沈阳药科大学药剂学固体制剂

沈阳药科大学药剂学试题4药剂学试题4 一、解释下列名词（10分）1药典2表面活性剂3HLB值4流变学5休止角6固体分散体7热原8冷冻干燥9等张溶液10絮凝剂11三相气雾剂12缓释制剂13浸出制剂14经皮吸收制剂15被动靶向制剂16表观分布容积17肾清除率18主动转运19代谢20肠肝循环二、写出下列辅料的中文名称及用途（10分）1Tween 802Span 803βCYD4EC5Eudragit E6Eudragit RL7Eudragit RS8HPMCP9CAP10PEG11PVP12HPMC13L-HPC14CCNa15MC16CMC-Na17PVPP18MCC19Poloxamer20Carbomer三、多选题（将答案写在括号里）（20分）1 下列哪些叙述是正确的（）a 剂型不同只能改变药物的作用强度，并不能改变药物的作用性质。

b 法定处方主要是指药典和部颁标准收载的处方。

c 表面活性剂均有一定的毒性，其毒性大小顺序为阳离子型> 阴离子型 > 非离子型。

d 表面活性剂具有增溶作用时其浓度一定大于cmc。

e 增溶体系是热力学稳定体系，因此即使再用溶剂稀释亦不会发生溶质溶解度下降而析出的现象。

2 下列关于乳剂的描述哪些是正确的（）a 静脉注射用乳剂为o/w型乳剂，多用磷脂为乳化剂。

b油相与水相混合分散时形成乳剂的类型取决于乳化剂的种类而与相体积比无关。

c乳化剂在乳滴周围定向排列形成乳化膜，乳化膜的牢固程度与乳剂的稳定密切相关。

d乳剂的分层为可逆过程，分层速度与相体积比成反比。

乳剂絮凝亦是可逆过程，但该现象是乳剂破坏的前奏。

e乳剂中常加入辅助乳化剂，其主要作用是提高乳剂的粘度和增强乳化膜的强度，本身乳化能力很弱或无乳化能力。

3 下列哪些叙述是正确的（）a 热原可被活性炭吸附除去，也可被酸碱破坏，但热压灭菌（121℃30分钟）却不能破坏热原。

b 反渗透法能制得供注射用的注射用水，而电渗析法却只能用于原水的处理。

沈阳药科大学药剂学实验计划一、实验课程的目标与意义药剂学是一门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。

药剂学实验作为药剂学课程的重要组成部分，旨在通过实践操作，加深学生对药剂学理论知识的理解和掌握，培养学生的实验技能、创新思维和科学素养，为今后从事药学相关工作打下坚实的基础。

