劳拉西泮片人体生物等效性研究  

Bioavailability and pharmacokinetics of lorazepam tablets in healthy volunteers

作　　者：张建国 王本杰[2] 石炳娟 孔祥麟[2] 彭青 郭瑞臣[2] 

机构地区：[1]高密市人民医院临床药学室,山东高密261500 [2]山东大学齐鲁医院临床药理研究所,山东济南250012 [3]潍坊市药品检验所,山东潍坊261000

出　　处：《中国医院药学杂志》2008年第10期814-817,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:进行劳拉西泮片试验与参比制剂单剂口服双交叉试验,研究其生物等效性。方法:健康志愿者20名随机分两组,随机交叉自身对照,高效液相色谱法测定劳拉西泮经时血药浓度,数据经DAS程序处理,得劳拉西泮片药动学参数。结果:劳拉西泮试验制剂和参比制剂主要药动学参数t_(1/2)分别为(19.7±2.0)h和(18.9±1.7)h,t_(max)分别为(2.58±0.18)h和(2.60±0.21)h,C_(max)分别为(24.8±4.0)μg·L^(-1)和(24.6±3.6)μg·L^(-1),AUC_(0-60)分别为(628.2±90.7)μg·L^(-1)·h和(636.2±62.6)μg·L^(-1)·h,AUC_(o-∞)分别为(718.1±84.6)μg·L^(-1)·h和(722.9±57.9)μg·L^(-1)·h。试验制剂劳拉西泮片相对生物利用度F为(98.7±8.8)%。试验与参比制剂AUG_(o-∞)、AUC_(0-60)、t_(max)、t_(1/2)、C_(max)方差分析、双向单侧t检验显示,主要药动学参数周期间、剂型间差异无显著性(P>0.05)。结论:劳拉西泮血药浓度测定方法适用;试验制剂与参比制剂具有生物等效性。OBJECTIVE To study pharmacokinetics and bioequivalence of lorazepam tablets by dual crossing test of test sample and reference sample. METHODS Twenty health volunteers were randomly divided into 2 groups, randomized,self cross over study was used. The plasma lorazepam concentration was determined by HPLC. The data were processed by DAS program to obtaine the pharmacokinetic parameters. RESULTS The main pharmacokinetic parameters： t1/2 of lorazepam tablets were （19. 7 ± 2. 0）h in test group and（ 18. 9 ± 1.7）h in reference group, tmax were （2. 58 ± 0. 18）h and （2. 60 ± 0. 21 ）h, Cmax were（24. 8 ± 4. 0）μg·L^-1 and （24. 6±3. 6）μg·L^-1 ,AUC0-6were （628. 2 ± 90. 7）μg·L^-1·h and （636. 2 ± 62. 6）μg·L^-1 · h, AUC0-∞ were （718. 1 ± 84. 6） μg·L^-1 · h and （722. 9 ± 57. 9） μg·L^-1 · h. h relative bioavailability F of lorazepam tablet test sample was （98. 7 ± 8. 8）%. There was no significant difference in AUC0-∞, AUC0-60, tmax, tl/2, Cmax between the two groups by variance analysis and two-way-one-side test （P〉0. 05）. CONCLUSION The method established is suitable for determining the plasma lorazepare concentration,The two preparations are bioequivalent.

关 键 词：劳拉西泮 生物等效性 药动学 高效液相色谱法 

分 类 号：R969[医药卫生—药理学]