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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
—— ABC-type Fe3+ transporter 9000-83-3 —— ——
—— Na+/K+-exchanging ATPase 9000-83-3 —— ——
—— P-type K+ transporter 9000-83-3 —— ——
—— ABC-type Mn2+ transporter 9000-83-3 —— ——
—— P-type Ag+ transporter 9000-83-3 —— ——
—— P-type Na+ transporter 9000-83-3 —— ——
—— ABC-type Cd2+ transporter 9000-83-3 —— ——
—— P-type H+-exporting transporter 9000-83-3 —— ——
—— minus-end-directed kinesin ATPase 9000-83-3 —— ——
—— myosin ATPase 9000-83-3 —— ——
—— channel-conductance-controlling ATPase 9000-83-3 —— ——
—— dynein ATPase 9000-83-3 —— ——
—— proteasome ATPase 9000-83-3 —— ——
—— plus-end-directed kinesin ATPase 9000-83-3 —— ——
—— non-chaperonin molecular chaperone ATPase 9000-83-3 —— ——
—— vesicle-fusing ATPase 9000-83-3 —— ——
—— peroxisome-assembly ATPase 9000-83-3 —— ——
—— factor-independent urate hydroxylase 9002-12-4 —— ——
—— papain 9001-73-4 —— ——
—— nicotinamide adenine dinucleotide 53-84-9 —— ——
—— Duract 120638-55-3 C15H13BrNNaO4
Duract
—— Fluvastatin acid 93957-54-1 C24H26FNO4
Fluvastatin acid
—— (6R,7R)-7-[[(2E)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-8-oxo-3-(5,6,7,8-tetrahydroquinolin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 118443-89-3 C23H25N6O5S2+
(6R,7R)-7-[[(2E)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-8-oxo-3-(5,6,7,8-tetrahydroquinolin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
—— (18S,19R,21S,35S)-3-[[(3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyl-2-oxanyl]oxy]-19,25,27,29,32,33,35,37-octahydroxy-18,20,21-trimethyl-23-oxo-22,39-dioxabicyclo[33.3.1]nonatriaconta-4,6,8,10,14,16-hexaene-38-carboxylic acid 1400-61-9 C47H75NO17
(18S,19R,21S,35S)-3-[[(3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyl-2-oxanyl]oxy]-19,25,27,29,32,33,35,37-octahydroxy-18,20,21-trimethyl-23-oxo-22,39-dioxabicyclo[33.3.1]nonatriaconta-4,6,8,10,14,16-hexaene-38-carboxylic acid
—— (E)-but-2-enedioic acid;[2-(dimethylamino)-2-phenylbutyl] 3,4,5-trimethoxybenzoate 34140-59-5 C22H29NO5.C4H4O4
(E)-but-2-enedioic acid;[2-(dimethylamino)-2-phenylbutyl] 3,4,5-trimethoxybenzoate
—— 19-Norpregn-5(10)-en-20-yn-3-one, 17-hydroxy-, (17alpha)- 68-23-5 C20H26O2
19-Norpregn-5(10)-en-20-yn-3-one, 17-hydroxy-, (17alpha)-
—— (6R,7R)-7-[[(2Z)-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-carboxylic acid 84957-29-9 C22H23N6O5S2+
(6R,7R)-7-[[(2Z)-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-carboxylic acid
—— methyl (2S,9R,10R,11S,14R,15S,17R)-2,15-dimethyl-5,5'-dioxospiro[18-oxapentacyclo[8.8.0.01,17.02,7.011,15]octadec-6-ene-14,2'-oxolane]-9-carboxylate 107724-20-9 C24H30O6
methyl (2S,9R,10R,11S,14R,15S,17R)-2,15-dimethyl-5,5'-dioxospiro[18-oxapentacyclo[8.8.0.01,17.02,7.011,15]octadec-6-ene-14,2'-oxolane]-9-carboxylate
—— Calcium p-aminosalicylate 133-15-3 C14H12CaN2O6
Calcium p-aminosalicylate
—— (Z)-Lanoconazole 101530-10-3 C14H10ClN3S2
(Z)-Lanoconazole
—— Merbromin sodium 129-16-8 C20H8Br2HgNa2O6
Merbromin sodium
—— (4S,5R,9R,12S,13R)-1,5,9-trimethyl-11,14,15,16-tetraoxatetracyclo[10.3.1.0^{4,13}.0^{8,13}]hexadecan-10-one 63968-64-9 C15H22O5
(4S,5R,9R,12S,13R)-1,5,9-trimethyl-11,14,15,16-tetraoxatetracyclo[10.3.1.0^{4,13}.0^{8,13}]hexadecan-10-one
—— (E)-but-2-enedioic acid;(E)-1-[4-(2-oxo-2-pyrrolidin-1-ylethyl)piperazin-1-yl]-3-(3,4,5-trimethoxyphenyl)prop-2-en-1-one 26328-04-1 C26H35N3O9
