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PART 3 INDUSTRIAL PHARMACYUnit 11 Tablets (The Pharmaceutical Tablets Dosage Form)Role in TherapyThe oral route of drug administration is the most important method of administering drugs for systemic effects. Except in cases of Insulin therapy，the parenteral route is not routinely used for self-administration of medications. The topical route of administration has only recently been employed to deliver drugs to the body for systemic effects，with two classes of marketed products: Nitroglycerin硝酸甘油酯for the treatment of angina心绞痛and scopolamine莨菪胺for the treatment of motion sickness晕动病，指晕车、晕船等. Other drugs are certain to follow，but the topical route of administration is limited in its ability to allow effective drug absorption for systemic drug action. The parenteral route of administration is important in treating medical emergencies in which a subject is comatose昏迷的or cannot swallow，and in providing various types of maintenance therapy for hospitalized patients. Nevertheless，it is probable that at least 90 % of all drugs used to produce systemic effects are administered投药，给药by the oral route. When a new drug is discovered，one of the first questions a pharmaceutical company asks is whether or not drug can be effectively administered for its intended effect by the oral route. If it cannot，the drug is primarily relegated to被降级到administration in a hospital setting or physician's office. If patient self- administration cannot be achieved，the sales of the drug constitute only a small fraction of what the market would be otherwise. Of drugs that are administered orally，solid oral dosage forms represent the preferred class of product. The reasons for this preference are as follows. Tablets and capsules represent unit dosage forms in which one usual dose of the drug has been accurately placed. By comparison相比之下，liquid oral dosage forms，such as syrups，suspensions，emulsions，solutions，and elixirs，are usually designed to contain one dose of medication in 5 to 30 ml. The patient is then asked to measure his or her own medication using a teaspoon，第三部分工业药剂学第11单元药片(医药的片剂剂型)在治疗中的作用口服给药途径是通过给药获得全身作用效果中最重要的方法。
所选译文位置：《制药工程专业英语》Unit10，P108外文文献原稿和译文原稿The basic crude process that had been employed for extraction and the accompanying extraneous factors determines the purification process 。
The purification process should be designed to decolorize the Heparins in as gentle a manner as possible ,and to minimize alterations in the molecule 。
The oxidizing agents used in scheme 1,and the conditions employed should not in themselves react with heparin ,but not only act on color bodies or to remove unwanted impurities .Alkaline conditions have been shown to have no effect on potency 。
Reducing agents are infrequently used 。
these compounds are primarily useful for removal of metallic salt contamination 。
The use of complexing agents or ion exchange resins in a purification scheme serves to still further purify the crude Hreparins 。
1、Digitalis is one of the most frequently used medications in the treatment of heart failure and arrhythmia. It increases the contractility of the heart muscle and modifies vascular resistance. It also slows conduction through the atrioventricular node in the heart, making it useful in the treatment of atrial fibrillation and other rapid heart rhythms洋地黄是其中一个最常用的药物治疗心力衰竭和心律失常。
它增加了的心肌收缩血管阻力和修改。
它也减慢传导通过传导节点的心使它有用的治疗房颤和其他快速心律2、The formulation of a parenteral product involves the combination of one or more ingredientswith a medicinal agent to enhance the convenience，acceptability，or effectiveness of the product. Rarely is it preferable to dispense a drug singly as a sterile dry powder unless the formulation of a stable liquid preparation is not possible非肠道用产品的配方涉及一个或者更多组成部分间的结合，这些组成部分（各自）都含有一种用以提高产品方便性、可接受性或者疗效的有效成分。
