Traditional Chinese medicine composition for promoting wound healing and relieving inflammatory response and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly provides a traditional Chinese medicine composition for promoting wound healing and relieving trauma local lesion inflammatory response, which is prepared by adopting radix sophorae flavescentis, alum, raw rhubarb, scutellaria baicalensis, golden cypress and mint as raw materials and performing proper weight proportioning; in the formula, radix sophorae flavescentis and alum are used as monarch drugs, rheum officinale, scutellaria baicalensis and golden cypress are used as ministerial drugs, mint is used as adjuvant and conductant drugs, the drug effects are guided to the exterior, and the whole formula has the effects of clearing heat and drying dampness, removing toxicity and diminishing swelling, and activating blood and promoting tissue regeneration, and aims at skin lesions with damp-heat syndromes. Under the combined action of all the medicine components, the traditional Chinese medicine composition has the effects of clearing heat, drying dampness, detoxifying, diminishing swelling, activating blood and promoting tissue regeneration, postoperative incision healing can be effectively promoted, local skin lesion inflammatory response is improved, clinical observation research and animal experiment research prove that the effect is remarkably superior to that of a common western medicine treatment method, and the traditional Chinese medicine composition is worthy of popularization and application. The application range is wide, and the medicine safety is good.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response of traumatic lesions, and its preparation method. Background Technology

[0002] Local incision complications are common after circumcision, laparoscopic surgery, or open surgery, such as infection and edema. The occurrence of surgical complications is closely related to the surgical method and the surgeon's skill. Meanwhile, injuries from everyday activities, such as cuts, needlestick injuries, abrasions, contusions, and burns, have a high incidence rate, are prone to infection, and can also lead to similar surgical complications, severely impacting daily activities. These types of injuries are routinely cleaned with iodine solution, saline solution, or Kangfuxin solution to maintain wound cleanliness to some extent, but varying degrees of edema and inflammation may still occur. For middle-aged and elderly patients or those with conditions like diabetes that slow wound healing, the wound healing process may face even more complications.

[0003] Traditional Chinese medicine (TCM) external therapies, guided by the holistic concept and syndrome differentiation of TCM, leverage their advantages. Dampness syndrome often manifests as water metabolism disorders, while progressing to damp-heat syndrome involves increased inflammation levels and high expression of various inflammatory factors, indicating a close link between damp-heat syndrome and inflammatory responses. TCM believes that if blood stasis and toxins are not cleared from the wound site, blood circulation will be impaired, leading to qi and blood stagnation and hindering new tissue growth. This is similar to the mechanisms of angiogenesis and fibroblast proliferation in modern medicine. Therefore, based on clinical manifestations of redness, swelling, heat, and pain, a local diagnosis of damp-heat syndrome can be made, and treatments such as clearing heat and drying dampness, detoxifying and reducing swelling can effectively promote local skin healing and alleviate inflammatory responses. Numerous clinical studies have shown that TCM has certain advantages in preventing and treating postoperative wound or local skin inflammation, effectively improving discomfort symptoms and enhancing quality of life, demonstrating broad clinical application prospects. Summary of the Invention

[0004] To address the aforementioned problems in existing technologies, this invention provides a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory responses in traumatic lesions, along with its preparation method. This traditional Chinese medicine composition, when used on postoperative incisions or local skin lesions, can effectively promote wound healing, reduce local inflammatory responses in traumatic lesions, improve local symptoms, and enhance the patient's quality of life.

[0005] The technical solution adopted in this invention is as follows: A traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions, comprising, by weight: 5-60 parts of Sophora flavescens, 2-20 parts of alum, 5-60 parts of raw rhubarb, 5-60 parts of Scutellaria baicalensis, 5-60 parts of Phellodendron chinense, and 5-60 parts of Mentha haplocalyx.

[0006] Further preferred raw material components of the traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions include: 15 parts of Sophora flavescens, 10-15 parts of alum, 15 parts of raw rhubarb, 15 parts of Scutellaria baicalensis, 15 parts of Phellodendron chinense, and 6 parts of Mentha haplocalyx (by weight).

[0007] Further preferred embodiments of the traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions include: 5-60 parts of purslane.

[0008] The preparation method of the traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response of traumatic lesions includes the following steps: (S1) Take each raw material and mix them thoroughly to obtain a mixture; (S2) Add water to the mixture, soak it, then boil it for the first time, filter it, and obtain the first decoction. (S3) Add water to the filter residue obtained in step (S2), boil for a second time, filter, and obtain the second decoction; (S4) Combine the first decoction and the second decoction to obtain the Chinese medicine composition.

[0009] In step (S2), during the first decoction, 4-20 times the mass of water is added to the mixture, and the soaking time is 30-60 minutes; the first decoction time is 0.5-1.5 hours.

[0010] In step (S3), during the second decoction, 4-20 times the mass of water of the mixture is added; the second decoction time is 0.5-1.5 hours.

[0011] Preferably, the method of using the prepared traditional Chinese medicine composition involves heating it to 25-37°C and then soaking it locally on the skin or applying it as a wet compress with gauze or a sponge.

[0012] Preferably, the traditional Chinese medicine composition is preserved by sealing and refrigerating at 0-5°C.

[0013] Preferably, the traditional Chinese medicine composition further includes a pharmaceutically acceptable carrier or excipient.

