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目的在健康志愿者体内研究多剂量口服六味地黄丸对细胞色素P450(CYP)3A4活性的影响作用。方法采用随机开放两周期试验设计,8例健康志愿者口服六味地黄丸14d(每天3次,每次8粒)的前后单剂量口服咪达唑仑15mg,HPLC测定给药后咪达唑仑10h内的不同时间点的血浆浓度。结果口服六味地黄丸前与口服六味地黄丸14d后的咪达唑仑ρmax,AUC0-10,CL/F和t1/2比值的90%可信区间分别为(44.5,78.5)ng·mL-1,(58.9,85.8)ng.h.mL-1,(116.4,170.7)L.h-1和(88.1,124.9)h,口服六味地黄丸前后咪达唑仑tmax无明显差异。结论口服六味地黄丸14d对肠道CYP3A4有诱导作用。
Objective To investigate the effects of multiple doses of oral Liu Wei Di Huang Wan on the activity of cytochrome P450 (CYP) 3A4 in healthy volunteers. METHODS Randomized open-label two-cycle design was used. Eight healthy volunteers received a single oral dose of midazolam 15 mg (three times per day, 8 capsules per day) for 14 days. Midazolam 10 h after administration was determined by HPLC. Plasma concentrations at different time points within. Results The 90% confidence intervals of the ratios of midazolam ρmax, AUC0-10, CL/F, and t1/2 after oral administration of Liuwei Dihuang Pills and Liuwei Dihuang Pills for 14 days were (44.5, 78.5) ng·mL-1, respectively. (58.9,85.8) ng.h.mL-1,(116.4,170.7)Lh-1 and (88.1,124.9)h. There was no significant difference in the tmax of midazolam before and after oral administration of Liu Wei Di Huang Wan. Conclusion The oral administration of Liu Wei Di Huang Wan 14d has an inducing effect on intestinal CYP3A4.