摘要
目的:研究复方氨基酸注射液(20AA)在非PVC五层共挤膜软袋包装基础上,另加外阻隔袋内置抗氧剂并抽真空封口包装条件下的稳定性。方法:根据《药物稳定性研究指导原则》和复方氨基酸注射液(20AA)的质量标准,对样品进行光照试验、加速试验和长期试验。结果与结论:复方氨基酸注射液(20AA)在非PVC五层共挤膜软袋包装基础上,另加外阻隔袋内置抗氧剂并抽真空封口包装条件下,与非PVC五层共挤膜软袋包装比较,其性状、透光率、含量明显改善,但p H值有所下降。
Objective： To study the stability of the compound amino acid injection （20AA） in the non PVC five-layer coextrusion film soft bag packaging, combined with external vacuum sealed barrier bag containing antioxidants. Methods： According to the Drug Stability Research Guidelines and quality standards of the compound amino acid injection （20AA）, the samples were subjected to light tests, accelerated tests and long- term tests. Results and Conclusion： The compound amino acid injection （20AA） in the non PVC five-layer coextrusion film soft bag packaging, combined with external vacuum sealed barrier bag containing antioxidants, were obviously improved in its characteristics, light transmittance and content while decreased in its pH value, compared with that only in the non PVC five-layer coextrusion film soft bag packaging.
出处
《中国药事》
CAS
2017年第5期542-549,共8页
Chinese Pharmaceutical Affairs
基金
军队医疗机构制剂标准单品种研究课题计划-复方氨基酸注射液标准研究(编号14TG0529)
关键词
氨基酸注射液
非PVC药包材
光照试验
加速试验
阻隔袋
药物稳定性
amino acid injection
non PVC drug packaging material
light test
accelerated test
barrier bag
drug stability
