A traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectum, and a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectum, a preparation method and application thereof, and is based on a classic Chinese medicine plaster, combined with clinical experience, and is formed by optimizing a traditional Chinese medicine compound preparation, and is wrapped by using glycerol as a wrapping agent, to form a stable temperature-sensitive in-situ hydrogel drug delivery system, so that the traditional Chinese medicine preparation is combined with the hydrogel, and problems existing in traditional plasters are effectively solved. The traditional Chinese medicine hydrogel composition directly acts on a wound, has good adhesion and histocompatibility, can prolong the residence time of the drug in a medication site, and improves the bioavailability; effective components of the traditional Chinese medicine compound preparation prevent the formation of a bacterial biofilm on a postoperative wound of anorectum, and inhibit wound infection; the hydrogel dosage form forms a moist protective film on the postoperative wound, forms a microenvironment conducive to wound healing, thereby accelerating healing, promoting recovery, effectively alleviating the pain of patients, and having important medical value.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery, its preparation method, and its application. Background Technology

[0002] Anorectal surgery refers to surgical procedures involving the anus and rectum, used to treat various anorectal diseases. Anorectal surgeries often employ open drainage incisions, inevitably leading to wound exposure and fecal contamination, which affects wound healing. Clinical studies show that wound infection is an independent risk factor for poor wound healing after anorectal surgery. Improper management can easily cause delayed healing, non-healing, pseudo-healing, and scar contracture, resulting in prolonged disease course or recurrence. According to literature reports, the recurrence rate after anorectal surgery can be as high as 57%, causing prolonged illness, repeated medical visits, increased patient suffering, delayed recovery of work and daily living abilities, increased psychological stress, and reduced quality of life. It also results in a significant waste of medical resources. Therefore, postoperative wound repair and healing is the final step in determining the prognosis of anorectal diseases; the quality of healing directly affects the course of the disease, treatment efficacy, and prognosis.

[0003] Controlling bacterial contamination in open wounds is crucial. Studies have confirmed that infection of open drainage incisions after clinical anorectal surgery is mainly due to bacterial contamination. Bacterial colonization and growth, forming bacterial biofilms and altering the wound microenvironment, are significant causes of impaired wound healing. Bacterial biofilms can form an immune barrier, facilitate bacterial gene mutation and drug resistance gene exchange, enhance bacterial adhesion to the wound, strengthen intermicrobial coordination, and promote the dormancy and latency of retained bacteria. Therefore, conventional debridement methods are often ineffective in removing bacterial biofilms from the wound, leading to prolonged infection and slow wound healing.

[0004] In clinical practice, antibiotics are commonly used to combat infection. However, antibiotics are highly susceptible to drug resistance, especially since the biofilm barrier formed by drug-resistant bacteria due to antibiotic abuse is more difficult to eliminate and more likely to cause dysbiosis, leading to further deterioration of the condition. Traditional Chinese medicine (TCM) is mostly composed of natural ingredients, characterized by low cost and mild side effects. Thousands of years of clinical practice have proven the advantages of TCM in treating infections: simplicity, effectiveness, affordability, and naturalness. For example, the classic TCM surgical formulas recorded in *Yizong Jinjian* are widely used in the prevention and treatment of various infectious diseases, with significant efficacy, and can be considered the "holy medicine" of TCM surgery. However, classic TCM surgical formulas, or existing formulas based on them, all use Coptis chinensis (Huanglian) as the chief ingredient, along with various other herbs. Coptis chinensis, cold in nature and bitter in taste, enters the heart, liver, stomach, and large intestine meridians. Its functions are: clearing heat and drying dampness, purging fire and detoxifying. Although Coptis chinensis has a certain antibacterial effect and a strong inhibitory effect on Gram-positive bacteria, the wound environment exposed in anorectal surgery is complex and faces more bacterial infections. Therefore, the existing classic Coptis chinensis ointment has an unsatisfactory inhibitory effect on bacterial biofilm formation in anorectal surgery.

[0005] Furthermore, existing traditional Chinese medicine formulas for preventing and treating postoperative wound infections in anorectal surgery are mostly ointments or creams. For example, Chinese patent application CN112972368A discloses a pharmaceutical composition for promoting postoperative wound healing in anorectal surgery, which is prepared into a cream formulation using drug-loaded microemulsions, drug-loaded microspheres, stem cell exosomes, liposomes, and gels. The drug-loaded microemulsion is a W / O type emulsion, composed of an aqueous phase, an oil phase, and an emulsifier in a mass ratio of 2–3:6–7:1. The oil phase is one of jojoba oil, sesame oil, olive oil, or sweet almond oil. The presence of the oil phase leads to oil stains in these formulations, making wound cleaning difficult and increasing the pain during dressing changes. Furthermore, inadequate wound cleaning can create a favorable environment for bacterial biofilm formation, increasing the probability of recurrent wound infection and prolonging the healing time.

[0006] Hydrogels are special pharmaceutical preparations that can absorb and retain large amounts of water, promoting wound healing and reducing postoperative symptoms such as pain and edema. For example, Chinese patent document CN110624054B discloses a traditional Chinese medicine compound hydrogel for treating skin wound healing, its preparation method, and its application. This hydrogel is formulated with multi-component traditional Chinese medicine and a carbomer matrix to treat skin wounds, improve the histopathology of damaged skin, and promote the healing of mechanically damaged skin wounds. However, while carbomer, as a synthetic polymer, has good biocompatibility, its biodegradability is poor, posing an allergic risk to some sensitive individuals. Most importantly, carbomer contains a large number of carboxylic acid groups, making it acidic (pH 2.5-3.0). Using it as a gel matrix requires additional pH adjusters to bring the drug to the appropriate pH value. This not only complicates the drug composition but also, since commonly used pH adjusters, such as triethanolamine, are somewhat alkaline, improper use can easily lead to unsuitable pH levels that irritate wounds and increase the difficulty of healing. Furthermore, components like triethanolamine may interact with certain traditional Chinese medicine ingredients, affecting the overall stability of the formulation.

