粉液双室袋产品的质量控制风险分析及其设计  

The quality risk and R&D of solid-liquid dual-chamber bag products

作　　者：蒋煜[1] 黄晓龙[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2016年第7期733-738,共6页Chinese Journal of New Drugs

摘　　要：自20世纪90年代以来,即配型软袋包装在注射剂中的应用日益广泛。目前多家国内企业已经申报粉液双室袋产品,国家食品药品监督总局也发布了相应的技术指导原则。注射剂是风险程度最高的给药途径之一,粉液双室袋产品涵盖了大容量注射液以及无菌制剂的生产特点,但是生产风险并非二者的简单加和,而是一加一远大于二的关系。本文基于质量源于设计的理念,对粉液双室袋产品的质量风险来源进行了分析。探讨了粉液双室袋产品在设计和生产过程中,需关注的关键因素,以及相应的控制策略。The products of dual-chamber bag infusion are increasingly widespread since the early 1990 s.Some domestic enterprises have applied for this kind of products. The China Food and Drug Administration（ CFDA） already released relevant Guidance in 2015. Infusion is one of the highest risk products among those for different drug administration routes. The dual-chamber bag products amalgamate the characteristics of large volume injections and sterile injections,though,the production risk and the complex degree of the risk control are much higher than the two products each. That means one plus one is far greater than two. The quality risk sources of the dual-chamber bag products were elaborated upon the conception of Quality by design（ Qb D） in this article. The critical factors and control strategy of the design and production process were discussed.

关 键 词：粉液双室袋 风险分析 质量源于设计 

分 类 号：R95[医药卫生—药学]