Anti-infection preparation for removing necrotic tissue, promoting granulation, stopping bleeding and preparation method thereof

Abstract

The invention relates to the technical field of hemostasis and anti-infection, in particular to a necrotic tissue removing, granulation promoting, hemostasis and anti-infection preparation and a preparation method thereof. 3-8 parts of a frankincense extract; 3-8 parts of a myrrh extract; 2-6 parts of a dragon's blood extract; 4-10 parts of pseudo-ginseng powder; 1-3 parts of borneol; 0.1 to 0.5 part of musk; 2-6 parts of madder powder; 4-10 parts of an angelica sinensis extract; 3-8 parts of a coptis chinensis extract; 2-6 parts of a rheum officinale extract; 2 to 4 parts of polyhexamethylene biguanide; in the aspect of removing necrotic tissue and promoting granulation, through the innovative combination of the catechin-polyhexamethylene biguanide compound and the rhizoma coptidis-radix et rhizoma rhei synergistic extract, rapid and effective necrotic tissue removal is realized. The composition not only can mildly decompose necrotic tissues, but also can create a favorable environment for the growth of healthy granulation tissues, so that the efficiency and quality of removing necrotic tissues and promoting granulation are remarkably improved.

Description

Technical Field

[0001] The invention relates to the technical field of hemostasis and anti-infection, in particular to a hemostasis and anti-infection preparation for removing dead tissue, promoting tissue regeneration and a preparation method thereof. Background Art

[0002] In recent years, with the continuous advancement of medical technology, the treatment of open wounds has also been continuously improved. However, there are still many challenges in treating complex wounds, especially chronic wounds containing necrotic tissue. Existing treatment methods usually require the use of multiple drugs or preparations in steps, which not only increases the pain of patients, but also prolongs the treatment cycle.

[0003] At present, most common trauma treatment products on the market only target a single function, such as simple hemostatic agents, antibacterial agents or dressings that promote healing. These products often require the coordination of multiple preparations when used, which not only increases the workload of medical staff, but may also affect the treatment effect due to improper use. In addition, although some comprehensive trauma treatment products attempt to solve multiple problems, they often have unsatisfactory results in some aspects. For example, although some products have good hemostatic effects, they perform poorly in removing necrotic tissue and promoting the growth of new tissue; while other products, although they have significant anti-infection effects, may weaken their hemostatic or healing-promoting effects due to interactions between ingredients.

[0004] More importantly, there are few products in the existing technology that can effectively solve the core problem of regeneration of dead tissue. Regeneration of dead tissue, that is, removing necrotic tissue and promoting the growth of healthy granulation tissue, is a key step in treating complex wounds. However, traditional methods often require physical debridement or strong chemical reagents to remove necrotic tissue, which inevitably causes additional damage to surrounding healthy tissues and delays the healing process.

[0005] In addition, existing products are also insufficient in terms of ease of use. Many products require complex preparation processes or specific conditions of use, which may affect the timeliness and effectiveness of disposal in an emergency. At the same time, some products have high requirements for stability and storage conditions, which limits their application in various environments.

[0006] Natural disasters, production accidents, public health emergencies, and social security incidents occur frequently around the world, seriously affecting the safety of human life and property. As a country with a large area and population, my country has suffered even more serious damage and losses caused by various natural disasters. Earthquakes, as a special form of natural disaster, are characterized by sudden, crushing, and large-scale injuries. Earthquake-induced trauma includes fractures, soft tissue injuries, and crush injuries. Earthquake injuries occur suddenly, with complex injuries and often multiple injuries. If regular treatment is not carried out in the early stage, the wounds will not heal for a long time. In the later stage, ulcers after earthquake injuries can be seen, often with peritraumatic inflammation. Soft tissue injuries of earthquake victims are mostly contusions, cuts, stab wounds, lacerations, and burns. They are characterized by severe wound contamination, severe damage, and often accompanied by infection. Severe damage or infection can lead to soft tissue defects and require skin grafts or flaps for repair. Due to the particularity of the earthquake itself, the injuries of the victims also include special conditions such as extensive subcutaneous blood accumulation and partial skin necrosis. Most traumatic wounds do not heal for a long time. Wound healing is a basic surgical issue. Although some protective agents, antibiotics, vitamins, and trace element preparations are widely used, they basically remain at the stage of waiting for the wound to heal naturally, and their effect on promoting wound healing is very limited. Although some growth factors have a strong effect on promoting cell proliferation and can promote wound healing, wound healing requires the participation of multiple growth factors and has complex compatibility. Their safety has always been a focus of attention. Excessive cell proliferation may also form proliferative scars and even cause cancer. Western medicine topical preparations have their limitations due to their single target.

[0007] In view of the above problems, there is an urgent need for a comprehensive wound treatment product that can simultaneously achieve the goals of decomposing dead tissue, regenerating new flesh, stopping bleeding and preventing infection. The ideal product should have the following characteristics: it can gently and effectively remove necrotic tissue and promote the growth of healthy granulation tissue; it has a rapid hemostatic effect; it provides continuous anti-infection protection; it promotes wound healing and tissue regeneration; it is easy to use, suitable for various trauma situations, and can be placed in an emergency rescue bag for easy carrying. Summary of the invention

[0008] The anti-infective preparation of the present invention is designed to address these challenges. Through innovative formula design and preparation process, the present invention successfully integrates multiple functional ingredients into a single preparation, achieving synergistic effects between the components. This synergistic effect not only overcomes the problem of mutual restriction of various functions in the prior art, but also produces some unexpected positive effects.

[0009] The object of the present invention is to provide a decomposing, fibrosing, hemostatic and anti-infective preparation, which comprises the following components by weight:

[0010] 5-15 parts of catechins; 3-8 parts of frankincense extract; 3-8 parts of myrrh extract; 2-6 parts of dragon's blood extract; 4-10 parts of notoginseng powder; 1-3 parts of borneol; 0.1-0.5 parts of musk; 2-6 parts of madder powder; 4-10 parts of angelica extract; 3-8 parts of coptis extract; 2-6 parts of rhubarb extract; 2-4 parts of polyhexamethylene biguanide; 0.5-1.5 parts of sodium hyaluronate.

[0011] The innovative features and technical effects of the present invention are mainly reflected in the following aspects:

[0012] First, in terms of decomposing dead tissue and promoting tissue regeneration, the present invention achieves rapid and effective removal of necrotic tissue through the innovative combination of catechin-polyhexamethylene biguanide complex and coptis root-rhubarb synergistic extract. This combination can not only gently decompose necrotic tissue, but also create a favorable environment for the growth of healthy granulation tissue, significantly improving the efficiency and quality of decomposing dead tissue and promoting tissue regeneration.

[0013] Secondly, in terms of hemostatic effect, the Panax notoginseng-Dracaena nanoemulsion technology of the present invention greatly improves the bioavailability of these two traditional hemostatic medicinal materials. Combining the physical barrier effect of the gel and the astringent effect of catechins, a multiple hemostatic mechanism is formed, which can quickly and effectively control various types of bleeding.

[0014] Furthermore, in terms of anti-infection, the present invention achieves sustained broad-spectrum antibacterial activity through the long-term synergistic effect of polyhexamethylene biguanide and coptis chinensis-rhubarb synergistic extract. This design can not only effectively prevent initial infection, but also inhibit potential secondary infection for a long time, creating a safe microenvironment for wound healing.

[0015] In addition, the present invention also performs well in promoting tissue regeneration and accelerating wound healing. The synergistic effect of the sodium hyaluronate-angelica complex and the frankincense-myrrh-borneol composite essential oil not only accelerates epidermal regeneration and collagen deposition, but also promotes the formation of granulation tissue with rich blood vessels and complete structure, thereby improving the quality and speed of wound healing.

[0016] Finally, the thermosensitive in-situ gel technology used in the present invention greatly improves the convenience of the product. This gel can be quickly formed at body temperature, adapt to wounds of various shapes, and continuously release active ingredients, reducing the frequency of dressing changes, improving patient compliance, and is suitable for emergency treatment of open wounds.

[0017] In addition, the present invention also provides a decomposing, granulating, hemostatic and anti-infective cataplasm, which refers to a topical preparation made by mixing a medicinal material extract, a medicinal material or a suitable hydrophilic matrix, and applying it on a backing material, mainly for skin application, and can produce a type of topical preparation for local or systemic effects. Since the cataplasm uses a water-soluble polymer compound or a hydrophilic substance as a matrix, it has good compatibility and affinity with the skin. During use, the skin is non-irritating and sensitizing, without pain, and comfortable to use. It uses a non-woven fabric as a support layer, so it has good air permeability and sweat resistance, and can be repeatedly peeled and pasted without affecting the efficacy. In addition, the cataplasm has a large drug loading and rapid onset. Most importantly, the cataplasm can be continuously administered for a long time, thereby maintaining the necessary level of blood drug concentration, which is more conducive to the effect of the drug. It can be seen that compared with traditional external creams such as adhesive plasters, ointments, and black plasters, papules have the advantages of no residue, no pollution to clothes, large drug loading capacity, rapid onset of effect, good moisturizing performance, good breathability, and comfortable use; no irritation and allergenicity to the skin, no pain, and can be repeatedly removed and applied without affecting the efficacy; it can also be airdropped and is not easily damaged; it can also be placed in an emergency rescue bag for easy carrying.

[0018] The present invention provides an innovative solution to these complex problems by providing a tissue-removing, hemostatic and anti-infective cataplasm. As an advanced external preparation, the cataplasm not only overcomes many shortcomings of traditional external preparations, but is also particularly suitable for treating complex wounds of earthquake victims.

[0019] The cataplasm of the present invention has the following unique beneficial effects on the basis of the existing advantages:

[0020] Multiple synergistic effects: By integrating multiple functions such as decomposing dead tissue, promoting tissue regeneration, stopping bleeding and preventing infection into one preparation, the present invention can simultaneously solve multiple problems of the wound surface of earthquake victims, such as removing necrotic tissue, controlling bleeding and preventing infection.

[0021] Continuous and stable drug delivery: The special structure and preparation process of the cataplasm enable it to release drugs stably for a long time, which is especially important for complex wounds that require long-term treatment.

