Technique for improving purity of diphtheria toxoid

Abstract

The invention relates to a process for improving the purity of diphtheria toxin. The manufacture process comprises the following steps of solid culture medium transfer, culture in a liquid culture medium fermentor, removal of thalli by centrifugation, primary salting-out, secondary salting-out, ultrafiltration desalting, gel filtration, aseptic filtration, removal of toxin, detection and storage stock solution, preparation of semi-finished products, finished products, wherein the liquid culture medium in the liquid culture medium fermentor is treated to remove proteins with the molecular weight of more than 50,000, and the culture products are almost diphtheria toxin with the molecular weight of more than 50,000; and by salting out and gel filtration, the proteins and other impurity proteins of which the molecular weight is less than 50,000 in the liquid product are further removed, so that the diphtheria toxin with high purity is obtained.

Description

technical field [0001] The invention relates to a process for improving the purity of diphtheria toxoid, which belongs to the field of biomedicine manufacturing. Background technique [0002] Diphtheria is an acute respiratory infectious disease. Diphtheria bacilli grow and multiply in the nasopharynx after invading the human body, causing local inflammation and tissue necrosis and producing exotoxin (a protein with a molecular weight of 62,000, which is a polypeptide chain). film and continue to spread, causing breathing disorders and even suffocation. Exotoxin can cause damage to myocardium, nervous system, liver, kidney, adrenal gland and other organs, and symptoms of systemic poisoning will appear. Diphtheria toxoid can effectively control the diphtheria epidemic. The original manufacturer of diphtheria toxoid and diphtheria vaccine in China is the six major biological products research institutes affiliated to China Biological Products Group Corporation. The process i...

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Problems solved by technology

Its disadvantages: Although the adsorbed diphtheria vaccine, DTP, DtaP, and adsorbed diphtheria vaccine have been marketed in China, due to the limitation of the process in the production process, there are serious adverse reactions when adults are immunized. Pappenheimer believes that it may be Hypersensitivity to leucoids, or to non-toxin protein of bacteria, or both, when Henncq inoculates avirulent diphtheria bacillus culture filtrate to those who are allergic to the original system of leucoids, the recipients have a positive reaction

Diphtheria was cultured in excess iron culture solution, iron inhibited the formation of diphtheria toxin, but could not inhibit the formation of allergens

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