闰年霉素晶体的制备及稳定性研究

Preparation and Stability of Lipiarmycin Crystal

以闰年霉素无定形粉为原料,以闰年霉素结晶粉纯度和收率为评价指标,进行结晶参数优化,开发了一种闰年霉素晶体制备方法,通过扫描电镜、粒度分析仪、X-射线衍射仪对闰年霉素晶体进行表征,并通过加速稳定性实验对其稳定性进行评价。结果表明,以75%甲醇为结晶溶剂,在料液比为1∶20(g∶mL)、结晶温度为2~10℃的条件下,可以得到柱状、均匀规整、粒度分布集中、稳定性好的闰年霉素晶体。该方法操作简单、收率高、可行性强,适于工业化生产。

Using Lipiarmycin amorphous powder as a raw material,the purity and yield of Lipiarmycin crystal powder as evaluation indexes,we optimized the crystallization parameters,and developed a preparation method of Lipiarmycin crystal.Moreover,we characterized the Lipiarmycin crystal by SEM,particle size distribution,and XRD.Furthermore,we evaluated the stability of the Lipiarmycin crystal by accelerated stability experiments.The results show that the columnar,uniform,and regular Lipiarmycin crystal with concentrated particle size distribution and good stability can be obtained under the optimum conditions as follows:75%methanol is adopted as the crystallization solvent,the solid-liquid ratio is 1∶20(g∶mL),and the crystallization temperature is 2-10℃.The method has the advantages of simple operation,high yield,and strong feasibility,which is suitable for industrial production.