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药品包装材料中铝材机械性能测试方法比较研究

Comparative study on test methods of mechanical properties of aluminum used in pharmaceutical packaging materials
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摘要 目的:结合目前的检测技术和方法,探索药品包装材料铝材延伸率和抗拉强度的准确的检测手段,为今后检测工作提供参考,以及下一步的标准制修订提供依据。方法:本实验采用了传统检测方法和引伸计检测方法,其中引伸计检测包括接触式电阻式引伸计检测和非接触式视频引伸计检测。结果:通过实验过程和数据发现,三种检测方法当中,视频引伸计对延伸率和拉伸强度的检测,数据结果精度高、数值分布均匀,重复性好,而传统检测方法存在人为误差,电阻式引伸计检测对于引伸计的精度和灵敏度要求较高,数据精度则是置于前二种检测方法之间。结论:通过数据结果总结分析,视频引伸计检测方法由于检测结果精度高,误差小,重复性好,可作为药品包装材料铝材物理机械性能项目的最佳检测方法,但由于其设备价格昂贵,目前各实验室无法普及推广使用,因此建议作为仲裁法采用。 Objective:To explore the accurate detection methods for the elongation and tensile strength of aluminum packaging materials for pharmaceuticals in combination with current detection technologies and methods,to provide a reference for future inspections,and to provide a basis for the next standard development and revision.Methods:The traditional detection method and extensometer detection method were used in this experiment.The extensometer detection includes contact resistance extensometer detection and non contact video extensometer detection.Results:Through the experimental process and data,it is found that among the three detection methods,the video extensometer detects the elongation and tensile strength.The data results have high accuracy,uniform numerical distribution,and good repeatability.The traditional detection methods have human error and resistance.The extensometer detection requires higher accuracy and sensitivity of the extensometer,and the data accuracy is placed between the first two detection methods.Conclusion:Based on the summary analysis of the data results,the video extensometer detection method can be used as the best detection method for the physical and mechanical properties of pharmaceutical packaging materials due to the high accuracy,small error,and good repeatability.The laboratory cannot be popularized,so it is recommended to be adopted as an arbitration law.
作者 马晓彬 马林玉 任永斌 王丽 胡云 翁稚颖 MA Xiaobin;MA Linyu;REN Yongbin;WANG Li;HU Yun;WENG Zhiying(Yunnan Institute of Medical Device Testing,Kunming 650106,China;Kunming Medical University,Kunming 650500,China;Yunnan Baiyao Group Co.,Ltd,Kunming 650500,China;Kunming Pharmaceutical Co.,Ltd,Kunming 650100,China)
出处 《中国药品标准》 CAS 2020年第3期244-248,共5页 Drug Standards of China
基金 昆明医科大学生创新创业示范工程中心J1301307434。
关键词 药用铝材 引伸计 抗拉强度 延伸率 检测方法 pharmaceutical package aluminum extensometer tensile strength elongation rate test method
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