A multi-effect compound scar-removing gel for sensitive skin scar repair and its preparation method

Abstract

This invention discloses a multi-effect compound scar-removing gel for repairing scars on sensitive skin and its preparation method, belonging to the technical field of preparation of skin pharmaceutical formulations. The multi-effect compound scar-removing gel comprises the following ingredients by weight percentage: 0.05%–0.08% recombinant type III humanized collagen, 0.63%–0.66% carbomer, 0.18%–0.21% sodium calcium phosphosilicate, 0.09%–0.11% γ-polyglutamic acid, 1.6%–2.2% L-DOPA-aminosilicone oil mixture, 0.8%–1.1% oxidized Ganoderma lucidum polysaccharide, with the balance being deionized water to bring the total to 100%. This invention involves mixing and dispersing recombinant type III humanized collagen, carbomer, sodium calcium phosphosilicate, polyglutamic acid, a mixture of L-DOPA and aminosilicone oil, oxidized Ganoderma lucidum polysaccharide, and deionized water to form a dispersion. The dispersion is then adjusted to a weakly alkaline environment for cross-linking and then adjusted to a neutral state for static gelation to obtain a multi-effect compound scar removal gel. This gel is effective in repairing scars and does not cause redness or swelling.

Description

Technical Field

[0001] This invention belongs to the field of preparation technology of pharmaceutical formulations for skin use, specifically relating to a multi-effect compound scar removal gel for sensitive skin scar repair and its preparation method. Background Technology

[0002] As the largest organ in the human body, the skin consists of three layers: the epidermis, dermis, and subcutaneous tissue. The skin has a protective function, forming a physical protective barrier between the external and internal environments to defend against the invasion of harmful substances such as physical, chemical, and microbial agents. It also helps prevent the loss of water and electrolytes and maintains the stability of the internal environment. Furthermore, the skin has sensory functions. Because the nerve endings and specialized receptors of sensory and motor nerves are widely distributed in the epidermis, dermis, and subcutaneous tissue, it can perceive various stimuli from both inside and outside the body, generating various sensations and triggering corresponding nerve reflexes. The skin is in direct contact with the external environment and is the body's first line of defense against external damage. As a powerful biological barrier, it protects the body from the invasion of external bacteria, prevents excessive loss of body water, regulates normal body temperature, and maintains the stability of the internal environment. When skin is damaged by physical, biological, or chemical factors, resulting in wounds, it may experience significant loss of moisture and protein, disruption of the immune system, and infection. This can lead to severe damage to the soft tissues of the skin, preventing complete self-repair. During the wound healing process, fibrous tissue replaces the damaged tissue, but this also results in scarring. Scars are a general term for the changes in the appearance and histopathology of normal skin tissue caused by various traumas; they are an inevitable product of the body's wound repair process. If scar growth exceeds a certain limit, various complications can occur, such as disfigurement and functional impairment, causing immense physical and psychological suffering, especially scars left after burns, scalds, and severe trauma. The scar-prone population is large; in daily life, most people will develop scars of varying degrees due to unavoidable bumps, bruises, or surgeries. Currently, the scar-prone population is large, the market size is significant, and the physiological and psychological harms caused by scars are severe. Existing treatment methods and approaches each have their own advantages and disadvantages. In particular, surgical treatment is expensive and painful during the procedure, and it can also cause secondary damage and new scars, making it inconvenient.

[0003] Patent CN105709266A discloses a human-like collagen scar repair silicone gel. This invention prepares the scar repair silicone gel by mixing and stirring human-like collagen, silica, cyclopentasiloxane, polydimethylsiloxane alcohol, water and polydimethylsiloxane.

[0004] Patent CN106983784A discloses a scar-removing silicone gel and its preparation method. This invention uses dimethyl silicone oil, hexamethyldisiloxane, polydimethylsiloxane self-crosslinking polymer, natural plant antibacterial agent and antipruritic agent as raw materials for mixing and stirring. Under the action of hexamethyldisiloxane, dimethyl silicone oil and polydimethylsiloxane self-crosslinking polymer can quickly crosslink and combine with other components. Moreover, hexamethyldisiloxane has strong volatility, which can quickly promote the crosslinking and combination of various substances to form a thin film. It adheres well to the epidermis, ensures skin hydration, and has the effect of smoothing and softening scars caused by various external factors, thereby achieving the effect of improving scars.

[0005] The aforementioned silicone products, which extensively use organosilicone compounds, may cause slight irritation to the skin around the scar during actual use, manifesting as mild redness or discomfort. Furthermore, silicone scar gels are easily rubbed off by external forces and have weak water resistance, resulting in limited repair effects.