[0014] The preparation method of the traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response of traumatic lesions includes the following steps: (SS1) Preparation of traditional Chinese medicine extract powder: (a) Take all raw materials except alum, mix them thoroughly to obtain a mixture; (b) Add water to the mixture, soak it, then boil it for the first time, filter it, and obtain the first decoction. (c) Add water to the filter residue obtained in step (b), boil it a second time, filter it, and obtain the second decoction; (d) The first decoction and the second decoction are combined, concentrated and precipitated with alcohol in sequence, filtered, and the filtrate is concentrated to a thick paste, dried and pulverized to obtain the Chinese herbal extract powder. (SS2) Take ethanol, add 10-30 parts by weight of polyacrylic acid resin and 0-10 parts by weight of corn gluten, stir, and let stand until completely dissolved; (SS3) Add 0-5 parts by weight of povidone and 0-5 parts by weight of polyethylene glycol, and stir until completely dissolved; (SS4) Under stirring conditions, add 2-20 parts by weight of the Chinese herbal extract powder, add 0-2 parts by weight of peppermint oil, and stir evenly; (SS5) Under stirring conditions, 10-30 parts by weight of ethyl acrylate-methyl methacrylate copolymer and 1 part by weight of alum powder are added sequentially and mixed thoroughly to obtain the traditional Chinese medicine composition.

[0015] In step (b), add 8-12 times the weight of water to the mixture and soak for 30-60 minutes; the first decoction time is 60 minutes. In step (c), during the second decoction, 8-12 times the mass of water of the mixture is added; the second decoction time is 60 minutes.

[0016] In step (SS2), take 54 parts by weight of ethanol, add 16.2 parts by weight of polyacrylic acid resin and 5 parts by weight of corn gluten; In step (SS3), add 1 part by weight of povidone and 0.8 parts by weight of polyethylene glycol.

[0017] In step (SS4), add 5.75 parts by weight of the herbal extract powder and add 0.25 parts by weight of peppermint oil. In step (SS5), 16 parts by weight of ethyl acrylate-methyl methacrylate copolymer are added.

[0018] Preferably, the polyacrylic resin is any one of type I, type II, type III, and type IV polyacrylic resin. The polyethylene glycol is any one of polyethylene glycol 400, polyethylene glycol 600, polyethylene glycol 800, and polyethylene glycol 1000; the povidone is K30 or K90 type povidone.

[0019] A further preferred method for preparing the traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions includes the following steps: (SSS1) Extraction of peppermint volatile oil: Take peppermint, soak it in water first, then extract the volatile oil to obtain peppermint volatile oil, and collect the residue after extracting the volatile oil; (SSS2) Take Sophora flavescens, rhubarb, Scutellaria baicalensis, Phellodendron chinense, and Portulaca oleracea, mix them thoroughly, soak them in water, and boil them; then add the dregs obtained from the extraction of volatile oil in step (SSS1); mix them thoroughly and evenly, decoct and filter to obtain the first decoction; (SSS3) Add water to the filter residue obtained in step (SSS2), boil for a second time, filter, and obtain the second decoction; (SSS4) Add water to the filter residue obtained in step (SSS3), boil for the third time, filter, and obtain the third decoction; (SSS5) The first decoction, the second decoction and the third decoction are combined, concentrated and precipitated with alcohol in sequence, filtered, and the filtrate is concentrated and the ethanol is recovered to obtain a concentrated medicinal solution. (SSS6) Add activated carbon and diatomaceous earth to the concentrated drug solution obtained in step (SSS5), refrigerate overnight, and then filter to obtain the filtered drug solution. (SSS7) Take the peppermint volatile oil obtained in step (SSS1) and β-cyclodextrin and mix them evenly to obtain peppermint oil inclusion complex; (SSS8) First, add EDTA-Na2 and chlorhexidine acetate to the filtered drug solution, then add peppermint oil inclusion complex and mix thoroughly. Then, add glycerin and polyethylene glycol in sequence and stir evenly. Slowly add PVA solution and sodium polyacrylate solution, and finally add water and stir evenly to obtain the traditional Chinese medicine composition.

[0020] The application of the aforementioned traditional Chinese medicine composition in the preparation of drugs for treating skin pathological changes is also within the scope of protection of this invention. The aforementioned skin pathological changes manifest as epithelial cell degeneration, exudation, proliferation, and necrosis.

[0021] The application of the traditional Chinese medicine composition described in this invention in the preparation of any of the following drugs: Drugs that promote wound healing, wherein the wound includes at least one of the invasive surgeries such as circumcision, laparoscopic surgery, and open surgery, or accidental injuries such as cuts, punctures, abrasions, and burns.

[0022] A drug for treating inflammatory reactions of local skin lesions, wherein the inflammatory reactions are manifested as redness, swelling, heat, and pain, and wherein the local skin lesions include at least one of the following diseases: duct-related infection, balanitis, vulvitis, scrotal eczema, perineal abscess, scrotal abscess, acute orchitis, and acute epididymitis.

[0023] Sophora flavescens, bitter in taste and cold in nature, has the functions of clearing heat and drying dampness, dispelling wind and relieving itching. The *Lei Gong Pao Zhi Yao Xing Jie* states that it "treats severe wind-heat and all kinds of small rashes caused by wind-heat...it is particularly effective in treating dampness," and is used for skin itching, impetigo, scabies, leprosy, and other ailments. Its main bioactive components include alkaloids (41 in total), including matrine, and flavonoids (108 in total).

[0024] Alum, also known as alum, has a sour taste and cold nature. It has the functions of detoxifying, killing insects, drying dampness and relieving itching, clearing heat and eliminating phlegm. When used externally, it can promote tissue regeneration and heal sores. The "Changsha Materia Medica" states that it "is good at absorbing dampness and is most effective in resolving blood stasis and turbidity". It is often used for sores, scabies, eczema and itching.

[0025] Raw rhubarb is bitter and cold in nature. It has the functions of clearing heat and purging fire, detoxifying, promoting blood circulation and removing blood stasis. It can be used externally for sores and burns caused by heat toxins. The Changsha Materia Medica states that it "purges heat and promotes blood circulation, clears blockages and opens obstructions...unblocks meridians and breaks up masses, eliminates carbuncles and drains pus and blood."