Pharmaceutical engineering is a specialized field that combines the principles of engineering with the science of medicine to design,develop,and manufacture pharmaceutical products.This interdisciplinary approach is crucial for the advancement of healthcare and the creation of innovative treatments for various diseases and conditions.Introduction to Pharmaceutical EngineeringPharmaceutical engineering involves the application of chemical,mechanical,and electrical engineering principles to the production of drugs and medicines.It is a rapidly evolving field that plays a pivotal role in the development of new pharmaceutical products,from the initial stages of research and development to the final stages of manufacturing and quality control.Education and TrainingTo excel in pharmaceutical engineering,one must have a strong foundation in science and mathematics.A bachelors degree in pharmaceutical engineering,chemical engineering,or a related field is typically required.Advanced degrees such as a masters or Ph.D.can provide specialized knowledge and research opportunities,opening doors to more advanced roles in the industry.Key Areas of Pharmaceutical Engineering1.Drug Design and Formulation:Engineers in this area focus on the development of new drugs and the optimization of existing formulations to improve efficacy,safety,and patient compliance.2.Process Engineering:This involves designing and optimizing the manufacturing processes for pharmaceutical products,ensuring efficiency,costeffectiveness,and adherence to regulatory standards.3.Quality Control and Assurance:Engineers in this area are responsible for ensuring that pharmaceutical products meet the required quality standards through testing and inspection methods.4.Equipment Design:Designing and improving the machinery and equipment used in pharmaceutical manufacturing,including reactors,separators,and packaging machinery.5.Regulatory Compliance:Understanding and adhering to the complex regulatorylandscape governing the pharmaceutical industry,including FDA regulations and international standards.Technological AdvancementsThe field of pharmaceutical engineering is constantly being shaped by new technologies and innovations.Some of the key technological advancements include: Biotechnology:The use of biological processes to develop new drugs and therapies. Nanotechnology:The application of nanotechnology in drug delivery systems to improve the targeting and efficacy of medications.Bioinformatics:The use of computational methods to analyze biological data,aiding in drug discovery and development.3D Printing:The potential use of3D printing in the production of complex drug formulations and personalized medicine.Career OpportunitiesPharmaceutical engineers can find employment in various sectors,including:Pharmaceutical and biotechnology companiesContract manufacturing organizations CMOsResearch institutions and universitiesRegulatory agenciesConsulting firmsConclusionPharmaceutical engineering is a dynamic and essential field that plays a critical role in the healthcare industry.As the demand for new and improved pharmaceutical products continues to grow,the role of pharmaceutical engineers becomes increasingly important in driving innovation and ensuring the safety and efficacy of medications.With a strong educational background and a passion for science and engineering,pharmaceutical engineers can make a significant impact on the development of lifesaving treatments and therapies.。
Unit 13 Sterile ProductsSterile ProductsSterile products are dosage forms of therapeutic agents that are free of viable microorganisms. Principally，these include parenteral，ophthalmic，irrigating preparations. Of these, and parenteral products are unique among dosage forms of drugs because they are injected through the skin or mucous membranes into internal body compartment. Thus，because they have circumvented the highly efficient first line of body defense，the skin and mucous membranes，they must be free from microbial contamination and from toxic components as well as possess an exceptionally high level of purity. All components and processes involved in the preparation of these products must be selected and designed