溴吡斯的明缓释微丸的制备及处方优化

目的：制备溴吡斯的明缓释微丸，并对处方进行优化。方法：采用流化床包衣技术，分别以不同黏度的乙基纤维素为包衣材料制备缓释微丸，以体外释放度为指标，采用均匀设计优化处方。结果：当PEG为12.8%，邻苯二甲酸二乙酯（DEP）为22.7%，增重为21.6%时，微丸的累积释放度与参比释放曲线相比相似因子（f₂）为86.5，释放曲线符合一级动力学方程。结论：采用流化床包衣技术制备的缓释微丸累积释放度达到释放要求。

Preparation and formula optimization of sustained-release pellets of pyridostigmine bromide

OBJECTIVE To prepare and optimize formula of sustained-release pellets of pyridostigmine bromide.METHODS Sustained-release pellets were prepared with ethyl celluloses of different viscosity as coating material by fluid-bed technology, and the formula was optimized by using uniform design, with in vitro release as the parameter.RESULTS When PEG was 12.8%, DEP 22.7% and weight gain 21.6%, release in vitro of prepared PB sustained-release pellets followed first-order kinetic equation, the similarity factor (f₂) was 86.5 compared with reference release curve of commercial sustained-release tablets.CONCLUSION Dissolution rate of sustained-release pellets prepared by fluid-bed technology could satisfy release requirements.