论文部分内容阅读
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.
The solid dispersions of nifedipine were prepared by solvent method using water-soluble and enteric-coated materials as carrier. X-ray diffraction and DTA analysis showed that nifedipine was present in the carrier in an amorphous state. In vitro dissolution results showed that the dissolution rate of nifedipine from solid dispersion in artificial gastrointestinal juice was significantly higher than that of nifedipine (P <0.01) .Extraction in vitro also showed that this product has good sustained release , The release amount of 30min was 33.8%, and the cumulative release amount of 8h was 88.6%. The release rate basically conformed to the zero-order process after 1h.The stability test (temperature 40 ± 1 ℃ RH75%, 3 months) showed that the product has better The physical, chemical stability.