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盐酸阿替卡因的多晶型研究
Study on the polymorphs of articaine hydrochloride
【摘要】 目的:建立盐酸阿替卡因多晶型的测定方法并研究其理化性质。方法:研究了不同晶型的盐酸阿替卡因的制备方法,采用熔点测定、差示扫描量热法(DSC)、红外吸收光谱法(IR)及粉末X-衍射法(Powder X-ray)研究了不同晶型的特征,并考察了2种晶型在高湿、高温和光照条件下的稳定性。结果:盐酸阿替卡因存在2种不同的晶型,晶型Ⅰ和晶型Ⅱ。通过熔点测定、DSC和IR分析及粉末X-衍射法可区分2种晶型。晶型Ⅰ有较强的吸湿性,而晶型Ⅱ不易吸湿,2种晶型对光照和高温均较稳定。结论:盐酸阿替卡的晶型Ⅱ适合作为药物应用。
【Abstract】 Objective:To establish methods for the detection of physical and chemical characteristics of the polymorphs of articaine hydrochloride crystals. Methods: Two polymorphic forms of arti caine hydrochloride crystals were obtained. The polymorphs of articaine hydrochloride crystals were determined by melting point,differential scanning calorimetry (DSC), IR spectra (IR) and powder X-ray diffraction. The stability of the two polymorphs was measured under heat,light and humidity. Results: Two polymorphs of articaine hydrochloride crystals were defined as form Ⅰ and form Ⅱ. The two polymorphic forms showed different melting points, DSC, IR,and powder X-ray diffraction patterns. The form Ⅰ had higher hygroscopicity than the form Ⅱ. Conclusion: Form Ⅱ is more stable form a gainst humidity,and suitable to be a drug substance.
- 【文献出处】 中国新药杂志 ,Chinese New Drugs Journal , 编辑部邮箱 ,2004年09期
- 【分类号】R927
- 【被引频次】8
- 【下载频次】422