[0006] Therefore, it is of great significance to design a scar-reducing gel that reduces the use of organosilicon compounds to decrease skin irritation while having a good scar-repairing effect. Summary of the Invention

[0007] To address the shortcomings of existing technologies, this invention involves mixing and dispersing recombinant type III humanized collagen, carbomer, sodium calcium phosphosilicate, polyglutamic acid, a mixture of L-DOPA and aminosilicone oil, oxidized Ganoderma lucidum polysaccharide, and deionized water to form a dispersion. The dispersion is then adjusted to a weakly alkaline environment for cross-linking, followed by further adjustment to a neutral state and allowing it to gel statically, resulting in a multi-effect compound scar-removing gel. This solves the technical problems mentioned in the background art. Specifically, the technical solution of this invention includes the following:

[0008] A multi-effect compound scar removal gel for sensitive skin scar repair, the multi-effect compound scar removal gel comprising the following ingredients by weight percentage:

[0009] 0.05%–0.08% recombinant type III humanized collagen, 0.63%–0.66% carbomer, 0.18%–0.21% sodium calcium phosphosilicate, 0.09%–0.11% γ-polyglutamic acid, 1.6%–2.2% L-DOPA-aminosilicone oil mixture, 0.8%–1.1% oxidized Ganoderma lucidum polysaccharide, with the balance being deionized water to bring the total to 100%.

[0010] Furthermore, the multi-effect compound scar removal gel contains the following ingredients by weight percentage:

[0011] 0.07% recombinant type III humanized collagen, 0.65% carbomer, 0.2% sodium calcium phosphosilicate, 0.1% γ-polyglutamic acid, 2% L-DOPA-aminosilicone mixture, 1% oxidized Ganoderma lucidum polysaccharide and 95.98% deionized water.

[0012] Furthermore, the preparation method of the L-DOPA-aminosilicone oil mixture includes the following steps:

[0013] L-DOPA, amino silicone oil, EDC hydrochloride, N-hydroxysuccinimide and acetone are mixed and ultrasonically dispersed to form a dispersion. The pH of the dispersion is adjusted to 5.0-5.5 and then stirred to obtain the L-DOPA-amino silicone oil mixture.

[0014] Furthermore, the weight ratio of L-DOPA: amino silicone oil: EDC hydrochloride: N-hydroxysuccinimide: acetone is 1:5-10:1-1.5:1-1.5:20-30.

[0015] Furthermore, the conditions for ultrasonic dispersion include an ultrasonic power of 400W to 500W and an ultrasonic time of 10min to 15min.

[0016] Furthermore, the stirring reaction includes a reaction temperature of 20℃~25℃ and a reaction time of 12h~15h.

[0017] Furthermore, the preparation method of the oxidized Ganoderma lucidum polysaccharide includes the following steps:

[0018] Ganoderma lucidum fruiting body powder, deionized water and compound enzyme solution are mixed and then heated to obtain enzymatic hydrolysate;

[0019] The enzymatic hydrolysate was subjected to high-temperature inactivation and decolorization treatments in sequence to obtain a Ganoderma lucidum polysaccharide dispersion.

[0020] The oxidized Ganoderma lucidum polysaccharide was obtained by mixing the Ganoderma lucidum polysaccharide dispersion with sodium periodate and oxidizing it in a light-protected environment.

[0021] Furthermore, the complex enzyme solution is obtained by mixing cellulase and papain in a weight ratio of 2:1.

[0022] Furthermore, the weight ratio of the Ganoderma lucidum fruiting body powder, deionized water, and compound enzyme solution is 1:20-30:0.005-0.01.

[0023] Furthermore, the conditions for the heating enzymatic hydrolysis include an enzymatic hydrolysis pH of 5.0–5.5, an enzymatic hydrolysis temperature of 40°C–50°C, and an enzymatic hydrolysis time of 1.5–2 hours.

[0024] Furthermore, the conditions for high-temperature inactivation include an inactivation temperature of 80°C to 90°C and an inactivation time of 5 min to 10 min.

[0025] Furthermore, the decolorization process includes adding activated carbon at 1% of the total weight of the enzymatic hydrolysate and stirring for 20 to 30 minutes.

[0026] Furthermore, the weight ratio of the Ganoderma lucidum polysaccharide dispersion to sodium periodate is 1:0.1-0.2.

[0027] Furthermore, the oxidation treatment conditions in the light-protected environment include an oxidation temperature of 25°C to 30°C and an oxidation time of 5 to 6 hours.

[0028] Furthermore, the preparation method includes the following steps:

[0029] Add deionized water and carbomer to an emulsifying pot and stir until homogeneous. Then add oxidized Ganoderma lucidum polysaccharide, heat to 80℃~90℃ and homogenize for 5min~8min. Then cool down to 50℃~60℃ and keep warm. At this temperature, add sodium calcium phosphosilicate and γ-polyglutamic acid, homogenize for 2min~3min, then cool down to 30℃~35℃ and keep warm. Finally, add recombinant type III humanized collagen and L-DOPA-aminosilicone oil mixture and stir to form a dispersion.

[0030] After adjusting the dispersion to an alkaline environment, it was allowed to stand until a cloudy gel appeared. Finally, it was adjusted to a neutral state and allowed to stand to form a hydrogel, thus obtaining a multi-effect compound scar removal gel.

