A traditional Chinese medicine composition for treating skin trauma, a preparation method thereof and application thereof

Abstract

This invention provides a traditional Chinese medicine composition for treating skin trauma, its preparation method, and its application, relating to the field of traditional Chinese medicine technology. The traditional Chinese medicine composition of this invention comprises the following raw materials in parts by weight: Astragalus membranaceus 20-30 parts, Piper kadsura vine 20-30 parts, Dragon's blood 10-20 parts, Rheum palmatum 3-8 parts, Coptis chinensis 3-8 parts, Phellodendron chinense 3-8 parts, Angelica sinensis 8-15 parts, Panax notoginseng 1-5 parts, Angelica dahurica 5-10 parts, Rehmannia glutinosa 5-10 parts, Scrophularia ningpoensis 3-8 parts, Aucklandia lappa 1-5 parts, Paeonia suffruticosa 5-10 parts, Rosin 3-8 parts, Vespa nidus 10-15 parts, and Carbonized human hair 1-5 parts. The various medicinal materials of this invention interact and complement each other, possessing the effects of promoting diuresis and reducing swelling, promoting tissue regeneration and detoxification, anti-inflammatory and analgesic effects, and activating blood circulation and removing blood stasis. It can reduce tissue swelling and redness, effectively prevent infection of burn wounds, and improve wound healing speed. It has significant therapeutic effects on skin trauma caused by burns and scalds, with no toxic side effects.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating skin trauma, its preparation method, and its application. Background Technology

[0002] Burns and scalds are mostly caused by intense heat invading the body, leading to the rotting of skin and flesh. Mild cases involve only skin and flesh damage, while severe cases involve intense heat toxicity, depletion of body fluids, and damage to Yin energy, resulting in both Qi and Yin deficiency. Alternatively, the heat toxicity may enter the blood and affect the internal organs, causing disharmony and imbalance of Yin and Yang. The causes of burns and scalds are complex, influenced by a series of physical changes, chemical reactions, and radiation. Western medicine is widely used in the local treatment of burns and scalds, with silver sulfadiazine being a common choice. While it has strong antibacterial effects, it exhibits significant cytotoxicity, and studies have shown that this compound can delay wound healing and cause systemic complications with long-term use. Traditional Chinese medicine (TCM) has a long history of treating burns and scalds, with a unique theoretical foundation. It offers a wide variety of medicines and dosage forms, characterized by simple preparation, safety, practicality, low cost, and significant efficacy. Some studies have shown that TCM or TCM compound formulas can promote wound healing and prevent scar hyperplasia through mechanisms such as anti-inflammation, anti-infection, promotion of tissue growth factor secretion and release, and inhibition of scar hyperplasia. However, current medications for treating burns still suffer from unsatisfactory therapeutic effects, leading to prolonged wound healing times and infections. Furthermore, some medications have complex compositions and expensive raw materials. Therefore, it is necessary to conduct in-depth research into the etiology, pathogenesis, treatment methods, and advantages and disadvantages of dosage forms for burns, with the aim of developing a highly effective traditional Chinese medicine composition to address the existing problems of traditional Chinese medicine in treating burns. Summary of the Invention

[0003] The purpose of this invention is to provide a traditional Chinese medicine composition for treating skin injuries. This composition can effectively prevent infection of burn wounds, improve the healing speed of wounds, and has significant therapeutic effects on skin injuries caused by burns, and is safe and has no toxic side effects.

[0004] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine composition for treating skin trauma, the composition comprising the following raw materials in parts by weight: Astragalus membranaceus 20-30 parts, Piper kadsura vine 20-30 parts, Dragon's blood 10-20 parts, Rheum palmatum 3-8 parts, Coptis chinensis 3-8 parts, Phellodendron chinense 3-8 parts, Angelica sinensis 8-15 parts, Panax notoginseng 1-5 parts, Angelica dahurica 5-10 parts, Rehmannia glutinosa 5-10 parts, Scrophularia ningpoensis 3-8 parts, Aucklandia lappa 1-5 parts, Paeonia suffruticosa 5-10 parts, Pine resin 3-8 parts, Vespa nidus 10-15 parts, and Carbonized human hair 1-5 parts.

[0005] This invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: weighing Astragalus membranaceus, Piper kadsura, Rheum palmatum, Coptis chinensis, Phellodendron chinense, Angelica sinensis, Panax notoginseng, Angelica dahurica, Rehmannia glutinosa, Scrophularia ningpoensis, Aucklandia lappa, Paeonia suffruticosa, and bee honeycomb according to the stated weight proportions, grinding them into powder, sieving, adding water to decoct, filtering the decoction, and combining the filtrates; concentrating the filtrate under reduced pressure, adding ethanol, allowing the precipitate to stand, filtering to obtain the supernatant, and then concentrating it under reduced pressure to obtain a concentrated traditional Chinese medicine solution; Weigh out the bloodstains, rosin, and charred human hair according to the weight proportions, mix them, grind them into powder, and sift them to obtain fine powder of traditional Chinese medicine. Simply mix the fine powder of Chinese medicine with the concentrated liquid of Chinese medicine at a weight ratio of 1:2~5.

