罗红霉素胶囊人体生物等效性研究

Bioequivalence of Roxithromycin Capsule in Healthy Volunteers

目的:探讨试验药罗红霉素胶囊在人体的相对生物等效性。方法:20名健康志愿受试者随机交叉单剂量口服试验药或对照药罗红霉素胶囊300 mg,采用微生物杯碟法测定血清中罗红霉素浓度,用3P97软件计算药动学参数,并评价其生物等效性。结果:试验药与对照药药时曲线符合口服二室模型。主要药动学参数t1/2β分别为(10.41±6.28)h和(12.50±6.40)h;Cmax分别为(7.19±2.72)μg.mL-1和(7.31±2.38)μg.mL-1;Tmax分别为(2.80±1.21)h和(2.52±0.91)h;AUC0-t分别为(67.72±32.92)μg.h.mL-1和(69.21±31.38)μg.h.mL-1。试验药相对生物利用度为(97.85±14.19)%。结论:经方差分析和单双侧t检验,试验药罗红霉素胶囊与对照药罗红霉素胶囊具有生物等效性。

Objective：To study the bioequivalence and pharmacokinetics of roxithromycin capsules in 20 healthy male volunteers.Methods： A single dose of 300 mg of roxithromycin capsules were administered to 20 volunteers with a randomized,2-way crossover design and the serum concentrations of roxithromycin were determined by microbiological assay.The pharmacokinetic parameters were calculated with 3P97 pharmacokinetic program and the bioequivalence was evaluated.Results： The t1/2β,Cmax,Tmax and AUC0-t of two roxithromycin capsules were（10.41±6.28） h and（12.50±6.40） h,（7.19±2.72） μg/mL and（7.31±2.38） μg/mL,（2.80±1.21） h and（2.52±0.91） h,（67.72±32.92） μg·h·mL-1 and（69.21±31.38） μg·h·mL-1,respectively.The relative bioavailability of test capsules were（97.85±14.19） %.Conclusions： Both roxithromycin capsules are bioequivalent.