摘要
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。
Aim The bioavailability and bioequivalence of clarithromycin disperse tablets (as test preparation) and Limaixian tablets (as reference preparation) were studied in 8 healthy volunteers with a double-cross design test.Methods The serum concentrations of clarithromycin after a sigle oral dose of 500 mg of the test preparation or reference preparation were determined by microassay method.Datum were analysed with 3p97 pharmacokinetic programme and two-one sided t-test and (1-2α) confidence interval analysis.Results The Ka, t1/2(α),t1/2(β),Cmax,AUC(0～∞) of the two preparations were 0.7843 and 0.5893 h-1,1.7324 and 2.3140 h, 4.1449 and 3.8635 h, 2.2308 and 1.8742μg·ml-1, 17.7410 and 16.2751 μg·h·ml-1,respectively.The relative bioavailability of clarithromycin desperse tablet was 106.21%. Conclusion The bioequivalence of AUC between test and reference preparations, phases and subjects shows no significant differences (P>0.05).
出处
《中国临床药理学与治疗学》
CAS
CSCD
1999年第3期202-205,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
