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制药工程专业英语课文翻译

制药工程专业英语课文翻译

Unit 1 Production of DrugsAbout 5000 antibiotics have already been isolated from microorganisms,but of these only somewhat fewer than 100 are in therapeutic use. It must be remembered,however,that many derivatives have been modified by partial synthesis for therapeutic use;some 50,000 agents have been semisynthetically obtained from户lactams alone in the last decade. Fermentations are carried out in stainless steel fermentors with volumes up to 400 m3. To avoid contamination of the microorganisms with phages etc. the whole process has to be performed under sterile conditions. Since the more important fermentations occur exclusively under aerobic conditions a good supply of oxygen or air(sterile)is needed. Carbon dioxide sources include carbohydrates,e. g. molasses,saccharides,and glucose. Additionally the microorganisms must be supplied in the growth medium with nitrogen-containing compounds such as ammonium sulfate,ammonia,or urea,as well as with inorganic phosphates. Furthermore,constant optimal pH and temperature are required. In the case of penicillin G,the fermentation is finished after 200 hours,and the cell mass is separated by filtration. The desired active agents are isolated from the filtrate by absorption or extraction processes. The cell mass,if not the desired product,can be further used as an animal feedstuff owing to its high protein content.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。

制药专业英语原文翻译

制药专业英语原文翻译

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。

生物制药专业英语

生物制药专业英语

6、The physicist rightly dreads precise argument, since an argument that is convincing only if it is precise loses all its force if the assumption on which it is based are slightly changed, whereas an argument that is convincing though imprecise may well be stable under small perturbations of its underlying assumptions. 物理学家不敢做精确的论证,因为一个只有当它是精确 的时候才令人信服的论证,如果作为它的基础的假设发生 了一点点变化,就失去了其全部的说服力;而一个尽管不 很精确但是令人信服的论证,当作为它的基础的假设稍有 波动时,仍有可能是稳定的。
heterogeneous nuclear RNA.
真核生物细胞中蛋白质的合成与原核生物中的区别在 于真核生物染色体的初级转录本并不是mRNA,而是一 个高分子量的不均一核RNA。
11、The Kjedahl method is less general than of Duma’s, but it is useful for the rapid analysis of specific groups of low nitrogen content, for example protein.
mRNA被传送出细胞核到达细胞质,然后被一种我
们称之为核糖体的细胞器翻译成它所编码的蛋白质,该 细胞器把氨基酸以mRNA分子中碱基的序列所规定的 次序串联在一起。

制药行业专业英语

制药行业专业英语

制药行业专业英语1,药品生产质量管理规范GMP:Good ManufacturingPractice2,国家食品与药品监督管理局State Food and Drug Administration3,总则GeneralProvisions4,《中华人民共和国药品管理法》the DrugAdministration Law of the People's Republic of China 5,制剂Preparation6,原料药API: Active PharmaceuticalIngredient7,成品finished goods8,工序process9,机构与人员organization and personnel10,专业知识professional knowledge11,生产经验production experience12,组织能力organizational skill13,技术人员technical staff14,实施implementation15,药品生产pharmaceutical manufacturing16,质量管理quality management17,质量检验quality inspection18,专业技术培训professional and technicaltraining19,基础理论知识basic theoreticalknowledge20,实际操作技能practical operationskills 21,高生物活性highly potent22,高毒性high toxicity23,污染contamination24,考核评估assessment25,厂房与设施buildings and facilities 26,生产环境production environment 27,空气洁净级别clean air level28,昆虫insect29,洁净室(区)clean room(area)30,光滑smooth31,无裂缝no cracks32,无颗粒物脱落no particle shedding 33,耐受endure34,消毒disinfection35,无菌sterile36,交界处junction, joint37,弧形arc38,灰尘积聚dues accumulation 39,储存区store area40,生产规模production scale41,设备equipment42,物料material43,中间产品intermediate product 44,待验品quarantined material 45,交叉污染cross-contamination 46,管道pipeline, ductwork47,风口tuber48,公用设施, 公用工程utilities of publicservice 49,照明lighting50,照度illumination。

制药专业英语词汇完整翻译版

制药专业英语词汇完整翻译版

medicinal药品,药物, 药的,药用的,治疗的 medical 医学的,医术的pharmaceutical 药学的,制药的,药品 be split into 分成,分为alkaloid 生物碱 enzyme 酶polysaccharide 多糖,多聚糖 precursor 前体steroid 甾体 peptide 肽hormone 激素 gall 胆汁insulin 胰岛素 pancreas胰腺 serum/sera血清,浆液vaccine 疫苗 cholesterol 胆固醇gelatine 骨胶,明胶 antibiotic 抗生素,抗菌的interferon 干扰素 antibody 抗体fermentation 发酵 therapy 治疗/ therapeutic治疗的therapeutic margin caffeine咖啡因dopamine多巴胺 yeast 酵母mucous membrane粘液的,分泌粘液的 plasma 血浆,淋巴液,等离子体penicillin 青霉素 penicillium 青霉菌derivative衍生物 sterile无菌的,不能生育的aerobic 需氧的 oxygen氧,氧气feedstuff 饲料 lymph淋巴,淋巴液starch 淀粉 regiospecific reaction区域专一性反应stereospecific reaction立体专一性反应 glucose葡萄糖immobilize 固定 heterogeneous 不均匀的,多相的contamination污染 genetic 创始的,遗传学的hygienic 卫生学的,卫生的 intermediate中间体extraction 萃取 recrystallization 重结晶/ crystal 晶体,晶体的xylene 二甲苯 toluene 甲苯ether 醚 benzene苯/ chlorobenzene氯苯synthetic, 合成的,人造的;化学合成品 semisynthetic,半合成的synthesis [复syntheses] 综合,综合物,合成(法) synthesize vt 综合,合成 lead structure先导结构preparation 制备,制剂 isolate使分离,使离析 / isolation heart glycoside tocopherol 生育酚hydrolysis水解/hydrolysate水解产物/hydrolyze水解hydroxylation 羟基化 dextran 葡聚糖,代血浆wool 羊毛 ーlactamβ-内酰胺amino acid 氨基酸/ amino 氨基的 penicilamine 青霉胺ammonia 氨 ammonium 铵 / ammonium sulfate硫酸铵amine 胺 amide酰胺microorganism 微生物 micro b iological微生物学的mutant 变异的;突变型,突变体 starting material 起始原料natural source天然来源 organ器官/target organ 靶器官pancreas 胰腺 natural product 天然产物mould 霉,霉菌;发霉 high performance 高效bacterial 细菌的 protein 蛋白质degradation 降解 metabolism新陈代谢 / metabolize metabolite代谢物molecule n. 分子;微小颗粒/molecular weight分子量food additive 食品添加剂organic有机(体)的;有组织的,系统的;器官的;根本的lactic acid乳酸 citric acid 柠檬酸tetracycline 四环素 carbon dioxide 二氧化碳carbohydrate 碳水化合物 saccharide 糖/多糖polysaccharide nitrogen 氮 urea 尿素phosphate 磷酸盐 optimal 优化的,最佳的separate vt 分离 Food additiveabsorption 吸收 absorb vt. 吸收filtration 过滤 filtrate 滤液filte 过滤(vt),过滤器(n) recombinant 重组的,重组子purification 纯化 encode vt. 把(电文等)译成电码(或密码), 编码calcium 钙 chromatographic procedure 色谱操作步骤isomerization异构化 /isomeric phenol 酚fructose 果糖 fumaric acid 富马酸countless test 非计数的 diagnose诊断 diagnosticprotease 蛋白酶analysis分析/analyze 分析vt / analyst分析家/ analytical分析的Ingredient 成分 in combination with 结合Digestion 消化。

