论文部分内容阅读
目的 :考察 2种格列吡嗪片剂在正常人体的药物动力学 ,评价其生物等效性。方法 :8名健康受试者随机自身交叉口服格列吡嗪片A(爱宝 )和格列吡嗪片B(金晓 )各 10mg ,用反相HPLC内标法测定经时血药浓度。结果 :HPLC测定的线性范围2 0～ 10 0 0 μg·L- 1(r =0 .9995) ;回收率 99.70 %～10 6 .34% ;天内精密度为 3.0 9%～ 6 .83% ;天间精密度为 2 .2 2 %～ 4 .13%。格列吡嗪片A和片B的Cmax为 (555± 173) μg·L- 1和 (552± 86 ) μg·L- 1;Tmax为 (1.1± 0 .2 )h和 (1.6± 0 .3)h ;T12 为 (4 .6±1.2 )h和 (4 .2± 0 .6 )h ;AUC0 -T为 (2 876± 4 6 8) μg·L- 1·h- 1和 (310 4± 582 ) μg·L- 1·h- 1。方差分析示T12 ,AUC0 -T和Cmax差异无显著意义 (P >0 .0 5) ,片A的Tmax显著小于片B(P <0 .0 1)。结论 :2种格列吡嗪片具有生物等效性。
Objective: To investigate the pharmacokinetics of two glipizide tablets in normal human and to evaluate their bioequivalence. Methods: Eight healthy volunteers were randomly assigned to receive 10 mg each of glipizide A and glipizide B (Jin Xiao) at randomized crossover intervals. Results: The linear range of HPLC was 20 ~ 100 μg · L -1 (r = 0.9995). The recoveries ranged from 99.70% to 106.34%. The intra-day precision was 3.09% -6.33% The interplanetary precision is 2 .2 2% ~ 4 .13%. The Cmax of glipizide tablets A and B were (555 ± 173) μg · L -1 and (552 ± 86) μg · L -1, respectively; the Tmax was (1.1 ± 0.2) h and (1.6 ± 0. 3) h; T12 was (4.6 ± 1.2) h and (4.2 ± 0.6) h; AUC0-T was (2876 ± 468) μg · L- 1 · h-1 and 4 ± 582) μg · L-1 · h-1. Analysis of variance showed no significant difference in T12, AUC0-T and Cmax (P> 0.05), and Tmax in Table A was significantly lower than that in Table B (P <0.01). Conclusion: Two kinds of glipizide tablets have bioequivalence.