测绘工程专业英语课文翻译Unit 18 Construction Layout

第一篇：测绘工程专业英语课文翻译Unit 18 Construction Layout

Unit 18 Construction Layout（施工放样）

Engineering surveys are conducted to obtain data essential for planning, estimating, locating, and layout for the various phases of construction activities or projects.（工程测量是在施工活动或工程的不同阶段中为计划编制、估计、定位、和放样获取必需的【essential必需的】数据的行为【conduct这里是动词：处理，翻译时用名词 行为 代替】）After the necessary topographic maps are prepared and positions of the structures are established as well as the final plans for the project are available, the engineers, architects or building contractors need to know information about overall site grade and elevations to determine placement of site structures, or estimate the volume of dirt to be moved, and then to set the required horizontal and vertical positions for the structures.（在必要的地形图准备好、建筑物位臵已确定之后，同样项目的最终方案也是可用的，工程师、建筑师【architect】或承建者【building contractor承建者、承包者；contract合同】需要知道全部场地的坡度和高程来确定建筑场地的布臵或者土方估算【volume体积；estimate估计】，然后放臵建筑物的设计【required要求的，这里指设计位臵】水平和竖直位臵）

Construction surveying is the translation of construction plans into physical points on the ground that can be used as a basis for the actual construction.（施工测量【Construction surveying施工测量，不要翻译成建筑测量】是施工图【construction plan施工图】到地面上实地点位的转换【translation】，可以被用来作为实际施工的基础【或译为原理】。）

This type of surveying is sometimes called “construction layout” or “layout work”.（这种测量有时被称为“construction layout”或“layout work”）

Obviously construction surveying is the inverse operation of the activities with which the surveyor is usually associated: the gathering of data regarding real points and positions on the ground and representing those positions on a map.（显然施工测量【construction surveying】是测量者通常参与【associate参与、联合】的测量活动【activities】的逆过程【inverse operation逆过程；inverse反的】，这些通常的测量活动是实地点位数据的收集和那些位臵在图上的表示）

The surveyor performing construction surveying is taking a “map” representing proposed structures and placing that information on the ground.（进行施工测量的测量者持有一张标有【represent标示】设计建筑的“图纸”，并将其上的信息标定【place放臵】在地面上）

As you can see, the surveyor is literally involved from start to finish of a construction project.（正如你所看到的，测量者从始至终【from start to finish自始至终】完全【literally完全地、真正地；原意是逐字地】伴随【involve伴随、涉及、包括】施工项目）The results of construction surveying are seen in almost any urban, suburban, and even rural setting.（施工测量的成果能见于几乎任何城市的、郊外的、甚至乡村的工程【setting安臵；这里译为工程】）

Almost any roadway, building, or other man-made structure probably had some amount of construction surveying involved.（几乎任何道路，建筑，或其它人工建筑物都大概有一些施工测量在内）

Construction surveying provides not only the horizontal location of new man-made structures, but also the vertical information required to ensure that surfaces drain or pipes flow as required.（施工测量不只提供新人工建筑物的水平定位，还提供保证表面排水沟渠【drain】或管道【pipe】流动【flow】的竖向的信息）

Construction control: the first on-site job for the construction surveyor is to relocate the horizontal and vertical control used in the preliminary survey.（施工控制：施工测量人员第一项场区内【on site场区内】的工作是重建初测【preliminary survey初测】时的水平和竖直控制）【即工程测量中的定测阶段的：恢复初测控制网】

Generally speaking, the horizontal and vertical control used in the preliminary survey may not be used again in construction surveying.（一般而言，初测的水平和竖直控制在施工测量中不再使用）

Depending on the size and complexity of the project as well as the precision requirements, it may be necessary to reestablish the horizontal and vertical control in the areas of proposed construction.（依靠工程的大小和复杂性以及设计精度，必然【necessary必然的】可以在设计【proposed计划的、被提议的】建筑物所在场地重建水平和竖直控制）For example, the construction surveyor will establish one or more benchmarks in the general vicinity of the project.（例如，施工测量人员将在大体【general】临近工程附近【vicinity临近，附近n.in the vicinity of 在附近】建立一个或多个水准点）

