具有区分力的溶出曲线-谢沐风

ChineseJournalofPharmaceuticals2014,457687pH1-311.1201203TQ460A1001-8255201407-0687-032014-03-101972Tel[phone]×[e-mail]thDistinguishingAbilityXIEMufengShanghaiInstituteforFoodandDrugControl,Shanghai201203ABSTRACT:Dissolutiontestplaysaveryimportantroleinthedevelopmentoforalsolidformulations.Acriticaldissolutionconditionfordistinguishingthedissolutionbehaviorsoftheproductsshouldbefound.Thepaperdescribeshowtochooseacriticaldissolutionconditionforshowingtheinherentpropertiesofdifferentsolidproducts.KeyWords:originalpreparation;genericformulation;dissolutioncurve;distinguishment41.2515min85FDAFDA/CDER201226ChineseJournalofPharmaceuticals2014,4576882003722.1pHpH-88pH50r/min15min85120min85pH±0.54560min85pH90120min85pH45min7070+1585120min120min85120min85..,20083852.250r/min120min8545120min852.3/95min6030min7010min305045min752.450r/min1/d24h850r/min24h100r/min12h200r/min8h200r/min8h1/d200r/min7hWS1-X-152-2005Z2.5ChineseJournalofPharmaceuticals2014,4576891100r/minpH1.22h10.0100r/min100r/minpH4.52h10.0pH4.5pH200650r/minpH6.0pHtmax58100r/minpH6.0850r/minpH6.850r/minpH1.22h+pH6.8BE50r/minpH4.52h+pH6.83201141011/1.J.,2005,367:447-451.2.J.,2005,66:42-46.3.J.,2006,71:48-51.S83A50r/minpH1.2B50r/minpH6.0C50r/minpH6.8D100r/minpH6.01Fig.1ComparasionofinvitroDissolutionProfilesintheR&DofaGenericEntericFormulationinJapanChineseJournalofPharmaceuticals2014,457S833.42013146894.J.,2007,3811:A152-A154.5.EB/OL.2014-01-17.=/chrome/cases/show_Essay/DefaultDetail.htm?essayKey=63529123991203874376FDA.M.:,2012.7.EB/OL.2003-09-23.=largePage&id=13828.J.,2012,433:A23-A32.9,.J.,2006,74:69-70.10.CTDEB/OL.2011-04-12.=largeInfo&id=31213611.J.,2012,3211:2094-2096.S45-33LiuJBTetrahedronLett,2014,55:2872Pd2Cl2PPh325molK2CO33eq10mol6048hSuzuki226090S45-34N-ItohITetrahedronLett,2014,55:3160N-2-0.1eq22W30h97199N-30N-S45-35AgaMATetrahedronLett,2014,55:263910mol3eqR-157998ee8098S45-36HumneVTTetrahedronLett,2014,55:2337120,1.5eq1017h15145185