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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
—— 7-[[(2E)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-(6,7-dihydro-5H-cyclopenta[b]pyridin-1-ium-1-ylmethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate;sulfuric acid 98753-19-6 C22H24N6O9S3
7-[[(2E)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-(6,7-dihydro-5H-cyclopenta[b]pyridin-1-ium-1-ylmethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate;sulfuric acid
—— (6S,7R)-7-((R)-2-Amino-2-(4-hydroxyphenyl)acetamido)-8-oxo-3-((E)-prop-1-en-1-yl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 92665-29-7 C18H19N3O5S
(6S,7R)-7-((R)-2-Amino-2-(4-hydroxyphenyl)acetamido)-8-oxo-3-((E)-prop-1-en-1-yl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
—— 3-{1-[2-(Aminomethyl)-1,3-thiazol-4-YL]prop-1-EN-2-YL}-7,11-dihydroxy-8,8,10,12,16-pentamethyl-4,17-dioxabicyclo[14.1.0]heptadecane-5,9-dione 280578-49-6 C27H42N2O6S
3-{1-[2-(Aminomethyl)-1,3-thiazol-4-YL]prop-1-EN-2-YL}-7,11-dihydroxy-8,8,10,12,16-pentamethyl-4,17-dioxabicyclo[14.1.0]heptadecane-5,9-dione
—— 6-[4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-14-ethyl-7,12,13-trihydroxy-4-(5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl)oxy-3,5,7,9,11,13-hexamethyl-oxacyclotetradecane-2,10-dione;2,3,5,6-tetrahydroxy-4-[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanoic acid 3847-29-8 C49H89NO25
6-[4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-14-ethyl-7,12,13-trihydroxy-4-(5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl)oxy-3,5,7,9,11,13-hexamethyl-oxacyclotetradecane-2,10-dione;2,3,5,6-tetrahydroxy-4-[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanoic acid
—— ipamorelin 170851-70-4 C38H49N9O5
ipamorelin
—— (5E)-PGB<sub>2</sub> 13367-85-6 C20H30O4
(5E)-PGB<sub>2</sub>
—— decanoyl-Trp-Asn-Asp-Thr(1)-Gly-Orn-Asp-D-Ala-Asp-Gly-D-Ser-Glu(3S-Me)-Asp(Ph(2-NH2))-(1) 103060-53-3 C72H101N17O26
decanoyl-Trp-Asn-Asp-Thr(1)-Gly-Orn-Asp-D-Ala-Asp-Gly-D-Ser-Glu(3S-Me)-Asp(Ph(2-NH2))-(1)
—— Deaminooxytocin 113-78-0 C43H65N11O12S2
Deaminooxytocin
—— cis-2,6-dimethyl-4-((S)-2-methyl-3-(4-(tert-pentyl)phenyl)propyl)morpholine 78613-35-1 C21H35NO
cis-2,6-dimethyl-4-((S)-2-methyl-3-(4-(tert-pentyl)phenyl)propyl)morpholine
—— (R)-cefuroxime 1-acetoxyethyl ester 64544-07-6 C20H22N4O10S
(R)-cefuroxime 1-acetoxyethyl ester
—— 17α-Methyl-5β-androst-1-en-17β-ol-3-on 65-04-3 C20H30O2
17α-Methyl-5β-androst-1-en-17β-ol-3-on
—— 17β-Hydroxy-17α-methyl-androst-1-en-3-on 65-04-3 C20H30O2
17β-Hydroxy-17α-methyl-androst-1-en-3-on
—— 17α-Methyl-Δ<sup>1</sup>-5α-androstenol-(17β)-on-(3) 65-04-3 C20H30O2
