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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—— | iclepertin | 1421936-85-7 | C20H18F6N2O5S |
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—— | (4-nitrophenyl)methyl (5R,6S)-3-diphenoxyphosphoryloxy-6-[(1R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate | 75321-08-3 | C28H25N2O10P |
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—— | Insulin (cattle) | 11070-73-8 | C254H377N65O75S6 |
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—— | Hydroxocobalamin (hydrochloride) | 13422-52-1 | C62H91ClCoN13O15P |
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—— | Sulfobromophthalein sodium hydrate | 123359-42-2 | C20H10Br4Na2O11S2 |
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—— | sodium (R)-4-((3R,5S,7R,8R,9S,10S,12S,13R,14S,17R)-3,7,12-trihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoate hydrate | 73163-53-8 | C24H41NaO6 |
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—— | 6β-((R)-2-amino-2-phenyl-acetylamino)-penicillanic acid (S)-3-oxo-1,3-dihydro-isobenzofuran-1-yl ester | 47747-56-8 | C24H23N3O6S |
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—— | azelastine hydrochloride | 79307-93-0 | C22H26ClN3O*ClH |
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—— | 4-(2-{[(6R,7R)-2-carboxylato-7-[(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]sulfanyl}-1,3-thiazol-4-yl)-1-methylpyridin-1-ium acetic acid hydrate | 866021-48-9 | C24H27N8O11PS4 |
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—— | (2R,3R,4R,5R)-2-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-2-cyano-5-((isobutyryloxy)methyl)tetrahydrofuran-3,4-diyl bis(2-methylpropanoate) | 2647442-13-3 | C24H31N5O7 |
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—— | deamino-Cys(1)-DL-Tyr-DL-Phe-DL-Gln-DL-Asn-DL-Cys(1)-DL-Pro-DL-Arg-Gly-NH2.2CH3CO2H | 16789-98-3 | C50H72N14O16S2 |
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—— | 16α-Hydroxy-prednisolon | 13951-70-7 | C21H28O6 |
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—— | Clobetasol propionate | 25122-46-7 | C25H32ClFO5 |
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—— | (+)-Cinchonine monohydrochloride | 5949-11-1 | C19H23ClN2O |
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—— | Injectafer | 9007-72-1 | C24H44FeO25- |
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—— | 1,2-Ethanediamine, N,N'-bis(phenylmethyl)-, bis((2S-(2alpha,5alpha,6beta))-3,3-dimethyl-7-oxo-6-((phenoxyacetyl)amino)-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate), octahydrate | 63690-57-3 | C48H72N6O18S2 |
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—— | epi-dihydroquinine | 522-66-7 | C20H26N2O2 |
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—— | (1S,3S,5Z)-5-[(2E)-2-[(1R,3aR,7aR)-1-[(E,2S)-5-Cyclopropyl-5-hydroxy-pent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidene-cyclohexane-1,3-diol | 112965-21-6 | C27H40O3 |
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—— | (+)-<i>N</i><sup>4</sup>,<i>N</i><sup>4</sup>-diethyl-<i>N</i><sup>1</sup>-(6-chloro-2-methoxy-acridin-9-yl)-1-methyl-butanediyldiamine; dihydrochloride | 56100-42-6 | C23H30ClN3O*2ClH |
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—— | Calcium;2-[[4-[(2-amino-5-formyl-4-oxo-3,6,7,8-tetrahydropteridin-6-yl)methylamino]benzoyl]amino]pentanedioate;pentahydrate | 41927-89-3 | C20H31CaN7O12 |
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—— | Dihydroergotoxine mesilate | 8067-24-1 | C134H184N20O32S4 |
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—— | Benzenesulfonic acid, hydroxymethoxy-, monopotassium salt | 1321-14-8 | C7H7KO5S |
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—— | [(2R,3R,4S,6S)-3-hydroxy-6-[(2R,3S,4S,6S)-4-hydroxy-6-[(2R,3S,4S,6R)-4-hydroxy-6-[[(3S,5R,8S,9R,10S,13R,14S,17R)-14-hydroxy-10,13-dimethyl-17-(5-oxo-2H-furan-3-yl)-1,2,3,4,5,6,7,8,9,11,12,15,16,17-tetradecahydrocyclopenta[a]phenanthren-3-yl]oxy]-2-methyloxan-3-yl]oxy-2-methyloxan-3-yl]oxy-2-methyloxan-4-yl] acetate | 1111-39-3 | C43H66O14 |
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—— | fumagillin | 23110-15-8 | C26H34O7 |
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—— | (8S,9R,10S,11S,13S,14S,16R,17R)-17-(2-chloroacetyl)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one | 25122-41-2 | C22H28ClFO4 |
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—— | 17β-Hydroxy-7α-methyloestr-4-en-3-on-acetat | 6157-87-5 | C21H30O3 |
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—— | alpha-D-Glucopyranosiduronic acid, (3beta,20beta)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-beta-D-glucopyranuronosyl-, monopotassium salt | 68797-35-3 | C42H62KO16 |
