Preparation and detection of in vitro dissolution of finasteride coated dispersible tablets
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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。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.
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Key words:
- finasteride /
- dispersible tablets /
- film coating /
- orthogonal experiment /
- dissolution
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[1] 刘建芳, 邓 鸣, 侯艳宁. 非那雄胺的药理及临床应用研究进展[J]. 华北国防医药, 2006, 18(4):286. [2] 胡容峰, 冯志英, 王 剑, 等. 非那雄胺的研制及稳定性[J]. 中国医院药学杂志, 2001,22(5):287-289. [3] 冯泽岸, 廖明琪, 邵婷玑, 等. 南沙参多糖分散片的制备[J]. 中国医院药学杂志,2012,33(9):699-703. [4] 国家药典委员会. 中华人民共和国药典2010版二部[S]. 北京:化学工业出版社,2010:33. [5] 崔福德. 药剂学[M]. 北京:人民卫生出版社,2007:335-339. [6] 韩 莎, 朱云峰, 曹青日, 等. 三七总皂苷分散片的制备及体外评价[J]. 中成药, 2010,32(8):1324-1328. -
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