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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
—— evans blue 314-13-6 C34H28N6O14S4*4Na
evans blue
—— Indigotine 860-22-0 C16H10N2NaO8S2+
Indigotine
—— 1-b]Furan-21-yl acetate 13292-46-1 C43H58N4O12
1-b]Furan-21-yl acetate
—— [(7S,11S,12R,13S,14R,15R,16R,17S,18S)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-26-[(4-methylpiperazin-1-yl)iminomethyl]-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate 13292-46-1 C43H58N4O12
[(7S,11S,12R,13S,14R,15R,16R,17S,18S)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-26-[(4-methylpiperazin-1-yl)iminomethyl]-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate
—— Ceftobiprole medocaril 376653-43-9 C26H26N8O11S2
Ceftobiprole medocaril
—— Nintedanib esylate 656247-18-6 C33H39N5O7S
Nintedanib esylate
—— [(7S,9E,11S,12R,13R,14R,15R,16R,17S,19E,21Z)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-26-[(4-methylpiperazin-1-yl)iminomethyl]-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate 13292-46-1 C43H58N4O12
[(7S,9E,11S,12R,13R,14R,15R,16R,17S,19E,21Z)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-26-[(4-methylpiperazin-1-yl)iminomethyl]-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate
—— (E)-2,2'-((4-hydroxyphenyl)methylene)bis(4-((E)-(5-methyl-1H-tetrazol-1-ylimino)methyl)phenol) 235106-62-4 C25H22N10O3
(E)-2,2'-((4-hydroxyphenyl)methylene)bis(4-((E)-(5-methyl-1H-tetrazol-1-ylimino)methyl)phenol)
—— rifapentine hydrochloride 127923-87-9 C47H64N4O12*ClH
rifapentine hydrochloride
—— (4S,6S,12aR)-7-chloro-4-(dimethylamino)-1,6,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide 57-62-5 C22H23ClN2O8
(4S,6S,12aR)-7-chloro-4-(dimethylamino)-1,6,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide
—— Narasin 55134-13-9 C43H72O11
Narasin
—— 17α-Ethinyl-17β-hydroxy-18-methyl-11-methylen-Δ<sup>4</sup>-estren-3-on 54048-10-1 C22H28O2
17α-Ethinyl-17β-hydroxy-18-methyl-11-methylen-Δ<sup>4</sup>-estren-3-on
—— 6β-(5-methyl-3-phenyl-isoxazole-4-carbonylamino)-penicillanic acid; sodium salt 1173-88-2 C19H18N3O5S*Na
6β-(5-methyl-3-phenyl-isoxazole-4-carbonylamino)-penicillanic acid; sodium salt
—— cuscohygrine 454-14-8 C13H24N2O
cuscohygrine
—— Isosparteine, alpha 90-39-1 C15H26N2
Isosparteine, alpha
—— Novobiocin(1-) 1476-53-5 C31H35N2O11-
Novobiocin(1-)
—— (17R)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,14,15,16-octahydrocyclopenta[a]phenanthren-3-one 16320-04-0 C21H24O2
(17R)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
—— 1-(Isopropylamino)-3-(p-[beta-methoxyethyl]phenoxy)-2-propanol tartrate 56392-17-7 C34H56N2O12
1-(Isopropylamino)-3-(p-[beta-methoxyethyl]phenoxy)-2-propanol tartrate
—— [(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4-acetyloxy-1,9,12-trihydroxy-15-[2-hydroxy-3-[(2-methylpropan-2-yl)oxycarbonylamino]-3-phenylpropanoyl]oxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.03,10.04,7]heptadec-13-en-2-yl] benzoate 114915-20-7 C43H53NO14
[(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4-acetyloxy-1,9,12-trihydroxy-15-[2-hydroxy-3-[(2-methylpropan-2-yl)oxycarbonylamino]-3-phenylpropanoyl]oxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.03,10.04,7]heptadec-13-en-2-yl] benzoate
—— (8R,9S,10R,13S,14S)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one 6533-00-2 C21H28O2
(8R,9S,10R,13S,14S)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one
—— thiamine propyl disulfide 59-58-5 C15H24N4O2S2
thiamine propyl disulfide
—— [(7S,9E,11S,12R,13S,14R,15R,16R,17S,18S,19E,21Z)-26-[(Z)-(4-cyclopentylpiperazin-1-yl)iminomethyl]-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate 61379-65-5 C47H64N4O12
[(7S,9E,11S,12R,13S,14R,15R,16R,17S,18S,19E,21Z)-26-[(Z)-(4-cyclopentylpiperazin-1-yl)iminomethyl]-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate
—— Lactulose 4618-18-2 C12H22O11
Lactulose
—— nifuratel 4936-47-4 C10H11N3O5S
nifuratel
—— erythritol tetranitrate 7297-25-8 C4H6N4O12
erythritol tetranitrate
—— somatostatin 51110-01-1 C76H104N18O19S2
somatostatin
—— 5-Morpholin-4-ylmethyl-3-{[1-(5-nitro-furan-2-yl)-meth-(Z)-ylidene]-amino}-oxazolidin-2-one 139-91-3 C13H16N4O6
5-Morpholin-4-ylmethyl-3-{[1-(5-nitro-furan-2-yl)-meth-(Z)-ylidene]-amino}-oxazolidin-2-one
—— Berbamine (dihydrochloride) 6078-17-7 C37H42Cl2N2O6
Berbamine (dihydrochloride)
—— S-Dithiopropyl-thiamin 59-58-5 C15H24N4O2S2
S-Dithiopropyl-thiamin
—— (2S,3S,4S,5R,6R)-6-[(2S,3R,4S,5S,6S)-2-[[(3S,6Ar,6bS,8aS,11S,12aR,14aR,14bS)-11-carboxy-4,4,6a,6b,8a,11,14b-heptamethyl-14-oxo-2,3,4a,5,6,7,8,9,10,12,12a,14a-dodecahydro-1H-picen-3-yl]oxy]-6-carboxy-4,5-dihydroxyoxan-3-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid 1405-86-3 C42H62O16
(2S,3S,4S,5R,6R)-6-[(2S,3R,4S,5S,6S)-2-[[(3S,6Ar,6bS,8aS,11S,12aR,14aR,14bS)-11-carboxy-4,4,6a,6b,8a,11,14b-heptamethyl-14-oxo-2,3,4a,5,6,7,8,9,10,12,12a,14a-dodecahydro-1H-picen-3-yl]oxy]-6-carboxy-4,5-dihydroxyoxan-3-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid
—— fluocinolone acetonide 67-73-2 C24H30F2O6
fluocinolone acetonide
—— Aclacinomycin A (Aclarubicin) 57576-44-0 C42H53NO15
Aclacinomycin A (Aclarubicin)
—— (+)-1-cyclohexyl-1-phenyl-3-piperidino-propan-1-ol; hydrochloride 52-49-3 C20H31NO*ClH
(+)-1-cyclohexyl-1-phenyl-3-piperidino-propan-1-ol; hydrochloride
—— 1-N-Ethylsisomycin 56391-56-1 C21H41N5O7
1-N-Ethylsisomycin
—— [(7S,11S,12R,13S,14R,15R,16R,17S,18S)-26-[(4-cyclopentylpiperazin-1-yl)iminomethyl]-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate 61379-65-5 C47H64N4O12
[(7S,11S,12R,13S,14R,15R,16R,17S,18S)-26-[(4-cyclopentylpiperazin-1-yl)iminomethyl]-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate
—— Aureolic acid 18378-89-7 C52H76O24
Aureolic acid
—— cefaclor 53994-73-3 C15H14ClN3O4S
cefaclor
—— leucomycin A3 16846-24-5 C42H69NO15
leucomycin A3
—— [(7S,9E,11S,12R,13S,14R,15R,16R,17S,18S,19E,21E)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-26-[(E)-(4-methylpiperazin-1-yl)iminomethyl]-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate 13292-46-1 C43H58N4O12
[(7S,9E,11S,12R,13S,14R,15R,16R,17S,18S,19E,21E)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-26-[(E)-(4-methylpiperazin-1-yl)iminomethyl]-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate
—— [(7S,11S,12R,13S,14R,15R,16R,17S,18S)-26-[(E)-(4-cyclopentylpiperazin-1-yl)iminomethyl]-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate 61379-65-5 C47H64N4O12
[(7S,11S,12R,13S,14R,15R,16R,17S,18S)-26-[(E)-(4-cyclopentylpiperazin-1-yl)iminomethyl]-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate
—— [(7S,9E,11S,12R,13R,14R,15R,16R,17S,18S,19E,21E)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-26-[(E)-(4-methylpiperazin-1-yl)iminomethyl]-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate 13292-46-1 C43H58N4O12
[(7S,9E,11S,12R,13R,14R,15R,16R,17S,18S,19E,21E)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-26-[(E)-(4-methylpiperazin-1-yl)iminomethyl]-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate
—— Pharmakon1600-01500529 13292-46-1 C43H58N4O12
Pharmakon1600-01500529
—— levocetirizine dihydrochloride 130018-87-0 C21H25ClN2O3*2ClH
levocetirizine dihydrochloride
—— hesperidin 520-27-4 C28H32O15
hesperidin
—— ertapenem sodium 153773-82-1 C22H24N3O7S*Na
ertapenem sodium
—— cefcapene 105889-45-0 C17H19N5O6S2
cefcapene
—— oxilofrine 365-26-4 C10H15NO2
oxilofrine
—— prontosil 103-12-8 C12H13N5O2S
prontosil
—— naltrexone hydrochloride 16590-41-3 C20H23NO4
naltrexone hydrochloride
—— (1R,9S,12S,15R,16E,18R,19R,21R,23S,24Z,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-[(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone 159351-69-6 C53H83NO14
(1R,9S,12S,15R,16E,18R,19R,21R,23S,24Z,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-[(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone