Natural plant extraction colloid dressing for postoperative skin flap and preparation method of natural plant extraction colloid dressing

Abstract

The invention provides a natural plant extraction colloid dressing for postoperative skin flaps and a preparation method thereof.The dressing comprises, by weight, 30-35 parts of hydrogel matrix solution and 10-30 parts of traditional Chinese medicine extract nano-particle suspension liquid, and the traditional Chinese medicine extract nano-particle suspension liquid is prepared from, by weight, 30-35 parts of hydrogel matrix solution and 10-30 parts of traditional Chinese medicine extract nano-particle suspension liquid. The traditional Chinese medicine extract nanoparticle suspension is prepared from the following raw material extracts through ultrasonic crushing treatment: 12 to 18 parts of honeysuckle flower extract, 8 to 12 parts of radix salviae miltiorrhizae extract, 8 to 12 parts of rhizoma coptidis extract, 8 to 11 parts of fructus cnidii extract, 10 to 12 parts of radix astragali seu hedysari extract, 5 to 7 parts of borneol and 6 to 8 parts of tea polyphenol. The colloid dressing disclosed by the invention can resist bacteria for a long time, promote blood circulation to remove blood stasis, reduce local moist of skin flaps and promote healing, and has important significance on postoperative wound healing.

Description

Technical Field

[0001] The invention belongs to the technical field of biomedical materials, and in particular relates to a natural plant extract colloid dressing for postoperative skin flaps and a preparation method thereof. Background Art

[0002] The most common problems in wound healing after breast cancer surgery are flap ischemia, necrosis and infection. The ideal condition for patient recovery and healing is that the flap can complete tissue healing in a microenvironment with rich blood supply, sterility and continuous warmth. Therefore, the contradictions faced by flap healing after surgery include: (1) The thoroughness of tumor resection requires the flap to be as thin as possible, which will damage blood supply, while postoperative flap healing requires good blood supply; (2) The contradiction between the need for frequent dressing changes to inhibit bacteria in the skin and environment after surgery and the need for flap healing to rest and recuperate, maintain a stable and warm environment and avoid frequent interference.

[0003] Skin flaps after breast cancer surgery are ischemic, have poor vitality and poor anti-infection ability, especially in summer, hot and humid environment, or when patients are weak and sweat a lot, which makes it easy for bacteria to breed. When patients sweat a lot, it is more likely to have a vicious cycle of skin flap ischemia → local infection → aggravated ischemia → further wet necrosis. In clinical practice, the use of some disinfectants to wet wounds and skin flaps can reduce the occurrence of this vicious cycle, and the rate of skin flap necrosis and infection is significantly reduced, but medical disinfectants often cause certain damage to the skin and it is difficult to achieve the purpose of sustained effectiveness.

[0004] Commonly used topical drugs with similar functions include: (1) Compound honeysuckle liquid, main ingredients: honeysuckle, forsythia, etc. Efficacy: clearing heat and detoxifying, antibacterial and anti-inflammatory, commonly used for skin problems such as eczema and dermatitis; application scenarios: mainly used for skin diseases caused by various bacterial infections, such as furuncle, eczema, etc. (2) Compound Sophora flavescens liquid, main ingredients: Sophora flavescens, Phellodendron amurense, etc. Efficacy: clearing heat and dampness, killing insects and relieving itching; the active ingredients in Sophora flavescens have broad-spectrum antibacterial effects, suitable for eczema, skin ulcers, etc.; application scenarios: eczema, skin pruritus and chronic skin ulcers, etc. (3) Jingwanhong ointment, main ingredients: rhubarb, Phellodendron amurense, Sophora flavescens, etc. Efficacy: clearing heat and detoxifying, promoting blood circulation and removing blood stasis, promoting wound healing; mainly used for wound healing and ulcer treatment and inflammation treatment; application scenarios: burns, scalds, ulcers, traumatic infections, etc., can effectively prevent wound infection and promote skin healing. (4) Lithospermum officinale oil, main ingredients: Lithospermum officinale, Coptis chinensis, etc.; efficacy: clearing away heat and detoxification, promoting blood circulation and relieving pain, anti-inflammatory, widely used in the treatment of trauma and burns; application scenarios: mild burns, abrasions, eczema and other skin diseases, helping to reduce infection and promote wound healing. (5) Compound Sophora flavescens wash, main ingredients: Sophora flavescens, Stemona radix and other Chinese medicinal ingredients; efficacy: clearing heat and drying dampness, killing insects and relieving itching, suitable for skin infectious diseases, especially itchy skin diseases; application scenarios: vaginitis, eczema, dermatitis, skin itching and other external skin problems. (6) Compound Phellodendron chinense liquid, main ingredients: Phellodendron chinense, Sophora flavescens, Lonicera japonica, Taraxacum mongolicum, Rhubarb, Scutellaria baicalensis, etc.; efficacy: clearing heat and detoxification, reducing swelling and removing rot; application scenarios: used for sores and ulcers, wound infections, and patients with Yang syndrome. Compound Phellodendron chinense liquid is suitable for various skin problems caused by damp-heat toxic evil, such as eczema, infectious skin diseases, etc. Its advantages lie in its anti-inflammatory and antibacterial effects, but due to the lack of long-acting sustained-release and blood-activating functions, it is more often used to treat milder infections or as a short-term local treatment. Compound Phellodendron chinense liquid is more suitable for the treatment of routine infections and inflammations.

