头孢克洛干糖浆人体生物利用度试验

Study on the Bioavailability of Domestic Cefaclor Dried Syrups in Healthy Volunteers

本试验对8名男性健康志愿受试者口服国产头孢克洛干糖浆和市售进口头孢克洛混悬剂的血药浓度和药代动力学参数进行比较。血药浓度用HPLC法检测,用3P87和NDST程序,按非室模型药代动力学分析。结果表明:口服国产的头孢克洛干糖浆和市售进口头孢克洛混悬剂后,其AUC分别为24.37±2.81与25.26±1.87mg/L·h,Tpeak:0.81±0.12与0.81±0.12h,Cmax:13.60±1.22与14.27±0.87mg/L。两制剂的相同参数经统计学处理均无明显差异(P>0.05),结果表明国产头孢克洛干糖浆口服后的药代动力学参数与市售进口混悬剂相仿,其相对生物利用度为96.48％。

Eight healthy male volunteers administed 500mg domestic cefaclor dried syrups and inported cefaclor suspension orally byb a randomized cross over design. The cefaclor in plasma was detected by HPLC. The pharmaco-kinetic parameters were analized by 3987 and NDST programme. The main pharmacokinetic parameters of domes- tic and inported preparations were as following (mean±SD). AUC: 24. 37±2. 18 and 25. 26±1. 87mg/L·h, Tpeak: 0.81±0.12 and 0.81±0.12h, Cmax: 13.60±1. 22 and 14. 27±0. 87 mg/L, respectively. All the parameters were not different with statistic signifcance examined by pair t-test (P>0. 05). The relative bioavail- ability of domestic cefaclor dried syrupus was 96.48% .