头孢唑肟钠制备条件最优化研究

Study on the optimal conditions for preparation of ceftizoxime sodium

本文就头孢唑肟钠生产过程中影响其产品质量和收率的各种因素进行了单因素实验和正交实验,旨在获得生产头孢唑肟钠的最佳工艺条件。结果表明:生产头孢唑肟钠的最佳条件为反应温度低于30℃,无水碳酸钠:头孢唑肟酸(质量比)=0.15∶1.0,反应时间2h,结晶前控制pH值为6.7,乙醇:头孢唑肟酸=30ml∶1.0g,乙醇滴加速度450 ml/h,养晶时间2h。产品收率达95.5%,产品质量满足药典标准。

This pa single factor experiment and per study on the effect of Various factors to the quality and yield of ceftizoxime sodium by orthogonal methods. The aim is to obtain the optimal conditions of the product. Results showed that the optimal conditions for preparation of ceftizoxime sodium were as follows ： reaction temperature is less than 30℃, and the mass ratio of sodium carbonate to ceftizoxime acid is 0.15, and reaction time is 2h, and pH is adjusted to 6.7（ before crystallization）, and the ratio of ethanol to ceftizoxime acid is 30mE/g, the velocity of dripping ethanol is 450mE/h, time of crystal growth is 2h, and the product＇s yield reaches to 95.5%, and the quality meets the Chinese Pharmacopoeia standards.