药品运输包装的性能测试浅析  

A review on the performance testing for transport packages of pharmaceutical products

作　　者：牛寒冬 连潇嫣 高蕾 王亚敏[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国药科大学学报》2017年第6期751-758,共8页Journal of China Pharmaceutical University

摘　　要：运输包装是以运输储存为主要目的的产品包装,其性能优劣将直接影响货物流通期间的产品质量。药品开发过程中,国内企业往往较为重视内包装的选择与研究,而容易忽视药品流通过程中潜在的运输风险,忽略对运输包装实际性能的有效检测及评价。本文论述了药品运输包装性能测试的必要性,分析对比了国内外药品申报注册的相关现状,并通过介绍药品运输包装的性能测试中的可参考标准,尤其是美国材料与试验协会《运输容器系统性能检测标准规范》(ASTM D4169),以期为药品运输包装的性能测试及评价提供相应思路及参考。The transport packages are primarily developed for transportation and storage,whose capabilities directly affect the product qualities during the circulation.During pharmaceutical development,the domestic pharmacy enterprises tend to put emphasis on the inner packing,but neglect the potential hazard elements in the distribution cycles and performance tests for transport packages of pharmaceutical products,which ultimately result in the disregard of hidden quality peril.This paper analyzes the necessity and significance ofthe performance tests for pharmaceuticals,follow by its domestic and overseas status.And then several testing standards for transport packages,especially ASTM D4169（Standard Practice for Performance Testing of Shipping Containers and Systems）,are introduced in order to provide some suggestions of the performance testing for transport packages of pharmaceutical products.

关 键 词：药品开发 运输包装 性能测试 运输风险 ASTM D4169 

分 类 号：F203[经济管理—国民经济]