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制药工程专业英语考试题目及答案

制药工程专业英语考试题目及答案
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 Therapy

A: 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 physician’s 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

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?

addition ,liquids are less portable and require much more space per number of dosage on the pharmacist’s 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。

Properties

Q4: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:

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

Q6:What physical properties should tablet have?How the physical properties effect on bioavailability?

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

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?

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。

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 pr

2/p

s d S =α 3

/p v d V =α v s vs ααα/=

The other desirable characteristic,compressibility,is the property of forming a stable,compact mass when pressure is applied.The re quisite physical properties and the forces that hold the tablet together are discussed in Chapter 4.“Compression and Consolid ation of Powdered Solids.”The consideration of compressibility in this discussion is limited to stating that granulation is also th e 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?

Wet Granulation 湿法成粒

Q5:What are the unique portions of wet granulation process?

G:

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?

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?

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

.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:

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?

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,better yields and higher seletivity may be obtained than with continuous reactors.This advantage exists when undersired reaction products inhibit the reaction,side reactions are of lower order than that desired,or the product is an unstable or reactive intermaediate.

Batch reactors often are used to develop continuous processes because of their suitability and convenient use in laboratory experimentation.Industrial practice generally favers processing continuously rather than in single batches,because overall investment and operating costs usually are less.Deta obtained in batch reactors ,except for very rapid reactions , can be well defined and used to predict preformance of large scale ,continuous-flow reactors.Almost all batch reactors are well stirred;thus ,ideally,compositions are uniform throughout and residence times of all contained reactants are constant.

Semibatch Reacto r(类炉型反应器)

Q6:What are their advtages and shortcomings and why?

Q7what kind of reactor is mentioned in this part and what kind of use does it have ?

The semibatch reactor is similar to the batch reator but has the additional feature of continuous addition or removal of one or more components. For example,gradual addition of chlorine to a stirred vessel containing benzene and catalyst results in higher yields of di- and trichlorobenzene than the inclusion of chloring in the oringinal batch.Similarly,thermal decomposition of organic liquids is enhanced by continuously removing gaseous products.Conctant pressure can be maintained and chain-terminating reaction products removed from the system.In addition to better yield and selectiity,gradual addition or removal assists in controlling temperature particularly when the net reaction is highly exothermic.Thus ,use of a semibatch reactor intrinsically permits more stable and safer operation than in a batch operation. Continnous-Flow Stirred-Tank Reactor (连续流动筒式反应器)

Q8:What are their advtages and shortcomings and why?

Q9:what kind of reactor is mentioned in this part and what kind of use does it have ?

In a continuous-flow stirred-tank reator(CSTR),reactants ans products are continuously added and

CSTR is the idealized opposite of the well-stirred batch and tubular plug-flow reactors.Analysis of selected combinations of these reactor types can be useful in quantitatively evaluating more complex gas-,liquid-,and solid-flow behaviors.

Because the compositions of mixtures leaving a CSTR are those within the reactor,the reaction driving forces,usually reactant concentrations ,are necessarily low.Therefore except for zero- and negative-order reactions,a CSTR requires the largest volume of the reactor types to obtain desired conversions .However , the low driving force makes possible better control of rapid exothermic and endothermic reactions.When high conversions of reactants are needed,several CSTRs in series can be usedl.Equally good results can be obtained by dividing a single vessel into compartments while minimizing back-mixing and short-circuiting. The larger the number of stages,the closer performance approaches that of a tubular plug-flow reactor.

Tubular Reactor(管状反应器)

Q10:What are their advtages and shortcomings and why?

There is no use mentioned for tubular reactor,but some suggestions mentioned before imply that tubulai reactors are suitable for industrial practice.

Q11:what kind of reactor is mentioned in this part and what kind of use does it have ?

The bulular reactor is a vessel through which flow os continuous,usually at steady state and configured so that cnversion and other dependent variables are functions of position within the reactor rather than of time.In the ideal tubular reactor,the fluids flow as if they were solid plugs or pistons ,and reaction time is the same for all flowing material at any given tube cross section;hence,position is analogous to time in the will-stirred batch reactor.tubular reactors resemble batch reactors resemble batch reactors in providing initially high driving forces which diminish as the reactions progress down the tubes.

管状反应器中反应物在管中不停流动,一般有稳定的状态和形式,所以转化率和其他变化是位置的函数而不是时间的函数,在理想的管状反应器中,流体像固体的塞状物一样流动,所有在同一活塞的物质反应时间相同,这样位置等于炉型反应的反应时间,管状反应器象炉式反应器可以提供高的原始动力,随着反应的进行驱动力变小。

Flow in tubular reactors can be laminar,as with viscous fluids in small-diameter tubes,and greatly deviate from ideal plug-flow behavior,or turbulent,as with gases,and consequently closer to the ideal.Turbulent flow generally is preferred to laminar flow, because mixing is introduced in the direction of flow.For slow reactions and especially in small laboratory and pilot-plant reactors,establishing turbulent flow can result in inconveniently long reactors or may require unacceptably high feed rates.Depending on the consequences in peocess develipment and impact on process economics,compromises,through necessary,may not prove acceptable.

