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目的根据液相层积原理,采用流化床包衣法制备了硝苯地平缓释微丸。方法采用离心造粒装置制备了硝苯地平速释微丸,将制得的微丸采用微型流化床以EudragitNE30D包衣制得了24h释药的硝苯地平缓释微丸。结果所得缓释微丸体外释放符合一级释放与Higuchi方程。结论液相层积法制得微丸体外释放符合缓控释制剂的要求。
Objective To prepare nifedipine sustained-release pellets by fluid-bed coating according to the principle of liquid-phase stratification. Methods Nifedipine immediate release pellets were prepared by centrifugal granulator. The prepared pellets were coated with Eudragit NE30D in a microfluidized bed for 24 hours. Results The sustained release pellets released in vitro were in accordance with the first order release and Higuchi equation. Conclusion The in vitro release of micro-pellets prepared by liquid-phase deposition meets the requirements of controlled-release tablets.