| 小儿布洛芬栓剂生物等效性研究 |
| 投稿时间：2009-03-16 点此下载全文 |
| 引用本文：姜楠,杨永革,许雪廷,赵刚涛,杨凡.小儿布洛芬栓剂生物等效性研究[J].药学实践杂志,2009,27(4):258~260,320 |
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| 中文摘要:目的:建立测定人血浆中布洛芬(ibuprofen)浓度的LC-MS-MS方法,研究布洛芬小儿剂量在健康人体内的药动学行为,评价两种制剂的生物等效性。方法:采用随机双周期两制剂交叉实验设计,用建立的LC-MS-MS方法对20名健康受试者直肠给药50 mg布洛芬栓剂(受试制剂)和50 mg布洛芬栓剂(参比制剂)后12 h内多点抽取静脉血进行血药浓度检测。应用DAS 2.0统计软件计算主要动力学参数,并评价2种制剂的生物等效性。结果:布洛芬的线性范围为0.05～6.4 mg/L,受试制剂与参比制剂中布洛芬的主要药动学参数分别为:t1/2(2.77±0.65)和(3.02±0.99)h,ρmax(2.148±0.643)和(2.013±0.844)mg/L,tmax(3.2±0.7)和(3.1±0.5)h,AUC0-12(11.37±3.56)和(11.30±4.62)mg.h/L。结论:所用测定方法简便、专属性高,统计学分析结果显示,两种制剂具有生物等效性。 |
| 中文关键词:小儿布洛芬 栓剂 液相色谱质谱联用仪 生物等效性 |
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| Bioequivalence of two paediaric ibuprofen suppositories in healthy volunteers |
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| Abstract:Objective:To develop a LC-MS-MS assay for the determination of ibuprofen in human serum and to investigate the pharmacokinetics and bioequivalence of two preparation in Chinese healthy volunteers.Methods: A single per rectum dose of 50 mg ibuprofen test suppositories and reference suppositories was given to 20 healthy male volunteers in a randomized double cross-over design.Ibuprofen concentration were determined by LC-MS-MS assay,and pharmacokinetic parameters were calculated with DAS2.0 practical pharmacokinetics program.Results:The calibration curve was linear over the range of 0.05～6.4 mg/L.The main pharmacokinetic parameters of test suppositories and reference suppositories were as follow: t1/2(2.77±0.65) and(3.02±0.99) h,ρmax(2.148±0.643) and(2.013±0.844) mg/L,tmax(3.2±0.7) and(3.1±0.5) h,AUC0-12(11.37±3.56) and(11.30±4.62)mg·h/L.Conclusion:The method applied was convenient,accurate and specific,and the statistical analysis showed that the test and reference preparation bioequivalent. |
| keywords:pediatric ibuprofen suppository LC-MS-MS bioequivalence |
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