目的 建立一套完整的质量提取方法，对注射用头孢他啶(规格为15 mL，1.0 g)的包装系统的密封完整性进行研究。方法 通过对阴性对照样品、阴性样品以及阳性样品进行测试，进而优化试验参数，完成系统适用性、检出限以及质量提取法的方法学确认，并对在加速条件下存放的0月、3月、6月的6批样品进行测试。加速条件:温度为(40±2)℃，相对湿度为(75±5)%。结果 该方法的检测限为2 μm，检测灵敏便捷，本品的密封完整性符合要求。结论 质量提取方法可用于顶空无菌包装系统的注射用头孢他啶的密封性研究。

The work aims to establish a complete set of mass extraction method to study the container closure integrity of the packaging system of ceftazidime for injection (specification:15 mL; 1.0 g). The experimental parameters were optimized by testing the negative control samples, negative samples and positive samples to complete system suitability confirmation, detection limit confirmation and methodological confirmation of mass extraction method, and test the 6 batches of samples after storage at acceleration conditions (temperature:40 ℃±2 ℃ and relative humidity 75%±5%)for 0, 3 and 6 months. This method had a detection limit of 2 μm, which was sensitive and convenient and the container enclosure integrity of the product complied with the requirements. The mass extraction method can be used to study the container closure integrity of ceftazidime for injection in the headspace aseptic packaging system.