药品塑料包材中邻苯二甲酸酯类增塑剂向药品迁移的规律研究
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摘要
目的建立药品塑料包材中6种塑化剂的检测方法,并研究药品塑料包材中邻苯二甲酸酯类增塑剂向药品迁移的规律。方法分别以水、60%乙醇、3%乙酸溶液、植物油和空白片剂、颗粒剂、胶囊剂模拟液体制剂、固体制剂建立迁移模型。采用气相色谱-质谱联用测定增塑剂的含量,采用加速稳定法研究增塑剂向制剂迁移的规律。结果两种药品塑料包材中检测到DBP和DEHP两种增塑剂残留。药品塑料包材中的增塑剂DBP和DEHP向制剂有不同程度的迁移,其迁移量与制剂剂型、极性、接触时间等相关。结论该方法灵敏度高,准确可靠,能够用于检测药品模拟制剂中增塑剂的迁移量。
Objective To establish a method for detecting six plasticizers in pharmaceutical plastic packaging materials,and to study the law of migration of phathalic acid esters to drugs in pharmaceutical plastic packaging materials.Methods The migration model was established by simulating liquid preparations and solid preparations with water, 60%ethanol, 3% acetic acid solution, vegetable oil and blank tablets, granules and capsules. The content of plasticizer was determined by gas chromatography-mass spectrometry. The accelerated stabilization method was used to study the law of migration of plasticizers to the preparations. Results Two plasticizer residues of DBP and DEHP were detected in the plastic packaging materials of the two drugs. The plasticizers of DBP and DEHP in the pharmaceutical plastic packaging materials showed different degrees of migration to the preparations. The amount of migration was related to the dosage form, polarity, contact time, etc. Conclusion This method is sensitive, accurate and reliable, and can be used to detect the amount of migration of plasticizers in simulated drug preparations.
Objective To establish a method for detecting six plasticizers in pharmaceutical plastic packaging materials,and to study the law of migration of phathalic acid esters to drugs in pharmaceutical plastic packaging materials.Methods The migration model was established by simulating liquid preparations and solid preparations with water, 60%ethanol, 3% acetic acid solution, vegetable oil and blank tablets, granules and capsules. The content of plasticizer was determined by gas chromatography-mass spectrometry. The accelerated stabilization method was used to study the law of migration of plasticizers to the preparations. Results Two plasticizer residues of DBP and DEHP were detected in the plastic packaging materials of the two drugs. The plasticizers of DBP and DEHP in the pharmaceutical plastic packaging materials showed different degrees of migration to the preparations. The amount of migration was related to the dosage form, polarity, contact time, etc. Conclusion This method is sensitive, accurate and reliable, and can be used to detect the amount of migration of plasticizers in simulated drug preparations.
引文
[1]李伟营,纪律,李启,等.黄酒接触材料中增塑剂迁移探讨[J].中国卫生检验杂志,2018,28(1):26-28.
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[8]孙啸涛,刘淼,曾凤鸣,等. QuEChERS结合GC-MS法快速检测酿酒玉米中14种邻苯二甲酸酯类增塑剂[J].食品工业科技,2018,39(8):199-204,209.
[9]李婉莹,赵锦花,蒋世翠,等.气液微萃取技术联用气相色谱-质谱法快速检测包装食品中15种邻苯二甲酸酯[J].食品安全质量检测学报,2017,8(12):4782-4788.
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[11]甘源,覃梅,何岸檐,等.气相色谱-质谱同位素内标法测定瓶桶装饮用水中16种邻苯二甲酸酯[J].中国卫生检验杂志,2017,27(23):3352-3356.
[12]陈泱,沈好文,裘婧,等.气相色谱-质谱联用法检测药品包装用聚氯乙烯类硬片材料中5种邻苯二甲酸酯类增塑剂的研究[J].药物分析杂志,2014,34(9):1650-1653.
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[15]冯振斌,薄天儒,郭美玲.气相色谱-质谱联用法测定胶囊壳中16种邻苯二甲酸酯类增塑剂[J].中国药事,2016,30(7):675-680.
[16]杨国伟,王莉佳,阎安婷.气相色谱-质谱法同时测定藿香正气水中16种邻苯二甲酸酯类化合物残留量[J].临床医药文献电子杂志,2017,4(100):19603-19605.
[17]李舟,蔡小军,向铮. GC-MS同时测定药品及其包装中16种邻苯二甲酸酯类化合物[J].温州医科大学学报,2018,48(2):106-109.