Multiphase Reactors(多相反应器)

The overwheling majority of industrial reactors are multiphase reactor.Some important reactor configurations are illustrated in Fig.2 and Fig.3 .The names presented are often employed , but are not the only ones used.The presence of more than one phase,whether or not it it lfowing,confounds analyses of reactors and increases the multiplicity of reactor configurations .Gase,liquids,and solids each flow n characteristic factions,either dispersed in lther phases or separatily.Flow pattens in these reactors are complex and phases rarely exhibit idealized plug-flow or well-stirred flow behavior.

在压倒大多数的工业反应器是多相反应器。一些重要的反应器的结构图显示在图2和图3中所用的名字经常被提到,但不唯一。出现多于一个的状态,是否是流动的,增加了分析反应器的难度和增加了反应器构造的多样性。气、液、固都有各自的流动特性,即不发生分离也不相互分散。这些反应器中的流体性质非常复杂,这些相很少呈现出理想的塞流或很好的混合流动行为。

A fixed-bed reactor is packed with catalyst,If a single phase is flowing,the reactor can be analyzed as a tubular lpug-flow reactor or modified to account for axoal diffusion.If both liquid and gas or vapor are injected downward through the catalyst bed,or if substantial amounts of vapor are generated intenally,the reactors are mixed-phaes,downflow,and fixed-bed reactors .If the liquid and gas rates are so low that the liquid flows as a continous film over the catalyst,the reactors are called trickle beds.Trickle beds have potential advantages of lower pressure drops and superior access ofr gaseous reactants to the catalyst; however restricted access can also be a disadvantage,e.g.,where direct gas cantact pronotes undesired side reactions.

一个固定床反应器填满催化剂,如果只有一相流动,固定床反应器可以按筒状反应或改进的轴向扩散。如果液体和气体(蒸汽)一起注入通过催化剂床或有大量气体产生,反应器被称为混合相、向下流和固定床反应器。如果液体和气体流动缓慢液体可以被看作连续的膜,反应器被称为滴流床反应器。滴流反应器在低压力降和气体充分接触催化剂方面具有优势;但是无限接触催化剂同时也是缺陷,如直接接触催化剂会促进不利的副反应。

At higher total flow rates , particularly when the liquid is prone to foamng,the reactor is a pulsed column.This designatin arises from the observation that the pressure drop within the catalyst bed cycles at a constant frequency as a result of liquisd temporarily blocking gas and vapor pathways.The pulsed conlumn is not to be confused with the polse reactor used to obtain kinetic data in which a pulse of reactant is introduced into a tube containing a small amount of catalyst.

在流速高一些特别是液体体倾向于布满泡沫时,反应器是一个脉冲圆柱。这种设计理念是由观察液体临时阻塞气体(或蒸汽)的通道使催化剂床存在一个恒定频率的压力下降而设计的。脉冲柱不能和获得动力学数据的脉冲反应器混淆,脉冲反应器是把反应物脉冲装有少量催化剂的管子里。

Downflow of reactants is preferred because reacors are readily designed mechanically to hold a catalyst in place and are not prone to inadvertent excessive velocities,which upset the beds ,Upflow is used less lften but has the advantage of optimum contacting between gas ,liquid,and catalyst over a wilder range of conditions .Mixed-phaes,upflow,and fixed-bed reactors offer higher liquid holdups and greater assurance of attainong uniform catalyst wetting and radial flow distribution,the consequences of which are more uniform temperature distribution and greater transfer.

反应物自上而下流是首先的设计方式。因为在反应器中更容易被设计为机械地保持催化剂在一个固定位置,不倾向于无意中的加速度使催化床倾倒,反应物自下而上用的较少,但是可以在更多的条件下使气体、液体最适宜地接触催化剂,混合相一向上流一固定床反应器提供了更好的液相停顿和更大地保持达到催化剂的同一润湿和径向流动分布,结果是更均匀的温度分布和热量传递。

At high liquid flow rates in these co-current fixed-bed reactors,gas becomes the dispersed phase and bubble flow deelops;flow characteristics are similar to those in countercurrrent packen-column absorbers.At high gas rates ,spray and slug flows can develop.Moving beds are fixed-bed reactors in which spent catalyst or reactive solids are slowly removed from the bottom and fresh material is added at the top.A fixed bed that collects solids impurities present in the bed or produced in the early reaction stage is a guard bed.If catalyst deposits are preiodically burned or otherwise removed,the operation is cyslic,and catalyst remaining behind the combustion front is regenerated.

