法莫替丁肠溶片的血浓度测定及其在人体的药代动力学研究

High performance liquid chromatography determination of plasma famotidine and its use in pharmacokinetic study

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 establish a high performance liquid chromatagraphy (HPLC) method for determining plasma famotidine concentration,and to use it for pharmcokinetic study.Methods Solid-phase extracting (SPE) was used for extracting famotidine from plasma and a HPLC-UV method was used.For pharmacokinetic study,a single dose of 40 mg famotidine was given to 18 healthy male volunteers.Blood samples were collected at different time spots.Results The pharmacokinetic parameters,AUC0→12,AUC0→∞,Cmax,Tmax and T1/2 ,in the volunteers after taking a single dose of 40 mg famotidine tablet was (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 The method is simple and reliable.The parameters obtained in this study are similar to those from domestic and overseas reports.