Cream for repairing radiodermatitis and preparation method thereof

Abstract

The invention relates to cream for repairing radiodermatitis and a preparation method of the cream, and belongs to the technical field of biomedical skin treatment. The cream consists of the following components in percentage by weight: 8% of glycerin monostearate, 6% of stearic acid, 5% of white vaseline, 4% of liquid wax, 1-2% of tea tree oil, 1-2% of eugenol, 1-2% of vitamin E, 3% of trehalose, 8% of polyethylene glycol (PEG-400), 10% of glycerol, 0.5% of methylparaben, 1% of triethanolamine and the balance of purified water. According to the cream disclosed by the invention, the natural traditional Chinese medicine component eugenol and the natural substance vitamin E are utilized to synergistically enhance the anti-oxidation and bacteriostatic effects, and the tea tree oil, the trehalose and other effective components are utilized to repair radiodermatitis from multiple aspects of anti-inflammation, bacteriostasis, antioxidation, promotion of skin barrier repair and the like. The cream is simple in component, good in treatment effect, high in safety and convenient to produce and process, and can be popularized and applied to treatment of radiodermatitis.

Description

Technical Field

[0001] This invention belongs to the field of biomedical skin treatment technology, and relates to a cream for the repair of radiation dermatitis and its preparation method. Background Technology

[0002] Radiation dermatitis is an inflammatory condition of the skin and mucous membranes caused by radiation (mainly beta and gamma rays and X-rays). In cancer patients undergoing radiation therapy, unavoidable damage to normal cells occurs. Low-energy photons remain in the superficial layers, causing skin damage, including reversible erythema, itching, hair loss, dermatitis, and pigmentation, as well as irreversible ulceration, bleeding, and radiation-induced tissue necrosis. Statistics show that over 90% of radiotherapy patients develop radiation dermatitis to varying degrees, severely impacting their treatment and quality of life. Therefore, timely treatment of radiation dermatitis can effectively alleviate patient suffering and reduce its adverse effects.

[0003] Currently, there is a lack of effective methods and standardized protocols for treating radiation dermatitis in clinical practice. Besides routine daily care such as cleansing, moisturizing, and sun protection, existing treatments mainly rely on marketed triethanolamine products. However, their preventative effects are poor and they are irritating, causing varying degrees of pain or allergic reactions at the inflamed area after application. In addition, corticosteroids are also commonly used to treat radiation dermatitis, but the clinical use of steroid drugs remains controversial, and they have side effects such as delayed wound healing.

[0004] In response to the problems faced by existing clinical treatments for radiation dermatitis, preparations made from natural Chinese herbal ingredients have been developed to treat radiation dermatitis. Their advantages include multi-component, multi-target, mild and non-irritating effects, high overall safety, and avoidance of the potential risks of long-term use of hormones or antibiotics. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide a cream for the repair of radiation dermatitis and its preparation method. The cream utilizes the natural Chinese herbal ingredient eugenol and the natural substance vitamin E to synergistically enhance the antioxidant and antibacterial effects, as well as other effective ingredients such as tea tree oil and trehalose, to provide comprehensive treatment for radiation dermatitis from multiple aspects such as anti-inflammatory, antibacterial, antioxidant and skin barrier repair promotion.

[0006] To achieve the above objectives, the present invention provides the following technical solution: This invention provides a cream for the repair of radiation dermatitis, comprising the following components in the indicated weight proportions: 8% glyceryl monostearate, 6% stearic acid, 5% white petrolatum, 4% liquid wax, 1-2% tea tree oil, 1-2% eugenol, 1-2% vitamin E, 3% trehalose, 8% polyethylene glycol (PEG-400), 10% glycerin, 0.5% methylparaben, 1% triethanolamine, with the remainder being purified water.

[0007] Furthermore, the pH value of the cream is 6.0-8.0.

[0008] The present invention also provides a method for preparing the above-mentioned cream, specifically including the following steps: (1) Preparation of oil phase: Glyceryl monostearate, stearic acid, white petrolatum, liquid wax, eugenol and vitamin E are added to the oil phase pot, heated and stirred to disperse them evenly; (2) Preparation of aqueous phase: Trehalose, PEG-400, glycerol, methylparaben, triethanolamine and purified water were added to the aqueous phase pot, heated and stirred to disperse them evenly; (3) Preheat the main pot, add the oil phase and water phase into the main pot separately, heat and stir to mix them evenly; (4) Stop heating, stir and cool, add tea tree oil, and stir thoroughly to disperse it evenly.

