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1、药药品品说说明明书书阅阅读读第一节第一节 药品名称药品名称第二节第二节 性性 状状第三节第三节 药理作用药理作用第四节第四节 适适 应应 症症第五节第五节 禁禁 忌忌 症症第六节第六节 用法用量用法用量第七节第七节 不良反应不良反应第八节第八节 注意事项注意事项第九节第九节 包包 装装第十节第十节 贮贮 存存第十一节第十一节 其它项目其它项目1药品说明书药品说明书:Instructions，Directions，Description现在多用PackageInsert，或简称Insert，也有用Leaflet或DataSheets。较简单的说明书较简单的说明书：成分、适应症、禁忌症、用法与用量
2、成分、适应症、禁忌症、用法与用量等内容；较详尽的说明书较详尽的说明书：除上述内容外还包括，药品性状、药理药品性状、药理作用、临床药理、临床前动物试验、临床经验、药代动力学、作用、临床药理、临床前动物试验、临床经验、药代动力学、庄意事项、不良反应或副作用、用药过量、药物的相互作用、庄意事项、不良反应或副作用、用药过量、药物的相互作用、警告、有效期、包装、贮存条件、患者须知及参考文献等。警告、有效期、包装、贮存条件、患者须知及参考文献等。21.常见药品名称常见药品名称：商品名商品名：TradeName或ProprietaryName；通用名通用名：GenericName；化学名化学名：Chemic
3、alName。例如：熊去氧胆酸片，商品名为Ursosan（Tablets）：通用名为UrsodesoxycholicAcid（熊去氧胆酸）；化学名为3,7-dihydroxy-5-Cholanoicacid（3，7-二羟基-5-胆烷酸）。R：表示该产品已经本国的有关部门核准，取得了此项专用的注册商标（RegisteredTradeMark）。商品名（通用名或化学名）：Rulide（Roxithromycin）罗力得（罗红霉素）32.药品名称的翻译药品名称的翻译（1）音译音译：如：Tamoxifin它莫西芬，Ritalin利他林，Amcacin阿米卡星。（2）意译意译：如：cholicAcid胆
4、酸，Tetracyline四环素;Minidiab灭糖尿（治疗糖尿病药物），Natulan疗治癌（细胞生长抑制剂），Uraly消石素（治疗尿路结石药物）。（3）音意合译音意合译：例如：Coumadin香豆定（coumarin香豆素），Neo-Octin新握克丁（neo-新）；Medemycin麦迪霉素（mycin霉素），Cathinone卡西酮（one酮）。（4）谐音译意谐音译意：例如：Antrenyl安胃灵，Doriden多睡丹，Legalon利肝隆，Webilin胃必灵。4Catalin（卡他林）化学名称：1Hydroxy-5oxo-5Hpyrido（3，2a）Phenoxazine3-c
5、arboxylicacid1-羟基5氧5H吡啶开(3，2a)吩嗪3羧酸。chloride氯化物；sulfate（sulphate）硫酸盐；acetyl一乙酰基；amino氨基；di-二；dihydro-二氢；nitro-硝基；ester酯；lactone内酯；one酮；oxide氧化物；urea脲。5第二节第二节性状性状2.1 1常用的标题常用的标题：DescriptionChemicalStructure化学结构Composition成分PhysicalandChemicalProperties理化性质62.2本项中常见的句型本项中常见的句型例例1 1Folicacidisayellowis
6、htoorange,crystallinepowder;odourlessoralmostodourless.例例2 2Intralipos10%isawhiteopaquefatemulsionforintravenousinjection,containing10W/V%ofpurifiedsoybeanoil.例例3 3UrsosanTablet50mgisawhiteplaintabletwhichcontains50mgofursodesoxycholicacid.例例4 4Sterilepyrogen-free,orangered,freeze-driedpowderinvials
7、containing10mgand50mgofdoxorubicinhydrochloridewithlactose.7例例5 5Itoccursasawhitetooff-white,crystallinesolid,poorlysolubleinwater,diluteacidandmostorganicsolvents.例例6 6Pamine,chemicallyknownasepoxytropinetropatemethylbromide,hastheempiricalformulaC18H24NO4Brandthemolecularweight398.3.例例7 7Kanendomy
8、cinisaverystableantibiotic,anditsactivitydoesnotdecreasewhenthepowderisplacedinanairlightcontainerandkeptatroomtemperaturesformorethan2years.例例8 8Thisproductispreparedfromunitsofhumanplasmawhichhavebeentestedandfoundnonreactiveforhepatitisassociated(Australia)antigen.82.3 3 本项中常用的词语本项中常用的词语（1）表示组成、制