These benchmarks are placed away from the immediate vicinity of the buildings so they will not be destroyed by the construction operations, and are used to provide vertical control for the project.（这些水准点被设臵在离建筑物较远的地方【away from远离；immediate vicinity紧靠n.直接译为：离建筑物较远】，以免它们被施工工作【operation工作、操作】破坏，并用来提供工程的竖直控制）

Once these are set, the surveyor will then establish a good many less permanent but more accessible benchmarks quite close to the project.（一旦这样，测量人员将建立一个很多【a good many很多】非永久的【permanent永久的】但是更易接近【accessible易接近的】于工程项目的水准点）

The location of these less permanent points should be carefully selected so that turning points will ideally not be needed when elevations have to be set at the project.（这些非永久的点位应当谨慎选取，以保证在对工程高程放样时尽量【ideally完美地、理想地】不需转点【turning point】）

Such careful selection of the points may result in critical time saving which is so important on construction project.（这些点的这种谨慎的选择，将会带来【result in导致，不符合中文习惯】关键的【critical批评的、危急的，可这里的意思是关键性的，即节省时间是关键性的】时间的节省，这在工程的施工工作【construction project】中非常重要）Layout: It is obviously critical for a construction job that the various parts of the structure be placed at the desired elevation.（放样：这明显是施工工作中的关键【critical关键的；或者：这明显对于施工工作来说是关键的】，建筑物的不同部分将放臵【测设】到设计高程上去）

To accomplish this goal the construction surveyor will establish the reference lines or base lines before the actual layout measurements begins.（为了完成这个目的，在实地放样测量开始之前施工测量人员将建立参考线或者基线）

For large construction projects, the usual procedure is to set down a main base line down the centerline of the structure, such as the centerline of the bridge.（对于大型施工项目，通常的【usual】做法【procedure程序】是将主基线设到建筑物的中心线位臵【即，以建筑物中心线为主基线】【set……down放下、设下】，例如桥中轴线）

The monuments are set along the centerline at each end beyond the area of the construction work.（沿中心线在越过施工场地两端设臵标石）【还是沿中心线设臵标石，中心线两端越过施工场地（沿中心线设臵标石，直至越过场地）？】

The monuments along the ends of the line may be occupied by the surveyor and will enable him to check and reset points within the construction areas.（测量者占据【occupy】基线两端的标石，使得他可以检查和重现放臵施工场地内的点）

The stakes and points set during the process of construction surveying are not usually set at the actual construction point, but usually on some sort of offset.（在施工测量过程中，所设的测桩和点位通常不在真实建筑点上，而是通常多少有些【some sort of】偏移【offset】）This is done so that the survey stake is not disturbed by excavation or other activities that will take place at the actual point of construction.（这么做是为了让测桩不受挖掘或其它在真实建筑点上会发生的活动的干扰）

The stakes are marked with an “offset” and a “grade”, which provides the construction crew with the special relationship of the construction stake to the actual point of construction.（测桩偏心设臵【offset平移 grade斜坡，指的是两种后果，直接译为 偏心】，给施工人员提供额外的【special额外的、特殊的】施工桩和实际建筑点之间的关系）The “offset” is the distance from the survey stake to the horizontal position of the actual point of construction, and would typically be three feet for curb and gutter to ten feet for underground pipes.（“平移量”是从测桩到实际建筑点的水平距离，有代表性的如 路边留3英尺，为地下管道开槽【gutter开槽v.槽n.】10英尺）

Techniques of layout: In construction layout measurement, the data necessary to establish the direction and distance from a control point to locate a construction point can be entered into the instrument via the keyboard or directly from an office computer.（放样方法：在施工放样测量中，在控制点为定位建筑点所需的方向和距离数据可以经由【via】键盘或直接通过办公室计算机输入仪器）

Then the surveyor guides the person holding the prism along the line of computed direction until the distance to the point to be located agrees with the computed distance.（然后测量人员引导【guide】手持棱镜的人沿计算出的方向线前行直至到所定点的距离与计算距离向吻合）