制药工程专业英语第1、5、6、7、9、11、13、16、21、24、25单元文章翻译(吴达俊庄思永)

制药工程专业英语第1、5、6、7、9、11、13、16、21、24、25单元文章翻译(吴达俊庄思永)

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。

制药工程专业英语详细Unit1.3.6详细翻译

制药工程专业英语详细Unit1.3.6详细翻译

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。

可以得到以下产品类型:1.细胞原料(单细胞蛋白)2.酶3.主要降解产物(初级代谢物)4.次要降解产物(次级代谢物).除了某些微生物(如肠膜明串珠菌)的黏膜所合成葡萄糖以外第2类和第3类都是与药物的制备相关的物质。

分子量为5万到10万的葡萄糖可以作为血浆替代品。

在这些初级代谢物中谷氨酸棒状杆菌和黄色短杆菌的突变体产生的L —氨基酸是特别有意义的。

利用这些生物体大约可以生产35万吨味精(食物添加剂)和7万吨L —赖氨酸(用于植物蛋白补充)。

更重要的初级代谢产物有嘌。

呤核苷酸,有机酸,乳酸,柠檬酸和维生素,例如谢曼丙酸杆菌产生的维生素12其中首先要提到的次级代谢物是抗生素.以下五类抗生素每年全球销售额170亿美元:青霉素(黄青霉)头孢菌素(假头状孢子头枝顶孢属)四环素(金色链霉菌)红霉素(红霉素链霉菌)氨基糖苷类抗生素(灰色链霉菌)微生物已经分离出大约5000种抗生素的,但其中只有不到100种应用于临床治疗。

制药工程 专业英语 Unit 6

制药工程 专业英语 Unit 6

Tannins of the first type which are found in tea generally yield glucose and gallic acid when they are hydrolyzed. These tannins are esters of gallic acid and glucose. They represent structures in which some of the hydroxyl groups in glucose have been esterified by digalloyl groups. The non-hydrolyzable tannins found in tea are condensation polymers of catechin. These polymers are not uniform in structure, but catechin molecules are usually linked together at ring positions 4 and 8.
When tannins are extracted into hot water, the hydrolyzable ones are partially hydrolyzed, meaning that free gallic acid is also found in tea. The tannins, by virtue of their phenolic groups, and gallic acid by virtue of its carboxyl groups, are both acidic. If calcium carbonate, a base, is added to tea water, the calcium salts of these acids are formed. Caffeine can be extracted from the basic tea solution with chloroform, but the calcium salts of gallic acid and the tannins are not chloroform soluble and remain behind in the aqueous solution.