9、备的单词及短语表示组成、制备的单词及短语，如：bederivedfrom由衍生；consistof由组成；beobtained制得；contain含有；bepreparedfrom由制备；have(possess)有（2）表示性质的一些词语表示性质的一些词语，如：colo(u)r颜色；stable稳定的；taste味道；molecularformular分子式odo(u)rless无臭的；molecularweight分子量；crystalline结晶的structure结构；solubility溶解度；injection注射剂；insoluble不溶的；solution溶液；odo(u)r气
10、味；tablets片剂；colo(u)rless无色的；derivative衍生物；tasteless无味的；liquid液体；sterile无菌的；powder粉沫；soluble可溶的；solid固体9第三节第三节药理作用药理作用药理作用、临床药理(ClinicalPharmacology)、体外试验(invitroexperiments)、药物代谢(Metabolism)、药效(Potency)及毒性(Toxicity)等。常用标题常用标题：PharmacologicalAction药理作用；PharmacologicalProperties药理性质；Pharmacology药理学；Cl
11、inicalPharmacology临床药理其他的表示方法其他的表示方法：Actions作用；ActionsandProperties作用与性质；ClinicalEffect(Use)临床效果（用途）；MechanismofAction作用机理；ModeofAction作用方式；抗生素抗生素：BiologicalAction生物活性；Microbiology微生物学103.13.1常见句型举例常见句型举例例例1 1.Meanpeekserumconcentrationsoftobramycinoccurbetween30andabout60minutesafterintramuscularad
12、ministration.例例2 2.NembutalSodiumexertsadepressantactionontheCNSandsharesthesedative-hypnoticactionstypicalofthebarbiturates.例例3 3.Inclinicaltrialsthedrugwasshowntobehighlyeffectiveinimprovingandnormalizingthealternatedcerebralcirculationandthosedisordersrelatedtoinsufficientarterialflowinthelimbs.例
13、例4 4.Orbeninisstabletostaphylococcalpenicillinase,andhighlyeffectiveagainstresistantstaphylococci.Itisbactericidal,acid-stableandwellabsorbedbyeithertheoralortheintramuscularroute.11例例5.Nystainhasbeenfoundtoinhibitthegrowthofyeastlikefloraintheintestinaltract.例例6.Fenarolhasprovedtobeeffectiveasastri
14、atedmusclerelaxant.例例7.Halcionisapotentshort-actinghypnoticagent,whichproducesitshypnoticactivityfromthefirstnightofadministration.例例8.Therapeutically,ATPinjectionexhibitseffects,especiallysuchasactivationofthefunctionandmetabolismofthenerve,andalsocoronaryandperipheralvasodilationtoincreasetheblood
15、stream.123.2常用词及短语举例常用词及短语举例3.2.1动词动词absorb吸收；act作用；cause(becauseby)引起（由引起）；demonstrate显示；exert(actionon)起作用；exhibit显示；inhibit抑制；accumulate积蓄；administrate投药；excrete排泄；resultin导致；indicate表明；maintain维持；produce产生；protect(from)保护（不变）；reach达到；show显示，表明；treat治疗；metabolize代谢；promote促进；prevent阻止，预防；tolerate
16、耐受133.2.2 形容词形容词(be)active(effective)against对有效的；(be)relatedto与有关的；(be)sensitiveto对敏感的；resistantto有耐药性的；average平均的；minimum最低（小）的；maximum最高（大）的；normal正常的3.2.3 3.2.3 名词名词ability能力；activity活性；distribution分布；excretion排泄；action作用；clearance廓清率；effecton对的作用；function功能，作用；halflife半衰期；invitro体外；kidney肾；mecha
17、nism机理；serumconcentration血清浓度；tolerance耐受性；infection感染；invivo体内；level水平，浓度；plasmlever血浆浓度（水平）；toxicity毒性14第四节第四节适应症适应症4.1 4.1 表示方法表示方法Indications适应症；IndicationsandUsage适应症与用途；Major(Principal)Indications主要适应症；Uses用途；ActionandUse作用与用途4.2疾病名称以及微生物（尤其是致病菌）的名称疾病名称以及微生物（尤其是致病菌）的名称anginapectoris心绞痛；cancer癌
