药剂学英文名词解释整理文档格式.docx

1、 Other drugs decrease the flow of urine, diminish body secretions, or induce constipation （便秘）Drug standards The united states pharmacopeia （药典） and the national formulary （国家药品标准） Pharmakon, meaning “drug”; poiein, meaning “make”; The combination indicates any recipe or formula or other standards r

2、equired to make or prepare a drug. Organized sets of monographs or books of these standards are called pharmacopeias or formularies.International Organization for standardization （ISO）is an international consortium of representative bodies constituted to develop and promote uniform or harmonized int

3、ernational standards.国际标准化组织是一个代表性的国际联合会，其设立是为了发展和增进国际标准的均一性和协调性。ISO 9000-ISO9004 used in the pharmaceutical industry ISO included standards pertaining to development, production, quality assurance, quality control, detection of defective products, quality management, and other issues as product saf

4、ety and liability. ISO 包括标准适合开发、生产、质量保证、质量控制、缺陷产品的检测、质量管理和其他如产品安全性和责任的问题。 Internationally recognized quality- management system.Prodrugsis a term used to describe a compound that requires metabolic biotransformation after administration to produce the desired pharmacologically active compound. （前体药物

5、使之能够在给药后经体内代谢性生物转化成具有期望的药理活性化合物的化合物。）a lead compoundis a prototype（原形化学物质） chemical compound that has a fundamental desired biologic or pharmacologic activity.（先导化合物是一种具有生物学和药理学活性基本要求的原型化学物质。a goal drug In theory, a “goal drug” would produce the specifically desired effect, be administered by the mo

6、st desired route （generally orally） at minimal dosage and dosing frequency, have optimal onset and duration of activity, 理论上，目标药物应能通过最理想的途径（通常为口服）以最小的剂量和给药频率给药，能产生特异的期望疗效，具有最理想的起效和持续时间， exhibit no side effects, following its desired effect would be eliminated from the body efficiently, completely, a

7、nd without residual effect. it would be easily produced at low cost, be pharmaceutically elegant, physically and chemically stable under various conditions of use and storage. （无副作用，并在发挥疗效后能完全有效地从体内消除，且无残留效应。它应该易于生产，费用低，制剂产品美观，在不同的使用和贮藏条件下物理和化学上稳定。5（知） Pharmacodynamics is the study of the biochemica

8、l and physiological effects of drugs and their mechanisms of action. Pharmacokinetics deals with the absorption, distribution, metabolism or biotransformation, and excretion of drugs. Clinical pharmacology applies pharmacologic principles to the study of the effects and actions of drugs in humans.A

9、treatment IND or a treatment protocol permits the use of an investigational drug in the trentment of patients not enrolled in the clinical study but who have a serious or immediately life-threatening disease for which there is non satisfactory alternative therapy.1 药剂学定义The general area of study con

10、cerned with theformulationmanufacturestabilityeffectivenessof pharmaceutical dosage forms is termed pharmaceutics.Biopharmaceutics is the area of study embracing the relationship between the physical, chemical, and biological sciences as they apply to drugs, dosage forms, and to drug action.（生物药剂学是围

11、绕物理学、化学和生物科学及它们关于药物、剂型和药物作用相互关系的研究领域。药物动力学The area of study which elucidates the time course of drug concentration in the blood and tissues is termed pharmacokinetics.It is the study of the kinetics of absorption, distribution, metabolism and excretion （ADME） of drugs and their corresponding pharmac

12、ologic, therapeutic, or toxic response in animals and man.Pharmacokinetics also may be applied in the study of interactions between drugs.Active transport denotes a process of the solute or drug being moved across the membrane against a concentration gradient, that is, from a solution of lower conce

13、ntration to one of a higher concentration or, if the solute is an ion, against an electrochemical potential gradient（主动转运是指溶质或药物穿过生物膜的转运的过程是逆浓度梯度进行，即从低浓度向高浓度转运或当溶质是离子时逆电化学电势梯度转运。endocytosis（内吞）Many large molecules and particles can not enter cells via passive or active mechanisms. However, some may

14、enter, as yet, by a process known as endocytosis（内吞）In phagocytosis （吞噬） （cell eating）, large particles suspended in the extracellular fluid are engulfed and either transported into cells or are destroyed within the cell. This is a very important process for lung phagocytes and certain liver and spl

15、een cells. Pinocytosis （胞饮） （cell drinking） is a similar process but involves the engulfing of liquids or very small particles that are in suspension within the extracellular fluid. The bioavailability describes the rate and extent to which an active drug ingredient or therapeutic moiety is absorbed

