Purification method for reducing protein content in sodium hyaluronate and derivatives thereof

Abstract

The invention discloses a purification method for reducing the protein content in sodium hyaluronate and derivatives thereof. The specific preparation process comprises the following process steps of adding a specific type of protein complexing agent into a sodium hyaluronate and derivative crude product solution, filtering to remove insoluble substances, and carrying out alcohol precipitation to obtain pure products of sodium hyaluronate and derivatives thereof. Under the action of the protein complexing agent, the method has a very good effect of removing proteins in sodium hyaluronate and derivative products thereof, and the content of the proteins in the sodium hyaluronate and the derivatives thereof can be reduced to 0.015% or below, so that the risk of anaphylactic reaction of sodium hyaluronate and derivative preparations thereof caused by heterologous proteins is remarkably reduced; the clinical application value is extremely high; the method disclosed by the invention is simple in technological process, low in cost, easy to operate, good in economical efficiency and more suitable for industrial production; the sodium hyaluronate and the derivative thereof obtained by the invention are high in purity, good in safety and less in anaphylactic reaction, and bring maximum benefits to patients.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical production, in particular to a purification method for reducing protein content in sodium hyaluronate and its derivatives. Background technique [0002] Sodium hyaluronate, also known as sodium hyaluronate or hyaluronic acid, is an acidic mucopolysaccharide. In 1934, Meyer et al. in the United States first isolated the substance from the vitreous body of the bull's eye. Its disaccharide unit is a polymer formed by repeated alternation of D-glucuronic acid and N-acetyl-D-glucose disaccharide units. Repeat The disaccharide units of glycosides are connected into sugar chains by β-1,4 glycosidic bonds, and their weight-average molecular weight is generally 100,000 to 10 million Da. Sodium hyaluronate exists in the lens of the eyeball, mucus in the joint cavity, skin, arterial wall, umbilical cord and other connective tissues in nature, cockscombs and capsules of some bacteria. [0003] Sodium...

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Problems solved by technology

[0015] There are great drawbacks in these technological methods, because the technological time of sodium hyaluronate redissolution, complexation and dissociation is too long, generally 8~10 hours, cause the waste of time and energy consumption, multiple alcohol precipitation processes have increased solvent Dosage, at the same time, because the processing time is too long, it may cause the degradation of the sodium hyaluronate macromolecule, and the molecular weight will decrease. A large amount of protein remains, unable to meet the quality standard of sodium hyaluronate, thus affecting the performance of the product

[0016] There are many disadvantages in the purification methods in the prior art. Therefore, there is an urgent need for a purification method that reduces the protein content in sodium hyaluronate and its derivatives, so as to achieve sodium hyaluronate and its derivatives with lower protein content.

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