替考拉宁的分离纯化

Separation and purification of teicoplanin

目的优化替考拉宁纯化工艺,制备纯度高、满足欧洲药典标准的替考拉宁。方法采用大孔树脂吸附、结晶等技术分离替考拉宁,结合二元液相色谱系统,以聚合物微球为载体,对填料的型号和洗脱条件进行优化,最终得到高质量替考拉宁样品。结果 PS30-300微球为最佳纯化介质,洗脱剂为65%甲醇-水,上样量为10mg/mL填料,洗脱流速为1.5~2.0BV/h柱体积时洗脱效果最佳。在此实验条件下产品纯度≥99%,纯化收率≥75%。结论该分离纯化方法简单,快速,易于操作,适于工业化生产。

Objective By optimizing the purification process, teicoplanin with high purity and meeting the European pharmacopoeia standard was prepared. Methods Teicoplanin was separated by macroporous resin adsorption and crystallization techniques. Combining with binary liquid chromatography system and using polymer microspheres as carriers, the preparation process of teicoplanin was studied by optimizing the type of polymer microsphere and purification conditions. Finally, high quality teicoplanin samples were obtained. Results PS30-300 microsphere was selected as the separating medium with the following chromatographic conditions: the eluent was 65% methanol-water, sample loading was 10 mg/mL, and the elution flow rate was 1.5~2.0 BV/h column volume. The product purity was more than 99% and the yield of teicoplanin was above 75% under the optimum conditions. Conclusion The separation and purification method is simple and rapid, it is easy to operate and suitable for industrial production.