非诺贝特胶囊在健康人体内的药物代谢动力学研究  

Study on pharmacokinetics of fenofibrate in healthy volunteers

作　　者：张玮[1] 刘守信[1] 

机构地区：[1]大连医科大学附属第一医院药学部,辽宁大连116011

出　　处：《中国现代医学杂志》2014年第31期56-59,共4页China Journal of Modern Medicine

摘　　要：目的研究健康志愿者单剂量口服非诺贝特胶囊的药动学。方法健康志愿者20名（其中男10名,女10名）,单剂量口服非诺贝特胶囊400 mg,采用HPLC法测定血浆中苯扎贝特的含量。用DAS软件程序进行数据处理,用SPSS软件对不同性别药动学参数进行统计学分析。结果受试者单剂量口服400 mg非诺贝特胶囊的主要药动学参数：c_max为（11.24±3.15）μg/m L,t_max为（2.02±0.36）h,t_1/2为（2.05±0.31）h,AUC0_0-12为（37.54±9.45）（μg·h）/m L;AUC0_0-∞为（39.46±9.82）（μg·h）/m L。结论健康志愿者单剂量口服非诺贝特胶囊的体内药动学过程符合二室开放模型。经统计学分析,健康志愿者药动学过程不存在性别差异。[ Objective ] To study the pharmacokinetics of fenofibrate capsules after a single oral dose in healthy volunteers. [ Methods ] Ten healthy male volunteers and ten healthy female volunteers were involved in the study. Each subject received a single dose of 400 mg fenofibrate capsules. The plasma concentration was determined by HPLC. The pharmacokinetic parameters were calculated by DAS software and were statistically analyzed by SPSS software. [ Results ] The main pharmacokinetic parameters were as follows： Cmax was （11.24±3.15） μg/mL, tmax was （2.02±0.36） h, t_l/2 was （2.05±0.31） h, AUC_0-12 was （37.54±9.45）（μg·h）/mL; AUC_0-∞ was （39.46±9.82）（μg·h）/mL. [Conclusion] The results showed that the plasma concentration-time curve of fenofibrate was fitted to a two-com- partment open model and the main pharmacokinetic parameters of fenofibrate have not significant differences between male and female volunteers.

关 键 词：非诺贝特 高效液相色谱法 药动学 

分 类 号：R969.1[医药卫生—药理学]