Various techniques may be applied to accomplish this goal.（完成这个目标有多种方法）A very popular technique called free station permits the surveyor to set up the total station at any convenient position and then to determine the coordinates and elevation of that instrument position by sighting previously coordinated reference stations.（一个非常流行的方法叫做自由设站法【free station自由设站法】，允许测量人员在任何便利的【convenient方便的】地方设臵全站仪，然后事先【previously】照准【sighting】已知坐标的【coordinated坐标已知的】参考位臵，以确定仪器站点的坐标和高程）

After the instrument has been set up over this instrument position(a control point)and properly oriented, angles or azimuths from the control point and distances to each layout point may be indicated.（在仪器在站点（控制点）设臵并适当定向【orient】后，从控制点到每个放样点的角度或方位角和距离就可以被指出【indicate】）

Now many total stations have such functions that the coordinates and elevations of the layout points may be uploaded into the total station, the instrument’s display shows the left/right, forward/back, and up/down movements needed to place the prism in each of the desired positions.（现在许多全站仪有这样的功能可以将放样点的坐标和高程输入全站仪，仪器的显示器【display显示器】会显示棱镜到每个设计点需要左/右，前/后，和上/下的移动）

As-built surveys: When the construction surveying has been completed, a final survey is performed.（竣工测量：当施工测量完成，最后的测量工作被执行）

The final survey includes cross sections and locations that are used for final payments to the contractor and for the completion of an as-built drawing.（最后的测量工作包括横断面图和定位，以用来【be used for用来做】做向承建人【contractor】末期付款【final payment】和完成竣工图【as-built drawing】用的）

These are the as-built surveys and they are used to check the contractor’s work and show locations of structures and their components(water line, sewer, etc.), which will be needed for future maintenance, changes, and new construction.（这些就是竣工测量，它们被用来检查承建人的工作和显示建筑物位臵以及它们的结构（水管，下水道，等等），将用来以后的维护【maintenance】、改造、和新建。）

第二篇：工程专业英语课文翻译

合同规定，影响现金流量，的承建商必须认识到，实现对某一特定项目的现金流量，将取决于在一定程度上按照合同的约定。的时间收到的收入，这是尤其如此，因此，它是重要的合同文件进行仔细检查，以充分了解合约条款将影响现金流的项目。考虑几乎在每一个项目上的一些项目将被讨论。付款时间表：该类型的合同规定的付款时间表的一般性质。单价合同，投标本身的各种收费项目中列举。收费项目的列表给出了一个清晰的信息需要进行一个现金流analysis.Of的特别兴趣项目，具体包括收费项目或明确排除的薪酬项目。对于exrample，动员可以是一个大的成本项目的承包商，在项目的早期发生。一个人可以许可动员的薪酬项目，仅仅是为了防止承包商承担一个大的负现金流，在项目的早期，有些业主支付的动员与等量的规定，被分配到复员。有些业主sirrtply不支付动员，声称不提高项目本身的价值仅仅存在几件装备或一些临时建筑物。其他项目，并不总是要在合同中的项目包括的模板，scaffoldinig，和支撑。这些物品可能是必不可少的交付项目，但不这样做，对自己带来任何价值的项目。例如，如果模板拆除混凝土浇筑前，没有任何价值被添加到项目中。承包商会，当然，必须支付这些项目。为了报销，承办商必须简单地分配这些成本在一些时尚的其他收费项目。的分布可能是“一刀切”的费用可转移到一定的工资项目，可能会产生更有利的承包商的现金流。这种分配的成本必须小心。

第三篇：测绘工程专业英语

From the discussion thus far it can be stated with absolute certainty that all measured values contain errors , whether due to lack of refinement in reading , instrumental imperfection or human limitations.Some of these errors result from physical conditions that cause them to occur in systematic way , whereas others occur with apparent randomness.Accordingly , errors are classified as either systematic or random.But before defining systematic and random errors , it is helpful to define mistakes.These three terms are defined as follows:

1、Mistake.Mistake or blunders(gross errors)actually are not errors because they usually are so gross in magnitude compared to the other two types of errors.Carelessness , inattention , improper training , bad habits ,poor judgement , adverse measuring or observing conditions , and various negative attitudes and emotions are the traces or the common reasons for mistakes.They are not classified as errors and must be removed form any set of observations.Typical example of mistakes are omitting a whole tape length when measuring distance , sighting the wrong target in a round of angles , writing down 27.55 for 25.75 in recording.Therefore great care must be taken to obviate them

