2. According to this naming principle, the drug name is the drug name (CADN) approved by China. CADN is formulated by the Pharmacopoeia Committee and reported to the State Food and Drug Administration for the record.
3. The name of the drug should be scientific, clear and short; As far as possible, the translated names determined by stem are adopted to make similar drugs systematic.
4. The naming of drugs should avoid using drug names related to pharmacology, anatomy, physiology, pathology or therapeutics that may give hints to patients, and should not be named by codes. Traditional Chinese medicine and biopharmaceuticals have no INN name.
5. The English name of drugs should adopt the international generic drug name 1 substance (INN for short) compiled by the World Health Organization as far as possible; If there is no inn, you can use other suitable English names.
6. For long-term use of drug names, if it is necessary to change, the previous name can be listed as a transition.
7. The categories of notes after drug names are classified according to the main pharmacological action or mechanism of action or disciplines of drugs, or directly translated from the categories classified by INN for reference only.
8. The generic names of drugs do not adopt the trade names of drugs (including mbth and Chinese names). The English and Chinese translations of generic names of drugs (including INN) and their special stems shall not be used as trade names or trade names used to constitute trademark registration.
(2) Detailed rules for naming generic names of traditional Chinese medicines
1. nomenclature of Chinese herbal medicines
Chinese herbal medicines refer to plants, animals and mineral medicines as raw materials of Chinese herbal pieces, Chinese herbal extracts and Chinese patent medicines. The names of Chinese medicinal materials should include Chinese names (with Chinese Pinyin) and Latin names.
(1) Chinese names of Chinese herbal medicines
① Generally, it should be named after the names commonly used in most parts of the country; If the commonly used names in different places are inconsistent or it is difficult to determine a more suitable name, you can choose the plant name for naming.
② The Chinese names of Chinese herbal medicines with medicinal parts should be clear. Such as cogongrass rhizome
(3) The Chinese names of Chinese medicinal materials made by artificial methods should be different from those of natural products. Such as: artificial musk, artificially cultivated bezoar.
(2) Latin scientific names of Chinese herbal medicines
(1) Except for a few Chinese medicinal materials that need to be marked with medicinal parts, the Latin names of medicinal parts should be written in the first place, followed by the second place. If there are adjectives, they should be listed at the end. * For example, polygala tenuifolia; Bitter almond and Armenian nut; Light fermented soybean sauce
(2) When a Chinese herbal medicine includes two different medicinal parts, the main or most commonly used medicinal parts are listed in front and connected by "ET". Such as rhubarb
③ A Chinese herbal medicine comes from two plants (animals), belonging to different families or different medicinal parts of the same plant (animal), and should be listed as two Latin scientific names. Such as Cirsium japonicum and Cirsium japonicum roots.
④ Latin names of Chinese herbal medicines are generally named after common names or scientific names.
⑤ Named after the genus name: only one species of the same genus is used as medicine. Or this genus has several varieties of sources, but it is used as a Chinese herbal medicine. Such as: Ginkgo biloba (only one plant species in a genus is used as medicine) and ephedra (several plant species in a genus are used as medicine). Although some plants (animals) of Chinese herbal medicines belong to the same genus, different Chinese herbal medicines use several plant varieties, but it is customary to use common names as Latin names, which are generally unchanged. Chinese herbal medicines belonging to other plant varieties should be distinguished by their names. Such as: Asarum, Du Heng Du Heng, Polygonatum odoratum, Polygonatum odoratum, Polygonatum odoratum.
⑥ Naming by genus and species: There are several varieties of the same genus, which are used as different Chinese herbal medicines. According to this method, they are named: Angelica sinensis, Angelica pubescens and Angelica dahurica. .
⑦ Named after a specific species: It's an idiom, so use it less. Such as pomegranate seeds, pomegranate seeds, persimmon,
Cardamom and cardamom
(8) Naming with representative genera and species: when several species belonging to the same genus are used as a Chinese herbal medicine, but the Latin scientific name of the Chinese herbal medicine cannot be used, the representative genera and species are used for naming. Such as Polygonum hydropiper and Polygonum hydropiper of Polygonum hydropiper; However, Polygonum multiflorum Thunb, Polygonum hydropiper, etc. It can't be named Polygonum hydropiperis in Latin, so it is named HEBRA HYDROPIPERIS, which is represented by the widely used scientific name of Polygonum hydropiperis.
Pet-name ruby Chinese medicinal materials with Latin names are commonly used in the world, and the source of varieties is the same as that of foreign countries, so they can be directly used. Scorpio doesn't need Boetes. White mustard seed is not used; Ferula ferula is used internationally, and the varieties made in China come from different sources, so Ferula ferula is used instead.
