国产和进口缬沙坦胶囊的人体生物利用度  

The bioavailability of domestic and imported valsartan capsule in human body

作　　者：刘红梅[1] 刘艳[1] 程彦文[1] 金锐[1] 王珍[1] 孙考祥[1] 樊宏伟[1] 陆义诚[1] 

机构地区：[1]哈尔滨医科大学附属第二医院,黑龙江哈尔滨150086

出　　处：《中国医院药学杂志》2001年第12期724-726,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的 :研究国产和进口缬沙坦胶囊的相对生物利用度。方法 :2 2名健康受试者随机、自身交叉服用单剂量的缬沙坦16 0mg ,用HPLC法测定血浆中的药物浓度 ,梯形法计算药时曲线下面积 ,并对主要参数进行统计学分析。 结果 :国产制剂与进口制剂的主要药动学参数 :Cmax为 (2 .1± 0 .6 ) ,(2 .1± 0 .8) μg·ml-1;Tmax为 (2 .3± 0 .5 ) ,(2 .4± 0 .6 )h ;AUC0～ 2 4为 (10 .5±3.2 ) ,(10 .8± 3.5 ) μg·ml-1·h-1;AUC0～∞ 为 (11.7± 3.4 ) ,(12 .0± 3.5 ) μg·ml-1·h-1。国产和进口缬沙坦的主要药动学参数差异无显著性 (P >0 .0 5 )。国产胶囊对进口胶囊的相对生物利用度为 98%。结论OBJECTIVE To study the relative bioavailability of domestic and imported valsartan capsule. METHODS This is a randomized, self crossover study on 22 healthy human volunteers after oral administration of domestic and imported valsartan 160 mg. AUC was calculated by trapezoid method, and the main pharmacokinetic parameters were analyzed by statistic method. RESULTS The main pharmacokinetic parameters of domestic and imported preparations were as follow: C max were ( 2.1 ± 0.6 ),( 2.1 ± 0.8 ) μg·ml -1 ; T max were ( 2.3 ± 0.5 ),( 2.4 ± 0.6 ) h;AUC 0～24 ( 10.5 ± 3.2 ),( 10.8 ± 3.5 ) μg·ml -1 ·h -1 ;AUC 0～∞ were ( 11.7 ± 3.4 ),( 12.0 ± 3.5 ) μg·ml -1 ·h -1 respectively. There was no significant difference between the two formulations ( P > 0.05 ).The relative bioavailability of domestic valsartan capsule was 98%. CONCLUSIONS The two formulations were bioequivalent.

关 键 词：缬沙坦 高效液相色谱法 生物利用度 

分 类 号：R972.4[医药卫生—药品] R969.1[医药卫生—药学]