碳酸氢钠注射液非PVC袋包装研究  

Study on Non-PVC Bag Packaging of Sodium Bicarbonate Injection

作　　者：王丽丽 吴连文 赵海英 刘达飞 仙雯 WANG Lili;WU Lianwen;ZHAO Haiying;LIU Dafei;XIAN Wen(China Resources Double-Crane Pharmaceutical Co.,Ltd.,Beijing 100121,China)

机构地区：[1]华润双鹤药业股份有限公司,北京100121

出　　处：《山东化工》2024年第23期46-49,共4页Shandong Chemical Industry

摘　　要：目的:筛选碳酸氢钠注射液非PVC袋装的包装材料组合,确定外包生产工艺操作和中间产品存放时限,实现产品规模化生产。方法:通过对不同pH值药液灭菌前后,中间产品室温存放48 h,加速试验稳定性考察等因素或条件下,考察关键质量属性(外观、pH值、失水率)的变化情况。结果:由三层共挤输液用袋C袋和高阻隔外袋Y袋组成包装系统,外袋包装工艺为灭菌后真空外包工艺,对关键工艺步骤的中间产品明确存放时限,保证产品稳定性(相容性)和密封性。结论:按筛选的包装材料及生产工艺制成的碳酸氢钠注射液非PVC袋包装系统,可实现规模化商业化生产,储存期内产品质量稳定可控。Objective:To choose the packaging material combination of sodium bicarbonate injection non-PVC bag,determine the outsourcing production process operation and the storage time limit of intermediate products,and realize the large-scale production of products.Methods:The changes of critical quality attributes(appearance,pH value,water loss rate)were investigated by factors or conditions such as the storage of intermediate products at room temperature for 48 hours before and after sterilization of different pH value liquids,and the accelerated test stability investigation.Results:The packaging system consists of a three-layer co-extruded infusion bag C bag and a high barrier outer bag Y bag.The outer bag packaging process is a vacuum outsourcing process after sterilization.The storage time limit of the intermediate products in the critical process steps is clearly defined to ensure the stability(compatibility)and sealing of the product.Conclusion:The non-PVC bag packaging system of sodium bicarbonate injection made according to the selected packaging materials and production process can realize large-scale commercial production,and the product quality is stable and controllable during the storage period.

关 键 词：碳酸氢钠注射液 非PVC袋 高阻隔外袋 存放时限 PH值 失水率 

分 类 号：TQ460.69[化学工程—制药化工] R944.1[医药卫生—药剂学]