国产去羟肌苷肠溶胶囊在中国健康男青年体内药物动力学研究  

Pharmacokinetics of domestic didanosine enteric capsules in healthy Chinese young men

作　　者：赵红卫[1] 秦玉花[1] 张伟[1] 丁祖锐[1] 赵钰敏[1] 张逸凡 

机构地区：[1]河南省人民医院药剂科,郑州市450003 [2]上海药物代谢研究中心

出　　处：《中华实用诊断与治疗杂志》2009年第1期10-11,共2页Journal of Chinese Practical Diagnosis and Therapy

基　　金：河南省医学科技攻关工程资助项目

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。Objective To study the pharmacokinetics healthy Chinese young men. Methods Seventeen healthy dose of didanosine enteric capsules 200 mg. Blood was coil concentrations of didanosine were measured with valida spectrometry. With DAS 2.0 pharmacokinetic program, p of domestic didanosine enteric capsules in volunteers were administrated with single ected according to the protocol and plasma ted liquid chromatographytandem mass harmacokinetic parameters were calculated on personal computer. Results The main pharmacokinetic parameters of didanosine were as follows： tmax（2.4±0. 8） h, c （432.0±278.6） ug/L, AUC0-∞（1188.8±577.5） ug · h/L, AUC0-∞（1221.6± 587.2） ug· 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.

关 键 词：药物动力学 去羟肌苷 肠溶胶囊 液相色谱-串联质谱 

分 类 号：R969.1[医药卫生—药理学]