新型载药容器中添加剂的提取试验研究  

Extraction of Additives in Drug Loading Container of a Novel Syringe

作　　者：王文刚[1] 吴艳[1] 暴铱[1] 耿铮[1] 孙建绪[2] 郑爱萍[2] 武向峰[1] 

机构地区：[1]总后勤部卫生部药品仪器检验所,北京100166 [2]军事医学科学院毒物药物研究所,北京100850

出　　处：《解放军药学学报》2016年第3期215-218,242,共5页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：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 the additives （antioxidants and metallic elements） in a novel drug loading container used for infusion and to inspect the extractable contents. Methods With methylbenzene as the extraction solvent, high performance liquid chromatography was used for antioxidant content determination in drug loading containers under the European Pharmacopoeia chromatographic conditions. A high-pressure steam sterilizer was used to extract the samples and atomic absorption spectrophotometry was used for determination of metallic element contents in drug loading containers. The above two measurement methods were validated by methodology. Results After testing, zinc was detected in 3 batches of fluorine plastic liquid medicine barrels and 3 batches of butyl rubber stoppers respectively. Antioxidant 1076 and another undefined additive were detected in 3 batches of butyl rubber stoppers. Three types of additives were identified as potential extracts for further migration test. Conclusion This additive detection method established for the novel drug loading container used for infusion is simple, accurate, and applicable to assay of extractable contents and quality control.

关 键 词：载药容器 抗氧剂 金属元素 添加剂 

分 类 号：R917[医药卫生—药物分析学]