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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—— | 7775-11-3 | CrH2NaO4 |
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—— | alpha-Tocopherol nicotinate | 16676-75-8 | C35H53NO3 |
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—— | 125-02-0 | C21H29NaO8P |
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—— | 1,8-dihydroxy-3-(hydroxymethyl)-10-[(3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]-10H-anthracen-9-one | 1415-73-2 | C21H22O9 |
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—— | 4697-14-7 | C15H16N2NaO6S2 |
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—— | (2S,3R,4S,5R,6R)-4-amino-2-[(1S,2S,3R,4S,6R)-4,6-diamino-3-[(2R,3S,6S)-3-amino-6-(aminomethyl)oxan-2-yl]oxy-2-hydroxycyclohexyl]oxy-6-(hydroxymethyl)oxane-3,5-diol;sulfuric acid | 58580-55-5 | C18H39N5O12S |
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—— | 928659-17-0 | C5H6N6NaO4S |
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—— | (R)-N-(3-(7-methyl-1H-indazol-5-yl)-1-(4-(1-methylpiperidin-4-yl)piperazin-1-yl)-1-oxopropan-2-yl)-4-(2-oxo-1,2-dihydroquinolin-3-yl)piperidine-1-carboxamide hydrochloride | 1414976-20-7 | C36H46N8O3*ClH |
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—— | 163706-36-3 | C17H25Cl2F3N5NaO12P3S2 |
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—— | 1-[(2R)-6-fluoro-3,4-dihydro-2H-chromen-2-yl]-2-[[(2R)-2-[(2S)-6-fluoro-3,4-dihydro-2H-chromen-2-yl]-2-hydroxyethyl]amino]ethanol | 118457-14-0 | C22H25F2NO4 |
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—— | Zeniplatin | 111490-36-9 | C11H20N2O6Pt |
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—— | 150399-23-8 | C20H21N5NaO6 |
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—— | 9Lyl8crr6L | 137391-68-5 | C17H18N4O7 |
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—— | methyl violet | 8004-87-3 | C25H31N3 |
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—— | [(1S,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenylpropanoate;sulfuric acid | 55-48-1 | C34H48N2O10S |
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—— | (2R,3R,4S,5S,6R)-2-[(1R,2R,3S,4S,6R)-2,3-Dihydroxy-6-hydroxymethyl-4-((1S,4R,5S,6R)-4,5,6-trihydroxy-3-hydroxymethyl-cyclohex-2-enylamino)-cyclohexyloxy]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol | 37248-47-8 | C20H35NO13 |
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—— | 1H-Indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylicacid, 9-bromo-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-12-hydroxy-, methylester, (12R,13aR,13bR)-rel- | 57475-17-9 | C21H25BrN2O3 |
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—— | (R)-4-(5-(4-methoxy-3-propoxyphenyl)pyridin-3-yl)-1,2-oxaborolan-2-ol | 2415085-44-6 | C18H22BNO4 |
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—— | calicheamicin γ1I | 108212-75-5 | C55H74IN3O21S4 |
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—— | sodium salt of lasalocid A | 25999-20-6 | C34H53O8*Na |
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—— | (E)-(S)-4-((S)-2-{3-[(5-methylisoxazole-3-carbonyl)amino]-2-oxo-2H-pyridin-1-yl}pent-4-ynoylamino)-5-((S)-2-oxopyrrolidin-3-yl)pent-2-enoic acid ethyl ester | 343565-99-1 | C26H29N5O7 |
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—— | 5-[2-ethoxy-5-(cis-3,5-dimethylpiperazine-1-sulfonyl)phenyl]-1-methyl-3-n-propyl-7,6-dihydro-1H-pyrazolo[4,3-d]pyrimidin-7-one | 496835-35-9 | C23H32N6O4S |
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—— | N-[(3S,6S,12R,15S,16R,19S,22S)-3-benzyl-12-ethyl-4,16-dimethyl-2,5,11,14,18,21,24-heptaoxo-19-phenyl-17-oxa-1,4,10,13,20-pentazatricyclo[20.4.0.06,10]hexacosan-15-yl]-3-hydroxypyridine-2-carboxamide;(10R,11R,12E,21S)-21-hydroxy-11,19-dimethyl-10-propan-2-yl-9,26-dioxa-3,15,28-triazatricyclo[23.2.1.03,7]octacosa-1(27),6,12,17,19,25(28)-hexaene-2,8,14,23-tetrone | 11006-76-1 | C71H84N10O17 |
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—— | 4-EPIOXYTETRACYCLINE | 79-57-2 | C22H24N2O9 |