[0026] Scutellaria baicalensis, bitter in taste and cold in nature. It clears heat and dries dampness, drains fire and detoxifies, stops bleeding, and calms the fetus. It is used for damp-heat syndrome, summer-heat syndrome with chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, blood-heat vomiting and nosebleeds, carbuncles and boils, and threatened abortion.

[0027] Phellodendron bark, bitter in taste and cold in nature. It clears heat and dries dampness, drains fire and eliminates steaming heat, detoxifies and heals sores. It is used for damp-heat diarrhea, jaundice, leukorrhea, urinary tract infection, beriberi, flaccidity, bone steaming fever, night sweats, seminal emission, sores and carbuncles, eczema and itching.

[0028] Peppermint, pungent in taste and cool in nature. It disperses wind-heat, clears the head and eyes, and promotes rash eruption. It is used for wind-heat colds, early stages of wind-heat syndrome, headache, red eyes, sore throat, mouth ulcers, urticaria, measles, and chest and rib distension.

[0029] The present invention has the following beneficial effects: This invention provides a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory responses in traumatic lesions. It utilizes Sophora flavescens, alum, raw rhubarb, Scutellaria baicalensis, Phellodendron chinense, and Mentha haplocalyx as raw materials in appropriate weight ratios. Sophora flavescens and alum are the principal herbs, rhubarb, Scutellaria baicalensis, and Phellodendron chinense are the assistant herbs, and Mentha haplocalyx is the adjuvant herb, guiding the medicinal effects to the exterior. The entire composition has the functions of clearing heat and drying dampness, detoxifying and reducing swelling, and promoting blood circulation and tissue regeneration, aiming to target skin lesions exhibiting damp-heat syndrome. Under the combined action of the above-mentioned drug components, the traditional Chinese medicine composition of this invention has the effects of clearing heat and drying dampness, detoxifying and reducing swelling, and promoting blood circulation and tissue regeneration. It can effectively promote postoperative wound healing and improve local inflammatory responses in skin lesions. Clinical observation and animal experiments have verified that its effects are significantly superior to common Western medicine treatments, and it has a wide range of applications and good drug safety. Attached Figure Description

[0030] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0031] Figure 1Photomicrographs of skin histological specimens obtained by H&E staining at 3, 7 and 12 days after drug administration to mice. Detailed Implementation

[0032] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be described in detail below. Obviously, the described embodiments are merely some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other implementation methods obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0033] Unless otherwise specified, all raw materials and excipients of the traditional Chinese medicine composition of the present invention can be obtained commercially. Any range of traditional Chinese medicine composition described in the present invention, including any value between the endpoints and any sub-ranges formed by the endpoints or any value between the endpoints, can achieve the purpose of promoting wound healing and treating local inflammatory reactions of skin lesions.

[0034] The term "parts by weight" in this invention specification refers to the proportion of each raw material in the traditional Chinese medicine composition. Depending on the actual application, "1 part by weight" in this invention can be "1g", "1kg" or any other arbitrary weight.

[0035] The daily dosage of the traditional Chinese medicine composition described in this invention can be adjusted according to the patient's condition.

[0036] Example 1 This embodiment provides a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response in traumatic lesions, and is particularly suitable for treating post-circumcision conditions. The raw material components of the traditional Chinese medicine composition include: 10 parts Sophora flavescens, 10 parts alum, 10 parts raw rhubarb, 15 parts Scutellaria baicalensis, 15 parts Phellodendron chinense, and 6 parts Mentha haplocalyx.

[0037] The method for preparing the traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response of traumatic lesions includes the following steps: (S1) Take each raw material and mix them thoroughly to obtain a mixture; (S2) Add 12 times the mass of water to the mixture, soak for 45 minutes, then decoct for 1 hour, filter, and obtain the first decoction. (S3) Add water to the filter residue obtained in step (S2), the amount of water being 12 times the mass of the formula medicine, and decoct for a second time for 1 hour. Filter to obtain the second decoction. (S4) Combine the first decoction and the second decoction to obtain the Chinese medicine composition.

[0038] The method for preserving the prepared traditional Chinese medicine composition is to seal it and refrigerate it at 5°C.

[0039] The method of using the prepared traditional Chinese medicine composition is to heat it to 37°C and then soak it locally on the skin or apply it as a wet compress with gauze or sponge.

[0040] Example 2 This embodiment provides a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response in traumatic lesions, and is particularly suitable for treating urinary tract-related infections. The raw material components of the traditional Chinese medicine composition include: Sophora flavescens 10 parts, alum 8 parts, raw rhubarb 10 parts, Scutellaria baicalensis 10 parts, Phellodendron chinense 10 parts, and peppermint 6 parts.

[0041] The method for preparing the traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response of traumatic lesions includes the following steps: (S1) Take each raw material and mix them thoroughly to obtain a mixture; (S2) Add 10 times the mass of water to the mixture, soak for 40 minutes, then boil for 60 minutes for the first time, filter, and obtain the first decoction. (S3) Add 10 times the mass of water to the filter residue obtained in step (S2), boil for a second time for 60 minutes, filter, and obtain the second decoction. (S4) Combine the first decoction and the second decoction to obtain the Chinese medicine composition.

[0042] The method for preserving the prepared traditional Chinese medicine composition involves sealing and refrigerating it at 0°C.

[0043] The method of using the prepared traditional Chinese medicine composition is to heat it to 25°C and then soak it locally on the skin or apply it as a wet compress with gauze or sponge.

