盐酸氟桂利嗪胶囊的人体相对生物利用度研究  

Study on relative bioavailability of two flunarizine hydrochloride capsules

作　　者：刘建芳[1] 杨燕燕[1] 薛洪源[1] 章文[1] 刘会臣[1] 

机构地区：[1]白求恩国际和平医院临床药理室,河北石家庄050082

出　　处：《中国药学杂志》2003年第7期527-529,共3页Chinese Pharmaceutical Journal

摘　　要：目的　研究两种盐酸氟桂利嗪胶囊的人体相对生物利用度。方法　按照随机交叉试验设计 ,2 0名健康男性志愿者分别po单剂量两种盐酸氟桂利嗪胶囊 2 0mg ,用液相色谱 质谱联用方法测定血浆中氟桂利嗪的浓度 ,采用NDST程序对药动学参数进行方差分析和双单侧t检验。结果　受试制剂和参比制剂在受试者体内的药动学参数如下 :cmax分别为 (5 3± 15 )和 (5 2± 15 )ng·mL-1,tmax分别为 (3.0± 0 .8)和 (3.3± 1.3)h ,t1/2 分别为 (8.1± 1.2 )和 (8.2± 2 .0 )h ,AUC0～ 2 4分别为 (5 39± 2 0 6 )和 (5 0 3± 15 6 )ng·h·mL-1,受试制剂对参比制剂的相对生物利用度为 (10 5 .6± 16 .2 ) %。结论　两种制剂具有生物等效性。OBJECTIVE: To study the relative bioavailability of two flunarizine hydrochloride capsules in human. METHODS: A single oral dose of 20 mg flunarizine hydrochloride capsules was given to 20 healthy male volunteers according to a randomized crossover design. The concentrations of flunarizine in plasma were determined by HPLC/MS assay. The pharmacokinetic parameters were processed with NDST program for variance analysis and two one-sided t test. RESULTS: The main pharmacokinetic parameters of the test and the reference capsules were as follow: cmax(53 ± 15) ng&middotmL -1 and (52 ±15) mg&middotmL-1, tmax (3. 0 ± 0. 8) and (3.3 ± 1.3) h, t1/2 (8.1 ± 1.2) and (8.2 ± 2. 0) h, AUC0-24 (539 ± 206) and (503 ± 156) ng&middoth&middotmL-1 respectively. The relative bioavailability of the test capsules was (105.6 ± 16.2)%. CONCLUSION: The two capsules were bioequivalent.

关 键 词：盐酸氟桂利嗪胶囊 人体 生物利用度 研究 

分 类 号：R972[医药卫生—药品]