【摘要】 目的:研究国产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:17名健康志愿者分别单剂量口服200mg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200mg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(2.4±0.8)h,cmax(432.0±278.6)μg/L,AUC0-t(1188.8±577.5)μg.h/L,AUC0-∞(1221.6±587.2)μg.h/L,t1/2(1.7±0.3)h,Vd(547.0±373.4)L,CL(218.3±139.1)L/h。结论:国产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。更多还原

【Abstract】 Objective To study the pharmacokinetics of domestic didanosine enteric capsules in healthy Chinese young men.Methods Seventeen healthy volunteers were administrated with single dose of didanosine enteric capsules 200 mg.Blood was collected according to the protocol and plasma concentrations of didanosine were measured with validated liquid chromatography-tandem mass spectrometry.With DAS 2.0 pharmacokinetic program,pharmacokinetic parameters were calculated on personal computer.Results The main pharmacokinetic parameters of didanosine were as follows:tmax(2.4±0.8)h,cmax(432.0±278.6)μg/L,AUC0-t(1188.8±577.5)μg·h/L,AUC0-∞(1221.6±587.2)μg·h/L,t1/2(1.7±0.3)h,Vd(547.0±373.4)L,CL(218.3±139.1)L/h.Conclusion The absorption of domestic didanosine enteric capsules is slower than its tablets,dispersible tablets,and powder,while the main pharmacokinetic parameters were similar to the other formulas.更多还原