沈阳药科大学药剂学学习指导
沈阳药科大学《药剂学》课件第三章 灭菌制剂与无菌制剂(4)
3. 无菌 眼部有无外伤是滴眼剂无菌要求严格程 度的界限。 用于眼外伤的眼用制剂要求绝对无菌， 包括手术后用药在内。不能添加抑菌剂 一般滴眼剂要求没有致病菌（绿浓杆菌 和金黄色葡萄球菌）。 多剂量滴眼剂需加入抑菌剂。滴眼剂的 抑菌剂要作用迅速，要在 1 ～ 2 小时内达 到无菌。
第四节 输 液
一、概述 （一）概念：输液(infusion solution)： 是指由静脉滴注输入体内的大剂量 注射液，它是注射剂一个分支。 由于其用量和给药方式与普通注射 剂不同，故质量要求，生产工艺等 均有一定差异，
(二) 输液的种类
1. 电解质输液：用以补充体内水份、电解质， 纠正体内酸碱平衡等。如氯化钠注射液、复 方氯化钠注射液、乳酸钠注射液等。 2. 营养输液 ：有糖类输液、氨基酸输液、脂肪 乳剂输液等。 3. 胶体输液：有多糖类、明胶类、高分子聚合 物等，
涤纶膜的处理： 逐张分散，用药用乙醇浸泡或放入蒸馏水 中于112～115℃热处理30分钟或煮沸30分 钟再用滤清的注射用水动态漂洗备用。 操作中要严格控制环境，防止污染。 对于某些碱性药液如碳酸氢钠，可考虑使 用聚丙烯薄膜。
(三) 输液的配制
输液配制，通常加入0.01%～0.5%的针用 活性炭，具体用量，视品种而异。 活性炭有吸附热原、杂质和色素的作用， 并可作助滤剂。 活性炭分次吸附较一次吸附好。 配制用具与安瓿剂基本相同 配制方法：浓配法和稀配法。
3.
粉末晶形检查 粉末晶形与制备工艺有密切关系， 如喷雾干燥法制得的多为球形，机 械分装易于控制。 而溶剂结晶者有针形、片状或各种 性状的多面体等，针形粉末分装时 最难掌握。 还应测定粉末的松密度(比容)，即单 位体积内药物的重量，
沈阳药科大学药剂学
沈阳药科大学《药剂学I》教案《Pharmaceutics I》 teaching plan For students major in Pharmacy (in English)Shirui Mao毛世瑞Shenyang Pharmaceutical UniversityChapter 1 Introduction课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce definition, contents, tasks of pharmaceutics, importance of dosage forms and some other related information.[Basic requirements]Master：The definition, contents, tasks of pharmaceutics; importance of dosage forms; pharmacopoeia; drug standards of China;Familiarize：Pharmaceutics related subjects; classification of dosage forms; application of excipients in pharmaceutics; the development of Chinese Pharmacopoeia; prescription drug and OTC; GMP, GLP and GCP.Understand: pharmaceutics historical perspective.二、Emphases and difficulties (教学重点和难点)Emphases：Definitions and tasks of pharmaceutics, importance of dosage form.Difficulties：Classification of dosage forms based on different criteria.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class.四、Teaching contents(教学内容)Definitions of pharmaceutics; contents of pharmaceutics; tasks of pharmaceutics; pharmaceutics related subjects; importance of dosage from; variation in time of onset of action for different dosage forms; classification of dosage forms; application of excipients in pharmaceutics; examples of pharmaceutical excipients; definition of pharmacopoeia, the development of Chinese pharmacopoeia, other important pharmacopoeia( USP, BP, JP, EP, Ph. Int); Drug standards in China; prescription drug and OTC; GMP, GLP, GCP; pharmaceutics historical perceptive.五、Questions/Homework after class (课后思考题或作业)1. Definitions: pharmaceutics; dosage form; pharmacopoeia; OTC; GMP; GLP; GCP.2. What are the tasks of pharmaceutics?3. Can you describe the importance of dosage forms?4. Based on administration route, how can dosage forms be classified?5. Please describe the important stages during the development of Chinese Pharmacopoeia.Chapter 2 Liquid preparationsPart I Introduction, solvents and excipients 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce definition, classification, advantages and disadvantages of liquid preparations and commonly used solvents and excipients in liquid formulations.[Basic requirements]Master：the classification of liquid preparations; advantages and disadvantages of liquid formulations; solvents for liquid formulations; excipients in liquid formulations especially the concept of solubilizer, hydrotropy agent, cosolvents and preservatives; properties of surfactants.Familiarize：quality of liquid dosage forms; the mechanism of solubilization; classification of hydrotropy agents; flavors including sweeting agents, flavoring agents and mucilage; colorants.Understand: mechanism of cosolvency and hydrotroy.二、Emphases and difficulties (教学重点和难点)Emphases：the solvents and excipients in pharmaceuticsDifficulties：the mechanism of solubilization, cosolvency and hydrotropy.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class.四、Teaching contents(教学内容)1. Introduction: definition of liquid preparations; classification of liquid preparations; advantages and disadvantages of liquid dosage forms; quality of liquid dosage form.2. Solvents for liquid preparationsz Aqueous solvent: waterz Non-aqueous solvents: alcohol, glycerin, propylene glycol, polyethylene glycol, dimethylsulfoxide, fatty oils…3. Excipients in liquid formulations:z Solubilizer: introduce surfactant related knowledge.z Hydrotropy agents: definition, examples, mechanism and classification of hydrotropy agents. z Cosolvency: definition and mechanismz Preservatives; criteria of selection; commonly used substances and their properties: paraben, benzoic acid and sodium benzoate; sorbic acid and others…z Flavors: sweeting agents, flavoring agents, mucilagez Other excipients.五、Questions/Homework after class (课后思考题或作业)1. Definitions: liquid preparations; solubilization; hydrotropy; cosolvency; surfactant2. What are the advantages and disadvantages of liquid preparations?3. Why can surfactants be used to increase the solubility of poorly water soluble drugs?4. When sodium benzoate is used as a preservative in a formulation, the concentration shouldbe higher than that of benzoic acid, why?Part II Solutions and suspensions 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the preparation and characterization of low molecular weight solutions, polymer solutions and suspensions.[Basic requirements]Master：Preparation methods of low molecular weight solutions; syrup and its preparation; tincture; physical stability of suspension and stabilizers in suspension; definition of sedimentation volume and degree of flocculation.Familiarize：definition of aromatic waters and spirits; reasons for suspension preparation; methods of suspension preparation, quality control of suspension.Understand: properties of polymer solution; two processes in the preparation of polymer solutions; the double layer theory; the mechanism of flocculation in suspension.二、Emphases and difficulties (教学重点和难点)Emphases：Physical stability of suspension and stabilization strategies.Difficulties：To understand the mechanism of flocculation and deflocculation.三、Teaching methods and means (教学方法与教学手段)1. Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration.四、Teaching contents(教学内容)1. Low molecular solutions: definition, preparation of solutions; syrups definition, components and preparation methods; aromatic waters; tinctures; spirits.2. Polymer solutions: definition, properties of polymer solutions, preparation of polymer solutions, some commonly used natural and synthesized polymers.3. Suspensions: definitions, reasons for suspension preparation; features desired in a pharmaceutical suspension; physical stability of suspension ( flocculation and deflocculation; sedimentation, particle size increase and crystal growth); stabilizers in suspensions (suspending agents, wetting agents, flocculating and deflocculating agents…); preparation of suspensions (dispersing method, coagulation methods); apparatus for suspension preparation; quality evaluation of suspension( sedimentation volume, degree of flocculation…).五、Questions/Homework after class (课后思考题或作业)1. Definitions: syrups, single syrups, spirit, aromatic water, tincture, suspension; sedimentationvolume; degree of flocculation.2. What are the properties of polymer solutions?3. Can you describe the physical stability of suspensions?4. Which kinds of stabilizers should be used in order to increase the physical stability ofsuspension?Part III Emulsions 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce preparation, stability and quality evaluation of emulsions.[Basic requirements]Master：definition of emulsion, its composition, emulsion types; formulation of emulsions ( choice of emulsion type, oil phase and emulsifying agents…); HLB calculation; methods of emulsion preparation; stability of emulsion;Familiarize：emulsion types identification; classification of emulsions; commonly used emulsifying machines; factors influencing emulsification; multiple emulsions; quality evaluation of emulsions.Understand: theory of emulsification.二、Emphases and difficulties (教学重点和难点)Emphases：Preparation and stability of emulsions.Difficulties：Theory of emulsification.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussions.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration.四、Teaching contents(教学内容)1. Introduction: definition of emulsion; composition of emulsion; emulsion types and identification; classification of emulsions; properties of emulsions; basic requirements for emulsifying agents.2. Preparation of emulsions:z Formulation of emulsions: choice of emulsion type, oil phase and emulsifying agents;formulation by the HLB method; HLB calculation.z Drug substance additionz Methods of emulsion preparation: manual methods ( dry gum method, wet gum method and direct mixing method); mechanical method; commonly used emulsifying machines3. Stability of emulsion: creaming, flocculation, phase inversion, and coalescence (breaking,cracking).4. Multiple emulsions: definition, preparation and stability5. Quality evaluation五、Questions/Homework after class (课后思考题或作业)1. Definitions: emulsions, dry gum method, wet gum method; phase inversion; creaming;emulsion flocculation; emulsion coalescence.2. Please describe emulsion preparation process by using dry gum method.3. Can you describe the potential physical stability problem of emulsion?4. In the design of emulsion formulations, which parameters should you consider?Chapter 3 Parenteral and ophthalmic preparationsPart I Solvents and excipients for injections 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce solvents and vehicles for injections.[Basic requirements]Master：advantages and disadvantages of injections; quality requirement of injections; definition of pyrogen, properties of pyrogen, sources of pyrogen, methods to remove pyrogens; definition of water for injection, sterile water for injection; parenteral added substances such as antibacterial agents, antioxidants, buffers, tonicity contributors.Familiarize：Routes of injection administration.Understand: Properties of different administration routes二、Emphases and difficulties (教学重点和难点)Emphases：definition and properties of pyrogen, sources of pyrogen and methods to remove pyrogen.Difficulties：parenteral formulation additives selection.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class.四、Teaching contents (教学内容)1. Introduction: definition of injections; types of injections; advantages and disadvantages ofparenteral administration; parenteral routes of administration; quality requirement of injections.2. Pyrogens: definition of pyrogen; properties of pyrogen (thermostable, filterable, water soluble, non-volatile); sources of pyrogen; methods to remove pyrogens (heating at high temperature, acid-base method, adsorption method, ion-exchange, gel filtration, reverse osmosis).3. Solvents and vehicle for injections:z Aqueous vehicles: water for injection, sterile water for injection…z Nonaqueous vehicles: fixed vegetable oil, alcohol, glycerin, propylene glycol, PEG…4. Parenteral additives: antibacterial agents, antioxidants, buffers, tonicity contributors…五、Questions/Homework after class (课后思考题或作业)1. Definitions: injections, water for injection, sterile water for injection, pyrogen2. What are the advantages and disadvantages of parenteral preparations?3. What are properties of pyrogen? What are the sources?4. How to remove pyrogen during the preparation of injections?Part II Injections and infusions 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the preparation and characterization of injections and infusions.[Basic requirements]Master：the preparation process of injections (ampules washing methods, ingredients for preparations, filling volume criteria and sterilization methods); the type of glass and their properties; quality control ( sterility testing, clarity testing and pyrogen testing); infusion and quality control; infusion related problems; fat emulsions for intravenous injection; injectable sterile powder; advantages and disadvantage of freeze drying;Familiarize：environmental control for injections preparation; osmolarity definition and calculation; total parenteral nutrition; problems related to freeze drying; sterile divided products.Understand: plasma substitutes; the phase diagram for water二、Emphases and difficulties (教学重点和难点)Emphases：the preparation and characterization of injections and infusions.Difficulties：To solve the injection, infusion related problems.三、Teaching methods and means (教学方法与教学手段)1. Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration.四、Teaching contents(教学内容)1. Preparation of injections: environmental control; choice of containers; type of glass; preparation process (ampule washing, drying and sterilization methods; ingredients for preparations; solution preparation and filtration; recommended filling volume; sterilization).2. Quality control: sterility testing; clarity testing, pyrogen testing.3. Infusion: definition, preparation of infusion, quality control; osmolarity and its calculation; infusion related problems.4. Others: total parenteral nutrition, fat emulsions for intravenous injection, plasma substitute, injectable sterile powder, sterile divided products…五、Questions/Homework after class (课后思考题或作业)1. Definitions: infusion, osmolarity, total parenteral nutrition,2. Please describe the classification of glass for parenterals.3. What are the sterilization requirements for injections?4. Which methods can be used for pyrogen testing?5. Please describe infusion related problems.6. Please describe the composition and quality requirement of fat emulsions for intravenousinjection.7. What are the advantages and disadvantages of freeze drying?Part III R&D of injection and ophthalmic drug delivery课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the design of injection formulations and ophthalmic drugdelivery system.[Basic requirements]Master：in which cases antibacterial can be added in injections; definition of iso-osmotic solution and isotonic solution; osmotic pressure adjustment methods: freezing point depression method and sodium chloride equivalent method); pharmaceutical requirement of ophthalmic drug delivery system;Familiarize：small volume and large volume parenterals; types of ophthalmic preparations; factors influencing ocular drug absorption.Understand: the physiological structure of eyes.二、Emphases and difficulties (教学重点和难点)Emphases：the methods and calculation for osmolarity adjustmentDifficulties：formulation design of injections.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussions.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration.四、Teaching contents(教学内容)1. Research and development of injections: formulation design; when antibacterials can be added;safety of injections; definition of iso-osmotic solutions, isotonic solutions and their relationship; osmotic pressure adjustment by using freezing point depression method or sodium chloride equivalent method and the calculation method; formulation analysis.2. Ophthalmic drug delivery: definition and classification; types of ophthalmic preparations;pharmaceutical requirements (pH, osmolarity, sterility…);五、Questions/Homework after class (课后思考题或作业)1. Definitions: iso-osmotic solution, isotonic solution; freezing point depression method;sodium chloride equivalent.2. When antibacterials can be added in injections?3. What is the relationship between iso-osmotic solution and isotonic solution?4. What are the quality requirement of ophthalmic formulations?Chapter 4 Solid dosage formsPart I Powders 课时安排：3学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the preparations of powders and how to evaluate its properties.[Basic requirements]Master：the definition and classification of powders, properties of powders, preparation of powders; characteristics of fluid energy mill; sieve specifications in CP; the definition of geometric dilution, critical relative humidity (CRH), elder hypothesis; quality control of powder Familiarize：methods of comminution; comminution instruments such as ball mill, impact mill and fluid energy mill; blending methods; factors influencing the mixing process; dosing methods二、Emphases and difficulties (教学重点和难点)Emphases：The mechanism and characteristics of fluid energy mill; the concept of CRH and elder hypothesis.Difficulties：Analyze factors influencing the mixing process.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class.