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.
出处
《中国中药杂志》
CAS
CSCD
北大核心
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)
关键词
热毒宁注射液
细菌内毒素
吸附
超滤
Reduning injection
bacterial endotoxins
adsorption
ultrafiltration