药品说明书-ppt课件.ppt

1、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1ppt课件 药品说明书药品说明书: Instructions，Directions，Description 现在多用Package Insert，或简称 Insert，也有用Leaflet或Data Sheets。 较简单的说明书较简单的说明书：成分、适应症、禁忌症、用法与用量成分

2、、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。2ppt课件1.常见药品名称常见药品名称：商品名商品名： Trade Name或Proprietary Name；通用名通用名： Generic Name；化学名化

3、学名：Chemical Name。例如：熊去氧胆酸片，商品名为 Ursosan（Tablets）：通用名为 Ursodesoxycholic Acid（熊去氧胆酸）；化学名为3,7- dihydroxy-5-Cholanoic acid（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（Registered Trade Mark） 。商品名（通用名或化学名 ）：Rulide（ Roxithromycin ） 罗力得（罗红霉素）3ppt课件 2.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，Amcac

4、in 阿米卡星。（2）意译意译：如：cholic Acid 胆酸，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。 4ppt课件Catalin（卡他林）化学名称：1Hyd

5、roxy- 5oxo-5Hpyrido（3，2a） Phenoxazine3-carboxylic acid 1-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。 5ppt课件第二节第二节 性状性状 2.1 1常用的标题常用的标题： Description Chemical Structure 化学结构 Composition 成分 Physical and Chemica

6、l Properties 理化性质 6ppt课件 2.2 本项中常见的句型本项中常见的句型例例1 1Folic acid is a yellowish to orange, crystalline powder; odourless or almost odourless.例例2 2Intralipos 10% is a white opaque fat emulsion for intravenous injection, containing 10 W/V % of purified soybean oil.例例3 3Ursosan Tablet 50mg is a white plain

7、 tablet which contains 50 mg of ursodesoxycholic acid.例例4 4Sterile pyrogen-free, orange red, freeze-dried powder in vials containing 10mg and 50mg of doxorubicin hydrochloride with lactose.7ppt课件例例5 5It occurs as a white to off-white, crystalline solid, poorly soluble in water, dilute acid and most

8、organic solvents.例例6 6Pamine, chemically known as epoxytropine tropate methylbromide, has the empirical formula C18H24NO4Br and the molecular weight 398.3. 例例7 7Kanendomycin is a very stable antibiotic, and its activity does not decrease when the powder is placed in an airlight container and kept at

9、 room temperatures for more than 2 years.例例8 8This product is prepared from units of human plasma which have been tested and found nonreactive for hepatitis associated (Australia) antigen.8ppt课件2. 3 3 本项中常用的词语本项中常用的词语（1）表示组成、制备的单词及短语表示组成、制备的单词及短语，如：be derived from 由衍生；consist of 由组成；be obtained 制得；c

10、ontain 含有； be prepared from 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；molecular formular 分子式odo(u)rless 无臭的；molecular weight 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 气味； tablets 片剂；colo(u)rless 无色的 ；derivative

11、 衍生物；tasteless 无味的；liquid 液体；sterile 无菌的；powder 粉沫；soluble 可溶的 ； solid 固体 9ppt课件第三节第三节 药理作用药理作用 药理作用、临床药理(Clinical Pharmacology)、体外试验(in vitro experiments)、药物代谢(Metabolism)、药效(Potency)及毒性(Toxicity)等。常用标题常用标题： Pharmacological Action 药理作用；Pharmacological Properties 药理性质 ；Pharmacology 药理学；Clinical Phar

12、macology 临床药理 其他的表示方法其他的表示方法： Actions 作用；Actions and Properties 作用与性质；Clinical Effect (Use) 临床效果（用途）；Mechanism of Action 作用机理；Mode of Action 作用方式；抗生素抗生素： Biological Action 生物活性 ；Microbiology 微生物学 10ppt课件3.13.1常见句型举例常见句型举例例例1 1. Mean peak serum concentrations of tobramycin occur between 30 and about

