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