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目的快速测定法莫替丁在人血浆中的浓度,并研究其药动学。方法12名健康志愿者单剂量空腹po法莫替丁片40mg,于给药后不同时间收集血浆样品,固相萃取,以阿莫西林为内标,采用液相色谱-质谱联用法测定法莫替丁在血浆中的浓度,并计算药动学参数。结果在优化条件下,法莫替丁的线性范围是0.3~400ng·mL-1(r=0.9993),最低定量限为0.3ng·mL-1,RSD=9.14%。法莫替丁片在所选受试者体内的动力学过程符合一室模型。Tmax=2.63±0.36h;Cmax=150.52±6.09ng·mL-1;AUC0-15=764.54±87.56μg·h·L-1;t1/2=2.77±0.32h。结论所建方法灵敏度高、准确度好、专属性强,分析速度快,适用于法莫替丁血药浓度的测定及其药动学的研究。
Objective To rapidly determine the concentration of famotidine in human plasma and to study its pharmacokinetics. Methods Twelve healthy volunteers were given a single dose of 40 mg fastidiin on an empty stomach. Plasma samples were collected at different times after administration. The samples were collected by solid-phase extraction. Amoxicillin was used as an internal standard. The plasma samples were determined by liquid chromatography-mass spectrometry For the concentration of Ding in plasma, and calculate the pharmacokinetic parameters. Results Under optimized conditions, the linear range of famotidine was 0.3-400 ng · mL-1 (r = 0.9993), the lowest limit of quantification was 0.3 ng · mL-1 and RSD was 9.14%. The kinetics of famotidine tablets in the selected subjects fitted the one-compartment model. Tmax = 2.63 ± 0.36h; Cmax = 150.52 ± 6.09ng · mL-1; AUC0-15 = 764.54 ± 87.56μg · h · L-1; t1 / 2 = 2.77 ± 0.32h. Conclusion The proposed method has high sensitivity, good accuracy, specificity and fast analysis speed. It is suitable for the determination of famotidine blood concentration and its pharmacokinetics.