萘普生脉冲释药片的研制及体外释药影响因素考察

Study on the preparation and the release influencing factors of pulsatile controlled release tablets of naproxen

目的:制备萘普生脉冲释药片并考察体外释放的影响因素。方法:以乙基纤维素和丙烯酸树脂Ⅱ号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释药片体外释放的影响。结果:崩解剂的用量、包衣液中致孔剂的含量及包衣膜的厚度为影响药物体外释放的主要因素。结论:萘普生脉冲释药片在体外具有脉冲释药特性。

OBJECTIVE To prepare pulsatile controlled release tablets （PCRT） of naproxen and investigate the influence factors in vitro release. METHODS The PCRT of naproxen with ethylcellulose （EC） and acrylic resin Ⅱ as coating materials were prepared by using coating technique. The influence factors on the lag time were investigated by dissolution test. RESULTS The amount of disintegrant, the coating weight and the concentration of the pore former had significant effects on the lag time of naproxen from PCRT. CONCLUSION The PCRT have the pulsatiling property in vitro release test.