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中国临床药理学与治疗学 ›› 2003, Vol. 8 ›› Issue (1): 35-38.

• 研究原著 • 上一篇    下一篇

反相高效液相色谱法测定兰索拉唑及其代谢产物5' -羟基兰索拉唑和兰索拉唑砜的血药浓度

付良青, 黄丰1, 吴德政, 郭军华   

  1. 军事医学科学院附属医院临床药理室, 北京 100850; 1暨南大学药学院, 广州 510632
  • 收稿日期:2002-07-15 接受日期:2002-08-15 出版日期:2003-02-26 发布日期:2020-11-25
  • 通讯作者: FU Liang-Qing, female, Ph.D, engaged in clinical pharmacology.Tel:010-66874965 Fax:010-66931772 Email:fuliangqing@yahoo.com
  • 作者简介:WU De-Zheng, male, professor, engaged in clinical pharmacology and molecular biology of tumor.

Determination of lansoprazole and its metabolites 5' -hydroxy lansoprazole and lansoprazole sulphone in human plasma by reversed-phase HPLC

FU Liang-Qing, HUANG Feng1, WU De-Zheng, GUO Jun-Hua   

  1. Department of Clinical Pharmacology, Affiliated Hospital, Academy of Military Medical Science, Beijing 100039; 1College of Pharmacy, Jinan University, Guangzhou 510632
  • Received:2002-07-15 Accepted:2002-08-15 Online:2003-02-26 Published:2020-11-25

摘要: 目的: 建立测定兰索拉唑及其代谢产物5' -羟基兰索拉唑和兰索拉唑砜的血药浓度的方法, 用于测定其血药浓度并进行临床药代动力学研究。方法: 采用高效液相-二极管阵列色谱法测定兰索拉唑及其代谢产物5' -羟基兰索拉唑和兰索拉唑砜的血药浓度。结果: 兰索拉唑的校正标准曲线为Y=0.01358 +0.001227X (r=0.9994), 其25, 200, 2000μg·L-1 三浓度的血样回收率分别为87.99 %,94.38 %, 77.21 %;精密度分别7.79 %, 1.21 %,5.49 %;5' -羟基兰索拉唑的校正标准曲线分别为Y=0.002536 +0.0009126X (r=0.9990), 其20, 100,500 μg·L-1 三浓度的血样回收率分别为85.85 %,87.64 %, 107.70 %;精密度分别为10.73 %, 6.98 %,5.62 %;兰索拉唑砜的校正标准曲线分别为Y=0.01486 +0.001462X (r=0.9995), 其20, 100, 1000μg·L-1 三浓度的血样回收率分别为79.84 %,85.18 %, 100.68 %;精密度分别为9.22 %, 2.36 %,4.81 %。志愿受试者禁食口服30 mg 兰索拉唑胶囊后, 兰索拉唑及其代谢产物5' -羟基兰索拉唑和兰索拉唑砜的Cmax 分别为113.21, 1561.54, 131.14 μg ·L-1结论: 此方法可满足测定要求, 可用于兰索拉唑的药代动力学研究。

关键词: 药理学, 兰索拉唑, 血药浓度, 高效液相色谱

Abstract: AIM: To set up a method to determine the blood concentration of lansoprazole and its metabolites 5' -lansoprazole and lansoprazole sulphone.METHODS: The blood concentration of lansoprazole was determined by HPLC.RESULTS: Calibrated standard curve of lansoprazole in blood was Y=0.0136 +0.0012 X (r= 0.9994);the recoveries at three concentrations of 25, 200, and 2000 μg ·L -1 were 87.99 %, 94.38 %, and 77.21 %, respectively; and the RSD values were 7.79 %, 1.21 %, and 5.49 %, respectively.Calibrated standard curve of its metabolite 5' -OH lansoprazole in plasma was Y=0.0025 +0.000926 X (r=0.9990). The recoveries at three concentrations (20, 100, and 500 μg·L -1)were 85.85 %, 87.64 %, and 107.70 %, respectively;and the RSD values were 10.73 %, 6.98 %, and 5.62 %, respectively.Calibrated standard curve of another metabolite lansoprazole sulphone in plasma was Y=0.01486 +0.001462X (r=0.9995), the recoveries at three concentrations (20, 100, and 1000 μg ·L -1) were 79.84 %, 85.18 %, and 100.68 %;respectively; and the RSD values were 9.22 %, 2.36 %, and 4.81 %, respectively.After 30 mg of lansoprazole was administered by a volunteer po, the values of Cmax of 5' - OH lansoprazole, lansoprazole, and lansoprazole sulphone were 113.21, 1561.54, and 131.14 mg·L -1, respectively.CONCLUSION: The method is accurate for determining the blood concentration of lansoprazole and its metabolites 5' -lansoprazole and lansoprazole sulphone.

Key words: pharmacology, lansoprazole, plasma concentration, HPLC

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