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目的建立新型载药容器组件材料中添加剂(抗氧剂及金属元素)的含量测定方法,并通过提取试验对可提取物进行考察。方法采用欧洲药典项下色谱条件,以甲苯为提取溶剂,利用HPLC法对载药容器的抗氧剂含量进行测定;采用高压蒸汽灭菌器进行提取,利用原子吸收分光光度法对载药容器中的金属元素进行提取量测定,并对2种测量方法进行初步方法学验证。结果氟塑料药液桶和丁基橡胶瓶塞各3批样品均检出锌,3批丁基橡胶瓶塞均检出抗氧剂1076和某未知添加剂;确定该3种物质作为潜在浸出物进行迁移试验考察。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,可用于该容器中添加剂的提取量检测和质量控制。
OBJECTIVE To establish a method for determination of additives (antioxidants and metal elements) in new drug delivery container components and investigate the extractables by extraction test. Methods The chromatographic conditions of the European Pharmacopoeia, toluene as the extraction solvent, the use of HPLC method for the determination of the antioxidant content of the drug-carrying containers; high-pressure steam sterilizer for extraction, the use of atomic absorption spectrophotometry in drug-carrying containers Of the metal element extraction volume determination, and two kinds of measurement methods for preliminary methodological verification. Results Fluorine plastic bucket and butyl rubber stopper all three batches of samples were detected zinc, three batches of butyl rubber stopper were detected antioxidant 1076 and an unknown additive; to determine the three substances as a potential leachate Migration test inspection. Conclusions The new method 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 amount of additives in the container.