[0009] (5) Cool the mixing pot to room temperature, discharge the semi-finished product, and perform sampling and testing and material transfer; (6) Fill, package and inspect the semi-finished products in step (5) that have passed the inspection to obtain the cream product.

[0010] Preferably, the heating temperature in step (1) is 80℃-85℃; Preferably, the heating temperature in step (2) is 80℃-85℃; Preferably, the heating temperature in step (3) is 80℃-85℃, and the stirring time is 20~30 minutes; Preferably, the cooling temperature in step (4) is 40℃~60℃.

[0011] The present invention also provides the application of the above-mentioned cream in the repair of radiation dermatitis.

[0012] The beneficial effects of this invention are as follows: This invention provides a cream for the repair of radiation dermatitis. It utilizes the natural Chinese herbal ingredient eugenol and the natural substance vitamin E to synergistically enhance antioxidant and antibacterial effects, resulting in a significantly better therapeutic effect than either eugenol or vitamin E alone. The added Melaleuca alternifolia leaf extract and tea tree oil possess antibacterial and dermatitis-repairing properties, while trehalose effectively improves skin barrier damage. Triethanolamine provides both cleansing and cell-stimulating effects. This product treats radiation dermatitis from multiple perspectives, including anti-inflammatory, antibacterial, antioxidant, and skin barrier-repair-promoting effects, demonstrating superior therapeutic efficacy compared to similar products both domestically and internationally. This cream contains no potentially allergenic or irritating chemical ingredients. Its texture is refreshing with a herbal fragrance, leaving no foreign body sensation on the skin after application, providing a pleasant user experience and improving patient compliance. Furthermore, its components are simple and readily available, and the cream is easy to prepare and process, facilitating its widespread application in the treatment of radiation dermatitis.

[0013] Other advantages, objectives, and features of the invention will be set forth in part in the description which follows, and in part will be apparent to those skilled in the art from the following examination, or may be learned from practice of the invention. The objectives and other advantages of the invention can be realized and obtained through the following description. Attached Figure Description

[0014] To make the objectives, technical solutions, and advantages of the present invention clearer, the preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings, wherein: Figure 1 This is a schematic diagram of the preparation process for a cream used to repair radiation dermatitis. Figure 2 The results of antioxidant performance tests for cream products with different formulations; Figure 3 Results of antibacterial performance tests for cream products with different formulations; Figure 4 Results of tests on the synergistic antioxidant effects of eugenol and vitamin E in different cream formulations; Figure 5 Comparison of test results of synergistic antibacterial effects of eugenol and vitamin E in cream products from different sources; Figure 6 Comparison of cytotoxicity test results for cream products from different sources; Figure 7 A comparison of the treatment results of different source cream products on a radiation dermatitis model in SD rats; Figure 8 Comparison of HE staining and Masson staining results of tissue sections after treatment of SD rat radiation dermatitis model with cream products from different sources; Figure 9A comparison of the effects of cream products from different sources on the secretion of inflammatory factors. Detailed Implementation

[0015] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the following embodiments are only schematic representations of the basic concept of the present invention. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0016] Example 1 A cream for the repair of radiation dermatitis comprises the following components in the indicated weight proportions: 8% glyceryl monostearate, 6% stearic acid, 5% white petrolatum, 4% liquid wax, 1% tea tree oil, 1% eugenol, 1% vitamin E, 3% trehalose, 8% polyethylene glycol (PEG-400), 10% glycerin, 0.5% methylparaben, 1% triethanolamine, with the balance being purified water.

[0017] The specific preparation method is as follows: (1) Preparation of oil phase: Add 0.8g of glyceryl monostearate, 0.6g of stearic acid, 0.5g of white petrolatum, 0.4g of liquid wax, 0.1g of eugenol and 0.1g of vitamin E to the oil phase pot, heat to 80℃, and stir thoroughly to disperse evenly; (2) Preparation of aqueous phase: 0.3g of trehalose, 0.8g of PEG-400, 1g of glycerol, 0.05g of methylparaben, 0.1g of triethanolamine and 5.15g of purified water were added to the aqueous phase pot, heated to 80℃ and stirred thoroughly to disperse evenly; (3) Preheat the main pot to 80°C, add the oil phase and water phase into the main pot respectively, heat and stir for 20 minutes to make them evenly mixed; (4) Stop heating, stir and cool to 40°C, add 0.1g of tea tree oil, and stir thoroughly to disperse it evenly.