二、实验课程的基本要求1、学生应在实验前认真预习实验内容，了解实验目的、原理、方法和步骤，熟悉实验仪器和设备的使用方法。

2、学生应遵守实验室的规章制度，保持实验室的整洁和安静，爱护实验仪器和设备，节约实验药品和材料。

3、学生应在实验过程中严格按照实验操作规程进行操作，认真观察实验现象，如实记录实验数据，及时分析和处理实验中出现的问题。

4、学生应在实验结束后认真撰写实验报告，总结实验结果和体会，回答实验思考题。

三、实验项目设置实验项目一：溶液型液体制剂的制备1、实验目的（1）掌握溶液型液体制剂的制备方法和操作要点。

（2）熟悉溶液型液体制剂的质量检查方法。

2、实验内容（1）制备复方碘溶液、薄荷水等溶液型液体制剂。

（2）观察制剂的外观、色泽、澄清度等，并测定其 pH 值、渗透压等质量指标。

3、实验仪器和设备电子天平、量筒、烧杯、玻璃棒、pH 计、渗透压计等。

实验项目二：混悬型液体制剂的制备1、实验目的（1）掌握混悬型液体制剂的制备方法和稳定剂的选择原则。

（2）熟悉混悬型液体制剂的质量评价方法。

2、实验内容（1）制备炉甘石洗剂、复方硫磺洗剂等混悬型液体制剂。

（2）观察制剂的沉降体积比、微粒大小、分散均匀度等，并评价其稳定性。

3、实验仪器和设备电子天平、量筒、烧杯、玻璃棒、显微镜、离心机等。

实验项目三：乳剂型液体制剂的制备1、实验目的（1）掌握乳剂型液体制剂的制备方法和乳化剂的选择原则。

（2）熟悉乳剂型液体制剂的类型鉴别和质量评价方法。

2、实验内容（1）制备鱼肝油乳、液状石蜡乳等乳剂型液体制剂。

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.。

28 实验六 栓剂的置换价测定及其制备一、 实验目的1．掌握热熔法制备栓剂的工艺过程。

2．掌握置换价测定方法及应用。

二、 实验指导栓剂是指药物与基质均匀混合后制成的具有一定形状和重量的专供腔道给药的固体制剂，它在常温下应为固体，但遇体温时应能溶化或软化。

栓剂既可以发挥局部作用，也可以发挥全身作用。

目前，常用的栓剂有肛门栓（直肠栓）和阴道栓。

肛门栓一般做成鱼雷形或圆锥形，阴道栓有球形、卵形、鸭舌形等形状。

栓剂的基本组成是药物和基质。

常用基质可分为油脂性基质与水溶性基质两大类。

油脂类基质，如可可豆脂、半合成脂肪酸酯、氢化植物油等。

水溶性基质，如甘油明胶、聚氧乙烯硬脂酸酯（S —40）和聚乙二醇类等。

某些基质中还可加入表面活性剂使药物易于释放和被机体吸收。

栓剂的制备方法有搓捏法、冷压法和热熔法三种。

脂溶性基质栓剂的制备可采用三种方法中的任何一种，而水溶性基质的栓剂多采用热溶法制备。

热熔法制备栓剂的工艺流程如下：制备栓剂用的固体药物，除另有规定外，应为100目以上的粉末，为了使栓剂冷却后易从模型中推出，灌模前模型应涂润滑剂。

水溶性基质涂油溶性润滑剂，如液体石蜡；油溶性基质涂水溶性润滑剂，如软皂乙醇液（由软皂、甘油各一份及90%乙醇五份混合而成）。

不同的栓剂处方用同一模型制得的容积是相同的，但其重量则随基质与药物密度的不同而有差别。

为了正确确定基质用量以保证剂量准确，常需预测药物的置换价。

29置换价（f ）定义为主药的重量与同体积基质重量的比值。

如碘仿与可可豆脂的置换价为3.6，即3.6g 碘仿和1g 可可豆脂所占容积相等。

由此可见，置换价即为药物的密度与基质密度之比值。

所以，对于药物与基质的密度相差较大及主药含量较高的栓剂，测定其置换价尤具有实际意义。

当药物与基质的密度已知时，可用下式计算。

基质密度药物密度=f当基质和药物的密度不知时，可用下式计算：()W M G Wf −−= （1）式中W-每枚栓剂中主药的重量，G- 每枚纯基质栓剂的重量， M-每枚含药栓剂的重量。

药剂学试题1姓名班级一、名词解释：（20分）1.表面活性剂2.助溶：3.靶向给药系统：4.置换价：5.溶出度；6.增溶：7.浊点：8.生物利用度：9.消除：10.表观分布容积：11.平均稳态血药浓度：12.Krafft点：13.HLB值：14.沉降容积比：15.助悬剂：16.热原：17.脂质体：18.灭菌法：19.絮凝：20.休止角：二、多项选择题：（将答案填写在括号内）（18分）1.关于表面活性剂的描述下列哪些是正确的（）a.低浓度时可显著降低表面张力，表面浓度大于内部浓度。

b.在结构上为长链有机化合物，分子中含有亲水基团和亲油基团。

c.表面活性剂溶液浓度达到CMC时，表面张力达到最低。

形成胶束后，当浓度继续增加时，则分子缔和数继续增加。

d.表面活性剂均有Krafft点，吐温类的Krafft点较司盘类高。

e.表面活性剂因其对药物有增溶作用，故对药物吸收有促进作用，不可能降低药物的吸收。

2.关于高分子药用辅料的描述，下列哪些是正确的（）a.微晶纤维素可做为片剂填充剂、吸收剂、崩解剂、粘合剂。

b.CAP可作为薄膜衣材料，常用做胃溶性包衣材料使用。

c.CMS-Na可作为稀释剂使用。

d.HPMCP常作为肠溶性薄膜衣材料使用。

3.下列关于流变学的描述哪些是正确的（）a.在一定浓度下，牛顿流体流动时切变速度和切变应力成正比，即S=ηD。

b.在塑性流动曲线中（D-S曲线）存在着屈服值So ，当S值大于So时则D正比于Sc.在假塑性流动中，存在着切变稀化现象，即随着切变速度的增加，切变应力迅速增加。

