关键词: font-size:medium, ">药品包装材料；金属元素检测技术；常规检测；相容性研究

Abstract: Pharmaceutical packaging materials refer to the packaging materials and containers that are directly in contact with the pharmaceuticals produced by pharmaceutical manufacturers and the preparations made by medical institutions， which are divided into glass， metal， plastic， rubber， pre-filling and other types. Conventional testing of pharmaceutical packaging materials means to supervise the quality of pharmaceutical packaging materials in accordance with the inspection methods and technical requirements stipulated in the national standards for pharmaceutical packaging materials (2015).The compatibility study of drugs is a process to prove that there is no serious interaction between drugs and packaging materials， which leads to changes in drug stability and effectiveness， or safety risks.The quality， safety， performance and compatibility of pharmaceutical packaging materials have important influence on drug quality.The heavy metal elements such as arsenic， mercury， lead and cadmium contained in the pharmaceutical packaging materials may not only cause the drug effect to decrease， but also cause damage to human body because of indigestibility and less-elimination.Strengthening the supervision on the content of metal elements in pharmaceutical packaging materials and improving the detection level of metal elements are not only the objective needs for ensuring drug safety for the public， but also the inevitable requirements of drug consistency evaluation and joint review. Based on conventional detection and compatibility studies， this research reviews the recent detection technology of metal elements in pharmaceutical packaging materials according to the material type，including atomic absorption spectrometry， uv-vis spectrophotometry， colorimetric method， inductively coupled plasma atomic emission spectrometry and inductively coupled plasma mass spectrometry. Besides， the problems encountered in the actual testing are discussed in detail to provide constructive suggestions for the future testing work.

Key words: font-size:medium, ">Pharmaceutical packaging materials；Metal element detection technology； Conventional detection； Compatibility study