首页|榄香烯乳状注射液粒度测定方法的研究

榄香烯乳状注射液粒度测定方法的研究

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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。
Investigation on the particle size determination method of elemene emulsion injection
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.

particle size distributionlight scattering technologyelemeneelemene emulsion injectionshading ratemicroscopic observation

梅冬雪、杨友剑、刘小丹、王一惠、徐文书

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大连华立金港药业有限公司,辽宁大连 116000

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

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
年,卷(期):2024.25(5)