人血白蛋白注射液包装系统密封完整性研究  

Study on the sealing integrity of packaging system for human albumin injection

作　　者：张鹏 熊巍 李文丽 张静 许凯 ZHANG Peng;XIONG Wei;LI Wen-li;ZHANG Jing;XU Kai(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging Materials,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：《药物分析杂志》2025年第2期275-279,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立人血白蛋白注射液注射剂瓶包装系统密封完整性的研究方法。方法:针对人血白蛋白注射液注射剂瓶包装系统,采用玻璃微量移液管制备了1μm阳性对照样品,采用激光打孔制备了2、5和10μm的阳性对照样品。使用真空衰减法和高压放电法2种确定性的密封完整性测试方法进行方法参数开发和测试。结果:真空衰减法因人血白蛋白药物制剂堵塞漏孔,不能有效检测出灌装人血白蛋白的注射剂瓶包装阳性对照样品的泄漏;高压放电法可有效避免因药液堵塞漏孔而无法检出泄漏。高压放电法测试电压为9 kV,阈值为15 W,经方法学验证表明,高压放电法具备良好的重复性、中间精密度、准确度和耐用性,泄漏检测限为1μm。结论:高压放电法可作为人血白蛋白注射液注射剂瓶包装系统密封完整性的有效考察手段,操作简单,结果真实可靠,且对包装无损,适合商业化产品的包装系统密封完整性检查。Objective:To establish the research method for the sealing integrity of the injection bottle packaging system for human albumin injection.Methods:For the injection bottle packaging system of human albumin injection,positive control samples with pore diameter of 1μm were prepared using a glass micropipette,positive control samples with pore diameter of 2,5 and 10μm were prepared using laser drilling.Two deterministic sealing integrity testing methods,vacuum decay method and high-voltage leak detection method were developed and tested.Results:The vacum decay method could not effectively detect the leakage of the packaging system for the human albumin drug preparation due to the blockage of the leakage hole.In contrast,the high voltage leak detection method effectively avoided undetected leakage caused by the blockage of the leakage hole by the liquid medicine.The test voltage was set at 9 kV,with a threshold of 15 W.Method validation demonstrated that the high voltage leak detection method exhibited good repeatability,intermediate precision,accuracy,and durability,with a leakage detection limit of 1μm.Conclusion:The high-voltage leak detection method can serve as an effective means of inspecting the sealing integrity of the injection bottle packaging system for human albumin injection.The procedure is straightforward,and the results are both accurate and reliable,while also being non-destructive to the packaging.This method is well-suited for the sealing integrity inspection of commercial product packaging systems.

关 键 词：高压放电法 注射剂瓶包装系统 真空衰减法 密封完整性 人血白蛋白注射液 漏孔堵塞 检测限 

分 类 号：R917[医药卫生—药物分析学]