摘要
目的:研究口服加替沙星胶囊在20名健康志愿者体内药代动力学和相对生物利用度。方法:用双交叉试验,20名健康志愿者口服单剂量加替沙星胶囊和片两种制剂0.4g,用HPLC法测定人血浆中加替沙星浓度。结果:胶囊和片t1/2分别为6.49±0.84h和6.80±0.96h,tmax分别为1.5±0.6h和1.6±0.7h,Cmax分别为4.27±0.65mg·L-1和4.16±0.84mg·L-1,AUC0-36分别为33.33±4.23mg·h·L-1和30.99±3.15mg·h·L-1。试验品的相对生物利用度为（105.84±9.63）％。结论:加替沙星胶囊与片具有生物等效性。
OBJECTIVE: To study pharmacokinetics and bioavailablity of Gatifloxacin capsule in 20 healthy volunteers. METHODS:According to the crossover design, each volunteer was orally given Gatifloxacin capsule and tablet. The plasma concentrations were determined by HPLC. Pharmacokinetic parameters were obtained using excel ,and were calculated on the basis of noncompartment model.RESULTS: After a single oral dose(0.4g), t1/2 was 6.49±0.84 h and 6.80±0.96 h, Cmax was4.27±0.65 mg·L-1 and 4.16±0.84mg·L-1 at 1.5±0.6 h and 1.6±0.7h and AUC 0-36 was33.33±4.23mg·h·L-1 and 30.99±3.15 mg·h·L-1 for tested formulation and referenced formulation, respectively. Relative bioavailability of gatifloxacin capsule was(105.84+9.63)%. CONLUTION: The result shows that two formulations are of bioequivalence .
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2002年第3期200-203,共4页
The Chinese Journal of Clinical Pharmacology
