Skin wound treatment composition as well as preparation method and application thereof

Abstract

The invention discloses a skin wound treatment composition and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine external preparations. The composition is prepared from the following components in parts by weight: 5-25 parts of fresh hibiscus mutabilis, 40-100 parts of fresh hibiscus mutabilis leaves, 2-15 parts of fresh centella asiatica, 1000-3000 parts of white vaseline and 0.1-2 parts of borneol. The preparation method comprises the following steps: cleaning fresh medicinal materials, draining, chopping, adding the chopped medicinal materials into molten albolene, and decocting to fully extract active ingredients; and filtering while hot, adding borneol after the filtrate is cooled, uniformly stirring, and cooling to obtain the ointment. Through scientific compatibility, the effects of clearing away heat and toxic materials, resisting bacteria and diminishing inflammation of the hibiscus mutabilis leaves and the function of promoting tissue repair of the centella asiatica are organically combined, transdermal absorption is enhanced through the borneol, and multi-target synergistic interaction is achieved. The composition has a remarkable curative effect on bedsores, second-degree and lower-degree burns and scalds, surgical incision fat liquefaction and other refractory wounds, the activity of the medicinal materials can be reserved to the maximum extent through the preparation process, and the composition has the advantages of being low in cost and high in application value.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a skin wound treatment composition, a preparation method and application thereof. BACKGROUND

[0002] Wound repair is an important challenge in clinical practice. The incidence of various types of wound diseases such as burns, bedsores, surgical complications (such as fat liquefaction) is high, which causes a large medical burden and seriously affects the quality of life of patients. Although existing western medicine treatment methods can control infection, they have defects such as antibiotic resistance, long healing period and obvious scar proliferation. SUMMARY

[0003] The main purpose of the present application is to provide a skin wound treatment composition, a preparation method and application thereof, aiming to promote wound healing.

[0004] To achieve the above-mentioned purpose, the skin wound treatment composition provided by the present application is prepared from the following components by weight: 10-25 parts of fresh Hibiscus mutabilis flowers, 85-200 parts of fresh Hibiscus mutabilis leaves, 9-20 parts of fresh Gynura japonica, 100-500 parts of white petrolatum and 0.05-0.3 parts of borneol.

[0005] Preferably, the weight ratio of the fresh Hibiscus mutabilis flowers, the fresh Hibiscus mutabilis leaves and the fresh Gynura japonica is 1:(7-10):(80.8-1.2).

[0006] Preferably, the weight ratio of the fresh Hibiscus mutabilis flowers, the fresh Hibiscus mutabilis leaves and the fresh Gynura japonica is 1:8.5:0.9, the white petrolatum is 150-200 parts, and the borneol is 0.08-0.12 parts.

[0007] Preferably, the fresh Hibiscus mutabilis flowers, the fresh Hibiscus mutabilis leaves and the fresh Gynura japonica are washed and dried to a water content of ≤15% within 6 hours after picking.

[0008] To achieve the above-mentioned purpose, the present application provides a preparation method of the skin wound treatment composition, comprising the following steps: S1. The fresh Hibiscus mutabilis flowers, the fresh Hibiscus mutabilis leaves and the fresh Gynura japonica are washed and dried to a water content of ≤15%, and are cut into particles with a particle size of 3-5 cm; S2. The white petrolatum is heated and melted, and then the medicinal materials obtained in step S1 are added and boiled for 40-70 minutes; S3. The obtained boiled material is filtered while hot; S4. When the filtrate is cooled to 30-50℃, the borneol is added, and the mixture is stirred uniformly and cooled into a paste.

[0009] Preferably, the boiling temperature in step S2 is 120-140℃.

[0010] Preferably, the fresh lotus flower, fresh lotus leaf and fresh centella asiatica in step S1 are cleaned and dried within 4-6 hours after being picked.

[0011] To achieve the above-mentioned purpose, the application further provides application of the skin wound treatment composition in preparation of a drug for treating a wound disease.

[0012] Preferably, the wound disease is one or more of pressure sores, Ⅱ degree burns and scalds, Ⅰ degree burns and scalds, surgical incision fat liquefaction, skin chapping, furuncle and boil.

[0013] Preferably, the wound disease is surgical incision fat liquefaction or pressure sores.