[0031] Compared with the prior art, the present invention has the following beneficial effects:

[0032] (1) In this invention, levodopa and amino silicone oil are first mixed and reacted to obtain a levodopa-amino silicone oil mixture. The levodopa-amino silicone oil mixture with amino groups and oxidized Ganoderma lucidum polysaccharide with aldehyde functional groups are used as inclusion structures. Then, recombinant type III humanized collagen, carbomer, sodium calcium phosphosilicate, polyglutamic acid, levodopa-amino silicone oil mixture and oxidized Ganoderma lucidum polysaccharide are mixed and dispersed to form a dispersion. Then, the dispersion is adjusted to a weakly alkaline environment for cross-linking and then adjusted to a neutral state for static gelation to obtain a multi-effect compound scar removal gel. Recombinant type III humanized collagen accelerates cell growth and migration, thereby improving healing speed and quality; inhibits tyrosinase activity, reducing melanin production and achieving skin whitening; and promotes the growth and proliferation of epithelial cells and fibroblasts, thereby accelerating the repair and regeneration of damaged tissues. Ganoderma lucidum polysaccharides have strong antioxidant effects. By cleaving the ortho-dihydroxy groups in their structure to generate aldehyde groups, cross-linking is achieved between the aldehyde groups and a mixture of amino-containing L-DOPA and amino silicone oil, thus encapsulating the recombinant type III humanized collagen. Simultaneously, it synergistically enhances antioxidant capacity with the recombinant type III humanized collagen, thereby reducing scar pigmentation. L-DOPA, under low-dose amino silicone oil application, can undergo alkali-catalyzed self-polymerization to form a poly-L-DOPA structure with an adhesive effect, improving the adhesion of the multi-effect compound scar-removing gel to the skin and preventing detachment.

[0033] (2) Carbomer acts as an emulsifier and stabilizer in oil or aqueous phases, contributing to a more uniform and delicate product texture and improving product stability and skin feel. Sodium calcium phosphosilicate stimulates the growth of growth factors during its degradation in the body, repairing damaged cells and tissues, and possesses anti-inflammatory and antibacterial properties. It can repair, replace, and regenerate body tissues and form bonds with them. Polyglutamic acid has a strong moisturizing effect, combining with moisture in the stratum corneum to form a protective film, reducing moisture loss and thus providing a moisturizing effect. Detailed Implementation

[0034] The technical solution of the present invention will be clearly and completely described below through embodiments. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0035] Unless otherwise stated, all raw materials and reagents used in this invention are commercially available or can be prepared by known methods.

[0036] Preparation Example 1:

[0037] The preparation method of the L-DOPA-aminosilicone oil mixture specifically includes the following steps:

[0038] One part by weight of levodopa and five parts by weight of amino silicone oil were added to 20 parts by weight of anhydrous acetone and heated to 40°C, then stirred to form a mixture. Subsequently, one part by weight of EDC hydrochloride and one part by weight of N-hydroxysuccinimide were added to the mixture, and the mixture was placed in an ultrasonic disperser with an ultrasonic power of 400W for 10 minutes. After ultrasonic dispersion, the dispersion was removed, the pH was adjusted to 5.0 with dilute hydrochloric acid, and then placed in a water bath at 20°C. The mixture was then magnetically stirred for 12 hours. After the reaction, the mixture was poured into a dialysis bag with a molecular weight cutoff of 3500 kDa. Dialysis was performed first with 0.1 mol / L sodium chloride for one day, then with anhydrous ethanol for one day, and finally with deionized water for one day to obtain the levodopa-amino silicone oil mixture.

[0039] Preparation Example 2:

[0040] The preparation method of the L-DOPA-aminosilicone oil mixture specifically includes the following steps:

[0041] One part by weight of levodopa and seven parts by weight of amino silicone oil were added to 24 parts by weight of anhydrous acetone and heated to 40°C, then stirred to form a mixture. Subsequently, 1.2 parts by weight of EDC hydrochloride and 1.2 parts by weight of N-hydroxysuccinimide were added to the mixture, and the mixture was placed in an ultrasonic disperser with an ultrasonic power of 400W for 12 minutes. After ultrasonic dispersion, the dispersion was removed, the pH was adjusted to 5.0 with dilute hydrochloric acid, and then placed in a water bath at 20°C. The mixture was then magnetically stirred for 13 hours. After the reaction, the mixture was poured into a dialysis bag with a molecular weight cutoff of 500 Da. Dialysis was performed first with 0.1 mol / L sodium chloride for one day, then with anhydrous ethanol for one day, and finally with deionized water for one day to obtain the levodopa-amino silicone oil mixture.

[0042] Preparation Example 3:

[0043] The preparation method of the L-DOPA-aminosilicone oil mixture specifically includes the following steps:

[0044] One part by weight of levodopa and nine parts by weight of amino silicone oil were added to 28 parts by weight of anhydrous acetone and heated to 40°C, then stirred to form a mixture. Subsequently, 1.4 parts by weight of EDC hydrochloride and 1.4 parts by weight of N-hydroxysuccinimide were added to the mixture, and the mixture was placed in an ultrasonic disperser with an ultrasonic power of 500W for 14 minutes. After ultrasonic dispersion, the dispersion was removed, the pH was adjusted to 5.5 with dilute hydrochloric acid, and then placed in a water bath at 25°C for 14 hours with magnetic stirring. After the reaction, the mixture was poured into a dialysis bag with a molecular weight cutoff of 500 Da. Dialysis was performed first with 0.1 mol / L sodium chloride for one day, then with anhydrous ethanol for one day, and finally with deionized water for one day to obtain the levodopa-amino silicone oil mixture.

