目的 对三层共挤(粉-液)输液用袋与注射用乳糖阿奇霉素和氯化钠注射液的相容性进行相关试验评价。方法 将该无菌药粉装入不同厂家的输液用膜,观察加速试验后的浊度情况;考察包装材料(包括输液用膜和内盖)添加剂在不同酸碱及不同极性介质中的被提取情况;测试输液袋装注射用乳糖酸阿奇霉素和氯化钠注射液有关成分的迁移情况。结果 相比于4种普通膜,专用膜材适用性最好,未发生药液浑浊;试验所用的三层共挤(粉-液)输液用袋膜材和聚丙烯组合盖(拉环式)内盖在不同的提取试验溶液中,均未检出抗氧剂,镁及铝元素含量均小于0.05 μg·mL-1;在迁移物安全性分析中,专用膜袋中所含的各类添加剂的最大迁移值、单日最大摄入值、累计最大摄入值均远低于其毒理学统计数据。结论 三层共挤(粉-液)输液用袋包装所得样品质量稳定,包材迁移和吸附试验符合要求,即输液用袋与本品的相容性良好。
Abstract
OBJECTIVE To evaluate the compatibility of 3-layer coextrusion (powder-liquid) infusion bag with lactose azithromycin powder and sodium chloride injection. METHODS The sterile powder of lactose azithromycin was dispensed in different infusion bags and the turbidities were observed after the accelerated test. The dissolve degree of packaging materials and additives, including infusion membrane and inner cap, in different acid, alkali and polar solvent were studied. The extent of migration of packaging material components into the drugs were researched after the lactose azithromycin powder and sodium chloride injection were dispensed in the 3-layer coextrusion (powder-liquid) infusion bag. RESULTS Compared with the four kinds of common membrane, the membrane material we chosed was the best and the turbidities of liquid were meet the specification. In the extraction studies of different test solution, the antioxidant was not checked out, and the content of both Mg and Al was less than 0.05 μg·mL-1. In the security evaluation of migration, the maximum migration, the biggest one-day intake value and the accumulated maximum intake of additives in the special infusion bag were far lower than its toxicology statistics. CONCLUSION The quality of 3-layer coextrusion (powder-liquid) infusion bag is good. The migration and adsorption degree of of packaging material are tested to make sure the packaging material could ensure the drug quality and stability. The compatibility of 3-layer coextrusion (powder-liquid) infusion bag with drug is nice.
关键词
粉-液双室输液袋 /
三层共挤膜 /
包材相容性 /
注射用乳糖酸阿奇霉素
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Key words
powder-liquid double-chamber infusion bag /
3-layer coextrusion film /
compatibility /
lactose azithromycin powder sodium chloride injection
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中图分类号：
R944
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参考文献
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脚注
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基金
全军后勤科研“十二五”项目(CWS11J198)
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