药品命名ATC分类结构和原理.docx

1、药品命名ATC分类结构和原理药品ATC 的结构和原理注：本资料是从网上看到的，感觉有用，希望能给大家提供帮助，同时谢谢本资料的原始作者。结构解剖学治疗学化学（ATC）的分类系统时根据活性物质的治疗学，药理学和化学性质在人体器官或系统上的作用，被分成了不同的类。药品分类为五个级别层次。药品分为十四个大类（第一级），根据药理学/治疗学分成亚类（第二级），第三和第四级是化学/药理/治疗小类，第五级是化学物质。第二，第三和第四水平通常用来确定药理分类，优先于的治疗或化学分类。以二甲双胍的完整分类为例说明代码的结构：A消化系统及新陈代谢（第一级，解剖大类）A10糖尿病用药（第二级，治疗学亚类）A10B降

2、血糖药物，不含胰岛素（第三级，药理学次亚类）A10BA双胍类（第四级，化学小类）A10BA02二甲双胍（第五级，化学物质）因此，在ATC系统的所有普通二甲双胍制剂的代码为A10BA02命名法国际非专利名称（INN）是首选。如果与国际非专利名称不分配，则使用中国药典中的药品名称，中国药典没有记录的名称选用USAN（美国通用名称）或BAN（英国批准的名称）的名字。ATC的不同级别的命名使用世界卫生组织的药物用语（药理作用和治疗用的药物 用语清单）；世界卫生组织的药物用语没有包含的类别，参照中国药典进行命名。Inclusion and exclusion criteria(to the top)Th

3、e WHO Collaborating Centre in Oslo establishes new entries in the ATC classification on requests from the users of the system. These include manufacturers, regulatory agencies and researchers. The coverage of the system is not comprehensive. A major reason why a substance is not included is that no

4、request has been received.入选和排除标准在奥斯陆世卫组织合作中心建立从该系统的用户的请求ATC分类中的新条目。这包括制造商，监管机构和研究人员。该系统的范围并不全面。一个重要原因是不包括的物质是没有请求已被接受。Active ingredients which fulfil one of the following criteria will normally be included in the ATC system.活性成分完全满足下列条件之一者通常包含在ATC系统。they are new chemical entities (active ingredient

5、s) orbiologicals proposed for licensing in a range of countries. A new chemical entity is normally not included in the ATC system before an application for marketing authorisation is submitted in at least one country. they are existing well defined chemical entities used in a variety of countries. A

6、n INN should preferably be established for the active ingredient. Alternatively other official names, e.g. USAN or BAN names should be available. the are herbal medicinal products assessed and approved by regulatory authorities based on dossiers including efficacy, safety, and quality data (e.g. the

7、 well-established use procedure in EU). 它们是新化学实体（有效成分）或授权提出一系列国家生物制品。一种新的化学实体，通常不包括在空管系统的销售许可之前，申请至少在一个国家提交。他们是现有的明确界定的国家化学品用于各种实体。一家旅店最好应建立有效成分。或者其他官方名称，例如蔚山或者禁止的名称应该可用。是草药产品的评估和监管当局批准，包括有效性，安全性档案材料为基础，（如欧盟行之有效的使用过程）质量数据。Other medicinal productsare considered on a case by case basis.Complementary,

8、homeopathic and herbaltraditional medicinal products are in general not included in the ATC system.其他药用产品是考虑按个别情况。互补，顺势疗法和草药产品在传统医药中没有包括在ATC。General principles for classification 通用原则和分类Medicinal products are classified according to the main therapeutic use of the main active ingredient, on the basi

9、c principle of only one ATC code for each route of administration (i.e. pharmaceutical forms with similar ingredients and strength will have the same ATC code).医药产品分类根据主要治疗作用的主要活性成分的只有一个ATC代码的基本原则，为每一个给药途径（即药物具有相似成分和规格的形式将有相同的ATC）。Immediate and slow release tablets will normally have the same ATC co

