中文
原(yuan)料(liao)药(yao)(yao)英(ying)文名(ming)API(Active Pharmaceutical Ingredient), 原(yuan)料(liao)药(yao)(yao)在ICH Q7A中(zhong)的完善定义：旨在用(yong)于药(yao)(yao)品制造(zao)中(zhong)的任何一种(zhong)物质或物质的混合物，而且在用(yong)于制药(yao)(yao)时，成为(wei)药(yao)(yao)品的一种(zhong)活(huo)性成分。
此种物(wu)(wu)质在疾病(bing)的(de)(de)(de)诊断，治疗，症状缓解，处理或疾病(bing)的(de)(de)(de)预防(fang)中有药理活(huo)性(xing)或其他直接(jie)作(zuo)用(yong)，或者能影响(xiang)机体的(de)(de)(de)功能或结(jie)构。指用(yong)于生(sheng)产各类制(zhi)剂(ji)的(de)(de)(de)原料药物(wu)(wu)，是制(zhi)剂(ji)中的(de)(de)(de)有效成份(fen)由化(hua)学合成、植物(wu)(wu)提取或者生(sheng)物(wu)(wu)技术所制(zhi)备(bei)的(de)(de)(de)各种用(yong)来作(zuo)为药用(yong)的(de)(de)(de)粉末、结(jie)晶、浸(jin)膏等，但病(bing)人(ren)无法(fa)直接(jie)服用(yong)的(de)(de)(de)物(wu)(wu)质。
药(yao)(yao)(yao)(yao)(yao)剂(ji)的有(you)效成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)分(fen)(fen)。原(yuan)(yuan)料药(yao)(yao)(yao)(yao)(yao)只(zhi)有(you)加(jia)工成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)为(wei)(wei)药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)制剂(ji)，才能成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)为(wei)(wei)可(ke)(ke)供(gong)临床(chuang)应(ying)用(yong)(yong)的医药(yao)(yao)(yao)(yao)(yao)。原(yuan)(yuan)料药(yao)(yao)(yao)(yao)(yao)根据它的来源(yuan)分(fen)(fen)为(wei)(wei)化(hua)(hua)学合(he)(he)(he)(he)成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)药(yao)(yao)(yao)(yao)(yao)和(he)(he)天然(ran)化(hua)(hua)学药(yao)(yao)(yao)(yao)(yao)两大类。化(hua)(hua)学合(he)(he)(he)(he)成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)药(yao)(yao)(yao)(yao)(yao)又可(ke)(ke)分(fen)(fen)为(wei)(wei)无(wu)机合(he)(he)(he)(he)成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)药(yao)(yao)(yao)(yao)(yao)和(he)(he)有(you)机合(he)(he)(he)(he)成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)药(yao)(yao)(yao)(yao)(yao)。无(wu)机合(he)(he)(he)(he)成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)药(yao)(yao)(yao)(yao)(yao)为(wei)(wei)无(wu)机化(hua)(hua)合(he)(he)(he)(he)物(wu)(wu)(极个别为(wei)(wei)元素)，如(ru)用(yong)(yong)于(yu)治疗胃(wei)及十二(er)指肠(chang)溃疡的氢(qing)氧(yang)化(hua)(hua)铝(lv)、三硅酸(suan)镁等；有(you)机合(he)(he)(he)(he)成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)药(yao)(yao)(yao)(yao)(yao)主要(yao)是由基本(ben)有(you)机化(hua)(hua)工原(yuan)(yuan)料，经一系列有(you)机化(hua)(hua)学反(fan)应(ying)而制得(de)的药(yao)(yao)(yao)(yao)(yao)物(wu)(wu)（如(ru)阿(a)司匹林、氯霉素、咖啡(fei)因等）。天然(ran)化(hua)(hua)学药(yao)(yao)(yao)(yao)(yao)按其(qi)(qi)来源(yuan)，也可(ke)(ke)分(fen)(fen)为(wei)(wei)生(sheng)(sheng)(sheng)物(wu)(wu)化(hua)(hua)学药(yao)(yao)(yao)(yao)(yao)与植物(wu)(wu)化(hua)(hua)学药(yao)(yao)(yao)(yao)(yao)两大类。抗生(sheng)(sheng)(sheng)素一般系由微生(sheng)(sheng)(sheng)物(wu)(wu)发酵制得(de)，属于(yu)生(sheng)(sheng)(sheng)物(wu)(wu)化(hua)(hua)学范畴。近年出现的多种半合(he)(he)(he)(he)成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)抗生(sheng)(sheng)(sheng)素，则(ze)是生(sheng)(sheng)(sheng)物(wu)(wu)合(he)(he)(he)(he)成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)和(he)(he)化(hua)(hua)学合(he)(he)(he)(he)成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)相结合(he)(he)(he)(he)的产(chan)(chan)品(pin)。原(yuan)(yuan)料药(yao)(yao)(yao)(yao)(yao)中，有(you)机合(he)(he)(he)(he)成(cheng)(cheng)(cheng)(cheng)(cheng)(cheng)药(yao)(yao)(yao)(yao)(yao)的品(pin)种、产(chan)(chan)量(liang)(liang)及产(chan)(chan)值所占(zhan)比例最大，是化(hua)(hua)学制药(yao)(yao)(yao)(yao)(yao)工业的主要(yao)支(zhi)柱。原(yuan)(yuan)料药(yao)(yao)(yao)(yao)(yao)质(zhi)量(liang)(liang)好坏(huai)决定制剂(ji)质(zhi)量(liang)(liang)的好坏(huai)，因此其(qi)(qi)质(zhi)量(liang)(liang)标准(zhun)要(yao)求很严(yan)，世界各国对于(yu)其(qi)(qi)广(guang)泛应(ying)用(yong)(yong)的原(yuan)(yuan)料药(yao)(yao)(yao)(yao)(yao)都制订(ding)了严(yan)格的国家药(yao)(yao)(yao)(yao)(yao)典标准(zhun)和(he)(he)质(zhi)量(liang)(liang)控制方法。
