不同材质超滤膜对细菌内毒素与有效成分的影响

Effect of Ultrafiltration Membrane with Different Materials on Bacterial Endotoxin and Active Ingredients

目的:考察不同材质超滤膜对注射用芪红脉通的适用性。方法:以细菌内毒素与有效成分透过率为指标,采用截留相对分子质量100 kDa的聚砜、聚醚砜、聚丙烯、混纺4种不同材质的中空纤维超滤膜进行超滤,以动态浊度法检测超滤前后细菌内毒素的去除情况,并结合有效成分的透过率,综合评价超滤膜材质对注射用芪红脉通的适用性。结果:聚丙烯材质超滤膜去除细菌内毒素的效果好,且有效成分的透过率较高,适于本品的精制。结论:超滤法去除细菌内毒素效果理想,且不同材质超滤膜去除细菌内毒素的效果存在差异。

Objective： To investigate applicability of uhrafihration membrane with different materials in Qihong Maitong injection. Method： With transmissivity of active ingredients and bacterial endotoxin as indexes, 4 kinds of different materials （polysulfone, polyether sulfone, polypropylene and blending ） hollow fiber ultrafiltration membrane with the same entrapped relative molecular mass of 100 kDa were selected to ultrafihrate. The removal of bacterial endotoxin and transmittance of active ingredients before and after uhrafihration was detected by kenitie-turbidimetry method, which were adopted to determine the best appropriate ultrafihration membrane material. Result： Polypropylene-100 kDa ultrafihration membrane not only could effectively remove bacterial endotoxin, but also had a higher transmittance of active ingredients, it was suitable for purification of Qihong Maitong injection. Conclusion： Ultrafihration could effectively remove bacterial endotoxin, while removal effect of bacterial endotoxin with different materials of ultrafiltration membranec was different.