2. Naming of Chinese herbal pieces
Chinese herbal pieces refer to the processed products of Chinese herbal medicines after cleaning, chopping or processing, and their names should correspond to the names of Chinese herbal medicines. The names of Chinese herbal pieces include Chinese names and Latin names.
(1) Chinese name of Chinese herbal pieces
(1) net-prepared and cut pieces, named after the original Chinese herbal medicines; Toxic medicinal materials under special management shall be preceded by the word "raw"; The word "fresh" should be added before the name of fresh slices. Such as: fresh mint. Such as: Aconitum kusnezoffii, Rhizoma Arisaematis, etc.
(2) Chinese herbal pieces processed by decocting, steaming and calcining. , with the processing method as the prefix or suffix, to adopt the processed morphological name. Chinese herbal pieces processed with auxiliary materials should be named as auxiliary materials. Such as: stewed nutmeg and calcined gypsum (processing method); Croton paste, Sanguisorba charcoal (named after processing). Such as: white peony root with wine and clear Pinellia tuber (should be named as auxiliary materials).
⑵ The Latin names of Chinese herbal pieces are fried after the Latin names of Chinese herbal medicines.
3. Naming of traditional Chinese medicine extracts
Traditional Chinese medicine extract refers to the raw materials for the production of Chinese patent medicine made of pure medicinal materials or processed by appropriate methods.
(1) Chinese name of traditional Chinese medicine extract
① The names of Chinese herbal medicine extracts are generally composed of Chinese herbal medicine names and extracts.
(2) If it has been purified to a certain class of ingredients, it should be named after the name of the medicinal material plus the category of ingredients, and if necessary, a second-class name can be added.
4. Naming of Chinese patent medicines
Chinese patent medicine refers to various preparations made from Chinese herbal medicines, Chinese herbal pieces or Chinese herbal extracts by appropriate methods. The names of Chinese patent medicines include Chinese names, and single-flavor preparations should have Latin names.
(1) Chinese name of Chinese patent medicine
(1) dosage form should be placed after the name.
(2) it is not appropriate to use names of people, places and enterprises. Such as: Tongren Wuji Baifeng Pill, Yunnan Yao Hong, etc.
③ Homonyms of nouns with specific meanings should not be used. Such as: homonym of celebrity names, etc.
④ Don't use exaggerated, boastful and unrealistic words. Such as "treasure", "spirit", "essence", "strength" and "quick effect" and so on. Such as Longfei Despair Pill, Chang 'e Jiali Pill, Anti-aging Yishou Pill, Nanbao Capsule, Xinshubao Tablet, Ruanmailing Oral Liquid, Zhimiling Suppository, Ganteling Capsule and Chufengjing; Li Qiang Ganmao Tablet, Xiao Su Niuhuang Pill, Zhonghua Da Die Pill, Zhonghua Ganmao Capsule, Dongfang Huoxue Ointment. There is no clear dosage form in the name, such as Zi Xue, Yijinjing, Guilingji and Jianyanling. The name contains flattering words such as imperial system, secret system and refining, such as Yuping 'an Pill, Mishugan Pill and Lianyinqiao Jiedu Tablet.
⑤ Don't use feudal superstition and unhealthy language. Such as Meiling Pill, Snow Mountain Golden Lohan Paintings for Pain Relief.
⑥ Generally, the word "compound" is not used for naming. Such as: compound Danshen tablets.
⑦ Generally, the number of words does not exceed 8.
⑵ Single-flavor preparations should generally be named after Chinese herbal medicines, Chinese herbal pieces or Chinese herbal extracts plus dosage forms.
⑶ Compound preparations can be named by the following methods according to the different composition of prescriptions.
① Naming of compound preparations made of Chinese herbal medicines, Chinese herbal pieces and Chinese herbal extracts.
② It can be named by the number of drugs in the prescription, the name of Chinese herbal medicine, its medicinal function and dosage form. Encourage the use of names with traditional Chinese medicine cultural connotation under the principle of naming. Such as: Liuwei Dihuang (Ziyin) Pill.
(3) Varieties originated from the ancient prescription can adopt the name of the ancient prescription without violating the naming principle. Such as Sini decoction (oral liquid).
(4) Naming of compound preparations containing a certain ingredient or a single ingredient. It should be named after ingredients plus dosage forms. Such as: Danshen oral liquid, Cordyceps powder capsules; Coriolus versicolor glycopeptide capsule, saffron polysaccharide glycoside tablet, etc. A single preparation (including extract) can be named by Latin name or its abbreviation when necessary, such as Kanglaite injection.
