A repair, anti-inflammatory and moisturizing composition containing recombinant collagen and its application

Abstract

The present invention relates to a repair, anti-inflammatory and moisturizing composition containing recombinant collagen and its application. The repair, anti-inflammatory and moisturizing composition containing recombinant collagen includes recombinant collagen, schizophyllan polysaccharide and succinyl carboxymethyl chitosan. In the present invention, the recombinant collagen plays a role in repair and regeneration and can promote the healing of skin wounds; the schizophyllan polysaccharide plays a role in repair and moisturization and can provide a moist environment for the wound surface; the succinyl carboxymethyl chitosan plays an antibacterial and anti-inflammatory role. By using recombinant collagen, schizophyllan polysaccharide and succinyl carboxymethyl chitosan, the composition of the present invention synergistically exerts the effects of antibacterial, anti-inflammatory, moisturizing and repair, and can better promote the healing of skin wounds.

Description

Technical Field

[0001] The present invention belongs to the field of medical materials, and particularly relates to a repair, anti-inflammatory and moisturizing composition containing recombinant collagen and its application. Background Art

[0002] The skin is the most important physical barrier for protecting the human body from damage by the external environment. Skin damage can affect the epidermal tissue and vascular network, and the dermal structure may also be damaged, bringing a series of safety hazards. Skin damage caused by trauma and trauma infections is a common case in hospitals. Wound dressings can act as a protective barrier and serve as a temporary covering for wounds. During the wound healing process, they can temporarily replace the damaged skin to play a protective role, prevent wound infection and inflammation, and provide a favorable environment for the rapid healing of wounds.

[0003] Due to a series of problems exposed by traditional dressings such as gauze and bandages during use, such as wound adhesion, poor moisturizing property, easy infection, and no wound healing promotion effect, with the development of materials science and industrial science, a variety of new dressings are gradually replacing traditional dressings and playing an important role in the field of wound repair.

[0004] CN117205356A discloses a medical dressing containing seaweed extract and its preparation method. The preparation method includes the following steps: sodium alginate undergoes an oxidation reaction under the action of sodium periodate to generate an oxidized derivative of sodium alginate; the oxidized derivative of sodium alginate reacts with sodium alginate, chitosan, and tosylmethyl isocyanide to generate an alginic acid derivative; the alginic acid derivative is mixed with sodium alginate and deionized water to obtain an alginic acid spinning solution, and the alginic acid spinning solution is electrospun into an electrospun fiber dressing through an electrospinning process; the electrospun fiber dressing is placed in a calcium chloride solution for impregnation, and after the impregnation is completed, it is washed and dried to obtain a medical dressing containing seaweed extract. In this invention, the prepared alginic acid spinning solution has low conductivity and small surface tension, good electrospinning performance, and the prepared medical dressing containing seaweed extract has good mechanical strength and excellent antibacterial properties.

[0005] CN115400260A discloses a repair gel containing recombinant humanized collagen and its preparation method; the raw materials for preparing the repair gel include the following components calculated by mass percentage: active ingredient 0.01 - 2%, thickener 0.5 - 8%, humectant 2 - 10%, coupling agent 0.1 - 1%, medical preservative 0.01 - 1%. The recombinant human type III collagen in the repair gel provided by this invention can supplement the reduction or deficiency during the wound repair process and promote the regeneration of skin cells, and a repair gel with high mechanical strength and containing recombinant humanized collagen is prepared.

[0006] The above dressing can cover the wound and provide an environment for promoting wound healing, but its moisturizing, repairing, antibacterial and anti-inflammatory effects need to be improved. Therefore, there is an urgent need to provide a product with moisturizing, repairing, antibacterial and anti-inflammatory effects to meet the application requirements. Summary of the Invention

[0007] Aiming at the deficiencies of the prior art, the purpose of the present invention is to provide a repair, anti-inflammatory and moisturizing composition containing recombinant collagen and its application. The product components provided by the present invention have mild properties and excellent anti-wrinkle, repair and moisturizing effects.

[0008] To achieve the purpose of this invention, the following technical solutions are adopted:

[0009] In the first aspect, the present invention provides a repair, anti-inflammatory and moisturizing composition containing recombinant collagen. The repair, anti-inflammatory and moisturizing composition containing recombinant collagen includes recombinant collagen, schizophyllan polysaccharide and succinyl carboxymethyl chitosan.

[0010] In the present invention, recombinant collagen plays a role in repair and regeneration and can promote the healing of skin wounds; schizophyllan polysaccharide plays a role in repair and moisturizing and can provide a moist environment for the wound surface; succinyl carboxymethyl chitosan plays an antibacterial and anti-inflammatory role. The composition of the present invention exerts antibacterial, anti-inflammatory, moisturizing and repair effects through the combined use of recombinant collagen, schizophyllan polysaccharide and succinyl carboxymethyl chitosan, and can better promote the healing of skin wounds. In addition, the combined use of two polysaccharides, schizophyllan polysaccharide and succinyl carboxymethyl chitosan, in the present invention can improve the activity and stability of recombinant collagen, and further accelerate the metabolism of skin wound surface cells to help repair damaged tissues.

