中国临床药学杂志

目的 :比较国产和进口哌拉西林钠 /他唑巴坦钠复方制剂 (8∶ 1)在健康志愿者体内的药物动力学。方法 :8例健康志愿者随机分为两组 ,分别交叉 iv gtt两种制剂 ,采用 RP- HPL C法测定哌拉西林、他唑巴坦在体内的血药浓度 ,对两种制剂的药物动力学进行比较。结果 :iv gtt4.5 g后国产制剂的哌拉西林和他唑巴坦的 T1 / 2β分别为 (0 .83± 0 .12 )、(0 .81± 0 .0 5 ) h,AUC分别为 (6 17.72± 94.83)、(70 .78± 2 .88) m g· h/L;进口制剂两组分为 T1 / 2β分别为 (0 .81± 0 .0 9)、(0 .82± 0 .0 5 ) h,AUC分别为 (6 6 3.84± 70 .35 )、(72 .30± 3.72 ) mg· h/L,经双单侧 t检验 ,两种制剂的药物动力学参数无显著性差异。结论 :两种制剂具有生物等效性

AIM: To compare the pharmacokinetics of piperacillin sodium/tazobactam between domestic and imported preparations in Chinese healthy volunteers. METHODS: Eight healthy male subjects were divided into 2 groups and administered with single inject dose of 4 5 g of 2 piperacillin/tazobactam preparations respectively. The piperacillin and tazobactam plasma concentrations were determined by reversed phase high performance liquid chromatography method. RESULTS: The pharmacokinetic parameters of piperacillin in 2 formulations were T 1/2β =(0 83±0 12), (0 81±0 05) h; AUC= (617 72±94 83), (663 84±70 35) mg·h/L, respectively. The pharmacokinetic parameters of tazobactam in 2 formulations were T 1/2β =(0 81±0 05), (0 82±0 05) h; AUC =(70 78±2 88), (72 39±3 72) mg·h/L respectively. There were no statistical significant differences of the pharmacokinetic parameters between 2 preparations by double single side test. CONCLUSION: The results demonstrate that the piperacillin/tazobactam of domestic and imported preparations are bioequivalent.