[0006] Preferably, the sieve mesh size is 100-200 mesh.

[0007] Preferably, the volume ratio of the herbal composition to water during decoction is 1:5~8.

[0008] Preferably, the simmering time is 5-8 hours.

[0009] Preferably, the decoction is performed 3 to 5 times.

[0010] Preferably, the vacuum concentration conditions are 0.04MPa~0.09MPa and 80~85℃.

[0011] Preferably, the concentration of the ethanol is 80-95%.

[0012] The present invention also provides the application of the traditional Chinese medicine composition or the traditional Chinese medicine composition obtained by the preparation method in the preparation of a drug for treating skin injuries caused by burns.

[0013] Preferably, the traditional Chinese medicine composition is formulated into a clinically acceptable plaster, ointment, gel, or spray by adding pharmaceutically acceptable excipients.

[0014] Compared with the prior art, the present invention has the following technical effects: The various medicinal materials in this invention interact and complement each other, with the main treatment principles of promoting diuresis and reducing swelling, supporting tissue regeneration and detoxification, anti-inflammatory and analgesic effects, and promoting blood circulation and removing blood stasis, effectively promoting rapid repair and healing of wound tissues. The traditional Chinese medicine composition of this invention uses Astragalus membranaceus and Piper kadsura as the principal herbs, with Astragalus membranaceus being used in large quantities to replenish qi and support tissue regeneration and detoxification; Piper kadsura is used for anti-inflammatory and analgesic effects, effectively inhibiting inflammatory responses and preventing wound infection; Dragon's blood, Panax notoginseng, and Angelica sinensis are used as assistant herbs, assisting the principal herbs in promoting wound healing, tissue regeneration, blood circulation, and relieving pain; Angelica dahurica, Paeonia suffruticosa, Aucklandia lappa, rosin, carbonized human hair, and Vespa nidus are used as adjuvant herbs to assist the principal and assistant herbs in detoxifying, reducing swelling, and relieving pain; Rheum palmatum, Coptis chinensis, Phellodendron chinense, Scrophularia ningpoensis, and Rehmannia glutinosa are used as guiding herbs to harmonize the various herbs, achieving the effects of promoting blood circulation, clearing heat, and detoxifying.

[0015] The traditional Chinese medicine formula of this invention reduces the use of highly irritating herbs such as myrrh and frankincense, as well as expensive animal-derived medicinal materials. It mainly uses anti-inflammatory, analgesic, and tissue-regenerating plant-derived medicinal materials, which can reduce tissue swelling and redness, effectively prevent infection of burn wounds, and improve the healing speed of wounds. It has significant therapeutic effects on skin injuries caused by burns and scalds and has no toxic side effects. Detailed Implementation

[0016] This invention provides a traditional Chinese medicine composition for treating skin trauma, the composition comprising the following raw materials in parts by weight: Astragalus membranaceus 20-30 parts, Piper kadsura vine 20-30 parts, Dragon's blood 10-20 parts, Rheum palmatum 3-8 parts, Coptis chinensis 3-8 parts, Phellodendron chinense 3-8 parts, Angelica sinensis 8-15 parts, Panax notoginseng 1-5 parts, Angelica dahurica 5-10 parts, Rehmannia glutinosa 5-10 parts, Scrophularia ningpoensis 3-8 parts, Aucklandia lappa 1-5 parts, Paeonia suffruticosa 5-10 parts, Pine resin 3-8 parts, Vespa nidus 10-15 parts, and Carbonized human hair 1-5 parts. The preferred weight ratio of the raw materials in the traditional Chinese medicine composition is as follows: Astragalus membranaceus 23-28 parts, Piper kadsura 23-28 parts, Dragon's blood 12-18 parts, Rheum palmatum 4-7 parts, Coptis chinensis 4-7 parts, Phellodendron chinense 4-7 parts, Angelica sinensis 9-13 parts, Panax notoginseng 2-4 parts, Angelica dahurica 6-8 parts, Rehmannia glutinosa 6-8 parts, Scrophularia ningpoensis 4-7 parts, Aucklandia lappa 2-4 parts, Paeonia suffruticosa 6-8 parts, Rosin 2-6 parts, Vespa nidus 11-14 parts, and Carbonized human hair 2-4 parts. A further preferred ratio is: Astragalus membranaceus 25 parts, Piper kadsura 25 parts, Dragon's blood 15 parts, Rheum palmatum 6 parts, Coptis chinensis 6 parts, Phellodendron chinense 6 parts, Angelica sinensis 12 parts, Panax notoginseng 4 parts, Angelica dahurica 8 parts, Rehmannia glutinosa 8 parts, Scrophularia ningpoensis 6 parts, Aucklandia lappa 3 parts, Paeonia suffruticosa 8 parts, Rosin 5 parts, Vespa nidus 12 parts, and Carbonized human hair 3 parts.

[0017] In this invention, Astragalus membranaceus is sweet and slightly warm in nature, and enters the lung and spleen meridians. It has the effects of tonifying qi and raising yang, promoting tissue regeneration and detoxification, and promoting diuresis and reducing swelling. In the herbal composition of this invention, Astragalus membranaceus plays the role of tonifying qi, promoting tissue regeneration and detoxification, and promoting wound healing.

