文章摘要
吴伟,鲍实,朱亚丽,等.高效液相色谱法测定比格犬血浆中伏立康唑及其药物动力学研究[J].安徽医药,2017,21(9):1598-1600.
高效液相色谱法测定比格犬血浆中伏立康唑及其药物动力学研究
Determination of voriconazole in beagle dog′s plasma by HPLC and its application in the pharmacokinetic study
投稿时间:2017-01-10  
DOI:
中文关键词: 伏立康唑  Beagle犬  药动学  高效液相色谱法
英文关键词: 
基金项目:
作者单位
吴伟 江苏联合职业技术学院南通卫生分院药学系,江苏 南通 226000 
鲍实 湖北省食品药品监督检验研究院药品检验所,湖北 武汉 430000 
朱亚丽 江苏联合职业技术学院南通卫生分院药学系,江苏 南通 226000 
顾健 江苏联合职业技术学院南通卫生分院药学系,江苏 南通 226000 
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中文摘要:
      建立高效液相色谱法(HPLC)测定Beagle犬血浆中伏立康唑(咪唑类抗真菌药)的方法,并比较伏立康唑冻干粉针(参比制剂)和伏立康唑亚微乳(受试制剂)的药动学特点。方法 采用Diamonsil C18柱(250 mm×4.6 mm,5 ),流动相为乙腈-水-乙酸 (55∶45∶0.25,v/v/v),流速为1.0 mL·min-1,外标法测定。结果 在选定的HPLC条件下伏立康唑与血浆杂质分离良好,伏立康唑的线性范围为0.2~50.0 mg·L-1,定量下限为0.2 mg·L-1。提取回收率为97.37%~110.00%,日内和日间RSD均小于10%,Beagle犬静脉滴注伏立康唑亚微乳及冻干粉针后的平均血药浓度-时间曲线符合二室模型,主要药动学参数:t1/2分别为(6.88±1.16) h和(6.82±1.73) h,Ke分别为(0.107±0.025) h-1和(0.109±0.031) h-1,AUC(0~∞)为(136±47.5) mg·h-1·L-1和(179±48.3) mg·h-1·L-1,MRT0~∞为(9.51±1.83) h和(9.35±2.75) h,消除率为(1.01±0.45) mL·min-1·kg-1和(0.68±0.21) mL·min-1·kg-1。结论 该方法灵敏度高,无杂质干扰,结果准确。两种制剂具有类似的药动学行为,可为伏立康唑亚微乳临床研究提供科学依据。
英文摘要:
      Objective To establish an HPLC method for the determination of voriconazole in beagle dog′s plasma and to study its pharmacokinetics.Methods HPLC method was conducted using a Diamonsil C18 column.The mobile phase consisted of acetonitrile-water-acetic acid(55∶45∶0.25,v/v/v).The flow rate was 1.0 mL·min-1.Results The linear calibration curve was obtained in the concentration range of 0.2-50.0 mg·L-1.The lower limit of quantification was 0.2 mg·L-1 and the extraction recovery was 97.37%-110.00%.Intra-day and inter-day precisions were both less than 10%.The pharmacokinetic process fitted to the two compartment open models after intravenous drip of voriconazole submicro-emulsion freeze-dried preparation and voriconazole freeze-dried injection.The main pharmacokinetic parameters of voriconazole were reported as follows:t1/2(6.88±1.16) h and(6.82±1.73) h;Ke(0.107±0.025) h-1 and(0.109±0.031) h-1;AUC(0-∞)(136±47.5) mg·h-1·L-1 and(179±48.3)mg·h-1·L-1; MRT0-∞(9.51±1.83) h and(9.35±2.75) h,Clearace late(1.01±0.45) mL·min-1·kg-1 and(0.68±0.21) mL·min-1·kg-1。 Conclusions The HPLC method established in this study was proved to be sensitive,pure,and accurate for pharmacokinetic study of voriconazole in dogs.
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