Process for the preparation of highly purified injectable form of medicines for the treatment of degenerative diseases of the motor system

摘要

1. A method for producing highly purified a medicament for the treatment of degenerative diseases of the musculoskeletal system by cleaning solutions of chondroitin sulfate, activated charcoal from impurities, characterized in that the aqueous chondroitin sulfate solution is added amino acid L-proline and filtered through charcoal filters, chondroitin formulation was prepared with a purity of not less than 99% stabilized with amino acid L-proline, with the minimum acceptable content of the following impurities: protein - not more than 0.2%, lipids (1 mg basic substances a) - no more than 0.5 micrograms of nucleic acids (1 mg base material) - not more than 0.05 mg, bacterial endotoxin (1 mg of base material) - not more than 0.05 EE.2. A method according to claim 1, characterized in that the chondroitin sulfate solution contains the basic substance in an amount of not more than 11.5% .3. A method according to claim 1, characterized in that the concentration of the amino acid L-proline in the solution is 10-70 g / l.4. A method according to claim 1, characterized in that the deep-filtration through activated carbon filters is carried out at a temperature of 20-50 ° C.5. A method according to claim 1, characterized in that the filter is used for charcoal filters following grades ZetaCarbon (Cuno) R54SLP, R51SLP, R53SLP or AKS filters (Pall) - AKS 1, 2, 6, 7, or other similar filters proizvoditeley.6. The preparation obtained by the method according to claims 1-5, may be a liquid or lyophilized dosage form.