI），26ng（3.3NCI）和80ng（10NCI）48bours。使用40mg / kg非标记丙二醇的治疗剂量施用三种胆汁淤积的另外婴儿。使用非线性混合效应建模，开发了描述荨二醇浓度的药代动力学模型。在该试点研究中尿溶醇的药代动力学是由一个双隔室模型描述的一级消除。本研究表明，微孔和微磨机方法在儿科研究中的可行性和效用。

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