18、；diabetes（mellitus）糖尿病；hypertension高血压；gram-positivemicroorganisms(bacteria)革兰氏阳性菌；virus病毒；gramnegativemicroorganisms（bacteria）革兰氏阴性菌；coli大肠杆菌154.3 4.3 常见句型常见句型4.3.1 不完全句结构仅列出疾病或微生物的名称不完全句结构仅列出疾病或微生物的名称例例1、Anginapectoris,Prinzmetalsangina,hypertension例例2Thefollowingdiseasescausedbybacteriaincludingg
19、rampositiveandgramnegativebacteriasuchasStaphylococcus，Streptcoccus,Escherichiacoli,Klebsiellapneumonia4.3.2由由For（或或In等）引出的短语等）引出的短语例例3Forpreventionoftheadvanceofcataract.例例4Inthetreatmentofallformsofpulmonarytuberculosisinassociationwithotherantituberculardrugs.4.3.3To+动词原形构成的短语动词原形构成的短语例例5Topreven
20、ttheformationofurinarycalculi，especiallyincaseswheretheytendtorecur.16例例6Toprotectthelivercellduringadministrationofdrugshazardoustotheliver4.3.4完整的句子结构或段落，有时结构很复杂完整的句子结构或段落，有时结构很复杂例例7AmikacinisusefulinthetreatmentofinfectionsfromGramnegativesensitivespecies，thereincludedthePseudomonasspecies；itmaya
21、lsobeusefultotreatinfectionscausedbysensitivestaphylococci,例例8Nebcinisindicatedforthetreatmentofthefollowinginfectionscausedbysusceptiblemicroorganisms.17例例9OctinumDhasprovedeffectiveintheprophylaxisandtherapyofdisordersarisingfromspasmofthesmoothmusculature.例例10Fungizoneintravenousisespeciallyinten
22、dedtotreatcryptococcosis例例11KanamycinisactivebothinvitroandvivoagainstGrampositiveandGramnegativebacteriaaswellasacid-fastbacteria例例12Benemidisrecommendedforthetreatmentofgoutandgoutyarthritis,andtoincreaseandprolongtheplasmaconcentrationofpenicillinsandcephalosporinsduringanti-infectivetherapy.18例1
23、3InformationavailableatpresentsuggeststhatOncovinmaybeusefuleitheraloneorinconjunctionwithotheroncolyticdrugsforthetreatmentofacuteleukaemias例14Adriamycinisfrequentlyusedincombinationchemotherapyregimentswithothercytotoxicdrugs.例15Concomitanttherapywithothercalciumantagonists,antihypertensivesandalc
24、oholmaypotentiatethehypotensiveactionofthedrug.194.4常用词及短语常用词及短语beactiveagainst对有效；beintendedto适用于；beadministratedin适用于；beofvalueof适用于；beeffectivein（for，against）对有效；berecommendedfor推荐用于；beemployedto用于；beusedto（for，as）用于；behelpfulin用于；beusefulin用于；beindicatedin（for）适用于；for（in）thetreatment（management）
25、of用于治疗（控制）表示与表示与“其他药物合用其他药物合用”的结构有：的结构有：beassociatedwith；inassociationwith；becombinedwith；incombinationwith；becompatiblewith；inconjunctionwith;concomitantwith；togetherwith20第五节第五节禁忌症禁忌症Contraindications，RestrictionsonUse5.1 5.1 涉及到禁用（或慎用）某些药物的患者或某种特殊情况涉及到禁用（或慎用）某些药物的患者或某种特殊情况5.1.1孕妇、妊娠期或哺乳期，幼童等孕妇、妊娠
