Unit 13 Sterile 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 1micromho (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，
Added Substances.
Substances added to a product to enhance its stability are essential for almost every product. Such substances include solubilizers，antioxidants，chelating agents，buffers，tonicity contributors，antibacterial agents，antifungal agents，hydrolysis inhibitors，antifoaming agents，and numerous other substances for specialized purposes. At the same time，these agents must be prevented from adversely affecting the product. In general，added substances must be nontoxic in the quantity administered to the patient. They should not interfere with the therapeutic efficacy nor with the assay of the active therapeutic compound. They must also be present and active when needed throughout the useful life of the product. Therefore，these agents must be selected with great care，and they must be evaluated as to their effect upon the entire formulation.- An extensive review of excipients used in parenteral products and the means for adjusting pH of these products has recently been published and should be referred to for more detailed information.
Formulation
The formulation of a parenteral product involves the combination of one or more ingredients with a medicinal agent to enhance the convenience，acceptability，or effectiveness of the product. Rarely is it preferable to dispense a drug singly as a sterile dry powder unless the formulation of a stable liquid preparation is not possible.
On the other hand，a therapeutic agent is a chemical compound subject to the physical and chemical reactions characteristic of the class of compounds to which it belongs. Therefore，a careful evaluation must be made of every combination of two or more ingredients to ascertain whether or not adverse interactions occur，and if they do，of ways to modify the formulation so that the reactions are eliminated or minimized. The formulation of sterile products is challenging，therefore，to the knowledge and ingenuity of the persons responsible. The amount of information 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）。
添加剂
添加到产品当中用以提高产品稳定性的物质，对于几乎每种产品来说都是必不可少的。这样的物质包括增溶剂、抗氧剂、螯合剂、缓冲剂、tonicity contributor、抗菌剂、杀菌剂、水解抑制剂、消沫剂和许多其他的有专门用途的物质。同时，这些组分必须不能对产品有不利影响。一般来说，添加剂必须在病人的给药量范围内是无毒的。它们不应该干扰（产品的）治疗效果，也不能干扰有效活性化合物的测定。在产品的整个有效期内，需要它们时，它们必须存在并且有效。因此，对这些物质必须非常小心地进行挑选，而且对它们对整个配方的影响也必须进行评估。一篇关于用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。
配方
非肠道用产品的配方涉及一个或者更多组成部分间的结合，这些组成部分（各自）都含有一种用以提高产品方便性、可接受性或者疗效的有效成分。（人们）很少愿意把药物仅仅以一种无菌的、干燥的粉末（的形式）配售，除非（把它做成）稳定的液体制剂的配方是行不通的。
另一方面，治疗剂（药物的有效成分）是具有它所属化合物种类的物理和化学反应特性的一种化合物。因此对每一个两种或更多组成部分间的结合都必须有一个仔细的评估，弄清楚会不会有不良反应发生。如果有，则须找到
available to the formulator concerning the physical and chemical properties of a therapeutic agent，particularly if it is a new compound，is often quite meager. Information concerning basic properties muse be obtained，including molecular weight，solubility，purity，colligative properties，and chemical reactivity，before an intelligent approach to formulation can begin. Improvements in formulation are a continuing‘ process，since important properties of a drug or of the total formulation may not become evident until the product has been stored or used for a prolonged time: However，because of the extensive test documentation required by the U. S. Food and Drug Administration (FDA)，only outstanding formulations can be justified for continuance to the state of a maketed product.
Production
The production process includes all of the steps from the accumulation and combining of the ingredients of the formula to the enclosing of the product in the individual container for distribution. Intimately associated with these processes are the personnel who carry them out and the facilities in which they are performed. The most ideally planned processes can be rendered ineffective by personnel who do not have the right attitude or training，or by facilities that do not provide an efficiently controlled environment.