[0011] Preferably, the mass ratio of the recombinant collagen, schizophyllan polysaccharide and succinyl carboxymethyl chitosan is (0.1-1):(0.1-2):(0.1-1).

[0012] Among them, "0.1-1" can be 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8 or 0.9, etc.;

[0013] "0.1-2" can be 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8 or 1.9, etc.;

[0014] "0.1-1" can be 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8 or 0.9, etc.

[0015] Preferably, the mass ratio of the recombinant collagen, schizophyllan and succinyl carboxymethyl chitosan is (0.1-1):(0.1-0.5):(0.1-1).

[0016] Preferably, the mass ratio of the schizophyllan and succinyl carboxymethyl chitosan is (1-2):1.

[0017] In the present invention, when the mass ratio of schizophyllan to succinyl carboxymethyl chitosan is (1-2):1, the activity and stability of the recombinant collagen can be maintained optimally.

[0018] Preferably, the recombinant collagen includes any one of type I recombinant collagen, type II recombinant collagen and type III recombinant collagen.

[0019] Preferably, the amino acid sequence of the recombinant collagen includes the amino acids at positions 950-1075 of type I collagen, and the amino acids at positions 594-729 and 1193-1199 of type III collagen.

[0020] Preferably, the schizophyllan is octenyl succinic anhydride modified schizophyllan.

[0021] In the present invention, after being modified with octenyl succinic anhydride, the stability of the schizophyllan is improved, and its compatibility with other components is better.

[0022] In a second aspect, the present invention provides an application of a repair, anti-inflammatory and moisturizing composition containing recombinant collagen as described in the first aspect in a medical device.

[0023] Preferably, the medical device includes a medical gel and / or a medical dressing.

[0024] In a third aspect, the present invention provides a gel with repair, anti-inflammatory and moisturizing effects. The gel with repair, anti-inflammatory and moisturizing effects includes 0.1-5 parts of the repair, anti-inflammatory and moisturizing composition containing recombinant collagen as described in the first aspect, 5-15 parts of polyvinyl alcohol, 2-5 parts of sorbitol, 10-30 parts of auxiliary materials and 20-50 parts of deionized water by weight.

[0025] The gel with repair, anti-inflammatory and moisturizing effects provided by the present invention has good biocompatibility, can provide a moist recovery environment for skin wounds, and thus accelerate the repair and healing speed of skin wounds.

[0026] Preferably, the auxiliary materials include a humectant and / or a skin conditioner.

[0027] Preferably, the auxiliary materials include a humectant and a skin conditioner.

[0028] Preferably, the humectant includes glycerol and / or butanediol.

[0029] Preferably, the skin conditioner includes plant extracts and / or niacinamide.

[0030] Preferably, the skin conditioner is a combination of plant extracts and niacinamide.

[0031] Preferably, the mass ratio of the plant extracts to niacinamide is 1:(0.5 - 2), and can be, for example, 1:0.6, 1:0.7, 1:0.8, 1:0.9, 1:0.10, 1:0.11, 1:0.12, 1:0.13, 1:0.14, 1:0.15, 1:0.16, 1:0.17, 1:0.18 or 1:0.19, etc.

[0032] Preferably, the plant extracts include any one or a combination of at least two of aloe extract, cactus extract, angelica extract or notoginseng extract.

[0033] Preferably, the plant extracts are a combination of aloe extract, cactus extract and notoginseng extract.

[0034] In the present invention, the plant extracts are selected as a combination of aloe extract, cactus extract and notoginseng extract. All three have the effects of antibacterial and anti - inflammatory, and can provide a moist environment for the skin wound surface, prevent the surrounding skin from being macerated, and are more conducive to the repair of the wound surface.

[0035] Preferably, the mass ratio of the aloe extract, cactus extract and notoginseng extract is (1 - 3):(1 - 2):(0.1 - 1).

[0036] Among them, "1 - 3" can be 1.1, 1.3, 1.5, 1.7, 1.9, 2, 2.1, 2.3, 2.5, 2.7 or 2.9, etc.;

[0037] "1 - 2" can be 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8 or 1.9, etc.;

[0038] "0.1 - 1" can be 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8 or 0.9, etc.

[0039] Preferably, the auxiliary materials further include any one or a combination of at least two of emulsifiers, stabilizers or thickeners.

[0040] Preferably, the emulsifiers include any one or a combination of at least two of polysorbate - 80, PEG - 40 hydrogenated castor oil, PEG - 60 hydrogenated castor oil, glycerol monostearate or cetearyl alcohol.

[0041] Preferably, the stabilizer includes EDTA-2Na and / or sodium oleate.

