To establish a laser diffraction method for the determination of particle size distribution of budesonide suspension for inhalation.
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 1 000 r·min-1,and laser obscurations were 6%-12%.
RSD of D50 was lower than 2%,RSDs of D10 and D90 were both lower than 5%.The particle size distribution D90 values of 3 batches of budesonide suspension for inhalation were less than 5 μm.
The method is simple,accurate and producible,which is suitable for the particle size detection of budesonide suspension for inhalation.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |