학술논문
血液透析导管中残留单体二苯基甲烷二异氰酸酯的检测 / Detection of residual diphenylmethane diisocyanate monomer in a hemodialysis catheter
Document Type
Academic Journal
Author
Source
中国组织工程研究 / Chinese Journal of Tissue Engineering Research. 22(6):927-931
Subject
Language
Chinese
ISSN
2095-4344
Abstract
背景:目前,含聚氨酯医疗器械的质量控制文件和技术标准中均未明确残留单体二苯基甲烷二异氰酸酯(diphenylmethane diisocyanate,MDI)的控制指标及检测方法,考虑到MDI对人体具有致癌的潜在风险,为控制该类产品的安全有效性,应及早建立质量标准.目的:建立测量血液透析导管中残留单体MDI的测试方法,分析该产品的MDI溶出量对人体是否存在风险.方法:取血液透析导管样品用乙酸乙酯加热回流,采用气相色谱法分析MDI含量.色谱条件为:DB-5 MS色谱柱(30 m×0.25 mm),起始温度60℃,保持5min,然后以15℃/min升至280℃,保持6min;进样口温度280℃;检测器:FID,温度280℃;载气:氦气,99.999％.结果与结论:MDI在4.970-99.40 mg/L(r=0.999 64)范围线性关系良好;平均加标回收率为100.9％,相对标准偏差(RSD)=3.2％(n=6).3批样品的MDI残留量低于可耐受接触量.该方法灵敏、快速、准确、专属性强,可为血液透析导管的质量标准研究提供依据.
BACKGROUND:In the current quality control file or technical standards of the hemodialysis catheter,the indicators of the component contents and detection methods of the residual diphenylmethane diisocyanate (MDI) monomer are undefined.To ensure the safety and effectiveness of these products,we should try to establish and improve the quality standards.OBJECTIVE:To establish a method for determination of the residual MDI monomer in a hemodialysis catheter by gas chromatography (GC),and to analyze the bio-security of the MDI.METHODS:Samples collected in the hemodialysis catheter were heated to reflux with ethyl acetate and the residual MDI content was analyzed by the GC.The GC separation was performed on a DB-5 MS column (30 mx0.25 mm),the temperature of which rose by program.The initial temperature was 60 ℃,maintained for 5 minutes,rose to 280 ℃ with a rate of 15 ℃/min,and maintained for 6 minutes.The temperature of the Injector and FID detector was both 280 ℃.Carrier gas was 99.999％ nitrogen.RESULTS AND CONCLUSION:The linearity was achieved in the range of 4.970-99.40 mg/L (r=0.999 64) for MDI.The mean recovery rate was 100.9％ with the relative standard deviation of 3.2％ (n=6).The residue of MDI monomer in the three batches of samples was lower than the tolerable exposure.Therefore,it is a sensitive,rapid,accurate,specific method that can be used for the quality control of the residual MDI monomer in the hemodialysis catheter.
BACKGROUND:In the current quality control file or technical standards of the hemodialysis catheter,the indicators of the component contents and detection methods of the residual diphenylmethane diisocyanate (MDI) monomer are undefined.To ensure the safety and effectiveness of these products,we should try to establish and improve the quality standards.OBJECTIVE:To establish a method for determination of the residual MDI monomer in a hemodialysis catheter by gas chromatography (GC),and to analyze the bio-security of the MDI.METHODS:Samples collected in the hemodialysis catheter were heated to reflux with ethyl acetate and the residual MDI content was analyzed by the GC.The GC separation was performed on a DB-5 MS column (30 mx0.25 mm),the temperature of which rose by program.The initial temperature was 60 ℃,maintained for 5 minutes,rose to 280 ℃ with a rate of 15 ℃/min,and maintained for 6 minutes.The temperature of the Injector and FID detector was both 280 ℃.Carrier gas was 99.999％ nitrogen.RESULTS AND CONCLUSION:The linearity was achieved in the range of 4.970-99.40 mg/L (r=0.999 64) for MDI.The mean recovery rate was 100.9％ with the relative standard deviation of 3.2％ (n=6).The residue of MDI monomer in the three batches of samples was lower than the tolerable exposure.Therefore,it is a sensitive,rapid,accurate,specific method that can be used for the quality control of the residual MDI monomer in the hemodialysis catheter.