黄凡士林中邻苯二甲酸酯类塑化剂的迁移情况分析

Analysis of Migration of Phthalate Plasticizers in Yellow Vaseline

目的:了解黄凡士林塑料类包装材料中邻苯二甲酸酯类塑化剂的迁移情况。方法:依据国家标准GB31604.30-2016,采用GC-MS法,以外标法测定50批黄凡士林样品中17种邻苯二甲酸酯类成分的含量。并参照国家标准GB9685-2008中的限度规定对结果进行讨论。结果:50批黄凡士林中有19批检出邻苯二甲酸酯类塑化剂成分,检出的邻苯二甲酸酯类塑化剂成分主要为DEP、DIBP、DBP、DEHP;其中2批黄凡士林DBP、DEHP均超出规定限值(DBP≤0.3 mg·kg^(-1),DEHP≤1.5 mg·kg^(-1)),1批黄凡士林DBP超出规定限值。结论:黄凡士林采用塑料类或橡胶类作为内包装材料,会导致邻苯二甲酸酯类塑化剂迁移,从而可能引起药品制剂的安全风险。

Objective:To understand the migration of phthalate plasticizers in plastics packaging materials.Methods:According to the National Standard GB31604.30-2016 of People’s Republic of China,the contents of 17 phthalate esters in 50 batches of yellow vaseline samples were determined by a GC-MS method with an external standard.The results were discussed with reference to the limits in the National Standard GB9685-2008 of People’s Republic of China.Results:In the 50 batches of yellow vaseline,phthalate plasticizer components were detected out in 19 batches,and the detected phthalate plasticizer components were mainly DEP,DIBP,DBP and DEHP.DBP and DEHP in two batches of yellow vaseline exceeded the prescribed limits(DBP≤0.3 mg·kg^(-1),DEHP≤1.5 mg·kg^(-1)),and DBP in one batch of yellow vaseline exceeded the prescribed limit.Conclusion:The use of plastic or rubber as inner packaging material for yellow vaseline may cause the migration of phthalate plasticizer,which may induce safety risks of pharmaceutical preparation.