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

作　　者：梅冬雪 杨友剑 刘小丹 王一惠 徐文书 MEI Dongxue;YANG Youjian;LIU Xiaodan;WANG Yihui;XU Wenshu(Dalian Huali Jingang Pharmaceutical Co.,Ltd,Dalian 116000,China)

机构地区：[1]大连华立金港药业有限公司,辽宁大连116000

出　　处：《中国药品标准》2024年第5期489-494,共6页Drug Standards of China

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0.0001~0.1,折射率1.52~1.54;搅拌转速800~1600 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。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 determination of elemene emulsion injection was explored.The test conditions were as follows:shading rate 5%-10%,absorption rate 0.0001-0.1,refractive index1.52-1.54,mixing speed 800-1600 r·min^(-1),balance time 0.5-1 min.After the methodology verification,3 batches of elemene emulsion injection were taken and determined 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 

分 类 号：R921.2[医药卫生—药学]