Recombinant III-type humanized collagen scar gel as well as preparation method and application thereof

Abstract

The invention relates to recombinant III-type humanized collagen scar gel as well as a preparation method and application thereof, and relates to the technical field of medical treatment. The recombinant III type humanized collagen scar gel is prepared from the following components: 0.1 to 1 part of recombinant III type humanized collagen, 0.1 to 1 part of chitosan, 10 to 20 parts of silicon dioxide, 20 to 30 parts of cyclopentasiloxane, 0.1 to 1 part of injection water and 60 to 70 parts of a polydimethylsiloxane alcohol / polydimethylsiloxane mixture. The scar gel added with the components such as the chitosan and the recombinant III type humanized collagen not only can promote the healing of an injured part and relieve the pain and swelling degree of scars, but also can prevent the formation of scar hyperplasia and keep the skin moist and elastic, and has more obvious application advantages than silicone gel on the market in scar prevention and treatment; the device can be applied to auxiliary treatment of scars caused by burns, scalds, wounds and surgical operations, and has wide application.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a recombinant type III humanized collagen scar gel and a preparation method and application thereof. Background Art

[0002] Scar hyperplasia is a skin injury caused by excessive growth of fibrous connective tissue. Following injury, the skin often experiences a burning sensation and pain. During the healing process, scar tissue rises above the skin's surface, causing redness, drying, and hardening, and resulting in various cosmetic changes and functional impairments. Scars reportedly occur in 40-70% of cases following skin injuries and surgery, and as high as 90% after burns and scalds. This creates significant physical and psychological challenges for patients. Studies have shown that applying silicones to the skin can reduce water evaporation, promote scar tissue hydration, and inhibit fibroblast proliferation and collagen deposition. While currently available silicone creams and gels have shown promising results in improving scar hyperplasia, they do not eliminate the burning sensation of scars or effectively restore skin elasticity. Summary of the Invention

[0003] In order to solve the above problems, the present invention provides a recombinant type III humanized collagen scar gel and its preparation method and application.

[0004] In a first aspect, the present invention provides a recombinant type III humanized collagen scar gel, which comprises the following components in parts by weight:

[0005] 0.1-1 parts of recombinant humanized type III collagen, 0.1-1 parts of chitosan, 10-20 parts of silicon dioxide, 20-30 parts of cyclopentasilane, 0.1-1 parts of injection water, and 60-70 parts of polydimethylsiloxane / polydimethylsiloxane mixture.

[0006] Furthermore, the recombinant type III humanized collagen scar gel comprises the following components in parts by weight:

[0007] 0.5 parts of recombinant humanized type III collagen, 0.5 parts of chitosan, 15 parts of silicon dioxide, 25 parts of cyclopentasilane, 0.5 parts of injection water, and 65 parts of polydimethylsiloxane / polydimethylsiloxane mixture.

[0008] In a second aspect, the present invention provides a method for preparing the recombinant humanized type III collagen scar gel according to any one of the first aspects, the preparation method comprising the following steps:

[0009] Stirring silica, cyclopentasilane and dimethicone / dimethicone mixture to obtain phase A;

[0010] Stir the recombinant type III humanized collagen and injection water until completely dissolved to obtain Phase B.

[0011] Add the Phase B and chitosan to the Phase A and stir evenly to obtain the recombinant type III humanized collagen scar gel.

[0012] In a third aspect, the present invention provides the use of the recombinant type III humanized collagen scar gel according to any one of the first and second aspects in the preparation of a product for treating scars.

[0013] In a fourth aspect, the present invention provides a product for treating scars caused by burns and scalds, and the product for treating scars caused by burns and scalds includes the recombinant type III humanized collagen scar gel according to any one of the first and second aspects.

[0014] In a fifth aspect, the present invention provides a product for treating scars caused by trauma, and the product for treating scars caused by burns and scalds includes the recombinant type III humanized collagen scar gel according to any one of the first and second aspects.

