双氯灭痛结肠靶向脉冲控释片的研究

Studies on pulsatile controlled release tablets of diclofenac sodium

[目的 ]以双氯灭痛为模型药物 ,研制脉冲控释片并考察其体外释放的影响因素 .[方法 ]以乙基纤维素和丙烯酸树脂为包衣材料制备包衣片 ,通过体外释放度的测定来考察片芯及包衣材料等因素对脉冲控释片体外释放的影响 .[结果 ]崩解剂的用量、包衣液中致孔剂的用量及包衣膜的厚度为影响药物体外释放的主要因素 ,可以根据需要调节药物的释放时滞 .[结论

OBJECTIVETo prepare the pulsatile contro ll ed release tablets (PCRT) of diclofenac sodium (DS) as a drug model and investig ate the influence factors in vitro release.METHODSThe PCRT o f DC with ethycellulose (EC) and acrylic resin as coating materials were prepar ed by using coating technique. The influence factors on the lag time were invest igated by dissolution test.RESULTSThe amount of disintegrant s, the coating weight and the concentration of the pore former had significa nt e ffects on the lag time of DS from PCRT. The lag time could be controlled by adju stment if needed.CONCLUSIONThe PCRT had the pulsatiling property in vitro release test.