【摘要】 采用高效液相色谱柱切换法，研究了单剂口服国产氟康唑胶囊剂２００、１５０ｍｇ与进口氟康唑１５０ｍｇ胶囊剂的志愿受试者体内药物动力学过程。结果表明：单剂口服不同剂量的两种胶囊血药浓度－时间曲线符合二至模型。国产氟康唑胶囊２００、１５０ｍｇ及进口氟康唑胶囊剂１５０ｍｇ的药物动力学参数依序如后：消除半衰期（Ｔ１／２β）分别为３４．５５±５．９７、３４．７６±２．６８及３１．０７±２．４２ｈ。达峰时间（Ｔｍａｘ）分别为１．５５±０．２８、１．６１±０．８９及１．９７±０．４４ｈ。峰浓度（Ｃｍａｘ）分别为４．６３±０．３３、３。７７±０．５３及３．９２±０．５２ｍｇ／Ｌ。曲线下面积（ＡＵＣ）分别为１９９．５４±２３．５２、１６８．２４±１３．８２及１６４．３１±１４。９１ｍｇ·ｈ／Ｌ。Ｖ／Ｆ（ｃ）值分别为３２．９７±４．３６、３１．３２±７．６７及３０．１２±２．４６Ｌ。清除率（Ｃｌ（ｓ））分别为１．０１±０．１１、０．９０±０．０７及０．９２±０．０９Ｌ／ｈ。国产胶囊剂对美国进口胶囊剂的平均相对生物利用度为１０２．８７％。更多还原

【Abstract】 The pharmacokinetic prefile of oral adniinistration of a single 200 or 150mgdose of domestic fluconazole and 150mg of Pfizer’s product Diflucan was investigated by HPLCin 8 healthy volunteers. The pharmacokinetic parameters of fluconazolc capsules were listed asfollows according the sequence of domestic 200, 150mg and Difiucan 150mg : T1/2β: 34.55±5. 97, 34. 76±2. 68 and 31.07±2. 42h. Tmax:1.55±0. 28.1.67±0.89 and 1. 97±0. 44h. Cmax:4. 63±0. 33, 3. 77±0. 53 and 3. 92±0. 52mg/L.AUC:199. 54 ±23. 52 ,168. 24±13. 82 and164.31±14. 91 h·mg/L.V/F (c) : 32.97±4.36,31.32±7.67 and 30. 12±2.46L,Cl(s):1.01±0. 11 , 0. 90 ±0. 07 and 0. 92± 0. 09 L/h. The bioavailability of domestic fluconazolecapsule in oomparison with Diflucan was 102. 87%±9.56%.更多还原