膠囊劑生產設備

CapsuleProductionEquipment制藥設備使用與維護

OperationandMaintenanceofCommonPharmaceuticalEquipment知識目標KnowledgeObjectives（1）掌握膠囊劑生產流程（軟膠囊、硬膠囊）。(1)Mastertheproductionprocessofcapsuleformulations(softcapsules,hardcapsules).（2）熟悉常用膠囊劑生產設備的結構與工作原理。(2)Familiarizewiththestructureandworkingprinciplesofcommonlyusedcapsuleproductionequipment.（3）了解常用膠囊劑設備的維護與保養及故障排除。(3)Understandthemaintenance,upkeep,andtroubleshootingofcommonlyusedcapsuleequipment.能力目標AbilityObjectives學會正確操作常用膠囊劑生產設備。Learntheproperoperationofcommonlyusedcapsuleproductionequipment.素質目標

Qualitygoal（1）認真執行GMP，嚴格按照SOP的要求進行生產。(1)StrictlyfollowGMPandadheretotherequirementsofSOPintheproductionprocess.（2）使學生具備膠囊劑生產崗位必備的基本知識、基本技能和職業素質。(2)Equipstudentswithessentialknowledge,basicskills,andprofessionalqualitiesrequiredforcapsuleproductionpositions.（3）通過“毒膠囊”案例強調職業道德、誠實守信品德的培養。(3)Emphasizethecultivationofprofessionalethics,honesty,andintegritythroughthecaseof"poisoncapsule".重點KeyPoints膠囊劑生產設備的結構與工作原理StructureandWorkingPrinciplesofCapsuleProductionEquipment難點Difficulties膠囊劑生產設備的正確操作ProperOperationofCapsuleProductionEquipment學習目標

LearningObjectives硬膠囊劑是指將一定量的藥物或藥物加輔料制成均勻的粉末或顆粒充填于空心膠囊中制成的固體制劑。Hardcapsulesrefertosoliddosageformsmadebyfillingacertainamountofuniformpowderorgranules,consistingofdrugsandexcipients,intohollowcapsules.制劑簡介

FormulationIntroduction硬膠囊劑生產流程

HardCapsuleFormulationProcess空心膠囊是由明膠或其它適宜的藥用材料制成的具有彈性的兩節圓筒，分別稱為囊體和囊帽，兩者能互相緊密套合。Hollowcapsulesarecomposedofelastictwo-partcylindricalbodiesmadeofgelatinorothersuitablepharmaceuticalmaterials.Thesepartsareknownasthecapsulebodyandthecapsulecap,whichfittightlytogether.制劑簡介

FormulationIntroduction我國藥用空膠囊標準共分8個型號，常用的為4、3、2、1、0、00號，其號數越大，容積越小。InChina,pharmaceuticalcapsulesarecategorizedinto8sizes,withcommonlyusedsizesbeing4,3,2,1,0,and00.Largernumberscorrespondtosmallervolumes.硬膠囊劑生產流程

HardCapsuleFormulationProcess硬膠囊劑是目前應用最廣泛的劑型之一

Hardcapsulesareoneofthemostwidelyuseddosageforms.原輔料Rawexcipients內包材Innerpackagematerial外包材OuterpackagematerialD級潔凈區ClassDcleanzone粉碎Crushing過篩Sieving混合Mixing內容物制備“粉末、顆粒、小丸等”Preparationofcontents"powder,granule,pellets,etc."空膠囊Emptycapsule消毒Disinfect消毒Disinfect膠囊填充Capsulefilling內包Insourcing外包Outsourcing入庫Enterwarehouse工序質量控制點

QualityControlPointsintheProcess硬膠囊劑的生產工序：空膠囊的制備和充填物料的制備、裝囊（充填）、拋光、質檢、包裝等。ProductionStepsofHardCapsules:Preparationofemptycapsulesandfillingmaterials,capsulefilling,polishing,qualityinspection,packaging,etc.主要設備

MainEquipment

半自動膠囊填充機結構和工作原理

StructureandWorkingPrinciplesofSemi-AutomaticCapsuleFillingMachine由送囊定向分離機構、藥料充填機構、播囊機構、鎖囊機構、氣動控制和電器控制系統、保護裝置等部件以及真空泵和氣泵附件組成。Composedofcomponentssuchasthecapsulefeedingandseparatingmechanism,drugfillingmechanism,capsuledispensingmechanism,capsulelockingmechanism,pneumaticcontrolandelectricalcontrolsystems,safetydevices,aswellasvacuumandairpumpattachments.設備外觀

