论文部分内容阅读
目的采用超滤法去除A群脑膜炎球菌多糖料液中的苯酚。方法选取Omega OS010C10膜包(C型筛网,10 KD,过滤面积0.1 m2)和Omega OS010T12膜包(T型筛网,10 KD,过滤面积0.1 m2),分别对A群脑膜炎球菌多糖料液进行超滤,比较两种膜包不同压力对膜滤速的影响,测定超滤前后膜净水滤速的恢复率,分析经超滤和透析后样品中磷和苯酚含量及固体总量。结果 OS010T12膜包切向流速和压力的增加对滤速的影响较OS010C10膜包更显著,且在较低的压力差和过膜压力下,OS010T12膜包具有更高的过滤速度;在浓缩和洗滤阶段,OS010T12膜包的平均滤速较OS010C10膜包高约1.3倍;膜包经清洗后,膜净水滤速OS010T12膜包可恢复至试验前水平;两种膜包超滤的滤出液中苯酚的含量均符合《中国药典》三部(2010版)要求,且多糖回收率均高达90%以上,超滤用时比透析至少节约46 h,且耗水量只有透析工艺的20%。结论可用OS010T12膜包替换透析袋,对A群脑膜炎球菌多糖料液进行超滤,去除残余苯酚,为A群脑膜炎球菌多糖疫苗的生产提供了参考。
OBJECTIVE To remove phenol from the meningococcal polysaccharide A group by ultrafiltration. Methods Omega OS010C10 membrane package (C type sieve, 10 KD, filtration area 0.1 m2) and Omega OS010T12 membrane package (T type sieve, 10 KD, filtration area 0.1 m2) The effects of different pressures on the membrane filtration rate were compared. The recoveries of membrane filtration rate before and after ultrafiltration were measured. The content of phosphorus and phenol and total solids in the samples after ultrafiltration and dialysis were analyzed. Results The increase of tangential flow rate and pressure of OS010T12 membrane was more significant than that of OS010C10 membrane package. OS010T12 membrane package had higher filtration speed under lower pressure difference and membrane pressure. In the filtration stage, the average filtration rate of OS010T12 membrane package was about 1.3 times higher than that of OS010C10 membrane package. After the membrane package was cleaned, the membrane water filtration rate of OS010T12 membrane package could be restored to the pre-test level. The content of phenol in the Chinese Pharmacopoeia was in line with the requirements of the third edition of Chinese Pharmacopoeia (2010 edition), and the recoveries of polysaccharides were as high as 90%. The ultrafiltration time was at least 46 h lower than dialysis, and the water consumption was only 20% of the dialysis process. Conclusion The OS010T12 membrane bag can be used to replace the dialysis bag, and the meningococcal polysaccharide A group can be ultrafiltrated to remove the residual phenol, thus providing a reference for the production of group A meningococcal polysaccharide vaccine.