Oralsoliddosageform/Oralsolidpreparation口服固体制剂Materials[mə'tɪərɪəlz]物料,材料Rawmaterials原辅料Startingmaterials起始物料Packingmaterials包装材料ActivepharmaceuticalingredientAPI[,fɑːmə'suːtɪk(ə)l;-'sjuː-]原料ingredient[ɪn'griːdɪənt]n.原料;要素;组成部分adj.构成组成部分的Excipient,adjuvant辅料excipient[ik'sipint]n.【药物】赋形剂adjuvant['ædʒʊv(ə)nt]n.[药]佐药;助理员adj.辅助的Diluents稀释剂Fillers填充剂Starch淀粉starch[stɑːtʃ]Dextrin糊精dextrin['dekstrɪn]Lactose乳糖lactose['læktəʊz;-s]Moisteningagent,humectant[hjʊ'mekt(ə)nt]润湿剂Adhesive,binder粘合剂[əd'hiːsɪv;-zɪv]Ethanol['eθənɒl]乙醇Disintegrantsdisintegrant[dɪs'ɪntɪɡrənt]崩解剂Lubricant['luːbrɪk(ə)nt]润滑剂Glidants助流剂Antiadherent抗粘剂Talc[tælk]滑石粉Intermediates中间体Finishedproduct最终成品Supper供应商Distributor分销商Manufacturer[,mænjʊ'fæktʃ(ə)rə(r)]生产商Audit['ɔːdɪt]审计Tablet片剂Granules[grænju:ls]颗粒剂Capsules胶囊剂Powder散剂Pills丸剂Compressedtablet普通片Coatedtablet包衣片Sugarcoatedtablet糖衣片Filmcoatedtablet薄膜衣片Entericcoatedtablet肠溶衣片Effervescenttablet[efə'vesənt]泡腾片Chewabletablet咀嚼片Dispersibletablet分散片Sustainedreleasetablet缓释片Controlledreleasetablet控释片Multilayertablet['mʌltɪleɪə]多层片Manufacturingprocess生产工艺Milling/grinding['graɪndɪŋ]碾碎Sifting过筛Dispensing配料Blending['blendɪŋ]混合Granulating/granulation[,ɡrænjʊ'leɪʃən]成粒,制粒Drying干燥Tabletcompression压片compression[kəm'preʃ(ə)n]n.压缩,浓缩;压榨,压迫Dedust[di:'dʌst]除尘Coating包衣Polish['pɒlɪʃ]抛光Diesarrangement配模arrangement[ə'reɪn(d)ʒm(ə)nt]n.布置;整理;准备dies['daii:z]n.[机]模具(名词die的复数);(拉)日n.(Dies)人名;(英)戴斯;(西)迭斯v.死亡;消失(动词die的第三人称单数形式);凋谢Packing包装Bottlewashing洗瓶Bottledrying烘瓶Packaging包装,打包Labeling贴签Filling填充,灌装Capsuleshell胶囊壳shell[ʃel]n.壳,贝壳;炮弹;外形vt.剥皮;炮轰vi.剥落;设定命令行解释器的位置Blisterpacking起泡包装Innerpackingmaterial内包材Outerpackingmaterial外包材Wholetest全检Weight重量Fineness细度,粒度Particlesize粒度Lossondrying干燥失重Content含量Disintegration崩解度Dissolution溶出度Appearance外观Quality质量Quantity数量Equipment/facility/apparatus/device设备Processstep工艺步骤Weighing&dispensing称配Granulation制粒Compression压片Coating包衣Capsulefilling胶囊填充Batchproductioninstruction/order批生产指令Standardoperationprocedure标准操作规程Formulation处方Verification确认,检定Calibration校准Qualification确认Validation验证Authentication认证Weighingcover称重罩Weightingbox称重柜Balance天平Electronicplatformscale电子台秤Vibratingsieve振荡筛Mesh网眼Grinder/pulverizer粉碎机Inlet进料口Steeltooth钢齿Annularsieveplate换装筛板Outlet出粉口Charginghole加料口Horizontalshaft水平轴Shakingdevice抖动装置Airbleedingpocket放气袋Wetgranulation湿法制粒Drygranulation干法制粒Spraygranulation喷雾制粒Mixinggranulator混合制粒机Pneumaticlid-openingdevice启动开盖装置Cuttingmotor切割电机Coolingwaterenters冷却水进口Airadmissionorifice进气管口Coolingwaterout冷却水出口Touchscreen触摸屏Stirringmotor搅拌电机Powersupply电源Compressedairsource压缩空气源Controller控制器Cuttingknife造粒刀Drumlid桶盖Drum盛料筒Dischargehole出料口Stirrer搅拌器Drivingbelt传送皮带Machinebase机座Fluidbedgranulator流化床制粒机Hotaircirculatingoven热风循环烘箱Heater加热器Fan风扇Filtergauze滤网Mixingmachine混合机Qualitytest质量检查Weightdifference片重差异Hardness硬度Rigidity脆碎度Rotarytabletpress旋转式压片机Die冲模Punch冲头Upperpunch上冲Upperpinchroller上压轮Fillingsupport填充架Powderscraper刮粉器Die模圈Lowerpunch下冲Tabletweightadjuster片中调节器Lowerpinchroller下压轮ourletadjuster出片调节器coating包衣isolatedlayer隔离层sub-coatinglayer粉衣层sugar-coatinglayer糖衣层coloredsugar-coatinglayer有色糖衣层polishing打光coatingmachine/coater包衣机sidedoor侧门upperbox上箱体lowerbox下箱体airtightchamber密闭工作室coatingplaten包衣滚筒bigsprocket大链轮tensioner涨紧轮cyclechain链条washingpan清洗盘smallsprocket小链轮electromotor电动机capsulefillingmachine胶囊填充机adjustingscrew填充杆调节螺钉upperdie-set上模架column立柱powderloop盛粉环meteringplate计量盘lockscrew锁紧螺钉fixedscrew固定螺钉glandflange压板scale标尺cover盖板fillingbar填充杆powderscraper刮粉器hopper胶囊料斗linerbearing直线轴承forkslider拨叉滑块slidingvalve滑动门阀knob旋钮baffle挡板fasteningscrew紧固螺钉orderfork顺序叉shiftingfork胶囊拨叉invertedtrough胶囊导槽lyophilizedproducts/freezedryingpreparation冻干产品personnel人员equipment设备materials物料regulations法规environment环境cross-contamination交叉污染positivepressure正压negativepressure负压weighingroom称量室downflowbooth垂直层流工作室fandrivesystem风机驱动系统HEPAfilterHighefficiencyparticulateairfilter高效过滤器Bleedair排风Containmentzone控制区Backgroundenvironment背景环境Cleanarea洁净区GradeABUncleanarea一般区Differentialpressure压差Airspeed风速Temperature温度Humidity湿度Electronicbalance电子天平Operationkeys操作键Displaywithbacklight背光显示屏Modelplate型号标牌Draftshieldelement放风圈Weighingpan秤盘Draftshield防风罩Levelingfeet水平调节脚Hager秤钩ACadaptersocket交流电源适配器插座Interface接口Solutionpreparation配液Thickpreparation浓配Thinpreparation稀配Tanksforsolutionpreparation配液灌Sightglass视镜Hatch人孔Liquidlevelmeter液位计Liquidoutlet出液口Condensatewater冷凝水Steaminlet蒸汽入口Automaticcontrol自动化控制Sterilefiltration无菌过滤Cleaninplace在线清洗Sterilizationinplace在线灭菌Criticalprocessparameter关键工艺参数Visibleparticles可见异物Pressureparameter压力参数Processwater工艺用水Drinkingwater饮用水Purifiedwater纯化水Waterforinjection(WFI)注射用水Cooling/chilledwater冷冻水Puresteam纯蒸汽Compressedair压缩空气Activatedcarbon活性炭Adsorbenttemperature吸附温度Circulatingtemperature循环温度Passbox传递窗Stainlesssteelnozzle不锈钢喷嘴Visionglass观察窗Highstrengthhinge高强度合页Passwindow传递窗Airhandlingpanel通风板Handle把手Electronicinterlock电子互锁机构Primarymeshedplate初校网孔板Purificationfanunit净化风机Differentialpressuregauge压差表Intercomdevice对讲机Ultravioletlamp紫外灯Unpoweredroller无动力滚筒Cleaningandsterilization清洗灭菌Filterelement过滤器滤芯Visibleforeignmatters