26、期或哺乳期，幼童等pregnantwoman孕妇；lactation哺乳期；inpregnancy妊娠期；childrenunderyearsofage岁以下儿童；thefirsttrimester(3months)ofpregnancy妊娠期的最初三个月5.1.2患有某些疾病或过敏的患者患有某些疾病或过敏的患者allergic(hypersensitive)to对过敏的；allergic(anaphylactic)reaction过敏反应allergy(hypersensitivity)to对过敏；patientswith(who)患有的患者215.2疾病名称疾病名称cardiacfailu
27、re心力衰竭；hypertension高血压；cardiac(renal)insufficiency心（肾）功能不全；severehypotension严重低血压impairmentofkidney(renalfunction)肾功能损伤；diabetes糖尿病；liver(hepatic)damage肝损伤；severeanemia严重贫血225.3常见句型常见句型5.3.1省略句型，只列出禁忌对象或疾病名称等省略句型，只列出禁忌对象或疾病名称等例例1.Pregnacy,allergytomethotrexate,functionaldisordersofliverandkidneys,di
28、seasesofthehaematopoieticsystem(bonemarrowhypoplasia,leucopenia,thrombocy-topenia,anaemia),infectiousdiseases,ulcersoftheoralcavityandthegastrointestinaltract,recentoperationwounds.例例2.Hypersensitivitytoquinoiones,severerenalinsufficiency.235.3.2完整的句子或段落。其中常用的结构有完整的句子或段落。其中常用的结构有：contraindicationsar
29、e禁忌症是；becontraindicatedin(for)对禁忌；shouldnotbeused(employed)in不得用于；Itisadvisabletoavoidtheuseof建议不用于；mustnotbeadministered(given)to对不得用药；shouldbeusedwithcaution慎用；benotrecommendedfor最好不用于；nonereported未见报道；notknown不清楚例例3.Cetazolinsodiumiscontraindicatedinpatientswithknownhypersensitivitytocephalospori
30、ngroupofantibiotics.24例例4.4.ItisadvisabletoavoidtheuseofAraminewithcyclo-propaneorhalothaneanesthesia,unlessclinicalcircumstancesdemandsuchuse.例例5.5.DonottakeBenemidifprioradministrationresultedinhypersensitivityBenemidisnotrecommendedforpersonswithknowndisordersofthebloodoruricacidkidneystones.Dono
31、tgiveBenemidtochildrenundertwoyearsofage.例例6.6.Phenothiazinecompoundsshouldnotbeusedinpatientsreceivinglargedosesofhypnotics,andshouldbeused,withcautioninpatientswithahistoryofconvulsivedisorders,sincegrandmalconvulsionshavebeenknowntooccur.25例例7 7.Ursosanshouldnotbegiventopatientssufferingfromfulmi
32、nanthepatitisandbileductobstruction.例例8.8.Thisproductiscontraindicatedinthosepatientswhohaveshownhypersensitivitytoitunless,intheopinionofthephysician,theconditionrequiringtreatmentislifethreateningandamenableonlytoamphotencinBtherapy.例例9 9.Childrenunder5yearsofageshouldnotbetreatedwithAntistine.例例1
33、0.10.TheuseofAlexaninnursingmothersisnotrecommended.例例11.11.Pregnancy:Coumadiniscontraindicatedinwomenwhoareormaybecomepregnacybecausethedrugbassesthroughtheplacentalbarrierandmaycausefatalhemorrhagetothefetusinutero.265.4 5.4 Restrictionsonuse项目中小标题项目中小标题Contraindications禁忌症Precautions(Note)注意事项War
