氨酚曲马多片在中国健康志愿者体内的药动学研究  

Pharmacokinetics of tramadol hydrochloride-paracetamol tablets in Chinese healthy volunteers

作　　者：孙莉[1] 周芬[1] 范华莹[1] 梁军成[1] 刘丽京[1] 邓艳萍[1] 

机构地区：[1]北京大学中国药物依赖性研究所,北京100191

出　　处：《中国新药杂志》2011年第6期529-534,共6页Chinese Journal of New Drugs

摘　　要：目的:研究氨酚曲马多片在中国健康志愿者体内的药动学。方法:12名健康志愿者,男女各半,采用3×3拉丁方设计,分别顿服氨酚曲马多片(盐酸曲马多37.5 mg+对乙酰氨基酚325 mg)1,2,3片。反相HPLC-UV法检测对乙酰氨基酚、曲马多及其代谢物M1的含量,并采用3P97药动学软件估算药动学参数,Cmax和Tmax采用实测值计算,AUC0～tn采用梯形法计算。结果:口服不同剂量氨酚曲马多片后,对乙酰氨基酚、曲马多及其代谢物M1药-时曲线拟合结果均符合一室模型,各剂量组的Cmax和AUC0～24随剂量增加而增大。结论:在给药剂量范围内氨酚曲马多单次给药后的Cmax和AUC0～24与剂量的线性关系尚不能得出明确结论。Objective：To investigate the pharmacokinetics of tramadol hydrochloride-paracetamol tablets in Chinese healthy volunteers.Methods：12 volunteers（6 men and 6 women） were divided into six groups by 3×3 design,and administered with single dose of 1,2 and 3 tables in 3 cross periods.The concentrations of paracetamol,tramadol and its metabalite O-desmethyltramadol（M1） were determined by high performance liquid chromatography（HPLC）.The pharmacokinetic parameters were calculated using 3P97 software.Results：The concentration-time curves of paracetamol,tramadol and M1 were described by one-compartment open model.The pharmacokinetics parameters such as Cmax and AUC0～24 were proportionally increased with doses.Conclusion：There is no clear conclusions that the process of tramadol hydrochloride-paracetamol tablets in the dose range 1～3 tables in human body fits linear dynamic feature.

关 键 词：氨酚曲马多片 药动学 反相高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学] R971.1[医药卫生—药学]