制药工程专业英语考试题目及答案.docx

1、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 thera

2、py.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 fo

3、r 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

4、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

5、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 b

6、y 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

7、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

8、 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 mea

9、suring 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 d

10、oes 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 we

11、ighs 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

12、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 b

13、urden 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

14、 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.Properti

15、esQ4: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

16、 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 ag

17、ent(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 bioavail

18、ability? 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 dispensi

19、ng;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

20、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 b

21、e 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 emphas

22、izes 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

23、 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

24、 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，

25、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 mo

26、re 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 c

27、omponents 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 sphere

28、s?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

29、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 th

30、e 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

31、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 mat

32、erials 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 cal