高压放电法检测玻璃安瓿密封性及其影响因素分析  

Package Integrity Test of Glass Ampoules and Its Influencing Factors by High-Voltage Leak Detection Method

作　　者：李小伟 雷秀丽 胡佳音 李辉 LI Xiaowei;LEI Xiuli;HU Jiayin;LI Hui(Xi'an Libang Pharmaceutical Co.,Ltd.,Xi'an,Shaanxi,China 710075;Shaanxi Shengde Tellin Biosafety Technology Testing Co.,Ltd.,Xi'an,Shaanxi,China 710077)

机构地区：[1]西安力邦制药有限公司,陕西西安710075 [2]陕西盛德泰林生物安全技术检测有限公司,陕西西安710077

出　　处：《中国药业》2024年第17期91-95,共5页China Pharmaceuticals

基　　金：陕西省科技计划项目[2023-CX-PT-42]。

摘　　要：目的探讨高压放电法检测玻璃安瓿密封性的影响因素。方法通过高压放电法的方法学考察及影响因素试验,分析包装中的药液,安瓿的材质、厚度、外观,空气湿度与样品表面水分对检测结果的影响。结果该方法的准确度为100%,重复性和中间精密度试验结果的RSD均小于10%,检测限为3.573µm,耐用性良好。影响因素试验中,5种药液、2类安瓿的材质(低硼硅玻璃、中硼硅玻璃)对检测结果无显著影响,而安瓿的厚度、外观及空气湿度与样品表面水分均对电流值有不同程度影响。结论高压放电法用于玻璃安瓿包装系统密封性检测试验时应关注安瓿厚度、安瓿外观、空气湿度、样品表面水分等因素对电流测定结果的影响,以提高该方法的准确性。Objective To investigate the factors affecting the package integrity of glass ampoules by high-voltage discharge method.Methods The effects of the liquid in the package,ampoule material,ampoule thickness,ampoule appearance,air humidity,and surface moisture of samples on the detection results were analyzed through methodological investigation and influencing factor experiments by using high-voltage discharge method.Results The accuracy of the method was 100%,and the RSDs of repeatability and intermediate precision test results were lower than 10%.The limit of detection(LOD)was 3.573µm,and the durability was good.In the influencing factor experiment,five kinds of liquid medicine and two kinds of ampoule material(low-borosilicate glass,medium-borosilicate glass)had no significant effect on the detection results,while the thickness,appearance,air humidity,and surface moisture of samples had different degrees of influence on the current value.Conclusion When using high-voltage discharge method for the package integrity test of glass ampoule,attention should be paid to the influence of ampoule thickness,ampoule appearance,air humidity,surface moisture of samples and other factors on the detection results of the current,in order to improve the accuracy of the method.

关 键 词：包装系统密封性 高压放电法 玻璃安瓿 小容量注射剂 

分 类 号：R955[医药卫生—药学]