To enhance the assurance of successful manufacturing operation，all process steps must be carefully reduced to writing after being shown to be effective. These written process steps are often called standard. operating procedures (SOPs)⑥.No extemporaneous changes are permitted to be made in these procedures; any change must go through the same approval steps as the original written SOP. Further，extensive records must be kept to give assurance at the end of the production process that all steps have been performed as prescribed，an aspect emphasized in the FDA's Good Manufacturing Practices. Such in-process control is essential to assuring the quality of the product，since these assurances are even more significant than those from product release 改进配方的方法以使反应消除或者降低到最小。因此，无菌产品的配方是对负责人员知识和独创性的一个挑战。配方设计师可得到的关于治疗剂（药物的有效成分）物理和化学性质的信息量通常是很少的，尤其当治疗剂是一种新的化合物时。关于（治疗剂）基本性质的信息，包括分子量、溶解度、纯度、依数性和化学反应性，必须在一种好的组建配方的方法可以开始之前得到。配方的改善是一个连续不断的过程，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
生产过程包括从配方的各个组成部分的积聚和结合到产品封装入用于分售的单个包装内的所有步骤。和这些过程有紧密联系的是搬运人员和执行这些步骤的设备。计划出来的最理想的过程也会因为没有正确态度或没有接受正确培训的人员或者不能提供一个有效的控制环境的设备而变得无效。
为了增加成功的生产操作的保证，所有的过程步骤在证明是有效的之后都要仔细地归纳成书面材料，这些书面的过程步骤经常被称为标准操作规程（SOPs）。这些规程是不允许进行临时改动的;任何改动都必须经过和原有的书面规程一样的证明步骤的证明。而且，还需要做大量的记录，以便在生产过程的最后用来保证：所有的步骤都是按照规定执行的。这是美国食品及药物管理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 continuous，dedicated effort of the quality assurance，production，and quality control personnel within the plant in developing，performing，and confirming effective sops. Selected from Lachman Leon et al. The Theory and Practice of Industrial Pharmacy, 3rd ed.，Lea and Febiger, Philadelphia，1986. 调的一个方面。这些中间控制对于保证产品的质量来说是必要的，因为这些保证甚至比产品发行测试的控制还重要。一件优质产品的生产，是车间里在开发、执行和确认有效标准操作规程中的那些品质保证、生产和质量控制人员不懈而专注的努力的结果。
第一章汽车总论 1)Today’s average car contains more than 15,000 separate, individual parts that must work together. These parts can be grouped into four major categories: body, engine, chassis and electrical equipment 。P1 现在的车辆一般都由15000多个分散、独立且相互配合的零部件组成。这些零部件主要分为四类：车身、发动机、底盘和电气设备。 2)The engine acts as the power unit. The internal combustion engine is most common: this obtains its power by burning a liquid fuel inside the engine cylinder. There are two types of engine: gasoline (also called a spark-ignition engine) and diesel (also called a compression-ignition engine). Both engines are called heat engines; the burning fuel generates heat which causes the gas inside the cylinder to increase its pressure and supply power to rotate a shaft connected to the power train. P3 发动机作为动力设备，常见的类型是内燃机，其原理是通过发动机缸内的液体燃料燃烧而产生能量。发动机可分为两类：汽油机（点燃式）和柴油机（压燃式），都属于热力发动机。燃料燃烧产生热量使缸内气压上升，产生的能量驱动轴旋转，并传递给动力传动系。 第二章内燃机 1)Power train system: conveys the drive to the wheels 2)Steering system: controls the direction of movement 3)Suspension system: absorbs the road shocks 4)Braking system: slows down the vehicle P4 传动系把发动机输出的扭矩传递给驱动轮。传动系包括离合器（对应机械变速器）或液力变矩器（对应液力自动变速器）、变速器、驱动轴、主减速器、差速器和驱动桥。 5)Drum brakes have a drum attached to the wheel hub, and braking occurs by means of brake shoes expanding against the inside of the drum. With disc brakes, a disc attached to the wheel hub is clenched between two brake pads. P6 鼓式制动器的制动鼓和轮毂连接，制动蹄张开压紧制动鼓内侧从而产生制动。在盘式制动器上，连着轮毂的制动盘被紧紧夹在两个制动块之间。 