Biological repair tablet for endocranium and preparation method thereof

Abstract

The invention provides a biological repair tablet for endocranium and a preparation method thereof. The repair tablet uses small intestine submucosa tissues of inbred line animals without cell and DNA (deoxyribonucleic acid) components as the raw material, completely reserves the extracellular matrix component and structure, and has a micropore structure. The preparation method of the repair tablet comprises the following operation steps: determination of animal source, pretreatment and rough cleaning of small intestine tissues, virus inactivation, cell removal, DNA removal treatment, formation, packaging and sterilization. The biological repair tablet for endocranium prepared by the method uses an inbred line animal as an animal source, and thus, the hereditary features are pure, stable and uniform, thereby radically ensuring the stability and uniformity of different batches of products; and the biological repair tablet for endocranium has fewer animal source DNA residues, completely reserves the three-dimensional structure of natural ECM, and has the advantages of low immune source property and high infection resistance.

Description

technical field

[0001] The invention relates to the technical field of animal-derived implantable medical devices, in particular to a dura mater biological patch and a preparation method thereof. Background technique

[0002] The dura mater is a thick, tough double membrane. The outer layer is the periosteum on the inner surface of the skull, which is only loosely attached to the calvaria, especially in the occipital and temporal parts, and is called the periosteum layer; the inner layer is thicker and tougher than the outer layer, and is connected with the dura mater at the foramen magnum continuous, called the meningeal layer. The main function of the dura mater is to protect the brain tissue. Trauma, tumor, and neurosurgery can all cause dural defects. Dural reconstruction is the basic operation step of neurosurgery. An important measure; traditional dura mater reconstruction materials are mainly taken from autologous tissue, the source of materials is limited, and the...

Examples

Embodiment 1

[0045] Example 1: Preparation of 8-layer dura mater biological patch

[0046] The preparation method is as follows:

[0047] (1) Determination of animal source and pretreatment and initial washing of small intestine tissue

[0048] The Chinese inbred Wuzhishan minipig was selected as the animal source, and the animal species was determined using the method specified in the patent ZL200510008994.2. The small intestine tissue of the freshly slaughtered Chinese inbred Wuzhishan minipig was cleaned, and the small intestinal submucosa was separated and used Rinse with water for injection 3 times.

[0049] (2) Virus inactivation

[0050] Adopt the peracetic acid-ethanol solution method to inactivate the virus, this step is carried out in the constant temperature ultrasonic cleaner that the cleaning tank can vibrate, wherein the volume percentage of peracetic acid is 0.05~0.2% (preferably 0.1%), inactivation The time is 1 to 2 hours (preferably 1 hour), the temperature range is 4 ...

Embodiment 2

[0059] Embodiment 2: Physical and chemical properties, histology, growth factor and biological performance detection of the material prepared in embodiment 1

[0060] 1. The physical properties of the prepared 8-layer material are tested, and the testing items include porosity measurement, suture retention, tensile strength, and burst strength.

[0061] 1) Porosity measurement: Mercury porosimetry was used to measure the porosity of the material, and compared with and compared with Biodesign Surgisis products. Results: The porosity of the sample provided in Example 1 was 87.8±2.51, and the porosity of the Biodesign Surgisis product was 78.3±6.38.

[0062] 2) Suture retention test: method: use 2-0 surgical sutures or stainless steel wires of the same diameter to suture at 2 mm inside the edge of one end of the patch, and fix the suture or stainless steel wire and the other end of the patch on a tension meter On, stretch at a speed of 20mm / min until the suture point is torn, an...

technical field

[0001] The invention relates to the technical field of animal-derived implantable medical devices, in particular to a dura mater biological patch and a preparation method thereof. Background technique

[0002] The dura mater is a thick, tough double membrane. The outer layer is the periosteum on the inner surface of the skull, which is only loosely attached to the calvaria, especially in the occipital and temporal parts, and is called the periosteum layer; the inner layer is thicker and tougher than the outer layer, and is connected with the dura mater at the foramen magnum continuous, called the meningeal layer. The main function of the dura mater is to protect the brain tissue. Trauma, tumor, and neurosurgery can all cause dural defects. Dural reconstruction is the basic operation step of neurosurgery. An important measure; traditional dura mater reconstruction materials are mainly taken from autologous tissue, the source of materials is limited, and the...

Examples

Embodiment 1

[0045] Example 1: Preparation of 8-layer dura mater biological patch

[0046] The preparation method is as follows:

[0047] (1) Determination of animal source and pretreatment and initial washing of small intestine tissue

[0048] The Chinese inbred Wuzhishan minipig was selected as the animal source, and the animal species was determined using the method specified in the patent ZL200510008994.2. The small intestine tissue of the freshly slaughtered Chinese inbred Wuzhishan minipig was cleaned, and the small intestinal submucosa was separated and used Rinse with water for injection 3 times.

[0049] (2) Virus inactivation

[0050] Adopt the peracetic acid-ethanol solution method to inactivate the virus, this step is carried out in the constant temperature ultrasonic cleaner that the cleaning tank can vibrate, wherein the volume percentage of peracetic acid is 0.05~0.2% (preferably 0.1%), inactivation The time is 1 to 2 hours (preferably 1 hour), the temperature range is 4 ...

Embodiment 2

[0059] Embodiment 2: Physical and chemical properties, histology, growth factor and biological performance detection of the material prepared in embodiment 1

[0060] 1. The physical properties of the prepared 8-layer material are tested, and the testing items include porosity measurement, suture retention, tensile strength, and burst strength.

[0061] 1) Porosity measurement: Mercury porosimetry was used to measure the porosity of the material, and compared with and compared with Biodesign Surgisis products. Results: The porosity of the sample provided in Example 1 was 87.8±2.51, and the porosity of the Biodesign Surgisis product was 78.3±6.38.

[0062] 2) Suture retention test: method: use 2-0 surgical sutures or stainless steel wires of the same diameter to suture at 2 mm inside the edge of one end of the patch, and fix the suture or stainless steel wire and the other end of the patch on a tension meter On, stretch at a speed of 20mm / min until the suture point is torn, an...

Images