斯皮仁诺(伊曲康唑)胶囊和国内市售同品种制剂的质量研究  

Quality comparison of three branded itraconazole capsules

作　　者：包泳初[1] 瞿挺[1] 熊全美[1] 陈庆华[1] 

机构地区：[1]上海医药工业研究院,上海200437

出　　处：《中国新药杂志》2006年第14期1177-1180,共4页Chinese Journal of New Drugs

摘　　要：目的:本研究对3家不同药厂生产的伊曲康唑胶囊剂进行药学质量研究。方法:从室温加速试验检测3家产品在药物含量、溶出度和有关物质等指标上的变化。结果:斯皮仁诺(?)在溶出度和有关物质水平上有明显的优势;研究还分析了其他2个厂家同品种制剂质量存在问题的原因,为提高产品质量提供科研依据。结论:实验结果表明斯皮仁诺胶囊的质量比国内另2个厂家产品稳定。Objective： To evaluate the quality of three branded itraconazole capsules made in China. Methods：A long-term stability test and an acceleration stability test were conducted to compare concentration, dissolution and relative substances of the three branded capsules. Resuits：Spiranox produced by Xian Janssen Pharm. Co. showed significantly superior quality to the other two branded capsules in regard to drug dissolution or relative substances. The causes of the two inferior capsules were analyzed. Conclusion：The quality of Spiranox was better than the other two branded itraconazole capsules.

关 键 词：伊曲康唑 胶囊 微丸 溶出度 

分 类 号：R943.3[医药卫生—药剂学] R978.5[医药卫生—药学]