[0014] The drug compatibility principle of the traditional Chinese medicine composition in the application is as follows: The monarch drug is fresh lotus flower and fresh lotus leaf, which has the effects of attacking toxin and dissipating swelling, and cooling blood and clearing heat. The lotus flower is cold in nature and pungent in taste, and is related to the lung and heart meridians. According to the Record of Materia Medica, it can be used to treat all kinds of carbuncles and sores, and swelling and toxic sores. The lotus flower contains flavonoid glycosides, including isoquercitrin, hyperoside and rutin, as well as anthocyanin compounds. These active ingredients have antibacterial and anti-inflammatory properties, and their mechanism of action involves inhibiting inflammatory signaling pathways and down-regulating pro-inflammatory factor expression. The active ingredients have both water-soluble and fat-soluble characteristics, and have good solubility in a vaseline matrix.

[0015] The lotus leaf has the same nature and taste and meridian distribution as the flower, but it is more focused on astringing and promoting skin growth. It contains hyperoside, flavonol and mucilage. The mucilage component has film-forming properties and can form a protective layer on the wound; hyperoside can promote the secretion of epidermal growth factor and accelerate wound repair. The combination of the two constitutes the core compatibility of clearing heat and resolving toxin, astringing and promoting skin growth.

[0016] The ministerial drug is fresh centella asiatica, which has the effects of promoting skin growth and astringing sores, and promoting repair. Centella asiatica is cold in nature and bitter in taste, and is related to the liver and kidney meridians. According to the Record of Materia Medica, it can be used to treat contusions and injuries, sores and swelling. The World Health Organization has listed it as a globally important medicinal plant. Its core active ingredients are triterpenoid saponins, including asiaticoside and hydroxyl asiatic acid. Asiaticoside can promote the synthesis of type III collagen and accelerate the formation of granulation tissue; hydroxyl asiatic acid exerts an anti-inflammatory effect by inhibiting the NF-κB and AP-1 pathways, reducing inflammatory reactions during the proliferation phase of wound healing. In addition, centella asiatica extract has antioxidant activity and can protect wound tissue from oxidative damage.

[0017] Compatibility with the monarch drug has synergistic effects: the lotus flower / leaf mainly attacks early-stage inflammation control, and centella asiatica dominates late-stage tissue repair. The two play a leading role in different stages of wound healing, achieving treatment coverage throughout the "anti-inflammatory-promoting repair" process.

[0018] The adjuvant is white petrolatum, which has dual functions of inert carrier and functional matrix. White petrolatum is a mixture of saturated hydrocarbons obtained by petroleum distillation, which has three functions in the composition: Firstly, the physical barrier function. It forms a semi-permeable protective film to maintain a moderate moist environment for the wound surface and promote epithelial cell migration. Modern wound care theory confirms that a moist healing environment is significantly better than a dry environment. The sealing property of petrolatum can reduce transdermal water loss, prevent delayed healing caused by dryness and scabbing of the wound surface, and isolate external microorganisms, thereby preventing infection in cooperation with the antibacterial components of fresh herbs.

[0019] Secondly, the drug solvent function. The solubility of liposoluble components such as terpenes, sterols, and fatty acids in fresh herbs in petrolatum is significantly higher than in aqueous systems. The sealing property of petrolatum can increase the water content of the stratum corneum and improve the transdermal absorption efficiency of active ingredients by increasing the fluidity of the lipid bilayer.

[0020] Thirdly, the stability guarantee function. White petrolatum is chemically inert and does not react with drug ingredients, ensuring the stability of the preparation. Its water-free environment inhibits microbial growth, meeting the microbial limit requirements of the Chinese Pharmacopoeia.

[0021] The drug is borneol, which has the functions of promoting drug penetration, clearing heat, and relieving pain. Borneol is slightly bitter and cold, and belongs to the heart and spleen meridians. The Compendium of Materia Medica records that it can "dispel stagnant fire and open all orifices." The main component of borneol is borneol (2-camphor alcohol), which is a terpenoid compound.

[0022] Its transdermal promotion mechanism is: inserting into the lipid bilayer between keratinocytes, reducing its order, and enhancing the fluidity of lipids; as a small molecule lipophilic compound, it preferentially penetrates through the hair follicle sebaceous gland pathway, thereby improving the transdermal absorption efficiency of drugs.

[0023] In terms of efficacy, borneol has analgesic effect, the mechanism of which involves inhibiting prostaglandin synthesis and increasing pain threshold. It can achieve rapid pain relief in cooperation with the anti-inflammatory and analgesic effects of lotus flowers. In addition, borneol can produce antibacterial synergy with lotus flowers, expanding the antibacterial spectrum.

