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1、Oral route of drug administration 肠道给药途径Parenteral route of drug administration 非肠道给药途径Systemic effect 系统效应 /全身效应Self-administration of medication 自我服药Solid oral dosage forms 常规给药的固体剂型Liquid oral dosage forms 常规给药的液体剂型Expiration date 有效期In Vitro vi:tr ?u Test 体外试验In Vivo vi:v ?u Test 体内试验computer-ai
2、ded drug design(计算机辅助药物设计）“lead” compound (先导化合物）structure-activity relationship(SAR) 构效关系rational drug design 理性药物设计 /合理药物设计Medicinal agent 药用成分Bioavailability 生物利用度Compressed tablet 压制片剂Effective drug absorption 有效药物吸收One usual dose of the drug 每一剂的剂量Per number of doses 每单位剂量The efficacy of the dr
3、ug 药效Direct compression 直接压片法Compression granulation 挤压制粒法Wet granulation 湿法制粒法Basic charateristics: Good fluidity （流动性）Good compressibility （ 可 压 缩 性 ） CADD Computer-Aided Drug Design 计算机辅助药物设计SAR structure-activity relationship 构效关系Good lubricity （润滑能力）A steady-state blood or tissue level 稳定的血液或者组
4、织水平in vivo/in vitro environment 在体内 /体外环境Maximizing drug availability 达到最大的药物利用度sustained release 缓释controlled release 控释Gastrointestinal（GI ）tract 胃肠系统Crystal size distribution 晶体粒度分布Cooling crystallizer 冷却结晶器Evaporative crystallizer 蒸发结晶器salting-out crystallization 盐析结晶法The total solids test 固体总量测
5、试chemical oxygen demand 化学需氧量Marine drug 海洋药物Rational drug design 理性药物设计Marine natural products 海洋天然产物High-field nuclear magnetic resonance spectroscopy 高效核磁共振仪High-resolution fast atom bombardment mass spectrometry 高效快速原子轰击质谱仪High-performance liquid chromatography 高效液相色谱仪come into play 开始活动Orchestr
6、ate ?:kistreit 编管弦乐曲 ,使和谐地结合起来 ; 配合orchestra 管弦乐队UNIT 11 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 (归入 ) to adm
7、inistration in a hospital setting(医院管理 )or physicians office. If patient self-administration cannot be achieved，the sales of the drug constitute(组成、构成) only a small fraction of what the market would be otherwise Of drugs that are administered orally ，solid oral dosage forms represent the preferred c
8、lass of product. The reasons for this preference are as follows. Tablets and capsules (胶囊 ) represent unit dosage forms in which one usual dose of the drug has been accurately placed. By comparison, liquid oral dosage forms，such as syrups (糖浆 ) ，suspensions (悬浮液 ) ，emulsions (乳液 ) ，solutions ，and el
9、ixirs (甘香酒剂， 药酒) ，are usually designed to 旨在；目的在于 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, tablespoon，or other measuring device. Such dosage measurements are typically in error by a factor ranging from 20% to 50% w
10、hen the drug is self-administered by the patient. 通过口腔途径服药是使药物起效的重要的服药方法，除了胰岛素治疗，非肠道途径不是自我服药的常规方法。通过局部名师归纳总结 精品学习资料 - - - - - - - - - - - - - - -精心整理归纳 精选学习资料 - - - - - - - - - - - - - - - 第 1 页，共 8 页 - - - - - - - - - 途径进药在近几年开始应用于传递药物进入体内起效，在市场上有两类产品，一类是治疗心绞痛的硝酸甘油，另一类是治疗眩晕症的崀菪胺。其它药物化归于这两类，但局部给药受到药
11、物被充分吸收或起作用的能力方面的限制。非肠道给药对于病人昏迷或不能吞咽的紧急医疗状态，以及为提供住院病人各种维持治疗方面起重要作用。然而，至少90% 以上的药物是通过口腔途径给药的。当一种新药被开发，制药公司首先考虑药物是否可以通过口腔给药达到预期药效作用。如果不能，则这种药物规划为在一定医疗设备或医生的监督下给药。如果病人不能自我服药，则该药物的销量是可以自我服药情况下药物销售量的很少一部分。通过口腔途径给药的药物中，固体的口服剂型是最受欢迎的，原因如下，片剂和胶囊代表单位剂量，通常一剂量可以精确地划分为一片，相比之下， 液体口服药物， 如糖浆、悬浮液、 乳浊液、 溶液和甘香酒剂， 一般被设
