中国临床药理学杂志2013，Vol.29Issue(1)：28-30,3.
司帕沙星胶囊在健康人体的生物等效性
Bioequivalence of sparfloxacin capsules in healthy subjects
廖明琪 1乔华 2常威 1李琳 1焦凯 3李玲 4马海忠 1邵婷玑 2王婷 1梁莉 2李丹1
作者信息
- 1. 兰州大学第一医院药理基地
- 2. 兰州大学药学院,兰州 730000
- 3. 兰州大学第一医院检验科
- 4. 兰州大学第一医院药剂科,兰州 730000
- 折叠
摘要
Abstract
Objective To study the pharmacokinetics and bioequivalence of sparfloxacin capsules in healthy human. Methods In a randomized and cross - over study, 20 healthy volunteers were divided into two groups and orally given 0. 2 g sparfloxacin capsules ( test or reference). A sensitive and rapid HPLC method was developed to determine the metformin plasma concentration. The plasma concentration - time curves and the bioequivalence of reference ande test preparation were analyzed by DAS2. 1 software. Results The main pharmacokinetic parameters were as follows, Cmax were (1. 23 ± 0. 23 ) , (1. 23 ± 0. 23 ) μg · mL-1 ,tmax were(3. 70 ± 1. 56) , (3. 85 ± 1. 53 ) h, t1/2 (19. 98 ± 5. 04), (19. 11 ±5. 22)h, AUC0-72h were (27.61 ±4. 89), (26. 53 ±5.84) μg · h · mL -1 , respectively. The relative bioavailability of sparfloxacin capsules test was (106. 3 ± 16. 7) %. Conclusion The results demonstrated that the two preparations were bioequivalent关键词
司帕沙星胶囊/生物等效性/药代动力学/高效液相色谱法Key words
sparfloxacin capsules/ bioequivalence/ pahamacokinetics/ HPLC分类
医药卫生引用本文复制引用
廖明琪,乔华,常威,李琳,焦凯,李玲,马海忠,邵婷玑,王婷,梁莉,李丹..司帕沙星胶囊在健康人体的生物等效性[J].中国临床药理学杂志,2013,29(1):28-30,3.
