片剂的制备工业药剂演示文稿

片剂的制备工业药剂演示文稿目前一页\总数三十六页\编于十点（优选）片剂的制备工业药剂目前二页\总数三十六页\编于十点PurposeIntroductionEquipmentsandMaterialsProceduresExperimentalInstructionsQuestionsTestreport

目前三页\总数三十六页\编于十点Purpose1.Tomasterthebasictechnologicalcourseoftabletsthroughthepreparationofaspirintablets.2.Tobefamiliarwiththequalitycontroloftablets.3.Tobefamiliarwiththebasicstructureandoperationmethodofsingle-punch.目前四页\总数三十六页\编于十点IntroductionTabletsaresolidpreparationsofvariousshapes,usuallyround,andobtainedbycompressinguniformvolumesofparticlescontainingoneormoreactiveingredientswithsuitableexcipients.目前五页\总数三十六页\编于十点Introduction--tablettypesSomeofthepharmaceuticaltablettypesbasedonthewayofadministrationorpresentationtothepatientarelistedontheright:1.Simpleuncoatedtablets2.Coatedtablets3.Effervescenttablets4.Buccalandsublingualtablets5.Chewabletablets6.Multilayeredtablets7.Sugarcoatedtablets8.Fast-disintegratingtablets9.Vaginaltablets10.Osmotictablets11.Controlled-releasetablets12.Multicomponenttablets目前六页\总数三十六页\编于十点Introduction--

tabletdesignTabletformulationdesignstartswithapredeterminedvalue,whichisthedosesize.Tabletdesignisbasedontheexperienceandknowledgeofexcipients,whicharematerialsservingthepurposeofmakingagoodtabletwhencombinedwithadrug.目前七页\总数三十六页\编于十点Introduction--

tabletdesignTabletexcipientscanbeclassifiedonthebasisoftheirfunctionalityaslistedbelow:1.Fillers/diluents2.Binders3.Disintegrants4.Lubricants5.Glidants6.Bufferingagents7.Sweeteners8.Wettingagents9.Coatingagents10.Matrixformers目前八页\总数三十六页\编于十点Introduction--

manufacturingprocessesDecidingonamanufacturingmethodisacomplextaskthatrequirestime,equipment,andformulationoptimization,aswellasaclosecollaborationbetweenformulationscientistsandprocessengineers.Ingeneralterms,therearethreemanufacturingprocessesfortablets:wetgranulation,drygranulation,anddirectcompression.目前九页\总数三十六页\编于十点Introduction--

manufacturingprocessesThepurposeofwetgranulationistoconvertthedrugandexcipientmixtureintogranulesthatflowwellintodies,pressibilityWetgranulationcompressionmethodhasbeenwidelyusedintabletsproduction,especiallyfordrugsresistanttowetandheat.目前十页\总数三十六页\编于十点Introduction--

manufacturingprocessesThestepsofwetgranulationPremixingdrugwithotheringredientsusingamixer.Transferringthemixtureintoatraditionallowsheargranulatorwhereabindersolutionisaddedunderamechanicalshearuntilacertaindampmassandacertaingranulesizeareobtained.Wetsievingofgranulesthroughadesiredscreensize.Dryingofgranulesinatray-ovendryer.Drysieving/millingofgranulestoacertainparticlesizedistribution.Addingalubricanttothedrygranules.Compressingthegranulesintotablets.目前十一页\总数三十六页\编于十点Introduction--

manufacturingprocessesThestepsofwetgranulation目前十二页\总数三十六页\编于十点

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目前十三页\总数三十六页\编于十点EquipmentsandMaterialsEquipments:electronicbalance,single-punchpress,nylonsieve(16and18mesh),punch(9.5mmshallowconcavepunch),etc.Materials:aspirin(ingranulecrystal),tartaricacid,talcumpowder,starch,concentratedhydrochloricacid,sodiumhydroxide,distilledwater,etc.目前十四页\总数三十六页\编于十点Procedure1.Preparationofaspirintablets(1)Formulation(weightin100tablets)Aspirin 30gStarch 2gTartaricacid 0.2g10%starchpaste qsStarch 1gTalcumpowder 1.5g目前十五页\总数三十六页\编于十点(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目前十六页\总数三十六页\编于十点single-punchpressrotarytabletpress目前十七页\总数三十六页\编于十点2.Single-punchpressmanualdrivingwheelhopperfeedshoecamgearingcorecomponents

die(模圈)lowerpunch(下冲)upperpunch(上冲)

目前十八页\总数三十六页\编于十点目前十九页\总数三十六页\编于十点目前二十页\总数三十六页\编于十点目前二十一页\总数三十六页\编于十点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。目前二十二页\总数三十六页\编于十点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。目前二十三页\总数三十六页\编于十点(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。目前二十四页\总数三十六页\编于十点(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。目前二十五页\总数三十六页\编于十点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。目前二十六页\总数三十六页\编于十点5.QualitycontroloftabletsAftermanufacturingtablets,aseriesoftestsarecarriedouttoassurethattheymeetthespecificationsofpharmacopoeiaorindustrystandards.Thesetestsareaslistedontheright:WeightWeightvariationDisintegrationHardnessFriabilityDissolutionDrugcontentuniformityThickness目前二十七页\总数三十六页\编于十点(1)TabletweightandweightvariationThequantityoffillplacedinthediecavityofatabletpressdeterminestheweightoftheresultingtablet.Weightvariation:sampleamount20tablets.Tabletsshouldcomplywiththefollowingrequirementsstatedinthetablebelow.AverageweightWeightvariationlimitLessthan0.3g±7.5%0.3gormore±5%目前二十八页\总数三十六页\编于十点(2)TablethardnessIngeneral,tabletsshouldbesufficientlyhardtoresistbreakingduringnormalhandling,packagingandshipping,andyetsoftenoughtodisintegrateproperlyafterswallowing.Hardnessofthetabletiscontrolledby(orisaffectedby)thedegreeofthepressureappliedduringthecompressionstage.目前二十九页\总数三十六页\编于十点(2)TablethardnessSampleamount4tablets.目前三十页\总数三十六页\编于十点(3)TabletdisintegrationtestTabletsmustbetestedtoensuredisintegration.TheCP,BP,USPandEPhaveofficialstandards,includingdescriptionsoftheapparatustypedimensionsandtestconditions.目前三十一页\总数三十六页\编于十点(3)TabletdisintegrationtestSampleamount6tablets.目前三十二页\总数三十六页\编于十点(4)TabletfriabilityThistestshowsthestrengthoftabletsagainstmechanicalattrition.Method:allowingthetabletstorollandfallwithintherotatingapparatus(friabilator);determinethelossinweight;Requirement:weightloss≤1%目前三十三页\总数三十六页\编于十点(4)Tabletfriability目前三十四页\总数三十六页\编于十点ExperimentalInstructions1.Aspirinacidshouldbemilledandforcedthroughscreen(80mesh),th