摘要实验以产品的不同点和GMP的相关要求,从实际情况出发,对产品生产工艺做出合理的分析和演示。生产设计的步骤主要是以下几点(1)生产设计。根据《中国药典》2012年版三拗片的车间生产工艺和生产方法,计算并画出生产工艺流程图。(2)反应料计算。(2)根据生产任务及生产制度确定批量为200万片,在200万片批量的基础上完成各工序的物料衡算。(3)设备选型。利用各个生产步骤的物料投入含量和产率,根据各个基本操作各类型的生产范围,选出设备的最佳型号,合理的安排生产工作人员进行周期性工作。(4)车间设置。保证生产条件合理,生产安全以及环境保护良好的原则下,按照分类和就近原则,对车间的整体布局进行设计,达到车间设计的最佳效果。(5)非工艺设计。根据《建筑设计防火规范》等其他的规范和生活标准,从废物处理、安全防火以及劳动安全等多方面对非工艺进行处理。关键词:三拗片;GMP;车间设计;工艺设计AbstractBasedonthedifferencesofproductsandtherequirementsofGMP,thispapermakesareasonableanalysisanddemonstrationoftheproductionprocessfromtheactualsituation.Thestepsofproductiondesignaremainlyasfollows(1)productiondesign.Accordingtotheworkshopproductionprocessandproductionmethodofthe2012editionofChinesepharmacopoeia,theflowchartofproductionprocessiscalculatedanddrawn.(2)calculationofreactionmaterial.(2)accordingtotheproductiontaskandproductionsystem,thebatchof2millionpiecesisdetermined,andthematerialbalanceofeachprocessiscompletedonthebasisof2millionpiecesofbatch.(3)equipmentselection.Usingeachstepofproductionmaterialinputcontentandyield,accordingtothebasicoperationofvarioustypesofproductionrange,choosethebesttypeoftheequipment,thearrangementofthereasonableproductionstaffworkperiodically.(4)workshopsetting.Ensurereasonableproductionconditions,productionsafetyandenvironmentalprotectionundertheprinciplesofgood,inaccordancewiththeprincipleofclassificationandnearby,theoveralllayoutofworkshopdesign,toachievethedesiredeffectoftheworkshopdesign.(5)non-technologicaldesign.Accordingtootherstandardsandstandardofliving,suchas"buildingdesignfirepreventioncode",wecandealwiththenon-processfromwastedisposal,safetyfirepreventionandlaborsafety.Keywords:Infantilestagnationspleenpill;GMP;Workshopdesign;Processdesign目录1绪论..........................................................................................................................11.1设计的背景及目的和意义..........................................................................................11.1.1设计的背景..............................................................................................................11.1.2设计的目的和意义..................................................................................................11.2设计的研究现状.........................................................................................................21.3工艺设计思路..............................................................................................................32工艺流程及物料衡算..............................................................................................42.1产品信息......................................................................................................................42.2标准处方及工艺流程图.............................................................................................42.3物料衡算.....................................................................................................................62.3.1工业配方...