[0007] Furthermore, postoperative care of anorectal wounds presents unique challenges, including the risk of repeated contamination. For complex wounds such as high-lying anal fistulas and perianal abscesses, existing hydrogels often lack sufficient mechanical stability to maintain their integrity within deep wounds. This hinders drug application, shaping, and precise adaptation to the wound's shape and size, as well as filling fistulas and dead spaces. Most importantly, the form of the herbal ingredients directly determines the treatment effect. Since decoctions of traditional Chinese medicine are generally solutions, existing hydrogels struggle to stably encapsulate liquid herbal preparations. This results in rapid release of the liquid during use, failing to achieve long-lasting antibacterial and repairing effects.

[0008] Therefore, developing a traditional Chinese medicine hydrogel suitable for postoperative wound infection of anorectal surgery remains an urgent problem to be solved. Summary of the Invention

[0009] To address the aforementioned problems with existing oil-based ointments, such as difficulty in wound debridement and poor inhibition of bacterial biofilm formation; and the potential for pH irritation to the wound and interactions between pH adjusters and some traditional Chinese medicine components, as well as poor drug encapsulation and lack of long-lasting antibacterial effect when using carbomer and other similar bases to formulate hydrogels, this invention provides a traditional Chinese medicine hydrogel composition for preventing and treating postoperative anorectal wound infections, along with its preparation method and application. Based on classic traditional Chinese medicine surgical formulas and combined with clinical experience, this invention innovates by rationally combining principal, assistant, adjuvant, and guiding herbs to formulate a modified traditional Chinese medicine compound, effectively blocking bacterial biofilm formation and promoting postoperative anorectal wound repair. Simultaneously, it incorporates natural polymer materials to prepare a hydrogel dressing formulation, solving the problem of difficult debridement with oil-based ointments while enhancing the efficacy of the traditional Chinese medicine and facilitating drug infusion into deep wounds such as high-level complex anal fistulas and perianal abscesses. The specific technical solution is as follows:

[0010] First, this invention provides a traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection in anorectal surgery. This composition comprises a traditional Chinese medicine compound and a hydrogel matrix. The traditional Chinese medicine compound consists of the following 12 herbs:

[0011] Chief herbs: Coptis chinensis and Scutellaria baicalensis.

[0012] The following herbs are used as adjuvants: Forsythia, Phellodendron bark, and Rhubarb.

[0013] Adjuvant herbs: turmeric, angelica, rehmannia root, gromwell root, sophora root, purslane.

[0014] Used drug: Borneol;

[0015] The hydrogel matrix includes a gel skeleton and an encapsulating agent;

[0016] The gel skeleton is a natural hydrogel polymer material;

[0017] The encapsulating agent is glycerol, and its amount is 8-10% of the total mass of the hydrogel matrix.

[0018] The aforementioned herbal hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery comprises 12 herbs in the herbal compound, which are distributed in the following proportions by weight: Coptis chinensis 12-36 parts, Scutellaria baicalensis 12-36 parts, Phellodendron chinense 12-36 parts, Curcuma longa 12-36 parts, Rheum palmatum 9-27 parts, Forsythia suspensa 12-36 parts, Sophora flavescens 12-36 parts, Angelica sinensis 18-54 parts, Rehmannia glutinosa 36-108 parts, Portulaca oleracea 12-36 parts, Lithospermum erythrorhizon 9-27 parts, and Borneol 2-6 parts.

[0019] Preferably, in the aforementioned herbal hydrogel composition for preventing postoperative infection of anorectal wounds, the 12 herbs in the herbal compound are, by weight, as follows: Coptis chinensis 12 parts, Scutellaria baicalensis 12 parts, Phellodendron chinense 12 parts, Curcuma longa 12 parts, Rheum palmatum 9 parts, Forsythia suspensa 12 parts, Sophora flavescens 12 parts, Angelica sinensis 18 parts, Rehmannia glutinosa 36 parts, Portulaca oleracea 12 parts, Lithospermum erythrorhizon 9 parts, and Borneol 2 parts.

[0020] The aforementioned herbal hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery, wherein the gel matrix of the hydrogel is any one or a combination of several of hyaluronic acid, alginate, water-soluble chitosan, cellulose, gelatin, agarose, silk protein, and collagen; preferably a combination of hyaluronic acid and water-soluble chitosan; the mass ratio of hyaluronic acid to water-soluble chitosan is 2-4:3-5, preferably 3:4.

[0021] The aforementioned herbal hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery, wherein the hyaluronic acid is non-crosslinked sodium hyaluronate with a molecular weight of 1,000,000 to 1,800,000 Da; and the water-soluble chitosan is carboxymethyl chitosan with a molecular weight of 150 to 250 kDa and a degree of substitution of 35 to 45%.

[0022] Secondly, the present invention provides a method for preparing the aforementioned traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery, comprising the following steps:

[0023] 1) Extraction and preparation of concentrated Chinese medicine liquid: Weigh the raw materials of the Chinese medicine compound, except for borneol, wash the other raw materials with water and decoct and concentrate them, and finally add borneol to prepare concentrated Chinese medicine liquid.

[0024] 2) Preparation of hydrogel framework: Weigh a quantitative amount of the hydrogel matrix's gel framework, dissolve it in an appropriate amount of water, and prepare the hydrogel framework;

[0025] 3) Drug loading: The concentrated Chinese medicine solution prepared in step 1) is added to the hydrogel framework prepared in step 2) while hot, and stirred to disperse the drug in the gaps of the hydrogel framework, forming a hydrogel drug loading system.

[0026] 4) Oil encapsulation: Add glycerin and stir at an appropriate speed to form an oil film on the gaps of the hydrogel skeleton, encapsulating the concentrated Chinese medicine liquid in the gaps of the hydrogel skeleton to form a stable temperature-sensitive in-situ hydrogel drug delivery system. After cooling to room temperature, the Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery can be obtained.

[0027] As a preferred technical solution, in step 1), the specific process of extracting and preparing concentrated traditional Chinese medicine solution is as follows:

[0028] Weigh out the raw materials of the traditional Chinese medicine compound preparation in quantitative terms. Except for borneol, wash the remaining raw materials with water.

[0029] Soak in twice the amount of water at room temperature for 30 minutes; then begin simmering.

