摘要
针对采用高效液相色谱法检测对乙酰氨基酚原料药,时常检测出对乙酰氨基酚二聚体杂质,造成对乙酰氨基酚质量不合格,导致返工处理的问题,研究了对乙酰氨基酚粗品精制过程中二聚体杂质的去除方法,对对乙酰氨基酚精制过程中反应溶剂、反应温度、反应时间及抗氧化剂进行了系统考察。实验结果表明:反应溶剂选用乙醇,反应温度为80℃,反应时间为0.5 h,采用焦亚硫酸钠或保险粉做抗氧化剂,可明显降低对乙酰氨基酚二聚体杂质的含量,提高了对乙酰氨基酚的纯度,为提高对乙酰氨基酚的质量提供了理论依据。
Aiming at the problem that acetaminophen dimer impurities are often detected in the detection of acetaminophen raw material by high performance liquid chromatography,resulting in unqualified quality of acetaminophen and rework,the removal method of dimer impurities in the refining process of crude acetaminophen was studied,the reaction solvent,reaction temperature,reaction time and antioxidants in the refining process of acetaminophen were systematically investigated.The experimental results show that the reaction solvent was ethanol,the reaction temperature was 80℃,the reaction time was 0.5 h,and sodium pyrosulfite or insurance powder was used as antioxidant,the content of acetaminophen dimer impurity was significantly reduced,the purity of acetaminophen was improved,and a theoretical basis for improving the quality of acetaminophen was provided.
作者
马宁宁
刘晓莲
Ma Ningning;Liu Xiaolian(Hebei Jiheng Pharmaceutical Corporation Ltd.,Hengshui 053400,China)
出处
《煤炭与化工》
CAS
2021年第8期136-138,共3页
Coal and Chemical Industry
作者简介
马宁宁(1986—),女,河北衡水人,工程师。
