药学英语课文翻译 课后翻译节选 中英双语对照 第四版

本篇包括人卫第四版Unit 3B，Unit4A，5A，8A，10A，12AB，

13A等七篇课文

Unit 3 Text B The Other Side of Antibiotics

抗生素的另一面

Antibiotics have eliminated or controlled so many infectious diseases that virtually everyone has benefited from their use at one time or another. Even without such personal experience, however, one would have to be isolated indeed to be unaware of the virtues, real and speculative, of these “miracle” drugs1. The American press, radio, and television have done a good job of reporting the truly remarkable story of successes in the chemical war on germs. What′s more, any shortcomings on their part have been more than made up for by the aggressive public relations activity of the pharmaceutical companies which manufacture and sell antibiotics.

抗生素可以消除或控制很多种感染疾病，以致几乎每人生病时都习惯于使用它而受益，但是如果一个人没有这样的亲身经历，他必定是离群索居才会不知道这些“特效药物”或真实或推测的优点。美国的出版物、电台或电视台用大量的篇幅报道了有关对细菌的化学战中获得的这些显著功绩。而它的缺点却被生产和销售抗生素的制药公司通过公关活动掩藏了。

In comparison, the inadequacies and potential dangers of these remarkable drugs are much less widely known. And the lack of such knowledge can be bad, especially if it leads patients to pressure their doctors into prescribing antibiotics when such medication isn’t really needed, or leads them to switch doctors until they find one who is, so to speak, antibiotics-minded2.

相比而言，使用这些药物的危险性并不广为人知。对这种知识的缺乏将更糟糕，特别是当患者要求医生开处方用抗生素而事实并不需要，或患者频繁地更换医生直至找到一个同意开抗生素处方的医生。

Because the good side of the antibiotics story is so very well-known, there seems more point here to a review of some of the immediate and long-range problems that can come from today’s casual use of these drugs. It should be made clear in advance that calamities from the use of antibiotics are rare in relation to the enormous amounts of the drugs administered. But the potential hazards, so little touched on generally, do need a clear statement.

因为抗生素的好的一面已广为人知，今天抗生素的滥用导致短期或长期问题。我们预先应该知道与抗生素的巨大的使用量相比,它产生危害的例子是少见的。但是，尽管十分少见，需要对这种潜在的危险作一个清楚的说明。

The antibiotics are not, strictly speaking, exclusively prescription drugs. A number of them are permitted in such over-the-counter products as nasal sprays, lozenges, troches, creams, and ointments. Even if these products do no harm there is no point whatsoever in using them. If you have an infection serious enough to warrant the launching of chemical warfare, you need much bigger doses of the antibiotics than any of the non-prescription products are allowed to contain.

严格来讲，抗生素并不全是处方药。许多抗生素被允许作为非处方药(如鼻喷雾剂、键剂、片剂、软膏和乳膏),尽管它们没有危害，也不能随意地使用。如果你患了严重的感染，你就得需要比非处方药所允许最大剂量更大剂量的抗生素了。

Over-the-counter products, however, account for only a small percentage of total antibiotics production. It is the prescription dosages that give people trouble.

然而，非处方药品只是整个抗生素类产品的一小部分，正是处方药物给人类带来了麻烦。

These drugs—even allowing for the diverse abilities of the many narrow-spectrum ones and the versatility of the broad-spectrum ones—are not the cure-alls they often are billed as being. There are wide gaps in their ability to master contagious diseases. Such important infections as mumps, measles, common colds, influenza, and infectious hepatitis still await conquest. All are virus infections and despite intense efforts, very little progress has been made in chemotherapy against viruses. Only small progress has been achieved against fungi. Many strains of bacteria and fungi are naturally resistant to all currently available antibiotics and other chemotherapeutic drugs.

这些药物一即使允许最大能力,很多窄谱抗生素和广谱抗生素也并不是如宣传的那样治疗百病。它们的能力与治疗传染性疾病间还存在很大的差距。如腮腺炎、麻疹、普通感冒、流行性感冒和传染性肝炎等严重感染性疾病仍有待解决。这些都是病毒感染，尽管做出了很大的努力，但是在抗病毒的化疗药物的研究上几乎没有什么进展。抗真菌药物的研究上只取得一点小成就。很多细菌和真菌对现有的抗生素和其他化疗药物具有耐药性。

Some microorganisms originally sensitive to the action of antibiotics, especially staphylococcus, have developed resistant strains. This acquired resistance imposes on the long range value of the drugs a very important limitation, which is not adequately met by the frequent introduction of new antimicrobial agents to combat the problem.

一些原来对抗生素敏感的细菌，特别是葡萄球菌现在也产生了耐药性，这些获得的耐药性对药物的长期使用产生重要的限制，频繁引人新的抗菌药物也不能完全解决这个问题。

It has been pretty well established that the increase in strains of bacteria resistant to an antibiotic correlates directly with the duration and extent of use of that antibiotic in a given location. In one hospital a survey showed that, before erythromycin had been widely used there, all strains of staphylococci taken from patients and personnel were sensitive to its action. When the hospital started extensive use of erythromycin, however, resistant staphylococcus strains began to appear.

现已经确定，在一些地区，抗生素广泛和长期的使用与细菌耐药性增加有直接的相互关系。某医院调查显示，在红霉素广泛使用以前，所有从病人身上取出的葡萄球菌都对红霉素敏感.然而，自从医院开始广泛应用红霉素以来，耐药葡萄球菌菌株开始出现。

The development of bacterial resistance can be minimized by a more discriminating use of antibiotics, and the person taking the drug can help here. When an antibiotic must be used, the best way to prevent the development of resistance is to wipe out the infection as rapidly and thoroughly as possible. Ideally, this requires a bactericidal drug, which destroys, rather than a bacteriostatic drug, which inhibits. And the drug must be taken in adequate dosage for as long as is necessary to eradicate the infection completely. The doctor, of course, must choose the drug, but patients can help by being sure to take the full course of treatment recommended by the doctor, even though symptoms seem to disappear before all the pills are gone. In rare instances the emergence of resistance can be delayed or reduced by combinations of antibiotics. Treatment of tuberculosis with streptomycin alone results in a high degree of resistance, but if para-aminosalicylic acid or isoniazid is used with streptomycin the possibility that this complication will arise is greatly reduced.

更有区别的应用抗生素可以最大限度地抑制细菌耐药性的发展，使用药物的病人可对此有所帮助。当必须使用一种抗生素时，最好的避免耐药性方法就是尽快彻底地去除感染。这就需要用能杀死细菌的杀菌药，而不是抑制细菌的抑菌药。这种药物必须使用一定剂量，并且一定的时间以完全根除这种感染。医生当然得选这种药，但患者须遵医嘱、使用足够的治疗量，即使在药物吃完以前症状似乎已经消失。少数情况下联合用药可以推迟或降低耐药性的产生。用链霉素单独治疗结核病会导致高度的耐药，但如果链霉素联用对氨基水杨酸或异烟肼将大大降低耐药性。

In hospital treatment of severe infections, the sensitivity of the infecting organism to appropriate antibiotics is determined in the laboratory before treatment is started. This enables the doctor to select the most effective drug or drugs; it determines whether the antibiotic is bactericidal or bacteriostatic for the germs at hand; and it suggests the amount needed to destroy the growth of the bacteria completely. In either hospital or home, aseptic measures can help to reduce the prevalence of resistant strains of germs by preventing cross infection and the resultant spreading of organisms.

在医院治疗严重感染时，感染菌对抗生素的敏感性在治疗前已在实验室确定，这样可以使医生选择最有效的药物，可以决定使用抑菌还是杀菌的抗生素，并可对能完全破坏细菌生长所需的用量给出建议。无论在医院或是在家里，无菌措施由于避免了交叉感染以及由此造成的生物体传播，从而可以降低细菌耐药菌株的广泛流行。

Every one of the antibiotics is potentially dangerous for some people. Several serious reactions may result from their use. One is a severe, sometimes fatal, shock-like anaphylactic action, which may strike people who have become sensitized to penicillin. Anaphylactic reaction happens less frequently and is less severe when the antibiotic is given by mouth. It is most apt to occur in people with a history of allergy, or a record of sensitivity to penicillin. Very small amounts of penicillin, even the traces which get into the milk of cows for a few days after they are treated with the antibiotic for mastitis, may be sufficient to sensitize; hence, the strong campaign by food and drug officials to keep such milk off the market.

