国产替米沙坦片的人体生物等效性  

Bioequivalence of telmisartan tablets in Chinese healthy volunteers

作　　者：刘皋林[1] 缪海均[1] 恽芸蕾[1] 陶霞[1] 孙静慧[1] 

机构地区：[1]中国人民解放军第二军医大学长征医院药学部,上海200003

出　　处：《中国临床药学杂志》2005年第2期89-91,共3页Chinese Journal of Clinical Pharmacy

摘　　要：目的　评价单剂量口服国产与进口替米沙坦片的人体药动学特性和生物等效性。方法　采用随机、交叉试验设计,2 0名男性健康志愿者单剂量口服80mg替米沙坦片,用HPLC -荧光检测法测定了体内替米沙坦的血药浓度。结果　口服国产和进口替米沙坦片的主要药动学参数分别为:T1/ 2 (2 0 9±6 5 4 )、(19 8±5 6 6 )h ;cmax(313 2±10 6 3)、(310 7±91 6 ) μg·L-1;tmax(0 98±0 35 )、(1 0 1±0 4 0 )h ;AUC0→48(14 98 0±5 72 2 )、(14 6 1 7±5 37 1) μg·h·L-1;AUC0→∞(1718 9±6 6 2 8)、(16 4 8 5±5 77 4 ) μg·h·L-1。经方差分析,国产与进口替米沙坦片主要药动学参数比较均无统计学意义。国产替米沙坦片的相对生物利用度为(10 2 8±13 4 ) % ,经双单侧t检验,2种制剂生物等效。ATM To study the pharmacokinetics and bioequivalence of domestic and imported telmisartan tablets in healthy volunteers. METHODS A randomized,crossover study of 20 Chinese healthy volunteers was conducted with single oral dose of 80 mg telmisartan. The concentrations of telmisartan in plasma were determined by HPLC-fluorescence method. RESULTS The pharmacokinetic parameters for domestic and imported telmisartan were as follows: T 1/2(20.9±6.54) h and (19.8±5.66)h;c max(313.2±106.3) μg·L -1and (310.7±91.6)μg·L -1,t max(0.98±0.35)h and (1.01±0.40)h;AUC 0→48(1 498.0±572.2)μg·h·L -1 and (1 461.7±537.1)μg·h·L -1,AUC 0→∞(1 718.9±662.8)μg·h·L -1 and (1 648.5±577.4)μg·h·L -1,respectively. There were no significant differences (P>0.05) in main pharmacokinetic parameters between two preparations by analysis of variance according to crossover design. The relative bioavailability of domestic telmisartan tablet was (102.8±13.4)% compared with imported. CONCLUSION The study shows that the domestic and imported telmisartan tablets are bioequivalent.

关 键 词：替米沙坦 药动学 生物等效性 高效液相色谱 

分 类 号：R96[医药卫生—药理学]