湖北省药包材监督抽验情况分析

On Surveillance and Sampling Inspection of Pharmaceutical Packaging Materials in Hubei Province

目的:对湖北省4年来的药包材质量监督抽验情况进行分析探讨。方法:按照国家食品药品监督管理局颁布的《直接接触药品的包装材料和容器标准汇编》,重点对所抽验样品的鉴别、红外光谱、透湿、透氧、正己烷不挥发物、溶剂残留量等项目进行检测。结果与结论:2012-2015年,湖北省药包材的抽验合格率逐年提高,药包材监督抽验是有效的监管手段,对提高药包材整体质量有促进作用。

Objective： To analyze and study the results of the quality monitoring and sampling inspection of drug packaging materials and containers in Hubei Province in the last 4 years. Methods： Items including identification, infrared spectrum, water vapor transmission, oxygen transmission, n-hexane nonvolatile matter, and residual organic solvents were tested according to Quality Standards Compilation for Drug Packaging Materials and Containers issued by China Food and Drug Administration. Results and Conclusion： The qualified rates of the samples gradually increased from 2012 to 2015. The supervision sampling of pharmaceutical packaging is an effective regulatory means, and it can promote the overall quality levels of drug packaging materials.