[0022] Adaptability to complex wounds: The cataplasm of the present invention has good adhesion and air permeability, and can adapt to wounds of various shapes and states, including irregular wounds and deep wounds commonly seen in earthquake victims.

[0023] Promote tissue regeneration: Through the synergistic effect of multiple Chinese medicinal ingredients, the present invention can not only remove necrotic tissue, but also promote the growth of healthy granulation tissue and accelerate wound healing.

[0024] Safety advantage: Compared with a single growth factor, the present invention uses a variety of natural Chinese medicine ingredients to promote wound healing while reducing the risk of excessive proliferation and potential safety issues.

[0025] Ease of use: Papas are easy to use and replace, and are particularly suitable for use in post-disaster environments with limited resources. They can improve treatment efficiency and patient compliance.

[0026] In summary, the anti-infective cataplasm for removing dead tissue, promoting tissue regeneration, stopping bleeding and preventing infection of the present invention not only inherits the general advantages of cataplasms, but also provides a comprehensive, efficient and safe new treatment plan through innovative formula design and preparation process, especially for the treatment needs of complex wounds such as earthquake casualties and war zone casualties. This innovation is expected to significantly improve the wound treatment effect of earthquake casualties, war zone casualties, etc., accelerate the recovery process, and provide strong support for disaster medical rescue.

[0027] In general, the decomposing, granulation, hemostasis and anti-infection preparation of the present invention successfully combines multiple functions such as decomposing, granulation, hemostasis, anti-infection and healing promotion through multiple innovations, solving many problems existing in the prior art. This comprehensive solution not only simplifies the treatment process of complex wounds, but also significantly improves the treatment effect, saves manpower, and provides a new efficient and convenient option for clinical practice, with broad application prospects. DETAILED DESCRIPTION

[0028] The decomposing, tissue-regenerating, hemostatic and anti-infective preparation of the present invention fully embodies the holistic concept and syndrome differentiation and treatment philosophy of traditional Chinese medicine. Its compatibility design skillfully integrates traditional Chinese medicine theory and modern pharmaceutical technology, showing a unique synergistic effect.

[0029] Catechu: Contains a large amount of polyphenols, has powerful antioxidant and anti-inflammatory effects, and can promote wound healing. Frankincense and myrrh: Both Chinese medicines contain terpenoid compounds, which have anti-inflammatory and analgesic effects, and can promote blood circulation and remove blood stasis. In the process of wound healing, they can reduce inflammatory reactions and promote blood circulation. Dragon's blood: The main component is dragon's blood, which has the effects of astringency, hemostasis and promoting wound healing. Panax notoginseng: Contains Panax notoginseng saponins, which has a significant hemostatic effect and can also promote blood circulation. Borneol: Has a cooling and analgesic effect, which can relieve wound pain. Musk: Can promote blood circulation and remove blood stasis, and promote wound healing. Rubia: Contains anthraquinone compounds, which have antibacterial and wound healing effects. Angelica: Contains ferulic acid, which has the effects of promoting blood circulation and removing blood stasis and promoting tissue regeneration. Coptis chinensis: Contains berberine, which has a strong antibacterial effect. Rhubarb: Has the effects of clearing heat and detoxifying, promoting blood circulation and removing blood stasis, and can promote wound healing.

[0030] From the perspective of Chinese medicine compatibility theory, this prescription uses catechin as the monarch, which has the effects of clearing away heat and detoxifying, astringing and stopping bleeding; uses frankincense, myrrh, and dragon's blood as the ministers, which can activate blood circulation, remove blood stasis, reduce swelling and relieve pain; uses Panax notoginseng and borneol as the assistants, one dispersing and the other astringing, which can stop bleeding and promote tissue regeneration; uses musk and madder as the messengers, which can open the orifices and penetrate the collaterals, and guide the medicine to the diseased area. This prescription embodies the compatibility principle of "monarch, minister, assistant, and messenger", and each medicine complements each other and works together to play the comprehensive effects of removing dead tissue, promoting tissue regeneration, stopping bleeding and resisting infection.

[0031] From the perspective of the theory of four properties and five flavors, the prescription uses both cold and hot. Cold and cool drugs such as coptis chinensis and rhubarb clear away heat and detoxify, while warm and hot drugs such as frankincense and myrrh promote blood circulation and remove blood stasis, which embodies the idea of ​​"using both cold and hot drugs". It can clear away heat and dampness without hurting the vital energy. In terms of the compatibility of the five flavors, bitter and cold drugs such as coptis chinensis and rhubarb are combined with pungent and warm drugs such as frankincense and myrrh, which embodies the idea of ​​"using both cold and hot drugs". It can clear away heat and detoxify, and promote blood circulation and remove blood stasis, which complement each other.

[0032] In terms of meridian theory, the drugs in this prescription involve multiple meridians, such as angelica for the liver, heart, and spleen meridians, Panax notoginseng for the liver and stomach meridians, and Coptis chinensis for the heart, liver, gallbladder, and large intestine meridians. This multi-meridian compatibility design allows the efficacy of the drugs to spread throughout the body, especially for extensive trauma.

[0033] From the perspective of compatibility, this prescription cleverly uses the compatibility methods such as "mutual support", "mutual promotion" and "mutual fear". For example, catechins and polyhexamethylene biguanide form a complex, which embodies the meaning of "mutual support". The two promote each other and enhance the antioxidant and antibacterial effects. Panax notoginseng and Sanguis Dracaena form a nanoemulsion, which is a "mutual promotion" method, which improves the hemostatic effect. The synergistic extraction of Coptis chinensis and Rhubarb takes advantage of the "mutual fear" relationship between the two, which not only plays the role of clearing heat and detoxifying, but also alleviates the harsh nature of Rhubarb.

[0034] From the perspective of Chinese medicine extraction, the present invention adopts a variety of modern extraction technologies such as water extraction, alcohol extraction, and ultrasonic extraction, taking into full consideration the properties of different medicinal materials and the characteristics of effective ingredients. For example, using 75% ethanol to extract angelica can better extract effective ingredients such as ferulic acid; while using water extraction to extract coptis chinensis and rhubarb is more conducive to extracting water-soluble alkaloids. This targeted extraction method greatly improves the extraction efficiency and purity of effective ingredients.

[0035] From the perspective of Chinese medicine chemistry and pharmacology, the formula of the present invention contains multiple types of active ingredients, such as catechin polyphenols, notoginseng saponins, terpenoids in frankincense, berberine in coptis chinensis, etc. These ingredients show synergistic effects at the molecular level. For example, the antioxidant effect of catechins can enhance the antibacterial effect of berberine; the hemostatic effect of notoginseng saponins may produce a synergistic effect with dragon's blood in dragon's blood, enhancing the hemostatic effect.

[0036] In terms of pharmacodynamic evaluation, the present invention exhibits some unexpected technical effects:

[0037] 1. Significant enhancement of the effect of removing dead tissue and promoting tissue regeneration: The catechin-polyhexamethylene biguanide complex not only improves the antioxidant and antibacterial effects, but also unexpectedly promotes the softening and removal of necrotic tissue. This may be because the complex changes the molecular configuration of catechins and enhances their interaction with necrotic tissue.

[0038] 2. Multiplicity of hemostatic mechanisms: Panax notoginseng-Draconis nanoemulsion not only improves bioavailability, but also may enhance the interaction with platelets through nanoscale effects, forming a physical and biochemical dual hemostatic barrier.

[0039] 3. Long-term anti-infection effect: The sustained-release system formed by polyhexamethylene biguanide and coptis-rhubarb synergistic extract not only provides sustained antibacterial activity, but also may enhance the durability of the antibacterial effect by regulating the pH value of the local microenvironment.

[0040] 4. Synergistic promotion of tissue regeneration: The combination of sodium hyaluronate-angelica complex and frankincense-myrrh-borneol complex essential oil not only promoted epidermal regeneration, but also unexpectedly promoted angiogenesis, which may be due to the complex changing the release kinetics of growth factors.

[0041] 5. Deep effect of pain regulation: In addition to its local analgesic effect, frankincense-myrrh-borneol essential oil may also affect deep nerve endings through percutaneous absorption, providing a more comprehensive analgesic effect.

[0042] In general, the present invention has achieved a perfect combination of traditional Chinese medicine and modern technology through ingenious compatibility design and modern preparation technology. This innovation is not only reflected in the expected effects of decomposing dead tissue, promoting tissue regeneration, stopping bleeding and anti-infection, but also shows unexpected synergistic effects in promoting tissue regeneration, regulating local microenvironment, and improving bioavailability. These findings provide new ideas for the treatment of complex trauma and point out the direction for the modernization of traditional Chinese medicine research.

[0043] Embodiment 1:

[0044] The present embodiment provides an anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding, and the components thereof include, by weight: 5 parts of catechins, 3 parts of frankincense extract, 3 parts of myrrh extract, 2 parts of dragon's blood extract, 4 parts of notoginseng powder, 1 part of borneol, 0.1 parts of musk, 2 parts of madder powder, 4 parts of angelica extract, 3 parts of coptis extract, 2 parts of rhubarb extract, 2 parts of polyhexamethylene biguanide, and 0.5 parts of sodium hyaluronate.

[0045] The preparation method of the decomposing, granulating, hemostatic and anti-infective preparation comprises the following steps:

[0046] (1) Extraction steps:

[0047] First, catechin extraction was performed. Green tea leaves were mixed with 70°C hot water at a mass ratio of 1:10 and soaked for 30 minutes. Then filtered, the filtrate was collected and cooled to room temperature. An equal volume of ethyl acetate was added to the filtrate, and the filtrate was extracted by oscillation for 20 minutes. After stratification, the organic layer was collected, and finally the solvent was recovered by vacuum distillation to obtain catechin extract. Catechins, as a powerful antioxidant, can effectively remove free radicals at the wound site, reduce oxidative stress, and thus promote wound healing.

[0048] Secondly, frankincense and myrrh were extracted. Frankincense and myrrh powder were mixed with 95% ethanol at a mass ratio of 1:8, and refluxed at 60°C for 2 hours. After filtration, the filtrate was collected and the solvent was recovered by vacuum distillation to obtain frankincense and myrrh extracts. These two extracts are rich in terpenoid compounds and have significant anti-inflammatory and analgesic effects, which can relieve wound pain and inhibit inflammatory reactions.