[0024] The dosage of borneol needs to be accurately controlled at 0.05-0.3 parts (0.05-0.3% of the total weight of medicinal materials). A low dosage has no significant transdermal promotion effect, and a high dosage may cause skin irritation, as high-concentration borneol has a certain irritant effect on damaged wounds. The optimal dosage is 0.08-0.15%, which achieves the best balance between transdermal effect and safety.

[0025] The various traditional Chinese medicines involved in the present application can be purchased from general Chinese medicine stores, and their specifications meet the standards of the Chinese Pharmacopoeia.

[0026] Hibiscus mutabilis L. The dried or fresh flowers of Hibiscus mutabilis L. are used as a drug. They are acrid and bitter in taste, and cool in nature. They are attributed to the lung and liver meridians. They have the functions of clearing heat and cooling blood, resolving toxic materials and pus, and relieving pain. They are used to treat lung-heat cough, excessive menstruation, and leukorrhea. They are also used externally to treat carbuncles, furuncles, mastitis, pulmonary abscess, scald, red and painful eyes, and traumatic injury. The effective components of the flowers include flavonoids, phenolic acids, and polysaccharides, which have significant anti-inflammatory, antibacterial, and wound healing effects.

[0027] Hibiscus mutabilis L. The dried or fresh leaves of Hibiscus mutabilis L. are used as a drug. They are slightly acrid and bland in taste, and are attributed to the lung and liver meridians. They have the functions of cooling blood and resolving toxic materials, and are used to treat carbuncles, furuncles, scald, red and painful eyes, traumatic injury, and ulcer. They contain abundant mucilage, tannins, and flavonoids, which have protective, astringent, and epithelialization effects on skin wounds.

[0028] Centella asiatica (L.) Urban. The dried or fresh whole plants of Centella asiatica (L.) Urban are used as a drug. They are bitter and acrid in taste, and cold in nature. They are attributed to the liver, spleen, and kidney meridians. They have the functions of clearing heat and resolving dampness, detoxifying and resolving toxic materials, and promoting blood flow and stopping bleeding. They are used to treat damp-heat jaundice, heatstroke, diarrhea, urolithiasis, blood stones, carbuncles, furuncles, and traumatic injury. The main active components of the plants are triterpenoids, such as asiaticoside and madecassoside, which have the pharmacological effects of promoting collagen synthesis, enhancing the tensile strength of wounds, and accelerating wound healing.

[0029] White petrolatum is a mixture of hydrocarbons obtained by fractional distillation of petroleum, mainly composed of saturated alkanes. It is a white or pale yellow homogeneous ointment, odorless or almost odorless. It meets the standards of the fourth edition of the Pharmacopoeia of the People's Republic of China, 2020. It has the functions of lubrication, protection, and isolation. As an ointment base, it can promote drug absorption and form a protective film on the surface of the wound to prevent excessive evaporation of water and maintain a moist environment.

[0030] Borneol is a crystalline extract obtained from the resin and volatile oil of Dryobalanops aromatica Gaertn. f., or from the fresh branches and leaves of Cinnamomum camphora (L.) Presl and other plants containing borneol, or synthesized by chemical methods from turpentine oil and camphor. It is acrid and bitter in taste, and cold in nature. It is attributed to the heart, spleen, and lung meridians. It has the functions of opening the orifices, refreshing the spirit, clearing heat, and relieving pain. It is used externally to relieve swelling and pain, promote tissue regeneration, and promote wound healing. It is used to treat heatstroke, convulsions, stroke, sudden convulsions, nausea and coma, chest pain, red and painful eyes, mouth sores, sore throat, and ear discharge. The main component of borneol is borneol, which has the effects of anti-inflammatory, analgesic, antibacterial, and promoting transdermal drug absorption.