制药行业专业英语

制药行业专业英语

CPP marketing authorization (MA)FDA Abbreviated New Drug Application (ANDA) Number FDA active ingredientFDA ANDAFDA Approval HistoryFDA Approval LetterFDA Biologic License Application (BLA)FDA Biologic ProductFDA Brand Name DrugFDA discontinued drugFDA Dockets Management System (DMS)FDA dosage formFDA Dosage FormFDA drugFDA Drug ProductFDA DrugFDA FDA Action DateFDA FDA Application Number FDA Federal Registers (FR)FDA Generic DrugFDA LabelFDA Marketing statusFDA medication guideFDA New Drug Application (NDA) NumberFDA Over-the-Counter Drugs (OTC)FDA Patient Package Insert (PPI)FDA Pharmaceutical EquivalentsFDA Pre-NDA meetingFDA The CDER Data Standards Manual (The CDER DSM)FDA the Center-wide Oracle Management Information System (COMIS)FDA the Developers and Distributors System (DADS)FDA the Division Files System (DFS)FDA the Drug Product Reference File (DPRF)FDA the Drug Registration and Listing System (DRLS)FDA the Federal Dockets Management System (FDMS) FDA the Special Products On-Line Tracking System (SPOTS) FDA the United States Adopted Names Council (USAN) ICH Common Technical Document (CTD)ICH Electronic Common Technical Document (eCTD)ICH Expert Working Groups (EWGs)ICH Global Cooperation Group (GCG)ICH ICH guidelinesICH ICH steering committeeICH Impurities in New Drug ProductsICH International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)ICH Terms of ReferenceICH the International Conference on Harmonisation (ICH)ICH-Q7A Active Pharmaceutical Ingredient (API)(or Drug Substance) ICH-Q7A API Starting MaterialICH-Q7A Batch (or Lot)ICH-Q7A Batch Number (or Lot Number)ICH-Q7A BioburdenICH-Q7A CalibrationICH-Q7A Computer SystemICH-Q7A Computerized SystemICH-Q7A ContaminationICH-Q7A Contract ManufacturerICH-Q7A CriticalICH-Q7A Cross-ContaminationICH-Q7A Drug (Medicinal) ProductICH-Q7A Expiry Date (or Expiration Date)ICH-Q7A ImpurityICH-Q7A Impurity ProfileICH-Q7A In-Process Control (or Process Control) REACH Agency(Central Agency)REACH Animal testingREACH ArticleREACH authorisationREACH Business impact assessment (BIA) REACH CMR物质REACH Competent AuthoritiesREACH Computer modellingREACH DeadlinesREACH Downstream usersREACH Endocrine disruptersREACH Epidemiological studiesREACH European Chemicals BureauREACH EvaluationREACH Existing chemicalsREACH ExposureREACH Globally Harmonised Syste (GHS)REACH In vitro testringREACH Intergovernmental Forum on Chemicals Safety (IFCS) REACH IntermediatesREACH New chemicalsREACH Persistent, Bio-accumulative and Toxic Chemicals REACH PolymersREACH POP物质REACH PPORDREACH PrepartionREACH Prior Informed Consent (PIC)REACH RegistrantREACH RegistrationREACH Registration, Evaluation and Authorization of Chemicals (European Commission)REACH RiskREACH Small and medium sized enterprises (SME) REACH Substances in articlesREACH SubstitutionREACH Sustainable developmentREACH Technical Expert Working GroupsREACH Tonnage thresholdREACH United Nations Environment Programme (UNEP) REACH very Persistent and very Bio-accumulative Chemicals保健品health food(s), functional food(s), dietary supplement(s)保健品new resource food法律-比较case law法学法律-比较civil law system法学法律-比较common law法学法律-比较common law system法学法律-比较Comparative Law法学法律-比较Comprative Study of Law法学法律-比较legal doctrine法学法律-比较法学Legal System, Legal Family, Legal Group, Legal Genealogy, legal tradition法律-比较法学Study of Comprative Law公司类型Aktiengesellschaft (A.G.)公司类型aktieselskab (丹麦文), aktieselskab(挪威文) (A/S)公司类型Altiebolag (AB)公司类型Berhad (BHD)公司类型Besloten Vennootshap met beperkte aansprak-elijkhed (B.V.)公司类型Gesellschaft Mit Beschrankter Haftung (GmbH)公司类型Kabushiki Kaisha (K.K)公司类型mPte, PVT公司类型Naamloze Vennootschap (N.V.)公司类型Osakeyhtio (OY)公司类型Perseroan Terbatas (PT)公司类型Proprietary (MPTY)公司类型Public Limited Company (PLC)公司类型PVT, PTV公司类型SDN BHD公司类型Sendirian (ESDN)公司类型Sociedad Anonima de Capital Variable (S.A. de C.V.)公司类型societa a responsabilita limitata (SRL)公司类型societa per azioni (SPA)公司类型société à responsabilitéé limitée (S.A.R.L.)公司类型Societe Anoym (法语), Societa Anonima (意大利语),Sociedad Anonima (西班牙语) (S.A.)公司类型TBK 公司类型Yugen Kaisha (Y.K.)机构Beaufour IPSEN (Tianjin) Pharmaceutical Co., Ltd.,机构China Academy of Engineering Physics 机构China Association for Pharmaceutical Equipment (CAPE )机构China Council for the Promotion of International Trade (CCPIT)机构China National Pharmaceutical Industry Corporation Ltd 机构Committee for Medicinal Products for Human Use (Centrale Humanitaire Médico-Pharmaceutique )(CHMP)机构Committee for Proprietary Medicinal Products (CPMP)机构Ethypharm 机构European Directorate for the Quality of Medicines &HealthCare (EDQM)机构European Medicines Evaluation Agency 机构European Public Assessment Report (EPAR)机构Fournier Pharma 机构French Health Products Safety Agency (Agence française de sécurité sanitaire des produits de santé) (AFSSAPS)机构Insititute of Nuclear Physics and Chemistry 机构Joincare Pharmaceutical Group Industry Co.,Ltd.机构LAWSON MARDON PACKAGING BEIJING REPRESENTATIVE OFFICE 机构National Development and Reform Commission (NDRC)机构National Institute for the Control of Pharmaceutical and Biological Products (NICPBP)机构National Order of Pharmacists (Ordre Nationale des Pharmaciens )(NOP)机构North China pharmaceutical group corporation机构Pharmaceuticals and Medical Devices Evaluation(PMDEC)机构Pharmacovigilance Working Party (PhVWP)机构SCAS Ecoscience Technology Inc机构School of Pharmacy , Fudan University机构Second Military Medical University机构Shanghai Ethypharm Pharmaceutical Co., Ltd.机构Shanghai Institute for Food and Drug Control (SIFDC)机构Shanghai International Pharmaceutical Co. Ltd机构Tianjin Institute of Pharmaceutical Research (TIPR)机构TIPR Pharmaceutical.co.ltd机构Zuellig Pharma进口报验bills of lading进口报验certificate of origin进口报验invoices of freight进口报验packing lists进口报验purchase contract美国adulterated美国Caution,Federal law prohibits dispensing withoutprescription.美国caveat emptor美国Federal Trade Commission (FTC)美国Food Chemicals Codex (FCC)美国Journal of the American Medical Association美国misbranded美国Pharmaceutical Manufactures Association (PMA)美国Rx美国1820U.S. Pharmacopeia (USP)美国1836Patent Office美国1847American Medical Association (AMA)美国1848Drug Importation Act美国1852American Pharmaceutical Association (APhA)美国1862Chemical Division, U.S. Department of Agricalture Bureau 美国1888National Formulary美国1902Hygienic Table美国1902Poison Squad美国1906Pure Food and Drugs Act (PFDA), Wiley Act美国1912Sherley Amendment美国1938Food, Drugs, and Cosmetic Act (FDCA)美国1951Prescription Drug Amendment, Durham-Humphrey Amendment美国1962Kefauver-Harris Amendments 欧盟European Community (EC)欧盟European Federation of Pharmaceutical Industries and Associations (EFPIA)欧盟European Union (EU)申请类型abbreviated new drug applications (ANDAs)申请类型investigational new drug applications (INDs)申请类型new drug applications (NDAs)市场aging country市场blockbuster drug市场brand name drug, branded drug, innovator drug/ product市场Catalogue of State Basic Medical Insurance and Employment Injury Insurance Medicines市场compound annual growth rate (CAGR)市场current preparations市场distributor市场first marketed市场first-line therapy市场Franchised Distributor市场gain popularity市场generic drug市场increase in popularity市场Industries Ltd.市场lag time市场market exclusivity市场market prospect市场marketing authorization (MA)市场mental health市场off-label use;unapproved use市场patient compliance市场product pipeline市场regimen市场sales in revenue市场sales in volume市场Substance Abuse, Drug Abuse市场SWOT analysis - strength(优势),weakness(弱势),opportunity(机会),threat(威胁)市场wholesale市场withdrawal syndrome外包Active Pharmaceutical Ingredients (API)外包Contract Manufacturing Organization (CMO)外包Contract Research Organization (CRO)外包Outsourcing外包Pharmaceutical Development Services (PDS)外包Pharmaceutical Resource Organization (PRO)外包Trials Management Organization (TMO)文件份数in decuplicate文件份数in duplicate文件份数in nonuplicate文件份数in octuplicate文件份数in quadruplicate文件份数in quintuplicate文件份数in septuplicate文件份数in sextuplicate文件份数in triplicate文献检索Abstract文献检索Catalog Number文献检索Postscript文献检索Report Author文献检索Report Title行政ASSISTANT COUNSEL行政ASSISTANT MINISTER行政ASSTANT CONSULTANT行政checker行政China International Consultancy Co.