[0045] Preparation Example 4:

[0046] The preparation method of the L-DOPA-aminosilicone oil mixture specifically includes the following steps:

[0047] One part by weight of levodopa and ten parts by weight of amino silicone oil were added to 30 parts by weight of anhydrous acetone and heated to 40°C, then stirred to form a mixture. Subsequently, 1.5 parts by weight of EDC hydrochloride and 1.5 parts by weight of N-hydroxysuccinimide were added to the mixture, and the mixture was placed in an ultrasonic disperser with an ultrasonic power of 500W for 15 minutes. After ultrasonic dispersion, the dispersion was removed, the pH was adjusted to 5.5 with dilute hydrochloric acid, and then placed in a water bath at 25°C. The mixture was then magnetically stirred for 15 hours. After the reaction, the mixture was poured into a dialysis bag with a molecular weight cutoff of 500 Da. Dialysis was performed first with 0.1 mol / L sodium chloride for one day, then with anhydrous ethanol for one day, and finally with deionized water for one day to obtain the levodopa-amino silicone oil mixture.

[0048] Preparation Example 5:

[0049] The preparation method of the dopamine hydrochloride-amino silicone oil mixture specifically includes the following steps:

[0050] One part by weight of dopamine hydrochloride and ten parts by weight of amino silicone oil were added to 30 parts by weight of anhydrous acetone and heated to 40°C, then stirred to form a mixture. Subsequently, 1.5 parts by weight of EDC hydrochloride and 1.5 parts by weight of N-hydroxysuccinimide were added to the mixture, and the mixture was placed in an ultrasonic disperser with an ultrasonic power of 500W for 15 minutes. After ultrasonic dispersion, the dispersion was removed, the pH was adjusted to 5.5 with dilute hydrochloric acid, and then placed in a water bath at 25°C. The mixture was then magnetically stirred for 15 hours. After the reaction, the mixture was poured into a dialysis bag with a molecular weight cutoff of 500 Da. Dialysis was performed first with 0.1 mol / L sodium chloride for one day, then with anhydrous ethanol for one day, and finally with deionized water for one day to obtain the dopamine hydrochloride-amino silicone oil mixture.

[0051] Preparation Example 6:

[0052] The preparation method of oxidized Ganoderma lucidum polysaccharides specifically includes the following steps:

[0053] The Ganoderma lucidum fruiting bodies were washed clean with water and then dried in an oven at 55°C until constant weight. The dried fruiting bodies were then pulverized using a pulverizer and passed through a 100-mesh sieve to obtain Ganoderma lucidum fruiting body powder. One part by weight of the Ganoderma lucidum fruiting body powder was then added to 20 parts by weight of deionized water and stirred until completely dispersed. Then, 0.005 parts by weight of a compound enzyme solution (composed of cellulase and papain in a 2:1 weight ratio) was pipetted into the aqueous dispersion of the Ganoderma lucidum fruiting body powder. The pH was adjusted to 5.0, and the mixture was placed in a water bath at 40°C for 1.5 hours of enzymatic hydrolysis. After hydrolysis, the hydrolysate was further heated to 80°C in the water bath for 5 minutes of inactivation treatment. After inactivation, the mixture was allowed to cool naturally to room temperature, and 1% (by weight) of activated charcoal was added for decolorization treatment for 20 minutes. After decolorization, the activated charcoal was removed by filtration to obtain a Ganoderma lucidum polysaccharide dispersion. Mix 1 part by weight of Ganoderma lucidum polysaccharide dispersion with 0.1 part by weight of sodium periodate, stir, and then place in a dark environment at 25°C for 5 hours of oxidation treatment. After the oxidation treatment, immediately add ethylene glycol of twice the weight of sodium periodate for quenching treatment to obtain a reaction solution. Then pour the reaction solution into oxidized Ganoderma lucidum polysaccharide powder with a molecular weight cutoff of 1000 Da.

[0054] Preparation Example 7:

[0055] The preparation method of oxidized Ganoderma lucidum polysaccharides specifically includes the following steps:

[0056] The Ganoderma lucidum fruiting bodies were washed clean with water and then dried in an oven at 55℃ until constant weight. The dried fruiting bodies were then pulverized using a pulverizer and passed through a 100-mesh sieve to obtain Ganoderma lucidum fruiting body powder. One part by weight of the Ganoderma lucidum fruiting body powder was then added to 24 parts by weight of deionized water and stirred until completely dispersed. Then, 0.007 parts by weight of a compound enzyme solution (composed of cellulase and papain in a 2:1 weight ratio) was pipetted into the aqueous dispersion of the Ganoderma lucidum fruiting body powder. The pH was adjusted to 5.0, and the mixture was placed in a water bath at 45℃ for 1.5 hours of enzymatic hydrolysis. After hydrolysis, the hydrolysate was further heated to 85℃ in the water bath for 7 minutes of inactivation treatment. After inactivation, the mixture was allowed to cool naturally to room temperature, and 1% (by weight) of activated charcoal was added for decolorization treatment for 25 minutes. After decolorization, the activated charcoal was removed by filtration to obtain a Ganoderma lucidum polysaccharide dispersion. One part by weight of Ganoderma lucidum polysaccharide dispersion and 0.14 parts by weight of sodium periodate were mixed and stirred, then placed in a dark environment at 25°C for 5.5 hours of oxidation treatment. After the oxidation treatment, ethylene glycol with a weight of twice that of sodium periodate was immediately added for quenching to obtain a reaction solution. The reaction solution was then poured into oxidized Ganoderma lucidum polysaccharide powder with a molecular weight cutoff of 1000 Da.

