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目的优化返魂草素干粉吸入剂的制备工艺。方法采用喷雾干燥技术制备返魂草素干粉吸入剂,利用激光粒度测定仪测定粒径大小,扫描电镜观察干粉的表观形貌,双层液体碰撞装置测定其体外肺沉积率,热重分析仪测定干粉的水分含量。以产品收率、粉末的空气动力学粒径、水分含量及体外肺沉积率为考察指标,通过正交设计法优化制备工艺。结果通过正交试验-多指标综合评价,最佳制备工艺为:喷雾压力210 k Pa、供液速度9.1 m L·min-1、干燥风速0.6 m3·min-1、入口温度130℃。按最佳制备工艺制得的干粉收率为51.19%,空气动力学粒径为2.92μm,水分含量为4.18%,体外肺沉积率为54.45%。结论正交试验结合多指标综合评价法用于返魂草素干粉吸入剂制备工艺的优化有效可用。
Objective To optimize the preparation process of resorcinol dry powder inhaler. Methods Respiramycin dry powder inhaler was prepared by spray drying technique. The particle size was determined by laser particle sizer. The apparent morphology of dry powder was observed by scanning electron microscopy. The lung deposition rate was measured by double liquid collision device. Determination of the moisture content of dry powder. The product yield, the aerodynamic size of the powder, the moisture content and the rate of lung deposition in vitro were used as indexes to optimize the preparation process by orthogonal design. The results of orthogonal test - a comprehensive evaluation of multiple indicators, the best preparation process: spray pressure 210 kPa, liquid speed 9.1 m L · min-1, drying wind speed 0.6 m3 · min-1, inlet temperature 130 ℃. The best dry powder yield was 51.19%, the aerodynamic diameter was 2.92μm, the moisture content was 4.18%, and the lung deposition rate in vitro was 54.45%. Conclusion Orthogonal test combined with the multi-index comprehensive evaluation method is suitable for the optimization of the preparation process of rehmannia root dry powder inhaler.