Mistakes will never be completely eliminated from measurements , but surveyor's careful , attentive , conscientious attitude can reduce the mistakes in most cases.Through proper training and development of good work habits , development and maintenance of positive attitudes , and understanding the theory and practically eliminated.2、systematic errors.Systematic errors are defined as those errors whose magnitude and algebraic sign can be calculated and applied as a correction to the measured quantity , or these errors follow some physical law and thus can be predicted.Some systematic errorsare removed by some correct measurement procedures(e , g, , balancing backsight and foresight distance in differential leveling to compensate for earth curvature and refraction).Others are removed by deriving corrections based on the physical conditions that were responsible for their creation(e ,g , applying a computed correction for earth curvature and refraction on a trigonometric leveling observation).Surveyors should know how to deal with systematic errors.The first requirement is to recognize and accept the possible existence of errors.Next , identify the various sources that might be affecting a reading systematically , then , determine what the system is.Is it a constant , linear, or in proportion to the size of the quantity being measured ? Or , does it follow some other mathematical relationship ? Is there some physics involved ? Once systematic errors discovered and quantified , the errors can be essentially compensated by certain processes of measuring or correctedto reduce their effect.Careful calibration of all instruments is an essential part of controlling systematic errors3、Random errors.Random(also known as a accident)errors are introduce into each measurement mainly because of human and instrument imperfections as well as uncertainties in determining the effects of the environment on measurements.After all mistakes and systematic errors have been removed from the measured values , the random errors remain.In general , random errors are unavoidable and relatively small.They usually do not follow any physical law , but it can be deal with and estimated according to the mathematical laws of probability.Examples of random errors are(a)imperfect centering over a ground point during distance measurement with an EDM instrument ,(b)bubble not centered at the instant a level rod is read , and(c)small errors in reading graduated scales

Understanding the nature of random errors helps to understand why random errors never really

fully corrected , since the observation of the physical phenomena contains personal , random errors.Thus , measurement have “uncertainties” or random errors that remain unquantifiable.Random errorsare dealt with by controlling or managing them.It is a quality control process.They cannot be corrected or eliminated , only minimized and controlled.

第四篇：制药工程专业英语 Unit 13 课文翻译

Unit 13Sterile Products

Sterile Products

Sterile products are dosage forms of therapeutic agents that are free of viable microorganisms.Principally，these include parenteral，ophthalmic，irrigating preparations.Of these, and parenteral products are unique among dosage forms of drugs because they are injected through the skin or mucous membranes into internal body compartment.Thus，because they have circumvented the highly efficient first line of body defense，the skin and mucous membranes，they must be free from microbial contamination and from toxic components as well as possess an exceptionally high level of purity.All components and processes involved in the preparation of these products must be selected and designed to eliminate，as much as possible，contamination of all types，whether of physical，chemical，or microbiologic origin.Preparations for the eye, though not introduced into internal body cavities，are placed in contact with tissues that are very sensitive to contamination.Therefore，similar standards are required for ophthalmic preparations).Irrigating solutions are now also required to meet the same standards as parenteral solutions because during an irrigation procedure，substantial amounts of these solutions can enter the bloodstream directly through open blood vessels of wounds or abraded mucous membranes.Therefore，the characteristics and standards presented in this chapter for the production of large-volume parenteral solutions apply equally to irrigating solutions.Sterile products are most frequently solutions or suspensions，but may even be solid pellets for tissue implantation.The control of a process to minimize contamination for a small quantity of such a product can be achieved with relative ease.As the quantity of product increases，the problems of controlling the process to prevent contamination multiply.Therefore，the preparation of sterile products has become a highly specialized area in pharmaceutical processing.The standards established，the attitude of personnel，and the process control must be of a第13 单元 无菌产品 无菌产品 无菌产品是不含微生物活体的治疗剂剂型，其主要包括非肠道用的、眼用的和冲洗用的制剂。这之中，非肠道用产品在药物剂型当中是（较为）特别的因为它们是通过皮肤和黏膜被注射到人体内部的。这样，由于它们进入了高效率的人体第一道免疫防线——皮肤和黏膜，（所以）它们必须没有微生物感染和有毒成分，同时又（必须）具有特别高的纯度。这些产品的制备过程中涉及到的所有组分和（工艺）流程都必须经过选择和设计以尽可能地消除各种类型的污染，无论是来自物理的、化学的，还是微生物的。眼用制剂尽管没有被引入到内部体腔，但它仍与对污染（物）敏感的组织有接触，因此，对眼用制剂也要求（与非肠道用制剂）类似的标准。冲洗液现在也要求满足和非肠道用溶液一样的标准，因为在冲洗过程中，大量的冲洗液都可以通过敞开的血管伤口或者擦伤的黏膜组织直接进入到血液。因此，本章中描述的有关非肠道用溶液大批量生产的特点和标准，对于冲洗液同样适用。无菌产品通常是溶液或者悬浮液，但甚至也可以是用于组织对端植入的固体药丸。对于少量的这种产品，使其污染降到最低的工艺控制可以相对容易地实现。（但）随着产品量的增加，控制工艺流程从而防止污染的困难也会增加。因而，无菌产品的制备已经成为药品加工里一个高度专业化的领域。制定的标准、人员的态度和工艺流程的控制都必须有着优秀的水平。