17α-Methyl-Δ<sup>1</sup>-5α-androstenol-(17β)-on-(3)
—— (Z)-tert-Butyl 2-(((1-(2-aminothiazol-4-yl)-2-(benzo[d]thiazol-2-ylthio)-2-oxoethylidene)amino)oxy)-2-methylpropanoate 89604-92-2 C20H22N4O4S3
(Z)-tert-Butyl 2-(((1-(2-aminothiazol-4-yl)-2-(benzo[d]thiazol-2-ylthio)-2-oxoethylidene)amino)oxy)-2-methylpropanoate
—— [(2S,3S,4R,5S,6S)-6-[(1R,2R)-2-chloro-1-[[(2R,4S)-1-methyl-4-propylpyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] dihydrogen phosphate 24729-96-2 C18H34ClN2O8PS
[(2S,3S,4R,5S,6S)-6-[(1R,2R)-2-chloro-1-[[(2R,4S)-1-methyl-4-propylpyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] dihydrogen phosphate
—— 2-(2-(((Benzyloxy)carbonyl)amino)thiazol-4-yl)-5-((3-methylbut-2-en-1-yl)oxy)-5-oxopent-2-enoic acid 102199-30-4 C21H22N2O6S
2-(2-(((Benzyloxy)carbonyl)amino)thiazol-4-yl)-5-((3-methylbut-2-en-1-yl)oxy)-5-oxopent-2-enoic acid
—— Floridosid 534-68-9 C9H18O8
Floridosid
—— p-nitrobenzyl (5R,6S)-2-diphenoxy phosphoryloxy-6-[(R)-1-hydroxyethyl]-1-carbapen-2-em-3-carboxylate 77171-49-4 C28H25N2O10P
p-nitrobenzyl (5R,6S)-2-diphenoxy phosphoryloxy-6-[(R)-1-hydroxyethyl]-1-carbapen-2-em-3-carboxylate
—— 15-Ethyl-14-ethynyl-5-(hydroxyimino)tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-ol 53016-31-2 C21H29NO2
15-Ethyl-14-ethynyl-5-(hydroxyimino)tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-ol
—— mibefradil dihydrochloride 116666-63-8 C29H38FN3O3*2ClH
mibefradil dihydrochloride
—— (2S)-2-amino-3-{[(3-chloro-2-methyl-5-sulfophenyl)carbamoyl]amino}propanoic acid 1333218-50-0 C11H14ClN3O6S
(2S)-2-amino-3-{[(3-chloro-2-methyl-5-sulfophenyl)carbamoyl]amino}propanoic acid
—— 2-Pentenedioic acid, 2-[2-[[(phenylmethoxy)carbonyl]amino]-4-thiazolyl]-, 5-(3-methyl-2-buten-1-yl) ester 115065-79-7 C21H21N2O6S-
2-Pentenedioic acid, 2-[2-[[(phenylmethoxy)carbonyl]amino]-4-thiazolyl]-, 5-(3-methyl-2-buten-1-yl) ester
—— lycoramine 18797-70-1 C17H23NO3
lycoramine
—— (E)-but-2-enedioic acid;(4-ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxo-6-tricyclo[5.4.3.01,8]tetradecanyl) 2-[2-(diethylamino)ethylsulfanyl]acetate 55297-96-6 C4H4O4*C28H47NO4S
(E)-but-2-enedioic acid;(4-ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxo-6-tricyclo[5.4.3.01,8]tetradecanyl) 2-[2-(diethylamino)ethylsulfanyl]acetate
—— (3S,9R,12R,15S,18S,21R,24R,27S,30S,33R,36R)-6,18,30-trimethyl-3,9,12,15,21,24,27,33,36-nona(propan-2-yl)-1,7,13,19,25,31-hexaoxa-4,10,16,22,28,34-hexazacyclohexatriacontane-2,5,8,11,14,17,20,23,26,29,32,35-dodecone 2001-95-8 C54H90N6O18
(3S,9R,12R,15S,18S,21R,24R,27S,30S,33R,36R)-6,18,30-trimethyl-3,9,12,15,21,24,27,33,36-nona(propan-2-yl)-1,7,13,19,25,31-hexaoxa-4,10,16,22,28,34-hexazacyclohexatriacontane-2,5,8,11,14,17,20,23,26,29,32,35-dodecone
