Technical Development, Fresenius Kabi AB, Uppsala, Sweden.
Int J Pharm. 2010 Jun 15;392(1-2):198-200. doi: 10.1016/j.ijpharm.2010.03.045. Epub 2010 Mar 27.
The droplet size distribution of 50 batches of multi-chamber bags containing the parenteral nutrition emulsions Intralipid (Kabiven and Kabiven Peripheral) or Structolipid (StructoKabiven and StructoKabiven Peripheral), respectively, has been investigated. The results show that the non-compounded lipid emulsions analysed are in compliance with the United States Pharmacopeia (USP) chapter 729, Method II limit for the droplet size distribution, PFAT(5)<0.05%.
分别对含有肠外营养乳剂 Intralipid(Kabiven 和 Kabiven Peripheral)或 Structolipid(StructoKabiven 和 StructoKabiven Peripheral)的 50 批多腔袋中的液滴大小分布进行了研究。结果表明,所分析的非复合脂质乳剂符合美国药典(USP)第 729 章方法 II 对液滴大小分布的限制,PFAT(5)<0.05%。