10、de.立即和缓释片，通常会具有相同的ATC代码A medicinal product can be given more than one ATC code if it is available in two or more strengths or routes of administration with clearly different therapeutic uses. Two examples of this are as follows:如果一种药品有两个或两个以上的规格或给药途径并有明确的不同的治疗用途，它可以得到一个以上的ATC代码。两个例子如下：Sex hormones i

11、n certain dosage forms or strengths are only used in the treatment of cancer and are thus classified under L02 - Endocrine therapy. Remaining dosage forms/strengths are classified under G03 - Sex hormones and modulators of the genital system. Clonidine is available in two different strengths. One st

12、rength, which is used mainly in the treatment of hypertension, is classified under C02 - Antihypertensives. Another strength is mainly used in the treatment of migraine and is classified under N02C - Antimigraine preparations. 某些剂型或规格的性激素仅用于治疗癌症，因而分类在L02下 - 内分泌治疗， 剩余剂型/规格划分在G03的 - 性激素及生殖系统调制剂。可乐定有两个

13、不同的规格。一种一种规格是用于治疗高血压为主，归类C02 - 抗高血压药物。另一种规格是主要用于治疗偏头痛，分类在N02C类 抗偏头痛药物。Different pharmaceutical forms for topical and systemic use are also given separate ATC codes. 对局部和全身使用的不同的药物剂型，并给出不同的ATC代码Example:Prednisolone in single ingredient products is given several ATC codes due to different therapeutic

14、use and different local application formulations.例如：由于不同的治疗用途和不同的局部使用剂型，单一成分产品氢化泼尼松，给出几个ATC代码。A07EA01 Intestinal antiinflammatory agentsC05AA04Antihemorrhoidals for topical useD07AA03Dermatological preparationsH02AB06 Corticosteroids for systemic useR01AD02 Nasal decongestantsS01BA04 Ophthalmologica

15、lsS02BA03 OtologicalsA07EA01肠道抗炎药物C05AA04外用防痔D07AA03皮肤病制剂H02AB06全身使用皮质类固醇R01AD02鼻充血药S01BA04眼科用药S02BA03耳科用药A medicinal product may be used for two or more equally important indications, and the main therapeutic use of a drug may differ from one country to another. This will often give several classif

16、ication alternatives. Such drugs are usually only given one code, the main indication being decided on the basis of the available literature. Problems are discussed in the WHO International Working Group for Drug Statistics Methodology where the final classification is decided. Cross-references will

17、 be given in the guidelines to indicate the various uses of such drugs.一种药用产品可用于两个或多个同样重要的适应症，也是最主要的治疗药物的使用可能因国家而异。这常常使一些分类办法。这种药物通常只给一个代码，主要指标是对现有文献的基础上决定。问题进行了讨论在世卫组织国际工作小组药物统计方法在决定最终分类。交叉引用将给予指引表明这种药物的各种用途。The ATC system is not strictly a therapeutic classification system. At all ATC levels, ATC

18、codes can be assigned according to the pharmacology of the product. Subdivision on the mechanism of action will, however, often be rather broad, since a too detailed classification according to mode of action often will result in having one substance per subgroup which as far as possible is avoided

19、(e.g. antidepressants). Some ATC groups are subdivided in both chemical and pharmacological groups (e.g. ATC group J05A - Direct acting antivirals). If a new substance fits in both a chemical and pharmacological 4th level, the pharmacological group should normally be chosen.ATC系统并非严格意义上的治疗分类系统。在所有各级

20、ATC，ATC代码可以根据产品的药理学进行分配。关于作用机制的细分将，但是，往往是相当广泛的，因为过于详细的分类，按作用方式往往会导致有一子群每尽量避免（如抗抑郁药）的物质。有些ATC组细分在化学和药理团体（如ATC组J05A - 直接作用抗病毒药物）。如果一个新物质同时符合第四级的化学性质及药理性质，一般应选择药理性质分类。Substances classified in the same ATC 4th level cannot be considered pharmacotherapeutically equivalent since their mode of action, ther

