發(fā)布時(shí)間：2018-05-12 00:41

  本文選題：替莫唑胺 + 生物等效性��； 參考：《中國(guó)新藥雜志》2015年04期

【摘要】：目的:研究國(guó)產(chǎn)與進(jìn)口替莫唑胺膠囊在Beagle犬體內(nèi)的藥動(dòng)學(xué)及生物等效性。方法:6只Beagle犬隨機(jī)交叉單劑量口服進(jìn)口替莫唑胺膠囊(參比制劑)和國(guó)產(chǎn)替莫唑胺膠囊(受試制劑),采用HPLC法測(cè)定犬血漿中替莫唑胺的濃度,Bapp 3.0軟件計(jì)算其主要藥動(dòng)學(xué)數(shù)據(jù),并進(jìn)行兩種制劑的等效性評(píng)價(jià)。結(jié)果:參比制劑與受試制劑的Cmax分別為(11.35±1.35)和(11.70±2.77)μg·m L-1;Tmax分別為(0.97±0.56)和(1.08±0.49)h;t1/2β分別為(1.44±0.37)和(1.43±0.24)h;AUC0~t分別為(27.34±2.30)和(28.34±7.47)μg·h·m L-1,AUC0~∞分別為(29.85±4.49)和(30.85±8.46)μg·h·m L-1。受試制劑對(duì)參比制劑的相對(duì)生物利用度為(106.1±36.1)%。結(jié)論:本實(shí)驗(yàn)結(jié)果表明,兩種替莫唑胺膠囊在Beagle犬體內(nèi)具有生物等效性。
[Abstract]:Aim: to study the pharmacokinetics and bioequivalence of domestic and imported temozolidomide capsules in Beagle dogs. Methods six Beagle dogs were randomly cross-administered with imported temozolidomide capsule (reference preparation) and domestic temozolidomide capsule (test preparation). The main pharmacokinetic data of temozolidomide in dog plasma were determined by HPLC method and the software Bapp 3.0 was used to calculate the main pharmacokinetic data. The equivalence of the two preparations was evaluated. Results: the Cmax of reference preparation and test preparation were 11.35 鹵1.35) and 11.70 鹵2.77 渭 g ml 路L ~ (-1) T _ (max), respectively (0.97 鹵0.56) and 1.08 鹵0.49 h ~ (-1 / 2) 尾 were 1.44 鹵0.37) and 1.43 鹵0.24 h AUC _ (0T) were 27.34 鹵2.30) and 28.34 鹵7.47 渭 g h m L ~ 鈭，

本文編號(hào)：1876382