复方烟酸缓释片在beagle犬体内药代动力学研究

Study on Pharmacokinetics Compound Niacin Extended-release Tablets in Beagle Dogs

目的研究复方烟酸缓释片在beagle犬体内的缓释成分烟酸的药代动力学和生物等效性。方法根据交叉试验方法给予复方烟酸缓释片和烟酸普通片,采用反相高效液相色谱法测定血液中烟酸的浓度。结果单剂量试验品500mg给药后药时曲线下面积(AUC)为(292.6±35.8)μg·h/mL,峰浓度(Cmax)为(69.2±10.2)μg/mL,达峰时间(Tmax)为(3.3±0.3)h,消除半衰期(t1/2)为(2.1±0.3)h。结论两种制剂的Cmax,Tmax和AUC均有显著性差异(P<0.05),被试制剂相对生物利用度为(99.5±17.0)%。

Objective To study the pharmacokinetics of compound niacin extended-release tablets in beagle dogs and bioequivalence. Methods A single oral dose of 500 mg was given according to a crossover design. The niacin concentrations in plasma were determined by RP -HPLC. Results In the single dose of 500rag experiment tablets the AUG, Cmax Tmax and h/2 of the subject were （292.6 ±35, 8）μg · h/mL, （69.2 ± 10. 2） μg/mL, （3.3 ± 0. 3） h, （2, I ± 0. 3 ） h, Conclusion The two pharmaceutical preparations had marked differences in C max Tmax and AUC （ P 〈0, 05）. The relative bioavailability was （99.5 ± 17.0）%.