13、60 minutes after intramuscular administration.例例2 2. Nembutal Sodium exerts a depressant action on the CNS and shares the sedative-hypnotic actions typical of the barbiturates.例例3 3. In clinical trials the drug was shown to be highly effective in improving and normalizing the alternated cerebral cir

14、culation and those disorders related to insufficient arterial flow in the limbs.例例4 4. Orbenin is stable to staphylococcal penicillinase, and highly effective against resistant staphylococci.It is bactericidal, acid-stable and well absorbed by either the oral or the intramuscular route.11ppt课件例例5. N

15、ystain has been found to inhibit the growth of yeast like flora in the intestinal tract.例例6. Fenarol has proved to be effective as a striated muscle relaxant.例例7. Halcion is a potent short-acting hypnotic agent, which produces its hypnotic activity from the first night of administration.例例8. Therape

16、utically, ATP injection exhibits effects, especially such as activation of the function and metabolism of the nerve, and also coronary and peripheral vasodilation to increase the blood stream.12ppt课件3.2 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 (be cause by) 引起（由引起）；demonstrate 显示；exert (act

17、ion on) 起作用；exhibit 显示；inhibit 抑制；accumulate 积蓄；administrate 投药；excrete 排泄；result in 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 耐受 13ppt课件3.2.2 形容词形容词 (be) active (effective) against 对有效的；(be) related to 与

18、有关的；(be) sensitive to 对敏感的；resistant to 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；effect on 对的作用；function 功能，作用；half life 半衰期；in vitro 体外；kidney 肾；mechanism 机理；serum concentration 血清浓度；toler

19、ance 耐受性；infection 感染；in vivo 体内；level 水平，浓度；plasm lever 血浆浓度（水平）；toxicity 毒性 14ppt课件第四节第四节 适应症适应症4.1 4.1 表示方法表示方法 Indications适应症；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 angina pectoris 心绞痛；cancer癌；diabe

20、tes（mellitus）糖尿病；hypertension 高血压；gram-positive microorganisms (bacteria)革兰氏阳性菌；virus 病毒；gramnegative microorganisms（bacteria）革兰氏阴性菌；coli 大肠杆菌15ppt课件 4.3 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、Angina pectoris, Prinzmetals angina, hypertension例例 2 The following diseases caused by

21、bacteria including grampositive and gramnegative bacteria such as Staphylococcus，Streptcoccus, Escherichia coli, Klebsiella pneumonia4.3.2 由由For（或（或In等）引出的短语等）引出的短语例例3 For prevention of the advance of cataract.例例 4 In the treatment of all forms of pulmonary tuberculosis in association with other ant

22、itubercular drugs.4.3.3 To+动词原形构成的短语动词原形构成的短语例例 5 To prevent the formation of urinary calculi，especially in cases where they tend to recur. 16ppt课件例例6 To protect the liver cell during administration of drugs hazardous to the liver 4.3.4 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 7 Amikacin is useful in

23、the treatment of infections from Gramnegative sensitive species，there included the Pseudomonas species；it may also be useful to treat infections caused by sensitive staphylococci,例例 8 Nebcin is indicated for the treatment of the following infections caused by susceptible microorganisms.17ppt课件例例 9 O

24、ctinum D has proved effective in the prophylaxis and therapy of disorders arising from spasm of the smooth musculature.例例10 Fungizone intravenous is especially intended to treat cryptococcosis例例11 Kanamycin is active both in vitro and vivo against Grampositive and Gramnegative bacteria as well as ac

25、id-fast bacteria例例12 Benemid is recommended for the treatment of gout and gouty arthritis, and to increase and prolong the plasma concentration of penicillins and cephalosporins during anti-infective therapy.18ppt课件例 13 Information available at present suggests that Oncovin may be useful either alon

26、e or in conjunction with other oncolytic drugs for the treatment of acute leukaemias 例14 Adriamycin is frequently used in combination chemotherapy regiments with other cytotoxic drugs. 例 15 Concomitant therapy with other calcium antagonists, antihypertensives and alcohol may potentiate the hypotensi