[0005] Products similar to compound phellodendron liquid are mainly some traditional Chinese medicine external preparations based on traditional Chinese medicine, which have the functions of antibacterial and anti-inflammatory, promoting healing, and clearing heat and dampness. Such products are often used in clinical cases such as skin diseases, wound care and eczema. These products are all composite external preparations based on traditional Chinese medicine, some of which focus on antibacterial and anti-inflammatory, and some focus on clearing heat and detoxification, removing dead tissue and promoting muscle regeneration. Their application scenarios are either used for the treatment of skin diseases such as dermatitis and eczema, or for anti-inflammatory and debridement of infected wounds, removing dead tissue and promoting muscle regeneration. Moreover, the production process is relatively simple, the effect time is short after each use, and it cannot play a role continuously. It needs to be used repeatedly every day, which greatly increases the inconvenience of patients, and is not suitable for the characteristics of breast surgery flaps that need to recuperate and maintain a continuous warm environment to facilitate healing. The needs for sustained-release antibacterial, blood-activating and blood-stasis-clearing, and prevention of necrosis and infection of breast cancer postoperative flaps cannot be met. At present, there is no preparation that can be used in the clinic to prevent and treat ischemic necrosis and infection of breast cancer postoperative flaps and promote wound healing. Summary of the invention

[0006] The present invention provides a natural plant extract colloid dressing for postoperative skin flap and a preparation method thereof, so as to solve the problem that the preparations in the existing methods cannot simultaneously meet the effects of continuous antibacterial, blood activating and blood stasis removal, and wound healing promotion. The colloid dressing of the present invention can continuously and long-term antibacterial, blood activating and blood stasis removal, reduce local moisture of the skin flap and promote healing, improve the blood supply of the skin flap, prolong the interval time of dressing change, and reduce the interference and stimulation caused by frequent dressing change to the skin flap, which is of great significance for postoperative wound healing.

[0007] The technical solution of the present invention is as follows: According to one aspect of the present invention, a natural plant extract colloidal dressing for postoperative skin flaps is provided, comprising a hydrogel matrix solution and a suspension of nanoparticles of a Chinese herbal medicine extract, wherein the hydrogel matrix solution is 30 to 35 parts by weight, and the suspension of nanoparticles of the Chinese herbal medicine extract is composed of nanoparticle suspensions of the following raw material extracts formed by ultrasonic crushing: 12 to 18 parts of a honeysuckle extract, 8 to 12 parts of a salvia miltiorrhiza extract, 8 to 12 parts of a coptis chinensis extract, 8 to 11 parts of a cnidium monnieri extract, 10 to 12 parts of an astragalus extract, 5 to 7 parts of borneol, and 6 to 8 parts of tea polyphenols.

[0008] Optionally, in the above-mentioned natural plant extract colloidal dressing for postoperative skin flaps, the hydrogel matrix solution is 32 parts, and the Chinese medicine extract nanoparticle suspension is composed of the following raw material extract nanoparticle suspensions formed by ultrasonic crushing: 15 parts of honeysuckle extract, 10 parts of salvia miltiorrhiza extract, 10 parts of coptis extract, 9 parts of cnidium monnieri extract, 11 parts of astragalus extract, 6 parts of borneol and 7 parts of tea polyphenols.

[0009] Optionally, in the above-mentioned natural plant extract colloidal dressing for postoperative skin flaps, the hydrogel matrix solution is prepared by dissolving sodium hyaluronate and polyethylene glycol (PEG) in a mass ratio of 5:1 in purified water.

[0010] Optionally, in the above-mentioned natural plant extract colloid dressing for postoperative skin flap, the viscosity of the hydrogel matrix solution is 2000-3000 mPa·s.

