摘要
探讨导致溶媒结晶法制得氨苄西林钠澄清度变化的影响因素 ,经过实验对比发现氨苄西林钠中残留的异辛酸是导致原粉与胶塞接触后澄清度变化的主要因素。针对溶媒法氨苄西林钠澄清度问题 ,对各种生产工艺进行了分析 ,开发了 ATN溶媒结晶新工艺 ,并对 ATN溶媒结晶工艺各操作条件的变化对产品质量及收率的影响进行了系统研究 ,最后对 ATN工艺进行了优化。
Factors influenced the stability of the clarity of ampicillin sodium by solvent crystallization method were investigated. Experiments showed that 2 ethtyhexanic acid in the final product contacting with elastomeric closure caused the unstable clarification. In order to solve the problem, various techniques were analyzed and a new process developed with ATN as solvent. The operation parameters affecting product quality and yield were overall studied and optimized.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2005年第1期56-57,61,共3页
Chinese Journal of Antibiotics
关键词
氨苄西林钠
澄清度
稳定性
异辛酸
新工艺
Ampicillin sodium
Clarification
Stability
2-ethtyhexanic acid
New process
