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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
—— cyctochalasin B 14930-96-2 C29H37NO5
cyctochalasin B
—— monensin 17090-79-8 C36H62O11
monensin
—— 17-methyltestosterone 58-18-4 C20H30O2
17-methyltestosterone
—— [8-Acetyloxy-11-ethyl-5-hydroxy-6,16,18-trimethoxy-13-(methoxymethyl)-11-azahexacyclo[7.7.2.12,5.01,10.03,8.013,17]nonadecan-4-yl] 4-methoxybenzoate 79592-91-9 C35H49NO10
[8-Acetyloxy-11-ethyl-5-hydroxy-6,16,18-trimethoxy-13-(methoxymethyl)-11-azahexacyclo[7.7.2.12,5.01,10.03,8.013,17]nonadecan-4-yl] 4-methoxybenzoate
—— 6β-[(<i>R</i>)-2-(furan-2-carbonyloxy)-4-methyl-pentanoylamino]-penicillanic acid 54340-65-7 C19H24N2O7S
6β-[(<i>R</i>)-2-(furan-2-carbonyloxy)-4-methyl-pentanoylamino]-penicillanic acid
—— (c)(3/4)-Oryzanol;Gamma Oryzanol 11042-64-1 C40H58O4
(c)(3/4)-Oryzanol;Gamma Oryzanol
—— 3ξ-hydroxy-androst-5-en-17-one 53-43-0 C19H28O2
3ξ-hydroxy-androst-5-en-17-one
—— sulbactam 68373-14-8 C8H11NO5S
sulbactam
—— Strophanthin 11005-63-3 C36H54O14
Strophanthin
—— (3S,5R,E)-7-(3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl)-3,5-dihydroxyhept-6-enoic acid 93957-54-1 C24H26FNO4
(3S,5R,E)-7-(3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl)-3,5-dihydroxyhept-6-enoic acid
—— artesunate 88495-63-0 C19H28O8
artesunate
—— 1-[3-(Acetylsulfanyl)-2-methylpropanoyl]prolylphenylalanine 74258-86-9 C20H26N2O5S
1-[3-(Acetylsulfanyl)-2-methylpropanoyl]prolylphenylalanine
—— (+)-anhydrovinblastine 38390-45-3 C46H56N4O8
(+)-anhydrovinblastine
—— 16b-Ethyl-19-nortestosterone 33765-68-3 C20H30O2
16b-Ethyl-19-nortestosterone
—— 4-Epi Minocycline (>80%, contains unidentified salts) 10118-90-8 C23H27N3O7
4-Epi Minocycline (>80%, contains unidentified salts)
—— 3-alpha-Hydroxy-7-oxo-5-beta-cholan-24-oic acid 4651-67-6 C24H38O4
3-alpha-Hydroxy-7-oxo-5-beta-cholan-24-oic acid
—— alfaxalone 565-99-1 C21H32O3
alfaxalone
—— borneol 507-70-0 C10H18O
borneol
—— naltrexone 16590-41-3 C20H23NO4
naltrexone
—— (d5 major; contains D0) 103060-53-3 C72H101N17O26
(d5 major; contains D0)
—— [6-[4-(Dimethylamino)-3-hydroxy-5-(4-hydroxy-4,6-dimethyl-5-propanoyloxyoxan-2-yl)oxy-6-methyloxan-2-yl]oxy-10-hydroxy-5-methoxy-9,16-dimethyl-2-oxo-7-(2-oxoethyl)-1-oxacyclohexadeca-11,13-dien-4-yl] propanoate 35457-80-8 C41H67NO15
[6-[4-(Dimethylamino)-3-hydroxy-5-(4-hydroxy-4,6-dimethyl-5-propanoyloxyoxan-2-yl)oxy-6-methyloxan-2-yl]oxy-10-hydroxy-5-methoxy-9,16-dimethyl-2-oxo-7-(2-oxoethyl)-1-oxacyclohexadeca-11,13-dien-4-yl] propanoate
—— [6-[2-[4-(11-Ethyl-10,12-dihydroxy-3,17-dimethoxy-7,9,13,15-tetramethyl-18-oxo-1-oxacyclooctadeca-4,6,14,16-tetraen-2-yl)-3-hydroxypentan-2-yl]-2-hydroxy-5-methyl-6-prop-1-enyloxan-4-yl]oxy-4-hydroxy-2-methyloxan-3-yl] carbamate 80890-47-7 C46H75NO14
[6-[2-[4-(11-Ethyl-10,12-dihydroxy-3,17-dimethoxy-7,9,13,15-tetramethyl-18-oxo-1-oxacyclooctadeca-4,6,14,16-tetraen-2-yl)-3-hydroxypentan-2-yl]-2-hydroxy-5-methyl-6-prop-1-enyloxan-4-yl]oxy-4-hydroxy-2-methyloxan-3-yl] carbamate