d.在胀性流动中，存在着切变稠化现象，即在小切变应力阶段，随着切变应力的增加，切变速度增幅较大。

4.下面关于制粒的描述哪些是正确的（）a.制粒的目的主要是改善流动性，防止各成分的离析，阻止粉尘飞扬及器壁上的粘附。

b.在湿法制粒中，随着液体量的增加，物料分别经过以下状态：悬摆状→索带状→泥浆状→毛细管状c.从液体架桥到固体架桥的过渡存在着多种形式如粘合剂的固结，部分溶解和固化，药物溶质的析出。

沈阳药科大学学科介绍研究生专业学科介绍药剂学（国家级重点学科）药剂学学科是我校最早设置的几个主要学科之一，1955年院系调整时，以留英归国的著名药剂学家顾学裘教授为核心，进行本学科重组，使得本学科实力显著提高。

主编了国内首部《药剂学》（第一版、第二版）和大型参考书《药物制剂注解》（第二版），造就了阵容强大的药剂学专家群体。

从1956年开始招收研究生，1981年取得了博士学位授予权，1988年被评为国家重点学科，设有博士后流动站。

本学科已形成的五个主要研究方向：1.制剂技术与制剂工程主要研究内容：以控缓释为目的的造粒技术（球晶造粒技术、离心造粒技术、包衣技术等）；以提高生物利用度为目的的固体分散技术、包合技术；以微囊化、油性药物的固体化、中药浸出液的固体化等目标的喷雾造粒技术；固体物料的粉体学性质以及压缩成型性研究。

特色：造粒技术，在一步过程中直接完成难溶性药物的固体分散、速释或缓释微丸的制备，收率高。

为国家"九五"科技攻关项目，国内外领先，已申请专利和新药；离心造粒技术使颗粒球形化，具有外观美，收率高，容易包衣等特点；固体分散物的老化是一个难克服的问题，本学科已找到克服老化的方法，并制成难溶性药物的分散片及缓释制剂，为国家"八五"科技攻关项目，取得成果列为国家重点科技推广项目，有些制剂的研究已达到国际先进水平，正审批生产；用喷雾技术制备肠溶性微囊（已申请专利、并获得中国优秀专利称号）、油性药物的固体化、中药浸出液的固体化等为进一步制备颗粒剂、片剂等打下坚实的基础，特别是婴幼儿服用的肠溶颗粒剂，掩盖药物的不良嗅味，已经开始得到很好的经济效益；粉体学研究固体粒子的基本性质，对固体制剂的量化控制、保证产品的重现性有着重要意义。

2.研究方向名称：药物新剂型主要内容：渗透泵控释新剂型的研究：采用激光技术，在包有半透性薄膜的片剂表面上制成微小的释药孔，使药物以恒定的速度释放出来，达到长效、稳定的治疗效果；靶向给药新剂型的研究：研制脂质体、热敏脂质体、热敏磁性脂质体、纳米超顺磁制剂等靶向给药新剂型，使药物直接到达并浓集于靶部位（病变部位），从而最大限度地发挥药物的治疗作用；粘膜给药新剂型的研究：利用鼻粘膜、口腔粘膜、肺粘膜、眼粘膜下丰富的血管，以人体粘膜作为给药新途径，使药物直接吸收入血治疗全身性疾病；透皮给药新剂型的研究：以皮肤为给药途径，利用高分子材料压敏胶将药物制成透皮贴剂的形式，辅以物理、化学促渗手段，使药物透过皮肤进入血液循环，治疗全身性疾病。

依托于药品GMP实训中心的实践课程改革与管理作者：沙露平郭永学刘剑桥周欣羽来源：《教育教学论坛》2020年第39期[摘要] 为順应时代发展，满足药企对复合应用型人才的需求，沈阳药科大学对新工科背景下药学综合实践教学活动进行了改革。

