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 |
|---|---|---|---|
| —— | Disodium 7-{2-[(2-amino-2-carboxylatoethyl)sulfanyl]acetamido}-7-methoxy-3-{[(1-methyl-1H-tetrazol-5-yl)sulfanyl]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate | 92636-39-0 | C16H19N7Na2O7S3 |
| —— | Prostaglandin I2; Prostacyclin | 61849-14-7 | C20H31NaO5 |
| —— | 6-(1-Hydroxyethyl)-3-[2-[[[(4-nitrophenyl)methoxy-oxomethyl]amino]methylideneamino]ethylthio]-4-[(4-nitrophenyl)methyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate | 98367-45-4 | C27H26N5O10S- |
| —— | HR 111V sulfate;HR-111V sulfate;HR111V sulfate | 84957-30-2 | C23H26N6O9S3 |
| —— | (3S,5R,E)-tert-Butyl 7-(3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl)-3,5-dihydroxyhept-6-enoate | 129332-29-2 | C28H34FNO4 |
| —— | Cefodizime (sodium) | 86329-79-5 | C20H18N6Na2O7S4 |
| —— | 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 |
| —— | Bisoprolol; butenedioic acid | 104344-23-2 | C22H35NO8 |
| —— | sodium 7-[[2-(2-azanyl-1,3-thiazol-4-yl)-2-methoxyimino-ethanoyl]amino]-3-[[2-methyl-5,6-bis(oxidanylidene)-1H-1,2,4-triazin-3-yl]sulfanylmethyl]-8-oxidanylidene-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate | 74578-69-1 | C18H17N8NaO7S3 |
| —— | Sodium;7-[[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 | 68401-82-1 | C13H12N5NaO5S2 |
| —— | (4-Nitrophenyl)methyl 2-[(sulfamoylamino)methyl]-4-sulfanylpyrrolidine-1-carboxylate | 148017-03-2 | C13H18N4O6S2 |
| —— | N-[1-[4-(4-amino-5-hydroxy-6-methyloxan-2-yl)oxy-2,5,12-trihydroxy-7-methoxy-6,11-dioxo-3,4-dihydro-1H-tetracen-2-yl]ethylideneamino]benzamide;hydrochloride | 36508-71-1 | C34H36ClN3O10 |
| —— | Foradil Aerolizer | 43229-80-7 | C42H52N4O12 |
| —— | Nutriacholate | 4651-67-6 | C24H38O4 |
| —— | Hesperetin-rutinoside | 520-26-3 | C28H34O15 |
| —— | Oxytocin injection | 50-56-6 | C43H66N12O12S2 |
| —— | sodium;4-[(2R,3aS,8bS)-2-hydroxy-1-[(E,3S)-3-hydroxy-4-methyloct-1-en-6-ynyl]-2,3,3a,8b-tetrahydro-1H-cyclopenta[b][1]benzofuran-5-yl]butanoate | 88475-69-8 | C24H29NaO5 |
| —— | (1R,3R,5S,6S,9S,11S,15S,16S,17R,18S,19E,21E,23E,25E,27E,29E,31E,33R,35S,36R,37S)-33-[(3R,4R,5R,6S)-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 |
| —— | calcium;(E,3S,5S)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate | 147098-20-2 | C44H54CaF2N6O12S2 |
| —— | (1R,9S,12S,15R,16E,18R,19R,21R,23R,24Z,26E,28E,30S,35R)-1,18-dihydroxy-12-[(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone | 159351-69-6 | C53H83NO14 |
| —— | Pharmakon1600-01505803 | 81131-70-6 | C23H36NaO7+ |
| —— | Pharmakon1600-01500448 | 7240-38-2 | C19H19N3NaO5S+ |
| —— | sodium;(2S,5R,6R)-6-[[3-(2,6-dichlorophenyl)-5-methyl-1,2-oxazole-4-carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid | 13412-64-1 | C19H17Cl2N3NaO5S+ |
| —— | Pharmakon1600-01500395 | 7246-14-2 | C17H20N2NaO6S+ |
