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1、ChineseJournalofNewDrugs2005,Vol.14No.8中国新药杂志2005年第14卷第8期固相萃取高效液相色谱法测定人血浆中氟康唑浓度及其药动学研究夏春华,章新晶,李艳艳,熊玉卿(江西医学院临床药理研究所,南昌330006)[摘要]目的:建立测定人体血浆中氟康唑浓度的高效液相色谱法,并对供试制剂与参比制剂的生物等效性进行评价。方法:血样处理采用固相萃取方法,萃取小柱用甲醇活化后加入血浆1mL,过柱后用含20%甲醇的水溶液10mL洗涤,再用02mL甲醇洗脱收集,取20L进样。色谱柱为C18柱(150mm46mm,5m),流动
2、相为001-1-1molL磷酸二氢钾(用磷酸调pH值为50)乙腈(7525);流速为10mLmin,检测波长为267nm。人体药动学试验采用双周期交叉设计方案,将18例志愿受试者随机分为2组,分别口服氟康唑供试胶囊和参比胶囊150mg。-1-1结果:本方法线性范围为01~64mgL,r=09999,最低检测浓度为01mgL,方法回收率为957%~1080%,日内、日间RSD均小于15%,供试制剂与参比制剂主要药动学参数经统计学分析差异无显著性,供试制剂的相对生物利用度为(1057126)%。结论:本方法灵敏度高,特异性强,重现性好,供
3、试制剂与参比制剂具有生物等效性。[关键词]氟康唑;药动学;高效液相色谱法;固相萃取法[中图分类号]R9785;R9691[文献标识码]A[文章编号]1003-3734(2005)08-1039-03PharmacokineticsofserumfluconazolebyasolidphaseextractionHPLCXIAChunhua,ZHANGXinjing,LIYanyan,XIONGYuqing(InstituteofClinicalPharmacology,JiangxiMedicalCollege,Nanchang330006,
4、China)[Abstract]Objective:TocomparethepharmacokineticprofilesandbioequivalenceoffluconazolecapsulesbyanestablishedHPLC.Methods:Anopenlabel,randomizedandcrossoverdoseclinicalstudyrecruited18malevolunteers,whowererandomlytreatedwithasinglecrossoverdoseoftestorreferencefluconazolecapsules
5、(150mgeach).Theplasmasamples(10mL)fromthevolunteerswereloadedontoaC18cartridgesactivatedwithmethanol.Thecartridgewaselutedwith10mLaqueoussolutionscontaining20%methanol,andsubsequentlyelutedwith02mLmethanol.20LoftheeluatewasanalyzedbyHPLC,whichconsistedofaDiamonsilODSC18column(150mm4
6、6mm5m),themobilephasemadeof001-1molLKH2PO4solution(pH=50,adjustedwithH3PO4)acetonitrile(7525)withaflowrateof-110mLmin,anddetectionat267nm.Results:Thecalibratedlinearcurvewasintherangeof01~64-1-1mgL(r=09999).Thedetectionlimitwas01mgLandtherecoverywas957%~1080%.Themeanwith
7、indayandamongdayRSDwerelessthan15%;thePvalueshowednostatisticaldifferencebetweenthetestandreferencecapsules.Therelativebioavailabilityofthetestcapsuleswas(1057126)%.Conclusion:Thesensitive,reproducibleandspecificHPLCconfirmedthatthetestfluconazolecapsuleswerebioequiv
