片劑的制備工業(yè)藥劑

片劑的制備工業(yè)藥劑Purpose1.Tomasterthebasictechnologicalcourseoftabletsthroughthepreparationofaspirintablets.2.Tobefamiliarwiththequalitycontroloftablets.3.Tobefamiliarwiththebasicstructureandoperationmethodofsingle-punch.IntroductionTabletsaresolidpreparationsofvariousshapes,usuallyround,andobtainedbycompressinguniformvolumesofparticlescontainingoneormoreactiveingredientswithsuitableexcipients.Introduction--tablettypesSomeofthepharmaceuticaltablettypesbasedonthewayofadministrationorpresentationtothepatientarelistedontheright:1.Simpleuncoatedtablets2.Coatedtablets3.Effervescenttablets4.Buccalandsublingualtablets5.Chewabletablets6.Multilayeredtablets7.Sugarcoatedtablets8.Fast-disintegratingtablets9.Vaginaltablets10.Osmotictablets11.Controlled-releasetablets12.MulticomponenttabletsIntroduction--tabletdesignTabletformulationdesignstartswithapredeterminedvalue,whichisthedosesize.Tabletdesignisbasedontheexperienceandknowledgeofexcipients,whicharematerialsservingthepurposeofmakingagoodtabletwhencombinedwithadrug.Introduction--tabletdesignTabletexcipientscanbeclassifiedonthebasisoftheirfunctionalityaslistedbelow:1.Fillers/diluents2.Binders3.Disintegrants4.Lubricants5.Glidants6.Bufferingagents7.Sweeteners8.Wettingagents9.Coatingagents10.MatrixformersIntroduction--manufacturingprocessesDecidingonamanufacturingmethodisacomplextaskthatrequirestime,equipment,andformulationoptimization,aswellasaclosecollaborationbetweenformulationscientistsandprocessengineers.Ingeneralterms,therearethreemanufacturingprocessesfortablets:wetgranulation,drygranulation,anddirectcompression.Introduction--manufacturingprocessesThepurposeofwetgranulationistoconvertthedrugandexcipientmixtureintogranulesthatflowwellintodies,pressibilityWetgranulationcompressionmethodhasbeenwidelyusedintabletsproduction,especiallyfordrugsresistanttowetandheat.Introduction--manufacturingprocessesThestepsofwetgranulationPremixingdrugwithotheringredientsusingamixer.Transferringthemixtureintoatraditionallowsheargranulatorwhereabindersolutionisaddedunderamechanicalshearuntilacertaindampmassandacertaingranulesizeareobtained.Wetsievingofgranulesthroughadesiredscreensize.Dryingofgranulesinatray-ovendryer.Drysieving/millingofgranulestoacertainparticlesizedistribution.Addingalubricanttothedrygranules.Compressingthegranulesintotablets.Introduction--manufacturingprocessesThestepsofwetgranulation

混合壓片填充劑黏合劑崩解劑API輔料粉碎和過篩制軟材干燥整?；旌现茲窳櫥瑒┍澜鈩穹ㄖ屏浩に嚵鞒蘄ntroduction--manufacturingprocessesEquipmentsandMaterialsEquipments:electronicbalance,single-punchpress,nylonsieve(16and18mesh),punch(9.5mmshallowconcavepunch),etc.Materials:aspirin(ingranulecrystal),tartaricacid,talcumpowder,starch,concentratedhydrochloricacid,sodiumhydroxide,distilledwater,etc.Procedure1.Preparationofaspirintablets(1)Formulation(weightin100tablets)Aspirin 30gStarch 2gTartaricacid 0.2g10%starchpaste qsStarch 1gTalcumpowder 1.5g(2)PreparingprocessesPreparing10%starchpaste:Heatingtheaqueousdispersionofstarch(2gstarchand0.2gtartaricacidin20mLwater)at80℃for15min.Grindingaspirintopassthesieveof80meshes.Mixingaspirinpowderwithstarch.Adding10%starchpastetoprepareadampmass.Screeningthedampmassthroughanylonsieveof18meshesintogranules.Dryingofthewetgranulesat60℃for15min.Drysievingofgranulesthrough16meshes.Addingstarchandtalcumpowdertodrygranuleswithblendinguniformly.Compressingthegranulesintotablets.制軟材制濕粒研磨混合干燥整粒壓片混合制淀粉漿single-punchpressrotarytabletpress2.Single-punchpressmanualdrivingwheelhopperfeedshoecamgearingcorecomponentsdie(模圈)lowerpunch(下沖)upperpunch(上沖)