(E)-but-2-enedioic acid;(E)-1-[4-(2-oxo-2-pyrrolidin-1-ylethyl)piperazin-1-yl]-3-(3,4,5-trimethoxyphenyl)prop-2-en-1-one
—— 2-(7-Cyano-8,16-dihydroxy-9,11,13,15-tetramethyl-18-oxooxacyclooctadeca-4,6-dien-2-yl)cyclopentanecarboxylic acid 7184-60-3 C28H43NO6
2-(7-Cyano-8,16-dihydroxy-9,11,13,15-tetramethyl-18-oxooxacyclooctadeca-4,6-dien-2-yl)cyclopentanecarboxylic acid
—— (4S,7R,8S,9S,13Z,16S)-4,8-Dihydroxy-5,5,7,9,13-pentamethyl-16-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]oxacyclohexadec-13-ene-2,6-dione 189453-10-9 C27H41NO5S
(4S,7R,8S,9S,13Z,16S)-4,8-Dihydroxy-5,5,7,9,13-pentamethyl-16-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]oxacyclohexadec-13-ene-2,6-dione
—— Cefatiolene 77360-52-2 C20H18N8O8S3
Cefatiolene
—— 5-(Morpholin-4-ylmethyl)-3-[(Z)-(5-nitrofuran-2-yl)methylideneamino]-1,3-oxazolidin-2-one;hydrochloride 3759-92-0 C13H17ClN4O6
5-(Morpholin-4-ylmethyl)-3-[(Z)-(5-nitrofuran-2-yl)methylideneamino]-1,3-oxazolidin-2-one;hydrochloride
—— 1-Methyl-2-(nitrosomethylidene)-1,2-dihydropyridine--hydrogen iodide (1/1) 94-63-3 C7H9IN2O
1-Methyl-2-(nitrosomethylidene)-1,2-dihydropyridine--hydrogen iodide (1/1)
—— (5E)-5-[(2E)-2-[1-[(E)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol 112965-21-6 C27H40O3
(5E)-5-[(2E)-2-[1-[(E)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol
—— Neocarzinostatin 9014-02-2 C35H35NO12
Neocarzinostatin
—— 2-[Bis[2-[bis(carboxymethyl)amino]ethyl]amino]acetic acid;gadolinium(3+) 80529-93-7 C14H23GdN3O10+3
2-[Bis[2-[bis(carboxymethyl)amino]ethyl]amino]acetic acid;gadolinium(3+)
—— fosinopril sodium 88889-14-9 C30H45NO7P*Na
fosinopril sodium
—— sodium (6R,7R)-3-[(carbamoyloxy)methyl]-7-[(2E)-2-(furan-2-yl)-2-(methoxyimino)acetamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate 56238-63-2 C16H15N4NaO8S
sodium (6R,7R)-3-[(carbamoyloxy)methyl]-7-[(2E)-2-(furan-2-yl)-2-(methoxyimino)acetamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
—— Azimilide hydrochloride 149888-94-8 C23H30Cl3N5O3
Azimilide hydrochloride
—— 3-Desethenyl-3-methyl Cefixime (Cefixime EP Impurity E) 72701-01-0 C15H15N5O7S2
3-Desethenyl-3-methyl Cefixime (Cefixime EP Impurity E)
—— (6R,7R)-7-({(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-[(2-ethoxy-2-oxoethoxy)imino]acetyl}amino)-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 79368-95-9 C18H19N5O7S2
(6R,7R)-7-({(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-[(2-ethoxy-2-oxoethoxy)imino]acetyl}amino)-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
—— 3-(4-Sulfamoylphenyl)propanoate 90610-69-8 C9H10NO4S-
3-(4-Sulfamoylphenyl)propanoate
—— (6S,8R,9S,10R,13S,14S,17R)-17-Acetyl-6,10,13-trimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl acetate 71-58-9 C24H34O4
(6S,8R,9S,10R,13S,14S,17R)-17-Acetyl-6,10,13-trimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl acetate
—— [(1S,3S,5R,6S)-6-hydroxy-8-methyl-8-azabicyclo[3.2.1]octan-3-yl] (2S)-3-hydroxy-2-phenylpropanoate 55869-99-3 C17H23NO4
[(1S,3S,5R,6S)-6-hydroxy-8-methyl-8-azabicyclo[3.2.1]octan-3-yl] (2S)-3-hydroxy-2-phenylpropanoate
—— (6R,7R)-3-[[3-amino-2-(2-hydroxyethyl)pyrazol-1-ium-1-yl]methyl]-7-[[(2E)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate;sulfuric acid 122841-12-7 C19H24N8O10S3
(6R,7R)-3-[[3-amino-2-(2-hydroxyethyl)pyrazol-1-ium-1-yl]methyl]-7-[[(2E)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate;sulfuric acid