四、Teaching contents(教学内容)Introduction: definition of powders and classification; properties of powders; preparation of powders; methods of communication; communication instruments including ball mill, impact mill, fluid energy mill and their properties; sieve specifications in CP; sifting process; blending methods including spatulation, trituration, sifting and tumbling; factors influencing the mixing process; the definition of geometric dilution, critical relative humidity (CRH), elder hypothesis; dosing methods; quality of powders五、Questions/Homework after class (课后思考题或作业)1. Definitions: geometric dilution, critical relative humidity (CRH), elder hypothesis2. Please describe the mechanism and characteristics of fluid energy mill.3. Can you describe the factors influencing the mixing process?4. Please describe the preparation process of powders.Part II Tablets preparation 课时安排：4学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the commonly used tablets excipients and tablets preparation methods.[Basic requirements]Master：commonly used tablets excipients especially fillers, binders, disintegrants and lubricants, their abbreviations and properties; prerequisite for tablet preparation; tablet preparation methods including wet granulation, dry granulation and direct compressionFamiliarize：Advantages and disadvantages of tablets; tape of tablets; granulation purpose; factors influencing the compressibility of tablets; processing problemsUnderstand: the mechanism of disintegration; tablet compression machinery二、Emphases and difficulties (教学重点和难点)Emphases：Commonly used tablets excipients, especially for direct compression; methods of tablet preparationDifficulties：Analyze processing problems during tablet preparation三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration四、Teaching contents(教学内容)1. Introduction: the definition of tablets, tablet forms, advantages and disadvantages of tablets; types of tablets; quality of tablets.2. Tablet excipients: including commonly used fillers (diluents), binders (adhesives), disintegrants,lubricants, introduce the properties of each excipients, their full name and abbreviations; a brief introduction about absorbents, wetting agents, and some other excipients; mention the new development in the area of excipients, the co-processed excipients.3. Tablets preparation: prerequisite for tablet preparation; granulation purpose; wet granulation process will be explained in detail; dry granulation method; direct compression method and commonly used diluents; advantages and disadvantages of direct compression; tablet machinery4. Processing problems: capping and lamination, loose, adhere to the punch, high weigh variance, slow disintegration, poor dissolution, and so on.五、Questions/Homework after class (课后思考题或作业)1. Definitions: diluents, disintegrants, lubricants, direct compression2. Please describe the commonly used tablets excipients, list at least two examples in eachtype.3. Can you describe the purpose of granulation?4. Please describe the preparation process of tablets by wet granulation5. What is the prerequisite for tablet preparation?6. For tablets preparation, what are the advantages of direct compression compared to wetgranulation methods?Part III Tablets coating 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce tablets coating methods and tablet quality control parameters.[Basic requirements]Master：Types of tablet coating; sugar coating processes; properties of film coating; tablet quality parameters; preparation of granulesFamiliarize：Purpose of tablet coating; types of different coating equipments.Understand: Properties of different coating equipments.二、Emphases and difficulties (教学重点和难点)Emphases：Tablets coating methods; tablet quality controlDifficulties：Film evaluation三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussions.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration.四、Teaching contents(教学内容)1. Introduction: reasons for tablet coating, types of tablet coating2. Sugar coating: steps in sugarcoating, including waterproofing and sealing if needed, subcoating, smoothing and final rounding, finishing and coloring if desired and polishing; disadvantages of sugar coating3. Film coating: advantages of film coating; basic components of the coating formulation; aqueous film coating formulation; coating equipments.4. Tablet quality control: tablet weight variation, tablet hardness, tablet friability, tablet disintegration, tablet dissolution…5. Granules: definition, classification, preparation of granules and quality control五、Questions/Homework after class (课后思考题或作业)1. What are the reasons for tablet coating?2. Please describe sugar coating process and the purpose for each step.3. What are the advantages of tablet film coating compared to sugar coating?4. How to control the quality of tablets?5. In which case tablet dissolution should be tested?Part IV Capsules and pills 课时安排：3学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce hard gelatin capsules and soft gelatin capsules, their preparation methods and quality control.[Basic requirements]Master：type of capsules; properties of capsules; limitation of gelatin capsules; manufactureof hard gelatin capsules; hard capsule sizes; composition of soft capsule shell composition, limitation of liquid contents; preparation of soft gelatin capsules; quality control of capsules.Familiarize：Capsule filling machine; drop pills and quality control.Understand: mechanically interlocking caps and bodies.二、Emphases and difficulties (教学重点和难点)Emphases：Hard gelatin and soft gelatin capsules properties, composition and preparation Difficulties：Comparison of hard and soft gelatin capsules and their limitations in liquid content.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussions.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class.四、Teaching contents(教学内容)1. Introduction: definition of capsules; types of capsules; properties of capsules; limitation of gelatin capsules.2. Hard gelatin capsules: composition of hard gelatin shells; advantages and disadvantages of hard gelatin capsules; manufacture of hard gelatin capsule shells; hard capsule sizes; preparation process of filled hard gelatin capsules; capsule filling machines.3. Soft gelatin capsules: soft capsule shell components; limitation of liquid contents; advantages and disadvantages of soft gelatin capsules; preparation methods of soft gelatin capsules (dripping method and rotary die process); comparison of soft gelatin and hard gelatin capsules.4. Quality control of capsules, package and storing capsules; drop pills and quality control.五、Questions/Homework after class (课后思考题或作业)1. Can you describe the classification of capsules?2. What are the properties of capsules?3. What are the limitations of gelatin capsules?4. How many hard capsule sizes are available?5. Please describe the advantages and disadvantages of soft gelatin capsules.Chapter 5 Semisolid formulationsPart I Ointments 课时安排：4学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the commonly used ointment bases and methods of ointment preparation.[Basic requirements]Master：Properties of ointment bases, including oleaginous bases, emulsion bases, water-soluble bases and gels, and the commonly used bases; additives in ointments; preparation method selection based on the properties of the ointment bases; gels; ophthalmic ointment; ointment formulation analysis.Familiarize：Absorption of ointments; selection of appropriate bases; paste二、Emphases and difficulties (教学重点和难点)Emphases：ointment bases and ointment preparation methods.Difficulties：Ointment formulation analysis三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class; 3) Experimentation will be provided with demonstration四、Teaching contents(教学内容)1. Introduction: definition of ointments, absorption of ointments.2. Ointment bases and their properties:z Oleaginous bases: hydrocarbon bases, fat and fixed oil bases, silicones, absorption bases z Emulsion bases: hydrophilic ointment and cold creamz Gel bases: cellulose derivatives, carbopol 934…3. Preparation of ointments:z Oleaginous based ointments: trituration, levigation, fusion…z emulsion based ointments: melting and emulsification4. Others: pastes, ophthalmic ointment, formulation analysis, quality control…五、Questions/Homework after class (课后思考题或作业)1. Definitions: ointment, cream, gel, paste2. Please describe the classification of ointment bases.3. What is the composition of ophthalmic ointment?4. How to select the preparation method based on the properties of ointment bases?Part II Suppository 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the commonly used suppository bases and suppository preparation methods.