[0030] For the first decoction, add 5 times the amount of water, simmer over low heat for 60 minutes, filter the original liquid, and keep the filtrate for later use.

[0031] Continue simmering, add 4 times the amount of water, simmer over low heat for 45 minutes, filter the original liquid, and keep the filtrate for later use.

[0032] Add 3 times the amount of water and simmer over low heat for 30 minutes. Filter the original liquid and keep the filtrate for later use.

[0033] The filtrates from the three decoctions were combined and concentrated at a constant temperature of 60℃ to prepare a concentrated Chinese herbal medicine stock solution with a concentration of 1g / ml.

[0034] Then add ethanol until the ethanol content reaches 70%, let stand for 24 hours, filter, and distill the filtrate at a constant temperature of 60℃ under reduced pressure to remove alcohol, and obtain the concentrated alcohol-precipitated Chinese herbal compound.

[0035] Take the concentrated alcohol-precipitated Chinese herbal medicine, add 4 times the amount of purified water, heat in a 60°C water bath, filter the precipitate with defatted cotton while hot, concentrate under reduced pressure, and then add borneol to obtain a concentrated Chinese herbal medicine solution with a concentration of 1g / ml.

[0036] As a preferred technical solution, in step 2), the specific process of preparing the hydrogel framework is as follows: weigh non-crosslinked sodium hyaluronate and carboxymethyl chitosan according to the mass ratio, add them to distilled water respectively, and prepare a 30 mg / mL sodium hyaluronate solution and a 40 mg / mL carboxymethyl chitosan solution at 60°C; then slowly add the carboxymethyl chitosan solution to the sodium hyaluronate solution at a volume ratio of 1:1, and stir at a speed of 200-300 rpm to mix them thoroughly to obtain the hydrogel framework.

[0037] As a preferred technical solution, in step 3), the volume ratio of the concentrated traditional Chinese medicine solution to the hydrogel skeleton is 5 to 10:1; the temperature of the concentrated traditional Chinese medicine solution is 60°C; and the stirring speed after adding the hydrogel skeleton is 200 to 300 rpm.

[0038] As a preferred technical solution, in step 4), the oil-encapsulation involves cooling the hydrogel drug-carrying system to 35-40°C, adding glycerin, and controlling the stirring speed of the encapsulation to 50-150 rpm.

[0039] In addition, the present invention also provides the application of the aforementioned traditional Chinese medicine hydrogel composition in the preparation of drugs for preventing and treating infections of various anorectal surgical wounds, including the preparation of drugs that prevent the formation of bacterial biofilms in various anorectal surgical wounds and promote wound healing.

[0040] The innovative points and beneficial effects of this invention are as follows:

[0041] 1) The traditional Chinese medicine compound of this invention is based on classic Chinese medicine ointments and powders, combined with clinical experience, and further modified and optimized. First, the traditional Chinese medicine compound of this invention uses Coptis chinensis and Scutellaria baicalensis as the principal herbs. These two herbs have similar properties and effects. Their combination as principal herbs not only enhances the effects of clearing heat and drying dampness, purging fire and detoxifying, but also allows the active ingredients in Coptis chinensis and Scutellaria baicalensis to work synergistically to inhibit the formation of bacterial biofilms. Coptis chinensis has a strong inhibitory effect on Gram-positive bacteria, while Scutellaria baicalensis has a good inhibitory effect on Gram-negative bacteria. Their antibacterial spectra are complementary, providing a more comprehensive coverage of inhibiting different types of bacteria, which helps to inhibit the formation of bacterial biofilms on wounds. In addition, the active ingredient baicalein in Scutellaria baicalensis can interfere with bacterial signaling molecules, preventing bacterial aggregation. Coptis chinensis can degrade bacterial endotoxins, destroy bacterial cells, and inhibit their growth. The combination of these two herbs can more effectively inhibit bacterial colonization, reproduction, and growth, effectively blocking bacterial infection and biofilm formation on postoperative anorectal wounds, thereby inhibiting recurrent wound infections and preventing inflammatory reactions.

[0042] Secondly, the traditional Chinese medicine compound of the present invention uses three herbs, namely Phellodendron bark, rhubarb, and forsythia, as assistant herbs to assist the principal herbs in enhancing their effects of clearing heat and drying dampness, purging fire and detoxifying. At the same time, these three herbs can also promote blood circulation, remove blood stasis, eliminate carbuncles and dissipate nodules, thereby improving the microcirculation of the wound, further preventing bacterial infection of the wound, reducing wound edema and pain, and promoting healing.

[0043] Furthermore, the traditional Chinese medicine compound of this invention uses Angelica sinensis, Curcuma longa, Rehmannia glutinosa, Lithospermum erythrorhizon, Sophora flavescens, and Portulaca oleracea as adjuvant herbs. These six herbs assist the principal and assistant herbs in further enhancing their effects of clearing heat, detoxifying, and drying dampness, while also strengthening their effects of promoting qi and blood circulation, clearing the channels, and relieving pain. Among them, Angelica sinensis and Curcuma longa are warm in nature, which helps to mitigate the adverse effects of the bitter and cold nature of the other herbs, promotes blood circulation, removes blood stasis, clears the channels, and relieves pain. Portulaca oleracea and Rehmannia glutinosa nourish yin, replenish blood, and promote new blood production, thus promoting healing.

[0044] Finally, the traditional Chinese medicine compound of the present invention uses borneol as the guiding herb, taking advantage of its strong pungent aroma and its ability to move and not linger, to guide the other herbs in the formula directly to the affected area, fully exerting the effects of each herb in the formula, thereby achieving broad-spectrum antibacterial and bactericidal effects, effectively inhibiting bacterial bioformation, while also improving local microcirculation, accelerating metabolism, and promoting the healing of surgical wounds after anorectal surgery.

[0045] 2) The herbal hydrogel composition of this invention not only effectively solves the problem of oil stains in traditional Chinese medicine ointments and powders, but also has good formability, is easy to use, has a long-lasting effect, and is conducive to wound healing. Specifically, the hydrogel matrix of the herbal hydrogel composition of this invention uses natural hydrogel polymer materials as a framework, which not only has good biocompatibility and biodegradability, further ensuring the safety of the drug; at the same time, the natural hydrogel framework has good adhesion and shaping ability, which is beneficial for drug irrigation in deep wounds such as high-level complex anal fistulas and perianal abscesses.

