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液质联用快速测定血浆中非布司他浓度及其人体药动学研究

发布时间:2018-10-17 22:29
【摘要】:目的研究非布司他片在中国健康受试者体内单次及多次给药的药动学特征。方法 30名受试者随机分为3组,每组10人,男女各半,一组进行非布司他片中剂量(80 mg)的单/多次给药人体药动学试验,10名受试者每天服药1次,每次80mg,一共服药6次;一组进行非布司他片低剂量(40 mg)的单次给药人体药动学试验;一组进行非布司他片高剂量(120 mg)的单次给药人体药动学试验。血药浓度用LC-MS/MS快速测定。结果单次空腹口服非布司他片40,80,120 mg后,其主要药动学参数如下:ρmax分别为(2 578±743),(4 522±1 376)和(6 407±2 463)ng·m L-1;tmax分别为(1.80±1.15),(1.78±1.18)和(2.28±1.57)h;t1/2分别为(6.21±2.11),(6.14±0.99)和(5.93±1.82)h;AUC0-36 h分别为(6 949±1 947),(14 875±4 200)和(23 881±6 225)ng·h·m L-1;AUC0-∞分别为(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,其主要药动学参数如下:tmax为(1.60±0.74)h,t1/2为(5.27±1.08)h,cSSmax为(4 326±1 477)ng·m L-1,cSSmin为(33.97±7.84)ng·m L-1,cSSav为(622.7±165.8)ng·m L-1,AUCSS为(14 945±3 979)ng·h·m L-1,AUC0-36 h为(15 196±4 119)ng·h·m L-1,AUC0-∞为(15 291±4 110)ng·h·m L-1。结论非布司他片在剂量为40~120 mg内呈线性药代动力学特征,多次口服非布司他片每日1次,每次80 mg,不存在蓄积现象。
[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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