聚合物微球纯化FR-179642工艺研究  

Purification Process of FR-179642 with Polymer Microsphere

作　　者：李宁[1] 徐岩[1] 任风芝[1] 张雪霞[1] 仲伟潭[1] LI Ning;XU Yan;REN Feng-zhi;ZHANG Xue-xia;ZHONG Wei-tan(New Drug Research&Development Co.,Ltd.of NCPC,National Engineering Research Center of Microbial Medicine,Hebei Industry Microbial Metabolic Engineering&Technology Research Center,Shijiazhuang 050015,China)

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

出　　处：《化学与生物工程》2018年第7期47-50,共4页Chemistry & Bioengineering

基　　金：河北省科技条件建设项目(169676404G)

摘　　要：采用聚合物微球预装色谱柱,连接高效液相色谱仪,以分离度、拖尾因子为考察指标,对聚合物微球型号及流动相进行筛选;采用中压层析色谱,以峰纯度及收率为考察指标,对洗脱流速及上样量进行筛选。确定UniPSA30-300型聚合物微球为层析介质,以3%甲醇-水(含1‰乙酸)为流动相,洗脱线性流速为1.88cm·min-1,上样量为10.0mg·mL-1(粗品质量/树脂体积),收集峰纯度≥95%的洗脱液,纳滤,冻干,得到FR-179642纯度不低于99%,收率可达85%以上。该工艺简便易行,产品质量可控,适合工业化生产。By preloading chromatographic columns with polymer microspheres in HPLC,we selected the types of polymer microspheres and the mobile phases through analyzing the resolution and tailing factors.Moreover,by medium pressure chromatography,we selected the flow rate and the sampling amount through analyzing the peak purity and yield.Finally,taking UniPSA30-300 polymer microspheres as chromatographic media and 3%methanol water(containing 1‰acetic acid)as a mobile phase,we find that the linear flow rate is 1.88 cm·min^-1,and the sampling amount is 10.0 mg·mL^-1(the mass of crude FR-179642/the volume of resin).The eluent with a peak purity of not less than 95%can be collected,and the FR 179642 with purity of not less than 99%and the yield of more than 85%after nanofiltration and freeze drying can be obtained.The process is simple and feasible,and the product quality is controllable,which is suitable for industrial production.

关 键 词：FR-179642 聚合物微球 纯化 结构鉴定 

分 类 号：R978.5[医药卫生—药品] TQ465.9[医药卫生—药学]