[Basic requirements]Master：Classification of suppository; commonly used suppository bases; preparation of suppository; displacement value and its calculation;Familiarize：Pharmaceutical additives in suppositories; the advantages and disadvantages of suppository for systemic action; factors influencing absorption from rectal suppositories.Understand: the physiological structure in the rectal.二、Emphases and difficulties (教学重点和难点)Emphases：Commonly used suppository bases; suppository preparation methods; displacement value.Difficulties：Using displacement value as the parameter for bases amount calculation in the formulation design of suppository.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration四、Teaching contents(教学内容)1. Introduction: the definition of suppository; classification of suppository; composition of suppositories.。
沈阳药科大学-药剂学-包合技术
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（六）热分析法
•热 分 析 法 中 包 括 差 热 分 析 法
• 例 如 盐 酸 氯 丙 咪 嗪 与 β-CD 和 DMβ-CD的包合物的荧光光谱如图1812所示。盐酸氯丙咪嗪与环糊精形 成包合物后，在350nm附近的荧光 强度明显增加。
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图18-12 CIP-ß-CD体系的荧光光谱
1.CIP 2.CIP+ß-CD 3.CIP+DM-ß-CD
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（四） 圆二色谱法
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（3）超声波法
• 将环糊精饱和水溶液中加 入客分子药物，混合后用 超声波处理，将析出沉淀 溶剂洗涤、干燥，即得稳 定的包合物。
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（4）冷冻干燥法和喷雾干燥法
• 对受热干燥过程中易分解且 易溶于水的药物，可以采用 冷冻干燥的方法制备包合物。
• 喷雾干燥法适用于遇热较稳 定、难溶性或疏水性药物。
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16
（一）药物极性的影响
在环糊精的空洞内，非 极性客分子更容易与疏水性 空洞相互作用，因此疏水性 药物、非解离型药物易被包 合。
.
17
（二）药物与环糊精的比例
• 包合物不仅在水和有机溶剂中能形成，而且 在固态中也能形成。
• 包合物以溶液态存在时，客分子在主分子的 空穴内；包合物以晶体存在时，客分子不一 定都在空穴内，也可以在晶格空隙中。
• CD对酸较不稳定，对碱、热和机械作用 都相当稳定，与某些有机溶剂共存时， 能形成复合物而沉淀。可利用CD在不同 溶剂中的溶解度不同而进行分离。
沈阳药科大学药剂学PPT
（制剂通则：剂型的概念、一般标准、常规检 查方法等）
２、处方 处方的概念
医疗和生产部门用于药剂调剂的重要书面文件。
类型 ▪ 法定处方：药典、部标、国标收载的，有法律约束力； ▪ 协定处方：根据本医院或本地区需要制定，医院药剂科用于常用
L-HPC
吸水体积膨胀500-700倍
交联PVP
水中迅速溶胀，不形成凝胶；性能优
交联羧甲基纤维素钠 不溶于水，吸水溶胀；与CMS-Na
CCNa
合用效果优
泡腾剂
碳酸氢钠+酸
（避免受潮）
泡腾片
崩解剂加入方法： 内加（25-50％）、外加（75-50％）或内外加（片重的5-20％）
4、润滑剂（助流、抗粘、润滑剂）
4、包衣材料与工序
种类
糖衣
工序
隔离层 粉衣层 无色糖衣 有色糖衣
材料
10％玉米朊乙醇液、15－20％虫胶乙醇液 糖浆+滑石粉交替 糖浆 糖浆＋色素
打光
川蜡
胃溶 高效包衣机 HPMC、羟丙基纤维素（HPC）、PVP、
型
↓
丙烯酸树脂Ⅳ号（Eudragit E型）
薄肠 膜溶 衣型
水不 溶型
包衣材料雾化 丙烯酸树脂Ⅰ、Ⅱ、Ⅲ号（ Eudragit L、S型）
喷入
邻苯二甲酸醋酸纤维素（CAP）
↓
温风干燥 邻苯二甲酸羟丙基甲基纤维素（HPMCP）
↓
邻苯二甲酸聚乙烯醇酯（PVAP）
固化
EC、醋酸纤维素
50℃干燥
包衣辅助性辅料：
▪ 增塑剂－－－丙二醇、蓖麻油、聚乙二醇、
硅油、甘油、邻苯二甲酸二乙酯
沈阳药科大学药剂学
沈阳药科大学《药剂学I》教案《Pharmaceutics I》 teaching plan For students major in Pharmacy (in English)Shirui Mao毛世瑞Shenyang Pharmaceutical UniversityChapter 1 Introduction课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce definition, contents, tasks of pharmaceutics, importance of dosage forms and some other related information.[Basic requirements]Master：The definition, contents, tasks of pharmaceutics; importance of dosage forms; pharmacopoeia; drug standards of China;Familiarize：Pharmaceutics related subjects; classification of dosage forms; application of excipients in pharmaceutics; the development of Chinese Pharmacopoeia; prescription drug and OTC; GMP, GLP and GCP.Understand: pharmaceutics historical perspective.二、Emphases and difficulties (教学重点和难点)Emphases：Definitions and tasks of pharmaceutics, importance of dosage form.Difficulties：Classification of dosage forms based on different criteria.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class.四、Teaching contents(教学内容)Definitions of pharmaceutics; contents of pharmaceutics; tasks of pharmaceutics; pharmaceutics related subjects; importance of dosage from; variation in time of onset of action for different dosage forms; classification of dosage forms; application of excipients in pharmaceutics; examples of pharmaceutical excipients; definition of pharmacopoeia, the development of Chinese pharmacopoeia, other important pharmacopoeia( USP, BP, JP, EP, Ph. Int); Drug standards in China; prescription drug and OTC; GMP, GLP, GCP; pharmaceutics historical perceptive.五、Questions/Homework after class (课后思考题或作业)1. Definitions: pharmaceutics; dosage form; pharmacopoeia; OTC; GMP; GLP; GCP.2. What are the tasks of pharmaceutics?3. Can you describe the importance of dosage forms?4. Based on administration route, how can dosage forms be classified?5. Please describe the important stages during the development of Chinese Pharmacopoeia.Chapter 2 Liquid preparationsPart I Introduction, solvents and excipients 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce definition, classification, advantages and disadvantages of liquid preparations and commonly used solvents and excipients in liquid formulations.[Basic requirements]Master：the classification of liquid preparations; advantages and disadvantages of liquid formulations; solvents for liquid formulations; excipients in liquid formulations especially the concept of solubilizer, hydrotropy agent, cosolvents and preservatives; properties of surfactants.Familiarize：quality of liquid dosage forms; the mechanism of solubilization; classification of hydrotropy agents; flavors including sweeting agents, flavoring agents and mucilage; colorants.Understand: mechanism of cosolvency and hydrotroy.二、Emphases and difficulties (教学重点和难点)Emphases：the solvents and excipients in pharmaceuticsDifficulties：the mechanism of solubilization, cosolvency and hydrotropy.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class.四、Teaching contents(教学内容)1. Introduction: definition of liquid preparations; classification of liquid preparations; advantages and disadvantages of liquid dosage forms; quality of liquid dosage form.2. Solvents for liquid preparationsz Aqueous solvent: waterz Non-aqueous solvents: alcohol, glycerin, propylene glycol, polyethylene glycol, dimethylsulfoxide, fatty oils…3. Excipients in liquid formulations:z Solubilizer: introduce surfactant related knowledge.z Hydrotropy agents: definition, examples, mechanism and classification of hydrotropy agents. z Cosolvency: definition and mechanismz Preservatives; criteria of selection; commonly used substances and their properties: paraben, benzoic acid and sodium benzoate; sorbic acid and others…z Flavors: sweeting agents, flavoring agents, mucilagez Other excipients.五、Questions/Homework after class (课后思考题或作业)1. Definitions: liquid preparations; solubilization; hydrotropy; cosolvency; surfactant2. What are the advantages and disadvantages of liquid preparations?3. Why can surfactants be used to increase the solubility of poorly water soluble drugs?4. When sodium benzoate is used as a preservative in a formulation, the concentration shouldbe higher than that of benzoic acid, why?Part II Solutions and suspensions 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the preparation and characterization of low molecular weight solutions, polymer solutions and suspensions.[Basic requirements]Master：Preparation methods of low molecular weight solutions; syrup and its preparation; tincture; physical stability of suspension and stabilizers in suspension; definition of sedimentation volume and degree of flocculation.Familiarize：definition of aromatic waters and spirits; reasons for suspension preparation; methods of suspension preparation, quality control of suspension.Understand: properties of polymer solution; two processes in the preparation of polymer solutions; the double layer theory; the mechanism of flocculation in suspension.二、Emphases and difficulties (教学重点和难点)Emphases：Physical stability of suspension and stabilization strategies.Difficulties：To understand the mechanism of flocculation and deflocculation.三、Teaching methods and means (教学方法与教学手段)1. Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration.