克拉维酸/阿莫西林分散片与普通片的人体相对生物利用度研究

目的　利用反相液相色谱法比较克拉维酸 /阿莫西林分散片与克拉维酸 /阿莫西林普通片安奇的人体生物利用度。方法　 18名男性健康志愿受试者采用两周期随机交叉试验 ,分别口服克拉维酸 /阿莫西林分散片与克拉维酸 /阿莫西林普通片安奇 (克拉维酸 12 5mg ,阿莫西林 5 0 0mg)。用HPLC法同时测定血浆中克拉维酸和阿莫西林的浓度 ,计算克拉维酸和阿莫西林的药代动力学参数 ,计算分散片的相对生物利用度。结果　分散片和普通片克拉维酸的Tmax为(0 89± 0 2 5 )h和 (1 0 1± 0 30 )h ;Cmax为 (1 92± 0 6 4 )mg·L-1和 (1 4 9± 0 6 5 )mg·L-1;AUC0→∞ 为 (4 347±1 5 4 2 )mg·h·L-1和 (3 395± 1 4 6 8)mg·h·L-1,相对生物利用度 15 1 0 9%± 86 0 0 %。阿莫西林Tmax 为 (1 15±0 4 1)h和 (1 34± 0 4 0 )h ;Cmax(5 81± 1 4 0 )mg·L-1和(4 6 0± 1 37)mg·L-1;AUC0→∞ 为 (13 4 72± 3 114 )mg·h·L-1和 (11 937± 2 735 )mg·h·L-1,相对生物利用度118 4 1%± 31 5 6 %。两者间除阿莫西林Tmax的差异无统计学意义外 ,克拉维酸 /阿莫西林分散片的克拉维酸Tmax小于克拉维酸 /阿莫西林普通片安奇的克拉维酸Tmax(P <0 0 5 ) ,克拉维酸 /阿莫西林分散片的克拉维酸Cmax、AUC0→∞ 和阿莫西林Cm

Relative bioavailability of clavulanic acid/amoxicillin dispersive tablets in healthy volunteers

AIM To study the relative bioavailability of clavulanic acid/amoxicillin dispersive tablets. METHODS A single oral administration of 125 mg clavulanic acid and 500 mg amoxicillin of dispersive tablet and Anqi tablet to 18 healthy male volunteers in a randomized cross over study. The plasma concentration of clavulanic acid and amoxicillin simultaneous were determined with HPLC. RESULTS The pharmacokinetic parameters of dispersive tablet and Anqi tablet for clavulanic acid were: T max (0 89±0 25) h and (1 01±0 30) h; C max (1 92±0 64) mg·L -1 and (1 49±0 65) mg·L -1 ; AUC 0→∞ (4 347±1 542) mg·h·L -1 and (3 395±1 468) mg·h·L -1 , the pharmacokinetic parameters for amoxycillin were: T max (1 15±0 41) h and (1 34±0 40) h; C max (5 81±1 40) mg·L -1 and (4 60±1 37) mg·L -1 ; AUC 0→∞ (13 472±3 114) mg·h·L -1 and (11 937±2 735) mg·h·L -1 .The clavulanic acid T max of clavulanic acid/amoxicillin dispersive tablet was significantly shorter, clavulanic acid and amoxicillin C max ? AUC 0→∞ of clavulanic acid/amoxicillin dispersive tablet were significantly greater than the control Anqi tablet respectively, while there was no significant difference between amoxicillin T max of two tablets. CONCLUSION The bioavailability of clavulanic acid/amoxicillin dispersive tablet is superior to Anqi tablet.