superior level.Vehicles

By far the most frequently employed vehicle for sterile

products is water，since it is the vehicle for all natural body

fluids.The superior quality required for such use is

described in the monograph on Water for Injection in the

USP.Requirements may be even more stringent for some

products，however.One of the most inclusive tests for the quality of water is

the total solids content，a gravimetric evaluation of the

dissociated and undissociated organic and inorganic

substances present in the water.However，a less

time-consuming test，the electrolytic measurement of

conductivity of the water，is the one most frequently used.Instantaneous measurements can be obtained by immersing

electrodes in the water and measuring the specific

conductance, a measurement that depends on the ionic

content of the water.The conductance may be expressed by

the meter scale as conductivity in micromhos，resistance in

megohms , or ionic content as parts per million(ppm)of

sodium chloride.The validity of this measurement as an

indication of the purity of the water is inferential in that

methods of producing high-purity water，such as distillation

and reverse osmosis，can be expected to remove

undissociated substances along with those that are

dissociated.Undissociated substances such as pyrogens，however，could be present in the absence of ions and not be

disclosed by the test.Therefore，for contaminants other than

ions，additional tests should be performed.Additional tests for quality of Water for Injection with

permitted limits are described in the USP monographs.When comparing the total solids permitted for Water for

Injection with that for Sterile Water for Injection，one will

note that considerably higher values are permitted for Sterile

Water for Injection.This is necessary because the latter

product has been sterilized，usually by a thermal method，in

a container that has dissolved to some extent in the water.Therefore，the solids content will be greater than for the

nonsterilized product.On the other hand，the 10 ppm total

solids officially permitted for Water for Injection may be

much too high when used as the vehicle for many products.In practice, Water for Injection normally should not have a

conductivity of more than 1 micromho(1 megohm，approximately 0.1 ppm NaCl).溶媒 到目前为止，最常被用于无菌产品的溶媒就是水，因为水（也）是所有自然体液的溶媒。该用途所要求的优良特性在《美国药典》的《注射用水》专题论文中有所描述。但对于某些产品来说，要求可能会更为苛刻。水质检验的一种最普遍的测试就是固体总含量，一种对水中解离的和不解离的有机物和无机物在重量上的评估。然而，一种用时较少的测试——水导电性的电解测量——则是最常用的（测试方法），它通过把电极浸入水中测出具体的电导率，就可以实现即刻测量，是一种基于水中离子含量的测量方法。电导率可以通过表头刻度盘以电导／微姆欧、电阻／兆欧姆或者离子含量／ppm NaCl的形式显示出来。作为水纯度的指示，这种测量方法的正确性只是推理性的，因为一些生产高纯度水的方法，比如蒸馏和反渗透，可以将不解离的物质同那些解离的物质一起除去。但是不解离的物质例如热原，可以不以离子的形式存在，因而不能被这种方法检测出来。因此，对于除离子之外的（其他）污染物，还需要进行另外的检测。具有特殊用途的注射用水的水质附加测试在美国药典中有专篇描述。当把注射用水和无菌注射用水所允许的固体总含量做比较时，你会发现无菌注射用水允许有相当高的值。这是必要的，因为后者是经过灭菌的，通常是通过一种热途径，在一个在一定程度上溶解于水的容器中。因而，其固体含量会比没有灭菌的产品要高得多。另一方面，官方对于注射用水所允许的10 ppm的固体总含量，对于许多产品来说，作为溶媒其值可能都太高了。事 实上，注射用水其电导一般不应 该超过1微姆欧（1兆欧，大约 0.1 ppm NaCl）。

