CN115054539A

CN115054539A - Preparation process of gel for diminishing inflammation and removing scars

Info

Publication number: CN115054539A
Application number: CN202110994185.2A
Authority: CN
Inventors: 徐念; 王岭南; 沈梓粤
Original assignee: Hunan Keluoke Pharmaceutical Co ltd
Current assignee: Hunan Keluoke Pharmaceutical Co ltd
Priority date: 2021-08-27
Filing date: 2021-08-27
Publication date: 2022-09-16

Abstract

The invention relates to the field of A61K8/81, in particular to a preparation process of an anti-inflammation scar-removing gel, which comprises the steps of uniformly mixing a first gel, a second gel and a third gel in proportion, wherein the preparation method of the first gel comprises the following steps: (1) adding a first chelating agent into pure water for dissolving; (2) continuously adding the first humectant, and adding the first gelling agent while stirring for homogenizing; (3) the pH is adjusted with a first pH adjusting agent. The repairing gel is added with a specific eosin coloring agent, combined with fluorescence with specific wavelength in a Lumihel therapeutic apparatus or a Kleresca therapeutic apparatus, a chromophore in the gel converts blue light emitted by the therapeutic apparatus into fluorescent light energy, and the generated multicolor fluorescence penetrates through an epidermal layer and a dermal layer of skin to trigger the self healing reaction of the skin and activate the healing mechanism of the skin.

Description

Preparation process of gel for diminishing inflammation and removing scars

Technical Field

The invention relates to the field of A61K8/81, in particular to a preparation process of an anti-inflammation scar-removing gel.

Background

After skin tissues are damaged by external force, such as burns and scalds, car accidents, medical and aesthetic failures, medical operations and severe acne, the skin is damaged, the brought scars and hyperplasia are once considered to be permanent and difficult to eliminate by the industry, and the pharmaceutical industry has been dedicated to developing a special medicine capable of effectively eliminating the scars for many years. With the development of science and technology, in recent years, instruments and gel compounding methods are more and more popular, surface necrotic cells are excised in a laser mode, surface skin after operation is scabbed and then falls off, and the skin looks as new after repeated times. The mode destroys the stratum corneum of the skin, the skin after laser treatment is extremely sensitive and fragile, the treatment period is long, the cost is high, and the scabbing period of about 10 days after treatment affects the life of patients.

CN103495155A discloses a film for repairing hyperplastic scars and a preparation method thereof, wherein the hyperplastic parts of the skin are treated in an application mode through medicinal active ingredients, but the treated objects are only the hyperplastic skin after healing, and the wounds at the inflammatory stage cannot be treated.

CN102108211A discloses a chitosan collagen gel and application thereof, wherein the problem of incomplete absorption is solved by adding chitosan, and the chitosan collagen gel has little treatment effect on the hormone-type skin problems of facial acne, comedo, acne rosacea and the like and is difficult to radically cure.

Disclosure of Invention

The invention provides a preparation process of an anti-inflammation scar-removing gel, which comprises the following steps of uniformly mixing a first gel, a second gel and a third gel in proportion: (1) adding a first chelating agent into pure water for dissolving; (2) continuously adding the first humectant, and adding the first gelling agent while stirring for homogenizing; (3) the pH is adjusted with a first pH adjusting agent.

Preferably, the preparation raw materials of the first gel comprise, by weight: 0.5-1 part of first chelating agent, 50-100 parts of first humectant, 0.5-1.5 parts of first pH regulator, 0.5-3 parts of first gelling agent and 15-35 parts of pure water.

Further preferably, the preparation raw materials of the first gel comprise, by weight: 0.6 part of first chelating agent, 65 parts of first humectant, 0.7 part of first pH regulator, 2.5 parts of first gelling agent and 20 parts of pure water.

As a preferred embodiment, the preparation method of the second gel comprises the following steps: (1) slowly adding a premixed solution of a second chelating agent and pure water into a second humectant, continuously adding a premixed solution of a bacteriostatic agent, an emulsifier and pure water, and uniformly stirring; (2) adding a second gelling agent for homogenization, and adjusting the pH value by using a second pH regulator; (3) adding a premixed solution of the coloring agent and the pure water, stirring, and continuously adjusting the pH value by using a second pH regulator.

In a preferred embodiment, the pH values are both 4.5 to 7.5.

Preferably, the pH values are all 6.0.

As a preferred embodiment, the weight of the third gel is 50-80 wt% of the weight of the first gel.

