片剂课程设计

武汉工程大学课程设计1目录目录................................................................1摘要............................................................3Abstract............................................................4第1章概述....................................................51.1设计要求....................................................51.2任务........................................................51.3设计范围....................................................51.4文字部分....................................................5第2章设计背景.....................................................62.1设计所需技术参数............................................62.1.1单片处方..............................................62.1.2产品规格及设计基准....................................62.2产品简介....................................................62.2.1盐酸度洛西汀简介......................................62.2.2物化性质..............................................72.2.3药理毒理.............................................72.2.5药物相互作用..........................................82.2.6临床应用.............................................102.2.7禁忌.................................................102.3设计方案选定...............................................102.3.1分散片的特点.........................................102.3.2分散片的处方.........................................112.3.3辅料.................................................112.3.4分散片的处方特点.....................................132.3.4分散片的工艺特点.....................................13第3章工艺流程与单元操作.........................................153.1工艺流程的选择.............................................153.1.1产品的工艺流程.......................................153.1.2单元操作.............................................15武汉工程大学课程设计23.1.3生产过程控制分析....................................213.2生产工艺验证...............................................213.2.1验证的目的和意义.....................................213.2.2工艺验证的要求.......................................213.2.3验证内容及标准.......................................22第4章物料衡算...................................................234.1物料衡算...................................................234.1.1基础计算数据.........................................234.1.2物料衡算内容.........................................234.2原辅料用量衡算............................................234.3包装材料衡算..............................................25第5章工艺设备计算与选型.........................................275.1工艺设备选型与设备选型原则.................................275.2工艺设备设计与选型的步骤...................................275.3主要设备选型与计算.........................................275.3.1粉碎设备.............................................285.3.2筛分设备.............................................295.3.3混合制粒.............................................305.3.4干燥.................................................305.3.5整粒.................................................325.3.6总混.................................................325.3.7压片设备.............................................335.3.8包装.................................................345.3.8.1内包装.............................................345.3.8.2包装纸盒的印字机械.................................355.3.8.3外包装.............................................365.3.8.4封箱机.............................................37第6章附录........................................................386.1设备一览表.................................................386.2参考文献...................................................39武汉工程大学课程设计3摘要本课程设计的任务是年产10亿片盐酸度洛西汀分散片剂物料衡算与设备选型。根据《药品生产质量管理规范》和我以往的实习车间实践，联系我们所学的专业课各方面知识，参照了《药剂学》、《药物分析》、《化工原理》、《制剂设备及车间工艺设计》等文献，以及丰富的网络资源，严格按照2010年版GMP等多种设计规范和管理规范进行，在老师和同学的帮助下努力成功完成了本次课程设计。经过准确额的计算和仔细的筛选，并参照药典规范，我设计了合理的工艺流程路线，设备选型，车间布置设计。此外，我还做了严格的物料衡算、热量衡算，力求达到GMP的标准。这次设计是专业知识和工程初步设计实践的结合，整个过程中得到了老师和同学们的大力支持和帮助，它培养了我们分析和解决工程中实际问题的综合能力，提高了应用AutoCAD绘制工程图纸的能力，增强了在中英文文献中收集有用信息的能力，同时也使我认识到在工艺生产中的任何一个环节都是至关重要的。关键词：分散片；盐酸度洛西汀；车间设计;武汉工程大学课程设计4AbstractThiscoursedesigntaskistoproduce1billionpiecesscatteredduloxetinehydrochloridetabletmaterialbalanceandequipmentselection.AccordingtoGoodManufacturingPracticeandmypreviousinternshipworkshoppractice,contactSpecializedknowledgeinallaspectsofourschool,referringtothepharmacy,druganalysis,ChemicalPrinciples,preparationequipmentandprocessdesignworkshopandotherliterature,aswellasarichnetworkofresources,instrictaccordancewiththe2010versionofGMP,thepharmaceuticalindustrycleandesignandotherdesignspecificationsandmanagementnorms,withthehelpofteachersandstudentsoftheeffortsofthesuccessfulcompletionofthiscoursedesign.AftercalculatingtheamountofaccurateandcarefulscreeningandreferPharmacopoeiaspecifications,Idesignedareasonableprocessroutes,equipmentselection,plantlayoutdesign.Inaddition,Ialsodoarigorousmaterialbalance,heatbalance,andstrivetoachieveGMPstandards.Thisdesignisacombinationofexpertiseandpreliminaryengineeringdesignpractice,thewholeprocesshasbeenateacherandstudentssupportandhelp,ithastrainedustoanalyzeandsolvepracticalproblemsinacomprehensiveengineeringcapabilities,improvedapplicationAutoCADdrawingabilitytoengineeringdrawings,andenhancetheabilitytogatherusefulinformati