Development and Manufacture of Drug Substances
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
Final Concept Paper
Q11: Development and Manufacture of Drug Substances
(chemical entities and biotechnological/biological entities)
dated 11 April 2008
Endorsed by the ICH Steering Committee on 11 April 2008
Type of Harmonisation Action Proposed
A new tripartite Technical Guidance is proposed for Active Pharmaceutical Ingredients (APIs harmonising the scientific and technical principles relating to the description and justification of the development and manufacturing process (CTD sections S 2.2. – S 2.6) of Drug Substances including both chemical entities and biotechnological/biological entities.
This document will take into consideration and provide examples as appropriate for describing the principles and concepts which are included in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10). However, the approaches to, and extent of, development (e.g., traditional/empirical or systematic/enhanced) will be based on the development strategy designed by each manufacturer.
This guideline is intended to provide guidance for drug substances as defined in the scope of the ICH Guideline Q6A (“NCE”) and ICH Guideline Q6B (“Biotechnological/biological”).
Statement of the Perceived Problem
Background and Summary
Several aspects of technical guidance specifically related to the quality of chemical entities and biotechnological/biological drug substances have been harmonised through ICH guidelines. Although it is generally accepted that there is a strong linkage between the manufacturing process for medicinal products and their quality attributes, there is limited guidance regarding the description and justification of development and manufacturing processes for drug substances and the type and extent of information to be submitted in regulatory dossiers. During discussions at the ICH-Q Drug Substance Roundtable meeting held in Washington in September, 2007, the experts agreed that many of the principles and concepts that have been addressed in ICH guidelines Q8, Q9, and Q10 are also applicable to the development and manufacture of drug substances. The importance of an API guideline for both chemical and biotechnological/biological products was emphasised and the development of a formal concept paper and business plan was endorsed by the ICH SC in October 2007.
Therefore, it is recommended to develop a new tripartite high level Technical Guidance harmonising the scientific and technical principles relevant to the design, development and manufacture of drug substances as part of a total control strategy designed to ensure product quality and consistency. Problem Statement.
Consistent with modern global manufacturing and scientific practices (described in the ICH Quality Vision presented and endorsed in Brussels, July 2003), and economic considerations, the development and establishment of a robust manufacturing process for drug substances to deliver a product of consistent quality accounts for a significant proportion of manufacturers’ resources and efforts.
While there are many similarities in the development approaches for chemical entities and biotechnological/biological drug substances, biotechnological/biological drug substances present a number of unique manufacturing and quality challenges. Therefore it will be important to identify what is common and what is different between the development and manufacturing of biotechnological/biological and chemical entities.
The guidance developed needs to take into account these similarities and differences, as appropriate. A harmonized guideline including common terminology and definitions is currently not available but would be beneficial, since it would enable a consistent approach for providing and evaluating this information across the three regions.
Additionally, there is variability in the content and level of detail requested by the various regions for evaluating the concisely described meaningful scientific knowledge gained during development. Because of a lack of guidance in the area of drug substance development and manufacturing manufacturers, no general developed harmonized approaches to demonstrating process understanding, particularly regarding sources of variability in product quality, are currently available. Additionally, region-specific requirements are conveyed to the applicants by the authorities on a case-by-case basis. In general, there is currently little consensus or agreement across the industry and the regulatory bodies with respect to manufacturing process information and justification that should be included in the dossier.
The direct impact of these currently differing approaches and uncertainties is:
-disharmony and administrative burden;
-inefficient use of industry resources to determine and comply with regulatory requirements of individual regions;
-region-specific data packages and data presentation describing manufacturing process data are submitted;
-inefficient use of reviewer/assessor and industry resources to clarify the rationale and intent of the manufacturing process data.
Issues to be Resolved
Section 3.2.S2 of the CTD is intended to provide a comprehensive understanding of the relationship of the Drug Substance quality attributes and the manufacturing process for reviewers and inspectors/facility investigators. It provides an opportunity to present the knowledge gained through the application of scientific approaches, definition of critical controls, and risk management, in the manufacture of a Drug Substance. It should define and justify the manufacturing operations and describe where the process/product robustness will permit wide operating ranges or where tighter monitoring and controls may be necessary. Enhanced understanding of manufacturing sciences and technologies can also create a basis for alternative approaches to control the quality of a product. The content of Section S2 of the CTD will need to take into account the different technological approaches and requirements for ensuring product quality and consistency in the manufacture of chemical and biotechnological/biological drug substances.
Some examples of technical elements, which are recognised as having a strong need for harmonisation of scientific approaches, include general principles and concepts for:
-Selection of materials and components for manufacture of the Drug Substance;
-Identification and justification of key and critical manufacturing steps, process controls, process parameters, choice of analytical procedures and acceptance criteria as elements
of a total control strategy designed to ensure product quality and consistency;
-The capacity of processes to reduce or remove impurities and product- related substances;
-Evaluation of process robustness;
-Suitability of scaled-down models for evaluation and validation;
-Identification and control of critical intermediates.
