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目的 :研究两种阿莫西林克拉维酸钾 (AMO&CLV)片的药物动力学及生物等效性。方法 :采用反相高效液相色谱法测定 10名志愿受试者单剂量口服 75 0mg两种AMO&CLV片 (内含AMO 5 0 0mg ,CLV 2 5 0mg)后 ,AMO和CLV血药浓度的变化情况 ,数据经 3p87药物动力学程序处理。结果 :AMO药时曲线下面积分别是 :(2 4.6± 2 .6 ) μg·ml-1·h-1与 (2 5 .0± 2 .5 )μg·ml-1·h-1;达峰时间分别为 :(1.4± 0 .2 )h与 (1.4± 0 .2 )h ;峰浓度分别是 :(6 .2± 0 .7) μg·ml-1与 (6 .4± 0 .6 ) μg·ml-1。CLV药时曲线下面积分别是 :(13.5± 1.0 ) μg·ml-1·h-1与 (14.0± 1.1) μg·ml-1·h-1;达峰时间分别为 :(1.3± 0 .2 )h与 (1.3± 0 .2 )h ;峰浓度分别是 :(3.6± 0 .4) μg·ml-1;与 (3.7± 0 .4) μg·ml-1。结论 :配对t检验与双单侧t检验结果表明 :二者药时曲线下面积、峰浓度及达峰时间差异无显著性 (P >0 .0 5 ) ,两种AMO&CLV片为生物等效制剂。供试品的相对生物利用度分别为 :(98.5± 4.9) % (AMO) ,,(96 .9± 6 .8) % (CLV)。
Objective: To study the pharmacokinetics and bioequivalence of two amoxicillin and potassium clavulanate (AMO & CLV) tablets. Methods: The changes of plasma concentrations of AMO and CLV after oral administration of 75Omg two AMO & CLV tablets (containing AMO 500 mg and CLV 250 mg) in 10 volunteers were determined by RP-HPLC. Data were processed by the 3p87 pharmacokinetic program. Results: The area under the AMO curve was (2 4.6 ± 2 .6) μg · ml-1 · h-1 and (25.0 ± 2.5) μg · ml-1 · h-1 respectively The peak times were (1.4 ± 0.2 h) and (1.4 ± 0.2 h), respectively; the peak concentrations were (6.2 ± 0.77) μg · ml-1 and (6.4 ± 0. 6) μg · ml-1. The area under the curve of CLV’s time was (13.5 ± 1.0) μg · ml-1 · h-1 and (14.0 ± 1.1) μg · ml-1 · h-1, respectively. 2) h and (1.3 ± 0.2 h) respectively; the peak concentrations were (3.6 ± 0.4) μg · ml-1 and (3.7 ± 0.4) μg · ml-1, respectively. Conclusion: The paired t-test and double-sided t-test showed that there was no significant difference in the area under the drug-time curve, the peak concentration and the time to peak (P> 0.05), and the two AMO & CLV tablets were bioequivalent . The relative bioavailability of the test samples were (98.5 ± 4.9)% (AMO), (96.9 ± 6.8%) (CLV), respectively.