上海市中药代煎用包装膜材中邻苯二甲酸酯类塑化剂含量的调查与分析

Investigation and analysis on content of phthalic acid esters plasticizer in traditional Chinese medicine decoction packaging film materials in Shanghai

目的:调查和分析上海市中药代煎行业中药代煎用塑料包装膜材中邻苯二甲酸酯类(PAEs)塑化剂的含量及临床风险。方法:采用随机抽样调查法抽取上海市中药代煎服务公司共30批次的中药代煎包装膜材,采用气质联用法(GC-MS)检测中药代煎包装膜材中PAEs的含量。结果:各成分在0.01~5.00 mg/L范围内线性关系良好,相关系数>0.998,检出限为0.002 mg/L。根据相关法规,30批中药代煎包装膜材中,PAEs含量的合格率仅为20%,主要原因是邻苯二甲酸二(2-乙基)己酯、邻苯二甲酸二正丁酯、邻苯二甲酸二异丁酯等含量超标。结论:该GC-MS法符合检测PAEs塑化剂的要求。上海市中药代煎行业中部分中药煎液包装膜材中PAEs含量存在超标现象,给代煎药的质量和服药患者的健康带来了隐患,期望相关部门加强和规范对中药代煎行业塑料包装膜材的监管。

Objective:To investigate and analyze the content of phthalic acid esters(PAEs)in traditional Chinese medicine(TCM)decoction packaging film materials in Shanghai.Methods:A total of 30 batches of packaging film materials were selected from Shanghai TCM decoction service companies by random sampling survey method.Then the content of PAEs in TCM decocting packaging film was determined by gas chromatography-mass spectrometry(GC-MS).Results:The linear range of each component was 0.01~5.00 mg/L,between which the linear relationship was good.The correlation coefficient was>0.998,and the detection limit was 0.002 mg/L.The standard curve and correlation coefficient showed a good linear relationship from 0.01 to 5.00 mg/L,the correlation coefficient was>0.998,the detection limit was 0.002 mg/L.According to the relevant regulations,the qualified rate of PAEs content in 30 batches of TCM decoction packaging film was only 20%.The main reason was that the content of bis(2-ethylhexyl)phthalate,dibutyl phthalate,diisobutyl phthalate and other PAEs exceed the standard.Conclusion:The GC-MS method meets the requirement for determining PAES plasticizer.The content of PAEs in some packaging film materials of TCM decoctions exceeds the standard in Shanghai,which brings hidden dangers to the quality of the decoctions and the health of the patients.It is expected that the relevant departments should strengthen and standardize the supervision of plastic packaging film materials in TCM decoction industry.