34、ning警告PregnancyandLactation妊娠与哺乳27第六节第六节用量与用法用量与用法DosageandAdministration用（剂）量与用法RouteofAdministration给药途径（用法）Administration用法DirectionforUse用法Methodof(for)Administration用法ApplicationandDosage用法与用（剂）量ModeofApplication用法Dosage用（剂）量HowtoUse用法Posology剂量学286.1常用表示剂量的术语常用表示剂量的术语averagedose平均剂量；minimal(mi
35、nimum)dose最小有效量dailydose日剂量（一日量）；multipledose多剂量divideddose分次剂量；overdose(overdose)过量fatal(lethal)dose致死量；singledose一次剂量indicateddose有效蛴量；standarddose标准（合适）剂量initial(beginning,starting)dose首次量；suggested(recommended)dose推荐剂量maintenancedose维持量；therapeuticdose治疗剂量maximumdose最大剂量（极量）usual(normal)dose常用剂量
36、296.2常用的剂量单位表示法常用的剂量单位表示法g=gram克l=liter(litre)升mg=milligram毫克ml=milliliter毫升kg=kilogram千克c.c.毫升mcg=microgram微克I.U.=internationalunit国际单位ug微克bodyweight体重persquaremeterofbodysurface每平方米体表面积306.3每次给药次数的表示方法每次给药次数的表示方法daily(perday,aday,everyday)每日everyhours每隔小时intervalsof每隔once(twice)daily(aday)每日一（二）次e
37、veryotherday每隔一日threetimesaday(daily)每日三次threetimesaweek每周三次once(twice)aweek(weekly)每周一（二）次Dividedintodoses分次intwoorthreedivideddoses分为二或三次（个剂量）316.4给药对象给药对象adolescents青少年；infant(s)幼儿adult(s)成年人；male男性baby(babies)婴儿；newbornbaby(babies)新生儿children(child)儿童 patient(s)患者，病人debilitatedpatients体弱患者pediat
38、ric儿科的elderlypatient(s)老年患者 pregnantwomen孕妇；female女性senilepatient(s)老年患者（病人）326.5给药方式的表示法（多用副词成或介词短语表示）给药方式的表示法（多用副词成或介词短语表示）intra-arterially静脉内给药；bymouth(OS)口服；intragluteally臀肌内给药；byphleboclysis静脉输液；intramuscularly肌内给药；byintramuscular(IM)injection肌肉注射；intraperitoneally腹（膜）腔内给药；intrathecally鞘内给药；byi
39、ntravenous(IV)injection静脉注射；intravenously静脉内给药；intrapleurally胸（膜）腔内给药；bytheintra-articulateadministration关节内给药；bytheintramuscularadministration(route)肌内给药；bytheintranasalroute鼻内给药；locally局部给药；orally口服给药；parenterally肠道外给药336.6给药方式的表示法（多用副词成或介词短语表示）给药方式的表示法（多用副词成或介词短语表示）bytheintraperitonealadministrat
40、ion腹（膜）腔内给药；subconjunctivally结膜下给药；bytheintravenousinfusion(perfusion)静脉输注；subcutaneously皮下给药；sublingually舌下给药；submucously粘膜下给药；bytheintrathecaladministration鞘内给药；byaerosol喷雾给药bythesubligualadministration舌下给药；bydripphleboclysis点滴静脉输液；perrectum直肠给药；byenema灌肠；pervaginum阴道给药；bylumbar腰椎给药；prorecta直肠给药34
41、6.7表示表示“投药投药”的常用动词的常用动词administer(或beadministered、give、begiven、indicate、beindicated)给药、投药；use(或beused、employ、beemployed)用药recommend(berecommended、suggest、besuggested)推荐给药6.8表示不同的用药方式的动词表示不同的用药方式的动词take服用；inhale吸入；applyto用于、涂于、敷于；spray喷雾inject注射；swallow吞服6.9其它的短语或句型其它的短语或句型accordingto根据beadjusted调整de
42、pendon依据adaptto适合，修改；onthebasisof在基础上varyfromto变化范围由至，因而异；rangefromto变化范围由至；itisadvisableto(itisrecommendedto、itissuggestedto)建议356.10 6.10 常用句型常用句型例例1 1Unlessotherwiseprescribedbythephysician,theaveragedailydoseis1capsule3timesdaily.例例2 2Thesuggesteddoseis10to15mgperkgbodyweightdailyin3-4divideddos