[0011] According to another aspect of the present invention, a method for preparing the above-mentioned natural plant extract colloidal dressing is provided, comprising the following steps: S1. each raw material extract is subjected to ultrasonic crushing treatment to obtain a nanoparticle suspension of each raw material primary extract, wherein the ultrasonic frequency is 20kHz~25kHz, and the ultrasonic treatment time is 30 minutes; S2. each raw material primary extract nanoparticle suspension is subjected to low-temperature vacuum concentration at 30~40°C to 1 / 5 to 1 / 3 of the original volume to obtain each raw material extract nanoparticle suspension; S3. sodium hyaluronate and polyethylene glycol (PEG) are dissolved in purified water at a ratio of 5:1 at 30~40°C, and stirred until completely dissolved to obtain a hydrogel matrix solution; and S4. the nanoparticle suspensions of each raw material extract obtained after concentration are added to the hydrogel matrix solution in sequence, mixed evenly at 30~40°C, filtered to remove insoluble matter, and obtained a colloidal dressing.

[0012] Optionally, in the preparation method of the above-mentioned natural plant extract colloidal dressing, step S5 is further included, wherein the obtained colloidal dressing is filled under sterile conditions and filled with an inert gas. Optionally, in the preparation method of the above-mentioned natural plant extract colloidal dressing, in step S4, the mixture is mixed evenly at a stirring speed of 200 rpm, and filtered using a 0.22 μm microporous filter membrane.

[0013] Optionally, in the preparation method of the natural plant extract colloid dressing, before step S1, the method further includes obtaining extracts of various raw materials, wherein: The method for obtaining the honeysuckle extract is as follows: the honeysuckle is divided into two groups, and water extraction and ethanol extraction are performed respectively, wherein water extraction: the honeysuckle is extracted in a 60°C water bath for 2 hours, extracted twice, and the amount of water added each time is 10 times the amount of the medicinal material, the extracts are combined, and concentrated to 1 / 5 of the original volume to obtain a water extract; ethanol extraction: using 70% ethanol solution, the honeysuckle after water extraction is soaked at room temperature for 24 hours, the soaking liquid is filtered, and concentrated to 1 / 5 of the original volume to obtain an ethanol extract; combined extract: the water extract and the ethanol extract are mixed to obtain a honeysuckle extract; The method for obtaining the Danshen extract is as follows: extract with 70% ethanol at 50°C for 2 hours, extract twice, add 8 times the amount of ethanol each time, combine the extracts, and concentrate to 1 / 4 of the original volume; The method for obtaining the coptis root extract is as follows: using boiling water for extraction, extracting at 100°C for 1 hour, extracting twice, adding 12 times the amount of water each time, combining the extracts, and concentrating to 1 / 5 of the original volume; The method for obtaining the Cnidium monnieri extract is as follows: extract with 70% ethanol at 40°C for 2 hours, extract twice, add 10 times the amount of ethanol each time, combine the extracts, and concentrate to 1 / 4 of the original volume; The method for obtaining the astragalus extract is as follows: extract in an 80°C water bath for 1.5 hours, extract twice, add 8 times the amount of water each time, combine the extracts, and concentrate to 1 / 3 of the original volume; Tea polyphenols: Soak chrysanthemum in 60% ethanol at room temperature for 24 hours, filter the soaking liquid and concentrate it to 1 / 5 of the original volume; Obtaining Borneol: Use 95% ethanol solution to completely dissolve the Borneol at room temperature and filter the solution.

[0014] According to the technical solution of the present invention, the beneficial effects produced are: The present invention combines a variety of natural plant extracts and utilizes a hydrogel carrier system to achieve sustained release of drugs, exerting the effects of sustained-release antibacterial, activating blood stasis, inhibiting sweating, and promoting healing, thereby reducing the frequency of dressing changes and the occurrence of flap necrosis and infection. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the specific implementation of the present invention or the technical solution in the prior art, the drawings required for use in the specific implementation or the description of the prior art are briefly introduced below.

[0016] Figure 1 It is a schematic diagram of the process of the present invention. DETAILED DESCRIPTION

[0017] In order to make the purpose, technical method and advantages of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific examples. These examples are only illustrative and not limiting of the present invention.

[0018] The natural plant extract colloidal dressing for postoperative skin flap of the present invention comprises a hydrogel matrix solution and a suspension of nanoparticles of Chinese medicine extracts. By weight, the hydrogel matrix solution is 30-35 parts, and the suspension of nanoparticles of Chinese medicine extracts is composed of the following raw material extract nanoparticle suspensions formed by ultrasonic crushing: 12-18 parts of honeysuckle extract, 8-12 parts of salvia miltiorrhiza extract, 8-12 parts of coptis chinensis extract, 8-11 parts of cnidium monnieri extract, 10-12 parts of astragalus extract, 5-7 parts of borneol, and 6-8 parts of tea polyphenols. In a preferred embodiment, in the colloidal dressing, the hydrogel matrix solution is 32 parts, and the suspension of nanoparticles of Chinese medicine extracts is composed of the following raw material extract nanoparticle suspensions formed by ultrasonic crushing: 15 parts of honeysuckle extract, 10 parts of salvia miltiorrhiza extract, 10 parts of coptis chinensis extract, 9 parts of cnidium monnieri extract, 11 parts of astragalus extract, 6 parts of borneol, and 7 parts of tea polyphenols.

