药品说明书翻译.ppt

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,医药说明书翻译指导,INSTRUCTONS,第一节,药品说明书,基本结构,药品说明书,英文表达方式有：,Instructions,，,Directions,，,Description,现在多用,Package Insert,，或简称,Insert,，,也有用,Leaflet,或,Data Sheets,包括下列内容,:,药品名称,(Drug name),性状,(Description),药理作用,(Pharmacological Actions),适应症,(Indication),禁忌症,(Contraindication),注意事项,(Precaution),副作用,(Side effects),剂量和用法,(Dosage and administration),包装,(Packing),有效期,(Expiry date),出厂日期,(Manufacturing date),参考文献,(References),药品名称有商品名,(Trade name),、,通用名（,Generic Name,）,化学名（,Chemical Name,）,药品说明书上最常用的名称是商品名。,有时在商品名之下（或后）又列有通用名或化学名,.,例如：,Rulide,（罗力得）之后 列有（,Roxithromycin,，罗红霉素）；,Minipress,（脉宁平）之后列有（,Praxosin,HCl,，盐酸哌唑嗪）,一药品名称,(,Drug Name,),1.,商品名,(Trade name),商品名是由生产厂家命名并向该国政府有关部门,(,国家食品药品管理局,),注册的药品名,.,商品名右上角往往有一符号,意思是注册商标，是,Register,的缩写。,商品名因厂而异,因国而异,一种药物可以有几个,几十个商品名,因此仅根据商品名很难确定该药为何种药物,需要查阅其化学结构,.,药物说明书一开头,除了商品名外,还有时标有,“,Issued to/for the medical profession only,”,意思为,“,仅供医学界专业参考,”,2.,商品名译法,药品名称的中文翻译方法有多种，包括音译、意译、音意合译、谐音译以及按药理作用或药物成分翻译。,a.,音译,Penicilin,盘尼西林，,Cediland,(,西地兰,),Persantin,(,潘生丁,),aspirin(,阿司匹林,),b.,意译,Chlorimycin,氯霉素；,Tetracyclin,四环素；,Cholic,Acid,胆酸,c.,音意合译,Medemycin,麦迪霉素（,mycin,霉素）,d.,谐音,Legalon,利肝隆，,Webilin,胃必灵,e.,按药理作用或药物成分翻译,二药品性状（,Description,）,药品性状：包括药品的外观、理化性质、成分、结构、特征等。,除了用,Description,外，还常用,Property/Properties;,Physical and chemical properties;,Characteristics(,性状,),；,有些说明书介绍很简单，仅给出化学结构或成分，标题为：,Chemical structure(,化学结构,);,Composition(,成分,),Active ingredients(,有效成分,),等,此部分结构差异较大，长短不一。介绍药物多用,被动语态,。除了普通性和描述性词汇外，还常涉及到化学化工词汇。由于是对药物性质的一般描述，故,多用一般式,。,1,结构特点,：,Example 1,Description,Buflomedil,Hydrochloride,(,丁咯地尔盐酸盐,脑功能改善药,),the active ingredient of,Ikelan,(,麦道可兰,(,含,buflomedil,hydrochloride),is a,vasoactive,(,血管活性的,),and nerve protective drug.The empirical,formular,(,实验组成,),is C,17,H,25,NO,4,.,HCl,representing a molecular weight of 343.8.Each ampoule,（,一次用量的针剂,，,安瓿,）,of,Ikelan,injection contains 50mg,Buflomedil,Hydrochloride.It is a clear,colorless or light yellow solution,（,溶液,）,.Each film coated tablet,（,薄膜衣片剂,）,for oral administration contains 150mg or 300mg of,Buflomedil,Hydrochloride.Each ml of the oral solution drops contains 150mg,Buflomedil,Hydrochloride.,Example 2,Properties,This drug is an,angiotensin,converting enzyme inhibitor,（,ACEI,，,血管紧张素转换酶抑制剂,）,.,Example 3,Description,Kirin Sterile Powder contains,spectinomycin,hydrochloride,（,盐酸奇放线菌素,）,which is an,aminocyclitol,antibiotics,（,卡那霉素B,）,produced by a species of soil microorganism designated as,Streptomyces,spectabilis,（,紫色团孢链霉菌,）,.,例,1,Folic acid is a yellowish to orange,，,crystalline powder;,odourless,or almost,odourless,.,叶酸是淡黄色至橙色结晶粉沫，无臭或几乎无臭。