两性霉素B分离纯化工艺研究

本文开发了一种高纯度两性霉素B的分离纯化工艺，通过工艺参数精细化控制，探索了两性霉素B的溶出率和乙醇加入量、溶液pH的关系，将陶瓷膜超滤技术应用于浸泡液处理，以及表面活性剂甘油应用于结晶体系，并确定了结晶的最佳pH值，本方法制备的两性霉素B结晶粉的生物效价检测含量大于970u/mg，面积归一百分含量大于95%，杂质含量低，产品质量优于同行业产品。 本工艺稳定，流程简单，便于规模化生产。

Studies on the separation and purification process of amphotericin B

The separation and purification process of high purity amphotericin B was established. Through strict control of the process parameters, we explored the relationship between the dissolution rate of amphotericin B and the amount of ethanol added and the pH of the solution. The ceramic membrane ultrafiltration technology was applied to the treatment of soaking solution, and the surfactant glycerin was applied to the crystallization system and the optimal pH of crystallization was confirmed. The product quality of amphotericin B with more than 970u/mg biological titer detection content, more than 95% area percentage content and low impurity content is better than that of the same product in the market. The process is stable, simple and convenient for large-scale production.