公开(公告)号：EP3064214B1

公开(公告)日：2019-08-07

申请号：EP14857463.5

申请日：2014-10-27

申请人： Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory

发明人： LI, Enmin ,  ZHUANG, Yiyun ,  WANG, Jue ,  SUN, Xinqiang ,  LAO, Xuejun ,  JIANG, Biwang

IPC分类号： A61K38/14 ,  C07K9/00 ,  C07K1/22

公开(公告)号：EP3064214A1

公开(公告)日：2016-09-07

申请号：EP14857463.5

申请日：2014-10-27

申请人： Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory

发明人： LI, Enmin ,  ZHUANG, Yiyun ,  WANG, Jue ,  SUN, Xinqiang ,  LAO, Xuejun ,  JIANG, Biwang

IPC分类号： A61K38/14 ,  C07K9/00 ,  C07K1/22

CPC分类号： C07K1/36 ,  A61K38/14 ,  C07K1/20 ,  C07K1/34 ,  C07K9/008

摘要： Provided is a separation and purification method for vancomycin hydrochloride of high purity. The method comprises the following steps: (1) obtaining a vancomycin hydrochloride solution from a crude vancomycin product by ion exchange chromatography and obtaining a concentrate by nanofiltration desalination and concentration; (2) adjusting the concentrate with a hydrochloric acid solution and then performing a column chromatography using a reverse chromatography column for the adjusted concentrate; (3) collecting the chromatographic solution of vancomycin to obtain a mixed chromatographic solution; (4) adjusting the mixed chromatographic solution, and separating the solution and the salts by nanofiltration desalination and concentration to obtain a concentrate; and (5) obtaining a vancomycin dry powder with a chromatographic purity of up to 99% and a pure white appearance by dehydrating and drying the concentrate of step (4), or by solvent crystallization or salting-out crystallization.

摘要翻译： 本发明提供了高纯度盐酸万古霉素的分离纯化方法。 该方法包括以下步骤：（1）通过离子交换色谱法从粗万古霉素产品中获得盐酸万古霉素溶液，并通过纳滤脱盐浓缩获得浓缩物; （2）用盐酸溶液调节浓缩物，然后使用反相色谱柱进行柱色谱用于调整浓缩物; （3）收集万古霉素的色谱溶液，得到混合色谱溶液; （4）调整混合色谱溶液，并通过纳滤脱盐浓缩分离溶液和盐，得到浓缩物; 和（5）通过使步骤（4）的浓缩物脱水干燥，或通过溶剂结晶或盐析结晶获得色谱纯度高达99％的纯净白色外观的万古霉素干粉。