,例,2,Intralipos,10%is a white opaque fat emulsion for intravenous injection,，,containing 10 W/V%of purified soybean oil.,脂肪乳剂（,10%,）是白色，不透明，供静脉注射用的脂肪乳剂，含有,10%,（,W/V,）的精制大豆油。,例,3,Ursosan,Tablet 50mg is a white plain tablet which contains 50mg of,ursodeoxycholic,acid.,熊去氧胆酸片为白色素片，每片含,50mg,熊去氧胆酸。,例,4,Sterile,pyrogen,-free,，,orange red,，,freeze-dried powder in vials containing 10mg and 50mg of doxorubicin hydrochloride with lactose.,（本品）为小瓶装，灭菌无热原，桔红色冻干粉沫，每小瓶含有,10mg,盐酸阿霉素和,50mg,的乳糖。,例,5,It occurs as a white to off-white,，,crystalline solid,，,poorly soluble in water,，,dilute acid and most organic solvents.,本品（炎痛息康）为白色至类白色结晶固体，难溶于水、稀酸及大多数有机溶剂中。,例,6,Pamine,，,chemically known as,epoxytropine,tropate,methylbromide,，,has the empirical formula C,18,H,24,NO,4,Br and the molecular weight 398.3.,哌明的化学名称为环氧莨菪碱托品酸酯溴代甲烷，实验式为,C18H24NO4Br,，分子量为,398.3,。,例,7,Kanendomycin,is a very stable antibiotic,，,and its activity does not decrease when the powder is placed in an airtight container and kept at room temperatures for more than 2 years.,卡内多霉素是一种很稳定的抗生素，其粉沫置于密封容器中，在室温下保存二年以上，活性不减。,例,8,This product is prepared from units of human plasma which have been tested and found nonreactive for hepatitis associated(Australia)antigen.,本品由人血浆制备，此血浆业经检验，并且证明对肝炎（澳大利亚）抗原无反应。,2.,常用词语,(1),性状部分常用词语表达,color,颜色,taste,味道,tasteless,无味,colorless,无色,crystalline,结晶的,solubility,溶解度,yellowish,淡黄色,bitter,苦味,whitish,微白色的,odour,气味,greenish,淡绿色的,odourless,无嗅,sterile,灭菌，无菌的,orange red,桔红色的,pyrogen,-free,无热原的,soluble,可容的,insoluble,brown,棕色,brownish,浅棕色的,transparent,透明的,opaque,不透明的,off-white,类白色 或 黄白色的,stable,稳定的,molecular,formular,injection liquid,molecular weight solution powder,chemical structure tablet solid,(2),表示组成、来源、制备方法的常用表达,constituents,组成,;,prepare,制备,be derived from,由,衍生,;,be obtained from,由,制的,;,be prepared from,由,制备,;,obtained by,由,获得,;,consist of,由,组成,;,be composed of,由,组成,;,contain;have;possess,有（具有）,三,.,药理作用,(Pharmacological Actions),较详细的药品说明书一般要介绍药品的临床药理、体外实验、药效、药物代谢、毒性和毒理作用等。该部分常用的标题为：,Pharmacological Actions,药理作用,Pharmacology,药理学,Pharmacological Properties,药理性质,Actions and properties,作用与性质,Mechanism of Action,作用机理,Mode of Action,作用方式,Clinical Experiments,临床实验,Pharmacology and toxicology,药理学与毒理学,Biological Activity,生物活性（若为抗生素类药品，常用之）,有时还列出小标题，例如：,Clinical Pharmacology,临床药理学,;,Clinical effect/use,临床效果,/,用途,;,Pharmacodynamics,药效学,;,Pharmacokinetics,药物代谢动力学。