【摘要】 目的:研究苯丙哌林三种口服制剂单次及连续用药的药动学特征,评价制剂的人体生物等效性。方法:健康受试者口服苯丙哌林肠溶衣片、缓释片及双层缓释片,用高效液相色谱法测定血清中苯丙哌林浓度,计算药动学参数。结果:口服苯丙哌林肠溶片、缓释片及双层缓释片的人体药动学参数分别为:Cmax522.85±171.18、135.19±48.85和334.61±138.53μg/L,Tmax1.56±0.59、3.33±2.11和1.86±0.64h,Ka4.91±11.34、2.73±4.60和8.98±10.80h,T1/24.76±1.93、20.10±7.91和10.11±4.68h,AUC0-t3555.96±1281.73、2505.85±858.37和3915.05±1508.44μg/L·h。连续服药7d,药物无蓄积,三制剂生物利用程度等效,剂型特征明显。结论:研究结果对临床治疗有指导意义。更多还原

【Abstract】 Objective:The pharmacokinetics profiles of three oral preparations of benproperine were study after a single oral dosage and multiple oral dosage,and estimate for bioequivalency in human.Methods:Benproperine enteric coating tablet,extended tablet,double-dek extended tablet were taken peroral,respectively.Concentration of benproperine in human serum was detecting by HPLC. Pharmacokinetics parameters were calculated.Results:The human pharmacokinetics parameter of benproperine enteric coating tablet,extended tablet and double-dek extended tablet were:Cmax 522.85±171.18?135.19±48.85 and 334.61±138.53μg/L,respectively.Tmax 1.56±0.59?3.33±2.11 and 1.86±0.64h,respectively.Ka 4.91±11.34?2.73±4.60 and 8.98±10.80h.T1/2 4.76±1.93?20.10±7.91 and 10.11±4.68h,AUC0-t 3555.96±1281.73?2505.85±858.37 and 3915.05±1508.44μg/L·h.Administration was continuing for 7 days there was no benproperine accumulation in body.Thrce type preparations were bioequivalency and showed marked dosage character.Conclusion:The study is fitted to direct theclinical medication.更多还原