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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
—— Dolasetron mesylate hydrate 115956-13-3 C20H26N2O7S
Dolasetron mesylate hydrate
—— Oxabel Sodium salt 1173-88-2 C19H19N3NaO5S+
Oxabel Sodium salt
—— Pharmakon1600-01502038 30034-03-8 C18H18N6NaO5S2+
Pharmakon1600-01502038
—— [(5R)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl]-quinolin-4-ylmethanol 118-10-5 C19H22N2O
[(5R)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl]-quinolin-4-ylmethanol
—— MK-0991 (Acetate);L-743872 (Acetate) 179463-17-3 C56H96N10O19
MK-0991 (Acetate);L-743872 (Acetate)
—— 2-Cyano-5-(m-chlorophenethyl)-pyridin 31255-58-0 C14H11ClN2
2-Cyano-5-(m-chlorophenethyl)-pyridin
—— (1S,3R,5S,7S,8Z,12R,14Z,16Z,18Z,20Z,22S,24S,25R,26R)-22-[(3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatricyclo[22.3.1.05,7]octacosa-8,14,16,18,20-pentaene-25-carboxylic acid 7681-93-8 C33H47O13N
(1S,3R,5S,7S,8Z,12R,14Z,16Z,18Z,20Z,22S,24S,25R,26R)-22-[(3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatricyclo[22.3.1.05,7]octacosa-8,14,16,18,20-pentaene-25-carboxylic acid
—— (4-Ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxo-6-tricyclo[5.4.3.01,8]tetradecanyl) 2-[1-[(2-amino-3-methylbutanoyl)amino]-2-methylpropan-2-yl]sulfanylacetate;hydrochloride 133868-46-9 C31H53ClN2O5S
(4-Ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxo-6-tricyclo[5.4.3.01,8]tetradecanyl) 2-[1-[(2-amino-3-methylbutanoyl)amino]-2-methylpropan-2-yl]sulfanylacetate;hydrochloride
—— (1S,3E,4S)-3-[(2E)-2-[(1R,3aS,7aR)-1-[(E,2R)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylcyclohexan-1-ol 67-96-9 C28H46O
(1S,3E,4S)-3-[(2E)-2-[(1R,3aS,7aR)-1-[(E,2R)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylcyclohexan-1-ol
—— 2,3-dihydroxybutanedioic acid;methyl 11-acetyloxy-12-ethyl-4-(16-ethyl-12-methoxycarbonyl-1,10-diazatetracyclo[12.3.1.03,11.04,9]octadeca-3(11),4,6,8,15-pentaen-12-yl)-10-hydroxy-5-methoxy-8-methyl-8,16-diazapentacyclo[10.6.1.01,9.02,7.016,19]nonadeca-2,4,6,13-tetraene-10-carboxylate 125317-39-7 C53H66N4O20
2,3-dihydroxybutanedioic acid;methyl 11-acetyloxy-12-ethyl-4-(16-ethyl-12-methoxycarbonyl-1,10-diazatetracyclo[12.3.1.03,11.04,9]octadeca-3(11),4,6,8,15-pentaen-12-yl)-10-hydroxy-5-methoxy-8-methyl-8,16-diazapentacyclo[10.6.1.01,9.02,7.016,19]nonadeca-2,4,6,13-tetraene-10-carboxylate
—— Lactacyd 72-17-3 C3H6NaO3+
Lactacyd
—— (5Z)-5-[(2E)-2-[1-(6-hydroxy-6-methylheptan-2-yl)-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol 32222-06-3 C27H44O3
(5Z)-5-[(2E)-2-[1-(6-hydroxy-6-methylheptan-2-yl)-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol
—— Sodium levothyroxine pentahydrate 55-03-8 C15H21I4NNaO9+
Sodium levothyroxine pentahydrate
—— (2R,3R,6S)-3-[[(3R)-3-amino-5-[carbamimidoyl(methyl)amino]pentanoyl]amino]-6-(4-amino-2-oxopyrimidin-1-yl)-3,6-dihydro-2H-pyran-2-carboxylic acid 2079-00-7 C17H26N8O5
(2R,3R,6S)-3-[[(3R)-3-amino-5-[carbamimidoyl(methyl)amino]pentanoyl]amino]-6-(4-amino-2-oxopyrimidin-1-yl)-3,6-dihydro-2H-pyran-2-carboxylic acid