[0018] Piper kaempferia is the dried stem of the piper plant Piper kaempferia. It has a pungent and bitter taste, is slightly warm in nature, and enters the liver meridian. It has the effects of dispelling wind and dampness, clearing the meridians, and relieving pain. It is mainly used for wind-cold-dampness arthralgia, joint pain, muscle spasms, and difficulty in flexion and extension. In the herbal composition of this invention, it plays an antibacterial and anti-inflammatory role, inhibiting inflammatory responses and preventing wound infection.

[0019] Dragon's blood resin is made from the resin exuded from the fruit of the palm tree (Dracaena cochinchinensis). It has a sweet and salty taste, is neutral in nature, and enters the heart and liver meridians. It has the effects of promoting blood circulation and relieving pain, removing blood stasis and stopping bleeding, promoting tissue regeneration and wound healing. It is mainly used to treat traumatic injuries, abdominal pain due to blood stasis, external bleeding, and non-healing sores.

[0020] Rhubarb is bitter and cold in nature. It enters the liver, gallbladder, spleen, and lung meridians. It has the functions of purging and eliminating accumulations, clearing heat and purging fire, cooling blood and detoxifying, and removing blood stasis and promoting menstruation.

[0021] Coptis chinensis is the dried rhizome of the plant Coptis chinensis (Ranunculaceae family). It is bitter and cold in nature. It enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying. It is mainly used to treat damp-heat fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever with delirium, excessive heart fire, restlessness and insomnia, palpitations, hematemesis due to blood heat, red eyes, toothache, thirst, carbuncles and boils; externally, it is used to treat eczema, damp sores, and ear discharge.

[0022] Phellodendron bark has the functions of clearing heat and drying dampness, purging fire and eliminating steaming, detoxifying and healing sores. It is used for damp-heat diarrhea, jaundice with red urine, leukorrhea and vulvar itching, painful and difficult urination, beriberi with weakness and curling, bone steaming fever, night sweats, seminal emission, sores and carbuncles, eczema and damp sores.

[0023] Angelica sinensis is the dried root of the plant Angelica sinensis, belonging to the Apiaceae family. It has a sweet and pungent taste, and is warm in nature; it enters the liver, heart, and spleen meridians. It has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, traumatic injuries, carbuncles and sores, and constipation due to intestinal dryness. Angelica sinensis infused with wine promotes blood circulation and regulates menstruation. It is used for amenorrhea and dysmenorrhea, rheumatic arthralgia, and traumatic injuries.

[0024] Panax notoginseng is the dried root of the plant Panax notoginseng, belonging to the Araliaceae family. It has a sweet and slightly bitter taste and is warm in nature. It is used to disperse blood stasis, stop bleeding, reduce swelling, and relieve pain. It is primarily used to treat bleeding disorders, traumatic injuries, and swelling and pain due to blood stasis.

[0025] Angelica dahurica is the dried root of the plant Angelica dahurica, belonging to the Apiaceae family. It has a pungent taste and warm properties; it enters the lung, spleen, and stomach meridians. It has the effects of relieving exterior syndromes and dispelling cold, dispelling wind and relieving pain, clearing nasal passages, drying dampness and stopping leukorrhea, reducing swelling and draining pus, and dispelling wind and relieving itching. It is mainly used to treat colds due to wind-cold, headaches, toothaches, rheumatic pain, sinusitis, leukorrhea, and carbuncles and boils.

[0026] Rehmannia root, sweet and bitter in taste, and cold in nature; it enters the heart, liver, and kidney meridians. It has the effects of clearing heat and cooling the blood, nourishing yin and generating fluids. It is mainly used to treat febrile diseases with heat entering the blood level, high fever with delirium, dry mouth and crimson tongue, etc.

[0027] Scrophularia is the dried root of the plant Scrophularia ningpoensis. It tastes sweet, bitter, and salty, and is slightly cold in nature; it enters the lung, stomach, and kidney meridians. It has the effects of clearing heat and cooling the blood, nourishing yin and reducing fire, and detoxifying and dispersing nodules. It is mainly used to treat febrile diseases with heat affecting the blood; fever; thirst; crimson tongue; rashes; steaming bone cough; restlessness and insomnia; constipation due to fluid depletion; blurred vision; sore throat; scrofula; carbuncles and boils, etc.

[0028] Costus root is the dried root of the Aucklandia lappa plant, belonging to the Asteraceae family. It has a pungent and bitter taste, and is warm in nature; it enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. It has the effects of regulating qi and relieving pain, strengthening the spleen and promoting digestion. It is mainly used for chest and rib pain, abdominal distension and pain, tenesmus after diarrhea, indigestion, and loss of appetite. Stewing costus root can solidify the intestines and stop diarrhea, and is used for diarrhea and abdominal pain.

[0029] Peony bark is the root bark of the peony plant (Paeonia suffruticosa), belonging to the Ranunculaceae family. It is slightly cold in nature and has a bitter and pungent taste; it enters the heart, liver, and kidney meridians. It has the effects of clearing heat and cooling the blood, promoting blood circulation and removing blood stasis.

