大孔吸附树脂法纯化达福普汀  

Purification of dalfopristin by macroporous resin

作　　者：赵传猛[1] 裘鹏程[1] 肖立[1] 尹明星 张福利[1] 

机构地区：[1]上海医药工业研究院,创新药物与制药工艺国家重点实验室,上海200040 [2]浙江海正药业股份有限公司,台州318000

出　　处：《中国抗生素杂志》2013年第3期208-213,共6页Chinese Journal of Antibiotics

基　　金：上海市科技人才计划项目(10XD1422800)

摘　　要：目的研究大孔吸附树脂法分离纯化达福普汀的工艺条件,以得到高纯度药用级达福普汀。方法建立HPLC检测方法,考察树脂对达福普汀的吸附和解吸性能,以达福普汀解吸率和纯度为指标,优化上样量和解吸条件等工艺参数。结果筛选出国产H-60型树脂纯化达福普汀,最大上样量20mg/mL湿树脂,解吸溶剂为12%乙腈的pH=3.0的甲烷磺酸水溶液,解吸率90%以上,成品纯度可达99.5%以上。结论该工艺纯化效果好,解吸率高,适用于高纯度达福普汀的制备及工业化生产。Objective The process on separation and purification of Dalfopristin with macroporous resins was studied to obtain high quality product for pharmaceutics. Methods HPLC method was setup to detect the purity of dalfopristin in order to study the absorption and desorption performance of resins. Then, the loading amount and desorption conditions were optimized based on the value of desorption rate and purity of Dalfopristin. Results According to experimental data, the most suitable resin is H-60, a domestic macroporous resin with 20mg/ml as the maximum loading amount. The desorption solvent is 12% acetonitrile （ACN） in methyl sulfonie acid （MeSOaH） aqueous solution with pH equal to 3.0. Under these conditions, desorptign rate is more than 90%; the purity of final product is above 99.5% at same time. Conclusion This process is applicable for industrial production and preparation of dalfopristin with high purity and desorption rate.

关 键 词：达福普汀 大孔吸附树脂 纯化 

分 类 号：R978.1[医药卫生—药品]