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原料药

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
—— iclepertin 1421936-85-7 C20H18F6N2O5S
iclepertin
—— (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
(4-nitrophenyl)methyl (5R,6S)-3-diphenoxyphosphoryloxy-6-[(1R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
—— Insulin (cattle) 11070-73-8 C254H377N65O75S6
Insulin (cattle)
—— Hydroxocobalamin (hydrochloride) 13422-52-1 C62H91ClCoN13O15P
Hydroxocobalamin (hydrochloride)
—— Sulfobromophthalein sodium hydrate 123359-42-2 C20H10Br4Na2O11S2
Sulfobromophthalein sodium hydrate
—— 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
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
—— 6β-((R)-2-amino-2-phenyl-acetylamino)-penicillanic acid (S)-3-oxo-1,3-dihydro-isobenzofuran-1-yl ester 47747-56-8 C24H23N3O6S
6β-((R)-2-amino-2-phenyl-acetylamino)-penicillanic acid (S)-3-oxo-1,3-dihydro-isobenzofuran-1-yl ester
—— azelastine hydrochloride 79307-93-0 C22H26ClN3O*ClH
azelastine hydrochloride
—— 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
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
—— (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
(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)
—— 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
deamino-Cys(1)-DL-Tyr-DL-Phe-DL-Gln-DL-Asn-DL-Cys(1)-DL-Pro-DL-Arg-Gly-NH2.2CH3CO2H
—— 16α-Hydroxy-prednisolon 13951-70-7 C21H28O6
16α-Hydroxy-prednisolon
—— Clobetasol propionate 25122-46-7 C25H32ClFO5
Clobetasol propionate
—— (+)-Cinchonine monohydrochloride 5949-11-1 C19H23ClN2O
(+)-Cinchonine monohydrochloride
—— Injectafer 9007-72-1 C24H44FeO25-
Injectafer
—— 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
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
—— epi-dihydroquinine 522-66-7 C20H26N2O2
epi-dihydroquinine
—— (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
(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
—— (+)-<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
(+)-<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
—— 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
Calcium;2-[[4-[(2-amino-5-formyl-4-oxo-3,6,7,8-tetrahydropteridin-6-yl)methylamino]benzoyl]amino]pentanedioate;pentahydrate
—— Dihydroergotoxine mesilate 8067-24-1 C134H184N20O32S4
Dihydroergotoxine mesilate
—— Benzenesulfonic acid, hydroxymethoxy-, monopotassium salt 1321-14-8 C7H7KO5S
Benzenesulfonic acid, hydroxymethoxy-, monopotassium salt
—— [(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
[(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
—— fumagillin 23110-15-8 C26H34O7
fumagillin
—— (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
(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
—— 17β-Hydroxy-7α-methyloestr-4-en-3-on-acetat 6157-87-5 C21H30O3
17β-Hydroxy-7α-methyloestr-4-en-3-on-acetat
—— 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
alpha-D-Glucopyranosiduronic acid, (3beta,20beta)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-beta-D-glucopyranuronosyl-, monopotassium salt
—— 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
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
—— Nebramycin II (sulfate) 41194-16-5 C21H43N5O15S
Nebramycin II (sulfate)
—— (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
(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
—— (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
(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
—— 6-Chlor-6-dehydro-17α-hydroxyprogesteron 1961-77-9 C21H27ClO3
6-Chlor-6-dehydro-17α-hydroxyprogesteron
—— L-Ascorbic acid, 2-(dihydrogen phosphate), magnesium salt (2:3) 114040-31-2 C12H10Mg3O18P2-2
L-Ascorbic acid, 2-(dihydrogen phosphate), magnesium salt (2:3)
—— 1,1'-bis(pyridinium-4-aldoxime)trimethylene dibromide 56-97-3 2Br*C15H18N4O2
1,1'-bis(pyridinium-4-aldoxime)trimethylene dibromide
—— N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methy]-L-valine 137863-60-6 C24H29N5O3
N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methy]-L-valine
—— 1-methyl-1-nitroso-3-[(3R,4R,5S)-2,4,5-trihydroxy-6-(hydroxymethyl)oxan-3-yl]urea 18883-66-4 C8H15N3O7
1-methyl-1-nitroso-3-[(3R,4R,5S)-2,4,5-trihydroxy-6-(hydroxymethyl)oxan-3-yl]urea
—— kanamycin A 59-01-8 C18H36N4O11
kanamycin A
—— 7-Chlor-7-deoxylincomycin 16684-06-3 C18H33ClN2O5S
7-Chlor-7-deoxylincomycin
—— 12115-66-1 CHMgO4-3
—— 2-chloro-6β,9α-difluoro-11β,17α,21-trihydroxy-16β-methyl-pregna-1,4-diene-3,20-dione 50629-82-8 C22H27ClF2O5
2-chloro-6β,9α-difluoro-11β,17α,21-trihydroxy-16β-methyl-pregna-1,4-diene-3,20-dione
—— calcium (S)-pantothenate 137-08-6 2C9H16NO5*Ca
calcium (S)-pantothenate
—— Streptomycin sulfate 3810-74-0 2C21H39N7O12*3H2O4S
Streptomycin sulfate
—— 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
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)
—— Calcifediol hydrate 63283-36-3 C27H46O3
Calcifediol hydrate
—— [(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
[(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
—— hexacalcium myo-inositol hexakis(phosphate) 7776-28-5 C6H6O24P6*6Ca
hexacalcium myo-inositol hexakis(phosphate)
—— L-carbenicillin 4697-36-3 C17H18N2O6S
L-carbenicillin
—— 3,3',3''-Trimethyl-1,1',1''-triphenyl-4,4',4''-tris-(2-pyrazolin-5-on) 124009-63-8 C30H26N6O3
3,3',3''-Trimethyl-1,1',1''-triphenyl-4,4',4''-tris-(2-pyrazolin-5-on)
—— (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
(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
—— 17-deacetylated norgestimate 53016-31-2 C21H29NO2
17-deacetylated norgestimate