氨苄西林钠合成工艺研究

Study on the Synthesis Process of Ampicillin Sodium

本文涉及一种氨苄西林钠的合成方法,属于药物合成技术领域,文章重点优化氨苄西林三水酸合成氨苄西林钠工艺。为提高合成收率,引入去除氨苄西林三水酸结晶水操作,并系统摸索脱水温度及溶剂用量;为提高氨苄西林钠含量、降低异辛酸残留,线性验证异辛酸钠用量、结晶温度、结晶方式及洗料方式等工艺点。综合以上改进工艺,重量收率达到93%,氨苄西林钠含量>92%,异辛酸残留<0.3%。

This article relates to a synthetic method of ampicillin sodium,which belongs to the field of drug synthesis technology.The article focuses on optimizing the process of ampicillin sodium synthesis from ampicillin trihydrate acid.In order to improve the synthesis yield,the operation of removing the crystal water of ampicillin trihydrate was introduced,and the dehydration temperature and solvent dosage were systematically explored;In order to increase the content of ampicillin sodium and reduce the residue of isooctanoic acid,the process points such as the dosage of isooctanoic acid sodium,crystallization temperature,crystallization method and material washing method are verified linearly.Based on the above improved process,the weight yield reached 93%,the content of ampicillin sodium was more than 92%,and the residue of isooctanoic acid was less than 0.3%.