不同厂家非那雄胺片在4种溶出介质中的溶出曲线比较研究  

Comparative Studies on Dissolution Curves of Finasteride Tablets from Different Pharmaceutical Manufactures in 4 Dissolution Mediums

作　　者：曾俊[1] 孟霞[1] 李倩雯[1] 谢细妹 徐雄波[1] 

机构地区：[1]长沙医学院,湖南长沙410219

出　　处：《中国药物评价》2016年第6期481-484,共4页Chinese Journal of Drug Evaluation

基　　金：长沙医学院2014年度大学生研究性学习与创新性课题(长医教[2014]10号);2014年湖南省校企合作人才培养示范基地项目(湘教通[2014]272号)

摘　　要：目的:比较不同厂家非那雄胺片在4种不同溶出介质中的溶出曲线,为全面评价药品质量提供依据。方法:采用桨法,以4种不同溶出介质各900 m L,转速为50 r·min^(-1),采用HPLC法,测定不同厂家非那雄胺片溶出曲线。结果:不同厂家的非那雄胺片在4种溶出介质中的溶出曲线不完全相似。结论:相关厂家应改进制剂的处方工艺,以改善制剂的溶出行为,提高药品质量。Objective： To compare the dissolution profiles of finasteride tablets from different pharmaceutical manufactures in 4 dissolution mediums, and provide the basis for a comprehensive evaluation of the quality of finasteride tablets. Methods： The dissolution profiles of finasteride tablets were determined by HPLC method with 900mL of different dissolution medium and 50rpm by paddle method. Results ： The dissolution profiles of finasteride tablets produced by different manufacturers in 4 dissolution media are not completely similar. Conclusion： It is advised that pharmaceutical manufactures should improve the product quality by changing the formulation and process.

关 键 词：非那雄胺片 溶出曲线 HPLC 

分 类 号：R927.2[医药卫生—药学]