[0030] Rosin, bitter and sweet in taste, is warm in nature; it enters the liver and spleen meridians. It has the effects of dispelling wind and dampness, draining pus and removing toxins, promoting tissue regeneration and relieving pain. It is suitable for boils, carbuncles, eczema, external bleeding, and burns.

[0031] Honeycomb, sweet in taste and neutral in nature; enters the stomach meridian. It has the effects of attacking toxins and killing parasites, dispelling wind and relieving pain. It is commonly used for sores and carbuncles, mastitis, scrofula, stubborn skin diseases, tinea pedis, toothache, and rheumatic pain.

[0032] Charred human hair, bitter in taste and neutral in nature; it enters the liver and stomach meridians. It has the effects of astringing and stopping bleeding, removing blood stasis, and promoting diuresis. It is mainly used to treat various types of bleeding such as epistaxis, hematuria, hematochezia, hemoptysis, and metrorrhagia; when decocted into a paste, it can stop bleeding and promote tissue regeneration, treat traumatic bleeding or non-healing ulcers, and can be blown into the nose to stop epistaxis.

[0033] The various medicinal materials in this invention interact and complement each other, with the main treatment principles of promoting diuresis and reducing swelling, promoting tissue regeneration and detoxification, anti-inflammatory and analgesic effects, and invigorating blood circulation and removing blood stasis, effectively promoting rapid repair and healing of wound tissues. The herbal composition of this invention uses Astragalus membranaceus and Piper kadsura as the principal herbs, with Astragalus membranaceus being used in large quantities to replenish qi and promote tissue regeneration and detoxification; Piper kadsura is used for anti-inflammatory and analgesic effects, effectively inhibiting inflammatory reactions and preventing wound infection; Dragon's blood, Panax notoginseng, and Angelica sinensis are used as assistant herbs, supplementing the principal herbs to promote wound healing, invigorate blood circulation, and relieve pain; Angelica dahurica, Paeonia suffruticosa, Aucklandia lappa, rosin, carbonized human hair, and Vespa nidus are used as adjuvant herbs to assist the principal and assistant herbs in detoxifying, reducing swelling, and relieving pain; Rheum palmatum, Coptis chinensis, Phellodendron chinense, Scrophularia ningpoensis, and Rehmannia glutinosa are used as guiding herbs to harmonize the other herbs, achieving the effects of promoting blood circulation, clearing heat, and detoxifying. The scientifically formulated herbal composition of this invention can reduce tissue swelling and redness, effectively prevent infection of burn wounds, and improve wound healing speed. It has significant efficacy and no toxic side effects for skin injuries caused by burns and scalds.

[0034] This invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: weighing Astragalus membranaceus, Piper kadsura, Rheum palmatum, Coptis chinensis, Phellodendron chinense, Angelica sinensis, Panax notoginseng, Angelica dahurica, Rehmannia glutinosa, Scrophularia ningpoensis, Aucklandia lappa, Paeonia suffruticosa, and bee honeycomb according to the stated weight proportions, grinding them into powder, sieving, adding water to decoct, filtering the decoction, and combining the filtrates; concentrating the filtrate under reduced pressure, adding ethanol, allowing the precipitate to stand, filtering to obtain the supernatant, and then concentrating it under reduced pressure to obtain a concentrated traditional Chinese medicine solution; Weigh out the bloodstains, rosin, and charred human hair according to the weight proportions, mix them, grind them into powder, and sift them to obtain fine powder of traditional Chinese medicine. Simply mix the fine powder of Chinese medicine with the concentrated liquid of Chinese medicine at a weight ratio of 1:2~5.

[0035] In this invention, the sieve mesh size is 100-200 mesh. Preferably, the Astragalus membranaceus, Piper kadsura, Rheum palmatum, Coptis chinensis, Phellodendron chinense, Angelica sinensis, Panax notoginseng, Angelica dahurica, Rehmannia glutinosa, Scrophularia ningpoensis, Aucklandia lappa, Paeonia suffruticosa, and Vespa nidus are ground into powder and then sieved to a mesh size of 100-150 mesh; more preferably, 120-140 mesh; the mixture of Dragon's Blood, Rosin, and Carbonized Human Hair is ground into powder and then sieved to a mesh size of 120-200 mesh; more preferably, 150-180 mesh.

[0036] In this invention, the volume ratio of the herbal composition to water during decoction is preferably 1:5 to 8; more preferably 1:6.

[0037] In this invention, the decocting time is preferably 5-8 hours; more preferably 6-7 hours.

[0038] In this invention, the decoction is preferably performed 3 to 5 times; more preferably 4 times. The decoction method of this invention allows for the full extraction of the effective components of the traditional Chinese medicine.

[0039] In this invention, the vacuum concentration conditions are preferably 0.04MPa~0.09MPa and 80~85℃; more preferably 0.05MPa~0.08MPa and 82℃.

