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目的:采用正交试验法,研究超滤工艺对血塞通注射液有效成分的影响。方法:以血塞通注射液中有效成分三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1、人参皂苷Rd为检测指标,HPLC法分析,观察其有效成分超滤前后的瞬时浓度变化,并采用正交试验法考察不同孔径聚砜膜(PS膜)、操作压力、药液温度以及药液浓度对血塞通注射液有效成分动态透过率的影响。结果:在超滤过程中三七皂苷R1和人参皂苷Rg1的动态透过规律基本一致,超滤工艺各组的平均动态透过率范围为45%～95%,其中药液浓度具显著性影响,其他因素无显著性影响。人参皂苷Rb1和人参皂苷Rd的动态透过规律影响基本一致,超滤工艺各组的平均透过率范围分别为2.8%～62%、1.8%～45%,超滤过程中这两个成分损失较大,其中药液温度和膜孔径对人参皂苷Rb1和人参皂苷Rd的动态透过率有显著性影响,药液浓度对人参皂苷Rd动态透过率也有较显著的影响。结论:该研究为血塞通注射液的工艺优化提供了客观的技术指导。
Objective: To study the effect of ultrafiltration on the effective components of Xuesaitong injection by orthogonal test. Methods: The effective components of Xuesaitong injection Panax notoginsenoside R1, ginsenoside Rg1, ginsenoside Rb1, ginsenoside Rd detection index, HPLC analysis, observe the active ingredient before and after ultrafiltration instantaneous concentration changes, and the use of positive The effects of different pore diameter polysulfone membrane (PS membrane), operating pressure, liquid temperature and liquid concentration on the dynamic transmittance of the active ingredient of Xuesaitong injection were investigated by hand-on test. Results: The dynamic transmission law of notoginsenoside R1 and ginsenoside Rg1 were basically the same during ultrafiltration. The average dynamic transmittance of each group in ultrafiltration ranged from 45% to 95%, and the concentration of liquid was significantly affected , Other factors no significant effect. The dynamic transmission law of ginsenoside Rb1 and ginsenoside Rd was basically the same. The average transmittance of each group in the ultrafiltration process ranged from 2.8% to 62% and 1.8% to 45%, respectively. The loss of these two components during ultrafiltration The results showed that liquid temperature and membrane pore size had a significant effect on the dynamic transmittance of ginsenoside Rb1 and ginsenoside Rd, and the liquid drug concentration also had a significant effect on the dynamic transmittance of ginsenoside Rd. Conclusion: This study provides objective technical guidance for Xuesaitong injection process optimization.