四、Teaching contents(教学内容)1. Low molecular solutions: definition, preparation of solutions; syrups definition, components and preparation methods; aromatic waters; tinctures; spirits.2. Polymer solutions: definition, properties of polymer solutions, preparation of polymer solutions, some commonly used natural and synthesized polymers.3. Suspensions: definitions, reasons for suspension preparation; features desired in a pharmaceutical suspension; physical stability of suspension ( flocculation and deflocculation; sedimentation, particle size increase and crystal growth); stabilizers in suspensions (suspending agents, wetting agents, flocculating and deflocculating agents…); preparation of suspensions (dispersing method, coagulation methods); apparatus for suspension preparation; quality evaluation of suspension( sedimentation volume, degree of flocculation…).五、Questions/Homework after class (课后思考题或作业)1. Definitions: syrups, single syrups, spirit, aromatic water, tincture, suspension; sedimentationvolume; degree of flocculation.2. What are the properties of polymer solutions?3. Can you describe the physical stability of suspensions?4. Which kinds of stabilizers should be used in order to increase the physical stability ofsuspension?Part III Emulsions 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce preparation, stability and quality evaluation of emulsions.[Basic requirements]Master：definition of emulsion, its composition, emulsion types; formulation of emulsions ( choice of emulsion type, oil phase and emulsifying agents…); HLB calculation; methods of emulsion preparation; stability of emulsion;Familiarize：emulsion types identification; classification of emulsions; commonly used emulsifying machines; factors influencing emulsification; multiple emulsions; quality evaluation of emulsions.Understand: theory of emulsification.二、Emphases and difficulties (教学重点和难点)Emphases：Preparation and stability of emulsions.Difficulties：Theory of emulsification.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussions.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration.四、Teaching contents(教学内容)1. Introduction: definition of emulsion; composition of emulsion; emulsion types and identification; classification of emulsions; properties of emulsions; basic requirements for emulsifying agents.2. Preparation of emulsions:z Formulation of emulsions: choice of emulsion type, oil phase and emulsifying agents;formulation by the HLB method; HLB calculation.z Drug substance additionz Methods of emulsion preparation: manual methods ( dry gum method, wet gum method and direct mixing method); mechanical method; commonly used emulsifying machines3. Stability of emulsion: creaming, flocculation, phase inversion, and coalescence (breaking,cracking).4. Multiple emulsions: definition, preparation and stability5. Quality evaluation五、Questions/Homework after class (课后思考题或作业)1. Definitions: emulsions, dry gum method, wet gum method; phase inversion; creaming;emulsion flocculation; emulsion coalescence.2. Please describe emulsion preparation process by using dry gum method.3. Can you describe the potential physical stability problem of emulsion?4. In the design of emulsion formulations, which parameters should you consider?Chapter 3 Parenteral and ophthalmic preparationsPart I Solvents and excipients for injections 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce solvents and vehicles for injections.[Basic requirements]Master：advantages and disadvantages of injections; quality requirement of injections; definition of pyrogen, properties of pyrogen, sources of pyrogen, methods to remove pyrogens; definition of water for injection, sterile water for injection; parenteral added substances such as antibacterial agents, antioxidants, buffers, tonicity contributors.Familiarize：Routes of injection administration.Understand: Properties of different administration routes二、Emphases and difficulties (教学重点和难点)Emphases：definition and properties of pyrogen, sources of pyrogen and methods to remove pyrogen.Difficulties：parenteral formulation additives selection.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class.四、Teaching contents (教学内容)1. Introduction: definition of injections; types of injections; advantages and disadvantages ofparenteral administration; parenteral routes of administration; quality requirement of injections.2. Pyrogens: definition of pyrogen; properties of pyrogen (thermostable, filterable, water soluble, non-volatile); sources of pyrogen; methods to remove pyrogens (heating at high temperature, acid-base method, adsorption method, ion-exchange, gel filtration, reverse osmosis).3. Solvents and vehicle for injections:z Aqueous vehicles: water for injection, sterile water for injection…z Nonaqueous vehicles: fixed vegetable oil, alcohol, glycerin, propylene glycol, PEG…4. Parenteral additives: antibacterial agents, antioxidants, buffers, tonicity contributors…五、Questions/Homework after class (课后思考题或作业)1. Definitions: injections, water for injection, sterile water for injection, pyrogen2. What are the advantages and disadvantages of parenteral preparations?3. What are properties of pyrogen? What are the sources?4. How to remove pyrogen during the preparation of injections?Part II Injections and infusions 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the preparation and characterization of injections and infusions.[Basic requirements]Master：the preparation process of injections (ampules washing methods, ingredients for preparations, filling volume criteria and sterilization methods); the type of glass and their properties; quality control ( sterility testing, clarity testing and pyrogen testing); infusion and quality control; infusion related problems; fat emulsions for intravenous injection; injectable sterile powder; advantages and disadvantage of freeze drying;Familiarize：environmental control for injections preparation; osmolarity definition and calculation; total parenteral nutrition; problems related to freeze drying; sterile divided products.Understand: plasma substitutes; the phase diagram for water二、Emphases and difficulties (教学重点和难点)Emphases：the preparation and characterization of injections and infusions.Difficulties：To solve the injection, infusion related problems.三、Teaching methods and means (教学方法与教学手段)1. Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration.四、Teaching contents(教学内容)1. Preparation of injections: environmental control; choice of containers; type of glass; preparation process (ampule washing, drying and sterilization methods; ingredients for preparations; solution preparation and filtration; recommended filling volume; sterilization).2. Quality control: sterility testing; clarity testing, pyrogen testing.3. Infusion: definition, preparation of infusion, quality control; osmolarity and its calculation; infusion related problems.4. Others: total parenteral nutrition, fat emulsions for intravenous injection, plasma substitute, injectable sterile powder, sterile divided products…五、Questions/Homework after class (课后思考题或作业)1. Definitions: infusion, osmolarity, total parenteral nutrition,2. Please describe the classification of glass for parenterals.3. What are the sterilization requirements for injections?4. Which methods can be used for pyrogen testing?5. Please describe infusion related problems.6. Please describe the composition and quality requirement of fat emulsions for intravenousinjection.7. What are the advantages and disadvantages of freeze drying?Part III R&D of injection and ophthalmic drug delivery课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the design of injection formulations and ophthalmic drugdelivery system.[Basic requirements]Master：in which cases antibacterial can be added in injections; definition of iso-osmotic solution and isotonic solution; osmotic pressure adjustment methods: freezing point depression method and sodium chloride equivalent method); pharmaceutical requirement of ophthalmic drug delivery system;Familiarize：small volume and large volume parenterals; types of ophthalmic preparations; factors influencing ocular drug absorption.Understand: the physiological structure of eyes.二、Emphases and difficulties (教学重点和难点)Emphases：the methods and calculation for osmolarity adjustmentDifficulties：formulation design of injections.