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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—— | esomeprazole sodium salt | 161796-78-7 | C17H18N3O3S*Na |
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—— | flunarizine hydrochloride | 30484-77-6 | C26H26F2N2*ClH |
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—— | flupentixol dihydrochloride | 2413-38-9 | C23H25F3N2OS*2ClH |
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—— | 3,4,5-trihydroxybenzoate | 5995-86-8 | C7H5O5 |
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—— | toosendanin | 58812-37-6 | C30H38O11 |
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—— | 13-(R,S)-dihydrodaunorubicin | 28008-55-1 | C27H31NO10 |
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—— | 10-hydroxycamptothecin | 19685-09-7 | C20H16N2O5 |
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—— | (6R,7R)-7-[2-furanyl-(Z)-2-methoxyimino]acetamido-3-carbamoyloxymethyl-3-cephem-4-carboxylic acid sodium salt | 56238-63-2 | C16H15N4O8S*Na |
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—— | netromycin | 56391-56-1 | C21H41N5O7 |
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—— | maytansin-3N-methyl-L-alaninepropanamide-3-thiol | 139504-50-0 | C35H48ClN3O10S |
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—— | DM-1 | 139504-50-0 | C35H48ClN3O10S |
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—— | lipoate | 62-46-4 | C8H13O2S2 |
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—— | N-[(3S,6S,9S,11R,20R,21S,24S,25S)-21-(2-aminoethylamino)-3-[(1R)-3-amino-1-hydroxypropyl]-6-[(1S,2S)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-11,20,25-trihydroxy-15-[(1R)-1-hydroxyethyl]-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexazatricyclo[22.3.0.09,13]heptacosan-18-yl]-10,12-dimethyltetradecanamide | 162808-62-0 | C52H88N10O15 |
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—— | (2R)-5'-methyl-4-azaspiro[bicyclo[2.2.2]octane-2,2'-[1,4]oxathiolane] | 107233-08-9 | C10H17NOS |
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—— | N-[3-[(3-amino-3-oxoprop-1-en-2-yl)amino]-3-oxoprop-1-en-2-yl]-2-[(1R,11E)-37-butan-2-yl-18-[(2R)-2,3-dihydroxybutan-2-yl]-11-ethylidene-59-hydroxy-8,31-bis(1-hydroxyethyl)-26,40,46-trimethyl-43-methylidene-6,9,16,23,28,38,41,44,47-nonaoxo-27-oxa-3,13,20,56-tetrathia-7,10,17,24,36,39,42,45,48,52,58,61,62,63,64-pentadecazanonacyclo[23.23.9.329,35.12,5.112,15.119,22.154,57.01,53.032,60]tetrahexaconta-2(64),4,12(63),19(62),21,29(61),30,32(60),33,51,54,57-dodecaen-51-yl]-1,3-thiazole-4-carboxamide | 1393-48-2 | C72H85N19O18S5 |
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—— | (7R,13S)-6-[(2S)-4-(Dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-14-ethyl-7,12,13-trihydroxy-4-[(4R)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-10-(2-methoxyethoxymethoxyimino)-3,5,7,9,11,13-hexamethyl-oxacyclotetradecan-2-one | 80214-83-1 | C41H76N2O15 |
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—— | (1R,2R,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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—— | N-[1-[[1-[[1-[[1-[[1-[[1-[[1-[2-[(2-azanyl-2-oxidanylidene-ethyl)carbamoyl]pyrrolidin-1-yl]-5-[bis(azanyl)methylideneamino]-1-oxidanylidene-pentan-2-yl]amino]-4-methyl-1-oxidanylidene-pentan-2-yl]amino]-3-naphthalen-2-yl-1-oxidanylidene-propan-2-yl]amino] | 76932-56-4 | C66H83N17O13 |
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—— | Cytovirin | 2079-00-7 | C17H26N8O5 |
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—— | (2S,3'R,3aS,4S,4'S,5'R,6R,6'R,7S,7aS)-4-[(1R,2S,3R,5S,6R)-3-amino-2,6-dihydroxy-5-(methylamino)cyclohexyl]oxy-6'-[(1R)-1-amino-2-hydroxyethyl]-6-(hydroxymethyl)spiro[4,6,7,7a-tetrahydro-3aH-[1,3]dioxolo[4,5-c]pyran-2,2'-oxane]-3',4',5',7-tetrol | 31282-04-9 | C20H37N3O13 |
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—— | (1R,2R,3Z,7S,11Z,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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—— | Dalfopristina | 112362-50-2 | C34H50N4O9S |
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—— | Vancoled (TN) | 1404-93-9 | C66H76Cl3N9O24 |
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—— | Framycetin sulphate | 1405-10-3 | C23H52N6O25S3 |
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—— | Spectinomycin dihydrochloride pentahydrate | 22189-32-8 | C14H27ClN2O8 |
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—— | Antibiotic U 29135 | 30562-34-6 | C29H40N2O9 |
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—— | (3'R,3aS,4S,4'S,5'R,6R,6'R,7S,7aS)-4-[(1R,2S,3R,5S,6R)-3-amino-2,6-dihydroxy-5-(methylamino)cyclohexyl]oxy-6'-(1-amino-2-hydroxyethyl)-6-(hydroxymethyl)spiro[4,6,7,7a-tetrahydro-3aH-[1,3]dioxolo[4,5-c]pyran-2,2'-oxane]-3',4',5',7-tetrol | 31282-04-9 | C20H37N3O13 |
