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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
—— potassium penicillin V 132-98-9 C16H17N2O5S*K
potassium penicillin V
—— <i>rac</i>-6β-(2-phenoxy-acetylamino)-penicillanic acid ; potassium-salt 132-98-9 C16H17N2O5S*K
<i>rac</i>-6β-(2-phenoxy-acetylamino)-penicillanic acid ; potassium-salt
—— 2H-Quinolizinium, 3-(di-2-thienylmethylene)octahydro-5-methyl-,bromide 69664-12-6 Br*C19H24NS2
2H-Quinolizinium, 3-(di-2-thienylmethylene)octahydro-5-methyl-,bromide
—— (17β<i>H</i>)-pregn-4-en-20-yno[2,3-<i>d</i>]isoxazol-17-ol 17230-88-5 C22H27NO2
(17β<i>H</i>)-pregn-4-en-20-yno[2,3-<i>d</i>]isoxazol-17-ol
—— Pregnan-3α-ol-11,20-dion 565-99-1 C21H32O3
Pregnan-3α-ol-11,20-dion
—— 3α-Hydroxy-5α-pregnan-11,20-dion 565-99-1 C21H32O3
3α-Hydroxy-5α-pregnan-11,20-dion
—— 3α-Hydroxy-5β-pregnan-11,20-dion 565-99-1 C21H32O3
3α-Hydroxy-5β-pregnan-11,20-dion
—— 1-[[[5-(4-chlorophenyl)-2-furanyl]methylene]amino]-3-[4-(4-methyl-1-piperazinyl)butyl]-2,4-imidazolidinedione 149908-53-2 C23H28ClN5O3
1-[[[5-(4-chlorophenyl)-2-furanyl]methylene]amino]-3-[4-(4-methyl-1-piperazinyl)butyl]-2,4-imidazolidinedione
—— Maprotiline 10262-69-8 C20H23N
Maprotiline
—— (+/-)-Ritodrine 26652-09-5 C17H21NO3
(+/-)-Ritodrine
—— DU-21220 26652-09-5 C17H21NO3
DU-21220
—— (12aξ)-6-methoxy-10-methyl-1,12-cyclo-12,12a-seco-galantham-1-en-3β-ol; hydrobromide 69353-21-5 BrH*C17H21NO3
(12aξ)-6-methoxy-10-methyl-1,12-cyclo-12,12a-seco-galantham-1-en-3β-ol; hydrobromide
—— (2S,5R,6R)-3,3-dimethyl-6-[[2-[(3-methylsulfonyl-2-oxoimidazolidine-1-carbonyl)amino]-2-phenylacetyl]amino]-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 51481-65-3 C21H25N5O8S2
(2S,5R,6R)-3,3-dimethyl-6-[[2-[(3-methylsulfonyl-2-oxoimidazolidine-1-carbonyl)amino]-2-phenylacetyl]amino]-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
—— terconazole 67915-31-5 C26H31Cl2N5O3
terconazole
—— carpipramine dihydrochloride 7075-03-8 C28H38N4O*2ClH
carpipramine dihydrochloride
—— 2H-1,4-Benzothiazin-3(4H)-one, 2-[2-[3-[[2-(1,3-benzodioxol-5-yloxy)ethyl]methylamino]propoxy]-5-methoxyphenyl]-4-methyl-, (2R)-, (2E)-2-butenedioate (1:1) (9CI) 116476-13-2 C29H32N2O6S
2H-1,4-Benzothiazin-3(4H)-one, 2-[2-[3-[[2-(1,3-benzodioxol-5-yloxy)ethyl]methylamino]propoxy]-5-methoxyphenyl]-4-methyl-, (2R)-, (2E)-2-butenedioate (1:1) (9CI)
—— Ribostamycin 25546-65-0 C17H34N4O10
Ribostamycin
—— 9α-Fluor-11,17α,21-trihydroxy-pregnen-(4)-dion-(3,20) 127-31-1 C21H29FO5
9α-Fluor-11,17α,21-trihydroxy-pregnen-(4)-dion-(3,20)
—— 9,10-Secoergosta-5,7,10(19),22-tetraen-3-ol, (3b,5Z,7E,22E)- 50-14-6 C28H44O
9,10-Secoergosta-5,7,10(19),22-tetraen-3-ol, (3b,5Z,7E,22E)-
—— tenylidone 893-01-6 C16H14OS2
tenylidone
—— ozagrel sodium 82571-53-7 C13H11N2O2*Na
ozagrel sodium
—— spironolactone 52-01-7 C24H32O4S
spironolactone
—— tylosin tartrate 74610-55-2 C4H6O6*C46H77NO17
tylosin tartrate
—— quinine; monohydrochloride dihydrate 6119-47-7 C20H24N2O2*ClH*2H2O
quinine; monohydrochloride dihydrate
—— sodium camphorsulfonate 34850-66-3 C10H15O4S*Na
sodium camphorsulfonate
—— 8-[[4-methyl-3-[[3-[[3-[[2-methyl-5-[(4,6,8-trisulfonaphthalen-1-yl)carbamoyl]phenyl]carbamoyl]phenyl]carbamoylamino]benzoyl]amino]benzoyl]amino]naphthalene-1,3,5-trisulfonic acid 129-46-4 C51H40N6O23S6
8-[[4-methyl-3-[[3-[[3-[[2-methyl-5-[(4,6,8-trisulfonaphthalen-1-yl)carbamoyl]phenyl]carbamoyl]phenyl]carbamoylamino]benzoyl]amino]benzoyl]amino]naphthalene-1,3,5-trisulfonic acid
