非那雄胺包衣分散片的制备及体外溶出度测定
投稿时间:2013-08-13  修订日期:2013-12-06  点此下载全文
引用本文:邱俊,徐燕茹,曾棋平,钟桂香,朱建明,宋洪涛.非那雄胺包衣分散片的制备及体外溶出度测定[J].药学实践杂志,2014,32(4):273~277
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作者单位E-mail
邱俊 南京军区鼓浪屿疗养院药械科, 福建 厦门 361002  
徐燕茹 南京军区鼓浪屿疗养院药械科, 福建 厦门 361002  
曾棋平 南京军区福州总医院药学科, 福建 福州 350025  
钟桂香 南京军区福州总医院药学科, 福建 福州 350025  
朱建明 南京军区鼓浪屿疗养院药械科, 福建 厦门 361002  
宋洪涛 南京军区福州总医院药学科, 福建 福州 350025 sohoto@vip.163.com 
中文摘要:目的 优化非那雄胺分散片的处方及制备工艺,测定其溶出度。方法 采用湿法制粒压片,正交试验优化处方工艺。结果 非那雄胺片的处方组成:稀释剂为40%微晶纤维素和50%乳糖,崩解剂为5%低取代羟丙基纤维素,黏合剂为5%聚维酮K30 25%的乙醇溶液,包衣液为15%的85G型欧巴代,45 min时溶出度可达90%以上。结论 自制非那雄胺片质量稳定,工艺可靠,适合工业化生产要求。
中文关键词:非那雄胺  分散片  薄膜包衣  正交试验  溶出度
 
Preparation and detection of in vitro dissolution of finasteride coated dispersible tablets
Abstract:Objective To optimize the prescription and preparation technology of finasteride dispersible tablets.Methods Wet granulation technique was applied to optimize the formulation and technology of finasteride tablets.Results The formulation of finasteride tablets was that microcrystalline cellulose and lactose acts as diluent, 5% of low-substituted hydroxypropyl cellulose acts as disintegrant, 5% of povidone in alcohol water mixture acts as adhesive and 15% of opadry 85 G type acts as coating solution.The percentage of dissolution was more than 90% in 45 miniutes.Conclusion The self-made finasteride tablets had stable quality, reliable process and were suitable for industrialized mass production.
keywords:finasteride  dispersible tablets  film coating  orthogonal experiment  dissolution
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