The goals of the proposed guideline are:
-Harmonise and encourage the submission of the relevant documents regarding the manufacturing process information and its justification;
-Outline the science-based concepts relevant to the design of a robust manufacturing process that reliably delivers a quality drug substance;
-Provide examples as appropriate of acceptable approaches for demonstrating process and product understanding;
-Facilitate the regulatory evaluation process for authorities;
-Recommend approaches for demonstrating process and product understanding;
-Address the complexity of different manufacturing processes and products;
-Accommodate variable approaches to development and corresponding information to be provided as described in Q8 and Q8R;
-Address enhanced approaches to manufacturing that can also create a basis for alternative approaches to control the quality of a product and for the application of
innovative technologies for the manufacture of APIs (e.g. continuous manufacture);
-Address systematic approaches to drug substance development, application of quality risk management, and concepts such as design space, control strategies (including real-
time release) over the lifecycle of the product.
Topics already covered by other ICH guidelines such as viral safety evaluation and analytical procedure validation will be cross-referenced, as appropriate.
The guideline will not address:
-Information relevant to the manufacturing process development of the Drug Product (to be covered by Q8 and Q8(R1));
-Qualification of facilities and equipment and other activities covered by GMP guidance
(e.g., ICH Q7).
Type of Expert Working Group
The proposed guidance will be Technical Guidance in the Quality area for chemical and biotechnological/biological drug substances. The working group should be a six-party expert working group (plus observers Health Canada, EFTA and WHO, and interested parties WSMI, IGPA and Biotech Industry). The EWG should follow the process used by the CTD-Q EWG where biotechnological/biological and chemical experts work together and in parallel (if necessary) and will use interim teleconferences and face to face meetings as appropriate.
Proposed timing
Approval of Topic/Rapporteur & EWG Defined April 2008
First EWG Meeting June 2008
Step 2 Sign-off 4Q 2009
古代晋灵公不君、齐晋鞌之战原文及译文
晋灵公不君（宣公二年） 原文： 晋灵公不君。厚敛以雕墙。从台上弹人，而观其辟丸也。宰夫胹熊蹯不熟，杀之，寘诸畚，使妇人载以过朝。赵盾、士季见其手，问其故而患之。将谏，士季曰：“谏而不入，则莫之继也。会请先，不入，则子继之。”三进及溜，而后视之，曰：“吾知所过矣，将改之。”稽首而对曰：“人谁无过？过而能改，善莫大焉。诗曰：‘靡不有初，鲜克有终。’夫如是，则能补过者鲜矣。君能有终，则社稷之固也，岂惟群臣赖之。又曰：‘衮职有阙，惟仲山甫补之。’能补过也。君能补过，衮不废矣。” 犹不改。宣子骤谏，公患之，使鉏麑贼之。晨往，寝门辟矣，盛服将朝。尚早，坐而假寐。麑退，叹而言曰：“不忘恭敬，民之主也。贼民之主，不忠；弃君之命，不信。有一于此，不如死也！”触槐而死。 秋九月，晋侯饮赵盾酒，伏甲将攻之。其右提弥明知之，趋登曰：“臣侍君宴，过三爵，非礼也。”遂扶以下。公嗾夫獒焉。明搏而杀之。盾曰：“弃人用犬，虽猛何为！”斗且出。提弥明死之。 初，宣子田于首山，舍于翳桑。见灵辄饿，问其病。曰：“不食三日矣！”食之，舍其半。问之，曰：“宦三年矣，未知母之存否。今近焉，请以遗之。”使尽之，而为之箪食与肉，寘诸橐以与之。既而与为公介，倒戟以御公徒，而免之。问何故，对曰：“翳桑之饿人也。”问其名居，不告而退。——遂自亡也。 乙丑，赵穿①攻灵公于桃园。宣子未出山而复。大史书曰：“赵盾弑其君。”以示于朝。宣子曰：“不然。”对曰：“子为正卿，亡不越竟，反不讨贼，非子而谁？”宣子曰：“呜呼!‘我之怀矣，自诒伊戚。’其我之谓矣。” 孔子曰：“董狐，古之良史也，书法不隐。赵宣子，古之良大夫也，为法受恶。惜也，越竞乃免。” 译文： 晋灵公不行君王之道。他向人民收取沉重的税赋以雕饰宫墙。他从高台上用弹弓弹人，然后观赏他们躲避弹丸的样子。他的厨子做熊掌，没有炖熟，晋灵公就把他杀了，把他的尸体装在草筐中，让宫女用车载着经过朝廷。赵盾和士季看到露出来的手臂，询问原由后感到很忧虑。他们准备向晋灵公进谏，士季说：“如果您去进谏而君王不听，那就没有人能够再接着进谏了。还请让我先来吧，不行的话，您再接着来。”士季往前走了三回，行了三回礼，一直到屋檐下，晋灵公才抬头看他。晋灵公说：“我知道我的过错了，我会改过的。”士季叩头回答道：“谁能没有过错呢？有过错而能改掉，这就是最大的善事了。《诗经》说：‘没有人向善没有一个开始的，但却很少有坚持到底的。’如果是这样，那么能弥补过失的人是很少的。您如能坚持向善，那么江山就稳固了，不只是大臣们有所依靠啊。
