Guided tissue regeneration membrane and its preparation method

Abstract

The invention relates to a guided tissue regeneration membrane, which comprises a compact coating and a loose coating, wherein the compact coating is composed of collagen-I or collagen-I composite hyaluronic acid; and the loose coating is composed of collagen-I or collagen-I composite calcium salt. A preparation method of the guided tissue regeneration membrane comprises the following steps of: preparing a collagen solution or a collagen and hyaluronic acid mixed solution by the use of acetic acid; injecting the solution into a self-made die, and drying it in the air to prepare the compact coating; injecting the collagen solution or a mixed liquor of the collagen solution and calcium salt onto the compact coating, and uniformly spreading; precooling the die at ultralow temperature, followed by freeze-drying to prepare the guided membrane with the compact coating and loose coating structure; carrying out vacuum high-temperature crosslinking and chemical crosslinking; and finally cleaning. The regeneration membrane has good histocompatibility and mechanical strength, low antigenicity and strong guided tissue regeneration capability. Its degradation rate in vivo is 3-8 months. The method is easy to operate, is suitable for automatic and continuous large-scale production, and solves the problems of large size of collagen membrane and material uniformity during industrial production.

Description

technical field

[0001] The invention relates to the field of biomedical materials, in particular to a membrane guiding tissue regeneration and a preparation method thereof. Background technique

[0002] Guided tissue regeneration membrane (GTRM) refers to the application of membrane barrier technology to prevent the growth of connective tissue and epithelial cells into the bone defect area, guide osteoblasts to occupy the bone space, and promote the repair of bone defects. GTRM is surgically placed above the bone defect. The side in contact with the soft tissue can block epithelial cells and fibroblasts from the defect, and the side in contact with the bone tissue can guide the osteogenic cells from the periosteal bone marrow to stick on its surface. Attach, and then proliferate and differentiate into osteoblasts. GTRM provides a relatively closed tissue environment for new bone tissue and plays a role in selective tissue regeneration. According to the absorption and degra...

Examples

example 1

[0052] The specific preparation method of the guide film prepared by the present invention is as follows:

[0053] 1) Use 0.5% acetic acid solution within the range of PH=2-3 to prepare a collagen solution with a concentration of 0.6%;

[0054] 2) After the collagen is dissolved, centrifuge at a speed of 4400rp / min;

[0055] 3) A certain amount of centrifuged collagen is injected into the mold 1 through the expander 2, the mold is heated to 45°C, and dried in the air for two days to prepare a dense layer;

[0056] 4) After the dense layer is prepared, inject a certain amount of centrifuged collagen solution on it through the spreader 2 and spread it evenly, and place it for 1 hour;

[0057] 5) After placement, put the mold in an ultra-low temperature refrigerator at -86°C for two hours, and then put it in a freeze dryer to dry for 24 hours to prepare a guide film with a double-layer structure;

[0058] 6) Put the prepared guide film into a vacuum dryer, and cross-link at 90°...

example 2

[0064] The specific preparation method of the guide film prepared by the present invention is as follows:

[0065] 1) Use 0.5% acetic acid solution within the pH range of 2-3, and prepare I collagen solution with a concentration of 1%;

[0066] 2) After the collagen is dissolved, centrifuge at 4400rp / min;

[0067] 3) A certain amount of centrifuged collagen is injected into the mold 1 through the expander 2, the mold is heated to 45°C, and dried in the air for two days to prepare a dense layer;

[0068] 4) In the centrifuged collagen solution, add β-tricalcium phosphate and stir evenly, the mass fraction of β-tricalcium phosphate is 0.5%; 0.5% β-tricalcium phosphate collagen solution, spread evenly, and place for 1 hour;

[0069] 5) After placement, put the mold in an ultra-low temperature refrigerator at -86°C for two hours, and then put it in a freeze dryer to dry for 24 hours to prepare a guide film with a double-layer structure;

