制药工程专业英语考试题目及答案.docx

制药工程专业英语考试题目及答案.docx

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制药工程专业英语考试题目及答案

专业英语

考试内容：

单词10分句子翻译24分根据课文回答问题24分英译汉药品说明书21分翻译汉译英摘要21分

Unit11Tablet（ThePharmaceuticalTabletsDosageForm）药片（医药片剂剂型）

RoleinTherapy

A:

Theoralrouteofdrugadmininistrationisthemostimportantmethodofadministeringdrugsofrsystemiceffects.ExceptincasesofInsulintherapy.theparenteralrouteisnotroutinelyusedforself-administrationofmedication.Thetopicalrouteofadministrationhasonlyrecentlybeenemployedtodeliverdrugstothebodyforsystemiceffects,withtwoclassesofmarketedproducts:

Nitroglycerinforthetreatmintofanginaandscopolamineforthetreatmentofmotionsickness.Otherdrugsarecertaintofollow,butthetopicalrouteofadministrationislimitedinitsabilitytoalloweffectivedrugabsorptionforsystemicdrugaction.

A:

口服给药是全身效应用药方法中最为重要的。

除了胰岛素治疗，非肠道药途径不常用在自我服药方面。

局部给药途径只是最近才被应用到身体药物输送达到系统效应。

有两类上市药物（应用到该方法）：

治疗心绞痛药物的硝酸甘油和治疗眩晕病的莨菪胺。

其他药粉也效用此法，但局部给药途径受系统药物作用的药物有效吸收能力的限制。

B:

Theparenteralroueofadministrationisimportantintreatingmedicalemergenciesinwhichasubjectoscomatoseorcannotswallow,andinprovidingvarioustypesofmaintenancetherapyforhospitalizedpatients.

B:

注射给药在处理病人昏迷或者不能吞咽的紧急情况和各种保守治疗的就医病人时十分重要。

Nevertheless,itisprobablethatatleast90%ofalldrugsusedtoproducesystemiceffectsareaddministeredbytheoralrote.

C:

Whenanewdrugisdiscovered,oneofthefirstquedtionsapharmaceuticalcompanyasksiswhetherornotdrugcanbeeffectivelyadministeredforitsintdendedeffectbytheoralroute.Ifitcannot,thedrugisprimarilyrelegatedtoadministrationinahospitalsettingorphysician’soffice.Ifpatientself-admnistrationcannotbeachieved,thesalesofthedrugconstituteonlyasmallfractionofwhatthemarketwouldbeotherwise.

C:

当一种新药被研制出来，制药公司首先考虑的一个问题就是，这种药物是否可以口服。

如果这种药物不能口服，它将被交给医院或医师来管理。

如果病人不能自己服药，这种药物的市场前景会比口服小得多。

Ofdrugsthatareaddministredorally,solidoraldosgeformsrepresentthepreferredclassofproduct.Thereasonsforthispreferenceareasfollows.Tabletsandcapsulesrepresentunitdosageformsinwhichoneusualdoseofthedrughasbeenaccuratelyplaced.Bycomparison,liquidoraldosage

forms,suchassyrups,suspensions,emulsions,solutions,andelixirs,areusuallydesignedtocontainonemedicationdoseofmedicationin5to30ml.Thepatientisthenaskedtomeasurehisorherownmedicationusingateaspoon,tablespoon,orothermeasuringdevice.Suchdosagemeasurementsaretypicallyinerrorbyafctorrangingfrom20%to50%whenthedrugisself-administeredbythepatient.

Q1:

Howmanykinksoftherouteofdrugadministrationarethere?

Canyoupresenttheseusualdosageformofthedrugthatareadministeredorally?

Q2:

Whydoesthesolidoraldosageformrepresentthepreferredclassofdrugsthatareadministeredorally?

Q3:

Whydopeoplemakeliquiddosageformofdrug?

