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《Journal of Beijing University of Chemical Technology》 2004-03
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Optimization of process conditions for preparation ofsalbutamol sulfate ultrafine particles by orthogonal test

Xu Jing 1 Liu Xiao lin 1 Lei Ji xia 1 Chen Jian feng 1 Jimmy Yun 2(1 Research Center of the Ministry of Education for High Gravity Engineering and Technology, Beijing University of Chemical Technology, Beijing 100029, China; 2 Nanoimaterials Technology Pte Ltd, Singapore 139944, Singapore)  
It is well known that ultrafine salbutamol sulfate drug particles have higher bioavaibability than larger particles. A novel reactive precipitation process was used to prepare ultra fine salbutamol sulfate powders. In this work, salbutamol and sulphuric acids were used as reactants and isopropanol was used as a solvent. The effects of the concentration of sulphuric acid, reaction temperature, stirring speed and the reaction time on the particle size and the product yield of ultrafine salbutamol sulfate were investigated by orthogonal test. The ultrafine particles of salbutamol sulfate can be obtained and their particle sizes can be well controlled under following optimized conditions i.e. the sulphuric acid concentration of 1 0?mol/L, reaction temperature of 5?℃, stirring speed of 900?r/min and reaction time of 10?min. The particles are needle shaped, with mean short diameter of 50~60?nm, average aspect ratio of 20~35 and narrow particle size distribution. The product purity is more than 98% and its yield reaches 95 0%. All those characteristics were in accord with Chinese Pharmacopoeia (2002) and B. P. (1993). The operation of the experiment was very simple, and the particles were separated easily.
【Fund】: 国家高技术“ 86 3”研究发展计划项目(2 0 0 1AA2 1 80 6 1 ) ;; 国家自然科学基金项目 (2 0 2 36 0 2 0 ) ;; 中新国际合作项目 (S2 0 0 1 0 3)
【CateGory Index】: TQ46323
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