首页|生物制品中防腐剂的使用和质量控制进展

生物制品中防腐剂的使用和质量控制进展

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生物制品易受污染,常需无菌工艺或防腐剂防控.本文介绍苯甲醇、苯酚、硫柳汞、对羟基苯甲酸甲酯等7种常用防腐剂特性及在胰岛素、疫苗等制品中的使用情况,阐述各国药典对防腐剂使用的规定,探讨防腐剂安全性、与蛋白质相互作用对稳定性的影响及质量控制方法(包括传统方法和HPLC、毛细管电泳法等新方法),总结生物制品单剂量制剂或多剂量制剂的原则,为实际工作中选择防腐剂提供参考.
Progress in the Use and Quality Control of Preservatives in Biological Products
This paper focuses on the issue of preservatives in biological products.Biological products are prone to contamination and often require aseptic processes or preservatives for prevention and control.This paper introduces the characteristics of seven commonly used preservatives such as benzyl alcohol,phenol,thiomersal and methylparaben,as well as their usage in products like insulin and vaccines.It also elaborates on the regulations of various national pharmacopoeias regarding the use of preservatives,and explores the safety of preservatives,the impact of their interaction with proteins on stability,and quality control methods(including traditional methods and new methods such as HPLC and capillary electrophoresis).Finally,it summarizes the principles for single-dose and multi-dose biological products,providing a reference for the selection of preservatives in practice.

Biological productsPreservativeSafetyStabilityQuality control

崔运全、石蓓佳、赵述强、刘梦媛、张文慧、陆益红

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江苏省食品药品监督检验研究院,南京 210019

中国药科大学 药学院,南京 211198

生物制品 防腐剂 安全性 稳定性 质量控制

2024

药学与临床研究
江苏省药学会

药学与临床研究

CSTPCD
影响因子:0.95
ISSN:1673-7806
年,卷(期):2024.32(6)