北京生物医学工程

离子色谱法测定液体创可贴中的氮含量

Determination of nitrogen content in liquid bandage by ion chromatography

作者：崔永平林红赛黄永富王利霞岳卫华

单位：北京市医疗器械检验所(北京 101111)

关键词：液体创可贴; 氮含量; 离子色谱

分类号：R318

出版年·卷·期（页码）：2020·39·1（86-91）

摘要：

目的建立离子色谱法检测液体创可贴中氮含量的方法，对液体创可贴中氮含量进行准确定量来衡量液体创可贴中硝化棉的投料量，进而间接衡量液体创可贴的成膜性、硬度、附着力等性能。方法用DIONX ICS-1100离子色谱仪进行检测，色谱柱AS9-HC柱（4 mm×250 mm），淋洗液为5.0 mmol/L对羟基苯甲酸和5.3 mmol/L N,N-二乙基乙醇胺混合液，流速1 mL/min，电导检测器，外标法定量，用不同浓度梯度的亚硝酸根离子对照品和不同浓度梯度的硝酸根离子对照品分别绘制工作曲线，分别分析不同浓度的亚硝酸根离子和硝酸根离子的出峰时间和峰面积，选取A医疗器械厂家的液体创可贴产品为待测样品，最后将待测样品消解后与对照品平行的进行样品处理并检测。结果亚硝酸根离子在浓度2.999 8~6.999 5 mg/mL范围内与峰面积保持良好的线性关系（r=0.999 0），检出限为0.149 99 mg/mL（S/N=3），精密度RSD：1.62%（n=5），平均加标回收率为99.9%（n=9）；硝酸根离子在浓度1.7015~3.9701 mg/mL范围内与峰面积保持良好的线性关系（r=0.9999），检出限为0.085 07 mg/mL（S/N=3），精密度RSD：1.48%（（n=5），平均加标回收率为100.9%（n=9），最后对测试样本测试的结果进行计算得出测试样本中氮的平均含量为11.24 mg/g。结论该方法具备良好的线性范围、准确度高、重复性好，样品经过前处理后，不受样品中其他组分的干扰，可用于液体创可贴中氮含量的测定。

Objective To establish a method for determination of nitrogen content in liquid bandage by Ion Chromatography. The nitrogen content in the liquid bandage was accurately quantified to measure the amount of nitrocotton in the liquid bandage, and then the film formation, hardness, adhesion and other properties of the liquid bandage were indirectly measured. Methods DIONX ICS-1100 ion chromatograph equipped with AS9-HC column (4 mm×250 mm) and a conductivity detector was used to detect. The eluant was mixture of 5.0mmol/L phydroxybenzoic acid and 5.3mmol/L N,N-Diethylethanolamine with flow rate 1mL/min. and quantified by external standard method. With different concentration gradient of nitrite ion concentration gradient of the reference substance and the different of nitrate ions working curve drawing reference substance respectively, analyzed the different concentrations of nitrite ion and nitrate ion peak time and peak area, selected A bandage products for medical equipment manufacturer liquid sample under test, the final would be under test sample digestion with reference substance after parallel sample processing and testing. Results The linear range of NO2- was 2.999 8 mg/mL to 6.999 5 mg/mL(r=0.999 0). The limit of quantitation was 0.149 99mg/mL（S/N=3）.The precision RSD was 1.62% (n=5). And the average recovery was 99.9% (n=9). The linear range of NO3- was 1.701 5 mg/mL to 3.970 1 mg/mL (r=0.999 9).The limit of quantitation was 0.08507mg/mL（S/N=3）The precision RSD was 1.48%（n=5）. And the average recovery was 100.9%（n=9）. The average nitrogen content in the test sample was 11.24 mg/g. Conclusions The method has good linear range, high accuracy and good repeatability. The sample is not disturbed by the other components in the sample after the sample is treated. Therefore the method can be used for the determination of nitrogen content in liquid bandage.

参考文献：

[1] Choi SJ, Lee JH, Lee YH, et al. Synthesis and propertiesofpolyurethane-urea-based liquid bandage materials[J]. Journal of Applied Polymer Science, 2011,121(6): 3516-3524.

[2] Devinder MT. Recent advances in topical therapy in dermatology[J]. Indian Journal of Dermatology, 2003, 48(1): 5019-5154.

[3] R Petkewich.Liquid Bandages[J].Chemical＆Engineering News,2008,86(27):61-62.

[4] 国家食品药品监督管理总局.医疗器械分类目录（6864 医用卫生材料及敷料）[EB/OL]. (2017-8-3) ).[ 2018-08-01]. http://www.nmpa.gov.cn/WS04/CL2138/300389.html.

[5]国家食品药品监督管理总局.医疗器械分类规则（国家食品药品监督管理总局令第15号).[EB/OL].(2015-06-03).[2016-01-01]. http://samr.cfda.gov.cn/WS01/CL0053/124222.html.

[6] 石杰, 马海鸣, 王瑞勇, 等.流动注射化学发光法测定过氧亚硝酸根的研究[J].光谱实验室, 2011, 28(1): 192-195.

Shi J, Ma HM, Wang RY, et al. Determination of peroxynitrite by flow injection chemiluminescence[J]. Chinese Journal of Spectroscopy Laboratory, 2011, 28(1): 192-195.

[7] 田大民,刘向云,李晓,等.可见分光光度法测定酸腌菜中亚硝酸根的含量[J]. 安徽农业科学, 2010, 38(10): 5312-5314.

Tian DM, Liu XY, Li X, et al. Visible spectrophotometric determination of nitrite in sour pickles[J]. Journal of Anhui Agriculture Sciences, 2010, 38(10): 5312-5314.

[8] 胡浩光,王耀,谢翠美, 等.连续流动分析法测定环境水样中痕量亚硝酸盐[J].现代仪器, 2010(6): 68-70.

Hu HG, Wang Y, Xie CM, et al. Determination nitrite in environmental water samples by continuous flowing analysis[J]. Modern Instruments, 2010(6): 68-70.

[9] 冯珍鸽,蔡慧农,王力,等.腌制食品中亚硝酸盐的电化学检测[J].中国食品学报,2011,11(2):192-196.

Feng ZG, Cai HN ,Wang L, et al. Determination of nitrite in pickled food by electrochemical method [J]. Journal of Chinese Institute of Food Science and Technology, 2011, 11(2):192-196.

服务与反馈：

【文章下载】【加入收藏】

提示：您还未登录，请登录！点此登录