to eliminate，as much as possible，contamination of all types，whether of physical，chemical，or microbiologic origin.Preparations for the eye, though not introduced into internal body cavities，are placed in contact with tissues that are very sensitive to contamination. Therefore，similar standards are required for ophthalmic preparations).Irrigating solutions are now also required to meet the same standards as parenteral solutions because during an irrigation procedure，substantial amounts of these solutions can enter the bloodstream directly through open blood vessels of wounds or abraded mucous membranes. Therefore，the characteristics and standards presented in this chapter for the production of large-volume parenteral solutions apply equally to irrigating solutions. Sterile products are most frequently solutions or suspensions，but may even be solid pellets for tissue implantation. The control of a process to minimize contamination for a small quantity of such a product can be achieved with relative ease. As the quantity of product increases，the problems of controlling the process to prevent contamination multiply. Therefore，the preparation of sterile products has become a highly specialized area in pharmaceutical processing. The standards established，the attitude of personnel，and the process control must be of a第13 单元无菌产品无菌产品无菌产品是不含微生物活体的治疗剂剂型，其主要包括非肠道用的、眼用的和冲洗用的制剂。
制药工程英语作文Pharmaceutical Engineering。
Pharmaceutical engineering is a branch of engineering that deals with the design, development, and production of drugs and pharmaceutical products. It is amultidisciplinary field that combines the principles of chemical engineering, biochemistry, and pharmacology. The objective of pharmaceutical engineering is to develop safe, effective, and affordable drugs that can be used to treat various diseases.The process of drug development begins with the identification of a potential drug target. This can be a protein, enzyme, or other biological molecule that is involved in the disease process. Once a target has been identified, researchers use various techniques to design and synthesize compounds that can interact with the target and modify its activity.The next step in drug development is preclinical testing. This involves testing the safety and efficacy of the drug in animal models. If the results of preclinical testing are promising, the drug can move on to clinical trials. Clinical trials are conducted in humans and are designed to test the safety and efficacy of the drug in a controlled setting.Pharmaceutical engineers are involved in all aspects of drug development, from the initial design and synthesis of compounds to the production and distribution of the final product. They work closely with chemists, biologists, and pharmacologists to develop new drugs and improve existing ones.One of the key challenges in pharmaceutical engineering is ensuring the safety and efficacy of drugs. This requires a thorough understanding of the biological processes involved in disease and the mechanisms of action of drugs. It also requires the use of advanced analytical techniques to monitor the quality and purity of drugs throughout the production process.Another challenge in pharmaceutical engineering is the cost of drug development. Developing a new drug can cost billions of dollars and take many years to complete. Pharmaceutical engineers must work to optimize the drug development process and reduce costs without compromising safety or efficacy.Despite these challenges, pharmaceutical engineering plays a critical role in improving human health. The development of new drugs has led to significant advances in the treatment of diseases such as cancer, HIV/AIDS, and Alzheimer's disease. With continued innovation and collaboration, pharmaceutical engineering will continue to make important contributions to the field of medicine.。
制药工程专业英语9单元课文翻译第一篇：制药工程专业英语9单元课文翻译Thoughout recorded纵观历史记载，细菌感染的人口定期付出沉重的收费。
鼠疫菌的“黑死病”鼠疫的1347-1351期间，估计有25万人在亚洲和欧洲死亡。
美国公共卫生服务统计为1910年和1920年的节目，在这个早在本世纪结核病死亡每1000名美国居民中的一个。
