甲磺酸培氟沙星胶囊及片剂在健康人体内的生物利用度比较

COMPARATIVE STUDY ON BIOAVAILABILITY OF PEFLOXACIN CAPSULES AND TABLETS IN HEALTHY VOLUNTEERS

１０名健康中国男性受试者单剂量随机交叉口服４００ｍｇ国产甲磺酸培氟沙星胶囊及片剂后，采用ＨＰＬＣ法测定血浆药物浓度。结果表明服用胶囊及片剂后血药浓度分别于１．０４±０．２６和１．１９±０．４８ｈ达到峰值４．１４±１．０２和４．０５±０．８９μｇ／ｍｌ，药时曲线下面积分别为５１．９９±Ｎ．５２和５１．８２±１７．１０μｇ·ｈ／ｍｌ。甲磺酸培氟沙星胶囊的相对生物利用度下为１０２．８％。

An open,randomized/crossover study on the bioavailability of Pefloxacin mesylate capsules and tablets in a single oral dose of 400mg have been achieved in 10 healthy male volunteers. The plasma drug concentrations were measured by HPLC. The peak plasma level of Pefloxacin for capsules and tablets averaged 4.14±0. 89 and 4.05±1.02μg/ml obtained at 1.04±0. 26 and 1.19±0.48 hours and the AUC obtained were 51.99±14.52 and 51.82±17.10μg. h/ml. The relative bioavailability of capsules vs,tablets was 102.8%and no significant differences in pharmacokinetic parameters were observed in the 2 dosage forms.