1. The term "drugs" in this naming principle includes traditional Chinese medicines, chemical drugs, biological drugs, radioactive drugs, diagnostic drugs, etc.

2. The drug names formulated according to this naming principle are China Approved Drug Names (CADN). CADN is organized and formulated by the Pharmacopoeia Committee and submitted to the State Food and Drug Administration for filing.

3. Drug names should be scientific, clear, and short; translations with determined stems should be used as much as possible so that similar drugs can reflect systematicity.

4. Drug names should avoid using drug names that may imply pharmacology, anatomy, physiology, pathology or therapy to patients, and no code names should be used. There is no discretionary approach to INN designation in traditional Chinese medicines and biopharmaceuticals.

5. The English name of the drug should try to use the International Nonproprietary Names for Pharmaceutica1 Substances (INN) compiled by the World Health Organization; if INN is not available, other suitable English names can be used.

6. If a drug name that has been used for a long time needs to be changed, its previous name can be listed as a transition.

7. The categories annotated after the drug name are classified according to the main pharmacological effects or the drug's mechanism of action or disciplines, or are directly translated from the categories classified by INN and are for reference only.

8. The generic name of a drug does not use the trade name of the drug (including foreign and Chinese names). The common names of drugs (including INN) and their English and Chinese translations of special stems may not be used as trade names or used to form trade names for trademark registration.

(2) Detailed naming rules for common names of traditional Chinese medicines

1. Naming of Chinese medicinal materials

Chinese medicinal materials refer to the raw materials used in Chinese medicine preparations, Chinese medicine extracts and Chinese patent medicines of plant, animal and mineral medicines. The names of Chinese medicinal materials should include Chinese names (with Chinese pinyin) and Latin names.

⑴ The Chinese names of Chinese medicinal materials

① Generally, they should be named according to the names commonly used in most areas of the country; if the commonly used names in different places are inconsistent or it is difficult to determine a more suitable name, plants can be used Named.

② The Chinese names of Chinese medicinal materials with added medicinal parts should clearly indicate the medicinal parts. For example: Imperata cogongrass

③ The Chinese names of artificial products made of Chinese medicinal materials should be different from the Chinese names of natural products. Such as: artificial musk, cultivated bezoar.

⑵ Latin names of Chinese medicinal materials

① Except for a few Chinese medicinal materials that do not need to indicate the medicinal part, if it is necessary to indicate the medicinal part, the Latin name should be written first, followed by the first case, use the second case when writing medicinal parts. If there are adjectives, they are listed at the end. * Such as: RADIX POLYGALAE; SEMEN ARMENIACAE AMARUM; SEMEN SOJAE PREPARATUM.

② When a Chinese herbal medicine includes two different medicinal parts, the main or commonly used medicinal parts in most areas are listed first and connected by "ET". For example: Rhubarb RADIX ET RHIZOMA RHEI

③ A Chinese medicinal material originates from two plants (animals) of different families and genera or different medicinal parts of the same plant (animal), and must be listed side by side. two Latin names. Such as: HERBA CIRSII JAPONICI and RADIX CIRSII JAPONICI.

④ The Latin names of Chinese medicinal materials are generally named after the genus name or the genus species name.

⑤ Named after the genus: only one species in the same genus is used for medicinal purposes. Or this genus has several species origins, but is used as a traditional Chinese medicine. For example: SEMEN GINKGO (one genus has only one plant species used as medicinal material), HERBA EPHEDRAE (one genus has several plant species used as the same medicinal material). The plant (animal) origin of some Chinese medicinal materials. Although there are several plant species in the same genus used for different Chinese medicinal materials, it is customary to use the genus name as the Latin name and generally do not change it.

Traditional Chinese medicinal materials originating from other plant species of the same genus should be distinguished by adding the species name. Such as: Asarum HERBA ASARI, Duheng HERBA ASARI FORBESII, Polygonatum RHIZOMA POLYGONATI, Polygonatum odoratum RHIZOMA POLYGONATI ODORATI.

