胶囊剂生产设备CapsuleProductionEquipment课件

胶囊剂生产设备

CapsuleProductionEquipment制药设备使用与维护

OperationandMaintenanceofCommonPharmaceuticalEquipment知识目标KnowledgeObjectives（1）掌握胶囊剂生产流程（软胶囊、硬胶囊）。(1)Mastertheproductionprocessofcapsuleformulations(softcapsules,hardcapsules).（2）熟悉常用胶囊剂生产设备的结构与工作原理。(2)Familiarizewiththestructureandworkingprinciplesofcommonlyusedcapsuleproductionequipment.（3）了解常用胶囊剂设备的维护与保养及故障排除。(3)Understandthemaintenance,upkeep,andtroubleshootingofcommonlyusedcapsuleequipment.能力目标AbilityObjectives学会正确操作常用胶囊剂生产设备。Learntheproperoperationofcommonlyusedcapsuleproductionequipment.素质目标

Qualitygoal（1）认真执行GMP，严格按照SOP的要求进行生产。(1)StrictlyfollowGMPandadheretotherequirementsofSOPintheproductionprocess.（2）使学生具备胶囊剂生产岗位必备的基本知识、基本技能和职业素质。(2)Equipstudentswithessentialknowledge,basicskills,andprofessionalqualitiesrequiredforcapsuleproductionpositions.（3）通过“毒胶囊”案例强调职业道德、诚实守信品德的培养。(3)Emphasizethecultivationofprofessionalethics,honesty,andintegritythroughthecaseof"poisoncapsule".重点KeyPoints胶囊剂生产设备的结构与工作原理StructureandWorkingPrinciplesofCapsuleProductionEquipment难点Difficulties胶囊剂生产设备的正确操作ProperOperationofCapsuleProductionEquipment学习目标

LearningObjectives软胶囊剂是将一定量的液体药物密封于软质囊材中制成的固体制剂，又称胶丸，主要供内服，也可以用于直肠、阴道等，是目前应用最广泛的剂型之一。Softgelatincapsulesaresoliddosageformswhereinaspecificamountofliquidmedicationisencapsulatedwithinaflexiblecapsuleshell.Alsoknownasgelatincapsulesor"gelcaps,"theyareprimarilyusedfororaladministrationbutcanalsobeemployedforrectalorvaginaldelivery,representingoneofthemostwidelyuseddosageformstoday.制剂简介

FormulationIntroduction软胶囊剂生产流程

ProductionProcessofSoftGelatinCapsules制剂简介

FormulationIntroduction滴制技术制成的软胶囊剂称之为无缝胶丸

whilethosecreatedusingthedrippingmethodaretermed"seamless"capsules.软胶囊剂的制备方法有压制法和滴制法两种。

Therearetwomainmethodsforpreparingsoftgelatincapsules:compressionmoldingandthedrippingmethod.压制技术制成的软胶囊剂为有缝胶丸

Softgelatincapsulesproducedthroughcompressionmoldingarereferredtoas"seam"capsules,“毒胶囊”事件

"ThePoisonCapsule"Incident河北一些企业，用生石灰处理皮革废料，熬制成工业明胶，卖给绍兴新昌一些企业制成药用胶囊，最终流入药品企业，进入患者腹中。由于皮革在工业加工时，要使用含铬的鞣制剂，因此这样制成的胶囊，往往重金属铬超标。经检测，修正药业等9家药厂13个批次药品，所用胶囊重金属铬含量超标。针对此事件，2012年4月21日，卫生部要求毒胶囊企业所有胶囊药停用，药用胶囊接受审批检验。2012年4月22日，公安部通报，经调查，公安机关已立案7起，依法逮捕犯罪嫌疑人9名，刑事拘留45人。InHebei,someenterprisesprocessleatherwastewithquicklime,refiningitintoindustrialgelatin,whichisthensoldtocertaincompaniesinShaoxing'sXinchangregion.Thesecompaniesusethegelatintoproducemedicinalcapsules,whichultimatelyfindtheirwayintopharmaceuticalenterprisesandintothebodiesofpatients.Duetotheuseofchromium-containingtanningagentsintheindustrialprocessingofleather,thecapsulesproducedinthismanneroftencontainexcessivelevelsoftheheavymetalchromium.Upontesting,itwasfoundthat13batchesofpharmaceuticalproductsfrom9companies,includingXiudingPharmaceuticals,hadexceededthepermissiblelevelsofchromiumintheircapsules.Inresponsetothisincident,onApril21,2012,theMinistryofHealthissuedadirectivetohalttheuseofcapsulesfromthetoxiccapsule-producingenterprises,anddemandedthatthecapsulesusedformedicinalpurposesundergoinspectionandapproval.OnApril22,2012,theMinistryofPublicSecurityannouncedthatafteraninvestigation,lawenforcementagencieshadinitiatedlegalproceedingsin7cases,leadingtothearrestof9suspectsandthedetentionof45individualsinaccordancewiththelaw.职业道德，诚实守信

Adherencetoprofessionalethicsandhonestyisessential.软胶囊剂生产流程

ProductionProcessofSoftGelatinCapsules

滴制法制备软胶囊工艺流程

ProcessFlowforSoftGelatinCapsulePreparationviatheDrippingMethodD级洁净区ClassDcleanzone溶胶Solsolution明胶Gelatin外包Outsourcing入库Enterwarehouse外包Outsourcing原辅料Rawexcipients配料Batching喷嘴Nozzle滴制Dripping滴丸Droppingpills定型Shaping洗丸Washingpills干燥Drying拣丸Sortingpills软胶囊剂生产流程