[0040] In this invention, the mass concentration of ethanol is preferably 80-95%; more preferably 85-90%. This invention uses ethanol to purify the concentrated water extract, which can effectively purify the active ingredients of the traditional Chinese medicine composition.

[0041] The present invention also provides the application of the traditional Chinese medicine composition or the traditional Chinese medicine composition obtained by the preparation method in the preparation of a drug for treating skin injuries caused by burns.

[0042] In this invention, the traditional Chinese medicine composition is formulated into clinically acceptable plasters, ointments, gels, or sprays by adding pharmaceutically acceptable excipients. In one possible implementation, the preparation of the traditional Chinese medicine composition according to the method of this invention is followed by mixing with an oily matrix excipient to prepare an ointment. The excipients include, but are not limited to, lanolin, liquid paraffin, beeswax, petrolatum, and glyceryl monostearate citrate. In another possible implementation, the preparation of the traditional Chinese medicine composition according to the method of this invention is followed by mixing with gel-forming excipients to prepare a gel. The excipients include, but are not limited to, carbomer, cellulose derivatives, chitosan, and calcium alginate. In yet another possible implementation, the traditional Chinese medicine composition of this invention is mixed with vegetable oil, heated, and then an oily matrix is ​​added, and coated onto a non-woven fabric to prepare an ointment. In yet another possible implementation, the preparation of the traditional Chinese medicine composition according to the method of this invention is followed by filling a specially designed device with the prepared medicine and suitable excipients to obtain a spray. During use, the contents are sprayed directly as a mist onto the skin or mucous membranes of cavities using methods such as manual pump pressure, ultrasonic vibration, or high-pressure gas.

[0043] The technical solutions of this invention will be clearly and completely described below with reference to the embodiments thereof. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0044] Example 1 A traditional Chinese medicine composition for treating skin injuries comprises the following raw materials in parts by weight: Astragalus membranaceus 25 parts, Piper kadsura vine 25 parts, Dragon's blood 15 parts, Rheum palmatum 6 parts, Coptis chinensis 6 parts, Phellodendron chinense 6 parts, Angelica sinensis 12 parts, Panax notoginseng 4 parts, Angelica dahurica 8 parts, Rehmannia glutinosa 8 parts, Scrophularia ningpoensis 6 parts, Aucklandia lappa 3 parts, Paeonia suffruticosa 8 parts, Rosin 5 parts, Vespa nidus 12 parts, and carbonized human hair 3 parts.

[0045] Example 2 A traditional Chinese medicine composition for treating skin trauma comprises the following raw materials in parts by weight: 20 parts Astragalus membranaceus, 20 parts Piper kadsura, 10 parts Dragon's blood, 3 parts Rheum palmatum, 3 parts Coptis chinensis, 3 parts Phellodendron chinense, 8 parts Angelica sinensis, 1 part Panax notoginseng, 5 parts Angelica dahurica, 5 parts Rehmannia glutinosa, 3 parts Scrophularia ningpoensis, 1 part Aucklandia lappa, 5 parts Paeonia suffruticosa, 3 parts Pine resin, 10 parts Vespa nidus, and 1 part Carbonized human hair.

[0046] Example 3 A traditional Chinese medicine composition for treating skin trauma comprises the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Piper kadsura vine 30 parts, dragon's blood 20 parts, rhubarb 8 parts, Coptis chinensis 8 parts, Phellodendron chinense 8 parts, Angelica sinensis 15 parts, Panax notoginseng 5 parts, Angelica dahurica 10 parts, Rehmannia glutinosa 10 parts, Scrophularia ningpoensis 8 parts, Aucklandia lappa 5 parts, Paeonia suffruticosa 10 parts, rosin 8 parts, bee honeycomb 15 parts, and human hair charcoal 5 parts.

[0047] Example 4 A method for preparing a traditional Chinese medicine composition for treating skin trauma includes the following steps: Weigh out the following ingredients according to the weight proportions described in Examples 1-3: Astragalus membranaceus, Piper kadsura, Rheum palmatum, Coptis chinensis, Phellodendron chinense, Angelica sinensis, Panax notoginseng, Angelica dahurica, Rehmannia glutinosa, Scrophularia ningpoensis, Aucklandia lappa, Paeonia suffruticosa, and Vespa nidus. Grind them into powder and pass through a 120-mesh sieve. Add 6 times the volume of water and decoct three times, the first two times for 5 hours and the third time for 6 hours. Filter and combine the decoctions from each decoction. Concentrate the filtrate under reduced pressure at 0.05 MPa and 85°C. Add 85% ethanol, allow the precipitate to stand, filter to obtain the supernatant, and concentrate under reduced pressure at 0.05 MPa and 85°C to obtain a concentrated traditional Chinese medicine solution. Weigh out the following ingredients according to the weight proportions: Dragon's blood, rosin, and carbonized human hair. Mix them and grind them into powder, passing through a 180-mesh sieve to obtain a fine powder. Mix the fine powder with the concentrated traditional Chinese medicine solution at a weight ratio of 1:3.

[0048] Example 5 Unlike Example 4, the ethanol concentration was 80%, but the other steps remained the same.

[0049] Example 6 Unlike Example 4, the ethanol concentration was 95%, while the other steps remained the same.

