摘要
建立了LC-MS/MS法测定人血浆中的文拉法辛,研究了24例男性健康受试者双周期、交叉、随机、单剂量口服盐酸文拉法辛胶囊50mg后的药动学和相对生物利用度。受试与参比制剂的主要药动学参数分别为:cmax(71.1±29.9)和(71.2±26.6)ng/ml;tmax(2.31±0.67)和(2.31±0.75)h;t1/2(4.68±1.30)和(4.83±1.39)h;AUC0→24(534.7±334.6)和(543.9±370.3)h·ng·ml-1,相对生物利用度为(101.8±18.3)%,两种制剂具有生物等效性。
A LC-MS/MS method was established for the determination of venlafaxine in human plasma. According to a randomized two-period crossover design, the pharmacokinetics and bioequivalence after single dose oral administration of test and reference capsules in 24 healthy volunteers were investigated. The pharmacokinetic parameters of test and reference capsules were as follows： Cmax （71.1±29.9） and （71.2±26.6） ng/ml, /max （2.31±0.67） and （2.31±0.75） h, t1/2 （4.68±1.30） and （4.83±1.39） h, AUC0→24 （534.7±334.6） and （543.9± 370.3） h·ng·ml^-1, respectively. The relative bioavailability of the preparation was （101.8± 18.3） %. The two formulations are bioequivalent.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2009年第11期837-839,843,共4页
Chinese Journal of Pharmaceuticals
