论文部分内容阅读
目的比较克拉霉素分散片与克拉霉素片(利迈先)的生物等效性。方法采用双交叉单剂口服给药法 ,以藤黄八叠球菌为指示菌 ,采用微生物法测定健康志愿者克拉霉素分散片和利迈先经时血药浓度。数据经3p97药代动力学程序处理及双单侧t检验和(1 -2α)置信区间分析。结果克拉霉素分散片和利迈先药物动力学参数Ka 为0.7843和0.5893h-1,t1/2(α)为1.7324和2.3140h ,t1/2(β)为4.1449和3.8635h,Cmax 为2.2308和1.8742μg·ml-1,AUC为17.741和16.2751μg·h·ml-1。克拉霉素分散片的相对生物利用度为106.21 %。结论两种制剂AUC值剂型间、阶段间和个体间均无显著性差异(P>0.05) ,两制剂为生物等效制剂。
Objective To compare the bioequivalence of clarithromycin dispersible tablets with clarithromycin tablets (limaisone). Methods The oral crossover single oral administration method was used to determine the serum concentration of clarithromycin dispersible tablets and limai melatonin in the healthy volunteers. Data were processed by 3p97 pharmacokinetic program and double unilateral t-test and (1 -2α) confidence interval analysis. Results The pharmacokinetic parameters of clarithromycin dispersible tablets and rimexan were 0.7843 and 0.5893 h-1, t1 / 2 (α) was 1.7324 and 2.3140 h, t1 / 2 (β) was 4.1449 and 3.8635 h, Cmax was 2.2308 And 1.8742μg · ml-1, AUC was 17.741 and 16.2751μg · h · ml-1. The relative bioavailability of clarithromycin dispersible tablets was 106.21%. Conclusion There was no significant difference in the AUC value between the two formulations (P> 0.05), and between the two formulations as bioequivalent formulations.