萘普伪麻双层缓释片的制备及其体外释药行为研究

 目的制备萘普伪麻双层缓释片并研究体外释药行为。方法采用固体分散技术,以羟丙甲纤维素为缓释骨架,二次压片制备萘普伪麻双层缓释片;并考察盐酸伪麻黄碱释放度的影响因素和释药特性。结果制备的萘普伪麻双层缓释片,萘普生钠在0.5h的溶出量大于85%,盐酸伪麻黄碱在0.5h的累积释放百分率20%～40%,2h为40%～60%,6h为60%～80%,8h为70%～90%,12h在90%以上。盐酸伪麻黄碱从缓释层释放行为符合Higuchi方程。结论制备的萘普伪麻双层缓释片具有明显的速释和缓释作用特征。

Studies on Preparation of Naproxen Sodium and Pseudoephedrine Hydrochloride Bilayed Sustained-Release Tablets and Their Release Behavior in Vitro

OBJECTIVE To prepare naproxen sodium(NPS-Na) and pseudoephedrine hydrochloride(PSE-HCl) bilayed sustained-release tablets and study its release behavior in vitro.METHODS Naproxen sodium and pseudoephedrine hydrochloride bilayed sustaineded-release tablets were prepared by the solid dispersion method and twice compressing method using HPMC as the matrix material.The factors influencing on the release of PSE-HCl from matrix tablets and drug release characteristics were studied. RESULTS The PSE-HCl releasing rate from the sustained-layer followed the Higuchi equation. NPS-Na released more than 85% in 0.5 h,while PES released 20%～40% in 0.5 h,40%～60% in 2 h,60%～80% in 6 h, 70%～90% in 8 h and more than 90% in 12 h.CONCLUSION Naproxen sodium and pseudoephedrine hydrochloride bilayed sustained-release tablets exhibite sustained-release and rapid release characteristics in vitro.