5.6种市售阿司匹林肠溶片的体外溶出试验比较

.296CHINESEJOURNALOFCLINICALPHARMACYZ()011056.(200032):6,.:,,,t.:6(0.lmol/L)pH6.8.5(P0.05),:6,;;;[IR971+.1;R944.4;R944.9A[.110074406(200l)()50296()3ComParisonofdissolutiontestsamong6kindsofcommercializedenteric-coatedtabletsofasPirinIuJian,IJuEnxian.,JiangZhiqiang(DPat,entofphaaeeuricazSeien,.Schooz,I.pa,naFudanUnive,sity,Shanghai200032)[ABSTRACT]AIM:Toinvestigateifthedissolutionresultsinvitroof6kindsoftheeommcreializeden-terieeoatedtabletsofaspirinarefittedinwiththerequirementsofPharmaeopoeiaofPeople5RepublieofChina,andiftherearediffereneesamong6kindsoftheenterieeoatedtablets.METHODs:Thedissolu-tiontestswereearriedoutindissolutiontestsystemwiththerotatingbasket.Theultravioletehro-matograplassaywasusedtodeterminetheeoneentrationofaspirinindifferentdissolutionmedia.Theeu-mulativedissolutionpereentofthelabelledamountwasealeulatedandtheWeibubll5equationwasusedtomodelthemaindissolutionparametersaeeordingtothedissolutiondata.Thediffereneesbetweendifferentgroupswerostatistieallyevaluatedbyatwotailsstudentsttest.RESULTS:Thedissolutionresultsof6kindsofaspirintabletsallwerefittedinwiththerequirementsofthePharmaeopoeiaduringdissolutiontestingeitherinaeidiemedium(0.1mol/IHCI)orinpH6.8phosphatebuffersolution.Thodissolutionratesofother5preparationswereremarkablyrapidthanthatofpreparation1.CONeLUsION:Thediss(-lutiondiffereneeamong6kindsofenterieeoatedtabletsofaspirinwillindueedifferenleffeetsontlleirpre-ventionortherapeutieuseduringlongternuseoflowdoseasPirinforeardiovaseularprophylaxis.[KEYWonDSlapirin;enterieeoatedtablet;lowdose;inoitrodissolution(aspirin),,,,LLsJ,,,CHINESEJOURNALOFCllNICALPHARMACY20011()5.297.6,l1.1ZRS4();UV754()1.2();1:(,,20000901,100mg);2:(B,20000303,25mg);3:(C,O154,40mg);4:(D,0005972,50mg);5:(E,20000901,50mg);6:(F,20000512,50mg);22.1,pH6.851020O6()100150pg/ml,(inil25ml,o.ln01/I10ml,smm5;111,pH6.83nn,A(()():.go7xlf5.668Xlu,(,=0.9999,n=6),515()g/m!,2.2pH6.8540150g/m5,,303nm16,(0.lmol/LHCI),3(96.063.41)%(98.700.58)(100.460.42)%,98.%2.31995,I()6,,100r/min,(370.5)C,750ml0.1mol/IJZh7ml37C0.2mol/1,250ml,,4mol/IJ(5ml)pH(6.80.05),45nin51015253545min,7ml,0.spm,6mlsoml,(),,611/.”-nU0in16.Fig1Cumulativereleaseeurvesof6kindsofasPirinenterlccoatedtabletsZhpH6.8TbCumulativedissolutionPereentor6kindsbuffersolutionatthedifferenttimeafterofeommercializedentericcotedtabletsofasPirinPredissolutioninacidicmediunforZhinpH6.8Pho5Phat(,,%.,,6)Prel()51015253545i()(1)l().)00.()00.640.273.341.1611,422.8070.506.6794.825.3998.651.3798.96l526.421.778.4516325.1612.4679.098.5486.968.6788.878.1890.()97.7992.678.2131.531.343.292.5128.8326.4150.2930.8986.5624.4890.6316.4i)2.2615.8394.30139140.000.0019.9812.6559.7814.7585.664.8792.111.9993.882.0194.832.5195.571.9751.781.006.204.8764.409.8294.422.8198.701.8899.581.3999.781.1710).191.1760.000.0035.4717.9179.7510.9788.714.7492.522.2793.812.1295.173.1795.984.02298CHINESEJOURNALOFCllNICAIPHARMACY20011()52.4[6j{:Inln[z/(1Y)=mlntInt}1,TslTdmt2.5(0.lmol/IJ),1,462h,2,35(1,ohZh)(6.421.77)%,(1.531.34)%(1.781.00)%[?]2.66Zh,pH6.86pH6.8T,Td(2),t1,l5(2),152Tab2Mainparametersofdissolutiontestordifrerentas-pirinenterieeoatedtablet,(s,n=6)PrepT,(min)TJ(mn)m121.900.7624.820.882.890.12212.111.7815.182.471.630.17315.364.slb18.595.42L1.900.2448.483.02Llo.953.211.380.35L510.631.44L12.961.411.850.2665.272.717.393101.040.35bP0.05,how,signifieantdffereneebetweenotherprepara-tlonsandpreparationl:1,462,35,6pH6.82,35,,pH6.8pH6,8Lanas:(),,3:6pH6.8235Zh,,,[l]Nagat,ukaK.UyamaO,Nakabaya,hi5.,tul.AnewIProaehtoantthrombietheraPyeva!uatonofeomblnedtherapyofthromboxane,ynthytaseinhibtorandverylowdoseofa,-P:rn.Stroke.1985,16(5):806[21VanagsD,Rodger,SE.LloydJV.az.Theantoplateleteffeetofdallylowdoseenterieeoatedasprninman:atmeeourseofon,etandreeovery.Thrombo,5Researeh,1990,59(6):9953SteorKA,WallaeeTM.Bolto,CH,tzA,p:r.nproreerslow1iPoproteinfromoxdntivemodifieaton.Heart,1997.77(4):333[4,,.,1996,27(7):3045]().:.1995:3273286....1990:1()7-1087.().:.1995:6869[8ColeAT,HudsonN,LiewL(,,tulProteet:onofhumanas-tremueo,aagain,taprinentereeoatin01dosereduetion,}AlimentPllarmaeoloTher,1999,13(2):187[9]lanasAl.Currentapproaehe,toredueinggastro.ntest.naltoxeityoflowdoseaspirin.AmJMed.20f)1.110z)57)(20010229)