[0046] Furthermore, the matrix framework formed by the natural hydrogel polymer material has a three-dimensional structure, which allows the concentrated traditional Chinese medicine liquid to be evenly dispersed and encapsulated within it. This, combined with glycerin encapsulation, creates a stable, temperature-sensitive in-situ hydrogel drug delivery system. During use, the traditional Chinese medicine hydrogel composition is applied directly to the wound, slowly releasing the liquid through the influence of body temperature, prolonging the drug's residence time at the application site and improving bioavailability.

[0047] 3) The herbal hydrogel composition of this invention uses glycerol as an encapsulating agent, which enables the concentrated herbal liquid to be stably encapsulated within the natural hydrogel matrix framework, preventing the liquid from being lost. At the same time, the amount of glycerol is controlled to 8-10% of the total mass of the hydrogel matrix, which helps to maintain the stability of the three-dimensional network structure of the natural hydrogel matrix framework and maintain the shaping and shaping ability of the gel composition, so as to achieve controlled drug release and adapt to long-term stable drug administration treatment on anorectal surgical wounds. It also helps to reduce the microbial load on the wound, reduce the susceptibility to bacterial colonization, promote the proliferation and migration of keratinocytes and fibroblasts, and further accelerate wound healing.

[0048] 4) The herbal hydrogel composition of the present invention contains natural hydrogel polymer materials rich in active groups, which can combine with the components in the herbal medicine to give them specific properties or drug sustained-release capabilities, which is conducive to the continuous and stable release of the efficacy of the herbal compound and enhances the drug efficacy; the two work together to further help solve the problems of easy contamination, bacterial colonization and growth, and bacterial biofilm formation in open drainage incisions after clinical anorectal surgery.

[0049] In particular, when using a combination of hyaluronic acid and water-soluble chitosan as the gel framework, the hyaluronic acid molecules contain carboxyl and hydroxyl groups. The carboxyl groups carry a negative charge in aqueous solution and can bind to the amino groups (positively charged molecules) in chitosan molecules through electrostatic interactions. The hydroxyl groups participate in the formation of intermolecular hydrogen bonds and interact with the carboxymethyl groups in water-soluble chitosan, which helps stabilize the hydrogel structure. At the same time, the combined gel framework of hyaluronic acid and water-soluble chitosan can interact with various chemical groups in traditional Chinese medicine components through its active groups, thereby achieving effective drug delivery and controlled release. Traditional Chinese medicine compound prescriptions often contain alkaloids such as Coptis chinensis, Scutellaria baicalensis, Forsythia suspensa, Phellodendron chinense, and Rheum palmatum. These alkaloids are typically alkaline and can electrostatically interact with the carboxyl groups in hyaluronic acid and water-soluble chitosan. Other herbs like Curcuma longa, Angelica sinensis, Rehmannia glutinosa, Lithospermum erythrorhizon, and Sophora flavescens contain phenolic compounds. The hydroxyl groups of these compounds can form hydrogen bonds with the carboxyl or amino groups in hyaluronic acid and water-soluble chitosan. Portulaca oleracea contains various bioactive substances, including fatty acids and flavonoids, which may bind to the hydrogel framework through hydrophobic interactions or hydrogen bonds. Borneol, a monoterpene compound, is hydrophobic and may interact with the hydrogel framework through hydrophobic interactions. This not only improves drug bioavailability but also optimizes drug release rates and therapeutic effects by adjusting the physicochemical properties of the hydrogel.

[0050] Clinical applications have confirmed that the herbal hydrogel composition of this invention can directly act on the lesion site, effectively prevent the formation of bacterial biofilm on the anorectal wound, and exert anti-inflammatory, analgesic, anti-swelling, blood-activating and tissue-regenerating effects, thereby inhibiting infection, relieving symptoms such as swelling, pain, bleeding and exudation, promoting recovery, effectively reducing patient suffering, and has important medical value. Attached Figure Description

[0051] Figure 1 The image shown is a scanning electron microscope (SEM) image (×2700) of the traditional Chinese medicine hydrogel composition prepared in Example 2 of the present invention.

[0052] Figure 2 This refers to the antibacterial results of Product 1 (traditional Chinese medicine hydrogel composition) against Escherichia coli in Example 4 of the present invention;

[0053] Figure 3 This refers to the antibacterial results of Product 2 (classic square hydrogel group) against Escherichia coli in Example 4 of this invention;

[0054] Figure 4 This refers to the antibacterial results of Product 3 (classic ointment) against Escherichia coli in Example 4 of this invention;

[0055] Figure 5 This refers to the antibacterial results of Product 1 (traditional Chinese medicine hydrogel composition) against Staphylococcus aureus in Example 4 of the present invention;

[0056] Figure 6 The antibacterial results of Product 2 (classic square hydrogel group) against Staphylococcus aureus in Example 4 of this invention.

[0057] Figure 7 This refers to the antibacterial results of Product 3 (classic ointment) against Staphylococcus aureus in Example 4 of the present invention;

[0058] Figure 8 The image shows the wound healing status of rats on days 3, 7, and 14 of treatment in Example 5 of this invention.

[0059] Figure 9 This is the result of the traditional Chinese medicine hydrogel composition in Example 5 of the present invention inhibiting bacterial biofilm;

[0060] Figure 10 This is the result of the classic ointment in Example 5 of the present invention inhibiting bacterial biofilm;

[0061] Figure 11 This is a pathological section of the infected wound in the rat animal model of Example 5 of the present invention;

[0062] Figure 12 The wound treated with the classic ointment in Example 5 of this invention;

[0063] Figure 13 This refers to the wound treated with the classic square hydrogel in Example 5 of this invention;

[0064] Figure 14 The wound treated with the hydrogel of the present invention in Example 5 of the present invention;

[0065] Figure 15 These are before and after photos of the treatment of postoperative anorectal infection wounds in a clinical patient in Example 8 of this invention;

[0066] Figure 16 This is a bacterial smear of the surgical wound of a patient after anorectal surgery in Example 8 of the present invention;

[0067] Figure 17 These are pathological sections of the anorectal wound before and after surgery in Example 8 of this invention. Detailed Implementation

[0068] To make the objectives, technical solutions, and advantages of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with embodiments.

