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Determination of particle size distribution of budesonide suspension for inhalation by laser diffraction method*
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Li XIE, Li SU, Yao XIAO, Rong-qin ZHANG, Ping ZHENG**
Chinese Journal of Pharmaceutical Analysis | 2024, 44(11) : 2004 - 2010
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(11): 2004-2010
• Quality Control •
Determination of particle size distribution of budesonide suspension for inhalation by laser diffraction method*
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Li XIE, Li SU, Yao XIAO, Rong-qin ZHANG, Ping ZHENG**
Affiliations
  • Chengdu Institute for Drug Control,SCMPA Key Laboratory for Quality Research and Control of Chemical Medicine,Chengdu 610041,China
Published: 2024-12-01 doi: 10.16155/j.0254-1793.2023-0812
Outline
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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 1 000 r·min-1,and laser obscurations were 6%-12%.

Results:

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.

Conclusion:

The method is simple,accurate and producible,which is suitable for the particle size detection of budesonide suspension for inhalation.

budesonide  /  suspension  /  laser diffraction method  /  wet determination  /  particle size distribution
谢莉, 粟立, 肖瑶, 张蓉琴, 郑萍. 激光衍射法测定吸入用布地奈德混悬液的粒度分布*. 药物分析杂志, 2024 , 44 (11) : 2004 -2010 . DOI: 10.16155/j.0254-1793.2023-0812
Li XIE, Li SU, Yao XIAO, Rong-qin ZHANG, Ping ZHENG. Determination of particle size distribution of budesonide suspension for inhalation by laser diffraction method*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (11) : 2004 -2010 . DOI: 10.16155/j.0254-1793.2023-0812
Year 2024 volume 44 Issue 11
862
426
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doi: 10.16155/j.0254-1793.2023-0812
  • Receive Date:2023-12-21
  • Online Date:2026-03-18
  • Published:2024-12-01
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  • Received:2023-12-21
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    Chengdu Institute for Drug Control,SCMPA Key Laboratory for Quality Research and Control of Chemical Medicine,Chengdu 610041,China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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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
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