胶囊剂生产设备CapsuleProductionEquipment61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硬胶囊剂是指将一定量的药物或药物加辅料制成均匀的粉末或颗粒充填于空心胶囊中制成的固体制剂。Hardcapsulesrefertosoliddosageformsmadebyfillingacertainamountofuniformpowderorgranules,consistingofdrugsandexcipients,intohollowcapsules.制剂简介

FormulationIntroduction硬胶囊剂生产流程

HardCapsuleFormulationProcess空心胶囊是由明胶或其它适宜的药用材料制成的具有弹性的两节圆筒，分别称为囊体和囊帽，两者能互相紧密套合。Hollowcapsulesarecomposedofelastictwo-partcylindricalbodiesmadeofgelatinorothersuitablepharmaceuticalmaterials.Thesepartsareknownasthecapsulebodyandthecapsulecap,whichfittightlytogether.制剂简介

FormulationIntroduction我国药用空胶囊标准共分8个型号，常用的为4、3、2、1、0、00号，其号数越大，容积越小。InChina,pharmaceuticalcapsulesarecategorizedinto8sizes,withcommonlyusedsizesbeing4,3,2,1,0,and00.Largernumberscorrespondtosmallervolumes.硬胶囊剂生产流程

HardCapsuleFormulationProcess硬胶囊剂是目前应用最广泛的剂型之一

Hardcapsulesareoneofthemostwidelyuseddosageforms.原辅料Rawexcipients内包材Innerpackagematerial外包材OuterpackagematerialD级洁净区ClassDcleanzone粉碎Crushing过筛Sieving混合Mixing内容物制备“粉末、颗粒、小丸等”Preparationofcontents"powder,granule,pellets,etc."空胶囊Emptycapsule消毒Disinfect消毒Disinfect胶囊填充Capsulefilling内包Insourcing外包Outsourcing入库Enterwarehouse工序质量控制点

QualityControlPointsintheProcess硬胶囊剂的生产工序：空胶囊的制备和充填物料的制备、装囊（充填）、抛光、质检、包装等。ProductionStepsofHardCapsules:Preparationofemptycapsulesandfillingmaterials,capsulefilling,polishing,qualityinspection,packaging,etc.主要设备

MainEquipment

半自动胶囊填充机结构和工作原理

StructureandWorkingPrinciplesofSemi-AutomaticCapsuleFillingMachine由送囊定向分离机构、药料充填机构、播囊机构、锁囊机构、气动控制和电器控制系统、保护装置等部件以及真空泵和气泵附件组成。Composedofcomponentssuchasthecapsulefeedingandseparatingmechanism,drugfillingmechanism,capsuledispensingmechanism,capsulelockingmechanism,pneumaticcontrolandelectricalcontrolsystems,safetydevices,aswellasvacuumandairpumpattachments.设备外观

EquipmentAppearance全自动胶囊填充机

FullyAutomaticCapsuleFillingMachine填充杆计量盘

FillingRodMeteringDisc胶囊板

CapsuleTray设备结构

EquipmentStructure空胶囊排序与定向装置

HollowCapsuleSortingandOrientingDevice拔囊装置

CapsuleExtractionDevice帽体错位装置

CapDisplacementDevice计量充填装置

MeteringFillingDevice剔除废囊装置

RemovingWasteCapsuleDevice闭合胶囊装置

CapsuleClosureDevice出囊装置

CapsuleEjectionDevice清洁装置

CleaningDevice设备结构

EquipmentStructure工作原理

Workingprinciple1.SupplyandarrangementorientationCleaning2.Separationofbodyandcap3.Capdisplacement4.Materialfilling5.Removalofwastecapsules6.Capclosure7.Capsuledischarge工作原理

Workingprinciple1.供给→排列

Supply→Arrangement空胶囊从供给池下落到排列轨道

Emptycapsulesfallfromthesupplypoolontothearrangementtrack.工作原理

Workingprinciple校准方向

CalibratingDirection先水平定向，囊体在前，囊帽在后；

Horizontalorientationfirst,withthecapsulebodyinfrontandthecapsulecapintheback;再垂直定向，囊体在下，囊帽在上。

Thenverticalorientation,withthecapsulebodybelowandthecapsulecapabove.定向原理

OrientationPrinciple推爪的推力点在囊体上；滑槽的宽度比囊帽的外径小，比囊体的外径大，滑槽只对囊帽有卡紧作用；Thepushingpointoftheclawisonthecapsulebody;thewidthofthechuteissmallerthantheouterdiameterofthecapsulecapbutlargerthantheouterdiameterofthecapsulebody,sothechuteonlyclampsthecapsulecap.工作原理

Workingprinciple2.体帽分离

2.SeparationofBodyandCap负压吸入空胶囊整体到上囊板模孔中，限位台阶孔挡住囊帽下行，胶囊体则落入下囊板孔中。Negativepressuresuckstheemptycapsuleasawholeintotheupperplatemoldhole,andthelimitstepholestopsthedownwardmovementofthecapsulecap,allowingthecapsulebodytofallintothelowerplatehole.限位台阶

Limitstep3.物料填充

3.MaterialFilling工作原理

WorkingprincipleTremiepipeFillingfinetuningknobFillingmissingprobeconductorFillingpushrodpositionscaleFillingscrewfixedplatformFillingpushrodPackingtablesupportshaftPack3.物料填充

3.MaterialFilling工作原理

Workingprinciple装药量的大小主要由设备中计量盘的厚度确定，计量盘厚度要根据充填物的粒度、流动性等因素来选择。

Theamountofmedicinefilledismainlydeterminedbythethicknessofthemeasuringdiscintheequipment.Thethicknessofthemeasuringdiscshouldbeselectedbasedonfactorssuchasthegranularityandfluidityofthefillingmaterial.作为一种判定标准，可以用现有充填物直接测量单个计量盘孔的装填量以确定计量盘的厚度是否合适。

Asacriterion,theamountoffillinginasinglemeasuringdischolecanbedirectlymeasuredusingexistingfillingmaterialtodetermineifthethicknessofthemeasuringdiscissuitable.充填杆由第1到第5工位下降深度一般为50%、30%、20%、10%、1%。

Thedescentdepthsofthefillingrodsforstations1to5aregenerally50%,30%,20%,10%,1%.PackStep6Step5Step4Step3Step2Step11-充填杆2-导向装置3-计量盘4-成型粉柱5-胶囊体1-Fillingrod2-Guidingdevice3-Measuringdisc4-Moldingpowdercolumn5-CapsulebodyFigure2Fillingmeasuringscheme4.剔除废囊

4.RemovalofWasteCapsules吸走空胶囊

Suckawayemptycapsules工作原理

Workingprinciple5.胶囊闭合

5.CapsuleClosure轴线对齐

Aligningtheaxes.工作原理

Workingprinciple6.出囊

6.CapsuleEjection工作原理

Workingprinciple7.清洁

7.Cleaning工作原理

WorkingprincipleConnectedtocompressedairsystemConnectedtothesuctionsystem“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,anddemandedthatthecapsulesusedformedicinalpurposesundergoinspectiona