膠囊劑生產(chǎn)設(shè)備CapsuleProductionEquipment課件

膠囊劑生產(chǎn)設(shè)備

CapsuleProductionEquipment制藥設(shè)備使用與維護(hù)

OperationandMaintenanceofCommonPharmaceuticalEquipment知識(shí)目標(biāo)KnowledgeObjectives（1）掌握膠囊劑生產(chǎn)流程（軟膠囊、硬膠囊）。(1)Mastertheproductionprocessofcapsuleformulations(softcapsules,hardcapsules).（2）熟悉常用膠囊劑生產(chǎn)設(shè)備的結(jié)構(gòu)與工作原理。(2)Familiarizewiththestructureandworkingprinciplesofcommonlyusedcapsuleproductionequipment.（3）了解常用膠囊劑設(shè)備的維護(hù)與保養(yǎng)及故障排除。(3)Understandthemaintenance,upkeep,andtroubleshootingofcommonlyusedcapsuleequipment.能力目標(biāo)AbilityObjectives學(xué)會(huì)正確操作常用膠囊劑生產(chǎn)設(shè)備。Learntheproperoperationofcommonlyusedcapsuleproductionequipment.素質(zhì)目標(biāo)

Qualitygoal（1）認(rèn)真執(zhí)行GMP，嚴(yán)格按照SOP的要求進(jìn)行生產(chǎn)。(1)StrictlyfollowGMPandadheretotherequirementsofSOPintheproductionprocess.（2）使學(xué)生具備膠囊劑生產(chǎn)崗位必備的基本知識(shí)、基本技能和職業(yè)素質(zhì)。(2)Equipstudentswithessentialknowledge,basicskills,andprofessionalqualitiesrequiredforcapsuleproductionpositions.（3）通過“毒膠囊”案例強(qiáng)調(diào)職業(yè)道德、誠(chéng)實(shí)守信品德的培養(yǎng)。(3)Emphasizethecultivationofprofessionalethics,honesty,andintegritythroughthecaseof"poisoncapsule".重點(diǎn)KeyPoints膠囊劑生產(chǎn)設(shè)備的結(jié)構(gòu)與工作原理StructureandWorkingPrinciplesofCapsuleProductionEquipment難點(diǎn)Difficulties膠囊劑生產(chǎn)設(shè)備的正確操作ProperOperationofCapsuleProductionEquipment學(xué)習(xí)目標(biāo)

LearningObjectives軟膠囊劑是將一定量的液體藥物密封于軟質(zhì)囊材中制成的固體制劑，又稱膠丸，主要供內(nèi)服，也可以用于直腸、陰道等，是目前應(yīng)用最廣泛的劑型之一。Softgelatincapsulesaresoliddosageformswhereinaspecificamountofliquidmedicationisencapsulatedwithinaflexiblecapsuleshell.Alsoknownasgelatincapsulesor"gelcaps,"theyareprimarilyusedfororaladministrationbutcanalsobeemployedforrectalorvaginaldelivery,representingoneofthemostwidelyuseddosageformstoday.制劑簡(jiǎn)介

FormulationIntroduction軟膠囊劑生產(chǎn)流程

ProductionProcessofSoftGelatinCapsules制劑簡(jiǎn)介

FormulationIntroduction滴制技術(shù)制成的軟膠囊劑稱之為無縫膠丸

whilethosecreatedusingthedrippingmethodaretermed"seamless"capsules.軟膠囊劑的制備方法有壓制法和滴制法兩種。

Therearetwomainmethodsforpreparingsoftgelatincapsules:compressionmoldingandthedrippingmethod.壓制技術(shù)制成的軟膠囊劑為有縫膠丸

Softgelatincapsulesproducedthroughcompressionmoldingarereferredtoas"seam"capsules,“毒膠囊”事件

