A bacteriostatic sheng muscle traditional Chinese medicine composition for chronic wounds and application thereof

Abstract

This invention belongs to the field of medical and nursing care products technology, specifically relating to a traditional Chinese medicine composition for chronic wounds that promotes antibacterial and tissue regeneration, and its application. The raw materials for this composition include Paris polyphylla, dragon's blood, frankincense, myrrh, rhubarb, Phellodendron bark, calamine, pearl powder, Oroxylum indicum, sappanwood, and Rosa laevigata leaves. When this traditional Chinese medicine combination is prepared into a topical ointment and applied to the wound, it possesses potent antibacterial, blood-activating, and tissue-regenerating effects, achieving simultaneous intervention at multiple stages. This improves wound healing and treatment outcomes, addressing issues such as bacterial resistance, insufficient regenerative capacity of modern dressings, and insufficient early-stage antibacterial and anti-inflammatory effects in existing chronic wound treatments. This provides a safe, effective, and economical new treatment option for clinical practice.

Description

Technical Field

[0001] This invention belongs to the field of medical and nursing care products technology, specifically relating to a traditional Chinese medicine composition for chronic wounds that inhibits bacteria and promotes tissue regeneration, and its application. Background Technology

[0002] Chronic wounds (such as diabetic foot, pressure injury, arteriovenous ulcers, etc.) are a challenge in clinical treatment. They are often accompanied by problems such as bacterial biofilm, microcirculatory disorders, and growth factor deficiency, resulting in long treatment cycles, unsatisfactory effects, and even the risk of paraplegia.

[0003] Modern medical treatments face a triple challenge: ① Severe bacterial resistance: According to a multicenter study published in the *Chinese Journal of Nosocomial Infection*, the MRSA detection rate among Staphylococcus aureus isolated from chronic wounds exceeded 30%; Pseudomonas aeruginosa also showed a quinolone resistance rate of over 20%, severely weakening the efficacy of antibiotics. ② Limited regenerative capacity: While modern dressings can provide a moist environment, they lack the pharmacological activity to actively stimulate granulation tissue growth and epithelialization, often encountering bottlenecks in the treatment of wounds stalled in the inflammatory phase. ③ High treatment costs: New antibacterial dressings and advanced antibiotics are expensive, increasing the burden on healthcare.

[0004] Traditional Chinese medicine preparations such as "Shengji Yuhong Ointment" are unique in their ability to "remove necrotic tissue and promote tissue regeneration," but their formulation focuses more on later-stage tissue regeneration and is insufficient in addressing mixed infections and excessive inflammatory responses in the early stages. Furthermore, existing external treatment regimens lack sequential and precise interventions targeting the "pustular stage, granulation stage, and wound-healing stage," resulting in incomplete removal of necrotic tissue and an unstable foundation for tissue regeneration, thus affecting the stability of therapeutic efficacy.

[0005] Therefore, there is an urgent need in this field to develop a novel topical Chinese medicine preparation that combines potent antibacterial and anti-inflammatory effects, promotes blood circulation and unblocks collaterals, and promotes tissue regeneration, in order to improve the overall treatment effect of chronic wounds. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine composition for chronic wounds that has antibacterial and tissue-regenerating effects. This invention aims to address the problems in existing chronic wound treatments, such as bacterial resistance, insufficient regeneration capacity of modern dressings, and insufficient antibacterial and anti-inflammatory effects of traditional Chinese medicine preparations in the early stages. The invention provides a traditional Chinese medicine composition and its external preparation that have strong antibacterial, blood-activating and meridian-clearing, and highly effective tissue-regenerating effects, thereby achieving multi-stage simultaneous intervention and improving wound healing and treatment outcomes.

[0007] A traditional Chinese medicine composition for chronic wounds with antibacterial and tissue-regenerating properties, comprising, by weight, 40-50 parts of Paris polyphylla, 55-65 parts of dragon's blood, 40-50 parts of frankincense, 40-50 parts of myrrh, 10-20 parts of rhubarb, 10-20 parts of phellodendron bark, 40-50 parts of calamine, 25-35 parts of pearl powder, 3-7 parts of Oroxylum indicum, 5-15 parts of sappanwood, and 5-10 parts of Rosa laevigata leaves.

[0008] Preferably, the mass ratio of Paris polyphylla, rhubarb, cork tree bark, and oroxylum indicum is (8-10):(2-4):(2-4):1.

[0009] Preferably, the mass ratio of the bloodwort, frankincense, myrrh, and sappanwood is (5-7):(4-5):(4-5):1.

[0010] Preferably, the mass ratio of calamine, pearl powder, and rosehip leaves is (5-7):(3-5):1.

