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目的建立人尿样中非布司他浓度的液相色谱-质谱联用(LC-MS)测定法,并研究健康中国受试者口服非布司他片后非布司他的尿药排泄特征。方法尿液样品酸化后用乙酸乙酯提取,进行LC-MS分析。色谱柱为Hedera ODS-2,流动相为甲醇-10 mmol.L-1的醋酸铵水溶液(含0.05%甲酸)(70∶30)。12名健康受试者分别单次口服非布司他片80 mg(规格:80 mg)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名健康受试者口服80 mg非布司他后,48 h内的尿药累积排泄量为(2.684±0.838)mg,累积排泄率为(3.4±1.0)%。男性与女性受试者间的累积排泄量和最大排泄速率无显著性差异。结论非布司他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,且不存在性别差异。
Objective To establish a liquid chromatography-mass spectrometry (LC-MS) method for the determination of febuxostat in human urine and to study the urinary excretion characteristics of febuxostat in healthy Chinese subjects after oral administration of febuxostat . Methods Urine samples were acidified and extracted with ethyl acetate for LC-MS analysis. The column was Hedera ODS-2 and the mobile phase was methanol-10 mmol·L-1 aqueous ammonium acetate (containing 0.05% formic acid) (70:30). Twelve healthy volunteers were given a single oral dose of 80 mg (80 mg) febuxostat to determine the urinary drug concentration, and the urinary excretion parameters were calculated and statistically analyzed. Results After 12 hours of oral administration of 80 mg febuxostat, urinary excretion of urine was (2.684 ± 0.838) mg within 48 h, and cumulative excretion rate was (3.4 ± 1.0)%. There was no significant difference in cumulative excretion and maximum excretion rates between male and female subjects. Conclusions The urinary excretion parameters of febuxostat in healthy Chinese subjects are consistent with those reported in the literature, and there is no gender difference.