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液质联用测定人血浆中泮托拉唑的浓度
引用本文: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.
作者姓名:刘朋  黄建权  陈頔  孙春华
作者单位:1.卫生部北京医院药学部, 北京 100730; 2. 航天中心医院药剂科, 北京 100049)
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。

关 键 词:高效液相质谱联用  泮托拉唑  生物等效性
收稿时间:2012-04-02;

Determination of Pantoprazole in Human Plasma by LC-MS/MS
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.
Authors:LIU Peng  HUANG Jian-quan  CHEN Di  SUN Chun-hua
Institution:1.Department of Pharmacy, Beijing Hospital, the Ministry of Health, Beijing 100730, China; 2.Department of Pharmacy, Aerospace Central Hospital, Beijing 100049, China
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.
Keywords:LC-MS/MS  pantoprazole  bioequivalence
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