Method for production of botulinum toxin

摘要

A method of making botulinum toxin comprises treating a culture of a botulinum toxin-producing strain with acid to precipitate a botulinum toxin; adding buffer to the precipitated botulinum toxin, followed by treatment with a protease inhibitor and nuclease, thereby extracting the botulinum toxin; treating the extracted botulinum toxin with acid to precipitate the botulinum toxin and dissolving the precipitate in buffer; and purifying the botulinum toxin by anion exchange chromatography. The use of the method makes it possible to produce a high-purity botulinum toxin by a simple process. The botulinum toxin produced by the method has high purity, and thus has an increased ability to act in a local area. Thus, the systemic circulation of the botulinum toxin is reduced to increase the safety. Accordingly, the botulinum toxin can be used for treatment of neuromuscular disorders, removal of wrinkles, and treatment of spastic hemiplegia and cerebral palsy.

主权项

1. A method for production of botulinum toxin, the method comprising the steps of:
(a) treating a culture of a botulinum toxin-producing strain with acid to precipitate a botulinum toxin; (b) adding buffer to the precipitated botulinum toxin, followed by treatment with a protease inhibitor and nuclease, thereby extracting the botulinum toxin; (c) treating the extracted botulinum toxin with acid to precipitate the botulinum toxin and dissolving the precipitate in buffer; and (d) purifying the botulinum toxin by anion exchange chromatography, wherein the acid precipitation of step (c) is performed by adding sulfuric acid or hydrochloric acid to the extracted botulinum toxin, so that the extracted botulinum toxin reaches a pH of 2.5-4.5.