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1、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。l Emetic (induc
2、e vomiting催吐剂) and antiemetic (prevent vomiting止吐剂) drugsl Diuretic drugs (increase the flow of urine利尿剂)l Expectorant drugs (increase respiratory tract fluid除痰剂)l Cathartics or laxatives (evacuate the bowel泻药) l Other drugs decrease the flow of urine, diminish body secretions, or induce constipatio
3、n (便秘)Drug standardsl The united states pharmacopeia (药典) and the national formulary (国家药品标准)l Pharmakon, meaning “drug”; poiein, meaning “make”;l The combination indicates any recipe or formula or other standards required to make or prepare a drug. l Organized sets of monographs or books of these s
4、tandards 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 international standards.国际标准化组织是一个代表性的国际联合会，其设立是为了发展和增进国际标准的均一性和协调性。ISO 9000-ISO9004 u
5、sed in the pharmaceutical industryl ISO included standards pertaining to development, production, quality assurance, quality control, detection of defective products, quality management, and other issues as product safety and liability.l 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。推荐精选l In
6、ternationally 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） c
7、hemical 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” l would produce the specifically desired effect, l be administered by the most desired route (generally orally) at minimal dosage and dosing freque
8、ncy,l 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，l exhibit no side effects,l following its desired effect would be eliminated from the body efficiently, completely, and without residual effect.l it would be easily produced at low cost
9、,l be pharmaceutically elegant,l physically and chemically stable under various conditions of use and storage.l （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)l Pharmacodynamics is the study of the biochemical and physiological effects of drugs and their mechanisms of a
10、ction.l Pharmacokinetics deals with the absorption, distribution, metabolism or biotransformation, and excretion of drugs.推荐精选l 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
11、 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 concerned with theformulationmanufacturestabilityeffectiven
12、essof 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 s
13、tudy 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 pharmacologic, therapeutic, or toxic response in animals and m
14、an.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 concentration to one of a higher concentration or, if the so
15、lute is an ion, against an electrochemical potential gradient推荐精选（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 enter, as yet, by a process known as endocytosis(内
16、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 spleen cells. Pinocytosis (胞饮) (cell drinking) is a s
17、imilar 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 from a drug product and becomes available at the
18、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 blood plasma or serum following a dose of the drug.For
19、 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 formulation. It is the rate of drug absorption that dete
20、rmines the time needed for the minimum effective concentration to be reached and thus for the initiation of the desired pharmacologic effect.推荐精选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 i
21、nto 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 same salt or ester of the same therapeutic moiety
22、, 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 uniformity, disintegration times, and/or dissolu
23、tion 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 the same amount or dosage form or as the same
24、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 times, and/or dissolution rates.（制剂替代品指含有相同治疗
25、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 when administered at the same molar dose of
26、the therapeutic moiety under similar experimental conditions, either single dose or multiple dose.推荐精选(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 administered to the same individuals in t
27、he 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 substance may be described by the modif
28、ied Noyes-Whitney equation:dc/dt=kS(cs-ct)in which dc/dt is the rate of dissolutionk is the dissolution rate constantS is the surface area of the dissolving solid,Cs is the saturation concentration of drug in the diffusion layerCt is the concentration of the drug in the dissolution medium at time tB
29、iotransformation 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 “inactivation” process.8（复）Explain shortly
30、about one compartment model and two compartment model？推荐精选l 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 constant.l In the two-compartment system, a d
31、rug 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 intended for internal or external use. e.g.
