新型大输液药物包装医用高分子复合膜的研究

Research On A New Type Macromolecule Multi - layer Film For The Intravenous Medical Solution Packaging

目的研制新型药液包装医用复合膜材料。方法根据大输液包装的技术要求,设计研究复合膜的结构、配方和生产工艺,对其进行理化及生物学实验和检测,并对药液的包装方式和安全性进行了初步探讨和论证。结果研制出新型的药液包装医用复合膜,经检测所有性能指标达到或超过国家标准,在国家药品监督管理局组织的成果鉴定和专题验收中认定为科技成果,并已经转让。结论本项研究可望改变我国临床大输液方式和药液包装材料的现状,替代进口医用软包装复合膜材料,且具有较好的经济和社会效益。

Object Developing a new type multi- layer film material for medical liquid packaging. Methods According to the technical request of intravenous medical solution packaging, the configuration, prescription and production technique of the multi - layer film were studied and designed and the physical, chemical and biological features were tested and measured.In addition, the packaging style and safety had been probed into and demonstrated elementarily.Results The new type multi - layer film for intravenous medical solution packaging has been created whose performance and features reached The National Standards after examination. Morever the multi - layer film had been recognized as scientific and technological product after the production appraisement and special topic approval orgnized by the Govemmet Medicine Supervisory Bureau, and had been conveyed.Conclusions It is expected, in our country, that the actuality of the clinical infusion mode and the solution packaging material will be changed. This new type multi - layer film material can substitute the imported, and bring preferable social and economic benefits.