应用中空纤维膜去除无细胞百日咳料液中的脱毒剂和色素

Removing detoxication agent and colouring molecule from detoxi-fied acellular pertussis preparation by hollow fiber module

目的应用中空纤维膜洗滤技术去除无细胞百日咳料液中的脱毒剂和色素。方法采用不同浓度的盐溶液作为中空纤维膜洗滤液,通过洗滤过程的水通量衰减程度,洗滤后制品外观和蛋白回收率,原液戊二醛残留量,原液效价和毒力来确定洗滤液。用物理和化学清洗相结合的方式对使用后的膜进行清洗再生,以水通量恢复率对清洗效果进行评估。结果用盐溶液Ⅱ作为洗滤液,在洗滤过程维持跨膜压基本恒定的情况下,中空纤维膜水通量大、且衰减缓慢,洗滤后收集的制品外观呈淡黄色,蛋白颗粒均匀,蛋白回收率高,所制备原液的戊二醛残留量、效价和毒力检定结果均符合《中国药典》三部(2010版)要求。中空纤维膜使用后,用物理和化学清洗相结合的清洗方式使中空纤维膜的水通量恢复率分别达99.06%,98.11%,99.62%。结论中空纤维膜可用于去除无细胞百日咳料液中的脱毒剂和色素。

Objective Removing detoxication agent and colouring molecule from detoxified acellular pertussis preparation by hollow fiber module. Methods Using different concentration salt solutions as washing filtrate, the better washing filtrate was determined by the results of the degree of water flux attenuation, the appearance of products after uhrafihration-diafilttration, the yield of protein, the residual determination of glutaraldehyde in bulk, the protection valence and the specific toxicity of bulk. For the used hollow-fibre membrane, its water flux was renewed by physical and chemical washing methods. The washing effects were estimated by water flux recovery rate. Results When washing filtrate was salt solution Ⅱ, the water flux was big and the attenuation was slow during the ultrafihration-diafihtration, meanwhile, transmembrane pressure was youghly costant;the appearance of products after ultrafiltration-diafilttration was better, the size of protein particle was uniform ,the yield of protein was high ,the residual determination of glutaraldehyde, the protection valence and the specific toxicity of bulk met the requirements in Chinese Pharmacopoeia（ Volume Ⅲ ,2010 edition）. The recovery rate of water flux reached 99.06% ,98. 11% ,99. 62% respectively by chemical and physical washing methods after use. Conclusion Hollow fiber module is adapted to remove detoxication agent and colouring molecule from in detoxifiod acellular pertussis preparation.