[0044] Example 3 This embodiment provides a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response in traumatic lesions, and is particularly suitable for treating post-circumcision conditions. The specific preparation method of the traditional Chinese medicine composition is as follows: (SS1) Preparation of traditional Chinese medicine extract powder: (a) Take each raw material (15 parts of Sophora flavescens, 15 parts of raw rhubarb, 15 parts of Scutellaria baicalensis, 15 parts of Phellodendron chinense, and 6 parts of Mentha haplocalyx), mix them thoroughly to obtain a mixture; (b) Add 10 times the weight of water to the mixture, soak for 45 minutes, then decoct for 60 minutes, filter to obtain the first decoction; (c) Add 10 times the weight of water to the residue obtained in step (b), decoct for 60 minutes, filter to obtain the second decoction; (d) Combine the first and second decoctions, concentrate under reduced pressure to a thick paste, add 95% ethanol to make the alcohol content about 65%, precipitate overnight, remove the supernatant, filter, recover the ethanol from the filtrate under reduced pressure until there is no alcohol taste, continue to concentrate to a thick paste, vacuum dry, pulverize, and pass through a 100-mesh sieve to obtain the fine powder, which is the Chinese herbal extract powder. (SS2) Take 54 parts by weight of 95% ethanol, add 16.2 parts by weight of type IV polyacrylic acid resin and 5 parts by weight of corn gluten, stir, and let stand until completely dissolved; (SS3) Add 1 part by weight of K90 type polyvinyl acetate and 0.8 parts by weight of 1000 type polyethylene glycol, and stir until completely dissolved; (SS4) Under stirring conditions, add 5.75 parts by weight of the Chinese herbal extract powder, add 0.25 parts by weight of peppermint oil, and stir evenly; (SS5) Under stirring conditions, 16 parts by weight of ethyl acrylate-methyl methacrylate copolymer (NE30D) and 1 part by weight of alum powder are added in sequence and mixed thoroughly to obtain the traditional Chinese medicine composition.

[0045] Example 4 This embodiment provides a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response in traumatic lesions, and is particularly suitable for treating post-circumcision conditions. The only difference between this embodiment and Embodiment 1 is the specific operating conditions of the preparation method. The preparation method of the traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response in traumatic lesions described in this embodiment includes the following steps: (S1) Take each raw material and mix them thoroughly to obtain a mixture; (S2) Add 4 times the mass of water to the mixture, soak for 60 minutes, then decoct for 0.5 hours, filter, and obtain the first decoction. (S3) Add water to the filter residue obtained in step (S2), the amount of water being 4 times the mass of the formula medicine, and decoct for a second time for 0.5 hours. Filter to obtain the second decoction. (S4) Combine the first decoction and the second decoction to obtain the Chinese medicine composition.

[0046] Example 5 This embodiment provides a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response in traumatic lesions, and is particularly suitable for treating post-circumcision conditions. The only difference between this embodiment and Embodiment 1 is the specific operating conditions of the preparation method. The preparation method of the traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response in traumatic lesions described in this embodiment includes the following steps: (S1) Take each raw material and mix them thoroughly to obtain a mixture; (S2) Add 20 times the mass of water to the mixture, soak for 30 minutes, then decoct for 1.5 hours, filter, and obtain the first decoction. (S3) Add water to the filter residue obtained in step (S2), the amount of water being 20 times the mass of the formula medicine, and decoct for a second time for 1.5 hours. Filter to obtain the second decoction. (S4) Combine the first decoction and the second decoction to obtain the Chinese medicine composition.

[0047] Example 6 This embodiment provides a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response in traumatic lesions, and is particularly suitable for treating post-circumcision conditions. The only difference between this embodiment and Embodiment 3 is the specific operating conditions of the preparation method. The specific preparation method of the traditional Chinese medicine composition described in this embodiment is as follows: (SS1) Preparation of traditional Chinese medicine extract powder: (a) Take each raw material (15 parts of Sophora flavescens, 15 parts of raw rhubarb, 15 parts of Scutellaria baicalensis, 15 parts of Phellodendron chinense, and 6 parts of Mentha haplocalyx), mix them thoroughly to obtain a mixture; (b) Add 8 times the mass of water to the mixture, soak for 60 minutes, then decoct for 60 minutes, filter to obtain the first decoction; (c) Add 8 times the mass of water to the residue obtained in step (b), decoct for 60 minutes, filter to obtain the second decoction; (d) Combine the first and second decoctions, concentrate under reduced pressure to a thick paste, add 95% ethanol to make the alcohol content about 65%, precipitate overnight, remove the supernatant, filter, recover the ethanol from the filtrate under reduced pressure until there is no alcohol taste, continue to concentrate to a thick paste, vacuum dry, pulverize, and pass through an 80-mesh sieve to obtain a fine powder, which is the Chinese herbal extract powder. (SS2) Take 54 parts by weight of 95% ethanol, add 10 parts by weight of type III polyacrylic acid resin and 0.1 parts by weight of corn gluten, stir, and let stand until completely dissolved; (SS3) Add 0.1 parts by weight of K30 type polyvinyl acetate and 0.1 parts by weight of 800 type polyethylene glycol, and stir until completely dissolved; (SS4) Under stirring conditions, add 2 parts by weight of the Chinese herbal extract powder and 0.1 parts by weight of peppermint oil, and stir evenly; (SS5) Under stirring conditions, 10 parts by weight of ethyl acrylate-methyl methacrylate copolymer (NE30D) and 1 part by weight of alum powder are added in sequence and mixed thoroughly to obtain the traditional Chinese medicine composition.