⑤ Abbreviations of the names of the main medicinal materials in the prescription are adopted and named in combination with the dosage forms. For example, Xianglian Pill consists of Radix Aucklandiae and Rhizoma Coptidis. Guifu Dihuang Pill consists of eight herbs: Cinnamomum cassia, Radix Aconiti Lateralis Preparata, Rhizoma Dioscoreae, Corni Fructus, Poria, Cortex Moutan and Alismatis Rhizoma. Gegenqin Lianpian is composed of Radix Puerariae, Scutellariae Radix, Coptidis Rhizoma and Glycyrrhrizae Radix.
6. Pay attention to the abbreviation of medicinal materials, which should be the main medicinal materials, and its abbreviation cannot be combined to violate other naming requirements.
⑦ Named after the main function plus dosage form. Such as Buzhong Yiqi mixture, Chutan Zhisou pill and Dabuyin pill.
⑧ Combine the names and functions of the main medicinal materials and name them after the dosage forms. Such as Niuhuang Qingxin Pill, Longdan Xiegan Pill and Amber Anshen Pill.
Pet-name ruby is named after the number of medicinal materials and the name of the main medicine or the number and efficacy of medicinal materials combined with the dosage form. Such as: Liuwei Dihuang
Pills, Shiquan Dabu Pills, etc.
Indications are composed of two drugs, which can be named according to the dosage proportion and dosage form in the prescription. For example, Liuyi Powder is composed of talcum powder and licorice, and the dosage ratio is 6:1; Jiuyi powder is composed of gypsum (calcined) and red powder, and the dosage ratio is 9: 1.
Using pictographic metaphor combined with dosage form naming. For example: Yupingfeng powder, which treats exterior deficiency and spontaneous sweating, describes the consolidation of exterior as the function of screen; Taishan Panshi Powder is a kind of anti-abortion agent, and its anti-abortion effect is as solid as Taishan Rock.
The main medicinal materials are named after the dosage form in combination with drug introduction. If Chuanxiong tea is scattered, replace it with tea.
If necessary, the clinical name of the drug can be added, such as Xiaoer Xiaoshi Tablet, Fuke Qianjin Tablet and Shangke Qiwei Tablet.
If necessary, the usage of drugs can be added to the name, such as Xiaoerqiuzhixie Powder, Huashangqing Tablet and Amethyst Ingot for external use.
⑷ Naming of compound preparations composed of traditional Chinese medicine and other drugs.
① It should conform to the basic principles of naming traditional Chinese medicine compound preparations, and give consideration to the names of other drugs.
(3) Detailed rules for naming generic names of chemicals
Naming of 1.API
(1) Common Chinese names should correspond to English names as much as possible. Transliteration, free translation or a combination of sound and free translation can be adopted, with transliteration as the main method.
2 inorganic chemicals, such as chemical names are commonly used and relatively simple, should adopt chemical names; If chemical names are not commonly used, popular names can be used, such as hydrochloric acid and borax. Acid salts are represented by "hydrogen", such as sodium bicarbonate, without the word "heavy"; The word "sub-"should be avoided in basic salts, such as bismuth subnitrate, and "bismuth subnitrate" should not be used.
(3) For organic chemicals with shorter chemical names, chemical names can be used, such as benzoic acid; Common popular names, such as saccharin sodium, glycerol, etc. Those who meet the medical conditions can be adopted as much as possible. If the chemical name is long, the following methods can be adopted according to the actual situation.
① transliteration naming. Those with few syllables can be transliterated completely, such as codeine codeine; Many syllables can be abbreviated, such as amitriptyline amitriptyline. Transliteration should be fluent and easy to read, words should be popular and elegant, pronunciation should not be confused, and stress should be translated.
② Free translation (including chemical naming and abbreviation naming of chemical groups) or naming by combining sound and meaning. In the case of transliteration disorder, such as too many syllables, you can use this method to name it, such as chlorpromazine.
(4) drugs that form salts or esters with acids, such as streptomycin sulfate, hydrocortisone acetate, hydrocortisone acetate, etc., should be listed in the acid table first, and then in the alkali (or alkali) table.
Usually, the word "acid" can be omitted from the names of drugs that form salts with organic acids, for example, Poldine Metisulfate is translated into thioperdine.
Ester drugs with English suffix "ate" can be directly named "××" ester, such as Fedrilate non-adducted ester. Drugs synthesized by adding condensation groups can also be classified as ×× esters, such as Da 1oxate cefCaneda ester in cefcarnet.
⑤ Quaternary ammonium salts generally put chlorine and bromine before ammonium, such as benzalkonium bromide. Except for long-term use, try not to use the name of.
