作为常用的脱毒剂或灭活剂,甲醛能与蛋白质的氨基或巯基间形成稳定且不可逆的连接,进而导致蛋白失活被广泛应用于类毒素疫苗、病毒灭活疫苗等各类疫苗产品的生产工艺中。另一方面,历史上由于对病毒灭活不完全导致的惨剧,也在时刻提醒研究人员对于生产工艺中甲醛使用的安全性和有效性予以充分的重视。本文从甲醛应用实例、生产工艺及安全控制要点和甲醛使用的局限性3个方面,对目前甲醛在疫苗产品生产中的使用进行综述,以期为该类产品的开发提供一定参考。
Abstract
As a commonly used detoxifying agent or inactivating agent,formaldehyde can form a stable and irreversible connection with the amino or sulfhydryl group of protein,and then lead to protein inactivation,so it is widely used in the manufacturing process of various vaccine products,such as toxoid vaccine and virus inactivated vaccine.On the other hand,the tragedies caused by incomplete virus inactivation in history also remind researchers to pay full attention to the safety and effectiveness of formaldehyde in the manufacturing process.This paper summarizes the current use of formaldehyde in the manufacturing process of vaccine products from three aspects: formaldehyde application examples,manufacturing process and safety control points,and the limitations of the use of formaldehyde,in order to provide some reference for the development of this kind of products.
关键词
甲醛 /
疫苗产品 /
生产工艺 /
安全控制 /
局限性
Key words
Formaldehyde /
Vaccine Product /
Manufacturing Process /
Safety Control /
Limitations
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参考文献
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