[0048] Example 7 This embodiment provides a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response in traumatic lesions, and is particularly suitable for treating post-circumcision conditions. The specific preparation method of the traditional Chinese medicine composition is as follows: (SSS1) Weigh out 150 parts of Sophora flavescens, 150 parts of rhubarb, 150 parts of Scutellaria baicalensis, 150 parts of Phellodendron chinense, 150 parts of Portulaca oleracea, and 150 parts of Mentha haplocalyx; Peppermint extract volatile oil: Add 150 parts peppermint to 1500 mL of pure water, soak for 30 minutes, and extract about 0.81 mL of volatile oil; collect the residue after extracting the volatile oil. (SSS2) Mix 150 parts of Sophora flavescens, 150 parts of rhubarb, 150 parts of Scutellaria baicalensis, 150 parts of Phellodendron chinense, and 150 parts of Portulaca oleracea. Add 7500 mL of water, soak for 30 minutes, boil, and then add the dregs collected after the extraction of peppermint volatile oil. Continue to simmer for 90 minutes. After the decoction is finished, filter to obtain the first decoction. (SSS3) Second decoction: Add 9000mL of water to all the dregs, bring to a boil and then simmer for 90 minutes. After the decoction is finished, filter to obtain the second decoction. (SSS4) Three decoctions: Add 9000mL of water to all the dregs, bring to a boil and then simmer for 90 minutes. After the decoction is finished, filter to obtain the third decoction liquid. (SSS5) Mix the filtered liquid from the above three decoctions and concentrate it under reduced pressure in a rotary evaporator to a thick paste; then add 95% medicinal ethanol to the thick paste for alcohol precipitation, and the alcohol content is measured to be 69%; after alcohol precipitation overnight, take off the supernatant, filter it, concentrate the filtrate under reduced pressure, and recover the ethanol until there is no alcohol taste to obtain the final concentrated liquid. (SSS6) Add 10g each of activated carbon and diatomaceous earth to the concentrated drug solution obtained above, refrigerate overnight, and then filter again to obtain the filtered drug solution. (SSS7) Preparation of peppermint oil inclusion complex: 0.81 ml of peppermint volatile oil obtained in step (SSS1) and 10.0048 g of β-cyclodextrin were mixed into a homogeneous solution to obtain peppermint oil inclusion complex; (SSS8) Add 0.2004g EDTA-Na2 and 0.5021g chlorhexidine acetate to the filtered drug solution, then add peppermint oil inclusion complex and mix well; then add 12.46g glycerin and 8.06g polyethylene glycol in sequence and mix well; then slowly add 400g PVA solution and 81g sodium polyacrylate solution, add pure water and stir well to obtain the final coating agent solution, which is the traditional Chinese medicine composition; The film-forming agent solution is heated for 30 minutes to sterilize; each dispensing tool and the solution are then irradiated with ultraviolet light for 30 minutes in a UV workbench, and finally packaged into ointment tubes under sterile conditions.

[0049] Example 8 This embodiment provides a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response in traumatic lesions, and is particularly suitable for treating post-circumcision conditions. The only difference between this embodiment and Embodiment 3 is the specific operating conditions of the preparation method. The specific preparation method of the traditional Chinese medicine composition described in this embodiment is as follows: (SS1) Preparation of traditional Chinese medicine extract powder: (a) Take each raw material (15 parts of Sophora flavescens, 15 parts of raw rhubarb, 15 parts of Scutellaria baicalensis, 15 parts of Phellodendron chinense, and 6 parts of Mentha haplocalyx), mix them thoroughly to obtain a mixture; (b) Add 12 times the weight of water to the mixture, soak for 30 minutes, then decoct for 60 minutes, filter to obtain the first decoction; (c) Add 12 times the weight of water to the residue obtained in step (b), decoct for 60 minutes, filter to obtain the second decoction; (d) Combine the first and second decoctions, concentrate under reduced pressure to a thick paste, add 95% ethanol to make the alcohol content about 65%, precipitate overnight, remove the supernatant, filter, recover the ethanol from the filtrate under reduced pressure until there is no alcohol taste, continue to concentrate to a thick paste, vacuum dry, pulverize, and pass through a 120-mesh sieve to obtain the fine powder, which is the Chinese herbal extract powder. (SS2) Take 54 parts by weight of 95% ethanol, add 30 parts by weight of type III polyacrylic acid resin and 10 parts by weight of corn gluten, stir, and let stand until completely dissolved; (SS3) Add 5 parts by weight of K90 type polyvinyl ketone and 5 parts by weight of 400 type polyethylene glycol, and stir until completely dissolved; (SS4) Under stirring conditions, add 20 parts by weight of the Chinese herbal extract powder and 2 parts by weight of peppermint oil, and stir evenly; (SS5) Under stirring conditions, 30 parts by weight of ethyl acrylate-methyl methacrylate copolymer (NE30D) and 1 part by weight of alum powder are added in sequence and mixed thoroughly to obtain the traditional Chinese medicine composition.

[0050] I. Typical Cases Mr. Tian, ​​a 53-year-old male, had phimosis for 53 years. He underwent circumcision on June 23, 2025. On the 3rd day after the operation, he applied the Chinese medicine composition obtained in Example 3 to the surgical site for one week, twice a day. The healing was followed up. On the 5th day after the operation, the surgical site was basically healed. On the 9th day, it was completely healed. On the 11th day, the external sutures began to fall off. On the 16th day, the sutures fell off completely, and the internal sutures were completely absorbed.

[0051] Mr. Liu, a 37-year-old male, had phimosis for 37 years. He underwent circumcision on July 16, 2025. On the 3rd day after the operation, he applied the Chinese medicine composition obtained in Example 3 to the surgical site for one week, twice a day. The healing was followed up. On the 6th day after the operation, the surgical site was basically healed. On the 11th day, it was completely healed. On the 12th day, the external sutures began to fall off. On the 15th day, the sutures fell off completely, and the internal sutures were completely absorbed.

[0052] II. Clinical Observation Study 1. Research Methods 1.1 Research Design This study complies with the ethical requirements of the World Medical Declaration of Helsinki. We retrospectively analyzed the medical records of 24 male patients who underwent circumcision at the Department of Urology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, between January and August 2025, observing the effects of alum-based detoxifying ointment therapy on wound healing and pain after circumcision.

