阿西美辛分散片的制备及其溶出度评价

摘要

OBJECTIVE: To prepare Acemetacin dispersible tablets and to evaluate the dissolution rate of it in vitro.METHODS: Acemetacin dispersible tablets were prepared with wet granulation using acemetacin as main component and microcrystalline cellulose (MCC) as filler.An orthogonal design was performed to optimize the preparation technology of Acemetacin dispersible tablets with disintegrating time as index and the amount of MCC and CMS-Na, the concentration of HPMC solution as factors.The second determination method of dissolution rate stated in Chinese Pharmacopeia was adopted to determine the in vitro dissolution rate of prepared tablets using phosphate buffer solution as solvent.RESULTS: The optimized technology was as follows: MCC 40％, CMS-Na 5％, HPMC 1％.Prepared tablets were characterized with primrose yellow and smooth appearance and disintegrating time of 20 s.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 30 min.CONCLUSION: The preparation method is simple and the dispersible tablets dissolve fast and completely.%目的:制备阿西美辛分散片,并对其进行体外溶出度评价.方法:以阿西美辛为主药,微晶纤维素(MCC)为填充剂,采用湿法制粒法制备片剂;取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,崩解时限为指标筛选处方;采用溶出度法第二法,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MCC 40%、CMS-Na 5%、HPMC 1%;所制片剂呈淡黄色、片面光洁.崩解时限20 S,含量、分散均匀性均符合2010年版相关要求;30 min内溶出度大于90%.结论:该制剂制备方法简单,分散片溶出速度快且完全.