即使在今天，主要是在发展中国家，结核分枝杆菌仍然是主要死亡原因由于在单染性病，全世界每年杀害超过三百万Such 整个脊椎动物进化过程中的这种不懈的微生物攻击，挑起了一个令人惊讶的复杂的保护性免疫系统的进化。
随着人类的外观，最终到达一个物种可以设法协助先天和后天免疫系统，避免感染。
通过利用微生物的抗原成分（疫苗和马血清抗毒素的产生），然后微生物次生代谢产物（抗生素），已成为人类善于预防和治疗许多以前致命的微生物疾病。
Within在短短的几十年，抗感染药药典的可用性突然提供了人类的潜力，以提高他们的生存前景下不断微生物拦河坝规避自然的经过时间考验的，活的或死的进化范式。
那些以前会屈服于成员现在可以存活时间较长的疫苗和抗生素的帮助助剂-抗感染免疫系统一起工作。
实际上，人类对这些助剂的就业可以作为例证在他们的免疫防御系统的自我做作的演变看。
Once当爵士亚历山大·弗莱明发现青霉素的效用已经证明，从发掘出的天然来源的其他抗生素乱舞紧随其后。
其中一些被证明适用于治疗疾病，通常经过化学改性，以提高天然化合物的效力，安全性或药代动力学AlphaFor对于大多数在过去50年中，看来，医学获得了强大的手上的细菌病。
某些制药厂和研发机构决定减少对抗生素的发现成果，因为它的出现，医生的抗菌军火库是充足。
但疾病的性质已经证明并非如此。
The在多种抗生素耐药病原体的发病率迅速升级现在提高全球非常严重的问题。
这种发展突出了强大的进化能力的细菌种群的选择压力下的抗生素治疗。
Resistance抗药性问题被视为与革兰氏阴性（例如大肠杆菌）和革兰氏阳性菌（如金黄色葡萄球菌），但目前关注的最后一组的病原体。
Apparatus--A specification for a definite size or type of container or apparatus in a test or assay is given solely as a recommendation, Where volumetric flasks or other exact measuring, weighing, or sorting devices are specified, this or other equipment of at least equivalent accuracy shall be employed. 仪器——为了一个明确的尺寸或规格类型的容器或设备在测验或分析给出了建议,纯粹,在培养皿或其他精确测量体积、计量、或排序装置是在合同中规定的;这个或其他设备至少应当使用等效精度。
Where low-actinic or light-resistant containers are specified, clear containers that have been rendered opague by application of a suitable coating r wrapping may be used. Where an instrument for physical measurement, such as a spectrophotometer, is speci fied in a test or assay by its distinctive name, another instrument of equivalent or greater sensitivity and accuracy may be used. In order to obtain solutions having concentrations that are adaptable to the working range of the instrument being used, solutions of proportionate. ly higher or lower concentrations may be prepared according to the solvents and proportions there of that are specified for the procedurecu .仪器——为了一个明确的尺寸或规格类型的容器或设备在测验或分析给出了建议,纯粹,在培养皿或其他精确测量体积、计量、或排序装置是在合同中规定的;这个或其他设备至少应当使用等效精度。
制药工程英语作文Pharmaceutical engineering is a fascinating field that combines the principles of engineering with the complexities of pharmaceuticals. It involves the design, development, and operation of processes and systems for the production of drugs and other pharmaceutical products.In pharmaceutical engineering, one of the key considerations is the need for strict adherence to regulatory standards and guidelines. This is crucial to ensure the safety, efficacy, and quality of pharmaceutical products. Engineers in this field must have a deep understanding of Good Manufacturing Practices (GMP) and other regulatory requirements.Another important aspect of pharmaceutical engineering is the use of advanced technologies and equipment in the manufacturing process. This includes the use of automation, robotics, and advanced control systems to optimize production processes and ensure consistency in productquality.In addition to the technical aspects, pharmaceutical engineering also involves a strong focus on research and development. This includes the development of new drug delivery systems, formulation technologies, and innovative manufacturing processes to improve the effectiveness and safety of pharmaceutical products.Furthermore, pharmaceutical engineering plays acritical role in addressing the challenges ofsustainability and environmental impact. Engineers in this field work to develop processes that minimize waste, reduce energy consumption, and maximize the use of renewable resources.Overall, pharmaceutical engineering is a dynamic and rapidly evolving field that requires a diverse set ofskills and knowledge. It offers exciting opportunities for professionals to contribute to the development of life-saving medications and to make a positive impact on global health.。
制药工程英语作文Pharmaceutical Engineering。
