摘要
目的:考察注射液生产工艺中活性炭吸附热原的适宜条件。方法:从活性炭加入比例、pH变化、吸附温度、加入次数和活化处理方式等5个方面进行分析,运用动态浊度法进行检测,研究最佳工艺条件。结果:活性炭去除热原的适宜工艺条件为添加比例0.3%、pH 5.0、温度50℃、二次吸附和105℃干燥活化处理。结论:建立了活性炭去除注射液中热原的常用方法。
Objective： To study the optimal process conditions for pyrogen removal from injections using activated carbon.Method： Five different factors including the adding percentage of activated carbon,the change in pH value,the absorption temperature,the adding frequency and the activation methods were investigated.The dynamic turbidity was used to assess the best parameters for the process.Result： The optimal process conditions for pyrogen removal was as follows： at pH 5.0 and 50℃,0.3% activated carbon was added followed by double absorption and dried activation at 105℃.Conclusion： The developed methods can be use for a general way to remove pyrogen in injections.
出处
《中国药师》
CAS
2012年第9期1301-1303,共3页
China Pharmacist
关键词
活性炭
热原
细菌内毒素
动态浊度法
Activated carbon
Pyrogen
Bacterial endotoxin
Dynamic turbidity method
