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 |
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—— | (6<i>R</i>)-7<i>t</i>-[2-(3,5-dichloro-4-oxo-4<i>H</i>-pyridin-1-yl)-acetylamino]-3-(5-methyl-[1,3,4]thiadiazol-2-ylsulfanylmethyl)-8-oxo-(6<i>r</i><i>H</i>)-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 56187-47-4 | C18H15Cl2N5O5S3 |
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—— | Betnesol | 312-93-6 | C22H30FO8P |
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—— | Testosterone enanthate | 315-37-7 | C26H40O3 |
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—— | 21-acetoxy-pregn-4-ene-3,20-dione | 56-47-3 | C23H32O4 |
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—— | 6b-Glycoloyl-5-hydroxy-4a,6a-dimethyl-8-propyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one | 51372-29-3 | C25H34O6 |
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—— | Methylprednisolone | 83-43-2 | C22H30O5 |
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—— | BREVICON | 68-22-4 | C20H26O2 |
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—— | Nurasin | 55134-13-9 | C43H72O11 |
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—— | naltrexone hydrochloride | 465-65-6 | C19H21NO4 |
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—— | Estradiol-benzoat | 50-50-0 | C25H28O3 |
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—— | sterigmatocystin | 10048-13-2 | C18H12O6 |
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—— | Antibiotic MA 144A1 | 57576-44-0 | C42H53NO15 |
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—— | 7-{[2-(2-Amino-1,3-thiazol-4-yl)-4-carboxybut-2-enoyl]amino}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 97519-39-6 | C15H14N4O6S2 |
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—— | erythromycin A | 114-07-8 | C37H67NO13 |
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—— | 3-[18-(2-Carboxyethyl)-7,12-bis(1-hydroxyethyl)-3,8,13,17-tetramethyl-21,23-dihydroporphyrin-2-yl]propanoic acid | 14459-29-1 | C34H38N4O6 |
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—— | 4,4,6a,9-Tetramethyl-1,2,3,4,4a,5,6,6a,11b,13b-decahydrobenzo[a]furo[2,3,4-mn]xanthen-11-ol | 22733-60-4 | C22H30O3 |
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—— | [6-[2-Chloro-1-[(1-methyl-4-propylpyrrolidine-2-carbonyl)amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] dihydrogen phosphate | 24729-96-2 | C18H34ClN2O8PS |
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—— | Isepamicine | 58152-03-7 | C22H43N5O12 |
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—— | pranlukast | 103177-37-3 | C27H23N5O4 |
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—— | 1-[2-[(3-Hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile | 1360862-63-0 | C17H25N3O2 |
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—— | 6-[2-(Diethylamino)ethylsulfonyl]-21-hydroxy-11,19-dimethyl-10-propan-2-yl-9,26-dioxa-3,15,28-triazatricyclo[23.2.1.03,7]octacosa-1(27),12,17,19,25(28)-pentaene-2,8,14,23-tetrone | 112362-50-2 | C34H50N4O9S |
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—— | cefmetazole | 56796-20-4 | C15H17N7O5S3 |
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—— | sparteine | 90-39-1 | C15H26N2 |
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—— | 7-(2-aminomethylphenylacetamido)-3-(1-carboxymethyltetrazol-5-ylthiomethyl)-3-cephem-4-carboxylic acid | 60925-61-3 | C20H21N7O6S2 |
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—— | Kanamycin B | 4696-76-8 | C18H37N5O10 |
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—— | Gibberellin A(7); 7-Desoxy-gibberellinsaeure | 510-75-8 | C19H22O5 |
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—— | 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-10-(2-methoxyethoxymethoxyimino)-3,5,7,9,11,13-hexamethyl-oxacyclotetradecan-2-one | 80214-83-1 | C41H76N2O15 |
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—— | glutathion | 70-18-8 | C10H17N3O6S |
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—— | Cerapp_24467 | 61991-54-6 | C47H80O17 |
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—— | 7-[[2-(2-Amino-1,3-thiazol-4-yl)-2-hydroxyiminoacetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 91832-40-5 | C14H13N5O5S2 |
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—— | dehydrotestosterone | 846-48-0 | C19H26O2 |
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—— | Cephacetril | 10206-21-0 | C13H13N3O6S |
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—— | progesterone | 57-83-0 | C21H30O2 |
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—— | methyl 4-[2-[2-(3,4-dihydroxyphenyl)ethoxy]-2-oxoethyl]-5-ethylidene-6-[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4H-pyran-3-carboxylate | 32619-42-4 | C25H32O13 |
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—— | diethylstilbestrol | 56-53-1 | C18H20O2 |
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—— | cephradine | 30959-67-2 | C16H19N3O4S |
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—— | (6<i>R</i>)-7<i>t</i>-((<i>R</i>)-2-amino-2-cyclohexa-1,4-dienyl-acetylamino)-3-methoxy-8-oxo-(6<i>r</i><i>H</i>)-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 51762-05-1 | C16H19N3O5S |
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—— | (2',15',17'-trihydroxy-11'-methoxy-3',7',12',14',16',18',22'-heptamethyl-4,6',23',29'-tetraoxospiro[1,3-dioxolane-2,27'-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(28),2,4,9,19,21,25-heptaene]-13'-yl) acetate | 14487-05-9 | C39H47NO14 |
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—— | Bleomycin A5 | 11116-32-8 | C57H89N19O21S2 |
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—— | Monocrotalin | 315-22-0 | C16H23NO6 |
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—— | Carbamic acid (6-hydroxy-5,11,21-trimethoxy-3,7,9,15-tetramethyl-16,20,22-trioxo-17-azabicyclo[16.3.1]docosa-1(21),8,12,14,18-pentaen-10-yl) ester | 30562-34-6 | C29H40N2O9 |
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—— | Einecs 234-275-5 | 11050-94-5 | C45H72O12 |
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—— | chlormadinone acetate | 302-22-7 | C23H29ClO4 |
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—— | Epi-doramectin | 117704-25-3 | C50H74O14 |
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—— | ALK-001 | 127-47-9 | C22H32O2 |
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—— | 2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2R)-2-amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1S,3S,5S)- | 361442-04-8 | C18H25N3O2 |
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—— | wortmannin | 19545-26-7 | C23H24O8 |
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—— | 2-amino-1-N-(3-butan-2-yl-7,11,14-trimethyl-2,5,9,12,15-pentaoxo-10-propan-2-yl-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl)-4,6-dimethyl-3-oxo-9-N-[7,11,14-trimethyl-2,5,9,12,15-pentaoxo-3,10-di(propan-2-yl)-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]phenoxazine-1,9-dicarboxamide | 8052-16-2 | C63H88N12O16 |
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—— | chaetocin | 28097-03-2 | C30H28N6O6S4 |
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—— | Methyl 7-[3-hydroxy-2-(3-hydroxy-4-phenoxybut-1-en-1-yl)-5-oxocyclopentyl]hepta-4,5-dienoate | 73121-56-9 | C23H28O6 |
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