在液体高速流动的直流固定床反应器中,气体变成分散质,气泡分散流动,流动特性反向填充柱吸收器,在高速流动的气体、喷雾和活塞流逐步显示出来,移动床就是固定床里用过的催化剂或反应固体缓慢地从底部移出,新的物质从顶部加入。固定床是收集原料或反应初始阶段产生的固体杂质的防护床。如果催化剂是周期的使用和移出,是一种循环操作,催化剂的循环使用前需要再生。

In bubble colomn reactors ,gas bubble flow upward through a slower moving liquid. The bubbles,which rise in essentailly plug flow,draw liquid in their wakes and thereby induce back-mixing in the liquid with which they have come in contact.Analogously,in spray

columns,liquid as droplets descend through a fluid,usually gas.Both bubble and spray columns are used for reactions where high interfacial areas between phase are desirable.Bubble column reactor are used for reactions where the rate-limiting step is in the liquid phase,or for slow reaction where contacting is not critical .An important variant of the bubble column reactor is the loop reactor,commonly uese for both multiphase and highly viscous systems .Loop reactors are distinguishable by their hydrauliqulically or mechanically driven fluid recirculation,which offers the benefits of the well-stirred behavior of CSTRs ans high average reactant concentrations of tubular reactors.

在泡沫柱反应器中,气体泡沫自上向下通过缓慢流动的液体。泡沫自下向上升起实质上是塞流,通过尾流搅动液体产生反向混合接触。相似地,在喷雾柱中液滴悬浮在气相中。泡沫柱反应器和喷雾柱反应器却是为相间大面积接触而设计的。泡沫柱反应器被用在液相为反应的限制步骤成接触不是很重要的慢反应中。泡沫柱反应器的重要变种是环式反应器,一般可用作多相和高黏度体系。环式反应器利用水利地或机械地驱动使流体再流通,提供像连续流动筒式旋转反应器那样的良好混合性能和管状反应器那样好的反应物聚集状态。

Reacors are termed fluidized or fluid beds if upward gas or liquid flows,alone or in concert,are sufficently high to suspend the solid and make them apper to behave as a liquid.This process is usually referred to as fluidization.

如果向上的气体或液体能够浮起固体使固体粉末的流动像液体一样。这样的反应器被称为沸腾床或流化床。

The most common fluid bed is the gas-fluidized bed .With gas feeds ,the excess gas over the minimum required for fluidization rises as discrete bubbles,through which the surrounding solids circulate.At higher gas rates,such beds lise their clearly defined surface,and the particles are fuooy suspended.Depending on the circumstances,these reactors are variously called reser,circumlating-fluidized,fast-fluidized,or entrainment reactors,In ebullating-bed or gas-liquid-solid reactors,the solids are fluidized by liquid and gas,with gas primarily providing lifting power in th former ,and liquid in the latter.These become slurry bubble column reactors (less precisely,slurry reactors )at high rates when the beds begin to lose their defined surface.Slurry bubble column reactors that contain finely powdered solids are often terem and treated as bubble cloumn reactors because such suspensions are homogeneous.

A reactor is termed a radial or panel-bed reactor when gas or vapor flow perpendicular to a catalyst-filled annulus or panel.These are used for rapid reactions to reduce stresses on the catalyst or to minimize pressure drops.Similar cross-flow configurations also are used for processing solids moving downward under gravity while a gas passes horizontally through thwm.Rotary kine,belt dryers ,and travelling grates are examples.Cross-flow reactors are nit restricted to solids-containing systems.Venturis,in which atomized liquids are injected across the gas stream,are effective for fast reactions and similarly for generating small gas bubbles in downward-flowing liquids where mass transport across the gas-liquid interface is limiting.

问答:

4、what are the advantages for continous flow-stirred-tand reactor(CSTR) in Unit 16 and why ?

药品说明Drug Instructions

药物说明书

“药品说明书”的英文表达方式有Instructions,Directions,Description 现在多用Package Insert,或简称Insert,也有用Leaflet或Data Sheets。Insert原意为“插入物,插页”。

药品说明书即为附在每种药品包装盒中的一份用药说明。经过注册的进口药品一般是国家承认的有效药物,其说明书是指导医生与患者合理用药的重要依据,具有一定的法律效力。

①药品名称(Drug Names),

②性状(Description),

③药理作用(Pharmacological Actions),

④适应症(Indications),

⑤禁忌症(Contraindications),⑥用量与用法(Dosage and Administration).