[0053] 1.2 Inclusion and Exclusion Criteria Based on the indications for circumcision in male patients with phimosis as described in "Wu Jieping's Urology", the diagnostic criteria for this study were established, namely, meeting one of the following criteria: ① having a fibrous constricting ring at the foreskin opening; ② recurrent balanitis; ③ severe stenosis at the foreskin opening after adulthood, with the foreskin unable to be retracted to expose the glans penis; ④ having the intention to undergo surgical treatment.

[0054] Inclusion criteria were: ① Age 18-65 years; ② Meeting the above surgical indications and having no contraindications, and having completed circumcision; ③ Voluntarily providing clinical data and giving informed consent.

[0055] Exclusion criteria are: ① Circumcision combined with other surgeries, such as excision of penile tumors or scrotal tumors; ② Combined use of other external washes.

[0056] The exclusion criteria were: ① patients with incomplete clinical data; ② patients who did not follow the prescribed course of treatment with the film-coated agent.

[0057] 1.3 Treatment methods Circumcision procedure: After routine disinfection of the surgical area, penile dorsal nerve block anesthesia was performed using 1% lidocaine. The foreskin was incised dorsally, preserving 1 cm of the frenulum and 0.5-0.8 cm of the inner foreskin. The wound was thoroughly electrocoagulated to achieve hemostasis. The frenulum and the inner and outer foreskin were sutured intermittently and equidistantly with 5-0 absorbable sutures. The wound was covered with Vaseline gauze and pressure bandaged along the lower edge of the coronal sulcus. The surgical wound was observed for 24 hours postoperatively, and decompression bandaging was applied. Both the high-dose exposure group and the low-dose exposure group underwent standard dorsal circumcision.

[0058] No intervention was performed within 3 days post-surgery. Starting on the 4th post-surgery day, the surgical site was soaked in the solution obtained in Example 1. Each time, the decoction was heated to 30°C and soaked locally in the wound for 10-15 minutes. The high-dose exposure group received the medication twice daily, while the low-dose exposure group received it once daily. Both groups received treatment at home for 7 consecutive days. No other interventions were combined in either group.

[0059] 1.4 Observation Indicators Observation endpoint: The surgical wound achieves grade A healing; or if the wound is not completely healed, follow-up continues until 6 weeks postoperatively.

[0060] The main observation indicators were the local healing status and healing time of the surgical wound under the foreskin. The healing grade at the end of the observation period was recorded, categorized as follows: ① Grade A healing: excellent healing, i.e., initial healing without adverse reactions; ② Grade B healing: poor healing, i.e., healing defects, but the wound did not suppurate; ③ Grade C healing: suppuration, i.e., the sutured wound needs to be separated or drained due to suppuration. If Grade A healing was achieved, the healing time was recorded.

[0061] The secondary observational indicator was pain level, which was assessed using the visual analog scale (VAS) before and 7 days after postoperative medication.

[0062] Safety indicators include the occurrence of postoperative complications. Adverse events should be recorded, such as surgical wound suppuration, redness, swelling, induration, hematoma, rupture, adhesions, urethral stricture, or even penile necrosis.

[0063] 1.5 Statistical Methods Statistical analysis was performed using SPSS 26.0 software. Continuous variables are expressed as mean ± standard deviation. x ± s This indicates that paired samples were used for comparisons before and after treatment. t Inspection or Wilcoxon The rank-sum test, comparing groups using two independent samples, is used. t Inspection or Mann-Whitney U The significance level is set at α = 0.05, meaning that when... P A value <0.05 is considered statistically significant.

[0064] 2. Research Results 2.1 Baseline Data Comparison A total of 23 patients who had undergone circumcision were included. Baseline data comparison showed no statistically significant differences in age, BMI, and comorbidities. P >0.05 (Table 1-1, Table 1-2).

[0065] Table 1-1 - Age and BMI of patients included after circumcision Table 1-2 - Age and BMI of patients included after circumcision 2.2 Comparison of patients' healing time, healing status, and postoperative complications All patients who used the medication obtained in Example 1 after circumcision achieved Grade A healing, with an overall average healing time of 5.91 ± 1.79 days. No postoperative complications were observed during follow-up.

[0066] 2.3 Comparison of VAS pain scores before and after treatment in the two groups of patients After 7 days of medication, the VAS scores of both groups of patients were significantly lower than before medication. P <0.001), Table 2 - Comparison of VAS scores before and after treatment with the medication obtained in Example 1 for patients after circumcision ( x ±s) Compared with before medication in this group, P <0.001.

[0067] III. Animal Experiments 1.1 Experimental Methods Experimental animals were randomly divided into three groups: Group 1 received the drug treatment obtained in Example 7, Group 2 received the drug treatment obtained in Example 3, and Group 3 was the positive control group (commercially available compound berberine solution). The number of animals in each group was equal. Wound treatment: A symmetrical wound was created on the body surface of each animal. The left wound served as the experimental treatment group (using different materials / drugs), and the right wound served as the blank control group (only routine treatment, no special dressing). Measurement time: Wound area was recorded at five time points from the first (baseline) to the fifth (final) measurement, using uniform units. Wound area data was obtained using imaging or calipers for each measurement.

[0068] 1.2 Statistical Methods Repeated measures ANOVA: A two-way repeated measures ANOVA (group × time) was performed only on the wound area data of the left-hand treatment group to test for time effects, group effects, and interaction effects. This method considers the correlation of the same subject at different time points and is suitable for longitudinal designs. The significance level was set at α=0.05.

[0069] Paired t-test: At each measurement time point, the difference between the treated wound area on the left side and the control wound area on the right side of the same animal was compared, and a two-tailed paired t-test was used to determine the significance of the treatment effect.

