人参皂苷CK水合物的制备及其稳定性研究

摘要：目的 研究人参皂苷CK的水合物及其稳定性差异。方法 采用X-射线粉末衍射、差示扫描量热仪和热重分析仪 对3种人参皂苷CK水合物进行表征；通过高温、高湿、光照、研磨及悬浮转晶等实验对3种水合物的稳定性进行对比研究。结 果 高温条件下，人参皂苷CK一水合物和半水合物稳定而二水合物会失水变化，而在高湿、光照、研磨条件下，3种水合物的 稳定性均良好；一水合物在乙腈/水(3:1)的混合溶剂中稳定，半水合物在丙酮溶剂中稳定，二水合物在甲醇溶剂中稳定，而在水 中3种水合物均不会发生晶型转变。结论 本研究确定人参皂苷CK一水合物更适合作为药用晶型，并为其结晶工艺和制剂工艺 的开发提供了数据基础。

Zhu Wen-ming1, Zhang Ling-jian1, Fang Jia-shuang1, and Zhang Hui2

Abstract Objective To estimate the difference and stability of ginsenoside compound-K hydrates. Methods X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), and thermogravimetric analysis (TGA) were used to perform detailed characterization of three ginsenoside compound-K hydrates. The stability of the three hydrates were evaluated by experiments of high temperatures, high humidity, strong illumination, grinding, and suspension. Results At high temperatures, the monohydrate and hemihydrate of ginsenoside compound-K are stable, while dihydrate can release water molecules. All of the hydrates showed good phase stability under high humidity, strong illumination, and grinding conditions. Conclusion This study confirms that the monohydrate of ginsenoside compound-K is more suitable for a commercialized solid state and provided data basis for the development of crystallization process and preparation