流通池法溶出度检查方法的研究和应用

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,,,[1],,,..,1997,:11.[2].().:,1992:176.[3]..,1962,9(6):140.[4],,,..,1992,20(1):6.[5].().:,1998:370~371.[6]..,1980,(3):18.[7]..,1992,(1):16.[8]..:,1989:296~297.[9]..:,1993:137~139.[10],,,..,1991,(1):18.[11]..,1985,(3):92.[12],,,..,1981,11(1):1.[13],,,..:,1987:39.[14]..:,1993:167.[15],..,1985,(2):1.[16],,,..,1999,(5):269.[17],,,..,1990,(1):48.[18],,,..,1993,16(5):3.[19],,,..,1993,16(8):6.[20],..,1992,23(1):42.[21],..,1994,(4):1.[22]..:,1991:312~313.[23],,..,1991,33(5):385.[24],,,..,1996,(1):29.[25],..,1997,20(10):534.[26]NganF,ShawP,ButP,etal.MolecularauthenticationofPanaxspecies,Phytochemistry1999,50.[27],,,.DNA.,1999,24(4):205.[28],,,.RAPDPCR.,1998,29(3):191.[29],,,.RAPD.,1998,29(9):625.[30].DNA..:,1998:4655.[31],,,.RAPD.,1999,34(4):312.[32]JunWen,ElizaberthA.Zimmer,PhylogenyandBiogeographyofPanaxL.(theGinsengGenus,Araliaceae):InferencesfromITSSequencesofNuclearRibosomalDNA.MolecularPhylogeneicsandEvolution,1997,6(2):167.[33]..,1996,29(4):1.[34]TanksleySD,McCoouchSR.Seedbanksandmolecularmaps:unlockinggeneticpotentialfromthewild.Science,1997,227:1063.(:19990706)流通池法溶出度检查方法的研究和应用左文坚(300070):介绍一种新的溶出度检查法流通池法的研究进展和应用情况:以国内外发表的研究论文为基础,对该方法的适应性优越性及其应用等方面进行综述:该方法与药典中常用的转篮法和桨法进行比较,测定结果有很好的相关性;在体内的生物利用度方面也有很好的相关性:国外采用流通池法进行固体制剂的研究越来越广泛,其优点是现行药典溶出度方法的补充和完善,在药物的溶出释放,特别是在栓剂和缓释制剂的研究和质量控制方面有着非常广阔的前景溶出度;流通池法(flowthroughcellmethod),(flowcelldissolutionmethod),231993133,,,,:!pH,∀,#,∃,%292%ChinPharmJ,2000May,Vol.35No.520005355&,,∋[1],[2~3]1231993133,[4~6]1.1循环式流通池法(封闭式系统,onlineautomaticsystem),37(,,37(,(2~50ml%min-1),,,1.2开放式流通池法(敞开式系统offlineautomaticsystem),,,2[7]2.1一般装配,,,,1,,(37)0.5)(,,,,,,1.6mm(PTFE)1流通池仪器装置图1-;2-;3-;4-2.2流通池装置,,,,2.2.122.6mm12mm,,,,:!,,∀,2.2.2,SOTAX(),,;,;,,,,,,2.2.3(V),,(V);,V,,2.3流体入口,,0.8mm,40∗,,,,,,(),,,1mm,,1mm,,,,2.4流速的配置,10~50ml%min-1,,,16ml%min-1,4ml%min-1,,1%,,,,[1],,4,816ml%min-1,16ml%min-1,960ml,USP3Keyhani[8],,:;;,3.1选择一种合适的合成滤膜%293%20005355ChinPharmJ,2000May,Vol.35No.5,,()(),,Chattaraj[9],(,),5,(celluloseacetate0.45m)!(polyvinylidenedifluoride0.45m)∀(polytetrafluoreoethylene0.45m)#(spectraporedialysis)∃(mixedextersofcellulose0.45m)30min,,:!∀#∃3.2温度的影响Chattaraj[9](32~37(),,,3.3流速的影响Chattaraj[9],:2.9,5.810ml%min-1,,,3.4体内外相关性实验Ishii[10],pH,,,pH,pH,pH,()[11]Loo[12],,:pH3.0,0.8ml%min-1,,,,,pH6.8,2.9ml%min-1,3.5除气,,,,20(,18.68g%ml-1,6.36g%ml-1;37(,14.08g%ml-1,4.69g%ml-1,,44.1在栓剂中的应用[13~16]Gjellan()8:22.6mm,14,28,50ml%min-1,,,,,,,,:,,,,,,,:22.6mm,28ml%min-1,,84.2在缓释剂型中的应用Saleh[17]5(4,1)(;SOTAX)6,40ml%min-1,1000ml,pHpH1.51h;pH5.31h;pH6.53h;pH7.23h,,pH1.51h,pH5.3pH1.5,:4,,t100r%min-1,1000ml,8h,,,pH,500ml(,),pH7.2,,1ml,,,,2.5min,,,(),,%294%ChinPharmJ,2000May,Vol.35No.520005355,,,,,,,,,,,,[1],..:..:,1999:188.