[0015] In a sixth aspect, the present invention provides a product for treating scars caused by surgical operations, and the product for treating scars caused by burns and scalds includes the recombinant type III humanized collagen scar gel according to any one of the first and second aspects.

[0016] The above technical solutions provided by the embodiments of the present invention have at least the following advantages compared with the prior art:

[0017] The embodiments of the present invention provide a recombinant type III humanized collagen scar gel. The scar gel of the present invention added with components such as chitosan and recombinant type III humanized collagen can not only promote the healing of the damaged area, reduce the degree of scar pain and swelling, but also prevent the formation of scar hyperplasia, maintain the moisture and elasticity of the skin, and has more obvious application advantages in preventing and treating scars than the silicone gel on the market. It can be applied in the adjuvant treatment of scars caused by burns and scalds, trauma and surgical operations, and has a wide range of uses. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The accompanying drawings here are incorporated into the specification and form a part of this specification, showing embodiments consistent with the present invention, and are used together with the specification to explain the principles of the present invention.

[0019] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the accompanying drawings required for the description of the embodiments or the prior art. Obviously, for those of ordinary skill in the art, other drawings can also be obtained based on these drawings without creative efforts.

[0020] Figure 1 Flow chart of the preparation method of the recombinant type III humanized collagen scar gel provided by the embodiments of the present invention;

[0021] Figure 2 Characterization result diagram of heavy metal content in the present invention.

[0022] Figure 3 Characterization result diagram of the contents of aerobic bacteria, molds and yeasts by the microbial counting method in the present invention.

[0023] Figure 4 Characterization result diagram of the presence of pathogenic bacteria by the control bacteria inspection method in the present invention. Detailed implementation manners

[0024] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some but not all of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0025] Unless otherwise specifically stated, various raw materials, reagents, instruments and equipment used in the present invention can be obtained through market purchase or can be prepared by existing methods.

[0026] In a first aspect, the present invention provides a recombinant type III humanized collagen scar gel, which, by weight parts, comprises the following components:

[0027] 0.1 - 1 part of recombinant type III humanized collagen, 0.1 - 1 part of chitosan, 10 - 20 parts of silicon dioxide, 20 - 30 parts of cyclopentasiloxane, 0.1 - 1 part of injection water, 60 - 70 parts of a polydimethylsiloxanol / polydimethylsiloxane mixture.

[0028] The embodiments of the present invention provide a recombinant type III humanized collagen scar gel. The scar gel of the present invention added with components such as chitosan and recombinant type III humanized collagen can not only promote the healing of the damaged area, reduce the pain and redness and swelling of the scar, but also prevent the formation of scar hyperplasia, keep the skin moist and elastic, and has more obvious application advantages in preventing and treating scars than the silicone gel on the market. It can be applied to the adjuvant treatment of scars caused by burns, traumas and surgical operations and has a wide range of uses. Specifically:

[0029] (1) Recombinant type III humanized collagen is found in the skin, blood vessels and muscles and is a major component of the extracellular matrix. It has a high level of biological activity and biocompatibility, can promote cell growth, support high cell adhesion performance, and has the effects of maintaining skin elasticity and repairing wounds. During the common healing process, scar hyperplasia is generally more severe, manifested as the scar tissue protruding above the skin surface, being dry, hard and showing various shape changes and functional disorders, and lacking good skin elasticity. Recombinant type III humanized collagen not only maintains the elasticity of the damaged body and provides moisturizing factors, but also reduces the problem of scar hyperplasia during the healing process.

[0030] (2) Chitosan can enhance the adhesion and aggregation of platelets and can form a separating membrane that can be absorbed by the body. It not only has the function of protecting the wound, but also takes into account the functions of anti-exudation, anti-adhesion, hemostasis, prevention of infection and wound healing. It is mostly used for treating various body surface wounds, preventing wound infections, promoting wound healing, having the effects of hemostasis and anti-inflammatory, reducing tissue fluid exudation, preventing tissue adhesion, being able to prevent infection and promote wound healing, and playing an important auxiliary role in the treatment of scars. It has hemostatic performance and antibacterial activity, can repair scars and reduce redness and pain.

