塞来昔布分散片的制备及其体外溶出度研究

Study on the Preparation of Celecoxib Dispersible Tablets and Its Dissolution Rate in Vitro

目的:制备塞来昔布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,并采用正交实验设计优化处方;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MCC 30%、CMS-Na 5%、HPMC3%;所制片剂呈白色、片面光洁,崩解时限20 s,含量、分散均匀性均符合2010年版《中国药典》相关要求,30 min内溶出度大于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 celecoxib dispersible tablets and to evaluate the dissolution rate in vitro. Methods： Celeeoxib dispersible tablets were prepared with wet granulation by using mierocrystalline cellulose（MCC） as filler. The prescribed dosages of MCC and CMS-Na, and the concentration of HPMC were as factors. The prescription was optimized by using orthogonal experimental design ; the second determination method of dissolution rate stated in Chinese Pharmacopeia was adopted to determine the in vitro dissolution rate of prepared tablets, and phosphate buffer solution was used as solvent. Results： The optimized prescription as follows： MCC 30%, CMS-Na 5%, and HPMC 3%. Prepared tablets were characterized with primrose white and smooth appearance, and disintegrating time was 20 seconds. 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 minutes. Conclusions： The preparation method is simple. The dispersible tablets spread evenly and dissolve quickly and completely.