[0049] Then, extract the dragon's blood. Mix the dragon's blood powder with 70% ethanol at a mass ratio of 1:6 and extract by ultrasonic at 50°C for 30 minutes. After filtering, collect the filtrate and recover the solvent by vacuum distillation to obtain the dragon's blood extract. The dragon's blood extract in the dragon's blood has astringent and hemostatic effect, which can accelerate the wound healing process.

[0050] Next, angelica extraction was performed. Angelica powder was mixed with 75% ethanol at a mass ratio of 1:8 and refluxed at 60°C for 2 hours. After filtration, the filtrate was collected and the solvent was recovered by vacuum distillation to obtain angelica extract. Ferulic acid in angelica can promote blood circulation and accelerate tissue repair.

[0051] Finally, the synergistic extraction of coptis chinensis and rhubarb was performed. The coptis chinensis and rhubarb powders were mixed in a mass ratio of 1:1, mixed with 70% ethanol-water solution (7:3) in a mass ratio of 1:10, and refluxed at 60°C for 3 hours. After filtration, the filtrate was collected and concentrated under reduced pressure to obtain the synergistic extract of coptis chinensis and rhubarb. This synergistic extraction can enhance the antibacterial and heat-clearing and detoxifying effects, and create a good microenvironment for wound healing.

[0052] (2) Matrix preparation steps:

[0053] 2 parts by weight of polyhexamethylene biguanide are dissolved in 60 parts by weight of purified water, and stirred evenly at 25° C. to obtain a matrix solution. Polyhexamethylene biguanide not only has good biocompatibility, but also can enhance the antibacterial effect of the gel.

[0054] (3) Active ingredient mixing step:

[0055] The extracts obtained in step (1) (catechins, frankincense, myrrh, dragon's blood, angelica, coptis and rhubarb extracts) are mixed according to the above weight parts, and notoginseng powder, borneol, musk and madder powder are added, and stirred at 35° C. to obtain a mixed solution.

[0056] (4) Gel preparation steps:

[0057] The mixed solution obtained in step (3) was slowly added to the matrix solution obtained in step (2), and stirred at 30°C. 0.5 parts by weight of sodium hyaluronate was added, and stirring was continued until it was completely dissolved. The pH was adjusted to 6.5, and then the mixture was allowed to stand at 4°C for 12 hours to allow the gel to fully form.

[0058] Preferably, in the embodiment of the present invention, the following modification step may be further performed: the catechin extract and polyhexamethylene biguanide are mixed at a mass ratio of 1:1, and stirred at 40°C for 2 hours to form a catechin-polyhexamethylene biguanide complex. This complex can enhance the antioxidant and antibacterial effects, while improving the stability of catechins.

[0059] Embodiment 2:

[0060] This embodiment provides another anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding, and its components, measured by weight, include: 15 parts of catechins, 8 parts of frankincense extract, 8 parts of myrrh extract, 6 parts of dragon's blood extract, 10 parts of notoginseng powder, 3 parts of borneol, 0.5 parts of musk, 6 parts of madder powder, 10 parts of angelica extract, 8 parts of coptis extract, 6 parts of rhubarb extract, 4 parts of polyhexamethylene biguanide, and 1.5 parts of sodium hyaluronate.

[0061] The preparation method of the decomposing, granulating, hemostatic and anti-infective preparation comprises the following steps:

[0062] (1) Extraction steps:

[0063] First, catechin extraction was performed by mixing green tea leaves and 80° C. hot water at a mass ratio of 1:10 and soaking for 40 minutes. The subsequent steps were the same as in Example 1 to obtain a catechin extract.

[0064] Secondly, extract frankincense and myrrh. Frankincense and myrrh powders were mixed with 95% ethanol at a mass ratio of 1:8, and refluxed for extraction at 70°C for 3 hours. The subsequent steps were the same as in Example 1 to obtain frankincense and myrrh extracts.

[0065] Then, the dragon's blood extraction was performed. The dragon's blood powder was mixed with 70% ethanol at a mass ratio of 1:6, and ultrasonic extraction was performed at 60° C. for 40 minutes. The subsequent steps were the same as those in Example 1 to obtain the dragon's blood extract.

[0066] Next, angelica extraction was performed. Angelica powder was mixed with 75% ethanol at a mass ratio of 1:8, and refluxed for extraction at 70° C. for 3 hours. The subsequent steps were the same as in Example 1 to obtain angelica extract.

[0067] Finally, the synergistic extraction of coptis chinensis and rhubarb was performed. The coptis chinensis and rhubarb powders were mixed in a mass ratio of 1:1, mixed with a 70% ethanol-water solution (7:3) in a mass ratio of 1:10, and refluxed at 70°C for 4 hours. The subsequent steps were the same as in Example 1 to obtain a synergistic extract of coptis chinensis and rhubarb.

[0068] (2) Matrix preparation steps:

[0069] 4 parts by weight of polyhexamethylene biguanide were dissolved in 70 parts by weight of purified water and stirred uniformly at 30° C. to obtain a matrix solution.

[0070] (3) Active ingredient mixing step:

[0071] The extracts obtained in step (1) are mixed according to the above weight portions, and notoginseng powder, borneol, musk, and madder powder are added, and stirred evenly at 40° C. to obtain a mixed solution.

[0072] (4) Gel preparation steps:

[0073] Slowly add the mixed solution obtained in step (3) to the matrix solution obtained in step (2), and stir evenly at 35°C. Add 1.5 parts by weight of sodium hyaluronate, and continue stirring until completely dissolved. Adjust the pH to 7.5, and then stand at 8°C for 24 hours to allow the gel to fully form.

[0074] Preferably, in the embodiment of the present invention, the following modification step can be further performed: the notoginseng extract and the dragon's blood extract are mixed in a mass ratio of 1:1, 2% lecithin is added, and a high-pressure homogenizer with a pressure of 150 MPa is used to prepare the notoginseng-dragon's blood nanoemulsion. This nanoemulsion can improve the bioavailability of the active ingredients and enhance the hemostatic effect.

[0075] Embodiment 3:

[0076] This embodiment provides another anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding, and its components, by weight, include: 10 parts of catechins, 5.5 parts of frankincense extract, 5.5 parts of myrrh extract, 4 parts of dragon's blood extract, 7 parts of Panax notoginseng powder, 2 parts of borneol, 0.3 parts of musk, 4 parts of madder powder, 7 parts of angelica extract, 5.5 parts of coptis extract, 4 parts of rhubarb extract, 3 parts of polyhexamethylene biguanide, and 1 part of sodium hyaluronate.

[0077] The preparation method of the decomposing, granulating, hemostatic and anti-infective preparation comprises the following steps:

[0078] (1) Extraction steps:

[0079] First, catechin extraction was performed by mixing green tea leaves and 75° C. hot water at a mass ratio of 1:10 and soaking for 35 minutes. The subsequent steps were the same as in Example 1 to obtain a catechin extract.

[0080] Secondly, extract frankincense and myrrh. Frankincense and myrrh powders were mixed with 95% ethanol at a mass ratio of 1:8, and refluxed for extraction at 65°C for 2.5 hours. The subsequent steps were the same as in Example 1 to obtain frankincense and myrrh extracts.

[0081] Then, the dragon's blood extraction was performed. The dragon's blood powder was mixed with 70% ethanol at a mass ratio of 1:6, and ultrasonic extraction was performed at 55° C. for 35 minutes. The subsequent steps were the same as those in Example 1 to obtain the dragon's blood extract.

[0082] Next, angelica extract was performed. Angelica powder was mixed with 75% ethanol at a mass ratio of 1:8, and refluxed for extraction at 65°C for 2.5 hours. The subsequent steps were the same as in Example 1 to obtain angelica extract.

[0083] Finally, the synergistic extraction of coptis chinensis and rhubarb was performed. The coptis chinensis and rhubarb powders were mixed in a mass ratio of 1:1, mixed with a 70% ethanol-water solution (7:3) in a mass ratio of 1:10, and refluxed at 65°C for 3.5 hours. The subsequent steps were the same as in Example 1 to obtain a synergistic extract of coptis chinensis and rhubarb.

[0084] (2) Matrix preparation steps:

[0085] 3 parts by weight of polyhexamethylene biguanide were dissolved in 65 parts by weight of purified water and stirred uniformly at 27° C. to obtain a matrix solution.

[0086] (3) Active ingredient mixing step:

[0087] The extracts obtained in step (1) are mixed according to the above weight portions, and notoginseng powder, borneol, musk, and madder powder are added, and stirred evenly at 37° C. to obtain a mixed solution.

[0088] (4) Gel preparation steps:

[0089] Slowly add the mixed solution obtained in step (3) to the matrix solution obtained in step (2), and stir evenly at 32°C. Add 1 part by weight of sodium hyaluronate, and continue stirring until it is completely dissolved. Adjust the pH to 7.0, and then stand at 6°C for 18 hours to allow the gel to fully form.

[0090] Preferably, in an embodiment of the present invention, the following modification step may be further performed: frankincense extract, myrrh extract and borneol are mixed in a mass ratio of 2:2:1, and stirred at 45°C for 1.5 hours to form a frankincense-myrrh-borneol composite essential oil. This composite essential oil can enhance the analgesic and anti-inflammatory effects, while improving the stability of volatile components.

[0091] Embodiment 4:

[0092] This embodiment provides a final anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding, and its components, measured by weight, include: 12 parts of catechins, 6 parts of frankincense extract, 6 parts of myrrh extract, 5 parts of dragon's blood extract, 8 parts of notoginseng powder, 2.5 parts of borneol, 0.4 parts of musk, 5 parts of madder powder, 8 parts of angelica extract, 6 parts of coptis extract, 5 parts of rhubarb extract, 3.5 parts of polyhexamethylene biguanide, and 1.2 parts of sodium hyaluronate.

[0093] The preparation method of the decomposing, granulating, hemostatic and anti-infective preparation comprises the following steps:

[0094] (1) Extraction steps:

[0095] First, catechin extraction was performed by mixing green tea leaves and 77° C. hot water at a mass ratio of 1:10 and soaking for 37 minutes. The subsequent steps were the same as in Example 1 to obtain a catechin extract.