1)Linking the piston by a connecting rod to a crankshaft causes the gas to rotate the shaft through half a turn.The power stroke"uses up"the gas,so means must be provided to expel the burnt gas and recharge the cylinder with a fresh petrol-air mixture:this control of gas movement is the duty of the valves;An inlet valve allows the mixture to enter at the right time and an exhaust valve lets out the burnt gas after the gas has done its job . P10 活塞通过连杆和曲轴连接，使得气体带动曲轴旋转半圈。作功冲程耗尽了所有的气体，这样就必须采取相应的措施排出废气并且向气缸内充入新的可燃混合气：气体的运动由气门来控制。进气门使可燃混合气在恰当的时刻进入气缸，排气门使燃烧后的废气排出气缸。 2)The spark-ignition engine is an internal-combustion engine with externally supplied in ignition,which converts the energy cntained in the fuel to kinetic energy.The cycle of operations is spread over four piston strokes. To complete the full cycle it takes two revolutions of the crankshaft. P11 火花点火式发动机是由外部提供点火的内燃机，从而将含在燃料内的能量转化成动能。发动机的一个工作循环分布在活塞的四个行程中，一个完整的工作循环曲轴需要转动两圈。 3)The oil pump in the lubricating system draws oil from the oil pan and sends it to all working parts in the engine. The oil drains off and runs down into the pan. Thus,there is constant circulation of oil between the pan and the working parts of the engine. P15
Unit 1 Production of Drugs About 5000 antibiotics have already been isolated from microorganisms，but of these only somewhat fewer than 100 are in therapeutic use. It must be remembered，however，that many derivatives have been modified by partial synthesis for therapeutic use;some 50，000 agents have been semisynthetically obtained from户lactams alone in the last decade. Fermentations are carried out in stainless steel fermentors with volumes up to 400 m3. To avoid contamination of the microorganisms with phages etc. the whole process has to be performed under sterile conditions. Since the more important fermentations occur exclusively under aerobic conditions a good supply of oxygen or air(sterile)is needed. Carbon dioxide sources include carbohydrates，e. g. molasses，saccharides，and glucose. Additionally the microorganisms must be supplied in the growth medium with nitrogen-containing compounds such as ammonium sulfate，ammonia，or urea，as well as with inorganic phosphates. Furthermore，constant optimal pH and temperature are required. In the case of penicillin G，the fermentation is finished after 200 hours，and the cell mass is separated by filtration. The desired active agents are isolated from the filtrate by absorption or extraction processes. The cell mass，if not the desired product，can be further used as an animal feedstuff owing to its high protein content. 关于5000抗生素已经分离出的微生物，但其中只有不到100有些治疗使用。必须记住，但是，许多衍生工具已被用于治疗使用部分合成修改;约50,000剂已被semisynthetically取得户内酰胺在过去十年孤独。发酵都是在不锈钢发酵罐出来的量高达400立方米。为了避免与噬菌体等微生物污染的全过程都必须在无菌条件下进行。由于更重要的发酵只发生在有氧条件下的氧气或空气好电源（无菌）是必要的。二氧化碳的来源包括碳水化合物，大肠杆菌克糖蜜，糖和葡萄糖。另外必须提供的微生物在与含氮如硫酸铵，氨水或尿素化合物生长介质，以及与无机磷酸盐。此外，不断最适pH和温度是必需的。在青霉素G的情况下，发酵完成200小时后，细胞的质量是由过滤分离。所需的活性剂是隔离的滤液吸收或提取工艺。大规模的细胞，如果不理想的产品，可进一步用作动物，由于其蛋白质含量高的饲料。 By modern recombinant techniques microorganisms have been obtained which also allow production of peptides which were not encoded in the original genes. Modified E. coli bacteria make it thus possible to produce A- and B- chains of human insulin or proinsulin analogs. The disulfide bridges are formed selectively after isolation，and the final purification is effected by chromatographic procedures. In this way human insulin is obtained totally independently from any pancreatic material taken from animals. Other important peptides，hormones，and enzymes，such as human growth hormone (HGH)，neuroactive peptides，somatostatin，interferons，tissue plasminogen activator (TPA)，lymphokines，calcium regulators like calmodulin，protein vaccines，as well as monoclonal antibodies used as diagnostics，are synthesized in this way. 