年产300吨头孢拉定原料药车间的工艺设计

I300T/年头孢拉定原料药生产车间的工艺设计摘要头孢拉定(Cephradine,Velosef)别名：先锋霉素Ⅵ、头孢菌素Ⅵ等。本品为第一代半合成头孢菌素，抗菌作用与头孢氨苄相似。头孢拉定是第一代头孢菌素类抗生素，该药是美国squibb公司首先研制成功并生产的一个即可口服又可注射的头孢菌素。本品自问世以来，由于其优良的抗菌活性和药动学特点而被广泛应用于人医临床，适用于敏感菌引起的感染及预防多种术后感染。2002年农业部批准将头孢拉定用于兽医临床，初步显示其在兽因临床上应用价值非常大。本设计基于原料药车间的设计对头孢拉定生产做了个详细的研究，并对头孢拉定原料药车间做了初步的设计。本设计以西宁市为厂址，根据实地情况和自然因素，经济因素规划了药厂的布局与面积。使得药厂具有自然、交通、人为的便利。根据西宁市的自然状况对药厂内部布局做了规划，整个药厂具有生活区，生产区，行政区，配套设施区。车间的布局符合生产最优化的原则，并严格按照CMP的要求进行设计，使得其能顺利进行头孢拉定原料药的生产。关键词：头孢拉定，初步工艺设计，原料药IIPreliminaryDesignofProductionPlantProcessof300TonsofCefradineABSTRACTCephradinewhichhasaliassuchasVanguardADMVI,cephalosporinsⅥ,andsoon.Thisproductisthefirstgenerationofsemi-syntheticcephalosporin.Theresultshowsthattheeffectofantibacterialissimilarwithcephalexin's.Cephradineisthefirstgenerationcephalosporinantibiotic,thedrugissuccessfullydevelopedfirstbythecompanyofSquibblocatesinUSwhichproducedthecephalosporinsthatcannotonlybetakenorallybutalsobeinjected.Sinceitwasdeveloped,thisproductiswidelyusedinhumanmedicineclinicalbecauseoftheirexcellentantibacterialactivityandpharmacokineticcharacteristicswhichapplicabletogoodscausedbyinfectionandpreventionofavarietyofpostoperativeinfection.In2002,CephradinewasapprovedtobeusedintheveterinaryclinicbyMinistryofAgriculture,andtheinitialvaluedisplayintheanimalduetotheclinicalapplicationisverylarge.Thisdesignisadetailedstudybasedonthebulkdrugs'workshopdesignedtocephalosporinsthatpullscheduledproduction,anditisalsoapreliminarydesignaboutcephalosporinRivetbulkdrugs'workshop.Accordingtothesituationonthegroundandnaturalfactors,economicfactors,thisdesignmakesXiningCityforthesiteandplansthelayoutandsizeofthepharmaceuticalcompaniessothatitwillequippedwiththepharmaceuticalnature,transportationandhumanconvenience.AccordingtothenaturalsituationinXiningCity,thepharmaceuticalinternallayoutplanthatitshouldhaveentirepharmaceuticallivingarea,productionarea,administrativeandancillaryfacilitiesarea.Thelayoutoftheworkshopisinlinewiththeprincipleofproductionoptimization,andinstrictaccordancewiththerequirementsoftheCMPdesign.SmoothCephradineproductionofbulkdrugs.KEYWORDS:Cefradine，thepreliminaryprocessdesign，bulkdrugsIII目录摘要................................................................IABSTRACT............................................................II1简介...............................................................11.1头孢拉定简介.................................................11.2头孢拉定市场分析.............................................11.3头孢拉定的发展前景...........................................21.4原料药的简述.................................................31.5头孢拉定原料药车间初步设计.....................................31.5.1设计的指导思想.............................................41.5.2设计依据...................................................41.5.3设计内容和重点.............................................41.5.4设计规模...................................................41.5.5设计的目的和意义...........................................52生产工艺设计.......................................................62.1生产安排.......................................................62.2生产工艺流程...................................................62.3生产工艺流程图..................................................72.4物料衡算.......................................................72.4.1物料衡算依据...............................................72.4.2总的物料衡算................................................72.4.37—ADCA硅脂化的物料衡算....................................82.4.4混合酸酐制备的物料衡算.....................................82.4.5缩合反应的物料衡算.........................................82.4.6水解反应的物料衡算.........................................92.4.7萃取的物料衡算.............................................102.4.8过滤脱色的物料衡算........................................112.4.9结晶反应的物料衡算........................................112.5能量衡算......................................................122.5.1能量衡算的目的.............................................122.5.2热量平衡方程式.............................................132.5.3缩合产物的能量衡算.........................................132.5.4头孢拉定的能量衡算.........................................143设备选型..........................................................15IV3.1设备选型步骤与原则............................................153.2选择设备......................................................163.3设备型号......................................................163.3.1蒸汽加热不锈钢反应釜......................................163.3.2不锈钢缩合釜..............................................173.3.3不锈钢水解釜..............................................173.3.4不锈钢结晶罐..............................................173.3.5列管式冷凝器...............................................183.3.6泵.........................................................193.3.7TA碟心离心机..............................................193.3.8活性碳过滤釜..............................................194设备工艺流程图....................................................214.1生产工艺简述...................................................214.2绘图说明.......................................................215原料药车间平面布置图......................................