行政CLERK行政CONSULTANT行政COUNSEL行政DEPUTY DIRECTOR行政DEPUTY DIRECTOR(VICE-MINISTER)行政DEPUTY DIRECTOR-GENERAL行政DEPUTY DIRECTOR-GENERAL行政DEPUTY DIRECTOR-GENERAL行政DEPUTY DIRECTOR-GENERAL行政DEPUTY SECRETARY-GENERAL行政DEPUTY SECTION CHIEF行政DIRECTOR OF A DIVISION行政DIRECTOR(MINISTER)行政DIRECTOR-GENERAL OF A BUREAU行政DIRECTOR-GENERAL OF A DEPARTMENT行政DIRECTOR-GENERAL OF A DEPARTMENT行政DIRECTOR-GENERAL OF THE GENERAL OFFICE 行政general director行政MINISTER行政MINISTER行政MINISTRY OF THE PEOPLE’S REPUBLIC OF CHINA 行政OFFICE OF THE STATE COUNCIL行政PREMIER行政PRINCIPAL STAFF MEMBER行政responsible person行政SECRETARY-GENERAL行政SECTION CHIEF行政SENIOR STAFF MEMBER行政senior vice president行政STAFF MEMBER行政STATE COMMISSION OF THE PEOPLE’S REPUBLIC OF CHINA行政STATE COUNCILLOR行政VICE-MINISTER行政VICE-MINISTER行政VICE-PREMIER行政文件all illegal medical practices 行政文件approval notification行政文件classified management of medical organizations; medical institutions classification administration行政文件draft for comment行政文件Drug Catalogue of National Basic Medical Insurance 行政文件drug production/ manufacture and distribution行政文件government guidance price/ pricing行政文件government price/ pricing行政文件health administrative departments/ authorities行政文件healthcare system reform行政文件illegal medical practice行政文件macro administration行政文件medical expenses行政文件medical institution行政文件medical insurance行政文件medical personnel行政文件medical service quality行政文件medical services行政文件preferential tax policies; tax privileges; favorable tax policies行政文件price monopoly行政文件price protection行政文件professional conduct; professional ethics行政文件reasonably priced行政文件rectify e conduct of medical personnel行政文件remain practically unchanged行政文件resources allocation行政文件socialist market economy行政文件supervision行政文件supervision system行政文件the basic medical insurance system for urban employees 行政文件the Central Party Committee行政文件the State Council行政文件urban employees研发Immediate Release Solid Oral Dosage Forms:Scale-Up and Post Approval Changes(SUPAC)研发In-house R&D 研发Licensing研发Merge研发Modified Release Solid Oral Dosage Forms:Scale-Up and Post Approval Changes(SUPAC-MR)研发Pharmaceutical Development Services (PDS)研发Pharmaceutical R&D Sponsor研发Pharmaceutical Resource Organization (PRO)研发Trials Management Organization (TMO)医改affordable medicines医改be managed at both central and provincial levels 医改cost structure医改differential pricing医改differentiation-pricing医改during the period of protection医改economic evaluation医改financial expense医改industrial policies医改level of innovation医改list of essential drugs (EDL)医改management expense医改parity-pricing医改period cost, period expense 医改policy maker医改price医改price structure医改product mix医改provincial government医改sales expense, selling expense医改sales profit rate医改sales profits医改state essential drugs医改the competent pricing department of the State Council 医改the Provincial People’s Government医改uniform pricing医改unprofitable medical institution印度Drugs & Cosmetics Act, 1940中国Chinese Dietary Reference Intakes (DRIs)中国Chinese Pharmacopoeia (Ch P)中国Good Agricultural Practice (GAP)中国the National Standard of the People's Republic of China (GB 5749-85 “Hygienic Standard of Living Drinking Water)注册申请表affix the official seal注册申请表after examination注册申请表Chinese Pharmacopoeia Commission注册申请表Chinese Phonetic Alphabet, Pinyin注册申请表contact person, person to be contacted注册申请表drug approval number注册申请表Drug Manufacturing License注册申请表examining authority注册申请表formulation composition注册申请表indication category注册申请表indications or functions注册申请表is in perfect accordance with注册申请表mailing address, contact address注册申请表monitoring period of new drugs注册申请表new drug certificate注册申请表Notification of Approval Opinion注册申请表official approvals of the research proposal 注册申请表official seal注册申请表organization code注册申请表patent declaration注册申请表patent information注册申请表position注册申请表products of the same drug by other enterprises注册申请表psycho-neurological注册申请表quantitative composition of the unit formula注册申请表registered address注册申请表registration category注册申请表shall not be altered专利Patent Cooperation Treaty (PCT)专利prior art专利priority date专利withdraw×× department above the municipal level where it islocated1906 Pure Food and Drugs Acta seal card for purchase of sthabove the municipal levelacceptance notificationaccommodate remarks and explanationsAcquisitionactive ingredientactive moietyactive partactive pharmaceutical ingredient (API), active ingredient(AI), drug substance, bulk drugsAcute Toxicityadditional sheetsadjust the classification of precursor chemicals or to add any other type other than those as prescribed in the present Regulations within its administrative jurisdiction administration departments at all levelsadministrative department for industry and commerce administrative protectionadverse drug reaction reportingAir Waybill (AWB)all the people's governments at or above the county level Alliance,PartnershipAmendmentAmerican Medical AssociationAmerican Pharmaceutical AssociationAmerican Society of Hospital Pharmacistsan internal management system for precursor chemicals anabolic steroids, anabolic-androgenic steroids (AAS) anabolic hormonesAnalytical MethodApplication For Registrationapplication pendingapproval numberapproved informationAs discussed at the FDA Pre-NDA meetingAsean Common Technical Document (ACTD) autonomous regionBased on the requirement to ensure public health, SFDA may implement a monitoring period for the approved new drugs so as to continue to monitor the safety of the new drug. The drug-monitoring period shall start from the date of approval for production, and shall not exceed 5 years. For the new drugs under the monitoring period, SFDA shall not approve production, dosage change and importation of the drug by other enterprises.batch certificationbatch releasebe chemically described asbe involved in one of the steps of the finished product manufacturingbe submitted in typefacebe up to (the standard), conform to, comply with biologicsbiologics license applications (BLAs) biopharmaceuticsblood productsbrand name, trade namebrand-name drugBureau of Biological and Physical SciencesBureau of ChemistryBUREAU OF FOOD AND DRUGS (BFAD) Business Address of Applicantbusiness scopebuy at wholesale and sell at retailCarcinogenicitycase sesitiveCaution: Federal law prohibits dispensing without prescriptionCenters for Disease Control and Prevention (CDC) certificate of incorporationcertificate of its need for legal useCertificate of Suitability for European Pharmacopeia (COS / CEP)Certificates of Product Registration (CPR) Certification Committee for Drugs (CCD) certifying authoritycheck, auditChemical Structurechemical APIsChemical Unitchemically reactive substanceChemistry, Manufacturing, and Controls (CMC) Chief ChemistChinese materia medicaChinese traditional patent medicineChronic ToxicityciryCitizens Advisory Committeecity divided into districtsclassified administrationClinic Trialcntinuation sheetsCode of Federal Regulations (CFR)combination of active ingredientscome into the marketcommercial company (CC)commercially availablecompetent authoritycompetent commerce departmentcompetent communications department competent environmental protection department competent health departmentcompetent national authoritycompetent pricing departmentcompetent railway departmentcomplete the submission-for-the-record formalities compound drugs containing ephedrine alkaloids compound preparationconsistencycontact addresscontact personcontainerContract Manufacturing Organization (CMO) Contract Research Organization (CRO) contractual partiescorporate identity numbercost, insurance and freight (CIF)country of origincurrent Good Manufacturing Practice (cGMP) direct contactdirect lineDivision of Penicillin Control and Immunology dosagedosage formdosage forms intended for oral administrationdosedraft guidancedrug approval numberdrug classification systemDrug Inspection LaboratoryDrug Master File (DMF)drug precursor, drug precursor chemicalsdrug productdrug registration specificationsdrug retailerearly Marcheffective as ofefficaciousefficacyempirical formulaentrusted purchaseEssential Oils Laboratoryessentially similar productestablish a ledger for sale of sthEuropean Directorate for the Quality of Medicines & HealthCare (EDQM)examination and approvalexcludeExp. Date, shelf lifeexplanatory notesExport QuantityExport RegionFDA(Food and Drug Administration)FDAMAFederal Food, Drug and Cosmetic ActFederal Trade CommissionFeeding Trialfinished productfixed dose combination (FDC)Food, Drug and Insecticide Administrationfor the purpose of inspectionformulationFrench Health Products Safety Agency (Afssaps)from the date of salefront-line workersgeneral informationgeneral instructionsgeneric druggeneric nameglobal clinical trialGood Practices applicable to the manufacture of medicinal products and to their quality controlguidelinesHak Atas Kekayaan Intelektual (Indonesia)Hatch-Waxman法案headed notepaperICH guidelineICH harmonised tripartite guidelineIf the tip-off turns out to be true, the people's government at or above the county level and the relevant competent administrative department shall award the relevant informant.illegal activitiesillegal productionillegally produceImport CoastImport Drug License (IDL)in all other casesin commercial packingin duplicateindustrial estateinformationinspectionintended useIntermediateInternational Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use) (ICH)International Nonproprietary Name (INN) Investigational