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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 the determination of additive (antioxidant 1076 and zinc element) in the new drug-carrying container component materials and investigate the migration of additives. Methods The migration amount of antioxidant 1076 and zinc in injection A and injection B were determined respectively by HPLC and atomic absorption spectrophotometry. The two methods were validated by methodology, Results Preliminary safety assessment. Results No migration of anti-oxidant 1076 was detected in injection A and injection B. The migration of zinc was less than 0.2 and 0.1 μg · ml -1 respectively, which would not cause harmful effects on human body. Conclusion The new method developed for the determination of additives in syringe-loaded containers developed in this paper is simple and accurate and can be used for the detection and quality control of the migration of antioxidants 1076 and zinc in the container.