| —— | Pharmakon1600-01500277 | 129-51-1 | C23H27N3O6 |
| —— | Pharmakon1600-01501105 | 58-58-2 | C22H30ClN7O5 |
| —— | Pharmakon1600-01502420 | 123171-59-5 | C19H25ClN6O5S2 |
| —— | (3R,4S,5R)-2-(6-aminopurin-9-yl)-5-methanidyloxolane-3,4-diol;cobalt(3+);[(3S,4R)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] 1-[3-[(5Z,10Z,15Z)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2,7,12,17-tetrahydro-1H-corrin-24-id-3-yl]propanoylamino]propan-2-yl phosphate | 13870-90-1 | C72H100CoN18O17P |
| —— | [(5R)-8,8-dimethyl-8-azoniabicyclo[3.2.1]octan-3-yl] 2-hydroxy-2-phenylacetate;bromide | 80-49-9 | C17H24BrNO3 |
| —— | Pharmakon1600-01504008 | 53123-88-9 | C51H79NO13 |
| —— | Pharmakon1600-01504144 | 62013-04-1 | C42H78N2O14 |
| —— | Pharmakon1600-01500441 | 6533-00-2 | C21H28O2 |
| —— | Pharmakon1600-01502029 | 52152-93-9 | C22H20N4NaO8S2+ |
| —— | Pharmakon1600-01502343 | 5630-53-5 | C21H28O2 |
| —— | Pharmakon1600-01505763 | 130-40-5 | C17H21N4NaO9P+ |
| —— | (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,30S,32S,35R)-1,18-dihydroxy-12-[(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone | 159351-69-6 | C53H83NO14 |
| —— | [(6S,8S,9R,10S,13S,14S,16R,17R)-6,9-difluoro-17-(fluoromethylsulfanylcarbonyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate | 80474-14-2 | C25H31F3O5S |
| —— | (2R,3S)-2,3-dihydroxybutanedioic acid;1-methyl-2-[(E)-2-(3-methylthiophen-2-yl)ethenyl]-5,6-dihydro-4H-pyrimidine | 26155-31-7 | C16H22N2O6S |
| —— | [(1R,2S)-1-hydroxy-1-(3-hydroxyphenyl)propan-2-yl]azanium;(2R,3S)-2,3,4-trihydroxy-4-oxobutanoate | 33402-03-8 | C13H19NO8 |
| —— | (1S,3R,4R,7R,9R,11R,15S,16R,17R,18S,19E,21E,25E,27E,29E,31E,33R,36R,37S)-33-[(2S,3R,4R,5R,6S)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,4,7,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,25,27,29,31-hexaene-36-carboxylic acid | 1400-61-9 | C47H75NO17 |
| —— | Atropine sulfate | 5908-99-6 | C34H48N2O10S |
| —— | Sodium;[2,7-dibromo-9-(2-carboxyphenyl)-3-hydroxy-6-oxoxanthen-4-yl]mercury;hydrate | 129-16-8 | C20H11Br2HgNaO6+ |
| —— | 23,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone, 9,10,12,13,14,21,22,23,24, 25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-, [3S-[3R*[S* (1R*,3S*,4S*)],6S*,7E,9S*,10S*,12S*,14R*,15E,17E,19E,21R*, 23R*,26S*,27S*,34aR*]]- | 53123-88-9 | C51H79NO13 |
| —— | beta-Carotene beta,beta-Carotene Carotene Solatene trans-beta-Carotene | 7235-40-7 | C40H56 |
| —— | Poncuronium bromide | 15500-66-0 | C35H60BrN2O4+ |
| —— | [(1S,2R,3S,5S,6S,16E,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 |
| —— | Wln: AL2 S-O4*3 | 10043-01-3 | AlH2O4S |
| —— | Benzyl penicillin Na salt | 69-57-8 | C16H18N2NaO4S+ |
| —— | 42-O-(2-hydroxyethyl)rapamycin) | 159351-69-6 | C53H83NO14 |
| —— | Veham-Sandoz | 29767-20-2 | C32H32O13S |