原料药,通俗来说就是药品的原材料。只有经过加工制成药物制剂,才能成为可供临床应用的医药产品。因此,我们日常服用的药品实际上都是成品药。
根据来源不同,原料药主要分为化学合成药和天然化学药两大类。
化学合成药又可以进一步分为无机合成药与有机合成药。无机合成药主要包括无机化合物(个别为元素),例如用于治疗胃及十二指肠溃疡的氢氧化铝、三硅酸镁等;而有机合成药主要是由基本有机化工原料,通过一系列有机化学反应制得的药物,如阿司匹林、氯霉素、咖啡因等。
天然化学药则按其来源可细分为生物化学药与植物化学药两大类。抗生素通常是由微生物发酵制备得到的,属于生物化学范畴;近年来出现的各种半合成抗生素则是生物合成和化学合成相结合的产品。在原料药中,有机合成药品种最多、产量最大且产值最高,是化学制药工业的主要支柱。
由于原料药的质量直接影响制剂质量,因此对其质量标准要求极为严格。世界各国对于广泛应用的原料药都制定了严格的国家药典标准及质量控制方法。
中文名称 | 英文名称 | CAS号 | 化学式 | 结构式图片 |
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—— | Iron;2,3,4,5,6-pentahydroxyhexanoic acid | 299-29-6 | C12H24FeO14 |
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—— | (2R,4R)-1-[5-(diaminomethylideneamino)-2-[(3-methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonylamino]pentanoyl]-4-methylpiperidine-2-carboxylic acid | 74863-84-6 | C23H36N6O5S |
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—— | (4S,7R,8S,9S,16S)-4,8-dihydroxy-5,5,7,9,13-pentamethyl-16-[1-(2-methyl-1,3-thiazol-4-yl)prop-1-en-2-yl]-1-oxacyclohexadec-13-ene-2,6-dione | 189453-10-9 | C27H41NO5S |
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—— | (6R,7R)-7-[(2-amino-2-cyclohexa-1,4-dien-1-ylacetyl)amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid;dihydrate | 31828-50-9 | C16H23N3O6S |
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—— | 1-[Amino-(4-chloroanilino)methylidene]-2-(1,1,1,3,3,3-hexadeuteriopropan-2-yl)guanidine | 500-92-5 | C11H16ClN5 |
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—— | N-[(6S,12S,15S,16S,19R,22S)-3-benzyl-12-ethyl-4,16-dimethyl-2,5,11,14,18,21,24-heptaoxo-19-phenyl-17-oxa-1,4,10,13,20-pentazatricyclo[20.4.0.06,10]hexacosan-15-yl]-3-hydroxypyridine-2-carboxamide;(10S,11S,12E,17E,19E,21S)-21-hydroxy-11,19-dimethyl-10-propan-2-yl-9,26-dioxa-3,15,28-triazatricyclo[23.2.1.03,7]octacosa-1(27),6,12,17,19,25(28)-hexaene-2,8,14,23-tetrone | 11006-76-1 | C71H84N10O17 |
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—— | ansamitocin P 3' | 66547-09-9 | C32H43ClN2O9 |
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—— | 7-{2-(2-Amino-thiazol-4-yl)-2-[(Z)-carboxymethoxyimino]-acetylamino}-3-methyl-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 72701-01-0 | C15H15N5O7S2 |
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—— | [2-[2-[2-[[6-amino-2-[3-amino-1-[(2,3-diamino-3-oxopropyl)amino]-3-oxopropyl]-5-methylpyrimidine-4-carbonyl]amino]-3-[[5-[[1-[2-[4-[4-(3-dimethylsulfoniopropylcarbamoyl)-1,3-thiazol-2-yl]-1,3-thiazol-2-yl]ethylamino]-3-hydroxy-1-oxobutan-2-yl]amino]-3-hydroxy-4-methyl-5-oxopentan-2-yl]amino]-1-(1H-imidazol-5-yl)-3-oxopropoxy]-4,5-dihydroxy-6-(hydroxymethyl)oxan-3-yl]oxy-3,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxymethanimidate;sulfuric acid | 9041-93-4 | C55H85N17O25S4 |
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—— | 5-Formyl-5,6,7,8-tetrahydrofolic acid calcium salt hydrate | 1492-18-8 | C20H23CaN7O8 |
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—— | (4R)-4-[(3R,5R,6S,10R,13R,17R)-3,6-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid | 83-49-8 | C24H40O4 |
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—— | Methylhesperidin | 11013-97-1 | C29H36O15 |
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—— | Dtxcid7028691 | 337-03-1 | C21H29FO4 |
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—— | 17-beta-Hydroxy-2-(hydroxymethylene)-17-methyl-5-alpha-androstan-3-one | 434-07-1 | C21H32O3 |
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—— | Zinc Oxide | 55204-38-1 | OZn |
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—— | Unii-S7RL72610R | 12542-36-8 | C33H36O9 |
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—— | Furo[3',4':6,7]naphtho[2,3-d]-1,3-dioxol-6(5aH)-one, 9-[[4,6-O-(1R)-ethylidene-beta-D-glucopyranosyl]oxy]-5,8,8a,9-tetrahydro-5-(4-hydroxy-3,5-dimethoxyphenyl)-, (5R,5aR,8aR,9S)- | 33419-42-0 | C29H32O13 |
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—— | N-Demethyllincomycin | 2256-16-8 | C17H32N2O6S |
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—— | Lincocin | 859-18-7 | C18H35ClN2O6S |
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—— | 22-[(2R,3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatricyclo[22.3.1.05,7]octacosa-8,14,16,18,20-pentaene-25-carboxylic acid | 7681-93-8 | C33H47O13N |
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—— | (R)-[(2S,4R,5R)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl]-(6-methoxyquinolin-4-yl)methanol;sulfuric acid;dihydrate | 6119-70-6 | C40H54N4O10S |
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—— | carbamic acid [(3R,5S,6R,7S,10S,11S)-6-hydroxy-5,11,21-trimethoxy-3,7,9,15-tetramethyl-16,20,22-trioxo-17-azabicyclo[16.3.1]docosa-1(21),8,12,14,18-pentaen-10-yl] ester | 30562-34-6 | C29H40N2O9 |
