对乙酰氨基酚粗品纯化技术研究  

Study on purification technology of crude acetaminophen

作　　者：张少萌 赵建威 张冬 Zhang Shaomeng;Zhao Jianwei;Zhang Dong(Hebei Provincial Drug Evaluation Center,Shijiazhuang 050033,China;Hebei Jiheng Group Corporation Ltd.,Hengshui 053000,China;Hebei Pharmaceutical and Medical Device Inspection and Research Institute,Shijiazhuang 050033,China)

机构地区：[1]河北省药品审评中心,河北石家庄050033 [2]河北冀衡集团有限公司,河北衡水053000 [3]河北省药品医疗器械检验研究院,河北石家庄050033

出　　处：《煤炭与化工》2023年第3期122-126,共5页Coal and Chemical Industry

摘　　要：对乙酰氨基酚传统精制或纯化粗品的方法是使用水做溶剂对粗品进行重结晶,得到的产品纯度较低。为得到纯度较高的成品,通过实验,确定了未知杂质二聚体的结构式。通过分析其结构式的物理和化学性质,判断未知杂质易溶于醇类试剂。根据生产经验选用乙醇作溶剂,并通过对活性炭的用量、脱色温度和时间的考察,确定了最佳的生产工艺条件:乙醇溶剂的加入量为4030 kg,脱色温度为81~84℃,活性炭的加入量为60~90 kg,脱色时间为30 min,产品可满足欧洲药典EP9的要求。The traditional method of refining or purifying the crude acetaminophen is to use water as solvent to recrystallize the crude product,and the purity of the product is low.In order to obtain the finished product with higher purity,the structural formula of the unknown impurity dimer was determined by experiments.By analyzing the physical and chemical properties of its structural formula,it was judged that the unknown impurity was easily soluble in alcohol reagents.Ethanol was selected as the solvent according to the production experience,and through the investigation of the amount of activated carbon,decolorization temperature and time,the optimum production process conditions were determined:the amount of ethanol solvent added is 4030 kg,the decolorization temperature is 81~84℃,the amount of activated carbon added is 60~90 kg,and the decolorization time is 30 min.The products can meet the requirements of European Pharmacopoeia EP9.

关 键 词：对乙酰氨基酚 粗品 精制 提纯 乙醇 溶剂 

分 类 号：TQ460.6[化学工程—制药化工]