,1,结构特点,该部分涉及到多学科的词汇，如 药理学（药效学，药物代谢动力学）、生理学、毒理学、化学与微生物学等专业的词汇，有时较难理解。,此外，在本部分还经常遇到一些医学缩略词，如：,CNS,（中枢神经系统）、,EEG,（脑电图）、,LD,50,（半数致死量）、,ED,50,（半数有效量）、,t,1/2,(,半衰期,),等。该项,一般用陈述句,，句子结构有时比较复杂。,2,常用词语,（,1,）动词,：,Indicate,表明，提示；,Maintain,维持；,Demonstrate,显示；,exert(action on),起一作用,Exhibit,显示；,Inhibit,抑制；,Accumulate,积蓄（积累）；,metabolize,代谢；,Administer,给药；,Excrete,排泄；,Tolerate,耐受,（,2,）形容词,：,average,mean,平均的；,be effective against,对,有效；,be related to,与,有关；,（,be,）,sensitive to,对,敏感；,（,be,）,resistant to,对,有耐药,（,3,）名 词,Activity,活性；,Mechanism,机理；,Absorption,吸收；,Distribution,分布；,Elimination,清除；,Excretion,排泄，,Serum concentration,血清浓度；,Tolerance,耐受性,;,Clearance rate,廓清率；,Toxicity,毒性；,Plasma level,血浆浓度（水平）；,Half life,半衰期；,Effect on,对,的作用,;,In vitro,体外；,in vivo,体内。,常见句型举例,例,1.Peak serum concentrations of,tobramycin,occur between 30 and about 60 minutes after intramuscular administration.,肌注后约,3060,分钟之间妥布毒素的血药浓度达到高峰。,例,2.Nembutal Sodium exerts a depressant action on the CNS and shares the sedative-hypnotic actions typical of the barbiturates.,戊巴比妥钠对中枢神经系统产生抑制作用，并显示戊巴比妥类特有的镇静催眠作用。,例,3.,已发现制霉菌素（,Nystain,）在肠道内可抑制酵母菌（,yeast,）的生长。,Nystain,has been found to inhibit the growth of yeast in the intestinal tract.,例,4.,熊去氧胆酸的生物半衰期时,3.5-5.8,天,the biological half-life of,ursodeoxycholic,acid is 3.5-5.8 days,四适应症,Indications,该项是药品说明书的重点，常用标题：,Indications,适应症,;,Indications and Usage,适应症与用途；,Major,Principal Indications,主要适应症；,Uses,用途；,Action and Use,作用与用途。,1,结构特点,一般来说，该项仅列出疾病名称，或用短语表示该药能治疗的疾病。,较详细的说明书亦用完整的句子表述该药能治疗什么病，及对哪些细菌和微生物有效或无效。由于疾病和细菌、病毒名称太多，请查阅英汉医学词汇等工具书。,2,常用词语,疾病名称是适应症部分最常见的词汇还涉及到微生物（尤其是各种致病菌）方面的词汇。例如：,（,1,）名词和名词短语,：,bacteria,细菌；,germs,病菌；,microbes,，,microorganisms,微生物,;,aerobes,需氧菌；,anaerobes,厌氧菌；,Gram-Positive bacteria,革兰阳性菌；,gram-negative bacteria,革兰阴性菌；,staphylococcus,葡萄球菌：,staph.,Aureus,金黄色葡萄球菌；,streptococcus,链球菌,;,faecalis,粪链球菌；,Escherichia coil,大肠杆菌,Pseudomonas,aeruginosa,绿脓杆菌；,Klebsiella,pneumoniae,肺炎杆菌；,Diplococcus,pneumoniae,肺炎双球菌；,Cryptococcus,隐球菌；,virus,病毒。,（,2,）形容词及词组,：,acid-fast,耐酸的；,resistant,to,耐受；,susceptible to,对,敏感的；,be active against,，,be effective in,for,against,对,有效,;,have(has)action against,对,有作用；,be used to,，,be used in/for,，,be employed to,用于；,be of value of,，,be intended to,，,be indicated in,for,适用于,;,for,in the treatment of.,用于治疗,；,for,in the management of.,用于控制,.,表示与“其他药物合用”的结构有：,be associated with in association with be combined with in combination with be compatible with in conjunction with concomitant with together with,常见句型,1.,不完全句结构仅列出疾病或微生物的名称例如：例,1 Angina pectoris,hypertension.,心绞痛，高血压。