超滤在灯盏花素注射液中的应用研究

Applicationon Dengzhanhuasu Injectionin the Process of Ultrafiltration

目的:考察4种不同规格的超滤膜对灯盏花素注射液的细菌内毒素和化学成分的影响,选择适合生产使用的超滤膜。方法:分别选取10KD聚醚砜、10KD纤维素、30KD聚醚砜、30KD纤维素超滤膜对灯盏花素注射液进行超滤,测定不同超滤过程前后细菌内毒素、含量、有关物质以及膜通量变化,筛选适宜灯盏花素注射液使用的超滤膜。结果:不同截留相对分子质量的超滤膜对灯盏花素注射液的过滤效果存在差异:10KD超滤膜对药液灯盏花素含量及有关物质截留率较高,相应的水通量恢复率较低;聚醚砜超滤膜膜通量大于纤维素超滤膜,过滤时间短。结论:10KD聚醚砜超滤膜能有效去除细菌内毒素,保留有效成分并去除杂质分子,同时能保证较高的膜通量,适用于灯盏花素注射液的生产。

Objective：To inspect the influence on Dengzhanhuasu Injection by using four different ultrafiltration membranes and select one applicable for manufacturing. Methods： Determining the bacterial endotoxin, content, related substance and membrane flux before and after Dengzhanhuasu Injection was filtered respectively by 10KD PES membrane, 10KD cellulose membrane, 30KD PES and 30KD cellulose membrane. Results：The filtering effects of four membranes are different. Membrane of 10KD owed higher retention rate of content and related substance but lower pure water flux recovery rate. PES membranes owed higher membrane flux and faster speed than cellulose. Conclusion： 10KD PES membrane is applicable for manufacturing Dengzhanhuasu Injection with effectively removing the bacterial endotoxin and impurity, retaining effective components and higher membrane flux.