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目的:测定人血清中特布他林浓度,研究中国男性健康志愿者口服该药后药代动力学规律。方法:用LCMS法测定特布他林浓度。流动相:2%冰乙酸—异丙醇(985∶15);色谱柱:ShimadzuVPODS;流速:05mL·min-1;柱温:30℃。结果:特布他林浓度在02~20ng·mL-1范围内线性关系良好(γ=09998)。方法的回收率高于90%,最低浓度的日内及日间精密度分别为82%和129%,最低检测限为005ng。10名健康志愿者单剂量口服特布他林口服液75mg后,药代动力学行为符合二房室模型。结论:此法灵敏度高、选择性强,符合生物样品分析要求。
OBJECTIVE: To determine the concentration of terbutaline in human serum and study the pharmacokinetics of the drug in Chinese male healthy volunteers. Methods: The determination of terbutaline by LC MS method. Mobile phase: 2% glacial acetic acid-isopropanol (985:15); column: ShimadzuVP-ODS; flow rate: 0.5mL · min-1; column temperature: 30 ℃. Results: Terbutaline concentration ranged from 02 to 20 ng · mL-1. The linear relationship was good (γ = 09998). The recovery rate of the method was higher than 90%. The intra- and inter-day precision of the lowest concentration were 8.2% and 12.9%, respectively. The lowest detection limit was 0. 05ng. Ten healthy volunteers oral single dose of terbutaline oral 5mg, pharmacokinetic behavior in line with two-compartment model. Conclusion: This method has high sensitivity and strong selectivity, which meets the requirements of biological sample analysis.