超滤技术去除苦参素注射液的细菌内毒素

Elimination of Bacterial Endotoxins in Kushensu Injection by Ultrafiltration Device

目的:考察超滤技术去除苦参素注射液中细菌内毒素的效果。方法:采用10KDa截留分子量超滤膜对苦参素注射液进行超滤,以动态浊度法定量检测超滤前后苦参素注射液中细菌内毒素的含量。结果:样液超滤前细菌内毒素为8.0540EU/mL,超滤后为0.3024EU/mL,内毒素去除率为96.24%,其有效成分氧化苦参碱的透过率为96%。结论:超滤技术可以很好的去除苦参素注射液中细菌内毒素,有效成分损失少,可提高其用药安全性。

Objective：To studies the elimination effect of bacterial endotoxins in Kushensu injection by ultrafiltration device. Method：Kushensu injection was ultrafiltrated with molecular weight cut-off （MWCO） 10k ultrafitration membrane. The kinetic-turbidimetric method was used to determine the content of bacterial endotoxins in Kushensu injection before and after using the ultrafiltration. Result：The content of bacterial endotoxins was 8.0540EU/mL before ultrafitration,and 0.3024EU/mL after ultrafitration.The elimination efficiency of bacterial endotoxins was 96.24%,the transmittance of effective constituent of Oxymatrine was 96%. Conclusion：Bacterial endotoxins in Kushensu injection can be well eliminated by ultrafiltration,the effective constituent was little missed,and the safety of drug could be improved.