美沙拉嗪肠溶缓释片的制备与体外释放度考察

目的 制备美沙拉嗪肠溶缓释片,考察其体外释放.方法 以体外释放相似因子(f2)为主要评价指标,通过单因素处方筛选和正交试验设计得到最优处方,重现3批,比较自制美沙拉嗪肠溶缓释片与参比制剂的体外释放行为.结果 片芯中羧甲基纤维素钠(CMC 7HXF PH)用量为45 mg,羧甲淀粉钠(CMSNa)用量为35 mg;肠溶包...

Preparation and In vitro Release of Mesalamine Delayed-release Tablets

Objective To prepare mesalamine delayed-release tablets and investigate the in vitro release behaviors. Methods With the similarity factor (f₂) in vitro release as the evaluation index,the optimal formulation was determined by single factor experiments and orthogonal experiments. Three batches of mesalamine delayed-release tablets were reproduced and compared with the reference listed drug. Results The amount of sodium carboxymethylcellulose(CMC 7HXF PH) was 45mg and the amount of sodium starch glycolate(CMSNa) was 35mg in the tablet core. The ratio of Eudragit L100 to Eudragit S100 was 2:3 and the coating weight gain was 6% in the enteric coating shell. The f₂ values were all greater than 50. Conclusion The release behaviors of the self-made mesalamine delayed-release tablets and the reference listed drug are similar. The formulation and preparation process are stable and reproducible,which can be applied to prepare mesalamine delayed-release tablets .