Investigation on the particle size determination method of elemene emulsion injection
10.19778/j.chp.2024.05.010
- VernacularTitle:榄香烯乳状注射液粒度测定方法的研究
- Author:
Dongxue MEI
1
;
Youjian YANG
;
Xiaodan LIU
;
Yihui WANG
;
Wenshu XU
Author Information
1. 大连华立金港药业有限公司,辽宁大连 116000
- Keywords:
particle size distribution;
light scattering technology;
elemene;
elemene emulsion injection;
shading rate;
microscopic observation
- From:
Drug Standards of China
2024;25(5):489-494
- CountryChina
- Language:Chinese
-
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.