[0018] (5) Cool the mixing pot to room temperature, discharge the semi-finished product, and perform sampling and testing and material transfer; (6) Fill, package and inspect the semi-finished products in step (5) that have passed the inspection to obtain the cream product.

[0019] A schematic diagram of the specific preparation process is shown below. Figure 1 As shown.

[0020] Example 2 A cream for the repair of radiation dermatitis comprises the following components in the indicated weight proportions: 8% glyceryl monostearate, 6% stearic acid, 5% white petrolatum, 4% liquid wax, 1.5% tea tree oil, 1.5% eugenol, 1.5% vitamin E, 3% trehalose, 8% polyethylene glycol (PEG-400), 10% glycerin, 0.5% methylparaben, 1% triethanolamine, with the balance being purified water.

[0021] The specific preparation method is as follows: (1) Preparation of oil phase: Add 0.8g of glyceryl monostearate, 0.6g of stearic acid, 0.5g of white petrolatum, 0.4g of liquid wax, 0.15g of eugenol and 0.15g of vitamin E to the oil phase pot, heat to 85℃, and stir thoroughly to disperse evenly; (2) Preparation of aqueous phase: 0.3g of trehalose, 0.8g of PEG-400, 1g of glycerol, 0.05g of methylparaben, 0.1g of triethanolamine and 5g of purified water were added to the aqueous phase pot, heated to 85℃ and stirred thoroughly to disperse evenly; (3) Preheat the main pot to 85°C, add the oil phase and water phase into the main pot respectively, heat and stir for 20 minutes to make them evenly mixed; (4) Stop heating, stir and cool to 50°C, add 0.15g of tea tree oil, and stir thoroughly to disperse it evenly.

[0022] (5) Cool the mixing pot to room temperature, discharge the semi-finished product, and perform sampling and testing and material transfer; (6) Fill, package and inspect the semi-finished products in step (5) that have passed the inspection to obtain the cream product.

[0023] Example 3 A cream for the repair of radiation dermatitis comprises the following components in the indicated weight proportions: 8% glyceryl monostearate, 6% stearic acid, 5% white petrolatum, 4% liquid wax, 2% tea tree oil, 2% eugenol, 2% vitamin E, 3% trehalose, 8% polyethylene glycol (PEG-400), 10% glycerin, 0.5% methylparaben, 1% triethanolamine, with the balance being purified water.

[0024] The specific preparation method is as follows: (1) Preparation of oil phase: Add 0.8g of glyceryl monostearate, 0.6g of stearic acid, 0.5g of white petrolatum, 0.4g of liquid wax, 0.2g of eugenol and 0.2g of vitamin E to the oil phase pot, heat to 85℃, and stir thoroughly to disperse evenly; (2) Preparation of aqueous phase: 0.3g of trehalose, 0.8g of PEG-400, 1g of glycerol, 0.05g of methylparaben, 0.1g of triethanolamine and 4.85g of purified water were added to the aqueous phase pot, heated to 85℃ and stirred thoroughly to disperse evenly; (3) Preheat the main pot to 85°C, add the oil phase and water phase into the main pot respectively, heat and stir for 30 minutes to make them evenly mixed; (4) Stop heating, stir and cool to 60°C, add 0.2g of tea tree oil, and stir thoroughly to disperse it evenly.

[0025] (5) Cool the mixing pot to room temperature, discharge the semi-finished product, and perform sampling and testing and material transfer; (6) Fill, package and inspect the semi-finished products in step (5) that have passed the inspection to obtain the cream product.

[0026] Example 4 Validation of the antioxidant properties of a cream used to repair radiation dermatitis Antioxidant properties are an important reference indicator for the treatment of radiation dermatitis. The main problem hindering the healing of radiation dermatitis is persistent inflammation, primarily caused by excessive accumulation of reactive oxygen species (ROS) at the wound site, which prevents cells from proliferating normally. Therefore, verifying whether a product can eliminate ROS at the wound site to alleviate inflammation is crucial for treating radiation dermatitis. Free radical scavenging experiments were conducted using 1,1-diphenyl-2-trinitrophenylhydrazine (DPPH), a common reactive oxygen species, to determine the ROS scavenging capabilities of three groups of cream products with different formulations prepared in Examples 1-3.

