缓释微丸工艺参数优化中的实证研究

Empirical research on process parameters of buspirone hydrochloride sustained-release pellets

目的以缓释盐酸丁螺环酮微丸为模型,通过实验设计和回归统计的方法筛选和优化其关键生产工艺参数。方法采用实验室型流化床,三因素三水平实验设计,以微丸的1 h、4 h和8 h累积释放度及包衣收率为考察指标,以关键工艺参数喷液压力、喷液速度和进风温度为自变量,建立优化拟合方程进而建立统计模型,并验证方程的准确性,最终通过方程计算最优的工艺参数。结果通过拟合方程获得的工艺参数,可获得释放曲线较为适宜的缓释微丸。结论所建模型具有较好的预测能力和实用性,统计模型的方法可以作为流化床工艺参数优化的一个可供选择的思路。

Objective To select and optimize the key process parameters of buspirone hydrochloride sustained-release pellets by experimental design and regression. Methods A three factor-three level design was used to evaluate the effect of atomizatione pres- sure, spraying rate and inlet air temperature, and the cumulative percent released in 1 h,4 h,8 h and coating yield were designated as dependent variables. A fitting equation was built and verified, and the best parameters were predicted by this analysis. Results Pel- lets with a desirable release action and a higher yield could be acquired through the fitting equation. Conclusion The experimental design and regression could be applied to the optimization of process parameters for fluidized bed processes.