IMPLANT FOR BONE REGENERATION AND METHOD FOR PRODUCTION THEREOF Russian patent published in 2019 - IPC A61F2/28 A61K38/02 A61K35/56 A61K38/39 A61K9/14 B02C19/18 B01F17/00 B01L7/00 B01D61/24 

FIELD: medicine.

SUBSTANCE: implant for bone tissue regeneration consists of composite microparticles characterized by porous structure with pore size from 10 to 85 mcm, content of silk fibroin from 65 to 75 wt. %, content of gelatine from 25 to 35 wt. %, as well as Young's modulus of compression in dehydrated state 83 ± 1 MPa, in wet - 590 ± 60 kPa. Method of implant production includes the following stages: preparing an aqueous solution of fibroin, preparing an aqueous solution of gelatine, forming a composite scaffold, cryomilling the scaffold obtained at the step of forming a composite scaffold, and deposition of composite microparticles obtained at step of cryophasing scaffold. Preparation of water solution of silk fibroin is performed by dissolving fibroin in amount of 100–150 mg/ml in CaCl₂ mixture: C₂H₅OH: H₂O in molar ratio of components of mixture of 1:2:8 for 5–7 hours while heating to 70 °C±5 °C and subsequent dialysis against water, centrifugation at 13,400 g for 10 minutes and bringing the obtained solution with water to concentration of 20–30 mg/ml. Preparation of aqueous solution of gelatine is carried out by dissolution of dry gelatine in water at rate of 20–30 mg/ml. Composite scaffold formation is performed by freezing for 6–8 days at temperature - (18–25) °C a mixture of solutions obtained at the steps of preparing an aqueous solution of silk fibroin and preparing an aqueous solution of gelatine in volume ratio of 7:3 and 0.8–1.2 vol. % dimethylsulphoxide (DMSO) with subsequent defrosting and treatment with 96 % ethanol, which provides formation β-flat structure, then scaffolds are frozen in distilled water. Creeping of scaffold obtained at the stage of composite scaffold formation is carried out in 70 % ethanol using a dispersant, followed by sorting obtained scaffold fragments to obtain composite microparticles with size of 100–250 mcm. Deposition of composite microparticles obtained at cryofilling of scaffold is suspended from suspension in 70 % ethanol at 13,000–18,000 g for 30–40 minutes followed by drying at 50–55°C for at least 2 days to form an implant for bone tissue regeneration.

EFFECT: inventions provide simplification of technology of implant obtaining combined with improvement of mechanical characteristics of obtained implant, in particular of Young's modulus when measuring for compression, improvement of its osteinductive properties that promotes faster healing and regeneration of bone tissue.

3 cl, 6 dwg