益肝灵缓释胶囊制作过程中湿度对释放度影响的研究

The influence of the humidity to release degree in Yiganling Release Capsule Manufacturing Process

目的考察不同湿度环境下制得的益肝灵缓释胶囊湿度和释放度的关系。方法采用加湿器,对湿度进行调整,采用流化床对益肝灵缓释胶囊内容物小丸进行缓释包衣。结果湿度为影响药物释放的关键因素,所得小丸具有明显的缓释效果。结论益肝灵缓释胶囊体外释放度符合Higuch模型,湿度与释放度之间存在回归,湿度的变化会引起药物释放度的变化。

OBJECTIVE To investigate the relationship between humidity and release of Yiganling release capsules that obtained under different humidity.METHODS That adopted is humidifier,humidity adjusted,using fluidized bed Yiganling release capsule contents to release coated pellets.RESULTS Humidity is the key factors that affecting the drug release,and the obvious release effect from pellets.CONCLUSION That Yiganling release capsule met Higuch model in vitro release,and the return of humidity humidity and release between will cause the changes of drug release.