【摘要】 目的:研究烟酸缓释片的人体药代动力学及相对生物利用度。方法:30名男性健康志愿者采用随机交叉给药方案,单剂量口服1500mg国产烟酸缓释受试片或进口烟酸缓释参比片,反相离子对高效液相色谱法测定血药浓度,计算两者的药代动力学参数及相对生物利用度,并进行生物等效性评价。结果:单次口服1500mg烟酸缓释受试片和参比片的主要药代动力学参数AUC0-10h分别为(11.317±10.058)μg-ml-1·h和(12.030±11.081)μg·ml-1·h,AUC0-∞分别为(11.494±10.052)μg·ml-1·h和(12.334±11.110)μg·ml-1·h,Cmax分别为(6.58±5.28)μg·ml-1和(6.41±5.09)μg·ml-1,tmax分别为(4.90±0.67)h和(4.57±1.06)h,t1/2ke分别为(1.312±0.870)h和(1.467±0.907)h。结论:两种制剂具有生物等效性。更多还原

【Abstract】 Objective: To study the pharmacokinetics and relative bioavailability of nicotinic acid sustained-release tablet in Chinese healthy volunteers. Method: A single oral dose of 1 500 mg nicotinic acid sustained-release tablet of reference or test drugs was given to each volunteer according to an open randomized crossover study. The concentrations in plasma were determined by reverse-pha-seion pair HPLC. Pharmacokinetics and bioeguivalence of the two formulations were also studied. Result: The main pharmacokinetic parameters of nicotinic acid sustained-release tablets were as follows:AUC0-10 were (11.317±10.058)μg·ml-1·h and (12.030±11.081)μg·ml-1·h respectively; AUC0-∞ were (11.494±10.052)μg·ml-1·h and (12.334±11. 110) μg·ml-1·h,Cmax were (6.58±5.28) μg·ml-1 and (6.41±5.09)μg·ml-1 respectively;tmax(4.90±0.67)h and (4.57±1.06) h,t1/2ke were (1.312±0.870)h and (1.467±0.907)h, respectively. Conclusion: The results of statistical analysis showed that two formulations were bioequivalent.更多还原