硬片中氯乙烯单体和偏二氯乙烯单体测定法国内外比较及优化  

Comparison and optimization of determination methods of vinyl chloride monomer and ethylene dichloride monomer in hard tablet

作　　者：章蔼静 王丹丹 程磊 陈瑜 俞辉 陈悦 ZHANG Aijing;WANG Dandan;CHENG Lei;CHEN Yu;YU Hui;CHEN Yue(Zhejiang Institute for Food and Drug Control,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province,Hangzhou 310052,China)

机构地区：[1]浙江省食品药品检验研究院,浙江省药品接触材料质量控制研究重点实验室,杭州310052

出　　处：《中国药品标准》2022年第4期364-369,共6页Drug Standards of China

基　　金：国家药典委员会药品标准修订研究课题(名称:氯乙烯单体和偏二氯乙烯单体测定法标准提高;编号2020Y10);浙江省药品监管系统科技计划项目(编号2021003)。

摘　　要：目的:比较国内外泡罩包装用硬片中氯乙烯单体和偏二氯乙烯单体残留量测定法的区别,并对国家药包材标准中氯乙烯单体测定法(YBB00142003-2015)和偏二氯乙烯单体测定法(YBB00152003-2015)进行标准提高。方法:采用优化提高后的HS-GC法同时测定硬片中氯乙烯单体和偏二氯乙烯单体残留量。结果:采用内标法和外标法对四批样品中氯乙烯单体和偏二氯乙烯单体测定结果均一致。优化后的氯乙烯单体和偏二氯乙烯单体测定方法中对照品均在0.5~6.0μg范围内呈良好线性关系,r>0.999,平均加样回收率分别为85%和101%。采用内标法和外标法对四批样品中氯乙烯单体和偏二氯乙烯单体测定结果均一致。结论:优化提高后的氯乙烯单体和偏二氯乙烯单体测定法能快速、准确测定硬片中氯乙烯单体和偏二氯乙烯单体残留量,该研究为氯乙烯单体和偏二氯乙烯单体测定法的标准提高以及硬片的质量控制有指导意义。Objective:To compare the difference of determination methods of vinyl chloride monomer and ethylene dichloride monomer in hard tablet blister packing at home and abroad,In order to enhance the standards of vinyl chloride monomer determination(YBB00142003-2015)and ethylene dichloride monomer determination(YBB00152003-2015)in national standards for pharmaceutical packaging materials.Methods:The optimized the method after improvement HS-GC method was used to simultaneously determine the residues of vinyl chloride monomer and ethylene dichloride monomer.Results:The results of determination of vinyl chloride monomer and ethylene dichloride monomer in four batches of samples were consistent by internal standard method and external standard method.The optimized the method after improvement of vinyl chloride monomer and ethylene dichloride monomer has shown good linear relationship within the range of 0.5-6.0μg(r=0.999).The average recoveries were 85% and 101%,respectively.The results of determination of vinylidene chloride monomer and vinylidene chloride monomer in four batches of samples were consistent by internal standard method and external standard method.Conclusion:The optimized determination methods of vinyl chloride monomer and ethylene dichloride monomer can determine the vinyl chloride monomer and ethylene dichloride monomer content quickly and accurately.This study provides guidance for the improvement of the standard of vinyl chloride monomer and ethylene dichloride monomer determination methods and the quality control of the PVC and PVDC packaging materials.

关 键 词：聚氯乙烯 聚偏二氯乙烯 氯乙烯单体 偏二氯乙烯单体 比较 标准提高 

分 类 号：R921.2[医药卫生—药学]