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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
—— (3S,5R)-fluvastatin sodium 93957-55-2 C24H26FNNaO4
(3S,5R)-fluvastatin sodium
—— calcium;(E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid 147511-69-1 C25H24CaFNO4+2
calcium;(E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid
—— 17α-methyl-19-norpregna-4,9-diene-3,20-dione 10116-22-0 C21H28O2
17α-methyl-19-norpregna-4,9-diene-3,20-dione
—— 5-Chloro-6-(7,8-epoxy-10-hydroxy-2-oxo-3,5-undecadienyl)-beta-resorcylic acid mu-lactone 12772-57-5 C18H17ClO6
5-Chloro-6-(7,8-epoxy-10-hydroxy-2-oxo-3,5-undecadienyl)-beta-resorcylic acid mu-lactone
—— Pharmakon1600-01500346 101-31-5 C17H23NO3
Pharmakon1600-01500346
—— [(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
[(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
—— Filimarisin 11078-21-0 C35H58O11
Filimarisin
—— Monorden (B117339F008) 12772-57-5 C18H17ClO6
Monorden (B117339F008)
—— 4-hydroxy-N-[(5-nitro-2-furanyl)methylideneamino]benzamide 965-52-6 C12H9N3O5
4-hydroxy-N-[(5-nitro-2-furanyl)methylideneamino]benzamide
—— (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
(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
—— Josacine 16846-24-5 C42H69NO15
Josacine
—— (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
(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
—— (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
(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
—— Pharmakon1600-01500354 22254-24-6 C20H30BrNO3
Pharmakon1600-01500354
—— (3-Amino-1-hydroxy-1-phosphonopropyl)phosphonic acid; sodium 57248-88-1 C3H11NNaO7P2
(3-Amino-1-hydroxy-1-phosphonopropyl)phosphonic acid; sodium
—— Cloxacillin(1-) 642-78-4 C19H17ClN3O5S-
Cloxacillin(1-)
—— 2,3-dihydroxybutanedioic acid;N,N,2-trimethyl-3-phenothiazin-10-ylpropan-1-amine 4330-99-8 C40H50N4O6S2
2,3-dihydroxybutanedioic acid;N,N,2-trimethyl-3-phenothiazin-10-ylpropan-1-amine
—— Chloropheniramine maleate 113-92-8 C20H23ClN2O4
Chloropheniramine maleate
—— 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
1-Methyl-4-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)piperidine;trihydrate;hydrochloride
—— Oestriol-cyclopentylaether-(3) 1169-79-5 C23H32O3
Oestriol-cyclopentylaether-(3)
—— Perospirone hydrochloride 129273-38-7 C23H30N4O2S*ClH
Perospirone hydrochloride
—— (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
(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
—— d-Na{BiC4H2O6} 31586-77-3 Bi*C4H2O6*Na
d-Na{BiC4H2O6}
—— Zorubicin hydrochloride 36508-71-1 C34H36ClN3O10
Zorubicin hydrochloride
—— Cefditoren sodium 104146-53-4 C19H18N6NaO5S3+
Cefditoren sodium
—— (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
(1S,9R,13E)-1-amino-13-ethylidene-11-methyl-6-azatricyclo[7.3.1.02,7]trideca-2(7),3,10-trien-5-one
—— Davitamon D 50-14-6 C28H44O
Davitamon D
—— (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
(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
—— (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
(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
—— (Z)-7-[(2S)-2-amino-2-carboxyethyl]sulfanyl-2-[[(1R)-2,2-dimethylcyclopropanecarbonyl]amino]hept-2-enoic acid 82009-34-5 C16H26N2O5S
(Z)-7-[(2S)-2-amino-2-carboxyethyl]sulfanyl-2-[[(1R)-2,2-dimethylcyclopropanecarbonyl]amino]hept-2-enoic acid
—— 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
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
—— (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
(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
—— Ketocanazole 65277-42-1 C26H28Cl2N4O4
Ketocanazole
—— 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
Tylosin, 4A-O-de(2,6-dideoxy-3-C-methyl-alpha-L-ribo-hexopyranosyl)-20-deoxo-20-[(3R,5S)-3,5-dimethyl-1-piperidinyl]-
—— Aclatonium napadisilate 55077-30-0 C30H46N2O14S2
Aclatonium napadisilate
—— Bis(talmon); vanadium monoxide 38213-69-3 C12H12O7V
Bis(talmon); vanadium monoxide
—— calcium;(2S)-4-[(3aS,7aR)-1,3,3a,4,5,6,7,7a-octahydroisoindol-2-yl]-2-benzyl-4-oxobutanoate 145525-41-3 C38H48CaN2O6
calcium;(2S)-4-[(3aS,7aR)-1,3,3a,4,5,6,7,7a-octahydroisoindol-2-yl]-2-benzyl-4-oxobutanoate
—— 1-[(4S,5R)-3,4-dihydroxy-5-methyl-2-oxolanyl]-5-fluoropyrimidine-2,4-dione 3094-09-5 C9H11FN2O5
1-[(4S,5R)-3,4-dihydroxy-5-methyl-2-oxolanyl]-5-fluoropyrimidine-2,4-dione
—— (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
(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
—— (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
(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
—— (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
(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
—— Sucralfate 54182-58-0 C12H54Al9O55S8
Sucralfate
—— Elobixibat Hydrate 1633824-78-8 C36H47N3O8S2
Elobixibat Hydrate
—— (E)-7-[(2R)-2-amino-2-carboxyethyl]sulfanyl-2-[(2,2-dimethylcyclopropanecarbonyl)amino]hept-2-enoic acid 82009-34-5 C16H26N2O5S
(E)-7-[(2R)-2-amino-2-carboxyethyl]sulfanyl-2-[(2,2-dimethylcyclopropanecarbonyl)amino]hept-2-enoic acid
—— 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
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
—— (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
(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
—— (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
(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
—— Cefsulodin sodium salt hydrate, third-generation cephalosporin antibiotic 52152-93-9 C22H21N4NaO8S2+
Cefsulodin sodium salt hydrate, third-generation cephalosporin antibiotic
—— D-fructose-1,6-diphosphate 488-69-7 C6H14O12P2
D-fructose-1,6-diphosphate
—— (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
(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