一种盐酸普拉克索新晶型的制备及表征  

Preparation and characterization of a new crystal form of pramipexole hydrochloride

作　　者：刘旭[1] 尹利献 戴华山 施晓枫 朱晶[1] 翟佳平 罗宏军 梁慧兴[1] LIU Xu;YIN Li-xian;DAI Hua-shan;SHI Xiao-feng;ZHU Jing;ZHAI Jia-ping;LUO Hong-jun;LIANG Hui-xing(Yangtze River Pharmaceutical Group Co.,Ltd.,Taizhou Jiangsu 225321)

机构地区：[1]扬子江药业集团有限公司,江苏泰州225321

出　　处：《中南药学》2023年第1期130-133,共4页Central South Pharmacy

摘　　要：目的制备一种盐酸普拉克索新晶型(半水合物)。方法利用粉末X射线衍射法、差示扫描量热法、热重法和红外光谱法分别对半水合物晶型和原研一水合物晶型进行表征分析,并通过加速6个月试验分别考察了半水合物晶型、一水合物晶型及无水物晶型的稳定性。结果表征分析确认了两种晶型存在明显的差别,加速6个月试验显示半水合物晶型有关物质稳定性最佳。结论半水合物晶型有很大潜力成为盐酸普拉克索的一种优势药用晶型。Objective To prepare a new crystal form of pramipexole hydrochloride(hemihydrate).Methods The crystal forms of hemihydrate and original monohydrate were characterized and analyzed by powder X-ray diffraction,differential scanning calorimetry,thermogravimetry and infrared spectroscopy.The stability of hemihydrate crystal form,monohydrate crystal form and amorphous crystal form was investigated by 6-months acceleration tese.Results The characterization confirmed that there were obvious differences between the two crystal forms,and the 6-months acceleration test showed that the stability of the related substances with the hemihydrate crystal form was the best.Conclusion The hemihydrate crystal form may become the dominant pharmaceutical crystal form for pramipexole hydrochloride.

关 键 词：盐酸普拉克索 晶型 半水合物 表征 稳定性 

分 类 号：R917.1[医药卫生—药物分析学]