实践教学是培养药学人才的工程实践能力和创新能力的重要环节。

但是由于制药行业的特殊性，学生在生产实习过程中进入核心车间学习的时间较短，多属于认识性实习，难以满足实践教学的需要，也无法达到制药工业对工程人才实践能力的要求。

因此发展GMP实训教育势在必行。

文章旨在探讨新工科背景下，依托于GMP实训中心的药学工程类实践课程的改革和规范化管理方式。

通过构建多层次GMP实训教学体系、虚拟仿真教学平台、增设劳动课、开展多元化实践教学活动，培养学生实践创新能力和优良品性。

实践课程的规范化管理要通过建立科学的课程考核制度和合理的课堂管理制度实现，同时要配合建立完善的中心管理制度，保障中心高效、有序运转，进而全面提升教学质量。

[关键词] GMP实训中心;工程类实践课程改革;规范化管理[基金项目] 2018年辽宁省教育厅发布沈阳药科大学普通高等教育本科教学改革研究立项项目“基于制药产业技术需求的制药工程专业工程课程教学内容、课程体系改革研究与实践”[作者简介] 沙露平（1988—），女（回族），辽宁抚顺人，药剂学博士，沈阳药科大学制药工程学院讲师，研究方向为药物递送系统和难溶性药物增溶;郭永学（1973—），男，内蒙古赤峰人，生物化工博士，沈阳药科大学制药工程学院教授，硕士生导师（通信作者），主要从事固体制剂工程与产业化关键技术研究。

[中图分类号] G642 ; ;[文献标识码] A ; ; [文章编号] 1674-9324（2020）39-0214-03 ; ;[收稿日期] 2019-11-06实践表明，我校化学和药学相关课程内容，设置合理、系统、规范，而工程类相关课程体系不够完善，存在部分教学内容陈旧、有重复，侧重点和深广度与专业实际结合不紧密等问题，一定程度上制约了制药人才培养质量[1]。

28 实验六 栓剂的置换价测定及其制备一、 实验目的1．掌握热熔法制备栓剂的工艺过程。

2．掌握置换价测定方法及应用。

二、 实验指导栓剂是指药物与基质均匀混合后制成的具有一定形状和重量的专供腔道给药的固体制剂，它在常温下应为固体，但遇体温时应能溶化或软化。

栓剂既可以发挥局部作用，也可以发挥全身作用。

目前，常用的栓剂有肛门栓（直肠栓）和阴道栓。

肛门栓一般做成鱼雷形或圆锥形，阴道栓有球形、卵形、鸭舌形等形状。

栓剂的基本组成是药物和基质。

常用基质可分为油脂性基质与水溶性基质两大类。

油脂类基质，如可可豆脂、半合成脂肪酸酯、氢化植物油等。

水溶性基质，如甘油明胶、聚氧乙烯硬脂酸酯（S —40）和聚乙二醇类等。

某些基质中还可加入表面活性剂使药物易于释放和被机体吸收。

栓剂的制备方法有搓捏法、冷压法和热熔法三种。

脂溶性基质栓剂的制备可采用三种方法中的任何一种，而水溶性基质的栓剂多采用热溶法制备。

热熔法制备栓剂的工艺流程如下：制备栓剂用的固体药物，除另有规定外，应为100目以上的粉末，为了使栓剂冷却后易从模型中推出，灌模前模型应涂润滑剂。

水溶性基质涂油溶性润滑剂，如液体石蜡；油溶性基质涂水溶性润滑剂，如软皂乙醇液（由软皂、甘油各一份及90%乙醇五份混合而成）。

不同的栓剂处方用同一模型制得的容积是相同的，但其重量则随基质与药物密度的不同而有差别。

为了正确确定基质用量以保证剂量准确，常需预测药物的置换价。

29置换价（f ）定义为主药的重量与同体积基质重量的比值。

如碘仿与可可豆脂的置换价为3.6，即3.6g 碘仿和1g 可可豆脂所占容积相等。

由此可见，置换价即为药物的密度与基质密度之比值。

所以，对于药物与基质的密度相差较大及主药含量较高的栓剂，测定其置换价尤具有实际意义。

当药物与基质的密度已知时，可用下式计算。

基质密度药物密度=f当基质和药物的密度不知时，可用下式计算：()W M G Wf −−= （1）式中W-每枚栓剂中主药的重量，G- 每枚纯基质栓剂的重量， M-每枚含药栓剂的重量。