[0011] By selecting Paris polyphylla, rhubarb, Phellodendron amurense, and Oroxylum indicum as raw materials and compounding them in specific proportions, the traditional Chinese medicine composition can achieve a broader antibacterial spectrum and stronger antibacterial intensity against drug-resistant strains of Staphylococcus aureus, Pseudomonas aeruginosa, and Pseudomonas aeruginosa, while reducing wound exudation and improving local microcirculation. This is because Paris polyphylla, as the core active ingredient, has the highest proportion, and its saponins can disrupt the integrity of bacterial cell membranes, forming a multi-target antibacterial network with rhubarb and Phellodendron amurense. The blood-activating and stasis-removing effects of rhubarb and the drying and dampness-removing effects of Phellodendron amurense synergistically improve wound blood supply to enhance drug penetration efficiency and reduce exudation to prevent bacterial growth. Meanwhile, the small dose of Oroxylum indicum contains baicalin and oroxylum indicum glycosides, which can help clear inflammatory factors, and its fiber components can enhance the dispersibility of the powder, playing a gentle synergistic role without interfering with the core antibacterial function.

[0012] By selecting dragon's blood, frankincense, myrrh, and sappanwood as raw materials and compounding them in a specific ratio, microcirculation can be improved in a sustained manner, necrotic tissue can be sloughed off, granulation tissue growth can be promoted, and wound pain can be significantly relieved. This is because dragon's blood, as the core active ingredient, contains dragon's blood extract, which can effectively dilate microvessels. It forms a synergistic effect of promoting qi circulation, blood circulation, and removing blood stasis with frankincense and myrrh, providing oxygen and nutrients for granulation tissue growth while promoting tissue repair. The small dose of sappanwood contains hematoxylin and brassinolide, which can gently assist in promoting blood circulation and removing blood stasis, avoiding excessive effects of the core blood-activating components that may cause wound bleeding. At the same time, it works synergistically with frankincense and myrrh to enhance the analgesic effect, significantly improve patient compliance, and lay a solid foundation for subsequent tissue regeneration.

[0013] A traditional Chinese medicine composition, made by combining calamine, pearl powder, and Rosa laevigata leaves in specific proportions, can rapidly reduce wound exudation, accelerate granulation tissue regeneration, shorten the epithelialization cycle, and reduce the risk of secondary infection. This is because calamine, as the core active ingredient, contains active zinc oxide that can astringe and dry, forming a physical protective film and providing a clean and dry environment for healing. Together with pearl powder, it forms a highly efficient repair system that prioritizes protection before regeneration. Small doses of Rosa laevigata leaves contain tannins and flavonoids that can further enhance the astringent effect and reduce exudation. Its mild detoxifying effect can also reduce the risk of secondary wound infection, while strengthening the stability of the protective film. This allows the nourishing components of pearl powder to act more effectively on the granulation tissue, comprehensively improving the quality and efficiency of wound healing.

[0014] The preparation method of the traditional Chinese medicine combination for consolidating chronic wound healing includes the following steps: preparing Paris polyphylla powder; pretreating Phellodendron bark, rhubarb, Oroxylum indicum, dragon's blood, frankincense, myrrh, sappanwood, calamine, pearl powder, and Rosa laevigata leaves respectively, and then mixing and pulverizing them with the Paris polyphylla powder to obtain the final product.

[0015] The method for preparing the Paris polyphylla powder includes the following steps: S1. After drying and pulverizing Paris polyphylla, pass it through a 120-200 mesh sieve to obtain coarse Paris polyphylla powder. Add auxiliary materials and water to adjust the moisture content to 50%-60%. After sterilization, cool to room temperature to obtain pre-fermentation liquid. S2. Inoculate the pre-fermentation liquid with mold and bacteria in sequence to obtain the fermentation product; S3. Add water to the fermentation product to adjust the water content to 80%-90%, add enzyme for enzymatic hydrolysis, inactivate the enzyme, and obtain the enzymatic hydrolysate. S4. Add ethanol to the enzymatic hydrolysate until the ethanol concentration in the system reaches 65%-75%. After reflux extraction 1-3 times, centrifuge and combine the supernatants. Concentrate under reduced pressure to a thick paste with a relative density of about 1.10-1.15 at 60℃. Spray dry to obtain the final product.

[0016] Preferably, in step S1, the auxiliary materials are wheat bran and corn flour in a mass ratio of 4:1; the mass of the auxiliary materials is 30%-40% of the mass of Paris polyphylla coarse flour.

[0017] Preferably, in step S1, the specific sterilization conditions are: temperature of 115-121℃ and time of 35-45min.

[0018] Preferably, in step S2, the mold is any one of Aspergillus niger and Aspergillus oryzae; the fungus is any one of Ganoderma lucidum and Hericium erinaceus.

