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目的采用国产非PVC五层共挤输液用膜生产输液,并对其可行性进行研究。方法采用国产五层共挤输液用膜生产乳酸左氧氟沙星氯化钠注射液,通过提取试验、迁移试验和吸附试验等考察药品和包装材料的相容性。结果国产五层共挤输液用膜中抗氧剂、金属离子和苯乙烯量符合要求;加速试验条件下乳酸左氧氟沙星氯化钠注射液中抗氧剂、金属离子和苯乙烯量符合要求;吸附试验、稳定性研究和渗透失水率均符合要求。结论使用国产非PVC五层共挤输液用膜能生产出符合质量要求的输液,具有可行性。
Objective To produce infusion of domestic non-PVC five-layer coextrusion infusion membrane and study its feasibility. Methods The domestic five-layer co-extrusion infusion film was used to produce levofloxacin lactate sodium injection. The compatibility of the drug and the packaging material was investigated by extraction test, migration test and adsorption test. Results The contents of antioxidants, metal ions and styrene in the membrane of domestic five-layer coextrusions met the requirements. The amount of antioxidants, metal ions and styrene in the levofloxacin lactate lactate injection satisfied the requirements under the accelerated test conditions. The adsorption test , Stability studies and water loss rate are in line with requirements. Conclusion The use of domestic non-PVC five-layer co-extruded infusion film can produce a line with the quality requirements of the infusion is feasible.