—— (2S,4R)-N-((1R,2R)-2-Hydroxy-1-((2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(methylthio)tetrahydro-2H-pyran-2-yl)propyl)-4-propylpyrrolidine-2-carboxamide 2256-16-8 C17H32N2O6S
(2S,4R)-N-((1R,2R)-2-Hydroxy-1-((2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(methylthio)tetrahydro-2H-pyran-2-yl)propyl)-4-propylpyrrolidine-2-carboxamide
—— Testosteron-acetat 1045-69-8 C21H30O3
Testosteron-acetat
—— 7-[(2-Amino-2-carboxyethyl)thio]-2-[[(2,2-dimethylcyclopropyl)-oxomethyl]amino]-2-heptenoic acid 82009-34-5 C16H26N2O5S
7-[(2-Amino-2-carboxyethyl)thio]-2-[[(2,2-dimethylcyclopropyl)-oxomethyl]amino]-2-heptenoic acid
—— hyodeoxycholic acid 83-49-8 C24H40O4
hyodeoxycholic acid
—— Cltc 64-72-2 C22H23ClN2O8
Cltc
—— blasticidin s 2079-00-7 C17H26N8O5
blasticidin s
—— 4-Amino-3-{[3-amino-6-(aminomethyl)-3,4-dihydro-2h-pyran-2-yl]oxy}-6-(ethylamino)-2-hydroxycyclohexyl 3-deoxy-4-c-methyl-3-(methylamino)pentopyranoside 56391-56-1 C21H41N5O7
4-Amino-3-{[3-amino-6-(aminomethyl)-3,4-dihydro-2h-pyran-2-yl]oxy}-6-(ethylamino)-2-hydroxycyclohexyl 3-deoxy-4-c-methyl-3-(methylamino)pentopyranoside
—— Phenoxyisopropyl-peniciliin 4780-24-9 C18H22N2O5S
Phenoxyisopropyl-peniciliin
—— ethisterone 434-03-7 C21H28O2
ethisterone
—— Gentamicin 1403-66-3 C21H43N5O7
Gentamicin
—— 9-((2 R,5S)-5-(hydroxymethyl)-tetrahydrofuran-2-yl)-1H-purin-6(9H)-one 69655-05-6 C10H12N4O3
9-((2 R,5S)-5-(hydroxymethyl)-tetrahydrofuran-2-yl)-1H-purin-6(9H)-one
—— methyl (4R)-4-[(3R,5R,6S,8S,9S,10R,13R,14S,17R)-3,6-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoate 2868-48-6 C25H42O4
methyl (4R)-4-[(3R,5R,6S,8S,9S,10R,13R,14S,17R)-3,6-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoate
—— (2,15,17-Trihydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,23,27,29-tetraoxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(28),2,4,9,19,21,25-heptaen-13-yl) acetate 13553-79-2 C37H45NO12
(2,15,17-Trihydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,23,27,29-tetraoxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(28),2,4,9,19,21,25-heptaen-13-yl) acetate
—— penicillin-<i>V</i> 87-08-1 C16H18N2O5S
penicillin-<i>V</i>
—— cabazitaxel 183133-96-2 C45H57NO14
cabazitaxel
—— 3-[9-(3-Aminopropyl)-3,24,27-tribenzyl-21-(carboxymethyl)-15-[(4-hydroxyphenyl)methyl]-6-(2-methylpropyl)-2,5,8,11,14,17,20,23,26,29-decaoxo-12-propan-2-yl-1,4,7,10,13,16,19,22,25,28-decazabicyclo[28.3.0]tritriacontan-18-yl]propanoic acid 1404-88-2 C66H85N11O15
3-[9-(3-Aminopropyl)-3,24,27-tribenzyl-21-(carboxymethyl)-15-[(4-hydroxyphenyl)methyl]-6-(2-methylpropyl)-2,5,8,11,14,17,20,23,26,29-decaoxo-12-propan-2-yl-1,4,7,10,13,16,19,22,25,28-decazabicyclo[28.3.0]tritriacontan-18-yl]propanoic acid
—— [11-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] butanoate 13609-67-1 C25H36O6
[11-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] butanoate
