流化制粒法制备速释硝苯地平胶囊

Use fluidized-bed spray granulation to prepare immediate-release nifedipine capsules

目的研究速释硝苯地平胶囊的处方工艺,并考察其体外溶出度。方法采用高速剪切搅拌将硝苯地平制成混悬液,用流化制粒法将水性药液喷于辅料而制成颗粒,装入胶囊,并对工艺进行验证。结果10min时溶出约90%,比市售普通片剂高约23%。结论此工艺可行,方法简单,可用于大生产。

Objective To research the preparation technolog of the nifedipine immediate-release capsules and to study their drug release in vitro. Methods The granulation were prepared by Fluidized-bed spray granulation with nifedipine suspension which was prepared by high-speed shear mixing technique and were filled in capsule ,Furthermore, to validate the technolog. Results The nifedipine immediate-release capsules dissolution achieved 90% in 10 minutes, which was greater than approximately 23% compared with the market ordinary tablet. Conclusion The technolog is feasible and simple and it can be available in large-scale production.