Preferably, the weight of the third gel is 66.7 wt% of the weight of the first gel.

As a preferred embodiment, the weight ratio of the first gel to the second gel is (3-7): (0.5-1).

Preferably, the weight ratio of the first gel to the second gel is 6: 1.

preferably, the preparation raw materials of the second gel comprise, by weight: 0.07-0.5 part of bacteriostatic agent, 0.5-1 part of second chelating agent, 35-65 parts of second humectant, 20-25 parts of emulsifier, 0.5-1.5 parts of second pH regulator, 0.5-3 parts of second gelling agent, 0.1-2 parts of coloring agent and 20-40 parts of pure water.

Preferably, the preparation raw materials of the second gel comprise, by weight: 0.2 part of bacteriostatic agent, 0.6 part of second chelating agent, 40 parts of second humectant, 20 parts of emulsifier, 0.5 part of second pH regulator, 1.5 parts of first gelling agent, 0.9 part of coloring agent and 25 parts of pure water.

As a preferred embodiment, the preparation raw materials of the third gel comprise, by weight: 1-15 parts of peroxide and salts thereof.

Preferably, the peroxide and its salt comprise at least one of carbamide peroxide, hydrogen peroxide, sodium percarbonate and sodium perborate.

Preferably, the peroxide and its salts are carbamide peroxide or hydrogen peroxide.

In a preferred embodiment, the first humectant comprises at least one of glycerin, propylene glycol, sodium hyaluronate, polyglutamic acid, caprylyl glycol, 1,2 pentanediol, urea, hydrolyzed protein, xylitol, and trehalose.

Preferably, the first humectant is glycerin or propylene glycol.

Preferably, the weight ratio of the glycerol to the propylene glycol is (4-7): (1-3).

Preferably, the weight ratio of the glycerol to the propylene glycol is 5: 2.

preferably, the second humectant is glycerin.

As a preferred embodiment, the weight ratio of the second humectant to the emulsifier is (1-3): 1.

preferably, the weight ratio of the second humectant to the emulsifier is 2: 1.

preferably, the emulsifier is propylene glycol.

In a preferred embodiment, the first and second chelating agents include at least one of EDTA salt, sodium polyphosphate, and sodium metaphosphate.

Preferably, the first chelating agent and the second chelating agent are EDTA salts.

Preferably, the EDTA salt comprises at least one of disodium EDTA and tetrasodium EDTA.

Preferably, the first chelating agent and the second chelating agent are disodium EDTA.

In a preferred embodiment, the first gelling agent and the second gelling agent comprise at least one of carbomer, xanthan gum, locust bean gum, guar gum, glucomannan, carrageenan, sodium alginate, beta-cyclodextrin, sodium carboxymethylcellulose, and tamarind polysaccharide gum.

In a preferred embodiment, the viscosities of the first gelling agent and the second gelling agent are 40000-.

Preferably, the first gelling agent and the second gelling agent are carbomers.

Further preferably, the carbomer has a viscosity (25 ℃, 0.5% by weight in water) of 40000-60000cps as purchased from Shanghai Shunhua chemical company, Inc. under the model Carbopol 940.

As a preferred embodiment, the bacteriostatic agent comprises at least one of methylparaben, propylparaben, nanosilver, benzalkonium chloride, benzalkonium bromide, polyhexamethylene biguanide salt or chlorhexidine, galangin, licoflavone and eugenol, zinc undecylenate, disodium undecylenate monoethanolamide sulfosuccinate, climbazole, dichlorophenyl imidazoldioxolane, pyridoxine, hexamidine isethionate.

In a preferred embodiment, the bacteriostatic agent is methyl hydroxybenzoate or propylparaben.

Preferably, the weight ratio of the methyl hydroxybenzoate to the propylparaben is (0.5-3): (0.2-2).

Preferably, the weight ratio of the methyl hydroxybenzoate to the propyl hydroxybenzoate is 1.5: 1.

in a preferred embodiment, the coloring agent is eosin.

The first pH adjuster and the second pH adjuster are not particularly limited in the present invention, and any pH adjuster commonly used in the art may be used, including but not limited to sodium hydroxide, citric acid, and sodium citrate.

Compared with the prior art, the invention has the following beneficial effects:

1. the repairing gel is respectively provided with the first gel, the second gel and the third gel for combined use, and the repairing gel is prepared in situ and has no effect when being used respectively.

