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| 洛芬葡锌那敏分散片中布洛芬与复方锌布颗粒中布洛芬在健康人体的生物等效性 | |
| 引用本文： | 李晓,曹琦琛,张锡玮,李晓斌,韩可丽,陈颖萍,王文萍. 洛芬葡锌那敏分散片中布洛芬与复方锌布颗粒中布洛芬在健康人体的生物等效性[J]. 中国临床药理学杂志, 2011, 27(1) |
| 作者姓名： | 李晓 曹琦琛 张锡玮 李晓斌 韩可丽 陈颖萍 王文萍 |
| 作者单位： | 辽宁中医药大学,附属医院国家药物临床试验机构,沈阳,110032 |
| 摘 要： | 目的建立准确、灵敏的液相色谱-质谱联用法(LC-MS/MS),并比较健康受试者单剂量口服洛芬葡锌那敏(非甾体抗炎药)分散片(受试制剂)和复方锌布颗粒(参比制剂)后的生物等效性。方法采用随机开放、双周期自身交叉单剂量给药试验设计(清洗期为2周)。20名志愿受试者分别单次空腹口服等剂量洛芬葡锌那敏分散片(受试制剂)和复方锌布颗粒(参比制剂)(相当于布洛芬300 mg)。以吲达帕胺为内标,用ESI负离子选择性反应监测(SRM)模式测定血浆中布洛芬浓度,计算药代动力学参数及进行临床生物等效性评价。结果洛芬葡锌那敏分散片(受试制剂)中布洛芬的Cm ax为(24.11±12.15)μg.mL-1,tm ax为(2.23±0.84)h,AUC0-t为(70.81±31.02)μg.h.mL-1,AUC0-∞为(72.67±31.11)μg.h.mL-1,t1/2为(1.59±0.32)h。复方锌布颗粒(参比制剂)中布洛芬的Cm ax为(24.94±9.25)μg.mL-1,tm ax为(1.81±0.84)h,AUC0-t为(70.53±27.31)μg.h.mL-1,AUC0-∞为(72.81±27.08)μg.h.mL... |
| 关 键 词： | 布洛芬 药代动力学 液相色谱-质谱联用法 生物等效性 |
Bioequivalence of luofenpuxinnamin dispersible tablets and compound zinc gluconate and ibuprofen granules in healthy volunteers |
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| LI Xiao,CAO Qi-chen,ZHANG Xi-wei,LI Xiao-bin,HAN Ke-li,CHEN Ying-ping,WANG Wen-ping. Bioequivalence of luofenpuxinnamin dispersible tablets and compound zinc gluconate and ibuprofen granules in healthy volunteers[J]. The Chinese Journal of Clinical Pharmacology, 2011, 27(1) | |
| Authors: | LI Xiao CAO Qi-chen ZHANG Xi-wei LI Xiao-bin HAN Ke-li CHEN Ying-ping WANG Wen-ping |
| Affiliation: | LI Xiao,CAO Qi-chen,ZHANG Xi-wei,LI Xiao-bin,HAN Ke-li,CHEN Ying-ping,WANG Wen-ping(The Institute for Drug Clinical Trial of the Hospital Attached to Liaoning College of Traditional Chinese Medicine,Shenyang 110032,China) |
| Abstract: | Objective To establish a liquid chromatography-mass spectrometry(LC-MS/ MS) method for evaluating the bioequivalence of luofenpuxinnamin dispersible tablets(test)and compound zinc gluconate and ibuprofen granules(reference)in healthy volunteers.Methods According to a random opening,two-period crossover design(cleaning phase is two weeks).Twenty healthy volunteers take a single same oral dose of luofenpuxinnamin dispersible tablets(test)and compound zinc gluconate and ibuprofen granules(reference)(equal to 3... |
| Keywords: | ibuprofen pharmacokinetics LC-MS/MS bioequivalence |
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