摘要
目的 考察注射用阿莫西林钠舒巴坦钠的人体相对生物利用度及生物等效性。方法选择20名健康男性志愿者,随机交叉肌注单剂量阿莫西林钠舒巴坦钠(试验和参比制剂)1 500 mg后,用HPLC法测定其2种活性成分阿莫西林钠和舒巴坦钠的经时血药浓度,计算其药代动力学参数和相对生物利用度。结果 20名受试者交叉肌注2制剂后的主要药代动力学参数较接近,阿莫西林、舒巴坦的相对生物利用度分别为(104.0±16.2)％,(103.3±23.2)％。主要药代动力学参数的方差分析和双单侧f检验结果表明,试验和参比制剂Auc¨无显著性差异(P>0.05),阿莫西林、舒巴坦的90％的置信区间分别为93.0％～109.8％,96.5％～109.6％;2制剂的Cmax之间亦无显著性差异(P>0.05),阿莫西林、舒巴坦的90％置信区间分别为90.8％～112.6％,95.2％～115.1％。结论 注射用阿莫西林钠舒巴坦钠试验与参比制剂具有生物等效性。
Objective To determine the relative bioavailability and bioequivalence of amoxicillin sodium/sulbactam sodium injection formulation in healthy adult male volunteers. Methods In a randomized two-period cross-over study, 20 healthy volunteers were administrated intramuscularly single 1 500mg dose of amoxicillin sodium/sulbactam sodium (test or reference formulation) . The plasma concentrations of amoxicillin and sulbactam were determined separately by a specific high-performance liquid chromatographic (HPLC) method. The pharmacokinetic parameters of the two preparations and the relative bioavailability of amoxicillin sodium and sulbactam sodium injection after intramuscular injection were calculated with statistical analysis. Results Following intramuscular injection of the two preparations, the relative bioavailability (F) of amoxicillin and sulbactam in test were (103.3 ± 23.2)%; (104.0±16.2)%, respectively. There were no significant difference with the pharmacokinetic parameters between test and reference formulation (P>0.05). The 90% confidence interval of AUC0-t were 93.0%~109.8% (amoxicillin),96.5%~109.6% (sulbactam), Cmax were 90.8%~112.6% (amoxicillin), 95.2% ~ 115.1 %(sulbactam). Conclusion The two preparations were bioequivalent.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2004年第3期196-200,共5页
The Chinese Journal of Clinical Pharmacology
