激光衍射法测定吸入用布地奈德混悬液的粒度分布

Determination of particle size distribution of budesonide suspension for inhalation by laser diffraction method

目的:建立激光衍射法用于测定吸入用布地奈德混悬液的粒度分布。方法:采用Mastersizer 3000激光粒度分析仪和Hydro SV型湿法进样器,样品超声混匀后立即注入样品池,折射率为1.592,吸收率为0.01,分散介质为0.5%吐温-80的布地奈德饱和溶液,其折射率为1.33,搅拌速率为1000 r·min^(-1),遮光度为6%~12%。结果:方法学精密度考察结果D50的RSD小于2.0%,D_(10)和D_(90)的RSD均小于5.0%;3批吸入用布地奈德混悬液粒度分布的D_(90)均小于5μm。结论:该方法操作简便,准确度高,重复性好,适用于吸入用布地奈德混悬液的粒度分布测定。

Objective:To establish a laser diffraction method for the determination of particle size distribution of budesonide suspension for inhalation.Methods:The Master sizer 3000 laser size analyzer with the Hydro SV wet sampler was used.The sample solution should be immediately measured after ultrasonication.The measurement conditions were as follows:refractive index of budesonide was 1.592,absorbency of budesonide was 0.01,dispersing medium was saturated solution of budesonide containing 0.5%Tween 80 with refractive index of 1.33,stirring rate was 1000 r·min^(-1),and laser obscurations were 6%-12%.Results:RSD of D_(50)was lower than 2%,RSDs of D_(10)and D_(90)were both lower than 5%.The particle size distribution D_(90)values of 3 batches of budesonide suspension for inhalation were less than 5μm.Conclusion:The method is simple,accurate and producible,which is suitable for the particle size detection of budesonide suspension for inhalation.