—— 2-[3-Acetamido-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-22-amino-5,15-dichloro-64-[3-(decanoylamino)-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-26,31,44,49-tetrahydroxy-21,35,38,54,56,59-hexaoxo-47-[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-7,13,28-trioxa-20,36,39,53,55,58-hexazaundecacyclo[38.14.2.23,6.214,17.219,34.18,12.123,27.129,33.141,45.010,37.046,51]hexahexaconta-3,5,8,10,12(64),14,16,23(61),24,26,29(60),30,32,41(57),42,44,46(51),47,49,62,65-henicosaene-52-carboxylic acid 61036-62-2 C88H97Cl2N9O33
2-[3-Acetamido-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-22-amino-5,15-dichloro-64-[3-(decanoylamino)-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-26,31,44,49-tetrahydroxy-21,35,38,54,56,59-hexaoxo-47-[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-7,13,28-trioxa-20,36,39,53,55,58-hexazaundecacyclo[38.14.2.23,6.214,17.219,34.18,12.123,27.129,33.141,45.010,37.046,51]hexahexaconta-3,5,8,10,12(64),14,16,23(61),24,26,29(60),30,32,41(57),42,44,46(51),47,49,62,65-henicosaene-52-carboxylic acid
—— Albacarcin M 92934-54-8 C27H28O9
Albacarcin M
—— dl-18-Methyl-17α-ethinyl-17β-ol-4.9.11-oestratrien-3-on 16320-04-0 C21H24O2
dl-18-Methyl-17α-ethinyl-17β-ol-4.9.11-oestratrien-3-on
—— 4-Cyclohexyl-1-[2-[(2-methyl-1-propanoyloxypropoxy)-(4-phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid 98048-97-6 C30H46NO7P
4-Cyclohexyl-1-[2-[(2-methyl-1-propanoyloxypropoxy)-(4-phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid
—— 6-[[2-[[2-azaniumyl-4-(methylamino)-4-oxobutanoyl]amino]-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 63329-59-9 C21H27N5O7S
6-[[2-[[2-azaniumyl-4-(methylamino)-4-oxobutanoyl]amino]-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
—— Aethinyl-oestradiol 57-63-6 C20H24O2
Aethinyl-oestradiol
—— 4,8-Dihydroxy-5,5,7,9-tetramethyl-16-[1-(2-methyl-1,3-thiazol-4-YL)prop-1-EN-2-YL]-1-oxacyclohexadec-13-ene-2,6-dione 186692-73-9 C26H39NO5S
4,8-Dihydroxy-5,5,7,9-tetramethyl-16-[1-(2-methyl-1,3-thiazol-4-YL)prop-1-EN-2-YL]-1-oxacyclohexadec-13-ene-2,6-dione
—— Rifamycin, 3-formyl- 13292-22-3 C38H47NO13
Rifamycin, 3-formyl-
—— 2,2'-Anhydrocytidin 31698-14-3 C9H11N3O4
2,2'-Anhydrocytidin
—— 3-acetamido-5-[acetyl(methyl)amino]-2,4,6-triiodo-N-[2,4,5-trihydroxy-6-(hydroxymethyl)oxan-3-yl]benzamide 31112-62-6 C18H22I3N3O8
3-acetamido-5-[acetyl(methyl)amino]-2,4,6-triiodo-N-[2,4,5-trihydroxy-6-(hydroxymethyl)oxan-3-yl]benzamide
—— 6'-Butan-2-yl-21,24-dihydroxy-12-[5-(5-hydroxy-4-methoxy-6-methyloxan-2-yl)oxy-4-methoxy-6-methyloxan-2-yl]oxy-5',11,13,22-tetramethylspiro[3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-6,2'-oxane]-2-one 70288-86-7 C48H74O14
6'-Butan-2-yl-21,24-dihydroxy-12-[5-(5-hydroxy-4-methoxy-6-methyloxan-2-yl)oxy-4-methoxy-6-methyloxan-2-yl]oxy-5',11,13,22-tetramethylspiro[3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-6,2'-oxane]-2-one