片剂的制备工业药剂PPT课件

-,1,PurposeIntroductionEquipmentsandMaterialsProceduresExperimentalInstructionsQuestionsTestreport,-,2,Purpose,1.Tomasterthebasictechnologicalcourseoftabletsthroughthepreparationofaspirintablets.2.Tobefamiliarwiththequalitycontroloftablets.3.Tobefamiliarwiththebasicstructureandoperationmethodofsingle-punch.,-,3,Introduction,Tabletsaresolidpreparationsofvariousshapes,usuallyround,andobtainedbycompressinguniformvolumesofparticlescontainingoneormoreactiveingredientswithsuitableexcipients.,-,4,Introduction-tablettypes,Someofthepharmaceuticaltablettypesbasedonthewayofadministrationorpresentationtothepatientarelistedontheright:,1.Simpleuncoatedtablets2.Coatedtablets3.Effervescenttablets4.Buccalandsublingualtablets5.Chewabletablets6.Multilayeredtablets7.Sugarcoatedtablets8.Fast-disintegratingtablets9.Vaginaltablets10.Osmotictablets11.Controlled-releasetablets12.Multicomponenttablets,-,5,Introduction-tabletdesign,Tabletformulationdesignstartswithapredeterminedvalue,whichisthedosesize.Tabletdesignisbasedontheexperienceandknowledgeofexcipients,whicharematerialsservingthepurposeofmakingagoodtabletwhencombinedwithadrug.,-,6,Introduction-tabletdesign,Tabletexcipientscanbeclassifiedonthebasisoftheirfunctionalityaslistedbelow:,1.Fillers/diluents2.Binders3.Disintegrants4.Lubricants5.Glidants,6.Bufferingagents7.Sweeteners8.Wettingagents9.Coatingagents10.Matrixformers,-,7,Introduction-manufacturingprocesses,Decidingonamanufacturingmethodisacomplextaskthatrequirestime,equipment,andformulationoptimization,aswellasaclosecollaborationbetweenformulationscientistsandprocessengineers.Ingeneralterms,therearethreemanufacturingprocessesfortablets:wetgranulation,drygranulation,anddirectcompression.,-,8,Introduction-manufacturingprocesses,Thepurposeofwetgranulationistoconvertthedrugandexcipientmixtureintogranulesthatflowwellintodies,pressibilityWetgranulationcompressionmethodhasbeenwidelyusedintabletsproduction,especiallyfordrugsresistanttowetandheat.,-,9,Introduction-manufacturingprocesses,Thestepsofwetgranulation,Premixingdrugwithotheringredientsusingamixer.Transferringthemixtureintoatraditionallowsheargranulatorwhereabindersolutionisaddedunderamechanicalshearuntilacertaindampmassandacertaingranulesizeareobtained.Wetsievingofgranulesthroughadesiredscreensize.Dryingofgranulesinatray-ovendryer.Drysieving/millingofgranulestoacertainparticlesizedistribution.Addingalubricanttothedrygranules.Compressingthegranulesintotablets.,-,10,Introduction-manufacturingprocesses,Thestepsofwetgranulation,-,11,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,-,12,EquipmentsandMaterials,Equipments:electronicbalance,single-punchpress,nylonsieve(16and18mesh),punch(9.5mmshallowconcavepunch),etc.Materials:aspirin(ingranulecrystal),tartaricacid,talcumpowder,starch,concentratedhydrochloricacid,sodiumhydroxide,distilledwater,etc.,-,13,Procedure,1.Preparationofaspirintablets(1)Formulation(weightin100tablets)Aspirin30gStarch2gTartaricacid0.2g10%starchpasteqsStarch1gTalcumpowder1.5g,-,14,(2)PreparingprocessesPreparing10%starchpaste:Heatingtheaqueousdispersionofstarch(2gstarchand0.2gtartaricacidin20mLwater)at80for15min.Grindingaspirintopassthesieveof80meshes.Mixingaspirinpowderwithstarch.Adding10%starchpastetoprepareadampmass.Screeningthedampmassthroughanylonsieveof18meshesintogranules.Dryingofthewetgranulesat60for15min.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,-,15,single-punchpress,rotarytabletpress,-,16,2.Single-punchpress,manualdrivingwheel,hopper,feedshoe,camgearing,corecomponentsdie(模圈)lowerpunch(下冲)upperpunch(上冲),-,17,-,18,-,19,-,20,3.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。,-,21,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。,-,22,(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。,-,23,(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。,-,24,4.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。,-,25,5.QualitycontroloftabletsAftermanufacturingtablets,aseriesoftestsarecarriedouttoassurethattheymeetthespecificationsofpharmacopoeiaorindustrystandards.Thesetestsareaslistedontheright:,WeightWeightvariationDisintegrationHardnessFriabilityDissolutionDrugcontentuniformityThickness,-,26,(1)TabletweightandweightvariationThequantityoffillplacedinthediecavityofatabletpressdeterminestheweightoftheresultingtablet.Weightvariation:sampleamount20tablets.Tabletsshouldcomplywiththefollowingrequirementsstatedinthetablebelow.,-,27,(2)TablethardnessIngeneral,tabletsshouldbesufficientlyhardtoresistbreakingduringnormalhandling,packagingandshipping,andyetsoftenoughtodisintegrateproperlyafterswallowing.Hardnessofthetabletiscontrolledby(orisaffectedby)thedegreeofthepressureappliedduringthecompressionstage.,-,28,(2)TablethardnessSampleamount4tablets.,-,29,(3)TabletdisintegrationtestTabletsmustbetestedtoensuredisintegration.TheCP,BP,USPandEPhaveofficialstandards,includingdescriptionsoftheapparatustypedimensionsandtestconditions.,-,30,(3)TabletdisintegrationtestSamp