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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 investigate the effects of four different types of ultrafiltration membranes on bacterial endotoxin and chemical composition of Breviscapine Injection, and choose the suitable ultrafiltration membrane for production. Methods: The breviscapine injection was ultrafiltered by 10KD polyethersulfone, 10KD cellulose, 30KD polyethersulfone and 30KD cellulose ultrafiltration membrane, respectively. The bacterial endotoxin, content, related substances and membrane before and after different ultrafiltration were determined Flux changes, suitable for screening Breviscapine injection used in ultrafiltration membrane. Results: The results showed that there were differences in the filtration efficiency of the erigeron injection with different interception molecular weight ultrafiltration membranes: the 10KD ultrafiltration membrane had a higher content of breviscapine and the retention rate of related substances, and the corresponding water flux recovery rate Low; polyethersulfone ultrafiltration membrane flux greater than the cellulose ultrafiltration membrane, filtration time is short. Conclusion: 10KD polyethersulfone ultrafiltration membrane can effectively remove bacterial endotoxin, retain the active ingredients and remove impurities, while ensuring high membrane flux, suitable for the production of breviscapine injection.