超滤工艺对生脉注射液中有效成分透过率的影响

Effects of Ultrafiltration Process on Transmittance of Active Ingredients from Shengmai Injection

摘要:

目的：考察超滤工艺对生脉注射液中有效成分透过率的影响。方法：以人参皂苷Rg₁，Re，Rb₁，五味子醇甲透过率为指标，通过正交试验考察聚砜膜孔径、温度、压力对生脉注射液超滤工艺的影响。采用HPLC测定指标成分含量，流动相乙腈（A）-水（B）梯度洗脱（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），检测波长203 nm。结果：最佳超滤工艺为聚砜膜孔径50 000，温度45 ℃，压力11 psi；人参皂苷Rg₁，Rb₁，Re，五味子醇甲的透过率分别为80.26%，85.02%，50.69%，94.99%。结论：超滤工艺对生脉注射液中有效成分的透过率存在一定影响，为生脉注射液过滤工艺的优选提供实验依据。

Abstract:

Objective: To investigate effects of ultrafiltration process on transmittance of active ingredients from Shengmai injection. Method: With transmittance of ginsenosides Rg₁,Re,Rb₁ and schisandrin as indexes,orthogonal test was adopted to investigate effects of temperature,pressure and polysulfone membrane aperture on ultrafiltration process of Shengmai injection.HPLC was adopted to determine contents of index components with mobile phase of acetonitrile(A)-water(B)(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) and detection wavelength at 203 nm. Result: The best ultrafiltration process was as follows:temperature45 ℃,pressure 11 psi,polysulfone membrane aperture 50K;Under these conditions,transmittance of ginsenosides Rg₁,Re,Rb₁ and schisandrin were 80.26%,85.02%,50.69%,94.99%,respectively. Conclusion: Ultrafiltration process had a certain effect on transmittance of active ingredients from Shengmai injection,it could provide experimental basis for improvement of filtration process of Shengmai injection.