21、apeutic effect, drug interactions and adverse drug reaction profile may differ.在同一个ATC第四级分类物质不能被视为药理治疗学等效pharmacotherapeutically，因为他们的作用方式、疗效、药物相互作用和药物不良反应的个人资料可能有所不同。Normally, different stereoisomeric forms will have separate ATC codes. Exceptions will be described in the guidelines for the respect

22、ive ATC groups.通常情况下，不同的立体异构体的形式将有独立的ATC代码。例外的例子将在ATC的指南中阐述。A new medicinal substance not clearly belonging to any existing ATC 4th level group of related substances will as a main rule be placed in an X group (other group). To avoid a situation of several 4th levels with only one single substance i

23、n each, new 4th levels are as a general rule only established when at least two substances with marketing authorisations fit in the group. In addition, a new 4th level should be regarded a benefit for drug utilization research. New and innovative medicinal products will therefore often be classified

24、 in an X group and such groups could be established for only one single substance.一种新的药用物质没有明确属于任何现有ATC的有关物质第四级组将作为一个主要规则放置在X组（“其他”组）。为了避免几个4级，只有在每个单一物质形势，新的第四级别，因为只有建立在至少两个上市许可的物质适合于本集团的一般规则。此外，一个新的4级，应被视为一种药物利用研究的利益。新的和创新的医药产品将因此往往被归类在X组等组可以只设立一个单一物质。Prodrugs are usually assigned separate ATC code

25、s if the dosages used are different and/or the nonproprietary name of the prodrug and the active drugs are different. 如果前体药使用的是不同的剂量和/或该非专利药名和活性药物是不同的，通常是有单独的ATC代码。 Example:J01CA08 pivmecillinamJ01CA11 mecillinam例如：J01CA08 pivmecillinamJ01CA11 mecillinamClassification of plain products 普通产品分类Plain p

26、roducts are defined as:Preparations containing one active component (including stereoisomeric mixtures). Medicinal products which in addition to one active component contain auxiliary substances intended to increase the stability of the preparations (e.g. vaccines containing small amounts of antibac

27、terials), increase the duration (e.g. depot formulations) and/or increase the absorption (e.g. different solvents in various dermatologicals) are also considered as plain products. Plain products are classified according to the general principles outlined above.普通产品的定义是：含有一种活性成分的制剂（包括立体异构体的混合物）。附加在一

28、个活性成分中的药用产品，含有旨包括旨在提高该制剂的稳定性辅助物质（含少量的抗菌药物如疫苗），增加持续时间（如仓库配方）和/或增加吸收（如不同溶剂的各种皮肤科用药）也被视为普通的产品。普通产品乃根据上述的一般原则。Classification of combination products (to the top)Products containing two or more active ingredients are regarded as combination products. Combination products are classified according to three

29、 main principles.复方产品分类产品含有两个或两个以上有效成分被视为复方产品。复方产品根据三个主要原则分类。a)Combination products containing two or more active ingredients belonging to the same 4th level are normally classified using the 5th level codes 20 or 30. Example:N01BB02 lidocaineN01BB04 prilocaineN01BB20 combinations (e.g. lidocaine an

30、d prilocaine) b)Combination products containing two or more active ingredients not belonging to the same 4th level are classified using the 50-series. Example:R06AA02 diphenhydramineR06AA52 diphenhydramine, combinationsDifferent combination products sharing the same main active ingredient are usuall

31、y given the same ATC code. Thus, products containing phenylpropanolamine + brompheniramine and phenylpropanolamine + cinnarizine are both given the code R01BA51.c)Combination products containing psycholeptic drugs, which are not classified under N05 - Psycholeptics orN06 - Psychoanaleptics, are clas

32、sified at separate 5th levels using the 70-series.Example: N02BA71 - acetylsalicylic acid, combinations with psycholeptics (products containing other substances in addition to a psycholeptic are also classified here.) 一）复方产品含有两个或两个以上属于同一第四层的有效成分，通常使用的5级分类代码20或30。例如：N01BB02利多卡因N01BB04丙胺卡因N01BB20复方（例如，利多卡因和丙胺卡因）二）产品复方包含两个或多个活性成分不属于同一第四级别采用50系列。例如：R06AA02苯海拉明R06A