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K3025%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。
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.
出处
《药学实践杂志》
CAS
2014年第4期273-277,共5页
Journal of Pharmaceutical Practice
关键词
非那雄胺
分散片
薄膜包衣
正交试验
溶出度
finasteride
dispersible tablets
film coating
orthogonal experiment
dissolution