[0057] Preparation Example 8:

[0058] The preparation method of oxidized Ganoderma lucidum polysaccharides specifically includes the following steps:

[0059] The Ganoderma lucidum fruiting bodies were washed clean with water and then dried in an oven at 55°C until constant weight. The dried fruiting bodies were then pulverized using a pulverizer and passed through a 100-mesh sieve to obtain Ganoderma lucidum fruiting body powder. One part by weight of the Ganoderma lucidum fruiting body powder was then added to 28 parts by weight of deionized water and stirred until completely dispersed. Then, 0.009 parts by weight of a compound enzyme solution (composed of cellulase and papain in a 2:1 weight ratio) was pipetted into the aqueous dispersion of the Ganoderma lucidum fruiting body powder. The pH was adjusted to 5.5, and the mixture was placed in a water bath at 50°C for 2 hours of enzymatic hydrolysis. After hydrolysis, the hydrolysate was further heated to 85°C in the water bath for 10 minutes of inactivation treatment. After inactivation, the mixture was allowed to cool naturally to room temperature, and 1% (by weight) of activated charcoal was added for decolorization treatment for 30 minutes. After decolorization, the activated charcoal was removed by filtration to obtain a Ganoderma lucidum polysaccharide dispersion. One part by weight of Ganoderma lucidum polysaccharide dispersion and 0.18 parts by weight of sodium periodate were mixed and stirred, then placed in a dark environment and oxidized at 30°C for 5.5 hours. After the oxidation treatment, ethylene glycol with a weight of twice that of sodium periodate was immediately added for quenching to obtain a reaction solution. The reaction solution was then poured into oxidized Ganoderma lucidum polysaccharide powder with a molecular weight cutoff of 1000 Da.

[0060] Preparation Example 9:

[0061] The preparation method of oxidized Ganoderma lucidum polysaccharides specifically includes the following steps:

[0062] The Ganoderma lucidum fruiting bodies were washed clean with water and then dried in an oven at 55°C until constant weight. The dried fruiting bodies were then pulverized using a pulverizer and passed through a 100-mesh sieve to obtain Ganoderma lucidum fruiting body powder. One part by weight of the Ganoderma lucidum fruiting body powder was then added to 30 parts by weight of deionized water and stirred until completely dispersed. Then, 0.01 parts by weight of a compound enzyme solution (composed of cellulase and papain in a 2:1 weight ratio) was pipetted into the aqueous dispersion of the Ganoderma lucidum fruiting body powder. The pH was adjusted to 5.5, and the mixture was placed in a water bath at 50°C for 2 hours. After enzymatic hydrolysis, the hydrolysate was further heated to 90°C in the water bath for 10 minutes for inactivation. After inactivation, the mixture was allowed to cool naturally to room temperature, and 1% (by weight) of activated charcoal was added for decolorization for 30 minutes. After decolorization, the activated charcoal was removed by filtration to obtain a Ganoderma lucidum polysaccharide dispersion. Mix 1 part by weight of Ganoderma lucidum polysaccharide dispersion with 0.2 parts by weight of sodium periodate, stir, and then place in a dark environment at 30°C for 6 hours of oxidation treatment. After the oxidation treatment, immediately add ethylene glycol of twice the weight of sodium periodate for quenching treatment to obtain a reaction solution. Then pour the reaction solution into oxidized Ganoderma lucidum polysaccharide powder with a molecular weight cutoff of 1000 Da.

[0063] Preparation Example 10:

[0064] The preparation method of oxidized Ganoderma lucidum polysaccharides specifically includes the following steps:

[0065] The Ganoderma lucidum fruiting bodies were washed clean with water and then dried in an oven at 55°C until constant weight. The dried fruiting bodies were then pulverized using a pulverizer and passed through a 100-mesh sieve to obtain Ganoderma lucidum fruiting body powder. One part by weight of the Ganoderma lucidum fruiting body powder was then added to 30 parts by weight of deionized water and stirred until completely dispersed. Then, 0.01 parts by weight of cellulase was added to the aqueous dispersion of the Ganoderma lucidum fruiting body powder using a pipette, and the pH was adjusted to 5.5. The mixture was then placed in a water bath at 50°C for 2 hours. After enzymatic hydrolysis, the hydrolysate was further heated to 90°C in the water bath for 10 minutes for inactivation. After inactivation, the mixture was allowed to cool naturally to room temperature, and 1% (by weight) of activated charcoal was added for decolorization for 30 minutes. After decolorization, the activated charcoal was removed by filtration to obtain a Ganoderma lucidum polysaccharide dispersion. One part by weight of the Ganoderma lucidum polysaccharide dispersion was mixed with 0.2 parts by weight of sodium periodate and stirred. The mixture was then placed in a dark environment at 30°C for 6 hours for oxidation. After the oxidation treatment, ethylene glycol with a weight of twice that of sodium periodate was immediately added for quenching to obtain a reaction solution. The reaction solution was then poured into oxidized Ganoderma lucidum polysaccharide powder with a molecular weight cutoff of 1000 Da.