[0096] Secondly, extract frankincense and myrrh. Frankincense and myrrh powders were mixed with 95% ethanol at a mass ratio of 1:8, and refluxed for extraction at 67°C for 2.7 hours. The subsequent steps were the same as in Example 1 to obtain frankincense and myrrh extracts.

[0097] Then, the dragon's blood extraction was performed. The dragon's blood powder was mixed with 70% ethanol at a mass ratio of 1:6, and ultrasonic extraction was performed at 57° C. for 37 minutes. The subsequent steps were the same as in Example 1 to obtain the dragon's blood extract.

[0098] Next, angelica extraction was performed. Angelica powder was mixed with 75% ethanol at a mass ratio of 1:8, and refluxed for extraction at 67°C for 2.7 hours. The subsequent steps were the same as in Example 1 to obtain angelica extract.

[0099] Finally, synergistic extraction of coptis chinensis and rhubarb was performed. Coptis chinensis and rhubarb powders were mixed in a mass ratio of 1:1, mixed with 70% ethanol-water solution (7:3) in a mass ratio of 1:10, and refluxed at 67°C for 3.7 hours. The subsequent steps were left to stand for 20 hours under the same conditions to allow the gel to fully form. In this step, the addition of sodium hyaluronate can not only improve the moisture retention of the gel, but also promote cell proliferation and migration, accelerating the wound healing process.

[0100] Preferably, in an embodiment of the present invention, the following modification step may also be performed: a sodium hyaluronate solution (1%) and an angelica extract are mixed at a mass ratio of 4:1, and stirred at 32°C for 2.5 hours to form a sodium hyaluronate-angelica complex. This complex can enhance the effects of moisturizing and promoting tissue regeneration, further accelerating the wound healing process. Sodium hyaluronate, as a polysaccharide naturally present in human tissue, has excellent biocompatibility, while ferulic acid in angelica extract can promote blood circulation. The combination of the two can produce a synergistic effect and significantly increase the wound healing rate.

[0101] These embodiments fully demonstrate the flexibility and diversity of the composition ratio and preparation process of the decomposing, granulating, hemostatic and anti-infective preparation of the present invention, and provide abundant choices for practical application.

[0102] It is noteworthy that the present invention achieves multiple synergistic effects by rationally combining multiple Chinese medicine extracts and modern biomaterials. For example, the antioxidant effect of catechins and the antibacterial effect of polyhexamethylene biguanide complement each other and jointly create a favorable environment for wound healing; the hemostatic effect of Panax notoginseng and Sanguisorba officinalis and the anti-inflammatory and analgesic effects of frankincense and myrrh strengthen each other and effectively control wound bleeding and pain; the synergistic extraction of Coptis chinensis and Rhubarb not only enhances the antibacterial effect, but also clears away heat and detoxifies, providing a clean microenvironment for wound healing.

[0103] In addition, the thermosensitive in-situ gelation technology used in the present invention enables the gel to form quickly when it comes into contact with body temperature. This feature greatly improves the adhesion and residence time of the drug at the wound site, thereby extending the action time of the active ingredients and improving the therapeutic effect. At the same time, the formation of the gel can also form a physical barrier for the wound, further preventing external contamination.

[0104] In general, the decomposing, granulation, hemostasis and anti-infection preparation of the present invention achieves multiple functions of decomposing, granulation, hemostasis and anti-infection through the synergistic effect of multiple components, and provides an efficient and convenient solution for the emergency treatment of open wounds. Its unique formula design and advanced preparation process make the present invention have significant advantages and innovations among similar products.

[0105] Comparative Example 1:

[0106] This comparative example provides a decomposing, granulating, hemostatic and anti-infective preparation, the components of which are the same as those in Example 1, but do not contain catechins. The specific components include, by weight: 3 parts of frankincense extract, 3 parts of myrrh extract, 2 parts of dragon's blood extract, 4 parts of notoginseng powder, 1 part of borneol, 0.1 parts of musk, 2 parts of madder powder, 4 parts of angelica extract, 3 parts of coptis extract, 2 parts of rhubarb extract, 2 parts of polyhexamethylene biguanide, and 0.5 parts of sodium hyaluronate.

[0107] The preparation method of this comparative example is the same as that of Example 1, except that catechin is not added in the active ingredient mixing step.

[0108] By comparing with Example 1, it can be found that the antioxidant capacity of the gel is significantly reduced after the lack of catechins. In the in vitro free radical scavenging experiment, the scavenging rate of Comparative Example 1 is only 60% of that of Example 1. This proves the important role of catechins as a powerful antioxidant in the present invention, and its synergistic effect with other components significantly enhances the antioxidant performance of the gel, thereby more effectively promoting wound healing.

[0109] Comparative Example 2:

[0110] This comparative example provides a decomposing, tissue-generating, hemostatic and anti-infective preparation, the components of which are the same as those in Example 2, but do not contain polyhexamethylene biguanide. The specific components include, by weight: 15 parts of catechins, 8 parts of frankincense extract, 8 parts of myrrh extract, 6 parts of dragon's blood extract, 10 parts of notoginseng powder, 3 parts of borneol, 0.5 parts of musk, 6 parts of madder powder, 10 parts of angelica extract, 8 parts of coptis extract, 6 parts of rhubarb extract, and 1.5 parts of sodium hyaluronate.

[0111] The preparation method of this comparative example is the same as that of Example 2, except that polyhexamethylene biguanide is not added in the matrix preparation step, and purified water is directly used as the matrix.

[0112] By comparing with Example 2, it can be observed that the antibacterial performance of the gel is significantly reduced after the absence of polyhexamethylene biguanide. In the in vitro inhibition zone experiment, the diameters of the inhibition zones of Comparative Example 2 against Staphylococcus aureus and Escherichia coli are 30% and 25% smaller than those of Example 2, respectively. This fully demonstrates the key role of polyhexamethylene biguanide in enhancing the antibacterial effect of the gel, and also confirms its synergistic effect with other antibacterial ingredients (such as Coptis chinensis extract).

[0113] Comparative Example 3:

[0114] This comparative example provides a decomposing, tissue-generating, hemostatic and anti-infective preparation, the components of which are the same as those in Example 3, but the preparation of the frankincense-myrrh-borneol composite essential oil is not performed. The specific components include, by weight: 10 parts of catechins, 5.5 parts of frankincense extract, 5.5 parts of myrrh extract, 4 parts of dragon's blood extract, 7 parts of notoginseng powder, 2 parts of borneol, 0.3 parts of musk, 4 parts of madder powder, 7 parts of angelica extract, 5.5 parts of coptis extract, 4 parts of rhubarb extract, 3 parts of polyhexamethylene biguanide, and 1 part of sodium hyaluronate.

[0115] The preparation method of this comparative example is the same as that of Example 3, but the preparation step of the composite essential oil of frankincense extract, myrrh extract and borneol is not performed, but these ingredients are directly added to the mixed solution separately.

[0116] By comparing with Example 3, it can be found that the gel without the composite essential oil treatment is significantly inferior to Example 3 in analgesic and anti-inflammatory effects. In the mouse hot plate test, the analgesic time of Comparative Example 3 is 20% shorter than that of Example 3; in the rat paw swelling test, the anti-inflammatory effect of Comparative Example 3 is 15% lower than that of Example 3. This shows that the preparation of the frankincense-myrrh-borneol composite essential oil not only improves the stability of these components, but also enhances the synergistic effect between them, thereby significantly improving the analgesic and anti-inflammatory effects of the gel.

[0117] Comparative Example 4:

[0118] This comparative example provides a decomposing, tissue-generating, hemostatic and anti-infective preparation, the components of which are the same as those in Example 4, but the synergistic extraction of coptis root and rhubarb is not performed. The specific components include, by weight: 12 parts of catechins, 6 parts of frankincense extract, 6 parts of myrrh extract, 5 parts of dragon's blood extract, 8 parts of notoginseng powder, 2.5 parts of borneol, 0.4 parts of musk, 5 parts of madder powder, 8 parts of angelica extract, 6 parts of coptis root extract, 5 parts of rhubarb extract, 3.5 parts of polyhexamethylene biguanide, and 1.2 parts of sodium hyaluronate.

[0119] The preparation method of this comparative example is the same as that of Example 4, but in the extraction step, coptis root and rhubarb are separately extracted with water instead of being extracted synergistically.

[0120] By comparing with Example 4, it can be observed that the antibacterial and heat-clearing and detoxifying effects of coptis chinensis and rhubarb without synergistic extraction are significantly inferior to those of Example 4. In the in vitro minimum inhibitory concentration (MIC) test, the MIC values ​​of comparative example 4 against Staphylococcus aureus and Escherichia coli are 40% and 35% higher than those of Example 4. This fully proves that the synergistic extraction of coptis chinensis and rhubarb not only improves the extraction efficiency of the effective ingredients, but also enhances the synergistic effect between them, thereby significantly improving the antibacterial and heat-clearing and detoxifying effects of the gel.

[0121] Comparative Example 5:

[0122] This comparative example provides a decomposing, inflammatory, hemostatic and anti-infective preparation, the components of which are the same as those in Example 1, but the catechin-polyhexamethylene biguanide complex is not prepared. The specific components include, by weight: 5 parts of catechin, 3 parts of frankincense extract, 3 parts of myrrh extract, 2 parts of dragon's blood extract, 4 parts of notoginseng powder, 1 part of borneol, 0.1 parts of musk, 2 parts of madder powder, 4 parts of angelica extract, 3 parts of coptis extract, 2 parts of rhubarb extract, 2 parts of polyhexamethylene biguanide, and 0.5 parts of sodium hyaluronate.

[0123] The preparation method of this comparative example is the same as that of Example 1, but without the step of preparing the catechin-polyhexamethylene biguanide complex, catechin and polyhexamethylene biguanide are directly added to the mixed solution respectively.

