新型载药容器中添加剂及其迁移量测定

Determination of Additives in Drug Loading Container of a Novel Syringe and Migration of Additives

目的建立新型载药容器组件材料中添加剂(抗氧剂1076及锌元素)的含量测定方法,并对添加剂的迁移量进行考察。方法分别采用HPLC法和原子吸收分光光度法测定新型载药容器中抗氧剂1076及锌元素在注射液A和注射液B中的迁移量;对2种测量方法进行方法学验证,并对测定结果进行初步的安全性评估。结果注射液A和注射液B中均未检出抗氧剂1076的迁移,锌元素迁移量分别小于0.2、0.1μg·ml^(-1),不会对人体产生有害影响。结论本文建立的新型注射器载药容器中添加剂的检测方法简便,准确,可用于该容器中抗氧剂1076及锌元素的迁移量检测和质量控制。

Objective To establish a method for determination of additives（ antioxidant 1076 and zinc） in a novel drug loading container used for infusion and to measure the migration quantity. Methods Methods of high performance liquid chromatography and atomic absorption spectrophotometry were used respectively to determine the content of antioxidant 1076 and zinc in drug loading containers and the amount of migration in injection A and injection B. The above two measurement methods were validated by methodology,and medication safety was evaluated. Results There was no leachable antioxidant 1076 that could be detected in injection A or injection B.The leachable zinc was lower than 0. 2 and 0. 1 μg·ml-1in injection A and injection B respectively. There were no harmful effects on the human body. Conclusion The antioxidant 1076 and zinc detection methods established for the novel drug loading container used for infusion is simple,accurate,and applicable to assay of migration quantity and quality control.