混合材质超滤膜去除丹参滴注液中细菌内毒素的应用研究

Research on Application of Hybrid Material Ultrafiltration Membrane for Removing Bacterial Endotoxin in Danshen Injection

目的研究混合材质超滤膜去除丹参滴注液中细菌内毒素的适宜性。方法以动态浊度法和高效液相色谱法,测定丹参滴注液使用混合材质超滤膜及Millpore超滤膜前后药液中细菌内毒素和有效成分的含量,观察细菌内毒素去除效果及有效成分变化。结果截留分子量为10kDa的混合材质超滤膜和Millpore超滤膜对丹参滴注液中细菌内毒素去除率均大于99%,但丹酚酸B损失明显;截留分子量为50kDa时,Millpore超滤膜内毒素去除率明显下降,而混合材质超滤膜去除率大于99%,可以将内毒素控制在0.5EU/mL的限度内,且丹参滴注液中有效成分透过率均大于95%,丹酚酸B透过率为95.87%。结论混合材质超滤膜可以高效去除丹参滴注液中的内毒素并对成分无明显影响,尤其适用于大容积输液。

OBJECTIVE To investigate the application of hybrid material ultrafiltration membrane for removing bacterial endotoxin in Danshen Injection.METHODS The content of bacterial endotoxin was detected by kenetic-turbidimetry,the changes of active compounds were observed by HPLC before and after filtered by Millipore and hybrid material ultrafiltration membranes.RESULTS The removal efficacy of bacterial endotoxin afterwards was above 99% by using membranes of molecular weight cut-off（MWCO） 10 kDa,but the loss of Salvianolic acid B was obvious;the active compounds of Danshen Injection had high transmittance and the removal efficacy of bacterial endotoxin was above 99% after using filtered by membranes of MWCO 50 kDa;the removal efficacy of bacterial endotoxin was poor by Millipore ultrafiltration membrane.CONCLUSION Hybrid material ultrafiltration membrane has no significant effect on the compositions and can effectively remove endotoxin in Danshen Injection,especially suitable for the large volume of intravenous instillation.