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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。
OBJECTIVE: To investigate the effect of ultrafiltration on the transmission of active ingredients in Shengmai injection. Methods: The effects of ginsenoside Rg1, Re, Rb1 and schizandrin on the ultrafiltration of Shengmai injection were investigated by orthogonal test. The content of the indicator components was determined by HPLC. The mobile phase was eluted with acetonitrile-water (B) gradient (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) at a detection wavelength of 203 nm. Results: The optimal ultrafiltration process was as follows: the polysulfone membrane pore size was 50 000, the temperature was 45 ℃, and the pressure was 11 psi. The permeation rates of ginsenosides Rg1, Rb1, Re and schizandrin were 80.26%, 85.02%, 50.69% and 94.99 %. CONCLUSION: The ultrafiltration process has some influence on the transmission of active ingredients in Shengmai injection, which provides experimental basis for the optimization of filtration process of Shengmai injection.