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必特螺旋霉素的工业结晶过程
牛梦旗,朱家文,陈葵,吴艳阳,杨生武,应喜平
0
(华东理工大学化学工程研究所, 上海 200237;呼伦贝尔北方药业有限公司, 内蒙古 牙克石 022150)
摘要:
以未知杂质为考察的着重点,探索了25℃下必特螺旋霉素最佳结晶时的pH以及同一pH下温度对工业结晶的影响。利用高效液相色谱对结晶产品进行检测,并用外标法对必特螺旋霉素中各部分杂质进行了详细的分析,通过对比结晶过程有效组分和总未知杂质对螺旋霉素的选择性系数,在兼顾有效组分含量合格和杂质质量分数最低的前提下,确定最优结晶终点pH为7.5~8.0,最优结晶温度为25~35℃。该方法首次以未知杂质的含量变化来探索必特螺旋霉素结晶的规律,工业上便于实施,有利于指导工业生产。
关键词:  必特螺旋霉素  结晶pH  选择性系数  杂质
DOI:10.14135/j.cnki.1006-3080.2017.01.004
投稿时间:2016-05-18
基金项目:上海市科委生物医药科技重点项目(10431901500)
Crystallization Process of Bitespiramycin
NIU Meng-qi,ZHU Jia-wen,CHEN Kui,WU Yan-yang,YANG Sheng-wu,YING Xi-ping
(Chemical Engineering Research Center, East China University of Science and Technology, Shanghai 200237, China;Hulun Buir North Pharmaceutical Co. Ltd, Yakeshi 022150, Inner Mongolia, China)
Abstract:
Taking unknown impurities as the focal point,the optimum crystallization pH value was investigated at 25℃.The effect of temperature on crystallization process was explored at a certain pH value.Gradient elution was utilized to analyze components and impurities in product.Selectivity coefficients of effective components and total unknown impurities to spiramycin were compared with each other.In view of qualified effective compositions and lower impurities contents,the most suitable terminal pH value of crystallization operation was 7.5-8.0,temperature was 25-35℃.The variation of unknown impurities contents was first adopted to explore bitespiramycin crystallization in the existing studies,which would have a profound guiding significance for the practical production.
Key words:  bitespiramycin  crystallization pH value  selectivity coefficient  impurities

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