对有些人来说任何一种抗生素都可能有潜在的危险。一些严重的反应可能是由于它们的应用产生的，其中之一就是严重的有时甚至是致死性的过敏性休克，对青霉素过敏的人使用青霉素将很危险。口服抗生素将使过敏频率降低或降低严重性。青霉素过敏或有过敏史者更容易发生。奶牛使用抗生素治疗乳腺炎几天后，其牛奶中带入的极其少量甚至痕量的青霉素也可能足以引起过敏。所以食品药品监督官员采取强有力的措施防止这种牛奶进人市场。

To minimize the risk of anaphylactic shock in illnesses where injections of penicillin are the preferred treatment, a careful doctor will question the patient carefully about allergies and previous reactions. In case of doubt another antibiotic will be substituted, if feasible, or other precautionary measures will be taken before the injection is given.

当注射青霉素是首选治疗方案时，为降低这种过敏性休克，谨慎的医生会仔细询问病人的过敏史及其反应。如过敏史不清楚，医生会用其他抗生素代替或注射前用其他方法检查其是否过敏。

Other untoward reactions to antibiotics are gastrointestinal disorders—such as sore mouth, cramps, diarrhea, or anal itch—which occur most frequently after use of the tetracycline group but have also been encountered after use of penicillin and streptomycin. These reactions may result from suppression by the antibiotic of bacteria normally found in the gastrointestinal tract. With their competition removed, antibiotic-resistant staphylococci or fungi, which also are normally present, are free to flourish and cause what is called a super-infection. Such infections can be extremely difficult to cure.

其他抗生素不良反应包括胃肠道不适，如口腔疼痛、痉挛、腹泻、肛门瘙痒，这种情况在使用四环素类抗生素后经常发生，在使用青霉素和链霉素后也会遇到。这些反应可能是由于使用的抗生素抑制了正常的胃肠道菌群引起的。随着这种竞争的消除，正常存在的葡萄球菌或真菌耐药菌株自由繁殖并引起所谓的超感染，这种感染将更难治疗。

A few antibiotics have such toxic effects that their usefulness is strictly limited. They include streptomycin and dihydro-streptomycin, which sometimes cause deafness, and chloramphenicol,

which may injure the bone marrow. Drugs with such serious potential dangers as these should be used only if life is threatened and nothing else will work

有些抗生素有毒性作用，使其应用受到了严格的限制。这类抗生素包括会导致耳聋的链霉素和双氢链霉素，以及会产生骨髓损伤的氯霉素。这些有严重危险的药物只有在生命受到威胁或其他药物无效时才使用。

All the possible troubles that can result from antibiotic treatment should not keep anyone from using one of these drugs when it is clearly indicated. Nor should they discourage certain preventive uses of antibiotics which have proved extremely valuable.

由于有些抗生素疗效确切，因此使用抗生素所带来的所有可能的麻烦也不能阻止任何人用任何一种抗生素，对于被证明是有效的抗生素，人们不会不鼓励它们的使用。

翻译

1.另一种发现新的抗生素的高难度方法是合理药物设计，即利用有关分子结构的知识来进行全新的药品设计或改进。

Rational drug design is another more difficult method of new antibiotics discovery, that is to say, design or improve a brand new drug by using the knowledge of molecular structure.

2.制药工业在探索和开发新药的同时还要对抗现有抗生素不断増长的微生物耐药性，这将是一条漫长的道路。

When pharmaceutical industry explores and develops a new drug, it fights against the microbial resistances to available antibiotics all the time. It is a very long way.

3.应该大力鼓励医生、制药业以及公众态度的转变。必须将抗生素视为一种应被谨慎使用并且仅在真正必需时才使用的宝贵资源。

The change of doctors, pharmaceutical industry and the public attitudes should be encouraged greatly. The antibiotics must be viewed as a precious resource only used cautiously in real needs.

4.全世界都必须在医学教育的初期就进行关于抗生素的审慎使用及其耐药危险的灌输，并且，这种教育还应贯穿于医学工作者的整个医疗生涯。

The cautious use of antibiotics and their hazardous resistances should be pumped into the medical students during their early medical education throughout the world. What's more, this education should penetrate through the medical worker's whole career.

5.制药工业必须停止推进非临床使用抗生素的生产，并且，它应该认识到，它将从抗生素的合理使用中获利，因此，应该对为此所作的各种尝试提供财务援助。

Pharmaceutical industry must stop producing the non-clinical antibiotics, and it may realize that it will benefit a lot from rational use of antibiotics. Hence, it should offer financial aids to all these attempts.

Unit 4 Text A The Scope of Pharmacology

药理学范畴

In its entirety, pharmacology embraces the knowledge of the history, source, physical and chemical properties, compounding, biochemical and physiological effects, mechanisms of action, absorption, distribution, biotransformation and excretion, and therapeutic and other uses of drugs. Since a drug is broadly defined as any chemical agent that affects living processes, the subject of pharmacology is obviously quite extensive.

总体来说，药理学包括药物的以下诸方面内容:历史背景、来源、理化特性、合成、生化生理作用、作用机制、吸收、分布、生物转化和排泄以及治疗作用和其他作用。由于药物被

一般性定义为影响生命过程的化学物质，因而药理学范畴显然是极其广泛的。

For the physician and the medical student, however, the scope of pharmacology is less expansive than indicated by the above definitions. The clinician is interested primarily in drugs that are useful in the prevention, diagnosis, and treatment of human disease, or in the prevention of pregnancy. His study of the pharmacology of these drugs can be reasonably limited to those aspects that provide the basis for their rational clinical use. Secondarily, the physician is also concerned with chemical agents that are not used in therapy but are commonly responsible for household and industrial poisoning as well as environmental pollution. His study of these substances is justifiably restricted to the general principles of prevention, recognition, and treatment of such toxicity or pollution. Finally, all physicians share in the responsibility to help resolve the continuing sociological problem of the abuse of drugs.

然而，就医生和医学生生而言，药理学范畴并没有上述定义那么广泛。临床医生的主要兴趣在于药物对人类疾病的预防、诊断及治疗.或是在避孕方而所起的作用。因而他对这些药物的药理学研究不仅仅周限于某些方面，只要能为其合理的临床用药提供理论根据就行。其次，医生也关注某些化学物质，这些物质虽然不用于治疗，但通常与家庭中毒；工业中毒以及环境污染有关。医生对这些物质的研究当然仅限于一般性了解。对这类中毒或汚污染的防范、诊断和治疗。最后，所有医生都应责无旁贷地为解决药品滥用所引起的社会问题而做出自己的努力。

A brief consideration of its major subject areas will further clarify how the study of pharmacology is best approached from the standpoint of the specific requirements and interests of the medical student and practitioner. At one time, it was essential for the physician to have a broad botanical knowledge, since he had to select the proper plants from which to prepare his own crude medicinal preparations. However, fewer drugs are now obtained from natural sources, and, more importantly, most of these are highly purified or standardized and differ little from synthetic chemicals. Hence, the interests of the clinician in pharmacognosy are correspondingly limited. Nevertheless, scientific curiosity should stimulate the physician to learn something of the sources of drugs, and this knowledge often proves practically useful as well as interesting. He will find the history of drugs of similar value.

从医学生和从业医师的特別耑求和一般兴趣的角度来看，什么才是药理学学习的最佳途径呢？只要对其主要学科领域稍加研究便可知晓。以前，医师必须拥有广泛的植物方而的知识，因为他得挑选适当的植物，且将其制备成简单的药物制剂。然而，现在的药物已很少取自于天然植物，而且更为重要的是大多数天然药物已被高度提纯，且与合成的化学药物无甚区别，所以，临床医生对生药学的兴趣也相应减弱。尽管如此，应该激励临床医生了解药物的来源的科学好奇心，这方面知识往往被证明不但有趣，而且有用。他将会发现了解药物的历史同样具有价值。

The preparing, compounding, and dispensing of medicines at one time lay within the province of the physician, but this work is now delegated almost completely to the pharmacist1. However, to write intelligent prescription orders, the physician must have some knowledge of the physical and chemical properties of drugs and their available dosage forms, and he must have a basic familiarity with the practice of pharmacy. When the physician shirks his responsibility in this regard, he invariably fails to translate his knowledge of pharmacology and medicine into prescription orders and medication best suited for the individual patient.