[0042] Preferably, the thickener includes any one or a combination of at least two of xanthan gum, carbomer or sodium acrylate copolymer.

[0043] Preferably, the gel with the functions of repair, anti-inflammation and moisturization comprises, by weight, 0.1-5 parts of the repair, anti-inflammation and moisturization composition containing recombinant collagen as described in the first aspect, 5-15 parts of polyvinyl alcohol, 2-5 parts of sorbitol, 5-15 parts of a moisturizing agent, 5-10 parts of a skin conditioner, 1-3 parts of an emulsifier, 0.1-1 part of a stabilizer, 0.1-1 part of a thickener and 20-50 parts of deionized water.

[0044] In the gel with the functions of repair, anti-inflammation and moisturization of the present invention, the addition amount of the repair, anti-inflammation and moisturization composition containing recombinant collagen can be 0.5 part, 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts or 4.5 parts, etc.;

[0045] The addition amount of the polyvinyl alcohol is 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts or 14 parts, etc.;

[0046] The addition amount of the sorbitol can be 2.2 parts, 2.5 parts, 2.8 parts, 3 parts, 3.2 parts, 3.5 parts, 3.8 parts, 4 parts, 4.2 parts, 4.5 parts or 4.8 parts, etc.;

[0047] The addition amount of the moisturizing agent can be 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts or 14 parts, etc.;

[0048] The addition amount of the skin conditioner can be 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts or 9.5 parts, etc.;

[0049] The addition amount of the emulsifier can be 1.1 parts, 1.3 parts, 1.5 parts, 1.7 parts, 2 parts, 2.1 parts, 2.3 parts, 2.5 parts, 2.7 parts or 2.9 parts, etc.;

[0050] The addition amount of the stabilizer can be 0.2 parts, 0.3 parts, 0.4 parts, 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts or 0.9 parts, etc.;

[0051] The addition amount of the thickener can be 0.2 parts, 0.3 parts, 0.4 parts, 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts or 0.9 parts, etc.

[0052] Fourthly, the present invention provides a preparation method of a gel having the functions of repair, anti-inflammation and moisturization as described in the third aspect. The method includes mixing a repair, anti-inflammatory and moisturizing composition containing recombinant collagen, polyvinyl alcohol, sorbitol and optionally excipients in deionized water, and homogenizing to obtain the gel having the functions of repair, anti-inflammation and moisturization.

[0053] Preferably, the preparation method includes:

[0054] (1) Dissolve polyvinyl alcohol in a part of deionized water, and stir to obtain a polyvinyl alcohol solution;

[0055] Add the repair, anti-inflammatory and moisturizing composition containing recombinant collagen into the remaining deionized water and mix to obtain a mixed solution;

[0056] (2) Sequentially add the mixed solution prepared in step (1), sorbitol, humectant, skin conditioner, emulsifier, thickener and stabilizer into the polyvinyl alcohol solution prepared in step (1), mix and homogenize, then freeze at a low temperature, and thaw in a mold to obtain the gel having the functions of repair, anti-inflammation and moisturization.

[0057] Preferably, the part of deionized water in step (1) is 50-70% of the total amount of deionized water, and can be, for example, 52%, 55%, 58%, 60%, 62%, 65% or 68%, etc.

[0058] Preferably, the low temperature in step (2) is -20 to -30 °C, and can be, for example, -21 °C, -23 °C, -25 °C, -27 °C or -29 °C, etc.

[0059] Preferably, freezing at a low temperature and thawing in a mold in step (2) need to be carried out cyclically.

[0060] Preferably, the number of cycles is 3-5 times, and can be, for example, 3 times, 4 times or 5 times, etc.

[0061] Compared with the prior art, the present invention has the following beneficial effects:

[0062] (1) In the present invention, recombinant collagen plays a role in repair and regeneration, which can promote the healing of skin wounds; Schizophyllan plays a role in repair and moisturization, which can provide a moist environment for the wound; succinyl carboxymethyl chitosan plays an antibacterial and anti-inflammatory role. The composition of the present invention uses recombinant collagen, Schizophyllan and succinyl carboxymethyl chitosan, and the three work together to exert the effects of antibacterial, anti-inflammatory, moisturizing and repair, and can better promote the healing of skin wounds.

[0063] (2) In the present invention, two polysaccharides, Schizophyllan and succinyl carboxymethyl chitosan, are used in combination, which can improve the activity and stability of recombinant collagen, and further can accelerate the metabolism of skin wound cells and help repair damaged tissues.

[0064] (3) The gel with repair, anti - inflammation and moisturizing effects provided by the present invention has good biocompatibility, can provide a moist recovery environment for skin wounds, and thus accelerate the repair and healing speed of skin wounds.

[0065] (4) The preparation method of the gel with repair, anti - inflammation and moisturizing effects provided by the present invention has simple operation steps, low cost, and is easy for large - scale industrial production. Detailed Embodiments

[0066] To further illustrate the technical means and effects adopted by the present invention, the following further describes the technical solutions of the present invention in combination with the preferred embodiments of the present invention, but the present invention is not limited to the scope of the embodiments.

