临床合用那格列奈对氟伐他汀药代动力学的影响

Study on pharmacokinetic of Fluvastatin and Nateglinide administrated in combination

目的观察和探讨临床单用氟伐他汀钠胶囊及合用那格列奈片时体内的药代动力学特征。方法24名受试者随机分为两组,单用氟伐他汀钠胶囊组12人,合用那格列奈片12人,分别给予氟伐他汀钠胶囊、那格列奈片+氟伐他汀钠胶囊。采用HPLC法测定血药浓度,用DAS2.0药代动力学统计软件计算主要药代动力学参数。结果氟伐他汀钠在单用及合用时主要药代动力学参数Cmax分别为(435.54±142.22)ng·ml-1、482.35±136.18)ng·ml-1,Tmax分别为(1.02±0.25)、(1.10±0.31)h,t1/2β分别为(2.97±0.65)、(3.05±0.88)h,AUC0-t分别为(780.65±198.36)ng·h·ml-1、(854.00±227.45)ng·h·ml-1,组间比较差异无统计学意义(P>0.05)。结论两药合用后不会影响氟伐他汀钠在人体内的药代动力学过程,提示临床联合用药时安全性较高。

Objective To observe and explore the pharmacokinetic process of volunteers who were administra-ted with Fluvastatin Sodium Capsules alone and with the combination of Fluvastatin Sodium Capsules and Nateglin-ide.Methods 24 volunteers were divided into two groups.Fluvastatin Sodium Capsules were administrated to the group which included 12 volunteers.Combination group were administrated with the combination of Fluvastatin So-dium Capsules and Nateglinide which included 12 volunteers.The plasma concentration of Fluvastatin was deter-mined by HPLC-MS.The main pharmacokinetic parameters were calculated with DAS2.0 statistics software.Re-sults There was no significant differences of the main pharmacokinetic parameters of Fluvastatin with Cmax （435.54±142.22,482.35±136.18）ng·ml-1 ,Tmax （1.02±0.25,1.10±0.31）h,t1/2β（2.97 ±0.65,3.05 ±0.88） h,AUC0-t （780.65 ± 198.36,854.00 ± 227.45 ）ng · ml-1 between the single-drug group and the combination group.Conclusion The combination didn＆#39;t have any effect on the pharmacokinetic process in human,which indica-ted that it was pretty safe when these two drugs were administrated together in clinic.