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—— | 18-[[(1S)-4-[2-[2-[2-[2-[2-[2-[[(5S)-5-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-2-[[2-[[(2S)-2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]-2-methylpropanoyl]amino]-4-carboxybutanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-methylbutanoyl]amino]-3-hydroxypropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-4-carboxybutanoyl]amino]acetyl]amino]-5-oxopentanoyl]amino]propanoyl]amino]propanoyl]amino]-6-[[(2S)-1-[[(2S)-1-[[(2S,3S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-5-carbamimidamido-1-[[2-[[(2S)-5-carbamimidamido-1-(carboxymethylamino)-1-oxopentan-2-yl]amino]-2-oxoethyl]amino]-1-oxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1-oxopropan-2-yl]amino]-3-methyl-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-6-oxohexyl]amino]-2-oxoethoxy]ethoxy]ethylamino]-2-oxoethoxy]ethoxy]ethylamino]-1-carboxy-4-oxobutyl]amino]-18-oxooctadecanoic acid | 910463-68-2 | C187H291N45O59 |
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—— | Nebramycin II (sulfate) | 41194-16-5 | C21H43N5O15S |
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—— | (6R,7R)-3-(acetyloxymethyl)-7-[(5-amino-5-carboxypentanoyl)amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid;zinc | 59143-60-1 | C16H21N3O8SZn |
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—— | (2S,5R,6R)-6-[[3-(2-chlorophenyl)-5-methyl-1,2-oxazole-4-carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid;N,N'-dibenzylethane-1,2-diamine | 27487-35-0 | C35H38ClN5O5S |
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—— | 6-Chlor-6-dehydro-17α-hydroxyprogesteron | 1961-77-9 | C21H27ClO3 |
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—— | L-Ascorbic acid, 2-(dihydrogen phosphate), magnesium salt (2:3) | 114040-31-2 | C12H10Mg3O18P2-2 |
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—— | 1,1'-bis(pyridinium-4-aldoxime)trimethylene dibromide | 56-97-3 | 2Br*C15H18N4O2 |
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—— | N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methy]-L-valine | 137863-60-6 | C24H29N5O3 |
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—— | 1-methyl-1-nitroso-3-[(3R,4R,5S)-2,4,5-trihydroxy-6-(hydroxymethyl)oxan-3-yl]urea | 18883-66-4 | C8H15N3O7 |
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—— | kanamycin A | 59-01-8 | C18H36N4O11 |
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—— | 7-Chlor-7-deoxylincomycin | 16684-06-3 | C18H33ClN2O5S |
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—— | 12115-66-1 | CHMgO4-3 |
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—— | 2-chloro-6β,9α-difluoro-11β,17α,21-trihydroxy-16β-methyl-pregna-1,4-diene-3,20-dione | 50629-82-8 | C22H27ClF2O5 |
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—— | calcium (S)-pantothenate | 137-08-6 | 2C9H16NO5*Ca |
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—— | Streptomycin sulfate | 3810-74-0 | 2C21H39N7O12*3H2O4S |
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—— | D-Streptamine, O-2-deoxy-2-(methylamino)-α-L-glucopyranosyl-(1→2)-O-5-deoxy-3-C-formyl-α-L-lyxofuranosyl-(1→4)-N1,N3-bis(aminoiminomethyl)-, sulfate (2:3) | 3810-74-0 | C21H39N7O12*H2O4S |
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—— | Calcifediol hydrate | 63283-36-3 | C27H46O3 |
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—— | [(3S,4S,5R,6R)-2-[(2R,3S,4S,5S,6S)-2-[(1R,2S)-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,4R)-5-[[(3R)-1-[2-[4-[4-[3-(4-aminobutylamino)propylcarbamoyl]-1,3-thiazol-2-yl]-1,3-thiazol-2-yl]ethylamino]-3-hydroxy-1-oxobutan-2-yl]amino]-3-hydroxy-4-methyl-5-oxopentan-2-yl]amino]-1-(1H-imidazol-5-yl)-3-oxopropoxy]-4,5-dihydroxy-6-(hydroxymethyl)oxan-3-yl]oxy-3,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl] carbamate;hydrochloride | 55658-47-4 | C57H90ClN19O21S2 |
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—— | hexacalcium myo-inositol hexakis(phosphate) | 7776-28-5 | C6H6O24P6*6Ca |
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—— | L-carbenicillin | 4697-36-3 | C17H18N2O6S |
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—— | 3,3',3''-Trimethyl-1,1',1''-triphenyl-4,4',4''-tris-(2-pyrazolin-5-on) | 124009-63-8 | C30H26N6O3 |
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—— | (1R,3R,5Z)-5-[(2E)-2-[(1R,3aR,7aR)-1-[(E,2R)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol | 112828-00-9 | C27H40O3 |
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—— | 17-deacetylated norgestimate | 53016-31-2 | C21H29NO2 |
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