"ThePoisonCapsule"Incident河北一些企業(yè)，用生石灰處理皮革廢料，熬制成工業(yè)明膠，賣給紹興新昌一些企業(yè)制成藥用膠囊，最終流入藥品企業(yè)，進(jìn)入患者腹中。由于皮革在工業(yè)加工時(shí)，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(biāo)。經(jīng)檢測(cè)，修正藥業(yè)等9家藥廠13個(gè)批次藥品，所用膠囊重金屬鉻含量超標(biāo)。針對(duì)此事件，2012年4月21日，衛(wèi)生部要求毒膠囊企業(yè)所有膠囊藥停用，藥用膠囊接受審批檢驗(yàn)。2012年4月22日，公安部通報(bào)，經(jīng)調(diào)查，公安機(jī)關(guān)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.職業(yè)道德，誠(chéng)實(shí)守信

Adherencetoprofessionalethicsandhonestyisessential.軟膠囊劑生產(chǎn)流程

ProductionProcessofSoftGelatinCapsules

滴制法制備軟膠囊工藝流程

ProcessFlowforSoftGelatinCapsulePreparationviatheDrippingMethodD級(jí)潔凈區(qū)ClassDcleanzone溶膠Solsolution明膠Gelatin外包Outsourcing入庫(kù)Enterwarehouse外包Outsourcing原輔料Rawexcipients配料Batching噴嘴Nozzle滴制Dripping滴丸Droppingpills定型Shaping洗丸Washingpills干燥Drying揀丸Sortingpills軟膠囊劑生產(chǎn)流程

ProductionProcessofSoftGelatinCapsules原輔料

RawMaterials填充泵

FillingPump楔型注入器

WedgeInjector壓丸

PelletCompression定型

Shaping洗丸

Washing干燥

Drying揀丸

Sorting檢驗(yàn)

Inspection包裝

Packaging入庫(kù)

Warehousing膠漿

GelatinMass制膠帶

GelRibbonFormation膠帶

GelRibbonConveyance滾壓模

RollerCompactionMoldD級(jí)潔凈區(qū)

ClassDCleanArea壓制法制備軟膠囊工藝流程

ProcessofSoftGelatinCapsulePreparationviaCompressionMoldingMethod工序質(zhì)量控制點(diǎn)

QualityControlPointsintheProcess軟膠囊劑的生產(chǎn)工序：

ProductionStepsforSoftGelatinCapsules:溶膠、配料、制丸、干燥、檢丸和包裝。

Solsolution,formulation,pelletformation,drying,pelletinspection,andpackaging.主要設(shè)備

MainEquipment

軟膠囊壓制設(shè)備

EquipmentforSoftGelatinCapsuleCompressionMolding軟膠囊滴制設(shè)備

EquipmentforSoftGelatinCapsuleDripping設(shè)備結(jié)構(gòu)

EquipmentStructure滾模式軟膠囊機(jī)

RollingMoldSoftGelatinCapsuleMachine模壓法生產(chǎn)軟膠囊劑

ProductionofSoftGelatinCapsulesviaMoldingMethod主機(jī)、軟膠囊輸送機(jī)、定型干燥機(jī)、電氣控制系統(tǒng)、明膠貯桶、藥液貯桶。Mainmachine,softgelatincapsuleconveyor,shapinganddryingmachine,electricalcontrolsystem,gelatinreservoir,medicationliquidreservoir.軟膠囊壓制設(shè)備

EquipmentforSoftGelatinCapsuleCompressionMolding設(shè)備結(jié)構(gòu)

EquipmentStructureRJWJ-115SoftGelatinCapsuleProductionLineStructureSetdryingrotarycageSoftgelatincapsulesdeliverytubeConveyormotorFuelregulatingPressuredischargeRiseanddescendMeshregulationRubberguidewheelTouchcontrolpanelUniversalwheelSoftgelatincapsulesdischargehopperSoftgelatincapsulesdischargeportConveyerbeltPedestal工作原理

