Bei Chen, Libo Zhang, Hong L I, Guping Tang, Xiurong H U
School of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
Hangzhou Huadong Medicine Group Pharmaceutical Research Institute Co., Ltd, Hangzhou 310011, China.
Zhejiang Da Xue Xue Bao Yi Xue Ban. 2017 Mar 25;46(2):160-166. doi: 10.3785/j.issn.1008-9292.2017.04.07.
To study the characteristics and stability of new S(-) pantoprazole sodium hydrates. The X-ray single crystal diffractometer (SXRD), X-ray powder diffractometer (PXRD), thermogravimetric analysis (TG) and infrared spectrometry (IR) were used to characterize S(-) pantoprazole sodium hydrates. The stability of the hydrates was evaluated by high temperature test,affecting factors test and accelerated test. The crystalline water in S(-) pantoprazole sodium hydrates were very easy to lose and obtain, but crystal structure was not changed significantly. The transition from S(-) pantoprazole sodium trihydrate to S(-) pantoprazole sodium hemipentahydrate occurred at approximately 40 ℃ and reversible transitions from hemipentahydrate to trihydrate occurred at high humidity. Two hydrates had no significant difference in accelerated test. The crystal structure of the two hydrates are almost the same, hemipentahydrate is more stable than trihydrates at high temperature or at exposure to light(at 4500 ± 500 lx).
研究新型S(-)泮托拉唑钠水合物的特性与稳定性。采用X射线单晶衍射仪（SXRD）、X射线粉末衍射仪（PXRD）、热重分析（TG）和红外光谱（IR）对S(-)泮托拉唑钠水合物进行表征。通过高温试验、影响因素试验和加速试验对水合物的稳定性进行评估。S(-)泮托拉唑钠水合物中的结晶水很容易失去和获得，但晶体结构没有明显变化。S(-)泮托拉唑钠三水合物向S(-)泮托拉唑钠半五水合物的转变大约在40℃发生，在高湿度下从半五水合物到三水合物的转变是可逆的。两种水合物在加速试验中无显著差异。两种水合物的晶体结构几乎相同，在高温或光照（4500±500勒克斯）条件下，半五水合物比三水合物更稳定。