[0019] Among them, the honeysuckle extract (Lonicera japonica extract) is divided into two groups, and water extraction and ethanol extraction are performed respectively. Specifically, water extraction: extract the honeysuckle in a 60℃ water bath for 2 hours, extract twice, add 10 times the amount of water each time, combine the extracts, and concentrate to 1 / 5 of the original volume to obtain a water extract; ethanol extraction: use 70% ethanol solution, soak at room temperature for 24 hours, filter the soaking liquid, and concentrate to 1 / 5 of the original volume to obtain an ethanol extract; combined extract: mix the water extract with the ethanol extract. The efficacy of honeysuckle is broad-spectrum antibacterial and anti-inflammatory.

[0020] Salvia miltiorrhiza extract is extracted by ethanol, specifically including: using 70% ethanol at 50°C for 2 hours, extracting twice, adding 8 times the amount of ethanol each time, combining the extracts, and concentrating to 1 / 4 of the original volume. Salvia miltiorrhiza has the effects of promoting blood circulation and removing blood stasis, and anti-oxidation.

[0021] Coptis chinensis extract is extracted with water, specifically including: using boiling water to extract, maintaining 100℃ for 1 hour, extracting twice, adding 12 times the amount of water each time, combining the extracts, and concentrating to 1 / 5 of the original volume. Coptis chinensis efficacy: strong antibacterial, especially for Gram-positive and Gram-negative bacteria.

[0022] Borneol, the extraction method is to dissolve it in ethanol. Specifically, 95% ethanol solution is used to completely dissolve the borneol at room temperature, and the solution is filtered out. The efficacy of borneol: analgesia, promoting transdermal absorption of other drugs.

[0023] Cnidium monnieri extract is extracted by ethanol, specifically including: using 70% ethanol at 40°C for 2 hours, extracting twice, adding 10 times the amount of ethanol each time, combining the extracts, and concentrating to 1 / 4 of the original volume. Cnidium monnieri effects: dispelling wind and dampness, antibacterial, and anti-inflammatory.

[0024] Astragalus membranaceus extract is extracted by water, specifically including: using 80℃ water bath for 1.5 hours, extracting twice, adding 8 times the amount of water each time, combining the extracts, and concentrating to 1 / 3 of the original volume. The effects of Astragalus: replenishing qi and blood, promoting healing, and anti-oxidation.

[0025] Tea polyphenols are extracted by ethanol, specifically including: soaking chrysanthemum in 60% ethanol at room temperature for 24 hours, filtering the soaking liquid, and concentrating it to 1 / 5 of the original volume. Tea polyphenols have the following effects: anti-oxidation and antibacterial.

[0026] The natural plant extract colloid dressing of the present invention can achieve the following therapeutic effects: (1) It can release sustained antibacterial agents to reduce the frequency of dressing changes; (2) It can activate blood stasis and improve blood circulation of skin flaps; (3) It can reduce local moisture and bacterial growth caused by sweating; and (4) The skin nutrients in the dressing can promote injury repair and wound healing.

[0027] The preparation method of the natural plant extract colloid dressing for postoperative skin flap of the present invention comprises: S1. The raw material extracts are subjected to ultrasonic crushing treatment to obtain nanoparticle suspensions of the primary extracts of the raw materials.

[0028] The ultrasonic frequency is between 20kHz and 25kHz, and the ultrasonic treatment time is 30 minutes each time to ensure the uniformity and stability of the nanoparticles. In this step, the raw material extracts include honeysuckle extract, salvia miltiorrhiza extract, coptis root extract, cnidium monnieri extract, astragalus extract, borneol and tea polyphenols.

[0029] S2. The nanoparticle suspension of each raw material primary extract is concentrated under vacuum at 30-40° C. to 1 / 5 to 1 / 3 of the original volume to obtain a nanoparticle suspension of each raw material extract. The nanoparticle suspension of each raw material primary extract is concentrated to facilitate the subsequent process. Continuous stirring is required during the concentration process to avoid precipitation and ensure the stability of the active ingredients of the extract.

[0030] S3. Preparation of hydrogel matrix solution: dissolving sodium hyaluronate and polyethylene glycol (PEG) in a mass ratio of 5:1 in purified water at 30-40°C, stirring until completely dissolved, to prepare a hydrogel matrix solution, wherein the temperature should be maintained at 30-40°C during the dissolution process to prevent polymer degradation; and the viscosity of the finally formed hydrogel matrix solution should be controlled at 2000-3000 mPa·s so that the hydrogel matrix solution has a suitable viscosity and sustained release effect; and S4. Add the concentrated nanoparticle suspension of each raw material extract to the hydrogel matrix solution, mix evenly at 30-40° C., filter to remove insoluble matter, and obtain a colloidal dressing.

