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Chemical treatment method for bone allograft

An allogeneic and chemical treatment technology, applied in the treatment field of implantable biological materials, can solve the problems of reducing bone immunogenicity, unable to completely eliminate the allogeneic bone immunogenicity, etc., to facilitate large-scale production operation, Optimal osteogenic capacity and biomechanical properties, and the effect of reducing immunogenicity

Inactive Publication Date: 2012-02-01
上海安久生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the method of cryogenic freezing and freeze-drying alone cannot completely eliminate the immunogenicity of allogeneic bone, and other methods are needed to further reduce the immunogenicity of bone.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Cut the allogeneic bone material into bone particles, wash the cut allogeneic bone material with purified water, and remove the bone marrow; mix chemically pure acetone and bone material at a volume of 4:1, and store at 20-30°C Shake and degrease until the solution has no obvious slick oil.

[0024] Soak the bone material obtained above with 0.5-1mol / L oxalic acid solution for 2 hours; then soak the bone material obtained in the previous step with 75-85% alcohol for 4 hours. The bone material soaked in alcohol was dehydrated and then freeze-dried in an environment at -40°C for 16 hours. Finally, the freeze-dried bone material was cryogenically frozen at -70°C for 70 days and sterilized by irradiation with 20 kGy of cobalt-60.

Embodiment 2

[0026] Cut the allogeneic bone material into bone segments, wash the cut allogeneic bone material with purified water, and remove the bone marrow; mix chemically pure acetone and bone material at a volume of 5:1, and store at 20-30°C Shake and degrease until the solution has no obvious slick oil.

[0027] Soak the bone material obtained above with 0.5-1mol / L oxalic acid solution for 3.5 hours; then soak the bone material obtained in the previous step with 75-85% alcohol for 5 hours. The bone material soaked in alcohol was dehydrated and then freeze-dried in an environment at -40°C for 20 hours. Finally, the freeze-dried bone material was cryogenically frozen at -70°C for 82 days and sterilized by irradiation with cobalt-60 at a dose of 15 kGy.

Embodiment 3

[0029] Cut the allogeneic bone material into bone segments, wash the cut allogeneic bone material with purified water, and remove the bone marrow; mix chemically pure acetone and bone material at a volume of 7:1, and store at 20-30°C Shake and degrease until the solution has no obvious slick oil.

[0030] Soak the bone material obtained above with 0.5-1mol / L oxalic acid solution for 5 hours; then soak the bone material obtained in the previous step with 75-85% alcohol for 6 hours. The bone material soaked in alcohol was dehydrated and then freeze-dried in an environment at -40°C for 22 hours. Finally, the freeze-dried bone material was cryogenically frozen at -70°C for 90 days and sterilized by irradiation with 10 kGy of cobalt-60.

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Abstract

The invention provides a chemical treatment method for bone allograft. The chemical treatment method comprises the steps of bone cutting and profound-hypothermia freezing, and specifically comprises the steps of: cutting a bone material, cleaning the cut bone material by using purified water, processing the cleaned bone materials by using acetone, oxalate and alcohol in sequence, finally dewatering, lyophilizing the dewatered bone material for 15-25 hours at -40 DEG C, performing profound-hypothermia freezing below -70 DEG C, and performing irradiation sterilization to obtain a finished product of the bone allograft. According to the invention, the acetone, the oxalate and the alcohol are commonly used for processing so as to deactivate or remove cells and fat components inside bone marrow, meanwhile, by means of lyophilizing treatment and profound-hypothermia freezing, the immunogenicity of the bone allograft can be further removed, and better ossification capability and biomechanical performance of the bone allograft are kept at the same time. In addition, processing steps designed in the invention are simple, convenient and feasible and are convenient for scale production operation.

Description

technical field [0001] The invention relates to the field of biological materials, in particular to a processing method for implantable biological materials. Background technique [0002] Fracture trauma, tumors, etc. can lead to bone defects and structural damage. In the prior art, autologous bone or artificial bone materials are often used to repair bone defects. However, the autogenous bone is limited, and at the same time, the trauma of the patient is increased and the risk of complications is increased. However, when artificial bone materials such as ceramics are used for bone repair, their biomechanical properties are poor, and the bioactivity of bone needs to be improved. The allogeneic bone technology is to use legally donated human qualified donor bone tissue, which is processed and implanted into the body as a filling material, which is a substitute material for autologous bone transplantation. [0003] Allograft bone is currently the most widely used bone subst...

Claims

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Application Information

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IPC IPC(8): A61L27/36
Inventor 汤亭亭楼伟
Owner 上海安久生物科技有限公司
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