本文選題：阿莫曲坦 + 藥動學　； 參考：《中國新藥與臨床雜志》2017年03期

【摘要】：目的評價阿莫曲坦在中國健康志愿者中的單次給藥藥動學特征。方法采用隨機開放雙交叉試驗設計,12例健康受試者(男女各半)在空腹狀態(tài)下分別單次口服阿莫曲坦片12.5 mg或25 mg。以高效液相色譜-串聯(lián)質(zhì)譜(HPLC-MS/MS)法測定血漿中阿莫曲坦的濃度,采用Win Nonlin軟件計算藥動學參數(shù)。結果單次給藥(12.5、25 mg)后阿莫曲坦的主要藥動學參數(shù):t_(1/2)分別為(3.85±1.38)和(4.18±2.62)h;t_(max)分別為(2.04±0.09)和(2.33±1.39)h;ρ_(max)分別為(28.98±6.09)和(53.80±14.99)μg·L~(-1);AUC0-t分別為(196.1±52.5)和(390.2±78.9)μg·h·L~(-1);AUC_(0-∞)分別為(229.6±66.3)和(427.1±75.3)μg·h·L~(-1)。結論本研究建立的HPLC-MS/MS法準確快速,靈敏度高,專屬性強,適用于臨床試驗中阿莫曲坦血藥濃度測定;單次給藥(12.5、25 mg)后,阿莫曲坦的體內(nèi)過程符合一級線性動力學過程。
[Abstract]:Objective to evaluate the pharmacokinetics of amotrexan in Chinese healthy volunteers. Methods A randomized open double crossover trial was conducted in 12 healthy subjects (male and female) to take amotretan 12.5 mg or 25 mg on an empty stomach. The concentration of amotrexate in plasma was determined by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS / MS). The pharmacokinetic parameters were calculated by win Nonlin software. 緇撴灉鍗曟緇欒嵂(12.5,25 mg)鍚庨樋鑾洸鍧︾殑涓昏鑽姩瀛﹀弬鏁，

本文編號：2006113