预灌封注射器中硅油使蛋白药物产生不溶性微粒问题的探讨  

Discussion on Insoluble Particles of Protein Drugs Caused by Silicone Oil in Prefilled Syringes

作　　者：侯晴晴 张毅兰[1] HOU Qingqing;ZHANG Yilan(CFDA Research and Inspection Center of Pharmaceutical Packaging Materials, Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, Shanghai 201203)

机构地区：[1]中国医药工业研究总院上海医药工业研究院,国家食品药品监督管理总局药品包装材料科研检验中心,上海201203

出　　处：《中国医药工业杂志》2018年第6期730-736,共7页Chinese Journal of Pharmaceuticals

摘　　要：预灌封注射器(PFS)作为包装和给药双重功能的产品,凭借自身的优势,在生物药物领域的应用越来越广泛。PFS在发展的同时,其作为包装材料也面临着一些挑战。PFS各组合件与药物发生相互作用的可能性很大,特别是作为润滑剂的硅油与生物药物之间存在相容性问题。硅油会迁移至注射液中形成不溶性硅油滴,也可能引起蛋白质药物的聚集、增加不溶性微粒等问题。本文综述了PFS的发展、PFS常用的硅化技术、硅油引起的不溶性微粒问题及其解决方案等方面的研究进展。As packaging and delivery system combined products, pre-filled syringes（PFS） are becoming increasingly popular in the field of biopharmaceutical products for their own advantages. However, the development of biopharmaceutical products in PFS presents its own distinctive challenges. The components of the PFS are likely to interact with the drug, in particular, issues involving incompatibility with silicone oil which often be used as a lubricant. Silicone oil will migrate into injection to form droplets, which may induce aggregation of protein, resulting the formation of insoluble particles and other issues. Therefore, this paper reviews the development of PFSs, the siliconization technology for PFSs, the insoluble particles caused by silicone oil and the solutions to this matter.

关 键 词：预灌封注射器 生物药物 硅油 不溶性微粒 综述 

分 类 号：R944.11[医药卫生—药剂学]