ProductionProcessofSoftGelatinCapsules原辅料

RawMaterials填充泵

FillingPump楔型注入器

WedgeInjector压丸

PelletCompression定型

Shaping洗丸

Washing干燥

Drying拣丸

Sorting检验

Inspection包装

Packaging入库

Warehousing胶浆

GelatinMass制胶带

GelRibbonFormation胶带

GelRibbonConveyance滚压模

RollerCompactionMoldD级洁净区

ClassDCleanArea压制法制备软胶囊工艺流程

ProcessofSoftGelatinCapsulePreparationviaCompressionMoldingMethod工序质量控制点

QualityControlPointsintheProcess软胶囊剂的生产工序：

ProductionStepsforSoftGelatinCapsules:溶胶、配料、制丸、干燥、检丸和包装。

Solsolution,formulation,pelletformation,drying,pelletinspection,andpackaging.主要设备

MainEquipment

软胶囊压制设备

EquipmentforSoftGelatinCapsuleCompressionMolding软胶囊滴制设备

EquipmentforSoftGelatinCapsuleDripping设备结构

EquipmentStructure滚模式软胶囊机

RollingMoldSoftGelatinCapsuleMachine模压法生产软胶囊剂

ProductionofSoftGelatinCapsulesviaMoldingMethod主机、软胶囊输送机、定型干燥机、电气控制系统、明胶贮桶、药液贮桶。Mainmachine,softgelatincapsuleconveyor,shapinganddryingmachine,electricalcontrolsystem,gelatinreservoir,medicationliquidreservoir.软胶囊压制设备

EquipmentforSoftGelatinCapsuleCompressionMolding设备结构

EquipmentStructureRJWJ-115SoftGelatinCapsuleProductionLineStructureSetdryingrotarycageSoftgelatincapsulesdeliverytubeConveyormotorFuelregulatingPressuredischargeRiseanddescendMeshregulationRubberguidewheelTouchcontrolpanelUniversalwheelSoftgelatincapsulesdischargehopperSoftgelatincapsulesdischargeportConveyerbeltPedestal工作原理

Workingprinciple胶浆经过输胶管通过两侧预热的涂胶机箱1.Gelatinmassistransportedthroughfeedingpipestotheadhesivemachineboxesonbothsides,whicharepreheated.2.将胶浆涂布在温度为16℃～18℃的鼓轮上，随鼓轮转动定型成一定厚度的明胶带2.Thegelatinmassisspreadontothedrum,whichismaintainedatatemperatureof16°Cto18°C.Ittakestheshapeofagelribbonwithacertainthicknessasthedrumrotates.3.沿着胶带导杆和送料轴送入两滚模之间3.Thegelribbonisguidedalongbyribbonguidesandfedbetweenthetworollingmolds.4.同时药液由供料泵经导管进入楔形注射器4.Meanwhile,medicationliquidisdeliveredthroughconduitsintothewedgeinjector.LiquidreceiverConduitFedRibbonguideGelribbonTubeMoldMoldAdhesivemachineboxDrumFillingpumpWedgeinjectorTroughCapsulesconveyor工作原理

Workingprinciple5.借助供料泵的压力将药液及胶带压入两个滚模的凹槽中

5.Usingthepressurefromthefeedingpump,themedicationliquidandgelribbonarepressedintothegroovesofthetworollingmolds.6.滚模的连续转动，施加机械压力下使两条胶带呈两个半囊形并将药液包封其内

6.Thecontinuousrotationoftherollingmolds,aidedbymechanicalpressure,formstwosemi-capsulesfromthegelribbon,enclosingthemedicationliquidwithin.7.软胶囊依次落入导向斜槽内，并由输送机送出。

7.Thesoftgelatincapsulesfallsequentiallyintoguidingtroughsandarecarriedawaybytheconveyor.LiquidreceiverConduitFedRibbonguideGelribbonTubeMoldMoldAdhesivemachineboxDrumFillingpumpWedgeinjectorTroughCapsulesconveyor设备结构

EquipmentStructure滴制式软胶囊机

Dripping-TypeSoftGelatinCapsuleMachine:滴制法生产软胶囊剂

ProductionofSoftGelatinCapsulesviaDrippingMethod:滴制式胶囊机结构和工作原理

StructureandWorkingPrincipleofDripping-TypeCapsuleMachine:设备结构

EquipmentStructure滴制部分

DrippingSection:冷却部分

CoolingSection:电气控制部分

Electricalcontrolsection干燥部分

DryingSection:工作原理

Workingprinciple1.明胶液和油状药液分别由计量泵的活塞压入喷嘴的外层和内层，以不同的速度喷出。1.Gelatinoussolutionand

oilymedicationarepumpedintotheouterand

innerlayersofthenozzlebythepistonsofthemeteringpumps,andtheyaresprayedoutatdifferentspeeds.2.一定量的药液被定量的明胶液包裹滴入冷却柱。2.Aspecificamountofmedicationisenvelopedbyaprecisequantityofgelatinoussolutionanddrippedintothecoolingcolumn.MedicationliquidreservoirQuantitativecontrollerGelatinoussolutionconveyorSprinklerCoolingliquidparaffinoutletSprinkleramplificationCapsuleoutletCapsulecollectionboxCoolingpipeCoolingboxPumpLiquidparaffintank工作原理

Workingprinciple3.在冷却柱中，外层明胶液被冷却液冷却，并在表面张力的作用下收缩成球形，逐渐凝固成胶丸。3.Insidethecoolingcolumn,theoutergelatinoussolutioniscooledbyacoolingliquidand,undertheinfluenceofsurfacetension,contractsintoasphericalshape,graduallysolidifyingintocapsules.4.胶丸随液体石蜡流入过滤器，并被收集于滤网上，所得胶丸经清洗、烘干等工序后即得成品