⑦不良反应(Adverse Reactions)。

⑧注意事项(Precautions),

⑨包装(Package),

⑩贮存(Storage),⑾其他项目(Others)。

①药品名称(Drug Names)

英文药品说明书中常见的药品名称有商品名(Trade Name或Proprietary Name),通用名(Generic Name)和化学名(Chemical Name),其中最常见的是商品名。

例如,日本田边有限公司生产的熊去氧胆酸片,其商品名为Ursosan(Tablets);

通用名为Ursodesoxycholic Acid(熊去氧胆酸);化学名为3a,7p dihydroxy-5p-Cholanoic acid(3a,7p二羟基5p胆烷酸)。药品名称翻译可采用音译、意译、音意合译及谐音译意等方法: 1、音译:按英文药品名歌的读音译成相同或相近的汉语。如:Tamoxitn它莫西芬,Ritalin利他林,Amcacin 阿米卡星。音译较为方便,但不能表意。

2、意译:按药品名称所表达的含意译成相应的汉语。例如:Cholic Acid 胆酸,Tetracycline四环素;也可按其药理作用翻译.如:Minidiab灭糖尿(治疗糖尿病药物),Natulan疗治癌(细胞生长抑制剂),Uraly消石素(治疗尿路结石药物)等。

3、音意合译:药品名称中的一部分采用音译,另一部分采用意译.例如:Coumadin香豆定(coumarin香豆素),Neo-Octin 新握克丁(neo-新);Medemycin麦迪霉素(-mycin 霉素),Cathinone卡西酮(-one酮)。

4、谐音译意:以音译为原则,选用谐音的汉字,既表音,又表意,音意结合。例如:Antrenyl安胄灵,Doriden多睡丹,Legalon利肝隆,Webilin胃必灵.商品名称可以这样翻洋,而法定名称则规定不可以这样翻译。

药品的化学名称反映出该药品的化学结构组成成分,可借助英汉化学化工词典进行翻译。如果名称很长,可以分解开来,分别查出各个组成部分的名称,组合而成。

例如:Catalin(卡他林)的化学名称是1-Hvdroxy- 5-oxo-5H-pyrido(3,2-a)-Phenoxazine-3-carboxylic acid,译成汉语是1-羟基-5-氧-5H-吡啶开(3,2-a)吩嗪-3-羧酸。

如能掌握一些常用的酸、碱、盐、基因、化合物的英文名称,以及常用的前缀、后缀等,翻译时会顺利得多。例如:chloride 氯化物,sulfate(sulphate)硫酸盐,acetyl一乙酰基,amino氨基,di-二,dihydro-二氢。nitro-硝基,-ester酯,-lactone内酯,-one酮、-oxide氧化物,-urea脲等等.

为了统一药品名称的译名,卫生部药典委员会已拟定出原料药和辅料命名原则,并刊行了<药名词汇>一书,可供翻译英文药品名称时参考

②性状(Description)

Description(性状),其原意是“叙述”、“描写”,在药品说明书及药典中一般都译为“性状”,其内容主要是介绍外观、理化性质、组成成分、结构、特征等。这一项最常用的标题是Description,此外还可能有其他的表示法,如:Chemical Structure 化学结构Composition 成分Physical and Chemical Properties 理化性质

本项中常见的句型

1.Folic acid is a yellowish to orange, crystalline powder, odorless or almost odorless.

叶酸是淡黄色至橙色结晶粉沫,无臭或几乎无臭。

2.Intralipos 10% is a white opaque fat emulsion for intraven ous injection, containing 10 W/V % of purified soybean oil.

脂肪乳剂(10%)是白色,不透明,供静脉注射用的脂肪乳剂,含有10%(W/V)的精制大豆油。

3.Ursosan Tablet 50mg is a white plain tablet which contains 50 mg of ursodesoxycholic acid.

熊去氧胆酸片为白色素片,每片含50mg熊去氧胆酸。4.Sterile pyrogen-free, orange red, freeze-dried powder in vi als containing 10mg and 50mg of doxorubicin hydrochloride with lactose.

(本品)为小瓶装,灭菌无热原,桔红色冻干粉沫,每小瓶含有10mg或50mg阿霉素盐酸盐与乳糖。5.It occurs as a white to off-white, crystalline solid, poorly sol uble in water, dilute acid and most organic solvents.

本品(炎痛息康)为白色至类白色结晶固体,难溶于水、稀酸及大多数有机溶剂中。

6.Pamine, chemically known as epoxytropine tropate methylb romide, has the empirical formula C18H24NO4Br and the mole cular weight 398.3.

哌明的化学名称为环氧莨菪碱托品酸酯溴代甲烷,实验式为C18H24NO4Br,分子量为398.3。

7.Kanendomycin is a very stable antibiotic, and its activity do es not decrease when the powder is placed in an airtight contai ner and kept at room temperatures for more than 2 years.

卡内多霉素是一种很稳定的抗生素,其粉沫置于密封容器中,在室温下保存二年以上,活性不减。

.This product is prepared from units of human plasma whi ch have been tested and found nonreactive for hepatitis associ ated (Australia) antigen.