[0066] Preparation Example 11:

[0067] The preparation method of oxidized Ganoderma lucidum polysaccharides specifically includes the following steps:

[0068] The Ganoderma lucidum fruiting bodies were washed clean with water and then dried in an oven at 55°C until constant weight. The dried fruiting bodies were then pulverized using a pulverizer and passed through a 100-mesh sieve to obtain Ganoderma lucidum fruiting body powder. One part by weight of the Ganoderma lucidum fruiting body powder was then added to 30 parts by weight of deionized water and stirred until completely dispersed. Then, 0.01 parts by weight of a compound enzyme solution (composed of cellulase and papain in a 2:1 weight ratio) was pipetted into the aqueous dispersion of the Ganoderma lucidum fruiting body powder. The pH was adjusted to 5.5, and the mixture was placed in a water bath at 50°C for 2 hours. After enzymatic hydrolysis, the hydrolysate was further heated to 90°C in the water bath for 10 minutes for inactivation. After inactivation, the mixture was allowed to cool naturally to room temperature, and 1% (by weight) of activated charcoal was added for decolorization for 30 minutes. After decolorization, the activated charcoal was removed by filtration to obtain a Ganoderma lucidum polysaccharide dispersion. Mix 1 part by weight of Ganoderma lucidum polysaccharide dispersion with 0.5 parts by weight of sodium periodate, stir, and then place in a dark environment at 30°C for 6 hours of oxidation treatment. After the oxidation treatment, immediately add ethylene glycol of twice the weight of sodium periodate for quenching treatment to obtain a reaction solution. Then pour the reaction solution into oxidized Ganoderma lucidum polysaccharide powder with a molecular weight cutoff of 1000 Da.

[0069] Example 1:

[0070] A method for preparing a multi-effect compound scar-removing gel for repairing scars on sensitive skin, specifically including the following steps:

[0071] According to the weight percentage, 96.65% deionized water and 0.63% carbomer were added to an emulsifying pot and stirred until homogeneous. Then, 0.8% of the oxidized Ganoderma lucidum polysaccharide obtained in Preparation Example 6 was added, heated to 80°C, homogenized for 5 min, and then cooled to 50°C and kept warm. At this holding temperature, 0.18% sodium calcium phosphosilicate and 0.09% γ-polyglutamic acid were added, homogenized for 2 min, and then cooled to 30°C and kept warm. Then, 0.05% recombinant type III humanized collagen and 1.6% of the L-DOPA-aminosilicone oil mixture obtained in Preparation Example 1 were added and stirred to form a dispersion.

[0072] After adjusting the dispersion to an alkaline environment with a pH of 8.0, it was left to stand at room temperature for a period of time until a turbid gel appeared. Then, the pH was immediately adjusted to neutral, and the mixture was left to stand to produce hydrogelation, thus completing the preparation of the multi-effect compound scar removal gel.

[0073] Example 2:

[0074] A method for preparing a multi-effect compound scar-removing gel for repairing scars on sensitive skin, specifically including the following steps:

[0075] According to the weight percentage, 96.32% deionized water and 0.64% carbomer were added to an emulsifying pot and stirred until homogeneous. Then, 0.9% of the oxidized Ganoderma lucidum polysaccharide obtained in Preparation Example 7 was added, heated to 85°C, homogenized for 6 min, and then cooled to 55°C and kept warm. At this holding temperature, 0.19% sodium calcium phosphosilicate and 0.09% γ-polyglutamic acid were added, homogenized for 2 min, and then cooled to 30°C and kept warm. Then, 0.06% recombinant type III humanized collagen and 1.8% of the L-DOPA-aminosilicone oil mixture obtained in Preparation Example 2 were added and stirred to form a dispersion.

[0076] After adjusting the dispersion to an alkaline environment with a pH of 8.0, it was left to stand at room temperature for a period of time until a turbid gel appeared. Then, the pH was immediately adjusted to neutral, and the mixture was left to stand to produce hydrogelation, thus completing the preparation of the multi-effect compound scar removal gel.

[0077] Example 3:

[0078] A method for preparing a multi-effect compound scar-removing gel for repairing scars on sensitive skin, specifically including the following steps:

[0079] According to the weight percentage, 96.09% deionized water and 0.65% carbomer were added to an emulsifying pot and stirred until uniform. Then, 0.9% of the oxidized Ganoderma lucidum polysaccharide obtained in Preparation Example 8 was added, heated to 90°C, homogenized for 7 min, and then cooled to 60°C and kept warm. At this holding temperature, 0.19% sodium calcium phosphosilicate and 0.1% γ-polyglutamic acid were added, homogenized for 3 min, and then cooled to 35°C and kept warm. Then, 0.07% recombinant type III humanized collagen and 2% of the L-DOPA-aminosilicone oil mixture obtained in Preparation Example 3 were added and stirred to form a dispersion.