Drug BrochureIPissue the certificateJudicature ActLaboratory ErrorLaboratory Investigationlarge medical equipmentlaw enforcementlaw enforcement officialslaws, regulations and ruleslawyer's letterledgerlegal representativelegallizelicensed pharmacistlotMagna Cartamaintenance of recordsmandatory planmanufacturemanufacturing processmarket supply and demandmarketing authorizationmarketing authorization holdermedical technologymedicinal productmedicinal products for human useMemorandum of Understandingme-too drugMfg dateMft.Timeminimum packageMinistry of Health (MOH)mislabeled and adulterated drugs and foodmunicipalitymunicipality directly under the Central Government Mutagenicitymutually exclusiveName of ApplicantNames of Countries in Which Registered/Marketed National Center for Health Inspection and Supervision national drug standardnational drug standardsNational Institute for the Control of Pharmaceutical and Biological Products (nicpbp)national legislationnational non-proprietary namenational regulatory authoritiesNo designated production enterprise of ephedrine shall expand the production scale of ephedrine in the form of technology transfer, joint management or establishing branch plant without the approval of the state department of pharmaceutical administration.nonprescription drug, Over The Counter (OTC)Non-Steroidal Anti-Inflammatory Drug (NSAID)not applicablenot availablenotarial certificatenotarizationnotarizenotification, circularOffice of Drug AdministrationOffice of Drug ControlOffice of Food ControlOffice of Special Collaborative Investigations off-patent drug, patent expired drugOriginal SampleOrphan Drug ActOrphan drug, Orphan Medicinal ProductOut of Specification (OOS)overpriceoverstaffPackage Size(s)Package Insert (PI)packing listpacking listpacking sizepatent medicinespatent protectionPatent Protection Association of China (PPAC) patient information leafletPatient Information Leaflet (PIL)peptide hormonesPerson In Charge (PIC)pharma gradePharmaceutical Data Management Systemspharmaceutical formspharmaceutical preparationpharmaceutical preparationsPharmacological TestPharmacological Laboratorypharmacopoeial methodpharmacovigilance (PV)Physical and Chemical Propertiespollutant disposal facilitiespower of attorney (POA), letter of attorneyprepared plan for environmental emergenciesprepared sliceprepared slices of Chinese crude drugsprescription drugs, ethical drug, Rxprimary stability batchesProduct ManualProduction Informationproduction enterprise of chemical productsProduction/Marketing Approval Documents Manufacture of Production/GMP CertificateProprietary nameprovide recommendations to sbprovinceprovision(s)PTOPublic HealthPublic Health Codepublic securitypurchase and sale contractpurchaser qualificationPVT. LTD.qualificationqualification documentsQuality StandardsQuantitative CompositionReanalysisrecommended nutriednt intake (RNI)record of drug-related crimesReference/Chemical Reference Substance registered addressregistrantregistration dossierRegulations for Administration of Precursors and Chemicals used in Production of Narcotic Drugs and Psychotropic Substanceregulatory specificationreleaserelease datereport identifierReproductionre-registrationResampleResiduerestricted materialRetestsafe intakesafe production management systemsale unitsales networkSecretary of Health, Education, and Welfareself-manufacturedset up a sales officeShaanxi Hanjiang Pharmaceutical Group Co., Ltd Shanghai Pharmaceutical Professional Association site master file (SMF), plane master file (PMF) small and medium sized enterprises (SME) smugglespecial precautionsspecifyspecifystandardizationState Administration of Traditional Chinese Medicine (SATCM)StorageStrengthStrengthSubacute Toxicitysubmission-for-the-record, for the recordsubstances frequently uesd in the illicit manufacture of narcotic drugs and psychotropic substances, precursor chemicalsSummary of Product CharacteristicsSummary of Product Characteristics (SPC)Summary of Product Characteristics(SPC)Summary of Product Characteristics(SPC) supervision and inspection on sthsupervisory and administrative department of safe productionSupplemental NDAsSupplementary ApplicationSwiss Federal Health OfficesynonymSynthetic Products LaboratoryTECH GRADEtechnical dataTechnical Examination MeetingTechnical Reports SeriesTeratogenicitytest for releasethe American Society for Testing and Materials (ASTM) the applicant (for sth) in the exporting countrythe Chemical Abstracts Service (CAS)the conditions of delievery and useThe department that receives a tip-off shall keep secret the relevant informant.the early part of the month, the first ten days of the month The European Agency for the Evaluation of Medicinal Products ( EMEA)the first month in the quarterthe format recommended by the WHOthe General Administration of Customsthe International Organization for Standardization (ISO) The manufacture license is revoked in accordance with the law.the National Drug Code Number (NDC Number)the National Institutes of Standards and Technology (NIST) The Pediatric Exclusivity Provisionthe State Councilthe status of the medicinal productThe United States Pharmacopoeial Convention, USP Conventionto whom it may concernto-be-marketed drug producttoll manufactureToxicological Testtrade dresstrademarktrade-secrettropical diseasestruthfully recordtype of applicationU. S. Public Health Service(USPHS)unwritten rulesupper- and lower-caseuse ledgervalidated methodviolate the criminal law, a crime is constituted warehouse facilitiesWhere there is any of the following circumstances WHO International Conference of Drug Regulatory Authorities (WHO-ICDRA)wholesalewrapperwrit同比上市许可FDA的解释:This six digit number is assigned by FDA staff to eachapplication for approval to market a generic drug in the United States.FDA的解释:An active ingredient is any component that providespharmacological activity or other direct effect in the diagnosis, cure, mitigation,treatment, or prevention of disease, or to affect the structure or any function of FDA的解释:An Abbreviated New Drug Application (ANDA) contains datathat, when submitted to FDA's Center for Drug Evaluation and Research, Officeof Generic Drugs, provides for the review and ultimate approval of a genericdrug product. Generic drug applications are called "abbreviated" because theyare generally not required to include preclinical (animal) and clinical (human)data to establish safety and effectiveness. Instead, a generic applicant mustscientifically demonstrate that its product is bioequivalent (i.e., performs in thesame manner as the innovator drug). Once approved, an applicant maymanufacture and market the generic drug product to provide a safe, effective,low cost alternative to the American public.FDA的解释:The approval history is a chronological list of all FDA actionsinvolving one drug product having a particular FDA Application number(NDA). There are over 50 kinds of approval actions including changes in thelabeling, a new route of administration, and a new patient population for a drugproduct.FDA的解释:An official communication from FDA to a new drug application(NDA) sponsor that allows the commercial marketing of the product.FDA的解释:Biological products are approved for marketing under theprovisions of the Public Health Service (PHS) Act. The Act requires a firm whomanufactures a biologic for sale in interstate commerce to hold a license for theproduct. A biologics license application is a submission that contains specificinformation on the manufacturing processes, chemistry, pharmacology, clinicalpharmacology and the medical affects of the biologic product. If the informationprovided meets FDA requirements, the application is approved and a license isissued allowing the firm to market the product.FDA的解释:A biologic product is any virus, serum, toxin, antitoxin, vaccine,blood, blood component or derivative, allergenic product, or analogous productapplicable to the prevention, treatment, or cure of diseases or injuries. Biologicproducts are a subset of "drug products" distinguished by their manufacturingprocesses (biological process vs. chemical process). In general, the term "drugs"includes biologic products.FDA的解释:A brand name drug is a drug marketed under a proprietary,trademark-protected name.FDA的解释:A discontinued drug is a drug product that has been removedfrom the market in the United States for reasons other than safety oreffectiveness.后改为the Federal Dockets Management System (FDMS)A dosage form is the physical form in which a drug is produced and dispensed,such as a tablet, a capsule, or an injectable.FDA的解释:A dosage form is the physical form in which a drug is producedand dispensed, such as a tablet, a capsule, or an injectable.。

