摘要
目的:研究银杏叶提取物对华法林在人体内药动学和药效学的影响。方法:采用随机、单盲、双周期交叉、安慰荆对照试验设计。12名健康志愿者(男女各半)随机分为2组,连续5周每日分别服用银杏叶片(EGB,每片含总黄酮醇苷9.6mg,萜类内酯2.4 mg)或安慰剂2粒,1日3次;29 d口服单剂量华法林5 mg;第2周期2组交叉服用安慰剂或银杏叶片,其余给药方案不变。按要求收集志愿者血样,分别以半自动血凝仪测定常见凝血指标,以HPLC测定华法林的血药浓度。结果:单独服用银杏叶提取物4周后,华法林凝血酶原时间(PT)和活化部分凝血活酶时间(APTT)无显著变化。华法林药动学参数Cmax,AUC0-144,AUC0-∞,t1/2显著增加(P<0.05);CL(F)显著减小(P<0.05),tmax和Vd(F)没有显著变化。结论:银杏叶提取物可影响华法林的药动学指标,但不影响华法林的药效学;单独服用银杏叶提取物4周对凝血功能无明显影响。
Objective： To study the effects of Ginkgo biloba extract（GBE） on the pharmacokinetics and pharmacodynamics of warfarin and observe the anticoagulant activity of GBE.Method： A randomized,double-blinded,placebo-controlled,two-way cross-over trial was conducted.Twelve healthy volunteers（sex ratio was 1∶1） were randomized into two groups and received GBE（three pill,tid） or placebo（three pill,tid） for 5 weeks respectively.the subjects received a single dose of warfarin（5 mg） on the day 29.Blood samples for pharmacokinetics and pharmacodynamics assessment were collectd.Ressult： Compared with placebo,BE had no significant pharmacodynamics effects on warfarin and had no effects on prothrombin time（PT） and activated partial thromboplastin time（APTT）.GBE extract increased Cmax,AUC0-144 min,AUC0-∞,t1/2,of warfarin singnificantly and decreased CL（F） of warfarin significantly（P0.05）,and there were no singnificant difference of Vd（F）.Conclution： GBE has limited effects on the pharmacokinetics but no effects on the pharmacodynamics of single dose warfain in health subjects.GBE has no effects on clotting process alone.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2011年第16期2290-2293,共4页
China Journal of Chinese Materia Medica
基金
湖南省科技厅基金项目(2008sk3067)
关键词
银杏叶提取物
华法林
药物相互作用
凝血
血药浓度
Ginkgo biloba extract（GBE）
warfarin
anticoagulation
blood drug level
drug interaction