[0031] During the mixing process, the temperature is controlled at 30-40°C, and the stirring speed should be controlled at 200 rpm to avoid the generation of bubbles and degradation of active ingredients. When filtering to remove insoluble matter, a 0.22 μm microporous filter membrane is used to precisely filter the mixed solution to remove insoluble impurities and ensure the clarity and stability of the colloidal dressing.

[0032] S5. Filling: Fill the filtered colloid dressing into sterilized glass or plastic bottles in a clean room environment. Maintain aseptic operation during the filling process to avoid secondary contamination. Immediately after filling, seal the package and use inert gas (such as nitrogen) to fill it to improve the stability of the product.

[0033] The following is a detailed description of the preparation method and ingredients of the natural plant extract colloid dressing for postoperative skin flaps of the present invention in combination with the embodiments. Example 1 The colloidal dressing composition includes, by weight, 32 parts of hydrogel matrix solution, 15 parts of honeysuckle extract, 10 parts of salvia miltiorrhiza extract, 10 parts of coptis chinensis extract, 9 parts of cnidium monnieri extract, 11 parts of astragalus extract, 6 parts of borneol and 7 parts of tea polyphenols.

[0034] Preparation method: S1. Each raw material extract was subjected to ultrasonic crushing treatment to obtain a nanoparticle suspension of each raw material primary extract, wherein the ultrasonic frequency was 20kHz and the ultrasonic treatment time was 30 minutes each time; S2. The nanoparticle suspension of each raw material primary extract was concentrated by low temperature vacuum concentration at 30-40°C to 1 / 5 of the original volume to obtain a nanoparticle suspension of each raw material extract; S3. dissolving sodium hyaluronate and polyethylene glycol (PEG) in purified water at a mass ratio of 5:1 at 30-40° C., stirring until completely dissolved, to prepare a hydrogel matrix solution; S4. The nanoparticle suspensions of each raw material extract obtained after concentration are sequentially added to the hydrogel matrix solution, stirred and mixed uniformly at a stirring speed of 200 rpm at 30 to 40°C, and filtered through a 0.22 μm microporous filter membrane to remove insoluble matter to obtain a colloidal dressing; S5. Filling: Fill the filtered colloidal dressing into sterilized glass or plastic bottles in a clean room environment and fill with nitrogen to improve product stability.

[0035] Example 2 The colloidal dressing composition includes, by weight, 30 parts of hydrogel matrix solution, 12 parts of honeysuckle extract, 8 parts of salvia miltiorrhiza extract, 8 parts of coptis chinensis extract, 8 parts of cnidium monnieri extract, 12 parts of astragalus extract, 5 parts of borneol and 6 parts of tea polyphenols.

[0036] Preparation method: S1. Each raw material extract was subjected to ultrasonic crushing treatment to obtain a nanoparticle suspension of each raw material primary extract, wherein the ultrasonic frequency was 25kHz and the ultrasonic treatment time was 30 minutes each time; S2. The nanoparticle suspension of each raw material primary extract was concentrated by low temperature vacuum concentration at 30-40°C to 1 / 5 of the original volume to obtain a nanoparticle suspension of each raw material extract; S3. dissolving sodium hyaluronate and polyethylene glycol (PEG) in purified water at a mass ratio of 5:1 at 30-40° C., stirring until completely dissolved, to prepare a hydrogel matrix solution; S4. The nanoparticle suspensions of each raw material extract obtained after concentration are sequentially added to the hydrogel matrix solution, stirred and mixed uniformly at a stirring speed of 200 rpm at 30 to 40°C, and filtered through a 0.22 μm microporous filter membrane to remove insoluble matter to obtain a colloidal dressing; S5. Filling: Fill the filtered colloidal dressing into sterilized glass or plastic bottles in a clean room environment and fill with nitrogen to improve product stability.

[0037] Example 3 The colloidal dressing composition includes, by weight, 35 parts of hydrogel matrix solution, 18 parts of honeysuckle extract, 12 parts of salvia miltiorrhiza extract, 12 parts of coptis chinensis extract, 11 parts of cnidium monnieri extract, 10 parts of astragalus extract, 7 parts of borneol and 8 parts of tea polyphenols.