Workingprinciple膠漿經(jīng)過輸膠管通過兩側(cè)預(yù)熱的涂膠機(jī)箱1.Gelatinmassistransportedthroughfeedingpipestotheadhesivemachineboxesonbothsides,whicharepreheated.2.將膠漿涂布在溫度為16℃～18℃的鼓輪上，隨鼓輪轉(zhuǎn)動(dòng)定型成一定厚度的明膠帶2.Thegelatinmassisspreadontothedrum,whichismaintainedatatemperatureof16°Cto18°C.Ittakestheshapeofagelribbonwithacertainthicknessasthedrumrotates.3.沿著膠帶導(dǎo)桿和送料軸送入兩滾模之間3.Thegelribbonisguidedalongbyribbonguidesandfedbetweenthetworollingmolds.4.同時(shí)藥液由供料泵經(jīng)導(dǎo)管進(jìn)入楔形注射器4.Meanwhile,medicationliquidisdeliveredthroughconduitsintothewedgeinjector.LiquidreceiverConduitFedRibbonguideGelribbonTubeMoldMoldAdhesivemachineboxDrumFillingpumpWedgeinjectorTroughCapsulesconveyor工作原理

Workingprinciple5.借助供料泵的壓力將藥液及膠帶壓入兩個(gè)滾模的凹槽中

5.Usingthepressurefromthefeedingpump,themedicationliquidandgelribbonarepressedintothegroovesofthetworollingmolds.6.滾模的連續(xù)轉(zhuǎn)動(dòng)，施加機(jī)械壓力下使兩條膠帶呈兩個(gè)半囊形并將藥液包封其內(nèi)

6.Thecontinuousrotationoftherollingmolds,aidedbymechanicalpressure,formstwosemi-capsulesfromthegelribbon,enclosingthemedicationliquidwithin.7.軟膠囊依次落入導(dǎo)向斜槽內(nèi)，并由輸送機(jī)送出。

7.Thesoftgelatincapsulesfallsequentiallyintoguidingtroughsandarecarriedawaybytheconveyor.LiquidreceiverConduitFedRibbonguideGelribbonTubeMoldMoldAdhesivemachineboxDrumFillingpumpWedgeinjectorTroughCapsulesconveyor設(shè)備結(jié)構(gòu)

EquipmentStructure滴制式軟膠囊機(jī)

Dripping-TypeSoftGelatinCapsuleMachine:滴制法生產(chǎn)軟膠囊劑

ProductionofSoftGelatinCapsulesviaDrippingMethod:滴制式膠囊機(jī)結(jié)構(gòu)和工作原理

StructureandWorkingPrincipleofDripping-TypeCapsuleMachine:設(shè)備結(jié)構(gòu)

EquipmentStructure滴制部分

DrippingSection:冷卻部分

CoolingSection:電氣控制部分

Electricalcontrolsection干燥部分

DryingSection:工作原理

Workingprinciple1.明膠液和油狀藥液分別由計(jì)量泵的活塞壓入噴嘴的外層和內(nèi)層，以不同的速度噴出。1.Gelatinoussolutionand

oilymedicationarepumpedintotheouterand

innerlayersofthenozzlebythepistonsofthemeteringpumps,andtheyaresprayedoutatdifferentspeeds.2.一定量的藥液被定量的明膠液包裹滴入冷卻柱。2.Aspecificamountofmedicationisenvelopedbyaprecisequantityofgelatinoussolutionanddrippedintothecoolingcolumn.MedicationliquidreservoirQuantitativecontrollerGelatinoussolutionconveyorSprinklerCoolingliquidparaffinoutletSprinkleramplificationCapsuleoutletCapsulecollectionboxCoolingpipeCoolingboxPumpLiquidparaffintank工作原理

Workingprinciple3.在冷卻柱中，外層明膠液被冷卻液冷卻，并在表面張力的作用下收縮成球形，逐漸凝固成膠丸。3.Insidethecoolingcolumn,theoutergelatinoussolutioniscooledbyacoolingliquidand,undertheinfluenceofsurfacetension,contractsintoasphericalshape,graduallysolidifyingintocapsules.4.膠丸隨液體石蠟流入過濾器，并被收集于濾網(wǎng)上，所得膠丸經(jīng)清洗、烘干等工序后即得成品