[0019] Preferably, in step S2, the specific steps of sequentially inoculating mold and fungus for fermentation are as follows: activating and culturing mold and fungus to obtain mold spore suspension and mycelium respectively; inoculating mold spore suspension into pre-fermentation liquid; after the first fermentation, inoculating mycelium; and after the second fermentation, the product is ready.

[0020] Preferably, the concentration of the mold spore suspension is 1×10⁻⁶. 7 The mycelial dry weight is 15-20 g / L, and microscopic examination shows that the mycelial activity is vigorous and there is no contamination by other microorganisms.

[0021] Preferably, the inoculation amounts of the mold spore suspension and mycelium are 6-10% and 10-14% of the pre-fermentation liquid volume, respectively.

[0022] Preferably, the conditions for the primary fermentation are: temperature of 28-32℃, relative humidity of 68%-72%, protection from light, aerobic conditions, and standing for 4-6 days.

[0023] Preferably, the conditions for the secondary fermentation are: a temperature of 24-26℃, a relative humidity of 73%-77%, aerobic conditions, and a fermentation time of 9-11 days.

[0024] Preferably, in step S3, the enzymes include cellulase and pectinase; the amount of cellulase added is 80-120 U / g of Paris polyphylla powder; and the amount of pectinase added is 50-100 U / g of Paris polyphylla powder.

[0025] Preferably, in step S3, the specific conditions for enzymatic hydrolysis are: a temperature of 45-50℃ and enzymatic hydrolysis with shaking at a speed of 80-120 rpm for 1.5-2.5 hours.

[0026] Preferably, in step S3, the specific inactivation conditions are: a temperature of 83-87°C and a time of 8-10 minutes.

[0027] Preferably, in step S4, the specific conditions for reflux extraction are: temperature of 58-62℃ and extraction time of 0.5-1.5h.

[0028] Preferably, in step S4, the specific conditions for spray drying are: inlet air temperature of 160-180℃ and outlet air temperature of 80-90℃.

[0029] By employing a specific method—fermentation followed by enzymatic hydrolysis and alcohol extraction—to prepare Paris polyphylla powder, the total dissolution rate of the core active ingredient, Paris polyphylla saponins, can be increased. These saponins are then converted into acetylated derivatives with stronger transdermal permeability and higher antibacterial activity, significantly enhancing the antibacterial strength of the traditional Chinese medicine composition against drug-resistant bacteria such as Staphylococcus aureus and Pseudomonas aeruginosa. This is because the first step, mold fermentation, can efficiently degrade the dense cell walls of Paris polyphylla through the targeted secretion of cellulase and pectinase, opening channels for saponin release. The second step, bacterial fermentation, uses acetyltransferase produced by metabolism to directionally convert saponin structures. Stepwise inoculation and differentiated conditions avoid microbial competition for nutrients, ensuring maximum efficacy for each microorganism. Subsequent enzymatic hydrolysis and low-temperature alcohol extraction further enhance the disruption of residual cell walls and the enrichment of saponins. Spray drying completely preserves the heat-sensitive active ingredients. This method not only solves the core problems of poor solubility and insufficient activity of Paris polyphylla saponins but also comprehensively enhances the potent antibacterial, wound-healing-promoting, and economical performance of the traditional Chinese medicine composition through improved component utilization and process adaptability.

[0030] Preferably, the pretreatment methods for the leaves of Phellodendron bark, rhubarb, Oroxylum indicum, and Rosa laevigata are the same, and the pretreatment method is vacuum drying, with the specific conditions being: temperature of 40-45℃, vacuum degree of 0.08-0.09MPa, and drying to a moisture content of ≤8%.

[0031] Preferably, the pretreatment methods for the bloodwort, frankincense, and myrrh are the same, and the pretreatment method is freeze drying, with the specific conditions being: temperature of -20~-10℃ and freezing time of 3-5h.

[0032] Preferably, the pretreatment methods for calamine and pearl powder are the same, and the pretreatment method is forging, with the specific conditions being: temperature of 300-350℃ and time of 2-3h.

[0033] Preferably, the pretreatment method for the sappanwood is hot air drying, with the following specific conditions: temperature of 58-62℃, air velocity of 2-3 m / s, and drying until the moisture content is ≤10%.

[0034] Preferably, the specific conditions for the mixing and pulverizing are: rotation speed of 25,000-30,000 r / min, pulverizing for 10 minutes each time, with a 5-minute interval, repeated 3-4 times to ensure that all raw materials reach a fineness of 200 mesh or above.

[0035] The application of the aforementioned antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds is in the pharmaceutical field, and more preferably, it can be applied to the preparation of topical ointments.

