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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


Unit3 TextBThe Other Side of Antibiotics


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.


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.


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.


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.


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


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.


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.


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.


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.



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.


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.


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.


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.



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


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.



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 TextAThe Scope of Pharmacology


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.


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.


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.


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.


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.


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.


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.



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.


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,andbehavioralaspectsofdisease.Pharmacodynamics provides one of the best opportunities for this correlation during the study of both the preclinical and the clinical medical sciences.


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.





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.



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.



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.



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.



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


Unit8 Text A What Analytical Chemists Do?


Analytical chemistryis 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.


What is Analytical Science?


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 analyticalscience to describe the field. This term is used in a National Science Foundationreport 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.


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:



●How much?

●What arrangement, structure or form?






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 reproducedin 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.



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:


-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.





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?


The discipline of analytical chemistry consists of qualitative analysis and quantitativeanalysis. 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.


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‖ oforganic compounds or their functional groups.


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.




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






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.


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 technique s 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.



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


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.



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.



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.



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.



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)


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.


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).


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 SenateChamber 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.


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。


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



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.


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.


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


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




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 enforcecompliance 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




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







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.



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.




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.



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 orto remove designated products from the United States market.



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.



1 Evolution 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.



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