[0050] Example 7 An ointment for treating skin injuries is prepared from the traditional Chinese medicine composition and excipients of Example 1; comprising 1 part of the traditional Chinese medicine composition, 1 part of glyceryl monostearate citrate, 1 part of lanolin, and 10 parts of petrolatum; The preparation method is as follows: After preparing the traditional Chinese medicine composition according to the preparation method of Example 4, add glyceryl monostearate citrate, lanolin and petrolatum, and mix thoroughly.

[0051] Example 8 An ointment for treating skin injuries is prepared from the traditional Chinese medicine composition and excipients of Example 2; comprising 1 part of the traditional Chinese medicine composition, 0.6 parts of glyceryl monostearate citrate, 0.6 parts of lanolin, and 6 parts of petrolatum; The preparation method is as follows: After preparing the traditional Chinese medicine composition according to the preparation method of Example 4, add glyceryl monostearate citrate, lanolin and petrolatum, and mix thoroughly.

[0052] Example 9 An ointment for treating skin injuries is prepared from the traditional Chinese medicine composition and excipients of Example 3; comprising 1 part of the traditional Chinese medicine composition, 1.5 parts of glyceryl monostearate citrate, 1.5 parts of lanolin, and 15 parts of petrolatum; The preparation method is as follows: After preparing the traditional Chinese medicine composition according to the preparation method of Example 4, add glyceryl monostearate citrate, lanolin and petrolatum, and mix thoroughly.

[0053] Example 10 A gel for treating skin injuries, prepared from the traditional Chinese medicine composition and excipients of Example 1; wherein the traditional Chinese medicine composition comprises 1 part, carbomer 100 parts, glycerin 10 parts, and triethanolamine 80 parts.

[0054] The preparation method is as follows: Prepare the traditional Chinese medicine composition according to the preparation method of Example 4 for later use. Sprinkle carbomer into distilled water and allow it to swell fully. Take an appropriate amount of the swollen carbomer, add the above-mentioned medicine and glycerin while stirring, and then add triethanolamine. Continue stirring until uniform to obtain the gel.

[0055] Example 11 A plaster for treating skin injuries is prepared from the traditional Chinese medicine composition and excipients of Example 1. The preparation method of the plaster for treating skin injuries is as follows: Astragalus membranaceus, Piper kadsura, rhubarb, Coptis chinensis, Phellodendron chinense, Angelica sinensis, Panax notoginseng, Angelica dahurica, Rehmannia glutinosa, Scrophularia ningpoensis, Aucklandia lappa, Paeonia suffruticosa, and bee honeycomb are weighed and soaked in sesame oil for 1 day, then boiled for 2 hours. The dregs are filtered out to obtain the oil. Dragon's blood, rosin, and human hair charcoal are mixed, ground into powder and sieved. The powder is then thoroughly mixed with the above oil, mixed with a rubber matrix, and applied to a hard gauze to obtain the plaster.

[0056] Experimental Example 1 Test materials Seventy clean-grade SD rats, weighing 200-220g, 35 males and 35 females, were used. After 5 days of normal feeding, the model was established. The modeling method was as follows: the rats' backs were shaved, and after anesthesia, two circular burns with a diameter of about 3cm were made on the rats' backs with steam for 5 seconds. Pathological examination 1 day later confirmed that they were deep second-degree burns.

[0057] The animals were randomly divided into four groups: treatment group 1 (n=10), treatment group 2 (n=10), treatment group 3 (n=10), treatment group 4 (n=10), treatment group 5 (n=10), model group (n=10), and control group (n=10).

[0058] Test drugs: Treatment group 1 used the ointment of Example 7; treatment group 2 used the ointment of Example 8; treatment group 3 used the ointment prepared in Example 9; treatment group 4 used the gel of Example 10; treatment group 5 used the plaster of Example 11; the control group used Baicao Fuchuangning ointment provided by Shaanxi Fenghe Pharmaceutical Co., Ltd., see patent text CN105343399A.

[0059] Administration method: Treatment groups 1-4 and the control group: Apply an appropriate amount of the test ointment / gel evenly to the burn area and change the dressing once a day.

[0060] Treatment group 5: Apply the prepared plaster to the burn area for 3 hours each time, and change it daily.

[0061] Model group: Apply saline solution externally for 3 hours each time, once a day.

[0062] Observation indicators: On days 7, 14, and 21 post-injury, gross wound photographs were taken and entered into a computer. The images were analyzed using the LeicaOwin image analysis system, and the wound healing rate was calculated using the following formula: Wound healing rate = [(original wound area - unhealed wound area) / original wound area] × 100%.

[0063] Table 1 Comparison of wound healing rates among different groups of rats

[0064] As shown in Table 1 of this invention, compared to the model group, the traditional Chinese medicine preparations of this invention all exhibit a significant effect in promoting wound healing. Furthermore, the healing effect on burns varies with changes in dosage form and the ratio of the traditional Chinese medicine composition. Compared to the existing control group, Baicao Fuchuangning ointment, which treats skin injuries, the traditional Chinese medicine preparations of this invention show better wound healing effects for burns and shorten the wound healing time.