[0036] The raw materials for preparing the topical ointment include a traditional Chinese medicine composition for antibacterial and tissue-regenerating purposes for chronic wounds, yellow petrolatum, and sesame oil.

[0037] Preferably, the mass ratio of the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds, yellow petrolatum, and sesame oil is 1:3:1.

[0038] The yellow petrolatum mentioned is pharmaceutical grade, and the sesame oil is food grade; both are commercially available.

[0039] The preparation method of the topical ointment includes the following steps: mixing and blending the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds with yellow petrolatum and sesame oil to form an ointment.

[0040] The specific application method of the topical ointment is as follows: apply the topical ointment to sterile gauze or other dressing material, apply it to the affected area, and change the dressing 3 times a week.

[0041] Compared with the prior art, the advantages and beneficial effects of the present invention are as follows: 1. The antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds prepared in this invention integrates potent antibacterial (Paris polyphylla, Phellodendron chinense, Rheum palmatum, Oroxylum indicum), blood-activating and collateral-dredging (Dracaena cochinchinensis, Boswellia carterii, Commiphora myrrha, Caesalpinia sappan) and highly effective tissue-regenerating (Pearl powder, Calamine, Rosa laevigata) into one, breaking through the limitations of single antibacterial or tissue-regenerating agents, and achieving simultaneous intervention on multiple aspects of "bacteria, necrosis, blood stasis, and deficiency" in infected wounds, resulting in a more comprehensive therapeutic effect.

[0042] 2. The ingredients in this invention, such as Paris polyphylla, rhubarb, Phellodendron chinense, and Oroxylum indicum, have strong inhibitory effects on common wound infection bacteria, including some drug-resistant strains, such as Staphylococcus aureus and Pseudomonas aeruginosa, providing a new traditional Chinese medicine solution for clinical treatment of drug-resistant bacterial infections.

[0043] 3. The low-temperature pretreatment and intermittent pulverization process adopted in this invention effectively solves the processing problems of heat-sensitive and resin-based drugs, ensuring the retention of active ingredients and the high quality and high uniformity of the formulation. The 200-mesh fineness ensures the full release and transdermal absorption of the drug.

[0044] 4. All the ingredients in this invention are traditional Chinese medicines for external use, which are highly safe and have few adverse reactions; the ointment formulation is soft in texture, spreads well, is less irritating to the wound, and has high patient compliance. Attached Figure Description

[0045] 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.

[0046] Figure 1 These are before-and-after photos of the wound in Case Study 1 of this invention. a-Before treatment; b-After 10 days of ointment use; c-After 19 days of ointment use; d-After 40 days of ointment use; e-After 66 days of ointment use; f-After 77 days of ointment use.

[0047] Figure 2These are before-and-after photos of the wound in Case Study 2 of this invention. a-Before treatment; b-7 days after applying the ointment; c-11 days after applying the ointment; d-16 days after applying the ointment; e-21 days after applying the ointment; f-28 days after applying the ointment. Detailed Implementation

[0048] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0049] All raw materials used in this invention are commercially available, specifically: Aspergillus niger, strain number ACCC 32589; Hericium erinaceus, strain number ACCC 52776; both are from the China Agricultural Microbial Culture Collection Center.

[0050] Cellulase, with an enzyme activity of approximately 11,000 CFU / g; pectinase, with an enzyme activity of approximately 60,000 CFU / g; both are from Xiasheng (Beijing) Biotechnology Development Co., Ltd.

[0051] Yellow petrolatum is pharmaceutical grade, and sesame oil is food grade; both are commercially available.

[0052] Example 1 This embodiment provides a traditional Chinese medicine composition for antibacterial and tissue-regenerating chronic wounds. The raw materials for its preparation, by weight, include 45 parts of Paris polyphylla, 60 parts of dragon's blood, 45 parts of frankincense, 45 parts of myrrh, 15 parts of rhubarb, 15 parts of Phellodendron bark, 45 parts of calamine, 30 parts of pearl powder, 5 parts of Oroxylum indicum, 10 parts of sappanwood, and 8 parts of Rosa laevigata leaves.

[0053] The mass ratio of Paris polyphylla, rhubarb, cork tree bark, and oroxylum indicum is 9:3:3:1.

[0054] The mass ratio of the bloodwort, frankincense, myrrh, and sappanwood is 6:4.5:4.5:1.

[0055] The mass ratio of calamine, pearl powder, and Rosa laevigata leaves is 5.625:3.75:1.

[0056] The preparation method of the traditional Chinese medicine combination for consolidating chronic wound healing includes the following steps: preparing Paris polyphylla powder; pretreating Phellodendron bark, rhubarb, Oroxylum indicum, dragon's blood, frankincense, myrrh, sappanwood, calamine, pearl powder, and Rosa laevigata leaves separately, and then mixing and pulverizing them with the Paris polyphylla powder to obtain the final product.