[0038] Preparation method: S1. Each raw material extract was subjected to ultrasonic crushing treatment to obtain a nanoparticle suspension of each raw material primary extract, wherein the ultrasonic frequency was 22kHz and the ultrasonic treatment time was 30 minutes each time; S2. The nanoparticle suspension of each raw material primary extract is concentrated by low temperature vacuum concentration at 30-40°C to 1 / 3 of the original volume to obtain a nanoparticle suspension of each raw material extract; S3. dissolving sodium hyaluronate and polyethylene glycol (PEG) in purified water at a mass ratio of 5:1 at 30° C. to 40° C., stirring until completely dissolved, to prepare a hydrogel matrix solution; S4. The nanoparticle suspensions of each raw material extract obtained after concentration are sequentially added to the hydrogel matrix solution, stirred and mixed uniformly at a stirring speed of 200 rpm at 30 to 40°C, and filtered through a 0.22 μm microporous filter membrane to remove insoluble matter to obtain a colloidal dressing; S5. Filling: Fill the filtered colloidal dressing into sterilized glass or plastic bottles in a clean room environment and fill with nitrogen to improve product stability.

[0039] Quality control of natural plant extract colloid dressings used for postoperative skin flaps Microbial limit test: Conduct microbial limit test on finished products, using plate method or membrane filtration method to detect total colony count and specific pathogens to ensure that they meet sterility requirements.

[0040] Physical and chemical property inspection: Test the product's pH value (should be controlled between 5.5 and 7.0), viscosity, permeability and other physical and chemical properties to ensure that they meet the standard requirements. And use UV-visible spectrophotometer to measure the content of key ingredients to ensure the consistency and effectiveness of each batch of products.

[0041] Compared with existing similar products, the present invention has the following advantages: 1) Sustained sustained-release function: The colloidal dressing of the present invention combines nano-encapsulation technology with a hydrogel matrix to achieve 3 to 7 days of sustained slow release of drugs, thereby achieving sustained antibacterial effect, reducing the frequency of dressing changes, reducing interference with the flap, and creating a better healing environment for flap healing. This sustained-release mechanism makes the drug concentration more stable, avoiding the problems of excessive initial concentration and weakened efficacy in the later stage, thereby providing more lasting antibacterial and healing-promoting effects. In contrast, traditional Chinese medicine preparations such as compound phellodendron liquid usually do not have a sustained-release function, and it is difficult to maintain a stable drug concentration, resulting in a strong initial effect and a weakened effect in the later stage.

[0042] 2) Multifunctional comprehensive effect: In addition to antibacterial and anti-inflammatory effects, the colloidal dressing of the present invention can also simultaneously promote blood circulation, reduce sweating of skin flaps, and promote wound healing. This comprehensive effect is not possessed by other single antibacterial or heat-clearing and detoxifying products (such as compound honeysuckle liquid and compound sophora flavescens liquid). For example, the combined effects of its ingredients such as coptis root, salvia miltiorrhiza, and borneol can not only inhibit the growth of bacteria, but also improve blood circulation and alleviate the problem of skin flap ischemia. The dressing of the present invention is particularly suitable for the care of postoperative skin flaps, and can effectively meet clinical needs for problems such as ischemia, poor vitality, and infection of skin flaps after breast cancer surgery. In contrast, the functions of compound phellodendron liquid are concentrated in antibacterial and anti-inflammatory aspects, and lack the functions of promoting blood circulation and removing blood stasis and continuous moisturizing.

[0043] 3) Natural plant extracts: The dressing of the present invention uses natural plant extracts, such as honeysuckle, coptis root, salvia miltiorrhiza, etc., which not only have a broad-spectrum antibacterial effect, but also can achieve anti-inflammatory, antioxidant and healing effects through the synergistic effect of natural ingredients. This combination of natural ingredients is innovative in the care of skin flaps after breast cancer surgery. It can not only reduce the damage to the skin caused by the use of chemical disinfectants, but also provide long-term antibacterial protection. For example, the dressing of the present invention contains ingredients such as astragalus extract and sodium hyaluronate, which can promote wound healing and improve skin elasticity, provide nutritional support for the skin flap, and help postoperative recovery.

[0044] 4) Adapt to sweating and humid environment: The dressing of the present invention is specially designed for patients with excessive sweating, and can reduce local moisture and prevent infection caused by sweat. This feature is particularly important in hot and humid environments, and can reduce local bacterial growth and flap necrosis caused by sweating. Existing similar products (such as compound phellodendron liquid) have antibacterial effects, but are relatively weak in dealing with local moisture and preventing infection caused by moisture) and fail to meet this demand.

[0045] 5) Targeted application scenarios: The dressing of the present invention is particularly suitable for skin flap care after breast cancer surgery, especially when the patient's skin flap is ischemic, has poor vitality, and is susceptible to infection. It can provide continuous care with multiple functions; it can not only inhibit bacteria, but also improve blood circulation, reduce local moisture, and promote skin flap healing. Therefore, it is particularly suitable for long-term management of postoperative wounds. At present, there are no preparations for protecting skin flaps and promoting healing after breast cancer surgery. Existing similar products are mostly used for general skin diseases, eczema, or mild trauma treatment, and lack targeting.

