两种盐酸特拉唑嗪片剂人体生物等效性评价  

Studies on the bioequivalence of domestic terazosin tablet in healthy volunteers

作　　者：陈钧[1] 陆伟[1] 高科攀[1] 史振祺[1] 蒋新国[1] 荣征星[2] 陈红专[2] 

机构地区：[1]复旦大学药学院药剂学教研室,上海200032 [2]上海第二医科大学临床药理中心,上海200025

出　　处：《中国药学杂志》2003年第6期446-448,共3页Chinese Pharmaceutical Journal

摘　　要：目的　评价国产和进口盐酸特拉唑嗪片剂在中国人群中的生物等效性。方法　采用高效液相色谱 荧光检测方法测定2 0名健康受试者 po 2mg盐酸特拉唑嗪片后血浆中的盐酸特拉唑嗪浓度。采用 3P97计算药动学参数 ,并评价其生物等效性。结果　国产盐酸特拉唑嗪片剂和进口片剂的tmax分别为 (1 .0 8± 0 .54)和 (1 .1 8± 0 .37)h ,cmax为 (44.44± 1 1 .72 ) μg·L- 1和 (41 .2 8± 9.77) μg·L- 1 ,MRT为 (9.48± 0 .76)和 (9.36± 0 .90 )h ,t1 / 2 为 (1 0 .1 0± 1 .45)和 (9.77± 1 .76)h ,AUC0～ 36h为(372 .82± 97.44)和 (361 .57± 83 .2 1 ) μg·h·L- 1 。国产盐酸特拉唑嗪片剂的相对生物利用度为 (1 0 3± 1 3) %。结论　经统计学分析 。OBJECTIVE: To observe the bioavailability of domestic terazosin tablet and imported tablet. METHODS: A single oral dose of 2 mg domestic or imported terazosin tablet was given to 20 healthy volunteers in a randomized crossover study. Terazosin concentrations in plasma were determined by HPLC method. RESULTS: The main pharmacokinetics of the two products were as follow: t max(1.08 ± 0.54) and (1.18 ± 0.37) h, c max(44.44 ± 11.72) and (41.28 ± 9.77) μg &middot L-1, MRT (9.48 ± 0.76) and (9.36 ± 0.90) h, t 1/2 (10.10 ± 1.45) and (9.77 ± 1.76) h, AUC 0∼36 h (372.82 ± 97.44) and (361.57 ± 83.21) μg &middot h &middot L-1 respectively. The relative bioavailability of domestic to imported tablets was (103 ± 13) %. CONCLUSION: There was no significant difference between the parameters of two products (P > 0.5). The results demonstrated that the two preparations were bioequivalent.

关 键 词：盐酸特拉唑嗪片剂 人体生物等效性 评价 高效液相色谱 

分 类 号：R969[医药卫生—药理学]