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目的:在健康志愿者体内研究六味地黄丸对茶碱的药动学的影响。方法:采用随机开放2周期试验设计,8例健康志愿者口服六味地黄丸14d(tid,每次8粒)的前后单剂量服用氨茶碱0.1g,HPLC测定不同时间点茶碱的血浆浓度,计算药动学参数和比较口服六味地黄丸前后主要药动学参数。结果:Cmax为(2089.4±295.2)μg.L-1和(2337.8±267.1)μg.L-1;AUC0-24为(24015.2±4594.6)μg.h.L-1和(22179.8±2364.9)μg.h.L-1;tmax为(1.9±0.7)h和(1.8±1.1)h;t1/2为(7.2±1.1)h和(7.4±1.7)h;CL/F为(3.8±0.7)L.h-1和(4.1±0.5)L.h-1。Cmax、AUC0-∞、t1/2、CL/F差异无显著性(P>0.05)。结论:口服六味地黄丸14d对茶碱代谢无影响。
Objective: To study the effect of Liuweidihuangwan on the pharmacokinetics of theophylline in healthy volunteers. Methods: A randomized open-label two-cycle design was adopted. Eight healthy volunteers were given a single dose of aminophylline 0.1g before and after oral administration of Liuweidihuang Pills for 14 days (tid, 8 capsules each time). Plasma concentrations of theophylline were measured by HPLC at different time points. Pharmacokinetic parameters were calculated and compared before and after oral administration of Liu Wei Di Huang Wan major pharmacokinetic parameters. Results: Cmax was (2089.4 ± 295.2) μg.L-1 and (2337.8 ± 267.1) μg.L-1, AUC0-24 was (24015.2 ± 4594.6) μg.hL-1 and (22179.8 ± 2364.9) μg.hL- 1; tmax was (1.9 ± 0.7) h and (1.8 ± 1.1) h; t 1/2 was (7.2 ± 1.1) h and 4.1 ± 0.5) Lh-1. Cmax, AUC0-∞, t1 / 2, CL / F no significant difference (P> 0.05). Conclusion: Oral Liuwei Di Huang Wan 14d had no effect on the metabolism of theophylline.