ABSTRACT
Objective: To optimize the impurity removal technology before ultrafiltration, taking Qihong Maitong Injection (QMI) as the research object. Methods: The removal of impurities and related substances by the combined process of refrigeration, centrifugation, and activated carbon adsorption was investigated. Taking the contents of total saponins of astragalus, astragaloside, and hydroxy safflower yellow pigment A, solids reduction efficiency, protein concentration, and related substances inspection as the evaluation indexes, the feasibility of the impurity removal method was definited and the process parameters were optimized. Results: The optimized process parameters were as follows: refrigerated for 24 h, centrifugated for 15 min, at 5 000 r/min, activated carbon dosage of 0.3%, temperature 40 °C, adsorption time 30 min, and the original solution pH value. Conclusion: The impurity removal effect of refrigeration, centrifugation, and activated carbon adsorption is significant, which could effectively remove the resin, protein, and other impurities.
ABSTRACT
Objective: To study the application of four kinds of hollow fiber ultrafiltration membranes by taking Qihong Maitong Injection (QMI) microfiltrated liquid as the research object. Methods: Polysulfone, polyether sulfone, polypropylene, and blended composite membranes with the entrapment relative molecular mass of 100000 for ultrafiltration were selected to determine the best appropriate ultrafiltration membrane material. The membrane flux of ultrafiltration was determined by taking the content of active ingredients (Astragalus total saponin, astragaloside IV, and hydroxy safflower yellow A), solid reduction rate, protein reduction rate, related substances, and pyrogen inspection of different membrane materials as the evaluation indexes. Results: The suitability of four different kinds of ultrafiltration membrane materials with the same entrapment relative molecular mass was different. The pure water flux recovery rates of polypropylene, polyether sulfone, and blended composite materials are higher than that of polysulfone material. The component permeation rates of polypropylene and polyether sulfone materials were higher, while the solid and protein reduction rates of polysulfone and blend compound materials were higher. For QMI, the ultrafiltration membrane with entrapment relative molecular mass of 100000 could effectively remove the pyrogen. Conclusion: The polypropylene-100000 ultrafiltration membrane could not only effectively remove the solid and high polymer material, but also keep the active ingredients. It is suitable for the purification of QMI.