Pharmaceutical engineering is a branch of engineering that deals with the design, construction, and operation of pharmaceutical plants and facilities. It involves the application of engineering principles and techniques to the production of pharmaceuticals and other medical products.The pharmaceutical industry plays a crucial role in the healthcare system by developing and producing drugs and other medical products that help to prevent and treat diseases. Pharmaceutical engineering is essential to ensure that these products are manufactured in a safe, efficient, and cost-effective manner.One of the key aspects of pharmaceutical engineering is the design and construction of pharmaceutical plants and facilities. These facilities must be designed to meetstrict regulatory requirements and to ensure the safety andquality of the products being manufactured. Pharmaceutical engineers work closely with architects, chemical engineers, and other professionals to design and construct these facilities, taking into account factors such as the layout of the plant, the flow of materials and personnel, and the use of advanced technologies and equipment.Another important aspect of pharmaceutical engineering is the operation of pharmaceutical plants and facilities. This involves the use of advanced manufacturing processes and technologies to produce pharmaceutical products in a consistent and efficient manner. Pharmaceutical engineers are responsible for overseeing the operation of these facilities, ensuring that they meet regulatory requirements and that the products produced meet the highest standards of quality and safety.In addition to the design and operation of pharmaceutical plants and facilities, pharmaceutical engineering also involves the development of new pharmaceutical products and the improvement of existing ones. This may involve the use of advanced research anddevelopment techniques, as well as the application of innovative technologies and processes to improve the quality, safety, and effectiveness of pharmaceutical products.Overall, pharmaceutical engineering is a highly specialized field that requires a deep understanding of engineering principles, pharmaceutical science, and regulatory requirements. It plays a crucial role in the development and production of pharmaceutical products, and it is essential for ensuring the safety, quality, and effectiveness of these products.In conclusion, pharmaceutical engineering is a vital and rapidly evolving field that is essential for the development and production of pharmaceutical products. It involves the application of engineering principles and techniques to the design, construction, and operation of pharmaceutical plants and facilities, as well as the development and improvement of pharmaceutical products. Pharmaceutical engineers play a crucial role in ensuring the safety, quality, and effectiveness of pharmaceuticalproducts, and their work is essential for the advancement of the healthcare system.。
1、生产的药品其生产或出身不同药剂可以分为三类：Ⅰ.完全（合成纤维）合成材料，Ⅱ.天然产物，和Ⅲ.产品从（半合成产品）的部分合成。
本书的重点是团体的最重要的化合物Ⅰ和Ⅲ一所以药物合成。
这并不意味着，但是，天然产品或其他代理人并不太重要。
它们可以作为有价值的领导结构，他们常常为原料，或作为重要的合成中间体产品的需要。
表1给出了获取药剂的不同方法的概述。
（表1对药物的可能性准备）方法举例1、全合成，超过75％的药剂（合成纤维）2、分离（天然产物）天然来源：2.1植物-生物碱;酶;心甙，多糖，维生素E;类固醇的前体（薯蓣皂素，sitosterin），柠檬醛（中间产品维生素A，E和K）2.2动物器官一酶;肽激素;胆酸从胆;胰岛素）从胰脏;血清和疫苗2.3从角蛋白和明胶L -氨基酸;三一胆固醇从羊毛油脂的其他来源水解3.一抗生素发酵; L -氨基酸，葡聚糖，对类固醇有针对性的修改,例如11 -羟基化;也胰岛素，干扰素，抗体，肽激素，酶，疫苗4。
部分合成修改（半合成剂）天然产品: 一生物碱化合物;半合成/ 3-内酰胺类抗生素;类固醇;人胰岛素其中几个重要的治疗作用最初是从天然产品天然来源获得更有效的今天，我。
大肠杆菌更经济的准备..由全合成。
这样的例子包括L-氨基酸，氯霉素，咖啡因，多巴胺，肾上腺素，左旋多巴，肽类激素，前列腺素，D -青霉胺，长春胺，以及几乎所有的维生素。
在过去的几年里发酵-岛大肠杆菌微生物过程变得极其重要。
通过现代技术和基因选择的结果导致了突变体的微生物创造高性能，发酵，已成为首选方法各种各样的物质。
这两个Eukaryonts（酵母菌和霉菌）和Prokaryonts（单细胞细菌，放线菌和）用于微生物。
下列产品类型可以得到：1.细胞的物质（单细胞蛋白），2.酶，3.主要降解产物（主要代谢物），4.二级降解产物（次生代谢物）。
不顾来自某些微生物，大肠杆菌粘膜生产的葡聚糖克明串珠mesenteroides，2和3级是毒品有关的准备工作。
制药工程的学科英语作文题目，Pharmaceutical Engineering: Bridging Science and Industry。