[0031] (3) The scar gel of the present invention added with chitosan and recombinant type III humanized collagen can not only promote the healing of the damaged area, reduce the pain and redness of the scar, but also prevent the formation of scar hyperplasia, maintain the moisture and elasticity of the skin. The recombinant type III humanized collagen scar gel can effectively avoid the problems of skin burning, pain, redness, dryness and hardening after injury, prevent, improve and solve scar problems, and has more obvious application advantages than silicone gels on the market for preventing and treating scars.

[0032] In some specific embodiments, by weight, the recombinant type III humanized collagen scar gel comprises the following components:

[0033] 0.5 part of recombinant type III humanized collagen, 0.5 part of chitosan, 15 parts of silicon dioxide, 25 parts of cyclopentasiloxane, 0.5 part of injection water, 65 parts of a polydimethylsiloxanol / polydimethylsiloxane mixture.

[0034] Second, based on a general inventive concept, the present invention provides a preparation method of the recombinant type III humanized collagen scar gel according to any one of the first aspect, as Figure 1 shown, the preparation method comprises the following steps:

[0035] Stir silicon dioxide, cyclopentasiloxane and the polydimethylsiloxanol / polydimethylsiloxane mixture evenly to obtain phase A;

[0036] Stir the recombinant type III humanized collagen and injection water until completely dissolved to obtain Phase B.

[0037] Add the Phase B and chitosan to the Phase A and stir evenly to obtain the recombinant type III humanized collagen scar gel.

[0038] The preparation method of the recombinant type III humanized collagen scar gel provided by the present invention is simple in operation, does not require additional specific equipment, and is suitable for batch industrial production.

[0039] In a third aspect, based on a general inventive concept, the present invention provides the use of the recombinant type III humanized collagen scar gel according to any one of the first aspect and the second aspect in the preparation of a product for treating scars.

[0040] In a fourth aspect, based on a general inventive concept, the present invention provides a product for treating scars caused by burns and scalds, and the product for treating scars caused by burns and scalds includes the recombinant type III humanized collagen scar gel according to any one of the first aspect and the second aspect.

[0041] In a fifth aspect, based on a general inventive concept, the present invention provides a product for treating scars caused by trauma, and the product for treating scars caused by burns and scalds includes the recombinant type III humanized collagen scar gel according to any one of the first aspect and the second aspect.

[0042] In a sixth aspect, based on a general inventive concept, the present invention provides a product for treating scars caused by surgical operations, and the product for treating scars caused by burns and scalds includes the recombinant type III humanized collagen scar gel according to any one of the first aspect and the second aspect.

[0043] The following further elaborates the present invention in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. The experimental methods without specific conditions noted in the following embodiments are generally determined according to national standards. If there is no corresponding national standard, they are carried out according to general international standards, conventional conditions, or conditions recommended by the manufacturer.

[0044] Example 1

[0045] This example provides a recombinant type III humanized collagen scar gel, and in parts by weight, the recombinant type III humanized collagen scar gel includes the following components:

[0046] 0.5 part of recombinant type III humanized collagen, 0.5 part of chitosan, 15 parts of silicon dioxide, 25 parts of cyclopentasiloxane, 0.5 part of injection water, and 65 parts of a polydimethylsiloxanol / polydimethylsiloxane mixture.

[0047] The preparation method of the above-mentioned recombinant type III humanized collagen scar gel comprises the following steps:

[0048] (1) Prepare phase A: Phase A contains silicon dioxide, cyclopentasiloxane, and a mixture of dimethicone copolyol / dimethicone. Stir evenly.

[0049] (2) Prepare phase B: Phase B contains recombinant type III humanized collagen and injection water. Stir until completely dissolved to obtain recombinant type III humanized collagen solution.

