点刻痕玻璃安瓿折断力测试标准比较分析  

Comparison and analysis of the breaking force test standards of one-point-cut ampoules

作　　者：于晓慧 王冬伟 张博 张翔 李文丽 YU Xiaohui;WANG Dongwei;ZHANG Bo;ZHANG Xiang;LI Wenli(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,NMPA Key Laboratory of Quality Control for Pharmaceutical Packaging,Jinan 250101,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院,国家药品监督管理局药品包装材料质量控制重点实验室,济南250101

出　　处：《中国药品标准》2022年第4期370-375,共6页Drug Standards of China

摘　　要：目的:比较分析国内外点刻痕玻璃安瓿折断力测试标准,探讨国内玻璃安瓿折断力性能测试标准的科学合理性,为行业内标准的提高提供参考。方法:对YBB、GB及ISO玻璃安瓿标准中的折断力性能要求及试验方法进行了比对,通过对不同规格及材质的点刻痕安瓿进行折断力测试验证,进一步分析国内外不同标准的适用性和合理性。结果:YBB标准及GB标准规定的折断后断面的测试方法不同,测试结果相差很大,ISO标准并未对断面做出要求,但规定产品要满足的折断力力值较低,验证结果表明折断力力值较低的产品断面合格率较高。结论:ISO标准对药用玻璃安瓿折断力项目的要求更具科学合理性,更能够保证临床玻璃安瓿的使用安全。Objective:To improve the industry standard,the scientific rationality of the breaking force test standard of the one-point-cut ampoule in China was discussed by comparing and analyzing the breaking force test standard both at home and abroad.Methods:Breaking force requirements and test methods in YBB,GB and ISO Standards were compared,furthermore,suitability and rationality of the standards were analyzed by testing breaking force of ampoules of different specifications and materials.Results:YBB and GB standards specified different test methods of breaking surface,and the test results varied a lot.ISO standard did not require the broken surface,however,it specified a lower breaking force.Test results showed ampoules with lower breaking force had higher percent of pass on broken surface.Conclusion:Breaking force requirements in ISO standard are more scientific and rationale,which could ensure the safety of the clinical use of one-point-cut ampoules.

关 键 词：点刻痕安瓿 折断力 标准比较 折断面平整度 试验验证 

分 类 号：R921.2[医药卫生—药学]