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目的制备一种瑞巴派特球状结晶的新晶型并考察新晶型对瑞巴派特溶出速率的影响。方法以N,N-二甲基甲酰胺-乙酸乙酯重结晶法制备新晶型瑞巴派特球状晶体,通过扫描电镜法、红外吸收光谱法和X射线粉末衍射法对其进行结构分析;采用紫外-可见分光光度法考察其对在不同p H介质中的原料药溶出速率的影响。结果瑞巴派特针状晶体和球状晶体不仅晶体外观形状不同,且其红外吸收光谱图和X射线粉末衍射图谱都存在很大的差异。瑞巴派特球状晶体的溶出速率高于针状晶体。结论瑞巴派特球状晶体是新晶型,它与针状晶体的晶型不同并且二者的溶出速率也存在明显差异。
OBJECTIVE To prepare a new crystal form of rebamipide spherulites and investigate the influence of the new crystal form on the rebamipide dissolution rate. Methods The new crystal type of Rebamipide crystal was prepared by recrystallization from N, N - dimethylformamide - ethyl acetate. The structure of the crystal was analyzed by scanning electron microscopy, infrared absorption spectroscopy and X - ray powder diffraction. UV-visible spectrophotometry was used to investigate the effect of the drug substance dissolution rate on different p H media. Results Rebamite acicular crystals and spherical crystals not only have different crystal appearances, but also have very different infrared absorption spectra and X-ray powder diffraction patterns. The dissolution rate of rebamipide spherical crystals is higher than that of acicular crystals. Conclusion The rebamipide spherical crystal is a new crystal form, which is different from the crystal form of the acicular crystal and the dissolution rate of the two is obviously different.