[0050] (3) Prepare phase C: Phase C contains chitosan.

[0051] (4) Add the prepared recombinant type III humanized collagen solution of phase B and chitosan of phase C to phase A together, and stir evenly to obtain a recombinant type III humanized collagen scar gel containing.

[0052] To verify the successful preparation of the recombinant type III humanized collagen scar gel in this example, the prepared recombinant type III humanized collagen scar gel is characterized by heavy metal content, viscosity, and microbial limit, as follows:

[0053] 1. Heavy metal content

[0054] 1.1 Method: Accurately weigh 1.0 g of the recombinant type III humanized collagen scar gel sample, evaporate to dryness, slowly incinerate until completely carbonized, cool, add 0.5 - 1 mL of sulfuric acid to make it just moist, heat at low temperature until the sulfuric acid is removed, add 0.5 mL of nitric acid, evaporate to dryness, until the nitrogen oxide vapor is removed, cool, incinerate at 500 - 600 °C until completely ashed, cool, add 2 mL of hydrochloric acid, evaporate to dryness on a water bath, then add 15 mL of purified water, dropwise add ammonia test solution (take 40 mL of ammonia water and dilute it to 100 mL with purified water) until the phenolphthalein indicator solution (take 1.0 g of phenolphthalein and dissolve it in 100 mL of ethanol) shows a faint pink color, then add 2 mL of acetate buffer solution (pH 3.5), dissolve by gentle heating, transfer to a Nessler tube, and dilute to 25 mL with purified water as tube B; take another 1.0 mL of purified water, evaporate to dryness in a porcelain dish, add 2 mL of acetate buffer (pH 3.5) and 15 mL of water, dissolve by gentle heating, transfer to a Nessler tube, add 1.0 mL of standard lead solution, and then dilute to 25 mL with purified water as tube A; then add 2 mL of thioacetamide test solution to each of tubes A and B respectively, shake well, let stand for 2 minutes, place on white paper, and look down through from above. The color shown in tube B shall not be deeper than that in tube A.

[0055] 1.2 Test results: Test twice. The test results show that the color of the test solution is lighter than that of the control solution, that is

[0056] <10 μg / g, specifically as Figure 2 shown.

[0057] 2. Viscosity:

[0058] 2.1 Use a rotary viscometer and determine it according to the provisions of Method 3 in General Rule 0633 of the Pharmacopoeia of the People's Republic of China (2020 Edition, Volume IV).

[0059] 2.2 Test results: Under the conditions of this test, the viscosity of the test sample is 5670 mPa·S.

[0060] 3. Microbial Limit

[0061] 3.1 Microbial Counting Method

[0062] 3.1.1 Eluent and diluent: pH 7.0 sodium chloride peptone buffer solution

[0063] 3.1.2 Sample treatment: Weigh 10 g of the test sample from 3 independent packages under aseptic operation and transfer it to 100 ml of sterile eluent. After shaking 80 times, it is used as a 1:10 test solution for standby; for easy counting, the test solution is diluted by a ten-fold gradient; for aerobic bacteria culture: Take 2 ml of the test solution or the diluted test solution and inoculate it into 2 plates, 1 ml per plate. Inject about 20 ml of TSA into each plate and culture it at 32.5 °C for 5 days; for mold and yeast culture: Take 2 ml of the test solution or the diluted test solution and inoculate it into 2 plates, 1 ml per plate. Inject about 20 ml of SDA into each plate and culture it at 22.5 °C for 7 days;

[0064] 3.1.3 Negative control: Take sterile eluent instead of the test solution or the diluted test solution and culture it in the same method as 3.5.3 and 3.5.4;

[0065] 3.1.4 Counting: Count according to the colony counting principle, and then multiply by the dilution factor to calculate the colony number of each product.

[0066] 3.1.5 Results: Aerobic bacteria ≤ 10 cfu / g, molds and yeasts ≤ 10 cfu / g, specifically as Figure 3 shown.

