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    质量提取法对于左氧氟沙星氯化钠注射液包装系统的密封性研究

    Study on Container Closure Integrity of Packaging System of Levofloxacin Sodium Chloride Injection by Mass Extraction Method

      摘要
    • 摘要:
      目的 建立一套完整的质量提取方法，对左氧氟沙星氯化钠注射液的包装系统的密封性进行研究。
      方法  通过对阴性样品、阴性对照样品、大漏样品进行测试，优化预抽真空、检测大漏样品、微漏样品的时间试验参数，完成方法学确认，并对存放的0月样品、加速3月样品、加速6月样品以及长期6月、长期12月、长期24月样品的3批样品进行密封性测试。长期条件：温度为(25±2)℃，相对湿度为(40±5)%；加速条件：温度为(40±2)℃，相对湿度为(75±5)%。
      结果 该方法检测限为5 μm，检测方便灵敏，且本品的密封性符合要求。
      结论 该方法可用于三层共挤输液用袋包装系统的左氧氟沙星氯化钠注射液密封性研究。

       

      Abstract:
      OBJECTIVE To establish a complete set of quality extraction methods, and study the container-closure integrity of the packaging system of levofloxacin sodium chloride injection.
      METHODS  By testing negative samples, negative control samples, and large leakage samples, optimize the time test parameters of pre-vacuuming, detecting large leakage samples and micro-leakage samples, complete methodological validation, three batches of stored samples of 0, 3, 6 month and long-term samples of 6, 12, 24 month were tested for container-closure integrity. Long-term conditions: temperature is (25±2)℃, relative humidity is (40±5)%; acceleration conditions: temperature is (40±2)℃, relative humidity is (75±5)%.
      RESULTS  The detection limit of the method was 5 μm, which was convenient and sensitive, and the sealing property of the product meets the requirements.
      CONCLUSION  The method can be used to study the sealing property of levofloxacin sodium chloride injection in three-layer co-extruded infusion bag packaging system.

       

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