Liquidoraldosageformshaveotherdisadvantagesandlimitationswhencomparedwithtablets.Theyaremuchmoreexpensivetoship（oneliquiddosageweighs5gormoreversus0.25to0.4gfortheaveragetablet）,andbreakageorleakageduringshipmentisamoreseriousproblemwithliquidsthanwithtablets.Tastemaskingofthedrugisoftenaproblem（ifthedrugisinsolutionevenpartially）.Inaddition,liquidsarelessportableandrequiremuchmorespacepernumberofdosageonthepharmacist’sshelf.

D:

Drugsareingenerallessstable（bothchemicallyandphysically）inliquidformthaninadrystateandexpirationdatestendtobeshorter.Carefulattentionisrequiredtoassurethattheproductwillnotallowaheavymicrobiologicburdentodeveloponstandingorunderorundernormalconditionsofuseonceopened（preserationrequirements）.

D:

一般来说，药物在液态比固态片剂更不稳定（无论是化学性质还是物理性质），保质期都缩短。

需要特别注意的是确保产品一旦打开后，在存放时或常规使用下避免受到严重的微生物污染。

Therearebasicallythreereasonsforhavingliquiddosageformsofadrug:

（1）Theliquidformiswhatthepublichascometexpectforcertaintypesofproducts（e.g.coughmedicines）.

（2）Theproductismoreeffectiveinaliquidform（e.g.,manyadsorbentsandantacids）.（3）Thedrug（s）areusedfairlycommonlybyyoungchildrenortheelderly.whohavetroubleswallowingthesolidoraldosageforms.

Properties

Q4:

Whatisthebjectiveofdesignandmanufactureofthesompressedtablet?

Q5:

Whatisimportantasidefromthephysicalandchemicalproperticesofthemedicinicalagent（s）totheformulatedintoatablet?

E:

Theobjectiveofthedesignandmanufactureofthecompressedtabletistobeliverorallythecorrectamountofdrugintheproperformatoroverthepropertimeandinthedesiredlocation,andtohaveitschemicalintegrityprotectedtothatpoint.

E:

设计和制造扁平药片的目的是通过口服给药，把正确剂量适当形态的药物在适当的（或维持适当的）时间范围内送到指定的目标位置并保持其化学稳定性。

Asidefromthephysicalandchemicalpropertiesofthemedicinalagent（s）tobeformulateintoatablet,theactualphysicaldesign,manufacturingprocess,andcompletechemicalmadeupofthetabletcanhaveaprofoundeffectontheefficacyofthedrug（s）beingadministered.

Q6:

Whatphysicalpropertiesshouldtablethave?

Howthephysicalpropertieseffectonbioavailability?

Atablet

（1）shouldbeanelegantproducthavingitsownidentitywhilebeingfreeofdefectssuchaschips,cracks,discoloration,contamination,andthelike；

（2）shouldhavethestrengthtowithstandtherigorsofmechanicalshocksencounteredinitsproductionpackaging,shipping,anddispensing;and（3）shouldhavethechemicalandphysicalstabilitytomaintainitsphysicalattributeovertime.

F:

Phranaceuticalscientistsnowunderstandthatvariousphysicalpropertiesoftabletscanundergochangeunderenvironmentalorstressconditions,andthatphysicalstability,throughitseffectonbioavailabilityinparticular,canbeofmoresignificanceandconcerninsometabletsystemsthanchemicalstability.

F:

药物科学家现在认识到，片剂的不同物理性质会通过改变药物周围的环境或压力条件显著地影响生物药效率，这样一些药物作用体系中物理稳定性比化学稳定性更加重要和需要关注。

Q7:

Howtoarrangethemedicineeffectsandphysicalaspects?

Ontheotherhand,thetablet

（1）mustbeabletoreleasethemedicinalagent（s）inthebodyinapredictableandreprouduciblemannerand

（2）musthaveasuitablechemicalstabilityovertimesoasnottoallowaltertionofthemedicinalagent（s）.Inmanyinstances,thesesetsofobjectivesarecompeting.Thedesignaoftabletsthatemphasizesonlythedesiredmedecineeffectsmayproduceaphysicallyinadequateproduct.Thedesignofatabletemphasizingonlythephysicalaspectsmayproducetabletsoflimitedandvaryingtherapeuticeffects.Asoneexampleofthispoint,Meyerandassociatespresentinformantionon14Nitrofurantoinproducts,allofthiswhichpassedthecompendiaphysicalrequirements,butshowedstatistially,significantbioavailbilitydifferences.