药学英语第五版第三单元
Biochemistry Seeks to Explain Life in Chemical Terms The molecules of which living organisms are composed conform to all the familiar laws of chemistry, but they also interact with each other in accordance with another set of principles, which we shall refer to collectively as the molecular logic of life. These principles do not involve new or yet undiscovered physical laws or forces. Instead, they are a set of relationships characterizing the nature, function, and interactions of biomolecules. If living organisms are composed of molecules that are intrinsically inanimate, how do these molecules confer the remarkable combination of characteristics we call life? How is it that a living organism appears to be more than the sum of its inanimate parts? Philosophers once answered that living organisms are endowed with a mysterious and divine life force, but this doctrine (vitalism) has been firmly rejected by modern science. The basic goal of the science of biochemistry is to determine how the collections of inanimate molecules that constitute living organisms interact with each other to maintain and perpetuate life. Although biochemistry yields important insights and practical applications in medicine, agriculture, nutrition, and industry, it is ultimately concerned with the wonder of life itself. All Macromolecules Are Constructed from a Few Simple Compounds Most of the molecular constituents of living systems are composed of carbon atoms covalently joined with other carbon atoms and with hydrogen, oxygen, or nitrogen. The special bonding properties of carbon permit the formation of a great variety of molecules. Organic compounds of molecular weight less than about 500, such as amino acids, nucleotidase, and monosaccharide, serve as monomeric subunits of proteins, nucleic acids, and polysaccharides,
药学专业英语药学词汇
6-磷酸葡萄糖脱氢酶 glucose-6-phosphate dehydrogenase Janbon综合症 Janbon's syndrome PPB浓度 parts per billion concentration pphm浓度 parts per hundred million concentration PPH浓度 parts per hundred concentration ppm浓度 parts per million concentration 安全范围 safety range 安全试验法 innocuity test method 安全系统 safety coefficient 安慰剂 placebo 螯合剂 chelating agent 靶细胞 target cell 白蛋白微球制剂 albumin microballoons 百分浓度 percentage concentration 半合成抗生素 semisynthetic antibiotics 半抗原 haptene 半数致死剂量 half lethal dose ; median lethal dose; LD50 半衰期 half-life period; half life time 包衣片 coated tablet 薄膜衣 film-coating 饱和溶液 saturated solution 贝克勒尔 Becquerel 被动免疫 passive immunity 被动转运 passive transport
