片剂的制备工业药剂

片剂的制备工业药剂Purpose1.Tomasterthebasictechnologicalcourseoftabletsthroughthepreparationofaspirintablets.2.Tobefamiliarwiththequalitycontroloftablets.3.Tobefamiliarwiththebasicstructureandoperationmethodofsingle-punch.2021/4/272IntroductionTabletsaresolidpreparationsofvariousshapes,usuallyround,andobtainedbycompressinguniformvolumesofparticlescontainingoneormoreactiveingredientswithsuitableexcipients.2021/4/273Introduction--tablettypesSomeofthepharmaceuticaltablettypesbasedonthewayofadministrationorpresentationtothepatientarelistedontheright:1.Simpleuncoatedtablets2.Coatedtablets3.Effervescenttablets4.Buccalandsublingualtablets5.Chewabletablets6.Multilayeredtablets7.Sugarcoatedtablets8.Fast-disintegratingtablets9.Vaginaltablets10.Osmotictablets11.Controlled-releasetablets12.Multicomponenttablets2021/4/274Introduction--

tabletdesignTabletformulationdesignstartswithapredeterminedvalue,whichisthedosesize.Tabletdesignisbasedontheexperienceandknowledgeofexcipients,whicharematerialsservingthepurposeofmakingagoodtabletwhencombinedwithadrug.2021/4/275Introduction--

tabletdesignTabletexcipientscanbeclassifiedonthebasisoftheirfunctionalityaslistedbelow:1.Fillers/diluents2.Binders3.Disintegrants4.Lubricants5.Glidants6.Bufferingagents7.Sweeteners8.Wettingagents9.Coatingagents10.Matrixformers2021/4/276Introduction--

manufacturingprocessesDecidingonamanufacturingmethodisacomplextaskthatrequirestime,equipment,andformulationoptimization,aswellasaclosecollaborationbetweenformulationscientistsandprocessengineers.Ingeneralterms,therearethreemanufacturingprocessesfortablets:wetgranulation,drygranulation,anddirectcompression.2021/4/277Introduction--

manufacturingprocessesThepurposeofwetgranulationistoconvertthedrugandexcipientmixtureintogranulesthatflowwellintodies,pressibilityWetgranulationcompressionmethodhasbeenwidelyusedintabletsproduction,especiallyfordrugsresistanttowetandheat.2021/4/278Introduction--

manufacturingprocessesThestepsofwetgranulationPremixingdrugwithotheringredientsusingamixer.Transferringthemixtureintoatraditionallowsheargranulatorwhereabindersolutionisaddedunderamechanicalshearuntilacertaindampmassandacertaingranulesizeareobtained.Wetsievingofgranulesthroughadesiredscreensize.Dryingofgranulesinatray-ovendryer.Drysieving/millingofgranulestoacertainparticlesizedistribution.Addingalubricanttothedrygranules.Compressingthegranulesintotablets.2021/4/279Introduction--

manufacturingprocessesThestepsofwetgranulation2021/4/2710

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--

manufacturingprocesses2021/4/2711EquipmentsandMaterialsEquipments:electronicbalance,single-punchpress,nylonsieve(16and18mesh),punch(9.5mmshallowconcavepunch),etc.Materials:aspirin(ingranulecrystal),tartaricacid,talcumpowder,starch,concentratedhydrochloricacid,sodiumhydroxide,distilledwater,etc.2021/4/2712Procedure1.Preparationofaspirintablets(1)Formulation(weightin100tablets)Aspirin 30gStarch 2gTartaricacid 0.2g10%starchpaste qsStarch 1gTalcumpowder 1.5g2021/4/2713(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2021/4/2714single-punchpressrotarytabletpress2021/4/27152.Single-punchpressmanualdrivingwheelhopperfeedshoecamgearingcorecomponents

die(模圈)lowerpunch(下冲)upperpunch(上冲)

2021/4/27162021/4/27172021/4/27182021/4/27193.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。2021/4/2720Installingofthelowerpunch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。2021/4/2721(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。2021/4/2722(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。2021/4/27234.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。2021/4/27245.QualitycontroloftabletsAftermanufacturingtablets,aseriesoftestsarecarriedouttoassurethattheymeetthespecificationsofpharmacopoeiaorindustrystandards.Thesetestsareaslistedontheright:WeightWeightvariationDisintegrationHardnessFriabilityDissolutionDrugcontentuniformityThickness2021/4/2725(1)TabletweightandweightvariationThequantityoffillplacedinthediecavityofatabletpressdeterminestheweightoftheresultingtablet.Weightvariation:sampleamount20tablets.Tabletsshouldcomplywiththefollowingrequirementsstatedinthetablebelow.AverageweightWeightvariationlimitLessthan0.3g±7.5%0.3gormore±5%2021/4/2726(2)TablethardnessIngeneral,tabletsshouldbesufficientlyhardtoresistbreakingduringnormalhandling,packagingandshipping,andyetsoftenoughtodisintegrateproperlyafterswallowing.Hardnessofthetabletiscontrolledby(orisaffectedby)thedegreeofthepressureappliedduringthecompressionstage.2021/4/2727(2)TablethardnessSampleamount4tablets.2021/4/2728(3)TabletdisintegrationtestTabletsmustbetestedtoensuredisintegration.TheCP,BP,USPandEPhaveofficialstandards,includingdescriptionsoftheapparatustypedimensionsandtestconditions.2021/4/2729(3)TabletdisintegrationtestSampleamount