1、WhydopeoplemakeliqaiddosageformofdruginUnit11?

Unit12ManufactureofTablets药片的生产制造

TabletDesignandFormulatiom药片的设计与制造

A:

Thethreebasicmethodsoftabletmanufacturehavebeenpreviouslydetailed,thedesirablepropertiesandrequiredfeaturesofgranulations（成粒）andtabletsdefined,andtheinterrelationships（相互关系）betweenmany

ofthesepropertiesandtheprocessingandmachinevariables（变量）noted.

A:

先前已经详细介绍了三种基本的片剂制造方法，对成粒和成片中适合的、必须的特性作了详细说明，对这些要素之间的关系，处理过程各机械变量进行了注解。

Q1:

whatarethenondrugcomponentsintabletsandwhataretheirfunctions?

Regardlessifhowtabletsaremanufacturde,conventionaloraltabletsforingestionusuallycontainthesameclassesofcomponentsinadditiontotheactiveingredients（活性组分,有效成分）,whichareoneormoreagentsfunctioningas

（1）adiluent,

（2）abinderoranadhesive,（3）adisintegrant,and（4）alubricant.

B:

Sometabletformulationsmayadditionallyrequireaflowpromoter.

B:

一些药片还需要流动性促进剂。

C:

Othermoreoptionalcomponentsincludecolorants,andinchewabletablets,favorsandsweeteners.Allnondrugcomponentsifaformulaaretermedexcipients.

C:

其他的一些可选择的组分包括着色剂，可咀嚼的药片需要调味剂和甜味剂，所有非药组分术语为赋形剂。

TabletGranulations药片成粒

BasciCharacteristics基本特征

Q2:

whatcharacteristicsshouldtabletmaterialshave?

andwhy?

Q3:

Howtoassesstheshapeofparticlesandtheirrelativeregulatityorapproximationtospheres?

D:

Thecharateristicsofatabletthatmadeitapopulardosageform,d.g.,compactness,physicalstability,rapidproductioncapability,chenicalstability,andeffiicacy,areingeneraldictatedprinarilybythequalitiseofthegranulationfromwhichitismade.

D:

使片剂成为流行的用药形式的一些特征，如紧密，药理稳定性，高生产效率，化学稳定性和高效性，大体上主要是由成粒材料的品质决定的。

Basicallystated,materialsintendedforcompactionintoatabletmustpossesstwocharacteristocs:

fluidityandcompressibility.Toagreatextent,thesepropertiesarerequiredbythecompressionmachinedesign.

E:

Aspreviouslydiscussde,goodflowpropetiesareessentialforthetransportofthematerialthroughthehopper,intoandthroughthefeedframe,andintothedies.

E:

如前边讨论的，好的流动性是药品通过漏斗进入配料池和磨具进行传输的基础。

Tabletmaterialsshouldthereforebeinaphysicalformthatflowssmoothlyanduniformly.Theidealphysicalformforthispurposeisspheres,sincetheseofferminimumcontactsurfacesbetweenthemselvesandwiththewallsofthemachineparts.

F:

Unfortunately,mostmaterialsdonoteasilyformspheres;However,shapesthatapproachspheresimproveflowbility.Thereforegranulationisinpartthepharmaceuticalprocessthatattemptstoimprovetheflowofpowderedmaterialsbyformingspherelikeorregularlyshapedaggregatescalledgranules.

F:

不巧的是，大多数药品不易成球；不过近似球体也会增加流动性，因此制药过程包含把粉末状的药物制成类球状或规则形状以增加其流动性的成粒过程。

Theneedtoassesstheshapeofparticlesandtheirrelativeregularityorapproximatintosphereshasledtothedevelopmentofequationswherebycertain“factors”canbecalculatedtoprovidequantitativecomparisonsofdifferentparicleshapes.Bymeasuringparticlesurfacearea（S）,volume（V）andaprojectdeequivalentdiameter（

）,avolumeshapefactor（

）,asurfaceshapefactor

andashapesoefficient（

）canbecal