进口与国产比卡鲁胺片在健康人体的生物等效性  

Bioequivalence of domestic and imported bicalutamide tablets in healthy volunteers

作　　者：王天明[1] 马越鸣[1] 严东明[1] 谭波[1] 严惠萍[2] 刘岗[1] 黄维泉[3] 

机构地区：[1]上海中医药大学中药药代动力学实验室,上海201203 [2]上海市曙光医院,上海200021 [3]扬子江药业集团有限公司,江苏泰州225321

出　　处：《中国临床药理学杂志》2007年第5期358-361,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究比卡鲁胺片在(抗雄性激素药)在健康人体内的药代动力学,并比较国产与进口2种制剂的生物等效性。方法44名健康男性志愿者随机平行口服单剂量国产(试验制剂)或进口比卡鲁胺片(参比制剂)50mg后,用高效液相色谱法测定血浆中比卡鲁胺片浓度,用DAS软件计算2者的药代动力学参数及相对生物利用度,并评价2种制剂的生物等效性。结果国产和进口比卡鲁胺片的AUC0-n分别为(94.4±20.6)和(102.3±17.4)μg.h.mL-1;AUC0-∞分别为(102.1±20.8)和(108.7±18.9)μg.h.mL-1,Cmax分别为(538±151)和(619±167)ng·mL-1;tmax分别为(21±12)和(23±12)h,生物利用度F=93.9%。结论国产和进口比卡鲁胺片具有生物等效性。Objective To study the pharmacokinetic characteristics of bicalutamide in healthy volunteers and to compare the bioavailability and bioeqeivalence of domestic tablets with imported tablets. Methods A single oral dose of 50 mg either domestic tablets （test group） or imported tablets （ reference group） was given to 44 healthy volunteers in a randomized parallel design. The concentrations of bicalutamide in plasma were determined by HPLC. Pharmacokinetic parameters were calculated from the plasma concentration - time data with the DAS software and the bioequivalence of the two formulations were evaluated by the analysis of variance and the two one -sided t -test. Results The pharmacokinetic parameters of the test and the reference tablets for bicalutamide were as fol-lows： tmax were （21 ± 12）and（23 ± 12）h,Cmax were （538 ± 151）and （619 ± 167） ng·mL^-1 ,AUC（0-n）were （94.4 ± 20.6） and （102.3 ± 17.4）μg ·h · mL^-1,AUC（0-∞） were（102.1 ± 20.8） and （108.7 ± 18.9） μg ·h · mL^-1, respectively. Relative bioavailability of domestic tablets was 93.9%. Conclusion Two formulations are bioequivalence.

关 键 词：比卡鲁胺片 生物等效性 高效液相色谱 

分 类 号：R969.1[医药卫生—药理学] R977.1[医药卫生—药学]