[0027] The specific implementation steps are as follows: (1) Prepare the DPPH solution according to the DPPH kit instructions. Dilute the three cream products with the prepared DPPH solution to a final mass fraction of 1%. (2) Add the diluted solution to each of the 96-well plates and place the 96-well plates in a 37°C incubator to incubate in the dark for 30 minutes. (3) After incubation, place the 96-well plate in an ELISA reader to detect the absorbance at 520 nm and calculate the DPPH clearance rate based on the standard curve.

[0028] Each cream product group had 3-5 replicates, with phosphate buffer as a blank control group.

[0029] from Figure 2 It can be seen that, compared with the blank control group, the cream experimental group had a DPPH removal effect of more than 50%, and there was no significant difference in the removal effect of the three cream products on reactive oxygen species.

[0030] Example 5 Validation of the antibacterial effect of a cream used to repair radiation dermatitis Bacteria inherent in the environment and on the skin surface can easily colonize and multiply on broken wounds. During the treatment of radiation dermatitis, infection with Gram-negative / positive bacteria and fungi is common, potentially leading to local or even systemic infections. Furthermore, bacteria may enter the bloodstream, causing life-threatening conditions such as sepsis. Therefore, products for treating radiation dermatitis need to possess certain antibacterial properties. We verified the inhibitory effects of three groups of cream products with different formulations prepared in Examples 1-3 on bacterial and fungal growth. The specific experimental steps are as follows: (1) First, different bacterial strains (including Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans) were activated. After activation, they were inoculated into LB liquid medium and cultured at 37°C for 24 hours. The concentration of the bacterial strains was then adjusted to 10. 6 CFU / mL; (2) Take three groups of cream products, add 1% (w / w) of cream to each group of LB liquid medium, and inoculate the bacterial strain into the medium containing the cream. Each group of cream products is repeated three times in parallel. Inoculate the bacterial strain into LB medium without any cream product as a blank control. Place the bacterial culture tubes in a constant temperature shaker at 37°C for 12 hours; (3) After the culture was completed, the bacterial culture solution in the bacterial culture tubes was diluted with different concentration gradients. After the appropriate dilution concentration was tested by plate smear, the total number of surviving bacteria in different cream products was calculated by plate counting. The results are as follows: Figure 3 As shown.

[0031] The experimental results showed that the three different formulations of the cream products had a significant inhibitory effect on the growth of bacteria and fungi, indicating that the cream products can achieve a good antibacterial effect in the repair of radiation dermatitis and avoid bacterial and fungal infections.

[0032] Example 6 Verification of the synergistic antioxidant and antibacterial effects of eugenol and vitamin E in a cream used for the repair of radiation dermatitis Following the preparation method of Example 2, creams containing no eugenol and vitamin E, creams containing only 1.5% eugenol, creams containing only 1.5% vitamin E, and creams containing both 1.5% eugenol and 1.5% vitamin E (self-developed cream products) were prepared respectively. The proportions of other ingredients in the creams remained unchanged, verifying the synergistic antioxidant and antibacterial effects of eugenol and vitamin E in the creams.

[0033] The reactive oxygen species (ROS) scavenging capabilities of the four creams were determined using a free radical scavenging experiment with 1,1-diphenyl-2-trinitrophenylhydrazine (DPPH), a common reactive oxygen species, with phosphate buffered saline as a control group. The DPPH free radical scavenging experiment procedure is described in Example 4.

[0034] from Figure 4 It can be seen that the scavenging ability of cream products containing no ingredients or only one of eugenol or vitamin E is significantly lower than that of cream products containing both eugenol and vitamin E (self-developed cream products). The experimental results show that eugenol and vitamin E can synergistically scavenge reactive oxygen species, and their synergistic antioxidant effect is significantly better than that of eugenol or vitamin E alone.

[0035] We verified the antibacterial properties of our self-developed cream products by co-incubating the four creams with different bacteria, and compared them with foreign commercial cream products (Johnson & Johnson, France, BIAFINE, 3400932857012) and domestic commercial cream products (Hunan Cihui Medical Technology Co., Ltd., Baituokang Medical Radiation Protective Agent, 6971264851353).

