多剂量胰岛素制剂中防腐剂使用的考量  

Consideration for preservative usage in multi-dose insulin formulations

作　　者：赵靖 白玉[1] 罗建辉[1] 程速远 ZHAO Jing;BAI Yu;LUO Jian-hui;CHENG Su-yuan(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国新药杂志》2019年第23期2814-2817,共4页Chinese Journal of New Drugs

摘　　要：多剂量注射剂中通常使用防腐剂来防止患者在多次使用制剂过程中的微生物污染。酚类防腐剂作为最常用防腐剂被广泛用于胰岛素及其他多剂量生物制剂中。但在使用这类防腐剂过程中,除了考量防止微生物污染的作用之外,还需关注其对于生物分子高级结构的稳定作用以及对患者注射部位造成的副反应。本文结合当前生物制品申报资料中酚类防腐剂使用存在的问题,以多剂量胰岛素制剂为例,从防腐剂的使用、相关法规规定,制剂处方研究、稳定性研究等方面提出基于目前认知下的防腐剂使用的研究建议,旨在为多剂量生物制品中防腐剂的使用研究提供参考。Preservatives are commonly used in multi-dose formulation to prevent microbial contamination during multiple use.Antiseptic phenols,as the most commonly used preservative,have been widely used in insulin and other multi-dose biological formulations.However,for the used preservatives,besides the role of preventing microbial contamination,attention should also be paid to their stabilization of the biological molecule structures and the side effect on the local injection sites of the patients.Combining the problems of antiseptic phenols using in biological product regulatory submission,the use of preservatives,relevant regulations,formulation research and stability research of multi-dose insulin formulation were discussed in this article based on the existing cognitive in order to provide reference for the use of preservatives in multi-dose biological products.

关 键 词：多剂量制剂 生物制品 胰岛素 酚类防腐剂 抑菌效力 

分 类 号：R95[医药卫生—药学]