崩解度 disintegration 崩解剂 disintegrants 必需氨基酸 essential aminoacid 必需脂肪酸 essential fatty acid 变态反应 allergy; allergic reaction 表面活性 surface activity 表面张力 surface tension 丙种射线 gamma rays 补体 complement 补体系统 complement system 不良反应 adverse reaction 不完全抗原 incomplete antigen 搽剂 liniments 长期毒性实验 long term toxicity test 长效制剂 prolonged action preparation 肠肝循环 enterohepatic circulation 肠溶控释片 enteric controlled release tablets 肠溶衣 enteric coating 处方 prescription;recipe 穿透促进剂 penetration enhancers 磁性控释制剂 magnetic controlled release dosage form 磁性药物制剂 magnetic medicinal preparations 大分子 macromolecule 单克隆抗体 monoclonal antibody
如何翻译古文
如何翻译古文 学习古代汉语，需要经常把古文译成现代汉语。因为古文今译的过程是加深理解和全面运用古汉语知识解决实际问题的过程，也是综合考察古代汉语水平的过程。学习古代汉语，应该重视古文翻译的训练。 古文翻译的要求一般归纳为信、达、雅三项。“信”是指译文要准确地反映原作的含义，避免曲解原文内容。“达”是指译文应该通顺、晓畅，符合现代汉语语法规范。“信”和“达”是紧密相关的。脱离了“信”而求“达”，不能称为翻译；只求“信”而不顾“达”，也不是好的译文。因此“信”和“达”是文言文翻译的基本要求。“雅”是指译文不仅准确、通顺，而且生动、优美，能再现原作的风格神韵。这是很高的要求，在目前学习阶段，我们只要能做到“信”和“达”就可以了。 做好古文翻译，重要的问题是准确地理解古文，这是翻译的基础。但翻译方法也很重要。这里主要谈谈翻译方法方面的问题。 一、直译和意译 直译和意译是古文今译的两大类型，也是两种不同的今译方法。 1．关于直译。所谓直译，是指紧扣原文，按原文的字词和句子进行对等翻译的今译方法。它要求忠实于原文，一丝不苟，确切表达原意，保持原文的本来面貌。例如： 原文：樊迟请学稼，子曰：“吾不如老农。”请学为圃。子曰：“吾不如老圃。”（《论语?子路》） 译文：樊迟请求学种庄稼。孔子道：“我不如老农民。”又请求学种菜蔬。孔子道：“我不如老菜农。”（杨伯峻《论语译注》） 原文：齐宣王问曰：“汤放桀，武王伐纣，有诸？”（《孟子?梁惠王下》） 译文：齐宣王问道：“商汤流放夏桀，武王讨伐殷纣，真有这回事吗？（杨伯峻《孟子译注》） 上面两段译文紧扣原文，字词落实，句法结构基本上与原文对等，属于直译。 但对直译又不能作简单化理解。由于古今汉语在文字、词汇、语法等方面的差异，今译时对原文作一些适当的调整，是必要的，并不破坏直译。例如： 原文：逐之，三周华不注。（《齐晋鞌之战》） 译文：〔晋军〕追赶齐军，围着华不注山绕了三圈。
药学英语第五版原文翻译 (2)(2020年7月整理).pdf
Introduction to Physiology Introduction Physiology is the study of the functions of living matter. It is concerned with how an organism performs its varied activities: how it feeds, how it moves, how it adapts to changing circumstances, how it spawns new generations. The subject is vast and embraces the whole of life. The success of physiology in explaining how organisms perform their daily tasks is based on the notion that they are intricate and exquisite machines whose operation is governed by the laws of physics and chemistry. Although some processes are similar across the whole spectrum of biology—the replication of the genetic code for or example—many are specific to particular groups of organisms. For this reason it is necessary to divide the subject into various parts such as bacterial physiology, plant physiology, and animal physiology. To study how an animal works it is first necessary to know how it is built. A full appreciation of the physiology of an organism must therefore be based on a sound knowledge of its anatomy. Experiments can then be carried out to establish how particular parts perform their functions. Although there have been many important physiological investigations on human volunteers, the need for precise control over the experimental conditions has meant that much of our present physiological knowledge has been derived from studies on other animals such as frogs, rabbits, cats, and dogs. When it is clear that a specific physiological process has a common basis in a wide variety