[0067] 3.2 Control Bacteria Inspection Method

[0068] 3.2.1 Bacterial suspension preparation: Take the subcultures of Staphylococcus aureus and Pseudomonas aeruginosa and prepare a bacterial suspension with less than 100 cfu / ml for standby. Use the standard plate counting method to count the microorganisms (cfu);

[0069] 3.2.2 Test group: Pseudomonas aeruginosa: Take 10 ml of the test solution and inoculate it into 100 ml of TSB, and culture at 32.5 °C for 18 - 24 h. Take the above culture and streak inoculate it on the cetrimonium bromide agar medium plate, and culture at 32.5 °C for 18 - 72 h. Take the suspected colonies for isolation and purification, and conduct biochemical identification. Staphylococcus aureus: Take 10 ml of the test solution and inoculate it into 100 ml of TSB, and culture at 32.5 °C for 18 - 24 h. Take the above culture and streak inoculate it on the mannitol sodium chloride agar medium plate, and culture at 32.5 °C for 18 - 72 h. Take the suspected colonies for isolation and purification, and conduct biochemical identification.

[0070] 3.2.3 Negative control: Take the sterile diluent instead of the test solution and operate according to the test group.

[0071] 3.2.4 Positive control: Take the bacterial suspension instead of the test solution and operate according to the test group.

[0072] 3.2.5 Results: Staphylococcus aureus and Pseudomonas aeruginosa were not detected, as specifically shown in Figure 4 shown.

[0073] Example 2

[0074] This example provides a recombinant type III humanized collagen scar gel. Calculated by weight, the recombinant type III humanized collagen scar gel comprises the following components:

[0075] 0.1 part of recombinant type III humanized collagen, 0.1 part of chitosan, 10 parts of silicon dioxide, 20 parts of cyclopentasiloxane, 0.1 part of injection water, 60 parts of polydimethylsiloxanol / polydimethylsiloxane mixture.

[0076] The preparation method of the above recombinant type III humanized collagen scar gel comprises the following steps:

[0077] (1) Prepare phase A: Phase A contains silicon dioxide, cyclopentasiloxane, polydimethylsiloxanol / polydimethylsiloxane mixture, and stir evenly;

[0078] (2) Prepare phase B: Phase B contains recombinant type III humanized collagen and injection water, and stir until completely dissolved to obtain the recombinant type III humanized collagen solution;

[0079] (3) Prepare phase C: Phase C contains chitosan;

[0080] (4) Add the prepared phase B recombinant type III humanized collagen solution and phase C chitosan into phase A together, and stir evenly to obtain the recombinant type III humanized collagen scar gel containing.

[0081] Example 3

[0082] This example provides a recombinant type III humanized collagen scar gel. In parts by weight, the recombinant type III humanized collagen scar gel comprises the following components:

[0083] 1 part of recombinant type III humanized collagen, 1 part of chitosan, 20 parts of silicon dioxide, 30 parts of cyclopentasiloxane, 1 part of injection water, and 70 parts of a polydimethylsiloxanol / polydimethylsiloxane mixture.

[0084] The preparation method of the above-mentioned recombinant type III humanized collagen scar gel comprises the following steps:

[0085] (1) Prepare phase A: Phase A contains silicon dioxide, cyclopentasiloxane, and a polydimethylsiloxanol / polydimethylsiloxane mixture, and stir evenly.

[0086] (2) Prepare phase B: Phase B contains recombinant type III humanized collagen and injection water, and stir until completely dissolved to obtain a recombinant type III humanized collagen solution.

[0087] (3) Prepare phase C: Phase C contains chitosan.

[0088] (4) Add the prepared phase B recombinant type III humanized collagen solution and phase C chitosan to phase A together, and stir evenly to obtain a recombinant type III humanized collagen scar gel containing.

