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目的:探讨进口去羟肌苷肠溶胶囊在中国健康男青年体内的药物动力学。方法:18例健康志愿者分别单剂量口服250mg去羟肌苷肠溶胶囊后按试验方案采血,用液相色谱-串联质谱法测定血药浓度,DAS2.0程序计算药物动力学参数。结果:健康受试者单剂量给药250mg后去羟肌苷的体内过程符合二室模型,主要药物动力学参数分别为tmax(1.7±1.0)h,Cmax(604.6±415.1)μg/L,AUC0-t(1381.8±670.0)μg.h/L,AUC0-∞(1408.3±672.7)μg.h/L,t1/2(1.7±0.3)h,Vd(629.4±622.7)L,CL(252.6±206.9)L/h。结论:进口去羟肌苷肠溶胶囊吸收较片、分散片和散剂为慢,但主要药物动力学参数与其他剂型相近。
Objective: To investigate the pharmacokinetics of imported didanosine enteric-coated capsules in healthy young men in China. Methods: Eighteen healthy volunteers were given single oral dose of 500 mg of didanosine enteric-coated capsules and blood samples were collected according to the experimental protocol. The plasma concentration was determined by liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters were calculated by DAS 2.0 program. Results: In vivo, the single-dose administration of 250 mg of didanosine followed the two-compartment model. The main pharmacokinetic parameters were tmax (1.7 ± 1.0) h, Cmax (604.6 ± 415.1) μg / L and AUC0 (1381.8 ± 670.0) μg.h / L, AUC0-∞ (1408.3 ± 672.7) μg.h / L, t1 / 2 (1.7 ± 0.3) h, Vd (629.4 ± 622.7) L and CL ) L / h. Conclusion: Imported didanosine enteric-coated capsules absorbed more tablets, dispersible tablets and powder slowly, but the main pharmacokinetic parameters were similar to other dosage forms.