相似因子法评价氟康唑胶囊体外溶出度

目的:运用相似因子评价法,通过测定并评价原研厂家与国内仿制厂家氟康唑胶囊的体外溶出度曲线,筛选出溶出行为与原研厂家产品相似的厂家,从而进一步评价产品质量。方法:采用《中国药典》2010年版附录XC第一法的装置,用更为严格的50转转速,测定原研及仿制厂家氟康唑胶囊在0.1mol/L盐酸溶液、纯水、pH6.8磷酸盐缓冲液3种溶出介质中的体外溶出行为,绘制溶出曲线。结果:在0.1mol/L盐酸溶液介质中和纯水介质中,原研厂家A与仿制厂家B的溶出行为均一致,与仿制厂家C的溶出行为均不一致,在pH6.8磷酸缓冲液介质中,原研厂家A与仿制厂家B和仿制厂家C的溶出行为均不一致。结论:仿制厂家氟康唑胶囊在不同溶出介质中与原研产品均有不同的差异,三种介质中在pH6.8磷酸缓冲液介质中更有区分力。建议企业运用此方法进行自身产品评价,改进工艺,提高产品质量,缩短与发达国家企业间产品质量差异。

Using the Similarity Factor Method to Evaluate the Dissolution of Fluconazole Capsules

Objective： Using the similarity factor method to evaluate the dissolution of fluconazole capsules and choose the product of manufacture which is more close to the origin of the product. Methods： The dissolution of fluconazole capsules from three manufacturers in 0. lmol/L hydrochloric acid solution,water and phosphoric acid buffer（PH6.8） was determined with the related standard procedure indexed in China Pharmacopoeia （2010 edition）. Results：In 0. l mol/L hydrochloric acid solution and water,the dissolution of original manufacturer was similar to that of B manufacturer, hut was different from C manufacturer. In phosphoric acid buffer（PH6.8）, the dissolution of original manufacturer was different from the two copy manufacture. Conclusion： There are differences among the quality of fluconazole capsules from different manufactures. The quality of copy manufacture product needs to be improved.