利用现代微生物重组技术已获得这也让其中不是在原来的基因编码多肽的生产。改性大肠杆菌从而使可能产生A型和B -人胰岛素或胰岛素原类似物链。二硫键形成的选择性分离后，最终由色谱净化工序的影响。通过这种方式获得的人类胰岛素完全独立采取任何从动物胰腺材料。 其他重要肽，激素和酶，如人类生长激素（hGH），神经活性肽，生长抑素，干扰素，组织型纤溶酶原激活物（tPA），淋巴因子，如钙调节钙调蛋白，蛋白疫苗，以及作为诊断用单克隆抗体是合成了这种方式。 The enzymes or enzymatic systems which are present in a single microorganism can be used for directed stereospecific and regiospecific chemical reactions. This principle is especially useful in steroid chemistry. Here we may refer only to the microbiological 11-a- hydro xylation of progesterone to 11-a-hydroxyprogesterone，a key product used in the synthesis of cortisone. Isolated enzymes are important today not only because of the technical importance of the enzymatic saccharification of starch，and the isomerization of glucose to fructose，They are also significant in the countless test procedures used in diagnosing illness，and in enzymatic analysis which is used in the monitoring of therapy. A number of enzymes are themselves used as active ingredients. Thus preparations containing proteases (e. g. chymotrypsin，pepsin，and trypsin)，amylases and lipases，mostly in combination with synthetic antacids，promote digestion. Streptokinase and urokinase are important in thrombolytics，and asparaginase is used as a cytostatic agent in the treatment of leukemia. 这些酶或微生物在一个单一的酶系统，目前可用于立体定向和regiospecific化学反应。这个原则是有用的，尤其是在化学类固醇。在这里，我们只能引用的微生物十一水电黄体酮xylation至11人羟，一个关键的产品在可的松合成。隔离酶是重要的，不仅因为淀粉的酶法糖化技术重要性的今天，和葡萄糖异构果糖，他们也都在无数次试验在诊断疾病所用的程序显着，在酶的分析，在使用监测治疗。 数量的酶本身作为活性成分。因此，含有蛋白酶制剂（如糜蛋白酶，胃蛋白酶和胰蛋白酶），淀粉酶和脂肪酶的合成主要是在与抗酸药相结合，促进消化。链激酶和尿激酶溶栓是重要的，是天冬酰胺酶在治疗白血病细胞生长剂。 Finally mention must be made of the important use of enzymes as `biocatalysts’in chemical reactions where their
About car engine Of all automobile components,an automobile engie is the most complicated assembly with dominant effects on the function of an autombile.So, the engine is generally called the"heat"of an automobile. 在汽车的所有部件中，汽车发动机是最复杂的组件，其对整车性能有着决定性的作用。因而发动机往往被称作发动机的“心脏”。 There are actually various types of engines such as electric motors,stream engines,andinternal combustion engines.The internal combustion engines seem to have almost complete dominance of the automotive field.The internal combustion engine,as its name indicates,burns fuel within the cylinders and converts the expanding force of the combustion into rotary force used to propel the vehicle. 事实上，按动力来源分发动机有很多种，如电动机、蒸汽机、外燃机等。然而内燃机似乎在发动机领域有着绝对的统治地位。就像其字面意思一样，内燃机的染料在气缸内燃烧，通过将燃烧产生气体的膨胀力转换成转动力来驱动发动机前进。 Engine is the power source of the automobile.Power is produced by the linear motion of a piston in a cylinder.However,this linear motion must be changed into rotary motion to turn the wheels of cars or trucks.The puston attached to the top of a connecting rod by a pin,called a piston pin or wrist pin.The bottom of the connecting rod is attached to the crankshaft.The connecting rod transmits the up-and-down motion of the piston to the crankshaft,which changes it into rotary motion.The connecting rod is mounted on the crankshaft with large bearings called rod bearing.Similar bearings, called main bearings,are used to mount the crankshaft in the block. 发动机是整部车的动力来源。能量来自于活塞在气缸内的（往复）直线运动。