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.
作者
潘宏华
胡轶娟
PAN Honghua;HU Yijuan(Department of Pharmacy,Zhejiang Provincial Tongde Hospital,Hangzhou 310007,China;Research Center for Medicinal Resources,Zhejiang Institute of Traditional Chinese Medicine,Hangzhou 310012,China)
出处
《中国现代医生》
2018年第34期38-42,170,共6页
China Modern Doctor
基金
浙江省科技计划项目(2017C37065)
作者简介
通讯作者:胡轶娟
