兰索拉唑肠溶片稳定性和溶出度的影响因素研究

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ChinaPharmaceuticals·32·20101914,·230022。10d。。。TQ460.6R975+.2A1006-4931(2010)14-0032-02StudyonInfluentialFactorsofStabilityandDissolubilityofLansoprazoleEnteric-CoatedTabletsWangHe,SunBei,LiJianghui,LiuYu(AnhuiProvincialInstituteofMateriaMedica,AnhuiTechnologyEngineeringResearchCenterofDrugSustainedandControlledRelease,Hefei,Anhui,China230022)AbstractObjectiveTostudytheprescriptionfactorsaffectingthedissolutionandstabilityofLansoprazoleEnteric-CoatedTablets.MethodsWiththedissolutioncurvesandtherelatedsubstancesafter10daccelerationasindexes,thedifferentformulationfactorsaffectingthepreparationwereassessed.ResultsThekeyformulationparameterscontrollingthequalityofLansoprazoleEnteric-CoatedTabletswerees-tablished.ConclusionTheseestablishedformulationparametersarereasonableandsuitableforguidingtheindustrialproductionofLansopra-zoleEnteric-CoatedTablets.Keywords:lansoprazole;enteric-coatedtablets;dissolutionrate;stability[5].[J].2005278932-935.[6].[J].200521121505-1508.[7].[M].1991155298.[8].S180[J].2007247421-425.[9].[M].3.200391991929.[10].[J].2005329890.[11].[J].2008262295-297.[12].[J].·1999226323-326.[13].T[J].199922127-29.[14].[M].199698-123.[15].[J].2006331182-83.[16]EberhardtKB,TruedssonL,PetterssonH,etal.Diseaseactivityandjointdamageprogressioninearlyrheumatoidarthritis:relationtoIgG,IgA,andIgMrheumatoidfactor[J].AnnRheumDis,1990,49:906-909.[17]OkamotoYNishidaM.Cytokinebalanceinthepathogenesisofrheumatoidarthritis[J].YakugakuZasshi,2001(2):131.(2009-07-17)lansuoprazole1991Howle。、、、-Zollinger-Ellison[1]。、。。。。、。1TDPZRS-8G()LC-10ATVPN2000UV2400。0710120269-9701(,080103)、101JRS、、。22.1,。2.29→10001000mL100r/min2h。37℃pH=6.81000mL10mL284nm15mg1000mL2mLpH=6.8。。檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨檨ChinaPharmaceuticals·33·20101914∶=1∶1=1∶1.5∶=1∶1=1∶1.550%0d0.340.320.380.360.320.330.350.310.350.390.350.380.4910d0.680.650.941.250.870.390.390.380.380.450.390.390.58%12.360℃10dHPLC0d10d。[2]。2.4。11A。。。。。。、、、3。11B。。。。、50%。11C。。。。50%。HPMC5%[3]。10%10%。11D。。HPMC。。3。。、。。[4]、、。。。[5]、。。。。[1].[J].20033203-205.[2]WS1-(X-148)-2003Z[S].[3].[J].2007226643-645.[4],.[J].2008234394-396.[5].[J].1999343169-171.(2009-02-262010-01-21)100806040200/%10080604020001020304050/%CDA.B.C.D.1n=61234120102030405010080604020001020304050/%01020304050100806040200/%211234ABt/mint/mint/mint/min

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