进口及国产环丙沙星片剂的药动学和生物利用度比较

COMPARISON OF PHARMACOKINETICS AND BIOAVAILABILITY OF IMPORTED AND CHINESE CIPROFLOXACIN TABLETS

对进口和国产环丙沙星片剂的药动学和生物利用度(F)进行了比较,选定5名健康志愿受试者,交叉口服进口和国产 CPFX 片剂各250mg,并静脉输注 CPFX 针剂200mg,历时40min。血清和尿标本用微生物法测定,测得两种制剂的参数如下:T_(1/2)分别为3.15±0.74h 和2.77±1.08h,Cmax 分别为1.60±0.15mg/L 和1.38±0.28mg/L,Tmax 分别为1.55±0.44h 和1.39±0.15h,24h 尿排出药量分别为给药量的30.64%和29.76%,F 分别为77.01±9.56%和64.05±14.99%,这与国外报道类似。两种片剂的 F 无显著差异(P>0.05),说明进口与国产 CPFX 片剂生物效果相等。

The pharmacokinetics and bioavailability of imported and chineseCiprofloxacin were evaluated by giving a single oral dose of 250mg of both the tabletsSeparately and by giving an intravenous infusion of 200mg of both the infections sepa-rately for 40 min at random to each of 5 healthy volunteers.Serum and urine sampleswere analized microbiologically.The pharmacokinetic parameters of both the productswere respective as follows:T_(1/2) 3.15±0.74h and2.77±1.08h,Cmax 1.60±0.15mg/Land 1.38±0.28mg/L,Tmax 1.55±0.44h and 1.39±0.15h,Urinary recovery/24h30.64% and 29.76%,F 77.01±9.56% and 64.05±14.99%.The difference betweenboth the Products was not Significant(P>0.05)