法莫替丁滴丸剂和片剂的人体生物等效性  

Bioequivalence of famotidine pills and tablets in healthy volunteers

作　　者：高小玲[1] 陈钧[1] 胡凯莉[1] 蒋新国[1] 

机构地区：[1]复旦大学药学院药剂学教研室,上海200032

出　　处：《中国临床药学杂志》2005年第2期101-103,共3页Chinese Journal of Clinical Pharmacy

摘　　要：目的　采用HPLC法测定法莫替丁的血药浓度,评价法莫替丁滴丸剂和片剂的人体生物等效性。方法　2 0名健康志愿者分别单次口服法莫替丁滴丸剂或片剂4 0mg ,采用固相萃取HPLC法测定血药浓度。结果　法莫替丁滴丸剂和片剂的tmax分别为(2 .4 0±0 .6 4 )、(2 .5 5±0 .4 8)h ;cmax为(12 2±30 )、(135±37) μg·L-1;T1/2 为(3.35±0 .4 0 )、(3.2 4±0 .4 1)h ;AUC0→16h为(799±176 )、(84 4±2 2 3) μg·h·L-1;AUC0→∞为(84 5±188)、(885±2 2 9) μg·h·L-1。滴丸剂的相对生物利用度为(96 .98±16 .34) %。AIM To evaluate the bioequivalence of famotidine pills and tablets in healthy volunteers. METHODS Twenty healthy volunteers were given a single oral dose of 40 mg of famotidine pills or tablets. Plasma drug levels were determined by HPLC method coupled with solid-liquid extraction. RESULTS The t max, c max, T 1/2,AUC 0→16h and AUC 0→∞ of famotidine pills and tablets were (2.40±0.64) ,(2.55±0.48)h; (122±30), (135±37) μg·L -1;(3.35±0.40),(3.24±0.41)h;(799±176),(844±223) μg·h·L -1; (845±188),(885±229) μg·h·L -1, respectively. The relative bioavailability of famotidine pills was (96.98±16.34)%. CONCLUSION There is no statistical difference between the pharmacokinetic parameters of two formulations and they are proved to be bioequivalent.

关 键 词：法莫替丁 滴丸剂 片剂 生物等效性 

分 类 号：R96[医药卫生—药理学]