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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
—— meropenem trihydrate 119478-56-7 C17H25N3O5S*3H2O
meropenem trihydrate
—— KI*betaine 590-47-6 C5H11NO2*2H2O*IK
KI*betaine
—— betaine calcium chloride dihydrate 590-47-6 C5H11NO2*CaCl2*2H2O
betaine calcium chloride dihydrate
—— 2β,16α-bis(4',4'-dimethyl-1'-piperazino)-3α,17α-diacetoxy-5α-androstane dibromide 52212-02-9 2Br*C35H62N4O4
2β,16α-bis(4',4'-dimethyl-1'-piperazino)-3α,17α-diacetoxy-5α-androstane dibromide
—— 1,1-dioxo-1λ<sup>6</sup>-benz[<i>d</i>]isothiazol-3-one; saccharin 128-44-9 C7H4NO3S*Na*HgO
1,1-dioxo-1λ<sup>6</sup>-benz[<i>d</i>]isothiazol-3-one; saccharin
—— 2β,16β-bis(4',4'-dimethyl-1'-piperazino)-3α,17α-diacetoxy-5α-androstane dibromide 52212-02-9 2Br*C35H62N4O4
2β,16β-bis(4',4'-dimethyl-1'-piperazino)-3α,17α-diacetoxy-5α-androstane dibromide
—— 15500-66-0 2Br*C35H60N2O4
—— salicylic acid disodium salt 54-21-7 C7H4O3*2Na
salicylic acid disodium salt
—— Misoprostol impurity 58682-80-7 C22H38O5
Misoprostol impurity
—— pyridoxine hydrochloride cation radical 65-23-6 C8H10NO3*H
pyridoxine hydrochloride cation radical
—— Homatropin-methobromid 80-49-9 Br*C17H24NO3
Homatropin-methobromid
—— 4232-07-9 C34H48O7*2Na
—— digitoxin 71-63-6 C41H64O13
digitoxin
—— benzylpenicillin potassium salt 113-98-4 C16H17N2O4S*K
benzylpenicillin potassium salt
—— OLEANDOMYCIN PHOSPHATE 7060-74-4 C35H61NO12*H3O4P
OLEANDOMYCIN PHOSPHATE
—— digitoxin 71-63-6 C41H64O13
digitoxin
—— Diglycolaldehyde, .α.-(hydroxymethyl)-.α.'-(6-hydroxy-9H-purin-9-yl)- 6614-62-6 C10H10N4O5
Diglycolaldehyde, .α.-(hydroxymethyl)-.α.'-(6-hydroxy-9H-purin-9-yl)-
—— digitoxin 71-63-6 C41H64O13
digitoxin
—— (4,4'-sulfonyl-dianilino)-bis-methanesulfinic acid ; disodium-salt 144-75-2 C14H14N2O6S3*2Na
(4,4'-sulfonyl-dianilino)-bis-methanesulfinic acid ; disodium-salt
—— carbenoxolone disodium 7421-40-1 C34H48O7*2Na
carbenoxolone disodium
—— digitoxin 71-63-6 C41H64O13
digitoxin
—— amikacin sulfate 39831-55-5 C22H43N5O13*H2O4S
amikacin sulfate
—— DL-α-Glycerophosphate disodium salt hydrate 1555-56-2 C3H7O6P*2Na
DL-α-Glycerophosphate disodium salt hydrate
—— Tobramycin 32986-56-4 C18H37N5O9
Tobramycin
—— Tobramycin 32986-56-4 C18H37N5O9
Tobramycin
—— (+/-)-α-narcotine; hydrochloride 912-60-7 C22H23NO7*ClH
(+/-)-α-narcotine; hydrochloride
—— (7Z)-calcipotriol 112828-00-9 C27H40O3
(7Z)-calcipotriol
—— 1-epi-kanamycin A sulfate 3847-27-6 C18H36N4O11*2H2O4S
1-epi-kanamycin A sulfate
—— Aluminum hydroxide 21645-51-2 AlO3
Aluminum hydroxide
—— 1-[(3,4-Diethoxyphenyl)methylene]-6,7-diethoxy-1,2,3,4-tetrahydroisoquinoline hydrochloride 985-12-6 C24H32ClNO4
1-[(3,4-Diethoxyphenyl)methylene]-6,7-diethoxy-1,2,3,4-tetrahydroisoquinoline hydrochloride
—— 11-cis-retinal 116-31-4 C20H28O
11-cis-retinal
—— methyl 7-[(1R,2R,3R)-3-hydroxy-2-[(E,3R,5S)-3-hydroxy-5-methylnon-1-enyl]-5-oxocyclopentyl]-6-oxoheptanoate 70667-26-4 C23H38O6
methyl 7-[(1R,2R,3R)-3-hydroxy-2-[(E,3R,5S)-3-hydroxy-5-methylnon-1-enyl]-5-oxocyclopentyl]-6-oxoheptanoate
—— 13-dihydrodaunorubicin 28008-55-1 C27H31NO10
13-dihydrodaunorubicin
—— Vecuronium bromide 50700-72-6 Br*C34H57N2O4
Vecuronium bromide
—— 50-81-7 C6H8O6
—— 2-(4-ammonio-4-carboxy-butyrylamino)-2-(carboxymethyl-carbamoyl)-ethylsulfanyl 70-18-8 C10H16N3O6S*H
2-(4-ammonio-4-carboxy-butyrylamino)-2-(carboxymethyl-carbamoyl)-ethylsulfanyl
—— sodium sulfate 7757-82-6 2Na*O4S
sodium sulfate
—— 1α-hydroxy-5,6-trans-vitamin D3 41294-56-8 C27H44O2
1α-hydroxy-5,6-trans-vitamin D3
—— (2R)-2,5,7,8-tetramethyl-2-[(4R)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-ol 59-02-9 C29H50O2
(2R)-2,5,7,8-tetramethyl-2-[(4R)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-ol
—— Arginine Vasopressin 113-79-1 C46H65N15O12S2
Arginine Vasopressin
—— 1α-hydroxy-5,6-trans-vitamin D3 41294-56-8 C27H44O2
1α-hydroxy-5,6-trans-vitamin D3
—— Thiamine chloride 59-43-8 C12H16N4OS*ClH
Thiamine chloride
—— 1α-hydroxy-5,6-trans-vitamin D3 41294-56-8 C27H44O2
1α-hydroxy-5,6-trans-vitamin D3
—— heme b 927179-10-0 C34H32FeN4O4
heme b
—— cephaloglycin 2258-32-4 C18H19N3O6S
cephaloglycin
—— (4R,4aS,5aS,6S,12aR)-4-(dimethylamino)-1,6,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide,hydrochloride 64-75-5 C22H24N2O8*ClH
(4R,4aS,5aS,6S,12aR)-4-(dimethylamino)-1,6,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide,hydrochloride
—— Sulprostone 54348-36-6 C23H31NO7S
Sulprostone
—— sodium,(3R,5R)-7-[(1S,2S,6R,8S,8aR)-6-hydroxy-2-methyl-8-[(2S)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate 81131-70-6 C23H35O7*Na
sodium,(3R,5R)-7-[(1S,2S,6R,8S,8aR)-6-hydroxy-2-methyl-8-[(2S)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate
—— (4aS)-4c-dimethylamino-3,6c,10,12,12a-pentahydroxy-6t-methyl-1,11-dioxo-(4ar,5at,12ac)-1,4,4a,5,5a,6,11,12a-octahydro-naphthacene-2-carboxylic acid amide 60-54-8 C22H24N2O8
(4aS)-4c-dimethylamino-3,6c,10,12,12a-pentahydroxy-6t-methyl-1,11-dioxo-(4ar,5at,12ac)-1,4,4a,5,5a,6,11,12a-octahydro-naphthacene-2-carboxylic acid amide
—— gadopentetate dimeglumine 86050-77-3 2C7H17NO5*C14H18N3O10*Gd*2H
gadopentetate dimeglumine