摘要
目的提高硫酸依替米星氯化钠注射液产品的无菌保证值,并保证在正常生产时使浓配过滤速度和效果均能符合要求。方法灭菌工艺由115℃×30min变更为115℃×35min;药用炭用量由千分之一(0.1%)变更为万分之三(0.03%)。结果改变生产工艺后的产品无菌安全系数高,且细菌内毒素并没有因药用炭用量的改变而明显增加,质量稳定。结论改进后的生产工艺适应产品生产,且产品质量合格稳定,可作为批量生产的生产工艺。
Objective To elevate the sterility assurance level of etimicin and sodium chloride injection,and ensure that the filtration effect and rate of concentrated solution can meet the requirement of daily production.Methods The sterilization time changed fron 115℃×30Min to 115℃×35Min.The dosage of medical charcol was reduced to 0.03% from 0.1%.Results The safety factor of etimicin finished product had been improved and the bacterial endotoxic level was not significantly increased because of the change of medical charcoal dosage.Conclusion The production technology above is safe and effective,which can be used for mass production.
出处
《海南医学》
CAS
2011年第7期126-127,共2页
Hainan Medical Journal
关键词
硫酸依替米星氯化钠注射液
灭菌时间
药用炭用量
生产工艺
Etimicin sulfate and sodium chloride injection
Sterilization time
Luedical charcoal dosage
Production technology