[0069] Example 1

[0070] This embodiment addresses the shortcomings of traditional Chinese medicine formulas, which are mostly ointments or creams, such as oil stains and poor formability, as well as the unsuitability of carbomer-based hydrogels for postoperative anorectal wound repair. It proposes a Chinese medicine hydrogel composition for preventing postoperative anorectal wound infection, along with its preparation method and application. Based on classic Chinese medicine ointments and powders, and combined with clinical experience, a modified and optimized Chinese medicine compound is formed. A natural hydrogel polymer material is used as the framework, and glycerin is used as an encapsulating agent to encapsulate the concentrated medicinal liquid of the compound, forming a stable drug delivery system. This achieves the combination of Chinese medicine preparation and hydrogel, effectively solving the shortcomings of traditional ointments and powders, such as oil stains, poor formability, and inconvenience of use, as well as the problems of easy contamination, bacterial colonization, and bacterial biofilm formation in open drainage incisions after anorectal surgery.

[0071] The herbal hydrogel composition for preventing postoperative wound infection of anorectal surgery in this embodiment consists of a herbal compound and a hydrogel matrix. The herbal compound is based on classic Chinese medicine ointments and powders, combined with clinical experience, and further modified and optimized. It consists of the following 12 herbs: Coptis chinensis, Scutellaria baicalensis, Forsythia suspensa, Phellodendron chinense, Rheum palmatum, Curcuma longa, Angelica sinensis, Rehmannia glutinosa, Lithospermum erythrorhizon, Sophora flavescens, Portulaca oleracea, and Borneol.

[0072] The traditional Chinese medicine compound in this embodiment uses Coptis chinensis and Scutellaria baicalensis as the principal herbs. These two herbs share similar properties and effects; their combination as the principal herbs not only enhances their effects of clearing heat and drying dampness, purging fire and detoxifying, but also allows the active ingredients in Coptis chinensis and Scutellaria baicalensis to work synergistically to inhibit bacterial biofilm formation. Coptis chinensis has a strong inhibitory effect on Gram-positive bacteria, while Scutellaria baicalensis has a good inhibitory effect on Gram-negative bacteria. Their antibacterial spectra are complementary, allowing them to more comprehensively cover different types of bacteria when inhibiting wound bacteria. Furthermore, the active ingredient baicalein in Scutellaria baicalensis can interfere with bacterial signaling molecules, preventing bacterial aggregation, while the active ingredient in Coptis chinensis can degrade bacterial endotoxins, destroying bacterial cells and inhibiting bacterial growth. Therefore, the combination of these two herbs can more effectively inhibit bacterial infection and biofilm formation in postoperative anorectal wounds, suppress inflammatory responses, improve local microcirculation, and accelerate metabolism, resulting in significant efficacy in preventing and treating postoperative anorectal wound infections and promoting wound healing.

[0073] The formula uses three herbs—Phellodendron bark, rhubarb, and forsythia—as assistant herbs to enhance the effects of clearing heat and drying dampness, purging fire and detoxifying. At the same time, these three herbs can also promote blood circulation, remove blood stasis, eliminate carbuncles and dissipate nodules, thereby improving the microcirculation of the wound, further preventing bacterial infection of the wound, reducing wound edema and pain, and promoting healing.

[0074] With Angelica sinensis, Curcuma longa, Rehmannia glutinosa, Lithospermum erythrorhizon, Sophora flavescens, and Portulaca oleracea as adjuvant herbs, these six herbs assist the principal and assistant herbs in further enhancing their effects of clearing heat, detoxifying, and drying dampness, while also strengthening their effects of promoting qi and blood circulation, unblocking meridians, and relieving pain. Among them, Angelica sinensis and Curcuma longa are warm in nature, which helps to mitigate the adverse effects of the bitter and cold nature of the other herbs, promotes blood circulation, removes blood stasis, unblocks meridians, and relieves pain, while Portulaca oleracea and Rehmannia glutinosa nourish yin, replenish blood, and promote new blood production, thus promoting healing.

[0075] Borneol is used as the guiding ingredient, taking advantage of its strong pungent aroma and its ability to move and not stay still. It guides the other ingredients in the prescription directly to the affected area, giving full play to the effects of each ingredient in the prescription, thereby achieving broad-spectrum antibacterial and bactericidal effects, effectively inhibiting bacterial growth, and promoting wound healing.

[0076] In this embodiment, the dosage of the 12 herbs in the traditional Chinese medicine compound formula, by weight, is as follows: Coptis chinensis 12-36 parts, Scutellaria baicalensis 12-36 parts, Phellodendron chinense 12-36 parts, Curcuma longa 12-36 parts, Rheum palmatum 9-27 parts, Forsythia suspensa 12-36 parts, Sophora flavescens 12-36 parts, Angelica sinensis 18-54 parts, Rehmannia glutinosa 36-108 parts, Portulaca oleracea 12-36 parts, Lithospermum erythrorhizon 9-27 parts, and Borneol 2-6 parts. A preferred formula is: Coptis chinensis 12 parts, Scutellaria baicalensis 12 parts, Phellodendron chinense 12 parts, Curcuma longa 12 parts, Rheum palmatum 9 parts, Forsythia suspensa 12 parts, Sophora flavescens 12 parts, Angelica sinensis 18 parts, Rehmannia glutinosa 36 parts, Portulaca oleracea 12 parts, Lithospermum erythrorhizon 9 parts, and Borneol 2 parts.

