【摘要】：目的研究非布司他片在中國(guó)健康受試者體內(nèi)單次及多次給藥的藥動(dòng)學(xué)特征。方法 30名受試者隨機(jī)分為3組,每組10人,男女各半,一組進(jìn)行非布司他片中劑量(80 mg)的單/多次給藥人體藥動(dòng)學(xué)試驗(yàn),10名受試者每天服藥1次,每次80mg,一共服藥6次;一組進(jìn)行非布司他片低劑量(40 mg)的單次給藥人體藥動(dòng)學(xué)試驗(yàn);一組進(jìn)行非布司他片高劑量(120 mg)的單次給藥人體藥動(dòng)學(xué)試驗(yàn)。血藥濃度用LC-MS/MS快速測(cè)定。結(jié)果單次空腹口服非布司他片40,80,120 mg后,其主要藥動(dòng)學(xué)參數(shù)如下:ρmax分別為(2 578±743),(4 522±1 376)和(6 407±2 463)ng·m L-1;tmax分別為(1.80±1.15),(1.78±1.18)和(2.28±1.57)h;t1/2分別為(6.21±2.11),(6.14±0.99)和(5.93±1.82)h;AUC0-36 h分別為(6 949±1 947),(14 875±4 200)和(23 881±6 225)ng·h·m L-1;AUC0-∞分別為(7 039±1 931),(14 995±4 287)和(24 056±6 236)ng·h·m L-1。多次口服80 mg非布司他片后,其主要藥動(dòng)學(xué)參數(shù)如下:tmax為(1.60±0.74)h,t1/2為(5.27±1.08)h,cSSmax為(4 326±1 477)ng·m L-1,cSSmin為(33.97±7.84)ng·m L-1,cSSav為(622.7±165.8)ng·m L-1,AUCSS為(14 945±3 979)ng·h·m L-1,AUC0-36 h為(15 196±4 119)ng·h·m L-1,AUC0-∞為(15 291±4 110)ng·h·m L-1。結(jié)論非布司他片在劑量為40~120 mg內(nèi)呈線性藥代動(dòng)力學(xué)特征,多次口服非布司他片每日1次,每次80 mg,不存在蓄積現(xiàn)象。
[Abstract]:Objective to study the pharmacokinetic characteristics of Festa tablets in Chinese healthy volunteers. Methods Thirty subjects were randomly divided into 3 groups, 10 persons in each group, half male and half male. One group was given single or multiple doses of non-busulta tablets (80 mg) in human body pharmacokinetics test. 10 subjects took 80 mg of each drug once a day for 6 times. One group was given single pharmacokinetic test at low dose (40 mg) and the other group was given single dose (120 mg) of non-busulta tablet. Blood concentration was determined by LC-MS/MS. Results after a single fasting oral administration of Festa tablets for 40g / 80120 mg, 鍏朵富瑕佽嵂鍔ㄥ鍙傛暟濡備笅:蟻max鍒嗗埆涓，

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