[0057] The preparation method of the Paris polyphylla powder includes the following steps: S1. After drying and pulverizing Paris polyphylla, pass it through a 120-200 mesh sieve to obtain coarse Paris polyphylla powder. Add auxiliary materials, add water to adjust the moisture content to 55%, sterilize and cool to room temperature to obtain pre-fermentation liquid. S2. Inoculate the pre-fermentation liquid with mold and bacteria in sequence to obtain the fermentation product; S3. Add water to the fermentation product to adjust the water content to 85%, add enzyme for enzymatic hydrolysis, inactivate the enzyme, and obtain the enzymatic hydrolysate. S4. Add ethanol to the enzymatic hydrolysate until the ethanol concentration in the system reaches 70%. After reflux extraction twice, centrifuge and combine the supernatants. Concentrate under reduced pressure to a thick paste with a relative density of about 1.10-1.15 at 60℃. Spray dry to obtain the final product.

[0058] In step S1, the auxiliary materials are wheat bran and corn flour in a mass ratio of 4:1; the mass of the auxiliary materials is 35% of the mass of Paris polyphylla coarse flour.

[0059] In step S1, the specific sterilization conditions are: temperature 121℃ and time 40min.

[0060] In step S2, the mold is Aspergillus niger and the fungus is Hericium erinaceus.

[0061] In step S2, the specific steps for sequentially inoculating mold and fungus for fermentation are as follows: activate and culture the mold and fungus to obtain mold spore suspension and mycelium respectively; inoculate the mold spore suspension into the pre-fermentation liquid; after the first fermentation, inoculate the mycelium; and after the second fermentation, the product is ready.

[0062] The concentration of the mold spore suspension is 1×10⁻⁶. 7 The mycelial dry weight was 18 g / L, and microscopic examination showed that the mycelium was vigorous and free from contamination.

[0063] The inoculation amounts of the mold spore suspension and mycelium were 8% and 12% of the pre-fermentation liquid volume, respectively.

[0064] The conditions for the first fermentation are: temperature of 30℃, relative humidity of 70%, protection from light, aerobic conditions, and standing for 5 days.

[0065] The conditions for the secondary fermentation are: temperature of 25℃, relative humidity of 75%, aerobic conditions, and fermentation time of 10 days.

[0066] In step S3, the enzymes include cellulase and pectinase; the amount of cellulase added is 100 U / g of Paris polyphylla coarse powder; the amount of pectinase added is 80 U / g of Paris polyphylla coarse powder.

[0067] In step S3, the specific conditions for enzymatic hydrolysis are: a temperature of 48°C and enzymatic hydrolysis with shaking at 100 rpm for 2 hours.

[0068] In step S3, the specific inactivation conditions are: temperature 85℃ and time 10min.

[0069] In step S4, the specific conditions for reflux extraction are: temperature of 60℃ and extraction time of 1 hour.

[0070] In step S4, the specific conditions for spray drying are: inlet air temperature of 170°C and outlet air temperature of 85°C.

[0071] The pretreatment methods for the leaves of Phellodendron bark, rhubarb, Oroxylum indicum, and Rosa laevigata are the same, and the pretreatment method is vacuum drying. The specific conditions are: temperature of 42℃, vacuum degree of 0.08MPa, and drying to moisture content ≤8%.

[0072] The pretreatment methods for the bloodwort, frankincense, and myrrh are the same, and the pretreatment method is freeze-drying, with the specific conditions being: temperature of -20℃ and freezing time of 4h.

[0073] The pretreatment methods for calamine and pearl powder are the same, and the pretreatment method is forging, with the specific conditions being: temperature of 325℃ and time of 2.5h.

[0074] The pretreatment method for the sappanwood is hot air drying, with the following specific conditions: temperature of 60℃, air velocity of 2.5m / s, and drying to a moisture content of ≤10%.

[0075] The specific conditions for the mixing and pulverizing are as follows: rotation speed 28000 r / min, pulverizing for 10 minutes each time, with a 5-minute interval, repeated 4 times to ensure that all raw materials reach a fineness of 200 mesh or above.

[0076] The topical ointment is prepared from the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds.

[0077] The raw materials for preparing the topical ointment include a traditional Chinese medicine composition for antibacterial and tissue-regenerating purposes for chronic wounds, yellow petrolatum, and sesame oil, in a mass ratio of 1:3:1.

[0078] The preparation method of the topical ointment is as follows: the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds is mixed with yellow petrolatum and sesame oil to form an ointment.

