制药工程专业英语考试题目及答案.doc

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Unit 11 Tablet (The Pharmaceutical Tablets Dosage Form)药片（医药片剂剂型）Role in TherapyA: The oral route of drug admininistration is the most important method of administering drugs ofr systemic effects.Except in cases of Insulin therapy.the parenteral route is not routinely used for self-administration of medication.The topical route of administration has only recently been employed to deliver drugs to the body for systemic effects,with two classes of marketed products:Nitroglycerin for the treatmint of angina and scopolamine for the treatment of motion sickness.Other drugs are certain to follow,but the topical route of administration is limited in its ability to allow effective drug absorption for systemic drug action.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:The parenteral roue of administration is important in treating medical emergencies in which a subject os comatose or cannot swallow,and in providing various types of maintenance therapy for hospitalized patients.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,it is probable that at least 90% of all drugs used to produce systemic effects are addministered by the oral rote .C:When a new drug is discovered,one of the first quedtions a pharmaceutical company asks is whether or not drug can be effectively administered for its intdended effect by the oral route.If it cannot,the drug is primarily relegated to administration in a hospital setting or physicians office.If patient self-admnistration cannot be achieved,the sales of the drug constitute only a small fraction of what the market would be otherwise.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。Of drugs that are addministred orally,solid oral dosge forms represent the preferred class of product.The reasons for this preference are as follows.Tablets and capsules represent unit dosage forms in which one usual dose of the drug has been accurately placed.By comparison,liquid oral dosage forms,such as syrups,suspensions,emulsions,solutions,and elixirs,are usually designed to contain one medication dose of medication in 5 to 30 ml.The patient is then asked to measure his or her own medication using a teaspoon,tablespoon,or other measuring device.Such dosage measurements are typically in error by a fctor ranging from 20% to 50% when the drug is self-administered by the patient.Q1:How many kinks of the route of drug administration are there?Can you present these usual dosage form of the drug that are administered orally?Q2:Why does the solid oral dosage form represent the preferred class of drugs that are administered orally?Q3:Why do people make liquid dosage form of drug? Liquid oral dosage forms have other disadvantages and limitations when compared with tablets.They are much more expensive to ship (one liquid dosage weighs 5g or more versus 0.25 to 0.4g for the average tablet ),and breakage or leakage during shipment is a more serious problem with liquids than with tablets. Taste masking of the drug is often a problem (if the drug is in solution even partially ).In addition ,liquids are less portable and require much more space per number of dosage on the pharmacists shelf.D:Drugs are in general less stable (both chemically and physically)in liquid form than in a dry state and expiration dates tend to be shorter .Careful attention is required to assure that the product will not allow a heavy microbiologic burden to develop on standing or under or under normal conditions of use once opened(preseration requirements).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。There are basically three reasons for having liquid dosage forms of a drug:(1)The liquid form is what the public has come t expect for certain types of products(e.g. cough medicines).(2)The product is more effective in a liquid form(e.g.,many adsorbents and antacids).(3)The drug(s) are used fairly commonly by young children or the elderly.who have trouble swallowing the solid oral dosage forms.PropertiesQ4:What is the bjective of design and manufacture of the sompressed tablet?Q5:What is important aside from the physical and chemical propertices of the medicinical agent(s) to the formulated into a tablet?E: The objective of the design and manufacture of the compressed tablet is to be liver orally the correct amount of drug in the proper form at or over the proper time and in the desired location ,and to have its chemical integrity protected to that point .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。Aside from the physical and chemical properties of the medicinal agent(s) to be formulate into a tablet ,the actual physical design,manufacturing process,and complete chemical madeup of the tablet can have a profound effect on the efficacy of the drug(s) being administered.Q6:What physical properties should tablet have?How the physical properties effect on bioavailability? A tablet(1) should be an elegant product having its own identity while being free of defects such as chips ,cracks,discoloration ,contamination,and the like；（2）should have the strength to withstand the rigors of mechanical shocks encountered in its production packaging,shipping,and dispensing;and (3)should have the chemical and physical stability to maintain its physical attribute over time.F:Phranaceutical scientists now understand that various physical properties of tablets can undergo change under environmental or stress conditions,and that physical stability,through its effect on bioavailability in particular ,can be of more significance and concern in some tablet systems than chemical stability.