27、ve action of the drug.19ppt课件 4.4 常用词及短语常用词及短语be active against对有效；be intended to适用于；be administrated in 适用于；be of value of 适用于；be effective in （for，against）对有效；be recommended for 推荐用于；be employed to 用于；be used to（for，as）用于；be helpful in 用于；be useful in 用于；be indicated in（for）适用于；for（in） the treatme

28、nt（management）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：be associated with； in association with； be combined with；in combination with； be compatible with； in conjunction with; concomitant with； together with20ppt课件第五节第五节 禁忌症禁忌症 Contraindications，Restrictions on Use5.1 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

29、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、妊娠期或哺乳期，幼童等pregnant woman 孕妇；lactation 哺乳期；in pregnancy 妊娠期；children under years of age 岁以下儿童；the first trimester (3 months) of pregnancy 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

30、 (hypersensitivity) to 对过敏 ；patients with (who) 患有的患者21ppt课件5.2 疾病名称疾病名称cardiac failure 心力衰竭；hypertension 高血压；cardiac (renal) insufficiency 心（肾）功能不全；severe hypotension 严重低血压impairment of kidney (renal function) 肾功能损伤；diabetes 糖尿病；liver (hepatic) damage 肝损伤；severe anemia 严重贫血22ppt课件5.3 常见句型常见句型5.3.1

31、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, allergy to methotrexate, functional disorders of liver and kidneys, diseases of the haematopoietic system (bone marrow hypoplasia, leucopenia, thrombocy - to penia, anaemia), infectious diseases, ulcers of the oral cavity and the gastrointestinal tr

32、act, recent operation wounds.例例2. Hyper sensitivity to quinoiones, severe renal insufficiency.23ppt课件5.3.2 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：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 adminis

33、tered (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 不清楚例例3. Cetazolin sodium is contraindicated in patients with known hypersensitivity to cephalosporin group of antibiotics.24ppt课件例例4.4. It is advisable to avoid the use of Aramine with cyc

34、lo-propane or halothane anesthesia, unless clinical circumstances demand such use.例例5.5. Do not take Benemid if prior administration resulted in hypersensitivity Benemid is not recommended for persons with known disorders of the blood or uric acid kidney stones. Do not give Benemid to children under

35、 two years of age.例例6.6. Phenothiazine compounds should not be used in patients receiving large doses of hypnotics, and should be used, with caution in patients with a history of convulsive disorders, since grand mal convulsions have been known to occur. 25ppt课件例例7 7. Ursosan should not be given to

36、patients suffering from fulminant hepatitis and bile duct obstruction.例例8.8. This product is contraindicated in those patients who have shown hypersensitivity to it unless, in the opinion of the physician, the condition requiring treatment is life threatening and amenable only to amphotencin B thera

37、py.例例9 9. Children under 5 years of age should not be treated with Antistine.例例10.10. The use of Alexan in nursing mothers is not recommended.例例11.11. Pregnancy: Coumadin is contraindicated in women who are or may become pregnacy because the drug basses through the placental barrier and may cause fa

38、tal hemorrhage to the fetus in utero. 26ppt课件 5.4 5.4 Restrictions on use 项目中小标题项目中小标题 Contraindications 禁忌症 Precautions (Note) 注意事项 Warning 警告 Pregnancy and Lactation 妊娠与哺乳 27ppt课件第六节第六节 用量与用法用量与用法 Dosage and Administration 用（剂）量与用法 Route of Administration 给药途径（用法） Administration 用法 Direction for U

39、se 用法 Method of (for) Administration 用法 Application and Dosage 用法与用（剂）量 Mode of Application 用法 Dosage 用（剂）量 How to Use 用法 Posology 剂量学28ppt课件6.1 常用表示剂量的术语常用表示剂量的术语average dose 平均剂量； minimal (minimum) dose 最小有效量daily dose 日剂量（一日量）； multiple dose 多剂量divided dose 分次剂量； overdose (overdose) 过量fatal (leth

