摘要
针对国内由头孢呋辛钠无菌原料药经无菌分装得到的头孢呋辛钠粉针剂存在质量及稳定性差的情况,对头孢呋辛钠原料药结晶工艺进行了优化。通过对比碳酸氢钠、异辛酸钠等不同成钠剂,优化结晶温度、结晶pH值、搅拌强度和结晶体系等工艺参数,得到了与原研产品一致的晶型,从而提高了注射用头孢呋辛钠的质量和稳定性。
Cefuroxime sodium powder is obtained by aseptic packaging of cefuroxime sodium sterile raw material.The crystallization process of cefuroxime sodium is optimized.By comparing sodium bicarbonate with sodium isooctanate,the crystallization temperature,crystallization pH value,stirring strength and crystallization system were optimized,the crystalline form of the product is the same as that of the original product,thereby improving the quality and stability of cefuroxime sodium for injection.
作者
李亚卿
刘亚林
乔俊华
康健
谷艺凡
Li Yaqing;Liu Yalin;Qiao Junhua;Kang Jian;Gu Yifan(North China Pharmaceutical Hebei Huamin Pharmaceutical Corporation Ltd.,Shijiazhuang 052165,China)
出处
《煤炭与化工》
CAS
2018年第11期148-150,共3页
Coal and Chemical Industry
关键词
头孢呋辛钠
结晶
优化
cefuroxime sodium
crystallization
process optumization