[0036] The specific steps are as follows: (1) First, different bacterial strains (including Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans) were activated. After activation, they were inoculated into LB liquid medium and cultured at 37°C for 24 hours. The concentration of the bacterial strains was then adjusted to 10. 6 CFU / mL; (2) Add 1% by mass of different sources of cream to LB liquid medium, and inoculate the bacterial strains into the medium containing the different sources of cream. Each group of cream products is repeated 3 times in parallel. Inoculate the bacterial strains into LB medium without any cream products as a blank control. Place the bacterial culture tubes in a constant temperature shaker at 37°C for 12 hours; (3) After the culture was completed, the bacterial culture solution in the bacterial culture tubes was diluted with different concentration gradients. After the appropriate dilution concentration was tested by plate smear, the total number of surviving bacteria in different cream products was calculated by plate counting. The results are as follows: Figure 5 As shown.

[0037] from Figure 5 The following conclusions can be drawn: (1) Cream products containing no ingredients or only eugenol or vitamin E have significantly lower antibacterial effects than cream products containing both eugenol and vitamin E. The experimental results show that eugenol and vitamin E can synergistically enhance the antibacterial effect, and their synergistic antibacterial effect is significantly better than that of eugenol or vitamin E alone.

[0038] (2) Compared with commercially available cream products at home and abroad, the antibacterial rates of the self-developed cream products against Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans were 51.1%, 19.1%, 60.8% and 20.4% respectively, indicating that the self-developed cream products have good antibacterial effects against Gram-negative bacteria, Gram-positive bacteria and fungi.

[0039] Example 7 Comparison of cytotoxicity of commercially available creams from domestic and international markets with self-developed creams The non-toxicity of cream products is particularly important for repairing radiation dermatitis, and it is also a crucial criterion for evaluating whether a product is irritating. The good biocompatibility of three groups of cream products with different formulations prepared in Examples 1-3 was verified using live and dead cell staining fluorescence experiments and cell counting experiments, and compared with commercially available cream products from abroad (Johnson & Johnson, France, BIAFINE, 3400932857012) and domestically available cream products (Hunan Cihui Medical Technology Co., Ltd., Baituokang Medical Radiation Protective Agent, 6971264851353). The specific implementation steps are as follows: (1) High-glucose DMED medium (containing 10% fetal bovine serum) containing 1% by mass of different cream products was added to confocal dishes. Human keratinocytes (HaCaT), human umbilical vein endothelial cells (HUVEC), and fibroblasts were counted and seeded onto the medium at a rate of 60,000 cells per well. Three dishes were seeded for each type of cell for each cream product. Three dishes of each type of cell were seeded onto high-glucose DMED medium containing 10% fetal bovine serum without any cream products as blank controls.

[0040] (2) Place the confocal dish in a constant temperature incubator at 37℃ and 5% CO2 for 48 hours, and observe the cell status regularly during the period; (3) After 48 hours, remove the confocal dish, use a pipette to remove the remaining culture medium, wash each dish 2-3 times with PBS buffer, and add live cell staining reagent to the confocal dish according to the instructions of the live cell staining kit. (4) After incubating the confocal dish in a 37°C incubator in the dark for 15-20 minutes, observe the cell viability using an inverted fluorescence microscope. See below for specific staining results of viable and dead cells. Figure 6 -A.

[0041] according to Figure 6 The results of fluorescence staining of live and dead cells with -A showed that, compared with the blank control group, commercially available creams from both domestic and international markets, as well as self-developed creams, had no significant effect on cell membranes and cell morphology.

[0042] (1) High-glucose DMED medium (containing 10% fetal bovine serum) containing 1% by weight of different cream products was added to 96-well plates. Human keratinocytes (HaCaT), human umbilical vein endothelial cells (HUVEC), and fibroblasts were counted and seeded onto the medium at a rate of 10,000 cells per well. Each cream product was seeded into 3-5 wells for each cell type. Each cell type was seeded into 3-5 wells in high-glucose DMED medium containing 10% fetal bovine serum without any cream products as a blank control.