药学英语单词

药学英语单词

药学英语单词药学英语单词⼀、Pharmacology1、pharmacology 药理学2、drug 药物3、pharmacy 药房,制药业4、pharmacist 药剂师5、toxicology 毒理学6、drug actions 药物相互作⽤7、drug effect 药效8、desired effect 预期效果9、side effect 副作⽤10、adverse reaction 不良反应11、contraindication 禁忌症12、local effect 局部作⽤13、systemic effect 全⾝作⽤14、cumulation effect 蓄积作⽤15、oral administration ⼝服给药16、sublingual administration⾆下给药17、buccal administration⼝腔含化给药法18、inhalation administration吸⼊给药19、rectal administration 直肠给药20、vaginal administration阴道给药21、topical administration局部给药22、transdermal administration 经⽪给药23、parenteral administration胃肠外给药24、intradermal administration⽪内注射25、intramuscular administration肌⾁注射26、intravenous administration静脉注射27、subcutaneous administration⽪下注射28、analgesic 镇痛剂29、anesthetic ⿇醉剂30、antiarrhythmic 抗⼼律失常药物31、antibiotic(anti-infective)抗⽣素32、anticoagulant 抗凝剂33、anticonvulsant 抗惊厥剂34、antidepressant 抗抑郁药35、antidiabetic 抗糖尿病36、antidiarrheal ⽌泻药37、antidiuretic 抗利尿剂38、antiemetic ⽌吐剂39、antifungal 抗真菌剂40、antihistamine 抗组胺药41、antihypertensive 降压药42、anti-inflammatory 抗炎药43、antineoplastic 抗肿瘤药44、antitussive 镇咳药45、antiulcer agent 抗溃疡药46、antiviral agent 抗病毒剂47、beta blocker β-受体阻滞药48、bronchodilator ⽀⽓管扩张药49、hormone 荷尔蒙50、hypnotic 安眠药51、immunosuppressant 免疫抑制剂52、laxative 泻药53、lipid-lowering agent 降脂剂54、sedative 镇静剂,⽌痛药55、vitamin 维⽣素56、institute for safe medicationspractices (ISMP)安全药物试验研究所57、milliequivalent(mEq)毫当量⼆、R&D of New Drugs1、Acute 急性的2、Leukemia ⽩⾎病3、Chronic 慢性的4、Agonist 激动剂5、Antagonist 拮抗剂6、New chemical entity新化学实体7、Lead compound先导化合物8、Drug candidate候选药物9、In-vitro 在试管内10、In vivo 有活⼒的11、Synthesize 合成12、Supervise 监督,管理13、Authorize 批准,认可14、Double-blind 双盲15、Placebo 安慰剂/⽆效对照剂16、Indication 适应症17、Submission 投降,提交,服从18、Evolution of a new drug新药发展的历程19、drug development strategies新药研发的策略20、serendipity 意外发现,运⽓21、intuition 直觉22、roulette 轮盘赌23、staphylococci 葡萄状球菌24、penicillin 青霉素25、podophyllotoxin ⾜叶草毒素26、vincristine 长春新碱27、taxol 紫杉醇28、camptothecin 喜树碱29、molecular roulette 分⼦转轮30、minor structural changesin existing agents现有药物分⼦结构的细微修正31、programmed basic researchwith synthesis of specificchemicals对特定化合物的合成⽽制定的基础研究32、clinical observation of drug action in practice 使⽤中药物作⽤的临床观察33、berberine ⼩檗碱34、experimental pharmacology实验药理学35、subcellular particles 亚细胞粒⼦36、isolated tissue 离体组织37、perfused organs 灌注器官38、haematological ⾎液学的39、teratogenic 致畸的40、mutagenicity 诱变41、carcinogenicity 致癌性42、toxicological assessment毒物学监定43、rationale 基本原理三、drug dependence1、withdrawal 撤退,收回2、opiate 鸦⽚试剂3、cocaine 可卡因4、amphetamine 苯丙胺5、alcohol酒精6、barbiturate 巴⽐妥类7、cannabis ⼤⿇8、volatile solvents 挥发性⽓体9、psychic dependence精神成瘾性10、physical dependence⾝体成瘾性11、curiosity and wanting tobelong好奇和归属感12、psychiatric 精神病学的13、make-up 化妆品14、availability 可⽤性15、heroin(diacetylmorphine)咖啡因(⼆⼄酰吗啡)16、restlessness 躁动不安17、distress 悲痛18、nausea 恶⼼,晕船19、pyrexial 发热的,发烧的20、the possibility of over dosage可能吸⾷过量21、the frequent occurrenceof sepsis常发⽣败⾎症22、baby born to an addict成瘾者的⼩孩23、go to any length to想尽⼀切办法24、management 戒毒25、addicts must be registered成瘾者⼀定要登记在册26、methadone 美沙酮27、clonidine 可乐定28、the nasal septum ⿐隔膜29、appetite suppressor⾷欲抑制剂30、powerful stimulant 强效兴奋剂31、mental disturbances 精神紊乱32、hallucination 幻觉33、epileptic fits 癫痫发作34、resin 树脂,松⾹35、volatile solvent 挥发性溶剂36、euphoria 精神欢快37、detoxification and medically managed withdrawal去毒及医疗辅助下的撤去毒品38、long-term residential treatment 长期居家治疗39、short-term residential programs 短期居家治疗40、outpatient treatment门诊治疗41、individualized drug counseling 个性化毒品咨询42、group counseling集体咨询。

制药专业英语原文翻译

制药专业英语原文翻译

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。

生物制药专业英语

生物制药专业英语

4 Sample Sample must must must be be be treated treated treated with with with some some some organic organic organic solvent, solvent, solvent, previous previous previous to to to or or or simultaneously simultaneously simultaneously with with saponification or extraction process, in order to disrupt the structures where vitamin E can be associated to (membranes, lipoproteins, fat droplets . . . ), to eliminate interferences from big molecules molecules such such such as as as proteins or proteins or carbohydrates, carbohydrates, that that that are are are non-soluble non-soluble non-soluble in in in organic organic organic phases, phases, phases, and and to provide a medium in which analytes can be freely soluble. 样品在皂化或提取的时候,样品在皂化或提取的时候,或在此之前,或在此之前,必须用某些有机溶剂进行处理,必须用某些有机溶剂进行处理,其目的是为了破坏其目的是为了破坏VE 和细胞膜、脂蛋白、脂肪滴等之间的结合;消除蛋白质或碳水化合物等大分子的干扰,这些大分子在有机相中都是不可溶的;以及为被分析物提供能在其中充分溶解的介质。

