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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—— | (3S,5R)-fluvastatin sodium | 93957-55-2 | C24H26FNNaO4 |
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—— | calcium;(E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid | 147511-69-1 | C25H24CaFNO4+2 |
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—— | 17α-methyl-19-norpregna-4,9-diene-3,20-dione | 10116-22-0 | C21H28O2 |
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—— | 5-Chloro-6-(7,8-epoxy-10-hydroxy-2-oxo-3,5-undecadienyl)-beta-resorcylic acid mu-lactone | 12772-57-5 | C18H17ClO6 |
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—— | Pharmakon1600-01500346 | 101-31-5 | C17H23NO3 |
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—— | [(3R,5R,6S,7R,8E,10R,11R,12Z,14E)-6-hydroxy-5,11,21-trimethoxy-3,7,9,15-tetramethyl-16,20,22-trioxo-17-azabicyclo[16.3.1]docosa-1(21),8,12,14,18-pentaen-10-yl] carbamate | 30562-34-6 | C29H40N2O9 |
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—— | Filimarisin | 11078-21-0 | C35H58O11 |
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—— | Monorden (B117339F008) | 12772-57-5 | C18H17ClO6 |
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—— | 4-hydroxy-N-[(5-nitro-2-furanyl)methylideneamino]benzamide | 965-52-6 | C12H9N3O5 |
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—— | (1S,2R,5R,7R,8R,9S,11R,13R,14R)-8-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-9-methoxy-1,5,7,9,11,13-hexamethyl-15-[4-(4-pyridin-3-ylimidazol-1-yl)butyl]-3,17-dioxa-15-azabicyclo[12.3.0]heptadecane-4,6,12,16-tetrone | 191114-48-4 | C43H65N5O10 |
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—— | Josacine | 16846-24-5 | C42H69NO15 |
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—— | (2R,3R,6R,7S,8S,9R,10R,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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—— | (1S,2R,5S,7R,8R,9R,11R,13R,14R)-8-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-9-methoxy-1,5,7,9,11,13-hexamethyl-15-[4-(4-pyridin-3-ylimidazol-1-yl)butyl]-3,17-dioxa-15-azabicyclo[12.3.0]heptadecane-4,6,12,16-tetrone | 191114-48-4 | C43H65N5O10 |
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—— | Pharmakon1600-01500354 | 22254-24-6 | C20H30BrNO3 |
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—— | (3-Amino-1-hydroxy-1-phosphonopropyl)phosphonic acid; sodium | 57248-88-1 | C3H11NNaO7P2 |
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—— | Cloxacillin(1-) | 642-78-4 | C19H17ClN3O5S- |
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—— | 2,3-dihydroxybutanedioic acid;N,N,2-trimethyl-3-phenothiazin-10-ylpropan-1-amine | 4330-99-8 | C40H50N4O6S2 |
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—— | Chloropheniramine maleate | 113-92-8 | C20H23ClN2O4 |
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—— | 1-Methyl-4-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)piperidine;trihydrate;hydrochloride | 41354-29-4 | C21H28ClNO3 |
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—— | Oestriol-cyclopentylaether-(3) | 1169-79-5 | C23H32O3 |
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—— | Perospirone hydrochloride | 129273-38-7 | C23H30N4O2S*ClH |
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—— | (2R,3S,4S,4aS,10bR)-3,4,8,10-tetrahydroxy-2-(hydroxymethyl)-9-methoxy-3,4,4a,10b-tetrahydro-2H-pyrano[3,2-c][2]benzopyran-6-one | 477-90-7 | C14H16O9 |
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—— | d-Na{BiC4H2O6} | 31586-77-3 | Bi*C4H2O6*Na |
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—— | Zorubicin hydrochloride | 36508-71-1 | C34H36ClN3O10 |
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—— | Cefditoren sodium | 104146-53-4 | C19H18N6NaO5S3+ |
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—— | (1S,9R,13E)-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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—— | Davitamon D | 50-14-6 | C28H44O |
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—— | (4R,6R,8R,9E,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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—— | (2S,4R)-N-[(1S,2S)-2-Hydroxy-1-[(2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-methylsulfanyloxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide;hydrochloride | 859-18-7 | C18H35ClN2O6S |
