热毒宁注射液生产过程中关键工序对细菌内毒素去除效果研究  

Depyrogenation in key manufacturing processes of Reduning injection

作　　者：李淼[1,2] 徐玉玲[1] 宋娟[1,2] 王永香[1,2] 潘迎志[1,2] 王振中[1,2] 萧伟[1,2] 刘涛[1,2] 

机构地区：[1]江苏康缘药业股份有限公司,江苏连云港222001 [2]中药制药过程新技术国家重点实验室,江苏连云港222001

出　　处：《中国中药杂志》2011年第6期663-665,共3页China Journal of Chinese Materia Medica

基　　金：国家“重大新药创制”科技重大专项(2009ZX09308-003,2009ZX09313-032,2010ZX09502-005);国家重点基础研究发展计划(973计划)项目(2010CB735600)

摘　　要：目的:研究热毒宁注射液生产过程中关键工序对细菌内毒素去除效果的影响。方法:采用动态浊度法测定0.8%活性炭吸附前后、10×103截留相对分子质量超滤前后细菌内毒素含量变化,考察其去除情况。结果:活性炭对细菌内毒素吸附率为78.7%,10×103截留超滤对细菌内毒素去除率为99.6%。结论:关键工序能有效保证热毒宁注射液的安全性。Objective： To investigate the effect of removing bacterial endotoxin in the key processes of Reduning injection. Method： The content of bacterial endotoxins was detected by kenitic-turbidimetry and the removal efficacy was studied before and after using 0.8% of activated carbon and ultrafihration with molecular weight cut-off of 10 × 10^3. Result： The adsorption rate of bacterial endotoxins was 78.7% by using activated carbon, while the removal efficacy of bacterial endotoxins was 99.6% with ultrafiltration membrane at cut-off molecular weight 10 × 10^3. Conclusion： The key technology can effectively guarantee the safety of Reduning injection.

关 键 词：热毒宁注射液 细菌内毒素 吸附 超滤 

分 类 号：TQ461[化学工程—制药化工]