Pharmaceutical engineering, a multidisciplinary field that integrates principles from chemistry, biology, engineering, and pharmacology, plays a pivotal role in the development, manufacturing, and optimization of pharmaceutical products. In recent years, the field has witnessed significant advancements, driven by the ever-evolving demands of the healthcare industry and the constant pursuit of innovation.At its core, pharmaceutical engineering encompasses a wide array of processes and technologies aimed at ensuring the safety, efficacy, and quality of pharmaceutical products. From drug discovery and formulation to manufacturing and distribution, every stage of the pharmaceutical lifecycle relies heavily on the expertise of pharmaceutical engineers to overcome various challenges andoptimize outcomes.One of the key areas within pharmaceutical engineering is drug formulation, where scientists and engineers work together to design dosage forms that are safe, stable, and effective. This involves selecting appropriate excipients, optimizing drug delivery systems, and ensuring proper bioavailability of the active pharmaceutical ingredients (APIs). Through meticulous research and experimentation, pharmaceutical engineers strive to develop formulationsthat meet the diverse needs of patients while adhering to strict regulatory standards.In addition to formulation, pharmaceutical manufacturing represents another critical aspect of the field. Modern pharmaceutical manufacturing facilities are equipped with state-of-the-art equipment and technologies that enable the production of large quantities of pharmaceutical products with consistent quality and purity. Pharmaceutical engineers are responsible for overseeing these manufacturing processes, implementing Good Manufacturing Practices (GMP), and implementing qualitycontrol measures to minimize variability and ensure product uniformity.Furthermore, pharmaceutical engineering plays a crucial role in the development of novel drug delivery systems, such as nanoparticles, liposomes, and transdermal patches. These advanced delivery systems offer numerous advantages, including targeted drug delivery, sustained release, and improved patient compliance. By harnessing the principles of engineering and material science, pharmaceutical engineers are able to design and optimize these systems to enhance drug efficacy and minimize side effects.Moreover, pharmaceutical engineering extends beyond the laboratory and manufacturing plant to encompass the entire pharmaceutical supply chain. From raw material sourcing to distribution and logistics, pharmaceutical engineers work tirelessly to optimize efficiency, minimize waste, and ensure timely delivery of pharmaceutical products to patients worldwide. This requires a deep understanding of supply chain management principles, as well as the ability to adapt to changing market dynamics and regulatoryrequirements.In conclusion, pharmaceutical engineering serves as a bridge between science and industry, driving innovation and progress in the field of healthcare. Through the collaborative efforts of scientists, engineers, and healthcare professionals, pharmaceutical engineering continues to push the boundaries of what is possible, leading to the development of safer, more effective, and more accessible pharmaceutical products for the benefit of society as a whole. As we look to the future, the role of pharmaceutical engineering will only continue to grow in importance, shaping the landscape of healthcare for generations to come.。
Unit 1 Production of DrugsDepending on their production or origin pharmaceutical agents can be split into three groups:I .Totally synthetic materials (synthetics)，Ⅱ.Natural products，andⅢ.Products from partial syntheses (semi-synthetic products).The emphasis of the present book is on the most important compounds of groups I and Ⅲ一thus Drug synthesis. This does not mean，however，that natural products or other agents are less important. They can serve as valuable lead structures，and they are frequently needed as starting materials or as intermediates for important synthetic products.Table 1 gives an overview of the different methods for obtaining pharmaceutical agents.1单元生产的药品其生产或出身不同药剂可以分为三类：1。
完全（合成纤维）合成材料，Ⅱ。
天然产物，和Ⅲ。
产品从（半合成产品）的部分合成。
本书的重点是团体的最重要的化合物Ⅰ和Ⅲ一所以药物合成。
这并不意味着，但是，天然产品或其他代理人并不太重要。
它们可以作为有价值的领导结构，他们常常为原料，或作为重要的合成中间体产品的需要。