[0070] One-way ANOVA: For each time point, the differences in left-side wound area among different groups (groups 1, 2, and 3) were compared using one-way ANOVA. If homogeneity of variance in the population is not satisfied, nonparametric tests can be considered. Pairwise comparisons between groups can be further explored using post-hoc tests (such as Tukey HSD).

[0071] 1.3 Experimental Results Time effect: Repeated measures ANOVA showed that the wound area decreased significantly with prolonged healing time (main effect of time, P < 0.001), indicating that the wound area of ​​the treatment group as a whole changed significantly over time.

[0072] Group effect: The difference in wound area between groups was not statistically significant (group main effect P>0.05), and the group × time interaction was not statistically significant (P>0.05), suggesting that the overall efficacy of the three treatment methods is not significantly different.

[0073] Paired control comparison: Paired t-test results showed that in the early stage (e.g., the first measurement), the wound area in the left-side treatment group was significantly smaller than that in the right-side control group (P < 0.05); in the middle stage (the third measurement), significant differences also appeared in some groups (P < 0.05); in the later stage (the fourth and fifth measurements), there were no significant differences within the groups (P > 0.05). This indicates that the medication used promoted early wound healing, but the differences in the control group gradually decreased as healing progressed.

[0074] 1.3.1 Comparison between groups: One-way ANOVA showed that at each time point, there was no statistically significant difference in the left wound area between different groups (P>0.05), meaning that no one group was found to be consistently significantly better than the others.

[0075] First measurement: There was no statistically significant difference in the left and right wound areas among the three groups, as detailed in Table 3.

[0076] Table 3 - Comparison of left and right wound areas among the three groups Second measurement: There was no statistically significant difference in the left wound area among the three groups; for the right wound area, there were statistically significant differences between the drug treatment group of Example 7 and the compound Phellodendron amurense liquid group, and between the drug treatment group of Example 3 and the compound Phellodendron amurense liquid group, but no statistically significant difference between the drug treatment group of Example 7 and the drug treatment group of Example 3. See Tables 4-1 and 4-2 for details.

[0077] Table 4-1 Comparison of left and right wound areas among the three groups Table 4-2 - Pairwise comparisons among the three groups of right wounds Third measurement: There was no statistically significant difference in the left and right wound areas among the three groups, as shown in Table 5.

[0078] Table 5 - Comparison of left and right wound areas among the three groups Fourth measurement: There was no statistically significant difference in the left and right wound areas among the three groups, as shown in Table 6.

[0079] Table 6 - Comparison of left and right wound areas among the three groups Fifth measurement: There was no statistically significant difference in the left and right wound areas among the three groups, as shown in Table 7.

[0080] Table 7 - Comparison of left and right wound areas among the three groups 1.3.2 Within-group comparisons The comparison of wound area between the first and fifth wounds is shown in Table 8.

[0081] Table 8 - Intragroup comparison of wound area for the first and fifth wound treatments The comparison of wound area between the first and second wounds is shown in Table 9.

[0082] Table 9 - Comparison of wound area within the first and second groups The comparison of wound area within the second and third wound groups is shown in Table 10.

[0083] Table 10 - Intragroup comparison of wound area for the second and third wounds The comparison of wound area within the third and fourth groups is shown in Table 11.

[0084] Table 11 - Intragroup comparison of wound area for the third and fourth wounds The comparison of wound area within the fourth and fifth groups is shown in Table 12.

[0085] Table 12 - Intragroup comparison of wound area for the fourth and fifth wounds Histopathological analysis of the wound was performed to observe epidermal structure, fibroblast proliferation, and inflammatory cell infiltration. The levels of inflammatory response factor IL-6, pro-angiogenic factor VEGF-A, and the cytokine TGF-β regulating tissue inflammation and repair were also analyzed. This aims to reduce inflammatory response during wound healing and promote angiogenesis. Figure 1 ).

[0086] like Figure 1 The images shown are representative micrographs of skin tissue specimens obtained by H&E staining in mice in the high-dose drug treatment group of Example 3, 3 days, 7 days, and 12 days after drug administration. A is the control wound, and B is the drug-treated wound. The yellow line indicates the boundary between the wound tissue area ① and the surrounding skin area ②. Red triangles indicate a large number of inflammatory cells. Green arrows indicate microvessels. Original magnification ×200.

[0087] The molecular contents of inhibitory inflammatory factor expression, growth-promoting factor expression, and proliferation factor expression are shown in Tables 13-1, 13-2, and 13-3, respectively.

[0088] Table 13-1 Comparison of molecular levels of the inflammatory response factor IL-6 in different groups (pg / mg) Table 13-2 Comparison of molecular content of VEGF-A (a pro-angiogenic factor) in different groups (pg / mg) Table 13-3 Comparison of molecular levels of the cytokine TGF-β in different groups during the regulation of tissue inflammation and repair (pg / mg) In summary, this invention provides a traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory responses in traumatic lesions. It utilizes Sophora flavescens, alum, raw rhubarb, Scutellaria baicalensis, Phellodendron chinense, and peppermint as raw materials in appropriate weight ratios. Sophora flavescens and alum are the principal herbs, rhubarb, Scutellaria baicalensis, and Phellodendron chinense are the assistant herbs, and peppermint is the adjuvant herb, guiding the medicinal effects to the exterior. The entire formula has the functions of clearing heat and drying dampness, detoxifying and reducing swelling, and promoting blood circulation and tissue regeneration, aiming to target skin lesions exhibiting damp-heat syndrome. Under the combined action of the above-mentioned drug components, the traditional Chinese medicine composition of this invention has the effects of clearing heat and drying dampness, detoxifying and reducing swelling, and promoting blood circulation and tissue regeneration. It can effectively promote postoperative wound healing and improve local inflammatory responses in skin lesions. Clinical observation and animal experiments have verified that its effects are significantly superior to common Western medicine treatments, and it has a wide range of applications and good drug safety.

