烟酸缓释片在人体内的药物动力学及相对生物利用度  

Pharmacokinetics and relative bioavailability of niacin sustained-release tablet in Chinese healthy volunteers

作　　者：赵语[1] 陈钧[2] 蒋学华[2] 

机构地区：[1]重庆医科大学附属第一医院药剂科,重庆400016 [2]四川大学药学院临床药学教研室,成都610041

出　　处：《现代医药卫生》2004年第14期1337-1338,共2页Journal of Modern Medicine & Health

摘　　要：目的 :研究烟酸缓释片在正常人体内的药物动力学和相对生物利用度。方法 :采用随机交叉自身对照试验设计 ,对18名志愿受试者多剂量分别给予国产和进口烟酸缓释片 ,用反相高效液相色谱法测定烟酸的血药浓度变化情况 ,以3P97药动学程序进行数据处理。结果 :两种制剂的药动学参数AUC0→∞ 、AUC0→τ、Tmax 和Cmax 经方差分析和生物等效性检验 ,差异无显著性(P>0.05)。国产烟酸缓释片的相对生物利用度为 (101.62±12.91) %。结论 :两种制剂为生物等效制剂。Objective:To study the pharmacokinetics and relative bioavailability of niacin sustained-release tablets.Methods: Multiple doses of two different niacin sustained-release tablets were given orally to 18 healthy volunteers in an open randomized cross(over test, respectively. The concentrations of niacin in plasma were assayed by reversed-phase high performance liquid chromatography. Data were disposed with 3P97 software and computer.Results:The result of statistical analysis showed that there was no significant difference between the two preparations in of the AUC0→∞、AUC0→τ、Tmax and Cmax (P>0.05). The relative bioavailablilty of native niacin sustained-release Tablet was (101.62±12.91)%. Conclusion:The two preparations are bioequivalent.

关 键 词：烟酸缓释片 人体内 药物动力学 生物利用度 

分 类 号：R969.1[医药卫生—药理学]