[0080] After adjusting the dispersion to an alkaline environment with a pH of 8.0, it was left to stand at room temperature for a period of time until a turbid gel appeared. Then, the pH was immediately adjusted to neutral, and the mixture was left to stand to produce hydrogelation, thus completing the preparation of the multi-effect compound scar removal gel.

[0081] Example 4:

[0082] A method for preparing a multi-effect compound scar-removing gel for repairing scars on sensitive skin, specifically including the following steps:

[0083] According to the weight percentage, 95.64% deionized water and 0.66% carbomer were added to an emulsifying pot and stirred until homogeneous. Then, 1.1% of the oxidized Ganoderma lucidum polysaccharide obtained in Preparation Example 9 was added, heated to 90°C, homogenized for 8 minutes, and then cooled to 60°C and kept warm. At this holding temperature, 0.21% sodium calcium phosphosilicate and 0.11% γ-polyglutamic acid were added, homogenized for 3 minutes, and then cooled to 35°C and kept warm. Then, 0.08% recombinant type III humanized collagen and 2.2% of the L-DOPA-aminosilicone oil mixture obtained in Preparation Example 4 were added and stirred to form a dispersion.

[0084] After adjusting the dispersion to an alkaline environment with a pH of 8.0, it was left to stand at room temperature for a period of time until a turbid gel appeared. Then, the pH was immediately adjusted to neutral, and the mixture was left to stand to produce hydrogelation, thus completing the preparation of the multi-effect compound scar removal gel.

[0085] Comparative Example 1:

[0086] A method for preparing a multi-effect compound scar-removing gel for repairing scars on sensitive skin, specifically including the following steps:

[0087] The L-DOPA-amino silicone oil mixture in Example 3 was replaced with the L-DOPA-amino silicone oil mixture obtained in Preparation Example 5, and the other conditions remained the same as in Example 3.

[0088] Comparative Example 2:

[0089] A method for preparing a multi-effect compound scar-removing gel for repairing scars on sensitive skin, specifically including the following steps:

[0090] The oxidized Ganoderma lucidum polysaccharide in Example 3 was replaced with the oxidized Ganoderma lucidum polysaccharide obtained in Preparation Example 10, and the other conditions remained the same as in Example 3.

[0091] Comparative Example 3:

[0092] A method for preparing a multi-effect compound scar-removing gel for repairing scars on sensitive skin, specifically including the following steps:

[0093] The oxidized Ganoderma lucidum polysaccharide in Example 3 was replaced with the oxidized Ganoderma lucidum polysaccharide obtained in Preparation Example 11, and the other conditions remained the same as in Example 3.

[0094] Comparative Example 4:

[0095] A method for preparing a multi-effect compound scar-removing gel for repairing scars on sensitive skin, specifically including the following steps:

[0096] In Example 3, 0.9% of oxidized Ganoderma lucidum polysaccharide was replaced with 0.8% sodium alginate and 0.1% calcium chloride solution (calcium chloride solution mass concentration was 10%), and the remaining conditions were the same as in Example 3.

[0097] Scar treatment efficacy verification:

[0098] After anesthetizing rats, the hair on their backs was removed, and the skin where the hair was removed was disinfected with povidone-iodine. A 20mm diameter skin lesion was then artificially created using a disposable biopsy puncture device. The broken skin was then properly disinfected and cared for, and allowed to heal naturally to form a scar. The area of ​​the scar after natural healing was recorded. The multi-effect compound scar-removing gel prepared in Examples 1-4 and Comparative Examples 1-4 was then applied to the scar area twice daily for 30 consecutive days. Ten minutes after the initial application, the multi-effect compound scar-removing gel was rubbed onto the skin while wearing gloves, and the ease of removal was recorded. The results are shown in Table 1. On day 31, the scar area after treatment was recorded. The scar removal rate was calculated as (scar area after natural healing - scar area after treatment) / scar area after natural healing × 100%. The control group received no treatment. The results are shown in Table 1 below.

[0099] Table 1. Scar Treatment Efficacy

[0100]

[0101] The following conclusions can be drawn from Table 1 above:

[0102] (1) As can be seen from Examples 1 to 4, the present invention mixes and disperses recombinant type III humanized collagen, carbomer, sodium calcium phosphosilicate, polyglutamic acid, L-DOPA-aminosilicone mixture, oxidized Ganoderma lucidum polysaccharide and deionized water to form a dispersion, then adjusts the dispersion to a weakly alkaline environment for cross-linking and then adjusts it to neutral and allows it to stand and gel, resulting in a multi-effect compound scar removal gel that is effective in repairing scars and does not cause redness or swelling.

[0103] (2) Comparative Example 1 shows that the prepared multi-effect compound scar removal gel has poor adhesion. This may be because in this system, although dopamine hydrochloride can polymerize to form viscous polydopamine and achieve the same adhesion effect as levodopa, there is no carboxyl functional group on dopamine hydrochloride that can react with the amino group on amino silicone oil. As a result, dopamine hydrochloride and amino silicone oil cannot react. When dialysis is performed, dopamine hydrochloride is removed by dialysis, leaving only amino silicone oil. Under the formulation of this system, the adhesion is poor and it is easy to fall off, which is not conducive to practical use.

