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在8例健康志愿者中进行国产依诺沙星胶囊和进口依诺沙星片的药物动力学研究。随机交叉试验设计单剂量口服400mg,用高效液相色谱法(HPLC)测定血药浓度,按1室模型计算,求得2种制剂各项药物动力学参数。结果表明:胶囊的达峰时间较片剂短,而进口片剂的药-时曲线下面积要略高于胶囊,但经统计学分析,两者无显著性差异。
Pharmacokinetic studies of domestic enoxacin capsules and enoxacine tablets were conducted in 8 healthy volunteers. A randomized crossover trial was designed to receive 400 mg of a single oral dose of the drug. The plasma concentration was determined by high performance liquid chromatography (HPLC). The pharmacokinetic parameters of the two preparations were calculated according to the 1-compartment model. The results showed that the peak time of the capsules was shorter than that of the tablets, while the area under the drug-time curve of the imported tablets was slightly higher than that of the capsules. However, the statistical analysis showed no significant difference between the two.