of animal species, it is reasonable to assume that the same principles will apply to humans. The knowledge gained from this approach has given us a great insight into human physiology and endowed us with a solid foundation for the effective treatment of many diseases. The building blocks of the body are the cells, which are grouped together to form tissues. The principal types of tissue are epithelial, connective, nervous, and muscular, each with its own characteristics. Many connective tissues have relatively few cells but have an extensive extracellular matrix. In contrast, smooth muscle consists of densely packed layers of muscle cells linked together via specific cell junctions. Organs such as the brain, the heart, the lungs, the intestines, and the liver are formed by the aggregation of different kinds of tissues. The organs are themselves parts of distinct physiological systems. The heart and blood vessels form the cardiovascular system; the lungs, trachea, and bronchi together with the chest wall and diaphragm form the respiratory system; the skeleton and skeletal muscles form the musculoskeletal system; the brain, spinal cord, autonomic nerves and ganglia, and peripheral somatic nerves form the nervous system, and so on. Cells differ widely in form and function but they all have certain 生理学简介 介绍 生理学是研究生物体功能的科学。它研究生物体如何进行各种活动，如何饮食，如何运动，如何适应不断改变的环境，如何繁殖后代。这门学科包罗万象，涵盖了生物体整个生命过程。生理学成功地解释了生物体如何进行日常活动，基于的观点是生物体好比是结构复杂而灵巧的机器，其操作受物理和化学规律控制。 尽管从生物学整个范畴看，生物体某些活动过程是相似的——如基因编码的复制——但许多过程还是某些生物体群组特有的。鉴于此有必要将这门学科分成不同部分研究，如细菌生理学、植物生理学和动物生理学。 要研究一种动物如何活动，首先需要了解它的构成。要充分了解一个生物体的生理学活动就必须掌握全面的解剖学知识。一个生物体的各部分起着什么作用可通过实验观察得知。尽管我们对志愿者进行了许多重要的生理调查，但是实验条件需要精确控制，所以我们当前大多生理知识还是源于对其它动物如青蛙，兔子，猫和狗等的研究。当我们明确大多数动物物种的特定生理过程存在共同之处时，相同的生理原理适用于人类也是合理的。通过这种方法，我们获得了大量的知识，从而让我们对人类生理学有了更深入的了解，为我们有效治疗许多疾病提供了一个坚实的基础。 机体的基本组成物质是细胞，细胞结合在一起形成组织。组织的基本类型有上皮组织，结缔组织，神经组织和肌组织，每类组织都有各自的特征。许多结缔组织中细胞量相对较少，但是有大量的细胞外基质。相比而言，光滑的肌组织由大量密密麻麻的肌细胞通过特定的细胞连接组成。各种器官如脑，心脏，肺，小肠和肝等由不同种类的组织聚集而成。这些器官是不同生理系统的组成部分。心脏和血管组成心血管系统；肺，器官，支气管，胸壁和膈肌组成呼吸系统；骨骼和骨骼肌组成骨骼肌系统；大脑，脊髓，自主神经和神经中枢以及
药学英语专业词汇word精品
药学名词（中-英）6-磷酸葡萄糖脱氢酶glucose-6-phosphate dehydrogenase Janbon综合症Janbon's syndrome PPB浓度parts per billion concentration pphm 浓度parts per hundred million concentration PPH浓度parts per hundred concentration ppm 浓度parts per million concentration 安全范围safety range 安全试验法innocuity test method 安全系统safety coefficient 安慰剂placebo 螯合剂chelating agent 靶细胞target cell 白蛋白微球制剂albumin microballoons 百分浓度percentage concentration 半合成抗生素semisynthetic antibiotics 半抗原haptene 半数致死剂量half lethal dose ; median lethal dose; LD50 半衰期half-life period; half life time 包衣片coated tablet 薄膜衣film-coating 饱和溶液saturated solution 贝克勒尔Becquerel 被动免疫passive immunity 被动转运passive transport 崩解度disintegration 崩解剂disintegrants 必需氨基酸essential aminoacid 必需脂肪酸essential fatty acid 变态反应allergy; allergic reaction 表面活性surface activity 表面张力surface tension 丙种射线gamma rays 补体complement 补体系统complement system 不良反应adverse reaction 不完全抗原incomplete antigen 