国产托瑞米芬片剂人体药代动力学及生物等效性评价  

Studies on the pharmacokinetics and bioequivalence of domestic toremifene tablet in healthy volunteers

作　　者：傅军 李新华[2] 徐文炜 陈晓媛 

机构地区：[1]临床药理研究所 [2]卫生科江西医学院,江西南昌330006

出　　处：《中国临床药理学杂志》2003年第5期356-358,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 评价国产和进口托瑞米芬片剂在人体生物等效性。方法 用高效液相色谱法测定20名健康受试者po 20 mg托瑞米芬后血浆中托瑞米芬的浓度。结果 国产托瑞米芬片剂和进口片剂的t_(max)分别为3.15±0.37和3.00±0.65 h,C_(max)分别为1.73±0.32和1.74±0.25 mg·L^(-1),AUC_(0-504)分别为114.41±20.04和112.73±19.92mg·h·L^(-1),t_(1/2)分别为114.12±9.16和114.32±7.38 h,国产托瑞米芬片剂相对生物利用度为(102.4±14.0)％。结论 经统计学分析,国产托瑞米芬片剂和进口片剂具有生物等效性。Objective To observe the bioavailability of domestic toremifene tablet and imported tablet. Methods A single oral dose of 120mg domestic or imported toremifene tablet was given to 20 healthy volunteers in a randomized cross-over study toremifene concentrations in plasma were determined by HPLC methods. Results The main pharmacokinetics of the two products were as follow: t_(max) were 3.15± 0.37 and 3.00± 0.65 h, C_(max) were1.73± 0.32 and 1.74 ± 0.25 mg·L_(-1) , AUC_(0-504) 114.41±20.04 and 112.73± 19.92 mg·h·L^(-1), t_(1/2) 114.12±9.16 and 114.32±7.38 h, respectively. The relative bioavailability of domestic to imported tablets was (102.4±14.0)%. Conclusion There were no significant difference between the two parameters (P>0.05). The results demonstrated that the two preparations were bioequivalent

关 键 词：托瑞米芬片剂 人体 药代动力学 生物等效性 

分 类 号：R969.1[医药卫生—药理学]