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。

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.