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健康志愿者多剂量服用六味地黄丸对CYP3A4活性的影响
引用本文:裘福荣,赵亚男,孙华,高成璐,马越鸣,蒋健.健康志愿者多剂量服用六味地黄丸对CYP3A4活性的影响[J].中国药学杂志,2010,45(13):983-986.
作者姓名:裘福荣  赵亚男  孙华  高成璐  马越鸣  蒋健
作者单位:1.上海中医药大学附属曙光医院临床药理科, 上海 201203;2.皖南医学院弋矶山医院, 安徽 芜湖241000;3.上海中医药大学药代实验室,上海 201203
摘    要: 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14 d(每天3次,每次8粒)的前后单剂量口服咪达唑仑15 mg, HPLC测定给药后咪达唑仑10 h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14 d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14 d对肠道CYP3A4有诱导作用。

关 键 词:六味地黄丸  咪达唑仑  药物相互作用  细胞色素P450  3A4
收稿时间:2012-01-01;

Effect of Multiple Doses of Liuwei Dihuang Pills on Activity of CYP3A4 in Healthy Volunteers
QIU Fu-rong,ZHAO Ya-nan,SUN Hua,GAO Cheng-lu,MA Yue-ming,JIANG Jian.Effect of Multiple Doses of Liuwei Dihuang Pills on Activity of CYP3A4 in Healthy Volunteers[J].Chinese Pharmaceutical Journal,2010,45(13):983-986.
Authors:QIU Fu-rong  ZHAO Ya-nan  SUN Hua  GAO Cheng-lu  MA Yue-ming  JIANG Jian
Institution:1.Department of Clinical Pharmacology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201203,China; 2.Yijishan Hospital, Wannan Medical College, Wuhu 241000, China; 3.Lab of Pharmacokinetics, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
Abstract:OBJECTIVE To examine the potential effect of Liuwei Dihuang pills on the CYP3A4 activity. METHODS In a sequential study with two phases, 8 volunteers were given 15 mg midazolam on day 1 and day 15. From day 2 to day 15,volunteers received Liuwei Dihuang pills three times daily, eight pills each time for 14 d. On day 15, they received Liuwei Dihuang pills with 15 mg midazolam. The plasma concentrations of midazolam were measured on days 1 and 15 for 10 h. RESULTS The 90% confidence interval of ρmax, AUC0-10, CL/F and t1/2 of midazolam with 14 d Liuwei Dihuang pills vs.without comedication were (44.5, 78.5) ng·mL-1, (58.9, 85.8) ng·h·mL-1, (116.4, 170.7) L·h-1 and (88.1,124.9) h, respectively. The time to peak plasma midazolam concentration was unchanged by Liuwei Dihuang pills (P>0.05). CONCLUSION Liuwei Dihuang pills could decrease absorption of midazolam by inducing CYP3A4 in gut.
Keywords:Liuwei Dihuang pills  midazolam  drug interaction  CYP3A4
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