[0065] Test Example 2: Irritation reaction test of the traditional Chinese medicine ointment of Example 7 of the present invention after repeated use. Test substance: The herbal ointment in Example 7 of this invention.

[0066] Experimental animals and methods: Eight male guinea pigs, weighing 260-320g, were used. 75% ethanol was used as a negative control, and a self-comparison method was employed between the left and right sides of the animal's back. Twenty-four hours before the experiment, the hair on both sides of the guinea pig's back was removed. After 24 hours of observation, the hair-removed areas were checked to ensure no damage before application. The hair-removed area on each side was approximately 3cm × 3cm. The left side was designated as the application area, and the right side as the negative control area. 1mL of the test substance solution was applied directly and evenly to the skin of each animal's application area, then covered with a layer of non-irritating plastic film, and secured with non-irritating adhesive tape. The application time was 4 hours. Four hours after application, the application area was washed with warm water to remove residue. Application was repeated once daily for 7 consecutive days. Local skin reactions were observed 24 hours after each application, and the average score for each animal was calculated daily.

[0067] Average score per animal per day = Total score of erythema and edema of all test animals over 7 days / Number of test animals × 7.

[0068] Table 2 Skin Irritation Response Scoring Criteria

[0069] Table 3. Evaluation Criteria for Skin Irritation Intensity

[0070] The results of repeated intact skin stimulation tests in guinea pigs are shown in Table 4: Table 4 Results of the irritation test of the herbal ointment of this invention on intact guinea pig skin.

[0071] During the administration period, no abnormalities were observed in the animals' general condition, behavior, or physical signs. No abnormal symptoms such as erythema or edema were observed at the administration sites. According to the results in Table 4, the ointment of this invention did not cause any irritation to the skin of guinea pigs.

[0072] Test Example 3: Allergic Reaction Test of the Herbal Ointment Used in Example 7 of the Present Invention Test substance: The traditional Chinese medicine ointment of Example 7 of the present invention.

[0073] Experimental animals and methods: Guinea pigs, ordinary grade, weighing 200-300g, 15 per group, three groups in total: experimental group, positive control group, and negative control group.

[0074] In the experimental group of guinea pigs, the test substance was administered for both induction and challenge treatment. The positive control group was induced and challenged with the positive sensitizer 2,4-dinitrochlorobenzene. The negative control group was challenged with the test substance only.

[0075] 24 hours before the experiment, the hair on the left side of the guinea pig's back was removed in an area of ​​about 3cm x 3cm.

[0076] Induction of contact: Apply 0.5 mL of the test substance to the hairless skin on the left side, cover with two layers of gauze and one layer of cellophane, and then seal with non-irritating adhesive tape for 6 hours. Repeat the same method on the 7th and 14th days. The positive control group was treated with 0.5 mL of 1.0% 2,4-dinitrochlorobenzene in the same way.

[0077] Challenge contact: 14 days after the last induction contact, 0.5 mL of the test substance was applied to the right depilated area using the same method as the induction contact, and left for 6 hours. The negative control group was treated with 0.5 mL of the test substance in the same manner. The positive control group was treated with 0.5 mL of 0.5% 2,4-dinitrochlorobenzene in the same manner. Skin reactions were observed 24 hours and 48 hours after the covering was removed.

[0078] Table 5 Scoring criteria for the severity of skin allergic reactions

[0079] Table 6. Criteria for Evaluating Skin Sensitivity

[0080] Table 7 Results of skin allergy test on the herbal ointment of this invention

[0081] According to Table 7, the herbal ointment of Example 7 of the present invention was determined to be non-allergenic in the skin allergy test of guinea pigs based on the sensitization intensity grading standard.

[0082] Example 4: Application of the herbal ointment of the present invention in the treatment of skin injuries caused by burns and scalds. Traditional Chinese Medicine (TCM) diagnostic criteria: Refer to *Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine* (State Administration of Traditional Chinese Medicine, Nanjing University Press, 1994) and *Traditional Chinese Medicine Surgery* (edited by Chen Hongfeng, People's Medical Publishing House, 2nd edition, June 2012). A clear history of burns (such as from boiling water or flames), local skin swelling, burning pain, or blisters, epidermal loosening or peeling, and in severe cases, systemic symptoms such as dry mouth, fever, and irritability may occur. A diagnosis can be made based on the above-mentioned etiology and main symptoms.

[0083] Forty patients with burns and scalds who met the above diagnostic criteria were randomly divided into a treatment group and a control group, with 20 patients in each group, aged 5-55 years.

[0084] Administration method: Treatment group: The herbal ointment of Example 7 was used, applied twice a day to completely cover the wound, for 20 consecutive days.

[0085] Control group: Baicao Fuchuangning ointment was applied twice a day to completely cover the wound for 20 consecutive days.

[0086] Efficacy evaluation criteria: Refer to the "Standards for the Development of Traditional Chinese Medicine in the People's Republic of China" formulated by the State Administration of Traditional Chinese Medicine in 1994.

