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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—— | (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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—— | Dolasetron mesylate hydrate | 115956-13-3 | C20H26N2O7S |
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—— | Oxabel Sodium salt | 1173-88-2 | C19H19N3NaO5S+ |
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—— | Pharmakon1600-01502038 | 30034-03-8 | C18H18N6NaO5S2+ |
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—— | [(5R)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl]-quinolin-4-ylmethanol | 118-10-5 | C19H22N2O |
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—— | MK-0991 (Acetate);L-743872 (Acetate) | 179463-17-3 | C56H96N10O19 |
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—— | (1S,3R,5S,7S,8Z,12R,14Z,16Z,18Z,20Z,22S,24S,25R,26R)-22-[(3R,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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—— | (4-Ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxo-6-tricyclo[5.4.3.01,8]tetradecanyl) 2-[1-[(2-amino-3-methylbutanoyl)amino]-2-methylpropan-2-yl]sulfanylacetate;hydrochloride | 133868-46-9 | C31H53ClN2O5S |
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—— | (1S,3E,4S)-3-[(2E)-2-[(1R,3aS,7aR)-1-[(E,2R)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylcyclohexan-1-ol | 67-96-9 | C28H46O |
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—— | 2,3-dihydroxybutanedioic acid;methyl 11-acetyloxy-12-ethyl-4-(16-ethyl-12-methoxycarbonyl-1,10-diazatetracyclo[12.3.1.03,11.04,9]octadeca-3(11),4,6,8,15-pentaen-12-yl)-10-hydroxy-5-methoxy-8-methyl-8,16-diazapentacyclo[10.6.1.01,9.02,7.016,19]nonadeca-2,4,6,13-tetraene-10-carboxylate | 125317-39-7 | C53H66N4O20 |
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—— | Lactacyd | 72-17-3 | C3H6NaO3+ |
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—— | (5Z)-5-[(2E)-2-[1-(6-hydroxy-6-methylheptan-2-yl)-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol | 32222-06-3 | C27H44O3 |
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—— | Sodium levothyroxine pentahydrate | 55-03-8 | C15H21I4NNaO9+ |
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—— | (2R,3R,6S)-3-[[(3R)-3-amino-5-[carbamimidoyl(methyl)amino]pentanoyl]amino]-6-(4-amino-2-oxopyrimidin-1-yl)-3,6-dihydro-2H-pyran-2-carboxylic acid | 2079-00-7 | C17H26N8O5 |
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—— | Pharmakon1600-01502031 | 66309-69-1 | C16H17N3NaO7S2+ |
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—— | 5-[3,3a,4,5,6,6a-Hexahydro-5-hydroxy-4-(3-hydroxy-4-methyl-1-octen-6-ynyl)pentalen-2(1H)-ylidene]pentanoic acid | 78919-13-8 | C22H32O4 |
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—— | Triparsamide | 554-72-3 | C8H11AsN2NaO4+ |
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—— | Cilastatin, Antibiotic for Culture Media Use Only | 82009-34-5 | C16H26N2O5S |
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—— | 3-[[2-[2-[2-[[(2S,3R)-2-[[(2S,3S,4R)-4-[[(2S,3R)-2-[[6-amino-2-[(1S)-3-amino-1-[[(2S)-2,3-diamino-3-oxopropyl]amino]-3-oxopropyl]-5-methylpyrimidine-4-carbonyl]amino]-3-[(2R,3S,4S,5S,6S)-3-[(2R,3S,4S,5R,6R)-4-carbamoyloxy-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-3-(1H-imidazol-5-yl)propanoyl]amino]-3-hydroxy-2-methylpentanoyl]amino]-3-hydroxybutanoyl]amino]ethyl]-1,3-thiazol-4-yl]-1,3-thiazole-4-carbonyl]amino]propyl-dimethylsulfanium;hydrochloride | 67763-87-5 | C55H85ClN17O21S3+ |
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—— | tetrasodium;(6R,7R)-7-[[(2E)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyimino-1-oxidoethylidene]amino]-3-[(2-methyl-5,6-dioxo-1H-1,2,4-triazin-3-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate;heptahydrate | 104376-79-6 | C36H46N16Na4O21S6 |
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—— | 1-Methyl-4-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)piperidin-1-ium;dichloride;trihydrate | 41354-29-4 | C42H50Cl2N2O3 |
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—— | erythro-(+/-)-(E)-7-[3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid tert-butyl ester | 129332-29-2 | C28H34FNO4 |
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—— | component of Desenex | 557-08-4 | C11H20O2Zn+2 |
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—— | 4-N-[7-chloro-2-[2-(2-chlorophenyl)ethenyl]quinolin-4-yl]-1-N,1-N-diethylpentane-1,4-diamine | 10023-54-8 | C26H31Cl2N3 |
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—— | Bis(5-acetyl-8-hydroxyquinolinium) sulphate | 57130-91-3 | C22H20N2O8S |
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—— | Calcium titanium oxide (CaTiO3) | 37226-56-5 | CaO3Ti |
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—— | Bismuth oxide | 12048-50-9 | Bi2O3 |
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—— | Potassium manganate | 68081-75-4 | K2MnO4 |
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—— | Zirconium methacrylate | 84057-81-8 | C16H20O8Zr |
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—— | Spiramycini | 24916-50-5 | C43H74N2O14 |
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—— | Transderm scop (TN) | 51-34-3 | C17H21NO4 |
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—— | (3S,4S,5R)-2-(2-amino-6-methoxypurin-9-yl)-5-(hydroxymethyl)oxolane-3,4-diol | 121032-29-9 | C11H15N5O5 |
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—— | Disodium 3-{[(4-{[2-carboxy-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-en-3-yl]sulfanyl}pyrrolidin-2-yl)(oxidanidyl)methylidene]amino}benzoate | 153832-38-3 | C22H23N3Na2O7S |
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—— | methyl (1R,2S,9R,11S,14R,15S)-2,15-dimethyl-5,5'-dioxospiro[18-oxapentacyclo[8.8.0.01,17.02,7.011,15]octadec-6-ene-14,2'-oxolane]-9-carboxylate | 107724-20-9 | C24H30O6 |
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—— | 4-[4-[4-[4-[[(5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one | 171228-49-2 | C37H42F2N8O4 |
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—— | Copper citrate | 866-82-0 | C6H8Cu2O7+4 |
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