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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—— | (2R)-2-[(2R,5S,6R)-6-[(1S,2S,3S,5R)-5-[(3S,5R,7S,9S,10S,12R,15R)-3-[(2R,5R,6S)-5-ethyl-5-hydroxy-6-methyl-tetrahydropyran-2-yl]-15-hydroxy-3,10,12-trimethyl-4,6,8-trioxadispiro[4.1.5^{7}.3^{5}]pentadec-13-en-9-yl]-2-hydroxy-1,3-dimethyl-4-oxo-heptyl]-5-methyl-tetrahydropyran-2-yl]butanoic acid | 53003-10-4 | C42H70O11 |
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—— | 2-[(4R,5S,6S,7R,9R,11E,13E,15R,16R)-6-[(2R,3R,4R,5R,6R)-5-[(2S,4R,5S,6S)-4,5-dihydroxy-4,6-dimethyloxan-2-yl]oxy-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-16-ethyl-4-hydroxy-15-[[(3R,4R,5R,6R)-5-hydroxy-3,4-dimethoxy-6-methyloxan-2-yl]oxymethyl]-5,9,13-trimethyl-2,10-dioxo-1-oxacyclohexadeca-11,13-dien-7-yl]acetaldehyde | 1405-54-5 | C46H77NO17 |
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—— | 5-(methylsulfanylmethyl)-3-[(Z)-(5-nitrofuran-2-yl)methylideneamino]-1,3-oxazolidin-2-one | 4936-47-4 | C10H11N3O5S |
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—— | Dtxcid7010707 | 20562-02-1 | C45H73NO15 |
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—— | 3-acetamido-5-[acetyl(methyl)amino]-2,4,6-triiodo-N-[(2R,4S,5S)-2,4,5-trihydroxy-6-(hydroxymethyl)-3-oxanyl]benzamide | 31112-62-6 | C18H22I3N3O8 |
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—— | Atropine sulfate anhydrous | 5908-99-6 | C34H50N2O11S |
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—— | norgestimate | 20799-27-3 | C23H31NO3 |
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—— | (9S)-7-[4-amino-6-methyl-5-(oxan-2-yloxy)oxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione | 72496-41-4 | C32H37NO12 |
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—— | (1R,9S)-1-amino-13-ethylidene-11-methyl-6-azatricyclo[7.3.1.02,7]trideca-2(7),3,10-trien-5-one | 102518-79-6 | C15H18N2O |
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—— | 2-[3,4-bis(2-hydroxyethoxy)phenyl]-5-hydroxy-7-(2-hydroxyethoxy)-3-[[(3R,4S,5S,6R)-3,4,5-trihydroxy-6-[[(2R,3R,4R,5R,6S)-3,4,5-trihydroxy-6-methyl-2-oxanyl]oxymethyl]-2-oxanyl]oxy]-1-benzopyran-4-one | 7085-55-4 | C33H42O19 |
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—— | (6S,7R)-7-[[(2E)-2-(2-amino-1,3-thiazol-4-yl)-2-(carboxymethoxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 79350-37-1 | C16H15N5O7S2 |
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—— | Pharmakon1600-01500168 | 38821-53-3 | C16H19N3O4S |
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—— | (8aR,9R)-5-[[(2R,4aR,6R,7R,8R)-7,8-dihydroxy-2-thiophen-2-yl-4,4a,6,7,8,8a-hexahydropyrano[3,2-d][1,3]dioxin-6-yl]oxy]-9-(4-hydroxy-3,5-dimethoxyphenyl)-5a,6,8a,9-tetrahydro-5H-isobenzofuro[6,5-f][1,3]benzodioxol-8-one | 29767-20-2 | C32H32O13S |
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—— | Pharmakon1600-01500903 | 33419-42-0 | C29H32O13 |
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—— | (2S,4S)-4-cyclohexyl-1-[2-[[(1S)-2-methyl-1-(1-oxopropoxy)propoxy]-(4-phenylbutyl)phosphoryl]-1-oxoethyl]-2-pyrrolidinecarboxylic acid | 98048-97-6 | C30H46NO7P |
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—— | (1S,2S,3R,4S,6R)-4-amino-3-[(2S,3R)-3-amino-6-(aminomethyl)-3,4-dihydro-2H-pyran-2-yloxy]-6-(ethylamino)-2-hydroxycyclohexyl 3-deoxy-4-C-methyl-3-(methylamino)-beta-L-arabinopyranoside | 56391-56-1 | C21H41N5O7 |
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—— | Pharmakon1600-01503210 | 5593-20-4 | C28H37FO7 |
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—— | Pharmakon1600-01502203 | 2751-09-9 | C41H67NO15 |
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—— | (3S,4S,6S)-3-Methoxy-2-methyl-4-(methylamino)-29-oxa-1,7,17-triazaoctacyclo[12.12.2.12,6.07,28.08,13.015,19.020,27.021,26]nonacosa-8,10,12,14,19,21,23,25,27-nonaen-16-one | 62996-74-1 | C28H26N4O3 |
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—— | NCGC00380287-01_C28H33NO7_(1E,4S,6R,7E,11aS,14S,14aS,15S,15aR,16aS,16bS)-14-Benzyl-6-hydroxy-4,6,15,15a-tetramethyl-3,13,14,14a,15,15a,16a,16b-octahydro[1,3]dioxacyclotridecino[4,5-d]oxireno[f]isoindole-5,10,12(4H,6H)-trione | 36011-19-5 | C28H33NO7 |
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—— | 1-methyl-1-nitroso-3-[(2S,4S,5S)-2,4,5-trihydroxy-6-(hydroxymethyl)oxan-3-yl]urea | 66395-18-4 | C8H15N3O7 |
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—— | pirarubicin | 72496-41-4 | C32H37NO12 |
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—— | (R)-[(2R,5S)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl]-(4-quinolinyl)methanol | 118-10-5 | C19H22N2O |
