【摘要】 目的:研究阿奇霉素胶囊的人体生物等效性。方法:21名健康志愿者采用拉丁方设计,分为A、B、C3组,分别交叉单剂量口服阿奇霉素胶囊受试制剂1(规格:每粒0.25g)、受试制剂2(规格:每粒0.125g)及参比制剂(规格:每粒0.25g)后,用微生物法测定血药浓度,计算药动学参数,并进行生物等效性评价。结果:受试制剂1、受试制剂2、参比制剂的Cmax分别为(1.06±0.41)、(0.99±0.54)、(1.07±0.53)μg·mL-1,tmax分别为(2.38±0.86)、(1.86±0.85)、(2.52±1.40)h,AUC0～144分别为(11.00±6.15)、(10.65±5.17)、(10.49±5.17)μg·h·mL-1,AUC0～∞分别为(12.48±7.27)、(11.65±5.64)、(11.57±5.87)μg·h·mL-1;阿奇霉素胶囊受试制剂1、2的相对生物利用度分别为(102.73±15.63)%、(103.17±13.64)%。结论:2种规格的阿奇霉素胶囊与参比胶囊均具有生物等效性。更多还原

【Abstract】 OBJECTIVE: To study the bioequivalence of azihromycin capsules in healthy volunteers. METHODS: 21 healthy volunteers designed by latin square were divided into group A, B and C. The three groups were given single dose of azihromycin capsules 1(0.25 g in every capsule), azihromycin capsules 2(0.125 g in every capsule) and reference preparation(0.25 g in every capsule). The plasma concentrations of azihromycin were determined by microbiological assay and pharmacokinetic parameters were calculated and the bioequivalence was evaluated. RESULTS: Main pharmacokinetic parameters of three kinds of preparations were as follows:Cmax(1.06±0.41)μg·mL-1,(0.99±0.54) μg·mL-1 and (1.07±0.53) μg·mL-1; tmax(2.38±0.86)h, (1.86±0.85)h and (2.52±1.40)h; AUC0～144(11.00±6.15)μg·h·mL-1,(10.65±5.17) μg·h·mL-1 and (10.49±5.17)μg·h·mL-1;AUC0～∞(12.48±7.27)μg·h·mL-1,(11.65±5.64)μg·h·mL-1 and (11.57±5.87)μg·h·mL-1. The relative bioavailabitity of azihromycin capsules 1 and azihromycin capsules 2 were (102.73±15.63)% and (103.17±13.64)%. CONCLUSION: The results suggest that two specifications of azihromycin capsules are bioequivalent to reference preparation.更多还原