莫西沙星在中国健康受试者体内的药代动力学研究

发布时间：2018-01-24 17:28

本文关键词： 盐酸莫西沙星高效液相色谱质谱联用法药代动力学　出处：《中国临床药理学杂志》2015年13期 　论文类型：期刊论文

【摘要】：目的评价中国健康受试者连续4 d单剂量口服盐酸莫西沙星片400 mg的药代动力学。方法开放、随机、平行、单次、单周期试验设计。48名健康受试者,男女各半,单剂量口服盐酸莫西沙星片400 mg,连续4 d,用高效液相色谱串联质谱法测定血药浓度,用Win Nonlin 5.2.1程序计算药代动力学参数。结果有6例受试者中途退出,其余42名健康受试者口服莫西沙星后的主要药代动力学参数如下,t1/2为(11.71±3.53)h,Cmax为(0.51±0.19)×10-4ng·m L-1,tmax为(2.94±1.41)h,MRT0-24 h为(18.02±4.45)h,CLz/F为(0.84±0.75)×10-4m L·h-1,AUC0-24 h为(5.82±1.82)×10-4ng·m L-1·h。结论我国健康受试者口服莫西沙星血药浓度高、半衰期长、耐受性好,可参照国外剂量,并且服用同等剂量的莫西沙星时,女性的血药浓度比男性略高。
[Abstract]:Objective to evaluate the pharmacokinetics of single oral moxifloxacin hydrochloride tablets in Chinese healthy volunteers for 4 days. Methods the pharmacokinetics of moxifloxacin hydrochloride tablets was open, randomized, parallel and single. A single cycle experiment was designed in 48 healthy subjects, male and female, half of male and female, single dose of moxifloxacin hydrochloride tablets 400 mg for 4 days, the blood concentration was determined by high performance liquid chromatography-tandem mass spectrometry (HPLC / MS). Pharmacokinetic parameters were calculated by Win Nonlin 5.2.1 program. The main pharmacokinetic parameters of the other 42 healthy subjects after oral moxifloxacin were as follows: t 1 / 2 was 11.71 卤3.53 h. Cmax was 0.51 卤0.19) 脳 10 ~ (-4) ng 路m ~ (-1) t _ (max) was 2.94 卤1.41 h. The MRT0-24 h was 18.02 卤4.45mL 路h ~ (-1), and the MRT0-24 / F was 0.84 卤0.75) 脳 10 ~ (-4) mL 路h ~ (-1). AUC0-24 h was 5.82 卤1.82) 脳 10 ~ (-4) ng 路m ~ (-1) 路h 路h.Conclusion the plasma concentration of moxifloxacin in Chinese healthy volunteers is high, the half-life is long and the tolerance is good. The blood concentration of moxifloxacin in women is slightly higher than that in men.
【作者单位】：河南省人民医院药学部;解放军总医院药物临床研究中心;
【基金】：国家科技部十二五重大专项基金资助项目(2012ZX09303004)
【分类号】：R969.1
【正文快照】： 刘银萍1,秦玉花1,白楠2,唐铭婧2,王睿2,赵红伟1(1.河南省人民医院药学部,郑州450003;2.解放军总医院药物临床研究中心,北京100853)LIU Yin-ping1,QIN Yun-hua1,BAI Nan2,TANG Ming-jing2,WANG Rui2,ZHAO Hong-wei1(1.Department of Pharmacy,HenanProvince People's Hospital,

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