地红霉素肠溶微丸的制备与体外释放

Preparation of dirithromycin enteric-coated pellets and study on its release in vitro

目的:制备地红霉素肠溶微丸并考察其体外释放度。方法:采用离心造粒法制备地红霉素微丸,并利用该法对微丸进一步进行肠溶包衣。结果:主药与辅料的比例、黏合剂的浓度、主机转速对微丸的粒径分布和收率有较显著的影响,包衣膜增重对微丸释放有显著的影响作用。结论:在优化条件下采用离心造粒法可制备出表面光滑、圆整度较好的地红霉素肠溶微丸,18～24目微丸收率可达90.2%。

OBJECTIVE To prepare the dirithromycin enteric-coated pellets and study its release rate in vitro. METHODS The dirithromycin enteric-coated pellets were prepared by centrifugal granulation method. RESULTS The ratio of dirithromycin to excipient, the concentration of the adhesive agent and rotor rotation speed were found to have an significant influence on the size distribution and yield of pellets. The release rate of pellets was affected significantly by the weight of coating film membranes. CONCLUSION Under the optimized conditions, the micropellet wirth smooth surface and perfect shape can be prepared by the centrifugal granulator,the yields of dirithromycin micropellet are 90. 2%.