EquipmentAppearance全自動膠囊填充機

FullyAutomaticCapsuleFillingMachine填充桿計量盤

FillingRodMeteringDisc膠囊板

CapsuleTray設備結構

EquipmentStructure空膠囊排序與定向裝置

HollowCapsuleSortingandOrientingDevice拔囊裝置

CapsuleExtractionDevice帽體錯位裝置

CapDisplacementDevice計量充填裝置

MeteringFillingDevice剔除廢囊裝置

RemovingWasteCapsuleDevice閉合膠囊裝置

CapsuleClosureDevice出囊裝置

CapsuleEjectionDevice清潔裝置

CleaningDevice設備結構

EquipmentStructure工作原理

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

Workingprinciple1.供給→排列

Supply→Arrangement空膠囊從供給池下落到排列軌道

Emptycapsulesfallfromthesupplypoolontothearrangementtrack.工作原理

Workingprinciple校準方向

CalibratingDirection先水平定向，囊體在前，囊帽在后；

Horizontalorientationfirst,withthecapsulebodyinfrontandthecapsulecapintheback;再垂直定向，囊體在下，囊帽在上。

Thenverticalorientation,withthecapsulebodybelowandthecapsulecapabove.定向原理

OrientationPrinciple推爪的推力點在囊體上；滑槽的寬度比囊帽的外徑小，比囊體的外徑大，滑槽只對囊帽有卡緊作用；Thepushingpointoftheclawisonthecapsulebody;thewidthofthechuteissmallerthantheouterdiameterofthecapsulecapbutlargerthantheouterdiameterofthecapsulebody,sothechuteonlyclampsthecapsulecap.工作原理

Workingprinciple2.體帽分離

2.SeparationofBodyandCap負壓吸入空膠囊整體到上囊板模孔中，限位臺階孔擋住囊帽下行，膠囊體則落入下囊板孔中。Negativepressuresuckstheemptycapsuleasawholeintotheupperplatemoldhole,andthelimitstepholestopsthedownwardmovementofthecapsulecap,allowingthecapsulebodytofallintothelowerplatehole.限位臺階

Limitstep3.物料填充

3.MaterialFilling工作原理

WorkingprincipleTremiepipeFillingfinetuningknobFillingmissingprobeconductorFillingpushrodpositionscaleFillingscrewfixedplatformFillingpushrodPackingtablesupportshaftPack3.物料填充

3.MaterialFilling工作原理

Workingprinciple裝藥量的大小主要由設備中計量盤的厚度確定，計量盤厚度要根據充填物的粒度、流動性等因素來選擇。

Theamountofmedicinefilledismainlydeterminedbythethicknessofthemeasuringdiscintheequipment.Thethicknessofthemeasuringdiscshouldbeselectedbasedonfactorssuchasthegranularityandfluidityofthefillingmaterial.作為一種判定標準，可以用現有充填物直接測量單個計量盤孔的裝填量以確定計量盤的厚度是否合適。

Asacriterion,theamountoffillinginasinglemeasuringdischolecanbedirectlymeasuredusingexistingfillingmaterialtodetermineifthethicknessofthemeasuringdiscissuitable.充填桿由第1到第5工位下降深度一般為50%、30%、20%、10%、1%。

Thedescentdepthsofthefillingrodsforstations1to5aregenerally50%,30%,20%,10%,1%.PackStep6Step5Step4Step3Step2Step11-充填桿2-導向裝置3-計量盤4-成型粉柱5-膠囊體1-Fillingrod2-Guidingdevice3-Measuringdisc4-Moldingpowdercolumn5-CapsulebodyFigure2Fillingmeasuringscheme4.剔除廢囊

4.RemovalofWasteCapsules吸走空膠囊

Suckawayemptycapsules工作原理

Workingprinciple5.膠囊閉合

5.CapsuleClosure軸線對齊

Aligningtheaxes.工作原理

Workingprinciple6.出囊

6.CapsuleEjection工作原理

Workingprinciple7.清潔

7.Cleaning工作原理

WorkingprincipleConnectedtocompressedairsystemConnectedtothesuctionsystem“毒膠囊”事件

"ThePoisonCapsule"Incident河北一些企業，用生石灰處理皮革廢料，熬制成工業明膠，賣給紹興新昌一些企業制成藥用膠囊，最終流入藥品企業，進入患者腹中。由于皮革在工業加工時，要使用含鉻的鞣制劑，因此這樣制成的膠囊，往往重金屬鉻超標。經檢測，修正藥業等9家藥廠13個批次藥品，所用膠囊重金屬鉻含量超標。針對此事件，2012年4月21日，衛生部要求毒膠囊企業所有膠囊藥停用，藥用膠囊接受審批檢驗。2012年4月22日，公安部通報，經調查，公安機關已立案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