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机构地区:[1]福建省医学科学研究所药物研究室,福建福州350001
出 处:《中国药学杂志》2000年第11期758-760,共3页Chinese Pharmaceutical Journal
摘 要:目的 比较研究空腹、餐后单剂量po美欧卡霉素的药代动力学和生物利用度。方法 采用交叉给药方案 ,10名健康受试者空腹或餐后单剂量po 6 0 0mg美欧卡霉素 ,用HPLC测定血药浓度 ,SCIENTIST程序拟合药代动力学参数 ,t检验比较组间差异 ,双单侧t检验评价生物等效性。结果 空腹和餐后单剂量给药的药时曲线均符合单室模型 ,达峰时间tmax分别为 (0 .6 3± 0 .11) ,(1.0 2± 0 .31)h ,峰浓度cmax分别为 (2 .36± 0 .35 ) ,(1.82± 0 .32 ) μg·ml- 1 ,消除半衰期t1 2 分别为 (1.31± 0 .11) ,(2 .0 3± 0 .19)h ,药时曲线下面积AUC分别为 (6 .2 0± 1.2 8) ,(6 .88± 1.46 ) μg·h·ml- 1 。结论 进食使美欧卡霉素的吸收速度减慢、消除半衰期延长 ,但对吸收总量无显著影响 ,以AUC为指标进行评价 ,两者生物等效。OBJECTIVE To compare the pharmacokinetics and bioavailability of miocamycin under conditions of fasting and after meal.METHODS A single oral dose of miocamycin 600 mg was given to 10 healthy volunteers under the conditions of fasting and after meal in a crossover study.Serum miocamycin concentration was determined by HPLC.RESULTS The concentration time profile of miocamycin fitted to one compartment model and the pharmacokinetic parameters were: t max =(0.63±0.11) and (1.02±0.31) h, c max =(2.36±0.35) and (1.82±0.32) μg·ml -1 , t 1/2 =(1.31±0.11) h and (2.03±0.19) h, AUC =(6.20±1.28) and (6.88±1.46) μg·h·ml -1 in fasting and after meal conditions,respectively.The absorption rate of miocamycin was delayed and the peak concentration was reduced,with a long elimitration half time after meal.But the bioavailability of miocamycin had no significant difference.CONCLUSION Miocamycin was bioequivalence between the conditions of fasting and after meal.in terms of AUC .
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