| 头孢丙烯胶囊在健康人体的生物等效性 |
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| 引用本文： | 郭京艳,宋浩静,王本杰,魏春敏,衷桂妍,刘晓燕,郭瑞臣. 头孢丙烯胶囊在健康人体的生物等效性[J]. 中国临床药理学杂志, 2011, 27(9) |
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| 作者姓名： | 郭京艳 宋浩静 王本杰 魏春敏 衷桂妍 刘晓燕 郭瑞臣 |
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| 作者单位： | 1. 山东大学药学院,济南,250012;山东省医学科学院,附属医院,济南,250031
2. 山东大学齐鲁医院,临床药理研究所,济南,250012 |
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| 摘 要： | 目的测定口服头孢丙烯胶囊(第2代头孢类抗生素)人血浆顺式、反式头孢丙烯浓度,评价头孢丙烯试验制剂和参比制剂的生物等效性。方法 20例健康男性志愿者,按体质量配对随机分为2组,空腹口服头孢丙烯试验制剂或参比制剂500 mg,用高效液相色谱法测定顺式、反式头孢丙烯血浆浓度,用DAS2.0程序,计算其主要药代动力学参数,评价2制剂的生物等效性。结果头孢丙烯试验制剂与参比制剂的顺、反式头孢丙烯tmax分别为(1.82±0.52)h和(1.65±0.40)h,(1.75±0.30)h和(1.56±0.40)h;Cmax分别为(7.20±1.24)μg.mL-1和(6.69±1.06)μg.mL-1,(0.74±0.24)μg.mL-1和(0.68±0.17)μg.mL-1;t1/2分别为(1.39±0.38)h和(1.42±0.44)h,(1.12±0.38)h和(1.02±0.25)h;AUC0-12分别为(22.07±4.54)μg.mL-1.h和(20.33±3.04)μg.mL-1.h,(1.84±0.38)μg.mL-1.h和(1.73±0.40)μg.mL-1.h;AUC0-∞分别为(22.19±4.57)...
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| 关 键 词： | 顺、反式头孢丙烯 高效液相色谱法 生物等效性 |
Bioequivalence of cefprozil capsules in Chinese healthy volunteers |
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| GUO Jing-yan,SONG Hao-jing,WANG Ben-jjie,WEI Chun-min,YUAN Gui-yan,LIU Xiao-yan,GUO Rui-chen. Bioequivalence of cefprozil capsules in Chinese healthy volunteers[J]. The Chinese Journal of Clinical Pharmacology, 2011, 27(9) |
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| Authors: | GUO Jing-yan SONG Hao-jing WANG Ben-jjie WEI Chun-min YUAN Gui-yan LIU Xiao-yan GUO Rui-chen |
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| Affiliation: | GUO Jing-yan1,2,SONG Hao-jing3,WANG Ben-jie3,WEI Chun-min3,YUAN Gui-yan3,LIU Xiao-yan3,GUO Rui-chen3 (1.School of Pharmaceutical Science,Shandong University,Jinan 250012,China,2.Affiliated Hospital of Shandong Academy of Medical Sciences,Jinan 250031,3.Institute of Clinical Pharmacology,Qilu Hospital of Shandong University,China) |
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| Abstract: | Objective To determinate the plasma concentrations of cis-or trans-cefprozil and to evaluate the bioequivalence of two domestic cefprozil capsules in Chinese healthy volunteers.Methods Twenty subjects were randomly divided into two groups and the plasma concentrations of cis-and trans-cefprozil were determined by HPLC method after single oral dose of 500 mg cefprozil capsules.The main pharmacokinetic parameters of cis-and trans-cefprozil were calculated and the bioequivalence were evaluated by DAS 2.0.Resul... |
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| Keywords: | cis and trans cefprozil capsule HPLC bioequivalence |
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