40、al) dose 致死量； single dose 一次剂量indicated dose 有效蛴量； standard dose 标准（合适）剂量initial (beginning, starting) dose 首次量；suggested (recommended) dose 推荐剂量maintenance dose 维持量； therapeutic dose 治疗剂量maximum dose 最大剂量（极量）usual (normal) dose 常用剂量29ppt课件6.2 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=milli

41、gram 毫克 ml=milliliter 毫升 kg=kilogram 千克 c.c. 毫升 mcg=microgram 微克 I.U.=international unit 国际单位 ug 微克 body weight 体重 per square meter of body surface 每平方米体表面积30ppt课件6.3 每次给药次数的表示方法每次给药次数的表示方法 daily (per day, a day, every day ) 每日 every hours 每隔小时 intervals of 每隔 once (twice) daily (a day) 每日一（二）次 ever

42、y other day 每隔一日 three times a day (daily) 每日三次 three times a week 每周三次 once (twice) a week (weekly) 每周一（二）次 Divided into doses 分次 in two or three divided doses 分为二或三次（个剂量） 31ppt课件6.4 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；newborn baby (babies) 新生儿 children (

43、child) 儿童 patient (s) 患者，病人 debilitated patients 体弱患者 pediatric 儿科的 elderly patient (s) 老年患者 pregnant women 孕妇；female 女性 senile patient (s) 老年患者（病人）32ppt课件6.5 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； by mouth (OS) 口服；intragluteally 臀肌内给药 ；by phleboclysis 静脉输液；intramuscular

44、ly 肌内给药；by intramuscular (IM) injection 肌肉注射；intraperitoneally 腹（膜）腔内给药； intrathecally 鞘内给药；by intravenous (IV) injection 静脉注射；intravenously 静脉内给药；intrapleurally 胸（膜）腔内给药；by the intra-articulate administration 关节内给药；by the intramuscular administration (route) 肌内给药；by the intranasal route 鼻内给药；locall

45、y 局部给药； orally 口服给药；parenterally 肠道外给药33ppt课件6.6 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） by the intraperitoneal administration 腹（膜）腔内给药；subconjunctivally 结膜下给药； by the intravenous infusion (perfusion) 静脉输注；subcutaneously 皮下给药； sublingually 舌下给药；submucously 粘膜下给药； by the intrathecal administrati

46、on 鞘内给药； by aerosol 喷雾给药 by the subligual administration 舌下给药；by drip phleboclysis 点滴静脉输液； per rectum 直肠给药；by enema 灌肠； per vaginum 阴道给药；by lumbar 腰椎给药； pro recta 直肠给药 34ppt课件6.7 表示表示“投药投药”的常用动词的常用动词administer (或be administered、give、be given、indicate、be indicated) 给药、投药； use (或be used 、employ、be emp

47、loyed) 用药 recommend (be recommended、suggest、be suggested) 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； apply to 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 according to 根据 be adjusted 调整 depend on 依据 adapt to 适合，修改；on the basis of 在基础上 vary fromto 变化范围由至，因而异；range from to 变化范

48、围由至；it is advisable to (it is recommended to、it is suggested to ) 建议35ppt课件6.10 6.10 常用句型常用句型例例1 1 Unless other wise prescribed by the physician, the average daily dose is 1 capsule 3 times daily.例例2 2 The suggested dose is 10 to 15 mg per kg body weight daily in 3-4 divided doses orally, taken with

49、 meets.例例3 3 The initial dosage recommended is 1/2 tablet of Madopa 250 three times daily.例例4 4 Children: The usual dose is 50 to 100 mg/kg/day total, given in four equally divided and spaced doses.例例5 5 The recommended starting dose is 20mg given as a single daily dose. 36ppt课件例例6 the recommended s

50、ingle dose is 1 ampoule, given subcutaneously, intramuscularly or intravenously. 例例7 I.M injections should be administered in the amount of 25-50mg daily per kilo of body weight, subdivided into injections every 6-8-12 hours.例例8 For adults give intramuscular injection of 400 to 600 mg per day in 2-3