Bone repair material and preparation method thereof

Abstract

The invention relates to a bone repair material and a preparation method thereof. According to the bone repair material, the effective component consists of calcium sulfate hemihydrate and a Lugua polypeptide injection as raw materials. The method comprises the following steps of: mixing and stirring till the mixed liquid is in a gel shape; then, injecting the mixed liquid to a mould; and after high pressure pressing, taking out and placing at normal temperature to volatilize and cure. The biocompatibility of the bone repair material with human body is good, and has good bone inductive activity, so that bone defect can be quickly repaired, therefore, the bone repair material is very suitable for clinical application of bone surgery.

Description

technical field

[0001] The invention belongs to the field of medical biomaterials, and relates to a medical bone repair material and a preparation method thereof. Background technique

[0002] Existing bone repair materials include autologous bone, allogeneic bone and artificial bone materials. Autologous bone is taken from the cancellous bone such as the iliac crest and ribs. It has good osteoinductivity, osteoconductivity and biocompatibility, and is the gold standard for the treatment of bone defects. However, there is a small amount of available bone, and there are complications such as infection, bleeding, and pain at the site where the bone is taken, and it affects the appearance to a certain extent. Allograft bone comes from a wide range of sources and has good osteogenic properties, but there are risks of immune rejection and infection. Artificial bone material is a hotspot in current research and application. Calcium sulfate is a commonly used artificial bone mat...

Examples

Embodiment 1

[0026] A bone repair material, which is prepared by mixing calcium sulfate hemihydrate and lugua polypeptide injection in a weight ratio of 90:30, and then preparing through the following steps:

[0027] (1) Mix the quantitative calcium sulfate hemihydrate and Lugua polypeptide injection in a ratio of 90:30, and stir well until the calcium sulfate hemihydrate is evenly distributed in the Lugua polypeptide injection, and the mixture is gel-like. If it is simply mixed, but it is not stirred to a gel state, it indicates that the stirring is not sufficient, and the result will be that the calcium sulfate hemihydrate is not sufficiently dispersed in the Lugua polypeptide injection, which will eventually lead to uneven osteogenic activity of the bone repair material. thereby reducing the rate of bone formation

[0028] (2) Inject the mixed liquid obtained in the above step (1) into a mold with a diameter of 5 mm, and under the action of 10 MPa pressure, make the mixed liquid in the ...

Embodiment 2

[0034] The difference between Example 2 and Example 1 is that the bone repair material of this example is made of raw materials mixed with calcium sulfate hemihydrate, lugua polypeptide injection and pure water in a weight ratio of 90:15:15. The average length of the calcium sulfate hemihydrate crystals is between 30um, the average width is 25um, and the average aspect ratio is 1.25.

[0035] In the preparation method, step (2) is to make the mixed fluid in the mold into a 3 mm thick sheet material under the action of 10 MPa, and then volatilize it at normal temperature to obtain a cured product.

[0036] The rest of the preparation steps are consistent with Example 1.

Embodiment 3

[0038] The difference between Example 2 and Example 1 is that the bone repair material of this example is made of raw materials mixed with calcium sulfate hemihydrate, lugua polypeptide injection and pure water in a weight ratio of 90:10:15. The average length of the calcium sulfate hemihydrate crystals is between 33um, the average width is 26um, and the average aspect ratio is 1.28.

[0039] In the preparation method, the step (2) is to make the mixed liquid in the mold into a 3 mm thick sheet material under the action of 8 MPa, and then volatilize it at normal temperature to obtain a cured product.

[0040] The rest of the preparation steps are consistent with Example 1.

technical field

[0001] The invention belongs to the field of medical biomaterials, and relates to a medical bone repair material and a preparation method thereof. Background technique

[0002] Existing bone repair materials include autologous bone, allogeneic bone and artificial bone materials. Autologous bone is taken from the cancellous bone such as the iliac crest and ribs. It has good osteoinductivity, osteoconductivity and biocompatibility, and is the gold standard for the treatment of bone defects. However, there is a small amount of available bone, and there are complications such as infection, bleeding, and pain at the site where the bone is taken, and it affects the appearance to a certain extent. Allograft bone comes from a wide range of sources and has good osteogenic properties, but there are risks of immune rejection and infection. Artificial bone material is a hotspot in current research and application. Calcium sulfate is a commonly used artificial bone mat...

Examples

Embodiment 1

[0026] A bone repair material, which is prepared by mixing calcium sulfate hemihydrate and lugua polypeptide injection in a weight ratio of 90:30, and then preparing through the following steps:

[0027] (1) Mix the quantitative calcium sulfate hemihydrate and Lugua polypeptide injection in a ratio of 90:30, and stir well until the calcium sulfate hemihydrate is evenly distributed in the Lugua polypeptide injection, and the mixture is gel-like. If it is simply mixed, but it is not stirred to a gel state, it indicates that the stirring is not sufficient, and the result will be that the calcium sulfate hemihydrate is not sufficiently dispersed in the Lugua polypeptide injection, which will eventually lead to uneven osteogenic activity of the bone repair material. thereby reducing the rate of bone formation

[0028] (2) Inject the mixed liquid obtained in the above step (1) into a mold with a diameter of 5 mm, and under the action of 10 MPa pressure, make the mixed liquid in the ...

Embodiment 2

[0034] The difference between Example 2 and Example 1 is that the bone repair material of this example is made of raw materials mixed with calcium sulfate hemihydrate, lugua polypeptide injection and pure water in a weight ratio of 90:15:15. The average length of the calcium sulfate hemihydrate crystals is between 30um, the average width is 25um, and the average aspect ratio is 1.25.

[0035] In the preparation method, step (2) is to make the mixed fluid in the mold into a 3 mm thick sheet material under the action of 10 MPa, and then volatilize it at normal temperature to obtain a cured product.

[0036] The rest of the preparation steps are consistent with Example 1.

Embodiment 3

[0038] The difference between Example 2 and Example 1 is that the bone repair material of this example is made of raw materials mixed with calcium sulfate hemihydrate, lugua polypeptide injection and pure water in a weight ratio of 90:10:15. The average length of the calcium sulfate hemihydrate crystals is between 33um, the average width is 26um, and the average aspect ratio is 1.28.

[0039] In the preparation method, the step (2) is to make the mixed liquid in the mold into a 3 mm thick sheet material under the action of 8 MPa, and then volatilize it at normal temperature to obtain a cured product.

[0040] The rest of the preparation steps are consistent with Example 1.

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