阅读说明：本技术 一种甘油明胶赋型的dbm隆鼻材料 (Glycerol gelatin-shaped DBM nose-humping material ) 是由 韩丽伟 胡先同 衷鸿宾 李晋 袁军林 刘永进 赵子腾 于 2021-07-16 设计创作，主要内容包括：本发明公开了一种甘油明胶赋型的DBM隆鼻材料。由如下重量份数的原料制成：明胶5-15份、三蒸水80-120份、甘油250-350份、DBM骨粉280-350份。本发明制备的赋型DBM材料未引起局部炎性反应,组织相容性较理想,可促进骨生长；术后3M材料未出现明显降解,术后6M出现明显降解,可以达到中长效的隆鼻材料要求。(The invention discloses a glycerin gelatin-shaped DBM nose humping material. The feed is prepared from the following raw materials in parts by weight: 5-15 parts of gelatin, 80-120 parts of triple distilled water, 350 parts of glycerol 250-350 parts and 350 parts of DBM bone powder 280-350 parts. The excipient DBM material prepared by the invention does not cause local inflammatory reaction, has ideal histocompatibility and can promote bone growth; the 3M material after operation is not degraded obviously, and the 6M material after operation is degraded obviously, thus meeting the requirement of the nose humping material with medium and long acting.)

1. The glycerin-gelatin-shaped DBM hump nose material is characterized by being prepared from the following raw materials in parts by weight: 5-15 parts of gelatin, 80-120 parts of triple distilled water, 350 parts of glycerol 250-350 parts and 350 parts of DBM bone powder 280-350 parts.

2. The glycerogelatin-shaped DBM hump nose material according to claim 1, wherein said DBM bone powder is DBM bone powder with a decalcification degree of between 30 and 35%.

3. The method for preparing a glycerogelatin-shaped DBM hump nose material in accordance with claim 1, characterized by comprising the steps of:

(1) according to the weight portion, 5-15 portions of gelatin are taken and crushed to below 30 meshes;

(2) 80-120 parts of triple distilled water is prepared; adding the crushed gelatin in the step (1) into the gelatin for pre-swelling treatment for 1-3 h;

(3) heating 350 parts of 250-350 parts of glycerin to 80-90 ℃, adding the swollen gelatin prepared in the step (2), and uniformly mixing to form a sol system;

(4) irradiating the sol system formed in the step (3) by utilizing ultraviolet rays at the heating temperature of 40-60 ℃ for 18-36h, cooling to below 0 ℃, and carrying out low-temperature treatment for 60-80 h;

(5) and (3) restoring the sol system subjected to ultraviolet irradiation to room temperature, adding 280 portions of DBM bone meal and 350 portions of DBM bone meal, uniformly stirring, placing into a vacuum drying oven for 1-3h to remove bubbles, subpackaging, packaging and sterilizing.

4. The method for preparing the glycerin gelatin-shaped DBM hump nose material according to claim 3, characterized in that the temperature reduction of the step (4) is to-20 ℃.

5. The method for preparing a glycerogelatin-shaped DBM hump nose material according to claim 3, wherein said dispensing of step (5) is in the form of dispensing into 1ml syringes.

6. Use of the glycerogelatin-shaped DBM hump nose material of claim 1 for promoting tissue regeneration.

Technical Field

The invention belongs to the technical field of preparation of cosmetic shaping materials, and particularly relates to a glycerin gelatin shaped DBM nose-humping material.

Background

With the pursuit of beauty of people being higher and higher, more and more people adopt the method of implanting the nose raising material, the injected material can play the effect of moulding in a short time, needs to be implanted again after losing efficacy, and can cause irreversible damage to the skin tissue of the human body after the implantation times are more.

The patent 201410643147.2 discloses a high-viscosity injection excipient material resistant to irradiation sterilization, which comprises, by weight, 87-96% of injection-grade glycerol, 0.5-3% of gelatin, 2-12% of water and 0.22-1.5% of sodium chloride, wherein the gelatin and sodium chloride are uniformly dispersed in a solvent consisting of the glycerol and the water to form a sol with excellent fluidity, the viscosity range of the sol is up to 2000-3000 Pas, the sol has stable properties, and the sol can be used as an injection excipient of a material with a large specific gravity. Although the material has good shaping effect and can prevent and treat bacterial infection, the material is easy to degrade, is a material which needs to be frequently re-injected for use, and has a not long-term use effect.

Disclosure of Invention

The invention aims to provide a glycerin gelatin-shaped DBM nose-humping material.

A glycerin gelatin excipient DBM hump nose material is prepared from the following raw materials in parts by weight: 5-15 parts of gelatin, 80-120 parts of triple distilled water, 350 parts of glycerol 250-containing materials and 350 parts of DBM (decalcified bone matrix) bone meal 280-containing materials.

