头孢呋辛酯片制剂工艺研究.docx

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）-057-03StudyonpreparationprocessofCefuroximeAxetilTabletsLIUXiaoyanDepartmentofPharmacytheSecondPeople'sHospitalinHuai'anCityJiangsuProvinceHuai'an223002China[Abstract]Objective:TopreparetheCefuroximeAxetilTabletswiththedissolutionratemeetingtherequirementsbyselectingtherightauxiliarymaterialsandappropriateprocessingmethods.Methods:Theimpactofstarchmicrocrystallinecelluloselactosehydroxypropylcellulosesodiumsodiumcarboxymethylstarchcross-linkedpovidonemagnesiumstearatetalcpowderlaurylsodiumsulfatepovidoneK30aerosil2%HPMCaqueoussolution5%HPMCaqueoussolutionandotherauxiliarymaterialsusedinthewetprocessmaterialtablettingandthepowderdirecttablettingonthesampledissolutionwereobserved.Results:Theinternalandexternaladditionmethodtoaddsodiumcarboxymethylstarchwasusedtheaerosilwasusedtoabsorbtherawauxiliarymaterialsandthewetgranulationtocompresstabletsthetabletcoresrapidlydisintegratedintoparticlesthencollapsedintofinepowderwhichwasconducivetothedisintegrationofparticlesintofineparticles.Thesampledissolutionratewasidealandmetthequalitystandards.Conclusion:Themethodhassimplepreparationprocesslowequipmentrequirementsandhighproductqualificationrateandthereforecanbeusedforthelarge-scaleproductionofCefuroximeAxetilTablet.[Keywords]CefuroximeAxetilTablet;Internalandexternaladditionmethod;Wetgranulationtabletting;SodiumCarboxymethylStarch;Aerosil头