然而这种（往复）直线运动必须要转换成旋转运动才能驱动车轮。活塞与连杆通过一个销来连接，这个销称为活塞销。连杆的下部连接于曲拐。连杆把活塞的上下往复运动传递给曲拐，从而将往复直线运动转变成旋转运动。连杆和曲拐的连接使用大的轴承，称之为连杆轴承，类似的轴承也用于将曲轴连接到机体，称之为主轴承。 They are generally two different types of cooling system:water-cooling system and air-cooling system.Water-cooling system is more common.The cooling medium, or coolant, in them is either water or some low-freezing liquid, called antifreeze.A water-cooling system consists of the engine water jacket, thermostat, water pump, radiator, radiator cap, fan, fan drive belt and neccessary hoses. 主要有两种类型的冷却系统：水冷和风冷。水冷系统更为普遍。系统所用冷却介质或是冷却液常委水或其他低凝固点液体，称为抗凝剂。一个完整的水冷系统包括机体水套，节温器，水泵，散热器，散热器罩，风扇，风扇驱动皮带和必需的水管。 A water-cooling system means that water is used as a cooling agent to circulate through the engine to absorb the heat and carry it to the radiator for disposal.The ebgine is cooled mainly through heat transfer and heat dissipation.The heat generated by the mixture burned in the engine must be transferred from the iron or aluminum cylinder to the waterin the water jacket.The outside of the water jacket dissipates some of the heat to the air surrounding it, but most of the heat is carried by the cooling water to the radiator for dissipation.When the coolant temperature in the system reaches 90°,the termostat valve open fully, its slanted edge shutting off
PART 3 INDUSTRIAL PHARMACY Unit 11 Tablets (The Pharmaceutical Tablets Dosage Form) Role in Therapy The oral route of drug administration is the most important method of administering drugs for systemic effects. Except in cases of Insulin therapy，the parenteral route is not routinely used for self-administration of medications. 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硝酸甘油酯for the treatment of angina心绞痛and scopolamine莨菪胺for the treatment of motion sickness晕动病，指晕车、晕船等. 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. The parenteral route of administration is important in treating medical emergencies in which a subject is comatose昏迷的or cannot swallow，and in providing various types of maintenance therapy for hospitalized patients. Nevertheless，it is probable that at least 90 % of all drugs used to produce systemic effects are administered投药，给药by the oral route. When a new drug is discovered，one of the first questions a pharmaceutical company asks is whether or not drug can be effectively administered for its intended effect by the oral route. If it cannot，the drug is primarily relegated to被降级到administration in a hospital setting or physician's office. If patient self- administration cannot be achieved，the sales of the drug constitute only a small fraction of what the market would be otherwise. Of drugs that are administered orally，solid oral dosage 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相比之下，liquid oral dosage forms，such as syrups，suspensions，emulsions，solutions，and elixirs，are usually designed to contain one dose of medication in 5 to 30 ml. The patient is then asked to measure his or her own medication using a teaspoon， 第三部分工业药剂学 第11单元药片(医药的片剂剂型) 在治疗中的作用 口服给药途径是通过给药获得全身作用效果中最重要的方法。除了胰岛素疗法之外，肠外给药途径通常不用于（病人的）自主性用药。而局部给药途径则是在最近才被用来把药物送到体内从而产生全身作用。这种途径有两种上市产品：用于治疗心绞痛的硝酸甘油酯和用于治疗晕动病的莨菪胺。今后肯定还会有其他的药物相继出现，但是局部给药的途径在有效的药物吸收从而获得全身性药物作用方面仍有其局限性。在病人处于昏迷状态或病人不能吞咽的医疗急救处理中，肠外给药途径是很重要的，同时它也给住院的病人提供了各种不同类型的维持疗法。然而，可能至少有90%的被用于产生全身作用的药物是通过口服的途径给药的。当一种新的药物被研发出来的时候，制药公司问的第一个问题就是这种药物能否有效地通过口服给药途径来达到预期的效果。如果不能，那么这种药物就要被降级到医院或者医生的办公室里。如果病人的自主用药不能实现，那么（这种）药物的销量就会是能实现病人的自主用药的药物销量的很少一部分。在所有通过口服来给药的药物当中，固体口服制剂是（人们）偏爱的产品种类。其原因如下：药片和胶囊代表着单元剂量的形式，其中通常已经放置好了一个剂量的药物。相应地，液体口服制剂，比如说糖浆、悬浮液、乳剂、溶液和酏剂，则通常被设计成在5-30 ml （液体中）包含一个剂量的药物。病人会被要求用茶匙、调羹或其他测量装置来衡量他自己的用药量。病人自己用药时这种剂量测量方法，其误差范围通常