[0043] (2) Place the 96-well plate in a constant temperature incubator at 37°C and 5% CO2 for 48 hours, and observe the cell status regularly during the period; (3) After 48 hours, remove the 96-well plate, aspirate the remaining culture medium with a pipette, and wash each well 2-3 times with PBS buffer. After washing, add the corresponding reagent to each well according to the instructions of the cell counting kit. (4) After incubating the 96-well plate in a 37°C incubator in the dark for 1 hour, the absorbance at 450 nm was measured using a microplate reader. The toxicity of different products to cells was obtained by comparing the absorbance. The results are as follows: Figure 6 -B is shown.

[0044] The test results showed no significant difference in cell survival rates between commercially available creams and self-developed creams and the blank control group, indicating that commercially available creams and self-developed creams had no significant cytotoxicity to resident skin cells, including HaCaT, HUVEC, and Fibroblast.

[0045] In conclusion, the self-developed cream has good biocompatibility and will not cause allergic reactions or secondary damage to skin tissue during product use.

[0046] Example 8 Validation of the therapeutic effect of a cream for the repair of radiation dermatitis on a radiation dermatitis model in SD rats. The incidence of radiation dermatitis after radiotherapy exceeds 95%. Creams designed to repair radiation dermatitis not only need anti-inflammatory, antioxidant, and antibacterial properties, but also the ability to effectively promote skin barrier repair. We validated the therapeutic effect of our self-developed cream on radiation dermatitis through animal experiments and compared its therapeutic effects with those of commercially available foreign creams (Johnson & Johnson, France, BIAFINE, 3400932857012) and domestic commercial creams (Hunan Cihui Medical Technology Co., Ltd., Baituokang Medical Radiation Protective Agent, 6971264851353).

[0047] The specific experimental steps are as follows: Hair was removed from the backs of SD rats. Different experimental groups of SD rats were irradiated using a small animal radiation device. The total irradiation intensity was 40 Gy, with each irradiation dose being 8 Gy, for 5 consecutive days. After irradiation, different creams were applied to the mice in each experimental group daily for 12 days, and photos were taken periodically to record the results.

[0048] SD rats were sacrificed on days 14 and 21, respectively, and treated as follows: (1) Sample collection and tissue preparation: After the mice in each group were sacrificed, skin tissue from the alopecia areata area was quickly collected, fixed with 4% paraformaldehyde for 24 hours, embedded in paraffin, and serially sectioned for immunohistochemical staining. (2) Immunohistochemical staining (IHC): After dewaxing the tissue sections, HE and Masson staining were performed; (3) Image acquisition: Images were taken using a microscope and different groups were observed using image analysis software such as ImageJ.

[0049] like Figure 7 As shown, all model rats developed numerous erythematous patches on their skin surface on day 7, which subsequently progressed to necrotic ulcers, with severe swelling and redness in the legs. Treatment with commercially available creams (domestic and international) and a self-developed cream resulted in varying degrees of healing. After 21 days, the skin condition of the untreated group rats worsened over time, with severe swelling and redness in the legs. Rats treated with the commercially available cream showed some relief from necrotic ulcers, but remained in the pre-scab formation stage; necrotic skin tissue had not yet sloughed off, and the left leg still exhibited moderate swelling and redness. Rats treated with the commercially available cream had sloughed off the necrotic skin, with scabs forming at the wound sites and new hair growth; the legs showed no swelling and redness. In the self-developed cream group, the original necrotic skin had been replaced by new skin, accompanied by hair growth; the legs showed no swelling and redness. We subsequently used HE staining and Masson staining to observe the integrity of the skin tissue structure and collagen deposition in different groups. Figure 8 As shown, compared with the untreated group and the foreign commercially available product group, the domestic commercially available cream product group and the self-developed cream product group have better skin tissue repair effects and obvious collagen deposition, indicating that the cream product of the present invention can significantly improve radiation dermatitis in rats after radiotherapy.

[0050] Example 9 Analysis of the effect of a cream used to repair radiation dermatitis on the secretion of inflammatory factors in SD rats after treatment with radiation dermatitis. Inflammatory factors include pro-inflammatory factors (such as interleukin-1β (IL-1β)) and anti-inflammatory factors (such as interleukin-4 (IL-4)). After treatment with cream products, detecting inflammatory factors at the wound site is an important way to test whether the cream products can relieve inflammation.

