硫酸沙丁胺醇缓释微丸的制备及其释放度研究

Preparation of Salbutamol Sulfate sustained-release pellets and study of the release

目的制备硫酸沙丁胺醇缓释微丸并考察其体外释放度。方法采用流化床底喷包衣技术,在已有处方工艺研究的基础上,进一步考察致孔剂用量及缓释层增重对其释放度影响。用高效液相色谱法测定其释放度。结果致孔剂在缓释层中的用量占该固体总量的0.22%,缓释层增重为8.55%时,所制备微丸的释放度最优,该微丸释药行为符合一级方程。结论方法简单,工艺可行,质量稳定,释放度符合药典规定要求。

Objective To prepare salbutamol sulfate sustainedrelease pellets and evaluate the drug release characteristics in vitro. Methods Using the fluidized bed bottom spray coating technique, based on ex isting prescription process, investigating the amount of pore former and weight gain of the coating layer which effect on the release. The release rate of Salbutamol Sulfate sustainedrelease pellets was determined by HPLC. Results The optimal sustained release behavior in vitro of the sustainedrelease pellets was reached when the amount of slowrelease drugcontaining layer was 8.55% of total weight and porogen copolymer PVP used in sustained release layer accounted for 0. 22% of the total solids. Conclusion The established process and for mula were simple, the technology is feasible, stable quality. The release results consistent with ＂Chinese Phar macopoeia＂ requirement.