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussions.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration.四、Teaching contents(教学内容)1. Research and development of injections: formulation design; when antibacterials can be added;safety of injections; definition of iso-osmotic solutions, isotonic solutions and their relationship; osmotic pressure adjustment by using freezing point depression method or sodium chloride equivalent method and the calculation method; formulation analysis.2. Ophthalmic drug delivery: definition and classification; types of ophthalmic preparations;pharmaceutical requirements (pH, osmolarity, sterility…);五、Questions/Homework after class (课后思考题或作业)1. Definitions: iso-osmotic solution, isotonic solution; freezing point depression method;sodium chloride equivalent.2. When antibacterials can be added in injections?3. What is the relationship between iso-osmotic solution and isotonic solution?4. What are the quality requirement of ophthalmic formulations?Chapter 4 Solid dosage formsPart I Powders 课时安排：3学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the preparations of powders and how to evaluate its properties.[Basic requirements]Master：the definition and classification of powders, properties of powders, preparation of powders; characteristics of fluid energy mill; sieve specifications in CP; the definition of geometric dilution, critical relative humidity (CRH), elder hypothesis; quality control of powder Familiarize：methods of comminution; comminution instruments such as ball mill, impact mill and fluid energy mill; blending methods; factors influencing the mixing process; dosing methods二、Emphases and difficulties (教学重点和难点)Emphases：The mechanism and characteristics of fluid energy mill; the concept of CRH and elder hypothesis.Difficulties：Analyze factors influencing the mixing process.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class.四、Teaching contents(教学内容)Introduction: definition of powders and classification; properties of powders; preparation of powders; methods of communication; communication instruments including ball mill, impact mill, fluid energy mill and their properties; sieve specifications in CP; sifting process; blending methods including spatulation, trituration, sifting and tumbling; factors influencing the mixing process; the definition of geometric dilution, critical relative humidity (CRH), elder hypothesis; dosing methods; quality of powders五、Questions/Homework after class (课后思考题或作业)1. Definitions: geometric dilution, critical relative humidity (CRH), elder hypothesis2. Please describe the mechanism and characteristics of fluid energy mill.3. Can you describe the factors influencing the mixing process?4. Please describe the preparation process of powders.Part II Tablets preparation 课时安排：4学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the commonly used tablets excipients and tablets preparation methods.[Basic requirements]Master：commonly used tablets excipients especially fillers, binders, disintegrants and lubricants, their abbreviations and properties; prerequisite for tablet preparation; tablet preparation methods including wet granulation, dry granulation and direct compressionFamiliarize：Advantages and disadvantages of tablets; tape of tablets; granulation purpose; factors influencing the compressibility of tablets; processing problemsUnderstand: the mechanism of disintegration; tablet compression machinery二、Emphases and difficulties (教学重点和难点)Emphases：Commonly used tablets excipients, especially for direct compression; methods of tablet preparationDifficulties：Analyze processing problems during tablet preparation三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration四、Teaching contents(教学内容)1. Introduction: the definition of tablets, tablet forms, advantages and disadvantages of tablets; types of tablets; quality of tablets.2. Tablet excipients: including commonly used fillers (diluents), binders (adhesives), disintegrants,lubricants, introduce the properties of each excipients, their full name and abbreviations; a brief introduction about absorbents, wetting agents, and some other excipients; mention the new development in the area of excipients, the co-processed excipients.3. Tablets preparation: prerequisite for tablet preparation; granulation purpose; wet granulation process will be explained in detail; dry granulation method; direct compression method and commonly used diluents; advantages and disadvantages of direct compression; tablet machinery4. Processing problems: capping and lamination, loose, adhere to the punch, high weigh variance, slow disintegration, poor dissolution, and so on.五、Questions/Homework after class (课后思考题或作业)1. Definitions: diluents, disintegrants, lubricants, direct compression2. Please describe the commonly used tablets excipients, list at least two examples in eachtype.3. Can you describe the purpose of granulation?4. Please describe the preparation process of tablets by wet granulation5. What is the prerequisite for tablet preparation?6. For tablets preparation, what are the advantages of direct compression compared to wetgranulation methods?Part III Tablets coating 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce tablets coating methods and tablet quality control parameters.[Basic requirements]Master：Types of tablet coating; sugar coating processes; properties of film coating; tablet quality parameters; preparation of granulesFamiliarize：Purpose of tablet coating; types of different coating equipments.Understand: Properties of different coating equipments.二、Emphases and difficulties (教学重点和难点)Emphases：Tablets coating methods; tablet quality controlDifficulties：Film evaluation三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussions.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration.四、Teaching contents(教学内容)1. Introduction: reasons for tablet coating, types of tablet coating2. Sugar coating: steps in sugarcoating, including waterproofing and sealing if needed, subcoating, smoothing and final rounding, finishing and coloring if desired and polishing; disadvantages of sugar coating3. Film coating: advantages of film coating; basic components of the coating formulation; aqueous film coating formulation; coating equipments.4. Tablet quality control: tablet weight variation, tablet hardness, tablet friability, tablet disintegration, tablet dissolution…5. Granules: definition, classification, preparation of granules and quality control五、Questions/Homework after class (课后思考题或作业)1. What are the reasons for tablet coating?2. Please describe sugar coating process and the purpose for each step.3. What are the advantages of tablet film coating compared to sugar coating?4. How to control the quality of tablets?5. In which case tablet dissolution should be tested?Part IV Capsules and pills 课时安排：3学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce hard gelatin capsules and soft gelatin capsules, their preparation methods and quality control.[Basic requirements]Master：type of capsules; properties of capsules; limitation of gelatin capsules; manufactureof hard gelatin capsules; hard capsule sizes; composition of soft capsule shell composition, limitation of liquid contents; preparation of soft gelatin capsules; quality control of capsules.Familiarize：Capsule filling machine; drop pills and quality control.Understand: mechanically interlocking caps and bodies.二、Emphases and difficulties (教学重点和难点)Emphases：Hard gelatin and soft gelatin capsules properties, composition and preparation Difficulties：Comparison of hard and soft gelatin capsules and their limitations in liquid content.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussions.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class.四、Teaching contents(教学内容)1. Introduction: definition of capsules; types of capsules; properties of capsules; limitation of gelatin capsules.2. Hard gelatin capsules: composition of hard gelatin shells; advantages and disadvantages of hard gelatin capsules; manufacture of hard gelatin capsule shells; hard capsule sizes; preparation process of filled hard gelatin capsules; capsule filling machines.3. Soft gelatin capsules: soft capsule shell components; limitation of liquid contents; advantages and disadvantages of soft gelatin capsules; preparation methods of soft gelatin capsules (dripping method and rotary die process); comparison of soft gelatin and hard gelatin capsules.4. Quality control of capsules, package and storing capsules; drop pills and quality control.