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采用干血斑法测定药物浓度:Crl:CD(SD)大鼠采血和采集技术研究。

Determination of drug concentrations using dried blood spots: investigation of blood sampling and collection techniques in Crl:CD(SD) rats.

机构信息

GlaxoSmithKline Research and Development, Safety Assessment, Research Triangle Park, NC 27709-3398, USA.

出版信息

Lab Anim. 2011 Apr;45(2):109-13. doi: 10.1258/la.2010.010147. Epub 2011 Mar 28.

DOI:10.1258/la.2010.010147
PMID:21444352
Abstract

Dried bloodspot (DBS) technology has been available for many decades but only in the last five years has it been considered for routine bioanalysis of blood samples collected on preclinical and clinical studies as part of a drug development programme. Advantages of using DBS versus typical plasma samples include smaller blood volumes, less processing of the samples (e.g. no centrifugation) and no requirement for storing or shipping of the samples at frozen temperatures. The current study compared blood concentrations (AUC(0-t) and C(max)) from rats given an oral dose of acetaminophen (APAP) using two different sampling sites (caudal venepuncture versus tail snip), two different collection methods (3 separate 15 μL ethylenediaminetetraacetic acid [EDTA]-coated capillary tubes versus an EDTA integrated capillary blood collection system) and variability between blood spots on one card. There were no noteworthy differences (i.e. two-fold or greater) in blood concentrations of APAP using the different sites or methods. Furthermore, comparisons of the APAP blood concentrations in the original spot to a duplicate bloodspot from the same bloodspot card were within 12% of the original concentration.

摘要

干血斑(DBS)技术已经存在了几十年,但直到最近五年,它才被考虑用于临床前和临床研究中采集的血样的常规生物分析,作为药物开发计划的一部分。与典型的血浆样本相比,使用 DBS 的优势包括采血量更少、样本处理更少(例如无需离心)以及不需要将样本储存在冷冻温度下或运输。本研究比较了两种不同的采样部位(尾静脉穿刺与尾尖剪取)、两种不同的采集方法(3 个单独的 15 μL 乙二胺四乙酸(EDTA)涂层毛细管与 EDTA 集成毛细管血液采集系统)以及同一张卡片上的血斑之间的差异,结果显示,使用不同部位或方法的对乙酰氨基酚(APAP)血药浓度无明显差异(即两倍或更高)。此外,原始血斑与同一张血斑卡上的重复血斑的 APAP 血药浓度比较,其结果在原始浓度的 12%以内。

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