摘要
目的制备富马酸酮替芬缓释胶囊并考察其体外释放度。方法采用挤出滚圆机制备富马酸酮替芬含药丸芯,流化床对丸芯包衣,将缓释微丸灌装于空胶囊。单因素考察筛选不同包衣材料包衣增重和致孔剂对释放度的影响。采用相似因子法比较自制缓释胶囊与市售缓释片释放曲线相似性。结果缓释包衣材料选用Surelease,最佳包衣增重8%、致孔剂3%。3批自制缓释胶囊与3批市售缓释片体外平均释放度比较,相似因子f2值>50,批内批间RSD优于缓释片。结论该方法适用于制备富马酸酮替芬缓释胶囊,所得缓释胶囊具有良好的体外缓释释放效果。
Objective To prepare ketotifen fumarate sustained-release capsules and evaluate its release rate in vitro . Methods Extrusion spheronization technique was introduced to prepare ketotifen fumarate pellets.The pellets were coated in the fluidized bed and then filled in the vacant gelatin capsules.Effect of different coating material proportion, porogen on release rate was evaluated by single factor. Dissolution curve of the coated pellets was compared with that of the commercial pellets with similar factor method. Results Surelease was used as the sustained-release layer material with coating weight increment of 8%, porogen of 3%.Comparison of average release rate in vit ro between 3 batches of the coated pellets and 3 batches of commercial pellets showed the similarity factor f 2 was more than 50, and the RSD between batch and batch was better than that of sustained-release tablets. Conclusion The prepare method suitable to prepare ketotifen fumarate sustained-release capsules, the coating pellets has good effect of sustained-release in vitro .
作者
黎炜烘
LI Weihong(Guangzhou Coredes Pharma-Tech.Co., Ltd,Guangzhou 510260,China)
出处
《医药导报》
CAS
北大核心
2019年第3期365-370,共6页
Herald of Medicine
基金
广州市创新基金资助项目(2013J4400222)
关键词
酮替芬
富马酸
缓释胶囊
挤出滚圆法
流化床包衣
Ketotifen, fumarate
Sustained-release capsules
Extrusion/spheronization
Fluid-bed coating
