罗红霉素分散片人体生物等效性研究

目的: 观察两个不同厂家生产的罗红霉素分散片在健康人体的生物等效性。方法: 20名志愿者采用双周期交叉试验,分别单剂量口服罗红霉素分散片150mg,高效液相-质谱联用(LC-MS)法测定其血清中罗红霉素浓度,血药浓度-时间数据经DAS2.0统计软件处理,计算主要药物动力学参数,并进行两种制剂的生物等效性评价。结果: 受试制剂与参比制剂的药动学参数分别为:t_1/2(8.131±1.465) h和(9.020±2.914) h,C_max(3.065±0.940)μg/ml和(3.157±1.019)μg/ml,T_max(2.000±0.924) h和(2.306±1.363) h,AUC_0-48h(38.312±19.673)μg·h-1·ml-1和(41.029±21.842)μg·h-1·ml-1。受试制剂的相对生物利用度为(110.4±67.2)%。结论: 罗红霉素两种制剂具有生物等效性。

Bioequivalence of roxithromycin dispersible tablets in healthy volunteers

Objective: To investigate the bioequivalence of roxithromycin dispersible tablets from two factories in Chinese healthy volunteers.Methods: Twenty volunteers were randomly divided into two groups(test and reference),with double cross over design.The concentration of roxithromycin in serum was determined by LC-MS and pharmacokinetic parameters were calculated with DAS 2.0 practical pharmacokinetics program.Results: The pharmacokinetic parameters of the testee and reference were as follows:T_max(8.131±1.465)h and(9.020±2.914)h,C_max(3.065±0.940) μg/ml and(3.157±1.019) μg/ml,T_max(2.000±0.924)h and(2.306±1.363) h,AUC_0-48h(38.312±19.673) μg·h-1·ml-1 and(41.029±21.842) μg·h-1·ml-1.The relative bioavalibility of the testee was(110.4±67.2)%.Conclusions: The statistical analysis showed that the test and reference preparation were bioequivalent.