| 复方氯唑沙宗片人体生物等效性研究 |
| |
| 引用本文： | 董静,王永庆,孟玲,张静,王源园,刘云.复方氯唑沙宗片人体生物等效性研究[J].中国新药杂志,2008,17(23):2063-2066. |
| |
| 作者姓名： | 董静 王永庆 孟玲 张静 王源园 刘云 |
| |
| 作者单位： | 1. 南京大学医学院附属口腔医院,南京,210029
2. 南京医科大学第一附属医院,南京,210029 |
| |
| 摘 要： | 目的:研究2种复方氯唑沙宗片在健康志愿者体内的生物等效性.方法:20例男性健康志愿者随机交叉口服2种制剂(氯唑沙宗500 mg,对乙酰氨基酚600 mg),剂间间隔为1周.以非那西丁为内标,用高效液相色谱法同时测定氯唑沙宗和对乙酰氨基酚的血药浓度.结果:健康志愿者口服复方氯唑沙宗片后对乙酰氨基酚Cmax分别为(14.65±4.10)和(16.95±5.14)μg·mL-1;Tmax,分别为(0.8±0.3)和(0.7±0.3)h;AUC0-12分别为(47.63±13.21)和(48.89±14.43)h·μg·mL-1;t1/2分别为(2.90±0.99)和(2.82±0.62)h.氯唑沙宗Cmax分别为(18.07±5.07)和(18.30±3.31)μg·mL-1;Tmax分别为(1.2±0.5)和(1.1±0.4)h;AUC0-8分别为(43.14±7.33)和(43.90±6.39)h·μg·mL-1;t1/2分别为(1.09±0.17)和(1.12±0.25)h.各参数经统计学双单侧t检验,均有显著性差异(P<0.05).对乙酰氨基酚和氯唑沙宗同种成分的相对生物利用度分别为(109.1±30.9)%和(114.0±50.5)%.结论:2种氯唑沙宗片在健康志愿者体内的药动学参数相似,具有生物等效性.
|
| 关 键 词： | 复方氯唑沙宗片 生物等效性 |
Bioequivalence of compound chlorzoxazone tablets in healthy volunteers |
| |
| DONG Jing,WANG Yong-qing,MENG Ling,ZHANG Jing,WANG Yuan-yuan,LIU Yun.Bioequivalence of compound chlorzoxazone tablets in healthy volunteers[J].Chinese Journal of New Drugs,2008,17(23):2063-2066. |
| |
| Authors: | DONG Jing WANG Yong-qing MENG Ling ZHANG Jing WANG Yuan-yuan LIU Yun |
| |
| Institution: | DONG Jing1,WANG Yong-qing2,MENG Ling2,ZHANG Jing2,WANG Yuan-yuan2,LIU Yun2(1 The Affiliated Stomatological Hospital of Medical School,Nanjing University,2 The First Affiliated Hospital,Nanjing Medical University,Nanjing 210029,China) |
| |
| Abstract: | Objective: To investigate the bioequivalence of compound chlorzoxazone tablets in healthy volunteers.Methods: Single oral doses of two compound chlorzoxazone tablets(chlorzoxazone 500mg and acetaminophen 600mg) were given to 20 male volunteers in an open,randomized and cross-over study.The concentrations of chlorzoxazone and acetaminophen were determined by HPLC,and the pharmacokinetic parameters were calculated with DAS 2.0.Results: The pharmacokinetic parameters of acetaminophen for test and reference tab... |
| |
| Keywords: | HPLC |
| 本文献已被 CNKI 万方数据 等数据库收录！ |
|
