吸入用返魂草素干粉微粒制备工艺的优化研究

杨晓波，袭荣刚，王晓波

中国药学杂志 ›› 2016, Vol. 51 ›› Issue (14) : 1241-1244.

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中国药学杂志
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中国药学杂志 ›› 2016, Vol. 51 ›› Issue (14) : 1241-1244. DOI: 10.11669/cpj.2016.14.019
论著

吸入用返魂草素干粉微粒制备工艺的优化研究

  • 杨晓波1，2，袭荣刚2，王晓波2*
作者信息 +

Optimization for Preparation Process of Fanhuncaoin Dry Powder for Inhalation

  • YANG Xiao-bo1,2, XI Rong-gang2, WANG Xiao-bo2*
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摘要

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 kPa、供液速度9.1 mL·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2.92 μm，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。

Abstract

OBJECTIVE To optimize the preparation process conditions of fanhuncaoin dry powder for inhalation by orthogonal design. METHODS Fanhuncaoin dry powder was prepared by spray-drying method. Following spray-drying, particle size analysis was performed by laser diffraction. Resultant powders were characterized using scanning electron microscopy. The aerosolisation performance was determined using twin-stage liquid impinger. And moisture content was examined by thermogravimetric analysis. The preparation process conditions were optimized with orthogonal design combined with multi-index test. The powder yield, aerodynamic diameter, moisture content and respirable fraction were used as indices for orthogonal design. RESULTS The results of optimized process parameters were confirmed with atomization pressure of 210 kPa, feed flow rate of 9.1 mL·min-1, aspiration speed of 0.6 m3·min-1 and inlet temperature of 130 ℃. As a result,51.19% yield, 2.92 μm aerodynamic diameter,4.18% moisture content and 54.45% respirable fraction are obtained by the optimal process conditions. CONCLUSION Orthogonal design combined with multi-index test can be used to optimize the preparation process of fanhuncaoin dry powder for inhalation.

关键词

返魂草素 / 干粉吸入剂 / 正交设计 / 多指标综合评价法

Key words

fanhuncaoin / dry powder inhalation / orthogonal design / multi-index test

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杨晓波，袭荣刚，王晓波. 吸入用返魂草素干粉微粒制备工艺的优化研究[J]. 中国药学杂志, 2016, 51(14): 1241-1244 https://doi.org/10.11669/cpj.2016.14.019
YANG Xiao-bo, XI Rong-gang, WANG Xiao-bo. Optimization for Preparation Process of Fanhuncaoin Dry Powder for Inhalation[J]. Chinese Pharmaceutical Journal, 2016, 51(14): 1241-1244 https://doi.org/10.11669/cpj.2016.14.019
中图分类号： R944   

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