软袋产品包装密封性阳性样品的制作方法研究  

Positive samples of package sealing integrity for soft bag products

作　　者：蒋芙蓉 汤平 邹松 王显雷 陈超 JIANG Fu-rong;TANG Ping;ZOU Song;WANG Xian-lei;CHEN Chao(Hunan Kelun Pharmaceutical Co.,Ltd.,Yueyang Hunan 414100;Hunan Center for Drug Evaluation and Adverse Drug Reaction Monitoring,Changsha 410013)

机构地区：[1]湖南科伦制药有限公司,湖南岳阳414100 [2]湖南省药品审评与不良反应监测中心,长沙410013

出　　处：《中南药学》2024年第12期3378-3381,共4页Central South Pharmacy

摘　　要：目的 开发一种用于软袋包装密封性阳性样品制作的方法。方法 通过采用在软袋外壁连接电阻,模拟样品渗漏,通过高电压检漏的方法检测,并与传统的毛细管法比较检测结果。结果 模拟电阻法能够将≥10 μm的泄漏100%剔除,使用毛细管制作阳性样品,只能做到30 μm的孔径模拟,模拟电阻法替代阳性样品则可以实现更高的检出灵敏度。结论 模拟电阻法的灵敏度更高,而且阳性样品可以重复使用,更加节约成本。Objective To develop a method to make positive samples of package sealing integrity for soft bag products.Methods We simulated the sample leakage by connecting the resistance on the outer wall of soft bags to determine the leakage with high-voltage leak detection,and compared the results with those of traditional capillary method.Results The simulated resistance method could exclude the leakage bigger than 10 μm completely,while the traditional capillary method could only simulate at 30 μm pore size.The simulated electrical resistance method achieved higher detection sensitivity by replacing the positive samples.Conclusion The simulated electrical resistance method is sensitive,and the positive samples are recycled,which is more cost-effective.

关 键 词：包装密封完整性 高压放电检漏法 阳性样品 

分 类 号：R95[医药卫生—药学]