—— sodium ipodate 1221-56-3 C12H12I3N2O2*Na
sodium ipodate
—— octenidine dihydrochloride 70775-75-6 C36H62N4*2ClH
octenidine dihydrochloride
—— cefradine 31828-50-9 C16H19N3O4S*0H2O
cefradine
—— 3-[4-[2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]-1,1-dimethylurea 839712-12-8 C21H32Cl2N4O
3-[4-[2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]-1,1-dimethylurea
—— 3-[4-[2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]-1,1-dimethylurea,hydrochloride 1083076-69-0 C21H32Cl2N4O*ClH
3-[4-[2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]-1,1-dimethylurea,hydrochloride
—— trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol 18683-91-5 C13H18Br2N2O
trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol
—— amorolfine hydrochloride 78613-38-4 C21H35NO*ClH
amorolfine hydrochloride
—— amorolfine 78613-35-1 C21H35NO
amorolfine
—— Betahistine dihydrochloride 5579-84-0 C8H12N2*2ClH
Betahistine dihydrochloride
—— sodium (2S-(2α,5α,6β))-6-({[3-(2-chloro-6-fluorophenyl)-5-methylisoxazol-4-yl]carbonyl}amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 1847-24-1 C19H16ClFN3O5S*Na
sodium (2S-(2α,5α,6β))-6-({[3-(2-chloro-6-fluorophenyl)-5-methylisoxazol-4-yl]carbonyl}amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
—— streptomycin sulfate 3810-74-0 C21H41N7O16S
streptomycin sulfate
—— 9-[-2-(R)-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinoyl]methoxy]propyl]-adenine maleate 202138-50-9 C4H4O4*C19H30N5O10P
9-[-2-(R)-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinoyl]methoxy]propyl]-adenine maleate
—— (R)-1-methyl-3-phenyl-2,5-pyrrolidinedione 86-34-0 C11H11NO2
(R)-1-methyl-3-phenyl-2,5-pyrrolidinedione
—— prostaglandin E1 745-65-3 C20H34O5
prostaglandin E1
—— <i>rac</i>-(15Ξ)-11α,15-dihydroxy-9-oxo-(8ξ<i>H</i>)-prost-13<i>t</i>-en-1-oic acid 745-65-3 C20H34O5
<i>rac</i>-(15Ξ)-11α,15-dihydroxy-9-oxo-(8ξ<i>H</i>)-prost-13<i>t</i>-en-1-oic acid
—— latamoxef 64952-97-2 C20H20N6O9S
latamoxef
—— (+/-)-prostaglandin E1 745-65-3 C20H34O5
(+/-)-prostaglandin E1
—— 1-amino-13-ethylidene-11-methyl-6-aza-tricyclo[7.3.1.0<sup>2,7</sup>]trideca-2(7),3,10-trien-5-one 92138-20-0 C15H18N2O
1-amino-13-ethylidene-11-methyl-6-aza-tricyclo[7.3.1.0<sup>2,7</sup>]trideca-2(7),3,10-trien-5-one
—— (6<i>R</i>)-7<i>t</i>-[(Ξ)-2-carboxy-2-(4-hydroxy-phenyl)-acetylamino]-7<i>c</i>-methoxy-3-(1-methyl-1<i>H</i>-tetrazol-5-ylsulfanylmethyl)-8-oxo-(6<i>r</i><i>H</i>)-5-oxa-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid 64952-97-2 C20H20N6O9S
(6<i>R</i>)-7<i>t</i>-[(Ξ)-2-carboxy-2-(4-hydroxy-phenyl)-acetylamino]-7<i>c</i>-methoxy-3-(1-methyl-1<i>H</i>-tetrazol-5-ylsulfanylmethyl)-8-oxo-(6<i>r</i><i>H</i>)-5-oxa-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
—— <i>rac</i>-(15<i>S</i>)-11β,15-dihydroxy-9-oxo-prost-13<i>t</i>-en-1-oic acid 745-65-3 C20H34O5
<i>rac</i>-(15<i>S</i>)-11β,15-dihydroxy-9-oxo-prost-13<i>t</i>-en-1-oic acid
—— 7-[(1S,2R,3S)-3-hydroxy-2-[(E,3R)-3-hydroxyoct-1-enyl]-5-oxocyclopentyl]heptanoic acid 745-65-3 C20H34O5
7-[(1S,2R,3S)-3-hydroxy-2-[(E,3R)-3-hydroxyoct-1-enyl]-5-oxocyclopentyl]heptanoic acid
—— (-)-huperzine A 120786-18-7 C15H18N2O
(-)-huperzine A
—— [14C]-Perospirone 150915-41-6 C23H30N4O2S
[14C]-Perospirone
—— bleomycin A<sub>5</sub> 11116-32-8 C57H89N19O21S2
bleomycin A<sub>5</sub>