[0067] The weight parts involved in the following embodiments and comparative examples are calculated based on the actual active ingredients contained in the commercially available raw materials. The commercially available raw materials may also optionally contain any one or at least two combinations of solvents, fillers, diluents, stabilizers, pH regulators, antibacterial agents, antioxidants or impurities within the allowable range.

[0068] Some of the materials and grade information involved in the embodiments and comparative examples of the present invention are as follows:

[0069]

[0070]

[0071] The remaining raw materials can be used as long as they are purchased from regular distributors.

[0072] Preparation Example 1

[0073] This preparation example provides a schizophyllan polysaccharide modified with octenyl succinic anhydride, and its preparation method is as follows:

[0074] (1) Dissolve schizophyllan polysaccharide in deionized water, and the mass ratio of schizophyllan polysaccharide to deionized water is 1:40. Heat it in a water bath at 80 °C for 2 h until the schizophyllan polysaccharide is completely dissolved, and hydrate it at 4 °C for 12 h to obtain a schizophyllan polysaccharide solution;

[0075] (2) Heat the schizophyllan polysaccharide solution to 40 °C, adjust the pH to 9, and add octenyl succinic anhydride under continuous stirring and heating conditions. The mass ratio of schizophyllan polysaccharide to octenyl succinic anhydride is 1:0.5, react for 3 h, continuously measure the pH value of the reaction system and add 3% NaOH solution to keep the pH value of the reaction system at 8.0 - 9.0. When the pH change value within 20 min ≤ 1, add 1 mol / L HCl solution to adjust the pH value of the reaction system to 6.5, and the reaction stops to obtain a modified schizophyllan polysaccharide solution;

[0076] (3) The modified Schizophyllum commune polysaccharide solution is dialyzed for 60 h with a dialysis bag having a cut-off weight average molecular weight of 30,000, and then freeze-dried to obtain the octenyl succinic anhydride-modified Schizophyllum commune polysaccharide.

[0077] Example 1

[0078] This example provides a repair, anti-inflammatory and moisturizing composition containing recombinant collagen. The repair, anti-inflammatory and moisturizing composition containing recombinant collagen is composed of recombinant collagen, the Schizophyllum commune polysaccharide prepared in Preparation Example 1, and succinyl carboxymethyl chitosan at a mass ratio of 2:1:1.

[0079] Example 2

[0080] This example provides a repair, anti-inflammatory and moisturizing composition containing recombinant collagen. The repair, anti-inflammatory and moisturizing composition containing recombinant collagen is composed of recombinant collagen, the Schizophyllum commune polysaccharide prepared in Preparation Example 1, and succinyl carboxymethyl chitosan at a mass ratio of 1:5:2.5.

[0081] Example 3

[0082] This example provides a repair, anti-inflammatory and moisturizing composition containing recombinant collagen. The repair, anti-inflammatory and moisturizing composition containing recombinant collagen is composed of recombinant collagen, the Schizophyllum commune polysaccharide prepared in Preparation Example 1, and succinyl carboxymethyl chitosan at a mass ratio of 10:1.5:1.

[0083] Example 4

[0084] This example provides a repair, anti-inflammatory and moisturizing composition containing recombinant collagen. The difference between the repair, anti-inflammatory and moisturizing composition containing recombinant collagen and that in Example 1 is that the octenyl succinic anhydride-modified Schizophyllum commune polysaccharide prepared in Preparation Example 1 is replaced with an equal amount of unmodified Schizophyllum commune polysaccharide, and the other components and their addition amounts are the same as those in Example 1.

[0085] Example 5

[0086] This example provides a repair, anti-inflammatory and moisturizing composition containing recombinant collagen. The difference between the repair, anti-inflammatory and moisturizing composition containing recombinant collagen and that in Example 1 is that the succinyl carboxymethyl chitosan is replaced with an equal amount of unmodified chitosan, and the other components and their addition amounts are the same as those in Example 1.

[0087] Example 6

[0088] This example provides a repair, anti-inflammatory and moisturizing composition containing recombinant collagen. The repair, anti-inflammatory and moisturizing composition containing recombinant collagen is composed of recombinant collagen, the Schizophyllum commune polysaccharide prepared in Preparation Example 1, and succinyl carboxymethyl chitosan at a mass ratio of 2:3:1.

[0089] Example 7

[0090] This embodiment provides a repair, anti-inflammatory and moisturizing composition containing recombinant collagen. The repair, anti-inflammatory and moisturizing composition containing recombinant collagen is recombinant collagen, the schizophyllan polysaccharide of Preparation Example 1 and succinyl carboxymethyl chitosan with a mass ratio of 1:0.05:1.

