复方氨基酸注射液.pdfVIP

542 中国药事 2017 年 5 月 第 31 卷 第 5 期 ·技术研究 · 复方氨基酸注射液（20AA）包装材料改进及其稳 定性的研究 * 张庆明，张平，陈美惠，孙志伟，苏华，曹燕丽 （南京军区 南京 总 医院， 南 京 210002） 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 pH 值有所下降。 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 中图分类号：R954 文献标识码：A 文章编号： 1002-7777(2017)05-0542-08 doi:10.16153/j.1002-7777.2017.05.014 Study on the Improvement and Stability of Packaging Materials for Compound Amino Acid Injection (20AA) * Zhang Qingming, Zhang Ping, Chen Meihui, Sun Zhiwei, Su Hua, Cao Yanli (Nanjing General Hospital, Nanjing 210002, China) Abstract 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. Keywords amino acid injection; non PVC drug packaging material; light test; accelerated test; barrier bag; drug ： stability 复方氨基酸注射液（20AA）是我院黎介寿院