| 引用本文: | 郭燕燕,邱怡婷,张莞英,成婕,王晓兰,黄琬莎,任锟,张小春,胡敏,江燕,蒲小聪.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[J].中国现代应用药学,2025,42(8):64-68. |
| GUO Yanyan,QIU Yiting,ZHANG Wanying,CHENG Jie,WANG Xiaolan,HUANG Wansha,REN Kun,ZHANG Xiaochun,HU Min,JIANG Yan,PU Xiaocong.Study on Container Closure Integrity of Packaging System of Levofloxacin sodium chloride injection by Mass Extraction Method[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(8):64-68. |
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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 |
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郭燕燕, 邱怡婷, 张莞英, 成婕, 王晓兰, 黄琬莎, 任锟, 张小春, 胡敏, 江燕, 蒲小聪
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四川省药品检验研究院
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| 摘要: |
| 摘要：目的 建立了一套完整的质量提取方法，对左氧氟沙星氯化钠注射液（规格：100 mL，氧氟沙星 0.5g 氯化钠 0.9g）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（40±2）℃，相对湿度为（75±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。 |
| 关键词: 质量提取法 左氧氟沙星氯化钠注射液 输液用袋 |
| DOI： |
| 分类号:TB487?????????? ????? |
| 基金项目: |
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| Study on Container Closure Integrity of Packaging System of Levofloxacin sodium chloride injection by Mass Extraction Method |
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GUO Yanyan, QIU Yiting, ZHANG Wanying, CHENG Jie, WANG Xiaolan, HUANG Wansha, REN Kun, ZHANG Xiaochun, HU Min, JIANG Yan, PU Xiaocong
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Sichuan Institute for Drug Control
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| Abstract: |
| ABSTRACT: OBJECTIVE A complete set of quality extraction methods was established,the container-closure integrity of the packaging system of levofloxacin sodium chloride injection (specification: 100 mL, ofloxacin 0.5g sodium chloride 0.9g) was studied. 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 (40±2) ℃, relative humidity is (75±5) %, acceleration conditions: temperature is (40±2) ℃, relative humidity is (75±5) %. RESULTS The detection limit of the method is 5 μm, which is 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. |
| Key words: mass extraction method Levofloxacin sodium chloride injection Infusion bag |
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