[0077] In this embodiment, the hydrogel matrix comprises a gel skeleton and an encapsulating agent. The gel skeleton is a natural hydrogel polymer material, including any one or a combination of several of hyaluronic acid, alginate, water-soluble chitosan, cellulose, gelatin, agarose, silk fibroin, and collagen; the encapsulating agent is glycerol. Natural hydrogel polymer materials not only possess good biocompatibility and biodegradability, but also, because their pH value is approximately between 5 and 8, eliminate the need for additional pH adjusters, including triethanolamine, to adjust the pH value, avoiding the introduction of allergenic components, simplifying the drug composition of the pure product, and further ensuring drug safety. In this embodiment, the natural hydrogel polymer material forms a three-dimensional matrix skeleton, dispersing and encapsulating the concentrated traditional Chinese medicine liquid prepared from the compound herbal medicine within it, and then encapsulating it with glycerol, thus stabilizing the drug-carrying system and forming a stable, temperature-sensitive in-situ hydrogel drug delivery system. This system has a long-lasting effect, is easy to coat and clean, and effectively solves the shortcomings of traditional ointments and powders, such as oil stains, poor formability, and inconvenience in use. Meanwhile, natural hydrogel polymers are rich in active groups, which can combine with components in traditional Chinese medicine to impart specific properties or sustained-release capabilities, thus facilitating the continuous and stable release of the efficacy of traditional Chinese medicine compound preparations and enhancing drug efficacy. The synergistic effect of these two factors effectively addresses the problems of easy contamination, bacterial colonization, and biofilm formation in open drainage incisions after anorectal surgery. For example, using a combination of hyaluronic acid and water-soluble chitosan as the hydrogel matrix framework, the amino groups (-NH2) in water-soluble chitosan can covalently cross-link with the aldehyde groups (-CHO) in hyaluronic acid through a Schiff base reaction, forming a stable hydrogel structure and enhancing the mechanical strength and stability of the hydrogel. Specifically, hyaluronic acid molecules contain carboxyl and hydroxyl groups. The carboxyl groups carry a negative charge in aqueous solution and can combine with the amino groups (positively charged molecules) in chitosan molecules through electrostatic interactions; the hydroxyl groups participate in the formation of intermolecular hydrogen bonds, interacting with the carboxymethyl groups in water-soluble chitosan, which helps stabilize the hydrogel structure. Furthermore, natural hydrogel polymer materials can interact with various chemical groups in traditional Chinese medicine components through their active groups, thereby achieving effective drug delivery and controlled release. In this embodiment, the traditional Chinese medicine compound contains alkaloids such as Coptis chinensis, Scutellaria baicalensis, Forsythia suspensa, Phellodendron chinense, and Rheum palmatum. These alkaloids are generally alkaline and can interact electrostatically with the carboxyl groups in hyaluronic acid and water-soluble chitosan. Curcuma longa, Angelica sinensis, Rehmannia glutinosa, Lithospermum erythrorhizon, and Sophora flavescens contain phenolic compounds, whose hydroxyl groups can form hydrogen bonds with the carboxyl or amino groups in hyaluronic acid and water-soluble chitosan. Portulaca oleracea contains various bioactive substances, including fatty acids and flavonoids, which may bind to the hydrogel framework through hydrophobic interactions or hydrogen bonds. Borneol is a monoterpene compound that is hydrophobic and may interact with the hydrogel framework through hydrophobic interactions. This not only improves the bioavailability of the drug but also optimizes the drug release rate and therapeutic effect by adjusting the physicochemical properties of the hydrogel.

[0078] Studies show that due to surgical damage and microvascular leakage, the pH value of the wound increases, approaching the physiological pH value (7.4) that is conducive to bacterial infection. In an environment with a pH of approximately pH 7.4, the hydrogel framework of hyaluronic acid and water-soluble chitosan exhibits a weakened bond between the carboxyl group of hyaluronic acid and the amino group of chitosan molecules. Simultaneously, the binding force with alkaloid-containing components such as Coptis chinensis, Scutellaria baicalensis, Forsythia suspensa, Phellodendron chinense, and Rheum palmatum weakens. This alters the gel structure, releases drug components, inhibits bacterial growth in the wound, reduces the microbial load on the skin surface, lowers susceptibility to bacterial colonization, and prevents bacterial biofilm formation. Furthermore, it creates a suitable pH environment for the proliferation and migration of keratinocytes and fibroblasts, and, under the influence of components such as Angelica sinensis, Curcuma longa, Portulaca oleracea, and Rehmannia glutinosa, promotes yin-nourishing and tissue regeneration, thus accelerating wound healing.

[0079] In this embodiment, the preferred mass ratio of hyaluronic acid to water-soluble chitosan is 3:4, and the amount of glycerol used is 8-10% of the total mass of the hydrogel matrix. This makes the prepared herbal hydrogel composition soft in texture, with a suitable porous structure to provide drug-carrying space, while having good water absorption and moisturizing properties, good gel shaping ability and mechanical stability. This is to meet the needs of deep wounds such as high-level complex anal fistulas and perianal abscesses, which is conducive to drug application and shaping, adapting to the shape and size of the wound, and filling fistulas and dead cavities, thus increasing the application potential of the herbal hydrogel composition.

[0080] In this embodiment, the preparation method of the traditional Chinese medicine hydrogel composition includes the following steps:

[0081] 1) Preparation of concentrated traditional Chinese medicine solution: Weigh the raw materials of the traditional Chinese medicine compound, except for borneol, wash with water, decoct and concentrate, then add borneol to prepare a concentrated traditional Chinese medicine solution; the specific process is as follows:

[0082] Weigh out the raw materials of the traditional Chinese medicine compound preparation in quantitative terms. Except for borneol, wash the remaining raw materials with water, add twice the amount of water, and soak at room temperature for 30 minutes.

[0083] For the first decoction, add 5 times the amount of water, simmer over low heat for 60 minutes, filter the original liquid, and keep the filtrate for later use.

[0084] Continue simmering, add 4 times the amount of water, simmer over low heat for 45 minutes, filter the original liquid, and keep the filtrate for later use.

[0085] Add 3 times the amount of water and simmer over low heat for 30 minutes. Filter the original liquid and keep the filtrate for later use.

[0086] The filtrates from the three decoctions were combined and concentrated at a constant temperature of 60℃ to prepare a concentrated Chinese herbal medicine stock solution with a concentration of 1g / ml.

[0087] Then add ethanol until the ethanol content reaches 70%, let stand for 24 hours, filter, and distill the filtrate at a constant temperature of 60℃ under reduced pressure to remove alcohol, and obtain the concentrated alcohol-precipitated Chinese herbal compound solution.

