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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。
OBJECTIVE: To prepare pyridostigmine sustained-release pellets and to optimize the prescription. Methods: The fluidized bed coating technology was used to prepare sustained-release pellets with different viscosities of ethyl cellulose as coating materials. The in vitro release was used as an index to optimize the prescription. Results: When the PEG content was 12.8%, the DEP was 22.7% and the weight gain was 21.6%, the cumulative release of pellets was 86.5 compared with the reference release curve, Release curve in line with the first-order kinetic equation. Conclusion: The cumulative release of sustained-release pellets prepared by fluidized bed coating technology meets the release requirements.