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Bone repairing material and preparation method thereof

A bone repair and temperature control technology, applied in the field of medical materials, can solve the problems of difficult postoperative observation, high pH value, and high requirements for storage conditions, and achieve a high level of sterility assurance, good biocompatibility, and improved degradation. fast effect

Active Publication Date: 2013-08-21
成都迪康中科生物医学材料有限公司
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  • Abstract
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  • Claims
  • Application Information

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Problems solved by technology

However, BG has poor mechanical properties and is brittle; its application in the field of biomaterials is not as good as that of calcium phosphate ceramics
The main reason is the following problems in clinical use and operation: the granular product is loose due to the sandy shape, which makes it difficult to fill the bone defect during use, which brings inconvenience to clinical use; the porous bioactive glass block made of bioactive glass, because of its porous It provides beneficial channels for bone growth, facilitates the passage and metabolism of bone cells, and is conducive to the crawling growth of bones, but its block also has poor block strength in clinical use, and it is easy to break and fall off, and it is not easy to be damaged in bone defects. fully filled defect
[0006] 1. The environment is sensitive and the storage conditions are high: ointment products are sensitive to temperature and environmental humidity, and product storage and transportation must be refrigerated; glycerin has strong hygroscopicity and can easily absorb moisture in the air, resulting in the product being stored for a period of time. Viscosity decreases, which makes the plasticity performance worse and affects clinical use and operation
[0007] 2. Difficulty in production: due to the poor thermal stability of glycerin, it is very easy to oxidize and decompose, which increases the difficulty of high-temperature fusion process of ointment, and is not conducive to high-temperature sterilization treatment
[0008] 3. Difficulty in postoperative observation: bioglass ointment, in clinical use, X-ray imaging is not obvious, affecting postoperative observation
[0009] 4. The product degrades quickly, which is not conducive to the growth of new bone: the existing bone repair materials are added with bioactive glass powder to adjust the plastic performance, so as to reduce the situation of threshing and sand dropping
However, when the particle size of bioactive glass is less than 90 μm, it is easy to cause dense accumulation of bone repair materials, which is not conducive to the crawling growth of bone; and the degradation rate of bioactive glass particles with a particle size of less than 90 μm is too fast, resulting in too high local pH value, which is easy to produce inflammatory response
[0010] 5. Easy to breed bacteria: Glycerin is the main source of carbon source for bacterial growth, which provides conditions for bacterial growth and is not conducive to product sterility assurance

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  • Bone repairing material and preparation method thereof
  • Bone repairing material and preparation method thereof
  • Bone repairing material and preparation method thereof

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preparation example Construction

[0049] The preparation method of bone repair material of the present invention is:

[0050] (1) When the bone repair material does not contain hydroxyapatite:

[0051] A. After PEG is melted into a liquid state at a temperature of 60-120°C, PEG mixture I is formed;

[0052] B. Mix PEG mixture I with bioactive glass, and mix uniformly to obtain mixture II;

[0053] C. Mixture II is sterilized at high temperature (1-4h) under the protection of an inert gas; preferably sterilized at a temperature of 150-250°C, and the inert gas is carbon dioxide, nitrogen or helium;

[0054] D. After sterilization, stir the mixture II while cooling down, and stop stirring when the temperature drops to 30-40°C to obtain an ointment.

[0055] (2) When the bone repair material contains hydroxyapatite:

[0056] A. Mix hydroxyapatite and PEG, control the temperature at 60-120°C, melt into a liquid state, add dispersant such as silane coupling agent or sodium polyacrylate (the purpose of adding disp...

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Abstract

The invention relates to a bone repairing material and a preparation method thereof, belongs to the field of medical materials, and aims at providing a bone repairing material which is less influenced by the changes of ambient temperature and humidity and is more stable. The bone repairing material is prepared from the following components in percentage by weight: 60-75% of bioactive glass with particle size of 212-425 mu m, 25-40% of PEG (polyethylene glycol) and 0-15% of hydroxyapatite with particle size of 50-200 nm. According to the bone repairing material provided by the invention, high-molecular-weight PEG is used as a plasticizing agent, and low-molecular-weight PEG is used as a softening agent or lubricant, thus the ointment product can be in any shapes, and the product has the characteristics of being more stable and better biocompatibility and safety. The bone repairing material has the advantages of being convenient for storage and transport, needing no cold storage measure, being difficult in moisture absorption, threshing, sand falling and hand sticking, and being obvious in postoperative X-ray development and postoperative recovery observation.

Description

technical field [0001] The invention relates to a bone repair material and a preparation method thereof, belonging to the field of medical materials. Background technique [0002] Biomaterials are a class of materials with special functions that can replace, repair and regenerate diseased body tissues and bones. Due to the complexity of the functions of the human body, the requirements for various performance indicators of the materials are not the same according to the specific application forms and occasions of the biological materials in the human body; in addition, even for a specific application, the performance requirements for the biological materials It is not a single one, but a comprehensive balance of multiple functions. For example, the repair material of human tissue, the ideal tissue repair material should be gradually absorbed by the human body as the new tissue grows, until it is completely replaced by the new tissue. Biomaterials are "bioactive" when they ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/44A61L27/10A61L27/12A61L27/18
Inventor 高海利张凯周晓东李小恒
Owner 成都迪康中科生物医学材料有限公司
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