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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—— | (1R,3R,5S,8S,9R,12S,13R)-1-hydroxy-14-(2-hydroxypropan-2-yl)-13-methyl-4,7,10-trioxapentacyclo[6.4.1.19,12.03,5.05,13]tetradecane-6,11-dione;(1R,3R,5S,8S,9R,12S,13R)-1-hydroxy-13-methyl-14-prop-1-en-2-yl-4,7,10-trioxapentacyclo[6.4.1.19,12.03,5.05,13]tetradecane-6,11-dione | 124-87-8 | C30H34O13 |
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—— | methyl (9R,10S,11R,12R,19R)-11-acetyloxy-12-ethyl-4-[(13S,15R,17S)-17-ethyl-17-hydroxy-13-methoxycarbonyl-1,11-diazatetracyclo[13.3.1.04,12.05,10]nonadeca-4(12),5,7,9-tetraen-13-yl]-10-hydroxy-5-methoxy-8-methyl-8,16-diazapentacyclo[10.6.1.01,9.02,7.016,19]nonadeca-2,4,6,13-tetraene-10-carboxylate;sulfuric acid | 143-67-9 | C46H58N4O9.H2O4S |
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—— | (3Z)-3-[(2Z)-2-[1-(5-ethyl-6-methylheptan-2-yl)-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol | 71761-06-3 | C29H48O |
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—— | p-arsanilic acid monosodium salt | 127-85-5 | C6H7AsNO3*Na |
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—— | Piperazine, 2-hydroxy-1,2,3-propanetricarboxylate (3:2), hydrate | 7140-78-5 | C26H50N4O24 |
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—— | [(1S,2R,3S,5S,6S,16Z,18Z,20R,21S)-11-chloro-21-hydroxy-12,20-dimethoxy-2,5,9,16-tetramethyl-8,23-dioxo-4,24-dioxa-9,22-diazatetracyclo[19.3.1.110,14.03,5]hexacosa-10,12,14(26),16,18-pentaen-6-yl] (2S)-2-[acetyl(methyl)amino]propanoate | 35846-53-8 | C34H46ClN3O10 |
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—— | 3-O-De[2-(acetylmethylamino)-1-oxopropyl]-3-O-(1-oxobutyl)maytansine | 66584-72-3 | C32H43ClN2O9 |
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—— | Rifomycins | 13553-79-2 | C37H45NO12 |
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—— | 2-amino-4,6-dimethyl-3-oxo-1-N-[(3R,6S,7R,10S,16S)-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]-9-N-[(3R,6S,7R,16S)-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 | 50-76-0 | C62H86N12O16 |
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—— | Calcitriol (Rocaltrol) | 32222-06-3 | C27H44O3 |
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—— | N-[(3S,6S,12S,15S,16S,19R,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;(10S,11S,12E,17E,19E,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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—— | Vinorelbine ditartrate | 125317-39-7 | C53H66N4O20 |
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—— | (2S)-2-[(2R,5S,6R)-6-[(2S,3S,4S,6R)-6-[(3S,5S,7R,9S,10S,12R,15R)-3-[(2R,5R,6S)-5-ethyl-5-hydroxy-6-methyloxan-2-yl]-15-hydroxy-3,10,12-trimethyl-4,6,8-trioxadispiro[4.1.57.35]pentadec-13-en-9-yl]-3-hydroxy-4-methyl-5-oxooctan-2-yl]-5-methyloxan-2-yl]butanoic acid | 53003-10-4 | C42H70O11 |
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—— | (1S,2R,18R,19R,22S,25R,28R,40R)-48-{[(2S,3R,4S,5S,6R)-3-{[(2S,4S,6S)-4-amino-5-hydroxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-4,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl]oxy}-22-(2-amino-2-oxoethyl)-5,15-dichloro-2,18,32,35,37-pentahydroxy- | 1404-90-6 | C66H75Cl2N9O24 |
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—— | p-Aminosalicylic acid sodium salt dihydrate | 6018-19-5 | C7H7NNaO3+ |
