Hardened biocomposite for bone defect replacement

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, particularly to traumatology, orthopaedis, maxillofacial surgery, dentistry, neurosurgery, namely to osteoplastic formulation of biocomposites for treating human bone diseases and injures, and can be used as a material fully degradable in the body and replaceable by new bone tissue, for bone cell regeneration, as a biological filler for bone tissue defects, as an osteoconductive and osteoinductive biological frame for bone tissue regeneration. The hardened biocomposite for bone defect replacement on the basis of calcium phosphate contains magnesium phosphate, calcium hydrophosphate, amino acid; calcium phosphate is biological hydroxyapatite in the following proportions, wt %: hydroxyapatite - 45-47, magnesium phosphate - 32-34, calcium hydrophosphate - 16-19, amino acid - 1-5, as a binding agent - casein.

EFFECT: implementing the expansion of the biocomposites for bone defect replacement and endoprosthesis fixation.

1 cl

 

The invention relates to medicine, namely to traumatology, orthopedics, maxillofacial surgery, dentistry, neurosurgery, namely, of the compositions of biocomposite materials intended for the treatment of diseases and injuries of the skeletal system of a human, and can be used as a material capable of in the body to fully biodegradeable and replaced with new bone tissue for regeneration of bone cells, biological filler in the case of bone defects, osteoconductive and osteoinductive biological reference frame for the regeneration of bone tissue.

It is known tool to stimulate the growth of bone tissue, containing hydroxyapatite in aqueous suspension 18-36 wt. with a particle size of 0.015 to 0.16 μm (RU, patent No. 2077329, A61K 33/06, Publ. 20.04.1997 year).

The disadvantage of this tool is to stimulate the growth of bone tissue is that the wetted material is not resilient, not able to be fixed in the bone cavities and is capable of retaining a given shape, in connection with what is not provided even minimal samitaat mechanical damage newly formed bone tissue.

Closest to the claimed material is cement for replacement of bone tissue containing amorphous calcium phosphate, additional is a source of calcium, selected from the group of: calcium oxide, calcium hydroxide, calcium carbonate or calcium phosphate, and physiological aqueous solution (US patent # 5782971, C04B 12/02, C01B 25/32, Publ. 21.07.1998,).

The disadvantage of this cement to replace bone tissue is quite wide variations of its components (its quantitative composition) and in the absence of guidance on the quantitative content of the components, which leads essentially to an indeterminate range of different materials having, in the end, different composition, characteristics and structure. In addition, the cement does not possess sufficient ductility.

The basis of the invention is to expand the Arsenal of biocomposite materials to replace bone tissue and fixation of implants that after filling of bone defects in the curing process produces a material which is similar to the inorganic component of natural bone, and possessing biocompatibility, bioactivity, osteoconductive and osteoinductive properties, making it gradually replaced by natural bone tissue, effectively restoring the existing defects. This technical result is the implementation of this assignment.

Achieving the above technical result is ensured by the fact that the CTE is jdaemy biocomposite material for osseous defects based on calcium phosphates additionally contains magnesium phosphate, phosphate of calcium, amino acid, as calcium phosphates - biological hydroxyapatite in the following ratio of components, wt.%: hydroxyapatite - 45-47, magnesium phosphate - 32-34, phosphate calcium 16-19, amino acid - 1-5 and as a binder - casein in the form of ammonia solution at a ratio of ammonia solution of casein powder to the weight of the biocomposite material 1:1.

The content in the curable biocomposite material magnesium phosphate, calcium hydrogen phosphate, amino acids, phosphates of calcium - biological hydroxyapatite in the following ratio of components, % may: hydroxyapatite - 45-47, magnesium phosphate - 32-34, phosphate calcium 16-19, amino acid - 1-5 and as a binder - casein in the form of ammonia solution at a ratio of ammonia solution of casein powder to the weight of the biocomposite material 1:1, provides in the curing process of the formation material, which is analogous to the inorganic component of natural bone, and possessing biocompatibility, bioactivity, osteoconductive and osteoinductive properties, making it gradually replaced natural bone tissue, effectively restoring the existing defects.

Getting cured biocomposite material for osseous defects is carried out following the way.

Preparation of initial components includes receiving fractions of powders of hydroxyapatite, magnesium phosphate, calcium hydrogen phosphate with a particle size of from 1-40 μm. This operation consists in sifting powders through sieves of appropriate sizes. Powder of magnesium phosphate is prepared by mixing magnesium oxide and 70% orthophosphoric acid in the ratio of 1:1,18. The obtained magnesium phosphate were ground in a ball mill. The fractions obtained powders are mixed in a ball mill for 180 minutiae used to produce biocomposite material, have the grade of "analytical grade" or "chemically pure". Later in the powder mixture is added a solution of amino acid under vigorous stirring. As amino acids are arginine, ornithine, glutamine. The mixture is dried at a temperature of 40-60°C for 20 minutes. Drying of the filler at a temperature below 40°C leads to a longer processing time, and at temperatures above 60°C is the decomposition of amino acids. To the obtained powder mass is added to the ammonia solution of casein in the ratio of 1:1. Biocomposite material is grasped by 3 minutes. Adding casein is less than 1 powder biocomposite material shows elastic properties and crumbles. The addition of casein more than 1 leads to a prolonged setting time is then the dka 15 minutes and delamination of the system.

Used as a binder casein is obtained by interaction of skim milk with 10% citric acid with continuous stirring; the casein is precipitated in the form of grains. The temperature of deposition 37°C; the acidity of the mass should correspond to pH=4,6-4,8. Acid is added over a period of 8-10 minutes After the deposition of the precipitated precipitate is stirred for 10-15 minutes For best compaction of the grains are washed 3-4 times with distilled water at a temperature of 30°C. After washing the casein raw contains about 60% moisture. Before drying, the water is removed by pressing. After pressing, the casein is crushed. Powdered casein dried at a temperature of 25-30°C for 15-20 hours. Next to the use of casein as a binder in the biocomposite material is prepared 5-10% ammonia solution to dissolve the casein in the following ratios: 1 parts of casein and 3 parts of 5% solution of ammonia. 1 parts of casein and 1.5 parts of 10% ammonia solution. After dissolution of casein and obtain a homogeneous viscous mass is then added a 5% solution of calcium hydrogen phosphate dissolved in a 10% solution of orthophosphoric acid in the amount of 137,5 ml CaHPO41 l of dissolved casein.

After manufacturing the powder biocomposite material to be sterilized is placed in a plastic bag and sealed. Then are irradiated on the zoé 20000 Gr.

When using samples biocomposite material of the composition of all pre-dried solid components are mixed in a ball mill for a period of 180 minutes. To form the working of the paste immediately before use to the obtained powder add ammonia solution of casein and stirred for 2-3 min and obtained leave plastic material for 15-20 minutes to conduct polymerization process. The resulting material is placed in the bone defect. The setting time is 3 minutes, the test Results showed that in contrast to known materials proposed biocomposite material has fully biocompatible with bone tissue, Biodegradability, and creates conditions that eliminates the need for transplantation of bone tissue, and reduce the total duration of the surgical intervention.

Curing biocomposite material for osseous defects based on calcium phosphates, characterized in that it additionally contains magnesium phosphate, calcium phosphate, amino acid, and calcium phosphates in biological hydroxyapatite in the following ratio, wt.%:

Hydroxyapatite45-47
The magnesium phosphate32-34
Phosphate calcium16-19
Amino acid1-5

at the same time as the binder contains casein in the form of ammonia solution at a ratio of ammonia solution of casein powder and the mass of the biocomposite material 1:1.



 

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