43、esorally,takenwithmeets.例例3 3Theinitialdosagerecommendedis1/2tabletofMadopa250threetimesdaily.例例4 4Children:Theusualdoseis50to100mg/kg/daytotal,giveninfourequallydividedandspaceddoses.例例5 5Therecommendedstartingdoseis20mggivenasasingledailydose.36例例6therecommendedsingledoseis1ampoule,givensubcutaneo
44、usly,intramuscularlyorintravenously.例例7I.Minjectionsshouldbeadministeredintheamountof25-50mgdailyperkiloofbodyweight,subdividedintoinjectionsevery6-8-12hours.例例8Foradultsgiveintramuscularinjectionof400to600mgperdayin2-3divideddoses.Forinfantsgiveintramuscularinjectionof10-20mg/kgperdayintwodivideddo
45、ses.例例9Thetablets(orthesyrup)aretobetakenduringorafteramealwithalittleliquid.37例例10ApplytheNitro-Dursystemfirmlytotheskinsurface.TheNitro-Dursystemmaybeappliedtoanyconvenientskinarea,arecommendedsideofapplicationisthearmorchest.例例11Ingeneral1to3metereddosesshouldbeinhaledorsprayedontoorunderthetongu
46、eattheeveryonesetofanginalpain.例例12Dosageshouldbeadaptedtopatientsindividually,onthebasisofperiodictestsofglycosuriaandbloodsugar.例例13Itisadvisabletoinitiatetherapywithmassivedoses:3x2tabletsdailyaftermealsover2-4days.38例例14Inseverschroniccases,treatmentisstartedwithdaily1to2ampoulesofBilocidandcont
47、inuedwithoneampouleeveryotherday,injectedslowlybytheintravenousroute.例例15Thenumberofinjectionsrequiredmayvaryfrompatienttopatient.例例16ThedosageofGlutrilmustbeadjustedbythedoctoraccordingtotheindividualmetabolicstate.例例17Insuchinstance,itisrecommendedthatthedosebereduced.例例18Themaintenancedosageisdet
48、erminedbyresponseofthepatient.39第七节第七节不良反应不良反应7.1“不良反应不良反应”AdverseReaction（s）不良反应；Unwanted（Untoward）Reaction（s）不良反应7.2“副作用副作用”Side-effect(s)副作用；Unwanted（Undesirable）Effects副作用；SideReaction(s)副作用；By-effects副作用407.3常见毒副反应的症状及特征词语常见毒副反应的症状及特征词语allergic(hypersensitive，anaphylactic）reaction(s)过敏反应allergy
49、(hypersensitivity)过敏；dizziness眩晕；flush潮红gastrointestinaltract胃肠道；fever发热；localreaction(s)局部反应skinreaction（s）皮肤反应；headache头痛；symptom（s）症状nausea恶心；systematic全身的；pruritus瘙痒；anorexia厌食；rash皮疹；bloodcount白细胞计数；spasm痉挛；bloodpressure血压；thirst口渴；coma昏迷；tiredness疲倦；diarrhea腹泻；omitting呕吐417.4“毒性毒性”、“耐受性耐受性”的英语
50、表示法的英语表示法toxicity毒性tolerance（tolerability)耐受力，耐药性tolerate（toleration）耐受7.5“停药停药”的英语表示法的英语表示法abandon停药discontinue（discontinuance,discontinuation)停药，中断（治疗）cease（cessation）（stop）停药（停止治疗）dontuse勿使用（停药）；suspend停药terminate停止，结束withdraw（bewithdrawn，withdrawal）停药427.6其他常见的基本词汇及短语其他常见的基本词汇及短语acute急性的；control