药物的制备、合成与销售一度都是医生的职责，但这项工作现在几乎全归药师了。不过临床医师要想开出合理的处方，必须对药物的理化性质及其现有剂型有所了解,必须基本了

解药房业务。若临床医师逃避这方面责任，他肯定用不好药理学及药物知识，从而难以开出适合每位患者的最佳医疗处方。I

Pharmacokinetics deals with the absorption, distribution, biotransformation, and excretion of drugs. These factors, coupled with dosage, determine the concentration of a drug at its sites of action and, hence, the intensity of its effects as a function of time. Many basic principles of biochemistry and enzymology and the physical and chemical principles that govern the active and passive transfer and the distribution of substances across biological membranes are readily applied to the understanding of this important aspect of pharmacology2.

药物动力学涉及药物的吸收、分布、生物转化以及排泄等方面。这些因素再加上剂量便决定了药物在其作用点的浓度，进而决定了其与时间成函数关系的药效强度。在对药理学这一重要方面的理解过程中，常常运用到许多有关生物化学和酶学方面的基本原理和物理化学方面的一些基本法则，而这些原理和法则决定着物质在生物膜之间的主动和被动转移及分布。

The study of the biochemical and physiological effects of drugs and their mechanisms of action is termed as pharmacodynamics. It is an experimental medical science that dates back only to the later half of the nineteenth century. As a border science, pharmacodynamics borrows freely from both the subject matter and the experimental techniques of physiology, biochemistry, microbiology, immunology, genetics, and pathology. It is unique mainly in that attention is focused on the characteristics of drugs. As the name implies, the subject is a dynamic one. The student who attempts merely to memorize the pharmacodynamic properties of drugs is foregoing one of the best opportunities for correlating the entire field of preclinical medicine. For example, the actions and effects of the saluretic agents can be fully understood only in terms of the basic principles of renal physiology and of the pathogenesis of edema. Conversely, no greater insight into normal and abnormal renal physiology can be gained than by the study of the pharmacodynamics of the saluretic agents.

对药物的生化生理作用及其作用机制的研究称为药效学。这是一门实验医学，其历史仅可追溯到19世纪后半叶。作为边缘学科，药效学从生理学、生化学、微生物学、免疫学、遗传学和病理学等诸多学科的主要理论和实验技术中吸取了大量内容。该学科的独到之处主要在于其关注的要点是药物的特征。顾名思义，该科目属于动态学科。学生如果仅仅打算死记硬背药物的药效学特性的话，那他将会丧失把整个临床前期医学连为—体的这一最佳机会。例如:利盐排泄剂的活性和效用只有在肾脏生理学和水肿发病机制的基本原理的基础上才能完全理解。换句话说，只有通过对利盐排泄剂的药效学研究，才能最深人地了解肾脏生理学正常和异常两方面情况。

Another ramification of pharmacodynamics is the correlation of the actions and effects of drugs with their chemical structures. Such structure-activity relationships are an integral link in the analysis of drug action, and exploitation of these relationships among established therapeutic agents has often led to the development of better drugs. However, the correlation of biological activity with chemical structure is usually of interest to the physician only when it provides the basis for summarizing other pharmacological information.

药效学的另一分支是研究药物活性和效用与其化学结构的相互关系。这种构效关系是分析药物作用不可或缺的部分，将这种关系应用于现有的治疗药物中往往会促使药品的更新换代。然而，只有当生物活性与化学结构的关联能够为总结其他药物学信息提供基础时，临床医师才会对此产生兴趣。

The physician is understandably interested mainly in the effects of drugs in man. This emphasis

on clinical pharmacology is justified, since the effects of drugs are often characterized by significant interspecies variation, and since they may be further modified by disease. In addition, some drug effects, such as those on mood and behavior, can be adequately studied only in man. However, the pharmacological evaluation of drugs in man may be limited for technical, legal, and ethical reasons, and the choice of drugs must be based in part on their pharmacological evaluation in animals. Consequently, some knowledge of animal pharmacology and comparative pharmacology is helpful in deciding the extent to which claims for a drug based upon studies in animals can be reasonably extrapolated to man3.

临床医师的兴趣主要集中于药物对人体的疗效。临床药理重视这一点是合理的，因为药物的作用往往因种属的明显差异而大相径庭，并可能由于疾病的作用而发生进一步改而且有些药物作用——诸如对情绪和行为的作用—只有通过人体才能得以充分研究，不过药物对人体的药理学评价可能因技术、法律及伦理道德方面的原因而受到限制，对药物的选择在一定程度上也只得以它们在动物身上所进行的药理学评价为基础。因此，动物药理学和比较药理学方面的知识有助于确定以动物实验为基础的某种新药研制何时才可用于人体。

Pharmacotherapeutics deals with the use of drugs in the prevention and treatment of disease. Many drugs stimulate or depress biochemical or physiological function in man in a sufficiently reproducible manner to provide relief of symptoms or, ideally, to alter favorably the course of disease. Conversely, chemicotherapeutic agents are useful in therapy because they have only minimal effects on man but can destroy or eliminate parasites. Whether a drug is useful for therapy is crucially dependent upon its ability to produce its desired effects with only tolerable undesired effects. Thus, from the standpoint of the physician interested in the therapeutic uses of a drug, the selectivity of its effects is one of its most important characteristics. Drug therapy is rationally based upon the correlation of the actions and effects of drugs with the physiological, biochemical, microbiological, immunological, and behavioral aspects of disease. Pharmacodynamics provides one of the best opportunities for this correlation during the study of both the preclinical and the clinical medical sciences.

药物治疗学涉及如何在疾病防治中使用药物。许多药物以强有力的可重现方式促进或抑制着人体的生理生化功能，进而使症状得以缓解或促使病程朝着令人满意的方向转变。相反，化疗药物的治病功能是因为其对人体作用很小但却能杀死或清除寄生生物。—种药物是否可以用于治疗，关键取决于其能否产生预期的治疗效果，同时其副作用在可容忍的范围内。这样，从关注药物疗效的临床医师的观点来看，药物作用的选择性便是其最重要特点之一。药物的活性和疗效与疾病诸方面——生理、生化、微生物、免疫和行为——的联系理所当然地成为药物治疗的基础。药效学便为临床前期和临床期医学研究这种联系提供了一个绝好的机会。

Toxicology is that aspect of pharmacology that deals with the adverse effects of drugs. It is concerned not only with drugs used in therapy but also with the many other chemicals that may be responsible for household, environmental, or industrial intoxication. The adverse effects of the pharmacological agents employed in therapy are properly considered an integral part of their total pharmacology. The toxic effects of other chemicals are such an extensive subject that the physician must usually confine his attention to the general principles applicable to the prevention, recognition, and treatment of drug poisonings of any cause.

毒理学是研究药物副作用的药理学分支。它不仅涉及治疗药物，还涉及引起家庭、环境或工业中毒的许多其他化学物质。治疗性药物的副作用应被视为整个药理学的一个组成部分。其他化学物质的毒副作用范围太广，临床医师通常只能将注意力放在预防、确认和处理

各种药物中毒的基本原则上。

翻译

1)药物作用于人体的科学叫药理学，研究这门学问的科学家便是药理学家。药理学不是

一门能够独立研究的科学，而是与其它学科紧密相关的。药理学家不仅要了解人体内进行的正常反应过程，还应懂得机体功能是怎样受疾病影响的。

The science of the effects of drugs on the body is called pharmacology, and the scientists who study it are pharmacologists. Pharmacology is not a science that can be studied on its own, but that closely related to other branches of science. Pharmacologists should not only

understand the normal processes that take place in the body, but know how the functions of the body are affected by disease.

