藥品命名ATC分類結(jié)構(gòu)和原理.doc

.藥品ATC 的結(jié)構(gòu)和原理結(jié)構(gòu)解剖學治療學化學（ATC）的分類系統(tǒng)時根據(jù)活性物質(zhì)的治療學，藥理學和化學性質(zhì)在人體器官或系統(tǒng)上的作用，被分成了不同的類。藥品分類為五個級別層次。藥品分為十四個大類（第一級），根據(jù)藥理學/治療學分成亞類（第二級），第三和第四級是化學/藥理/治療小類，第五級是化學物質(zhì)。第二，第三和第四水平通常用來確定藥理分類，優(yōu)先于的治療或化學分類。以二甲雙胍的完整分類為例說明代碼的結(jié)構(gòu)：A消化系統(tǒng)及新陳代謝（第一級，解剖大類）A10糖尿病用藥（第二級，治療學亞類）A10B降血糖藥物，不含胰島素（第三級，藥理學次亞類）A10BA雙胍類（第四級，化學小類）A10BA02二甲雙胍（第五級，化學物質(zhì)）因此，在ATC系統(tǒng)的所有普通二甲雙胍制劑的代碼為A10BA02命名法國際非專利名稱（INN）是首選。如果與國際非專利名稱不分配，則使用中國藥典中的藥品名稱，中國藥典沒有記錄的名稱選用USAN（美國通用名稱）或BAN（英國批準的名稱）的名字。ATC的不同級別的命名使用世界衛(wèi)生組織的藥物用語（藥理作用和治療用的藥物 用語清單）；世界衛(wèi)生組織的藥物用語沒有包含的類別，參照中國藥典進行命名。Inclusion and exclusion criteria(to the top)The 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 request has been received.入選和排除標準在奧斯陸世衛(wèi)組織合作中心建立從該系統(tǒng)的用戶的請求ATC分類中的新條目。這包括制造商，監(jiān)管機構(gòu)和研究人員。該系統(tǒng)的范圍并不全面。一個重要原因是不包括的物質(zhì)是沒有請求已被接受。Active ingredients which fulfil one of the following criteria will normally be included in the ATC system.活性成分完全滿足下列條件之一者通常包含在ATC系統(tǒng)。 they are new chemical entities (active ingredients) 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. An 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 well-established use procedure in EU). 它們是新化學實體（有效成分）或授權(quán)提出一系列國家生物制品。一種新的化學實體，通常不包括在空管系統(tǒng)的銷售許可之前，申請至少在一個國家提交。他們是現(xiàn)有的明確界定的國家化學品用于各種實體。一家旅店最好應(yīng)建立有效成分。或者其他官方名稱，例如蔚山或者禁止的名稱應(yīng)該可用。是草藥產(chǎn)品的評估和監(jiān)管當局批準，包括有效性，安全性檔案材料為基礎(chǔ)，（如歐盟行之有效的使用過程）質(zhì)量數(shù)據(jù)。Other medicinal productsare considered on a case by case basis.Complementary, homeopathic and herbaltraditional medicinal products are in general not included in the ATC system.其他藥用產(chǎn)品是考慮按個別情況?；パa，順勢療法和草藥產(chǎn)品在傳統(tǒng)醫(yī)藥中沒有包括在ATC。General principles for classification 通用原則和分類Medicinal products are classified according to the main therapeutic use of the main active ingredient, on the basic 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).醫(yī)藥產(chǎn)品分類根據(jù)主要治療作用的主要活性成分的只有一個ATC代碼的基本原則，為每一個給藥途徑（即藥物具有相似成分和規(guī)格的形式將有相同的ATC）。Immediate and slow release tablets will normally have the same ATC code.立即和緩釋片，通常會具有相同的ATC代碼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:如果一種藥品有兩個或兩個以上的規(guī)格或給藥途徑并有明確的不同的治療用途，它可以得到一個以上的ATC代碼。兩個例子如下： Sex hormones in 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 strength, 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. 某些劑型或規(guī)格的性激素僅用于治療癌癥，因而分類在L02下 - 內(nèi)分泌治療， 剩余劑型/規(guī)格劃分在G03的 - 性激素及生殖系統(tǒng)調(diào)制劑。可樂定有兩個不同的規(guī)格。一種一種規(guī)格是用于治療高血壓為主，歸類C02 - 抗高血壓藥物。另一種規(guī)格是主要用于治療偏頭痛，分類在N02C類 抗偏頭痛藥物。Different pharmaceutical forms for topical and systemic use are also given separate ATC codes. 對局部和全身使用的不同的藥物劑型，并給出不同的ATC代碼Example:Prednisolone in single ingredient products is given several ATC codes due to different therapeutic use and different local application formulations.例如：由于不同的治療用途和不同的局部使用劑型，單一成分產(chǎn)品氫化潑尼松，給出幾個ATC代碼。A07EA01 Intestinal antiinflammatory agentsC05AA04Antihemorrhoidals for topical useD07AA03Dermatological preparationsH02AB06 Corticosteroids for systemic useR01AD02 Nasal decongestantsS01BA04 OphthalmologicalsS02BA03 OtologicalsA07EA01腸道抗炎藥物C05AA04外用防痔D07AA03皮膚病制劑H02AB06全身使用皮質(zhì)類固醇R01AD02鼻充血藥S01BA04眼科用藥S02BA03耳科用藥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 classification 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 be given in the guidelines to indicate the various uses of such drugs.一種藥用產(chǎn)品可用于兩個或多個同樣重要的適應(yīng)癥，也是最主要的治療藥物的使用可能因國家而異。這常常使一些分類辦法。這種藥物通常只給一個代碼，主要指標是對現(xiàn)有文獻的基礎(chǔ)上決定。