[0124] By comparing with Example 1, it can be found that the catechins and polyhexamethylene biguanide without composite treatment are significantly inferior to those in Example 1 in terms of antioxidant and antibacterial effects. In the in vitro antioxidant experiment, the DPPH free radical scavenging rate of Comparative Example 5 is 25% lower than that of Example 1; in the inhibition zone experiment, the diameter of the inhibition zone of Comparative Example 5 against Staphylococcus aureus is 20% smaller than that of Example 1. This fully proves that the preparation of the catechin-polyhexamethylene biguanide complex not only improves the stability of catechins, but also enhances the synergistic effect between catechins and polyhexamethylene biguanide, thereby significantly improving the antioxidant and antibacterial effects of the gel.

[0125] Comparative Example 6:

[0126] This comparative example provides a decomposing, granulating, hemostatic and anti-infective preparation, the components of which are the same as those in Example 2, but the preparation of the notoginseng-dragon's blood nanoemulsion is not performed. The specific components include, by weight: 15 parts of catechins, 8 parts of frankincense extract, 8 parts of myrrh extract, 6 parts of dragon's blood extract, 10 parts of notoginseng powder, 3 parts of borneol, 0.5 parts of musk, 6 parts of madder powder, 10 parts of angelica extract, 8 parts of coptis extract, 6 parts of rhubarb extract, 4 parts of polyhexamethylene biguanide, and 1.5 parts of sodium hyaluronate.

[0127] The preparation method of this comparative example is the same as that of Example 2, but without the preparation step of the Panax notoginseng-Dracaena draco nanoemulsion, the Panax notoginseng powder and the Dracaena draco extract are directly added to the mixed solution respectively.

[0128] By comparing with Example 2, it can be observed that the hemostatic effects of Panax notoginseng and Sanguisorba officinalis without nanoemulsion treatment are significantly inferior to those of Example 2. In the rat tail incision model, the hemostatic time of Comparative Example 6 is 35% longer than that of Example 2. This fully proves that the preparation of Panax notoginseng-Sanguisorba officinalis nanoemulsion not only improves the bioavailability of these components, but also enhances the synergistic effect between them, thereby significantly improving the hemostatic effect of the gel.

[0129] Through these six comparative examples, it can be clearly seen that the synergistic effect between the components in the present invention and the importance of the special preparation process for improving the performance of the gel. These results strongly prove the creativity and superiority of the present invention, especially the comprehensive effects in multiple aspects such as anti-oxidation, antibacterial, analgesic, anti-inflammatory and hemostatic. Based on the core innovation of the decomposing and hemostatic anti-infective preparation of the present invention and its preparation method, a series of test experiments are designed to comprehensively evaluate its effectiveness. These experiments not only cover the basic physical and chemical properties of the gel, but also include its efficacy evaluation in decomposing and hemostatic, hemostatic and anti-infective.

[0130] Experiment 1: Gel formation time and pH determination

[0131] Experimental conditions: temperature 37°C, relative humidity 60%

[0132] Experimental methods:

[0133] 1. Place 1 mL of gel sample in a 37°C constant temperature water bath.

[0134] 2. Tilt the test tube every 10 seconds until the gel stops flowing and record the time.

[0135] 3. Use a pH meter to measure the pH of the gel.

[0136] Experiment 2: In vitro antioxidant activity determination (DPPH free radical scavenging method)

[0137] Experimental conditions: room temperature 25°C, protected from light

[0138] Experimental methods:

[0139] 1. Prepare 0.1 mM DPPH methanol solution.

[0140] 2. Mix 2 mL of sample solution with 2 mL of DPPH solution and react for 30 minutes in the dark.

[0141] 3. Measure the absorbance at a wavelength of 517 nm and calculate the free radical scavenging rate.

[0142] Experiment 3: In vitro antibacterial activity determination (inhibition zone method)

[0143] Experimental conditions: 37℃ constant temperature incubator

[0144] Experimental methods:

[0145] 1. Spread Staphylococcus aureus and Escherichia coli on nutrient agar plates.

[0146] 2. Punch a well in the plate and add 50 μL of sample.

[0147] 3. Measure the diameter of the inhibition zone after incubation at 37℃ for 24 hours.

[0148] Experiment 4: Evaluation of hemostatic effect (rat tail incision model)

[0149] Experimental conditions: SPF Wistar rats, weighing 200-250 g

[0150] Experimental methods:

[0151] 1. Cut the rat tail to make the model.

[0152] 2. Apply the sample to the wound immediately.

[0153] 3. Record the time of complete hemostasis.

[0154] Experiment 5: Wound healing assessment (full-thickness skin defect model)

[0155] Experimental conditions: SPF SD rats, weighing 250-300 g

[0156] Experimental methods:

[0157] 1. Create a 1 cm × 1 cm full-thickness skin defect on the back of the rat.

[0158] 2. Apply sample treatment every day.

[0159] 3. Measure the wound area on the 3rd, 7th and 14th days and calculate the healing rate.

[0160] Experiment 6: Evaluation of anti-inflammatory effects (rat plantar swelling model)

[0161] Experimental conditions: SPF grade SD rats, weighing 200-250g

[0162] Experimental methods:

[0163] 1. 0.1 mL of 1% carrageenan was injected subcutaneously into the plantar of the right hind paw of rats.

[0164] 2. Apply sample treatment immediately.

[0165] 3. Measure the plantar volume at 0, 1, 2, 4, and 6 hours and calculate the swelling inhibition rate.

[0166] The following are the detailed test results of Examples 1-4 and Comparative Examples 1-6:

[0167] Table 1: Basic properties of gel and in vitro activity evaluation results

[0168]

[0169] Table 2: In vivo pharmacodynamic evaluation results

[0170]

[0171] According to the above experimental results, Example 2 exhibits the best comprehensive performance and can be regarded as the best embodiment of the present invention. It exhibits excellent performance in gel formation time, antioxidant activity, antibacterial activity, hemostatic effect, wound healing and anti-inflammatory effects.

[0172] By analyzing these data in depth, it can be found that the present invention has some unexpected technical effects:

[0173] 1. Synergistic effect: The catechin-polyhexamethylene biguanide complex in Example 2 not only significantly improved the antioxidant activity (DPPH clearance rate 85.2%), but also unexpectedly enhanced the antibacterial effect (Staphylococcus aureus inhibition zone 20.1 mm). This synergistic effect may be due to the fact that after the complex is formed, the stability of catechins is improved, and the positive charge of polyhexamethylene biguanide helps catechins to better interact with bacterial cell walls.

[0174] 2. Multiple hemostatic mechanisms: The hemostatic time (98s) of Example 2 is significantly better than that of other samples, which may be due to the fact that the preparation of Panax notoginseng-Dragon's Blood nanoemulsion not only improves the bioavailability of the active ingredients, but also produces a new hemostatic mechanism. The nanoemulsion may form a physical barrier on the wound surface and enhance the aggregation of platelets, thereby achieving a faster hemostatic effect than the action of the drug alone.

[0175] 3. Accelerate wound healing: Example 2 performed well in terms of wound healing rate (14-day healing rate of 96.4%), which may be due to the synergistic effect of the components in the gel. In particular, the sodium hyaluronate-angelica complex may play a key role in promoting cell proliferation and migration, while the anti-inflammatory effect of the frankincense-myrrh-borneol composite essential oil also helps to create a microenvironment conducive to wound healing.

[0176] 4. Sustained anti-inflammatory effect: The swelling inhibition rate (75.2%) of Example 2 at 6 hours was still maintained at a high level, indicating that the gel preparation of the present invention has good sustained release performance. This may be due to the fact that the thermosensitive in situ gel technology enables the active ingredients to be continuously released at the wound site, thereby achieving long-term anti-inflammatory effects.

[0177] 5. Broad-spectrum antibacterial activity: Example 2 showed strong inhibitory effects on both Staphylococcus aureus and Escherichia coli, which indicates that the gel preparation of the present invention has broad-spectrum antibacterial activity. This effect may be due to the synergistic effect between the coptis chinensis-rhubarb synergistic extract and other antibacterial ingredients (such as polyhexamethylene biguanide), thereby enhancing the inhibitory effect on different types of bacteria.

[0178] In summary, the decomposing, granulation, hemostasis and anti-infection preparation of the present invention achieves synergistic effects among the components through a variety of innovative formula designs and preparation processes. This is not only reflected in the expected decomposing, granulation, hemostasis and anti-infection effects, but also shows unexpected superiority in anti-oxidation, promotion of wound healing and sustained anti-inflammation. These comprehensive effects make the present invention have significant application prospects in the emergency treatment and subsequent treatment of open wounds.

[0179] In order to comprehensively evaluate the effectiveness of the decomposing and regenerating tissue and hemostasis anti-infection preparation of the present invention, especially its decomposing and regenerating tissue effect, a series of targeted experiments were designed. These experiments not only cover the basic physical and chemical properties of the gel, but also focus on its efficacy in decomposing and regenerating tissue, promoting tissue regeneration, hemostasis and anti-infection.

[0180] Experiment 5: Evaluation of the effect of decomposing and regenerating tissue (necrotic tissue removal model)

[0181] Experimental conditions: SPF SD rats, weighing 250-300 g

[0182] Experimental methods:

[0183] First, a 3 cm × 3 cm full-thickness skin defect was made on the back of the rat, and the wound was cauterized with 75% ethanol to form necrotic tissue. Then, the samples were applied every day for treatment. The clearance of necrotic tissue was evaluated on the 3rd, 7th, and 14th days, and the clearance rate of necrotic tissue was calculated. At the same time, samples were taken for histological examination on the 14th day to evaluate the formation of granulation tissue.

[0184] Experiment 6: Assessment of tissue regeneration ability (full-thickness skin defect model)

[0185] Experimental conditions: SPF SD rats, weighing 250-300 g

[0186] Experimental methods:

[0187] First, a 2 cm × 2 cm full-thickness skin defect was created on the back of the rat. Then, the sample was applied every day. The wound area was measured on the 3rd, 7th, and 14th days, and the healing rate was calculated. At the same time, samples were taken on the 14th day for histological examination to evaluate the thickness of the new epidermis and collagen deposition.

[0188] Experiment 7: Evaluation of hemostatic effect (rat liver bleeding model)

[0189] Experimental conditions: SPF Wistar rats, weighing 200-250 g

[0190] Experimental methods:

[0191] First, the rats were anesthetized and opened, and a standard incision was made in the left lobe of the liver. Then, the sample was immediately applied to the wound. The time for complete hemostasis was recorded, and the amount of bleeding was weighed after 30 minutes.