制药工程英语作文Pharmaceutical engineering is a specialized field that combines the principles of engineering with pharmaceutical sciences to design, develop, and manufacture pharmaceutical products. This interdisciplinary approach ensures the quality, safety, and efficacy of medications that are critical topublic health.The Importance of Pharmaceutical EngineeringPharmaceutical engineering plays a pivotal role in the healthcare industry. It is responsible for the innovation and optimization of drug production processes, which in turn can lead to more cost-effective and accessible treatments. Engineers in this field work closely with chemists,biologists, and medical professionals to understand the complex requirements of drug development and manufacturing.Educational RequirementsTo excel in pharmaceutical engineering, one typically needs a strong foundation in mathematics, chemistry, and biology,along with engineering principles. Many universities offer specialized degree programs that provide a comprehensive education in pharmaceutical engineering. These programs often include coursework in drug synthesis, bioprocessing, andquality control.Technological AdvancementsAdvancements in pharmaceutical engineering have led to the development of sophisticated technologies such as nanotechnology, which is used to improve drug delivery systems. This can increase the bioavailability of drugs, reduce side effects, and enhance patient compliance.Regulatory CompliancePharmaceutical engineers must also be well-versed in regulatory standards and guidelines, as the industry is heavily regulated to ensure the safety and efficacy of drugs. Compliance with agencies such as the FDA (Food and Drug Administration) is crucial for the approval and marketing of new pharmaceutical products.Career OpportunitiesGraduates with a degree in pharmaceutical engineering canfind employment in various sectors, including pharmaceutical companies, research institutions, and regulatory bodies. They may work in roles such as process development, quality assurance, project management, or regulatory affairs.Future OutlookThe future of pharmaceutical engineering looks promising, with ongoing research into new drug therapies and technologies. As the global population ages and the demandfor innovative treatments grows, the need for skilledpharmaceutical engineers is expected to increase. ConclusionPharmaceutical engineering is a dynamic and essential field that plays a critical role in the development and production of life-saving medications. It requires a unique blend of scientific knowledge and engineering skills, and offers a rewarding career path for those passionate about improving healthcare outcomes.。
Unit 1 Production of DrugsDepending on their production or origin pharmaceutical agents can be split into three groups:I .Totally synthetic materials (synthetics)，Ⅱ.Natural products，andⅢ.Products from partial syntheses (semi-synthetic products).The emphasis of the present book is on the most important compounds of groups I and Ⅲ一thus Drug synthesis. This does not mean，however，that natural products or other agents are less important. They can serve as valuable lead structures，and they are frequently needed as starting materials or as intermediates for important synthetic products.Table 1 gives an overview of the different methods for obtaining pharmaceutical agents.1单元生产的药品其生产或出身不同药剂可以分为三类：1。
完全（合成纤维）合成材料，Ⅱ。
天然产物，和Ⅲ。
产品从（半合成产品）的部分合成。
本书的重点是团体的最重要的化合物Ⅰ和Ⅲ一所以药物合成。
这并不意味着，但是，天然产品或其他代理人并不太重要。
它们可以作为有价值的领导结构，他们常常为原料，或作为重要的合成中间体产品的需要。
制药工程专业英语第、、、、、、、、、、单元文章翻译(吴达俊庄思永)————————————————————————————————作者：————————————————————————————————日期：1、生产的药品其生产或出身不同药剂可以分为三类：Ⅰ.完全（合成纤维）合成材料，Ⅱ.天然产物，和Ⅲ.产品从（半合成产品）的部分合成。
本书的重点是团体的最重要的化合物Ⅰ和Ⅲ一所以药物合成。
这并不意味着，但是，天然产品或其他代理人并不太重要。
它们可以作为有价值的领导结构，他们常常为原料，或作为重要的合成中间体产品的需要。
表1给出了获取药剂的不同方法的概述。
（表1对药物的可能性准备）方法举例1、全合成，超过75％的药剂（合成纤维）2、分离（天然产物）天然来源：2.1植物-生物碱;酶;心甙，多糖，维生素E;类固醇的前体（薯蓣皂素，sitosterin），柠檬醛（中间产品维生素A，E和K）2.2动物器官一酶;肽激素;胆酸从胆;胰岛素）从胰脏;血清和疫苗2.3从角蛋白和明胶L -氨基酸;三一胆固醇从羊毛油脂的其他来源水解3.一抗生素发酵; L -氨基酸，葡聚糖，对类固醇有针对性的修改,例如11 -羟基化;也胰岛素，干扰素，抗体，肽激素，酶，疫苗4。