2)医生和医学生对药理学的理解和要求没有其定义范畴那么广泛。临床医生主要关心药

品药理学所提供的合理临床用药的理论基础，他们的主要兴趣在于药物对人类疾病的预防、这段及治疗，或者在避孕方面所起的作用。

For physicians and medical students, the scope of pharmacology is not so expansive as its common definition. The clinician is interested primarily in drags that are useful in the

prevention, diagnosis, and treatment of human disease, or in the prevention of pregnancy.

3)所有医生都应该负起责任解决药品滥用所引起的各种社会问题。药物用得恰当，将是

人类的一大福音，用得不当，则可能毁了人类。病人（特别是老年病人）经常性使用一种以上治疗药物的话，往往会发生产生毒性的药物相互作用。

All physicians should share the responsibility to resolve kinds of sociological problems

caused by the abuse of drugs. Properly used, drugs are great blessing to mankind; improperly used, they could destroy human race. When a patient, particularly the elderly is prescribed frequently to take more than one therapeutic agent, drug interactions resulting in toxicity will occur.

4)以前，医师必须具备很广泛的植物学知识，因为他要懂得挑选适当的植物的能力和技

巧，并将它们制备成简单的草药。现在，由于大多数天然药物被高度提纯，且与合成的化学药物无甚区别，所以临床医生对生药学的兴趣也相应减弱。

At one time, it was essential for the physician to have broad botanical knowledge, because they had to possess the ability and skill to select proper plants from which to prepare his own crude medicinal preparations.

5)对药物的生化生理作用及其活性机制的研究叫做药效学，该学科的独到之处主要在于

其关注的要点是药物的特征。药效学作为一门边缘学科，大量借鉴了生理学、生物化学、免疫学、病理学等学科的理论和实验技术。

The study of biochemical and physiological effects of drags and their mechanisms of action is termed as pharmacodynamics, whose uniqueness lies mainly in that its attention is focused on the characteristics of the drug. As a broader science，it borrows freely from both the

theories and experimental techniques of physiology, biochemistry, immunology, and

pathology.

Unit 8 Text A What Analytical Chemists Do?

分析化学家做什么？

Analytical chemistry is concerned with the chemical characterization of matter and the answer to two important questions: what is it (qualitative) and how much is it (quantitative). Chemicals

make up everything we use or consume, and knowledge of the chemical composition of many substances is important in our daily lives. Analytical chemistry plays an important role in nearly all aspects of chemistry, for example, agricultural, clinical, environmental, forensic, manufacturing, metallurgical, and pharmaceutical chemistry. The nitrogen content of a fertilizer determines its value. Foods must be analyzed for contaminants (e.g., pesticide residues) and for essential nutrients (e.g. vitamin content). The air in cities must be analyzed for carbon monoxide. Blood glucose must be monitored in diabetics (and, in fact, most diseases; are diagnosed by chemical analysis). The presence of trace elements from gun powder on a murder defendant's hand will prove a gun was fired. The quality of manufactured products often depends on proper chemical proportions, and measurement of the constituents is a necessary part of quality control. The carbon content of steel will determine its quality. The purity of drugs will determine their efficacy.

分析化学是研究物质的化学特征并能回答两个重要问题:是什么(定性)以及有多少(定量)。我们所使用和消耗的一切都是由化学物质组成的，所以日常生活中了解物质的化学成分是非常重要的。分析化学几乎在化学的各个领域都起着至关重要的作用，比如农业、临床、环境、法医、制造业、冶金以及药物化学。化学肥料中氮的含量决定了其价值。对食物而言，必须分析其中的污染物(比如杀虫剂残留）和必要的营养成分(如维生素含量)。对城市空气而言，必须分析其中的一氧化碳含量。糖尿病患者需检测血糖(事实上，大多数疾病都是通过化学分析来诊断的)。谋杀嫌疑犯手上火药中痕量元素的存在可以证明手枪是开过火的。出厂产品的质量取决于合适的化学成分比例，因此对组分的测定是质量控制中必不可少的一个环节。钢铁中碳的含量决定其质量，药物的纯度决定其疗效。

What is Analytical Science?

什么是分析科学？

The above description of analytical chemistry provides an overview of the discipline of analytical chemistry. There have been various attempts to more specifically define the discipline. The late Charles N. Reilley said: "Analytical chemistry is what analytical chemists do" The discipline has expanded beyond the bounds of just chemistry, and many have advocated using the name analytical science to describe the field. This term is used in a National Science Foundation report from workshops on “Curricular Developments in the Analytical Sciences.” Even this term falls short of recognition of the role of instrumentation development and application. One suggestion is that we use the term analytical science and technology.

通过以上描述可以对分析化学这门学科有大致的了解，为更加明确地定义这门学科，人们也有过多种尝试。已故的CharlesN.Reilley曾说过:“分析化学家从事的工作就是分析化学”。这门学科的发展已跨越了纯化学的界限，许多人已提倡使用“分析科学”来描述该领域。在名为“分析科学的课程发展”的工作组所做的国家科学基金报告中已使用这一名词。但是该名词忽视了仪器发展和应用的作用，有人建议使用“分析科学和技术”这一名词。

The Federation of European Chemical Societies held a contest to define analytical chemistry, and the following suggestion by K. Cammann was selected.

Analytical Chemistry provides the methods and tools needed for insight into our material world …for answering four basic questions about a material sample:

●What?

●Where?

●How much?

●What arrangement, structure or form?

欧洲化学会联盟曾举行了一次会议来定义分析化学，K.Cammann所提出的如下建议被采纳：

分析化学提供了洞察物质世界所需要的方法和工具，它回答了关于某一物质样品的四个基本问题：

•是什么？

•在哪里？

•有多少？

•是何种排列、结构或形态？

The Division of Analytical Chemistry of the American Chemical Society provides a comprehensive definition of analytical chemistry, which may be found on their website. It is reproduced in most part here:

Analytical Chemistry seeks ever improved means of measuring the chemical composition of natural and artificial materials. The techniques of this science are used to identify the substances which may be present in a material and to determine the exact amounts of the identified substance.

美国化学会的“分析化学分类”为分析化学提供了一个全面的定义，可以在其网站査到，此处摘录部分内容：

分析化学探索不断改进的方法，用以检测天然和人造材料的化学组成。此种科学的技术手段用来鉴别可能存在于一种材料中的物质以及测定给定物质的准确含量。

Analytical chemists work to improve the reliability of existing techniques to meet the demands for better chemical measurements which arise constantly in our society. They adopt proven methodologies to new kinds of materials or to answer new questions about their composition and their reactivity mechanisms.They carry out research to discover completely new principles of measurement and are at the forefront of the utilization of major discoveries, such as lasers and microchip devices for practical purposes. Their efforts serve the needs of many fields:

分析化学家致力于提高已有技术的可靠性以更好地满足社会中频繁出现的化学检测的需求。他们将已证实的方法学应用于新型材料，或回答关于其组成及反应机制的新问题。他们开展研究，探索全新的检测原理，站在了将激光和微芯片等重大发现应用于实际用途的最前沿。他们的努力满足了许多领域的需求：

-In medicine, analytical chemistry is the basis for clinical laboratory tests which help physicians diagnose disease and chart progress in recovery.

-In industry, analytical chemistry provides the means of testing raw materials and for assuring the quality of finished products whose chemical composition is critical. Many household products, fuels, paints, pharmaceuticals, etc. are analyzed by the procedures developed by analytical chemists before being sold to the consumer.

-Environmental quality is often evaluated by testing for suspected contaminants using the techniques of analytical chemistry.

-The nutritional value of food is determined by chemical analysis for major components such as protein and carbohydrates and trace components such as vitamins and minerals.

Indeed, even the calories in a food are often calculated from its chemical analysis.

Analytical chemists also make important contributions to fields as diverse as forensics, archaeology, and space science.

