盐酸普拉克索B晶型的制备和表征  

Preparation and Characterization of Form B of Pramipexole Dihydrochloride

作　　者：胡秀荣[1] 沈金[1,2] 吴素香[2] 吴佳佳[1,2] 

机构地区：[1]浙江大学化学系,杭州310028 [2]浙江中医药大学药学院,杭州310053

出　　处：《中国现代应用药学》2015年第9期1086-1090,共5页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的制备盐酸普拉克索的B晶型并优化制备工艺,同时进行结构表征和稳定性研究。方法制备盐酸普拉克索的B晶型,采用热重法(TGA)、差示扫描量热法(DSC)、X射线粉末衍射(PXRD)、X射线单晶衍射(SXRD)等分析手段,对盐酸普拉克索B晶型进行表征研究。结果制备得到了盐酸普拉克索B晶型,其晶型属正交晶系,空间群P212121,结构中不含溶剂(包括水)。盐酸普拉克索B晶型热处理后晶型不发生转变。结论盐酸普拉克索B晶型为无水晶型,热稳定性优于一水合物晶型,具有高温稳定性。OBJECTIVE To obtain the new preparation method of polymorphic form B of pramipexole dihydrochloride and discuss it＇s thermodynamics stability and crystal structure. METHODS Polymorphic form B of pramipexole dihydrochloride was characterized by thermal gravimetric analysis（TGA）, differential scanning calorimetry（DSC）, powder X-ray diffraction（PXRD） and single crystal X-ray diffraction（SXRD）. RESULTS Preparation method, crystal structure and polymorphic stability of polymorphic form B of pramipexole dihydrochloride was obtained. The results showed that form B was in the orthorhombic space group P212121 with formula C10H19Cl2N3 S as the anhydrous form. Pramipexole dihydrochloride form B was more stable than pramipexole dihydrochloride monohydrate form in high temperature condition. CONCLUSION Form B of pramipexole dihydrochloride is anhydrous which is more stable at high temperature. Form B has good stability at high temperature.

关 键 词：盐酸普拉克索 B晶型 晶体结构 稳定性 

分 类 号：R913[医药卫生—药学]