北京生物医学工程2025，Vol.44Issue(3)：290-295,6.DOI:10.3969/j.issn.1002-3208.2025.03.011
GC-MS/MS法测定动物源性补片中未知可沥滤物研究
Research on the determination of unknown leachable substances in animal-derived patches by GC-MS/MS
摘要
Abstract
Objective With the increase of adverse events caused by leachable substances,the residual leachable substances in animal-derived patches,which are absorbable materials for human body,have the risk of inducing diseases.Therefore,a method for the determination of leachable substances in animal-derived patches is established by using gas chromatography-triple quadrupole mass spectrometry(GC-MS/MS),and its allowable limit is preliminarily established.Methods Using acetone as the solvent,leachable substances in 10 different types of animal-derived patches were extracted by ultrasonic treatment at 37℃for 30 minutes.The leachable substances were detected by GC-MS/MS after filtration,and the quantification was performed using an external standard method.Results Two leachable substances were detected in the extract,which were identified as 2,2′-methylenebis-(4-methyl-6-tert-butylphenol)(antioxidant 2246)and 1,4-butanediol diglycidyl(BDDE).The calibration curves of the two had good linear relationships in the ranges of 0.10-5.25 μg/mL and 0.11-5.45 μg/mL,with the correlation coefficients(r)of 0.9996 for both.At the low,medium,and high spiked levels,the recoveries of antioxidant 2246 and BDDE were 102.24%-111.58%and 91.21%-112.20%,with relative standard deviations(RSDs)of 0.62%-1.25%and 0.59%-1.12%.The limits of detection(LODs)were 0.027 μg/mL and 0.006 μg/mL,and the limits of quantification(LOQs)were 0.093 μg/mL and 0.020 μg/mL.The allowable limit(AL)of antioxidant 2264 was 84 mg/d for adult males and 69.6 mg/d for adult females.The AL of BDDE was 21mg/d for adult males and 17.4mg/d for adult females.The safety of margin(MOS)for both was much greater than 1,unacceptable health risks had very low possibility.Conclusions The animal-derived patch leachable analysis method established in this article can determine the type and content of leachable substances.It can help improve the quality evaluation system of animal-derived patches,and have important value for the development of medical field.关键词
动物源性补片/可沥滤物/气相色谱-三重四极杆质谱/浸提/允许限量Key words
animal-derived patches/leachable substances/gas chromatography-triple quadrupole mass spectrometry/extraction/allow limited quantity分类
医药卫生引用本文复制引用
郭采妮,刘璟,张玉龙,丁黎,付步芳..GC-MS/MS法测定动物源性补片中未知可沥滤物研究[J].北京生物医学工程,2025,44(3):290-295,6.基金项目
国家重点研发计划(专项)(2017YFC1105000)资助 （专项）
