中国药品标准2024,Vol.25Issue(5) :489-494.DOI:10.19778/j.chp.2024.05.010

榄香烯乳状注射液粒度测定方法的研究

Investigation on the particle size determination method of elemene emulsion injection

梅冬雪 杨友剑 刘小丹 王一惠 徐文书
中国药品标准2024,Vol.25Issue(5) :489-494.DOI:10.19778/j.chp.2024.05.010

榄香烯乳状注射液粒度测定方法的研究

Investigation on the particle size determination method of elemene emulsion injection

梅冬雪 1杨友剑 1刘小丹 1王一惠 1徐文书1
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作者信息

  • 1. 大连华立金港药业有限公司,辽宁大连 116000
  • 折叠

摘要

目的:用激光散射法测定榄香烯乳状注射液粒度分布,考察不同试验条件对结果的影响.方法:将摸索出的榄香烯乳状注射液粒度测定的方法-测定条件:遮光率5%~10%,吸收率0.000 1~0.1,折射率1.52~1.54;搅拌转速800~1 600 r·min-1,平衡时间0.5~1 min进行方法学验证,取3批榄香烯乳状注射液,在Bettersize2600激光粒度分布仪(湿法)上进行测定.结果:3批样品测定结果:d(0.1)、d(0.5)、d(0.9)、d(0.99)分别为 252、251、213,354、351、316 nm,543、532、476 nm,979、953、887 nm.结论:本试验方法可用于测定榄香烯乳状注射液的粒度分布,结果重现性好.

Abstract

Objective:To investigate the influence of different test conditions on the particle size distribution of elemene emulsion injection measured by laser light scattering method.Methods:The method of particle size deter-mination of elemene emulsion injection was explored.The test conditions were as follows:shading rate 5%-10%,absorption rate 0.000 1-0.1,refractive index1.52-1.54,mixing speed 800-1 600 r·min-1,balance time 0.5-1 min.After the methodology verification,3 batches of elemene emulsion injection were taken and deter-mined on the Bettersize 2600 laser particle size distribution instrument(wet method).Results:Measurement results of 3 batches of samples:d(0.1),d(0.5),d(0.9),d(0.99)were 252,251,213 nm;354,351,316 nm;543,532,476 nm;979,953,887 nm.Conclusion:This test method can be used to determine the particle size distribution of elemene emulsion injection with good reproducibility.

关键词

粒度分布/光散射技术/榄香烯/榄香烯乳状注射液/遮光率/显微观察

Key words

particle size distribution/light scattering technology/elemene/elemene emulsion injection/shading rate/microscopic observation

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出版年

2024
中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
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