[0091] Comparative Example 1

[0092] This comparative example provides a repair, anti-inflammatory and moisturizing composition containing recombinant collagen. The difference between the repair, anti-inflammatory and moisturizing composition containing recombinant collagen and Example 1 is only that the composition does not include schizophyllan polysaccharide, and the remaining components and their proportion relationships remain unchanged.

[0093] Comparative Example 2

[0094] This comparative example provides a repair, anti-inflammatory and moisturizing composition. The difference between the repair, anti-inflammatory and moisturizing composition and Example 1 is only that the composition does not include recombinant collagen, and the remaining components and their proportion relationships remain unchanged.

[0095] Comparative Example 3

[0096] This comparative example provides a repair, anti-inflammatory and moisturizing composition containing recombinant collagen. The difference between the repair, anti-inflammatory and moisturizing composition containing recombinant collagen and Example 1 is only that the composition does not include succinyl carboxymethyl chitosan, and the remaining components and their proportion relationships remain unchanged.

[0097] Application Example 1

[0098] This application example provides a gel with repair, anti-inflammatory and moisturizing effects. The gel with repair, anti-inflammatory and moisturizing effects includes, by weight, 5 parts of the repair, anti-inflammatory and moisturizing composition containing recombinant collagen as in Example 1, 10 parts of polyvinyl alcohol, 3 parts of sorbitol, 8 parts of glycerol, 4 parts of butanediol, 4 parts of plant extract, 4 parts of niacinamide, 1 part of glyceryl monostearate, 1 part of polysorbate - 80, 0.5 part of EDTA - 2Na, 0.3 part of carbomer, and deionized water is added to make up 100 parts;

[0099] The plant extract is aloe extract, cactus extract and notoginseng extract with a mass ratio of 2:1.5:0.5.

[0100] The preparation method of the gel with repair, anti-inflammatory and moisturizing effects is as follows:

[0101] (1) Dissolve polyvinyl alcohol in 60% deionized water and stir to obtain a polyvinyl alcohol solution;

[0102] (2) Add the repair, anti-inflammatory and moisturizing composition containing recombinant collagen to the remaining deionized water and mix to obtain a mixed solution;

[0103] (3) sequentially adding the mixed solution prepared in step (2), sorbitol, glycerol, butylene glycol, plant extract, niacinamide, glyceryl monostearate, polysorbate 80, EDTA-2Na and carbomer to the polyvinyl alcohol solution prepared in step (1), mixing and homogenizing, freezing at -25°C, and then thawing in a mold at room temperature. After repeated freezing and thawing for 5 times, the gel with the repairing, anti-inflammatory and moisturizing effects is obtained.

[0104] Application Example 2-7

[0105] This application example provides four types of gels with repairing, anti-inflammatory and moisturizing effects. The difference between the gels with repairing, anti-inflammatory and moisturizing effects and Application Example 1 is only that the repairing, anti-inflammatory and moisturizing composition containing recombinant collagen in Example 1 is replaced with an equal amount of the gels with repairing, anti-inflammatory and moisturizing effects of Examples 2-7, and the remaining components and amounts are consistent with those in Application Example 1. The preparation method refers to Application Example 1.

[0106] Application Example 8

[0107] This application example provides four types of gels with repairing, anti-inflammatory and moisturizing effects. The only difference between the gels with repairing, anti-inflammatory and moisturizing effects and Application Example 1 is that they do not include moisturizers, and the reduced amount is proportionally distributed to the various components of the skin conditioner. The remaining components and amounts are consistent with those in Application Example 1, and the preparation method refers to Application Example 1.

[0108] Application Example 9

[0109] This application example provides four types of gels with repairing, anti-inflammatory and moisturizing effects. The only difference between the gels with repairing, anti-inflammatory and moisturizing effects and Application Example 1 is that they do not include skin conditioners, and the reduced amount is distributed to glycerin and butylene glycol in proportion. The remaining components and amounts are consistent with those in Application Example 1, and the preparation method refers to Application Example 1.

[0110] Application Example 10

[0111] This application example provides four types of gels with repairing, anti-inflammatory and moisturizing effects. The only difference between the gels with repairing, anti-inflammatory and moisturizing effects and those in Application Example 1 is that niacinamide is not included in the skin conditioner, and the reduced amount is distributed to aloe extract, cactus extract and Panax notoginseng extract in proportion. The remaining components and amounts are consistent with those in Application Example 1, and the preparation method refers to Application Example 1.

[0112] Application Example 11

[0113] This application example provides four types of gels with repairing, anti-inflammatory and moisturizing effects. The difference between the gels with repairing, anti-inflammatory and moisturizing effects and those in Application Example 1 is that the skin conditioner does not include plant extracts, and the reduced amount is supplemented by niacinamide. The remaining components and amounts are consistent with those in Application Example 1, and the preparation method refers to Application Example 1.

