| 国产非PVC五层共挤输液用膜生产输液的可行性研究 |
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| 引用本文： | 孟玉芳. 国产非PVC五层共挤输液用膜生产输液的可行性研究[J]. 中国现代应用药学, 2016, 33(4): 455-460. |
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| 作者姓名： | 孟玉芳 |
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| 作者单位： | 1.浙江医药股份有限公司新昌制药厂，浙江 新昌 312500 |
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| 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。
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| 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 |
| 收稿时间： | 2015-10-01 |
| 修稿时间： | 2016-01-01 |
Feasibility Study on the Infusion Packaged with Domestic Non-PVC 5-layers Co-extruded Film |
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| MENG Yufang. Feasibility Study on the Infusion Packaged with Domestic Non-PVC 5-layers Co-extruded Film[J]. Chinese Journal of Modern Applied Pharmacy, 2016, 33(4): 455-460. |
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| Authors: | MENG Yufang |
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| Affiliation: | 1.Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical, Xinchang 312500, China |
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| 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. |
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| Keywords: | domestic non-PVC 5-layers co-extruded film compatibility extraction test migration test adsorption test |
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