—— 2-[(2<i>RS</i>)-6<i>c</i>-((<i>SR</i>)-β-hydroxy-phenethyl)-1-methyl-[2<i>r</i>]piperidyl]-1-phenyl-ethanone 90-69-7 C22H27NO2
2-[(2<i>RS</i>)-6<i>c</i>-((<i>SR</i>)-β-hydroxy-phenethyl)-1-methyl-[2<i>r</i>]piperidyl]-1-phenyl-ethanone
—— 4-EPIOXYTETRACYCLINE 79-57-2 C22H24N2O9
4-EPIOXYTETRACYCLINE
—— N,N-dimethylamino-3-(1-naphthanyloxy)-3-(2-thienyl)-1-propanamine 116817-11-9 C19H21NOS
N,N-dimethylamino-3-(1-naphthanyloxy)-3-(2-thienyl)-1-propanamine
—— BIBF 0775 334951-90-5 C31H34N4O2
BIBF 0775
—— ethyl chaulmoograte 623-32-5 C20H36O2
ethyl chaulmoograte
—— Herbimycin 70563-58-5 C30H42N2O9
Herbimycin
—— stiripentol 137767-55-6 C14H18O3
stiripentol
—— dl-dethiobiotine 533-48-2 C10H18N2O3
dl-dethiobiotine
—— (+/-)-6-(5<i>t</i>-methyl-2-oxo-imidazolidin-4<i>r</i>-yl)-hexanoic acid 533-48-2 C10H18N2O3
(+/-)-6-(5<i>t</i>-methyl-2-oxo-imidazolidin-4<i>r</i>-yl)-hexanoic acid
—— Dicopper citrate 866-82-0 C6H4Cu2O7
Dicopper citrate
—— neomycin B/C 66-86-4 C23H46N6O13
neomycin B/C
—— 1-Methyl-N-((1R,3R,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-YL)-1H-indazole-3-carboxamide 109889-09-0 C18H24N4O
1-Methyl-N-((1R,3R,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-YL)-1H-indazole-3-carboxamide
—— cinchonidine 485-71-2 C19H22N2O
cinchonidine
—— (4-nitrophenyl)methyl (2S,5S,6R)-6-[(1S)-1-hydroxyethyl]-3,7-dioxo-1-azabicyclo[3.2.0]heptane-2-carboxylate 74288-40-7 C16H16N2O7
(4-nitrophenyl)methyl (2S,5S,6R)-6-[(1S)-1-hydroxyethyl]-3,7-dioxo-1-azabicyclo[3.2.0]heptane-2-carboxylate
—— (E)-But-2-enedioic acid;2-[(E)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine 61718-82-9 C19H25F3N2O6
(E)-But-2-enedioic acid;2-[(E)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine
—— cinchonidine 118-10-5 C19H22N2O
cinchonidine
—— cevimeline 107233-08-9 C10H17NOS
cevimeline
—— octreotide diacetate 79517-01-4 2C2H4O2*C49H66N10O10S2
octreotide diacetate
—— nystatin A<sub>1</sub> 1400-61-9 C47H75NO17
nystatin A<sub>1</sub>
—— 7-bromo-6-chloro-3-[3-(3-hydroxy-2-piperidinyl)-2-oxopropyl]-4(3H)-quinazolinone 55837-20-2 C16H17BrClN3O3
7-bromo-6-chloro-3-[3-(3-hydroxy-2-piperidinyl)-2-oxopropyl]-4(3H)-quinazolinone
—— 2-(4'-fluorophenyl)-3-methoxy-6-(3''-methoxybenzylthio)imidazo<1,2-b>pyridazine 121041-20-1 C21H18FN3O2S
2-(4'-fluorophenyl)-3-methoxy-6-(3''-methoxybenzylthio)imidazo<1,2-b>pyridazine
—— Congo Red 573-58-0 C32H22N6O6S2
Congo Red
—— stilbamidine 122-06-5 C16H16N4
stilbamidine
—— amphotericin B 1397-89-3 C47H73NO17
amphotericin B
—— Win 35065-3 74163-84-1 C16H21NO2
Win 35065-3