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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—— | Sodium 1-hydroxy-3-(phosphonooxy)propan-2-olate | 17603-42-8 | C3H8NaO6P |
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—— | Thiostrepton 1 | 1393-48-2 | C72H85N19O18S5 |
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—— | (2R,3R,6R,7S,8S,9R,10S,12R,13S,15R,17S)-9-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-3-ethyl-2,10-dihydroxy-7-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-15-(2-methoxyethoxymethyl)-2,6,8,10,12,17-hexamethyl-4,16-dioxa-14-azabicyclo[11.3.1]heptadecan-5-one | 62013-04-1 | C42H78N2O14 |
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—— | Formacidine | 8025-81-8 | C43H74N2O14 |
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—— | 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid,7-[[2-(2-amino-4-thiazolyl)-4-carboxy-1-oxo-2-butenyl]amino]-8-oxo-,hydrate, [6R-[6a,7b(Z)]]- | 118081-34-8 | C15H16N4O7S2 |
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—— | 2,3-dihydroxybutanedioic acid;hydron;N,N,2-trimethyl-3-phenothiazin-10-ylpropan-1-amine | 1175-88-8 | C4H6O6*2C18H22N2S*2H |
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—— | Ionomycin | 56092-81-0 | C41H72O9 |
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—— | [[(2R,3S,4R,5S)-5-(6-aminopurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methoxy-hydroxyphosphoryl] [(2S,3R,4S,5S)-5-(3-carbamoylpyridin-1-ium-1-yl)-3,4-dihydroxyoxolan-2-yl]methyl phosphate | 53-84-9 | C21H27N7O14P2 |
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—— | Natacyn (TN) | 7681-93-8 | C33H47NO13 |
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—— | N-(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;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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—— | Disodium;7-[[2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(2-methyl-6-oxido-5-oxo-1,2,4-triazin-3-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate | 74578-69-1 | C18H16N8Na2O7S3 |
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—— | 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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—— | methyl N-[1-[(2S)-2-[5-[4-[4-[2-[(2S)-1-[2-(methoxycarbonylamino)-3-methylbutanoyl]pyrrolidin-2-yl]-1H-imidazol-5-yl]phenyl]phenyl]-1H-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate;dihydrochloride | 1009119-65-6 | C40H52Cl2N8O6 |
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—— | N2-(2-ethoxy-4-(4-methyl-4H-1,2,4-triazol-3-yl)phenyl)-6-methyl-N8-neopentylpyrido[3,4-d]pyrimidine-2,8-diamine | 1578245-44-9 | C24H30N8O |
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—— | Hydrotalcite | 12304-65-3 | CH24Al2Mg6O24-2 |
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—— | Rifomycin O | 14487-05-9 | C39H47NO14 |
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—— | Dihydroxyaluminium aminoacetate | 41354-48-7 | C2H8AlNO5 |
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—— | Homatropine Methylbromide; (1R,3r,5S)-3-[[(2RS)-2-Hydroxy-2-phenylacetyl]oxy]-8,8-dimethyl-8-azoniabicyclo[3.2.1]octane bromide | 80-49-9 | C17H24BrNO3 |
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—— | 2-[[1-(2-Amino-1,3-thiazol-4-yl)-2-[[2-carboxy-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-en-7-yl]amino]-2-oxoethylidene]amino]oxy-2-methylpropanoate;pentahydrate | 78439-06-2 | C22H32N6O12S2 |
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—— | 2-Pyridinepropanamine, gamma-(4-bromophenyl)-N,N-dimethyl-, (2Z)-2-butenedioate (1:1) | 980-71-2 | C20H25BrN2O4 |
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—— | Azanium;2-[6-[1-[2-[5-[3-(4,5-dimethoxy-6-methyloxan-2-yl)oxy-5-(6-hydroxy-3,5,6-trimethyloxan-2-yl)oxolan-2-yl]-5-methyloxolan-2-yl]-7-hydroxy-2,8-dimethyl-1,10-dioxaspiro[4.5]decan-9-yl]ethyl]-2-hydroxy-4,5-dimethoxy-3-methyloxan-2-yl]acetate | 84878-61-5 | C47H83NO17 |
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—— | (E)-roxithromycin | 80214-83-1 | C41H76N2O15 |
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—— | methyl (1R,10S,12R)-11-acetyloxy-12-ethyl-4-[(13S,17S)-17-ethyl-17-hydroxy-13-methoxycarbonyl-1,11-diazatetracyclo[13.3.1.04,12.05,10]nonadeca-4(12),5,7,9-tetraen-13-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;sulfuric acid | 143-67-9 | C46H58N4O9.H2O4S |
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—— | 95193-35-4 | MgOSi |
