阿奇霉素胶囊的人体相对生物利用度研究  

Study on Relative Bioavailability of Azithromycin Capsules in Human Body

作　　者：郑奇[1] 石萍[1] 陈湘潘[1] 

机构地区：[1]重庆市中山医院,重庆400013

出　　处：《中国药业》2007年第12期27-28,共2页China Pharmaceuticals

摘　　要：目的研究国产阿奇霉素胶囊的相对生物利用度。方法采用双周双制剂交叉试验设计,让20名健康男性志愿者随机单剂量口服国产四川维奥阿奇霉素胶囊和四川明欣阿奇霉素胶囊,剂量均为500mg,剂间间隔为2周。用微生物杯碟法测定血清中阿奇霉素浓度,并计算相对生物利用度。结果受试制剂和参比制剂的药代动力学参数无统计学差异,消除半衰期(t1/2β)分别为(53.29±19.33)h和(51.21±17.04)h,峰浓度(Cmax)分别为(0.360±0.118)μg/mL和(0.367±0.132)μg/mL,达峰时间(tmax)分别为(2.30±0.67)h和(2.30±0.86)h,AUC0～T分别为(5.42±1.89)μg·h/mL和(5.84±2.29)μg·h/mL。结论受试制剂阿奇霉素胶囊的相对生物利用度为(92.81±11.79)%,与参比制剂具有生物等效性。Objective To investigate the relative bioavailability of azitromycin capsules made domestically in healthy volunteers. Methods A single oral dose of 500 mg azithromycin capsules as the tested preparation or other in market capsule, as the control preparation were given according to a crossover design. Serum concentrations of azithromycin were measured by bioassay. Results After a single dose, the pharmacokinetic parameters for azithromycin in the tested capsules and the control capsules were as follows： T1/2β was （53.29 ± 19.33）h and （51.21 ± 17.40）h, Cmax was（0.360 ± 0.118）μg/mL and （0.367 ± 0.132）μg/mL, tmax was （2.30 ± 0.67）h and （2.30± 0.86）h, AUC0-τ was（5.42 ± 1.89）μg· h/mL and （5.84 ± 2.29）μg· h/mL, respectively. There was no statistical difference. Conclusion The relative bioavailability of test capsule was（92.81 ± 11.79）%, so it demonstrated that both preparations had bioequivalence.

关 键 词：阿奇霉素 药物动力学 相对生物利用度 微生物测定法 

分 类 号：R969.1[医药卫生—药理学] R978.19[医药卫生—药学]