节点文献
药用卤化丁基橡胶塞研究进展
Research Progress on Pharmaceutical Halogenated Butyl Rubber Stopper
【摘要】 药用卤化丁基橡胶塞广泛用于冻干粉针剂、注射剂和口服液包装材料中,药包材与药品的相容性和迁移实验对保证药品安全具有重要作用。本文综述近年来国内外关于药用卤化丁基橡胶塞中各可提取物含量和迁移量的分析方法与技术,以及目前药用卤化丁基橡胶塞的质量现状。不同的研究方法和技术对不同可提取物的含量和迁移量的测定,为评价药包材的安全性提供参考。
【Abstract】 Pharmaceutical halogenated butyl rubber stopper is widely used in freeze-dry powder injector, injection and oral liquid medicine packaging materials.The compatibility and migration experiment of medicines plays an important role in guarantee the drug safety. This paper reviewed the analysis methods and techniques of the content and migration of pharmaceutical halogenated butyl rubber stopper at home and abroad, and summarized the current quality situation of pharmaceutical halogenated butyl rubber stopper. Different research methods and techniques for different target determination of the content and the amount of migration provided a reference for evaluation the safety of the medicine packaging material.
【Key words】 pharmaceutical halogenated butyl rubber; compatibility; migration; safety evaluation; review;
- 【文献出处】 广东化工 ,Guangdong Chemical Industry , 编辑部邮箱 ,2022年03期
- 【分类号】TQ333.6
- 【下载频次】11