,2.,由,For,（或,In,等）引出的短语，例如：例,2 In the treatment of all forms of pulmonary tuberculosis in association with other,antitubercular,drugs.,与其他抗结核药配伍，治疗各种类型肺结核。,3.To+,动词原形构成的短语，如：,例,3 To protect the liver cell during administration of drugs hazardous to the liver,在服用对肝脏有危害的药物期间，用以保护肝细胞。,4.,完整的句子结构或段落，有时结构很复杂；,例,4,Nebcin,is indicated for the treatment of the following infections caused by susceptible microorganisms.,乃柏欣适用于治疗下列由敏感细菌引起的感染：,Example,(1),Cedilanid,is used for the treatment of,all forms of heart failure and cardiac,arrythmia,.,西地兰可用于治疗各类心力衰竭和心率不齐,(2),Hyminal,is also used for the treatment of,insomnia due to organic disorder.,海米那也可用于由器质性疾病引起的失眠症。,(3)The tablets,are effective for the prevention of,anginal,attack.,本片剂对预防心绞痛发作有疗效,(4)Clinically,Persantin,has proved,effective in the treatment of,coronary disease and heart condition,临床证明“潘生丁”治疗冠心病和心脏病有效。,(5)The drug,is effective against,various kinds of bacteria resistant to other drugs.,本药对于抗其他药物的各种细菌有效。,(6),Kanamycin,is effective,both in vitro and in vivo,against,gram-positive and gram-negative bacteria as well as,acid-fast,bacteria.,卡那霉素在体内外对革兰氏阳性和革兰氏阴性菌以及耐酸菌均有效。,(7)This antibiotics,has,strong antibacterial,action against,gram-positive and gram-negative bacteria.,本抗菌素对革兰氏阳性和革兰氏阴性菌有强的抗菌作用。,(8),Vionactane,has,a,specific,tuberculostatic,action against,tubercle bacilli.,“,紫霉素”对结核杆菌具有特殊的抑菌作用。,(9),Possess;manifests,;,show action against,displays;,exerts.,五禁忌症,Contraindications,本部分最常用的标题是,Contraindications,，,也可用,Restrictions on Use,（用药限制）,在,Restrictions on Use,下面常列小标题，,如：,Contraindications,（禁忌症）；,Precautions,Note,（注意事项）；,Warnings,（警告）等。,1,结构特点,本部分段落较短，句子结构一般不复杂，常用省略句和祈使句。,Example 1,：,Contraindications,禁忌症,The use of Kirin Sterile Powder is contraindicated in patients previously found hypersensitive to it,（对本品过敏者禁用）,常用的结构有：,contraindications are,禁忌症是,be contraindicated in(for),对,禁忌,should not be used(employed)in,不得用于,It is advisable to avoid the use of,建议不用于,must not be administered(given)to,对,不得用药,should be used with caution,慎用,be not recommended for,最好不用于,none reported,未见报道,not known,不清楚,2.,常用词语及句式：,（,1,）禁用或慎用药物的疾病。例如：,Cardiac failure,心力衰竭；,Cardiac insufficiency,心功能不全；,renal insufficiency,肾功能不全,;,impairment of the kidney,，,impairment of renal,funcion,肾功能损伤；,insufficiency of the liver,肝功能不全；,liver,hepatic damage,肝损伤；,functional disorder of liver,肝功能（异常）障碍；,hypertension,高血压；,severe hypotension,重度低血压；,severe anemia,重度贫血；,Diabetes,糖尿病,.,（,2,）禁用或慎用药物的人群、病人和情况,例如：,pregnant women,孕妇,;,Pregnancy,孕期，妊娠期；,the first/last,trimester/3 