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12名健康志愿者,随机交叉口服单剂量(200mg)国产司巴沙星胶囊和国外司巴沙星片,采用HPLC测得血浆中药物浓度分别在5.28±1.83,5.56±2.34h达到峰值711.7±116.3,751.8±95.9ng/ml。两种制剂的消除相半衰期分别为14.1±4.94,15.2±2.15h;血药曲线下面积分别为20576.9±4395.4,213787±38842ng·h/ml。药时曲线符合一级吸收的一室模型。以国外片为标准,算得国产司巴沙星胶囊的相对生物利用度为96.1±10.4%,经双单侧t检验,两种制剂具有生物等效性。
Twelve healthy volunteers were randomized to receive a single dose (200 mg) of domestic sparfloxacin capsules and sparfloxacin tablets at a randomized crossover level. The plasma concentrations of the drugs were 5.28 ± 1.83 and 5.56 ± 2.34 h reached a peak of 711.7 ± 116.3, 751.8 ± 95.9 ng / ml. The elimination phase half-lives of the two preparations were 14.1 ± 4.94 and 15.2 ± 2.15 h, respectively; the areas under the blood drug profile were 20576.9 ± 4395.4 and 21.3787 ± 3884.2 ng · h / ml. Pharmacokinetic curve in line with the absorption of a one-compartment model. The relative bioavailability of domestic sparfloxacin capsules was 96.1 ± 10.4% based on foreign tablets, and the bioavailability of the two preparations was bioequivalent.