| 引用本文: | 胡秀荣,沈金,吴素香,吴佳佳.盐酸普拉克索B晶型的制备和表征[J].中国现代应用药学,2015,32(9):1086-1090. |
| HU Xiurong,SHEN Jin,WU Suxiang,WU Jiajia.Preparation and Characterization of Form B of Pramipexole Dihydrochloride[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(9):1086-1090. |
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| 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。 |
| 关键词: 盐酸普拉克索 B晶型 晶体结构 稳定性 |
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| Preparation and Characterization of Form B of Pramipexole Dihydrochloride |
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HU Xiurong1, SHEN Jin1,2, WU Suxiang2, WU Jiajia1,2
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1.Chemistry Department of Zhejiang University, Hangzhou 310028, China;2.College of Pharmaceutical Science, Zhejiang Chinese Medical University, Hangzhou 310053, China
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| Abstract: |
| 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 C10H19Cl2N3S 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. |
| Key words: pramipexole dihydrochloride polymorphic form B crystal structure stability |
