聚合物纳米微球分离纯化达托霉素方法研究  

Studies on the separation and purification of daptomycin by nanoscale polymer particles

作　　者：林毅[1] 张雪霞[1] 李宁[1] 李晓露[1] 王海燕[1] 任风芝[1] 

机构地区：[1]微生物药物国家工程研究中心,河北省工业微生物代谢工程技术研究中心,华北制药集团新药研究开发有限责任公司,石家庄050015

出　　处：《中国抗生素杂志》2013年第8期588-591,共4页Chinese Journal of Antibiotics

基　　金：国家"重大新药创制"科技专项(项目编号:2010ZX09401-403)

摘　　要：目的开发高纯度达托霉素的分离纯化工艺。方法以聚合物纳米微球为载体,对洗脱条件进行优化,再进一步采用结晶的方法进行纯化。结果选择PS RPC-300型聚合物纳米微球为层析填料,上样量为0.5g/100g填料,流速控制为5mL/min,以体积分数为30%和40%的乙醇进行洗脱,收集40%乙醇洗脱液,浓缩后加入丙酮进行结晶,过滤,干燥得到纯度大于98.5%的达托霉素。结论建立了高纯度达托霉素的的分离纯化工艺,流程简单、可行,为该产品产业化开发提供基础。Objective To development the separation and purification processes of high-purity daptomycin. Methods The separation and purification processes of daptomycin was studied by choosing the type of nanoscale polymer particles, optimizing the elution condition, and crystallization purification. Results Type of PS RPC-300 nanoscale polymer particles was selected as the best chromatography filler. The optimal conditions as follows： the amount of sample was 0.5g/100g filter, the elution speed was 5.0mL/min, 40% ethanol was used as the eluant and acetone was used as the crystallization solvent. The purity of the final product was more than 98.5% under the optimal conditions. Conclusion The established purification process was simple and feasible for further industrialization of Daptomycin.

关 键 词：达托霉素 聚合物纳米微球 分离纯化 

分 类 号：R978.1[医药卫生—药品]