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—— | acetic acid;N-[(3S,6S,9S,11R,15S,18S,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 | 179463-17-3 | C56H96N10O19 |
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—— | (3S,4S)-3-[(Z)-2-(2-amino-4-thiazolyl)-2-[(carboxymethoxy)imino]acetamido]-4-carbamoyloxymethyl-2-oxo-1-azetidinesulphonic acid | 109362-10-9 | C12H14N6O10S2 |
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—— | Almitrine mesylate | 29608-49-9 | C28H37F2N7O6S2 |
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—— | (S,Z)-3-((E)-2-((1R,3aS,7aR)-1-((2R,5R,E)-5,6-dimethylhept-3-en-2-yl)-7a-methyldihydro-1H-inden-4(2H,5H,6H,7H,7aH)-ylidene)ethylidene)-4-methylenecyclohexanol | 50-14-6 | C28H44O |
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—— | thapsigargin | 67526-95-8 | C34H50O12 |
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—— | Thioacetazone | 104-06-3 | C10H12N4OS |
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—— | (3R,4S,5S,6R,7R,9R,10E,11S,12R,13S,14R)-6-[4-(Dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-14-ethyl-7,12,13-trihydroxy-4-(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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—— | Axepim; BMY 28142 hydrochloride | 123171-59-5 | C19H26Cl2N6O5S2 |
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—— | 17β-acetoxy-androst-4-en-3-one | 1045-69-8 | C21H30O3 |
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—— | 8-Isotestosteron-acetat | 1045-69-8 | C21H30O3 |
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—— | 2,2-dimethylpropanoyloxymethyl (6R,7R)-7-[[(2Z)-2-[2-[[(2S)-2-aminopropanoyl]amino]-1,3-thiazol-4-yl]-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate | 135821-54-4 | C22H28N6O8S2 |
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—— | (-)(R)-3-bromo-octane | 999-64-4 | C8H17Br |
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—— | Zorubicin HCl | 36508-71-1 | C34H36ClN3O10 |
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—— | 7-(((2-Amino-4-thiazolyl)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio)methyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid | 69739-16-8 | C20H20N6O7S4 |
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—— | Fursultiamine hydrochloride | 2105-43-3 | C17H27ClN4O3S2 |
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—— | myo-Inositol, hexakis(dihydrogen phosphate), calcium magnesium salt | 3615-82-5 | C6H18CaMgO24P6 |
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—— | [(2S,4R)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl] (2S)-3-hydroxy-2-phenylpropanoate | 51-34-3 | C17H21NO4 |
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—— | (5R,6S,7S)-6-methoxy-5-methyl-7-(methylamino)-6,7,8,9,15,16-hexahydro-5H,14H-5,9-epoxy-4b,9a,15-triazadibenzo[b,h]cyclonona[1,2,3,4-jkl]cyclopenta[e]-as-indacen-14-one | 62996-74-1 | C28H26N4O3 |
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—— | 5H-Cyclopenta[b]pyridinium, 1-[[(6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-6,7-dihydro-, sulfate (1:1); Broact; Cefpirome sulfate; HR 810 sulfate; Keiten | 98753-19-6 | C22H24N6O9S3 |
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—— | ganglioside G<sub>M1</sub> | 37758-47-7 | C73H131N3O31 |
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—— | cinerulose | 57576-44-0 | C42H53NO15 |
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—— | methyl (1R,2R,4S)-4-[(2S,4S,5R,6R)-4-(dimethylamino)-5-[(2R,4S,5R,6R)-4-hydroxy-6-methyl-5-[(2S,6R)-6-methyl-5-oxooxan-2-yl]oxyoxan-2-yl]oxy-6-methyloxan-2-yl]oxy-2-ethyl-2,5,7-trihydroxy-6,11-dioxo-3,4-dihydro-1H-tetracene-1-carboxylate | 57576-44-0 | C42H53NO15 |
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—— | acurarubicin | 57576-44-0 | C42H53NO15 |
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—— | Azatadine Maleate | 3978-86-7 | C28H30N2O8 |
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—— | (3S,5R,6S,7S,8R,11R,12S,13R,14S,15S)-12-[(4-O-acetyl-2,6-dideoxy-3-O-methyl-alpha-L-arabino-hexopyranosyl)oxy]-14-{[2-O-acetyl-3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl]oxy}-5,7,8,11,13,15-hexamethyl-4,10-dioxo-1,9-dioxaspiro[2.13]hexadec-6-yl acetate | 2751-09-9 | C41H67NO15 |
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—— | Oligomycin A, 28-oxo- | 11050-94-5 | C45H72O12 |
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—— | Hydroxystilbamidine | 495-99-8 | C16H16N4O |
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