months of pregnancy,妊娠期的最初后,3,个月；,Lactation,哺乳期；,children under years of age,岁以下儿童；,patient with/who,患者；,breast feeding,哺乳（的）,;,Hypersensitivity,过敏（性）,;,Allergic,过敏的；,Anaphylactic,过敏的,.,（,3,）常用句式,allergic/hypertensive/anaphylactic to,对,过敏,hypersensitivity test,过敏实验；,Contraindications are,禁忌症是,be contraindicated in/for,对,禁忌，禁用于,should not be used/employed in,不得用于,It is advisable to avoid the use of,建议不用于,must not be administered/given to,不得用于,should be used with caution,应慎用,be not recommended for,最好不用于,常见句型,1),省略句型，只列出禁忌对象或疾病名称等。,例,1.Hypersensitivity to,quinoiones,severe renal insufficiency.,对喹喏酮类过敏，严重肾功能不全。,2),完整的句子或段落,例,2.,Cetazolin,sodium is contraindicated in patients with known hypersensitivity to cephalosporin group of antibiotics.,先锋,5,号禁用于已知对头孢菌素类抗生素过敏的患者。,六用法与剂量,应特别注意该部分中各种剂量单位的表示法、成人、儿童和孕妇的剂量差别、服药时间以及剂量用法。,常用的标题有：,Dosage and Administration,剂量与用法,;,Application and Dosage,用法与用量,;,Administration,用法；,Direction for Use,用法；,method of Administration,用法；,How to use,用法；,Route of Administration,给药途径；,Dosage,剂量，用量；,Dosology,剂量学。,1,结构特点,用法与剂量是药品说明书不可缺少的内容，但祥略不一。,应特别注意本项中关于给药对象、给药方式、剂量、剂量单位、给药时间等用词的准确性，尤其是剂量单位，稍不小心，则差之千里。,本部分常用祈使句和省略句，句中谓语动词多用,被动语态,。,Example 1.,Dosage,Adults(including elderly patients):,The usual dosage is 1.6 3.2 g,Timentin,6 8 hourly according to body weight.The maximum recommended dosage is 3.2 g every 4 hours.,Dosage in renal impairment:,Mild impairment(,Creatinine,clearance 30 ml/minute):3.2 g every 8 hours.,Moderate impairment(,Creatinine,clearance l030 ml/minute):l.6 g every 8 hours.,Severe impairment(,Creatinine,clearance 10 ml/minute):l.6 g every 12 hours,Children:,The usual dosage of,Timentin,for children is 80 mg/kg bodyweight given every 6-8 hours.,For premature infants and full term infants during the,perinatal,period,the dosage is 80 mg/kg bodyweight every 12 hours,increasing to every 8 hours thereafter.,Children with renal impairment:,As with the adult dosage,similar reduction should be made for children.,Example 2,：,Dosage and Administration,Intramuscular administration,:,3 ampoules(150 mg)daily,i.m.in 3 divided doses for a period up to 14 days.,Intravenous administration,:,50 to 400 mg daily(1 to 8 ampoules)in divided doses for a period up to 10 days,at regular time intervals.In case of slow intravenous infusion,Ikelan,injectable,solution should be dissolved in 500 ml isotonic solution of dextrose or Sodium Chloride.After dilution,it must be administered within 4 hours.,Oral administration,:,The mean daily dose is 300 to 