法莫替丁片在健康志愿者的生物等效性研究  

Bioequivalence Study of Famotidine Tablets in Healthy Volunteers

作　　者：石焱[1] 弓小雪[1] 那婕[1] 曹庆柱[1] 牟小帆[1] 赵红京 

机构地区：[1]解放军210医院临床药理基地,辽宁大连116021 [2]石家庄市昌宏药业有限公司

出　　处：《中国药师》2010年第1期22-24,共3页China Pharmacist

摘　　要：目的:研究法莫替丁的药物动力学和生物等效性。方法:19名健康志愿者按双周期随机交叉试验设计口服受试制剂和参比制剂法莫替丁片,用高效液相色谱法测定血浆中法莫替丁浓度。结果:单剂量口服受试制剂和参比制剂法莫替丁片后C_(max)分别为(130.5±35.5)和(131.0±39.2)ng·ml^(-1),t_(max)分别为(2.13±0.57)和(2.29±0.75)h,AUC_(0-t)分别为(768±175)和(771±228)ng·h·ml^(-1),相对生物利用度为(99.5%±15.0)%。结论:两种法莫替丁片生物等效。Objective ： To study the pharmacokinetic activities and bioequivalence of famotidine tablets after oral administration in healthy volunteers. Method： A single administration of 40 mg test and reference famotidine tablets were given to 19 healthy male volun- teers in randomize crossover study respectively. The HPLC was developed to determine the concentration of famotidine in human plasma. Result： The pharmaeokinetics parameters after a single oral administration of 40 mg test and reference products were as follows ： Cmax were（130.5±35.5） and （131.0±39.2）ng.ml^-1 ,Tmax were（2.13 ±0.57） and （2.29 ±0.75） h,AUC0-t were （768 ± 175） and （771 ± 228 ） ng.h.ml^-1, respectively, the relative bioavailability was （99.5% ± 15.0 ）%. Conclusion： The test and reference products were bioequivalent.

关 键 词：法莫替丁片 高效液相色谱法 药物动力学 生物等效性 

分 类 号：R969.1[医药卫生—药理学]