•医药领域中,分析化学是临床实验室检测的基础，此类检测可以帮助医生诊断疾病，绘制康复过程图。

•工业领域中，分析化学提供原料的检测手段，保证对化学成分要求严格的最终产品的质量。许多家庭用品、燃料、涂料、药品等在出售给消费者前就已经被由分析化学家建立的方法分析检测。

•环境质量经常通过采用分析化学技术检测疑似污染物的方法得到评价。

食品的营养价值是通过对其中蛋白质、碳水化合物等主要成分以及维生素、矿物质等微量成分的化学分析而得以确定。实际上，甚至食物的热量也经常通过化学分析的方法来计箅的。

分析化学在法医学、考古学和太空科学等多个领域也作出了重要贡献。Qualitative and Quantitative Analyses: What Does Each Tell Us?

定性分析和定量分析:它们各自告诉我们什么？

The discipline of analytical chemistry consists of qualitative analysis and quantitative analysis. The former deals with the identification of elements, ions, or compounds present in a sample (we may be interested in whether only a given substance is present), while the latter deals with the determination of how much of one or more constituents is present. The sample may be solid, liquid, gas, or a mixture. The presence of gunpowder residue on a hand generally requires only qualitative knowledge, not of how much is there, but the price of coal will be determined by the percent of sulfur impurity present.

分析化学学科包括定性分析和定量分析。前者解决样品中所存在元素、离子和化合物的鉴别问题(我们感兴趣的仅是一种给定的物质是否存在)，而后者要解决测定已存在的一种或多种组分含量是多少的问题。检测样品可能是固体、液体、气体，也可能是混合物。手上的火药残留通常只需要定性的了解即可,并不需要知道残留量是多少，但煤炭的价格则由其中硫杂质的百分含量所决定。

Qualitative tests may be performed by selective chemical reactions or with the use of instrumentation. The formation of a white precipitate when adding a solution of silver nitrate to a dissolved sample indicates the presence of chloride. Certain chemical reactions will produce colors to indicate the presence of classes of organic compounds, for example, ketones. Infrared spectra will give “fingerprints” of organic compounds or their functional groups.

定性鉴别可能通过选择性的化学反应或者使用仪器完成。当把硝酸银溶液滴加到一份溶解样品中，生成白色沉淀就说明了氯离子的存在。特定的化学反应会产生颜色，指示某一类有机化合物的存在，如酮类化合物。红外光谱可以给出有机化合物或官能团的“指纹图谱”。

A clear distinction should be made between the terms selective and specific:

● A selective reaction or test is one that can occur with other substances but exhibits a degree of preference for the substance of interest.

● A specific reaction or test is one that occurs only with the substance of interest.

对选择性和专属性这两个术语应该做以明确的区分：

•选择性反应或鉴别是指可以和其他物质发生反应但对敏感物质显示一定程度的偏好。

•专属性反应或鉴别是指仅与敏感物质发生反应。

Unfortunately, few reactions are specific but many exhibit selectivity. Selectivity may be achieved by a number of strategies. Some examples are:

●Sample preparation (e.g., extractions, precipitation)

●Instrumentation (selective detectors)

●Target analyte derivatization (e.g., derivatize specific functional groups with detecting reagents)

●Chromatography, which provides powerful separation

可惜虽然许多反应呈现出选择性，但极少数反应具有专属性。通过许多途径可以实现选择性，例如：

•样品处理(如萃取和沉淀）

•使用仪器(选择性检测器）

•目标分析物衍生化(如用检测试剂衍生化特定的官能团）

•色谱法，可达到充分分离。

For quantitative analysis, a history of the sample composition will often be known (it is known that blood contains glucose), or else the analyst will have performed a qualitative test prior to performing the more difficult quantitative analysis. Modern chemical measurement systems often exhibit sufficient selectivity that a quantitative measurement can also serve as a qualitative measurement. However, simple qualitative tests are usually more rapid than quantitative procedures. Qualitative analysis is composed of two fields: inorganic and organic. The former is usually covered in introductory chemistry courses, whereas the latter is best left until after the student has had a course in organic chemistry.

对于定量分析，我们通常要知道样品组成的来历(就像我们知道血液中含有葡萄糖)，否则在更具难度的定量分析前，分析工作者先需要进行定性实验。现代化学检测系统往往具有较好的选择性，定量检测方法同样适合于定性检测。然而，简单的定性鉴别常常比定量的过程更为快捷。定型分析由无机和有机两个领域组成，前者通常包含于入门式的化学课程中，而后者最好在学生学完一门有机化学课程后再去涉猎。

In comparing qualitative versus quantitative analysis, consider, for example, the sequence of analytical procedures followed in testing for banned substances at the Olympic Games. The list of prohibited substances includes about 500 different active constituents: stimulants, steroids, beta-blockers, diuretics, narcotics, analgesics, local anesthetics, and sedatives. Some are detectable only as their metabolites. Many athletes must be tested rapidly, and it is not practical to perform a derailed quantitative analysis on each. There are three phases in the analysis: the fast-screening phase, the identification phase, and possible quantification. In the fast-screening phase, urine samples are rapidly tested for the presence of classes of compounds that will differentiate them from “normal” samples. Various techniques include immunoassays, gas chromatography, and liquid chromatography. About 5% of the samples may indicate the presence of unknown compounds that mayor may not be prohibited but need to be identified. Samples showing a suspicious profile during the screening undergo a new preparation cycle (possible hydrolysis, extraction, derivatization), depending on the nature of the compounds that have been detected. The compounds are then identified using the highly selective combination of gas chromatography/mass spectrometry (GC/MS). In this technique, complex mixtures are separated by gas chromatography, and they are then detected by mass spectrometry, which provides molecular structural data on the compounds. The MS data, combined with the time of elution from the gas chromatograph, provide a high probability of the presence of a given detected compound. GC/MS is expensive and time consuming, and so it is used only when necessary. Following the identification phase, some compounds must be precisely quantified since they may normally be present at low levels, for example, from food, pharmaceutical preparations, or endogenous steroids, and elevated levels must be confirmed. This is done using quantitative techniques such as spectrophotometry or gas chromatography.

比较定性分析和定量分析，我们不妨以奥林匹克运动会对违禁药物的检验为例了解分析过程的步骤。禁止药物目录中包含了大约500种不同的活性成分:兴奋剂类、类固醇，β阻断剂、利尿剂、麻醉剂、止痛剂、局部麻醉剂和镇静剂。有些只有以代谢物的形式才能被检

测。许多运动员必须快速被检测，对每个人做细致的定量分析是不可行的。分析过程中有三个阶段:快速筛选期、鉴别期以及可能需要的定量期。在快速筛选期，对尿样进行快速检测，找出其中区别于正常样品的各类组分,所使用的技术包括免疫分析、气相色谱及液相色谱。大约5%的样品会检测出未知化合物，不论这些物质被禁止与否，都需要做进一步鉴别。在筛选过程中显示出可疑情况的样品，需要根据已检出化合物的性质进行新一轮的处理过程(可能水解、萃取或衍生化)，然后使用高选择性的气相色谱一质谱联用技术(GC/MS)对该化合物进行鉴定。在该技术中，复杂混合物通过气相色谱得到分离，然后再通过可提供化合物的分子结构信息的质谱进行检测。结合质谱数据和气相色谱的洗脱时间，我们对确认给定的待测化合物的存在就有更大的把握。GC/MS昂贵、费时，因此在必要时才会使用。经过鉴定阶段以后，一些化合物需要准确定量。这些可能源于如食物、药品或内源性类固醇的化合物，在正常情况下即以很低的浓度存在的水平也需要确定。这可以通过分光光度法或气相色谱等定量技术来解决。

翻译

1)分析化学的核心任务在于解决两个问题: 一个是有什么;另一个是有多少。也就是定性

分析和定量分析。定性分析是指鉴别所含的物质而定量分析是测定物质的准确含量。

Analytical chemistry aims to resolve two questions: what it is and how much it is, that is

qualitative analysis and quantitative analysis. Qualitative analysis is to identify the elements, ions and compounds contained in a sample while quantitative analysis is to determine the exact quantity.

