Detection of residual diphenylmethane diisocyanate monomer in a hemodialysis catheter
10.3969/j.issn.2095-4344.0070
- VernacularTitle:血液透析导管中残留单体二苯基甲烷二异氰酸酯的检测
- Author:
Yuan-Li HUANG
1
;
Xue SUN
;
Lin-Nan KE
;
Chun-Ren WANG
Author Information
1. 中国食品药品检定研究院医疗器械所
- From:
Chinese Journal of Tissue Engineering Research
2018;22(6):927-931
- CountryChina
- Language:Chinese
-
Abstract:
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.