—— Pharmakon1600-01502031 66309-69-1 C16H17N3NaO7S2+
Pharmakon1600-01502031
—— 5-[3,3a,4,5,6,6a-Hexahydro-5-hydroxy-4-(3-hydroxy-4-methyl-1-octen-6-ynyl)pentalen-2(1H)-ylidene]pentanoic acid 78919-13-8 C22H32O4
5-[3,3a,4,5,6,6a-Hexahydro-5-hydroxy-4-(3-hydroxy-4-methyl-1-octen-6-ynyl)pentalen-2(1H)-ylidene]pentanoic acid
—— Triparsamide 554-72-3 C8H11AsN2NaO4+
Triparsamide
—— Cilastatin, Antibiotic for Culture Media Use Only 82009-34-5 C16H26N2O5S
Cilastatin, Antibiotic for Culture Media Use Only
—— 3-[[2-[2-[2-[[(2S,3R)-2-[[(2S,3S,4R)-4-[[(2S,3R)-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,4S,5S,6S)-3-[(2R,3S,4S,5R,6R)-4-carbamoyloxy-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-3-(1H-imidazol-5-yl)propanoyl]amino]-3-hydroxy-2-methylpentanoyl]amino]-3-hydroxybutanoyl]amino]ethyl]-1,3-thiazol-4-yl]-1,3-thiazole-4-carbonyl]amino]propyl-dimethylsulfanium;hydrochloride 67763-87-5 C55H85ClN17O21S3+
3-[[2-[2-[2-[[(2S,3R)-2-[[(2S,3S,4R)-4-[[(2S,3R)-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,4S,5S,6S)-3-[(2R,3S,4S,5R,6R)-4-carbamoyloxy-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-3-(1H-imidazol-5-yl)propanoyl]amino]-3-hydroxy-2-methylpentanoyl]amino]-3-hydroxybutanoyl]amino]ethyl]-1,3-thiazol-4-yl]-1,3-thiazole-4-carbonyl]amino]propyl-dimethylsulfanium;hydrochloride
—— tetrasodium;(6R,7R)-7-[[(2E)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyimino-1-oxidoethylidene]amino]-3-[(2-methyl-5,6-dioxo-1H-1,2,4-triazin-3-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate;heptahydrate 104376-79-6 C36H46N16Na4O21S6
tetrasodium;(6R,7R)-7-[[(2E)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyimino-1-oxidoethylidene]amino]-3-[(2-methyl-5,6-dioxo-1H-1,2,4-triazin-3-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate;heptahydrate
—— 1-Methyl-4-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)piperidin-1-ium;dichloride;trihydrate 41354-29-4 C42H50Cl2N2O3
1-Methyl-4-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)piperidin-1-ium;dichloride;trihydrate
—— erythro-(+/-)-(E)-7-[3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid tert-butyl ester 129332-29-2 C28H34FNO4
erythro-(+/-)-(E)-7-[3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid tert-butyl ester
—— component of Desenex 557-08-4 C11H20O2Zn+2
component of Desenex
—— 4-N-[7-chloro-2-[2-(2-chlorophenyl)ethenyl]quinolin-4-yl]-1-N,1-N-diethylpentane-1,4-diamine 10023-54-8 C26H31Cl2N3
4-N-[7-chloro-2-[2-(2-chlorophenyl)ethenyl]quinolin-4-yl]-1-N,1-N-diethylpentane-1,4-diamine
—— Bis(5-acetyl-8-hydroxyquinolinium) sulphate 57130-91-3 C22H20N2O8S
Bis(5-acetyl-8-hydroxyquinolinium) sulphate
—— Calcium titanium oxide (CaTiO3) 37226-56-5 CaO3Ti
Calcium titanium oxide (CaTiO3)
—— Bismuth oxide 12048-50-9 Bi2O3
Bismuth oxide
—— Potassium manganate 68081-75-4 K2MnO4
Potassium manganate
—— Zirconium methacrylate 84057-81-8 C16H20O8Zr
Zirconium methacrylate
—— Spiramycini 24916-50-5 C43H74N2O14
Spiramycini
—— Transderm scop (TN) 51-34-3 C17H21NO4
Transderm scop (TN)
—— (3S,4S,5R)-2-(2-amino-6-methoxypurin-9-yl)-5-(hydroxymethyl)oxolane-3,4-diol 121032-29-9 C11H15N5O5
