药用辅料的应用现状与未来发展

安徽理工大学毕业论文本科毕业论文药用辅料的应用现状与未来发展APPLICATIONSTATUSANDFUTUREDEVELOPMENTOFPHARMACEUTICALEXCIPIENTS学院：化学工程学院专业班级：制药工程06-1学生姓名：荣俊锋指导教师：陈小平高级工程师2010年6月8日安徽理工大学毕业论文I药用辅料的应用现状与未来发展摘要药用辅料是药物制剂的基础材料和重要组成部分,是生产药品和制剂配制时所用的赋形剂或附加剂,在制剂剂型和药品生产中起着关键作用,对药品质量起着至关重要的作用。没有优良的辅料就没有优质的制剂,开发出一种优良的新辅料,可促进开发一类新剂型、新系统和一批新制剂,带动一大批制剂产品质量的提高,其社会和经济效益并不亚于开发一种新药。本文从药用辅料的定义、作用、分类、质量要求、管理等基本概念出发，综述评论了药用辅料的应用现状，介绍了几种新型的药用辅料并就这些新型的药用辅料在缓控释制剂处方中的应用进行探讨。又列举了两种具有开发潜力的天然高分子材料：魔芋葡甘露聚糖和膨润土。最后，总结了药用辅料的未来发展，药用辅料将继续朝着安全性、功能性、适应性和高效性等方向发展，并在今后的实践中不断得以广泛应用。药用辅料的蓬勃发展将在新药新剂型中发挥更大作用，将取得更佳的社会效益和经济效益。关键词：药用辅料，应用现状，未来发展，药物制剂，新型药用辅料，研究安徽理工大学毕业论文IIAPPLICATIONSTATUSANDFUTUREDEVELOPMENTOFPHARMACEUTICALEXCIPIENTSABSTRACTPharmaceuticalExcipientsisabasicmaterialforpharmaceuticalpreparationsandimportantpartoftheproductionofdrugsandagentsusedduringpreparationexcipientsoradditives,andpharmaceuticalExcipientsplayavitalimportantroleinthepharmaceuticalformulationsandtheproductionofthedrugs.Asoneexpert’sview,notgoodqualityPharmaceuticalExcipientsandnopharmaceuticalformulations,thedevelopmentofagoodnewPharmaceuticalExcipients,canpromotethedevelopmentofanewclassofformulations,thenewsystem,andanumberofnewagents,bringalargenumberofproductquality,itssocialandeconomicbenefitsinferiortothedevelopmentofanewdrug.Inthisarticleweshallreviewthebasicconceptofthedefinitionofpharmaceuticalexcipients,function,classification,qualityrequirements,reviewcommentsontheapplicationofpharmaceuticalexcipients,introducesafewnewpharmaceuticalexcipientsandthesenewpharmaceuticalexcipientsofapplicationinthecontrolledreleasepreparations.Atthesametime,identifiedtwopotentialofnaturalpolymermaterialsfordevelopment:konjacglucomannanandbentonite.Finally,thesummaryofdevelopmentofpharmaceuticalexcipientsinthefuture,pharmaceuticalexcipientswillbedevelopedtowardsthesafety,functionality,adaptabilityandefficiency,andtheywillbewidelyusedinpracticeinthefuture.Therapiddevelopmentofpharmaceuticalexcipientsplayagreaterroleinthenewpharmaceuticalpreparations,canachievebettersocialandeconomicbenefits.KEYWORDS:pharmaceuticalexcipients,applicationstatus,futuredevelopment,pharmaceuticalpreparations,newpharmaceuticalexcipients,research安徽理工大学毕业论文i目录摘要（中文）..............................................................I摘要（英文）.............................................................II绪论......................................................................11序言....................................................................21.1药用辅料的定义......................................................21.2药用辅料的作用......................................................31.2.1药用辅料在药物制剂中的地位......................................31.2.2药用辅料的作用..................................................61.3药用辅料的分类......................................................61.4药用辅料的质量要求..................................................81.5药用辅料的管理......................................................81.5.1药用辅料的管理现状..............................................81.5.2药用辅料的审批管理.............................................101.6药用辅料的选择.....................................................122药用辅料的应用现状.....................................................142.1药用辅料的历史沿革.................................................142.2药用辅料的应用现状.................................................172.2.1药用辅料在各种制剂中的应用.....................................172.2.2国内药用辅料的应用现状.........................................172.2.3国内药用辅料和国外的差距.......................................182.2.4国外新辅料在科研研发方面特点...................................182.3几种新型的药用辅料.................................................192.3.1聚乙烯基吡咯烷酮...............................................192.3.2泊洛沙姆.......................................................222.3.3微粉硅胶.......................................................242.3.4其它...........................................................262.4药用辅料在缓控释制剂中的应用.......................................272.5具有开发为药用辅料的天然高分子材料举例.............................322.5.1魔芋葡甘露聚糖.................................................322.5.2膨润土.........................................................333药用辅料的未来发展.....................................................363.1药用辅料的研发趋势.................................................36安徽理工大学毕业论文ii3.2药用辅料的审批要求.................................................373.3药用辅料的国家标准.................................................383.4药用辅料与新技术新剂型.............................................383.4.1ALZA公司的OROS技术...........................................383.4.2Skyepharma公司的GeoMotrix技术................................393.4.3脉冲微粒给药系统...............................................393.4.4APR公司用于水不溶性药物颗粒的制备技术.........................393.4.5Elan公司的纳米结晶技术........................................404分析和总结.............................................................41参考文献.................................................................43谢辞.....................................................................44安徽理工大学毕业论文1绪论药用辅料是药物制剂的基础材料和重要的组成部分,是生产药品和制剂配制时所用的赋形剂或附加剂,在制剂剂型和药品生产中起着关键作用,对药品质量起着至关重要的作用。没有优良