[2]..,1996,8(1):52.[3]LangenbucherF,KrthW,BenzD,etal.Standardizedflowcellmethodasanalternativetoexistingpharmacopoeiadissolutiontesting.PharmInd,1989,51(11):1276.[4]MollerH,WirbitzkiE.Regulatoryaspectsofmodifiedreleasedosageforms:specialcasesofdissolutiontestingusingtheflowthroughsystem.BollChinFarm,1993,132(4):105.[5]AiacheJM.Frenchand/orEuropeanperspectiveonbiopharmaceuticalcharacterizationofdrugdosageforms.JPharmBiomedAnal,1990,8(6):499.[6]BronaughRI,StewartRF.Methodsforinvitropercutancousabsorptionstudies:IV,theflowthroughdiffusioncell.JPharmSci,1985,74:64.[7]CakiryldizC,MehtaPJ,RahmenW,etal.Dissolutionstudieswithamultichannelcontinuousflowapparatus.JPharmSci,1975,64(10):1692.[8]KeyhaniMorrisonEetal.Optimizationofaninvitromethodiforevaluatingthereleaseofanovelretinoidfromtopicalgels.PharmInd,1995,57(5):414.[9]ChattarajSC,KanferI.Releaseofacyctovirfromsemisoliddosageforms,seiautomatedprocedureusingasimpleplexiglassflowthroughcell.IntJPharm,1995,125(31):215.[10]IshiiK,KatayamaY,ItaiS,etal.Invitrodissolutiontestscorrespondingtotheinvivodissolutionofclarithromycintabletsinthestomachandintestine.ChemPharmBull(Tokyo),1995,43(11)(Nov):1943.[11]BozsikE,KissnoCE.Comparativeevatuationofdissolutionandmembranetransportmethodsofsuppositories.ActaPharmHung,1993,63(5):290.[12]LooJCK,RieglmanS.Newmethodforcalculatingtheintrinsicabsorptionrateofdrugs.JPharmSci,1968,57:918.[13]GjellanK,GraffnerC.Influenceofamountofhandfatinsuppositoriesontheinvitroreleaserateandbioavailabilityofparacetamol+.Acomparisonbetweenthreecomparisonandarectalsolution.IntJPharm,1994,104:215.[14]HorvathG,NagyK.Comparativeinvitrodissolutionstudiesofpiroxicamsuppositoriesusingthebasket,thepaddleandtheflowthroughmethods.ActaPharmHung,1994,64(4):135.[15]OosterhuisB,JonkmanJHG.Pharmacokineticstudiesinhealthyvolunteersinthecontextofinvitro/invivocorrelation.EurJDrugMetabPharmacokinet,1993,18:19.[16]SkellyJP,ShiuGF.Invitro/invivocorrelationinbiopharmaceutical,scientificandregulatoryimplications.EurJDrugMetabPharmacokinet,1993,18:121.[17]SalehSI,AiacheJm,KhiderSH,etal.Comparativedissolutionprofilesoffiveinternationallyavailablesustainedreleasediclofenacdosageforms.STPPharmaSci,1992,2(3):242.(:20000112)首届肉苁蓉学术研讨会召开,,536,,,−,,4,,54,,,,,,,,,,,,,,,./,,,,,,,,,−,,,[刘永久]%295%20005355ChinPharmJ,2000May,Vol.35No.5

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