五、Questions/Homework after class (课后思考题或作业)1. Can you describe the classification of capsules?2. What are the properties of capsules?3. What are the limitations of gelatin capsules?4. How many hard capsule sizes are available?5. Please describe the advantages and disadvantages of soft gelatin capsules.Chapter 5 Semisolid formulationsPart I Ointments 课时安排：4学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the commonly used ointment bases and methods of ointment preparation.[Basic requirements]Master：Properties of ointment bases, including oleaginous bases, emulsion bases, water-soluble bases and gels, and the commonly used bases; additives in ointments; preparation method selection based on the properties of the ointment bases; gels; ophthalmic ointment; ointment formulation analysis.Familiarize：Absorption of ointments; selection of appropriate bases; paste二、Emphases and difficulties (教学重点和难点)Emphases：ointment bases and ointment preparation methods.Difficulties：Ointment formulation analysis三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class; 3) Experimentation will be provided with demonstration四、Teaching contents(教学内容)1. Introduction: definition of ointments, absorption of ointments.2. Ointment bases and their properties:z Oleaginous bases: hydrocarbon bases, fat and fixed oil bases, silicones, absorption bases z Emulsion bases: hydrophilic ointment and cold creamz Gel bases: cellulose derivatives, carbopol 934…3. Preparation of ointments:z Oleaginous based ointments: trituration, levigation, fusion…z emulsion based ointments: melting and emulsification4. Others: pastes, ophthalmic ointment, formulation analysis, quality control…五、Questions/Homework after class (课后思考题或作业)1. Definitions: ointment, cream, gel, paste2. Please describe the classification of ointment bases.3. What is the composition of ophthalmic ointment?4. How to select the preparation method based on the properties of ointment bases?Part II Suppository 课时安排：2学时（药学（英语））一、Aim (教学目的)In this lecture we will introduce the commonly used suppository bases and suppository preparation methods.[Basic requirements]Master：Classification of suppository; commonly used suppository bases; preparation of suppository; displacement value and its calculation;Familiarize：Pharmaceutical additives in suppositories; the advantages and disadvantages of suppository for systemic action; factors influencing absorption from rectal suppositories.Understand: the physiological structure in the rectal.二、Emphases and difficulties (教学重点和难点)Emphases：Commonly used suppository bases; suppository preparation methods; displacement value.Difficulties：Using displacement value as the parameter for bases amount calculation in the formulation design of suppository.三、Teaching methods and means (教学方法与教学手段)1.Teaching methods：Lectures with questions and discussion.2. Teaching means：1）the slides are in English and the lectures are given in English；2）questions will be asked at random during the class. 3) Experimentation will be provided with demonstration四、Teaching contents(教学内容)1. Introduction: the definition of suppository; classification of suppository; composition of suppositories.。
沈阳药科大学药剂学第三章注射剂
蒸气
饱和蒸气 湿饱和蒸气 过热蒸气
应 采 用 饱和蒸气。
湿饱和蒸气因 含有水分，热 含量较低，热 穿透力较差， 灭菌效率较低
过热蒸气温度高于饱和蒸气， 但穿透力差，灭菌效率低
3）药品性质和灭菌时间
一般而言，灭菌温度愈高，灭菌时间愈 长，药品被破坏的可能性愈大。因此， 在设计灭菌温度和灭菌时间时必须考虑 药品的稳定性，即在达到有效灭菌的前 提下，尽可能降低灭菌温度和缩短灭菌 时间。
（三）无菌操作法
无菌操作法系指整个过程控制在无菌条 件下进行的一种操作方法。该法适合一 些不耐热药物的注射剂、眼用制剂、皮 试液、海绵剂和创伤制剂的制备。按无 菌操作法制备的产品，一般不再灭菌， 但某些特殊（耐热）品种亦可进行再灭 菌（如青霉素G等）。
1．无菌操作室的灭菌
（1）甲醛溶液加热熏蒸法：该方法的灭菌 较彻底，是常用的方法之一。
④灭菌完毕后必须先停止加热，逐渐减 压至压力表指针为“0”后，放出柜内蒸
气，使柜内压力与大气压相等，稍稍打 开灭菌柜，10~15min后全部打开。
（2）流通蒸气灭菌法
系指在常压下，采用100℃流通蒸气加热 杀灭微生物的方法。灭菌时间通常为 30~60min。该法适用于消毒及不耐高热 制剂的灭菌。但不能保证杀灭所有的芽 胞，是非可靠的灭菌法。
（1）火焰灭菌法
系指用火焰直接灼烧灭菌的方法。该法 灭菌迅速、可靠、简便，适用于耐火焰 材质（如金属、玻璃及瓷器等）的物品 与用具的灭菌，不适合药品的灭菌。
（2）干热空气灭菌法
系指用高温干热空气灭菌的方法。该法 适用于耐高温的玻璃和金属制品以及不
在允干许燥湿状气态穿下透，由的于油热脂穿类透（力如较油差性，软微膏生基物 的耐质热、性注较射强用，油必等须）长和时耐间高受温高的热粉作末用化才学能 达到药灭品菌的的灭目菌的，。不因适此于，橡干胶热、空塑气料灭及菌大法部采 用的分温药度品一的般灭比菌湿。热灭菌法高。为了确保灭 菌效果，一般规定为：135~145℃灭菌3~5h； 160~170℃ 灭 菌 2~4h ； 180~200℃ 灭 菌 0.5~1h 。
最新沈阳药科大学药剂课件(共19章全第十八章 制剂新技术讲学课件
长安街夜色
1．纤维素类
• 常用的有醋酸纤维素酞酸酯（CAP）、羟丙甲 纤维素酞酸酯（HPMCP，其商品有两种规格， 分 别 为 HP50 、 HP55 ） 以 及 羧 甲 乙 纤 维 素 （CMEC）等，它们不溶于胃液，但均能溶于 肠液中。
• 可用于制备胃中不稳定药物的固体分散体，使 其只在肠道中释放和吸收，使制剂获得较高的 疗效（即生物利用度较高）。
• 也可于制备缓释的固体分散体，控制药物的释 放，使制剂获得缓释的效果。
2．聚丙烯酸树脂类
• 常用聚丙烯酸树脂Ⅱ号及Ⅲ号， 前者在pH6以上的介质中溶解，后 者在pH7以上的介质中溶解，有时 两者联合使用，可制成缓释速率 较理想的固体分散体。
• 布 洛 芬 以 Eudragit L-100 及 Eudragit S-100共沉淀物中5hr释 药50%, 8h释药近于完全。
•按晶体结构看，可分为置换型和填充型固体 溶液；按药物与载体材料的互溶情况看，可 分为完全互溶和部分互溶固体溶液。
•如果药物与载体的分子大小很接近，则一种 分子可以代替另一种分子进入其晶格结构形 成置换型固体溶液，这种固体溶液往往在两 者不同组分比例下都能形成，故而又称完全 互溶固体溶液；
三、固体分散体的类型
（-）固体溶液（solid solution）
❖是指药物以分子状态均匀分散在载体材料中 而形成的固体分散体。如果将药物分子看成 溶质，载体看成是溶剂，则此类分散体即可 称为固体（态）溶液。
• 因为固体溶液中的药物以分子状态存在，分 散程度高、表面积大，所以在改善溶解度方 面比下述的低共熔混合物具有更好的效果。
➢加入HPC、PEG、PVP等水溶性物质作致孔 剂可以调节释药速率，获得更为理想的缓 控释效果。
沈阳药科大学药剂学学习指导
药剂学学习指导第一章绪论教学大纲要求①掌握药剂学、剂型、制剂的概念。
②掌握药典的概念、处方的概念和类型。
③熟悉制剂学、调剂学、药物、中药、生物技术药物的概念。
④熟悉剂型的作用及分类。
⑤了解药剂学的分支学科。
⑥了解药剂学的任务和发展。
⑦了解GMP、GLP、GCP。
⑧了解药品注册管理办法。
习题（一）名词解释1．药剂学2．调剂学3．制剂学4．剂型5．制剂6．药典7．法定处方8．医师处方*9．中药10．处方药11．非处方药（二）选择题Ⅰ单项选择题1．研究药物制剂的基本理论、处方设计、制备工艺、质量控制与合理应用的综合性技术科学，称为A．制剂学B．调剂学C．药剂学D．方剂学E．工业药剂学2．《中华人民共和国药典》最早颁布的时间是A．1949年B．1953年C．1963年D．1977年E．1985年3．根据《国家药品标准》的处方，将原料药物加工制成具有一定规格的制品，称为A．方剂B．调剂C．中药D．制剂E．剂型4．药品生产、供应、检验和使用的主要依据是A．GLP B．GMP C．药典D．药品管理法E．GCP5．下列关于药典作用的表述中，正确的是A．药典作为药品生产、检验、供应的依据B．药典作为药品检验、供应与使用的依据C．药典作为药品生产、供应与使用的依据D．药典作为药品生产、检验与使用的依据E．药典作为药品生产、检验、供应与使用的依据6．以下有关药物制成剂型的叙述中，错误的是A．药物剂型应与给药途径相适应B．药物供临床使用之前，都必须制成适合于应用的剂型C．一种药物只能制成一种剂型D．一种药物制成何种剂型与临床上的需要有关E.一种药物制成何种剂型与药物的性质有关7．现行的《中华人民共和国药典》版本为A．1990年版B．1995年版C．1998年版D．2005年版E．2000年版8．美国药典的英文缩写为A．USP B．GMP C．BP D．JP E．WHO9．我国开始对药品实行GMP认证制度的时间是A．1980年1月1日B．1985年7月1日C．1990年7月1日D．1995年10月1日E．2000年1月1日10．药剂学的分支学科有A．物理药剂学B．生物药剂学C．工业药剂学D．药物动力学E．A、B、C、D、都包括11．《中华人民共和国药典》是由A．国家编纂的药品规格、标准的法典B．国家颁布的药品集C．国家药品监督管理局制定的药品标准D．国家卫生部制定的药品标准E．国家药典委员会制定的药物手册12．《中华人民共和国药典》2005年版从什么时候开始实施A．2005年1月1日B．2005年5月1日C．2005年8月1日D．2005年7月1日E.2006年1月1日Ⅱ配伍选择题（备选答案在前，试题在后；每组均对应同一组备选答案，每题只有一个正确答案，每个备选答案可重复选用，也可不选用。
《药剂学》学习指导
《药剂学》学习指导复习思考题第一章绪论1．名词解释：药剂学；剂型；制剂；药典2．简答：（1）简述剂型的重要性？（2）简述药典的特点？参考答案药剂学：药剂学是研究药物制剂的基本理论、处方设计、制备工艺、质量控制和合理应用的综合性应用技术科学。
剂型：药物剂型是适合于疾病的诊断、治疗或预防的需要而制备的不同给药形式，简称剂型，如散剂、片剂等。
制剂：根据药典或药政管理部门批准的标准，为适应治疗或预防的需要而制备地药物应用形式的具体品种称为制剂。
药典：是一个国家记载药品规格、标准的法典。
简述剂型的重要性？区别：法定处方为国家标准收载的处方，其具有法律的约束力，在制造或医师开写法定制剂时，均需遵照其规定。
医师处方是医师为某一患者的治疗需要（或预防需要）而开写给药局的有关制备和发出药剂的书面凭证。
有具体的用药对象、用法和用量，同时具有法律上，技术上和经济上的意义。
第三章片剂1．名词解释：泡腾崩解剂；平衡水分；溶出度2．简答题：（1）简述片剂的质量要求？（2）简述片剂辅料的要求？（3）简述压片时，为何加入润滑剂，润滑剂的种类有那些？（4）简述制粒的目的？（5）简述西药湿法混合制粒压片前的工艺流程？（6）简述影响干燥恒速阶段速率的因素及改善方法？（7）简述影响干燥降速阶段速率的因素及改善方法？（8）简述包衣的目的？（9）简述片剂包衣的质量要求有哪些？（10）简述包糖衣有哪几道工序？(11)简述可能造成裂片的原因？(12)简述可能造成片剂崩解迟缓的原因有哪些？(13)简述可能造成粘冲的原因？3．论述题：（1）片剂赋形剂有哪几种？试举例说明其在片剂中的作用？(2)甘菊环烃泡腾片甘菊环烃2mg碳酸氢钠0.256g糖精钠0.010g羟丙基纤维素0.005g 酒石酸0.067g蔗糖0.048gPEG60000.002g薄荷油0.010g乙醇适量蒸馏水适量说明各成分的作用；写出该片剂的制备方法？（3）利血平片利血平0.26mg蓝淀粉0.010g糖粉0.033g糊精0.023g稀乙醇0.022g淀粉0.050g硬脂酸镁0.058g说明各成分的作用；写出该片剂的制备方法。
沈阳药科大学药剂学课件 12-2粉体学基础
第五节
吸湿性与润湿性
一、吸湿性（moisture absorption）
吸湿性是指在固体表面吸附水分的现象 将药物粉末臵于湿度较大的空气中时容易发生 不同程度的吸湿现象以至于使粉末的流动性下 降、固结、润湿、液化等，甚至促进化学反应 而降低药物的稳定性 因此防湿对策是药物制剂中的一个重要话题
当操作处理过程不同时，粉体流动的形式也不 同，比如有重力流动、振动流动、压缩流动、 流化流动等，所以流动性的评价方法有所不同 表13-7列出了流动形式与相应流动性的评价方 法 当定量地测量粉体的流动性时，最好采用与操 作处理过程相对应的方法
表13-7
流动形式与其相对应的流动性评价方法
流动性的评价方法 种 类 现象或操作 流出速度，壁面摩擦 角 瓶或加料斗中的流出 重力流动 休止角，流出界限孔 旋转容器型混合器，充填 径 休止角，流出速度， 振动加料，振动筛 振动流动 压缩度，表观密度 充填，流出
药物的吸湿性与空气状 态有关
图中p表示空气中水蒸 气分压，pw表示物料表 面产生的水蒸气压 ①当p大于pw空时发生 吸湿（吸潮） ②p小于pw时发生干燥 （风干） ③p等于pw 时吸湿与干 燥达到动态平衡，此时 的水分称平衡水分
由此可见:
将物料长时间放臵于一定空气状态后，物料中所含
水分即为平衡含水量
川北方程： 久野方程：
n 1 n C ab a
（12-24）
ln( f n ) kn ln( f 0 ) （12-25)
式中，ρ0 ,ρn ,ρf —分别表示最初（0次），n次，最终（体积不变）的密 度； C—体积减少度，即C=（V0-Vn）/V0； a—最终的体积减少度，a值越小流动性越好； k，b—充填速度常数，其值越大充填速度越大，充填越容易。
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药剂学学习指导第一章绪论教学大纲要求①掌握药剂学、剂型、制剂的概念。
②掌握药典的概念、处方的概念和类型。
③熟悉制剂学、调剂学、药物、中药、生物技术药物的概念。
④熟悉剂型的作用及分类。
⑤了解药剂学的分支学科。
⑥了解药剂学的任务和发展。