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—— | (Z)-7-[(2S)-2-amino-2-carboxyethyl]sulfanyl-2-[[(1R)-2,2-dimethylcyclopropanecarbonyl]amino]hept-2-enoic acid | 82009-34-5 | C16H26N2O5S |
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—— | 2-[(4E,6E)-7-cyano-8,16-dihydroxy-9,11,13,15-tetramethyl-18-oxo-1-oxacyclooctadeca-4,6-dien-2-yl]cyclopentane-1-carboxylic acid | 7184-60-3 | C28H43NO6 |
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—— | (2S,4R)-N-[2-chloro-1-[(3R,4S,5R,6R)-3,4,5-trihydroxy-6-methylsulfanyloxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide;hydrochloride | 21462-39-5 | C18H34Cl2N2O5S |
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—— | Ketocanazole | 65277-42-1 | C26H28Cl2N4O4 |
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—— | Tylosin, 4A-O-de(2,6-dideoxy-3-C-methyl-alpha-L-ribo-hexopyranosyl)-20-deoxo-20-[(3R,5S)-3,5-dimethyl-1-piperidinyl]- | 108050-54-0 | C46H80N2O13 |
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—— | Aclatonium napadisilate | 55077-30-0 | C30H46N2O14S2 |
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—— | Bis(talmon); vanadium monoxide | 38213-69-3 | C12H12O7V |
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—— | calcium;(2S)-4-[(3aS,7aR)-1,3,3a,4,5,6,7,7a-octahydroisoindol-2-yl]-2-benzyl-4-oxobutanoate | 145525-41-3 | C38H48CaN2O6 |
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—— | 1-[(4S,5R)-3,4-dihydroxy-5-methyl-2-oxolanyl]-5-fluoropyrimidine-2,4-dione | 3094-09-5 | C9H11FN2O5 |
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—— | (2E,5S,6R,7S,9R,10E,12E,15R,16Z,18E)-17-ethyl-6-hydroxy-3,5,7,9,11,15-hexamethyl-19-[(2R,3R)-3-methyl-6-oxo-2,3-dihydropyran-2-yl]-8-oxononadeca-2,10,12,16,18-pentaenoic acid | 87081-35-4 | C33H48O6 |
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—— | (2R)-2-[[(2S,3S,4S)-2-amino-5-carbamoyloxy-3,4-dihydroxypentanoyl]amino]-2-[(2R,3S,4R,5R)-3,4-dihydroxy-5-[5-(hydroxymethyl)-2,4-dioxopyrimidin-1-yl]oxolan-2-yl]acetic acid | 19396-06-6 | C17H25N5O13 |
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—— | (1S,4S,13S,16S,19R,22S,25S,28R,31S,37S,40R,41R,44R,47S,50S,53R,56R,65S,70R)-44-amino-47-(4-aminobutyl)-37-(2-amino-2-oxoethyl)-50-(3-amino-3-oxopropyl)-4,16,22-tribenzyl-31-[(R)-carboxy(hydroxy)methyl]-41,70-dimethyl-2,5,8,14,17,20,23,26,29,32,35,38,45,48,51,54,57,67-octadecaoxo-25-propan-2-yl-42,69,72-trithia-3,6,9,15,18,21,24,27,30,33,36,39,46,49,52,55,58,60,66-nonadecazapentacyclo[38.18.9.319,56.328,53.09,13]triheptacontane-65-carboxylic acid | 1391-36-2 | C89H125N23O25S3 |
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—— | Sucralfate | 54182-58-0 | C12H54Al9O55S8 |
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—— | Elobixibat Hydrate | 1633824-78-8 | C36H47N3O8S2 |
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—— | (E)-7-[(2R)-2-amino-2-carboxyethyl]sulfanyl-2-[(2,2-dimethylcyclopropanecarbonyl)amino]hept-2-enoic acid | 82009-34-5 | C16H26N2O5S |
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—— | sodium;4-[(1R,2R,3aS,8bS)-2-hydroxy-1-[(3S)-3-hydroxy-4-methyloct-1-en-6-ynyl]-2,3,3a,8b-tetrahydro-1H-cyclopenta[b][1]benzofuran-5-yl]butanoate | 88475-69-8 | C24H29O5*Na |
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—— | (6S,7S)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-hydroxyiminoacetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 91832-40-5 | C14H13N5O5S2 |
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—— | (6R,7S,10S,11R,12E,17Z,19E,21S)-6-[2-(diethylamino)ethylsulfonyl]-21-hydroxy-11,19-dimethyl-10-propan-2-yl-9,26-dioxa-3,15,28-triazatricyclo[23.2.1.03,7]octacosa-1(27),12,17,19,25(28)-pentaene-2,8,14,23-tetrone | 112362-50-2 | C34H50N4O9S |
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—— | Cefsulodin sodium salt hydrate, third-generation cephalosporin antibiotic | 52152-93-9 | C22H21N4NaO8S2+ |
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—— | D-fructose-1,6-diphosphate | 488-69-7 | C6H14O12P2 |
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—— | (2R)-2-[[(2S)-5-(diaminomethylideneamino)-1-[[(2R)-1-[[(2S)-5-(diaminomethylideneamino)-1-oxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1-oxopentan-2-yl]carbamoylamino]-3-phenylpropanoic acid | 37691-11-5 | C27H44N10O6 |
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