酮康唑水分散软颗粒的制备及稳定性考察

Preparation and stability of ketoconazole water dispersible soft granules

目的:研究酮康唑水分散软颗粒的制备及质量检测方法,并考察其稳定性。方法:采用熔融法制备酮康唑水分散软颗粒,用红外光谱法、扫描电镜法和X射线衍射法对其进行物相鉴别,用紫外分光光度法测定含量,最后考察其加速稳定性。结果:物相鉴别表明,酮康唑水分散软颗粒中酮康唑与辅料之间形成了类似于固体分散体之间的作用力,而非简单的物理混合;加速和长期稳定性试验表明,酮康唑水分散软颗粒中酮康唑含量基本无变化。结论:采用熔融法制粒,制得的酮康唑水分散软颗粒的稳定性较好,符合水分散软颗粒的质量要求。

Objective：To develop ketoconazole water dispersible soft granules and study the stability. Methods：Ketoconazole water dispersible soft granules were prepared by fusion method. Infrared spectrophotometery, scanning electronical microscope, X-ray diffraction and ultra-violet spectrophotometry were used for characterizations. The accelerated stability was investigated. Results：Ketoconazole water dispersible soft granules were not a simple physical mixture but the solid dispersion-like complexes in which there were interaction between ketoconazole and excipients. Results of the stability showed that the main active content was not changed significantly under the experimental conditions. Conclusions：The fusion method is suitable for preparation of ketoconazole water dispersible soft granules. The stability and measurements meet the Chinese Pharmacopoeia 2005 edition （Part I）.