搽剂liniments 长期毒性实验long term toxicity test 长效制剂prolonged action preparation 肠肝循环enterohepatic circulation 肠溶控释片enteric controlled release tablets 肠溶衣enteric coating 处方prescription;recipe 穿透促进剂penetration enhancers 磁性控释制剂magnetic controlled release dosage form 磁性药物制剂magnetic medicinal preparations 大分子macromolecule 单克隆抗体monoclonal antibody 胆碱酯酶cholinesterase 当量equivalent weight 当量定律equivalent law 当量浓度normality 当量溶液normal solution 等张溶液isotonic solution 低聚糖oligosaccharides 低密度脂蛋白low density lipoprotein 滴定titration 滴定曲线titration curve 滴丸剂 pill 递质transmitter 电解electrolyzation 电解质electrolyte 酊剂tincture 定向药物制剂directed pharmaceutical preparations 毒理学toxicology 毒性反应toxic response; toxic reaction 短期致癌实验short term carcinogenic test 对因治疗etiological treatment 对映体antipode 对症治疗symptomatic treatment 多功能酶multifunctional enzyme 多剂量给药multiple dose administration 多糖polyose 多肽polypeptide 儿茶酚胺catecholamine 二重感染superinfection 发酵fermentation 法定处方official formula
齐晋鞌之战原文和译文
鞌之战选自《左传》又名《鞍之战》原文：楚癸酉，师陈于鞌(1)。邴夏御侯，逢丑父为右②。晋解张御克，郑丘缓为右(3)。侯日：“余姑翦灭此而朝食(4)”。不介马而驰之⑤。克伤于矢，流血及屦2 未尽∧6)，曰：“余病矣(7)！”张侯曰：“自始合(8)，而矢贯余手及肘(9)，余折以御，左轮朱殷(10)，岂敢言病吾子忍之！”缓曰：“自始合，苟有险，余必下推车，子岂＿识之(11)然子病矣！”张侯曰：“师之耳目，在吾旗鼓，进退从之。此车一人殿之(12)，可以集事(13)，若之何其以病败君之大事也擐甲执兵(14)，固即死也(15)；病未及死，吾子勉之(16)！”左并辔(17) ，右援拐鼓(18)。马逸不能止(19)，师从之，师败绩。逐之，三周华不注(20) 韩厥梦子舆谓己曰：“旦辟左右！”故中御而从齐侯。邴夏曰：“射其御者，君子也。”公曰：“谓之君子而射之，非礼也。”射其左，越于车下；射其右，毙于车中。綦毋张丧车，从韩厥，曰：“请寓乘。”从左右，皆肘之，使立于后。韩厥俛，定其右。逢丑父与公易位。将及华泉，骖絓于木而止。丑父寝于轏中，蛇出于其下，以肱击之，伤而匿之，故不能推车而及。韩厥执絷马前，再拜稽首，奉觞加璧以进，曰：“寡君使群臣为鲁、卫请，曰：‘无令舆师陷入君地。’下臣不幸，属当戎行，无所逃隐。且惧奔辟而忝两君，臣辱戎士，敢告不敏，摄官承乏。” 丑父使公下，如华泉取饮。郑周父御佐车，宛茷为右，载齐侯以免。韩厥献丑父，郤献子将戮之。呼曰：“自今无有代其君任患者，有一于此，将为戮乎”郤子曰：“人不难以死免其君，我戮之不祥。赦之，以劝事君者。”乃免之。译文1：在癸酉这天，双方的军队在鞌这个地方摆开了阵势。齐国一方是邴夏为齐侯赶车，逢丑父当车右。晋军一方是解张为主帅郤克赶车，郑丘缓当车右。齐侯说:“我姑且消灭了这些人再吃早饭。”不给马披甲就冲向了晋军。郤克被箭射伤，血流到了鞋上，但是仍不停止擂鼓继续指挥战斗。他说:“我受重伤了。”解张说:“从一开始接战，一只箭就射穿了我的手和肘，左边的车轮都被我的血染成了黑红色，我哪敢说受伤您忍着点吧！”郑丘缓说:“从一开始接战，如果遇到道路不平的地方，我必定（冒着生命危险）下去推车，您难道了解这些吗不过，您真是受重伤了。”daier 解张说:“军队的耳朵和眼睛，都集中在我们的战旗和鼓声，前进后退都要听从它。这辆车上还有一个人镇守住它，战事就可以成功。为什么为了伤痛而败坏国君的大事呢身披盔甲，手执武器，本来就是去走向死亡，伤痛还没到死的地步，您还是尽力而为吧。”一边说，一边用左手把右手的缰绳攥在一起，用空出的右手抓过郤克手中的鼓棰就擂起鼓来。（由于一手控马，）马飞快奔跑而不能停止，晋军队伍跟着指挥车冲上去，把齐军打得打败。晋军随即追赶齐军，三次围绕着华不注山奔跑。韩厥梦见他去世的父亲对他说:“明天早晨作战时要避开战车左边和右边的位置。”因此韩厥就站在中间担任赶车的来追赶齐侯的战车。邴夏说:“射那个赶车的，他是个君子。”齐侯说: “称他为君子却又去射他，这不合于礼。”daier 于是射车左，车左中箭掉下了车。又射右边的，车右也中箭倒在了车里。（晋军的）将军綦毋张损坏了自己的战车，跟在韩厥的车后说: “请允许我搭乗你的战车。”他上车后，无论是站在车的左边，还是站在车的右边，韩厥都用肘推他，让他站在自己身后——战车的中间。韩厥又低下头安定了一下受伤倒在车中的那位自己的车右。于是逢丑父和齐侯（乘韩厥低头之机）互相调换了位置。将要到达华泉时，齐侯战车的骖马被树木绊住而不能继续逃跑而停了下来。（头天晚上）逢丑父睡在栈车里，有一条蛇从他身子底下爬出来，他用小臂去打蛇，小臂受伤，但他（为了能当车右）隐瞒了这件事。由于这样，他不能用臂推车前进，因而被韩厥追上了。韩厥拿着拴马绳走到齐侯的马前，两次下拜并行稽首礼，捧着一杯酒并加上一块玉璧给齐侯送上去，
药学英语第五版原文翻译
