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.
关键词
生物制品/防腐剂/安全性/稳定性/质量控制
Key words
Biological products/Preservative/Safety/Stability/Quality control
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