Objective: To establish an analytical method for determining the particle size distribution of cross-linked dextran gel microspheres in sodium hyaluronate gel for mucosal filling with a laser particle size analyzer. Methods: Firstly, the samples were enzymatic hydrolysis by hyaluronidase in a water bath, centrifuged, and washed. Finally we obtained precipitates. A Malvern 3000 laser particle size analyzer was used in the condition that the dispersion medium was 500 mL of water, the shading degree was 5%-15%, the pump speed was 1 500 r·min-1, and the sample measurement time and background measurement time were 10 s. Results: The average particle size distribution of D (0.1), D (0.5), and D (0.9) for the 3 batches of samples was 85.1, 124.7, 179 μm, respectively. The measurement results were basically consistent with the measurement results under the fiber morphology analyzer condition. Conclusion: This method is fast, convenient, reliable and good reproducible. It is suitable for the determination of the particle size of cross-linked dextran.
DU Yao-yao, JIANG Xiao-lu, ZHU Jia-ming, HE Du-juan, ZHOU Kui
. Determination of particle size of cross-linked dextran gel microspheres in sodium hyaluronate gel for mucosal filling[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(10)
: 1844
-1850
.
DOI: 10.16155/j.0254-1793.2021.10.23
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