[0104] (3) Comparative Example 2 shows that the prepared multi-effect compound scar removal gel performed poorly in terms of scar pigmentation. This may be because in this system, when cellulase is used alone for enzymatic hydrolysis, cellulase mainly plays the role of enzymatic hydrolysis of cell wall structure, thereby promoting the release of substances in the cell. However, due to the interference of proteins contained in Ganoderma lucidum fruiting body, the enzymatic hydrolysis efficiency may be low. Under the usage amount in this system, the content of Ganoderma lucidum polysaccharide may be low. The reduction of Ganoderma lucidum polysaccharide content makes the overall antioxidant performance of the multi-effect compound scar removal gel poor and prone to pigmentation, thus affecting the scar repair effect.

[0105] (4) Comparative Example 3 shows that the prepared multi-effect compound scar removal gel has poor adhesion. This may be because the amount of sodium periodate in this system is too high, resulting in excessive oxidation intensity. This leads to a high aldehyde content in the oxidized Ganoderma lucidum polysaccharide. During the mixing preparation, the high content of aldehyde and amino crosslinking may lead to excessive gelation, which hinders the process of L-DOPA polymerization to form poly-L-DOPA, thus resulting in poor adhesion of the multi-effect compound scar removal gel.

[0106] (5) Comparative Example 4 shows that although sodium alginate can achieve gelation through the metal coordination of calcium ions, the adhesion after gelation is low and sodium alginate does not have antioxidant capacity, resulting in poor scar repair effect.

[0107] The embodiments described above provide a detailed explanation of the technical solutions and beneficial effects of the present invention. It should be understood that the above descriptions are merely specific embodiments of the present invention and are not intended to limit the present invention. Various changes and modifications can be made to the present invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed.

Claims

1. A multi-effect compound scar-removing gel for repairing scars on sensitive skin, characterized in that, The multi-effect compound scar removal gel contains the following ingredients by weight percentage: 0.05%~0.08% recombinant type III humanized collagen, 0.63%~0.66% carbomer, 0.18%~0.21% sodium calcium phosphosilicate, 0.09%~0.11% γ-polyglutamic acid, 1.6%~2.2% L-DOPA-aminosilicone oil mixture, 0.8%~1.1% oxidized Ganoderma lucidum polysaccharide, with the balance being deionized water to bring the total to 100%. The preparation method of the L-DOPA-aminosilicone oil mixture includes the following steps: L-DOPA, amino silicone oil, EDC hydrochloride, N-hydroxysuccinimide and acetone are mixed and ultrasonically dispersed to form a dispersion. The pH of the dispersion is adjusted to 5.0~5.5 and then stirred to obtain the L-DOPA-amino silicone oil mixture. The preparation method of the oxidized Ganoderma lucidum polysaccharide includes the following steps: Ganoderma lucidum fruiting body powder, deionized water and compound enzyme solution are mixed and then heated to obtain enzymatic hydrolysate; The enzymatic hydrolysate was sequentially inactivated and decolorized to obtain a Ganoderma lucidum polysaccharide dispersion. The Ganoderma lucidum polysaccharide dispersion was mixed with sodium periodate and oxidized in a light-protected environment to obtain the oxidized Ganoderma lucidum polysaccharide. The weight ratio of the Ganoderma lucidum polysaccharide dispersion to sodium periodate is 1:0.1~0.2; The preparation method of the multi-effect compound scar removal gel includes the following steps: Add deionized water and carbomer to an emulsifying pot and stir until homogeneous. Then add oxidized Ganoderma lucidum polysaccharide, heat to 80℃~90℃ and homogenize for 5min~8min. Then cool down to 50℃~60℃ and keep warm. At this temperature, add sodium calcium phosphosilicate and γ-polyglutamic acid, homogenize for 2min~3min, then cool down to 30℃~35℃ and keep warm. Finally, add recombinant type III humanized collagen and L-DOPA-aminosilicone oil mixture and stir to form a dispersion. After adjusting the dispersion to an alkaline environment, it was allowed to stand until a cloudy gel appeared. Finally, it was adjusted to a neutral environment and allowed to stand to form a hydrogel, thus obtaining a multi-effect compound scar removal gel. The complex enzyme solution is obtained by mixing cellulase and papain in a weight ratio of 2:

1.

2. The multi-effect compound scar-removing gel for sensitive skin scar repair according to claim 1, characterized in that, The weight ratio of L-DOPA: amino silicone oil: EDC hydrochloride: N-hydroxysuccinimide: acetone is 1:5~10:1~1.5:1~1.5:20~30.

3. The multi-effect compound scar-removing gel for sensitive skin scar repair according to claim 1, characterized in that, The weight ratio of the Ganoderma lucidum fruiting body powder, deionized water, and compound enzyme solution is 1:20~30:0.005~0.

01.

4. The multi-effect compound scar-removing gel for sensitive skin scar repair according to claim 1, characterized in that, The conditions for the heating enzymatic hydrolysis include an enzymatic hydrolysis pH of 5.0 to 5.5, an enzymatic hydrolysis temperature of 40°C to 50°C, and an enzymatic hydrolysis time of 1.5 to 2 hours.

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