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1、头孢呋辛酯片制剂工艺研究[摘要]目的:通过选择合适辅料及适当的工艺方法,制备溶出度符合要求的头孢呋辛酯片。方法:考察包括淀粉、微晶纤维素、乳糖、羟丙纤维素钠、羧甲基淀粉钠、交联聚维酮、硬脂酸镁、滑石粉、十二烷基硫酸钠、聚维酮K30、微粉硅胶、2%HPMC水溶液、5%HPMC水溶液等辅料进行湿法制料压片、粉末直接压片对样品溶出的影响。结果:采用内外加法添加羧甲基淀粉钠,用微粉硅胶吸附原辅材料,湿法制粒压片,片芯迅速崩解为颗粒,然后再将其崩解为细粉,这样有利于颗粒继续崩解成细小颗粒,样品溶出度较为理想,符合质量标准要求。结论:该方法制备工艺简单,设备要求低,且成品合格率高,可
2、用于头孢呋辛酯片的规模化生产。[关键词]头孢呋辛酯;内外加法;湿法制粒压片;羧甲基淀粉钠;微粉硅胶[中图分类号]R978.1[文献标识码]A[文章编号]1673-7210(2011)11(b)-057-03StudyonpreparationprocessofCefuroximeAxetilTabletsLIUXiaoyanDepartmentofPharmacy,theSecondPeople'sHospitalinHuai'anCity,JiangsuProvince,Huai'an223002,China[Abs
3、tract]Objective:TopreparetheCefuroximeAxetil第8页共8页Tabletswiththedissolutionratemeetingtherequirements,byselectingtherightauxiliarymaterialsandappropriateprocessingmethods.Methods:Theimpactofstarch,microcrystallinecellulose,lactose,hydroxypropylcellulosesodium,sodiumcarboxymethylstarch,cro
4、ss-linkedpovidone,magnesiumstearate,talcpowder,laurylsodiumsulfate,povidoneK30,aerosil,2%HPMCaqueoussolution,5%HPMCaqueoussolutionandotherauxiliarymaterialsusedinthewetprocessmaterialtablettingandthepowderdirecttablettingonthesampledissolutionwereobserved.Results:Theinternalandexternaladd
5、itionmethodtoaddsodiumcarboxymethylstarchwasused,theaerosilwasusedtoabsorbtherawauxiliarymaterialsandthewetgranulationtocompresstablets,thetabletcoresrapidlydisintegratedintoparticles,thencollapsedintofinepowder,whichwasconducivetothedisintegrationofparticlesintofineparticles.Thesampledis
6、solutionratewasidealandmetthequalitystandards.Conclusion:Themethodhassimplepreparationprocess,lowequipmentrequirementsandhighproductqualificationrate,andthereforecanbeusedforthelarge-scaleproductionofCefuroximeAxetilTablet.[Keywords]CefuroximeAxetilTablet;Internaland第8页共8页externalad