⑥ Named after the genus and species name: There are several varieties in the same genus, which are used as different Chinese medicinal materials. They are named according to this method, such as: RADIX ANGELICAE SINENSIS, RADIX ANGELICAE PUBESCENTIS, RADIX ANGELICAE DAHURIOAE. . .

⑦ Named after the species name: This is a common usage and should be used sparingly. Such as: pomegranate seeds SEMEN GRANATI, persimmon stems CALYX KAKI,

red cardamom FRUCTUS GALANGAE.

⑧ Name with a representative genus and species name: When several species of the same genus come from the same source and are used as a Chinese medicinal material, but the genus name cannot be used as the Latin name of the Chinese medicinal material, a representative one will be used. Genus and species naming. For example: Polygonum, there are two types: Polygonum hydropiperl and Polygonum hydropiperl and Fiaccidum Meisn; and medicinal materials of the genus Polygonum also include Polygonum multiflorum, Phytophthora polygonum, etc. The genus name cannot be used as the Latin name of the medicinal material Polygonum, so it is used The scientific name of the widely used Polygonum sibiricum is representative and is designated as HEBRA POLYGONI HYDROPIPERIS.

⑨ Traditional Chinese medicinal materials with commonly used Latin names in the world, and the sources of varieties are the same as those abroad, can be used directly. For example: SCORPIO does not use BUTHUS. Mustard seeds SEMEN SINAPIS do not use SEMEN BRASSICAE; but asafoetida is used internationally as Asafoetida, and the sources of domestic varieties are different, so RESINA FERULAE is used instead.

2. Naming of Chinese herbal medicine pieces

Chinese herbal medicine pieces refer to processed products after purification, cutting or processing of Chinese herbal medicines, and their names should correspond to the names of the Chinese herbal medicines. The names of traditional Chinese medicine pieces include Chinese names and Latin names.

⑴Chinese name of traditional Chinese medicine pieces

① Clean and cut raw pieces should be named according to the original Chinese medicinal materials; toxic medicinal materials under special management should be preceded by "raw". ""; the word "fresh" should be added before the name of fresh decoction pieces. Such as: fresh mint. Such as: the birth of Cao Wu, the birth of Araceae, etc.

② For Chinese herbal medicine pieces prepared by frying, steaming, forging, etc., the name of the Chinese herbal medicine is preceded by the processing method or suffixed by the name of the processed form. Traditional Chinese medicine pieces prepared with excipients should be named after the excipients. Such as: simmered nutmeg, simmered gypsum (processing method); croton cream, burnt charcoal (processed form name). Such as: wine white peony root, clear pinellia (should be named as auxiliary ingredients).

⑵ The Latin name of Chinese herbal medicine pieces is added with Preparata after the Latin name of the medicinal materials.

3. Naming of traditional Chinese medicine extracts

Chinese medicine extracts refer to raw materials for the production of proprietary Chinese medicines that are extracted and purified by appropriate methods from pure medicinal materials or processed products.

⑴ Chinese name of traditional Chinese medicine extract

① The name of traditional Chinese medicine extract is generally composed of the name of the Chinese medicinal material plus the extract.

② Those that have been purified to a certain type of ingredients should be named with the name of the medicinal material plus the ingredient category, and a subname can be added if necessary.

4. Naming of Chinese patent medicines

Chinese patent medicines refer to various types of preparations made from Chinese medicinal materials, Chinese medicine pieces or Chinese medicine extracts and other drugs through appropriate methods. The names of proprietary Chinese medicines include Chinese names, and single-flavor preparations should have Latin names.

⑴ The Chinese name of the proprietary Chinese medicine

① The dosage form should be placed after the name.

② Personal names, place names, and company names should not be used. Such as: Tongren Wuji Baifeng Pills, Yunnan Red Medicine, etc.

③ Homophony of nouns with inherent specific meanings should not be used. Such as: homophonic names of celebrities, etc.

④ Exaggerated, boastful, or unrealistic terms should not be used. Such as "treasure", "spirit", "fine", "powerful", "quick effect", etc.