600 mg daily in two divided doses.,Dosage adjustment is not required in patients with renal failure or ill patients under,hemodialysis,.,Ikelan,drops do not contain sugar,thus it can be administered to diabetic patients.,2.,常用词语,(1),表示剂量,average,maintenance dose,平均维持剂量,minimal,minimum dose,最小剂量；,daily dosage,日剂量；,multiple doses,多剂量；,divided doses,分次剂量；,overal,dose/,overdosage,过量；,fatal/lethal dose,致死量；,single dose,一次剂量；,individual dose,单次剂量；,indicated dose,有效剂量；,standard dose,标准剂量,initial,starting/beginning dose,首次剂量；,suggested/recommended dose,推荐剂量；,therapeutic dose,治疗剂量；,maximum dosage,最大剂量；,usual,normal dose,常用普通剂量；,total dose,总剂量,（,2,）表示剂量单位,g=gram,克；,mg=milligram,毫克；,kg=kilogram,千克；,mcg=microgram,微克；,g,微克,;,L=liter,litre,升,;,ml=milliliter,毫升；,I,U,=international unit,国际单位,（,3,）表示给药次数,daily,per day,a day,every day,每日；,at intervals of,每隔,;,every.hours,每隔,小时,;,once,（,twice,）,a day,每日一（二）次；,three times a day,每日三次；,every other day,隔日；,every two,（,three,）,days,每隔,2,（,3,）日；,once,（,twice,）,a week,每周,1,（,2,）次；,three times a week,每周三次,;,divided intodose,分,次（服用给药）；,in two or three divided doses,分二或三次服用,.,（,4,）表示给药对象,newborn babies,新生儿；,Baby,婴儿；,Infants,幼儿；,Adolescents,青少年；,Children,儿童；,debilitated patients,体弱患者；,elderly patients,老年患者；,senile patients,老年病人,（,5,）表示给药方式,副词：,intra-arterially,动脉内给药；,intravenously,静注；,Intragluteally,臀肌内给药；,intrasmuscularly,肌注；,intraperitoneally,腹（膜）腔内给药；,intrapleurally,胸（膜）腔内给药；,Intrathecally,鞘内给药；,Locally,局部给药；,Topically,局部外敷；,orally,口服；,parenterally,肠道外给药；,subconjunctivally,结膜下给药；,Subcutaneously,皮下给药；,Sublingually,舌下给药；,Submucously,粘膜下给药,介词短语,：,by aerosol,喷雾给药；,by drip,phleboclysis,点滴静脉输液；,by enema,灌肠；,by lumbar,腰椎给药,;,by,phleboclysis,静脉输液,;,by intramuscular injection,（,i.m,.,）肌肉注射；,by intravenous injection,（,i.v,.,）静脉注射；,by intra-,articular,administration,关节内给药；,by the intramuscular administration,（,route,）肌内给药；,by the intranasal route,鼻内给药；,by the,Intraperitoneal,administration,腹（膜）腔内给药,;,by the intravenous infusion,（,perfusion,）静脉输液,;,by the,intrathecal,administration,鞘内给药；,by the sublingual administration,舌下给药；,per,os,(by mouth),经口；,per rectum,直肠给药；,per recto,直肠给药；,per,viginum,阴道给药,动词：,Take,服用,inhale,（,be inhaled,）吸人,;,apply to,涂于，敷于,;,spray,喷雾,;,Swallow,吞服；,Administer,给药，投药；,give,给药；,use,用药；,employ,用药；,recommend,suggest,推荐给药；,Suggest,推荐给药,常用句型：,例,1 Unless other wise prescribed by the physician,the average daily dose is 1 capsule 3 times daily.,如果医生不另开处方，平均日剂量为每日,3,次、每次,1,个胶囊。,例,2 The suggested dose is 10 to 15 mg per kg body weight d