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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—— | 7-[[(2E)-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-carboxylate;sulfuric acid | 98753-19-6 | C22H24N6O9S3 |
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—— | (6S,7R)-7-((R)-2-Amino-2-(4-hydroxyphenyl)acetamido)-8-oxo-3-((E)-prop-1-en-1-yl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 92665-29-7 | C18H19N3O5S |
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—— | 3-{1-[2-(Aminomethyl)-1,3-thiazol-4-YL]prop-1-EN-2-YL}-7,11-dihydroxy-8,8,10,12,16-pentamethyl-4,17-dioxabicyclo[14.1.0]heptadecane-5,9-dione | 280578-49-6 | C27H42N2O6S |
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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-3,5,7,9,11,13-hexamethyl-oxacyclotetradecane-2,10-dione;2,3,5,6-tetrahydroxy-4-[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanoic acid | 3847-29-8 | C49H89NO25 |
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—— | ipamorelin | 170851-70-4 | C38H49N9O5 |
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—— | (5E)-PGB<sub>2</sub> | 13367-85-6 | C20H30O4 |
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—— | decanoyl-Trp-Asn-Asp-Thr(1)-Gly-Orn-Asp-D-Ala-Asp-Gly-D-Ser-Glu(3S-Me)-Asp(Ph(2-NH2))-(1) | 103060-53-3 | C72H101N17O26 |
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—— | Deaminooxytocin | 113-78-0 | C43H65N11O12S2 |
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—— | cis-2,6-dimethyl-4-((S)-2-methyl-3-(4-(tert-pentyl)phenyl)propyl)morpholine | 78613-35-1 | C21H35NO |
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—— | (R)-cefuroxime 1-acetoxyethyl ester | 64544-07-6 | C20H22N4O10S |
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—— | 17α-Methyl-5β-androst-1-en-17β-ol-3-on | 65-04-3 | C20H30O2 |
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—— | 17β-Hydroxy-17α-methyl-androst-1-en-3-on | 65-04-3 | C20H30O2 |
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—— | 17α-Methyl-Δ<sup>1</sup>-5α-androstenol-(17β)-on-(3) | 65-04-3 | C20H30O2 |
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—— | (Z)-tert-Butyl 2-(((1-(2-aminothiazol-4-yl)-2-(benzo[d]thiazol-2-ylthio)-2-oxoethylidene)amino)oxy)-2-methylpropanoate | 89604-92-2 | C20H22N4O4S3 |
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—— | [(2S,3S,4R,5S,6S)-6-[(1R,2R)-2-chloro-1-[[(2R,4S)-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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—— | 2-(2-(((Benzyloxy)carbonyl)amino)thiazol-4-yl)-5-((3-methylbut-2-en-1-yl)oxy)-5-oxopent-2-enoic acid | 102199-30-4 | C21H22N2O6S |
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—— | Floridosid | 534-68-9 | C9H18O8 |
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—— | p-nitrobenzyl (5R,6S)-2-diphenoxy phosphoryloxy-6-[(R)-1-hydroxyethyl]-1-carbapen-2-em-3-carboxylate | 77171-49-4 | C28H25N2O10P |
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—— | 15-Ethyl-14-ethynyl-5-(hydroxyimino)tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-ol | 53016-31-2 | C21H29NO2 |
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—— | mibefradil dihydrochloride | 116666-63-8 | C29H38FN3O3*2ClH |
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—— | (2S)-2-amino-3-{[(3-chloro-2-methyl-5-sulfophenyl)carbamoyl]amino}propanoic acid | 1333218-50-0 | C11H14ClN3O6S |
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—— | 2-Pentenedioic acid, 2-[2-[[(phenylmethoxy)carbonyl]amino]-4-thiazolyl]-, 5-(3-methyl-2-buten-1-yl) ester | 115065-79-7 | C21H21N2O6S- |
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—— | lycoramine | 18797-70-1 | C17H23NO3 |
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—— | (E)-but-2-enedioic acid;(4-ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxo-6-tricyclo[5.4.3.01,8]tetradecanyl) 2-[2-(diethylamino)ethylsulfanyl]acetate | 55297-96-6 | C4H4O4*C28H47NO4S |
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—— | (3S,9R,12R,15S,18S,21R,24R,27S,30S,33R,36R)-6,18,30-trimethyl-3,9,12,15,21,24,27,33,36-nona(propan-2-yl)-1,7,13,19,25,31-hexaoxa-4,10,16,22,28,34-hexazacyclohexatriacontane-2,5,8,11,14,17,20,23,26,29,32,35-dodecone | 2001-95-8 | C54H90N6O18 |
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—— | 2-[(2<i>RS</i>)-6<i>c</i>-((<i>SR</i>)-β-hydroxy-phenethyl)-1-methyl-[2<i>r</i>]piperidyl]-1-phenyl-ethanone | 90-69-7 | C22H27NO2 |
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—— | 4-EPIOXYTETRACYCLINE | 79-57-2 | C22H24N2O9 |
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—— | N,N-dimethylamino-3-(1-naphthanyloxy)-3-(2-thienyl)-1-propanamine | 116817-11-9 | C19H21NOS |
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—— | BIBF 0775 | 334951-90-5 | C31H34N4O2 |
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—— | ethyl chaulmoograte | 623-32-5 | C20H36O2 |
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—— | Herbimycin | 70563-58-5 | C30H42N2O9 |
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—— | stiripentol | 137767-55-6 | C14H18O3 |
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—— | dl-dethiobiotine | 533-48-2 | C10H18N2O3 |
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—— | (+/-)-6-(5<i>t</i>-methyl-2-oxo-imidazolidin-4<i>r</i>-yl)-hexanoic acid | 533-48-2 | C10H18N2O3 |
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—— | Dicopper citrate | 866-82-0 | C6H4Cu2O7 |
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—— | neomycin B/C | 66-86-4 | C23H46N6O13 |
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—— | 1-Methyl-N-((1R,3R,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-YL)-1H-indazole-3-carboxamide | 109889-09-0 | C18H24N4O |
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—— | cinchonidine | 485-71-2 | C19H22N2O |
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—— | (4-nitrophenyl)methyl (2S,5S,6R)-6-[(1S)-1-hydroxyethyl]-3,7-dioxo-1-azabicyclo[3.2.0]heptane-2-carboxylate | 74288-40-7 | C16H16N2O7 |
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—— | (E)-But-2-enedioic acid;2-[(E)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine | 61718-82-9 | C19H25F3N2O6 |
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—— | cinchonidine | 118-10-5 | C19H22N2O |
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—— | cevimeline | 107233-08-9 | C10H17NOS |
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—— | octreotide diacetate | 79517-01-4 | 2C2H4O2*C49H66N10O10S2 |
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—— | nystatin A<sub>1</sub> | 1400-61-9 | C47H75NO17 |
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—— | 7-bromo-6-chloro-3-[3-(3-hydroxy-2-piperidinyl)-2-oxopropyl]-4(3H)-quinazolinone | 55837-20-2 | C16H17BrClN3O3 |
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—— | 2-(4'-fluorophenyl)-3-methoxy-6-(3''-methoxybenzylthio)imidazo<1,2-b>pyridazine | 121041-20-1 | C21H18FN3O2S |
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—— | Congo Red | 573-58-0 | C32H22N6O6S2 |
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—— | stilbamidine | 122-06-5 | C16H16N4 |
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—— | amphotericin B | 1397-89-3 | C47H73NO17 |
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—— | Win 35065-3 | 74163-84-1 | C16H21NO2 |
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