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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。
Objective: To study the pharmacokinetics of domestic didanosine enteric-coated capsules in healthy young men in China. Methods: Seventeen healthy volunteers were given single oral dose of 200 mg of didanosine enteric-coated capsules and the 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: The in vivo process of single-dose administration of 200 mg of didanosine in healthy subjects was in accordance with a two-compartment model. The main pharmacokinetic parameters were tmax (2.4 ± 0.8) h, cmax (432.0 ± 278.6) μg / L, AUC0 (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 ) L / h. CONCLUSION: Domestic didanosine enteric capsules absorbed more slowly than tablets, dispersible tablets and powders, but the main pharmacokinetic parameters were similar to other dosage forms.