12、计为每5ml到 30ml 为一剂量。 病人会要求用小匙或大匙或其它测量工具测量自己的用量。而这种测量方法通常存在20% 到 50% 的误差。The objective of the design and manufacture of the compressed (压制 ) tablet is to deliver orally the correct amount of drug in the proper form at or over the proper time and in the desired location，and to have its chemical integrit
13、y (完整 ) protected to that point. Aside from the physical and chemical properties of the medicinal agent(s) ( 药用成分 ) to be formulated into (制定成）a tablet， the actual physical design（物理设计，实体设计）， manufacturing process， and complete chemical makeup（组成）of the tablet can have a profound effect on the effic
14、acy of the drug(s)( 药效）being administered. （设计和生产压制的片剂时目的是：以适当的形式或在适当的时候、所需的位置提供常规的、正确的给药量，并保护药物的化学完整性。除了从药用剂的物理和化学性质（县）制定成片，实际的物理设计制造过程，以及完整的片剂的化学成分可能对药物的有效性产生深远的影响被管理。Unit 12 The three basic methods of tablet manufacture have been previously detailed，the desirable properties and required features(
15、特征 ) of granulations and tablets defined（定义） ，and the interrelationships between many of these properties and the processing and machine variables(机器变量） noted. Regardless of how tablets are manufactured，conventional oral tablets for ingestion（吸收）usually contain the same classes of components in addi
16、tion to the active ingredients（组分），which are one or more agents functioning as (1) a diluent，(2) a binder or an adhesive，(3) a disintegrant（崩解剂），and (4) a lubricant （润滑剂） . Some tablet formulations may additionally require a flow promoter （流动性促进剂） . Other more optional components include colorants，a
17、nd in chewable tablets，favors and sweeteners. All nondrug components of a formula are termed excipients（赋形剂） . 前面已经详细介绍了片剂的三种基本生产方法，对成粒和成片的有利性质、必要特征作了详细的说明，也对这些性质之间的关系、生产过程和机械变量进行了注解。吞服的常规口服片剂除了活性成分以外，包含的其它组成类型通常相同，为一种或者几种起稀释、粘合、胶粘、崩解和润滑作用的媒介。有些片剂还需要添加流动性促进剂。更多选择性成分还包括着色剂、咀嚼片中的香味剂和甜味剂。配方中的所有非药用成分称作赋
18、形剂。The characteristics of a tablet that make it a popular dosage form，e. g.，compactness （紧密度），physical stability，rapid production capability，chemical stability，and efficacy, are in general dictated（指示，确定） primarily by the qualities of the granulation from which it is made. Basically stated, material
19、s intended for（目的，用来 ) compaction into a tablet must possess two characteristics: fluidity and compressibility. 药物的性质决定于药物通常的剂量形式。例如，紧密度、物理稳定性、快速生产、化学稳定性和有效性，通常由制造片剂的制粒的质量决定的，基本上来讲，原材料想要压制成片剂必须拥有两个特性：流动性、可压缩性。The method of introducing the binder depends on its solubility and on the components of the
20、 mixture. Since ，in general，the mass should merely (仅仅，只 ) be moist (潮的 ) rather than wet ( 湿的 ) or pasty (浆状的 )，there is a limit to the amount of solvent that may be employed. Therefore ，when only a small quantity is permissible ，the binder is blended in with the dry powders initially; when a large