The DBM bone powder is the DBM bone powder with the decalcification degree of 30-35%.

The preparation method of the glycerin gelatin excipient DBM hump nose material comprises the following steps:

(1) according to the weight portion, 5-15 portions of gelatin are taken and crushed to below 30 meshes;

(2) 80-120 parts of triple distilled water is prepared; adding the crushed gelatin in the step (1) into the gelatin for pre-swelling treatment for 1-3 h;

(3) heating 350 parts of 250-350 parts of glycerin to 80-90 ℃, adding the swollen gelatin prepared in the step (2), and uniformly mixing to form a sol system;

(4) irradiating the sol system formed in the step (3) by utilizing ultraviolet rays at the heating temperature of 40-60 ℃ for 18-36h, cooling to below 0 ℃, and carrying out low-temperature treatment for 60-80 h;

(5) and (3) restoring the sol system subjected to ultraviolet irradiation to room temperature, adding 280 portions of DBM bone meal and 350 portions of DBM bone meal, uniformly stirring, placing into a vacuum drying oven for 1-3h to remove bubbles, subpackaging, packaging and sterilizing.

And (4) cooling to the temperature of minus 20 ℃.

And (5) subpackaging into 1ml syringes.

The decalcification degree of the DBM is 30-35%, the tissue regeneration can play a role in promoting the tissue growth, the compatibility and the degradation time of the material are remarkably better, and the long-acting effect of the material is remarkably superior to that of the existing material.

The invention has the beneficial effects that: the injection-shaped composite DBM material prepared by the invention does not cause local inflammatory reaction, has ideal histocompatibility and can promote the growth of bones and soft tissues; the material 12M after operation is not degraded obviously, and the material 18M after operation is degraded obviously, thus meeting the requirement of medium and long-term hump nose material.

Drawings

FIG. 1 shows the cytotoxicity results of the excipient DBM.

FIG. 2 shows the in vivo implantation histology of the excipient DBM.

Detailed Description

In order that the invention may be more fully understood, reference will now be made to the following description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

The DBM bone powder (70-100 mesh) used in the following examples was from Beijing Xinkangthen medical science and technology development Co.

Example 1

A glycerin gelatin excipient DBM hump nose material is prepared from the following raw materials in parts by weight: 10 parts of gelatin, 100 parts of triple distilled water, 300 parts of glycerol and 310 parts of DBM bone meal.

The preparation method of the glycerin gelatin excipient DBM hump nose material comprises the following steps:

(1) according to the weight portion, 10 portions of gelatin are taken and crushed to be below 30 meshes;

(2) taking 100 parts of triple distilled water; adding the crushed gelatin in the step (1) into the mixture to swell for 2 hours;

(3) taking 300 parts of glycerol, heating to 85 ℃, adding the swollen gelatin prepared in the step (2), and uniformly mixing to form a sol system;

(4) irradiating the sol system formed in the step (3) by utilizing ultraviolet rays at the heating temperature of 50 ℃ for 24 hours, cooling to-20 ℃, and carrying out low-temperature treatment for 72 hours;

(5) and (3) restoring the sol system subjected to ultraviolet irradiation to room temperature, adding 310 parts of DBM bone powder, uniformly stirring, putting into a vacuum drying oven for 2 hours to remove bubbles, subpackaging into a 1ml syringe, packaging and sterilizing.

Example 2

A glycerin gelatin excipient DBM hump nose material is prepared from the following raw materials in parts by weight: 8 parts of gelatin, 85 parts of 8% sodium chloride solution, 280 parts of glycerol and 290 parts of DBM bone meal.

The preparation method of the glycerin gelatin excipient DBM hump nose material comprises the following steps:

(1) according to the parts by weight, taking 8 parts of gelatin, and crushing the gelatin to below 30 meshes;

(2) taking 85 parts of triple distilled water; adding the crushed gelatin in the step (1) into the mixture to swell for 1 hour;

(3) heating 280 parts of glycerol to 80 ℃, adding the swollen gelatin prepared in the step (2), and uniformly mixing to form a sol system;

(4) irradiating the sol system formed in the step (3) by utilizing ultraviolet rays at the heating temperature of 45 ℃ for 36 hours, cooling to-20 ℃, and carrying out low-temperature treatment for 60 hours;

(5) and (3) restoring the sol system subjected to ultraviolet irradiation to room temperature, adding 290 parts of DBM bone powder, uniformly stirring, putting into a vacuum drying oven for 1 hour to remove bubbles, subpackaging into a 1ml syringe, packaging and sterilizing.

Example 3

A glycerin gelatin excipient DBM hump nose material is prepared from the following raw materials in parts by weight: 15 parts of gelatin, 120 parts of triple distilled water, 350 parts of glycerol and 350 parts of DBM bone meal.

