CAJ | 학술논문

研究了20名健康志愿者单剂量口服两种阿奇霉素片后的血药浓度经时过程，以及两者的生物等效性评价。以微生物法测定血清中阿奇霉素的浓度，供试制剂的Cmax为580.75±156.62 μg/L，Tmax为1.60±0.68 h，t1/2为36.60±3.74 h，MRT为40.30±5.43 h，AUC0-144为4491.03±979.05 μg*h*L-1。与参比制剂Tmax(2.45±0.69 h)比较，除供试剂(Tmax1.60±0.68 h)达峰时间明显提前，其他药物动力学参数经方差分析均无显著差异(P>0.05)，供试制剂的相对生物利用度为97.14±11.28%。经双单侧t检验，两种片剂在吸收程度上生物等效。
연구료20명건강지원자단제량구복량충아기매소편후적혈약농도경시과정，이급량자적생물등효성평개。이미생물법측정혈청중아기매소적농도，공시제제적Cmax위580.75±156.62 μg/L，Tmax위1.60±0.68 h，t1/2위36.60±3.74 h，MRT위40.30±5.43 h，AUC0-144위4491.03±979.05 μg*h*L-1。여삼비제제Tmax(2.45±0.69 h)비교，제공시제(Tmax1.60±0.68 h)체봉시간명현제전，기타약물동역학삼수경방차분석균무현저차이(P>0.05)，공시제제적상대생물이용도위97.14±11.28%。경쌍단측t검험，량충편제재흡수정도상생물등효。
The concentration-time process of azithromycin tablets in 20 healthy volunteers was observed.The plasma concentrations of azithromycin were determined by microbiological method.The pharmacokinetic parameters for the single oral dose of tested tablets were Cmax 580.75±156.62 μg/L,Tmax 1.60±0.68 h，t1/2 36.60±3.74 h，MRT 40.30±5.43 h and AUC0→144 4491.03±979.05 μg*h*L-1.The main pharmacokinetic parameters were not significantly different between the tested and reference tablets,except Tmax (2.45±0.69 h for the latter).The relative bioavalability of tested tablets was 97.14±11.28%.