Such as Feilong Duoming Pills, Chang'e Jiali Pills, Anti-Aging Yishou Pills, Nanbao Capsules, Xinshubao Tablets, Ruanmailing Oral Liquid, Zhimiling Suppository, Ganteling Capsules, Chufengjing; Qianghan Tablets, Quick-acting Bezoar Pills, Zhonghua Dieda Pills, Zhonghua Ganling Capsules, Dongfang Huoxue Ointment. There is no clear dosage form in the name, such as Zixue, Yinianjin, Guilingji, and Jianyanling. The names include "imperial", "secret", "refined" and other flattering words, such as imperial Ping'an Pills, secret Shugan Pills, and refined Yinqiao Jiedu Tablets.

⑤ Terms with feudal superstition and unhealthy content should not be used. Such as Meiling Pills and Snow Mountain Golden Arhat Pain Relief Coating.

⑥ Generally, the word "compound" is not used in naming. Such as: Compound Danshen Tablets, etc.

⑦ Generally, the number of words should not exceed 8 words.

⑵ Single-flavor preparations should generally be named after Chinese medicinal materials, Chinese medicinal pieces or Chinese medicinal extracts plus dosage forms.

⑶ Compound preparations can be named according to the following methods as appropriate according to the different compositions of the prescription.

① The naming of compound preparations made from Chinese medicinal materials, Chinese medicinal pieces and Chinese medicinal extracts.

② The number of medicinal flavors, names of Chinese medicinal materials, medicinal properties, functions, etc. in the prescription can be used and the dosage form can be named. Encourage the use of names with cultural connotations of traditional Chinese medicine in compliance with naming principles. For example: Liuwei Dihuang (Yin-nourishing) Pills.

③ For varieties derived from ancient recipes, if they do not violate the naming principles, they can use the name of the ancient recipe. Such as: Sini Decoction (oral liquid).

④ The naming of a certain type of ingredient or a compound preparation with a single ingredient. The ingredients plus dosage form should be named. Such as: Salvia miltiorrhiza oral liquid, Cordyceps militaris powder capsules; Yunzhi glycopeptide capsules, saffron polyglycoside tablets, etc. For single-flavor preparations (including extracts), if necessary, the Latin name of the medicinal material or its abbreviation can be used, such as Kanglaite Injection.

⑤ Use the abbreviations of the names of the main medicinal materials in the prescription and combine them with the dosage forms. For example, Xianglian Pills are composed of two medicinal materials: Cochinacea and Coptis; Guifu Dihuang Pills are composed of eight medicinal materials such as cinnamon, aconite, rehmannia glutinosa, yam, dogwood, poria, paeonol, and Alisma; Pueraria Qinlian Tablets are composed of Pueraria lobata, It is composed of four medicinal materials including skullcap, coptis and licorice.

⑥ Note that the abbreviation of the name of the medicinal material should be selected from the main medicinal material, and the abbreviation cannot be combined into a meaning that violates other naming requirements.

⑦ Use the main function and dosage form to name. For example: Buzhong Yiqi Mixture, Chutanzhichu Pills, Dabuyin Pills.

⑧ Use the name of the main medicinal materials combined with their functions and add the dosage form. Such as Niuhuang Qingxin Pills, Longdan Xiegan Pills, Amber Anshen Pills, etc.

⑨ Use the number of medicinal flavors and the name of the main medicinal materials or the number of medicinal flavors and functions combined with the dosage form to name. Such as: Liuwei Dihuang

Pills, Shiquan Dabu Pills, etc.

⑩ For prescriptions composed of two medicinal materials, the dosage ratio of the medicines in the prescription plus the dosage form can be used to name the prescription. For example: Liuyi Powder is composed of talcum powder and licorice, and the dosage ratio of medicinal materials is 6:1; Jiuyi Powder is composed of gypsum (calcined) and red powder, and the dosage ratio of medicinal materials is 9:1. Use pictographic metaphors combined with dosage form naming. For example: Yu Ping Feng Powder, this prescription treats superficial deficiency and spontaneous sweating, and is described as having a firm exterior effect like a screen; Taishan Panshi Powder, this prescription is an anti-fetal agent, and its anti-fetal effect is described as being as solid as a Taishan Rock. The main medicinal materials and medicinal references are combined and the dosage forms are named. For example, Chuanxiong tea powder can be mixed with tea. If necessary, the clinical name of the drug can be added, such as Pediatric Xiaoshi Tablets, Gynecology Qianjin Tablets, and Shangke Qiwei Tablets. If necessary, the usage of the drug can be added to the name, such as navel-applied antidiarrheal powder for children, Hanhua Shangqing tablets, and Zijin tablets for external use.