2. In the preparation process of the first gel, the first chelating agent is added in advance, then the first gelling agent is added for homogenization, the prepared gel has good stability and uniform density, and when the gel is used in combination with a Lumiheal therapeutic apparatus or a Kleresca therapeutic apparatus, green, yellow, orange and red spectral refraction light paths generated by fluorescent light energy are uniform and stable, so that the light paths can directly reach subcutaneous tissues to accelerate the healing reaction of the skin.

3. According to the preparation process of the second gel, the premixed solution of the second chelating agent and pure water is added into the second humectant, the premixed solution of the bacteriostatic agent, the emulsifying agent and the pure water is further added, and the coloring agent is added after homogenization.

4. The invention creatively adopts three gels and adopts a mode of being prepared at present, and no preservative is added, thereby solving the technical problems of poor storage resistance and poor health of the preservative in the prior art.

Drawings

Fig. 1-3 are graphs showing the effect of a patient on venous leg ulcers before and after treatment with the gel of example 1 in combination with a lumieal treatment device, wherein fig. 1 is before treatment, fig. 2 is day 15, fig. 3 is day 26, and fig. 4 is day 70.

FIGS. 4-6 are graphs showing the effect of a patient on diabetic foot ulcers, before and after treatment with the gel of example 1 in combination with a Lumiheal treatment apparatus, wherein FIG. 4 is before treatment, FIG. 5 is day 22, and FIG. 6 is day 75.

Fig. 7-9 are graphs of the effect of the gel of example 1 in combination with kleesca therapy apparatus before and after treatment of severe acne patients, wherein fig. 7 is day 1 of treatment, fig. 8 is day 21 of treatment, and fig. 9 is day 42 of treatment.

Fig. 10-11 are graphs of the effect of a patient with severe acne before and after treatment with the gel of example 1 in combination with a kleesca therapeutic device, where fig. 10 is day 1 of treatment and fig. 11 is day 42 of treatment.

Detailed Description

Example 1

The embodiment provides a preparation process of an anti-inflammation scar-removing gel, which comprises the steps of uniformly mixing a first gel, a second gel and a third gel in proportion, wherein the weight ratio of the first gel to the second gel to the third gel is 6: 1: 4.

the preparation method of the first gel comprises the following steps: (1) adding 0.6 part of EDTA disodium into 20 parts of pure water for dissolving; (2) continuing to add 65 parts of first humectant, adding 2.5 parts of carbomer (with viscosity (25 ℃, and mass concentration of 0.5% aqueous solution) of 40000-60000cps) while stirring, and homogenizing; (3) the pH was adjusted to 6.0 with 0.7 part of an aqueous solution of sodium hydroxide (20% by mass).

The first humectant is glycerol and propylene glycol in a weight ratio of 5: 2, compounding.

The preparation method of the second gel comprises the following steps: (1) slowly adding a premixed solution of 0.6 part of disodium EDTA and 10 parts of pure water into 40 parts of glycerol, continuously adding a premixed solution of 0.2 part of bacteriostatic agent, 20 parts of propylene glycol and 10 parts of pure water, and uniformly stirring; (2) adding 1.5 parts of carbomer (viscosity (25 ℃, mass concentration of 0.5% aqueous solution) of 40000-; (3) a premixed solution of 0.9 part of eosin and 15 parts of pure water was added thereto, followed by stirring, and the pH was further adjusted to 6.0 with 0.25 part of an aqueous solution of sodium hydroxide (20% by mass).

The bacteriostatic agent is methyl hydroxybenzoate and propylparaben in a weight ratio of 1.5: 1, compounding.

The preparation raw materials of the third gel comprise: 3 parts of hydrogen peroxide.

Comparative example 1

The present comparative example provides a preparation process of an anti-inflammatory scar-removing gel, which is the same as that in example 1, except that the weight ratio of the first gel to the second gel to the third gel is 1: 12: 3.

comparative example 2

The comparative example provides a preparation process of an anti-inflammatory scar-removing gel, which comprises the following steps of uniformly mixing a second gel and a third gel in a ratio of 1: the third gel was prepared as in example 1.

Comparative example 3

This comparative example provides a process for the preparation of an anti-inflammatory scar removing gel, which is similar to that of example 1, except that carbomer has a viscosity (25 ℃, 0.5% by mass in water) of 30500-39400cps, as purchased from Shanghai Shunhua chemical Co., Ltd., model number Carbopol 934.

