阿司匹林复方片剂车间工艺设计说明书.docx

阿司匹林复方片剂车间工艺设计摘要阿司匹林是全世界应用最广泛的解热、镇痛和抗炎药物，也是比较和评价其他药物的标准制剂；阿司匹林复方片剂是一解热镇痛药物，其中阿司匹林和非那西丁均具有解热镇痛作用，咖啡因可以加强前两药缓解头痛的效果；片剂是国内外临床治疗中使用得最为广泛的剂型之一，它的化学稳定性较其他的剂型好，并且它具有携带方便、生产机械化程度高等优点；为了满足市场需求，本文对阿司匹林的车间与工艺进行了设计。制剂的工艺流程是以保证实现处方的功能主治为目的，紧紧围绕功能主治的要求，对药物的处理原则、方法和程序所作的最基本的规定。它决定着制剂质量的优劣，也决定着该制剂大生产的可行性和经济效益，本设计采用湿法制粒，然后进行压片、包衣和包装，在说明书中对生产工艺做了详细的介绍，并且对生产所需的设备进行了选型。生产规模为1.6亿片/年，在说明书中对所需的物料、包材进行了衡算。在设计中严格遵照《GMP》和《洁净厂房设计规范》等标准进行设计，车间布置设计时遵守设计程序，按照布局设计的原则，进行细致而周密的考虑，绘制了车间平面布置图，也对空调净化系统进行了相应的设计。关键词：阿司匹林复方片剂，车间，工艺，设计，设备选型THEDESIGNOFASPIRINCOMPOUNDTABLETSWORKSHOPPROCESSAspirinistheworld'smostwidelyusedantipyretic,analgesicandanti-inflammatorydrugs,butalsomorestandardpreparationandevaluationofotherdrugs.AspirinCompoundTabletsisanantipyreticandanalgesicdrug.Inthiscompoundtablets,aspirinandphenacetinhaveantipyreticandanalgesiceffects,caffeinecanenhancetheeffectofthefirsttwodrugstorelieveheadaches.Thetabletisoneofthemostwidelyusedformsinthedomesticandinternationalclinicaltreatment.Itschemicalstabilityisbetterthanotherformulations,anditiseasytocarryandProducebymechanical.Inordertomeetmarketdemand,aspirinworkshopandprocessaredesignedinthispaper.ThepurposeofthepreparationprocessistoensurethatachieveprescriptionIndications.ItisthebasicprovisiontightlyaroundIndicationsrequirements,principlesofdrugs,methodsandprocedures,andalsodeterminesthequalityofthepreparations,thefeasibilityandcostofthepreparationoflarge-scaleproduction.Inthispaper,wetgranulationisused.Thenthetabletswerecompressedcoatedandpackaged.Theproductionprocessisdescribedindetailinthespecification.Theproductionscaleis160millionperyear.Thenecessaryequipmentsusedinproductionareselected.Thedesiredmaterialsandpackagingmaterialsareaccountedinthespecification.Theworkshopisdesignedinstrictaccordancewiththe"GMP"and"cleanroomdesignspecificationsandotherstandards.DetailedandcarefulconsiderationisusedundercompliancewiththedesignprocessandinaccordancewiththeprinciplesoflayoutdesignatWorkshoplayoutdesign.Theworkshopfloorplanisdraw.Andtheairpurificat