制药行业常用英语

制药行业常用英语
Criteria:标准用来描述为了确保原料药符合规格标准,必须控制在预定范围内的工艺步骤、工艺条件、测试要求或其它有关参数或项目。
Cross-Contamination:交叉污染(一种物料或产品对另一种物料或产品的污染)
Deviation:偏差(对批准的指令或规定的标准的偏离0
Drug (Medicinal) Product:药品(经最后包装准备销售的制剂-参见Q1A)
Batch (or Lot):批由一个或一系列工艺过程生产的一定数量的物料,因此在规定的限度内是均一的。在连续生产中,一批可能对应于与生产的某一特定部分。其批量可规定为一个固定数量,或在固定时间间隔内生产的数量。
Batch Number (or Lot Number):批号
用于标识一批的一个数字、字母和/或符号的唯一组合,从中可确定生产和销售的历史。
Process Aids:工艺辅料除溶剂外,在原料药或中间体生产中起辅助作用、本身不参与化学或生物学反应的物料(例如,助滤剂、活性炭)。Production:生产
在原料药制备过程中,从接收原料,到工艺加工和原料药包装所涉及的所有操作。
Qualification:确认证明设备或辅助系统,安装正确、工作正常、确实产生预期的结果,并以文件佐证。确认是验证的一部分,但单独的确认步骤不构成工艺验证。
Reference Standard, Secondary:二级参考标准品
与基准参考标准品比较显示具有规定的质量和纯度,并用作日常实验室分析的参考标准品。
Reprocessing:返工将不符合标准或规格的一个中间体或原料药返回工艺过程,重复规定的生产工艺中的某一结晶步骤或其它合适的化学或物理处理步骤(如蒸馏,过滤,层析,磨粉),这种做法通常是可以接受的。在中间控制的测试表明一工艺步骤没有完成,从而继续该步骤,是正常工艺的一部分,而不是返工。

制药专业英语词汇大全

制药专业英语词汇大全

制药专业英语Accelerated testing 加速试验Reproducibility 重复性Climatic zones 气候带Detection limit 检测限Commitment batches 承诺批次Quantitation limit 定量限Container closure system 包装容器Linearity 线性Drug substance 原料药Range 范围Excipient 赋型剂Robustness 耐用性Expiration date 有效日期Chemical development studies 化学开发研究Formal stability studies 正式稳定性研究Enantiomeric impurity 异构体杂质Intermediate testing 中间试验Extraneous contaminant 外源性污染Long term testing 长期试验Identified impurity 鉴定的杂质New molecular entity 新分子实体Identified threshold 鉴定阙值(鉴定限)Primary batch 申报批次Impurity 杂质Production batch 大生产批次Impurity profile 杂质概况Re-test date 复检日期Intermediate 中间体Re-test period 复检期New drug substance 新原料药Specification 质量标准Precision 精密度Stress testing (drug substance) 强降解试验Repeatability 重复性Analytical procedure 分析方法Intermediate precision 中间精密度Accuracy 准确度Polymorphic form 多晶型Potential impurity 潜在杂质Combination product 复方制剂Qualification threshold 界定阙值(界定限)Chiral 手性Reagent 试剂Degradation product 降解产物Reporting threshold 报告阙值(报告限)Enantiomer 异构体Solvent 溶剂Identified impurity 鉴定杂质Specified impurity 特定杂质In-process tests 过程中检测Starting material 起始物料Polymorphism 多晶型Unidentified impurity 未鉴定杂质New drug substance 新原料药Acceptance criteria 可接受标准Racemate 外消旋体Permitted daily exposure 每日可接受药物中残留溶剂的最大摄入量Quality 质量Universal test 常规检测Specification 质量标准Acceptance criteria 可接受标准Solvent 溶剂Active pharmaceutical ingredient 药物活性组分(原料药)Specific test 专属性试验API starting material API起始物料 Specified impurity 特定杂质Batch 批Unidentified impurity 未鉴定杂质Batch number 批号Contract manufacturer 合同制造商Calibration 校验Critical 关键Computer system 计算机系统Cross-contamination 交叉污染Computerized system 计算机化系统Deviation 偏差Contamination 污染Expiry date 失效日期Lot 批In-process control 生产过程控制Lot number 批号Mother liquor 母液Packaging material 包装材料Reprocessing 再处理Material 物料Retest date 复测期Procedure 规程Reworking 返工Process aids 工艺辅助材料Signature(signed) 签名Process control 工艺控制Validation 验证Qualification 确认Validation protocol 验证方案Quality assurance 质量保证Yield, Expected 预期产量Quality control 质量控制Yield, Theoretical 理论产量Quality unit 质量部Design space 设计空间Production 生产Formal experimental design 正式实验设计Reference standard, primary 一级标准品Quarantine 待验Reference standard, secondary 二级标准品Raw material 原辅料Risk 风险Corrective action 纠正措施Risk management 风险管理Enabler 支持者Risk reduction 风险降低Key performance indicators 关键性能指标Decision maker 决策制定者Innovation 创新Detectability 检测能力Knowledge management 知识管理Product lifecycle 产品生命周期Pharmaceutical quality system 药品质量体系Quality risk management 质量风险管理Outsourced activities 外包活动Quality system 质量系统Preventive action 预防措施Requirements 要求Production realisation 产品实现Risk acceptance 风险认可Quality manual 质量手册Risk analysis 风险分析Quality planning 质量计划Risk assessment 风险评估Quality policy 质量方针Risk communication 风险通报Quality risk management 质量风险管理Risk control 风险控制Senior management 最高管理Risk evaluation 风险评价State of control 控制状态Risk identification 风险鉴定Change management 变更管理Risk review 风险回顾Trend 趋势Severity 严重性Continual improvement 持续改进Stakeholder 利益相关者Control strategy 控制策略Air lock 气锁 D value D值Alert level 警戒标准Dynamic 动态的Action level 纠偏标准Endotoxin 内毒素Aseptic manufacturing area 无菌生产区Gowning qualification 更衣确认Aseptic processing facility 无菌生产厂房HEPA filter 高效过滤器Aseptic processing room 无菌操作间HVAC 空调净化系统Asepsis 无菌(状态)Intervention 干预Bioburden 含氧菌(生物负荷)Isolator 隔离操作器Barrier 屏障Laminar flow 层流Biological indicator BI 生物指示剂Operator 操作人员Clean area 洁净区Overkill sterilization process 过度杀灭灭菌程序Component 组分Pyrogen 热原Colony Forming Unit(CFU) 菌落形成单位(菌落数)Sterile product 无菌产品Critical surface 关键区域Sterilizing filter 除菌过滤器Decontamination 去污染Quality control unit 质量部门Disinfection 消毒Unidirectional flow单向流Depyrogenation 去热原Terminal sterilization 最终灭菌Validation 验证ULPA filter 超低穿透过滤器Worse case 最差条件Vessel 管道Reaction 反应Vent排气口Tank 桶罐Tare 皮重Flush 冲洗Purified water 纯化水Gross weight 毛重Dry 干燥Unload 缷料centrifuge 离心机crystallize 结晶Rinse 漂洗Filtrate 过滤Precipitation 沉淀Separate 分离Adjust pH to 调节pH至Solvent 溶剂Transport container 周转桶Intermediate 中间体Organic layer 有机层Aqueous layer 水层Extraction 萃取Cleaning agent 清洁剂Vacuum distill 减压蒸馏Contamination 污染Hydrolyze 水解Residual 残留Time complete 终止时间G.L.R 搪玻璃反应器Time started 起始时间The stainless steel reactor 不锈钢反应器Condenser 冷凝器Reactor 反应釜Reflux 回流batch number 批号Heat 加热Preparation 制备Temperature 温度Charge 投料Net weight 净重Stir 搅拌Jacket 夹套Take a sample 取样Bottom valve 底阀Suck 吸入Sample retention 留样Recrystallization 重结晶Pressure 压力Spin dry 旋转干燥Purification 精制,提纯Monitor 监测Blending 混合Sponsor 主办者(指负责并着手临床研究者)Labeled amount 标示量Agency 审理部门(指FDA)Identity 真伪;鉴别;特性NF (美国)国家药品集USP 美国药典INN 国际非专有名称Protocol 方案Established name 确定的名称Adverse effect 副作用Preparing and submitting 起草和申报Benefit 受益Animal trial 动物试验Accelerated approval 加速批准Batch production record 生产批号记录POST-OR PRE- MARKET SURVEILLANCE 销售前或销售后监督Batch production 批量生产DMF holder DMF 持有者CFR (美国)联邦法规Panel 专家小组ANDA 简化新药申请DMF 药物主文件FDA (美国)食品药品管理局NDA 新药申请Adapter 接液管Air condenser 空气冷凝管Beaker 烧杯Crucible tongs 坩埚钳Boiling flask 烧瓶Condenser-Allihn type 球型冷凝管boiling flask-3-neck 三口烧瓶Condenser-west tube 直型冷凝管Burette clamp 滴定管夹Claisen distilling head 减压蒸馏头Burette stand 滴定架台Busher funnel 布氏漏斗Crucible with cover 带盖的坩埚Distilling head 蒸馏头Distilling tube 蒸馏管Erlenmeyer flask 锥型瓶Evaporating dish (porcelain) 瓷蒸发皿Filter flask(suction flask) 抽滤瓶Florence flask 平底烧瓶Fractionating column 分馏柱Geiser burette (stopcock) 酸氏滴定管graduated cylinder 量筒Hirsch funnel 赫氏漏斗Long-stem funnel 长颈漏斗Medicine dropper 滴管Mohr burette for use with pinchcock 碱氏滴定管Mohr measuring pipette 量液管Mortar 研钵Pestle 研杵Pinch clamp 弹簧节流夹Plastic squeeze bottle 塑料洗瓶Rubber pipette bulb 吸耳球Wide-mouth bottle 广口瓶Tripod 三角架Transfer pipette 移液管Watch glass 表皿volumetric flask 容量瓶Thiele melting point tube 提勒熔点管Test tube 试管Test tube holde 试管夹Separatory funnel 分液漏斗Stemless funnel 无颈漏斗Validation 验证Qualification/Verification 验证Stability 稳定性In compliance with 符合Active ingredients 主药Excipient 辅料Buffering agent 缓冲剂Towards lower limit 偏低限pH value 酸碱度Formulated amount 处方量。