[0079] Example 2 The difference between this embodiment and Embodiment 1 is that the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds, by weight, includes the following raw materials: 50 parts of Paris polyphylla, 60 parts of dragon's blood, 40 parts of frankincense, 50 parts of myrrh, 10 parts of rhubarb, 15 parts of phellodendron bark, 48 parts of calamine, 32 parts of pearl powder, 5 parts of Oroxylum indicum, 10 parts of sappanwood, and 8 parts of Rosa laevigata leaves.

[0080] The mass ratio of Paris polyphylla, rhubarb, cork tree bark, and oroxylum indicum is 10:2:3:1.

[0081] The mass ratio of the bloodwort, frankincense, myrrh, and sappanwood is 6:4:5:1.

[0082] The mass ratio of calamine, pearl powder, and Rosa laevigata leaves is 6:4:1.

[0083] Comparative Example 1 The difference between this comparative example and Example 1 is that the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds, by weight, includes the following raw materials: 20 parts of Paris polyphylla, 60 parts of dragon's blood, 45 parts of frankincense, 45 parts of myrrh, 30 parts of rhubarb, 15 parts of Phellodendron bark, 45 parts of calamine, 30 parts of pearl powder, 5 parts of Oroxylum indicum, 10 parts of sappanwood, and 8 parts of Rosa laevigata leaves.

[0084] The mass ratio of Paris polyphylla, rhubarb, cork tree bark, and Oroxylum indicum is 4:6:3:1.

[0085] The mass ratio of the bloodwort, frankincense, myrrh, and sappanwood is 6:4.5:4.5:1.

[0086] The mass ratio of calamine, pearl powder, and Rosa laevigata leaves is 5.625:3.75:1.

[0087] Comparative Example 2 The difference between this comparative example and Example 1 is that Scutellaria baicalensis is used to replace Oroxylum indicum in equal amounts, Salvia miltiorrhiza is used to replace Sappanwood in equal amounts, and Galla chinensis is used to replace Rosa laevigata in equal amounts.

[0088] Comparative Example 3 The difference between this comparative example and Example 1 is that the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds, by weight, includes the following raw materials: 45 parts of Paris polyphylla, 80 parts of dragon's blood, 30 parts of frankincense, 45 parts of myrrh, 15 parts of rhubarb, 15 parts of phellodendron bark, 45 parts of calamine, 30 parts of pearl powder, 5 parts of Oroxylum indicum, 10 parts of sappanwood, and 8 parts of Rosa laevigata leaves.

[0089] The mass ratio of Paris polyphylla, rhubarb, cork tree bark, and oroxylum indicum is 9:3:3:1.

[0090] The mass ratio of the bloodwort, frankincense, myrrh, and sappanwood is 8:3:4.5:1.

[0091] The mass ratio of calamine, pearl powder, and Rosa laevigata leaves is 5.625:3.75:1.

[0092] Comparative Example 4 The difference between this comparative example and Example 1 is that sappanwood is replaced with triangular sedge.

[0093] Comparative Example 5 The difference between this comparative example and Example 1 is that the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds, by weight, includes the following raw materials: 45 parts of Paris polyphylla, 60 parts of dragon's blood, 45 parts of frankincense, 45 parts of myrrh, 15 parts of rhubarb, 15 parts of phellodendron bark, 32 parts of calamine, 48 parts of pearl powder, 5 parts of Oroxylum indicum, 10 parts of sappanwood, and 8 parts of Rosa laevigata leaves.

[0094] The mass ratio of Paris polyphylla, rhubarb, cork tree bark, and oroxylum indicum is 9:3:3:1.

[0095] The mass ratio of the bloodwort, frankincense, myrrh, and sappanwood is 6:4.5:4.5:1.

[0096] The mass ratio of calamine, pearl powder, and Rosa laevigata leaves is 4:6:1.

[0097] Comparative Example 6 The difference between this comparative example and Example 1 is that only Aspergillus niger was used for a single fermentation.

[0098] Comparative Example 7 The difference between this comparative example and Example 1 is that Ganoderma lucidum was inoculated first for fermentation, and then Aspergillus niger was inoculated for fermentation.

[0099] Performance testing (I) Antibacterial activity test: The antibacterial rate of the traditional Chinese medicine composition against Staphylococcus aureus and Pseudomonas aeruginosa was tested with reference to the "Disinfection Technical Specifications" (2002 edition) after 2 minutes of action. Staphylococcus aureus strain number ATCC6538; Pseudomonas aeruginosa strain number CICC 24649, both strains were obtained from the China Industrial Microbial Culture Collection Center.