[18]杨梅,廉向金,张亿. UPLC-MS测定薄膜衣片中16种邻苯二甲酸酯类增塑剂[J].中国现代应用药学,2017,34(10):1437-1440.
[19]杨欣,程怡凡,邱涛,等. PVC硬片中邻苯二甲酸二(α-乙基己酯)对药物迁移的研究[J].世界最新医学信息文摘,2017,17(20):94-95.
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[21]孙岩,王振华,杜悦,等.食品包装材料中邻苯二甲酸酯类增塑剂迁移量的测定[J].塑料科技,2014,42(7):84-87.
[2]郑睿行,祝华明,黄立超,等.油茶籽中邻苯二甲酸酯类增塑剂的检测方法及迁移规律的研究[J].粮食与油脂,2015,28(2):66-69.
[3]黄琦,王徽,吕东.常规样品堆积-微乳毛细管电动色谱法检测白酒中邻苯二甲酸酯类增塑剂[J].广州化工,2018,46(7):91-93.
[4]韦航,邹强,林春滢,等.饼干加工过程中6种邻苯二甲酸酯类增塑剂迁移规律研究[J].中国食品学报,2018,18(3):53-58.
[5]周颖,安莹,曾惠琴.基质分散固相萃取-气质联用法测定含油食品中DBP、BBP、DEHP三种增塑剂含量[J].食品与发酵科技,2018,54(1):119-122.
[6]廖燕芝,陈耕,刘璞,等.油茶籽油中邻苯二甲酸酯污染风险来源分析及防范措施研究[J].中国油脂,2018,43(6):90-94.
[7]王磊,王岩,许文超.食用花生油中16种邻苯二甲酸酯类增塑剂的GPS-GC-MS检测方法研究[J].安徽农业科学,2018,46(11):146-148.
[8]孙啸涛,刘淼,曾凤鸣,等. QuEChERS结合GC-MS法快速检测酿酒玉米中14种邻苯二甲酸酯类增塑剂[J].食品工业科技,2018,39(8):199-204,209.
[9]李婉莹,赵锦花,蒋世翠,等.气液微萃取技术联用气相色谱-质谱法快速检测包装食品中15种邻苯二甲酸酯[J].食品安全质量检测学报,2017,8(12):4782-4788.
[10]陆姝欢,柴莎莎,程思,等.气相色谱-质谱法测定微胶囊粉剂中18种邻苯二甲酸酯[J].中国食品添加剂,2017,(12):181-182.
[11]甘源,覃梅,何岸檐,等.气相色谱-质谱同位素内标法测定瓶桶装饮用水中16种邻苯二甲酸酯[J].中国卫生检验杂志,2017,27(23):3352-3356.
[12]陈泱,沈好文,裘婧,等.气相色谱-质谱联用法检测药品包装用聚氯乙烯类硬片材料中5种邻苯二甲酸酯类增塑剂的研究[J].药物分析杂志,2014,34(9):1650-1653.
[13]秦青.聚氯乙烯药品包装材料和容器中邻苯二甲酸酯类增塑剂的监管现状分析[J].中国包装,2016,(4):78-80.
[14]秦青,胡健,杨光.气相色谱法测定聚氯乙烯固体药用硬片中17种邻苯二甲酸酯增塑剂[J].中国包装,2017,(2):51-55.
[15]冯振斌,薄天儒,郭美玲.气相色谱-质谱联用法测定胶囊壳中16种邻苯二甲酸酯类增塑剂[J].中国药事,2016,30(7):675-680.
[16]杨国伟,王莉佳,阎安婷.气相色谱-质谱法同时测定藿香正气水中16种邻苯二甲酸酯类化合物残留量[J].临床医药文献电子杂志,2017,4(100):19603-19605.
[17]李舟,蔡小军,向铮. GC-MS同时测定药品及其包装中16种邻苯二甲酸酯类化合物[J].温州医科大学学报,2018,48(2):106-109.
[18]杨梅,廉向金,张亿. UPLC-MS测定薄膜衣片中16种邻苯二甲酸酯类增塑剂[J].中国现代应用药学,2017,34(10):1437-1440.
[19]杨欣,程怡凡,邱涛,等. PVC硬片中邻苯二甲酸二(α-乙基己酯)对药物迁移的研究[J].世界最新医学信息文摘,2017,17(20):94-95.
[20]国家药典委员会.中华人民共和国药典2015版(第二部)[M].北京:中国医药科技出版社,2015:99.
[21]孙岩,王振华,杜悦,等.食品包装材料中邻苯二甲酸酯类增塑剂迁移量的测定[J].塑料科技,2014,42(7):84-87.