稳定的阿戈美拉汀晶型Ⅰ的制备方法

开发了一种稳定的阿戈美拉汀晶型I的制备方法。该方法采用在无水乙醇-正庚烷溶剂体系下添加PVP或在无水乙醇-水体系下添加HPMC的抗溶剂结晶法来实现。通过不同溶剂体系下高分子材料种类的筛选、不同浓度高分子材料的影响及溶剂体系中良溶剂和抗溶剂比例的影响的研究，确定了制备阿戈美拉汀晶型I的工艺。通过加速稳定性实验和长期稳定性实验对比表明，采用加高分子材料制备方法得到的阿戈美拉汀晶型I，具有较好的稳定性。

A reliable crystallization process for the preparation of agomelatine form I

A reliable crystallization process was developed for the preparation of stable agomelatine form I. This antisolvent crystallization was explored in ethanol-n-heptane by adding PVP and ethanol-water system by adding HPMC, respectively. Factors such as solvent, polymer, concentration of polymer, and solvent ratio were subjected to detailed examination. Accelerated and long-term stability observations indicates that the presence of polymeric additives in the crystallization process enhances the stability of agomelatine form I.