摘要
应用水溶性和肠溶性材料为载体,用溶剂法制备了硝苯啶的固体分散物。X衍射和DTA分析表明,硝苯啶以非晶态存在于载体中。体外溶出实验结果是,在人工胃肠液中硝苯啶从固体分散物中的溶出速度明显大于纯硝苯啶(P<0.01).体外释放实验还表明,本品具有较好的缓释作用,30min释放量为33.8%,8h累积释放量为88.6%.1h后释放速度基本符合零级过程.稳定性实验(温度40±1℃RH75%,3个月)结果表明,本品具有较好的物理、化学稳定性.
A solid dispersion of nifedipine (NFP) was prepared by solvent method with water-soluble material and enteric material as carriers.An X-ray diffraction and DTA analysis suggested that NFP was present in an amorphous form in the solid dispersion.Compared with the dissolution of undispersed NFP in simulated gastric loquid or simulated intestinal liquid that of NFP from the solid dispersion was remarkably improved. Release test in vitro showed that the solid dispersion had a sustained release effect in simulated intestinal liquid. It was also shown that NFP release could be fitted to the zero order process in the first 1—8h, and that the solid dispersion was stable chemically and physically at 40℃,75% RH for3months.
关键词
硝苯啶
肠溶性材料
固体分散物
Nifedipine
Solid dispersion
Enteric material
Dissolution behaviours
Stability