[0046] Study on the efficacy of the natural plant extract colloid dressing of the present invention in treating incisions of breast diseases 1. Methods: This study adopted a retrospective research method and collected patients undergoing breast surgery from January 2023 to September 2024.

[0047] 2. Inclusion criteria: Inclusion criteria: (1) patients who had undergone breast surgery; (2) patients with follow-up records of incisions and complete medical records; (3) patients were counted as one case regardless of the number of visits until the incision healed.

[0048] Exclusion criteria: (1) Patients with macules, papules, erythema, or herpes on the affected breast skin; (2) Patients with sepsis or other serious diseases that affect wound healing; (3) Patients using immunosuppressants or other drugs that may affect wound healing.

[0049] 3. Treatment Methods The treatment group (30 people) applied the natural plant extract colloid dressing of the present invention externally. Usage: Apply to the affected area after surgery, and change the dressing every 5-7 days. In clinical practice, the conventional dressing change interval is every 3 days. Prolonging the time will increase the risk of infection in patients. Therefore, the control group (30 people) used the current clinical conventional dressing change method, that is, disinfect the incision and apply the incision with sterile gauze, without applying medicine, and change the dressing every 2-3 days.

[0050] 4. Observation indicators 4.1 Wound healing time: It is calculated from the day of surgery until the incision is healed. If false healing occurs, the incision should be observed until it is completely healed.

[0051] 4.2 Skin color of incision: No color change 0 points, pale 1 point, redness and swelling 2 points, dark purple 3 points, black 4 points 4.3 Infection rate: number of people with infection observed at the incision / total number of people treated 4.4 Necrosis rate: number of patients with wound necrosis / total number of patients treated 5. Results: As shown in Tables 1 and 2, compared with the control group, the incision healing time of the treatment group using the natural plant extract colloid dressing of the present invention was significantly shortened, and the wound infection rate and necrosis rate were significantly reduced. In addition, the natural plant extract colloid dressing of the present invention can continuously inhibit bacteria and prolong the dressing change time interval.

[0052] Table 1 Incision healing time Group Wound healing time (d, x±s) Control group 14.81±3.83 Treatment Group 10.52±2.28△ Note: Compared with the control group, △P<0.05.

[0053] Table 2 Incision skin color score and infection and necrosis rate (points, x±s) project Control group Treatment Group Skin color of incision (points) 2.07±0.41 1.50±0.15△ Infection rate (%) 10.00 3.33 Necrosis rate (%) 13.33 3.33 Note: Compared with the control group, △P<0.05.

[0054] In vitro antibacterial assay 1. Sample preparation: Weigh the natural plant extract colloidal dressing of the present invention, and prepare it twice by the above-mentioned water extraction and alcohol extraction methods (such as the extraction method of honeysuckle) (i.e., extract the active ingredients in the colloidal dressing), and combine the two filtrates. Take 2 ml of the filtrate, centrifuge (12,000 rpm) for 5 minutes, and take the supernatant for testing.

[0055] 2. Microdilution method to detect the MIC value of plant extracts for in vitro antibacterial activity The results show that the natural plant extract colloidal dressing of the present invention has a good antibacterial effect, and the antibacterial effects on common Staphylococcus aureus, Streptococcus and Staphylococcus epidermidis caused by body surface and postoperative infections are shown in Table 3 below.

[0056] Table 3. In vitro inhibitory effect of plant extracts on different bacteria (mg / ml) bacteria MIC (Mean±SD) Staphylococcus aureus 12.31 ± 2.34 Streptococcus 11.53 ± 2.03 Staphylococcus epidermidis 11.54 ± 1.76 In summary, the present invention combines modern nanotechnology with the pharmacological effects of traditional Chinese medicine to design a colloid dressing with multifunctional effects such as long-acting sustained release, antibacterial, blood circulation, and promotion of wound healing, which has obvious technical innovations and clinical advantages.

[0057] The above description is the best embodiment based on the concept and working principle of the invention. The above embodiment should not be understood as limiting the protection scope of the present claims, and other implementations and combinations of implementations according to the concept of the present invention belong to the protection scope of the present invention.

Claims

1. A natural plant extract colloid dressing for postoperative skin flaps, characterized in that: The invention comprises a hydrogel matrix solution and a suspension of nanoparticles of Chinese herbal medicine extracts. The hydrogel matrix solution is 30 to 35 parts by weight, and the suspension of nanoparticles of Chinese herbal medicine extracts is composed of the following raw material extract nanoparticle suspensions formed by ultrasonic crushing: 12 to 18 parts of honeysuckle extract, 8 to 12 parts of salvia miltiorrhiza extract, 8 to 12 parts of coptis chinensis extract, 8 to 11 parts of cnidium monnieri extract, 10 to 12 parts of astragalus extract, 5 to 7 parts of borneol and 6 to 8 parts of tea polyphenols.