[0051] Based on the SD rats treated with the cream obtained in Example 8, the content of inflammatory factors at their wound sites was detected to evaluate the effects of foreign commercial cream products (Johnson & Johnson, France, BIAFINE, 3400932857012), domestic commercial cream products (Hunan Cihui Medical Technology Co., Ltd., Baituokang Medical Radiation Protective Agent, 6971264851353), and self-developed cream products on the secretion of inflammatory factors in SD rats after radiation dermatitis treatment.

[0052] The specific experimental steps are as follows: (1) Animal tissues treated in Example 8 were processed according to the instructions of the ELISA kit for detecting IL-1β and IL-4 to obtain animal tissue homogenates; (2) Add various detection reagents according to the kit instructions, and finally detect the absorbance at 450nm under the microplate reader. Calculate the concentrations of IL-1β and IL-4 in different groups based on the standard curve.

[0053] The results are as follows Figure 9 As shown, the results analysis showed that: (1) the self-developed cream product has a good effect of inhibiting the secretion of pro-inflammatory factor IL-1β or clearing IL-1β, and the content of anti-inflammatory factor IL-4 in the wound site after treatment with the self-developed cream product is significantly higher than that in the untreated group, indicating that the product has a good anti-inflammatory effect; (2) the self-developed cream product has a good anti-inflammatory effect, and the effect is no less than that of domestic and foreign cream products.

[0054] In summary, this invention provides a cream for repairing radiation dermatitis. It utilizes the natural Chinese herbal ingredient eugenol and the natural substance vitamin E to synergistically enhance antioxidant and antibacterial effects, resulting in a significantly better synergistic therapeutic effect than either eugenol or vitamin E alone. The added Melaleuca alternifolia leaf extract and tea tree oil possess antibacterial and dermatitis-repairing properties, while trehalose effectively improves skin barrier damage. Triethanolamine provides both cleansing and cell-stimulating effects. This treatment addresses radiation dermatitis from multiple perspectives, including anti-inflammatory, antibacterial, antioxidant, and skin barrier-repair-promoting effects, demonstrating superior therapeutic efficacy compared to similar products both domestically and internationally. This cream contains no potentially allergenic or irritating chemical ingredients. Its texture is refreshing with a herbal fragrance, leaving no foreign body sensation on the skin after application, providing a pleasant user experience and effectively improving patient compliance. The cream's components are simple and readily available, and its preparation and processing facilitate its widespread application in the treatment of radiation dermatitis.

[0055] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A cream for repair of radiodermatitis, characterized by, The cream is prepared from the following components in the following proportions by weight: glycerol monostearate 8%, stearic acid 6%, white vaseline 5%, liquid wax 4%, tea tree oil 1-2%, eugenol 1-2%, vitamin E 1-2%, trehalose 3%, polyethylene glycol (PEG-400) 8%, glycerol 10%, nipagin methyl ester 0.5%, triethanolamine 1%, and purified water in the remainder.

2. The cream according to claim 1, characterized in that, The pH value of the cream is 6.0-8.

0.

3. Process for the preparation of a cream based on claim 1, characterized in that, The method comprises the following steps: (1) Preparation of the oil phase: glycerol monostearate, stearic acid, white vaseline, liquid wax, eugenol, and vitamin E are added to an oil phase kettle and heated and stirred to disperse uniformly; (2) Preparation of the water phase: trehalose, PEG-400, glycerol, nipagin methyl ester, triethanolamine, and purified water are added to a water phase kettle and heated and stirred to disperse uniformly; (3) The main kettle is preheated, and the oil phase and the water phase are added to the main kettle, heated and stirred to mix uniformly; (4) Stop heating, stir and cool, add tea tree oil, and stir to disperse uniformly; (5) Stir the main kettle to cool to room temperature, discharge the semi-finished product, and perform sampling detection and material transfer; (6) The semi-finished product in step (5) that passes the detection is filled, packaged, and subjected to finished product inspection to obtain the cream product.

4. The production method according to claim 3, characterized by, The heating temperature in step (1) is 80-85°C.

5. The preparation method according to claim 3, characterized in that, The heating temperature in step (2) is 80-85°C.

6. The preparation method according to claim 3, characterized in that, The heating temperature in step (3) is 80-85°C, and the stirring time is 20-30 minutes.

7. The preparation method according to claim 3, characterized in that, The cooling temperature in step (4) is 40-60°C.

8. The cream according to claim 1 or 2, used for repairing radiation dermatitis.

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