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目的研究法莫替丁的血药浓度测定方法,并应用其进行法莫替丁片剂的人体药代动力学研究。方法采用固相萃取—高效液相色谱(HPLC)紫外检测法测定法莫替丁的血药浓度。18名健康男性志愿者,单剂量口服40mg法莫替丁片剂,不同时间点取静脉血,由血药浓度数据计算各自的主要药代动力学参数。结果所建立的血药浓度测定法能满足药代动力学实验要求。单次服用40mg法莫替丁片剂的主要药代动力学参数血药浓度-时间曲线下面积(AUC)0→12、AUC0→∞、Cmax、Tmax、T1/2分别为(882±185)、(912±187)ng·ml-1·h-1、(171±33)ng/ml、(2.3±0.4)和(2.6±2.7)h。结论法莫替丁的血药浓度测定方法简单、可靠。所得的药代动力学参数与国内外文献报道相似。
Objective To study the method for the determination of famotidine in plasma and to study the pharmacokinetics of famotidine tablets in human. Methods The plasma concentrations of famotidine were determined by solid phase extraction - high performance liquid chromatography (HPLC). Eighteen healthy male volunteers were given single oral dose of 40 mg famotidine tablets, venous blood was taken at different time points, and the main pharmacokinetic parameters were calculated from the plasma concentration data. Results The established plasma concentration assay could meet the requirements of pharmacokinetic experiments. The main pharmacokinetic parameters of single-dose 40 mg famotidine tablets were AUC 0 → 12, AUC0 → ∞, Cmax, Tmax and T1 / 2 (882 ± 185) , (912 ± 187) ng · ml-1 · h-1, (171 ± 33) ng / ml, (2.3 ± 0.4) and (2.6 ± 2.7) h, respectively. Conclusion Famotidine blood concentration determination method is simple and reliable. The obtained pharmacokinetic parameters are similar to those reported in the literature at home and abroad.