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:How to arrange the medicine effects and physical aspects?On the other hand , the tablet(1) must be able to release the medicinal agent(s) in the body in a predictable and reprouducible manner and(2) must have a suitable chemical stability over time so as not to allow altertion of the medicinal agent(s).In many instances,these sets of objectives are competing .The design a of tablets that emphasizes only the desired medecine effects may produce a physically inadequate product .The design of a tablet emphasizing only the physical aspects may produce tablets of limited and varying therapeutic effects.As one example of this point ,Meyer and associates present informantion on 14 Nitrofurantoin products,all of this which passed the compendia physical requirements,but showed statistially,significant bioavailbility differences.1、 Why do people make liqaid dosage form of drug in Unit 11? Unit 12 Manufacture of Tablets 药片的生产制造Tablet Design and Formulatiom 药片的设计与制造A: The three basic methods of tablet manufacture have been previously detailed,the desirable properties and required features of granulations(成粒) and tablets defined,and the interrelationships（相互关系） between many of these properties and the processing and machine variables（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:what are the nondrug components in tablets and what are their functions?Regardless if how tablets are manufacturde,conventional oral tablets for ingestion usually contain the same classes of components in addition to the active ingredients(活性组分, 有效成分),which are one or more agents functioning as (1) a diluent,(2) a binder or an adhesive ,(3)a disintegrant,and (4) a lubricant.B:Some tablet formulations may additionally require a flow promoter.B:一些药片还需要流动性促进剂。C:Other more optional components include colorants,and in chewable tablets,favors and sweeteners.All nondrug components if a formula are termed excipients.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。Tablet Granulations 药片成粒Basci Characteristics 基本特征Q2:what characteristics should tablet materials have?and why?Q3:How to assess the shape of particles and their relative regulatity or approximation to spheres?D: The charateristics of a tablet that made it a popular dosage form,d.g.,compactness,physical stability,rapid production capability,chenical stability,and effiicacy,are in general dictated prinarily by the qualitise of the granulation from which it is made .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。Basically stated,materials intended for compaction into a tablet must possess two characteristocs:fluidity and compressibility.To a great extent,these properties are required by the compression machine design.E:As previously discussde,good flow propeties are essential for the transport of the material through the hopper,into and through the feed frame,and into the dies.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。Tablet materials should therefore be in aphysical form that flows smoothly and uniformly.Theideal physical form for this purpose is spheres,since these offer minimum contact surfaces between themselves and with the walls of the machine parts .F:Unfortunately,most materials do not easily form spheres;However,shapes that approach spheres improve flowbility.Therefore granulation is in part the pharmaceutical process that attempts to improve the flow of powdered materials by forming spherelike or regularly shaped aggregates called granules.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。The need to assess the shape of particles and their relative regularity or approximatin to spheres has led to the development of equations whereby certain “factors”can be calculated to provide quantitative comparisons of different paricle shapes.By measuring particle surface area (S),volume (V) and a projectde equivalent diameter () , a volume shape factor () ,a surface shape factor ,and a shape soefficient () can be calculated using equations (1) to (3) for quantitative work. The shape xoefficient for a sphere is 6 .As a paarticle becomes more irregular in shape, the value of a increases.For a cube , is equal to 6.8. The other desirable characteristic,compressibility,is the property of forming a stable,compact mass when pressure is applied.The requisite physical properties and the forces that hold the tablet together are discussed in Chapter 4.“Compression and Consolidation of Powdered Solids.”The consideration of compressibility in this discussion is limited to stating that granulation is also the pharmaciutial process that converts a mixture of powders,which have poor cohesion,into aggregates capable of compaction.Manufacture of Granulations 成粒工艺Dry Manufacturing Methods 干法成粒Q4:What metheds are used to granulations for drug tablets?The manufacture of granulations for tablet compression may follw one r a combination of three establoshed methods:the dry methods of direct compression,compression granulation,and wet franulation.Wet Granulation 湿法成粒Q5:What are the unique portions of wet granulation process?G: The wet granulation technque uses the same preparatory and finishing steps (screening or milling,and mixing) as the two previously discussed granulation techniques.The unique portions of wet granulation process involve the wet massing of the powders,wet sizing or milling,and drying.G:湿法成粒工艺与前边提到的两种成粒工艺具有相同 的准备和完成步骤（筛（磨粉）和混合）。湿法制粒的独特部分包括湿法聚集药粉，湿法胶料（磨粉）和烘干。H:The theory,equipment,and methods associated with drying are discussed in Chapter 3.Methods.Wet granulation forms the granules by binding the powders together with an adhesive , instead if by compaction ,The wet granulation technique employs a solution,suspension,or slurry cimtaining a binder ,which is usually added to the powder mixture;However,the binder may be incorporated dry into the powder mix ,and the liquid may be added by itself.H:烘干的理论设备和方法在第3章方法中讨论湿法是用粘合剂成粒而不是用挤压法成粒。湿法成粒技术粘合剂以溶液、悬浮液成浆形式加入到药粉中，但是粘合剂可能使药粉变干，需加入上些液体维持湿度。