片剂的制备工业药剂PPT课件.ppt

PurposeIntroductionEquipmentsandMaterialsProceduresExperimentalInstructionsQuestionsTestreport Purpose 1 Tomasterthebasictechnologicalcourseoftabletsthroughthepreparationofaspirintablets 2 Tobefamiliarwiththequalitycontroloftablets 3 Tobefamiliarwiththebasicstructureandoperationmethodofsingle punch Introduction Tabletsaresolidpreparationsofvariousshapes usuallyround andobtainedbycompressinguniformvolumesofparticlescontainingoneormoreactiveingredientswithsuitableexcipients Introduction tablettypes Someofthepharmaceuticaltablettypesbasedonthewayofadministrationorpresentationtothepatientarelistedontheright 1 Simpleuncoatedtablets2 Coatedtablets3 Effervescenttablets4 Buccalandsublingualtablets5 Chewabletablets6 Multilayeredtablets7 Sugarcoatedtablets8 Fast disintegratingtablets9 Vaginaltablets10 Osmotictablets11 Controlled releasetablets12 Multicomponenttablets Introduction tabletdesign Tabletformulationdesignstartswithapredeterminedvalue whichisthedosesize Tabletdesignisbasedontheexperienceandknowledgeofexcipients whicharematerialsservingthepurposeofmakingagoodtabletwhencombinedwithadrug Introduction tabletdesign Tabletexcipientscanbeclassifiedonthebasisoftheirfunctionalityaslistedbelow 1 Fillers diluents2 Binders3 Disintegrants4 Lubricants5 Glidants 6 Bufferingagents7 Sweeteners8 Wettingagents9 Coatingagents10 Matrixformers Introduction manufacturingprocesses Decidingonamanufacturingmethodisacomplextaskthatrequirestime equipment andformulationoptimization aswellasaclosecollaborationbetweenformulationscientistsandprocessengineers Ingeneralterms therearethreemanufacturingprocessesfortablets wetgranulation drygranulation anddirectcompression Introduction manufacturingprocesses Thepurposeofwetgranulationistoconvertthedrugandexcipientmixtureintogranulesthatflowwellintodies pressibilityWetgranulationcompressionmethodhasbeenwidelyusedintabletsproduction especiallyfordrugsresistanttowetandheat Introduction manufacturingprocesses Thestepsofwetgranulation Premixingdrugwithotheringredientsusingamixer Transferringthemixtureintoatraditionallowsheargranulatorwhereabindersolutionisaddedunderamechanicalshearuntilacertaindampmassandacertaingranulesizeareobtained Wetsievingofgranulesthroughadesiredscreensize Dryingofgranulesinatray ovendryer Drysieving millingofgranulestoacertainparticlesizedistribution Addingalubricanttothedrygranules Compressingthegranulesintotablets Introduction manufacturingprocesses Thestepsofwetgranulation 混合 压片 填充剂 黏合剂 崩解剂 API 辅料 粉碎和过筛 制软材 干燥 整粒 混合 制湿粒 润滑剂 崩解剂 湿法制粒压片工艺流程 Introduction manufacturingprocesses EquipmentsandMaterials Equipments electronicbalance single punchpress nylonsieve 16and18mesh punch 9 5mmshallowconcavepunch etc Materials aspirin ingranulecrystal tartaricacid talcumpowder starch concentratedhydrochloricacid sodiumhydroxide distilledwater etc Procedure 1 Preparationofaspirintablets 1 Formulation weightin100tablets Aspirin30gStarch2gTartaricacid0 2g10 starchpasteqsStarch1gTalcumpowder1 5g 2 PreparingprocessesPreparing10 starchpaste Heatingtheaqueousdispersionofstarch 2gstarchand0 2gtartaricacidin20mLwater at80 for15min Grindingaspirintopassthesieveof80meshes Mixingaspirinpowderwithstarch Adding10 starchpastetoprepareadampmass Screeningthedampmassthroughanylonsieveof18meshesintogranules Dryingofthewetgranulesat60 for15min Drysievingofgranulesthrough16meshes Addingstarchandtalcumpowdertodrygranuleswithblendinguniformly Compressingthegranulesintotablets 制软材 制湿粒 研磨 混合 干燥 整粒 压片 混合 制淀粉浆 single punchpress rotarytabletpress 2 Single punchpress manualdrivingwheel hopper feedshoe camgearing corecomponentsdie 模圈 lowerpunch 下冲 upperpunch 上冲 3 Installingofsingle punchpressInstallingofcorecomponentsInstallingofthelowerpunch安装下冲 旋松下冲固定螺钉 转动大皮带轮使下冲芯杆升到最高位置 将下冲插入下冲芯杆的孔中 注意使下冲杆的缺口斜面对准下冲紧固螺钉 并要插到底 最后旋紧下冲固定螺钉 Installingofthelowerpunch安装上冲 旋松上冲紧固螺母 将上冲插入上冲芯杆的孔中 要插到底 旋紧上冲紧固螺母 Installingofthemould安装中模 旋松中模固定螺钉 将中模拿平放入中模台板的孔中 旋紧中模固定螺钉 缓缓转动大皮带轮 调整中模台板的位置 使上冲进入中模孔中 旋紧中模台板固定螺钉 2 Adjustmentofout of tablets出片调整转动大皮带轮使下冲升到最高位置 观察下冲口面是否与中模平面相齐 或高或低都将影响出片 若不齐则旋松蝶形螺丝 松开齿轮压板转动上调节齿轮 使下冲口面与中模平面相齐 然后将压板按上 旋紧蝶形螺丝 用手转动大皮带轮 空车运转若正常 则可加料试压 进行下一步调整 3 Adjustmentoftabletweight片重调节旋松蝶形螺丝 松开齿轮压板 转动下调节齿轮向左转使下冲芯杆上升 则充填深度减少 药片重量减轻 调节好后将轮齿压板按上 旋紧蝶形螺丝 4 Adjustmentoftablethardness硬度调节旋松连杆锁紧螺母 转动上冲芯杆 向左转使上冲芯杆向下移动 则压力加大 压出的药片硬度增加 反之 硬度降低 调节好后用扳手卡住上冲芯杆下部的六方 将连杆锁紧螺母锁紧 4 Tabletcompression压片冲模的安装 调试完成后 即可启动电机试压 检查片重 硬度和表面光洁度等 质量如合格 即可投料批量生产 在生产过程中仍须随时检查药片质量 及时调整 5 QualitycontroloftabletsAftermanufacturingtablets aseriesoftestsarecarriedouttoassurethattheymeetthespecificationsofpharmacopoeiaorindustrystandards Thesetestsareaslistedontheright WeightWeightvariationDisintegrationHardnessFriabilityDissolutionDrugcontentuniformityThickness 1 TabletweightandweightvariationThequantityoffillplacedinthediecavityofatabletpressdeterminestheweightoftheresultingtablet Weightvariation sampleamount20tablets Tabletsshouldcomplywiththefollowingrequirementsstatedinthetablebelow 2 TablethardnessIngeneral tabletsshouldbesufficientlyhardtoresistbreakingduringnormalhandling packagingandshipping andyetsoftenoughtodisintegrateproperlyafterswallowing Hardnessofthetabletiscontrolledby orisaffectedby thedegreeofthepressureappliedduringthecompressionstage 2 TablethardnessSampleamount4tablets 3 TabletdisintegrationtestTabletsmustbetestedtoensuredisintegration TheCP BP USPandEPhaveofficialstandards includingdescriptionsoftheapparatustypedimensionsandtestconditions 3 TabletdisintegrationtestS