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—— | (6R,7R)-7-[[2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(1-methyltetrazol-5-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid;hydrochloride | 75738-58-8 | C32H35ClN18O10S6 |
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—— | 2-[3-(diaminomethylideneamino)-4-[3-[4,5-dihydroxy-6-(hydroxymethyl)-3-(methylamino)oxan-2-yl]oxy-4-formyl-4-hydroxy-5-methyloxolan-2-yl]oxy-2,5,6-trihydroxycyclohexyl]guanidine;sulfuric acid | 3810-74-0 | C42H84N14O36S3 |
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—— | itraconazole | 110588-57-3 | C35H38F2N8O4 |
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—— | 4-acetamidobenzoic acid;9-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-1H-purin-6-one;1-(dimethylamino)propan-2-ol | 36703-88-5 | C24H34N6O9 |
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—— | Sodium antimonyl L-tartrate | 34521-09-0 | C8H4Na2O12Sb2 |
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—— | prednisolone sodium succinate | 1715-33-9 | C25H31O8*Na |
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—— | (6R,7R)-7-[[2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-(6,7-dihydro-5H-cyclopenta[b]pyridin-1-ium-1-ylmethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid;hydrogen sulfate | 98753-19-6 | C22H24N6O9S3 |
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—— | Glymidine sodium | 3459-20-9 | C13H14N3NaO4S |
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—— | 6-Hydroxyhyoscyamine | 55869-99-3 | C17H23NO4 |
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—— | Agrimophol | 65792-05-4 | C26H34O8 |
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—— | sodium;(6R,7R)-7-[[2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate | 68401-82-1 | C13H12N5NaO5S2 |
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—— | Azithromycin hydrate | 117772-70-0 | C38H76N2O14 |
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—— | 2-[3-(diaminomethylideneamino)-4-[3-[4,5-dihydroxy-6-(hydroxymethyl)-3-(methylamino)oxan-2-yl]oxy-4-hydroxy-4-(hydroxymethyl)-5-methyloxolan-2-yl]oxy-2,5,6-trihydroxycyclohexyl]guanidine;sulfuric acid | 1425-61-2 | C21H43N7O16S |
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—— | gold(1+);3,4,5-triacetyloxy-6-(acetyloxymethyl)oxane-2-thiolate;triethylphosphane | 34031-32-8 | C20H34AuO9PS |
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—— | (1S,9R,11S,14S,15S)-15-methyl-9-[9-(4,4,5,5,5-pentafluoropentanesulfinyl)nonyl]tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-2(7),3,5-triene-5,14-diol | 129453-61-8 | C32H47F5O3S |
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—— | (1S,3Z,7R,11E,13R,15R)-2,15-dihydroxy-7-methyl-6-oxabicyclo[11.3.0]hexadeca-3,11-dien-5-one | 20350-15-6 | C16H24O4 |
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—— | (1R,2R,3E,7S,13S,15S)-2,15-dihydroxy-7-methyl-6-oxabicyclo[11.3.0]hexadeca-3,11-dien-5-one | 20350-15-6 | C16H24O4 |
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—— | (1S,2S)-2-[(2R,4Z,6E,8S,9R,13R,15R,16R)-7-cyano-8,16-dihydroxy-9,11,13,15-tetramethyl-18-oxo-1-oxacyclooctadeca-4,6-dien-2-yl]cyclopentane-1-carboxylic acid | 7184-60-3 | C28H43NO6 |
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—— | (6S,7S)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(2-carboxypropan-2-yloxyimino)acetyl]amino]-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate | 72558-82-8 | C22H22N6O7S2 |
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—— | sodium;(6S,7S)-3-(carbamoyloxymethyl)-7-[[(2Z)-2-(furan-2-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate | 56238-63-2 | C16H15N4NaO8S |
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—— | (3R,4R,6R)-5-[(3R,4R,6R)-5-[(3R,4S,6R)-3,4-Dihydroxy-6-methyl-5-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)cyclohex-2-en-1-yl]amino]oxan-2-yl]oxy-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-(hydroxymethyl)oxane-2,3,4-triol | 56180-94-0 | C25H43NO18 |
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—— | Magnesium potassium aspartate | 8076-65-1 | C4H5KMgNO4+ |
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—— | Priomicina | 26016-99-9 | C3H7NaO4P+ |
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—— | Cefaloject | 24356-60-3 | C17H17N3NaO6S2+ |
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—— | 5-Amino-2-(aminomethyl)-6-[4,6-diamino-2-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]oxy-3-hydroxycyclohexyl]oxyoxane-3,4-diol;sulfuric acid | 53797-35-6 | C17H36N4O14S |
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—— | potassium hydrogen diformate | 20642-05-1 | CHO2*CH2O2*K |
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—— | Celestone Phosphate | 151-73-5 | C22H30FNaO8P+ |
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—— | 4-[(1S)-2-amino-1-hydroxyethyl]benzene-1,2-diol;2,3-dihydroxybutanedioic acid | 51-40-1 | C12H17NO9 |
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