[0100] (II) Wound healing performance test (mouse experiment) Experimental animals: SPF-grade ICR mice, half male and half female, 6-8 weeks old, weighing 20-25g (10 mice per group, sample size meets statistical requirements); Modeling: After hair removal on the back, a full-thickness skin defect wound (reaching the fascia layer) was prepared using an 8mm diameter skin punch, and covered with sterile gauze after the operation; Chronic treatment: On the 3rd day after modeling, MRSA bacterial solution (1×10⁻⁶) was dripped onto the wound. 6 50 μL of CFU / mL was used to induce infection and construct an infectious chronic wound model.

[0101] Administration method: Once daily, each test ointment is evenly applied to the wound (2mm thick), covered and fixed with sterile gauze. The invention group is dressed 3 times a week to simulate clinical application. Householding conditions: SPF grade animal room, temperature 22-25℃, humidity 50-60%, free access to food and water, feeding cycle 4 weeks.

[0102] Evaluation indicators and detection time points: The wound area was measured on the 14th day of treatment, and the healing rate was calculated as (initial area - area after 14 days of treatment) / initial area × 100%; Table 1 As shown in Table 1, the antibacterial and tissue-regenerating traditional Chinese medicine compositions for chronic wounds prepared in Examples 1-2 of this invention have strong inhibitory effects on common wound-infecting bacteria such as Staphylococcus aureus and Pseudomonas aeruginosa, and can effectively reduce the wound area, indicating a high healing rate. Comparative Example 1 had insufficient Paris polyphylla and excessive rhubarb; Comparative Example 2 replaced Oroxylum indicum with an equal amount of Scutellaria baicalensis, replaced Sappanwood with an equal amount of Salvia miltiorrhiza, and replaced Rosa laevigata with an equal amount of Galla chinensis; Comparative Example 3 had excessive Dragon's Blood and insufficient Frankincense; Comparative Example 4 replaced Sappanwood with Sparganium stoloniferum; Comparative Example 5 had insufficient calamine and excessive pearl powder; Comparative Example 6 used only Aspergillus niger for single-stage fermentation; Comparative Example 7 first inoculated with Ganoderma lucidum for fermentation, and then inoculated with Aspergillus niger for fermentation. The antibacterial rate and wound healing effect of the prepared traditional Chinese medicine compositions were different from those in Example 1.

[0103] (III) Clinical Trials I. Experimental Design: 1. Study Subjects: A total of 160 patients with stage IV pressure injury and lower extremity venous ulcers meeting the diagnostic criteria were selected and randomly divided into a treatment group and a control group according to the wound type, with 40 patients in each group. Inclusion criteria: ① Age < 80 years; ② Wound area ≤ 20 cm² 2 ; ③ The course of the disease is ≥4 weeks and is in a state of stagnant healing; Exclusion criteria: ① Combined with severe lower limb ischemia or combined with severe heart, liver and kidney dysfunction; ② Use of antibiotics within 2 weeks before enrollment; ③ Allergy to the drug components of this study; ④ Poor compliance, withdrawal midway or transfer to another hospital for treatment.

[0104] 2. Treatment methods: ①The treatment group used the topical ointment prepared in Example 1 of this invention to be evenly applied to sterile gauze with a thickness of 2-3 mm, applied to the wound and fixed.

[0105] ②The control group used commercially available traditional Shengji Yuhong Ointment, and its application and fixation methods were the same as those of the treatment group.

[0106] ③ Both groups had their dressings changed 3 times a week, and the treatment cycle was 4 weeks.

[0107] II. Evaluation Indicators 1. Bacterial culture positivity rate (%): Bacterial culture was performed on wound secretions collected before treatment and on the 7th day of treatment.

[0108] 2. Color of granulation tissue: Granulation tissue color score: Before treatment and at each dressing change, the color of the granulation tissue was compared with the color chart to complete the score. Complete: 0 points; Reddish: 1 point; Dark red: 2 points; Grayish white: 3 points; Purplish black: 4 points.

[0109] 3. Wound area: Measured before treatment and at each dressing change. Wound area (cm²) 2 = Longest diameter of wound (cm) × Widest diameter of wound (cm).

[0110] 4. Criteria for Evaluating Therapeutic Effect Based on the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine, the clinical criteria are as follows: Clinically cured: complete wound healing and disappearance of symptoms. Significantly effective: wound healing rate ≥75%, granulation tissue light red, no pus, significant disappearance of redness and swelling around the wound, and substantial reduction in pain. Effective: 25% ≤ wound healing rate <75%, granulation tissue bright red, possibly with a small amount of pus, and slight redness and swelling around the wound. Ineffective: wound healing rate <25% or no significant change or even worsening. Total effective rate = (number of cured cases + number of significantly effective cases + number of effective cases) / total number of cases × 100%.

[0111] 5. Statistical methods: SPSS 22.0 software was used. Quantitative data were expressed as mean ± standard deviation (x ± s), and t-tests were used for comparisons between groups. Count data were expressed as percentages (%), and χ² tests were used for comparisons between groups. P < 0.05 was considered statistically significant. Results are shown in Tables 2-5.