⑷ The naming of compound preparations composed of traditional Chinese medicine and other drugs.

① It should comply with the basic naming principles of traditional Chinese medicine compound preparations, taking into account the names of other drugs.

(3) Chemical drugs common name naming details

1. Naming of raw materials

⑴ The Chinese common name should correspond to the English name as much as possible. Transliteration, free translation, or a combination of phonetic and free translation can be used, but generally transliteration is the main method.

⑵ For inorganic chemicals, if the chemical name is commonly used and relatively simple, the chemical name should be used; if the chemical name is not commonly used, the popular name can be used, such as: hydrochloric acid, borax. Acidic salts are represented by "hydrogen", such as sodium bicarbonate, without the word "heavy"; basic salts should avoid using the word "sub-", such as basic bismuth nitrate, without the word "subnitrate".

⑶ Organic chemicals with shorter chemical names can use chemical names, such as: benzoic acid; commonly used common names can be used as much as possible if they are suitable for medicinal purposes, such as: saccharin sodium, Glycerin etc. If the chemical name is lengthy, the following method can be used according to the actual situation.

① Transliteration and naming. Those with few syllables can be fully transliterated, such as Codeine; those with many syllables can be abbreviated, such as Amitriptyline. The transliteration should be smooth and easy to read, the words used should be popular and elegant, the pronunciations of the words should not be confused, and the accents should be translated.

② Free translation (including chemical naming and abbreviated naming of chemical groups) or a combination of pronunciation and meaning. In cases where there are obstacles in transliteration, such as too many syllables, this method of naming can be used, such as: Chlorpromazine.

④ For drugs that form salts or esters with acids, the acid is listed first and the base (or base) is listed after, such as: Streptomycin Sulfate, Streptomycin sulfate, Hydrocortisone Acetate, Acetic acid hydrogenation can of pine.

For names of drugs that form salts with organic acids, the word "acid" can generally be omitted, such as: Poldine Metisulfate, which is translated as methylthiopoldine.

Ester drugs with the English suffix "ate" can be directly named "××" esters, such as: Fedrilate. Drugs that add to a condensation group to form esters can also be listed as esters, such as Cefcanel Da1oxate.

⑤ For quaternary ammonium salt drugs, chlorine and bromine are generally placed before ammonium, such as: Benzalkonium Bromide. Except for those that have been used for a long time, try not to use the names of chlorinated ××× and brominated ×××.

For the names of quaternary ammonium drugs composed of organic acids, the name of the acid is listed first, and the word "acid" is generally omitted. For example, Amezinium Metilsulfate is translated as magnesium methionate.

⑷ For the naming of optical isomers, left-handed or right-handed, precede the common name with left or right, and use Levo or Dex in English. Natural amino acids or sugars are not labeled with the L or D configuration. Synthetic D-configuration or racemic amino acids should be labeled; synthetic L-configuration or racemic sugars should be treated similarly.

⑸ For the naming of a specific racemate, racemic precedes the common name, and Race- is used in English.

⑹ For the naming of geometric isomers, cis or trans, cis or trans is preceded by the common name, and Cis or Trans in English.

⑺ The English name of biochemical drugs is generally based on INN; if the INN is not included, the biochemical nouns listed by the Noun Approval Committee of the Chinese Biochemical Association can be referred to, and it must be combined with the characteristics or routine of pharmacy. Use name formulation. Such as: Urokinase; Trypsin; Adenosine Triphosphaie is translated as adenosine triphosphate, not adenosine triphosphate.

According to their sources and pharmaceutical characteristics, Chinese translations of growth hormone drugs are developed using a combination of pronunciation and meaning, such as: Somatorelin, Somavubove, and Somenopor.

