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制药工程专业英语Unit 1production of drugs P1单词Compound 化合物intermediate 中间产物alkaloids 生物碱enzymes酶peptide 肽hormones 荷尔蒙modification 修饰chloramphenicol 氯霉素metabolites 代谢物substitute 替代品derivative衍生物active 活性absorption 吸收extraction 提取Recombinant 重组insulin 编码neuroactive 神经活性start materials 起始原料recrystallization 重结晶methanol 甲醇Ethanol 乙醇isopropanol 异丙醇butanol 丁醇benzene 苯翻译Known examples are the enzymatic cleavage of racemates of N-acetyl-D, L-amino acids to give L-amino acids, the production of 6-aminopenicillanic acid from benzylpenicillin by means of penicillinamidase and the aspartase-catalysed stereospecific addition of ammonia to fumaric acid in order to produce L-aspartic acid.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 -氨基青霉烷酸的青霉素酰胺酶手段和天冬氨酸酶，催化氨立体除了富马酸为了酸生产L -天门冬氨酸。
Reading material 1 p7Antagonist 抑制剂receptor 受体clinical investigation 临床研究antibacterial抗菌的inhibition 抑制mercurial 水银dominate 占主导Unit 3 chemotherapy: an introduction P29单词chemotherapy化学治疗superstition 迷信pathogenic 致病的翻译The activity of the arsenical drugs is explained as due to a blocking of essential thiol groups.For example, lipoic acid dehydrogenase contains two cysteine molecules, while are kept near each other by folding of the molecule. As a result, an arsenical can react with these thiol groups and inactivate the molecule, as show in equation.对含砷药物活性被解释为由于阻塞必不可少的巯基。
制药工程专业英语课后练习题含答案题目一：Drug Substance Manufacturing1.What is Drug Substance Manufacturing?–A. It is the process of producing a finished drug product.–B. It is the process of producing the activeingredient or drug substance used in a drug product.–C. It is the process of packaging and labeling a finished drug product.–D. It is the process of performing clinical trials ona drug product.Answer: B. It is the process of producing the active ingredient or drug substance used in a drug product.2.What are the steps involved in Drug Substance Manufacturing?–A. Synthesis, isolation, and purification.–B. Packaging, labeling, and testing.–C. Clinical trials, manufacturing, and distribution.–D. None of the above.Answer: A. Synthesis, isolation, and purification.3.What is the mn purpose of Drug Substance Manufacturing?–A. To produce a finished drug product for human use.–B. To provide the active ingredient or drug substance used in a drug product.–C. To test and validate the safety and efficacy of a drug product.–D. To distribute a drug product to consumers.Answer: B. To provide the active ingredient or drug substance used in a drug product.题目二：Pharmaceutical Formulation1.What is Pharmaceutical Formulation?–A. It is the process of producing a finished drug product.–B. It is the process of selecting and combining ingredients to produce a drug product.–C. It is the process of packaging and labeling a finished drug product.–D. It is the process of performing clinical trials ona drug product.Answer: B. It is the process of selecting and combining ingredients to produce a drug product.2.What are the key considerations in PharmaceuticalFormulation?–A. Safety, efficacy, and stability.–B. Cost, avlability, and taste.–C. Appearance, texture, and smell.–D. None of the above.Answer: A. Safety, efficacy, and stability.3.What is the role of excipients in Pharmaceutical Formulation?–A. They are the active ingredients in a drug product.–B. They are the inactive ingredients in a drug product that help to improve its properties.–C. They are the ingredients in a drug product that are responsible for the color and flavor.–D. None of the above.Answer: B. They are the inactive ingredients in a drug product that help to improve its properties.题目三：Good Manufacturing Practice (GMP)1.What is Good Manufacturing Practice (GMP)?–A. It is a set of regulations and guidelines that ensure the quality and safety of pharmaceutical products.–B. It is a set of regulations and guidelines that ensure the efficacy of pharmaceutical products.–C. It is a set of regulations and guidelines that ensure the affordability of pharmaceutical products.–D. None of the above.Answer: A. It is a set of regulations and guidelines that ensure the quality and safety of pharmaceutical products.2.What are the key components of Good Manufacturing Practice(GMP)?–A. Quality control, documentation, and facility design.