中国志愿受试者多剂量口服伊曲康唑后血液和指甲药代动力学研究  

Serum and nail pharmacokinetic studies of itraconazole after multiple oral dosing to 9 healthy Chinese volunteers

作　　者：陈秀兰[1] 白林[1] 吕晓川[1] 王晓蕾[1] 高翠萍[1] 

机构地区：[1]解放军总医院药检室

出　　处：《军医进修学院学报》1998年第4期265-267,共3页Academic Journal of Pla Postgraduate Medical School

摘　　要：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 serum and nail pharmacokinetics of itraconazole in 9 healthy Chinese volunteers. Methods:The regimen of dosing was 200mg,b.i.d for 7 days, on day 8, after oral administration of the drug 200mg, blood samples were collected, the nail samples were collected every month for 9 monthes. The serum and nail lever of itraconazole was determined by high performance liquid chromatography. Results:The mean value for maximum concentration of drug in serum was 1230. 83ug/ml;mean time for drug reaching peak level in serum was 4. 38 h; mean serum eliminative half life was 41.56h; mean AUC was 66396.52(ng·h)/ml; the mean nail levels for 7 days and 9 monthes after drug withdrawn were (957±1009)ng/g and (231±418)ng/g.

关 键 词：伊曲康唑 药代动力学 指甲 趾甲 剂量 

分 类 号：R978.5[医药卫生—药品]