Added Substances.添加剂

Substances added to a product to enhance its stability are 添加到产品当中用以提高产品稳essential for almost every product.Such substances include 定性的物质，对于几乎每种产品solubilizers，antioxidants，chelating agents，buffers，来说都是必不可少的。这样的物tonicity contributors，antibacterial agents，antifungal 质包括增溶剂、抗氧剂、螯合剂、agents，hydrolysis inhibitors，antifoaming agents，and 缓冲剂、tonicity contributor、抗numerous other substances for specialized purposes.At the 菌剂、杀菌剂、水解抑制剂、消same time，these agents must be prevented from adversely 沫剂和许多其他的有专门用途的affecting the product.In general，added substances must be 物质。同时，这些组分必须不能nontoxic in the quantity administered to the patient.They 对产品有不利影响。一般来说，should not interfere with the therapeutic efficacy nor with 添加剂必须在病人的给药量范围the assay of the active therapeutic compound.They must 内是无毒的。它们不应该干扰（产also be present and active when needed throughout the 品的）治疗效果，也不能干扰有useful life of the product.Therefore，these agents must be 效活性化合物的测定。在产品的selected with great care，and they must be evaluated as to 整个有效期内，需要它们时，它their effect upon the entire formulation.-An extensive 们必须存在并且有效。因此，对review of excipients used in parenteral products and the 这些物质必须非常小心地进行挑means for adjusting pH of these products has recently been 选，而且对它们对整个配方的影published and should be referred to for more detailed 响也必须进行评估。一篇关于用information.在非肠道用产品中的赋形剂和调节这些产品pH的方法的综述，最近已经出版，更多的详细信息 可参阅之。

Formulation配方

The formulation of a parenteral product involves the 非肠道用产品的配方涉及一个或combination of one or more ingredients with a medicinal 者更多组成部分间的结合，这些agent to enhance the convenience，acceptability，or 组成部分（各自）都含有一种用effectiveness of the product.Rarely is it preferable to 以提高产品方便性、可接受性或dispense a drug singly as a sterile dry powder unless the 者疗效的有效成分。（人们）很少formulation of a stable liquid preparation is not possible.愿意把药物仅仅以一种无菌的、On the other hand，a therapeutic agent is a chemical 干燥的粉末（的形式）配售，除compound subject to the physical and chemical reactions 非（把它做成）稳定的液体制剂characteristic of the class of compounds to which it belongs.的配方是行不通的。Therefore，a careful evaluation must be made of every 另一方面，治疗剂（药物的有效combination of two or more ingredients to ascertain whether or not adverse interactions occur，and if they do，of ways to 的物理和化学反应特性的一种化modify the formulation so that the reactions are eliminated 合物。因此对每一个两种或更多or minimized.The formulation of sterile products is 组成部分间的结合都必须有一个challenging，therefore，to the knowledge and ingenuity of 仔细的评估，弄清楚会不会有不the persons responsible.The amount of information 良反应发生。如果有，则须找到

