摘要
目的:制备酮基布洛芬分散片,并考察其体外溶出度。方法:以微晶纤维素(MCC)为填充剂,采用湿法制粒法制备分散片;以MCC、羧甲基淀粉钠(CMS-Na)的处方用量及羟丙基甲基纤维素(HPMC)的浓度为因素,并采用正交试验设计优化处方;采用中国药典溶出度法第二法,以磷酸盐缓冲液为介质进行体外溶出度考察。结果:最佳处方为MCC30%、CMSNa3%、HPMC1%;所制片剂呈白色、片面光洁,崩解时限20s,含量、分散均匀性均符合中国药典2010年版相关要求,30min溶出度大于90%。结论:该分散片制备方法简单,分散均匀,溶出速度快且完全。
OBJECTIVE To prepare ketoprofen dispersible tablet and evaluate its dissolution rate in vitro. METHODS Ke- toprofen dispersible tablets were prepared with wet granulation using microcrystalline cellulose（MCC）as filler; the prescribed dosages of MCC and CMS-Na, the concentration of HPMC as factors, and the prescription was optimized by using orthogonal experimental design; the second determination method of dissolution rate stated in Chinese Pharmacopeia was adopted to deter- mine the in vitro dissolution rate of prepared tablets using phosphate buffer solution as solvent. RESULTS The optimized pre- scription was as follows： MCC30%, CMS-Na3%, HPMC1 %. Prepared tablets were characterized with primrose white and smooth appearance and disintegrating time of 20s. The content and disperse homogeneity of prepared tablets were in line with the requirement of Chinese Pharmacopeia（2010 edition）. The dissolution rate of prepared tablets was more than 90% in 60 min. CONCLUSION The preparation method is simple, spread evenly and the dispersible tablets dissolve fast and completely.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2014年第7期547-549,583,共4页
Chinese Journal of Hospital Pharmacy
关键词
酮基布洛芬
分散片
正交试验
溶出度
ketoprofen
dispersible tablet
orthogonal test
dissolution rate