16、 from a drug product and becomes available at the site of drug action.The bioequivalence refers to the comparison of bioavailabilities of different formulations, drug products, or batches of the same drug product.Peak height （Cmax） concentration is the maximum drug concentration observed in the bloo

17、d plasma or serum following a dose of the drug.For conventional dosage forms, as tablets and capsules, the Cmax will usually occur at only a single time point, referred to as Tmax.Time of peak （Tmax）, maximum level of drug in the bloodThis parameter reflects the rate of drug absorption from a formul

18、ation. It is the rate of drug absorption that determines the time needed for the minimum effective concentration to be reached and thus for the initiation of the desired pharmacologic effect.Area under the serum concentration time curve （AUC）The AUC of a concentration-time plot is considered represe

19、ntative of the total amount of drug absorbed into the circulation following the administration of a single dose of that drug.The smaller the AUC, the less drug absorbed. Pharmaceutical equivalents are drug products that contain identical amounts of the identical active drug ingredient, i.e., the sam

20、e salt or ester of the same therapeutic moiety, in identical dosage forms, but not necessarily containing the same inactive ingredients, and that meet the identical compendial or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content un

21、iformity, disintegration times, and/or dissolution rates.（制剂等效指包含等量同种活性药物成分的药品，即：有相同治疗效应的相同盐或酯的形式，相同剂型。但并不一定包含相同的非活性成分，具有相同的外观或其他相应的性质如规格、质量、纯度，包括效价、含量均匀性、崩解时间和溶出速率。Pharmaceutical alternatives are drug products that contain the identical therapeutic moiety, or its precursor, but not necessarily in t

22、he same amount or dosage form or as the same salt or ester. Each such product individually meets either the identical or its own respective compendial or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration

23、times, and/or dissolution rates.（制剂替代品指含有相同治疗效果的组成部分或它的前体药物，不需要相同剂量、相同剂型、相同的盐或酯的形式。每种药品符合同样的或各自的外观和其他相应的性质如规格、质量、纯度，包括效价，含量均匀性、崩解时间和溶出速率。Bioequivalent drug products are pharmaceutical equivalents or pharmaceutical alternatives whose rate and extent of absorption do not show a significant difference

24、when administered at the same molar dose of the therapeutic moiety under similar experimental conditions, either single dose or multiple dose.（生物等效性药品指在相同的试验条件下，单次或多次给予相同治疗剂量的药物，其吸收的速率和程度没有显示显著性差异的制剂等效品或制剂替代品。Therapeutic equivalents has been used to indicate pharmaceutical equivalents which, when ad

25、ministered to the same individuals in the same dosage regimens, will provide essentially the same therapeutic effect. The half-life （T1/2） of a drug describes the time required for a drugs blood or plasma concentration to decrease by one half.4（复）What is Noyes-Whitney equation?The dissolution of a s

26、ubstance may be described by the modified Noyes-Whitney equation: dc/dt=kS（cs-ct） in which dc/dt is the rate of dissolution k is the dissolution rate constant S is the surface area of the dissolving solid, Cs is the saturation concentration of drug in the diffusion layer Ct is the concentration of t

27、he drug in the dissolution medium at time tBiotransformation is a term used to indicate the chemical changes that occur with drugs within the body as they are metabolized and altered by various biochemical mechanisms.The process of biotransformation is commonly referred to as the “detoxification” or

28、 “inactivation” process.8（复）Explain shortly about one compartment model and two compartment model？ The simplest pharmacokinetic model is the single compartment open-model system. This model depicts the body as one compartment characterized by a certain volume of distribution （Vd） that remains consta

29、nt. In the two-compartment system, a drug enters into and is instantaneously distributed throughout the central compartment.Its subsequent distribution into the second or peripheral compartment is slower.8 Powders are intimate mixtures of dry, finely divided drugs and /or chemicals that may be inten

30、ded for internal or external use. e.g. tablets, capsules, liquid dosage forms, ointments and creams.粘附性（adhesion）是指不同分子间产生的引力，如粉体粒子与器壁间的粘附。凝聚性（cohesion，粘着性）是指同分子间产生的引力，如粉体粒子之间发生粘附而形成聚集体（random floc）6 Capsules are solid dosage forms in which medicinal agents and/or inert substances are enclosed in a small shell of gelatin. Gelatin capsule shells may be hard or soft, depending on their composition.1（知）sustained-release preparations 缓释制剂系指在规定释放介质中，按要求缓慢地非恒速释放药物，其与相应的普通制剂比较，给药频率比普通制剂减少一半或给药频率比