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• Acknowledgements
• References
College of Chemistry and Chemical Engineering, SUES
3
专业文献的基础知识
专业文献的一般结构 • Title • Author • Abstract • Introduction • Methods • Results • Discussion • Acknowledgements • References First author Coauthor
Sometimes a title that summarizes the results is more effective:
“Diabetes resulted in a slight fall in the RNA to protein ratio in liver of the rat”
College of Chemistry and Chemical Engineering, SUES
College of Chemistry and Chemical Engineering, SUES
2
专业文献的基础知识
专业文献(Original paper)的一般结构 • Title
• Author
• Abstract • Introduction
• Methods
• Results • Discussion
College of Chemistry and Chemical Engineering,ntific research paper
Methods and Materials Methods is the easiest and can be started even when the research is unfinished. So start there .
you follow all of these to the letter.
Peruse some published papers to acquaint yourself with the journal’s style. This is much easier than reading the formatting instructions.
College of Chemistry and Chemical Engineering, SUES
9
Writing a scientific research paper
• Title • Abstract • Introduction • Methods • Results • Discussion
important contributions,
such as discussing the protocol, commenting on the manuscript, or buying you
pizza.
College of Chemistry and Chemical Engineering, SUES
Corresponding author
College of Chemistry and Chemical Engineering, SUES
4
专业文献的基础知识
专业文献的一般结构 • Title • Author • Abstract • Introduction • Methods • Results • Discussion • Acknowledgements • References An abstract, or summary, will give the reader a "preview" of what's to come. Abstracts allow other scientists to quickly scan the large scientific literature, and decide which articles they want to read in depth.
have reported?
College of Chemistry and Chemical Engineering, SUES
7
专业文献的基础知识
专业文献的一般结构 • Title • Author • Abstract • Introduction • Methods • Results • Discussion • Acknowledgements • References This section is optional. You can thank those who either helped with the experiments, or made other
课堂内容 专业文献的基础知识 英文专业文献的阅读和写作方法 英文专业文献的检索方法 课堂练习题的评讲
College of Chemistry and Chemical Engineering, SUES
1
专业文献的基础知识
专业文献的种类 Original paper:发表于专业期刊,用于报道科学研究内容和结果 的文献。 Short paper / Communication: 简要报道研究内容和结果的文献。 Review paper:指就某一时间内,作者针对某一专题,对大量原 始研究论文中的数据、资料和主要观点进行归纳整理、分析提炼而 写成的论文。综述具有一定的深度和时间性,能反映出这一专题的 历史背景、研究现状和发展趋势,具有较高的情报学价值。
College of Chemistry and Chemical Engineering, SUES
6
专业文献的基础知识
专业文献的一般结构 • Title • Author • Abstract • Introduction • Methods • Results • Discussion • Acknowledgements • References Highlight the most significant results in the Discussion section. How do these results relate to the original question? Do the data support your hypothesis? Are your results consistent with what other investigators
College of Chemistry and Chemical Engineering, SUES
11
Writing a scientific research paper
Title Make your title specific enough to describe the contents of the paper, but not so technical that only specialists will understand. The title should be appropriate for the intended audience. This should be as short as possible but should also give a clear indication of the paper’s content. The title usually describes the subject matter of the article: “Effect of diabetes on the rate of protein synthesis in tissues of the rat in vivo”
12
Writing a scientific research paper
Abstract No longer than 100-250 words. Should factually describe the purpose, techniques, results and implications. No details of methods . It should grab attention and create a desire to
College of Chemistry and Chemical Engineering, SUES
5
专业文献的基础知识
专业文献的一般结构 • Title • Author • Abstract • Introduction • Methods • Results • Discussion • Acknowledgements • References What question did you ask in your experiment? Why is it interesting? The introduction summarizes the relevant literature so that the reader will understand why you were interested in the question you asked.
Must be specific enough to permit replication. If you had a complicated protocol, it may helpful to include a diagram or table to explain the methods you used. Do not put results in this section. You may, however, include preliminary results that were used to design the main experiment that you are reporting on. ("In a preliminary study, I observed the owls for one week,
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