国产氟罗沙星胶囊剂的生物利用度研究  

RELATIVE BIOAVAILABILITY OF DOMETIC FLEROXACIN CAPSULE

作　　者：李华[1] 侯杰[1] 刘彦[1] 梁远军[2] 李家泰[1] 

机构地区：[1]北京医科大学临床药理研究所,北京100034 [2]航天医学工程研究所

出　　处：《中国新药杂志》1996年第1期55-58,共4页Chinese Journal of New Drugs

摘　　要：对国产氟罗沙星胶囊剂的生物利用度研究的结果表明,分别口服200 mg 的氟罗沙星片剂和胶囊以后用 HPLC 法测定血药浓度,所得主要药代动力学参数分别为:Cmax=2.22±0.42和2.40±0.45mg/L,Tpeak=1.56±0.86和1.40±0.63 h。AUC=38.5±7.1和39.09±9.54(mg·h)/L。t_(1/2)β=14.4±2.9和13.3±2.64 h。所有药代试验血样均以微生物法同步测定,Cmax=2.34±0.44和2.57±0.61 mg/L。Tpeak=1.39±0.72和1.57±0.69 h。AUC=33.6±5.6和41.7±8.50(mg·h)/L。t_(1/2)β=13.8±5.5h 和14.4±5.19 h。两种剂型之间相比和两种测定方法相比没有显著性差异(P>0.05)。24 h 内原形药物在尿中排泄量为32.30%±12.36%。药代动力学参数与文献相似。The study was conducted in 9 healthy volunteers by methods of HPLC and bioassy after oral administration of domestic fleroxacin capsules and tablets.Pharmacokinetic parameters detected by HPLC for tablet and capsule were Cmax=2.22±0.42 and 2.40± 0.45mg/L.Tpeak=1.56±0.86 and 1.40±0.63h.AUC=38.5±74.1 and 39.09±9.54 (mg·h)/L.t_(1/2)β=14.4±2.9 and 13.3±2.64h respectively.Pharmacokinetic parameters detected by bioassay for tablet and capsule were.Cmax=2.34±0.44 and 2.57±0.61 mg/L,Tpeak=1.39±0.72 and 1.57±0.69h.AUC=33.6±5.6 and 41.7±8.50 (mg·h)/L.t_(1/2)=13.8±5.5h and 14.4±5.19h respectively.Relative bioavailability of capsule was 101.29% compared with tablet.

关 键 词：氟罗沙星 药代动力学 生物利用度 微生物测定法 

分 类 号：R978.1[医药卫生—药品]