1亿粒年阿莫西林硬胶囊车间工艺设计

I1亿粒/年阿莫西林硬胶囊车间工艺设计摘要阿莫西林胶囊为新型半合成青霉素类药，具有吸收快、血药浓度高、杀菌力强、毒性极低、副作用小以及广泛的抗菌谱，对多种细菌的杀菌作用迅速而强等特点。硬胶囊剂系将一定量的药物加辅料制成均匀的粉末或颗粒，充填与空胶囊中，或将药物粉末直接填充与空胶囊中制成，是目前除片剂之外应用最为广泛的一种固体剂型。装入胶壳的药物可分为粉末、颗粒、微丸、片剂及胶囊，甚至液体或半固体糊状物。硬胶囊的生物利用度高，能够达到速释、缓释或控制释药等多种目的。此外，胶囊生产工艺过程相对简单，且能够弥补其他固体剂型的不足。由于胶壳具有掩味作用，因此能够有效地隔离药物的不良气味。本设计为1亿粒/年阿莫西林硬胶囊车间生产工艺的设计。在GMP的相关规定指导下，根据生产需要，进行物料衡算，完成工艺流程设计，厂房车间的设计，设备平面布置的设计，总平面布置设计，洁净级别设计，人物流走向设计。关键词：阿莫西林硬胶囊剂车间设计II100million/yearhardcapsulesamoxicillinProcessDesignWorkshopAbstractAmoxicillinisanewsemi-syntheticpenicillindrugs,withtheabsorptionoffast,highplasmaconcentration,bactericidalability,lowtoxicity,sideeffectsandwideantibacterialspectrum,bactericidalactionofbacteriaonavarietyofquickandstrongfeatures.Departmentofhardcapsuleswillbeacertainamountofdrugpluspercipientsintoahomogeneouspowderorgranules,filledwithemptycapsules,ordirectlytothedrugpowderintocapsulesfilledwithair,isthemostwidelyusedthantabletsoutsideakindsofsoliddosageforms.Drugsintotheplasticshellcanbedividedintopowder,granules,pellets,tabletsandcapsules,liquidorsemi-solidorpaste.Hardcapsulebioavailability,canachieverapidrelease,sustainedreleaseorcontrolledrelease,andotherpurposes.Inaddition,capsuleproductionprocessisrelativelysimple,andcanmakeupforlackofothersoliddosageforms.Theplasticshellwithatastemaskingeffect,sothedrugcaneffectivelyisolatethebadsmell.Thedesignforthe100million/yearhardcapsulesamoxicillinworkshopproductionprocessdesign.TherelevantprovisionsoftheGMPguidance,basedonproductionneeds,thematerialbalance,completetheprocessdesign,plantdesign,equipmentlayoutdesign,generallayoutdesign,clean-leveldesign,logisticstohumandesignsKeywords:amoxicillinhardcapsulesWorkshopDesignIII目录第一章文献综述...........................................................................................................11.1生产产品的基本情况..........................................................................................11.1.1阿莫西林胶囊的概述...................................................................................11.1.2阿莫西林的剂型...........................................................................................31.2生产剂型的基本情况..........................................................................................61.2.1胶囊及硬胶囊剂的概况...............................................................................61.2.2硬胶囊剂的特点...........................................................................................61.2.3适合制成胶囊剂的药物...............................................................................71.2.4硬胶囊剂的国内外发展现状.......................................................................81.2.5硬胶囊剂的制备...........................................................................................81.2.6空胶囊的规格和质量要求。.......................................................................91.2.7硬胶囊剂的填充.........................................................................................101.3硬胶囊剂的GMP车间建设.............................................................................121.3.1制剂GMP车间的基本要求.......................................................................121.3.1.1空气净化...............................................................................................121.3.1.2人员净化处理.......................................................................................121.3.1.3物料净化处理.......................................................................................131.3.1.4设备的清洗...........................................................................................131.3.2工艺设计.....................................................................................................131.3.3车间布局.....................................................................................................141.3.4制剂GMP对设备的要求及管理...............................................................141.4硬胶囊剂的质量评定与包装............................................................................151.4.1质量评定.....................................................................................................151.4.2包装与贮存.....................................................................................................................15第二章设计说明书...................................................................................................162.1设计内容...........................................................................................................162.2设计原则及依据...............................................................................................162.3生产车间布局....................................................................................................172.3.1厂址的选择.................................................................................................172.3.2厂区布局.....................................................................................................172.3.3厂房设计.....................................................................................................172.3.4车间设备..................................................................................................