【摘要】 目的:对灰白色、淡黄色及纯白色盐酸青藤碱3种晶形的纯度进行分析。方法:采用电子显微镜扫描法、红外光谱法、高效液相色谱法(HPLC法)、差示扫描热量法(DSC法)等进行分析。结果:溶解度灰白色晶形为9.1g/100mL,淡黄色晶形为9.0g/100mL,纯白色晶形为16.8g/100mL;电子显微镜扫描结果,纯白色盐酸青藤碱晶形表面光洁、透明,灰白色、淡黄色盐酸青藤碱晶形表面吸附有杂质斑点,且淡黄色比灰白色多;在HPLC图中,纯白色盐酸青藤碱晶形峰与对照品完全一致,灰白色晶形有2个小杂质峰,淡黄色3个小杂质峰;红外光谱图中,纯白色晶形与对照品峰形一致,灰白色晶形与淡黄色晶形在2400～2300cm-1有一个υC≡N吸收峰,且淡黄色晶形的吸收峰较灰白色晶形峰强;盐酸青藤碱对照品、灰白色、淡黄色及纯白色的DSC图谱在231～235℃均只有一个吸热峰,无多晶形现象。结论:盐酸青藤碱晶形纯度与生产工艺有关,在生产中应控制好原料质量。纯度分析方法快速、简便、专属性强,可为盐酸青藤碱质量控制提供参考。更多还原

【Abstract】 Objective:To study the purity of different kinds of sinomenine hydrochloride crystals with greyish white,light yellow and pure white in color.Methods:The electron microscope scanning, the infrared spectrophometry and the HPLC method were used to determine the purity of different kinds of sinomenine hydrochioride crystals and the difference of them were compared.Results:Electron microscope scanning showed,that the surface of the pure white simomenine hydrochlorid was smooth and transparent,but the greyish white and the light yellow simomenine hydrochloride were absorbed many impurity spots,and latter was more than the former.The solubilities of the pure white,greyish white and light yellow simomenine hydrochloride were 16.8 g/100 mL,9.1 g/100 mL,9.0 g/100 mL;respectively,The solubility of pure white simomenine hydrochloride was higher than that of greyish white and light yellow samples.The I R of pure white simomenine hydrochloridc was the same as that of contrast,a cyano absorbtent peak of the greyish white and the light yellow crystals was appeared between 2400～2300 cm-1,and the latter was stronger than the former.From the view of HPLC picture,pure white simomenine hydrochloride was the same as that of contrast, but the greyish white and the light yellow crystals had more than two impurity peaks,sinomenine hydrochloride crystal had only one caloric peak around 231～ 235℃,and has no polymorphs.Conclusion:The purity of sinomenine hydrochloride is related to the technology of production,The analytical methods of sinomenine hydrochloride by infrared spectrophometry,HPLC,etc are rapid,simple and special.It can be referenced to the quality control of sinomenine hydrochlonide.更多还原