毕业设计---注射剂制药车间设计

长春工业大学毕业设计年产5000万支恩必普注射剂车间工艺设计AnnualOutputof50MillionButylphthalideInjectionWorkshopProcessDesign学院：化学工程专业：制药工程班级：110607姓名：解亚楠指导教师：胡江磊2015年6月3日长春工业大学学士学位论文摘要恩必普（丁苯酞注射剂）是一种多靶点抗脑缺血药物，目前主要用于轻、中度急性缺血性脑卒中的治疗。是一种具有保护线粒体和改善微循环的独特作用的化学合成药物。3-(3’-羟基丁基)异苯丙呋喃-(3H)-酮是恩必普在动物体内的主要代谢产物，不仅含量高，同时还具有改善脑能量代谢、增加血流量、改善脑缺血、缩小脑梗塞面积、保护和修复缺血区神经细胞、抗血栓和抗血小板等药理活性。恩必普具有起效迅速可靠、生物利用度高、副作用极小等优点。恩必普是我国原创的抗脑缺血新化学实体药物，属于国家Ⅰ类新药。本设计包括恩必普注射剂的性质，恩必普注射剂的工艺路线选择及工艺流程设计，恩必普注射剂的工艺计算（物料衡算、能量计算、设备计算及其选型等），绘制工艺流程图建筑设计要求及说明。其中，生产工艺设计和车间设计是本设计的重点环节。提取车间与制剂车间是本设计的重点车间。安瓿洗烘封联动机组是本设计的重点设备。本设计采用现代化的设备和生产方法，确保了提高药品质量和降低成本。要求符合《中国药典》标准，对年产5000万支恩必普注射剂车间进行设计。关键词：恩必普注射剂，疗效，化学合成药物，生产工艺设计，车间设计长春工业大学学士学位论文AbstractButylphthalideandSodiumChiorideIntectionisamultipletargetdrugforthetreatmentofacutemildtomoderateischemiccerebralstroke.It’sthathasanti-cerebralischemiceffectthroughmitochondrialprotectionandmicro-circulationimprovementchemicalsynthesisdrug.3-（3’-hydroxybutyl)-isobenzofuran-（3H)-onewasreportedasoneofthemainmetabolitesofButylphthalidewhichhasmanypharmacologicalactivities,suchasimprovingcerebralbrainenergymetabolism,increasingbloodflow,improvingcerebralischemia,reducinginfarctsize,protectingandrepairingneuralcells,antithromboticandantiplateletactivities.Butylphthalidehastheadvantagethatithasarapidonset,reliable,highbioavailabilityandlittlesideeffect.ButylphthalideisaclassⅠinnovativedrugofnewchemicalentitiesinChina.ThedesignincludesprescriptioninjectionsButylphthalideintroduceditsnature,theprocessrouteselectionandprocessdesignButylphthalideinjections,processcalculationButylphthalideinjections(materialbalance,energycalculation,calculationandselectionofequipment,etc.),architecturaldesignrequirementsfordrawingflowchartanddescription.Amongthem,theproductionprocessdesignandplantdesignarekeyaspectsofthedesign.Extractionworkshopandpreparationworkshopisfocusedonthedesignworkshop.Sealedampoulewashingdryingequipmentlinkageunitisthefocusofthisdesign.Thisdesignusesmodernequipmentandproductionmethodstoensurethatthedrugsimprovequalityandreducecosts.ThedesignrequirementsinlinewiththeChinesePharmacopoeiastandards,theannualoutputof50millionButylphthalideinjectionsworkshopdesign.Keywords:Butylphthalideinjection,effect,chemicalsynthesisdrug,productionprocessdesign,plantdesign长春工业大学学士学位论文目录1概述..........................................................................................................................................................11.1恩必普注射剂各方面内容简介.....................................................................................................11.1.1恩必普注射剂的背景及来源.............................................................................................11.1.2恩必普的作用与特点.........................................................................................................21.1.3制备恩必普注射剂的意义.................................................................................................21.1.4恩必普注射剂存在的主要问题.........................................................................................21.2.恩必普注射剂的药理性质............................................................................................................21.3产品方案........................................................................................................................................31.3.1产品方案的要求和安排.....................................................................................................31.3.2恩必普的来源依据.............................................................................................................31.3.3恩必普具体功效.................................................................................................................31.4产品设计........................................................................................................................................41.4.1设计要求.............................................................................................................................41.4.2生产规模.............................................................................................................................41.4.3设计产品规格.....................................................................................................................41.4.4班产量和人员.....................................................................................................................42生产方法及工艺流程..............................................................................................................................42.1工艺流程设计的原则....................................................................................................................42.2工艺路线概述................................................................................................................................52.3各部分生产工艺内容....................................................................................................................62.3.1注射用水制取工艺.............................................................................................................62.3.1.1水源的分类........................................