注射用芪红脉通微滤液的超滤工艺适用性研究

Adaptability research on ultrafiltration process of microfiltrated Qihong Maitong Injection

目的以注射用芪红脉通微滤后药液为研究对象,考察4种不同材质的中空纤维超滤膜对注射用芪红脉通药液体系的适用性。方法分别选取截留相对分子质量为100 000的聚砜、聚醚砜、聚丙烯、混纺复合4种材质的超滤膜进行超滤,测定不同膜材质超滤过程的膜通量,指标成分黄芪总皂苷、黄芪甲苷、羟基红花黄色素A(hydroxy safflower yellowA,HSYA)透过率,固含物减少率,蛋白质减少率,有关物质及热原检查,筛选适宜本产品的超滤膜。结果相同截留相对分子质量的4种不同材质超滤膜对同一药液体系的适用性存在差异:聚丙烯、聚醚砜和混纺复合材质的膜纯水通量恢复率均较高,而聚砜材质的膜通量和膜纯水通量恢复率较低;聚丙烯与聚醚砜材质的指标成分透过率较高,聚砜与混纺复合材质的固含物与蛋白质去除率较高;对于本产品,截留相对分子质量为100 000超滤膜可有效去除热原。结论聚丙烯-100000超滤膜既能有效去除固含物与高分子物质,又能保留有效成分,适用于注射用芪红脉通的精制。

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 100 000 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 100 000 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.