[0088] Take the concentrated alcohol-precipitated Chinese herbal medicine, add 4 times the amount of purified water, heat in a 60°C water bath, filter the precipitate while hot with defatted cotton, concentrate under reduced pressure, and then add borneol to obtain a concentrated Chinese herbal medicine solution with a concentration of 1g / ml for later use.

[0089] 2) Preparation of the hydrogel framework: A quantitative amount of the hydrogel matrix's gel framework is weighed and dissolved in water to prepare the hydrogel framework. Taking a combination of hyaluronic acid and water-soluble chitosan as an example, hyaluronic acid and chitosan are weighed according to a set mass ratio and added separately to distilled water to prepare hyaluronic acid solution and chitosan solution. These are then mixed evenly according to a set volume ratio: concentrated traditional Chinese medicine solution: hydrogel framework = 5–10:1 to obtain the hydrogel framework for later use. To form a suitable three-dimensional network structure for drug loading, the stirring speed after mixing the hyaluronic acid solution and chitosan solution should be 200–300 rpm.

[0090] 3) Drug loading: The concentrated Chinese medicine solution prepared in step 1) is added to the hydrogel framework prepared in step 2) while hot, and stirred at a speed of 200-300 rpm to disperse the drug in the gaps of the hydrogel framework and form a hydrogel drug loading system.

[0091] 4) Oil-encapsulation: The hydrogel drug-loaded system is cooled to 35–45°C, and glycerol is added to form an oil film on the gaps of the hydrogel framework. The concentrated traditional Chinese medicine liquid is then encapsulated within the gaps of the hydrogel framework. After cooling to room temperature, a traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery is obtained. To ensure that the glycerol uniformly coats the gaps of the hydrogel framework without breaking it, and without affecting the gel framework system, the stirring speed for oil-encapsulation in the preparation method described in this invention is set to 50–150 rpm.

[0092] In addition, this embodiment also provides the application of the aforementioned traditional Chinese medicine hydrogel composition in the prevention and treatment of various anorectal surgical wound infections, specifically including preventing the formation of bacterial biofilms in various anorectal surgical wounds and promoting wound healing.

[0093] Example 2

[0094] This embodiment describes the preparation of a traditional Chinese medicine hydrogel composition for preventing postoperative wound infection of anorectal surgery using the method described in Example 1. All the raw materials used in this embodiment were commercially available; the hyaluronic acid used was non-crosslinked sodium hyaluronate (brand: Tianguangyuan Biotechnology, molecular weight 100-180 million Da); the water-soluble chitosan used was carboxymethyl chitosan (Sinopharm Chemical Reagent Co., Ltd., molecular weight 150-250 kDa, degree of substitution 35-45%); and glycerol (glycerol, brand: Shanghai Guoyao, analytical purity). The specific preparation process is as follows:

[0095] Step 1: Extraction and preparation of concentrated traditional Chinese medicine liquid

[0096] Weigh out 12g of Coptis chinensis, 12g of Scutellaria baicalensis, 12g of Phellodendron chinense, 12g of Curcuma longa, 9g of Rheum palmatum, 12g of Forsythia suspensa, 12g of Sophora flavescens, 18g of Angelica sinensis, 36g of Rehmannia glutinosa, 12g of Portulaca oleracea, 9g of Lithospermum erythrorhizon, and 2g of Borneol. Set the Borneol aside separately. Mix the remaining 11 herbs together, rinse with water until clear, add twice the amount of water and soak for 30 minutes; then begin decoction:

[0097] For the first decoction, add 5 times the amount of water, simmer over low heat for 60 minutes, filter the original liquid, and keep the filtrate for later use.

[0098] Continue simmering, add 4 times the amount of water, simmer over low heat for 45 minutes, filter the original liquid, and keep the filtrate for later use.

[0099] Add 3 times the amount of water and simmer over low heat for 30 minutes. Filter the original liquid and keep the filtrate for later use.

[0100] The filtrates from the three decoctions were combined and concentrated at a constant temperature of 60℃ to prepare a concentrated Chinese herbal medicine stock solution with a concentration of 1g / ml.

[0101] Then add ethanol until the ethanol content reaches 70%, let stand for 24 hours, filter, and distill the filtrate at a constant temperature of 60℃ under reduced pressure to remove alcohol, and obtain the concentrated alcohol-precipitated Chinese herbal compound.

[0102] Finally, take the concentrated alcohol-precipitated solution of the Chinese herbal medicine, add 4 times the amount of purified water, heat in a 60°C water bath, filter the precipitate with defatted cotton while hot, concentrate under reduced pressure, and then add borneol to obtain a concentrated Chinese herbal medicine solution with a concentration of 1g / ml for later use.

[0103] The second step is to prepare the hydrogel framework.

[0104] While preparing the concentrated traditional Chinese medicine solution, 30g of non-crosslinked sodium hyaluronate and 40g of carboxymethyl chitosan were weighed and added to 1000mL of distilled water respectively. The mixture was heated to 60℃ to fully dissolve the medicines, resulting in a 30mg / mL sodium hyaluronate solution and a 40mg / mL chitosan solution. The chitosan solution was then slowly added to the sodium hyaluronate solution, with the addition completed within 10 minutes, while stirring at 200rpm to obtain a hydrogel framework for later use.

[0105] The third step is drug loading.

[0106] The extracted concentrated Chinese herbal medicine was added to the hydrogel matrix solution while it was still hot (60°C). The volume ratio of the concentrated Chinese herbal medicine to the hydrogel matrix was 10:1. The mixture was stirred at 200 rpm for 15 minutes to ensure that the concentrated Chinese herbal medicine was fully dispersed in the hydrogel matrix and to form a drug-loaded system.

[0107] Step 4: Oil-filled packaging

[0108] The temperature of the drug-loaded system solution was lowered to 40℃, glycerol was added at a rate of 9% of the total mass of the hydrogel matrix, and the stirring speed was reduced to 80 rpm for 20 minutes. The mixture was then allowed to cool to room temperature to obtain the traditional Chinese medicine hydrogel composition (Product 1) for preventing and treating postoperative wound infection in anorectal surgery. Its microstructure is as follows: Figure 1 As shown.