2)分析化学的发展已经超出了化学的边界，因此有人提议用分析科学来描述这个领域。

但是，该名词忽视了仪器发展和应用的作用，有人建议使用“分析科学和技术”这一名词。

Analytical chemistry has expanded beyond the bounds of just chemistry, and many have advocated using the name analytical science to describe the field. Even this term falls short of recognition of the role of instrumentation development and application. One suggestion is that we use the term analytical science and technology.

3)分析化学家致力于提高已有技术的可靠性以更好的满足社会中频繁出现的化学检测的

需求。他们将已证实的方法学应用于新型材料，或回答关于其组成及反应机理的新问题。

Analytical chemists work to improve the reliability of existing techniques to meet the

demands for better chemical measurements which arise constantly in our society. They adopt proven methodologies to new kinds of materials or to answer new questions about their

composition and their reactivity mechanisms.

4)定性鉴别可能通过选择性的化学反应或者仪器分析来完成。例如当把硝酸银溶液滴加

到一份溶解样品中，生成白色沉淀就说明了样品中氯离子的存在。而红外光谱可以给出有机化合物或官能团的“指纹”。

Qualitative tests may be performed by selective chemical reactions or with the use of

instrumentation. For example ，the formation of a white precipitate when adding a solution of silver nitrate to a dissolved sample indicates the presence of chloride. Infrared spectra will give “fingerprints” of organic compounds or their functional groups.

5)违禁药物检查的第一阶段称作快速筛选阶段，通常采用气相色谱或液相色谱等定量分

析的方法检查出可疑样本；第二阶段使用气质联用对可疑样本进一步检测；最后，应用分光光度法或气相色谱进行准确定量。

The first phase in the testing of banned substances is called fast-screening phase, in which qualitative analysis such as GC or LC is adopted to test suspicious samples. In the second phase, GC-MS is employed for further testing of those suspicious samples. Finally, spectrophotometry or GC is applied for accurate quantification.

Unit 10 Text A The United States Pharmacopoeia （1）

美国药典(1)

The United States Pharmacopoeia (USP)—the National Formulary (NF) is published in continuing pursuit of the mission of United States Pharmacopoeia Convention (USPC): To improve the health of people around the world through public standards and related programs that help ensure the quality and safety of medicines and foods.

《美国药典/国家处方集》的出版是美国药典委员会不断追寻的使命:通过有助于保证食品和药品质量和安全的公共标准和相关计划，提高全世界人民身体健康。

This text from USP-NF, provides background information on the United States Pharmacopoeia Convention (USPC), as well as general information about the 32nd revision of the United States Pharmacopeia (USP 32) and the 27th edition of the National Formulary (NF 27).

本课文内容节选自《美国药典/国家处方集》，介绍了美国药典委员会的一些情况以

及《美国药典》第32版和《国家处方集》第27版的基本情况。

1. THE HISTORY OF USP-NF《美国药典/国家处方集》的历史

On January 1, 1820, 11 physicians met in the Senate Chamber of the U.S. Capitol building to establish a pharmacopoeia for the United States. These practitioners sought to create a compendium of the best therapeutic products, give them useful names, and provide recipes for their preparation. Nearly a year later, on December 15, 1820, the first edition of The Pharmacopoeia of the United States was published. Over time, the nature of the United States Pharmacopeia (USP) changed from being a compendium of recipes to a compendium of documentary standards that increasingly are allied with reference materials, which together establish the identity of an article through tests for strength, quality, and purity. The publishing schedule of the USP also changed over time. From 1820 to 1942, the USP was published at 10-year intervals; from 1942 to 2000, at 5-year intervals; and beginning in 2002, annually.

1820年1月1日，11位医生在美国国会大厦参议院会议厅召开会议制定美国药典。这些医师们试图制定一部最好治疗产品的手册，给出它们有效名称，提供制剂处方。大概—年以后，1820年12月15日，《美国药典》第一版出版了。经过一段时间，《美国药典》的性质从一部处方手册转变成了不断增加参照材料的文献标准手册，通过检査手段共同建立品种规格、质量和纯度等标准。后来，《美国药典》出版周期也发生了改变。从1820年到1942年，《美国药典》每隔十年出版一版;从1942年到2000年，每五年出版一版;从2002年开始，每年出版一版。

In 1888, the American Pharmaceutical Association published the first national formulary under the title The National Formulary of Unofficial Preparations (NF). Both the USP and the NF were recognized in the Federal Food and Drugs Act of 1906 and again in the Federal Food, Drug, and Cosmetic Act 1938. In 1975, USP acquired the National Formulary (NF), which now contains excipients standards with references to allied reference materials. Today, USP continues to develop USP and NF through the work of the Council of Experts into compendia that provide standards for articles based on advances in analytical and metrological science. As these and allied sciences evolve, so do USP and NF. 1

1888年，美国药学会出版了第一部国家处方集，名称为《非正式制剂的国家处方集》。《美国药典》（USP)和《国家处方集》（NF)都得到1906年《联邦食品药品法案》的认可。1975年USP合并了NF，现在NF通过引用相关参考材料收录了辅料的标准。如今，UPS不断通过专家委员会的工作，把USP和NF观发展成为提供以分析和计量科学进步为基础的品种标准手册。有了这些工作和科学的进展,USP和NF确实得到发展。

2. USP GOVERNANCE STANDARDS-SETTING, AND ADVISORY BODIES

USP's governing, standards-setting, and advisory bodies include the USP Convention, the Board of Trustees the Council of Experts and its Expert Committees, Advisory Panels, and staff. Additional volunteer bodies include Stakeholder Forums, Project Teams, and Advisory Groups, which act in an advisory capacity to provide input to USP's governing, standards-setting, and management bodies. 2

美国药典的管理、标准制定和顾问机构

美国药典的管理、标准制定和顾问机构包括:美国药典大会、理事委员会、专家委员会和专家小组委员会、顾问小组以及员工。•其他志愿机构包括:股东论坛、项目团队、和顾

问小组，他们以顾问身份给美药典的管理、标准制定和经营机构提供信息或资金。

USP Convention— USP's direction and priorities are determined by more than 400 Convention members divided into nine categories. Eligible organizations within each membership category are invited to appoint a representative. Convention composition is determined to ensure suitable representation of those sections of the health care system that are influenced by, and in turn influence, USP's activities. Convention members elect USP's President, Treasurer and other members of the Board of Trustees as well as the Council of Experts. They also vote on resolutions to guide USP's scientific policy and public health initiatives and update, as needed, USP's Constitution and By-Laws.

美国药典大会美国药典的方针和重点由超过400位的药典大会成员来决定，他们分为9个类别。下属类别中符合条件的组织被邀请派一个代表。药典大会的组成坚决保证卫生保健体系中的这些部门适当的代表性，这些部门受到药典大会的影响，反过来也影响药典大会的活动。药典大会成员选举USP总裁、财务主管、其他理事会和专家委员会的成员。他们也投票决定指导药典的科学决策、公共卫生措施，如果必要，也更新药典的章程和内部规章。

Board of Trustees— USP's Board of Trustees is entrusted with management of the business affairs, finances, and property of USP. During its five-year term, the Board defines USP's strategic direction through its key policy and operational decisions.

理事委员会药典的理事委员会负责管理药典的业务、金融和财产。在五年任期内，管理委员会通过关键决策和可操作性明确美国药典的策略方向。

Council of Experts—The Council of Experts is the standards-setting body of USP. It is composed of 57 Expert Committee Chairs elected to five-year terms by USP's Convention members.

