發(fā)布時間：2018-03-06 01:21

  本文選題：左乙拉西坦　切入點：空腹　出處：《中國新藥雜志》2016年19期 　論文類型：期刊論文

【摘要】：目的:研究在空腹和餐后條件下國產(chǎn)左乙拉西坦片的生物等效性,并探討餐后給藥試驗的意義和樣本量對試驗結(jié)果的影響。方法:分別進(jìn)行空腹和餐后單次給藥的二交叉生物等效性試驗,22名健康男性受試者口服國產(chǎn)左乙拉西坦片(受試制劑)或進(jìn)口左乙拉西坦片(參比制劑)0.5 g,液相色譜-串聯(lián)質(zhì)譜聯(lián)用法測定血漿中左乙拉西坦的濃度。采用Win Nonlin 6.4軟件,非房室模型法計算藥動學(xué)參數(shù),藥動學(xué)參數(shù)AUC和Cmax對數(shù)轉(zhuǎn)換后,以90%置信區(qū)間(90%CI)法進(jìn)行生物等效性評價。結(jié)果:在空腹和餐后條件下,健康男性受試者口服國產(chǎn)和進(jìn)口左乙拉西坦片后左拉西坦的AUC0~t,AUC0~∞和Cmax幾何均數(shù)比值(GMR)的90%CI均在80.00%~125.00%的范圍內(nèi)。與空腹給藥相比,餐后給藥后Tmax延長,Cmax降低,而AUC和t1/2沒有差異。結(jié)論:在空腹和餐后條件下國產(chǎn)和進(jìn)口左乙拉西坦片具有生物等效性;左乙拉西坦片的生物等效性試驗可僅進(jìn)行空腹試驗,且12例樣本量即可。
[Abstract]:Objective: to study the bioequivalence of domestic levoethylacetam tablets under fasting and postprandial conditions. To explore the significance of postprandial drug administration test and the effect of sample size on the results. Methods: 22 healthy male subjects were given domestic levoethylacetam orally in the two-cross bioequivalence test of fasting and single postprandial administration. The concentration of levoethylacetam in plasma was determined by liquid chromatography-tandem mass spectrometry (LC-MS) or imported levoethylacetam tablets (reference preparation 0.5 g). Win Nonlin 6.4 software was used to determine the concentration of levoethoxetam in plasma. The pharmacokinetic parameters were calculated by non-atrioventricular model method. After logarithmic conversion of pharmacokinetic parameters AUC and Cmax, bioequivalence was evaluated with the 90% confidence interval 90 CI method. Results: under fasting and postprandial conditions, The 90CI of domestic and imported levoxetam AUC0 ~ 鈭，

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