32、 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 capsu
33、le 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药物，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，血药浓度比缓释制剂更加平稳，且能显著增加患者的顺
34、应性的制剂。delayed-release preparations 迟释制剂迟释制剂系指在给药后不立即释放药物的制剂，包括肠溶制剂、结肠定位制剂和脉冲制剂等。1（知）定时释放系统（chronopharmacologic drug delivery system ）推荐精选是根据人体的生物节律变化特点，按时辰药理学和时辰治疗学原理设计的新型控释给药系统又称脉冲式给药系统(pulsatile drug delivery system) 片剂（Tablet) 系指药物与适宜的辅料通过制剂技术制成的片状或异型片状制剂，主要供口服使用。 Tablets are solid dosage forms u
35、sually prepared with the aid of suitable pharmaceutical excipients.（复）Ointments 1 are semisolid preparations intended for external application to the skin or mucous membranes.2 Ointments may be medicated or nonmedicated.3 Nonmedicated ointments are used for the physical effects that they provide as
36、protectants, emollients or lubricants.（复）Pharmaceutical creams are semisolid preparations containing one or more medical agents dissolved or dispersed in either an oil-in-water emulsion or in another type of water-washable base.（复）Gels are semisolid systems consisting of dispersions of small or larg
37、e molecules in an aqueous liquid vehicle rendered jelly-like through the addition of a gelling agent.（复）- transdermal drug delivery systems(TDDS)Transdermal drug delivery systems (TDDSs) facilitate the passage of therapeutic quantities of drug substances through the skin and into the general circula
38、tion for their systemic effect. 经皮给药系统能促进具治疗量的药物透过皮肤，进入体循环发挥系统作用。推荐精选（复）- iontophoresisIontophoresis is delivery of a charged chemical compound across the skin membrane using an electrical field.（离子导入法是指在电场作用下，带电荷的化合物导入皮肤粘膜的一种方法。）（复）- sonophoresis (超声导入法)Sonophoresis, is a process that exponentially
39、 increases the absorption of topical compounds (transdermal delivery) with high-frequency ultrasound.Sonophoresis occurs because ultrasound waves stimulate micro-vibrations within the skin epidermis and increase the overall kinetic energy of molecules making up topical agents.（复）- percutaneous absor
40、ption enhancerschemical permeation enhancers and physical methods that can increase percutaneous absorption of therapeutic agents. A chemical skin penetration enhancer increases skin permeability by reversibly damaging or altering the physicochemical nature of the stratum corneum to reduce its diffu
41、sional resistance. 化学吸收促进剂通过通过可逆地改变角质层的理化状态，降低扩散阻力而提高皮肤渗透率。SolutionsIn pharmaceutical terms, solutions are “liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents”.Because of a particular pharmaceutical solutions use,
42、 it may be classified as： oral solution, otic solution, ophthalmic solution, topical solution. （重）solubility推荐精选The solubility of an agent in a particular solvent indicates the maximum concentration to which a solution may be prepared with that agent and that solvent. Syrups （糖浆剂）are concentrated aq
43、ueous preparations of a sugar or sugar substitute with or without flavoring agents and medicinal substances.（复）Elixirsare clear, sweetened hydroalcoholic solutions intended for oral use and are uaually flavored to enhance their palatability.Nonmedicated elixirs are employed as vehicles;Medicated eli
44、xirs are used for the therapeutic effect of the medicinal substances they contain.（复）Tinctures are alcoholic or hydroalcoholic solutions prepared from vegetable materials or from chemical substances.Suspensions may be defined as preparations containing finely divided drug particles distributed somew
45、hat uniformly throughout a vehicle in which the drug exhibits a minimum degree of solubility.混悬剂系指难溶性固体药物以微粒状态分散于分散介质中形成的多相分散体系。（复）EmulsionsAn emulsion is a dispersion in which the dispersed phase is composed of small globules of a liquid distributed throughout a vehicle in which it is immiscible.乳剂
46、系指互不相溶的两相液体混合，其中一相以液滴状态分散于另一相中形成的非均匀分散液体制剂。推荐精选（复）floc or floccule.One common method of preventing rigid cohesion of small particles of a suspension is intentional formation of a less rigid or loose aggregation of the particles held together by comparatively weak particle-to-particle bonds.Such an a
47、ggregation of particles is termed a floc or a floccule（絮状物, 絮凝粒）.（复）creaming of the emulsionAggregates of globules of the internal phase have a greater tendency than do individual particles to rise to the top of the emulsion or fall to the bottom. Such a preparation of the globules is termed the cre
48、aming of the emulsion，and provided coalescence is absent, it is reversible process. （内相液滴的聚集体比其单个颗粒具有更大的趋势上浮到乳剂顶部或下沉到底部，这种聚集体的形成称为乳剂的分层。当未发生合并时，是一可逆过程。） （复）coalescence of the emulsion. Of greater destruction to an emulsion than creaming is the coalescence of the globules of the internal phase and the separation of that phase into a layer. The separation of the interna