超滤技术去除羟基喜树碱中细菌内毒素的研究

The Elimination Effect of Bacterial Endotoxins in Hydroxy Camptothecin by Ultrafiltration Device

考察了超滤技术去除羟基喜树碱原料药中细菌内毒素的效果。采用10 kDa截留分子量超滤膜对羟基喜树碱原料药溶解液进行超滤,以动态浊度法定量检测超滤前后羟基喜树碱中细菌内毒素的含量。结果表明:样液超滤前细菌内毒8.103 5 EU/mL,超滤后为0.307 6 EU/mL,内毒素去除率为96.20%,其有效成分羟基喜树碱的透过率为96.1%。超滤技术可以很好的去除羟基喜树碱原料药溶解液中细菌内毒素,有效成分损失极其微少,可提高其用药安全性。

To studies the elimination effect of bacterial endotoxins in Hydroxy camptothecin by ultrafiltration device. Hydroxy camptothecin solution was ukrafihrated with molecular weight cut - off （ MWCO ） 10k uhrafitration membrane. The kinetic - turbidimetric method was used to determine the content of bacterial endotoxins in Hydroxy camptothecin solution before and after using the ultrafiltration. The content of bacterialendotoxins was 8. 103 5 EU/mL before ultrafitration, and 0. 307 6 EU/mL after ultrafitration. The elimination efficiency of bacterial endotoxins was 96. 20% , the transmittance of effective constituent of oxymatrine was 96%. Bacterial endotoxins in hydroxy camptothecin solution can be well eliminated by uhrafihration, the effective constituent was little missed, and the safety of drug could be improved.