[0087] Complete healing: The wound has completely healed, the epithelium is completely covered, and the scar is firm; Significant effect: The wound shrinks by more than 75%, and the granulation tissue is fresh and bright red. Improvement: The wound has shrunk by 25-75%, and the granulation tissue is relatively fresh and red in color; Ineffective: The wound shrinks by less than 25%, the granulation tissue is dark in color, grows well, and shows no obvious shrinkage trend.

[0088] Table 8. Comparison of the therapeutic effects of the ointment of the present invention and the control group on burns and scalds.

[0089] As shown in Table 8, the traditional Chinese medicine preparation of the present invention has a significant therapeutic effect on burns and scalds, with a treatment effectiveness rate of up to 100%.

[0090] Typical Case: Case 1: Mr. Zhang, male, 33 years old, suffered scalds, diagnosed as deep second-degree burns, with local loss of sensation in the leg, blisters, epidermal sloughing, and a pale base. After cleaning the scalded area, the herbal ointment from Example 7 was applied twice daily. After 25 days of application, the wound healed completely without scarring or pigmentation.

[0091] Case 2: He, male, 8 years old, suffered steam burns, diagnosed as superficial second-degree burns. The burned area had blisters, a uniformly red and moist base, and local swelling. After cleaning the burned area, the herbal ointment from Example 7 was applied once a day. The patient recovered after 3 weeks of application.

[0092] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating skin injuries caused by burns and scalds, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: Astragalus membranaceus 20-30 parts, Piper kadsura vine 20-30 parts, dragon's blood 10-20 parts, rhubarb 3-8 parts, Coptis chinensis 3-8 parts, Phellodendron chinense 3-8 parts, Angelica sinensis 8-15 parts, Panax notoginseng 1-5 parts, Angelica dahurica 5-10 parts, Rehmannia glutinosa 5-10 parts, Scrophularia ningpoensis 3-8 parts, Aucklandia lappa 1-5 parts, Paeonia suffruticosa 5-10 parts, rosin 3-8 parts, bee honeycomb 10-15 parts, and human hair charcoal 1-5 parts. The preparation method of the traditional Chinese medicine composition includes the following steps: Weigh out the following ingredients according to the specified weight proportions: Astragalus membranaceus, Piper kadsura, Rheum palmatum, Coptis chinensis, Phellodendron chinense, Angelica sinensis, Panax notoginseng, Angelica dahurica, Rehmannia glutinosa, Scrophularia ningpoensis, Aucklandia lappa, Paeonia suffruticosa, and bee honeycomb. Grind them into powder, sift them, add water to decoct them, filter the decoction, and combine the filtrates. Concentrate the filtrate under reduced pressure, add ethanol, let the precipitate stand, filter the supernatant, and then concentrate it under reduced pressure to obtain a concentrated Chinese medicine solution. Weigh out the bloodstains, rosin, and charred human hair according to the weight proportions, mix them, grind them into powder, and sift them to obtain fine powder of traditional Chinese medicine. Simply mix the fine powder of Chinese medicine with the concentrated liquid of Chinese medicine at a weight ratio of 1:2 to 5.

2. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, The process includes the following steps: Weigh out the following ingredients according to the weight proportions specified in claim 1: Astragalus membranaceus, Piper kadsura, Rheum palmatum, Coptis chinensis, Phellodendron chinense, Angelica sinensis, Panax notoginseng, Angelica dahurica, Rehmannia glutinosa, Scrophularia ningpoensis, Aucklandia lappa, Paeonia suffruticosa, and bee honeycomb. Grind them into powder, sieve the powder, add water to decoct the powder, filter the decoction, and combine the filtrates. Concentrate the filtrate under reduced pressure, add ethanol, allow the precipitate to stand, filter the supernatant, and concentrate it under reduced pressure to obtain a concentrated Chinese medicine solution. Weigh out the bloodstains, rosin, and charred human hair according to the weight proportions, mix them, grind them into powder, and sift them to obtain fine powder of traditional Chinese medicine. Simply mix the fine powder of Chinese medicine with the concentrated liquid of Chinese medicine at a weight ratio of 1:2 to 5.

3. The preparation method according to claim 2, characterized in that, The sieve mesh size is 100-200 mesh.

4. The preparation method according to claim 2, characterized in that, The volume ratio of the herbal composition to water during decoction is 1:5 to 8.

5. The preparation method according to claim 2, characterized in that, The simmering time is 5 to 8 hours.

6. The preparation method according to claim 2, characterized in that, The decoction is prepared 3 to 5 times.

7. The preparation method according to claim 2, characterized in that, The vacuum concentration conditions are 0.04MPa~0.09MPa and 80~85℃.

8. The preparation method according to claim 2, characterized in that, The concentration of the ethanol is 80-95%.

9. The use of the traditional Chinese medicine composition according to claim 1 or the traditional Chinese medicine composition obtained by the preparation method according to any one of claims 2 to 8 in the preparation of a drug for treating skin injuries caused by burns and scalds.

10. The application according to claim 9, characterized in that, The traditional Chinese medicine composition is formulated into a clinically acceptable plaster, gel, or spray by adding pharmaceutically acceptable excipients.

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