Process for purifying typhoid Vi polysaccharide

Abstract

The invention provides a process for purifying typhoid Vi polysaccharide. In the process, phenol is not used for removing protein in the purification process, so use of the phenol is avoided, the dialysis step after phenol extraction is not required, production time is shortened, and production efficiency is improved. The phenol is not used in the technical process, so vaccine does not contain the phenol, a vaccinated object does not contact with the phenol and is not damaged by the phenol, health of vaccinees is contributed, health of production staff and ecological environment are protected, and the defect that a great deal of phenol is used in the traditional process is overcome.

Description

Technical field: [0001] The invention belongs to the field of biotechnology, and in particular relates to a polysaccharide purification process in the stock solution preparation in the typhoid Vi polysaccharide vaccine production process (bacteria preparation, stock solution preparation, semi-finished product preparation, and finished product preparation). Background technique: [0002] Typhoid fever is a severe acute infectious disease transmitted through the digestive tract caused by typhoid bacillus. It is a common intestinal infectious disease in developing countries, especially among school-age children. According to statistics in 2000, there were about 21 million cases of typhoid fever in the world and 210,000 deaths, with the highest incidence in Asia and southern Africa 1 . In recent years, the total incidence of typhoid fever in China has always been at the top of the list of legally notifiable infectious diseases, and some provinces (autonomous regions and municip...

AI Technical Summary

Problems solved by technology

[0004] In the traditional process, phenol extraction is used to remove protein, but phenol is a toxic substance that has toxic effects on humans. In the purification process, phenol is used to remove protein impurities. Although dialysis or ultrafiltration is used in subsequent processing steps The phenol content can be reduced to a safe limit (see the phenol residue detection item in the Chinese Pharmacopoeia’s polysaccharide product regulations raw liquid test item), but it is theoretically impossible to completely remove the phenol, and the crowd also absorbs phenol when they are vaccinated. Although the phenol content is within the safe limit, it still has potential risks to people; in the production process, it is generally extracted with phenol 3 to 4 times, and the production personnel will be in the environment of phenol for a long time in each batch of production. There are protective measures, but the use of phenol still has the risk of injury to production personnel; the treatment of waste phenol after use is also a high-risk link, and the direct discharge of waste phenol will seriously damage the ecological environment. If the waste phenol is recycled and reused in transportation and distillation Links also have the risk of damaging the environment

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