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—— | 147098-20-2 (Calcium) | 147098-20-2 | C44H54CaF2N6O12S2 |
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—— | Caspofungin | 162808-62-0 | C52H88N10O15 |
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—— | N-(3-amino-3-oxoprop-1-en-2-yl)-2-[(1S,18S,21Z,28R)-21-ethylidene-9,30-dihydroxy-18-[(1R)-1-hydroxyethyl]-40-methyl-16,19,26,31,42,46-hexaoxo-32-oxa-3,13,23,43,49-pentathia-7,17,20,27,45,51,52,53,54,55-decazanonacyclo[26.16.6.12,5.112,15.122,25.138,41.147,50.06,11.034,39]pentapentaconta-2(55),4,6,8,10,12(54),14,22(53),24,34(39),35,37,40,47,50-pentadecaen-8-yl]-1,3-thiazole-4-carboxamide | 56377-79-8 | C51H43N13O12S6 |
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—— | N-[3-[(3-amino-3-oxoprop-1-en-2-yl)amino]-3-oxoprop-1-en-2-yl]-2-[(8S,11Z,18R,25S,35R,59S)-37-butan-2-yl-18-(2,3-dihydroxybutan-2-yl)-11-ethylidene-59-hydroxy-31-(1-hydroxyethyl)-8-[(1R)-1-hydroxyethyl]-26,40,46-trimethyl-43-methylidene-6,9,16,23,28,38,41,44,47-nonaoxo-27-oxa-3,13,20,56-tetrathia-7,10,17,24,36,39,42,45,48,52,58,61,62,63,64-pentadecazanonacyclo[23.23.9.329,35.12,5.112,15.119,22.154,57.01,53.032,60]tetrahexaconta-2(64),4,12(63),19(62),21,29(61),30,32(60),33,51,54,57-dodecaen-51-yl]-1,3-thiazole-4-carboxamide | 1393-48-2 | C72H85N19O18S5 |
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—— | nosiheptide | 56377-79-8 | C51H43N13O12S6 |
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—— | Ramoplanin | 76168-82-6 | C106H170ClN21O30 |
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—— | Liraglutide | 204656-20-2 | C172H265N43O51 |
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—— | (6R,7R)-7-[[(2E)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-(furan-2-carbonylsulfanylmethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 80370-57-6 | C19H17N5O7S3 |
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—— | (7R,9R)-9-acetyl-7-[(2S,4R,5R,6R)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione;hydrochloride | 23541-50-6 | C27H30ClNO10 |
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—— | Doramectin synthetic | 117704-25-3 | C50H74O14 |
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—— | Calcium titanate | 12049-50-2 | CaTiO3 |
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—— | Hydroquinidine 4-methyl-2-quinolyl ether | 135042-89-6 | C30H33N3O2 |
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—— | Cromolyn disodium salt hydrate | 15826-37-6 | C23H16NaO11 |
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—— | (4R)-N-[(1S,2S)-2-chloro-1-[(3R,4S,5R,6R)-3,4,5-trihydroxy-6-methylsulfanyloxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide;hydrochloride | 21462-39-5 | C18H34Cl2N2O5S |
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—— | Dantrolene sodium salt | 14663-23-1 | C14H10N4NaO5 |
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—— | Thiostrepton from Streptomyces azureus | 1393-48-2 | C72H85N19O18S5 |
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—— | (4R,5S,6S,7R,9R,11E,13Z,15R,16S)-6-[(2R,3R,4S,5S,6R)-4-(Dimethylamino)-3,5-dihydroxy-6-methyloxan-2-yl]oxy-7-[2-[(3S,5R)-3,5-dimethylpiperidin-1-yl]ethyl]-16-ethyl-4-hydroxy-15-[[(2R,3R,4R,5R,6R)-5-hydroxy-3,4-dimethoxy-6-methyloxan-2-yl]oxymethyl]-5,9,13-trimethyl-1-oxacyclohexadeca-11,13-diene-2,10-dione | 108050-54-0 | C46H80N2O13 |
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—— | Fosfomycin disodium salt | 26016-99-9 | C3H5Na2O4P |