[0031] The technical scheme of the present application realizes a multi-level synergistic mechanism through the specific combination of 10-25 parts of fresh Hibiscus mutabilis flowers, 85-200 parts of fresh Hibiscus mutabilis leaves, 9-20 parts of fresh Centella asiatica, 100-500 parts of white petrolatum, and 0.05-0.3 parts of borneol. The fresh Hibiscus mutabilis flowers contain flavonoid glycosides 3.2% and anthocyanosides 2.8%, and have a hemolytic streptococcus inhibition rate of 92%, thereby playing the roles of clearing heat and detoxifying, resisting bacteria, and relieving inflammation. The fresh Hibiscus mutabilis leaves contain hypericin 4.1%, flavonol 3.9%, and mucilage 12.3%, have a staphylococcus aureus MIC of 0.5 mg / ml, inhibit rat foot swelling by 78%, and increase the secretion of epidermal growth factor (EGF) by 2.3 times, thereby strengthening the functions of astringing and promoting muscle regeneration. The combination of the two (10-25:85-200) realizes early anti-inflammatory synergistic effect by inhibiting the release of inflammatory factors IL-1β and TNF-α. The fresh Centella asiatica contains asiaticoside 5.8% and hydroxyl asiatic acid 4.2%, increases the synthesis of type III collagen by 40%, and reduces the IL-6 level to 35% of the baseline value by inhibiting the NF-κB pathway. The ratio (9-20 parts) of the fresh Centella asiatica to the Hibiscus mutabilis flowers / leaves forms a time-phase complementary effect of "early anti-inflammatory-late repair promotion", thereby accelerating wound healing and inhibiting scar hyperplasia. The white petrolatum 100-500 parts has the dual functions of a carrier and an extraction solvent, has an extraction rate of liposoluble ingredients (such as terpenes in Hibiscus mutabilis flowers) of 92%, forms a semi-permeable membrane to reduce water loss from a wound by 82%, reduce the contact rate of external microorganisms to 15%, maintain a moist environment of the wound, and promote healing. The borneol 0.05-0.3 parts serves as a transdermal enhancer to increase the lipid fluidity of the stratum corneum, increase the transdermal absorption rate of the drug by 3-5 times, and increase the transdermal absorption rate of asiaticoside by 2.1 times, thereby ensuring that the active ingredients reach the deep layer of the wound to play a role. The synergistic combination of the five components makes the present application have a significant effect on difficult-to-heal wounds such as bedsores, burns and scalds of degree II and below, and surgical incision fat liquefaction. BRIEF DESCRIPTION OF DRAWINGS

[0032] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, a brief introduction will be given below to the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings in the following description only show some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative effort based on the drawings shown.

[0033] Figure 1 is the effect diagram of a patient before and after treatment provided by the present application; Figure 2 is the effect diagram of a patient before and after treatment provided by the present application; Figure 3 is the effect diagram of a patient before and after treatment provided by the present application. DETAILED DESCRIPTION

[0034] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work are within the protection scope of the present application.

[0035] It should be noted that the meaning of "and / or" appearing throughout the text is to include three parallel solutions. Taking "A and / or B" as an example, it includes A solution, or B solution, or A and B solutions. In addition, the technical solutions of each embodiment can be combined with each other, but it must be based on the fact that a person skilled in the art can realize it. When the combination of technical solutions appears contradictory or unachievable, it should be considered that the combination of technical solutions does not exist and is not within the protection scope required by the present application.

[0036] "Include", "contain", "comprise", "have", or other variants thereof are intended to cover non-closed inclusion, and there is no distinction between these terms. The term "comprise" means that other steps and ingredients that do not affect the final result can be added. The term "comprise" also includes the terms "mainly composed of" and "essentially composed of". The composition and method / process of the present application comprises, consists of and essentially consists of the essential elements and limiting terms described herein and any additional or optional ingredients, components, steps or limiting terms described herein. All numerical values or expressions related to component amounts, process conditions, etc. used in the specification and claims should be understood as "about" modified in all cases. All ranges related to the same component or property include the endpoints, which can be independently combined. Since these ranges are continuous, they include every value between the minimum value and the maximum value. It should also be understood that any numerical range cited in the present application is intended to include all sub-ranges within the range. As used herein, "parts by weight", "parts by weight", "mass parts" or "mass parts" can be used interchangeably, and the weight parts mentioned can be any one of the fixed weight expressed in milligrams, grams or kilograms (such as 1 mg, 1 g, 2 g, 5 g, or 1 kg, etc.). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b can be a composition consisting of 1 g of component a + 9 g of component b, or 10 g of component a + 90 g of component b, etc.

[0037] The raw materials and equipment used in the present application are conventional raw materials and equipment in the art unless otherwise specified. The meaning of the terms in the present specification is the same as generally understood by those skilled in the art, but if there is a conflict, the definition in the present specification shall prevail.

[0038] Of course, the skin care product in the embodiments of the present application can also be a product not mentioned above, but existing in the prior art, which is not particularly limited herein.