IntroductiontoPhysiology Introduction Physiologyisthestudyofthefunctionsoflivingmatter.Itisconcernedwithhowanorganismperformsitsv ariedactivities:howitfeeds,howitmoves,howitadaptstochangingcircumstances,howitspawnsnewgenerati ons.Thesubjectisvastandembracesthewholeoflife.Thesuccessofphysiologyinexplaininghoworganismsp erformtheirdailytasksisbasedonthenotionthattheyareintricateandexquisitemachineswhoseoperationisgo vernedbythelawsofphysicsandchemistry. Althoughsomeprocessesaresimilaracrossthewholespectrumofbiology—thereplicationofthegenetic codefororexample—manyarespecifictoparticulargroupsoforganisms.Forthisreasonitisnecessarytodivid ethesubjectintovariouspartssuchasbacterialphysiology,plantphysiology,andanimalphysiology. Tostudyhowananimalworksitisfirstnecessarytoknowhowitisbuilt.Afullappreciationofthephysiolog yofanorganismmustthereforebebasedonasoundknowledgeofitsanatomy.Experimentscanthenbecarriedo uttoestablishhowparticularpartsperformtheirfunctions.Althoughtherehavebeenmanyimportantphysiolo gicalinvestigationsonhumanvolunteers,theneedforprecisecontrolovertheexperimentalconditionshasmea ntthatmuchofourpresentphysiologicalknowledgehasbeenderivedfromstudiesonotheranimalssuchasfrog s,rabbits,cats,anddogs.Whenitisclearthataspecificphysiologicalprocesshasacommonbasisinawidevariet yofanimalspecies,itisreasonabletoassumethatthesameprincipleswillapplytohumans.Theknowledgegain edfromthisapproachhasgivenusagreatinsightintohumanphysiologyandendoweduswithasolidfoundation fortheeffectivetreatmentofmanydiseases. Thebuildingblocksofthebodyarethecells,whicharegroupedtogethertoformtissues.Theprincipaltype softissueareepithelial,connective,nervous,andmuscular,eachwithitsowncharacteristics.Manyconnective tissueshaverelativelyfewcellsbuthaveanextensiveextracellularmatrix.Incontrast,smoothmuscleconsists https://www.wendangku.net/doc/b315706391.html,anssuchasthebrain,theh eart,thelungs,theintestines,andtheliverareformedbytheaggregationofdifferentkindsoftissues.Theorgans arethemselvespartsofdistinctphysiologicalsystems.Theheartandbloodvesselsformthecardiovascularsyst em;thelungs,trachea,andbronchitogetherwiththechestwallanddiaphragmformtherespiratorysystem;thes keletonandskeletalmusclesformthemusculoskeletalsystem;thebrain,spinalcord,autonomicnervesandgan glia,andperipheralsomaticnervesformthenervoussystem,andsoon. Cellsdifferwidelyinformandfunctionbuttheyallhavecertaincommoncharacteristics.Firstly,theyareb oundedbyalimitingmembrane,theplasmamembrane.Secondly,theyhavetheabilitytobreakdownlargemol eculestosmalleronestoliberateenergyfortheiractivities.Thirdly,atsomepointintheirlifehistory,theyposses sanucleuswhichcontainsgeneticinformationintheformofdeoxyribonucleicacid(DNA). Livingcellscontinuallytransformmaterials.Theybreakdownglucoseandfatstoprovideenergyforother activitiessuchasmotilityandthesynthesisofproteinsforgrowthandrepair.Thesechemicalchangesarecollect ivelycalledmetabolism.Thebreakdownoflargemoleculestosmalleronesiscalledcatabolismandthesynthes isoflargemoleculesfromsmalleronesanabolism. Inthecourseofevolution,cellsbegantodifferentiatetoservedifferentfunctions.Somedevelopedtheabil itytocontract(musclecells),otherstoconductelectricalsignals(nervecells).Afurthergroupdevelopedtheabi litytosecretedifferentsubstancessuchashormonesorenzymes.Duringembryologicaldevelopment,thispro cessofdifferentiationisre-enactedasmanydifferenttypesofcellareformedfromthefertilizedegg. Mosttissuescontainamixtureofcelltypes.Forexample,bloodconsistsofredcells,whitecells,andplatele ts.Redcellstransportoxygenaroundthebody.Thewhitecellsplayanimportantroleindefenseagainstinfection 生理学简介 介绍 生理学是研究生物体功能的科学。它研究生物体如何进行各种活动，如何饮食，如何运动，如何适应不断改变的环境，如何繁殖后代。这门学科包罗万象，涵盖了生物体整个生命过程。生理学成功地
