Tomlinson H S, Corlett S A, Chrystyn H
School of Pharmacy, University of Bradford, Bradford, BD7 1DP.
Br J Clin Pharmacol. 2003 Aug;56(2):225-7. doi: 10.1046/j.1365-2125.2003.01864.x.
To determine the reproducibility and dose-response relationship for urinary salbutamol excretion post inhalation.
Fifteen volunteers inhaled either one, two, three, four or five doses of 100 micro g salbutamol on separate days and then seven of these also repeated each of the one, three and five doses on five occasions. After each study dose urine was collected 30 min post inhalation.
The mean (SD) 30 min urinary salbutamol after one, two, three, four and five doses was 2.61 (1.0.), 5.47 (1.59), 8.68 (2.73), 12.34 (3.96) and 15.99 (4.50) micro g, respectively. Statistical analysis revealed a linear relationship (P < 0.001). Mean (SD) coefficient of variation after one, three and five doses was 10.5 (3.6), 10.1 (2.7) and 9.4 (2.3)%.
The 30 min salbutamol urinary excretion post inhalation pharmacokinetic method, to compare inhaled products, is linear with inhaled dose and reproducible.
确定吸入后尿中沙丁胺醇排泄的可重复性及剂量反应关系。
15名志愿者在不同日期分别吸入1、2、3、4或5剂100微克的沙丁胺醇,其中7名志愿者还对1、3和5剂分别重复吸入5次。每次研究剂量吸入后30分钟收集尿液。
1、2、3、4和5剂后30分钟尿中沙丁胺醇的平均(标准差)分别为2.61(1.0)、5.47(1.59)、8.68(2.73)、12.34(3.96)和15.99(4.50)微克。统计分析显示呈线性关系(P<0.001)。1、3和5剂后的平均(标准差)变异系数分别为10.5(3.6)%、10.1(2.7)%和9.4(2.3)%。
吸入后30分钟沙丁胺醇尿排泄药代动力学方法用于比较吸入产品时,与吸入剂量呈线性关系且具有可重复性。