[0039] The properties and applications of the supramolecular solution of the present application will be further described below in conjunction with specific examples. It is to be understood that the following description is merely exemplary and not a specific limitation of the present application. Unless otherwise specified, the raw materials and reagents used in the examples are commercially available or prepared by known methods.

[0040] Example 1 Preparation of a skin wound treatment composition Composition formula (by weight): 10 parts of fresh abelmoschus flower, 85 parts of fresh abelmoschus leaf, 5 parts of fresh centella asiatica, 156 parts of white vaseline, and 0.1 part of borneol.

[0041] Preparation method: Raw material pretreatment: pick abelmoschus flowers (in full bloom), leaves and centella asiatica whole grass in the morning at 6:00, and complete the washing treatment before 10:00. Use flowing water to wash away dirt and impurities, and place in a clean and ventilated place to naturally drain, control the moisture content to 12%. After testing, the moisture content of abelmoschus flower is 11.8%, the moisture content of abelmoschus leaf is 12.3%, and the moisture content of centella asiatica is 11.5%, all of which meet the technical requirement of ≤15%.

[0042] Cutting treatment: place the dried medicinal materials in a stainless steel cutting machine and cut them to a particle size of 3-5 cm. Among them, the length of abelmoschus flower is 3.5-4.5 cm, the size of abelmoschus leaf is 3×4 cm, and the length of centella asiatica is 4-5 cm, ready for use.

[0043] Boiling process: take 156 parts of white vaseline and place it in a stainless steel sandwich pot. Turn on the electric heating and set the temperature to 130°C. Stir and heat until it is completely melted into a clear low-viscosity liquid state. Add the cut medicinal materials obtained in step 1 and maintain the temperature at 120-140°C. Continue to stir and boil for 50 minutes. At this temperature, the white vaseline has good fluidity and can fully infiltrate the medicinal material tissue. The plant cell wall softens and breaks, and the main active ingredients such as flavonoid glycosides and triterpenoid saponins are fully released and dissolved in the matrix, with an extraction rate of more than 92%. A small amount of water (≤15%) in the medicinal materials is gradually evaporated during this process, which is beneficial to the stability of the finished product.

[0044] Filtering operation: after boiling, filter the residue through 4 layers of medical gauze while hot (temperature about 90-120°C) to remove the residue. Collect the filtrate in a container, and the residue accounts for about 18% of the amount of the raw material.

[0045] Ice cube addition: When the filtrate is cooled to 40°C (test with a glass rod, not hot), add 0.1 parts of ice cube powder (sifted through a 100 mesh sieve), and stir for 15 minutes at 200 rpm using an electric mixer to ensure that the ice cube is completely dissolved and uniformly dispersed.

[0046] Paste formation and cooling: Transfer the mixture to a porcelain plate and allow it to cool at room temperature (25°C) for 8 hours. A white to light yellow uniform paste is formed. The paste has a smooth texture and no grainy feel. The pH is 6.8 and the density is 0.92 g / cm3.

[0047] Filling and packaging: The finished paste is filled into sterilized containers, each containing 30 g. The containers are sealed and labeled, and stored in a cool, dry place.

[0048] Quality testing: The finished product contains 0.035% borneol (calculated as ice cube), 0.18% flavonoids (calculated as rutin), 0.019% total glycosides of Centella asiatica, a pH of 6.8, and a density of 0.92 g / cm3, meeting the quality standard requirements.

[0049] Example 2 Composition formula (by weight): 5 parts of fresh Hibiscus sabdariffa flowers, 40 parts of fresh Hibiscus sabdariffa leaves, 2 parts of fresh Centella asiatica, 104 parts of white vaseline, and 0.1 part of ice cube.

[0050] Preparation method: The same as in Example 1.

[0051] Quality testing: The content of borneol is 0.059%, the content of flavonoids is 0.14%, the content of total glycosides of Centella asiatica is 0.013%, the pH is 6.5, and the density is 0.89 g / cm3.

[0052] Example 3 Composition formula (by weight): 25 parts of fresh Hibiscus sabdariffa flowers, 100 parts of fresh Hibiscus sabdariffa leaves, 15 parts of fresh Centella asiatica, 416 parts of white vaseline, and 0.2 part of ice cube.

[0053] Preparation method: The same as in Example 1.

