HPLC法测定人血浆中伊曲康唑的含量及其药代动力学研究

Determination of itraconazole concentration and pharmacokinetics in human plasma by HPLC

目的建立HPLC法测定人血浆中伊曲康唑含量方法及药代动力学特征的研究。方法选取20名健康受试者高脂饮食后随机交叉口服受试制剂和参比制剂伊曲康唑片100mg。采用HPLC-UV法测定伊曲康唑的血药浓度。结果受试制剂的相对生物利用度为(99.7±9.2)%。结论伊曲康唑的药代动力学特征较明显,表明两制剂具有生物等效性。

Objective To determine of Itraconazole concentration and pharmacokinetics in human plasma by HPLC.Methods Single oral dose of 100 mg Itraconazole tablets of the test and reference preparations was given to 20 male healthy volunteers respectively in an open,randomized crossover study.The concentration of Itraconazole in plasma was determined by HPLC-UV.Results The relative bioavailability of itraconazole dispersible tablets were（99.7±9.2）%.Conclusion Pharmacokinetics of itraconazole is obviously,the relative bioavailability of itraconazole dispersible tablets were（99.7±9.2）%.Two kinds of preparations are bioequivalent in human plasma.