In the names of quaternary ammonium salts composed of organic acids, acid comes first, and the word "acid" is generally omitted. For example, the word "acid" is translated into methyl magnesium sulfate.
⑷ The naming of optical isomers, left-handed or right-handed, is usually preceded by a left crown or a right crown, and the English prefix is Levo or Dex. Natural amino acids or sugars are not marked with L configuration or D configuration. Synthetic D-configuration or racemic amino acids should be labeled; Synthetic l- configuration or racemic sugars are treated in the same way.
5] For the naming of the specified racemic body, the racemic crown is preceded by the generic name, and the English prefix is Race-.
[6] When naming geometric isomers, add cis or trans before cis or trans, and add cis or trans before English.
(7) biochemical drugs's English names are still dominated by INN; If the inn is not listed, you can refer to the biochemical terms listed by the Terminology Examination Committee of China Biochemical Association, and draw up the name according to the characteristics of pharmacy or routine use. Such as urokinase; Trypsin trypsin; Adenosine triphosphate is translated into adenosine triphosphate instead of adenosine triphosphate.
According to their sources and pharmaceutical characteristics, auxin drugs are translated into Chinese by combining sound and meaning, such as somarin growth-releasing hormone, somavor Niu Liang ammonia auxin, Somenopor pig auxin, etc.
(8) Monoclonal antibodies and interleukins are abbreviated by sound and meaning, such as: Dorlimomab Aritox atodumab, Biciromab than Xidan antibody; Teceleukin teixercillin。
(9) Radioactive drugs should be marked with square brackets after the nuclide in the drug name, indicating the nuclide symbol and its mass number, such as sodium iodide [125i].
(3) The mbth of natural drug extracts whose chemical structure has been determined is named according to its genus and species source, and its Chinese name can be named in combination with its genus and species name, such as artemisinin; Penicillamine penicillamine; Mbth does not combine species source names, and Chinese names can be transliterated, such as morphine and amikacin. If the chemical structure is not completely clear, it can be abbreviated according to its source or function, such as Bacitracin.
In order to be consistent with the chemical nomenclature, the name of aglycone conjugate root is replaced by "glycoside".
2. Naming of preparation
⑴ The names of pharmaceutical preparations are listed before the names of raw materials and after the dosage forms, such as indomethacin capsules and ondansetron hydrochloride injection. For powder injection, it is named XXX for injection in principle, such as ampicillin sodium for injection.
⑵ Adjectives describing the use or characteristics of pharmaceutical preparations should be listed before the name of the drug, such as absorbable gelatin sponge and ipratropium bromide solution for inhalation.
⑶ Compound preparations can be named by the following methods according to the different composition of prescriptions.
① Two-component: in principle, the names of the two drugs are juxtaposed, such as ceftazidime and sulbactam sodium injection, and the names can also be abbreviated, such as phenol coffee tablets and paracetamol and codeine tablets.
② Three-component: Because the common name formed by stems is too long, in principle, each component is named by abbreviation, and 1 ~ 2 words are selected to form the common name (stems are not allowed). When the ingredients are the same and the prescriptions are different, use (quantity/quantity) or Roman numerals I, II, III, etc.
(4) If there are more than three components, they shall be named by abbreviation and combined. Choose two or three parts to form a common name.
⑤ If it is difficult to abbreviate the name of a compound preparation composed of various active ingredients, the drug name can be combined with the variety number to name it. For example, an injection composed of 15 amino acids can be named compound amino acid injection (15AA), and if it is necessary to highlight that it contains branched-chain amino acids, it can be named compound amino acid injection (15HBC). Amino acid preparations with the same components but different proportions can be distinguished by adding serial numbers, such as compound amino acid injection (15AA- 1).
Compound preparations containing multivitamins or vitamins and trace elements can be named according to this principle, such as multivitamin tablets (15) and multivitamin and element tablets (10-1). The active ingredients are the same, but different prescriptions are distinguished by Roman characters, such as multi-dimensional element tablet II (10-1).
⑥ For the naming of insulin preparations, if it is recombinant insulin, the recombinant amino acids should be indicated, such as recombinant insulin lispro; For long-acting and intermediate-acting insulin, it is named after refined protein zinc insulin mixed injection plus (quick-acting ratio R), such as refined protein zinc recombinant insulin lispro mixed injection (25R).
25. Two-cavity and three-cavity parenteral nutrition solutions are named after each cavity. For example: fat emulsion/amino acid (16 )/ glucose (5.8%) injection, English name: fat emulsion/amino acid (16)/ glucose (5.8%) injection.
