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。
The pharmaeokinetics profiles of three oral preparations of benproperine were study after a single oral dosage and multiple oral dosage,and estimate for bioequivalency in human.nethods：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 ±138.53/μg/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±1508.44μLg/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.
出处
《中日友好医院学报》
2006年第3期165-169,共5页
Journal of China-Japan Friendship Hospital
关键词
苯丙哌林
肠溶片
缓释片
双层缓释片
药动学
benproperine
enteric coating tablet
extended tablet
double-dek extended tablet
pharmacokinetics
