咪达唑仑片在中国蒙古族和汉族健康受试者体内的药动学比较  

Comparison of pharmacokinetics of midazolam tablets in Chinese Mongolian and Han healthy volunteers

作　　者：夏东亚[1] 毛桂福[1,2] 郭涛[1] 赵东祥[3] 项勇[3] 

机构地区：[1]中国人民解放军沈阳军区总医院药剂科,辽宁沈阳110016 [2]沈阳药科大学药学院,辽宁沈阳110016 [3]中国人民解放军第313医院赤峰临床部,内蒙古赤峰024006

出　　处：《中国新药与临床杂志》2009年第4期245-248,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金：全军医学科学技术研究"十一五"计划科技攻关课题基金资助项目(06G023)

摘　　要：目的比较咪达唑仑片在中国蒙古族和汉族健康受试者体内的药动学。方法10名蒙古族和10名汉族健康受试者,口服咪达唑仑片15mg,高效液相色谱法测定血浆中咪达唑仑的浓度。用DAS2.0.1程序求算药动学参数。结果咪达唑仑的血药浓度-时间曲线存在双峰现象,蒙古族和汉族受试者的主要药动学参数:tmax分别为(1.0±s0.7)和(1.5±0.7)h;ρmax分别为(74±32)和(103±26)μg·L-1;t1/2分别为(2.2±0.7)和(3.0±0.8)h;AUC0～12分别为(207±138)和(369±103)μg·h·L-1。蒙古族和汉族健康受试者单剂量口服咪达唑仑片后的药动学参数存在较大的个体差异,2组间t1/2的差异有显著意义(P<0.05),结论咪达唑仑片在蒙古族和汉族健康受试者体内的t1/2存在差异,临床应用时应注意个体化给药。AIM To investigate the pharmacokinetics of midazolam tablets in Chinese Mongolian and Han healthy volunteers. METHODS Ten Mongolian and 10 Han healthy volunteers were given a single oral dose of midazolam tablets 15 mg. The plasma concentration of midazolam were determined by HPLC. The pharmacokinetic parameters were calculated with DAS software. RESULTS The main pharmacokinetic parameters of Mongolian and Han healthy volunteers were as follows： tmax （1.0 ± s 0.7）, （1.5 ± 0.7） h; ρmax （74 ± 32）, （103 ± 26） μg·L^-1; t1/2 （2.2 ± 0.7）, （3.0 ± 0.8） h; AUC0-12 （207 ± 138）, （369 ±103） μg·h·L^-1, respectively. There was large interindividual variabilities in the pharmacokinetic parameters after a single dose of midazolam tablet oral administration between the Chinese Mongolian and the Han healthy volunteers, the t1/2 of the two group showed significant difference （P 〈 0.05）. CONCLUSION There is significant difference in the t1/2 between Chinese Mongolian and Han healthy volunteers, individualization of midazolam dosage should be consided before administration.

关 键 词：咪达唑仑 药动学 色谱法 高压液相 种族药理学 蒙古族 汉族 

分 类 号：R961[医药卫生—药理学]