21、 quantity is required ，the binder is usually dissolved in the liquid. The solubility of the binder also has an influence on the choice of methods ，since the solution should be fluid enough to disperse ( 使分散 ) readily (容易地 ) in the mass. 加入粘合剂的方法是由它的溶解度以及混合物的组成确定的。因为通常混合物只需要微潮而不需要湿度过大或成浆状。因此使用的容器的量有一
22、定的限度。因此，当只需要使用很少量溶剂时，粘合剂就最初与干的粉状材料一起搅拌；当要求所加入的量较多时，粘合剂通常是溶解到液体中。粘合剂的溶解度的大小也影响方法的选择，因为溶液应该具有一定的流动性名师归纳总结 精品学习资料 - - - - - - - - - - - - - - -精心整理归纳 精选学习资料 - - - - - - - - - - - - - - - 第 2 页，共 8 页 - - - - - - - - - 使粘合剂容易分散到混合物中。Unit 14 With many drugs, the basic goal of therapy is to achieve a stead
23、y-state blood or tissue level that is therapeutically effective and nontoxic for an extended period of time . The design of regimens is an important element in accomplishing this goal.A basic objective in dosage form design is to optimize the delivery of medication so as to achieve a measure of cont
24、rol of the therapeutic effect in the face of uncertain fluctuations in the in vivo environment in which drug release takes place. This is usually accomplished by maximum drug availability, i. e., by attempting to attain a maximum rate and extent of drug absorption; however, control of drug action th
25、rough formulation( 配方 ) also implies controlling bioavailation to reduce drug absorption rates. In this chapter, approaches to the formulation of drug delivery 药物释放systems, based on the deliberate （深思熟虑的，这里理解成“ 有效的 ” ）control of drug availability, are considered with emphasis on peroral dosage forms
26、口服制剂 . 对于许多药物来说,治疗的基本目标是实现一个稳态的血液或组织水平，也就是在持续的一段时间内治疗上有效且没有毒性。为了达到这一目标，治疗方案的设计是一个重要的因素。剂型设计的一个基本的目标是优化药物的传递, 当遇到不确定的因素时药物能在体内环境有效释放，以便在某种程度上控制治疗效果。这一目标通常通过达到最大药物利用度来实现,也就是试图达到最大速度和最大程度的药物吸收率;然而 , 通过剂型来控制药物作用，也意味着通过控制生物利用度而达到降低药物的的吸收率的目的。在这一章中,以有效的控制药物利用度为基础，研究药物释放体系的途经, 主要研究的剂型是口服制剂。Sustained releas
27、e, sustained action, prolonged action, controlled release, extended action, timed release, depot, and repository dosage forms are terms used to identify drug delivery systems 药物释放that are designed to achieve a prolonged therapeutic effect长效作用 by continuously releasing medication药物释放 over an extended
28、 perior of time after administration（用药，服药）of a single dose.In the case of injectable dosage forms, this period may vary from days to months. In the case of orally administered forms 口服剂型 , however , this period is measured in hours and critically depends on the residence time of the dosage form in
29、the gastrointestinal (Gl) tract . The term “controlled release 控释 ” has become associated with those systems from which therapeutic agents may be automatically delivered at predefined rates 恒速 over a long period of time.Products of this type have been formulated for oral , injectable, and topical us
30、e , and include inserts for placement in body cavities as well. 缓释 ,持续的作用 ,持久的作用 ,控释 ,延长作用 ,定时释放 ,药性持久 ,药物库都是术语用来描述药物释放体系；该制剂的目的指用药后能在长时间内持续放药以达到长效作用的制剂。对于注射剂型,药物释放的时间可能是几天到几个月。然而，对于口服剂型,药物释放的时间以小时来计算，严格来说，药物释放时间的长短取决于其在肠胃系统里的停留时间。术语“ 控释 ” 和这些系统有关，这种剂型是在很长一段时间自动、匀速/恒速地向外释放药物的一种药物剂型。控释制剂有供口服、注射吸收、局部使
