300T/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PreliminaryDesignofProductionPlantProcessof300TonsofCefradineABSTRACTCephradinewhichhasaliassuchasVanguardADMVI,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，bulkdrugs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.........................................41.5.1设计的指导思想.................................................41.5.2设计依据.......................................................41.5.3设计内容和重点.............................................