[0112] Table 2. Comparison of pathogen detection rates in wounds before and after treatment in the two groups of patients [n(%)] Table 3. Comparison of granulation tissue color scores before and after treatment in the two groups of patients [mean ± standard deviation, points] Table 4 Comparison of wound area before and after treatment in the two groups [mean ± standard deviation, cm] 2 ] Table 5. Comparison of wound healing efficiency before and after treatment in the two groups [n, (%)] Case Study 1: Female, 79 years old, long-term bedridden, with a history of hypertension and stage 4 pressure injury. She underwent regular turning to relieve pressure on her left hip. She used the topical ointment prepared in Case Study 1 for 77 days, with a total of 33 dressing changes. Before and after wound photos are shown below. Figure 1 .Depend on Figure 1 It can be seen that the wound has basically healed.

[0113] Case Study 2: Male, 42 years old, food delivery worker, walks over 20,000 steps daily, with a 2-year history of chronic lower extremity venous ulcers accompanied by a 1-week acute infection. He presented with significant effusion and an unpleasant odor in the anterior tibial region of his right lower extremity, along with increased local skin temperature and marked redness and swelling around the wound. He used the topical ointment prepared in Case Study 2 for 28 days, with 12 dressing changes. Before and after photos of the wound are shown below. Figure 2 .Depend on Figure 2 It can be seen that the wound has basically healed.

[0114] In summary, this invention, through optimized formulation and process, provides a traditional Chinese medicine composition that combines potent antibacterial, blood-activating, and tissue-regenerating effects. Its efficacy has been verified through in vitro antibacterial tests, mouse experiments, and clinical trials. This formulation can systematically address multiple challenges in the treatment of chronic wounds, providing a safe, effective, and economical new treatment option for clinical practice.

[0115] The above description represents the preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles 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 the treatment of chronic wounds, characterized in that, The raw materials for its preparation, by weight, include 40-50 parts of Paris polyphylla, 55-65 parts of dragon's blood, 40-50 parts of frankincense, 40-50 parts of myrrh, 10-20 parts of rhubarb, 10-20 parts of phellodendron bark, 40-50 parts of calamine, 25-35 parts of pearl powder, 3-7 parts of Oroxylum indicum, 5-15 parts of sappanwood, and 5-10 parts of Rosa laevigata leaves.

2. The antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds according to claim 1, characterized in that, The mass ratio of Paris polyphylla, rhubarb, cork tree bark, and oroxylum indicum is (8-10):(2-4):(2-4):

1.

3. The antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds according to claim 1, characterized in that, The mass ratio of the bloodwort, frankincense, myrrh, and sappanwood is (5-7):(4-5):(4-5):

1.

4. The antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds according to claim 1, characterized in that, The mass ratio of calamine, pearl powder, and Rosa laevigata leaves is (5-7):(3-5):

1.

5. A method for preparing a traditional Chinese medicine composition for chronic wounds according to any one of claims 1 to 4, characterized in that, Includes the following steps: Paris polyphylla powder was prepared by processing the following ingredients: Phellodendron bark, rhubarb, Oroxylum indicum, dragon's blood, frankincense, myrrh, sappanwood, calamine, pearl powder, and Rosa laevigata leaves were pretreated separately, and then mixed and pulverized with the Paris polyphylla powder to obtain the final product.

6. The method for preparing the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds according to claim 5, characterized in that, The pretreatment methods for the leaves of Phellodendron bark, rhubarb, Oroxylum indicum, and Rosa laevigata are the same, which is vacuum drying. The specific conditions are: temperature of 40-45℃, vacuum degree of 0.08-0.09MPa, and drying to moisture content ≤8%.

7. The method for preparing the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds according to claim 5, characterized in that, The pretreatment methods for the bloodwort, frankincense, and myrrh are the same, and the pretreatment method is freeze drying, with the specific conditions being: temperature of -20~-10℃ and freezing time of 3-5h.

8. The method for preparing the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds according to claim 5, characterized in that, The pretreatment methods for calamine and pearl powder are the same, and the pretreatment method is forging, with the specific conditions being: temperature of 300-350℃ and time of 2-3 hours.

9. The application of a traditional Chinese medicine composition for chronic wounds according to any one of claims 1 to 4 in the pharmaceutical field.

10. The application of the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds according to claim 9, characterized in that, The antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds is used to prepare a topical ointment; the raw materials for preparing the topical ointment include the antibacterial and tissue-regenerating traditional Chinese medicine composition for chronic wounds, yellow petrolatum, and sesame oil.

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