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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—— | 4H-Cyclopent[f]oxacyclotridecin-4-one,1,6,7,8,9,11a,12,13,14,14a-decahydro-1,13-dihydroxy-6-methyl-,(1R,2E,6S,10E,11aS,13S,14aR)- | 20350-15-6 | C16H24O4 |
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—— | (R)-[(2R,4R,5S)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl]-(6-methoxyquinolin-4-yl)methanol;sulfuric acid | 50-54-4 | C40H50N4O8S |
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—— | [(1R,2R,4S,5S)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl] (2R)-3-hydroxy-2-phenylpropanoate;hydrobromide | 114-49-8 | C17H21NO4.BrH |
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—— | (3R,5S,E)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoate | 147526-32-7 | C25H23FNO4- |
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—— | (2-butyl-4-chloro-1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-imidazol-5-yl)methanolate | 124750-99-8 | C22H22ClN6O- |
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—— | 1H-Indole-3-carboxylic acid, octahydro-3-oxo-2,6-methano-2H-quinolizin-8-yl ester, (2alpha,6alpha,8alpha,9abeta)-, monomethanesulfonate | 115956-13-3 | C20H24N2O6S |
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—— | 85960-17-4 | C28H43N5NaO9S2 |
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—— | (E)-5-(3-methylbut-2-enoxy)-5-oxo-2-[2-(phenylmethoxycarbonylamino)-1,3-thiazol-4-yl]pent-2-enoic acid | 115065-79-7 | C21H22N2O6S |
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—— | 4-[2-(11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethoxy]-4-oxobutanoic acid;hydrate | 83784-20-7 | C25H36O9 |
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—— | (1R,3R,8S,9R,12S,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,8S,9R,12S,13R)-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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—— | (2S,3R,4S,5S,6S)-5-amino-2-(aminomethyl)-6-[(1S,2S,3R,4S,6R)-4,6-diamino-2-[(2S,3R,4S,5R)-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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—— | Kanamycin acid sulfate | 8063-07-8 | C18H40N4O19S2 |
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—— | (1S,2R,18R,19R,22S,25R,28R,40S)-48-[(2S,3R,4S,5S)-3-[(2S,4S,5S,6S)-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-[[(2R)-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;hydrochloride | 1404-93-9 | C66H76Cl3N9O24 |
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—— | (2S,3R,4S,5S)-2-[(1R,2S,3S,4R,6S)-4,6-diamino-3-[[3-amino-6-(aminomethyl)-3,4-dihydro-2H-pyran-2-yl]oxy]-2-hydroxycyclohexyl]oxy-5-methyl-4-(methylamino)oxane-3,5-diol;sulfuric acid | 53179-09-2 | C19H39N5O11S |
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—— | Sodium hydrogen bicarbonate | 497-19-8 | CH2NaO3 |
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—— | 554-13-2 | CH2LiO3 |
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—— | Benzo Congo Red | 573-58-0 | C32H24N6NaO6S2+ |
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—— | (1S)-3-[2-[(1R,7aR)-1-[(2R,5R)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol | 50-14-6 | C28H44O |
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—— | (3S,5S,6S,7R,8S,9R,12R,13R,14S,15R)-6-[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-14-hydroxy-8-[(2R,4S,5S,6S)-5-hydroxy-4-methoxy-6-methyloxan-2-yl]oxy-5,7,9,12,13,15-hexamethyl-1,11-dioxaspiro[2.13]hexadecane-10,16-dione;phosphoric acid | 7060-74-4 | C35H64NO16P |
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—— | Dimethyl-(2-phenoxyethyl)-(phenylmethyl)ammonium 3-hydroxy-2-naphthalenecarboxylic acid | 3818-50-6 | C28H30NO4+ |
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—— | Dtxcid7025479 | 53179-09-2 | C38H84N10O34S5 |
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—— | Pharmakon1600-01500122 | 1397-89-3 | C47H73NO17 |
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—— | GD-Tex | 156436-89-4 | C52H74GdN5O15 |
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—— | Hyoscyamine methylbromide | 2870-71-5 | C18H26BrNO3 |
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—— | (5Z,9Z,13Z)-6,10,14,18-tetramethylnonadeca-5,9,13,17-tetraen-2-one | 6809-52-5 | C23H38O |
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—— | Ganirelix Acetate | 129311-55-3 | C84H121ClN18O17 |