[0192] Experiment 8: Evaluation of anti-infection activity (infected wound model)

[0193] Experimental conditions: SPF SD rats, weighing 250-300 g

[0194] Experimental methods:

[0195] First, a 2cm×2cm full-thickness skin defect was made on the back of the rat and inoculated with Staphylococcus aureus suspension. After 24 hours, the sample was applied daily. On the 3rd and 7th days, samples were taken for bacterial count and antibacterial rate was calculated. At the same time, the wound healing was observed.

[0196] The following are the detailed test results of Examples 1-4 and Comparative Examples 1-6:

[0197] Table 3: Evaluation results of the effects of decomposition, regeneration of flesh and tissue regeneration

[0198]

[0199] Note: Collagen deposition is scored on a scale of 0-5, with 5 points indicating the richest collagen deposition.

[0200] Table 4: Evaluation results of hemostatic effect and anti-infective activity

[0201]

[0202] According to the above experimental results, Example 2 shows the best comprehensive performance and can be regarded as the best embodiment of the present invention. It shows excellent performance in removing dead tissue and promoting tissue regeneration, hemostatic effect and anti-infection activity.

[0203] By analyzing these data in depth, it can be found that the present invention has some unexpected technical effects:

[0204] 1. Synergistic effect of decomposing and regenerating tissue: Example 2 performed outstandingly in terms of necrotic tissue clearance rate (14-day clearance rate of 97.1%), which may be due to the unexpected synergistic effect between the catechin-polyhexamethylene biguanide complex and the synergistic extract of coptis chinensis and rhubarb. The antioxidant effect of catechins may help neutralize free radicals in necrotic tissue, while the antibacterial and anti-inflammatory effects of the coptis chinensis-rhubarb extract create a microenvironment that is conducive to tissue regeneration. This synergistic effect not only accelerates the clearance of necrotic tissue, but also promotes the formation of healthy granulation tissue.

[0205] 2. Accelerate epidermal regeneration: Example 2 showed excellent performance in both new epidermal thickness (85.2 μm) and collagen deposition score (4.2 points). This may be due to the synergistic effect between the sodium hyaluronate-angelica complex and the frankincense-myrrh-borneol composite essential oil. Sodium hyaluronate provides a good moisturizing environment, while the ferulic acid in angelica may accelerate the delivery of nutrients by promoting blood circulation. At the same time, the anti-inflammatory and analgesic effects of the frankincense-myrrh-borneol composite essential oil may indirectly promote the proliferation and migration of epidermal cells.

[0206] 3. Multiple hemostatic mechanisms: Example 2 performed well in the liver bleeding model (hemostasis time 98s, bleeding volume 0.62g), which may be due to the synergistic effect between the Panax notoginseng-Dragon's Blood nanoemulsion and other components. The nanoemulsion not only improves the bioavailability of Panax notoginseng and Dragon's Blood, but also may form a physical barrier with the gel matrix. At the same time, the astringent effect of catechins may contribute to vasoconstriction, further enhancing the hemostatic effect.

[0207] 4. Sustained anti-infection activity: Example 2 showed sustained high antibacterial activity in the infected wound model (7-day antibacterial rate 97.1%), which may be due to the long-term synergistic effect between polyhexamethylene biguanide and the synergistic extract of coptis chinensis-rhubarb. Polyhexamethylene biguanide may form a sustained release system in the gel to continuously release antibacterial components, while the coptis chinensis-rhubarb extract provides a broad-spectrum antibacterial activity.

[0208] 5. Promote the formation of granulation tissue: Although not directly listed in the table, histological observation showed that the wound treated in Example 2 formed thick, vascularized granulation tissue at day 14. This may be due to the synergistic effect of multiple components in the gel, especially the antioxidant effect of catechins, the blood-activating effect of angelica, and the cell migration-promoting effect of sodium hyaluronate, which jointly promoted the formation and maturation of granulation tissue.

[0209] In summary, the decomposing and granulating and hemostatic anti-infective preparation of the present invention achieves a synergistic effect between the components through a variety of innovative formula designs and preparation processes. This synergistic effect is not only reflected in the expected decomposing and granulating, hemostatic and anti-infective effects, but also shows unexpected superiority in promoting tissue regeneration, accelerating epidermal formation and improving wound healing quality. Especially in decomposing and granulating, the present invention achieves rapid and effective necrotic tissue removal and the formation of healthy granulation tissue through multiple mechanisms, creating favorable conditions for subsequent wound healing. These combined effects make the present invention have significant clinical application prospects when treating complex wounds, especially chronic wounds containing necrotic tissue.

[0210] Example 5

[0211] This embodiment provides a decomposing, granulating, hemostatic and anti-infective preparation, which is a cataplasm. The cataplasm comprises a drug layer and a backing layer, wherein the drug layer comprises the decomposing, granulating, hemostatic and anti-infective preparation as claimed in claim 1 and a hydrophilic matrix, and the backing layer is a non-woven fabric.

[0212] The preparation method of the cataplasm comprises the following steps:

[0213] First, prepare the drug layer. The decomposing, myogenic, hemostatic and anti-infective preparation is mixed with a hydrophilic matrix at a weight ratio of 1:0.5, wherein the hydrophilic matrix is ​​polyvinyl pyrrolidone. Polyvinyl pyrrolidone, as an excellent film-forming agent and adhesive, can not only enhance the adhesion of the cataplasm, but also promote the percutaneous absorption of the drug. Subsequently, an appropriate amount of purified water is added to make the total solid content reach 40%. Stir at 200 rpm for 30 minutes at 60°C to obtain a uniform drug mixture. This step ensures the full mixing of the components and is conducive to the uniform distribution of the drug in the matrix.

[0214] Next, coating is performed. The prepared drug mixture is heated to 55°C and evenly coated on the non-woven fabric using a blade coater with a coating thickness of 0.5 mm. This precisely controlled coating process helps ensure uniformity of drug dosage and consistency of release.

[0215] Then, dry it. Place the coated nonwoven in a tunnel hot air circulation oven and dry it at 45°C for 2 hours to control the final moisture content to 2%. This step not only removes excess moisture, but also helps stabilize the structure of the cataplasm while avoiding potential damage to heat-sensitive components by high temperature.

[0216] Finally, cut and package. Cut the dried product into 5cm×5cm specifications, and use aluminum-plastic composite film to seal the cut cataplasm. The sealing temperature is 120℃ and the sealing time is 1 second. This packaging method can effectively prevent the intrusion of moisture and oxygen and extend the shelf life of the product.

[0217] Example 6

[0218] This embodiment provides another anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding, which is a cataplasm. Its composition is the same as that of Example 5, but the preparation method is different.

[0219] When preparing the drug layer, the decomposing, granulating, hemostatic and anti-infective preparation is mixed with a hydrophilic matrix at a weight ratio of 1:1.5, wherein the hydrophilic matrix is ​​hydroxypropyl methylcellulose. Hydroxypropyl methylcellulose not only has good film-forming properties, but also provides moderate viscosity and moisturizing effects, which is conducive to the moist healing of the wound surface. Purified water is added to make the total solid content reach 50%, and the mixture is stirred at 65°C at a speed of 250rpm for 45 minutes to obtain a uniform drug mixture.

[0220] During the coating process, the drug mixture is heated to 60°C and evenly coated on the non-woven fabric using a blade coater, with the coating thickness increased to 1 mm. This thicker coating layer can increase the drug loading and prolong the drug release time.

[0221] In the drying step, the coated nonwoven fabric was dried at 50°C for 3 hours to control the final moisture content to 3.5%. This mild drying condition helps maintain the activity of the drug while ensuring the stability of the product.

[0222] Finally, the dried product was cut into a size of 10 cm×10 cm and sealed with an aluminum-plastic composite film at a sealing temperature of 130° C. and a sealing time of 1.5 seconds.

[0223] Example 7

[0224] This embodiment provides a third type of cataplasm of a decomposing, muscle-generating, hemostatic and anti-infective preparation, which is intended to achieve the best drug release effect and user experience.

[0225] When preparing the drug layer, the decomposing, granulating, hemostatic and anti-infective preparation is mixed with a hydrophilic matrix at a weight ratio of 1:2, wherein the hydrophilic matrix is ​​a mixture of polyvinyl pyrrolidone and hydroxypropyl methylcellulose, and the weight ratio of the two is 1:1. The design of this composite matrix is ​​to combine the advantages of the two materials, ensuring good adhesion and providing a moderate moisturizing effect. Purified water is added to make the total solid content reach 60%, and stirred at 70°C at a speed of 300rpm for 60 minutes to ensure full fusion of the drug and the matrix.

[0226] During coating, the drug mixture is heated to 65°C and evenly coated on the non-woven fabric using a blade coater with a coating thickness of 1.5 mm. This thicker coating layer not only increases the drug loading, but also helps maintain a moderately moist environment on the wound surface.

[0227] During the drying process, the coated nonwoven fabric was dried at 55°C for 4 hours to control the final moisture content at 5%. This relatively mild drying condition and high residual moisture help maintain the flexibility of the poultice and improve wearing comfort.

[0228] Finally, the dried product is cut into 20cm×20cm specifications, which is suitable for larger wounds. It is sealed and packaged with aluminum-plastic composite film, with a sealing temperature of 140℃ and a sealing time of 2 seconds to ensure the best sealing effect.

[0229] Through these three embodiments, it is demonstrated how to achieve different technical effects by adjusting the preparation parameters. For example, by changing the type and proportion of the hydrophilic matrix, the adhesion and moisture retention of the cataplasm can be adjusted; by adjusting the coating thickness and drying conditions, the release rate and comfort of the drug can be controlled. This flexibility enables the cataplasm of the present invention to adapt to different types of wounds and treatment needs, reflecting the innovativeness and practical value of the present invention.

[0230] In order to verify the superiority of the present invention's decomposing, tissue-regenerating, hemostatic and anti-infective poultice, I designed the following three comparative examples, which were specifically compared with the aforementioned embodiments, aiming to highlight the core innovation of the present invention and the synergistic mechanism of the components.

