江燕,任锟,冯霞兰,张莞英,郭宏伟,赵代国.荧光剂–示踪液体法检查滴眼剂包装密封完整性[J].包装工程,2023,44(11):293-298.
JIANG Yan,REN Kun,FENG Xia-lan,ZHANG Wan-ying,GUO Hong-wei,ZHAO Dai-guo.Closure Integrity of Eye Drops Packaging System by the Fluorescence-Tracer Liquid Method[J].Packaging Engineering,2023,44(11):293-298. |
| 荧光剂–示踪液体法检查滴眼剂包装密封完整性 |
| Closure Integrity of Eye Drops Packaging System by the Fluorescence-Tracer Liquid Method |
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| DOI：10.19554/j.cnki.1001-3563.2023.11.034 |
| 中文关键词: 荧光剂 示踪液体法 滴眼剂 密封完整性 |
| 英文关键词: fluorescence tracer liquid method eye drops closure integrity |
| 基金项目:四川省科技重点研发项目(2021YFG0089) |
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| 中文摘要: |
| 目的 建立一种荧光剂–示踪液体法检查利巴韦林滴眼液包装系统的密封完整性，为滴眼剂产品包装密封完整性验证提供通用廉价的方案。方法 以罗丹明B为示踪剂，采用高效液相色谱–荧光检测器法进行检测，评价利巴韦林滴眼液货架期的密封性，以及模拟临床开启后的密封性。结果 此方法可准确检测包装材料中发生的5 μm孔径泄漏，检测限级别达到《化学药品注射剂包装系统密封性研究技术指南》(试行)中的3级，能有效评价利巴韦林滴眼液包装系统的密封完整性。结论 该方法的通用性强、灵敏度高，可为滴眼剂产品包装系统密封完整性检查提供技术支持。 |
| 英文摘要: |
| The work aims to establish a fluorescence-tracer liquid method to test the closure integrity of ribavirin eye drops packaging system, and provide a universal and cheap scheme for the closure integrity verification of eye drops packaging. With Rhodamine B as the tracer, high performance liquid chromatography-fluorescence detector was used to test and evaluate the sealability of ribavirin eye drops during shelf life and after simulated clinical opening. The method could accurately detect 5 μm aperture leakage in packaging materials, and the detection limit level was up to level 3 in "Technical Guide for Sealing Research of Packaging System for Chemical Injection" (For Trial Implementation), and effectively evaluate the closure integrity of packaging system for ribavirin eye drops. The method has strong versatility and high sensitivity, which can provide technical support for testing the closure integrity of eye drops packaging. |
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