论文部分内容阅读
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 fasting and postprandial single dose po pokecone. Methods A cross-dosing regimen was used. Ten healthy volunteers received fasting or postprandial single-dose po 600 mg metochotomycin. Plasma concentrations were determined by HPLC. The pharmacokinetic parameters were fitted by the SCIENTIST program. Differences, double unilateral t-test to evaluate bioequivalence. Results The fasting and postprandial single-dose dosing curves were in accordance with the single-compartment model. The peak time tmax were (0.63 ± 0.11), (1.02 ± 0.31) h and peak concentration cmax (2.36 ± 0.35) and (1.82 ± 0.32) μg · ml-1, respectively, and the elimination half-life t1 2 were (1.31 ± 0.11) and (2.30 ± 0.19) h, The area under the curve of AUC was (6 .20 ± 1.2 8) and (6.88 ± 1.46) μg · h · ml-1, respectively. Conclusion The intake of mecamocuria slowed down and the elimination half-life was prolonged. However, it had no significant effect on the total amount of absorption. The AUC was used as an index for evaluation. Both of them were bioequivalent.