[0070] 6) Put the prepared guide film i...

example 3

[0076] The guide membrane prepared by Example 1 and Example 2 of the present invention was carried out in animal experiments, and used for the repair of the bone defect model around the dog's dental implant. Soft tissue contact, to prevent soft tissue from growing into the bone defect site; guide the loose layer of the membrane downward, in contact with the tissue surface of the bone defect, guide the bone-forming cells from the periosteum and bone marrow to attach to the surface, and then proliferate and differentiate into osteoblasts cells to promote the repair of bone defects. In this application example, the period of degradation of the guide membrane in vivo is 6 months.

technical field

[0001] The invention relates to the field of biomedical materials, in particular to a membrane guiding tissue regeneration and a preparation method thereof. Background technique

[0002] Guided tissue regeneration membrane (GTRM) refers to the application of membrane barrier technology to prevent the growth of connective tissue and epithelial cells into the bone defect area, guide osteoblasts to occupy the bone space, and promote the repair of bone defects. GTRM is surgically placed above the bone defect. The side in contact with the soft tissue can block epithelial cells and fibroblasts from the defect, and the side in contact with the bone tissue can guide the osteogenic cells from the periosteal bone marrow to stick on its surface. Attach, and then proliferate and differentiate into osteoblasts. GTRM provides a relatively closed tissue environment for new bone tissue and plays a role in selective tissue regeneration. According to the absorption and degra...

Examples

example 1

[0052] The specific preparation method of the guide film prepared by the present invention is as follows:

[0053] 1) Use 0.5% acetic acid solution within the range of PH=2-3 to prepare a collagen solution with a concentration of 0.6%;

[0054] 2) After the collagen is dissolved, centrifuge at a speed of 4400rp / min;

[0055] 3) A certain amount of centrifuged collagen is injected into the mold 1 through the expander 2, the mold is heated to 45°C, and dried in the air for two days to prepare a dense layer;

[0056] 4) After the dense layer is prepared, inject a certain amount of centrifuged collagen solution on it through the spreader 2 and spread it evenly, and place it for 1 hour;

[0057] 5) After placement, put the mold in an ultra-low temperature refrigerator at -86°C for two hours, and then put it in a freeze dryer to dry for 24 hours to prepare a guide film with a double-layer structure;

[0058] 6) Put the prepared guide film into a vacuum dryer, and cross-link at 90°...

example 2

[0064] The specific preparation method of the guide film prepared by the present invention is as follows:

[0065] 1) Use 0.5% acetic acid solution within the pH range of 2-3, and prepare I collagen solution with a concentration of 1%;

[0066] 2) After the collagen is dissolved, centrifuge at 4400rp / min;

[0067] 3) A certain amount of centrifuged collagen is injected into the mold 1 through the expander 2, the mold is heated to 45°C, and dried in the air for two days to prepare a dense layer;

[0068] 4) In the centrifuged collagen solution, add β-tricalcium phosphate and stir evenly, the mass fraction of β-tricalcium phosphate is 0.5%; 0.5% β-tricalcium phosphate collagen solution, spread evenly, and place for 1 hour;

[0069] 5) After placement, put the mold in an ultra-low temperature refrigerator at -86°C for two hours, and then put it in a freeze dryer to dry for 24 hours to prepare a guide film with a double-layer structure;

[0070] 6) Put the prepared guide film i...

example 3

[0076] The guide membrane prepared by Example 1 and Example 2 of the present invention was carried out in animal experiments, and used for the repair of the bone defect model around the dog's dental implant. Soft tissue contact, to prevent soft tissue from growing into the bone defect site; guide the loose layer of the membrane downward, in contact with the tissue surface of the bone defect, guide the bone-forming cells from the periosteum and bone marrow to attach to the surface, and then proliferate and differentiate into osteoblasts cells to promote the repair of bone defects. In this application example, the period of degradation of the guide membrane in vivo is 6 months.

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