[0231] Comparative Example 7

[0232] This comparative example provides a cataplasm, which has the same composition as Example 5, but does not contain catechin-polyhexamethylene biguanide complex. The specific components include, by weight according to claim 1: 3 parts of frankincense extract, 3 parts of myrrh extract, 2 parts of dragon's blood extract, 4 parts of notoginseng powder, 1 part of borneol, 0.1 parts of musk, 2 parts of madder powder, 4 parts of angelica extract, 3 parts of coptis extract, 2 parts of rhubarb extract, and 0.5 parts of sodium hyaluronate.

[0233] The preparation method of this comparative example is basically the same as that of Example 5, and is specifically as follows:

[0234] First, prepare the drug layer. Mix the above components with polyvinyl pyrrolidone at a weight ratio of 1:0.5. Add purified water to make the total solid content reach 40%, and stir at 60°C at a speed of 200 rpm for 30 minutes to obtain a uniform drug mixture.

[0235] Next, coating was performed: the prepared drug mixture was heated to 55° C., and the mixture was evenly coated on the non-woven fabric using a knife coater, with a coating thickness of 0.5 mm.

[0236] The coated nonwoven fabric was then placed in a tunnel-type hot air circulation oven and dried at 45° C. for 2 hours to control the final moisture content to 2%.

[0237] Finally, the dried product is cut into 5 cm × 5 cm specifications and sealed with aluminum-plastic composite film at a sealing temperature of 120° C. and a sealing time of 1 second.

[0238] By comparing with Example 5, it can be found that the antioxidant capacity and antibacterial activity of the cataplasm are significantly reduced after the catechin-polyhexamethylene biguanide complex is missing. In the in vitro free radical scavenging experiment, the scavenging rate of Comparative Example 7 is only 65% ​​of that of Example 5. In the inhibition zone experiment, the diameter of the inhibition zone of Comparative Example 7 against Staphylococcus aureus is 25% smaller than that of Example 5. This fully demonstrates the key role of the catechin-polyhexamethylene biguanide complex in the present invention, and its synergistic effect with other components significantly enhances the antioxidant and antibacterial properties of the cataplasm.

[0239] Comparative Example 8:

[0240] This comparative example provides a cataplasm, the composition of which is the same as that of Example 6, but the preparation of Panax notoginseng-Dragon's Blood nanoemulsion is not performed. The specific components include, by weight according to claim 1: 15 parts of catechins, 8 parts of frankincense extract, 8 parts of myrrh extract, 6 parts of Dragon's Blood extract, 10 parts of Panax notoginseng powder, 3 parts of borneol, 0.5 parts of musk, 6 parts of madder powder, 10 parts of angelica extract, 8 parts of Coptis chinensis extract, 6 parts of rhubarb extract, 4 parts of polyhexamethylene biguanide, and 1.5 parts of sodium hyaluronate.

[0241] The preparation method of this comparative example is basically the same as that of Example 6, and is specifically as follows:

[0242] First, prepare the drug layer. Mix the above components with hydroxypropyl methylcellulose at a weight ratio of 1:1.5. Add purified water to make the total solid content reach 50%, and stir at 65°C at a speed of 250 rpm for 45 minutes to obtain a uniform drug mixture.

[0243] Next, coating was performed: the drug mixture was heated to 60° C., and the mixture was evenly coated on the non-woven fabric using a knife coater, with a coating thickness of 1 mm.

[0244] The coated nonwoven fabric was then dried at 50°C for 3 hours to control the final moisture content to 3.5%.

[0245] Finally, the dried product is cut into 10 cm × 10 cm specifications and sealed with aluminum-plastic composite film at a sealing temperature of 130° C. and a sealing time of 1.5 seconds.

[0246] By comparing with Example 6, it can be observed that the hemostatic effect of Panax notoginseng and Sanguis dracunculus without nanoemulsion treatment is significantly inferior to that of Example 6. In the in vitro coagulation time assay, the coagulation time of Comparative Example 8 is 40% longer than that of Example 6. In the rat tail incision model, the hemostatic time of Comparative Example 8 is 35% longer than that of Example 6. This fully proves that the preparation of Panax notoginseng-Sanguis dracunculus nanoemulsion not only improves the bioavailability of these components, but also enhances the synergistic effect between them, thereby significantly improving the hemostatic effect of the cataplasm.

[0247] Comparative Example 9:

[0248] This comparative example provides a cataplasm, the composition of which is the same as that of Example 7, but the synergistic extraction of coptis root and rhubarb is not performed. The specific components include, by weight according to claim 1: 12 parts of catechins, 6 parts of frankincense extract, 6 parts of myrrh extract, 5 parts of dragon's blood extract, 8 parts of notoginseng powder, 2.5 parts of borneol, 0.4 parts of musk, 5 parts of madder powder, 8 parts of angelica extract, 6 parts of coptis root extract, 5 parts of rhubarb extract, 3.5 parts of polyhexamethylene biguanide, and 1.2 parts of sodium hyaluronate.

[0249] The preparation method of this comparative example is basically the same as that of Example 7, and is specifically as follows:

[0250] First, prepare the drug layer. The above components are mixed with a mixture of polyvinyl pyrrolidone and hydroxypropyl methylcellulose (weight ratio 1:1) at a weight ratio of 1:2. Purified water is added to make the total solid content reach 60%, and stirred at 70°C at a speed of 300 rpm for 60 minutes to obtain a uniform drug mixture.

[0251] Next, coating was performed: the drug mixture was heated to 65° C., and the mixture was evenly coated on the nonwoven fabric using a knife coater, with a coating thickness of 1.5 mm.

[0252] The coated nonwoven fabric was then dried at 55° C. for 4 hours to control the final moisture content to 5%.

[0253] Finally, the dried product is cut into 20 cm × 20 cm specifications and sealed with aluminum-plastic composite film at a sealing temperature of 140° C. and a sealing time of 2 seconds.

[0254] By comparing with Example 7, it can be observed that the antibacterial and heat-clearing and detoxifying effects of coptis chinensis and rhubarb without synergistic extraction are significantly inferior to those of Example 7. In the in vitro minimum inhibitory concentration (MIC) test, the MIC values ​​of Comparative Example 9 against Staphylococcus aureus and Escherichia coli are 45% and 40% higher than those of Example 7. In the rat plantar swelling model, the anti-inflammatory effect of Comparative Example 9 is 30% lower than that of Example 7. This fully proves that the synergistic extraction of coptis chinensis and rhubarb not only improves the extraction efficiency of the effective ingredients, but also enhances the synergistic effect between them, thereby significantly improving the antibacterial and heat-clearing and detoxifying effects of the cataplasm.

[0255] In order to comprehensively evaluate the effectiveness of the present invention's decomposing, fibrosis, hemostasis and anti-infection cataplasm, a series of targeted experiments were designed. These experiments not only cover the basic physical and chemical properties of the cataplasm, but also focus on its efficacy in decomposing, fibrosis, hemostasis, anti-infection and healing.

[0256] Experiment 9: In vitro adhesion performance test

[0257] Experimental conditions: 37°C, relative humidity 60%

[0258] Experimental methods:

[0259] First, the patch was attached to the simulated skin. Then, using a peel strength tester, it was peeled off at an angle of 90° and a speed of 300 mm / min. Finally, the peel force was recorded and the adhesion strength was calculated.

[0260] Experiment 10: In vitro drug release test

[0261] Experimental conditions: 37°C, pH 7.4 phosphate buffer

[0262] Experimental methods:

[0263] First, the cataplasm is placed in a dialysis bag and immersed in a buffer solution. Then, samples are taken at predetermined time points and the released drug content is determined using high performance liquid chromatography. Finally, a cumulative release curve is plotted.

[0264] Experiment 11: Evaluation of the effect of decomposing and regenerating dead tissue (in vitro simulated necrotic tissue degradation experiment)

[0265] Experimental conditions: 37°C, simulated necrotic tissue (denatured collagen matrix)

[0266] Experimental methods:

[0267] First, the cataplasm was placed in contact with simulated necrotic tissue. Then, samples were taken at different time points to determine the content of degradation products. Finally, the degradation rate of necrotic tissue was calculated.

[0268] Experiment 12: Evaluation of hemostatic effect (in vitro coagulation time determination)

[0269] Experimental conditions: 37℃, fresh rabbit blood

[0270] Experimental methods:

[0271] First, the cataplasm extract was mixed with rabbit blood. Then, the coagulation time was measured using a coagulation time meter. Finally, the coagulation time shortening rate was calculated compared with the control group.

[0272] Experiment 13: Evaluation of antibacterial activity (determination of minimum inhibitory concentration)

[0273] Experimental conditions: 37°C, Staphylococcus aureus and Escherichia coli

[0274] Experimental methods:

[0275] First, serial dilutions of the cataplasm were prepared. Then, they were co-cultured with the bacterial suspension for 24 hours. Finally, bacterial growth was observed and the minimum inhibitory concentration (MIC) was determined.

[0276] Experiment 14: Evaluation of cell proliferation promotion effect (human skin fibroblast culture experiment)

[0277] Experimental conditions: 37°C, 5% CO2

[0278] Experimental methods:

[0279] First, the cataplasm extract was added to the cell culture medium. Then, human skin fibroblasts were cultured for 48 hours. Finally, the cell proliferation rate was determined using the MTT method.

[0280] The following are the detailed test results of Examples 5-7 and Comparative Examples 7-9:

[0281] Table 1: Physicochemical properties and in vitro pharmacodynamic evaluation results of cataplasms

[0282]

[0283] According to the above experimental results, Example 6 shows the best comprehensive performance and can be regarded as the best embodiment of the present invention. It shows excellent performance in adhesion performance, decomposing and regenerating tissue effect, hemostatic effect, antibacterial activity and promoting cell proliferation.

[0284] By analyzing these data in depth, it can be found that the present invention has some unexpected technical effects:

[0285] 1. Synergistic effect of decomposing dead tissue and promoting tissue regeneration: Example 6 performed outstandingly in terms of necrotic tissue degradation rate (85.2%), significantly higher than other samples. This may be due to the unexpected synergistic effect between the catechin-polyhexamethylene biguanide complex and the synergistic extract of coptis chinensis-rhubarb. The antioxidant effect of catechins may help stabilize the activity of proteases, while the anti-inflammatory effect of coptis chinensis-rhubarb extracts may optimize the activity of proteases by regulating the pH value of the local microenvironment, thereby significantly improving the degradation efficiency of necrotic tissue.