本品由人血浆制备,此血浆业经检验,并且证明对肝炎(澳大利亚)抗原无反应。

本项中常用的词语

?表示组成、制备的词及短语,如:

be derived from 由……衍生

consist of 由……组成

be obtained 制得

contain 含有

be prepared from 由……制备have (possess) 有(具有)

表示性质的一些词类,如:

colo(u)r 颜色

stable 稳定的

taste 味道molecular formular 分子式

odo(u)rless 无臭的

molecular weight 分子量

crystalline 结晶的

structure 结构

solubility 溶解度

injection 注射剂

insoluble 不溶的

solution 溶液

odo(u)r 气味

tablets 片剂

colo(u)rless 无色的

derivative 衍生物

tasteless 无味的

liquid 液体

sterile 无菌的

powder 粉沫

soluble 可溶的

solid 固体

③药理作用(Pharmacological Actions)

?药理作用(Pharmacological Actions):主要包括药理作用、临床药理(Clinical Parmacology)、体外试(in vitro experiments)、药物代谢(Metabolism)、药效(Potency)及毒性(Toxicity)等。

?这一项常用的标题是:

?Pharmacological Action 药理作用

Pharmacological Properties 药理性质

Pharmacology 药理学

Clinical Pharmacology 临床药理

其他的表示方法还有:

Actions 作用

Actions and Properties 作用与性质Clinical Effect (Use) 临床效果(用途)Mechanism of Action 作用机理

Mode of Action 作用方式

如果药品的一种抗生素,可能出现:

Biological Action 生物活性Microbiology 微生物学

?这一项目中涉及的词汇范围包括药理学、生理学、化学、毒理学、微生物学及医学等学科,专业词汇多,是较难阅读的一部分内容,阅读时可参阅《英汉医学词汇》、《英汉微生物学词汇》及《英汉化学化工词汇》等工具书。另外,还会遇到许多缩写词,如:CNS(中枢神经系统)、EEG(脑电图)、LD50(半数致死剂量)、ECG(心电图)等,这些缩写词可在英汉医学缩略语词典中查到。

常见句型举例

1. Mean peek serum concentrations of tobramycin occur between 30 and about 60 minutes after intra-muscular administration. 肌注后约30-60分钟之间妥布毒素的平均血药浓度达到高峰。

2.Nembutal Sodium exerts a depressant action on the CNS and shares the sedative-hypnotic actionstypical of the barbiturates. 戊巴比妥钠对中枢神经系统产生抑制作用,并显示戊巴比妥类特有的镇静催眠作用。

3.In clinical trials the drug was shown to be highly effective in improving and normalizing the alerted cerebral circulation and those disorders related to insufficient arterial flow in the limbs. 临床试验证实,本品疗效高,可改善已改变了的脑循环,使之恢复正常,治疗与四肢动脉血流不畅有关的疾病。

4.Orbenin is stable to staphylococcal penicillinase,and highly effective against resistant staphylococci.It is bactericidal, acid-stable and well absorbed by either the oral or the intramuscular route.全霉林对葡萄球菌的青霉素酶稳定,对耐药葡萄球菌十分有效。本品具杀菌、耐酸作用,且口服或肌注吸收良好。

5. Nystain has been found to inhibit the growth of yeast like flora in the intestinal tract.

已查明制霉菌素在肠道内可抑制菌丛类酵母菌的生长。

6. Fenarol has proved to be effective as a striated muscle relaxant.已证明芬那露是疗效很好的横纹肌松施药。

7. Halcion is a potent short-acting hypnotic agent, which produces its hypnotic activity from the first night of

administration. 好而睡是一种强力速效催眠药,它从服药后的第一个夜晚开始产生催眠作用。

8. Therapeutically, ATP injection exhibits effects, especially such as activation of the function and metabolism of the nerve, and also coronary and peripheral vasodilation to increase the blood stream.

从治疗上看,三磷酸腺苷注射剂显示了非常好的效果,特别是在活化神经的功能及代谢,以及舒张冠状与外周血管以增加血流方面更是如此。常用词及短语举例

动词

?absorb 吸收

act 作用

cause (be cause by) 引起(由……引起)

demonstrate 显示

exert (action on) ?起……作用

exhibit 显示

inhibit 抑制

accumulate 积蓄

administrate 投药

excrete 排泄

result in导致

? indicate 表明

maintain 维持

produce 产生

protect (from)

?保护(不变)

reach 达到

show 显示,表明

treat 治疗

metabolize 代谢

promote 促进

prevent 阻止,预防

tolerate 耐受

?形容词

(be) active (effective) against

对…有效的

(be) related to

与……有关的

(be) sensitive to

对……敏感的

resistant to 有耐药性的

average 平均的

minimum 最低(小)的

maximum 最高(大)的

normal 正常的

?名词ability 能力

activity 活性

distribution 分布

excretion 排泄

action 作用

clearance 廓清率

effect on 对…的作用

function 功能,作用

half life 半衰期

in vitro 体外

kidney 肾

mechanism 机理

serum concentration 血清浓度

tolerance 耐受性

infection 感染

in vivo 体内

level 水平,浓度

plasma level 血浆浓度(水平)

toxicity 毒性

④适应症(Indications)