(3S,4S,5R)-2-(2-amino-6-methoxypurin-9-yl)-5-(hydroxymethyl)oxolane-3,4-diol
—— Disodium 3-{[(4-{[2-carboxy-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-en-3-yl]sulfanyl}pyrrolidin-2-yl)(oxidanidyl)methylidene]amino}benzoate 153832-38-3 C22H23N3Na2O7S
Disodium 3-{[(4-{[2-carboxy-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-en-3-yl]sulfanyl}pyrrolidin-2-yl)(oxidanidyl)methylidene]amino}benzoate
—— methyl (1R,2S,9R,11S,14R,15S)-2,15-dimethyl-5,5'-dioxospiro[18-oxapentacyclo[8.8.0.01,17.02,7.011,15]octadec-6-ene-14,2'-oxolane]-9-carboxylate 107724-20-9 C24H30O6
methyl (1R,2S,9R,11S,14R,15S)-2,15-dimethyl-5,5'-dioxospiro[18-oxapentacyclo[8.8.0.01,17.02,7.011,15]octadec-6-ene-14,2'-oxolane]-9-carboxylate
—— 4-[4-[4-[4-[[(5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one 171228-49-2 C37H42F2N8O4
4-[4-[4-[4-[[(5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one
—— Copper citrate 866-82-0 C6H8Cu2O7+4
Copper citrate
—— Dicloguamine maleate;MN1695 84504-69-8 C13H11Cl2N5O4
Dicloguamine maleate;MN1695
—— (6Ar,9R)-N-[(2S)-1-hydroxybutan-2-yl]-7-methyl-6,6a,8,9-tetrahydro-4H-indolo[4,3-fg]quinoline-9-carboxamide;but-2-enedioic acid 57432-61-8 C24H29N3O6
(6Ar,9R)-N-[(2S)-1-hydroxybutan-2-yl]-7-methyl-6,6a,8,9-tetrahydro-4H-indolo[4,3-fg]quinoline-9-carboxamide;but-2-enedioic acid
—— calcium;4-butyl-5-oxo-1,2-diphenylpyrazol-3-olate 70145-60-7 C38H38CaN4O4
calcium;4-butyl-5-oxo-1,2-diphenylpyrazol-3-olate
—— (S)-6-(p-Bromophenyl)-2,3,5,6-tetrahydroimidazo(2,1-b)thiazole oxalate 62284-79-1 C13H13BrN2O4S
(S)-6-(p-Bromophenyl)-2,3,5,6-tetrahydroimidazo(2,1-b)thiazole oxalate
—— (6aR)-6-methyl-5,6,6a,7-tetrahydro-4H-dibenzo[de,g]quinoline-10,11-diol;hydron;dichloride;hydrate 314-19-2 C34H38Cl2N2O5
(6aR)-6-methyl-5,6,6a,7-tetrahydro-4H-dibenzo[de,g]quinoline-10,11-diol;hydron;dichloride;hydrate
—— (4S,5R,9R,10S,12R,13R)-1,5,9-trimethyl-11,14,15,16-tetraoxatetracyclo[10.3.1.04,13.08,13]hexadecan-10-ol 71939-50-9 C15H24O5
(4S,5R,9R,10S,12R,13R)-1,5,9-trimethyl-11,14,15,16-tetraoxatetracyclo[10.3.1.04,13.08,13]hexadecan-10-ol
—— Cefprozil monohydrate 121123-17-9 C18H21N3O6S
Cefprozil monohydrate
—— (6R,7R)-3-((1H-imidazo[1,2-b]pyridazin-4-ium-1-yl)methyl)-7-((Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-(methoxyimino)acetamido)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate 113359-04-9 C19H17N9O5S2
(6R,7R)-3-((1H-imidazo[1,2-b]pyridazin-4-ium-1-yl)methyl)-7-((Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-(methoxyimino)acetamido)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
—— Cefotetan (disodium) 74356-00-6 C17H15N7Na2O8S4
Cefotetan (disodium)
—— Terbutaline Sulfate 23031-32-5 C24H40N2O10S
Terbutaline Sulfate
—— (2R,3S)-3-(1-oxonona-4,7-dienyl)-2-oxiranecarboxamide 17397-89-6 C12H17NO3
(2R,3S)-3-(1-oxonona-4,7-dienyl)-2-oxiranecarboxamide
—— Scopolamine 51-34-3 C17H21NO4
Scopolamine
—— Benzaldehyde, 4-(beta-D-allopyranosyloxy)- 80154-34-3 C13H16O7
Benzaldehyde, 4-(beta-D-allopyranosyloxy)-
—— Dtxcid3025962 71939-50-9 C15H24O5
Dtxcid3025962