⑻ Monoclonal antibodies and interleukin drugs are named using abbreviated names that combine sounds and meanings, such as: Dorlimomab, Aritox, Atolumab, Biciromab; Teceleukin.

⑼ For radioactive drugs, after the nuclide in the drug name, add right-angled square brackets to indicate the nuclide symbol and its mass number, such as: sodium iodine [125 I].

⑽ The foreign name of a natural drug extract whose chemical structure has been determined is based on the origin of its genus and species. The Chinese name can be combined with its genus and species name, such as: Artemisinin; Penicillamine Amine; if the foreign name is not combined with the source of the species, the Chinese name can be transliterated, such as: Morphine, Amikacin.

If the chemical structure is not completely clear, it can be named abbreviated according to its source or function, such as: Bacitracin.

The name of the glycoside conjugated root is replaced by "glycoside" in order to be consistent with the chemical nomenclature.

2. Naming of preparations

⑴ When naming pharmaceutical preparations, the name of the raw material drug is listed first, followed by the dosage form, such as: Indometacin Capsules, Ondansetron Hydrochloride Injection Dansetron injection. For injection powders, in principle, they are named ×××× for injection, such as ampicillin sodium for injection.

⑵ The adjective describing the purpose or characteristics of the drug preparation should be listed before the drug name, such as: Absorbable Gelatin Sponge, Ipratropium Bromide Solution for Inhalation.

⑶ Compound preparations can be named according to the different compositions of the prescription using the following methods.

① Two-component drugs: In principle, the names of the two drugs should be juxtaposed, such as ceftazidime and sulbactam sodium injection. They can also be named using abbreviations, such as phenolca tablets and acetaminophen tablets. Because of the film.

② Three components: Because the use of stems to form a common name is too long, in principle, the abbreviation method is used to name each component and 1 to 2 words are selected to form a common name (stems are not allowed ). If the ingredients are the same but the dosage is different, use (amount/amount) or use Roman numerals I, II, III, etc.

④ For more than three components: use abbreviation method to name, use compound formula, take two to three components and choose one to two characters each to form a common name.

⑤ For compound preparations composed of multiple active ingredients that are difficult to abbreviate, the name of the compound preparation can be combined with the number of varieties. For example, an injection composed of 15 kinds of amino acids can be named compound amino acid injection. Liquid (15AA), if it is necessary to highlight the presence of 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 multiple vitamins or vitamins and trace elements can be named according to this principle, such as Multivitamin Tablets (15), Multivitamin and Elements Tablets (10-11) ). The active ingredients are the same, but different prescription amounts are distinguished by Roman characters, such as Multi-dimensional Element Tablets II (10-11).

⑥For the naming of insulin preparations, if it is recombinant insulin, the recombinant amino acid should be specified, such as recombinant lispro insulin; for long and medium-acting insulin, use protamine zinc insulin mixed injection plus (quick-acting ratio R) naming, such as protamine zinc recombinant insulin lispro mixed injection (25R).

25. The names of two-chamber and three-chamber parenteral nutrition solutions are separated by / after the name of each chamber. For example: Fat Emulsion/Amino Acids (16)/Glucose (5.8%) injection, English name: Fat Emulsion/Amino Acids (16)/Glucose (5.8%) Injection.

26. The name of joint packaging : Composite packaging. Complex packing; add a slash (/) in the middle to indicate distinction.