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—— | sodium;2-[4-(3,7,12-trihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoylamino]ethanesulfonate;hydrate | 345909-26-4 | C26H46NNaO8S |
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—— | latamoxef disodium | 64953-12-4 | C20H18N6O9S*2Na |
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—— | 3-[[5-amino-2-[2-[[2-[[2-[[2-[[2-[[2-[[2-[[6-amino-2-[[2-[[2-[[2-[[2-[[2-[[2-[[2-[[2-[[5-amino-2-[[2-[[2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-3-carboxypropanoyl]amino]-3-hydroxypropanoyl]amino]-5-carbamimidamidopentanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoylamino]-5-oxopentanoyl]amino]-4-[[1-[[1-[[5-amino-1-[[1-[[1-[[1-[[4-amino-1-[(1-carboxy-2-hydroxypropyl)amino]-1,4-dioxobutan-2-yl]amino]-4-methylsulfanyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid | 9007-92-5 | C153H225N43O49S |
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—— | H-Cys-Ser-Asn-Leu-Ser-Thr-Cys-Val-Leu-Gly-Lys-Leu-Ser-Gln-Glu-Leu-His-Lys-Leu-Gln-Thr-Tyr-Pro-Arg-Thr-Asp-Val-Gly-Ala-Gly-Thr-Pro-NH2 | 57014-02-5 | C146H243N43O47S2 |
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—— | 10294-64-1 | H2KMnO4 |
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—— | Demethylrifampicin | 13292-45-0 | C42H56N4O12 |
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—— | Aclarubicin | 64520-15-6 | C42H53NO15 |
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—— | quinine hydrochloride | 130-89-2 | C21H26N2O2*ClH |
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—— | GESTONORONE CAPROATE | 1253-28-7 | C26H38O4 |
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—— | Androst-1-en-3-one, 17-hydroxy-1-methyl-, (5a,17a)- | 153-00-4 | C20H30O2 |
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—— | Oxytetracyclin | 35259-39-3 | C22H24N2O9 |
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—— | syn-norgestimate | 35189-28-7 | C23H31NO3 |
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—— | 10102-17-7 | H4NaO4S2 |
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—— | S-(-)-Cefotaxime | 1151540-28-1 | C16H17N5O7S2 |
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—— | 2-[(E)-3-(3-Methoxy-4-propoxy-phenyl)-acryloylamino]-benzoic acid | 53902-17-3 | C20H21NO5 |
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—— | (4S)-1-[4-cyano-4-(4-fluorophenyl)cyclohexyl]-3-methyl-4-phenylpiperidine-4-carboxylic acid;hydrochloride | 79547-78-7 | C26H30ClFN2O2 |
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—— | sodium;2-[4-[(3R,5R,7R,8R,9S,10S,13R,14S,17R)-3,7,12-trihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoylamino]acetate | 863-57-0 | C26H42NO6*Na |
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—— | 3,12,24-Trihydroxy-24,24-diphenyl-cholan | 83116-96-5 | C36H50O3 |
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—— | Aluminum Potassium sulfate dodecchydrate | 7784-24-9 | AlH4KO5S |
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—— | Dimethotrexate | 133073-73-1 | C40H44N16O10 |
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—— | N6-p-Methoxyphenyladenosin | 510-77-0 | C17H19NO3 |
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—— | 4-epi-Chlortetracycline Hydrochloride (>90% by HPLC) | 101342-45-4 | C22H24Cl2N2O8 |
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—— | (2S)-4-amino-N-[(1R,3S,4R)-5-amino-2-[(2S,5S)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4-[(2R,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]-2-hydroxybutanamide;sulfuric acid | 149022-22-0 | C22H45N5O17S |
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—— | (-)-pilocarpine; nitrate | 148-72-1 | C11H16N2O2*HNO3 |
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—— | 1-[10-(2-dimethylamino-propyl)-10<i>H</i>-phenothiazin-2-yl]-propan-1-one; radical cation | 362-29-8 | C20H24N2OS |
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—— | (S,E)-3-((E)-2-((1R,3aS,7aR)-1-((R)-6-hydroxy-6-methylheptan-2-yl)-7a-methylhexahydro-1H-inden-4(2H)-ylidene)ethylidene)-4-methylenecyclohexanol | 19356-17-3 | C27H44O2 |
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