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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。
Objective: To study the pharmacokinetics and relative bioavailability of nicotinic acid sustained release tablets. Methods: Thirty healthy male volunteers were randomized to receive a crossover regimen. A single oral dose of 1500 mg domestic niacin sustained-release test tablets or imported niacin sustained-release reference tablets was used. The plasma concentration was determined by reversed-phase high performance liquid chromatography The pharmacokinetic parameters and relative bioavailability of the two drugs were calculated and their bioequivalence was evaluated. Results: The main pharmacokinetic parameters AUC0-10h of single oral administration of 1500mg nicotinic acid sustained-release tablets and reference tablets were (11.317 ± 10.058) μg-ml-1 · h and (12.030 ± 11.081) μg · ml -1 · h and AUC0-∞ were (11.494 ± 10.052) μg · ml-1 · h and (12.334 ± 11.110) μg · ml-1 · h, respectively, with Cmax values of (6.58 ± 5.28) μg · ml- (6.41 ± 5.09) μg · ml-1, tmax was (4.90 ± 0.67) h and (4.57 ± 1.06) h respectively, and t1 / 2ke was (1.312 ± 0.870) h and (1.467 ± 0.907) h respectively. Conclusion: Both formulations are bioequivalent.