26. Name of combined packaging: combined packaging. Complex packaging; Add a slash (/) in the middle to distinguish it.
27. The principle of choosing words for commonly used drugs in compound preparations:
Two words, one word, two words, one word.
Acetaminophen, aminophenol, ammonia or phenol.
Pseudoephedrine hydrochloride pseudoephedrine hydrochloride pseudoephedrine hydrochloride
Chlorphenamine maleate (chlorphenamine maleate)
Dextromethorphan hydrobromide, dextromethorphan, dextromethorphan or dextromethorphan.
Guaiacol glycerol ether guaiacol glycerol ether
Caffeine coffee
Ibuprofen drops
Diphenhydramine hydrochloride benzene sea benzene
Benoberyl ester
Artificial bezoar
Amantadine hydrochloride
Aminopyrine-aminopyrine
Fina Xi Ding Fei Na Fei
Sedative agent
nembutal
Ephedrine hydrochloride ephedra
Methylephedrine methylamine hydrochloride
Lysine lysine
Aspirin Aspirin
Zinc gluconate
Calcium gluconate
Naphazoline
Benzalkonium bromide
benzalkonium chloride
Diclofenac sodium and chlorpheniramine
phenytoin sodium
Methyl salicylate
Menthol mint
Aminophylline tea
Borneol ice
Camphor Camphor
Eucalyptus oil eucalyptus
Holly oil green
Amine salicylate-amine salicylate
chlorzoxazone, chlorzoxazonum
Isogram of isopropyl antipyrine
rifampin
Isoniazid smoke
Pyrazine amide pyridine
Clomastine fumarate
Cetirizine
(4) Detailed rules for naming generic names of biopharmaceuticals
1. The commonly used Chinese names of biological products with INN names should correspond to their English names as much as possible, and the Chinese names are mainly translated freely. Such as recombinant human erythropoietin (inn name: Epoetin), translated into recombinant erythropoietin; It can also be transliterated or combined.
2. If there is no INN name, it can be named after diseases, microorganisms, specific ingredients or materials. And the dosage forms of drugs should be marked, such as live attenuated measles vaccine, human coagulation factor VIII for injection, recombinant interleukin -2 injection, etc. The specific provisions are as follows:
(1) If a product has multiple manufacturing methods, it should be indicated. Products made by recombinant DNA technology should be distinguished from non-recombinant products by adding the word "recombinant" before their names; The same product prepared with different cell matrices should be labeled separately, such as live attenuated rubella vaccine (2BS) and live attenuated rubella vaccine (rabbit kidney).
(2) Biotechnology products with amino acid changes (increase or decrease) or substitutions may indicate the position of amino acid changes, such as recombinant interleukin -2( 125phe).
⑶ Biotechnology products whose functional areas have changed should be renamed.
⑷ Some product names should also indicate the sources of biological materials for production, such as human albumin injection and recombinant bovine basic fibroblast growth factor.
(5) When the same product has both liquid and freeze-dried properties, the word "freeze-dried" should be added before the name of the preventive freeze-dried product, such as freeze-dried live attenuated hepatitis A vaccine; Preventive liquid products do not need to add the word "liquid" before the name. The word "for injection" should be added before the name of freeze-dried products for treatment, such as: recombinant interferon γ for injection; The word "injection" should be added at the end of the name of therapeutic liquid products, such as recombinant granulocyte stimulating factor injection.
[6] General usage is not indicated, and users of specific channels must indicate it. Such as: BCG for intradermal injection, live plague vaccine for intradermal scratch, immunoglobulin for injection (intravenous injection), etc.
(7) Products of the same name and type used to prevent zoonosis must be marked with the word "for human use" to distinguish them from veterinary products such as purified rabies vaccine for human use.
(8) Special products for adults or adolescents can be indicated in brackets after the name, such as adsorbed diphtheria vaccine (for adults and adolescents).
(9) For products containing two or more different antigen components, the word "combined" should be added before the product type, such as cell-free DTP combined vaccine and mumps combined vaccine.
If the same product contains different groups and types, it should be marked with "multivalent or N-valent", such as bivalent inactivated vaccine of hemorrhagic fever with renal syndrome and meningococcal polysaccharide vaccine of group A, etc.
⑽ For the same vaccine with dual functions of prevention and treatment, the word "therapeutic" should be added before the name of therapeutic vaccine, such as Brucella vaccine for treatment.
⑾ Generally, names of drugs are not used, and only a few products follow the long-standing practices at home and abroad, such as BCG for intradermal injection and Sikh test toxin.
⑿ Generally, the words "used for diagnosis" are not added to products used for in vivo diagnosis, such as purified tuberculosis protein and Sikh test toxin.