27. Principles of word selection for commonly used drugs in compound preparations:

Two words, one word, two words, one word

Acetaminophen Aminophen or phenol

Pseudoephedrine hydrochloride Pseudoephedrine

Chlorpheniramine maleate (chlorpheniramine) chloride

Dextermethane hydrobromide Fenmefen (Metha) Meiorfen

Guaiacol glyceryl ether Guaifenesin

Caffeine Coffee

Ibuprofen Ibuprofen< /p>

Diphenhydramine hydrochloride

Benoxate

Artificial bezoar bezoar

Amantadine hydrochloride Adamantine Gold

Aminopyrine Aminopyrine

Phenacetin Phenafil

Phenobarbital

Pentovil Linpentol

Ephedrine hydrochloride Ephedra

Methylephedrine hydrochloride Methylephedrine

Lysine Lysine

Aspirin A

Zinc gluconate

Calcium gluconate

Naphazoline naphtholine

Benzalkonium bromide Ammonium

Benzalkonium Chloride

Diclofenac Sodium Chlorofen

Phenytoin Sodium Toin

Methyl Salicylate Methyl Salicylate

Menthol Mint

Aminophylline Tea

Born Ice

Camphora Camphor

Eucalyptus Eucalyptus

Wintergreen Youqing

ethyl salicylate, salicylamine, salicylate

chlorzoxazone, chlorzoxazone

isopropylantibis Lin Yilin

Rifampicin

Isoniazid

Pyrazinamide

Clemastine fumarate

Cetirizine Cetirizine

(4) Detailed Naming Rules for Common Names of Biological Drugs

1. The Chinese common names of biological products that already have INN names should be used as much as possible Corresponding to its English name, its Chinese name should be mainly translated. For example: Recombinant Human Erythropoietin (INN name: Epoetin), translated as: recombinant erythropoietin; it can also be transliterated or a combination of transliteration and transliteration.

2. If there is no INN name, the disease, microorganism, specific component or material can be named, and the pharmaceutical dosage form should be indicated, such as measles live attenuated vaccine, human coagulation factor VIII for injection, recombinant interleukin- 2 Injections, etc. The specific provisions are as follows:

⑴ If there are multiple manufacturing methods for a product, it must be marked. For example, if a product is made using recombinant DNA technology, the word "recombinant" should be added before the name to distinguish it from non-recombinant products. ; The same product prepared using different cell matrices should be labeled separately, such as: live attenuated rubella vaccine (2BS), live attenuated rubella vaccine (rabbit kidney).

⑵ Biotechnology products with amino acid changes (increase, decrease) or substitutions can indicate the location of the amino acid changes, such as: recombinant interleukin-2(125phe).

⑶ Biotechnology products with changed functional areas should be renamed.

⑷ Some product names should also indicate the source of biological materials used for production, such as: human albumin injection, recombinant bovine basic fibroblast growth factor.

⑸ When the same product has both liquid and freeze-dried properties, the word "lyophilized" must be added before the name of the preventive freeze-dried product, such as: freeze-dried hepatitis A live attenuated vaccine; preventive freeze-dried products Liquid-like products do not need to add the word "liquid" before the name. Therapeutic freeze-dried products need to add the word "injection" before the name, such as: recombinant interferon gamma for injection; therapeutic liquid products should add the word "injection" at the end of the name, such as: recombinant granulocyte stimulating factor injection liquid.

⑹ General usage is not marked, users of specific channels must mark it. For example: BCG vaccine for intradermal injection, live plague vaccine for skin scratches, human immunoglobulin for injection (intravenous injection), etc.

⑺ Products of the same type used to prevent diseases caused by humans and animals must be labeled with the word "human use" to distinguish them from products for veterinary use, such as: purified rabies vaccine for human use.

⑻ Specific products for adults or adolescents can be indicated in parentheses after the name, such as: adsorbed diphtheria vaccine (for adults and adolescents).

⑼ For products containing two or more different antigenic components, the word "combination" should be added before the product type, such as: adsorbed acellular diphtheria-tetanus pertussis combined vaccine, measles-mumps combined vaccine.

If the same product contains different groups or types, "multivalent or n-valent" should be marked, such as: bivalent inactivated vaccine for hemorrhagic fever with renal syndrome, group A meningococcal polysaccharide vaccine.

⑽ For vaccines of the same type that have both preventive and therapeutic effects, the words "therapeutic" should be added before the product name for therapeutic vaccines, such as: therapeutic Brucella vaccine.

⑾ Personal names are generally not used in drug names. Only individual products follow long-standing practices at home and abroad, such as BCG vaccine for intradermal injection and Sik test toxin.

⑿ Products for in vivo diagnostic use generally do not have the word "diagnostic use" on them, such as: purified tuberculosis protein and Sikh test toxin.