离子色谱法测定壳聚糖类医疗器械中二甘醇酸

IC Determination of Diglycolic Acid in Chitosan Medical Devices

采用离子色谱法测定壳聚糖类医疗器械中二甘醇酸的含量。通过超滤离心法去除样品中的壳聚糖大分子,以16mmol·L^(-1)氢氧化钾溶液为淋洗液,采用抑制型电导检测器测定。二甘醇酸的质量浓度在0.100 2～10.02mg·L^(-1)内与其对应的峰面积呈线性关系,检出限(3S/N)为0.02mg·L^(-1)。加标回收率为92.2%～101%,测定值的相对标准偏差(n=6)为0.28%～3.3%。毒理学分析及安全性评价的结果表明:壳聚糖类医疗器械中二甘醇酸的含量未达到人体的可耐受接触量,因此不会对人体产生危害。

IC was applied to the determination of diglycolic acid in chitosan medical devices. Centrifugal ultrafiltration was used to remove the ehitosan macromolecules in the samples. 16 mmol · L^-1 KOH solution was used as eluant, and restraining conductance detector was used in determination. Linear relationship between values of peak area and mass concentration of diglycolic acid was kept in the range of 0. 100 2- 10.02 mg· L^- 1 with detection limit （3S/N） of 0.02 mg · L^-1. Values of recovery found by standard addition method were in the range of 92.2 %- 101 %, and values of RSDs （n = 6） were in the range of 0.28 %- 3.3 %. The results of toxicological analysis and safety evaluation showed that the content of diglycolic acid in the chitosan medical devices did not reach the tolerance of the human body and it would not cause harm to the human body.