盐酸文拉法辛多晶型现象的研究

Polymorphism of Venlafaxine Hydrochloride

建立了盐酸文拉法辛晶型分析方法。盐酸文拉法辛产品用各种溶剂重结晶及190℃加热相转变,所得样品用X-射线粉末衍射法和差示扫描量热法分析。溶剂结晶法易制得晶型2,晶型1次之。190℃加热相转变则得晶型6。工业化产品用异丙醇重结晶得到以晶型2为主的混合晶型。加速试验研究结果显示,混合晶型中的晶型6会转变为晶型2。

A polymorph analysis method was established for discussion of venlafaxine hydrochloride which recrystallized from various solvents and underwent phase transformation under 190 ℃. The samples were analyzed by X-ray powder diffraction and differential scanning calorimetry methods. Crystal form 2 with less form 1 was obtained from solvent recrystallization, and thermal phase transformation led to form 6. The industrial product recrystallized from isopropanol, was a polymorphic mixture with mainly form 2, form 6 was expected to transform into form 2 in the accelerated study.