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为评估头孢克洛在人体内的血药浓度及其生物利用度,建立了一种简便的反相高效液相色谱方法,以代替复杂的工作量较大的生物效价方法;10名健康志愿受试者分别交叉口服了头孢克洛胶囊剂(Keflor)、市售希刻劳胶囊剂(对照品),在一定的时间点抽取静脉血,测定生物利用度.结果表明:建立的高效液相色谱法平均回收率为98.0%,日内差,日间差为0.10~4.0%;测试品(Keflor)的主要药物动力学参数分别为:Tmax=0.55h,Cmax=5061μg.ml-1,AUC0-∞=11.13μg.h.ml-1,t1/2=0.90h;与对照品相比,Keflor的相对生物利用度为105.29%,经双单侧t检验分析,二者无统计意义差异.
In order to evaluate the plasma concentration of cefaclor in human and its bioavailability, a simple RP-HPLC method was developed to replace the complex and expensive bioequivalence method. Ten healthy volunteers Subjects crossed over with oral administration of cefaclor capsule (Keflor) and commercially available Xi Kerao capsule (control), and venous blood was drawn at a certain time point to determine bioavailability.The results showed that the established high performance liquid phase The average recovery of the chromatographic method was 98.0%, the intraday difference and the daytime difference were 0.10 ~ 4.0%. The main pharmacokinetic parameters of the test product (Keflor) were Tmax = 0.55h, Cmax = 5061μg.ml-1, AUC0- ∞ = 11.13μg.h.ml-1, t1 / 2 = 0.90h; Compared with the reference substance, the relative bioavailability of Keflor was 105.29%. There was no significant difference between the two groups .