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药品包装作为药品直接盛放的载体,与药品直接紧密接触,其安全与否直接关系到人民用药的安全,但又是容易被忽视的质量控制环节。目前,我国的输液软袋全部为非PVC全密闭输液软袋。作为软袋输液产品的包装系统涉及到不同材料的有机组合,主要包括:软袋用薄膜、加药管、输液管和阀(组合盖)组件、胶塞以及印膜和外包装袋,所有这些组成了完整的输液包装系统。本文从膜的生产工艺、胶塞材质、包装设计进行了对比分析,对临床关注的输液安全问题进行汇总,并结合部分省市的药品招标政策,对软袋输液的质量评价提出建议。
Drug packaging, as a direct carrier for pharmaceuticals, is in direct contact with the drug. The safety of the drug packaging is directly related to the safety of people’s drug use, but it is also an easily overlooked quality control link. At present, China’s infusion soft bags are all non-PVC fully sealed infusion soft bags. The packaging system as a soft bag infusion product involves the organic combination of different materials, including: film for soft bags, medicated tube, infusion tube and valve (combination cover) components, rubber stoppers, and film and packaging bags, all of which Formed a complete infusion packaging system. This paper analyzes the production process of the film, the material of the rubber plug, and the packaging design, summarizes the safety concerns of transfusions that are of clinical concern, and proposes suggestions for the quality evaluation of soft bag infusions in conjunction with the drug bidding policies of some provinces and cities.