Claims

1. A traditional Chinese medicine composition that promotes wound healing and reduces local inflammatory response in traumatic lesions, characterized in that, By weight, the raw material components include: 5-60 parts Sophora flavescens, 2-20 parts alum, 5-60 parts raw rhubarb, 5-60 parts Scutellaria baicalensis, 5-60 parts Phellodendron chinense, and 5-60 parts Mentha haplocalyx.

2. The traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions according to claim 1, characterized in that, By weight, the raw material components include: 15 parts Sophora flavescens, 10-15 parts alum, 15 parts raw rhubarb, 15 parts Scutellaria baicalensis, 15 parts Phellodendron chinense, and 6 parts Mentha haplocalyx.

3. The traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions according to claim 1 or 2, characterized in that, By weight, the raw material components also include 5-60 parts of purslane.

4. The method for preparing the traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions according to claim 1 or 2, characterized in that, Includes the following steps: (S1) Take each raw material and mix them thoroughly to obtain a mixture; (S2) Add water to the mixture, soak it, then boil it for the first time, filter it, and obtain the first decoction. (S3) Add water to the filter residue obtained in step (S2), boil for a second time, filter, and obtain the second decoction; (S4) Combine the first decoction and the second decoction to obtain the Chinese medicine composition.

5. The method for preparing the traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions according to claim 4, characterized in that, In step (S2), during the first decoction, 4-20 times the weight of water are added to the mixture, and the soaking time is 30-60 minutes; the first decoction time is 0.5-1.5 hours. In step (S3), during the second decoction, 4-20 times the mass of water of the mixture is added; the second decoction time is 0.5-1.5 hours.

6. The method for preparing the traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions according to claim 1 or 2, characterized in that, Includes the following steps: (SS1) Preparation of traditional Chinese medicine extract powder: (a) Take all raw materials except alum, mix them thoroughly to obtain a mixture; (b) Add water to the mixture, soak it, then boil it for the first time, filter it, and obtain the first decoction. (c) Add water to the filter residue obtained in step (b), boil it a second time, filter it, and obtain the second decoction; (d) The first decoction and the second decoction are combined, concentrated and precipitated with alcohol in sequence, filtered, and the filtrate is concentrated to a thick paste, dried and pulverized to obtain the Chinese herbal extract powder. (SS2) Take ethanol, add 10-30 parts by weight of polyacrylic acid resin and 0-10 parts by weight of corn gluten, stir, and let stand until completely dissolved; (SS3) Add 0-5 parts by weight of povidone and 0-5 parts by weight of polyethylene glycol, and stir until completely dissolved; (SS4) Under stirring conditions, add 2-20 parts by weight of the Chinese herbal extract powder, add 0-2 parts by weight of peppermint oil, and stir evenly; (SS5) Under stirring conditions, 10-30 parts by weight of ethyl acrylate-methyl methacrylate copolymer and 1 part by weight of alum powder are added sequentially and mixed thoroughly to obtain the traditional Chinese medicine composition.

7. The method for preparing the traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions according to claim 6, characterized in that, In step (b), add 8-12 times the weight of water to the mixture and soak for 30-60 minutes; the first decoction time is 60-90 minutes. In step (c), during the second decoction, 8-12 times the mass of water of the mixture is added; the second decoction time is 60-90 minutes.

8. The method for preparing the traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions according to claim 6, characterized in that, In step (SS2), take 54 parts by weight of ethanol, add 16.2 parts by weight of polyacrylic acid resin and 5 parts by weight of corn gluten; In step (SS3), add 1 part by weight of povidone and 0.8 parts by weight of polyethylene glycol; In step (SS4), add 5.75 parts by weight of the herbal extract powder and add 0.25 parts by weight of peppermint oil. In step (SS5), 16 parts by weight of ethyl acrylate-methyl methacrylate copolymer are added.

9. The method for preparing the traditional Chinese medicine composition for promoting wound healing and reducing local inflammatory response of traumatic lesions according to claim 3, characterized in that, Includes the following steps: (SSS1) Extraction of peppermint volatile oil: Take peppermint, soak it in water first, then extract the volatile oil to obtain peppermint volatile oil, and collect the residue after extracting the volatile oil; (SSS2) Take Sophora flavescens, rhubarb, Scutellaria baicalensis, Phellodendron chinense, and Portulaca oleracea, mix them thoroughly, soak them in water, and boil them; then add the dregs obtained from the extraction of volatile oil in step (SSS1); mix them thoroughly and evenly, decoct and filter to obtain the first decoction; (SSS3) Add water to the filter residue obtained in step (SSS2), boil for a second time, filter, and obtain the second decoction; (SSS4) Add water to the filter residue obtained in step (SSS3), boil for the third time, filter, and obtain the third decoction; (SSS5) The first decoction, the second decoction and the third decoction are combined, concentrated and precipitated with alcohol in sequence, filtered, and the filtrate is concentrated and the ethanol is recovered to obtain a concentrated medicinal solution. (SSS6) Add activated carbon and diatomaceous earth to the concentrated drug solution obtained in step (SSS5), refrigerate overnight, and then filter to obtain the filtered drug solution. (SSS7) Take the peppermint volatile oil obtained in step (SSS1) and β-cyclodextrin and mix them evenly to obtain peppermint oil inclusion complex; (SSS8) First, add EDTA-Na2 and chlorhexidine acetate to the filtered drug solution, then add peppermint oil inclusion complex and mix thoroughly. Then, add glycerin and polyethylene glycol in sequence and stir evenly. Slowly add PVA solution and sodium polyacrylate solution, and finally add water and stir evenly to obtain the traditional Chinese medicine composition.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-2 in the preparation of a medicament for promoting wound healing and reducing local inflammatory response of traumatic lesions.

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