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1、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 administra
2、tion)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
3、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),asp
4、irin(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：C
5、hemical 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,DescriptionBuflomedil 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 nerv
6、e protective drug.The empirical formular(实验组成)is C17H25NO4.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 contai
7、ns 150mg or 300mg of Buflomedil Hydrochloride.Each ml of the oral solution drops contains 150mg Buflomedil Hydrochloride.,Example 2PropertiesThis drug is an angiotensin converting enzyme inhibitor（ACEI，血管紧张素转换酶抑制剂）.,Example 3DescriptionKirin Sterile Powder contains spectinomycin hydrochloride（盐酸奇放线菌
8、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1Folic 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2Intralipos 10%is a white opaque fat emulsion for i
9、ntravenous 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3Ursosan 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4Sterile pyrogen-free，orange red，freeze-dried powder in vials containing 1
10、0mg 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5It 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6Pamine，chemically known as epoxytropine tro
11、pate methylbromide，has the empirical formula C18H24NO4Br 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7Kanendomycin 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 m
12、ore 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8This 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
13、 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 liquidmolecular
14、weight solution powderchemical 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、
15、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 Pharmac
16、ology 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）、LD50（半数致死量）、ED50（半数有效量）、t1/2(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；Demonstr
17、ate 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：averagemean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
18、；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
19、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
20、衰期时天 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
21、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P
22、seudomonas 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
23、 of，be intended to，be indicated infor 适用于;forin 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 Angin
24、a 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
25、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 t
26、he 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 aga
27、inst 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-
28、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Res
29、trictions 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
30、 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 insuff
31、iciency 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：pregna
32、nt women 孕妇;Pregnancy 孕期，妊娠期；the first/lasttrimester/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
33、 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 quinoio
34、nes,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;Applicati
35、on 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.DosageAdults(incl
36、uding 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
37、/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 bodywe
38、ight 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
39、.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 b
40、e 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
41、.常用词语,(1)表示剂量average maintenance dose 平均维持剂量 minimalminimum 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 initialstarting/beginning dose 首次剂量；suggested/rec
42、ommended 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=literlitre 升;ml=milliliter 毫升；IU=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.ho
43、urs 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；debil
44、itated 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；subconjunctival
45、ly 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 adminis
46、tration（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
47、 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；recommendsuggest 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
48、body weight daily in 3-4 divided doses orally,taken with meals.日剂量最好每公斤体重10-15mg，分3-4次口服，与食物共服。,例3 In severe chronic cases,treatment is started with daily 1 to 2 ampoules of Bilocid and continued with one ampoule every other day,injected slowly by the intravenous route.治疗严重的慢性疾病时，治疗从每日1-2支利胆素注射剂开始，继
49、续治疗时每隔一日1安瓶缓慢静脉注射。例4 the recommended single dose is 1 ampoule,given subcutaneously,intramuscularly or intravenously.建议一次剂量为1安瓶，皮下、肌肉或静脉注射给药。,七不良反应与副作用,本项主要指明药品的副作用、毒性作用、耐受、过敏反应及停药等。常用的标题有：Adverse Reaction（s），Unwanted Untoward Reaction（s）不良反应；Side effect（s），UnwantedUndesirable effects，Side Reaction（s
50、），By-Effects;After-Effects,1.结构特点,句子结构一般不复杂，常用短语或省略句，有时也用 陈述句。Example 1 Adverse reactionsFLUID AND ELECTROLYTE DISTURBANCESodium retention，congestive heart failure in susceptible patients，hypertension，fluid retention;potassium loss and hypokalemic alkalosis(低钾血症性碱中毒),MUSCULOSKELETALSodium myopathy，m
