单剂量复方法莫替丁咀嚼片在健康人体的药代动力学  

Pharmacokinetics of compound famotidine chewing tablets in Chinese healthy volunteers after a single oral dose administration

作　　者：刘丽京[1] 李素霞[1] 孙莉[1] 邓艳萍[1] 

机构地区：[1]北京大学中国药物依赖性研究所,北京100191

出　　处：《中国临床药理学杂志》2015年第19期1955-1957,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价中国健康志愿者单剂量口服复方法莫替丁咀嚼片后的药代动力学。方法按开放、随机、平行、单次、单周期试验设计。30名健康受试者,男女各半,分为3组,分别单次口服复方法莫替丁咀嚼片20,30,40 mg后,用HPLC法测定血浆中法莫替丁的浓度,用3P97软件计算药代动力学参数。结果单剂量口服复方法莫替丁咀嚼片后,20,30,40 mg组法莫替丁的主要药代动力学参数：Cmax分别为（68.94±15.34）,（100.34±31.95）,（98.82±42.87）ng·m L-1;tmax分别为（1.70±0.42）,（1.75±0.35）,（1.60±0.52）h;t1/2Ke分别为（2.88±0.48）,（2.86±0.68）,（3.61±0.42）h;AUC0-15分别为（345.99±98.99）,（448.50±104.02）,（478.84±200.98）ng·m L-1·h。结论复方法莫替丁咀嚼片的血药浓度-时间曲线符合一室模型,其剂量在20-40 mg是安全的。Objective To evaluate the pharmacokinetics of single dose of compound famotidine chewing tablets in Chinese healthy volunteers.Methods The study was designed as an open,randomized,parallel and single- dose single cycle study. Thirty healthy volunteers were divided into three groups. The drug concentrations of plasma sample from the volunteers after taking 20,30 and 40 mg famotidine were determined by HPLC. The pharmacokine-tic parameters were calculated by 3P97 software. Results The healthy volunteers were given single dose of famotidine with 20,30 and 40 mg,respectively. The main pharmacokinetic parameters were as follows： Cmaxwere（ 68. 94 ± 15. 34）,（ 100. 34 ± 31. 95）,（ 98. 82 ± 42. 87） ng·m L- 1,tmaxwere（ 1. 70 ± 0. 42）,（ 1. 75 ± 0. 35）,（ 1. 60 ± 0. 52） h, t1 /2Kewere（ 2. 88 ± 0. 48）,（ 2. 86 ± 0. 68）,（ 3. 61 ±0. 42） h,AUC0- 15were（ 345. 99 ± 98. 99）,（ 448. 50 ± 104. 02）,（ 478. 84 ± 200. 98） ng·h·m L^-1. Conclusion The plasma concentration- time curve fits one compartment model. The safe dose was 20- 40 mg.

关 键 词：复方法莫替丁咀嚼片 单次给药 高效液相色谱 药代动力学 血药浓度 

分 类 号：R975[医药卫生—药品] R969.1[医药卫生—药学]