摘要
目的：考察超滤技术应用于去除生脉注射液中细菌内毒素的可行性，为该制剂的临床用药安全提供参考。方法：采用不同材质和截留相对分子质量的超滤膜对生脉药液中间体进行超滤，利用HPLC和动态浊度法分别检测超滤前后药液中有效成分（人参皂苷Rg1，Re，Rb1及五味子醇甲）和细菌内毒素含量的变化，流动相乙腈（A）-水（B）梯度洗脱（0～30min，0—10％A；30～40min，10％～23％A；40～50min，23％A；50—85min，23％～60％A；85～95min，60％～100％A），检测波长203nm，优选生脉注射液的超滤工艺。结果：经不同孔径、材质的超滤膜超滤后，生脉药液中间体各有效成分的透过率存在明显差异；100kDa复合材质超滤膜对各有效成分的透过率均〉99％，对细菌内毒素去除率达97．79％，明显优于相同孔径的聚醚砜超滤膜。结论：使用100kDa复合材质超滤膜超滤生脉注射液的适用性良好，超滤技术在保证有效成分透过率的同时可有效去除细菌内毒素，为生脉注射液制备工艺的改进提供实验依据。
Objective： To investigate feasibility of uhrafihration technique for applicability on removal of bacterial endotoxins in Shengmai injections and provide a reference for clinical medication safety of this preparation. Method ： Shengmai intermediates was uhrafihrated by ultrafiltration membranes with different materials and relative molecular weight cut off. In order to optimize ultrafihration process, kinetic-turbidimetric method was used to determine the content of bacterial endotoxins in Shengmai intermediates before and after using uhrafihration; change of contents of active components was examined by HPLC, taking ginsenoside Rgl, Re, Rb1 and schisandrin as mark components, mobile phase was acetonitrile （A） -water （B） for gradient elution （0-30 min, 0-10%A; 30-40 min, 10%-23%A; 40-50 min, 23%A; 50-85 min, 23%-60%A; 85-95 rain, 60%-100% A） , detection wavelength was 203 nm. Result： Through ultrafiltration membranes with different apertures and materials, transmittance of Shengmai intermediates showed obvious differences. Transmittance of active components were above 99% and removal rate of endotoxins was 97.79% after 100 kDa composite uhrafiltration membrane, which were better than that of the same aperture of polyether sulfone ultrafihration membranes. Conclusion： Applicability of uhrafiltration for Shengmai injections is good using 100 kDa composite uhrafiltration membrane. Utrafiltration technique can be used to remove bacterial endotoxins with high recovery rate of active components in Shengmai intermediates, thus providing experimental basis for production improvement of this preparation.
出处
《中国实验方剂学杂志》
CAS
北大核心
2014年第23期21-24,共4页
Chinese Journal of Experimental Traditional Medical Formulae
基金
江苏省高校自然科学研究基金项目(12KJB360009)