Performance testing

The gel of the example was applied to the surface of the wound to a thickness of about 2mm in conjunction with a Lumiheal treatment apparatus for a single treatment time of 5min, the gel of the example was applied to the surface of the acne to a thickness of about 2mm in conjunction with a klenesca treatment apparatus for a single treatment time of 9min, and the effect profiles before and after treatment are shown in fig. 1-11.

FIGS. 1-3 are graphs showing the effect of a patient on venous leg ulcers before and after treatment with the gel of example 1 in combination with a Lumihel treatment apparatus; FIGS. 4-6 are graphs showing the effect of the gel of example 1 on diabetic foot ulcers before and after treatment with a Lumiheal treatment apparatus; FIGS. 7-9 are graphs of the effect of the gel of example 1 on a patient with severe acne before and after treatment with a Kleresca treatment instrument; FIGS. 10-11 are graphs of the effect of a patient with severe acne before and after treatment with the gel of example 1 in combination with a Kleresca therapeutic apparatus.

And (3) stability testing: the gels of examples and comparative examples were coated on plastic sheets, respectively, and irradiated with lumihel instruments, respectively, and then observed for the presence or absence of undesirable phenomena such as water analysis, foaming or solidification of the gels after irradiation.

	Stability of
		Example 1	Without change
Comparative example 1	The gel is obviously melted and a large amount of water is analyzed
		Comparative example 2	The gel is obviously melted, a large amount of water is analyzed out, and bubbles are arranged on the surface
Comparative example 3	The gel is obviously melted, a large amount of water is analyzed out, and bubbles are arranged on the surface

Claims

1. The preparation process of the inflammation diminishing and scar removing gel is characterized by comprising the following steps of uniformly mixing a first gel, a second gel and a third gel in proportion: (1) adding a first chelating agent into pure water for dissolving; (2) continuously adding the first humectant, and adding the first gelling agent while stirring for homogenizing; (3) the pH is adjusted with a first pH adjusting agent.

2. The preparation process of the anti-inflammatory scar-removing gel according to claim 1, wherein the preparation method of the second gel comprises the following steps: (1) slowly adding a premixed solution of a second chelating agent and pure water into a second humectant, continuously adding a premixed solution of a bacteriostatic agent, an emulsifier and pure water, and uniformly stirring; (2) adding a second gelling agent for homogenization, and adjusting the pH value by using a second pH regulator; (3) adding a premixed solution of the coloring agent and the pure water, stirring, and continuously adjusting the pH value by using a second pH regulator.

3. The process for preparing an anti-inflammatory scar-removing gel according to claims 1 and 2, wherein the pH values are both 4.5-7.5.

4. A process for preparing an anti-inflammatory scar-removing gel according to any one of claims 1-3, wherein the weight of the third gel is 50-80 wt% of the weight of the first gel.

5. The preparation process of the anti-inflammation scar-removing gel according to any one of claims 1 to 4, wherein the weight ratio of the first gel to the second gel is (3-7): (0.5-1).

6. The process for preparing an anti-inflammatory scar-removing gel according to any one of claims 2-4, wherein the first gelling agent and the second gelling agent comprise at least one of carbomer, xanthan gum, locust bean gum, guar gum, glucomannan, carrageenan, sodium alginate, beta-cyclodextrin, sodium carboxymethylcellulose, and tamarind seed polysaccharide gum.

7. The preparation process of the gel for diminishing inflammation and removing scars as claimed in any one of claims 1 to 2, wherein the viscosity of the first gelling agent and the viscosity of the second gelling agent are 40000-60000 cps.

8. The preparation process of the gel for diminishing inflammation and removing scars according to claim 2, wherein the bacteriostatic agent comprises at least one of methylparaben, propylparaben, nanosilver, benzalkonium chloride, benzalkonium bromide, polyhexamethylene monoguanidine salt, polyhexamethylene biguanidine salt or chlorhexidine, galangin, licoflavone and eugenol, zinc undecylenate, disodium undecylenate monoethanolamide sulfosuccinate, climbazole, dichlorophenyl imidazole dioxolane, pyridone ethanolamine, hexamidine isethionate.

9. The preparation process of the anti-inflammatory scar-removing gel according to claim 8, wherein the bacteriostatic agent is methyl hydroxybenzoate or propylparaben.

10. The preparation process of the anti-inflammatory scar-removing gel according to claim 2, wherein the weight ratio of the second humectant to the emulsifier is (1-3): 1.