31、用多种给药途径，也包括制成植入剂放置在人体腔中。缓释制剂按给药途径分类1、 经胃肠道给药：片剂（包衣片、骨架片、多层片）、丸剂、胶囊剂（肠溶胶囊、药树脂胶囊、涂膜胶囊）等。2、 不经胃肠道给药：注射剂、栓剂、膜剂、植入剂等。Unit 18 Crystallization is one of the oldest unit operations in the portfolio (文件夹 ,公事包 ) of industrial and /or laboratory separations. Almost all separation techniques involve formation o
32、f a second phase from a feed (加入原料 ) ，and processing conditions must be selected that allow relatively easy segregation ( 分离 ,隔离 ) of the two or more resulting phases. This is a requirement of crystallization also，and there are a variety of ( 多种的 ) other properties of the solid product that must be
33、considered in the design and operation of a crystallizer (结晶器 ). Interactions among process, function，product，and phenomena (现象 ) important in crystallization are illustrated in Fig. 1. 结晶操作是混合物在工业或者实验室分离中最古老的单元操作之一，几乎所有的分离操作从加入原料开始都涉及到了第二相的形成，所以在加工条件的选择上必须要使两相或者多相的最终产物相对易于分离。这也是结晶操作的一个必要条件，当然在结晶器的设
34、计和操作中还必须考虑到固体产品的其他（多种）性质。加工、功能、产品和结晶操作中的重要现象之间的交叉关系会在图一中阐明。Concentration. The concentration of fruit juice requires removal of solvent (water) from the natural juice. 名师归纳总结 精品学习资料 - - - - - - - - - - - - - - -精心整理归纳 精选学习资料 - - - - - - - - - - - - - - - 第 3 页，共 8 页 - - - - - - - - - This is commonly
35、 done by evaporation，but the derived (得到的 ) juices may lose flavor components芳香成分or undergo thermal degradation （热降解） during evaporation. 【degradation ,de r?dei? n n. 降格，降级；退化；堕落】In freeze concentration (冷冻浓缩 )，solvent is crystallized (frozen) in a relatively pure form to leave behind a solution wit
36、h a solute （溶质；溶解物） concentration higher than the original mixture. Significant advantages in product taste产品味道have been observed in the application of this process to concentration of certain fruit juice. 对果汁的浓缩操作中要求从天然的果汁中移除溶剂（水）。这一般可以通过蒸发操作实现，但所得到的浓缩果汁会失去芳香性成分或者在蒸发过程中发生热降解。在冷冻浓缩操作中，溶剂将以相对纯的形式结晶出来
37、而留下溶质浓度比原始混合物更高的溶液。这种方法在浓缩某些果汁的时候对产品味道的保留具有明显的优势。Unit 19 Usable fresh water（淡水，食用水）from water bodies accounts for a mere 0.3% of the hydrosphere( 水圈 ) by volume. More important economically( 此处省略了water) is river water. This is because，above all(首先，最重要 ),the rivers carry fresh water and span（跨度 , 跨越
38、, 范围） huge distances. Historically it has so happened that most cities， towns and other communities(社区 ) are situated at （位于 .的, 坐落在 .的）the river banks. The instantaneous（瞬间的 , 即刻的）reserves（储量） of water in all of the globes rivers is about 1200km3，and this volume is renewed(刷新 ) every 12 days on the
39、 average(平均） . 水体中的可用淡水量仅占水圈体积的0.3%。在经济上更为重要的是河水，这是因为，首先，河流携带者带水跨越极大的距离。它在历史上是如此的重要以致大多数的城市，乡镇和其它社区都坐落于河流附近。在全球的河流上时刻都有约1200 km3的水量，而这个体积平均每隔12 天被刷新一次。Surface water refers to the water flowing in rivers and canals （运河，沟渠）and held in （约束，抑制）oceans ， seas ， lakes，and water reservoirs（水库） . It contains
40、 a wide range of inorganic and organic substances ，depending on the climatic，geomorphological （地貌学）， soil， and geological conditions ， mans agricultural and hydraulic-engineering activities ， the impact of industry，and some other factors. 地表水包括流动在江河、运河中的水和储蓄在大洋、大海、湖泊和水库里面的水.地表水里包含的各种不同的无机物和有机物，取决于气候