問題進行了討論在世衛(wèi)組織國際工作小組藥物統(tǒng)計方法在決定最終分類。交叉引用將給予指引表明這種藥物的各種用途。The ATC system is not strictly a therapeutic classification system. At all ATC levels, ATC 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 (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系統(tǒng)并非嚴格意義上的治療分類系統(tǒng)。在所有各級ATC，ATC代碼可以根據(jù)產(chǎn)品的藥理學進行分配。關(guān)于作用機制的細分將，但是，往往是相當廣泛的，因為過于詳細的分類，按作用方式往往會導致有一子群每盡量避免（如抗抑郁藥）的物質(zhì)。有些ATC組細分在化學和藥理團體（如ATC組J05A - 直接作用抗病毒藥物）。如果一個新物質(zhì)同時符合第四級的化學性質(zhì)及藥理性質(zhì)，一般應(yīng)選擇藥理性質(zhì)分類。Substances classified in the same ATC 4th level cannot be considered pharmacotherapeutically equivalent since their mode of action, therapeutic effect, drug interactions and adverse drug reaction profile may differ.在同一個ATC第四級分類物質(zhì)不能被視為藥理治療學等效pharmacotherapeutically，因為他們的作用方式、療效、藥物相互作用和藥物不良反應(yīng)的個人資料可能有所不同。Normally, different stereoisomeric forms will have separate ATC codes. Exceptions will be described in the guidelines for the respective ATC groups.通常情況下，不同的立體異構(gòu)體的形式將有獨立的ATC代碼。例外的例子將在ATC的指南中闡述。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 in 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 in an X group and such groups could be established for only one single substance.一種新的藥用物質(zhì)沒有明確屬于任何現(xiàn)有ATC的有關(guān)物質(zhì)第四級組將作為一個主要規(guī)則放置在X組（“其他”組）。為了避免幾個4級，只有在每個單一物質(zhì)形勢，新的第四級別，因為只有建立在至少兩個上市許可的物質(zhì)適合于本集團的一般規(guī)則。此外，一個新的4級，應(yīng)被視為一種藥物利用研究的利益。新的和創(chuàng)新的醫(yī)藥產(chǎn)品將因此往往被歸類在X組等組可以只設(shè)立一個單一物質(zhì)。Prodrugs are usually assigned separate ATC codes if the dosages used are different and/or the nonproprietary name of the prodrug and the active drugs are different. 如果前體藥使用的是不同的劑量和/或該非專利藥名和活性藥物是不同的，通常是有單獨的ATC代碼。 Example:J01CA08 pivmecillinamJ01CA11 mecillinam例如：J01CA08 pivmecillinamJ01CA11 mecillinamClassification of plain products 普通產(chǎn)品分類Plain products 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 antibacterials), 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.普通產(chǎn)品的定義是：含有一種活性成分的制劑（包括立體異構(gòu)體的混合物）。附加在一個活性成分中的藥用產(chǎn)品，含有旨包括旨在提高該制劑的穩(wěn)定性輔助物質(zhì)（含少量的抗菌藥物如疫苗），增加持續(xù)時間（如倉庫配方）和/或增加吸收（如不同溶劑的各種皮膚科用藥）也被視為普通的產(chǎn)品。普通產(chǎn)品乃根據(jù)上述的一般原則。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 main principles.復方產(chǎn)品分類產(chǎn)品含有兩個或兩個以上有效成分被視為復方產(chǎn)品。復方產(chǎn)品根據(jù)三個主要原則分類。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 and 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 usually 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 classified 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）復方產(chǎn)品含有兩個或兩個以上屬于同一第四層的有效成分，通常使用的5級分類代碼20或30。例如：N01BB02利多卡因N01BB04丙胺卡因N01BB20復方（例如，利多卡因和丙胺卡因）二）產(chǎn)品復方包含兩個或多個活性成分不屬于同一第四級別采用50系列。例如：R06AA02苯海拉明R06AA52苯海拉明，復方不同的復方產(chǎn)品共享相同的主要活性成分通常是給予同樣的ATC代碼。因此，如產(chǎn)品含有苯丙醇胺+ brompheniramine和苯丙醇胺+桂利嗪都給出的代碼R01BA51。三）復方產(chǎn)品含有psycholeptic藥物，這是沒有根據(jù)N05分類 - Psycholeptics或N06 - Psychoanaleptics，分類為使用70系列獨立第五的水平。例如：N02BA71 - 乙酰水楊酸，與psycholeptics復方（含除其他物質(zhì)的產(chǎn)品一psycholeptic也被歸類在這里。）Some of the combination products containing psycholeptics have been classified at a separate third or fourth level (e.g. A03C - Antispasmodics in combination with psycholeptics). 該組合包含psycholeptics部分產(chǎn)品已歸類為一個獨立的第三或第四級（例如A03C - 與psycholeptics結(jié)合抗痙攣）。There are some exceptions to the main rules and these are explained in the guidelines.Separate ATC 3rd or 4th levels have been assigned for some important combinations, e.g. beta blocking agents and diuretics.It may be difficult to decide where a certain combination shou