【摘要】 目的:评价2种罗红霉素胶囊的生物等效性。方法:20名健康受试者单剂量随机交叉口服2种罗红霉素胶囊150 mg,采用HPLC-MS法测定血药浓度。结果:2种罗红霉素制剂的T1／2分别为(13.18±2.01),(13.31±2.45)h,tmax分别为(1.8±1.2),(2.2±1.1)h;cmax分别为(6.14±1.76),(6.47±2.42)nag·L-1,AUC0→72h分别为(71.81±28.40),(73.12±31.77)mg·h·L-1,受试制剂的相对生物利用度为(100.6±11.4)％。结论:2种制剂具有生物等效性。更多还原

【Abstract】 AIM:To estimate the bioequivalence of 2 roxithromycin capsules. METHODS: A randomized crossover design was performed in 20 healthy volunteers. The blood concentrations were determined by HPLC-MS. RESULTS: The main pharmacokinetic parameters were as follows: T1/2 were (13.18±2.01)h and(13.31±2.45)h , tmax were(1.8±1.2)h and(2.2±1.1)h, cmax were (6.14±1.76) mg·L-1 and(6.47±2.42)mg·L, AUC0→72h were (71.81±28.40)mg·h·L-1 and(73.12±31.77)mg·h-L-1, respectively. The relative bioavailability of the tested roxithromycin capsule was (100.6±11.4) % . CONCLUSION: The 2 preparations of roxithromycin are bioequivalent.更多还原