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目的 比较两种不同工艺生产的阿莫西林·克拉维酸钾片在健康志愿者体内的药代动力学及相对生物等效性 ,确保临床用药质量 .方法 健康志愿受试者 18例 ,男性 ,采用标准二阶段交叉设计自身对照试验法 ,用 RP- HPL C法测定血浆中阿莫西林和克拉维酸的经时浓度 ,以双单侧 t检验统计法比较两种不同工艺生产的阿莫西林·克拉维酸钾片之间的差异 .结果 两种阿莫西林·克拉维酸钾片在健康志愿者体内的药时曲线均符合一级吸收的单室开放模型 ,主要的药代动力学参数阿莫西林 :tmax分别为 (71.7± 9.7)和 (6 9.2±9.1) min,ρmax,AUC( 0～ 3 6 0 min) 分别为 :(8.8± 1.5 )和 (8.0±1.3) mg· L- 1 ;(140 6± 30 8)和 (12 39± 2 5 0 ) (mg· m in- 1 ·L- 1 ) ,Cla:tmax分别为 (6 8.3± 7.7)和 (6 7.5± 7.7) m in,ρmax,AU C( 0～ 3 6 0 min) 分别为 :(6 .2± 0 .8)和 (5 .9± 0 .7) mg· L- 1 ;(10 33± 176 )和 (96 2± 136 ) (mg· min- 1· L- 1 ) ,药动学参数间均无统计学差异 (P>0 .0 5 ) ,相对生物利用度阿莫西林 F为 115 % ;克拉维酸 F为 10 8% .结论 两种阿莫西林·克拉维酸钾片在健康志愿者体内具有相同的生物效应 ,可确保临床用药的安全有效性
Objective To compare the pharmacokinetics and relative bioequivalence of amoxicillin and clavulanate potassium tablets in healthy volunteers to ensure the quality of clinical medication.Methods 18 healthy volunteers, male, The standard two-phase crossover design self-control test method, the plasma concentration of amoxicillin and clavulanic acid by RP-HPL C method for the time concentration, two unilateral t-test statistical method compared two different production of amoxicillin · The difference between potassium clavulanate tablets.Results The two drug formulations of amoxicillin and clavulanate tablets in healthy volunteers were consistent with the one-compartment open model, and the main pharmacokinetic parameters Amoxicillin: tmax was (71.7 ± 9.7) and (6 9.2 ± 9.1) min, respectively, and pmax and AUC (0 ~ 3600 min) were (8.8 ± 1.5) and (8.0 ± 1.3) mg · L- 1, (140 6 ± 30 8) and (12 39 ± 250) mg · m -1 · L -1, respectively, and the values of Cla: tmax were (6 8.3 ± 7.7) and (6 7.5 ± 7.7) m (ρmax, AUc (0 ~ 3600 min) were (6.2 ± 0.8 and 5.9 ± 0.67) mg · L-1; (10 33 ± 176) and 96 2 ± 136) (mg · min -1 · L -1) , Pharmacokinetic parameters were not statistically different (P> 0.05), the relative bioavailability of amoxicillin F was 115%, clavulanic acid F was 108% .Conclusion The two amoxicillin clavulanate Potassium tablets have the same biological effect in healthy volunteers to ensure the safety and efficacy of clinical medication