国产非PVC五层共挤输液用膜生产输液的可行性研究

Feasibility Study on the Infusion Packaged with Domestic Non-PVC 5-layers Co-extruded Film

关键词:  国产非PVC五层共挤输液用膜  相容性  提取试验  迁移试验  吸附试验

Key words:  domestic non-PVC 5-layers co-extruded film  compatibility  extraction test  migration test  adsorption test

摘要:

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。

Abstract:

OBJECTIVE To prepare the infusion packaged with domestic non-PVC 5-layers co-extruded film and perform feasibility study. METHODS The levofloxacin lactate and sodium chloride infusion packaged with domestic 5-layers co-extruded film was prepared, the compatibility between the drug products and packaging materials was performed by extraction test, migration test and adsorption test etc. RESULTS The content of antioxidant, metal ions and styrene in domestic 5-layers co-extruded film conformed to the requirements. The content of antioxidant, metal ions and styrene in levofloxacin lactate and sodium chloride infusion met the requirements under the accelerated testing condition. The results of adsorption test, stability test and water loss on permeation met the requirements. CONCLUSION It is feasible that the infusion packaged with domestic non-PVC 5-layers co-extruded film can be produced and meet the requirements.