A Nominating Committee, consisting of the Chair of the Council of Experts, the Convention President, and the Vice Chair of the Nominating Committee for the Council of Experts, nominates individuals who are subsequently elected by the members of the Council of Experts to serve as Expert Committee members. Collectively, the Expert Committee Chairs and members comprise more than 500 volunteers drawn from 50 countries. The 41 Standards Expert Committees are responsible for the content of USP–NF, the Food Chemicals Codex and associated publications and organized in Collaborative Groups for topics of common interest. 专家委员会专家委员会是美国药典的标准制定机构。由药典大会选举出的57名专家主任委员组成，任期五年。由专家

委员会主任委员、药典大会总裁以及提名专家委员会的提名委员会副主任委员构成的提名委员会推荐候选人，然后由专家委员会选举担当专家委员会成员。专家委员会主任委员和成员包含从50个国家选择成立500多个志愿者。41个标准专家委员会负责《美国药典/国家处方集》、《食品化学物质集》以及相关出版物的内容，并成立多个协作小组讨论共同关注的话题。

Advisory Panels to the Council of Experts— The Chair of the Council of Experts may appoint Advisory Panels to assist the Council of Experts in reaching scientific decisions and implementing new USP directives relating to USP–NF. The list of the Advisory Panels changes frequently as the work of Advisory Panels concludes and new ones start their deliberations. There are more than 350 Advisory Panel members who contribute to the standards-setting activities of the Council of Experts. 专家委员会顾问小纽专家委员会主任委员可以任命顾问小组帮助专家委员会做科学决定、实施有关《美国药典/国家处方集》新方针。顾问小组名单随着顾问小组工作的结束以及新的顾问小组的审议工作的开始而经常改变。有超过350个顾问小组成员，他们为专家委员会制定标准作出了贡献

Stakeholder Forums and Project Teams— USP has formed several domestic and international Stakeholder Forums and Project Teams in the 2005–2010 cycle to exchange information and receive comment on USP's standards-setting activities. Depending on the topic, a stakeholder forum may form project teams to work on selected topics. 股东论坛和项目小组美国

药典在2005〜2010期间，在国内外成立了几个股东论坛和项目小组来交流信息，收集有关

USP标准建立活动的评论。依据这些话题，股东论坛就可以成立项目小组研究有关话题。

3. LEGAL RECOGNITION 法律认可

Recognition of USP–NF— USP–NF is recognized by law and custom in many countries throughout the world. In the United States, the federal Food, Drug, and Cosmetic Act (FD&C Act) defines the term “official compendium” as the official USP, the official NF, the official Homeopathic Pharmacopeia of the United States, or any supplement to them. FDA may enforce compliance with official standards in USP–NF under the adulteration and misbranding provisions of the FD&C Act. These provisions extend broad authority to FDA to prevent entry to or remove designated products from the United States market on the basis of standards in the USP–NF. 《美国药典/国家处方集》在世界各地都得到法律和传统的认可。在美国，联邦《食品药品化妆品法案》（FD&CAct)中明确的“官方手册”就是指官方的《美国药典》、

官方的《国家处方集》、官方的《美国顺势疗法药典》或者它们的《增补本》。FDA在《食品药品化妆品法案》的掺假和标示不符条文下可能会按照《美国药典/国家处方集》的官方标准强制执行。这些条文扩展了FDA的权威，它们可以依据《美国药典/国家处方集》的标准禁止某些指定产品流人或流出美国市场。

The identity of an official article, as expressed by its name, is established if it conforms in all respects to the requirements of its monograph and other relevant portions of the compendia. The FD&C Act stipulates that an article may differ in strength, quality, or purity and still have the same name if the difference is stated on the article's label. FDA requires that names for articles that are not official must be clearly distinguishing and differentiating from any name recognized in an official compendium. Official preparations (a drug product, a dietary supplement including nutritional supplements, or a finished device) may contain additional suitable ingredients.只要与各论中的要求和手册中其他相关部分相符，一个法定品种的统一性就可以确立，正如它名称所表达的。《食品药品及化妆品法案》规定品种在规格、质量或者纯度方面可以有不

同，而且只要在品种标签上注明可以用同样的名称。FDA要求非法定的品种名称必须和法定手册中认可的名称明确区分、区别开来。法定制剂(药成品、食品补充剂包括营养添加剂或者成品装置)可以包含附加的合适的制剂成分。

Drugs— USP's goal is to have substance and preparation (product) monographs in USP–NF for all FDA-approved drugs, including biologics, and their ingredients. USP also develops monographs for therapeutic products not approved by FDA, e.g., pre-1938 drugs, dietary supplements, and compounded preparations. Although submission of information needed to develop a monograph by the Council of Experts is voluntary, compliance with a USP–NF monograph, if available, is mandatory. 药品美国药典的目标就是让《美国药典/国家处方集》中药物和制剂(成品)各论涵盖所有FDA核准的药品，包括生物药品以及它们的成分。美国药典也开发不被FDA核准的治疗产品的各论，如1938年前的药品、食品补充剂和复合制剂。尽管专家委员会提交开发各论所需要的信息是自愿的，但是如能够提供的话，则必须符合《美国药典国家处方集》各论。

Biologics— In the United States, although some biologics are regulated under the provisions of the Public Health Service Act (PHSA), provisions of the FD&C Act also apply to these products. For this reason, products approved under the PHSA should comply with the adulteration and misbranding provisions of the FD&C Act at Section 501(b) and 502(g) and, thus, should conform to applicable official monographs in USP–NF. 生物制品在美国，尽管某些生物制品在《公共卫生服务法案》（PHSA)条文中受到管制，联邦《食品药品化妆品法案》条文也适用了这些产品。正因如此，《公共卫生服务法案》下核准的产品必须服从《食品药品化妆品法案》501项(b)条和502项（g)条下的掺假和标示不符条文，因此必须遵守《美国药典/国家处方集》中适用的官方各论。

Medical Devices— Section 201(h) of the FD&C Act defines a device as an instrument, apparatus, similar article, or component thereof recognized in USP–NF. There is no comparable recognition of USP's standards-setting authority and ability to define a medical device as exists for other FDA-regulated therapeutic products. 医疗器械《食品药品化妆品法案》第201项(h)条把装置定义为设备、仪器.、类似的品种或者在《美国药典/国家处方集》中认可的组件。美国药典委员会还没有被认可类似的标准制定权威和能力来定义现存的由FDA控制的治疗产品的其他医疗设备。

Dietary Supplements— The Dietary Supplement Health and Education Act of 1994 amendments to the FD&C Act name USP—NF as the official compendia for dietary supplements. The dietary supplement must be represented as conforming to a USP–NF dietary supplement monograph. 膳食补充剂对《食品药品及化妆品法案》修订的《1994膳食补充剂卫生和教育法案》把《美国药典/国家处方集》提名为膳食补充剂的官方手册^膳食补充剂必须与《美国药典/国家处方集》膳食补充剂各论相符。

Compounded Preparations— Preparation monographs provide information or standards applicable in compounding. Standards in USP–NF for compounded preparations may be enforced at both the state and federal levels, e.g., if a practitioner writes a prescription for a compounded preparation that is named in a USP–NF monograph, the preparation, when tested, must conform to the stipulations of the monograph so named. 复合制剂制剂各论提供适合调配的信息和标准。《美国药典/国家处方集》复合制剂的标准可以在州和联邦两个级别实施，比如:如果医师开复合制剂的处方，其名称在《美国药典/国家处方集》的各论中，在检查时该制剂必须遵照该名称下的各论规定。

4. PHARMACOPEIAL DISCUSSION GROUP’S (PDG) HARMONIOUS ACTIVITIES

A pharmacopoeial monograph for an active ingredient or excipient, preparation, or other substance used in the manufacture or compounding of a medicinal product generally provides a name, definition, description, and sometimes packaging, labeling, and storage statements. Thereafter, the monograph provides tests, procedures, and acceptance criteria that constitute the specification. For frequently cited procedures, a monograph may refer to a general chapter for editorial convenience. The Pharmacopoeial Discussion Group (PDG) works to harmonize excipient monographs and general chapters. This will reduce manufacturers' burden of performing analytical procedures in different ways, using different acceptance criteria. The Pharmacopoeial Discussion Group (PDG), which includes representatives from the European, Japanese, and United States pharmacopeias, and WHO (as an observer), harmonizes pharmacopoeial excipient monographs and General Chapters. At all times, the PDG works to maintain an optimal level of science consistent with protection of the public health. 3

4.药典讨论小组的协调活动

有关活性成分或辅料、制剂或者其他用于药品制造或复合的物质，药典各论提供了它们的名称、定义、性状，有时候还有包装、标签和贮藏说明。之后，各论介绍了构成执浦准的实验、程序和可接受标准。为了排版方便，对于频繁引用的程序’各论则要参考通则。药典讨论小组的工作就是协调辅料各论和通则。这将减少生产厂家采用不同可接受标准，用不同方法操作分析程序的负担。药典讨论小组由来自欧洲药典、日本药局方和美国药典的代表构成，世界卫生组织也派代表作为观察员，他们协调药典辅料各论与通则。药典讨论小组的工作始终就是维持最理想的科学水平

翻译

1)《美国药典》自1920年12月出版第一版以后，结果一段时间，它的性质也发生了变

化，从一部处方手册转变成了一部法规标准手册。但一直以来，《美国药典》的出版始终在实现美国药典委员会的使命：通过有助于保证药品和食品质量和安全的公共标准和相关计划，提高全世界人民的身体健康。

Since the first edition of United States Pharmacopeia was published in December 1920, after some time, its nature changed, from being a compendium of recipes to a compendium of

documentary standard. Ever since, its publishment is continuously pursuing the mission of USP Convention: to improve the health of people around the world through public standards and related programs that help ensure the quality and safety of medicines and foods.

