摘要
目的比较山西津华药业有限公司与青岛国风集团金海制药有限责任公司生产的法莫替丁片的人体相对生物利用度,评价法莫替丁片的人体生物等效性。方法采用随机分组,0.25、0.5、1.0、1.5、2.0、2.5、3.0、4.0、6.0、8.0、12.0 h采血5.0 mL,以RP-HPLC法测定血浆药物浓度。结果受试制剂与参比制剂的血药浓度-时间曲线基本一致,主要药动学参数Cmax分别为(1 764.83±271.26)和(1 731.42±243.30)ng/mL;tmax分别为(2.50±0.00)和(2.50±0.00)h;t1/2分别为(3.15±0.39)和(3.44±0.35)h;AUC0→12分别为(6 686.27±406.65)和(6 737.25±324.19)ng/(h.mL)。AUC0→∞分别为(7 538.99±671.55)和(7 835.74±491.16)ng/(h.mL)。结论血浆药物浓度测定方法灵敏、准确、精密。两种制剂具有生物等效性,受试制剂的相对生物利用度为(96.58±10.39)%。
Objective To compare the bioavailability of famotidine tablets between Shanxi Jinhua Pharmaceutial limited company and Jinhai Pharmaceutial limited-liability company of Qingdao Guofeng conglomerate,and to evalutate the bioequivalence of famotidine tablets in healthy volunteers.Methods A randomized,self-control,crossover design was adopted.18 healthy volunteers were administered 40 mg famotiding,and blood samples were taken at 0,0.25,0.5,1.0,1.5,2.0,2.5,3.0,4.0,6.0,8.0 and 12.0 h.Plasma concentrations of famotiding were determined by RP-HPLC.Results Concentration-time profile of the test tablets was well fitted to that of reference tablets.The main pharmacokinetic parameters of test and reference tablet were as follows：Cmax：（1 764.83±271.26） and（1 731.42±243.30） ng/mL;tmax：（2.50±0.00） and（2.50±0.00） h;t1/2：（3.15±0.39） and（3.44±0.35） h;AUC0→12：（6 686.27±406.65） and（6 737.25±324.19） ng/（h·mL）;AUC0→∞：（7 538.99±671.55） and（7 835.74±491.16） ng/（h·mL）.Conclusion The HPLC method was sensitive,accurate and precise.The results of statistical analysis showed that two formulations were bioequivalent.The relative bioavailability of test tablet is（96.58±10.39）%.
出处
《实用药物与临床》
CAS
2008年第4期253-255,共3页
Practical Pharmacy and Clinical Remedies
