凝胶渗透色谱-激光光散射联用法检测医用壳聚糖类产品稳定性

Determination of stability of medical chitosan products by gel permeation chromatography and laser light scattering

选取作为Ⅲ类医疗器械管理的4种医用壳聚糖类产品,当其有效期内在自然条件下存放于货架时,利用凝胶渗透色谱-激光光散射联用法跟踪检测其相对分子质量及其分布,以此来评价其产品的稳定性。以0.1 mol/L NaNO_(3)(含质量分数为2×10^(-4) NaN_(3))为流动相,选择Shodex SB806、SB805、SB804与保护柱串联进行分析。三种产品医用几丁糖、外科手术用防粘连冲洗液、医用防粘连改性壳聚糖(膜)的相对分子质量变化均小于38%,相对重均分子质量均维持在1.0×10~5及以上,壳聚糖基可吸收止血非织布相对分子质量降至9.3×10~4,减小90%以上。

Four kinds of medical chitosan products for Class Ⅲ medical devices management were selected,and the molecular weight and distribution of their shelf life were tracked and detected to evaluate the stability of their products.The molecular weight and its distribution were determined by gel permeation chromatography and laser light scattering.0.1 mol/L NaNO_(3) (with 2×10~(-4 )NaN_3) was selected as the mobile phase,and Shodex SB806,SB805,SB804 together with protective columns were selected in series for analysis.The molecular weight changes of the three products such as medical chitosan,surgical anti-adhesion rinsing solution,medical anti-adhesion modified chitosan (membrane) were less than 38%,and the weight average molecular weight of the three products was 1.0×10~5 or above.The molecular weight of chitosan group absorbable hemostatic nonwoven fabric was reduced to 9.3×10~4,and was reduced by more than 90%.