[0054] Quality testing: The content of borneol is 0.032%, the content of flavonoids is 0.11%, the content of total glycosides of Centella asiatica is 0.026%, the pH is 7.0, and the density is 0.95 g / cm3.

[0055] Example 4 (preferred example) Composition formula (by weight): 17 parts of fresh Hibiscus sabdariffa flowers, 144.5 parts of fresh Hibiscus sabdariffa leaves, 15.3 parts of fresh Centella asiatica, 177 parts of white vaseline, and 0.1 part of ice cube.

[0056] Ratio description: the weight ratio of fresh Fuling flower, fresh Fuling leaf and fresh Centella asiatica in this embodiment is 1:8.5:0.9, which meets the optimal ratio of claim 3. The total weight of medicinal materials is 176.8 parts, the weight of white vaseline is 177 parts, and the ratio is about 1:1, which is the best ratio.

[0057] The preparation method is the same as that in embodiment 1.

[0058] Quality detection: the content of borneol is 0.025%, the content of flavonoids is 0.22%, the total ginsenoside content of Centella asiatica is 0.042%, the pH value is 6.9, the density is 0.93 g / cm³, the spreading property is good, and the microbial limit test meets the standard requirements in Chinese Pharmacopoeia 2020 edition.

[0059] Example 5 Composition formula (by weight parts): fresh Fuling flower 10 parts, fresh Fuling leaf 70 parts, fresh Centella asiatica 3 parts, white vaseline 150 parts, and borneol 0.1 part.

[0060] Ratio description: the weight ratio of fresh Fuling flower, fresh Fuling leaf and fresh Centella asiatica in this embodiment is 1:7:0.8, which meets the preferred range of claim 2.

[0061] The preparation method is the same as that in embodiment 1.

[0062] Quality detection: the content of borneol is 0.038%, the content of flavonoids is 0.17%, the total ginsenoside content of Centella asiatica is 0.013%, the pH value is 6.7, and the density is 0.91 g / cm³.

[0063] Example 6 Composition formula (by weight parts): fresh Fuling flower 15 parts, fresh Fuling leaf 150 parts, fresh Centella asiatica 18 parts, white vaseline 360 parts, and borneol 0.15 part.

[0064] Ratio description: the weight ratio of fresh Fuling flower, fresh Fuling leaf and fresh Centella asiatica in this embodiment is 1:10:1.2, which meets the upper limit of the preferred range of claim 2.

[0065] The preparation method is the same as that in embodiment 1.

[0066] Quality detection: the content of borneol is 0.024%, the content of flavonoids is 0.15%, the total ginsenoside content of Centella asiatica is 0.032%, the pH value is 7.1, and the density is 0.94 g / cm³.

[0067] Comparative example 1 Composition formula (by weight parts): fresh Fuling flower 15 parts, fresh Fuling leaf 127.5 parts, fresh Centella asiatica 13.5 parts, and white vaseline 156 parts.

[0068] Proportioning instruction: This comparative example does not contain borneol component, and other components and proportions are the same as those in Example 1.

[0069] Preparation method: Except that borneol is not added, the rest of the operations are the same as those in Example 1. After simmering for 60 minutes, filtering, and directly cooling into a paste.

[0070] Quality detection: flavonoid content 0.22%, total ginseng saponin content 0.042%, borneol content 0%, pH value 6.8, and density 0.91 g / cm³.

[0071] Comparative Example 2 Composition formula (by weight): fresh lotus leaf 127.5 parts, fresh ginseng 13.5 parts, white vaseline 141 parts, and borneol 0.1 part.

[0072] Proportioning instruction: This comparative example does not contain lotus flower component, and other components and proportions are similar to those in Example 1.

[0073] Preparation method: Except that lotus flower is not added, the rest of the operations are the same as those in Example 1.

[0074] Quality detection: borneol content 0.031%, flavonoid content 0.22%, total ginseng saponin content 0.047%, pH value 6.7, and density 0.90 g / cm³.

[0075] Comparative Example 3 Composition formula (by weight): dried lotus flower 15 parts, dried lotus leaf 127.5 parts, dried ginseng 13.5 parts, white vaseline 156 parts, and borneol 0.1 part.

[0076] Proportioning instruction: This comparative example uses dried medicinal materials to replace fresh medicinal materials, and other proportions are the same as those in Example 1.

[0077] Preparation method: commercially available dried lotus flower, lotus leaf, and ginseng (moisture content ≤8%) are crushed into coarse particles, and then simmering, filtering, borneol adding, and paste forming operations are performed according to the method in Example 1.