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—— | (1R)((5R)-5-vinylquinuclidin-2-yl)-4-quinolylmethan-1-ol | 118-10-5 | C19H22N2O |
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—— | decanoyl-Trp-Asn-Asp-DL-Thr(1)-Gly-Orn-Asp-D-Ala-DL-Asp-Gly-D-Ser-Glu(3R-Me)-DL-Asp(Ph(2-NH2))-(1) | 103060-53-3 | C72H101N17O26 |
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—— | 6-[2-[[(6aR,6bS,8aS,11S,14bS)-11-carboxy-4,4,6a,6b,8a,11,14b-heptamethyl-14-oxo-2,3,4a,5,6,7,8,9,10,12,12a,14a-dodecahydro-1H-picen-3-yl]oxy]-6-carboxy-4,5-dihydroxyoxan-3-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid | 1405-86-3 | C42H62O16 |
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—— | [(2R,3S,4R,6R)-6-[(2R,4R,5S,6R)-2-[(2S,3R,4S)-4-[(2S,3S,4E,6Z,9R,10S,11S,12R,13R,14E,16Z)-11-ethyl-10,12-dihydroxy-3,17-dimethoxy-7,9,13,15-tetramethyl-18-oxo-1-oxacyclooctadeca-4,6,14,16-tetraen-2-yl]-3-hydroxypentan-2-yl]-2-hydroxy-5-methyl-6-[(E)-prop-1-enyl]oxan-4-yl]oxy-4-hydroxy-2-methyloxan-3-yl] carbamate | 80890-47-7 | C46H75NO14 |
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—— | [(4R)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl] 3-hydroxy-2-phenylpropanoate | 51-34-3 | C17H21NO4 |
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—— | (6R)-2,6-dimethylpiperidine | 504-03-0 | C7H15N |
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—— | (15S,16R,17R,18S,19E,21E,23E,25E,27E,29E,31E,33R,37S)-33-[(4R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid | 1397-89-3 | C47H73NO17 |
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—— | Pharmakon1600-01505112 | 108050-54-0 | C46H80N2O13 |
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—— | 2,2-dimethylpropanoyloxymethyl 7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(Z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate | 117467-28-4 | C25H28N6O7S3 |
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—— | (1R,2R,9S,10S)-7,15-diazatetracyclo[7.7.1.02,7.010,15]heptadecane;sulfuric acid | 6160-12-9 | C15H28N2O4S |
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—— | Blasticidin S | 2079-00-7 | C17H26N8O5 |
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—— | Sodium stibogluconate | 16037-91-5 | C12H36Na3O26Sb2+ |
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—— | 1-[4-[4-[[(2S)-2-(2,4-Dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone | 65277-42-1 | C26H28Cl2N4O4 |
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—— | (5S)-2-methylspiro[1,3-oxathiolane-5,3'-1-azabicyclo[2.2.2]octane] | 107233-08-9 | C10H17NOS |
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—— | 1-acetyloxyethyl (6S,7R)-3-(carbamoyloxymethyl)-7-[[(2E)-2-(furan-2-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate | 64544-07-6 | C20H22N4O10S |
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—— | (2S)-2-[(5R)-6-[(2R,3R,4R,6S)-6-[(3R,5R,7S,10R,12S,15S)-3-[(5S,6R)-5-ethyl-5-hydroxy-6-methyloxan-2-yl]-15-hydroxy-3,10,12-trimethyl-4,6,8-trioxadispiro[4.1.57.35]pentadec-13-en-9-yl]-3-hydroxy-4-methyl-5-oxooctan-2-yl]-5-methyloxan-2-yl]butanoic acid | 53003-10-4 | C42H70O11 |
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—— | [(4E,8R,10Z,12R,13S,14R,16R)-13-hydroxy-8,14,19-trimethoxy-4,10,12,16-tetramethyl-3,20,22-trioxo-2-azabicyclo[16.3.1]docosa-1(21),4,6,10,18-pentaen-9-yl] carbamate | 30562-34-6 | C29H40N2O9 |
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