Q6:How to add binder to the drug powers? The method of introducing the binder depends on its solubility and on the components of the mixture ,Since,in general,the mass should merely be moist rather than wet or pasty,there is a limit to the amount if solvent that may be employed.Therefore,when only a small quantity is permissible,the binder is blended in with the dry powders intially;when a large quantity is required,the binder is usually dissolved in the liquid.The solubility of the binder also has an influence on the choice of methods,cince the solution should be fluid enough to disperse readily in the mass. The wet screening process involves converting the moist mass into coarse,granular aggregate by passage through a hammer mill or oscillating granulator,equipped with screens having large perforations.The purpose is to further consolidate granules,increase particle contact points,and increase surface area to facilitate drying.Overly wet material dries slowly and forms hard aggregates,which tend to turn to powder during subsequent dry milling.There are many instances in which wet milling may be omitted,with considerable saving of time.The formulator should be alert these opportunities and not follow the old method blindly.I: A drying process is required in all wet granulation procefures to remove the solvent that was used in forming the aggregates and the reduce the moisture content to an optimum level of cincentration within the granules.During drying,interparticulate bonds result from fusion or recrystallization and curing of the binding agent,with van der Waals forces playing a significant role.I;所有的湿法制粒过程都包含烘干过程来除去形成聚集体时引入的溶剂和把药粒中的水分控制到最好的水平，烘干过程中主要通过范德华力来调节药粒中通过溶解、重结晶和加工等粘合过程所形成的化学键。 Aftrt drying,the granulation is screened again.The size of the screen depends upon the grinding equipment used and the size of the tablet to be made .Q7:How to make drugs by wet granulation technique?The wet granulation technique includes screening or milling introducting the binder wet screening,drying screening agan and mixing. Unit 16 Reactor Technology 反应器工艺Q1:what are the focuses of reactor technology?A :Reactor technology comprises the underlying principles of chemical reaction engineering (CRE) and the practices used in their application. The focuses of reactor technology are reactor configurations, operating conditions,external opering environments,developmental history ,industrial application,and evolutionary change .Reactor designs evolve from the pursuit of new products and uses,higher conversion,more favorable reaction selectivity,reduced fixed and operating costs,intrinsically safe operation,and environmentally acceptable processing.A: 应器工艺学由化学反应工程学的基础理论和实践组成，反应堆工艺学的重点为反应器构成，运行条件，外部运行环境，发展史工业应用和重大的演变。反应器的设计追求新产品和新应用，高转化率，高选择性，降低维护和操作成本，运行安全和环境允许等。Q2:what dose reactor technology include?B: Besides stoichiometry and kinetics,reactor technology includes requirements for introducing and removing reactants and products , efficiently supplying and withdrawing heat,accommodating phase changes and material transfers,assuring efficient contacting of reactants,and provinding for catalyst replenishment or regeneration.Cinsideration must be given to physical properties of feed and products (vapor,liquid,solid,or combinations),chanracteristics of chemical reactions (reactant concentrations,paths and rates ,operating conditions,and heat addition or removal),the nature of any catalyst used (activity,life,and physical form ),and requirements for contacting reactants and removing produres (flow charateristics,transport phenomena,mixing repuirements,and separating mechanisms).B:反应器工艺学除了包含化学计算和动力学，还包括加入原料和取出产品的心要条件。有效地供给和取走热量，调和相变和物质传递，保证反应物的有效接触，保证催化剂的补充和再生。必须考虑原料和产物的物理状态（气态、液态、固态和联合体）化学反应的特征（反应物的深度、反应途径和速度操作条件，热量的加入和取出）所用催化剂的性质（活性，寿命、物理状态）反应物有效接触和产物取出的条件（流体特性、传递现象、混合条件和分离装置）。Q3:what are the central focuse in applying reactor technology?C: All the factors are interdependent and be considered together .Requirements for contacting reactants and removing products are a central focus in applying reactor technology;other factors usually are set by the original selection of the reacting system,intended levels of reatant conversion and product selectivity,and economic and environmental considerations.C: 所有因素相互依赖需要一同考虑，在应用反应堆工艺学时反应物的有效接触和产品的取出是核心，其他要素按反应物的初选，理论的原料和产出比的条件，经济和环境上的考虑。2、 How to make drugs by wet granulation technique?3、 How to assess the shape of particles and their relative reqularity or apporximation to shapes?Reactor Types and Characteristics 反应器的类型和特征D: Specific reactor characterics depend on the particular use of the reactor as a laboratory pilot plant,or industrial unit . All reactors have in cmmon selected characteristecs of four basic reactor types:the well-stirred batch reactor,the semibatch reactor,the continuous-flow stirred-tank reactor,and the tubular reactor(Fig.1)D: 反应器的特征取决于它的用途（实验室、小规模试验性生产、工厂）所有的反应按选择性分4类：搅拌好的炉型反应器、类炉型反应器、持续流动的滚筒反应器和管状反应器Batch reactor (炉型反应器)Q5:What are their advtages and shortcomings and why?Q4:what kind of reactor is mentioned in this part and what kind of use does it have ? A batch reactor is one in which a feed material is treated as a whole for a fixed period of time.Batch reactors may be preferred for small-scale production of high priced products,particularly if many sequential operations are employed to obtain high product yields ,e.g.,a proccess requiring a complex cycle of temperature-pressure-reactant additions.Batch reactors also may be justified when multiple,low volume products are produced in the same requirement or when continnous flow is diffcult,as it is with highly or sticky solids-laden liquids,e.g.,in manufacture of polymer resins where molecular weight and product quality are mardedly affected by increasing viscosity and heat removal demands.Because residence times can be more uniform in batch reactors,be