unit1 body 车身chassis 底盘enclosure外壳、套hood车棚、车顶sway 摇摆frame车架steering转向、操作brake 制动weld焊接rivet铆钉bolt螺钉washer垫圈vibration 振动stabilizer稳定器ride乘坐舒适性handling操作稳定性linkages转向传动机构plier钳子distributor分电器alternator交流发电机regulator调节器carburetor化油器radiator散热器、水箱defroster除冰装置sludge金属碎屑transmission变速器differential 差速器power train 传动系unitized body 承载式车身suspension system 悬架系统steering system 转向系braking system 制动系shock absorbers减震器control arms控制臂steering wheel 转向盘steering column转向管柱steering gears 转向器tie rod 横拉杆idler arm随动臂brake shoe制动蹄disc brake 盘式制动器drum brakes 鼓式制动器ignition system 点火系统exhaust system 排气系统lubrication system 润滑系oil filters 机油滤清器drive（or propeller）shaft传动轴universal joints 万向节dynamo发电机horn喇叭swived 旋转steering box转向器timing gear 正时齿轮bevel gear 锥齿轮mesh with与啮合leaf spring 钢板弹簧stub axle 转向节 unit2 longitudinal纵向的transverse横向的reciprocate往复spin旋转piston活塞ignite点火rub摩擦quart夸脱reservoir油箱mechanical机械的enclosed被附上的gallon加仑stroke冲程camshaft凸轮轴combustion燃烧disengaged脱离啮合的flywheel飞轮internal-combustion engine内燃机diesel-fuel柴油LPG=Liquefied Petroleum Gas液化石油气体CNG=Compressed natural gas压缩天然气spark ignition火花点火compression ignition压缩点火spark plug火花塞gas-turbine engine蒸汽机Stirling engine斯特灵发动机lubricating system润滑系统oil pan油底壳oil pump机油泵exhaust system排气系统emission-control system排放控制系统energy conversion能量转换air/fuel ratio空燃比connecting rod连杆TDC=Top Dead Center上止点BDC=Bottom Dead Center 下止点intake stroke进气冲程compression stroke压缩冲程power stroke作功冲程exhaust stroke排气冲程compression ratio压缩比lifter挺柱rocker摇臂retainer弹簧座seal密封件tappet 推杆lobe凸起gasket垫圈valve train配气机构cam follower气门挺柱rocker arm摇臂combustion chamber燃烧室intake valve进气阀exhaust valve排气阀valve stem气门杆valve cover气门室盖valve port阀口valve guide气门导管 unit3
Fuel Supply System of Gasoline Engine(UNIT SEVEN) All the gasoline engines have substantially identical fuel systems and run on a mixture consisting of fuel vapor and air. The fuel system comprises the units designed to store, clear and deliver fuel, the units intended to clean air and a unit for preparing a mixture from fuel vapor and air. In a fuel system different components are used to supply fuel from the fuel tank into the engine cylinder. Some of the important components are fuel tank, fuel pump, fuel filter, carburetor, intake manifold and fuellines or tubes connecting the tank, pump and the carburetor. The fuel tank is a fuel container used for storing fuel. It is made of sheet metal. It is attached to the vehicle frame with metal traps and is located at the rear of the vehicle. They are mounted in a boot or boot-floor pan in case of front-engined cars and small commercial vehicles. In order to strengthen the tank as well as to prevent surging of fuel when the vehicle rounds a curve of suddenly stops, baffle plates are attached to the inside of the tank. A cap is used to close the filler opening of the tank. The fuel line is attached at or near the bottom of the tank with a filtering element placed at the connection. The other components of the fuel tank are the fuel gauge sending unit, a vent pipe, receiving unit. To prevent the dirt and water from entering the luggage compartment, a sealing strip is fitted between the fuel tank and boot floor