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—— | sodium;(6R,7S)-3-(acetyloxymethyl)-7-[[(2Z)-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 | 64485-93-4 | C16H16N5NaO7S2 |
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—— | Sodium;2-[6-[[2-[5-[5-[6-hydroxy-6-(hydroxymethyl)-3,5-dimethyloxan-2-yl]-3-methyloxolan-2-yl]-5-methyloxolan-2-yl]-7-methoxy-2,4,6-trimethyl-1,10-dioxaspiro[4.5]decan-9-yl]methyl]-3-methyloxan-2-yl]propanoate | 28643-80-3 | C40H67NaO11 |
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—— | Cidofovir hydrate | 149394-66-1 | C8H16N3O7P |
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—— | Floxacillin Na salt | 1847-24-1 | C19H17ClFN3NaO5S+ |
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—— | Thyroxine sodium salt | 55-03-8 | C15H11I4NNaO4+ |
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—— | Pharmakon1600-01500201 | 642-78-4 | C19H18ClN3NaO5S+ |
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—— | sodium;6-[(3R,4S,5S,7R)-7-[(2S,3S,5S)-5-ethyl-5-[(2R,5R,6S)-5-ethyl-5-hydroxy-6-methyloxan-2-yl]-3-methyloxolan-2-yl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2-hydroxy-3-methylbenzoic acid | 25999-20-6 | C34H54NaO8+ |
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—— | Mylis | 1099-87-2 | C19H28NaO5S+ |
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—— | Cacodylic acid, sodium salt | 124-65-2 | C2H7AsNaO2+ |
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—— | (S)-[(2R,5R)-5-ethylquinuclidin-2-yl]-(6-methoxy-4-quinolyl)methanol | 1435-55-8 | C20H26N2O2 |
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—— | Sulphathiazole sodium pentahydrate | 6791-71-5 | C9H18N3NaO7S2 |
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—— | Gadodiamidum | 122795-43-1 | C16H32GdN5O11 |
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—— | (S)-[(2S,4S,5R)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl]-(6-methoxyquinolin-4-yl)methanol;(2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoic acid | 7054-25-3 | C26H36N2O9 |
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—— | (1R,9S,12S,15R,16Z,18R,19R,21R,23S,24E,26Z,28E,30S,32S,35R)-1,18-dihydroxy-12-[(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone | 159351-69-6 | C53H83NO14 |
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—— | [(11E,13E)-6-[(2S,3R,4R,5S,6R)-4-(dimethylamino)-3-hydroxy-5-[(2S,4R,5R,6R)-4-hydroxy-4,6-dimethyl-5-propanoyloxyoxan-2-yl]oxy-6-methyloxan-2-yl]oxy-10-hydroxy-5-methoxy-9,16-dimethyl-2-oxo-7-(2-oxoethyl)-1-oxacyclohexadeca-11,13-dien-4-yl] propanoate | 35457-80-8 | C41H67NO15 |
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—— | (1R,9S,12S,15R,16Z,18R,19R,21R,23S,24Z,26Z,28Z,30S,32S,35R)-1,18-dihydroxy-12-[(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone | 159351-69-6 | C53H83NO14 |
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—— | Refosporin sodium salt | 63521-15-3 | C18H15Cl2N5NaO5S3+ |
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—— | N-(3-amino-3-oxoprop-1-en-2-yl)-2-[(21E)-21-ethylidene-9,30-dihydroxy-18-(1-hydroxyethyl)-40-methyl-16,19,26,31,42,46-hexaoxo-32-oxa-3,13,23,43,49-pentathia-7,17,20,27,45,51,52,53,54,55-decazanonacyclo[26.16.6.12,5.112,15.122,25.138,41.147,50.06,11.034,39]pentapentaconta-2(55),4,6,8,10,12(54),14,22(53),24,34(39),35,37,40,47,50-pentadecaen-8-yl]-1,3-thiazole-4-carboxamide | 56377-79-8 | C51H43N13O12S6 |
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—— | 2-[(4R,5S,6S,7R,9R,10R,11E,13E,16S)-6-[(2S,3R,4R,5S,6R)-5-[(2R,4S,5R,6R)-4,5-dihydroxy-4,6-dimethyloxan-2-yl]oxy-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-10-[(2R,5S,6S)-5-(dimethylamino)-6-methyloxan-2-yl]oxy-4-hydroxy-5-methoxy-9,16-dimethyl-2-oxo-1-oxacyclohexadeca-11,13-dien-7-yl]acetaldehyde | 8025-81-8 | C43H74N2O14 |
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—— | H-Aib-DL-His-DL-2Nal-DL-Phe-DL-Lys-NH2 | 170851-70-4 | C38H49N9O5 |
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—— | Ketek (TN) | 191114-48-4 | C43H65N5O10 |
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—— | 4-[1-Hydroxy-2-(propan-2-ylamino)ethyl]benzene-1,2-diol;sulfuric acid;hydrate | 299-95-6 | C11H21NO8S |
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—— | potassium;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole | 161796-84-5 | C17H19KN3O3S+ |
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—— | Halamid | 127-65-1 | C7H8ClNNaO2S+ |
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