Message Board

Respected readers, authors and reviewers, you can add comments to this page on any questions about the contribution, review,        editing and publication of this journal. We will give you an answer as soon as possible. Thank you for your support!

Name
E-mail
Phone
Title
Content
Verification Code

JIANG Nan, YANG Yong-ge, XU Xue-ting, ZHAO Gang-tao, YANG Fan. Bioequivalence of two paediaric ibuprofen suppositories in healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2009, 27(4): 258-260,320.
Citation: JIANG Nan, YANG Yong-ge, XU Xue-ting, ZHAO Gang-tao, YANG Fan. Bioequivalence of two paediaric ibuprofen suppositories in healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2009, 27(4): 258-260,320.

Bioequivalence of two paediaric ibuprofen suppositories in healthy volunteers

  • Received Date: 2009-03-16
  • 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.
  • 加载中
通讯作者: 陈斌, bchen63@163.com
  • 1. 

    沈阳化工大学材料科学与工程学院 沈阳 110142

  1. 本站搜索
  2. 百度学术搜索
  3. 万方数据库搜索
  4. CNKI搜索

Article Metrics

Article views(2689) PDF downloads(579) Cited by()

Related
Proportional views

Bioequivalence of two paediaric ibuprofen suppositories in healthy volunteers

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.

JIANG Nan, YANG Yong-ge, XU Xue-ting, ZHAO Gang-tao, YANG Fan. Bioequivalence of two paediaric ibuprofen suppositories in healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2009, 27(4): 258-260,320.
Citation: JIANG Nan, YANG Yong-ge, XU Xue-ting, ZHAO Gang-tao, YANG Fan. Bioequivalence of two paediaric ibuprofen suppositories in healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2009, 27(4): 258-260,320.

Catalog

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return