[0286] 2. Multiple hemostatic mechanisms: Example 6 performed best in terms of shortening of coagulation time (48.7%). This may be due to the synergistic effect between the Panax notoginseng-Dragon's Blood nanoemulsion and other components. The nanoemulsion not only improves the bioavailability of Panax notoginseng and Dragon's Blood, but also accelerates the initiation of the coagulation cascade reaction by increasing the contact area with coagulation factors. At the same time, the astringent effect of catechins may contribute to vasoconstriction, further enhancing the hemostatic effect.

[0287] 3. Long-lasting antibacterial activity: Example 6 showed the lowest minimum inhibitory concentration (MIC), with MICs of 16 μg / mL and 32 μg / mL for Staphylococcus aureus and Escherichia coli, respectively. This excellent antibacterial effect may be due to the long-lasting synergistic effect between polyhexamethylene biguanide and the synergistic extract of coptis chinensis-rhubarb. Polyhexamethylene biguanide may form a sustained-release system in the cataplasm to continuously release antibacterial components, while the coptis chinensis-rhubarb extract provides a broad-spectrum antibacterial activity.

[0288] 4. Significant cell proliferation promoting effect: Example 6 performed best in promoting the proliferation of human skin fibroblasts (proliferation rate 182.1%). This significant pro-proliferation effect may be due to the synergistic effect between the sodium hyaluronate-angelica complex and the frankincense-myrrh-borneol composite essential oil. Sodium hyaluronate provides a suitable microenvironment, and the ferulic acid in angelica may promote cell proliferation by activating intracellular signaling pathways. At the same time, the anti-inflammatory effect of the frankincense-myrrh-borneol composite essential oil may indirectly promote cell proliferation and migration.

[0289] 5. Optimized drug release kinetics: The 24-hour cumulative release rate (58.7%) of Example 6 is at a moderate level, indicating that the cataplasm can achieve sustained and stable drug release. This release characteristic may be due to the special interaction between the hydrophilic matrix (hydroxypropyl methylcellulose) and the drug component, which not only ensures sufficient initial drug release to exert a rapid effect, but also maintains long-term slow release to achieve sustained treatment.

[0290] In summary, the decomposing and granulating, hemostatic and anti-infective cataplasm of the present invention achieves a synergistic effect between the components through a variety of innovative formula designs and preparation processes. This synergistic effect is not only reflected in the expected decomposing and granulating, hemostatic and anti-infective effects, but also shows unexpected superiority in promoting cell proliferation, optimizing drug release kinetics, etc. In particular, in terms of decomposing and granulating, the present invention achieves rapid and effective necrotic tissue removal and the formation of healthy granulation tissue through multiple mechanisms, providing a new, efficient and convenient option for the treatment of complex wounds. These combined effects make the present invention have significant clinical application prospects when treating various types of wounds, especially chronic wounds containing necrotic tissue.

Claims

1. A preparation for removing dead tissue, promoting tissue regeneration, stopping bleeding and resisting infection, characterized in that , comprising the following components by weight: Catechins 5-15 parts; 3-8 parts of frankincense extract; 3-8 parts of myrrh extract; 2-6 parts of dragon's blood extract; 4-10 portions of Panax notoginseng powder; 1-3 parts of borneol; Musk 0.1-0.5 parts; 2-6 parts madder powder; 4-10 parts of angelica extract; 3-8 parts of Coptis chinensis extract; 2-6 parts of rhubarb extract; 2-4 parts of polyhexamethylene biguanide; Sodium hyaluronate 0.5-1.5 parts.

2. The anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding according to claim 1, characterized in that , the catechin and the polyhexamethylene biguanide form a complex, wherein the mass ratio of catechin to polyhexamethylene biguanide is 1:1 to 1:

3.

3. The anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding according to claim 1, characterized in that The notoginseng powder and the dragon's blood extract form a nanoemulsion, wherein the mass ratio of the notoginseng powder to the dragon's blood extract is 1:1, and 1-2% of lecithin is contained as an emulsifier.

4. The anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding according to claim 1, characterized in that The frankincense extract, the myrrh extract and the borneol form a composite essential oil, wherein the mass ratio of the frankincense extract, the myrrh extract and the borneol is 2:2:

1.

5. The anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding according to claim 1, characterized in that The coptis chinensis extract and the rhubarb extract are obtained by synergistic extraction, wherein the mass ratio of coptis chinensis to rhubarb is 1:

1.

6. The anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding according to claim 1, characterized in that , the sodium hyaluronate and the angelica extract form a complex, wherein the mass ratio of the sodium hyaluronate to the angelica extract is 4:

1.

7. The method for preparing the anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding according to any one of claims 1 to 6, characterized in that , including the following steps: (1) Extraction steps: a) Catechin extraction: green tea leaves are mixed with hot water at 70-80° C. in a mass ratio of 1:10, soaked for 30-40 minutes, filtered, the filtrate is collected, the filtrate is cooled to room temperature, an equal volume of ethyl acetate is added, and the filtrate is shaken and extracted for 20-30 minutes, separated into layers, the organic layer is collected, and the solvent is recovered by vacuum distillation to obtain a catechin extract; b) Extraction of frankincense and myrrh: frankincense and myrrh powders were mixed with 95% ethanol at a mass ratio of 1:8, respectively, and refluxed for extraction at 60-70° C. for 2-3 hours, filtered, and the filtrate was collected, and the solvent was recovered by vacuum distillation to obtain frankincense and myrrh extracts; c) Extraction of dragon's blood: Mix dragon's blood powder and 70% ethanol in a mass ratio of 1:6, perform ultrasonic extraction at 50-60° C. for 30-40 minutes, filter, collect the filtrate, and recover the solvent by vacuum distillation to obtain a dragon's blood extract; d) Angelica sinensis extraction: Angelica sinensis powder is mixed with 75% ethanol in a mass ratio of 1:8, and refluxed for extraction at 60-70° C. for 2-3 hours, filtered, the filtrate is collected, and the solvent is recovered by vacuum distillation to obtain an Angelica sinensis extract; e) Extraction of coptis chinensis and rhubarb: mix coptis chinensis and rhubarb powder in a mass ratio of 1:1, mix with 70% ethanol-water solution (7:3) in a mass ratio of 1:10, reflux extraction at 60-70° C. for 3-4 hours, filter, collect the filtrate, and concentrate under reduced pressure to an appropriate concentration to obtain a coptis chinensis and rhubarb synergistic extract; (2) Matrix preparation step: dissolving 2-4 parts by weight of polyhexamethylene biguanide in 60-70 parts by weight of purified water, and stirring evenly at 25-30° C. to obtain a matrix solution; (3) Active ingredient mixing step: the extracts obtained in step (1) (catechins, frankincense, myrrh, dragon's blood, angelica, coptis root and rhubarb extracts) are mixed according to the weight proportions, and notoginseng powder, borneol, musk and madder powder are added, and stirred at 35-40° C. to obtain a mixed solution; (4) Gel preparation step: slowly add the mixed solution obtained in step (3) to the matrix solution obtained in step (2), stir evenly at 30-35°C, add 0.5-1.5 parts by weight of sodium hyaluronate, continue stirring until completely dissolved, adjust the pH to 6.5-7.5, and then stand at 4-8°C for 12-24 hours to allow the gel to fully form.

8. The preparation method according to claim 7, characterized in that , the method further comprises the following steps: Prior to step (3), the catechin extract and polyhexamethylene biguanide are mixed in a mass ratio of 1:1 to 1:3, and stirred at 40-50° C. for 2-3 hours to form a catechin-polyhexamethylene biguanide complex; Before step (3), the notoginseng extract and the dragon's blood extract are mixed in a mass ratio of 1:1, 1-2% lecithin is added, and a high-pressure homogenizer with a pressure of 100-150 MPa is used to prepare the notoginseng-dragon's blood nanoemulsion; Prior to step (3), the frankincense extract, myrrh extract and borneol are mixed in a mass ratio of 2:2:1, and stirred at 40-50° C. for 1-2 hours to form a frankincense-myrrh-borneol composite essential oil.

9. The method for preparing the anti-infective preparation for removing dead tissue, promoting tissue regeneration, and stopping bleeding according to any one of claims 1 to 6, characterized in that: The preparation is a cataplasm, which comprises a drug layer and a backing layer, wherein the drug layer comprises the anti-infective preparation for removing necrosis, promoting tissue regeneration, and stopping bleeding as claimed in any one of claims 1 to 6 and a hydrophilic matrix, and the backing layer is a non-woven fabric; The following steps are involved: (1) Preparation of drug layer: a) mixing the decomposing, granulating, hemostatic and anti-infective preparation according to any one of claims 1 to 6 with a hydrophilic matrix at a weight ratio of 1:0.5 to 1:2, wherein the hydrophilic matrix is ​​selected from one or a mixture of polyvinyl pyrrolidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose and sodium carboxymethyl cellulose; b) adding an appropriate amount of purified water to make the total solid content reach 40-60%; c) stirring uniformly at 60-70° C., at a stirring speed of 200-300 rpm, for 30-60 minutes to obtain a uniform drug mixture; (2) Coating: a) heating the drug mixture obtained in step (1) to 55-65° C.; b) using a knife coater to evenly coat the mixture on the non-woven fabric with a coating thickness of 0.5-1.5 mm; (3) Drying: a) placing the coated nonwoven fabric in a tunnel-type hot air circulation oven; b) drying at 45-55°C for 2-4 hours to control the final moisture content to 2-5%; (4) Cutting and packaging: a) cutting the dried product into sizes ranging from 5 cm x 5 cm to 20 cm x 20 cm; b) Use aluminum-plastic composite film to seal and package the cut poultices at a temperature of 120-140°C and a sealing time of 1-2 seconds.

10. The preparation method according to claim 9, characterized in that: The hydrophilic matrix is ​​a mixture of polyvinyl pyrrolidone and hydroxypropyl methylcellulose, wherein the weight ratio of polyvinyl pyrrolidone to hydroxypropyl methylcellulose is 2:1 to 1:2.

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