available to the formulator concerning the physical and 改进配方的方法以使反应消除或chemical properties of a therapeutic agent，particularly if it is 者降低到最小。因此，无菌产品a new compound，is often quite meager.Information 的配方是对负责人员知识和独创concerning basic properties muse be obtained，including 性的一个挑战。配方设计师可得molecular weight，solubility，purity，colligative properties，到的关于治疗剂（药物的有效成and chemical reactivity，before an intelligent approach to 分）物理和化学性质的信息量通formulation can begin.Improvements in formulation are a 常是很少的，尤其当治疗剂是一continuing‘ process，since important properties of a drug or 种新的化合物时。关于（治疗剂）of the total formulation may not become evident until the 基本性质的信息，包括分子量、product has been stored or used for a prolonged time: 溶解度、纯度、依数性和化学反However，because of the extensive test documentation 应性，必须在一种好的组建配方required by the U.S.Food and Drug Administration(FDA)，的方法可以开始之前得到。配方only outstanding formulations can be justified for 的改善是一个连续不断的过程，continuance to the state of a maketed product.因为药物或整体配方的一些重要 性质只有在贮存或者使用了很长 时间之后才可能会变得明显。然 而，由于美国食品及药物管理局 大量的测试要求文件，（使得）只 有那些杰出的配方才能继续发展 成为上市产品。

生产

Production 生产过程包括从配方的各个组成 The production process includes all of the steps from the 部分的积聚和结合到产品封装入accumulation and combining of the ingredients of the 用于分售的单个包装内的所有步formula to the enclosing of the product in the individual 骤。和这些过程有紧密联系的是container for distribution.Intimately associated with these 搬运人员和执行这些步骤的设processes are the personnel who carry them out and the 备。计划出来的最理想的过程也facilities in which they are performed.The most ideally 会因为没有正确态度或没有接受planned processes can be rendered ineffective by personnel 正确培训的人员或者不能提供一who do not have the right attitude or training，or by facilities 个有效的控制环境的设备而变得that do not provide an efficiently controlled environment.无效。

To enhance the assurance of successful manufacturing 为了增加成功的生产操作的保operation，all process steps must be carefully reduced to 证，所有的过程步骤在证明是有writing after being shown to be effective.These written 效的之后都要仔细地归纳成书面process steps are often called standard.operating procedures 材料，这些书面的过程步骤经常(SOPs)⑥.No extemporaneous changes are permitted to be 被称为标准操作规程（SOPs）。made in these procedures;any change must go through the 这些规程是不允许进行临时改动same approval steps as the original written SOP.Further，的;任何改动都必须经过和原有extensive records must be kept to give assurance at the end 的书面规程一样的证明步骤的证of the production process that all steps have been performed 明。而且，还需要做大量的记录，as prescribed，an aspect emphasized in the FDA's Good 以便在生产过程的最后用来保Manufacturing Practices.Such in-process control is essential 证：所有的步骤都是按照规定执to assuring the quality of the product，since these assurances 行的。这是美国食品及药物管理are even more significant than those from product release 局药品生产质量管理规范中所强

testing.The production of.a quality product is a result of the 调的一个方面。这些中间控制对continuous，dedicated effort of the quality assurance，于保证产品的质量来说是必要

production，and quality control personnel within the plant in 的，因为这些保证甚至比产品发developing，performing，and confirming effective sops.行测试的控制还重要。一件优质Selected from Lachman Leon et al.The Theory and Practice 产品的生产，是车间里在开发、of Industrial Pharmacy, 3rd ed.，Lea and Febiger, 执行和确认有效标准操作规程中Philadelphia，1986.的那些品质保证、生产和质量控 制人员不懈而专注的努力的结 果。

第五篇：制药工程专业英语9单元课文翻译

Thoughout recorded纵观历史记载，细菌感染的人口定期付出沉重的收费。鼠疫菌的“黑死病”鼠疫的1347-1351期间，估计有25万人在亚洲和欧洲死亡。美国公共卫生服务统计为1910年和1920年的节目，在这个早在本世纪结核病死亡每1000名美国居民中的一个。即使在今天，主要是在发展中国家，结核分枝杆菌仍然是主要死亡原因由于在单染性病，全世界每年杀害超过三百万

Such 整个脊椎动物进化过程中的这种不懈的微生物攻击，挑起了一个令人惊讶的复杂的保护性免疫系统的进化。随着人类的外观，最终到达一个物种可以设法协助先天和后天免疫系统，避免感染。通过利用微生物的抗原成分（疫苗和马血清抗毒素的产生），然后微生物次生代谢产物（抗生素），已成为人类善于预防和治疗许多以前致命的微生物疾病。

