Research on Application of Removing Bacterial Endotoxin in Shengmai Injections by Ultrafiltration

Abstract:

Objective: To investigate feasibility of ultrafiltration 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 ultrafiltrated by ultrafiltration membranes with different materials and relative molecular weight cut off.In order to optimize ultrafiltration process,kinetic-turbidimetric method was used to determine the content of bacterial endotoxins in Shengmai intermediates before and after using ultrafiltration;change of contents of active components was examined by HPLC,taking ginsenoside Rg₁,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 min,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 ultrafiltration membrane,which were better than that of the same aperture of polyether sulfone ultrafiltration membranes. Conclusion: Applicability of ultrafiltration for Shengmai injections is good using 100 kDa composite ultrafiltration 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.