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—— | (1R,3S,5R,7R,8E,12R,14E,16E,18E,20E,24S,25R,26S)-22-[(2R,5S)-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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—— | Alaninamide;Bryamycin;Thiactin | 1393-48-2 | C72H85N19O18S5 |
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—— | Pharmakon1600-01500167 | 24356-60-3 | C17H17N3NaO6S2+ |
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—— | Ferrous Gluconate | 6047-12-7 | C12H22FeO14 |
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—— | Meticillin sodium | 132-92-3 | C17H19N2O6S- |
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—— | (1S,3S,7R,10S,11S,12S,16R)-7,11-Dihydroxy-8,8,10,12,16-pentamethyl-3-[(E)-1-(2-methyl-1,3-thiazol-4-yl)prop-1-en-2-yl]-17-oxa-4-azabicyclo[14.1.0]heptadecane-5,9-dione | 219989-84-1 | C27H42N2O5S |
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—— | (1R,3S,5S,7R,8Z,12R,14Z,16E,18E,20E,22R,24S,25R,26S)-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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—— | Lisinopril hydrate | 83915-83-7 | C21H33N3O6 |
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—— | aztreonam | 78110-38-0 | C13H17N5O8S2 |
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—— | Pharmakon1600-01500572 | 54-64-8 | C9H10HgNaO2S+ |
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—— | (2-Aminoethoxy)({5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene})amine; but-2-enedioic acid | 61718-82-9 | C19H25F3N2O6 |
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—— | Amasulin | 86832-68-0 | C12H12N6Na2O10S2 |
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—— | Iron gluconate | 299-29-6 | C12H24FeO14 |
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—— | 48-[3-[(4S)-4-amino-5-hydroxy-4,6-dimethyloxan-2-yl]oxy-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-22-(2-amino-2-oxoethyl)-5,15-dichloro-2,18,32,35,37-pentahydroxy-19-[[4-methyl-2-(methylamino)pentanoyl]amino]-20,23,26,42,44-pentaoxo-7,13-dioxa-21,24,27,41,43-pentazaoctacyclo[26.14.2.23,6.214,17.18,12.129,33.010,25.034,39]pentaconta-3,5,8(48),9,11,14,16,29(45),30,32,34(39),35,37,46,49-pentadecaene-40-carboxylic acid | 1404-90-6 | C66H75Cl2N9O24 |
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—— | Oligomycins | 1404-19-9 | C45H74O11 |
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—— | [5-[(1S,2S)-2-[(3S,9S,11R,18S,20R,21R,24S,25S,26S)-3-[(1R)-3-amino-1-hydroxy-3-oxopropyl]-11,20,21,25-tetrahydroxy-15-[(1R)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-18-[[4-[5-(4-pentoxyphenyl)-1,2-oxazol-3-yl]benzoyl]amino]-1,4,7,13,16,22-hexazatricyclo[22.3.0.09,13]heptacosan-6-yl]-1,2-dihydroxyethyl]-2-hydroxyphenyl] hydrogen sulfate | 235114-32-6 | C56H71N9O23S |
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—— | (6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-8-oxo-3-(5,6,7,8-tetrahydroquinolin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid;sulfuric acid | 118443-89-3 | C23H27N6O9S3+ |
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—— | carbanide;cobalt(3+);[(2R,3S,4R,5S)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2R)-1-[3-[(2R,3R,4Z,7S,9Z,12S,13S,14Z,17S,18S,19R)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2,7,12,17-tetrahydro-1H-corrin-21-id-3-yl]propanoylamino]propan-2-yl] phosphate | 13422-55-4 | C63H91CoN13O14P |
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—— | Estrumate (TN) | 55028-72-3 | C22H28ClNaO6 |
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—— | (2R,3'R,3aR,4S,4'R,5'R,6R,6'S,7S,7aS)-4-[(1R,2S,3R,5S,6R)-3-amino-2,6-dihydroxy-5-(methylamino)cyclohexyl]oxy-6'-[(1S)-1-amino-2-hydroxyethyl]-6-(hydroxymethyl)spiro[4,6,7,7a-tetrahydro-3aH-[1,3]dioxolo[4,5-c]pyran-2,2'-oxane]-3',4',5',7-tetrol | 31282-04-9 | C20H37N3O13 |
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—— | 2H-Oxacyclotetradecino[2,3-d]isoindole-2,18(5H)-dione,6,7,8,9,10,12a,13,14,15,15a,16,17-dodecahydro-5,13-dihydroxy-9,15-dimethyl-14-methylene-16-(phenylmethyl)-,(3E,5R,9R,11E,12aS,13S,15S,15aS,16S,18aS)- | 14930-96-2 | C29H37NO5 |
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—— | (1R,3R,5S,8S,13R)-1-hydroxy-14-(2-hydroxypropan-2-yl)-13-methyl-4,7,10-trioxapentacyclo[6.4.1.19,12.03,5.05,13]tetradecane-6,11-dione;(1R,3R,5S,8S,13R,14R)-1-hydroxy-13-methyl-14-prop-1-en-2-yl-4,7,10-trioxapentacyclo[6.4.1.19,12.03,5.05,13]tetradecane-6,11-dione | 124-87-8 | C30H34O13 |
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—— | (1S,2S,4R,8S,9S,11S,13R)-11-hydroxy-8-(2-hydroxyacetyl)-9,13-dimethyl-6-propyl-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-16-one | 51333-22-3 | C25H34O6 |
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