回顾分析药品包装材料阻隔性测定能力验证保障药品质量安全  

Retrospective Analysis of Barrier Property Proficiency Testing Projects of Pharmaceutical Packaging Materials to Ensure Drug Quality and Safety

作　　者：谢兰桂[1] 赵萌 项新华[1] 孙会敏[1] 赵霞[1] 肖新月[1] Xie Langui;Zhao Meng;Xiang Xinhua;Sun Huimin;Zhao Xia;Xiao Xinyue(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Phannaceutical Excipients,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院药用辅料质量研究与评价重点实验室,北京100050

出　　处：《中国药事》2021年第11期1225-1231,共7页Chinese Pharmaceutical Affairs

基　　金：中国食品药品检定研究院学科带头人培养基金项目(编号2017X2)。

摘　　要：目的:对2017-2020年开展的4次药包材阻隔性测定能力验证项目实施情况和数据进行回顾分析,确证各实验室在药包材阻隔性测定方面存在溯源不一致的问题,通过统一实验室的溯源物质和规范实验操作,实现测试数据的统一,促进药包材行业更好地服务于药品质量安全。方法:按照ISO/IEC17043实施4次能力验证计划,对参与实验室的能力给予评价,以描述性统计方法分析各实验室检测能力情况。结果:全国有30个省、自治区、直辖市的65家实验室累计147次参加能力验证活动,其中129次为满意,4次为可疑,14次为不满意。4次能力验证活动的满意率分别为92%、78%、94%和91%,每次活动中都有实验室出现可疑或不满意结果,原因集中在未使用统一的国家标准溯源物质。结论:药包材阻隔性的准确测定直接影响对药品包装在药品全生命周期内保护性能的准确评估。在能力验证活动中推进国家标准溯源物质的应用、规范实验操作,不仅有利于促进行业数据的统一,提升药包材及相关实验室的检测能力,更为药品生产企业选择合适药包材产品、保障药品质量提供准确的参考数据。Objective: Through the review and analysis of the implementation status and data of the four times of proficiency testing projects on the barrier property measurement of packaging materials from 2017 to 2020, to identify the inconsistent traceability issues in the barrier property measurement of packaging materials in various laboratories. By unifying the trace materials in the laboratory and standardizing the experimental operation,the test data could be unified, and the pharmaceutical packaging industry could be promoted to ensure the drug quality and safety. Methods: According to ISO/IEC17043, the proficiency testing projects have been carried out four times. The ability of participating laboratories was evaluated by descriptive statistical methods which were used to analyze the testing ability of each laboratory. Results: Sixty-five laboratories in 30 provinces, autonomous regions and municipalities were involved in 147 activities, 129 of which were satisfactory, 4 were suspicious and 14 were unsatisfactory. The satisfaction rates of the four competency verification activities were 92%, 78%, 94% and 91%, respectively. In each activity, there were laboratories with suspicious or unsatisfactory results, which is mainly attribute to the fact that the unified national standard traceability materials were not used. Conclusion:Accurate measurement of barrier property of packaging material could directly affect the accurate evaluation of protective performance of drug packaging in the whole life cycle of drugs. Promoting the application of national standard traceability materials and standardizing experimental operation in the ability verification activities will not only promote the unification of industry data, but also improve the detection ability of related laboratories, and provide accurate reference data for pharmaceutical manufacturers so as to select suitable packaging materials and ensure drug quality.

关 键 词：药包材 阻隔性能 氧气透过量 水蒸气透过量 能力验证 标准物质 

分 类 号：R95[医药卫生—药学]