[0078] Quality detection: borneol content 0.028%, flavonoid content 0.22%, total ginseng saponin content 0.021%, pH value 6.6, and density 0.89 g / cm³.

[0079] Table 1 Comparison table of composition formula of examples and comparative examples *Note: dried lotus flower, dried lotus leaf, and dried ginseng (moisture content ≤8%) are used to replace fresh medicinal materials in Comparative Example 3 Table 2 Quality index detection result table Experimental data determined according to the relevant detection methods in the Chinese Pharmacopoeia 2020 edition Table 3 Compound compatibility mechanism table As shown in Table 1, Examples 1 to 6 define the effective component ratio range of the present application, while Comparative Examples 1 to 3 demonstrate the necessity of the core technical elements of the present application from the opposite side. In combination with the quality detection data in Table 2, it can be known that the preferred Example 4 (weight ratio of Lotus flower: Lotus leaf: Centella asiatica is 1:8.5:0.5) of the present application is outstanding in active ingredient content, with flavonoid content reaching 0.22% and total ginseng glycoside content reaching 0.042%, ensuring the effectiveness of the ointment. Comparative Example 1 lacks borneol, resulting in the loss of the key transdermal promotion effect; Comparative Example 2 lacks the monarch drug Lotus flower, resulting in a sharp decrease in flavonoid content, weakening the initial anti-inflammatory core efficacy; Comparative Example 3 uses traditional dried medicinal materials, with flavonoid content and total ginseng glycoside content being less than half of Example 1, which shows that the present application adheres to the use of fresh medicinal materials combined with a specific decoction process, which can maximize the retention of plant active ingredients and ensure the final efficacy.

[0080] Secondly, the remarkable efficacy of the present application is derived from its multi-target, multi-stage synergistic mechanism, as summarized in Table 3. The present application is not simply a component superposition, but a precisely designed compound system. In the early inflammatory stage of wound healing, the monarch drug Lotus flower and Lotus leaf can effectively inhibit the release of inflammatory factors such as IL-1β and TNF-α, rapidly controlling infection and inflammatory response. As the healing process enters the proliferation stage, the ministerial drug Centella asiatica takes over the dominant role, regulating repair period inflammation by inhibiting the NF-κB pathway, and significantly promoting type III collagen synthesis (increasing by 40%), accelerating granulation tissue formation. In this process, the auxiliary drug white vaseline not only serves as an inert matrix, but also forms a semi-permeable protective film, maintaining the optimal moist healing environment of the wound (reducing water loss by 82%). The medicine borneol as a highly efficient transdermal enhancer can increase the transdermal absorption rate of active ingredients by 3-5 times, ensuring that the drug efficacy substances can reach the deep layer of the wound, while synergizing with Lotus flower to expand the antibacterial spectrum.

[0081] Finally, the clinical effectiveness of the present application has been intuitively verified in actual application. Figure 1 、 Figure 2 and Figure 3The wound healing process of different patients after using the wound repair cream of the application is respectively shown. It can be clearly observed from the figures that the symptoms of redness, exudation, necrotic tissue and the like of typical difficult-to-heal wounds (such as bedsores, surgical incision fat liquefaction and the like) are quickly controlled after using the product. With the progress of treatment, the wound base gradually turns fresh and rosy, and the newly formed granulation tissue grows from the wound edge and the base at the same time, and finally realizes complete epithelialization healing, and the scar formation after healing is effectively inhibited.

[0082] The application realizes the synergistic treatment effect of multiple targets and multiple stages by scientifically compounding the monarch drug (fresh lotus flower and lotus leaf), the ministerial drug (fresh centella asiatica), the auxiliary drug (white vaseline) and the assistant drug (ice) in specific proportions. The lotus flower and leaf combination rapidly plays an anti-inflammatory and antibacterial role in the early stage of wound healing, inhibits the release of inflammatory factors (such as IL-1β and TNF-α); the centella asiatica promotes the synthesis of type III collagen (40% increase) and the formation of granulation tissue in the middle and late stages of healing, speeds up tissue reconstruction and inhibits scar proliferation. This time-phase complementary mechanism of "early anti-inflammatory and late repair promotion" fully covers the wound healing process, and the effect is better than that of single component or traditional formula.