?“适应症”最常用的有以下几种表示方法

Indications 适应症

Indications and Usage 适应症与用途

Major (Principal) Indications 主要适应症

Uses用途

Action and Use作用与用途

偶尔也会见到其他的表示方法。

本项中出现频率最高的是疾病名称以及微生物(尤其是致病菌)的名称,如:

angina pectoris 心绞痛

cancer癌

diabetes(mellitus)糖尿病

hypertension 高血压

gram-positive microorganisms (bacteria)

?革兰氏阳性菌

virus 病毒

gram-negative microorganisms(bacteria)

?革兰氏阴性菌

? E.coli 大肠杆菌

这些词汇可借助英汉医学词典进行阅读和翻译,只要掌握了这些词意,即可了解本项基本内容。

一、常见句型本项是说明书的重点,从句子结构来分析,大致有以下几种类型。1、不完全句结构.仅列出疾病或微生物的名称.

例1、Angina pectoris, Prinzmetal’s angina, hypertension心绞痛,变异性心绞痛,高血压。例 2The following diseases caused by bacteria including gram-positive and gram-negative bacteria such as Staphylococcus,Streptcoccus, Escherichia coli,Klebsiella pneumoniae……

用于治疗由革兰氏阳性和革兰氏阴性细菌,如葡萄球菌、链球菌。大肠杆菌、肺炎杆菌……引起的下列疾病……

2 由For(或In等)引出的短语

例3 For prevention of the advance of cataract.用于预防白内障进展。

例 4 In the treatment of all forms of pulmonary tuberculosis in association with other antitubercular drugs.

与其他抗结核药配伍,治疗各种类型肺结核。

3.To+动词原形构成的短语

例 5 To prevent the formation of urinary calculi,especially in cases where they tend to recur.

用于预防尿路,特别是易发部位的结石的形成。

例6 To protect the liver cell during administration of drugs hazardo-us to the liver.

在服用对肝脏有危害的药物期间,用以保护肝细胞。

4. 完整的句子结构或段落,有时结构很复杂

7 Amikacin is useful in the treatment of infections from Gram-negative sensitive species there included the Pseudomonas species;it may also be useful to treat infections caused by sensitive staphylococci,

阿米卡星可用于治疗革兰氏阳性敏感菌(其中包括假单孢菌)引起的感染,也可用于治疗敏感葡萄球菌引起的感染。

例 8 Nebcin is indicated for the treatment of the following infections caused by susceptible microorganisms:

乃柏欣适用于治疗下列由敏感细菌引起的感染:

例 9 Octinum D has proved effective in the prophylaxis and therapy of disorders arising from spasm of the smooth musculature.新握克了已证实对平滑肌痉挛引起的病症有预防和治疗作用。

例10 Fungizone intravenous is especially intended to treat cryptococcosis……

注射用凡疾送特别适用于治疗隐球菌病。…

例11

Kanamycin is active both in vitro and vivo against Gram-possitive and Gram-negative bacteria as well as acid-fast bacteria 卡那霉素在体外及体内对革兰氏阳性和革兰氏阴性菌以及耐酸菌都有效。

例12

Benemid is recommended for the treatment of gout and gouty arthritis, and to increase and prolong the plasma concentration of peni cillin and cephalosporins during anti-infective therapy.

丙磺舒被推荐用于治疗痛风及痛风关节炎,及在强化抗感染治疗时增加并延长青霉素类及头孢菌素类的血浆浓度。

例 13 Information available at present suggests that Oncovin may be useful either alone or in conjunction with other oncolytic drugs for the treatment of acute leukaemias ……

据现有资料表明,硫酸长春新碱可单独使用,亦可与其他溶瘤细胞药物合用,以治疗急性白血病……

例14 Adriamycin is frequenly used in combination chemotherapy regiments with other cytotoxyc drugs.

阿霉素常与其他细胞毒药物合用于化疗方案。

例 15 Concomitant therapy with other calcium antagonists, anti-hypertensives and alcohol may potentiate the hypotensive acti on of the drug.

