1、药剂学英文名词解释整理1.What is pharmaceutics? How many branches of pharmaceutics ?2. What is a drug? Give some examples A drug is defined as an agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in humans or in other animals. 药物是有目的地用于诊断、缓解、治疗、治愈或预防人类或动物疾病的物质。Emetic
2、 (induce vomiting催吐剂) and antiemetic (prevent vomiting止吐剂) drugsDiuretic drugs (increase the flow of urine利尿剂)Expectorant drugs (increase respiratory tract fluid除痰剂)Cathartics or laxatives (evacuate the bowel泻药) Other drugs decrease the flow of urine, diminish body secretions, or induce constipation
3、 (便秘)Drug standardsThe united states pharmacopeia (药典) and the national formulary (国家药品标准)Pharmakon, meaning “drug; poiein, meaning “make;The bination indicates any recipe or formula or other standards required to make or prepare a drug. Organized sets of monographs or books of these standards are c
4、alled pharmacopeias or formularies.International Organization for standardization (ISO)is an international consortium of representative bodies constituted to develop and promote uniform or harmonized international standards.国际标准化组织是一个代表性的国际联合会,其设立是为了开展和增进国际标准的均一性和协调性。ISO 9000-ISO9004 used in the pha
5、rmaceutical industryISO included standards pertaining to development, production, quality assurance, quality control, detection of defective products, quality management, and other issues as product safety 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平安性和责任的问题。Internationally recognized
6、 quality- management system.Prodrugsis a term used to describe a pound that requires metabolic biotransformation after administration to produce the desired pharmacologically active pound. (前体药物使之能够在给药后经体代性生物转化成具有期望的药理活性化合物的化合物。a lead poundis a prototype原形化学物质 chemical pound that has a fundamental d
7、esired biologic or pharmacologic activity.先导化合物是一种具有生物学和药理学活性根本要求的原型化学物质。a goal drug In theory, a “goal drugwould produce the specifically desired effect, be administered by the most desired route (generally orally) at minimal dosage and dosing frequency,have optimal onset and duration of activity,
8、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, pletely, and without residual effect.it would be easily produced at low cost,be pharmaceutically elegant,physically and chemically stable
9、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 biochemical and physiological effects of drugs and their mechanisms of action.Pharmacokinetics deals with the absorption, distribution, metabolis
10、m or biotransformation, and excretion of drugs.Clinical pharmacology applies pharmacologic principles to the study of the effects and actions of drugs in humans.A treatment IND or a treatment protocol permits the use of an investigational drug in the trentment of patients not enrolled in the clinica
11、l 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 concerned with theformulationmanufacturestabilityeffectivenessof pharmaceutical dosage forms is termed pharmaceutics.Biopharmaceutics is the
12、 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 tissue
13、s is termed pharmacokinetics.It is the study of the kinetics of absorption, distribution, metabolism and excretion (ADME) of drugs and their corresponding pharmacologic, therapeutic, or toxic response in animals and man.Pharmacokinetics also may be applied in the study of interactions between drugs.
14、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 concentration 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
15、是逆浓度梯度进展,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(吞)Many large molecules and particles can not enter cells via passive or active mechanisms. However, some may enter, as yet, by a process known as endocytosis(吞)In phagocytosis (吞噬) (cell eating), large particles suspended in the extracellular fluid
16、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 spleen cells. Pinocytosis (胞饮) (cell drinking) is a similar process but involves the engulfing of liquids or very small particles that are in su
17、spension within the extracellular fluid. The bioavailability describes the rate and extent to which an active drug ingredient or therapeutic moiety is absorbed from a drug product and bees available at the site of drug action.The bioequivalence refers to the parison of bioavailabilities of different
18、 formulations, drug products, or batches of the same drug product.Peak height (Cmax) concentration is the maximum drug concentration observed in the blood 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
19、 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 formulation. It is the rate of drug absorption that determines the time needed for the minimum effective concentration to be reached and thus for the ini
20、tiation of the desired pharmacologic effect.Area under the serum concentration time curve (AUC)The AUC of a concentration-time plot is considered representative of the total amount of drug absorbed into the circulation following the administration of a single dose of that drug.The smaller the AUC, t
21、he less drug absorbed. Pharmaceutical equivalents are drug products that contain identical amounts of the identical active drug ingredient, i.e., the same salt or ester of the same therapeutic moiety, in identical dosage forms, but not necessarily containing the same inactive ingredients, and that m
22、eet the identical pendial or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, 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:有一样治疗效应的一样盐或酯的形式,一样剂型。但并不一定包含一样的非活性成分,具有一样的外观或其他相应的性质如规格、质量、纯度,包括效价、含量
23、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 the same amount or dosage form or as the same salt or ester. Each such product individually meets either the identical or its own respective pendial or
24、other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration times, and/or dissolution rates.制剂替代品指含有一样治疗效果的组成局部或它的前体药物,不需要一样剂量、一样剂型、一样的盐或酯的形式。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 dru
25、g products are pharmaceutical equivalents or pharmaceutical alternatives whose rate and extent of absorption do not show a significant difference 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一样
26、的试验条件下,单次或屡次给予一样治疗剂量的药物,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 administered to the same individuals in the same dosage regimens, will provide essentially the same therapeutic effect. The half-life (T1/2) of a drug descr
27、ibes 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 substance 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 const
28、ant 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 the 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
29、are metabolized and altered by various biochemical mechanisms.The process of biotransformation is monly referred to as the “detoxification or “inactivation process.8复Explain shortly about one partment model and two partment model?The simplest pharmacokinetic model is the single partment open-model s
30、ystem. This model depicts the body as one partment characterized by a certain volume of distribution (Vd) that remains constant.In the two-partment system, a drug enters into and is instantaneously distributed throughout the central partment.Its subsequent distribution into the second or peripheral
31、partment is slower.8 Powders are intimate mixtures of dry, finely divided drugs and /or chemicals that may be intended 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
32、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 position.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拟,给药频率比普通制剂减少一半或给药频率比普通制剂有所减少,且能显著增加患者的顺应性的制剂。controlled- release preparations 控释制剂系指在规定释放介质中,按要求缓慢地恒速或接近恒速释放
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