部分合成修改（半合成剂）天然产品: 一生物碱化合物;半合成/ 3-内酰胺类抗生素;类固醇;人胰岛素其中几个重要的治疗作用最初是从天然产品天然来源获得更有效的今天，我。
大肠杆菌更经济的准备..由全合成。
这样的例子包括L-氨基酸，氯霉素，咖啡因，多巴胺，肾上腺素，左旋多巴，肽类激素，前列腺素，D -青霉胺，长春胺，以及几乎所有的维生素。
在过去的几年里发酵-岛大肠杆菌微生物过程变得极其重要。
通过现代技术和基因选择的结果导致了突变体的微生物创造高性能，发酵，已成为首选方法各种各样的物质。
这两个Eukaryonts（酵母菌和霉菌）和Prokaryonts（单细胞细菌，放线菌和）用于微生物。
下列产品类型可以得到：1.细胞的物质（单细胞蛋白），2.酶，3.主要降解产物（主要代谢物），4.二级降解产物（次生代谢物）。
不顾来自某些微生物，大肠杆菌粘膜生产的葡聚糖克明串珠mesenteroides，2和3级是毒品有关的准备工作。
葡聚糖本身5万〜10万分子量，是用作血浆代用品。
其中主要来自谷氨酸棒杆菌代谢产物和黄色短杆菌突变体的L -氨基酸特别有趣。
从这些味精约35万吨L -谷氨酸（食品添加剂）生物体和L -赖氨酸（用于植物蛋白补充）约70,000吨的生产。
此外重要的初级代谢产物的普瑞纳核苷酸，有机酸，乳酸，柠檬酸和维生素，例如维生素B，从丙酸shermanii 2。
其中次生代谢产物的抗生素必须首先提到。
以下五组代表了美国每年170亿美元的全球价值：青霉素（青霉）头孢菌素（头孢枝顶）四环素（金色链霉菌）erythromycins（链霉菌）氨基糖苷类（如链霉素从灰色链霉菌）。
关于5000抗生素已经分离出的微生物，但其中只有不到100有些治疗使用。
必须记住，但是，许多衍生工具已被用于治疗使用部分合成修改;约50,000剂已被semisynthetically取得户内酰胺在过去十年孤独。
发酵都是在不锈钢发酵罐出来的量高达400立方米。
为了避免与噬菌体等微生物污染的全过程都必须在无菌条件下进行。
由于更重要的发酵只发生在有氧条件下的氧气或空气好电源（无菌）是必要的。
二氧化碳的来源包括碳水化合物，大肠杆菌克糖蜜，糖和葡萄糖。
另外必须提供的微生物在与含氮如硫酸铵，氨水或尿素化合物生长介质，以及与无机磷酸盐。
此外，不断最适pH和温度是必需的。
在青霉素G的情况下，发酵完成200小时后，细胞的质量是由过滤分离。
所需的活性剂是隔离的滤液吸收或提取工艺。
大规模的细胞，如果不理想的产品，可进一步用作动物，由于其蛋白质含量高的饲料。
利用现代微生物重组技术已获得这也让其中不是在原来的基因编码多肽的生产。
改性大肠杆菌从而使可能产生A型和B -人胰岛素或胰岛素原类似物链。
二硫键形成的选择性分离后，最终由色谱净化工序的影响。
通过这种方式获得的人类胰岛素完全独立采取任何从动物胰腺材料。
其他重要肽，激素和酶，如人类生长激素（hGH），神经活性肽，生长抑素，干扰素，组织型纤溶酶原激活物（tPA），淋巴因子，如钙调节钙调蛋白，蛋白疫苗，以及作为诊断用单克隆抗体是合成了这种方式。
这些酶或微生物在一个单一的酶系统，目前可用于立体定向和regiospecific化学反应。
这个原则是有用的，尤其是在化学类固醇。
在这里，我们只能引用的微生物十一水电黄体酮xylation至11人羟，一个关键的产品在可的松合成。
隔离酶是重要的，不仅因为淀粉的酶法糖化技术重要性的今天，和葡萄糖异构果糖，他们也都在无数次试验在诊断疾病所用的程序显着，在酶的分析，在使用监测治疗。
数量的酶本身作为活性成分。
因此，含有蛋白酶制剂（如糜蛋白酶，胃蛋白酶和胰蛋白酶），淀粉酶和脂肪酶的合成主要是在与抗酸药相结合，促进消化。
链激酶和尿激酶溶栓是重要的，是天冬酰胺酶在治疗白血病细胞生长剂。
最后必须提到的，作为他们在那里`biocatalysts'in化学stereospecificity和选择性反应的酶可用于制造重要的用途。
著名的例子是对N -乙酰- D，L -氨基酸消旋给予L -氨基酸酶裂解，从青霉素生产8 -氨基青霉烷酸的penicillinamidase手段和天冬氨酸酶，催化氨立体除了富马酸为了酸生产L -天门冬氨酸。
在这些酶可以在固定的形式使用的应用程序，在某种程度上势必运营商 - 等为异构催化剂。
这是有利的，因为他们可以很容易地分离反应介质和回收再利用。
另一个重要进程的具体行动蛋白酶是根据申请的半合成人胰岛素的生产。
与猪胰岛素这将启动，其中在30的B链的位置被替换为丙氨酸苏氨酸叔丁基由胰蛋白酶选择性作用酯。
胰岛素酯分离，水解为人体胰岛素和程序，最后由色谱纯化。
对酶的来源不仅包括微生物，而且蔬菜和动物材料。
在表1，已经显示，有超过75％是由药剂全合成获得。
因此，合成路线的知识是有用的。
认识也使我们能够认识到污染。
按中间体和副产品代理。
为了有效的质量控制在许多国家的登记要领对生产过程的完整的文档要求登记机关的原因。
药物合成知识提供了宝贵的刺激研发化学家以及。
有没有首选的所有药学活性化合物，也反应类型结构类型的首选。
这意味着几乎全部领域的有机和有机金属化学中的一部分也被覆盖。
不过，也有较大的起始原料和中间体数量较常用，所以它是非常有用的知道他们准备从初级品的可能性。
基于这个原因，它是在适当的地方，说明这本书的重要中间体，尤其是树。
后面这些中间体领导到数目庞大的代理商合成工艺中的关键化合物。
对于大多数的化学品是在涉及大量生产。
以类似的方式，这也是对工业芳香族化合物甲苯，苯酚和氯苯中间体为基础的真实。
另一个关键的化合物可能会显示在表格可在追踪syntheses.f交叉关系很有用除了实际的起始原料和中间体溶剂作为反应介质要求和通过再结晶纯化，两者。
常用的溶剂是甲醇，乙醇，异丙醇，丁醇，丙酮，醋酸乙酯，苯，甲苯和二甲苯。
在较小程度上乙醚，四氢呋喃，乙二醇醚，二甲基甲酰胺（DMF）和二甲基亚砜（DMSO）的使用在特殊的反应。
在较大的数额使用的试剂，不仅酸（盐酸，硫酸，硝酸，醋酸），而且无机和有机碱（氢氧化钠，氢氧化钾，碳酸钾，碳酸氢钠，氨，三乙胺，吡啶）。
进一步的辅助化学品包括活性炭和催化剂。
这些（如中间体）补充品都可以成为最终产品中杂质的来源。
1969年，世界卫生组织发表了`保障药品质量的论文中（WHO技术报告号418,1969，附录二，附录二是有关`适当的做法的赔偿和保障药品质量。
';号567,1975，附件1A）。
这已成为在此期间为'良好生产规范'或GMP规则众所周知的，现在应在这些药品生产服从。
它们构成的质量有关的药品生产证书互认的生产和检验的基础。
设施。
长期以来，美国药品管理局，美国食品和药物管理局（FDA）已发出的药品制剂类似于谁的规则规定，而且适用于这些严格。
向美国药物如成品者外，出口由FDA要求的生产设施进行定期检查。
5它可能只是在此指出，这种严格控制不仅适用于产品，而且对原材料（原辅料控制），同时还以中间体。
清楚。
对生产和储存方面的技术和设备必须符合卫生规定的条件。
由于只有少数的化合物，如乙酰水杨酸，对乙酰氨基酚和维生素，是在大量的准备，在实际生产中最需要的多用途（多产品）设施的地方。
特别小心，注意避免交叉通过什么可以按所使用的仪器良好的清洁影响其他产品的污染。
经过仔细的描述和所有储存的中间体和产品的定义是必要的。
(选择从黄建忠罗斯和A. Kleemann，药物化学，卷。
1，药物合成，埃利斯霍伍德有限公司，英国，1988年。
)1、回答下列问题：（1）有多少组可以药剂成其生产或出身而定分裂？（2）你能说明所取得的全合成药剂任何重大的例子吗？（3）什么是之间的合成药物和传统中药的区别？2、把以下内容翻译成英语：3、把成中文如下：多糖肽类激素疫苗非均相催化剂青霉素类固醇代谢物污染血浆4、填写以下动词的单词填空：目前构成派生词区别核酸是超高分子量聚阴离子分子。
这些聚合物的一个亚基或核苷酸，使整个通常是一个多核苷酸序列__________。
核酸是两个主要品种，核糖核酸（RNA）和脱氧核糖核酸（DNA）的。
DNA是主要存在于细胞核内的染色质，而90％是_____的RNA在细胞的细胞质和细胞核中的10 0Ø。
核酸类_____两对五碳糖或戊糖原子现有基础上小学。
一般两个种基地发现，在所有核酸。
一类是母体化合物嘌呤的衍生物。
原理是鸟嘌呤和腺嘌呤的例子。
在所有发现核酸碱基第二类是从母体化合物嘧啶_____。
5、药物研发（I）1、简介药品开发是一个非常复杂的过程，需要一个协调和沟通不同功能之间的群体广泛很大。
它是昂贵的，特别是在临床开发的后期阶段，在研究涉及的数百名病人。
据估计，目前约2.3亿美元（1987美元）的新药开发成本，并采取介于7和10多年的临床前开发阶段开始，首先市场（不包括监管滞后）。
药物开发是一项高风险业务，虽然利率不断上升，大约只有每十个新的化学研究在人类首次实体开展会不会成为一个产品。
作为候选药物的进步，通过发展'的失败降低风险hurdles'are克服前进的道路上。
失败的典型原因包括不可接受的毒性，缺乏有效性，或不能提供比其他竞争产品的优点（图1）损耗率的新化学实体（竞争性考试的）进入发展。
平均只有约400 ^ 1000我在化合物合成进入发展。
原因的罗富国教育学院的发展终止（不包括抗感染药）1：缺乏疗效2：药代动力学3：动物毒性4：杂项5：在人的不良影响6：商业上的原因图1磨损率和终止的原因2、发展规划候选药物是否有可能提供有竞争力优势的评估首先需要强调的地方有一个产品'的目标，目标产品或配置文件集。