[0083] The application uses fresh lotus flower, lotus leaf and centella asiatica picked within 6 hours and controlled to a specific moisture content (≤15%). Compared with the traditional dry medicinal material high-temperature decoction process, the decoction method (120-140℃) of the application can effectively avoid the destruction of heat-sensitive active ingredients (such as flavonoid glycosides and anthocyanins), so that the extraction rate and biological activity of active ingredients in medicinal materials are maximally retained. The comparative experiment (comparative example 3) data show that the content of flavonoids and total glycosides of the ointment prepared by using fresh medicinal materials is significantly higher than that of the control group using dry medicinal materials.

[0084] The application ingeniously uses white vaseline as a dual-function drug carrier and extraction solvent. In the decoction process, the extraction rate of liposoluble components in lotus flower and centella asiatica is as high as 92%. At the same time, the semi-permeable protective film formed by white vaseline on the wound can not only maintain an ideal moist healing environment (reduce water loss by 82%), but also can synergize with ice as a penetration enhancer, so that the drug transdermal absorption rate is increased by 3-5 times, ensuring that the active ingredients can penetrate the stratum corneum and reach the deep part of the wound to play a role.

[0085] The wound repair ointment prepared by the application is not only effective for conventional I and II degree burns, skin chaps, boils and abscesses, but especially shows excellent treatment effect for bedsores, surgical incision fat liquefaction and other clinically common difficult-to-heal wounds. It integrates antibacterial and anti-inflammatory, promotes granulation growth, accelerates epithelialization and inhibits scar formation, providing a safe, efficient and economical new choice for the treatment of complex wounds, and has extremely high clinical popularization value.

[0086] The foregoing examples are merely illustrative of the types of features that can be employed in the methods of the present application. The appended claims are intended to claim the broadest possible range of equivalents, and the examples presented herein are merely illustrative of the selection of embodiments according to all possible combinations of the features presented. Thus, it is the applicant's intention that the appended claims not be limited to the choice presented herein. Some numerical ranges are presented herein in a range format. It is to be understood that such ranges are named from the principle endpoints, and they are to be construed as being inclusive of the broader range as well as the endpoints.

Claims

1. A skin wound treatment composition, characterized in that, It is made from the following components in parts by weight: 10-25 parts fresh hibiscus flowers, 85-200 parts fresh hibiscus leaves, 9-20 parts fresh centella asiatica, 100-500 parts white petrolatum, and 0.05-0.3 parts borneol.

2. The skin wound treatment composition according to claim 1, characterized in that, The weight ratio of the fresh hibiscus flowers, fresh hibiscus leaves, and fresh centella asiatica is 1:(7-10):(0.8-1.2).

3. The skin wound treatment composition according to claim 2, characterized in that, The weight ratio of fresh hibiscus flowers, fresh hibiscus leaves, and fresh centella asiatica is 1:8.5:0.9, the amount of white petrolatum is 150-200 parts, and the amount of borneol is 0.08-0.12 parts.

4. The skin wound treatment composition according to claim 1, characterized in that, The fresh hibiscus flowers, fresh hibiscus leaves, and fresh centella asiatica were washed and dried to a moisture content of ≤15% within 6 hours of harvesting.

5. A method for preparing a skin wound treatment composition according to any one of claims 1-4, characterized in that, Includes the following steps: S1. Wash fresh hibiscus flowers, fresh hibiscus leaves, and fresh centella asiatica, drain them until the moisture content is ≤15%, and chop them into pieces with a particle size of 3-5cm. S2. Melt the white petrolatum by heating, then add the medicinal materials obtained in step S1 and simmer for 40-70 minutes; S3. The resulting product obtained by filtering while still hot; S4. When the filtrate cools to 30-50℃, add borneol, stir well, and then cool to form a paste.

6. The preparation method according to claim 5, characterized in that, The cooking temperature in step S2 is 120-140℃.

7. The preparation method according to claim 5, characterized in that, The fresh hibiscus flowers, fresh hibiscus leaves, and fresh centella asiatica mentioned in step S1 should be cleaned and dried within 4-6 hours after harvesting.

8. Use of the skin wound treatment composition according to any one of claims 1-4 in the preparation of a medicament for treating wound diseases.

9. The application according to claim 8, characterized in that, The wound disease is selected from one or more of the following: bedsores, second-degree burns, first-degree burns, surgical incision fat liquefaction, skin fissures, boils and carbuncles.

10. The application according to claim 8, characterized in that, The wound condition is either surgical incision fat liquefaction or bedsores.

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