[0089] In summary, the embodiment of the present invention provides a recombinant type III humanized collagen scar gel and a preparation method thereof. The scar gel of the present invention added with components such as chitosan and recombinant type III humanized collagen can not only promote the healing of the damaged area, reduce the degree of scar pain and swelling, but also prevent the formation of scar hyperplasia, maintain the moisture and elasticity of the skin, and has more obvious application advantages in preventing and treating scars than silicone gels on the market. It can be applied to the adjuvant treatment of scars caused by burns, traumas, and surgical operations, and has a wide range of uses.

[0090] The various embodiments of the present invention may exist in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be construed as a rigid limitation on the scope of the present invention; therefore, it should be considered that the range description has specifically disclosed all possible sub-ranges and single values within the range. For example, it should be considered that the range description from 1 to 6 has specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within the range, such as 1, 2, 3, 4, 5, and 6, regardless of the range. Additionally, whenever a numerical range is indicated herein, it means including any cited number (fraction or integer) within the indicated range.

[0091] In the present invention, unless otherwise specified, the orientation terms such as "upper" and "lower" specifically refer to the drawing directions in the attached drawings. Additionally, in the description of the specification of the present invention, terms such as "comprising" and "including" mean "including but not limited to". In this text, relative terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. In this text, "and / or" describes the associated relationship of associated objects and indicates that three relationships can exist. For example, A and / or B can represent: A exists alone, A and B exist simultaneously, and B exists alone. Where A and B can be singular or plural. In this text, "at least one" means one or more, and "a plurality" means two or more. "At least one kind", "at least one item (one) of the following" or similar expressions refer to any combination of these items, including any combination of single item (one) or plural items (one). For example, "at least one item (one) of a, b, or c", or, "at least one item (one) of a, b, and c" can both represent: a, b, c, a - b (i.e., a and b), a - c, b - c, or a - b - c, where a, b, and c can be single or multiple respectively.

[0092] The above are only specific embodiments of the present invention, enabling those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown herein, but rather to the broadest scope consistent with the principles and novel features claimed herein.

Claims

1. A recombinant type III humanized collagen scar gel, characterized in that, The recombinant type III humanized collagen scar gel comprises the following components in parts by weight: Recombinant type III humanized collagen 0.1 - 1 part, chitosan 0.1 - 1 part, silicon dioxide 10 - 20 parts, cyclopentasiloxane 20 - 30 parts, injection water 0.1 - 1 part, polydimethylsiloxanol / polydimethylsiloxane mixture 60 - 70 parts.

2. The recombinant type III humanized collagen scar gel according to claim 1, wherein The recombinant type III humanized collagen scar gel comprises the following components in parts by weight: Recombinant type III humanized collagen 0.5 part, chitosan 0.5 part, silicon dioxide 15 parts, cyclopentasiloxane 25 parts, injection water 0.5 part, polydimethylsiloxanol / polydimethylsiloxane mixture 65 parts.

3. A method for preparing the recombinant type III humanized collagen scar gel according to any one of claims 1 to 2, characterized in that, The preparation method comprises the following steps: Stir silicon dioxide, cyclopentasiloxane and polydimethylsiloxanol / polydimethylsiloxane mixture evenly to obtain phase A; Stir recombinant type III humanized collagen and injection water until completely dissolved to obtain phase B; Add the phase B and chitosan into the phase A and stir evenly to obtain the recombinant type III humanized collagen scar gel.

4. Use of the recombinant type III humanized collagen scar gel according to any one of claims 1 to 3 in the preparation of a product for treating scars.

5. A product for treating scars caused by burns and scalds, characterized in that, The product for treating scars caused by burns and scalds comprises the recombinant type III humanized collagen scar gel according to any one of claims 1 to 3.

6. A product for treating scars caused by trauma, characterized in that, The product for treating scars caused by burns and scalds comprises the recombinant type III humanized collagen scar gel according to any one of claims 1 to 3.

7. A product for treating scars caused by surgical operations, characterized in that, The product for treating scars caused by burns and scalds comprises the recombinant type III humanized collagen scar gel according to any one of claims 1 to 3.

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