IC Determination of Diglycolic Acid in Chitosan Medical Devices
摘 要
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16 mmol·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 2~10.02 mg·L-1内与其对应的峰面积呈线性关系,检出限(3S/N)为0.02 mg·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。
Abstract
IC was applied to the determination of diglycolic acid in chitosan medical devices. Centrifugal ultrafiltration was used to remove the chitosan 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.
中图分类号 O652.63 DOI 10.11973/lhjy-hx201811006
所属栏目 工作简报
基金项目 山东省重点研发计划(2016GSF201213)
收稿日期 2018/1/2
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备注许凯,工程师,主要从事医用高分子材料安全性能评价等方面的研究工作,xk021402173@126.com
引用该论文: XU Kai,MENG Kai,ZHAO Changshuai,QIN Dongli,LI Kefang,LIU Chenghu. IC Determination of Diglycolic Acid in Chitosan Medical Devices[J]. Physical Testing and Chemical Analysis part B:Chemical Analysis, 2018, 54(11): 1264~1267
许凯,孟凯,赵长帅,秦冬立,李克芳,刘成虎. 离子色谱法测定壳聚糖类医疗器械中二甘醇酸[J]. 理化检验-化学分册, 2018, 54(11): 1264~1267
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参考文献
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【2】SHIROKOVA L N, ALEXANDROVA V A. Radiation-chemical synthesis of silver nanoparticles in carboxymethyl chitin[J]. Doklady Physical Chemistry, 2015,464(2):234-237.
【3】任玲玲,祁欣,莫洪波.凝胶色谱-光散射联用法对壳聚糖及其产品的分子质量及分布的测量[J].分析测试学报, 2010,29(1):35-38.
【4】余慧,梁淑彩,钟海迪,等.新型壳聚糖荧光纳米粒的制备及pH敏感性能研究[J].分析化学, 2011,39(3):409-413.
【5】YU M M, JIANG T F, WANG Y H, et al. Identification and analysis of an impurity inducing clinical adverse effect in anti-adhesion carboxymethyl chitosan products[J]. Journal of Pharmaceutical and Biomedical Analysis, 2013,85:21-27.
【6】ROSCHER A A, JUSSEK E, NOGUCHI T, et al. Fatal accidental diglycolic acid intoxication[J]. Toxicologic Pathology, 1975,3(4):3-13.
【7】BESENHOFER L M, MCLAREN M C, LATIMER B, et al. Role of tissue metabolite accumulation in the renal toxicity of diethylene glycol[J]. Toxicological Sciences:An Official Journal of the Society of Toxicology, 2011,123(2):374-383.
【8】MUNLEY S M, KENNEDY G L, HURTT M E. Developmental toxicity study of glycolic acid in rats[J]. Drug & Chemical Toxicology, 1999,22(4):569-582.
【9】SILBERGELD S. Observations on the accumulation of oxalate in kidney following the oral administration of glycolica acid[J]. Toxicology & Applied Pharmacology, 1960,2(2):220-224.
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