pan. Moreover to limit the transmission of frame distortion to the tank giving rise to squeaking as the metal parts get rubbed together, rubber or felt pads are often fitted between the mountings and the tank. Provision is also made against drumming of the tank by these mountings. The tank may be placed at the side of the chassis frame for convenience in case of large commercial vehicles. The length of the connecting lines or tubes from the tank to the carburetor is also restricted by this at the same time. A porous filter is attached to the outlet lines. By drawing fuel from the tank through the filter, any water in the bottom of the tank as well as any dirt into the fuel gathers on the surface of the filter. To keep the fuel always under atmospheric pressure, the filter pipe or tank is vented. In order to prevent dirt in the fuel from entering the fuel pump or carburetor, fuel filters and screens are used in the fuel system. If the dirt is not removed from the fuel, the normal operation of these units will be prevented. The engine performance will also be reduced.
INTERNAL COMBUSTION ENGINE 引擎燃烧室 1. principle of operation 原理 Engine and power : Engine is used to produce power. The chemical energy in fuel is converted to heat by the burning of the fuel at a controlled rate. This process is called combustion. If engine combustion occurs with the power chamber. ,the engine is called internal combustion engine. If combustion takes place outside the cylinder, the engine is called an external combustion engine. Engine used in automobiles are internal combustion heat engines. Heat energy released in the combustion chamber raises the temperature of the combustion gases with the chamber. The increase in gas temperature causes the pressure of the gases to increase. The pressure developed within the combustion chamber is applied to the head of a piston to produce a usable mechanical force, which is then converted into useful mechanical power. 译: 引擎和能量: 引擎为汽车提供能量，燃料的化学能通过燃烧，转化为热能，这个过程叫燃烧。假如燃烧在燃烧室，这样的发动机叫内燃机。假如燃烧在气缸外，这样的发动机叫外燃机。 用在汽车上的一般是内燃机，热能在燃烧室释放，燃烧室气体温度升高。气体温度的升高使气体的压力曾加，燃烧室内的高压气体作用在活塞头部产生可以利用的化学能，化学能转化为机械能。 Engine T erms : Linking the piston by a connecting rod to a crankshaft causes the gas to rotate the shaft through half a turn. The power stroke “uses up” the gas , so means must be provided to expel the burnt gas and recharge the cylinder with a fresh petrol-air mixture :this control of gas movement is the duty of the valves ;an inlet valve allows the new mixture to enter at the right time and an exhaust valve lets out the burnt gas after the gas has done its job. Engine terms are : TDC(Top Dead Center):the position of the crank and piston when the piston is farther away from the crankshaft. BDC(Bottom Dead Center):the position of the crank and piston when the piston is nearest to the crankshaft. Stroke : the distance between BDC and TDC; stroke is controlled by the crankshaft. Bore : the internal diameter of the cylinder. Swept volume : the volume between TDC and BDC Engine capacity : this is the swept volume of all the cylinder e.g. a four-stroke having a capacity of two liters(2000cm) has a cylinder swept volume of 50cm. Clearance volume: the volume of the space above the piston when it is at TDC. Compression ratio = (swept vol + clearance vol)\(clearance vol) Two-stroke : a power stroke every revolution of the crank.