劳拉西泮片人体生物等效性研究  

Studies on the bioequivalence of lorazepam tablet in healthy volunteers

作　　者：卢晓阳[1] 申屠建中[1] 黄明珠[1] 陈志根[1] 史美甫[1] 罗金文[2] 

机构地区：[1]浙江大学医学院附属第一医院临床药理研究室,浙江杭州310003 [2]浙江省药品检验所,浙江杭州310016

出　　处：《中国药学杂志》2005年第8期612-614,共3页Chinese Pharmaceutical Journal

摘　　要：目的评价国产劳拉西泮片与已上市的进口劳拉西泮片的人体生物等效性方法20名男性健康志愿者随机交叉口服劳拉西泮受试制剂和参比制剂2 mg,采用液相色谱-质谱法测定血清药物浓度。结果劳拉西泮参比制剂及受试制剂的tmax分别为(2.925±1.017)和(2.825±0.832)h,cmax分别为(19.642±4.988)和(20.185±4.560)ng·mL-1,AUC0-60分别为(357.62±70.95)和(370.21±88.29)ng·h·mL-1,t1/2(ke)分别为(14.268±2.790)和(14.378±3.697)h,国产劳拉西泮片相对生物利用度为(103.33±12.32)%OBJECTIVE: To evaluate the bioequivalence of domestic lorazepam tablet and imported lorazepam tablet in healthy volunteers. METHODS: A single oral 2 mg test or reference preparations of lorazepam was given to 20 healthy volunteers in a randomized crossover study. The serum concentrations of lorazepam were determined by HPLC-MS assay. RESULTS: The main pharmacokinetic parameters of the two products were as follow: tmax(2.925 ± 1.017) and (2.825 ± 0.832) h; Cmax (19.642 ± 4.988) and (20.185 ± 4.560) ng&middotmL-1; AUC0-60 (357.62 ± 70.95) and (370.21 ± 88.29) ng&middoth&middot mL-1; t 1/2(ke) (14.268 ± 2.790) and (14.378 ± 3.697)h, respectively. The relative bioavailability of the test to reference tablet was (103.33 ± 12.32)%. CONCLUSION: The results of variance analysis and two one-side t test showed that the two formulations were bioequivalent.

关 键 词：劳拉西泮 生物等效性 高效液相色谱-质谱 

分 类 号：R969.1[医药卫生—药理学]