【摘要】 目的研究阿奇霉素分散片健康人体的药物动力学与生物等效性。方法高效液相色谱-质谱法(LC-MS)测定20名男性健康志愿者随机交叉口服阿奇霉素分散片受试制剂和参比制剂的药时数值。以DAS2.0软件计算其药动学参数,考察其生物等效性。结果受试制剂和参比制剂的药动学参数:tm ax分别为(2.1±0.8)h和(3.1±2.2)h;Cm ax分别为(433.5±138.1)μg/L和(425.7±184.3)μg/L;AUC0~120 h分别为(4 231±1 198)μg.L-1.h-1和(3 881±1 154)μg.L-1.h-1;AUC0~∞分别为(4 609±1 207)μg.L-1.h-1和(4 287±1 268)μg.L-1.h-1。以AUC0~120 h计算,受试阿奇霉素分散片和参比阿奇霉素分散片比较的人体相对生物利用度为(119.6±52.9)%。结论两种不同厂家的阿奇霉素分散片具有生物等效性。更多还原

【Abstract】 Objective To investigate the pharmacokinetics and bioequivalent of azithromycin dispersible tablets in healthy volunteers.Methods Twenty healthy subjects took oral azithromycin dispersible tablets in a randomized cross-over design in the case.The serum concentration of azithromycin was determined by LC-MS method.Pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two formulations.Results The pharmacokinetic parameters of the testee and references were as follows:tmax(2.1±0.8)h and(3.1±2.2) h;Cmax(433.5±138.1)μg/L and(425.7±184.3)μg/L;AUC0~120h(4 231±1 198)μg·L-1·h-1 and(3 881±1 154)μg·L-1·h-1;AUC0-∞(4 609±1 207)μg·L-1·h-1 and(4 287±1 268)μg·L-1·h-1.Calculated with AUC0~120 h,the bioavailability of two formulations was(119.6±52.9) %.Conclusion The test and reference formulation are bioequivalent.更多还原