41、、地貌、土壤、地质条件、人类的农业和水利工程活动、工业的影响和其他一些因素。Another way to class water is according to its salt content. Thus we have fresh water which carries up to 1g of salts per kilogram of water （g/kg); brackish（含盐的 ,微有咸味的） water with 1 to 10 grams of salts per kilogram，and saline（盐的）water with over 10g of salts per
42、 kilogram. 水的另一种分类方法是根据其含盐量。由此我们将每千克含盐量在一克以内的水归为淡水，含盐量在一到十克范围内的归为淡盐水，含盐量超过十克的归为盐水。Water quality is determined by physical， chemical， and bacteriological （细菌学的） tests. It is customary to describe water quality in terms of（根据， 按照） smell，taste，clarity（透明） (or turbidity （混浊） )，colour, temperature，suspen
43、ded solids content，total solids content, total and constituent （组分） alkalinity（碱度） , chemical oxygen demand，and pH value. 水质由物理、化学和细菌学测试测定。这通常根据水的气味、味道、澄清度（或浑浊度）、颜色、温度、固体悬浮物含量、固体总含量、总碱度及各组分碱度、化学含氧量和pH 值来描述。The suspended solids (悬浮固体 )test tells us what fraction of the total solids present in a water
44、 sample is present as suspensions of clay ，sand，and soil. Numerically it is expressed in milligrams per liter (mg/L) on a dry mass basis. 悬浮固体测试告诉我们在水样品中总的固体物质主要是泥土，沙子和土壤。在数字上它表示为每升含有多少毫克干固体成分。The total solids test quantifies（量化）all the solids in a water sample，both inorganic and organic，suspended a
45、nd dissolved ， in true solution and in colloidal form. This parameter( 参数） is found by evaporating a water sample to dryness and weighing the residue残渣 . The total quantity is expressed as milligrams per liter on a dry-mass-of-solids basis. 总的固体测试量化了水的样本中所有的固体颗粒,包含无机物和有机物、悬浮的和溶解的物质,以溶液和胶体形式状态存在的物质。这
46、个参数是由蒸发水量至干燥然后称重残余物得到的。总的固体含量在数字上它表示为每升含有多少毫克干固体成分。名师归纳总结 精品学习资料 - - - - - - - - - - - - - - -精心整理归纳 精选学习资料 - - - - - - - - - - - - - - - 第 4 页，共 8 页 - - - - - - - - - Unit 23 Essentially there are two approaches to the discovery of new drugs ” namely screening of natural products or chemical synthe
47、sis.Increasing knowledge in molecular and cellular( 细胞的 ) biology provides a basis for research aimed at( 针对，瞄准 ) rational drug design. However, screening of natural products for biological activity often leads to new or unanticipated（未曾料到的） types of action作用 which would probably not be discovered u
48、nder purely laboratory conditions.“Nature s chemists ” also have one major advantage over synthetic chemists， in that( 由于，因为 ) from their very beginning they have been manufacturing products that are functional part of a biological system. 基本上有两种方法可以发现新药，分子和细胞生物学领域知识的增加为理性药物设计研究提供了基础。筛选有生物活性的天然产物 ,常
49、常会出现新的或未预料到的类型的行为，这些行为在纯粹的实验室条件下可能不会被发现。“ 自然的化学家 ”和合成化学家相比有一个主要的优势，在于从一开始他们一直制造产品，这些产品是生物系统的功能部分。It should be kept clearly in mind that less than one percent of the known species of marine organisms（海洋生物） have been studied in even the most cursory(粗略的，草率的) manner as to（至于，关于）their pharmacological an
50、d biochemical properties. Many different factors come into play( 起作用 ) and must be orchestrated with care to fine detail if the end product is to be of benefit. 我们应该切记的是：在已知的海洋生物物种中，只有不到百分之一的（物种）的药理学和生物化学性质被哪怕是以最粗略的方式研究过。有许多不同的因素在起作用，如果终端产品是有益的，则必须留意细节，相互协调。For example, a research team in University