2)1888年，美国药学会出版了第一部国家处方集，1975年《美国药典》合并了《国家处

方集》。如今，美国药典委员会通过专家委员会的工作不断把《美国药典/国家处方

集》发展成为一个提供以分析和计量科学进步为基础的品种标准手册。从2002年开始，《美国药典/国家处方集》每年出版一版

In 1888, the American Pharmaceutical Association published the first national formulary, and in 1975 USP acquired NF. Now United States Pharmacopeia, through the Council of

Experts，work，continuously develops USP-NF into a compendium that provides the

standards of articles based on advances in analytical and metrological science. From 2002, NSP-NF has been published annually.

3)组成药典委员会就是保证合适地代表健康保健体系中的相关部门，这些部门受到药典

委员会的影响，反过来也影响药典委员会的活动。药典委员会成员选举专家委员会，以及药典总裁、财务主管，他们也投票决定指导药典的科学决策、公共卫生措施，如果必要，也更新药典的章程和内部规章。

USP Convention composition is determined to ensure suitable representation of some related

sections of the health care system that are influenced by, and in turn influence, USP’s

activities. Convention members elect USP's President, Treasurer and other members of the Board of Trustees as well as the Council of Experts, and also vote on resolutions to guide

USP，'s scientific policy and public health initiatives and update，,as needed, USP’s

Constitution and By-Laws.

4)在美国，联邦《食品药品化妆品法案》认为的“官方手册”就是指官方的美国药典，

官方的国家处方集，官方的《美国顺势疗法药典》或者它们的增补本。FDA可以依据《美国药典/国家处方集》的标准禁止某些指定产品流入或流出美国市场。

In the United States, the FD&C Act defines the term “official compendium” as the official USP, the official NF, the official Homeopathic Pharmacopeia of the United States, or any

supplement to them. FDA, on the basis of standards in the USP-NF, may prevent entry or to remove designated products from the United States market.

5)《食品药品及化妆品法案》规定品种在规格、质量或者纯度方面可以有不同，而且可

以用同样的名称，只要在品种标签上注明就可以。FDA要求非法定的品种名称必须和法定手册中认可的名称明确区分、区别开来。

The FD&C Act stipulates that an article may differ in strength, quality, or purity and | still have the same name if the difference is stated on the article s label. FDA requires that names for articles that are not official must be clearly distinguishing and differentiating from any name recognized in an official compendium.

Unit 12 Text A Development of New Drugs (1)

Drug development aims to produce a novel therapeutic agent which is superior in efficacy to existing remedies and which causes less frequent or less severe adverse effects.

新药的研制(一）

药物研制旨在生产出疗效上优于现有药品，且副作用发生率减少、程度降低的新型治疗药物。1Evolution of a new drug

The development of a new therapeutic agent involves a multidisciplinary group in many years of work. Formerly, drugs were extracted from natural plant and animal sources. Therapeutic use was empirical and based on traditional experience. Over the last 80 years an impressive number of drugs have been synthesized chemically. With the development of genetic engineering and the production of monoclonal antibodies it is likely that even more agents will be produced artificially.

1.新药评估

新药研制涉及多学科研究人员多年的共同研究成果。以前药物是从天然植物和动物中提取的，其治疗作用全凭经验和传统作法来确定的。在过去的80年中，人们通过化学合成，研制出大量药物。随着遗传工程学和单克隆抗体技术的发展，人们必将研制出更多新药。

Synthetic techniques have produced pure substances. This has led to increased specificity of action and, in some cases, greater efficacy and reduced toxicity. Unfortunately new drug development is expensive, and only a few substances (less than 1%) of those developed are actually marketed and used in practice.合成技术已研制出高纯度药物，这不仅提高了治疗的准确性，有时还提高了疗效，降低了毒副作用。遗憾的是，新药研制的费用太高，只有少量已研制出的药物(不到1%)被实际推向市场，投人使用。

The range of novel chemical entities developed has occasionally led to unexpected toxicity. As

a consequence, most governments have established bodies to regulate drug marketing, e.g. the committee on Safety of Medicines in Britain, and the Food and Drug Administration in the USA. These agencies supervise clinical research on new drugs and license new products. Although they serve to protect the public and are seen to do so, the statutory procedures that must be followed in applying for a license for a new drug add greatly to the costs and time of development1.在研制出的新型化学制品中，偶尔会产生意想不到的毒副作用。因此，大多数政府都设有药品上市管理机构，例如:英国的药品安全委员会和美国的食品和药品管理局。这些机构负责管理新药的临床研究和颁发新药证书。然而，尽管其作用是保护公众利益，但申报新药审批所必须遵循的诸多法律程序却大大增加了研制的成本和时间。

There is some evidence that the rate of introduction of entirely novel agents is slowing down. Whether this reflects economic pressures or diminished novel synthetic capacity or ability is not clear2.有迹象显示，全新药物投入使用的速率正在下降。这一现象是否可以反映企业经济压力增加，或者是新药数量不足或研制能力下降，具体原因尚不清楚。

2Drug development strategies

Several strategies have been used in the development of new drugs. Over the years all have had success but no single approach has been consistently successful. 2.新药研制方略。近年来，几种方略被用于新药的研发，他们均取得了成功，但没有哪种方法是长盛不衰的。

偶然发现、运气及直觉

Serendipity, luck and intuition.

This approach has been applied less frequently in recent years. The discovery of penicillin by Fleming was in this category.此法近年来应用较少。弗莱明发明青霉素属于此类

Molecular roulette.

Random chemical synthesis of new structures and pharmacological screening. This approach is wasteful and depends on the availability of sensitive animal or in-vitro models of human disease, which often do not exist.分子轮盘赌。对新结构式及药理筛选的随机化学合成。此法耗费巨大，且有赖于得到往往很难得到的可利用的敏感型动物或人类疾病的体外模型。

Minor structural changes in existing agents.

Occasionally this leads to compounds of greater efficacy and rarely to drugs with novel actions detected in pharmacological screening or clinical practice. 对现有药物分子结构的修饰。此法偶尔可产生功效更高的化合物，但罕有可能产生药理筛选和临床实践中被检测出具有全新功效的药物。

Programmed basic research with synthesis of specific chemical.

Intellectually this approach is the most satisfying. There have been spectacular results, e.g. levodopa and dopamine agonists in the treatment of Parkinsonism; beta-receptor blockers for angina; histamine (H2) antagonists in peptic ulcer disease; converting enzyme inhibitors in hypertension. However, this approach is expensive and there is no guarantee of success.针对特定化学物质合成而制定的有计划的基础研究。从研究的角度看，这种方法最为令人满意，至今已取得显著成功，例如:治疗帕金森神经功能障碍所用的左旋多巴及多巴胺;治疗心绞痛的肾上腺素受体阻滞剂;消化性溃疡病使用的组胺拮抗药;用于高血压的转换酶抑制剂。不过，此法耗费巨大，且前景莫测。

Clinical observation of drug action in practice.

This is the traditional means of drug assessment. New applications arise from measurement of drug action in man in disease states. The antihypertensive effects of thiazide diuretics and beta-blockers were not predicted from animal screening tests. They were only identified after the drugs