黏膜填充用修饰透明质酸钠凝胶中交联葡聚糖凝胶微球粒度的测定  

Determination of particle size of cross-linked dextran gel microspheres in sodium hyaluronate gel for mucosal filling

作　　者：杜瑶瑶 姜晓路 朱佳铭 何杜鹃 周奎 DU Yao-yao;JIANG Xiao-lu;ZHU Jia-ming;HE Du-juan;ZHOU Kui(Hangzhou Singclean Medical Products Co.,Ltd,Hangzhou 310018,China;Zhejiang Institute of Medical Device Testing,Hangzhou 310018,China)

机构地区：[1]杭州协合医疗用品有限公司,杭州310018 [2]浙江省医疗器械检验研究院,杭州310018

出　　处：《药物分析杂志》2021年第10期1844-1850,共7页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立采用激光粒度仪测定黏膜填充用修饰透明质酸钠凝胶中交联葡聚糖凝胶微球粒度的测定方法。方法:样品先通过玻璃酸酶酶解,离心洗涤,得沉淀物。采用马尔文3000激光粒度仪,分散介质水500 mL,遮光度为5%~15%,泵转速为1500 r·min^(-1),样品测量时间和背景测量时间为10 s。结果:3批样品中交联葡聚糖粒度分布特征D(0.1)、D(0.5)、D(0.9)平均值分别是85.1、124.7、179μm,测定结果和纤维形态分析仪下的测定结果基本吻合。结论:本法快速、方便、可靠,重现性好,适用于交联葡聚糖凝胶微球粒度的测定。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 1500 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 85.1,124.7,179μm,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.

关 键 词：透明质酸纳凝胶 交联葡聚糖 粒度 激光粒度仪 酶解 

分 类 号：R917[医药卫生—药物分析学]