头孢呋辛钠结晶工艺研究
郭明辉,赵洪娥
华北制药 河北华民药业有限责任公司,河北 石家庄 052165
Study on crystallization technology of cefuroxime sodium
Guo Minghui, Zhao Honge
NCPC Hebei Huamin Pharmaceutical Corportion Ltd., Shijiazhuang 052165, China
摘要 研究采用溶媒A+水溶解头孢呋辛酸,溶媒B溶解异辛酸钠进行结晶的新工艺。以头孢呋辛酸为原料,异辛酸钠为成盐剂,通过调整头孢呋辛酸的溶解液体系,优化了成盐以及结晶工艺,得到了头孢呋辛钠新晶型;得到的产品通过40 ℃加速试验,与原工艺加速试验进行对比,色级和pH值的稳定性更好,产品收率高,易于过滤、干燥、分装。该工艺产品质量好,收率高,操作简单,更适合工业化生产。
关键词 :
头孢呋辛钠 ,
结晶 ,
稳定性 ,
色级
Abstract :The new crystallization technology was studied by using dissolving cefuroxime acid in solvent A and purified water, dissolving sodium 2-ethylhexanoate in solvent B. Using cefuroxime acid as raw material and sodium 2-ethylhexanoate as salt agent, the new crystal form of cefuroxime sodium was obtained by adjusting the dissolving system of cefuroxime acid and salt agent, optimizing the crystallization process. The product is better in stability of color and pH value through 40 ℃ accelerated tests; the yield is high and the product is easy to filter, dry and packed. The technology is more suitable for industrial production because of better product quality, higher yield, and simple operation.
Key words :
cefuroxime sodium
crystallization
stability
color
作者简介 : 郭明辉( 1985— ),男,河北石家庄人,助理工程师。
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