甲苯咪唑片中药物活性成分的晶型鉴别

Crystal forms identification of active pharmaceutical ingredient in mebendazole tablets

目的:研究并快速鉴别甲苯咪唑片中活性组分的晶型特征。方法:利用甲苯咪唑不溶于水的特征,采用水洗去除制剂过程中添加的极性辅料,残渣经干燥后采用红外光谱扫描进行晶型的鉴别,并使用对甲苯咪唑晶型具有区分能力的溶出介质进一步验证。结果:目前国内外市场上的甲苯咪唑片中存在2种晶型,国内市场上甲苯咪唑片的原料均为有效晶型C;国外3家企业中有2家采用无效晶型A。结论:建立简便易行的方法测定制剂中甲苯咪唑的晶型,为监控甲苯咪唑片中的活性药用成分的晶型提供科学依据。

Objective:To investigate and identify the polymorphic forms of mebendazole in tablets.Methods:Using the water insoluble characteristic of mebendazole,the polar auxiliary material added during the preparation process in mebendazole tablets was removed by water washing. Then the residue dried was performed infrared scanning to identify the crystal forms;the crystal forms were further verified using a dissolution medium with a discriminating ability. Results:Two different crystal forms of mebendazole were observed. The raw materials of mebendazole tablets in the domestic market were all effective crystal C. Two of the three that from foreign enterprises adopted invalid crystal A. Conclusion:A simple and feasible method is established for the determination of the crystal forms of mebendazole in tablets,which can provide a scientific basis for monitoring the crystal forms of active medicinal ingredients in mebendazole tablets.