摘要
目的 :以左氧氟沙星片为标准参比制剂 ,研究盐酸左氧氟沙星片和甲磺酸左氧氟沙星胶囊健康人体药物动力学及相对生物利用度。方法 :按 3制剂、3周期的 3× 3拉丁方试验设计 ,9名健康男性受试者 ,分别口服 3种左氧氟沙星 2 0 0mg ,采用微生物法测定血药浓度 ,用 3P87软件经微机处理药 时数据。结果 :3种左氧氟沙星的体内过程均符合一房室模型 ,与标准参比制剂相比 ,两种被试制剂的相对生物利用度分别为 (98.4± 7.8) %与 (99.5± 9.8) %。结论 :对AUC、Cmax进行方差分析和双向单侧t检验证明 ,两种左氧氟沙星盐与左氧氟沙星片均具有生物等效性。
OBJECTIVE:Compared with levofloxacin tablets(LFT),to study the pharmacokinetics and relative bioavailabilities of levofloxacin hydrochloride tablets(LFHT) and levofloxacin mesylate capsules(LFMC).METHODS:9 male health volunteers orally took a single dose of 200 mg levofloxacins in crossways.The serum concentrations of levofloxacin were determined by microbiology assay.Data of serum level time were disposed with 3P87 of software and computer.RESULTS:The serum concentration time curves of the three preparations appeared to fit one compartment open model.These main parameters of LEHT,LFMC and LFT were as follows, C max :( 2.64 ± 0.29 ),( 2.64 ± 0.56 ) and ( 2.68 ± 0.67 )mg·L -1 ; T max :( 1.06 ± 0.17 ),( 1.11 ± 0.22 ) and ( 1.13 ± 0.30 )h; AUC :( 13.00 ± 2.08 ),( 13.10 ± 1.76 ) and ( 13.28 ± 2.28 )mg·h·L -1 .There were no significant differences in the pharmacokinetic parameters between LFHT of LFMC and LFT,respectively.Compared with LFT,the relative bioavailabilities of LFHT and LFMC were ( 98.4 ± 7.8 )% and ( 99.8 ± 9.8 )%,respectively.CONCLUSIONS:LFHT and LFMC will have the same effects as the LFT.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2000年第7期396-398,共3页
Chinese Journal of Hospital Pharmacy
关键词
左氧氟沙星
药物动力学
相对生物利用度
levofloxacin hydrochloride
levofloxacin mesylate
levofloxacin
pharmacokinetics
bioavailability
