液质联用测定人血浆中泮托拉唑的浓度

刘朋,黄建权,陈頔*,孙春华

中国药学杂志 ›› 2013, Vol. 48 ›› Issue (8) : 633-635.

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中国药学杂志 ›› 2013, Vol. 48 ›› Issue (8) : 633-635. DOI: 10.11669/cpj.2013.08.013
论著

液质联用测定人血浆中泮托拉唑的浓度

  • 刘朋1,黄建权2,陈頔1*,孙春华1
作者信息 +

Determination of Pantoprazole in Human Plasma by LC-MS/MS

  • LIU Peng1,HUANG Jian-quan2, CHEN Di1*, SUN Chun-hua1
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摘要

目的 测定人血浆中泮托拉唑的浓度,并评价国产和进口泮托拉唑钠肠溶片的生物等效性。方法 采用LC-MS/MS测定人血浆中泮托拉唑的浓度,以DAS2.0计算药动学参数考察其生物等效性。结果 受试制剂和参比制剂的泮托拉唑t1/2分别为(1.96±0.66)和(1.98±0.59)h,tmax分别为(3.17±0.84)和(3.09±0.81)h,ρmax分别为(3.53±0.78)和(3.41±0.79)μg·mL-1,AUC0-∞分别为(10.12±4.09)和(10.86±3.99)μg·h·mL-1。生物利用度为(97.9±22.3)%。结论 该方法重复性好,灵敏度高,泮托拉唑钠肠溶片受试制剂和参比制剂具有生物等效性。

Abstract

OBJECTIVE To determine the concentration of pantoprazole in human plasma and evaluate the bioequivalence of two kinds of pantoprazole sodium enteric-coated tablets. METHODS The concentration of pantoprazole in human plasma was determined by LC-MS/MS, and the pharmacokinetic parameters for evaluation of bioequivalence were calculated with DAS2.0. RESULTS The main pharmacokinetic parameters of test and reference formulation were as followst1/2 (1.96±0.66) and (1.98±0.59) h, (3.17±0.84) and (3.09±0.81) h, ρmax (3.53±0.78) and (3.41±0.79) μg·mL-1, AUC0-∞ (10.12±4.09) and (10.86±3.99) μg·h·mL-1. The relative bioavailability was (97.9±22.3)%. CONCLUSION The method is repeatable and sensitive. The test and reference formulation are bioequivalent.

关键词

高效液相质谱联用 / 泮托拉唑 / 生物等效性

Key words

LC-MS/MS / pantoprazole / bioequivalence

引用本文

导出引用
刘朋,黄建权,陈頔*,孙春华. 液质联用测定人血浆中泮托拉唑的浓度[J]. 中国药学杂志, 2013, 48(8): 633-635 https://doi.org/10.11669/cpj.2013.08.013
LIU Peng,HUANG Jian-quan, CHEN Di*, SUN Chun-hua. Determination of Pantoprazole in Human Plasma by LC-MS/MS[J]. Chinese Pharmaceutical Journal, 2013, 48(8): 633-635 https://doi.org/10.11669/cpj.2013.08.013
中图分类号: R969.11   

参考文献

PERES O, OLIVEIRA C H, BARRIENTOS-ASTIGARRAGA R E, et al. Determination of pantoprazole in human plasma by LC-MS-MS using lansoprazole as internal standard . Arzneimittelforschung, 2004, 54(6):314-319.
FILIPE A, ALMEIDA S, FRANCO SPNOLA A C, et al. Bioequivalence study of two entericcoated formulations of pantoprazole in healthy volunteers under fed . Arzneimittelforschung, 2008, 58(9):451-456.
YUN L, DING M J, MA J, et al. Quantification of pantoprazole in human plasma using LC-MS/MS for pharmacokinetics and bioequivalence study . Eur J Drug Metab Pharmacokinet, 2011, 35(3-4):147-155.
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