Within在短短的几十年，抗感染药药典的可用性突然提供了人类的潜力，以提高他们的生存前景下不断微生物拦河坝规避自然的经过时间考验的，活的或死的进化范式。那些以前会屈服于成员现在可以存活时间较长的疫苗和抗生素的帮助助剂-抗感染免疫系统一起工作。实际上，人类对这些助剂的就业可以作为例证在他们的免疫防御系统的自我做作的演变看。

Once当爵士亚历山大·弗莱明发现青霉素的效用已经证明，从发掘出的天然来源的其他抗生素乱舞紧随其后。其中一些被证明适用于治疗疾病，通常经过化学改性，以提高天然化合物的效力，安全性或药代动力学

Alpha

For对于大多数在过去50年中，看来，医学获得了强大的手上的细菌病。某些制药厂和研发机构决定减少对抗生素的发现成果，因为它的出现，医生的抗菌军火库是充足。但疾病的性质已经证明并非如此。

The在多种抗生素耐药病原体的发病率迅速升级现在提高全球非常严重的问题。这种发展突出了强大的进化能力的细菌种群的选择压力下的抗生素治疗。

Resistance抗药性问题被视为与革兰氏阴性（例如大肠杆菌）和革兰氏阳性菌（如金黄色葡萄球菌），但目前关注的最后一组的病原体。肺炎链球菌是呼吸道革兰氏阳性病原体，仅在美国一年的40000人死亡负责。，现在在许多国家，耐青霉素肺炎链球菌感染的患病率迅速上升。最糟的情况之一是在匈牙利，其中70％，从1988-1989年测试的儿童肺炎链球菌菌株对青霉素耐药

Bacteria细菌已经进化无数花招挫败抗生素的行动, 他们停用抗生素水解，酰化，磷酸化，或者核苷酸化反应；改变抗生素的目标站点或减少细胞内药物浓度降低细胞膜的通透性和/或积极抽水细胞的药物。with通过分子生物学和生物化学技术，这些耐药机制的认识提高，药物化学家一直试图绕过一些阻力问题提供目标。

A predominant针对内酰胺类药物的主要耐药机制（如青霉素），涉及内酰胺环的酶裂解。While虽然药物甲氧苯青霉素的开发，因为在1961年，短短两年后，药物首先到了广泛使用。MRSA菌株进化，使他们有一个额外的药物靶蛋白参与细胞壁合成，并改变这种蛋白具有非常低的亲和力几乎所有内酰胺。在一些医院，TO更的是，大多数MRSA菌株也有许多其他类抗生素

耐药，糖万古霉素的异常。Now现在世界各地，MRSA菌株日本很成问题（60％的金黄色葡萄球菌菌株MRSA），以及西班牙，法国，意大利和美国，与发病率大于30％

A particularly一个特别令人不安的里程碑是1988年耐万古霉素肠球菌（VRE）的出现。some一些抗万古霉素肠球菌现在不回应任何可用抗生素。肠球菌已成为最经常遇到的第二医院获得性病原体分离。抗万古霉素产生，因为1D-丙氨酸-e-乳酸渣（其中万古霉素结合知之甚少）已被通常在涉及细菌的细胞墙1五肽前体的终点，D-丙氨酸-e-丙氨酸残基取代合成There 在抗万古霉素肠球菌糖肽类如万古霉素抗性基因，将自然转移到金黄色葡萄球菌，已经实验证明可行威廉高贵圣托马斯医院，伦敦现在有一个极大的关注。作为万古霉素是治疗MRSA感染这种致命的病原体，抗万古霉素的自然预期收购不得已的药物会导致发人深省的回报预先抗生素治疗失败的时代，应该没有备用的有效疗法可用

Conclusions结论

人类使用抗生素迅速加快了人类和细菌之间的动态演化的相互作用。The新制剂，最近在多药耐药的革兰氏阳性细菌感染的迅速崛起，全世界敲响了一个响亮的电气警笛需要新的，有效的治疗方法，这里可以提供翻新阿森纳的医生。

The discovery细菌通过基因组学研究新的药物靶标，以及改善我们了解细菌耐药性机制的发现，按住发现多药耐药细菌感染治疗的新手段的承诺。给予足够的时间，细菌会最终是能够开发任何新的抗菌剂的阻力。这些药物可以通过一种新的机制攻击病原体有可能降低快速耐药性的发展的倾向。