The preparation method of the glycerin gelatin excipient DBM hump nose material comprises the following steps:

(1) taking 15 parts of gelatin according to parts by weight, and crushing the gelatin to below 30 meshes;

(2) 120 parts of triple distilled water; adding the crushed gelatin in the step (1) into the mixture to swell for 3 hours;

(3) heating 350 parts of glycerol to 90 ℃, adding the swollen gelatin prepared in the step (2), and uniformly mixing to form a sol system;

(4) irradiating the sol system formed in the step (3) by utilizing ultraviolet rays at the heating temperature of 60 ℃ for 20 hours, cooling to-20 ℃, and carrying out low-temperature treatment for 80 hours;

(5) restoring the sol system irradiated by ultraviolet rays to room temperature, respectively adding 350 parts of DBM bone powder with decalcification content of 10%, 32.5%, 65% and 97.5%, stirring, placing in a vacuum drying oven for 3h to remove bubbles, subpackaging in a 1ml syringe, packaging, and sterilizing. Respectively labeled A, B, C, D samples.

Experimental example 1: injection Performance test

And an HY-0580 microcomputer controlled electronic universal material testing machine is adopted to evaluate the injection performance of the forming DBM material. The sample of example 1 was tested by vertically fixing the sample in a test bench with a jig, the extrusion speed was 10mm/min, and the test results are shown in Table 1.

TABLE 1

Sample (I)	Maximum force/N
		Example 1	12.70±1.07

The test result shows that the injection force of the DBM material for injecting the hump nose prepared by the invention is 12.70 +/-1.07N, and the injection force can meet the requirements of clinical application of doctors.

Experimental example 2: cytotoxicity test

The cell compatibility of the shaped DBM material was evaluated using L929 cells. The sample of example 1 was added to the medium at a ratio of 0.2ml/1ml and extracted at 37 ℃ for 24h to obtain a leach solution. Taking normally cultured L929 cells, adjusting cell density to 2 × 10⁴Inoculating the culture medium to a 96-well culture plate, culturing for 24h, removing the original culture medium, and adding corresponding leaching liquor; after 72h, the original medium was discarded, 100ul of medium containing 10% CCK8 was added to each well, and absorbance was measured at a wavelength of 450nm after 30 min. The cell growth and relative proliferation rates of the cells in the sample group are shown in FIG. 1.

Test results show that the excipient DBM material prepared by the invention has no obvious influence on the growth state of cells, the relative proliferation rate of the cells is 96.93 +/-0.17%, and the cytotoxicity is 1 grade.

Experimental example 3: subcutaneous implantation test

Healthy New Zealand rabbits were sterilized by the ABCD injection hump nose DBM material of example 3, and injected subcutaneously into the backs of rabbits anesthetized with 10% chloral hydrate (2.5 mL/Kg body weight), and the control group was composed of a simple excipient and sodium hyaluronate. 3 animals were sacrificed at 6 and 12 months after surgery, respectively, and the implant material was taken out together with surrounding soft tissues, fixed with formalin, embedded with paraffin-removed, sectioned, stained, and observed with a light microscope.

No new zealand big ear rabbit after the material is implanted dies, and no red swelling, bleeding and liquid seepage appear on the wound. After postoperative material drawing, HE staining was performed for histological observation, and the results are shown in fig. 2. The observation under the light lens can be seen: after the DBM fine powder sample ABCD, sodium hyaluronate and the glycerogelatin excipient after being shaped are implanted into 1M and 3M of the material respectively, the tissue can observe the periphery of the material to form a package, the material is infiltrated by cells, obvious new bones are formed, blood vessels are infiltrated, partial degradation is caused, and the residual glycerogelatin excipient is not observed in the tissue. 6M residual material was less, with little new bone. Along with the prolonging of time, the material volume of the material-taking part is obviously reduced, and the occupation of the new fibrous tissue is not obvious. No decalcified bone matrix residual particles are observed in 12M after the operation, and the remodeling of the subcutaneous tissue is finished and the tissue is in a normal tissue structure shape. The DBM with decalcification degree of 32.5 percent can play a role in promoting tissue growth in tissue regeneration, the compatibility and degradation time of materials are remarkably better, and the long-acting effect of the DBM is remarkably superior to that of other groups.

Test results show that the excipient DBM material prepared by the invention does not cause local inflammatory reaction and has ideal histocompatibility; the 3M material after the operation is not obviously degraded, the 6M material after the operation is obviously degraded, decalcified bone matrix residual particles are not found after 12M observation after the operation, abnormal scar tissues are not generated, collagen fibers are uniformly distributed, inflammatory cells are not generated, the arrangement of tissue cells is regular, the shape is normal, and the structure of skin accessories and definite tissue levels can be seen. Can meet the requirement of the nose humping material with medium and long acting.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.