[0114] Application Example 12

[0115] This application example provides four gels with the functions of repair, anti - inflammation and moisturization. The difference between the gel with the functions of repair, anti - inflammation and moisturization and that of Application Example 1 is only that the aloe extract is not included in the plant extract, and the reduced amount is proportionally distributed to the cactus extract and the notoginseng extract. The other components and dosages are the same as those in Application Example 1, and the preparation method refers to Application Example 1.

[0116] Application Example 13

[0117] This application example provides four gels with the functions of repair, anti - inflammation and moisturization. The difference between the gel with the functions of repair, anti - inflammation and moisturization and that of Application Example 1 is only that the cactus extract is not included in the plant extract, and the reduced amount is proportionally distributed to the aloe extract and the notoginseng extract. The other components and dosages are the same as those in Application Example 1, and the preparation method refers to Application Example 1.

[0118] Application Example 14

[0119] This application example provides four gels with the functions of repair, anti - inflammation and moisturization. The difference between the gel with the functions of repair, anti - inflammation and moisturization and that of Application Example 1 is only that the notoginseng extract is not included in the plant extract, and the reduced amount is proportionally distributed to the aloe extract and the cactus extract. The other components and dosages are the same as those in Application Example 1, and the preparation method refers to Application Example 1.

[0120] Comparative Application Examples 1 - 3

[0121] This comparative application example provides three gels with the functions of repair, anti - inflammation and moisturization. The difference between the gel with the functions of repair, anti - inflammation and moisturization and that of Application Example 1 is only that the repair, anti - inflammation and moisturization composition containing recombinant collagen in Example 1 is equivalently replaced by the gels with the functions of repair, anti - inflammation and moisturization in Comparative Examples 1 - 3. The other components and dosages are the same as those in Application Example 1, and the preparation method refers to Application Example 1.

[0122] Comparative Application Example 4

[0123] This application example provides a gel with the functions of repair, anti - inflammation and moisturization. The difference between the gel with the functions of repair, anti - inflammation and moisturization and that of Application Example 1 is only that the repair, anti - inflammation and moisturization composition containing recombinant collagen is not included, and the reduced amount is supplemented by polyvinyl alcohol. The other components and dosages are the same as those in Application Example 1, and the preparation method refers to Application Example 1.

[0124] Test Example 1 Antibacterial Activity Test

[0125] The antibacterial activity of the extract was evaluated using the general Kirby-Bauer inhibition test. The Kirby-Bauer method is also known as the K-B disk diffusion method or the agar disk diffusion method, and it is a drug susceptibility test and antibacterial activity determination experimental method widely used in clinical microbiology laboratories around the world.

[0126] The basic operation steps of the K-B disk diffusion method are as follows: A circular sterile filter paper (6 mm) adsorbed with an appropriate amount of antibacterial active ingredient is flatly attached to the surface of the agar plate medium inoculated with the test strain. The components of the drug-loaded filter paper diffuse in the agar, and the logarithm of the concentration of the antibacterial drug decreases as the diffusion distance of the drug increases, thereby forming a circular concentration gradient circle with a decreasing concentration from high to low around the filter paper. Inside the concentration gradient circle higher than the minimum inhibitory concentration, the test bacteria are significantly inhibited or even basically unable to grow, while the strains outside the concentration gradient circle lower than the minimum inhibitory concentration will grow diffusely on the surface of the agar plate medium, thereby forming a transparent antibacterial circle around the filter paper. Generally, the larger the diameter of the antibacterial circle, the more significant the antibacterial performance of the drug or active ingredient.

[0127] Standard strains of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pyogenes were used as test strains. The products prepared in Application Examples 1-14 and Comparative Application Examples 1-4 were used as the test groups, and methylparaben of analytical purity was used as the positive control; at the same time, a blank control group (the test solvent was a 10 wt% aqueous glycerol solution) was set up, and the drug loading per filter paper was 20 μg. The specific test results of each sample are shown in Table 1.

[0128] Table 1

[0129]

[0130]

[0131] It can be seen from the data in Table 1 that the gel provided by the present invention has good inhibitory effects on Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pyogenes. From Application Example 1 and Comparative Application Examples 1-3, it can be seen that when any one of recombinant collagen, Schizophyllan, or succinyl carboxymethyl chitosan is missing, the antibacterial effect of the gel is significantly worse, indicating that recombinant collagen, Schizophyllan, and succinyl carboxymethyl chitosan have a synergistic effect in antibacterial; by comparing Application Example 1 with Application Examples 11-14, it can be seen that the addition of plant extracts also affects the antibacterial effect of the gel, and the selection of the type of plant extract also has an impact on the antibacterial effect.