⑦了解GMP、GLP、GCP。
⑧了解药品注册管理办法。
习题（一）名词解释1．药剂学2．调剂学3．制剂学4．剂型5．制剂6．药典7．法定处方8．医师处方*9．中药10．处方药11．非处方药（二）选择题Ⅰ单项选择题1．研究药物制剂的基本理论、处方设计、制备工艺、质量控制与合理应用的综合性技术科学，称为A．制剂学B．调剂学C．药剂学D．方剂学E．工业药剂学2．《中华人民共和国药典》最早颁布的时间是A．1949年B．1953年C．1963年D．1977年E．1985年3．根据《国家药品标准》的处方，将原料药物加工制成具有一定规格的制品，称为A．方剂B．调剂C．中药D．制剂E．剂型4．药品生产、供应、检验和使用的主要依据是A．GLP B．GMP C．药典D．药品管理法E．GCP5．下列关于药典作用的表述中，正确的是A．药典作为药品生产、检验、供应的依据B．药典作为药品检验、供应与使用的依据C．药典作为药品生产、供应与使用的依据D．药典作为药品生产、检验与使用的依据E．药典作为药品生产、检验、供应与使用的依据6．以下有关药物制成剂型的叙述中，错误的是A．药物剂型应与给药途径相适应B．药物供临床使用之前，都必须制成适合于应用的剂型C．一种药物只能制成一种剂型D．一种药物制成何种剂型与临床上的需要有关E.一种药物制成何种剂型与药物的性质有关7．现行的《中华人民共和国药典》版本为A．1990年版B．1995年版C．1998年版D．2005年版E．2000年版8．美国药典的英文缩写为A．USP B．GMP C．BP D．JP E．WHO9．我国开始对药品实行GMP认证制度的时间是A．1980年1月1日B．1985年7月1日C．1990年7月1日D．1995年10月1日E．2000年1月1日10．药剂学的分支学科有A．物理药剂学B．生物药剂学C．工业药剂学D．药物动力学E．A、B、C、D、都包括11．《中华人民共和国药典》是由A．国家编纂的药品规格、标准的法典B．国家颁布的药品集C．国家药品监督管理局制定的药品标准D．国家卫生部制定的药品标准E．国家药典委员会制定的药物手册12．《中华人民共和国药典》2005年版从什么时候开始实施A．2005年1月1日B．2005年5月1日C．2005年8月1日D．2005年7月1日E.2006年1月1日Ⅱ配伍选择题（备选答案在前，试题在后；每组均对应同一组备选答案，每题只有一个正确答案，每个备选答案可重复选用，也可不选用。
）[1-5题]A．物理药剂学B．工业药剂学C．生物药剂学D．药物动力学E．临床药学1．研究药物制剂工业生产的基本理论、工艺技术、生产设备和质量管理的一门学科*2．用化学动力学的原理研究药物在体内的吸收、分布、代谢和排泄过程的一门学科*3．应用物理化学的基本原理和手段研究药剂学有关剂型的性质的一门学科4．以病人为对象，研究合理、有效以及安全用药的一门学科5．研究药物及其剂型、生理因素与药效间关系的一门学科[6-7题]A.药物剂型B.药物制剂C.药剂学D.调剂学E.方剂6．根据药典等标准、为适应治疗或预防需要而制备的药物应用形式的具体品种称为7．为适应治疗或预防需要而制备的药物应用形式称为Ⅲ多项选择题1．药剂学论述的主要内容包括药物制剂的A．基本理论B．质量控制C．仓储保管D．生产技术E．临床应用2．以下关于《中华人民共和国药典》的叙述中，正确的是A．现行版是2005版B．由卫生部组织编纂C．是我国记载药品规格、标准的法典D．由国家药品监督管理局审批颁布E．2000版《中国药典》分为一、二两部3．有关药剂学概念的正确表述有A．药剂学所研究的对象是药物制剂B．药剂学所研究的内容包括基本理论、处方设计和合理应用C．药剂学所研究的内容包括基本理论、处方设计和制备工艺D．药剂学所研究的内容包括基本理论、处方设计、制备工艺、质量控制和合理应用E．药剂学是一门综合性技术科学4．下列关于处方药和非处方药的陈述中，不正确的是A．医疗机构可以使用处方药、非处方药B．处方药、非处方药必须由取得药品生产许可证的生产企业生产C．处方药、非处方药必须由取得药品经营许可证的企业经营D．处方药、非处方药均可在大众传播媒介进行广告宣传E．处方药必须凭医师处方购买5．以下属于法定处方的是A．《中国药典》收载的处方B．《国家药品标准》收载的处方C．医院的处方集D．地方药品标准收载的处方E．协议处方（三）是非题1．新药系指我国未生产过的药品。
（）2．自2002年12月1日起，研制新药应符合《药品注册管理办法》（试行）的要求。
（）3．非处方药是指由国家药品监督管理局公布的、不需要凭执业医师和执业助理医师处方，消费者可以自行判断、购买和使用的药品。
（）4．GMP是药品生产质量管理规范，系指在药品生产过程中，运用科学、合理、规范化的条件和方法保证生产优质药品的一整套科学管理方法。
（）5．《国家药品标准》是药剂工作者重要的参考依据，其不具有法律的约束力。
（）6．WHO编纂的《国际药典》对各国有很强的法律约束力。
（）（四）填空题1．将原料药加工制成适用于医疗和预防需要的形式，称为。
2．生物药剂学是阐明药物的剂型因素，用药对象的生物因素与三者关系的药剂学分支学科。
3．《药品生产质量管理规范》简称。
4．药典是一个国家的法典，由编纂，由政府颁布施行。
5．药剂学是研究药物制剂的基本理论、处方设计、制备工艺、质量控制与等的综合性应用技术科学。
6．美国药典简称。
7．英国药典简称。
8．日本药局方简称。
9．药物剂型按物态可分为固体、半固体、液体和等类型。
10．药物剂型按分散系统可分为真溶液类，胶体溶液类，乳浊液类，混悬液类，气体分散体类和。
（五）问答题1．简述药剂学各分支学科的内涵。
2．简述药典的性质与作用。
3．试述处方药与非处方药在使用上的主要区别。
4．药物剂型有哪几种分类方法？习题答案及要点（一）名词解释1．药剂学：是研究药物制剂的基本理论、处方设计、制备工艺、质量控制与合理应用的综合性技术科学。
2．调剂学：研究方剂的配制、服用等有关技术和理论的科学称为调剂学。
3．制剂学：研究药物制剂生产工艺理论的科学称为制剂学。
4．剂型：诊断、预防及治疗疾病用的药物在供临床应用以前必须制成一定的形式，即药物剂型（简称剂型）。
5．制剂：一种药物按照一定的质量标准，制成某一剂型，所得的具体药品称药物制剂（简称制剂）。
6．药典：是一个国定记载药品规格和标准的法典，由国家组织的药典委员会编写，由政府颁布施行。
药典中收载疗效确切、副作用小、质量较稳定的常用药物及其制剂。
7．法定处方：指药典和国家药品标准收载的处方。
它具有法定性质，在制备或医师写法定制剂时，均应遵照法定处方的规定。
8．医师处方：是医师对某一患者用药的书面文件，是调配与发给患者药剂的依据，具有法律上、技术上和经济上的意义。
9．中药：系指我国经典著作收载的、为中医师传统使用的药材和饮片。
10．处方药：凡必须凭执业医师或执业助理医师处方才可配制、购买和使用的药品称处方药。
11．非处方药：患者不需要凭执业医师或执业助理医师处方即可自行判断、购买和使用的药品称非处方药。
（二）选择题Ⅰ单项选择题1．C2．B3．D4．C5．E6．C7．D8．A9．D 10．E11．A 12．DⅡ配伍选择题1．B2．D3．A4．E5．C6．B7．AⅢ多项选择题1．ABDE2．ACDE3．ADE4．CD5．AB（三）是非题1．×（新药是指未曾在中国境内上市销售的药品。
）2．√3．√4．√5．×（国家药品标准是药剂工作者重要的工作依据，具有法律的约束力。
）6．×（WHO 编纂的《国际药典》对各国无直接的法律约束力，仅供各国编纂药典时参考。
）（四）填空题1．剂型2．药效3．GMP4．记载药品规格、标准；国家组织的药典委员会5．合理应用6．USP7．BP8．JP9．气体10．固体分散体类（五）问答题1．药剂学各分支学科的内涵如下。
①工业药剂学：是研究药物制剂生产的基本理论、工艺技术、生产设备和质量管理，为临床提供安全、有效、质量可控和使用方便的优质药品的一门分支学科。
②物理药剂学：是应用物理化学的基本原理、方法和手段，研究药剂学中剂型、制剂的处方、制备工艺及质量控制等的学科。
③药用高分子材料学：研究各种药用高分子材料的结构、制备、性能与应用的学科。
④生物药剂学：是研究药物及其制剂在体内的吸收、分布、代谢和排泄过程，阐明药物的剂型因素、用药对象的生物因素与药效三者关系的一门学科。
⑤药物动力学：是研究药物及其代谢产物在人体或动物体内的含量随时间变化的过程，并提出用于解释这一过程的数学模型，为指导合理安全用药、剂型和剂量设计等提供量化指标的一门学科。
⑥临床药学：是主要阐述药物在疾病治疗中的作用、相互作用及指导合理用药的一门学科。
2．药典的性质与作用：①药典是一个国家记载药品质量规格、标准的法典。
由国家组织药典委员会编纂，并由政府颁布施行，具有法律的约束力。
②作为药物生产、检验、供应与使用的依据。
③药典在一定程序上反映了该国家药物生产、医疗和科技的水平，也体现出医药卫生工作的特点和服务方向。
④药典在保证人民用药有效、安全，促进药物研究和生产上起到重大作用。
3．处方药与非处方药在使用上的主要区别：处方药一般在药效上专用性强或副作用大，需执业医师或执业助理医师处方，在专业人士指导下方可购买、使用，非处方药一般安全、有效、价廉，可不凭医师处方自行购买、使用。
4．药物剂型有三种分类方法，一是按形态分类，可分为液体剂型、半固体剂型、气体剂型和固体剂型；二是按分散系统分类，可分为溶液型、胶体溶液型、乳剂型、混悬型、气体分散型、固体分散型；三是按给药途径分类，可分为经胃肠道给药剂型和非胃肠道给药剂型。
第十一、十二章口服固体制剂(一)(散剂、颗粒剂、胶囊剂、滴丸剂)教学大纲要求①掌握粉碎、筛分、混合的概念和各操作的影响因素。
②掌握散剂、颗粒剂、滴丸剂的概念和特点。
③掌握胶囊剂的概念、特点和分类方法。
④掌握硬胶囊剂和软胶囊剂的组成、辅料的选择和制备工艺。
*⑤熟悉粉碎、筛分、混合的机理和方法。
⑥熟悉散剂、颗粒剂、滴丸剂的制备方法及质量检查。
*⑦了解粉碎、筛分、混合的设备。
习题(一)名词解释1．粉碎2．筛分3．散剂4．颗粒剂5．滴丸剂6．胶囊剂*7．粉碎度8．配研法(二)选择题Ⅰ单项选择题1．下列表述正确的是A．按我国药典规定的标准筛规格，筛号越大，孔越大B．工业用标准筛用“目”表示筛号，即每厘米长度上筛孔数目C．在无菌车间使用球磨机，可制备无菌产品D．两种组分数量差别大的物料混合时，应将组分数量大的物料先全部加入混合机中，再加入组分小的物料后混合均匀E．流能磨适用于无菌粉末粉碎，但不适用于低熔点及对热敏感药物2．以下适合于热敏感性药物的粉碎设备为A．万能粉碎机B．球磨机C．流能磨(气流式粉碎机)D．胶体磨E．冲击式粉碎剂机*3．以下关于球磨机的说法，错误的为A．装药量为筒体积的15％～20％B．圆球装量为筒体积的30％～50％C．工作转速为临界转速的60％～85％D．物料的直径应为圆球的1/2～1/4 E．球磨机主要是通过研磨作用进行粉碎*4．V型混合器适宜的转速和填充量分别为A．临界转速的70％～90％，容器体积的70％以上B．临界转速的30％～40％，容器体积的70％～90％C．临界转速的80％以上，容器体积的70％～90％D．临界转速的30％～40％，容器体积的30％E．临界转速的l0％以上，容器体积的70％～90％*5．下列关于粉碎的叙述哪一条是错误的A．散剂的粉碎机械常用的有球磨机和流能磨等，球磨机可粉碎低熔点的药物，因为它有冷却作用B．难溶于水的药物可采用加液研磨法制成极细粉C．流能磨是利用高压气流使药物的颗粒间以及颗粒与器壁间碰撞、摩擦而产生强烈的粉碎作用D．药物粉末粒子易聚集的，在粉碎时可加入辅料共同粉碎E．粉碎是将机械能转变为表面能6．下列对于药粉粉末分等叙述错误者为A．最粗粉可全部通过一号筛B．粗粉可全部通过三号筛C．中粉可全部通过四号筛D．细粉可全部通过五号筛E．最细粉可全部通过六号筛*7．下列关于粉碎的叙述，错误的是A．粉碎过程主要是靠外加机械力破坏物质分子的内聚力来实现的B．球磨机不能进行无菌粉碎C．流能磨适用于低熔点或热敏感药物的粉碎D．球磨机常用于毒、剧和贵重药品的粉碎E．自由粉碎是指在粉碎过程中已达到粉碎程度要求的粉末能及时排出的操作8．以下可作为软胶囊内容物的是A．药物的油溶液B．药物的水溶液C．药物的水混悬液D．O／W型乳剂E．药物的稀醇溶液9．下列对散剂特点的叙述，错误的是A．制备简单、剂量易控制B．外用覆盖面大，但不具保护、收敛作用C．贮存、运输、携带方便D．表面积大、易分散、奏效快E．便于小儿服用10．散剂按医疗用途可分为A．倍散与普通散剂B．内服散剂与外用散剂C．单散剂与复散剂D．分剂量散剂与不分剂量散剂E．一般散剂与泡腾散剂*11．下列关于散剂的叙述中，正确的是A．水不溶性药物有特定的CRH值B．两种水溶性药物混合物的CRH大约等于各药物CRH的和C．两种水溶性药物混合物的CRH大约等于各药物CRH的乘积D．由水不溶性药物组成且当不发生作用的混合物，其临界相对湿度等于各药物的CRH之乘积E．水溶性药物没有特定的CRH值12．下列关于滴丸剂的叙述，不正确的是A．发挥药效迅速，生物利用度高B．可将液体药物制成固体滴丸，便于运输C．生产设备简单、操作方便、利于劳动保护D．可制成缓释制剂E．滴丸在药剂学上又称胶丸*13．滴丸与胶丸的相同点为A．均采用明胶为基质B．均采用PEG为基质C．均为滴制法制备D．均为丸剂E．均为压制法制备14．下列关于胶囊剂的叙述不正确的是A．可将液态药物制成固体剂型B．可提高药物的稳定性C．可避免肝的首过效应D．可掩盖药物的不良嗅味E．可以掩盖内容物的苦味15．以下适合制成胶囊的药物为A．药物的水溶液B．易风化药物C．吸湿性很强的药物D．性质相对稳定的药物E．药物的稀乙醇溶液16．常用的软胶囊囊壳的组成为A．明胶、甘油、水B．淀粉、甘油、水C．可压性淀粉、丙二醇、水D．明胶、甘油、乙醇E．PEG、水17．胶囊剂不需要检查的项目是A．装量差异B．崩解时限C．硬度D．水分E．外观*18．下面的叙述错误的是A．除另有规定外，散剂的干燥失重不得超过2.0％B．散剂的粉碎度越大越好C．儿科和外用散剂应为最细粉D．粉碎度是物料粉碎前的粒径与物料粉碎后粒径的比值E．眼用制剂中混悬的不溶性颗粒的细度要求为极细粉*19．固体石蜡的粉碎过程中加入干冰，此粉碎过程属于A．混合粉碎B．开路粉碎C．低温粉碎D．湿法粉碎E．循环粉碎20．软胶囊的制备方法有压制法和A．乳化法B．熔融法C．塑制法D．滴制法 E.泛制法*21．流能磨的粉碎原理是A．不锈钢齿的撞击与研磨作用B．旋锤高速转动的撞击作用C．机械面的相互挤压作用D．圆球的撞击与研磨作用E．高速压缩空气使药物颗粒之间或颗粒与室壁之间通过撞击作用而粉碎22．药筛筛孔目数习惯上是指A．每厘米长度上筛孔数目B．每平方厘米面积上筛孔数目C．每英寸长度上筛孔数目D．每平方英寸面积上筛孔数目E．每市寸长度上筛孔数目23．以下关于颗粒剂的叙述，错误的是A．颗粒剂可包衣B．可适当添加矫味剂等调节口感C．颗粒剂的含水量不得超过3％D．飞散性和附着性较小E．吸湿性和聚集性较小24．制备空胶囊时，加入甘油的作用是A．延缓明胶溶解B．制成肠溶胶囊C．作为防腐剂D．增加可塑性E．起矫味作用*25．下列关于过筛过程的叙述，错误的是A．加到药筛的物料不宜过多，以免堆积过厚B．物料在筛网上的运动速率越小，则过筛效率越好C．含水量大的物料应先适当干燥再过筛D．为防止粉尘飞扬，过筛时应避免振动E．黏性、油性较强的药粉，应掺入其他药粉一同过筛26．下列关于颗粒剂的叙述，错误的是A．颗粒剂都要求溶解在水中服用B．颗粒剂分为可溶性颗粒剂、混悬性颗粒剂及泡腾性颗粒剂C．颗粒剂还有肠溶颗粒剂、缓释颗粒剂等D．颗粒剂是指药物与适宜的辅料制成的具有一定粒度的干燥颗粒状制剂E．药物与适宜的辅料制成的干燥粉末状或细粒状制剂称为细粒剂27．已规定检查溶出度的胶囊剂，不必再检查A．崩解度B．重量差异C．溶解度D．硬度E．脆碎度28．《中国药典》规定，软胶囊剂的崩解时限为A．45分钟B．60分钟C．120分钟D．15分钟E．30分钟*29．下列关于粉碎的叙述，错误的是A．湿法粉碎是指药物中加入适当水或其他液体进行研磨粉碎的方法B．湿法粉碎通常液体的选用是以药物遇湿不膨胀、两者不起变化、不妨碍药效为原则C．湿法粉碎常用的方法有“加液研磨”和“水飞法”D．干法粉碎就是使物料处于干燥状态下进行粉碎的操作E．湿法粉碎可以避免粉尘飞扬，但可使能量消耗增加30．硬胶囊剂的崩解时限为A．60分钟B．120分钟C．15分钟D．30分钟E．45分钟*31．下列关于粉碎方法的叙述中，错误的是A．氧化性药物和还原性药物必须单独粉碎B．贵重药物应单独粉碎C．含共熔成分时，不能混合粉碎D．粉碎过程应及时筛去细粉以提高效率E．性质及硬度相近的药物可混合粉碎32．制备颗粒剂的工艺流程为A．粉碎→过筛→混合→分剂量→包装B．粉碎→混合→制软材→制粒→干燥→整粒→包装C．粉碎→过筛→混合→制软材→制粒→分级→分剂量→包装D．粉碎→过筛→混合→制软材→制粒→干燥→整粒与分级→包装E．粉碎→过筛→混合→制软材→制粒→干燥→整粒→压片→包装*33．以下各项中，不影响散剂混合质量的因素是A．组分的堆密度B．含易吸湿性成分C．组分的吸湿性与带电性D．组分的比例E．各组分的色泽34．当胶囊剂内容物的平均装量为0.3 g时，其装量差异限度为A．±5.0％B．±2.0％C．±l.0％D．±l0.0％E．±7.5％35．当硬胶囊内容物为易风化药物时，将使硬胶囊A．分解B．软化C．变脆D．变形E．变色36．密度不同的药物在制备散剂时，采用A．将轻者加在重者之上混合B．等量递加混合C．将重者加在轻者之上混合D．搅拌混合E．多次过筛混合37．颗粒剂贮存的关键为A．防热B．防冷C．防潮D．防虫E．防光38．组分比例差异大的药物在制备散剂时，采用A．将剂量小的组分先加入容器中垫底，再加入剂量大的组分混合B．将组分一同加入容器中混合C．将剂量大的组分全部加入容器中垫底，再加入剂量小的组分混合D．长时间研磨混合E．将剂量大的组分的一部分先加入容器中垫底，再加入剂量小的组分混合*39．软胶囊的胶皮处方，较适宜的重量比是增塑剂：明胶：水为A．1:0.4～0.6:1 B．1:1:l C．0.4～0.6:1:1D．0.5:1:1 E．1:0.5:140．下列关于散剂的叙述，错误的是A．药物粉末混合时摩擦产生静电阻碍粉末混匀，通常可加少量表面活性剂B．散剂与液体制剂比较，散剂比较稳定C．散剂比表面积大，挥发性成分宜制成散剂D．散剂为一种或多种药物均匀混合制成的粉末状制剂E．散剂与片剂比较，散剂易分散、起效迅速、生物利用度高41．常用于混悬剂与乳剂等分散系粉碎的机械为A．气流粉碎机B．冲击式粉碎机C．球磨机D．胶体磨E．锤击式粉碎机42．用于制备空胶囊壳的主要原料为A．糊精B．明胶C．淀粉D．蔗糖E．阿拉伯胶*43. 下列各种辅料中，哪一组可以为泡腾颗粒剂的发泡剂A.聚乙烯吡咯烷酮-淀粉B.碳酸氢钠-硬脂酸C.氢氧化钠-枸橼酸D.碳酸氢钠-枸橼酸E.豆磷脂-吐温8044. 下列关于滴丸剂的叙述哪一条是不正确的A.可将液体药物制成固体丸，便于运输B.生产成本比片剂更低C.可制成缓释制剂D.发挥药效迅速，生物利用度高E.PEG6000w作基质，二甲基硅油作冷凝剂Ⅱ配伍选择题(备选答案在前，试题在后；每组均对应同一组备选答案，每题只有一个正确答案；每个备选答案可重复选用。