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目的建立人尿样中依普利酮浓度的HPLC-MS测定法,并研究依普利酮在健康人体内的尿药排泄特征。方法20名健康受试者分别单次口服依普利酮25、50和100mg,测定尿药浓度,计算尿药排泄参数,并进行统计比较。结果在给药后36h内低、中、高3个剂量下人体尿液中的累积排泄量分别为(594±s302)μg,(1085±185)μg和(2558±854)μg,排泄率为2.17%～2.56%。男性受试者的累积排泄量和最大排泄速率高于女性受试者。结论在25～100mg剂量范围内,依普利酮尿排泄量及最大排泄速率与剂量呈线性关系,不同剂量组之间排泄率无差异,依普利酮尿药排泄参数存在性别差异。
Objective To establish an HPLC-MS method for the determination of eplerenone in human urine and to study the characteristics of urinary excretion of eplerenone in healthy volunteers. Methods Twenty healthy volunteers were treated with 25, 50 and 100 mg of eplerenone orally for one time. Urinary drug concentrations were measured and urinary excretion parameters were calculated and compared statistically. Results The cumulative urinary excretion of human urine in the low, medium and high doses were (594 ± s302) μg, (1085 ± 185) μg and (2558 ± 854) μg, and the excretion rate was 2.17% ~ 2.56%. Male subjects had higher cumulative excretion and maximum excretion rates than female subjects. Conclusion In the range of 25 ~ 100mg, the urinary excretion and the maximum excretion rate of eplerenone have a linear relationship with the dose, there is no difference between the excretion rates of different dose groups, there is a gender difference in urinary excretion parameters of eplerenone.