2. The natural plant extract colloid dressing for postoperative skin flap according to claim 1, characterized in that: The hydrogel matrix solution is 32 parts, and the Chinese medicine extract nanoparticle suspension is composed of the following raw material extract nanoparticle suspensions formed by ultrasonic crushing: 15 parts of honeysuckle extract, 10 parts of salvia miltiorrhiza extract, 10 parts of coptis chinensis extract, 9 parts of cnidium monnieri extract, 11 parts of astragalus extract, 6 parts of borneol and 7 parts of tea polyphenols.

3. The natural plant extract colloid dressing for postoperative skin flap according to claim 1, characterized in that: The hydrogel matrix solution is prepared by dissolving sodium hyaluronate and polyethylene glycol (PEG) in a mass ratio of 5:1 in purified water.

4. The natural plant extract colloid dressing for postoperative skin flap according to claim 1, characterized in that: The viscosity of the hydrogel matrix solution is 2000 mPa·s to 3000 mPa·s.

5. The method for preparing the natural plant extract colloid dressing according to claims 1 to 3, characterized in that: The following steps are involved: S1. Each raw material extract was subjected to ultrasonic crushing treatment to obtain a suspension of nanoparticles of each raw material primary extract, wherein the ultrasonic frequency was 20kHz~25kHz, and the ultrasonic treatment time was 30 minutes; S2. The nanoparticle suspensions of the primary extracts of each raw material are respectively concentrated at 30°C to 40°C by low-temperature vacuum concentration to 1 / 5 to 1 / 3 of the original volume to obtain nanoparticle suspensions of the primary extracts of each raw material; S3. dissolving sodium hyaluronate and polyethylene glycol (PEG) in a ratio of 5:1 in purified water at 30°C to 40°C, stirring until completely dissolved, to prepare a hydrogel matrix solution; as well as S4. The nanoparticle suspensions of the raw material extracts obtained after concentration are sequentially added to the hydrogel matrix solution, mixed evenly at 30° C. to 40° C., filtered to remove insoluble matter, and obtained a colloidal dressing.

6. The method for preparing the natural plant extract colloid dressing according to claim 5, characterized in that: The method further comprises step S5 of filling the obtained colloid dressing under sterile conditions and using an inert gas for filling.

7. The method for preparing the natural plant extract colloid dressing according to claim 5, characterized in that: In step S4, the mixture was mixed at a stirring speed of 200 rpm and filtered using a 0.22 μm microporous filter membrane.

8. The method for preparing the natural plant extract colloid dressing according to claim 5, characterized in that: Before step S1, the process also includes obtaining extracts of various raw materials, wherein: The method for obtaining the honeysuckle extract is as follows: the honeysuckle is divided into two groups, and water extraction and ethanol extraction are performed respectively, wherein water extraction: the honeysuckle is extracted in a 60°C water bath for 2 hours, extracted twice, and the amount of water added each time is 10 times the amount of the medicinal material, the extracts are combined, and concentrated to 1 / 5 of the original volume to obtain a water extract; ethanol extraction: using 70% ethanol solution, the honeysuckle after water extraction is soaked at room temperature for 24 hours, the soaking liquid is filtered, and concentrated to 1 / 5 of the original volume to obtain an ethanol extract; combined extracts: the water extract and the ethanol extract are mixed to obtain the honeysuckle extract; The method for obtaining the salvia miltiorrhiza extract is as follows: extracting with 70% ethanol at 50°C for 2 hours, extracting twice, adding 8 times the amount of ethanol each time, combining the extracts, and concentrating to 1 / 4 of the original volume; The method for obtaining the Coptis chinensis extract is as follows: using boiling water for extraction, extracting at 100° C. for 1 hour, extracting twice, adding 12 times the amount of water each time, combining the extracts, and concentrating to 1 / 5 of the original volume; The method for obtaining the Cnidium monnieri extract is as follows: extracting with 70% ethanol at 40°C for 2 hours, extracting twice, adding 10 times the amount of ethanol each time, combining the extracts, and concentrating to 1 / 4 of the original volume; The method for obtaining the astragalus extract is as follows: extracting in an 80°C water bath for 1.5 hours, extracting twice, adding 8 times the amount of water each time, combining the extracts, and concentrating to 1 / 3 of the original volume; Tea polyphenols: Soak chrysanthemum in 60% ethanol at room temperature for 24 hours, filter the soaking liquid and concentrate it to 1 / 5 of the original volume; Obtaining Borneol: Use 95% ethanol solution to completely dissolve the Borneol at room temperature and filter the solution.

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