缬沙坦胶囊在人体的药物动力学及相对生物利用度  

Pharmacokinetics and relative bioavailability of valsartan capsule in Chinese healthy volunteers

作　　者：许长江[1] 刘骁[1] 王海学[1] 石劲敏[1] 李端[1] 

机构地区：[1]复旦大学药学院药理学教研室,上海200032

出　　处：《中国临床药学杂志》2002年第2期91-94,共4页Chinese Journal of Clinical Pharmacy

摘　　要：目的 :了解国产缬沙坦胶囊在人体的药物动力学和相对生物利用度。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试验品与参比品各 80mg ,用HPLC法测定血药浓度。结果 :试验品与参比品主要药物动力学参数为T1/ 2α:(1 86± 0 93)h与 (1 94± 0 80 )h ,T1/ 2 β:(9 93± 3 41)h与 (9 81± 4 18)h ,tmax:(2 33± 0 80 )h与 (2 2 8± 0 47)h ;cmax:(2 6 1±1 15 ) μg·mL-1与 (2 43± 1 0 4) μg·mL-1,AUC0→T:(17 2 5± 6 90 ) μg·h·mL-1与 (16 92± 6 34 ) μg·h·mL-1。经交叉试验方差分析 ,上述药物动力学参数无统计学差异 (P >0 0 5 )。试验品的相对生物利用度为 (10 2 2 7± 14 2 6 ) %。结论 :试验品与参比品的cmax与AUC0→t经双单侧t检验分析 ,结果表明两者具有生物等效性。AIM: To study the pharmacokinetics and relative bioavailability of valsartan capsule in Chinese healthy volunteers. METHODS: Twenty male Chinese healthy volunteers received 80 mg valsartan capsule orally in a random crossover design.Drug concentrations in serum were determined by high performance liquid chromatography. RESULTS: The pharmacokinetic parameters of tested and reference capsules were as follows: T 1/2α :(1 86±0 93)h and (1 94±0 80)h, T 1/2β :(9 93±3 41)h and (9 81±4 18)h, t max (2 33±0 80)h and (2 28±0 47) h, c max :(2 61±1 15) μg· ml -1 and (2 43±1 04)μg·mL -1 ,AUC 0→T :(17 25±6 90)μg·h·mL -1 and (16 92±6 34)μg·h·mL -1 ,respectively.There were no significant differences in the pharmacokinetic parameters above between 2 capsules( P >0 05). The relative bioavailability of valsartan capsules was (102 27±14 26)%. CONCLUSION: The results suggest that the 2 preparations have bioequivalence.

关 键 词：缬沙坦胶囊 药物动力学 相对生物利用度 

分 类 号：R969[医药卫生—药理学]