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目的:对9例中国健康志愿者多剂量口服西安扬森公司生产的伊曲康唑后的血液和指甲药代动力学进行研究。方法:用高效液相色谱法测定血清和指甲中药物浓度,以3p87实用药代动力学程序计算稳态后,一次给药的药代动力学参数。结果:血中药物消除半衰期(t1/2)平均为41.56h;血中药物最高浓度(Cmax)平均为1230.83ng/ml;血中药物达最高浓度的时间(Tmax)平均为4.38h;血药浓度-时间曲线下面积(AUC)平均为66396.52ng·h/ml。停药后d7和9个月,受试者指甲中伊曲康唑的平均浓度分别为(957±1009)ng/g和(231±418)ng/g。
OBJECTIVE: To study the pharmacokinetics of blood and nails after oral administration of itraconazole in nine Chinese healthy volunteers. Methods: Serum and nails were determined by high performance liquid chromatography (HPLC). Pharmacokinetic parameters were calculated by 3p87 practical pharmacokinetic program after steady state and once administration. Results: The average elimination half-life (t1 / 2) of blood was 41.56h; the average blood concentration of Cmax was 1230.83ng / ml; the mean concentration of blood in blood reached an average of 4.38h ; The area under the plasma concentration-time curve (AUC) was 66396.52 ng · h / ml. The mean concentrations of itraconazole in the nails of the subjects at d7 and 9 months after discontinuation were (957 ± 1009) ng / g and (231 ± 418) ng / g, respectively.