《鞌之战》阅读答案(附翻译)原文及翻译
《鞌之战》阅读答案（附翻译）原文及翻 译 鞌之战[1] 选自《左传成公二年（即公元前589年）》 【原文】 癸酉，师陈于鞌[2]。邴夏御齐侯[3]，逢丑父为右[4]。晋解张御郤克，郑丘缓为右[5]。齐侯曰：余姑翦灭此而朝食[6]。不介马而驰之[7]。郤克伤于矢，流血及屦，未绝鼓音[8]，曰：余病[9]矣！张侯[10]曰：自始合，而矢贯余手及肘[11]，余折以御，左轮朱殷[12]，岂敢言病。吾子[13]忍之！缓曰：自始合，苟有险[14]，余必下推车，子岂识之[15]？然子病矣！张侯曰：师之耳目，在吾旗鼓，进退从之[16]。此车一人殿之[17]，可以集事[18]，若之何其以病败君之大事也[19]？擐甲执兵，固即死也[20]。病未及死，吾子勉之[21]！左并辔[22]，右援枹而鼓[23]，马逸不能止[24]，师从之。齐师败绩[25]。逐之，三周华不注[26]。 【注释】 [1]鞌之战：春秋时期的著名战役之一。战争的实质是齐、晋争霸。由于齐侯骄傲轻敌，而晋军同仇敌忾、士气旺盛，战役以齐败晋胜而告终。鞌：通鞍，齐国地名，在今山东济南西北。 [2]癸酉：成公二年的六月十七日。师，指齐晋两国军队。陈，
列阵，摆开阵势。 [3]邴夏：齐国大夫。御，动词，驾车。御齐侯，给齐侯驾车。齐侯，齐国国君，指齐顷公。 [4]逢丑父：齐国大夫。右：车右。 [5]解张、郑丘缓：都是晋臣，郑丘是复姓。郤（x ）克，晋国大夫，是这次战争中晋军的主帅。又称郤献子、郤子等。 [6]姑：副词，姑且。翦灭：消灭，灭掉。朝食：早饭。这里是吃早饭的意思。这句话是成语灭此朝食的出处。 [7]不介马：不给马披甲。介：甲。这里用作动词，披甲。驰之：驱马追击敌人。之：代词，指晋军。 [8] 未绝鼓音：鼓声不断。古代车战，主帅居中，亲掌旗鼓，指挥军队。兵以鼓进，击鼓是进军的号令。 [9] 病：负伤。 [10]张侯，即解张。张是字，侯是名，人名、字连用，先字后名。 [11]合：交战。贯：穿。肘：胳膊。 [12]朱：大红色。殷：深红色、黑红色。 [13]吾子：您，尊敬。比说子更亲切。 [14]苟：连词，表示假设。险：险阻，指难走的路。 [15]识：知道。之，代词，代苟有险，余必下推车这件事，可不译。 [16]师之耳目：军队的耳、目（指注意力）。在吾旗鼓：在我们
《鞌之战》阅读答案附翻译
《鞌之战》阅读答案（附翻译） 《鞌之战》阅读答案（附翻译） 鞌之战[1] 选自《左传·成公二年（即公元前589年）》 【原文】 癸酉，师陈于鞌[2]。邴夏御齐侯[3]，逢丑父为右[4]。晋解张御郤克，郑丘缓为右[5]。齐侯曰：“余姑 翦灭此而朝食[6]。”不介马而驰之[7]。郤克伤于矢， 流血及屦，未绝鼓音[8]，曰：“余病[9]矣！”张侯[10]曰：“自始合，而矢贯余手及肘[11]，余折以御，左轮 朱殷[12]，岂敢言病。吾子[13]忍之！”缓曰：“自始合，苟有险[14]，余必下推车，子岂识之[15]？——然 子病矣！”张侯曰：“师之耳目，在吾旗鼓，进退从之[16]。此车一人殿之[17]，可以集事[18]，若之何其以 病败君之大事也[19]？擐甲执兵，固即死也[20]。病未 及死，吾子勉之[21]！”左并辔[22]，右援枹而鼓[23]，马逸不能止[24]，师从之。齐师败绩[25]。逐之，三周 华不注[26]。 【注释】 [1]鞌之战：春秋时期的著名战役之一。战争的实质是齐、晋争霸。由于齐侯骄傲轻敌，而晋军同仇敌忾、 士气旺盛，战役以齐败晋胜而告终。鞌：通“鞍”，齐
国地名，在今山东济南西北。 [2]癸酉：成公二年的六月十七日。师，指齐晋两国军队。陈，列阵，摆开阵势。 [3]邴夏：齐国大夫。御，动词，驾车。御齐侯，给齐侯驾车。齐侯，齐国国君，指齐顷公。 [4]逢丑父：齐国大夫。右：车右。 [5]解张、郑丘缓：都是晋臣，“郑丘”是复姓。郤（xì）克，晋国大夫，是这次战争中晋军的主帅。又称郤献子、郤子等。 [6]姑：副词，姑且。翦灭：消灭，灭掉。朝食：早饭。这里是“吃早饭”的意思。这句话是成语“灭此朝食”的出处。 [7]不介马：不给马披甲。介：甲。这里用作动词，披甲。驰之：驱马追击敌人。之：代词，指晋军。 [8]未绝鼓音：鼓声不断。古代车战，主帅居中，亲掌旗鼓，指挥军队。“兵以鼓进”，击鼓是进军的号令。 [9]病：负伤。 [10]张侯，即解张。“张”是字，“侯”是名，人名、字连用，先字后名。 [11]合：交战。贯：穿。肘：胳膊。 [12]朱：大红色。殷：深红色、黑红色。 [13]吾子：您，尊敬。比说“子”更亲切。
药学英语专业词汇
药学名词（中-英） 6-磷酸葡萄糖脱氢酶glucose-6-phosphate dehydrogenase Janbon综合症Janbon's syndrome PPB浓度parts per billion concentration pphm浓度parts per hundred million concentration PPH浓度parts per hundred concentration ppm浓度parts per million concentration 安全范围safety range 安全试验法innocuity test method 安全系统safety coefficient 安慰剂placebo 螯合剂chelating agent 靶细胞target cell 白蛋白微球制剂albumin microballoons 百分浓度percentage concentration 半合成抗生素semisynthetic antibiotics 半抗原haptene 半数致死剂量half lethal dose ; median lethal dose; LD50 半衰期half-life period; half life time 包衣片coated tablet 薄膜衣film-coating 饱和溶液saturated solution 贝克勒尔Becquerel 被动免疫passive immunity 被动转运passive transport 崩解度disintegration 崩解剂disintegrants 必需氨基酸essential aminoacid