–B. Clinical trials, manufacturing, and distribution.–C. Cost control, inventory management, and customer service.–D. None of the above.Answer: A. Quality control, documentation, and facility design.3.Why is Good Manufacturing Practice (GMP) important?–A. It helps to ensure the quality and safety ofpharmaceutical products.–B. It helps to reduce the cost of producingpharmaceutical products.–C. It helps to increase the avlability ofpharmaceutical products.–D. None of the above.Answer: A. It helps to ensure the quality and safety of pharmaceutical products.总结本文介绍了制药工程专业英语中的几个重要概念和术语，包括Drug Substance Manufacturing（药品物质制造）、Pharmaceutical Formulation（制剂开发）以及Good Manufacturing Practice（良好生产规范）。
制药工程专业英语详细Unit..详细翻译————————————————————————————————作者：————————————————————————————————日期：Unit 1 Production of Drugs根据其生产或来源不同药物制剂可以分为三类：Ⅰ.人工合成材料（全合成材料）Ⅱ.天然产物，和Ⅲ.半合成天然产物（半合成药物）。
本书的重点是这些第一组和第三组化合物都是合成药物。
然而这并不意味着那些天然药物和其他药物就不重要。
他们可以作为很有价值的先导结构，并经常被用为重要合成药物的原料或中间体。
表1概述了获取药物制剂的不同方法。
Table 1 Possibilities for the preparation of drugs表1药物制备的可能性方法例子1.全合成75％以上的药物制剂都是全合成的（合成物）2.从天然产物中分离（天然产物）2.1植物生物碱;酶;强心甙；多聚糖；维生素E; 类固醇前体（薯蓣皂苷配基，谷甾醇）；柠檬醛（中间产物维生素A，E，K）2.2动物器官酶;多肽；激素;胆酸；胆汁;胰岛素来自胰腺；血清和疫苗2.3其他来源胆固醇来自羊毛油；L-氨基酸来自角蛋白和明胶水解3.发酵抗生素; L -氨基酸，葡聚糖；对甾类有定向的修饰，例如11 -羟基化;胰岛素，干扰素，抗体，肽类激素，酶，疫苗生物碱化合物；半合成内酰胺类抗生素；甾类;人胰岛素4.天然产物的半合成修改（半合成药物）几种最初来自于天然原料有治疗意义天然产物如今用更有效也就是经济的全合成法制备。
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，长春蔓胺，以及几乎所有的维生素。
在过去的几年里发酵（即微生物处理）变得极其重要。
通过现代技术和遗传选择的结果产生了高效能微生物突变株，发酵已成为广泛的底物（物质）都可以选择的一种方法。
真核微生物（酵母菌和霉菌）和原核微生物（单细胞细菌和放线菌）用于微生物。
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。
Distillation columns are vertical, cylindrical vessels containing devices that provide intimate contacting of the rising vapor with the descending liquid.蒸馏塔是垂直的，可以提供给上升的蒸汽与下降的液体直接接触的圆柱形容器控制设备。
This contacting provides the opportunity for the two streams to achieve some approach to thermodynamic equilibrium.这种接触为两个流体实现热力学平衡提供了机会。
Depending on the type of internal devices used, the contacting may occur in discrete steps, called plates or trays, or in a continuous differential manner on the surface of a packing material.取决于使用的内部设备的类型，能使接触出现分离的叫塔板或者分流塔盘，或者是在一个能连续差分方式的包装材料的表面上。
The fundamental requirement of the column is to provide efficient and economic contacting at a required mass-transfer rate.蒸馏塔的根本要求，是为客户提供高效和经济的同时要与必要的质量传输速率相联系。
Individual column requirements vary from high vacuum to high pressure, from low to high liquid rates, from clean to dirty systems, and so on.个人塔的要求各不相同从高真空至高压力，从低到高的液率，从清洁到不清洁的系统，等等。
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。
1.This does not mean，however，that natural products or other agents are less important.但是，这并不意味着，天然产品或其他药剂并不太重要。
2. Table 1 gives an overview of the different methods for obtaining pharmaceutical agents.表1给出了获取药剂的不同方法的概述。
3.Fermentations are carried out in stainless steel fermentors with volumes up to 400 m3.发酵是在容量高达400立方米的不锈钢发酵罐中进行的。
4．In the case of penicillin G，the fermentation is finished after 200 hours，and the cell mass is separated by filtration.就青霉素G而言，在发酵200小时后完成此过程，通过过滤将细胞物质分离。
5. The desired active agents are isolated from the filtrate by absorption or extraction processes.所需活性剂是通过吸收或萃取过程，从滤液中被分离。
6. Depending on their production or origin pharmaceutical agents can be split into three groups。
根据药剂的产物或者来源，他们可以分为三种类型。
7. Dextran itself，with a molecular weight of 50,000 ~ 100,000，is used as a blood plasma substitute.葡聚糖本身分子量是5万〜10万，是用作血浆代用品。
P61 Unit 5 药物研发药物代谢作用和药代动力学药物代谢和制药学研究需要建立一套关于化合物代谢和方式的知识，化合物水平及其代谢产物根据药物给予量和施用时间长度变化的方式（决定）。
在早期药物临床发展临床阶段,很少有代谢数据权威性的管理要求。
然而，新陈代谢研究有助于解释毒理学结果和研究设计，以及有助于将动物安全性效率数据进行外插。
在生物学流体或组织中需要开发测定法测量药物和主要代谢产物水平。
目的是快速开发可重现性方法。
高效液相色谱通常用于分离，但其他技术如气相色谱在试用时也可以使用。
例如检测法可以是紫外光，荧光测定法，电化学方法，质谱法。
当化合物的活性很高时，体液和组织液中仅存痕量物质，检测可能出现问题。
放射免疫测定法可以提供更高的灵敏度，以及在给定时间内有可能分析出更多的化合物。
然而，放射免疫测定法有可能花很长时间来显影，并且缺少特异性将是一个问题。
需要关于化合物/代谢物血浆浓度的信息来支持毒理学研究，以及帮助选择剂量水平。
有最初需要建立药代动力学的线性区域，即其中剂量对AUC可被认为是一个线性的范围。
对非线性原因的确定例如代谢饱和的吸收/消除将有助于理解毒理学或药理学现象。
临床学一旦已经完成并分析充分的动物试验，药物公司将决定是否将药物投入人体研究阶段。
这一步通常包括公司专家，临床研究者和临床委员会的批准，并且在某些国家，例如在美国，还需要政府机构如FDA（美国食品和药品监督管理局）的审查。
当出资公司向FDA提出一种新药的调查申请时，这种新药就首先被FDA 审查。
FDA必须在30天内让出资者知道以他们的判断这个临床研究是否足够安全。
如果足够安全，实际上IND可考虑在其中并且临床可以继续进行。
如果不安全，FDA会将这个临床研究暂停直到他们的担忧成功解决。
规划这个临床方案时，很重要的是参考目标性质并且探究药物的潜在临床效益，尽可能早地参考这些，以便去除掉未能达到预期效果的候选药物。
新候选药物最初在人体内试用应遵循以下主要原则：确定药物在人体内的安全性和耐受性。