3.Installingofsingle-punchpressInstallingofcorecomponentsInstallingofthelowerpunch安裝下沖：旋松下沖固定螺釘，轉(zhuǎn)動大皮帶輪使下沖芯桿升到最高位置，將下沖插入下沖芯桿的孔中（注意使下沖桿的缺口斜面對準(zhǔn)下沖緊固螺釘，并要插到底）最后旋緊下沖固定螺釘。Installingofthelowerpunch安裝上沖：旋松上沖緊固螺母，將上沖插入上沖芯桿的孔中，要插到底，旋緊上沖緊固螺母。Installingofthemould安裝中模：旋松中模固定螺釘，將中模拿平放入中模臺板的孔中，旋緊中模固定螺釘。緩緩轉(zhuǎn)動大皮帶輪，調(diào)整中模臺板的位置，使上沖進入中模孔中，旋緊中模臺板固定螺釘。(2)Adjustmentofout-of-tablets出片調(diào)整轉(zhuǎn)動大皮帶輪使下沖升到最高位置，觀察下沖口面是否與中模平面相齊（或高或低都將影響出片），若不齊則旋松蝶形螺絲，松開齒輪壓板轉(zhuǎn)動上調(diào)節(jié)齒輪，使下沖口面與中模平面相齊，然后將壓板按上，旋緊蝶形螺絲。用手轉(zhuǎn)動大皮帶輪，空車運轉(zhuǎn)若正常，則可加料試壓，進行下一步調(diào)整。(3)Adjustmentoftabletweight片重調(diào)節(jié)旋松蝶形螺絲，松開齒輪壓板。轉(zhuǎn)動下調(diào)節(jié)齒輪向左轉(zhuǎn)使下沖芯桿上升，則充填深度減少（藥片重量減輕）。調(diào)節(jié)好后將輪齒壓板按上，旋緊蝶形螺絲。(4)Adjustmentoftablethardness硬度調(diào)節(jié)旋松連桿鎖緊螺母、轉(zhuǎn)動上沖芯桿，向左轉(zhuǎn)使上沖芯桿向下移動，則壓力加大，壓出的藥片硬度增加；反之，硬度降低。調(diào)節(jié)好后用扳手卡住上沖芯桿下部的六方，將連桿鎖緊螺母鎖緊。4.Tabletcompression壓片沖模的安裝、調(diào)試完成后，即可啟動電機試壓，檢查片重、硬度和表面光潔度等，質(zhì)量如合格，即可投料批量生產(chǎn)。在生產(chǎn)過程中仍須隨時檢查藥片質(zhì)量，及時調(diào)整。5.QualitycontroloftabletsAftermanufacturingtablets,aseriesoftestsarecarriedouttoassurethattheymeetthespecificationsofpharmacopoeiaorindustrystandards.Thesetestsareaslistedontheright:WeightWeightvariationDisintegrationHardnessFriabilityDissolutionDrugcontentuniformityThickness(1)TabletweightandweightvariationThequantityoffillplacedinthediecavityofatabletpressdeterminestheweightoftheresultingtablet.Weightvariation:sampleamount20tablets.Tabletsshouldcomplywiththefollowingrequirementsstatedinthetablebelow.AverageweightWeightvariationlimitLessthan0.3g±7.5%0.3gormore±5%(2)TablethardnessIngeneral,tabletsshouldbesufficientlyhardtoresistbreakingduringnormalhandling,packagingandshipping,andyetsoftenoughtodisintegrateproperlyafterswallowing.Hardnessoftheta