[0132] Test Example 2 Evaluation of Moisturizing Performance

[0133] The gels of Application Examples 1-14 and Comparative Application Examples 1-4 were respectively placed in a constant temperature culture test chamber at 25°C and 50% relative humidity, and the humidity in the relatively enclosed space was measured with an electronic humidity probe after 12 hours;

[0134] The test results are shown in Table 2:

[0135] Table 2

[0136]

[0137]

[0138] It can be seen from the data in Table 2 that compared with Comparative Application Example 4, the gels of Application Examples 1-3 containing the repair, anti-inflammatory and moisturizing composition with recombinant collagen have stronger moisturizing effects and can provide a suitable moist recovery environment for the wound; it can be seen from Comparative Application Examples 1-3 that recombinant collagen, schizophyllan and succinyl carboxymethyl chitosan in the composition have a certain synergistic effect on the above-mentioned effects. In addition, the addition of the moisturizer can affect the wetting effect of the product.

[0139] Test Example 3 Repair performance test:

[0140] Human skin fibroblasts (HFF-1) that had grown to 70%-80% of the culture dish area were taken, digested with 0.25% trypsin, and made into a cell suspension with a cell density of 1×10 5 cells / mL with complete culture medium. 100 μL of the cell suspension was inoculated into a 96-well culture plate and cultured in an incubator at 37°C and 5% CO2 saturated humidity. After 24 hours of cell culture, the complete culture medium was aspirated.

[0141] The experimental groups were the compositions of Examples 1-7 and Comparative Examples 1-3 of the present invention diluted with high-glucose DMEM medium at 0.1 mg / mL (set with 4 replicates); the control group was to add an equal amount of high-glucose DMEM medium without the composition of the present invention to the cells, and the blank group was an equal amount of DMEM medium without cells. They were continued to be cultured in an incubator at 37°C and 5% CO2 saturated humidity for 24 hours, 48 hours, 72 hours and 96 hours respectively. At regular intervals, 10 μL of CCK-8 reagent was added to each group, incubated in the cell culture incubator for 1-4 hours, and the absorbance value (OD value) of each well was measured at a wavelength of 450 nm using an enzyme-linked immunosorbent detector. According to the average absorbance of each group, the relative growth rate (RGR) of the cells was calculated according to the following formula:

[0142]

[0143] The results are shown in Table 3.

[0144] Table 3

[0145]

[0146]

[0147] As can be seen from the data in Table 3: Compared with the blank control group (100%), the relative cell proliferation rates of the composition of the present invention at 24 h, 48 h, 72 h, and 96 h of culture were all greater than 100%. Through the comparison between Example 1 and Comparative Examples 1-3, it can be seen that recombinant collagen, schizophyllan, and chitosan have a certain synergistic effect in this efficacy.

[0148] Test Example 4

[0149] Forty-eight white mice aged 10-12 weeks were randomly divided into 8 groups (6 mice in each group), with half males and half females, and a scald model was established.

[0150] The medical gels prepared in Application Examples 1-3 and Comparative Application Examples 1-4 were respectively used to coat the wounds of 7 groups of white mice as the experimental groups; a commercially available gel was taken to coat another group as the control group.

[0151] The wound healing (scab formation) time of 5-10 days is highly effective, 11-15 days is moderately effective, 16 days - 30 days is lowly effective, and more than 31 days is ineffective. The statistical test results are shown in Table 4 below.

[0152] Table 4

[0153]

[0154]

[0155] As can be seen from the results in Table 4, when the products of Application Examples 1-3 of the present invention were used for the wounds of white mice, the white mice all started to scab within 10 days, indicating that the products of the present invention can promote wound healing; in Comparative Application Examples 1-3, when any one of recombinant collagen, schizophyllan, and succinyl carboxymethyl chitosan was missing, the wound scabbing time of the white mice was longer, indicating that recombinant collagen, schizophyllan, and succinyl carboxymethyl chitosan have a synergistic effect in promoting wound repair and healing.

[0156] Test Example 5

[0157] Safety evaluation:

[0158] The specific method is as follows: Select 40 women aged 18 - 35 years old without a history of allergies. Each subject tries the products prepared in Application Examples 1 - 14. After cleaning the back of the subject, apply the patch tester with the sample on the selected position on the back using a non - irritating tape. After pasting, gently press it with fingers to make it evenly adhere to the skin and keep it for 24 hours. The subject should keep the patch area dry within 24 hours and avoid strenuous exercise, scratching the patch area, long - term sunlight exposure, etc. After 24 hours, remove the tester and make marks. After 30 minutes, when the indentation disappears, make a judgment under sufficient light.

[0159] The grading standard for skin adverse reactions is shown in Table 5 as follows:

[0160] Table 5

[0161]

[0162]

[0163] The results are shown in Table 6 as follows:

[0164] Table 6

[0165]

[0166] From the data in Table 6, it can be seen that all the subjects had negative reactions, indicating that the product described in the present invention has no adverse reactions to the human body and has high safety.

[0167] The applicant declares that the present invention uses the above - mentioned embodiments to illustrate a repair, anti - inflammatory and moisturizing composition containing recombinant collagen and its application, but the present invention is not limited to the above - mentioned embodiments, that is, it does not mean that the present invention must rely on the above - mentioned embodiments to be implemented. Those skilled in the art should understand that any improvement to the present invention, equivalent replacement of each raw material of the product of the present invention, addition of auxiliary components, selection of specific methods, etc. all fall within the protection scope and the disclosure scope of the present invention.

[0168] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details in the above - mentioned embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solutions of the present invention, and these simple modifications all belong to the protection scope of the present invention.

[0169] In addition, it should be noted that, in the case of no contradiction, the various specific technical features described in the above - mentioned specific embodiments can be combined in any appropriate way. To avoid unnecessary repetition, the present invention does not separately describe various possible combination methods.

Claims

1. A gel with the functions of repair, anti - inflammation and moisturization, characterized in that, The gel with repair, anti-inflammatory and moisturizing effects comprises, by weight parts, 0.1 - 5 parts of a repair, anti-inflammatory and moisturizing composition containing recombinant collagen, 5 - 15 parts of polyvinyl alcohol, 2 - 5 parts of sorbitol, 10 - 30 parts of auxiliary materials and 20 - 50 parts of deionized water; The repair, anti-inflammatory and moisturizing composition containing recombinant collagen is recombinant collagen, octenyl succinic anhydride modified schizophyllan polysaccharide and succinyl carboxymethyl chitosan with a mass ratio of (0.1 - 1):(1 - 2):1; The auxiliary materials include a moisturizer and a skin conditioner; the skin conditioner is a combination of a plant extract and niacinamide with a mass ratio of 1:(0.5 - 2); the plant extract is a combination of aloe extract, cactus extract and notoginseng extract with a mass ratio of (1 - 3):(1 - 2):(0.1 - 1).

2. The gel with the functions of repair, anti - inflammation and moisturization according to claim 1, characterized in that, The moisturizer includes glycerol and / or butanediol.

3. The gel with the functions of repair, anti - inflammation and moisturization according to claim 1, characterized in that, The auxiliary materials also include any one or a combination of at least two of an emulsifier, a stabilizer or a thickener.

4. The gel with the functions of repair, anti - inflammation and moisturization according to claim 3, characterized in that, The emulsifier includes any one or a combination of at least two of polysorbate - 80, PEG - 40 hydrogenated castor oil, PEG - 60 hydrogenated castor oil, glycerol monostearate or cetearyl alcohol.

5. The gel with the functions of repair, anti - inflammation and moisturization according to claim 3, characterized in that, The stabilizer includes EDTA - 2Na and / or sodium oleate.

6. The gel with the functions of repair, anti - inflammation and moisturization according to claim 3, characterized in that, The thickener includes any one or a combination of at least two of xanthan gum, carbomer or sodium acrylate copolymer.

7. The gel with the functions of repair, anti - inflammation and moisturization according to claim 1, characterized in that, The gel with repair, anti-inflammatory and moisturizing effects comprises, by weight parts, 0.1 - 5 parts of the repair, anti-inflammatory and moisturizing composition containing recombinant collagen, 5 - 15 parts of polyvinyl alcohol, 2 - 5 parts of sorbitol, 5 - 15 parts of a moisturizer, 5 - 10 parts of a skin conditioner, 1 - 3 parts of an emulsifier, 0.1 - 1 part of a stabilizer, 0.1 - 1 part of a thickener and 20 - 50 parts of deionized water.

8. The preparation method of the gel with the functions of repair, anti - inflammation and moisturization according to any one of claims 1 - 7, characterized in that, The method includes mixing the repair, anti-inflammatory and moisturizing composition containing recombinant collagen, polyvinyl alcohol, sorbitol and auxiliary materials in deionized water, and homogenizing to obtain the gel with repair, anti-inflammatory and moisturizing effects.

9. The preparation method according to claim 8, characterized in that, The preparation method includes: (1) Dissolving polyvinyl alcohol in part of the deionized water, and stirring to obtain a polyvinyl alcohol solution; Adding the repair, anti-inflammatory and moisturizing composition containing recombinant collagen to the remaining deionized water for mixing to obtain a mixed solution; (2) Sequentially adding the mixed solution prepared in step (1), sorbitol, a moisturizer, a skin conditioner, an emulsifier, a thickener and a stabilizer to the polyvinyl alcohol solution prepared in step (1), mixing and homogenizing, then freezing at a low temperature, and thawing in a mold to obtain the gel with repair, anti-inflammatory and moisturizing effects.

10. The preparation method according to claim 9, characterized in that, The part of the deionized water in step (1) is 50 - 70% of the total amount of deionized water.

11. The preparation method according to claim 9, characterized in that, The low temperature in step (2) is - 20°C to - 30°C.

12. The preparation method according to claim 9, characterized in that, Freezing at the low temperature in step (2) and thawing in a mold need to be carried out cyclically.

13. The preparation method according to claim 12, characterized in that, The number of cycles is 3 - 5 times.

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