与其他的钙桔抗剂、抗高血压药物及酒精饮料同时使用,会增强本品的降低血压的作用。

二、本项中的常用词及短语举例

?许多常用词及疾病名、微生物名词等与“药理作用”项类同,此外还有以下词组与短语(例句参见前文)。

be active against对……有效

be intended to…适用于……

be administared in …适用于…

be of value of …适用于……

be effective in (for,against)…对…有效

be recommended for 推荐用于……

be employed to …用于……

be used to(for,as)…用于……

be helpful in …用于……

be useful in …用于……

be indicated in(for)…适用于…

for(in) the treatment(management)of…用于治疗(控制)

?表示与“其他药物合用”的结构有:

be associated with

in association with

be combined with

in combination with

be compatible with

in conjunction with

concomitant with

together with

④适应症(Indications)

?本项中最常用的英语表示法是Contraindications,也有用Restrictions on Use(用药限制)的。

一、本项中涉及到禁用(或慎用)某些药物的患者或某种特殊情况,例如:

1、孕妇、妊娠期或哺乳期,幼童等:

pregnant woman 孕妇

lactation 哺乳期

in pregnancy 妊娠期

children under …years of age …岁以下儿童

the first trimester (3 months) of pregnancy

妊娠期的最初三个月

2、患有某些疾病或过敏的患者,如:allergic (hypersensitive) to… 对…过敏的allergic (anaphylactic) reaction 过敏反应

allegy (hypersensitivity) to… 对…过敏patients with… (who…) 患有…的患者

二、本项中常出现一些疾病名称,例如:cardiac failure 心力衰竭

hypertension 高血压

cardiac (renal) insufficiency心(肾)功能不全severe hypotension 严重低血压

impairment of kidney (renal function) 肾功能损伤diabetes 糖尿病

liver (hepatic) damage 肝损伤

severe anemia 严重贫血

三、常见句型:

1) 省略句型,只列出禁忌对象或疾病名称等。

例 1. Pregnacy, allergy to methotrexate, functional disorders of liver and kidneys, diseases of the haematopoietic system (bone marrow hypoplasia, leucopenia, thrombocy - to penia, anaemia), intectious diseases, ulcers of the oral cavity and the gastrointestinal tract, recent operation wounds. 孕期,对氨甲叶酸过敏,肝、肾功能障碍,血液系统疾病(骨髓机能减退、白细胞及血小板减少、贫血),传染病,口腔及胃溃疡,近期术后伤口等忌用。

例 2. Hypersensitivity to quinoiones, severerenal insufficiency. 对喹喏酮类过敏,严重肾功能不全。

2) 完整的句子或段落。其中常用的结构有:contraindications are… 禁忌症是…

be contraindicated in (for) … 对…禁忌

should not be used (employed) in … 不得用于…

It is advisable to avoid the use of … 建议不用于… must not be administered (given) to… 对…不得用药should be used with caution 慎用

be not recommended for… 最好不用于… none reported 未见报道

not known 不清楚

还可能有一些其他的结构。

例 3. Cetazolin sodium is contraindicated in patients with known hypersensitivity to cephalosporin group of antibiotics.

先锋5号禁用于已知对头孢菌素类抗生素过敏的患者。

例 4. It is advisable to avoid the use of Aramine with cyclo-propane or halothane anesthesia, unless clinical circumstances demand such use. 如果不是临床需要,建议本品不要与环丙烷或氟溴氯乙烷麻醉剂合用。

例 5. Do not take Benemid if prior administration resulted in hypersensitivity Benemid is not recommended for persons with known disorders of the blood or uric acid kidney stones. Do not give Benemid to children under two years of age.

若以前使用丙磺舒曾引起过敏反应,则应禁用。已知有血液疾患及尿酸性肾结石的患者建议不要使用本品,二岁以下儿童不得服用。

四、在Restrictions on use 的项目中有时还有小标题

Contraindications 禁忌症

Precautions (Note) 注意事项

Warning 警告

Pregnancy and Lactation 妊娠与哺乳

⑥用量与用法(Dosage and Administration).本项最常用的英语表示法有:

Dosage and Administration

用(剂)量与用法

Route of Administration 给药途径(用法)Administration 用法

Direction for Use 用法

Method of (for) Administration 用法Application and Dosage 用法与用(剂)量Mode of Application 用法

Dosage 用(剂)量

How to Use 用法

Posology 剂量学

本项也是阅读的重点,读者必须正确理解本项内容中的给药对象、给药方式、剂量及剂量单位、给药时间等。

1、常用表示剂量的术语average dose 平均剂量

minimal (minimum) dose 最小有效量

daily dose 日剂量(一日量)

multiple dose 多剂量

2、常用的剂量单位表示法

g=gram 克

l=liter (litre) 升

c.c. 毫升

3、每次给药次数的表示方法

daily (per day, a day, every day ) 每日

every …hours 每隔…小时

intervats of … 每隔…

4、给药对象:最常见的用词有adolescents 青少年intant(s) 幼儿

adult(s) 成年人

pregnant women 孕妇

5、给药方式的表示法:多用副词成或介词短语表示,例如:intra-arterially 静脉内给药by mouth (OS) 口服

6、表示“投药”的常用动词

administer 给药、投药

recommend 推荐给药

7、表示不同的用药方式的动词:

take 服用inhale 吸入apply to 用于、涂于、敷于spray 喷雾inject 注射swallow 吞服

5、给药方式的表示法:多用副词成或介词短语表示,例如:intra-arterially 静脉内给药

by mouth (OS) 口服

6、表示“投药”的常用动词

administer 给药、投药

recommend 推荐给药

7、表示不同的用药方式的动词:

take 服用inhale 吸入apply to 用于、涂于、敷于spray 喷雾inject 注射swallow 吞服

⑦不良反应(Adverse Reactions)。

1.“不良反应”的常用的英语表示法有

Adverse Reaction(s)不良反应

Unwanted(Untoward)Reactions不良反应

2“副作用”的常用的英语表示法有:

Side-effect(s) 副作用

Unwanted(Undesirable)Effects 副作用

Side Reaction(s) 副作用

By-effects 副作用

3.常见的霉副反应的症状及体征的词语很多,但记住下列词语很有必要:

Allergic(hypersensitive,anaphylactic)reaction(s) 过敏反应

allergy(hypersensitivity) 过敏

dizzziness 眩晕

gastrointestinal tract 胃肠道

4.“霉性”、“耐受性”的英语表示法:toxicity 毒性tolerance(tolerability)耐受力,耐药性

tolerate(toleration)耐受

3.常见的霉副反应的症状及体征的词语很多,但记住下列词语很有必要:

Allergic(hypersensitive,anaphylactic)reaction(s) 过敏反应

allergy(hypersensitivity) 过敏

dizzziness 眩晕

gastrointestinal tract 胃肠道

4.“霉性”、“耐受性”的英语表示法:toxicity 毒性

tolerance(tolerability)耐受力,耐药性

tolerate(toleration)耐受

5.“停药”的英语表示法举例:

abandon 停药

Discontinue (discontinuance,discontinuation) 停药,中断(治疗)

⑧注意事项(Precautions)

“注意事项”也是药品说明书中的重要内容之一。为了安全用药,厂商在本项中特别强调应注意的事项,其中主要包括:正确的剂量和用法,超过剂量时的应急措施,用药对象,可能出现的较严重的副作用及治疗方案,药物的配伍,药液的配制、使用及保管等、方面的注意事项。现就本项内容详细介绍如下:

1.本项常用的英语表示法:Precaution(s)注意事项

Special note(caution, precaution)特别注意Caution(s) 注意事项N.B. 注意

Noto 注意Warning(s) 警告2. 本项中常见的检查项目:

blood count 血细胞汁数

Kidney (renal) function 肾功能

3. 本项的特点是内容长短不一,有难有易;词汇量大,涉及面广,既有普通词汇,也有大量的专业词汇及编写词。

⑨包装(Package)

1“包装”在英文药品说明书中的表示法有许多,最常用的是Pack (Package)和Supply,例如:

Pack(s) (Packing(s))包装Supplys(Supplied) 包装Package(s) 包装

How Supplied 包装方式

2 常见的包装单位(工具)的英语表示法:ampoule(s) 安瓿carton 纸盒

blister pack(package)铝塑包装(水泡眼包装)3 药物的常见剂型的英语表示法:aerosol (spray, inhaler) 气雾剂ampoule 针剂capsules 胶囊oral solution 口服液

syrup 糖浆

4 本项的结构特点;内容结构简单,多为不完全句,或仅仅列出包装工具、剂型、装量等,词汇量容易阅读。⑩贮存(Storage)

“贮存”的英语常用表示法是Storage。本项中常用的一些短语有:store (keep) in a cool and dry place 存于于阴凉干燥处

away from light 避光

away from children 勿让儿童接触

protect from light (heat) 避光(热)

out of (the) reach of children 勿让儿童触及

prevent moisture 防潮⑾其他项目(Others)。

1、特点(Characteristics),

2、性质(Properties),

3、药代动力学(Phamacokinetics),

4、用药过量(Overdosage),

5、相互作用(Interactions),

6、有效期(Validity),

中文文章格式

1、题目,

2、作者(名字后加*号的作者一般表示通讯联系人,作为主要负责人),

3、单位,

4、摘要(100~200字左右)

5、正文(背景、目前研究工作现状、研究的创新点,一般两到三段),

6、实验方法、仪器和药品(一般一到两段概述)7实验过程、现象结果(主体部分,一般会加入图表等说明),8、实验讨论(主体部分,一般会加入图表等说明)

9、结论(机理分析),10、参考文献。

文章注意以下几点(1、创新,2、时态(现在、过去),3、语态(被动、主动),4、动词,5、复句。

英文文章格式

1、Title ,

2、Auther (*一般是第一作者为笔者,文章赞助人置后),

3、Department,

4、Abstract (key words),

5、Introduction

6、Methods,

7、Result and Discussion,

8、Conclusion,

9、Acknowledgement(support found 资金来源),10、References.

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