朱慧婷,徐召飞.临床合用那格列奈对氟伐他汀药代动力学的影响[J].济宁医学院学报,2015,(5):324-326,330 |
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 |
投稿时间:2015-09-08 |
DOI:10.3969/j.issn.1000-9760.2015.05.006 |
中文关键词: 氟伐他汀|那格列奈|药代动力学|相互作用 |
英文关键词: Fluvastatin|Nateglinide|Pharmacokinetic|Interaction |
基金项目:江西省卫生厅科技计划项目(编号:20141144) |
作者 | 单位 | 朱慧婷 | 江西省儿童医院, 江西南昌 330006 | 徐召飞 | 江西省儿童医院, 江西南昌 330006 |
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中文摘要: |
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。 |
英文摘要: |
Objective To observe and explore the pharmacokinetic process of volunteers who were administrated with Fluvastatin Sodium Capsules alone and with the combination of Fluvastatin Sodium Capsules and Nateglinide.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 Sodium Capsules and Nateglinide which included 12 volunteers.The plasma concentration of Fluvastatin was determined by HPLC-MS.The main pharmacokinetic parameters were calculated with DAS2.0 statistics software.Results 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't have any effect on the pharmacokinetic process in human,which indicated that it was pretty safe when these two drugs were administrated together in clinic. |
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