离心造粒法和流化床包衣制备硫普罗宁肠溶微丸

Preparation of tiopronin pellets by centrifugation pelletizing and fluid bed coating technology

目的:应用离心造粒法及流化床包衣制备硫普罗宁肠溶微丸,并对其性质进行考察。方法:采用国产离心造粒机制备硫普罗宁微丸,采用L9(34)正交设计实验优化工艺条件;用底喷流化床包衣设备,将微丸包肠溶衣,考察微丸的粉体学性质及不同包衣增重微丸的体外释放实验。结果:制得的硫普罗宁微丸圆整度好,大小均匀。20%包衣增重的微丸体外释放比较理想。结论:应用国产离心造粒机制备硫普罗宁微丸,工艺简便,制得的微丸质量好,结合流化床底喷包衣工艺,可制得硫普罗宁肠溶微丸。

Objective： To prepare tiopronin pellets by centrifugation pelletizing and bottom-spray fluid bed coating technology,and investigate the properties of the pellets.Methods： Tiopronin pellets were prepared using a domestic centrifugation pelletizing equipment.The optimal formulation was obtained by L9（34） orthogonal design.The pellets were enteric-coated using a fluid bed coating equipment.The micromeritics properties and in vitro dissolution of the pellets were investigated.Results： Tiopronin pellets prepared by centrifugation pelletizing were round,smooth and even.The results of the in vitro dissolution test from the coated pellets were perfect.Conclusion： The tiopronin pellets can be easily made with excellent quality using the domestic centrifugation pelletizing equipment and bottom-spray fluid bed technology.