右酮洛芬在健康受试者体内的尿药排泄特征  

Study on Urinary Excretion Characteristics of Dexketoprofen in Healthy Chinese Volunteers

作　　者：段虹飞[1] 丁黎[1] 潘虹[1] 钱亚芳[1] 王晶[1] 文爱东[2] 

机构地区：[1]中国药科大学,江苏南京210009 [2]中国人民解放军第四军医大学第一附属医院,陕西西安710032

出　　处：《亚太传统医药》2012年第8期9-12,共4页Asia-Pacific Traditional Medicine

摘　　要：目的:建立人尿液中右酮洛芬的液相色谱-质谱联用(LC-MS)测定方法,并研究健康中国受试者静脉滴注右酮洛芬氨丁三醇注射液后,右酮洛芬的药动学特征。方法:尿液样品以甲醇稀释后,离心取上清,进行HPLC-MS分析,色谱柱为Hedera ODS-2-C18,流动相为甲醇-5mmoL/L醋酸铵水溶液(含0.05%的乙酸)(65:35,v/v)。12名健康受试者分别单次静脉滴注右酮洛芬25mg及50mg后,测定尿药浓度,计算尿药排泄参数,并进行统计分析。结果:12名健康受试者单次静脉滴注右酮洛芬氨丁三醇注射液25mg后,在24h内尿液中原型药物累积排泄量为(289.1±217.2)μg,累积排泄率为(1.2±0.9)%。受试者单次静脉滴注右酮洛芬氨丁三醇注射液50mg后,在24h内尿液中原型药物的累积排泄量为(1352±867.7)μg,累积排泄率为(2.7±1.7)%。结论:右酮洛芬在健康中国受试者体内的尿药排泄参数与已有文献报道的结果基本一致。Objective：To develop an LC-MS method for the determination of dexketoprofen and to investigate the urinary excretion characteristics of dexketoprofen in healthy Chinese volunteers.Methods：After diluted with methanol and vortex‐mixed for 3 min,the urine sample was separated on a Hanbon Hedera ODS-2-C18 column,with a mobile phase of methanol-5mmoL/L ammonium acetate water solution containing 0.05% acetic acid（65∶35,v/v）.Twelve healthy volunteers were intravenous drip injection single doses of 25 mg and 50 mg dexketoprofen trometamol injection.The concentrations of dexketoprofen in urine were determined,and the pharmacokinetic parameters of dexketoprofen were calculated and compared between male and female volunteers by statistical analysis.Results：After single administration 25 mg and 50 mg dexketoprofen trometamol injection.The accumulated amount of dexketoprofen excreted in urine in 24 h was（289.1±217.2） μg and（1352±867.7） μg,respectively.The accumulated excretion rate was（1.2±0.9）% and（2.7±1.7）%,respectively.Conclusion：The urinary excretion characteristics of dexketoprofen in healthy Chinese volunteers is consistent with those reported in literature.There is no significant difference between the male and the female volunteers.

关 键 词：右酮洛芬 液相色谱-质谱联用 药动学 尿药排泄 累积排泄量 累积排泄率 

分 类 号：R961[医药卫生—药理学]