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—— | (2-Chlorophenyl)methyl-[2-[[2-[2-[(2-chlorophenyl)methyl-diethylazaniumyl]ethylamino]-2-oxoacetyl]amino]ethyl]-diethylazanium;chloride | 115-79-7 | C28H42Cl3N4O2+ |
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—— | 2-[2-[Carboxylatomethyl-[2-[carboxylatomethyl(carboxymethyl)amino]ethyl]amino]ethyl-(carboxymethyl)amino]-3-phenylmethoxypropanoate;gadolinium(3+);6-(methylamino)hexane-1,2,3,4,5-pentol | 113662-23-0 | C36H62GdN5O21 |
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—— | Sodium;6-[[22-[(3-acetyloxy-2-methylbutanoyl)oxymethyl]-21-hydroxy-8-(hydroxymethyl)-3,4,8,12,19,19-hexamethyl-23-oxahexacyclo[18.2.1.03,16.04,13.07,12.017,22]tricos-15-en-9-yl]oxy]-4-hydroxy-3-[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-5-(3,4,5-trihydroxyoxan-2-yl)oxyoxane-2-carboxylic acid | 20977-05-3 | C54H84NaO23+ |
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—— | Cozaar | 124750-99-8 | C22H22ClN6O- |
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—— | (1E)-2-[6-[[Amino-[(E)-[amino-(4-chloroanilino)methylidene]amino]methylidene]amino]hexyl]-1-[amino-(4-chloroanilino)methylidene]guanidine;(2S,3R,4S,5S)-2,3,4,5,6-pentahydroxyhexanoic acid | 18472-51-0 | C34H54Cl2N10O14 |
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—— | 7-[[2-amino-2-(4-hydroxyphenyl)acetyl]amino]-8-oxo-3-[(Z)-prop-1-enyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 121123-17-9 | C18H19N3O5S |
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—— | Homatropine methylbromide | 80-49-9 | C17H24BrNO3 |
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—— | Bacitracin A | 1405-87-4 | C66H103N17O16S |
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—— | 7-Amino-3-(methoxymethyl)-3-cephem-4-carboxylic acid | 24701-69-7 | C9H12N2O4S |
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—— | Lodoxamide Tromethamine | 63610-09-3 | C19H28ClN5O12 |
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—— | (4R,6S,8R,9Z,11E)-16-chloro-17,19-dihydroxy-4-methyl-3,7-dioxatricyclo[13.4.0.06,8]nonadeca-1(15),9,11,16,18-pentaene-2,13-dione | 12772-57-5 | C18H17ClO6 |
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—— | [(1R,5R)-8-methyl-8-propan-2-yl-8-azoniabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenylpropanoate;bromide | 22254-24-6 | C20H30BrNO3 |
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—— | Lapatinib Ditosylate | 388082-78-8 | C43H44ClFN4O11S3 |
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—— | pipemidic acid trihydrate | 72571-82-5 | C14H17N5O3*3H2O |
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—— | Vinorelbine Tartrate | 125317-39-7 | C53H66N4O20 |
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—— | 7β-[2-(2-amino-4-thiazoIyl)-2-(Z-hydroxyimino)acetamido]-3-vinyl-3-cephem-4-carboxylic acid | 91832-40-5 | C14H13N5O5S2 |
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—— | 1ξ-oxo-6β-(2-phenyl-acetylamino)-1λ<sup>4</sup>-penicillanic acid 4-methoxy-benzyl ester | 30034-13-0 | C24H26N2O6S |
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—— | strychnine hyudrochloride | 1421-86-9 | C21H22N2O2*ClH |
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—— | (+)-Pantothenic acid, calcium salt | 137-08-6 | C9H17CaNO5+2 |
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—— | diphenylmethyl 7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate | 36923-21-4 | C20H18N2O3S |
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—— | Monocrotaline | 315-22-0 | C16H23NO6 |
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—— | Encephabol | 60479-98-3 | C16H24Cl2N2O5S2 |
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—— | (1R,2R,3E,7S,11E,13R,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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—— | Phenoxymethylpenicillin benzathine | 2113728-41-7 | C48H64N6O14S2 |
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—— | fluorescein-5-isothiocyanate | 3012-71-3 | C21H11NO5S |
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—— | Methyl (1R,10S,11R,12R,19R)-11-acetyloxy-12-ethyl-4-[(13S)-17-ethyl-17-hydroxy-13-methoxycarbonyl-1,11-diazatetracyclo[13.3.1.04,12.05,10]nonadeca-4(12),5,7,9-tetraen-13-yl]-8-formyl-10-hydroxy-5-methoxy-8,16-diazapentacyclo[10.6.1.01,9.02,7.016,19]nonadeca-2,4,6,13-tetraene-10-carboxylate;sulfuric acid | 2068-78-2 | C46H58N4O14S |
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