[0109] Example 3

[0110] This embodiment describes the preparation of a hydrogel using a traditional Chinese medicine compound formula from the classic surgical formula recorded in the *Yizong Jinjian* (Golden Mirror of Medicine). The classic formula consists of: Coptis chinensis 9g, Angelica sinensis 15g, Phellodendron chinense 9g, Rehmannia glutinosa 30g, Curcuma longa 9g, sesame oil 360g, and beeswax 120g.

[0111] The preparation method of the hydrogel is the same as in Example 2, except for the preparation method of the concentrated traditional Chinese medicine stock solution. All other steps and the materials used, such as hyaluronic acid, water-soluble chitosan, and glycerin, are identical. The preparation method of the concentrated traditional Chinese medicine stock solution is as follows:

[0112] Since 360g of sesame oil and 120g of beeswax are the base for preparing the ointment, these two ingredients are omitted in this embodiment. Weigh out 9g of Coptis chinensis, 15g of Angelica sinensis, 9g of Phellodendron chinense, 30g of Rehmannia glutinosa, and 9g of Curcuma longa. Mix them, wash with water until clear, add twice the amount of water, soak for 30 minutes, and then begin decoction.

[0113] For the first decoction, add 5 times the amount of water, simmer over low heat for 60 minutes, filter the original liquid, and keep the filtrate for later use.

[0114] Continue simmering, add 4 times the amount of water, simmer over low heat for 45 minutes, filter the original liquid, and keep the filtrate for later use.

[0115] Add 3 times the amount of water and simmer over low heat for 30 minutes. Filter the original liquid and keep the filtrate for later use.

[0116] The filtrates from the three decoctions were combined and concentrated at a constant temperature of 60℃ to prepare a concentrated Chinese herbal medicine stock solution with a concentration of 1g / ml.

[0117] Then add ethanol until the ethanol content reaches 70%, let stand for 24 hours, filter, and distill the filtrate at a constant temperature of 60℃ under reduced pressure to remove alcohol, and obtain the concentrated alcohol-precipitated Chinese herbal compound solution.

[0118] Finally, take the concentrated alcohol-precipitated solution of the Chinese herbal medicine, add 4 times the amount of purified water, heat in a 60°C water bath, filter the precipitate with defatted cotton while hot, concentrate under reduced pressure, and then add borneol to obtain a concentrated Chinese herbal medicine solution with a concentration of 1g / ml.

[0119] Then, the concentrated Chinese medicine liquid was added to the hydrogel matrix and encapsulated in an oil to obtain the hydrogel (product 2). The drug loading and oil encapsulation steps were the same as in Example 2.

[0120] Example 4

[0121] This embodiment examines the antibacterial properties of the herbal hydrogel composition (product 1) prepared in Example 2, and compares it with the classic formula hydrogel (product 2) prepared in Example 3 and the classic formula ointment. The preparation method of the classic formula ointment is as follows (preparation of Coptis chinensis ointment by the "Zha Ku" method in "Yi Zong Jin Jian"): According to the proportions of the classic formula: Coptis chinensis 9g, Angelica sinensis 15g, Phellodendron chinense 9g, Rehmannia glutinosa 30g, Curcuma longa 9g, weigh out the medicinal materials, put the medicinal materials directly into 5 times the amount of sesame oil, fry at 200℃ for 4 hours, remove the residue, add 1 times the amount of beeswax, mix well, cool, solidify, and collect the ointment to obtain the classic formula ointment (product 3).

[0122] The evaluation method was to determine the antibacterial effects of each product against Escherichia coli and Staphylococcus aureus using the KB method.

[0123] Inside the biosafety cabinet, prepare a suspension of standard strains of *E. coli* and *Staphylococcus aureus* with a turbidity of 0.5 McFarland. Using a sterile cotton swab, evenly spread the suspension onto an MH agar plate, rotate the plate 60°, and repeat the streaking process three times. Finally, also spread bacteria along the edge of the agar plate. Place prepared drug sensitivity test strips (1cm diameter sterile circular filter paper strips, soaked in a classic formula ointment, a classic formula thermosensitive hydrogel, and the herbal thermosensitive hydrogel composition of this invention, respectively, overnight at 4°C to fully saturate the drug) flat on the agar plate. After placing the 6mm diameter drug sensitivity test strips, place the plate face up in a 35°C incubator for 24 hours. The experimental results can be observed after 24 hours, as shown in Table 1. Figures 2 to 7 As shown.

[0124] Table 1. Diameter of the inhibition zone for each product (x±s, mm)

[0125]

[0126] From Table 1 and Figures 2 to 7The results show that, compared to the classic formula ointment of Product 3, both the herbal hydrogel composition of this invention (Product 1) and the classic formula hydrogel (Product 2) have better antibacterial effects against Escherichia coli and Staphylococcus aureus, and the antibacterial effect of the herbal hydrogel composition of this invention (Product 1) is superior to that of the classic formula hydrogel (Product 2). This indicates that the herbal compound of the herbal hydrogel composition of this invention is superior to the classic formula, and the hydrogel dosage form is superior to the ointment dosage form.

[0127] Example 5

[0128] This embodiment examines the preventive and therapeutic effects of the traditional Chinese medicine hydrogel composition prepared in Example 2 on inhibiting bacterial biofilm formation on contaminated wounds on the back of mice and promoting wound healing.

[0129] In this embodiment, the test sample includes:

[0130] Sample 1: The herbal hydrogel composition prepared in Example 2 (Product 1).

[0131] Sample 2: The concentrated Chinese medicine solution with a concentration of 1 g / ml prepared in Example 2 was cooled to room temperature.

[0132] Sample 3: The hydrogel framework prepared in Example 2 was not subjected to drug loading, but was encapsulated in oil. The encapsulation operation was the same as in Example 2, and the sample was cooled to room temperature.

[0133] Sample 4: Hydrogel prepared in Example 3 (Product 2).

[0134] Sample 5: Ointment prepared according to the classic formula in Example 4 (Product 3).

[0135] The investigation process is as follows:

[0136] 1) Modeling: A contaminated wound model on the back of a rat was used. Thirty healthy experimental rats were selected, their skin was prepared, and a circular wound with a diameter of approximately 2.0 cm was made using a wound-making instrument, reaching the muscle layer. The thickness of the muscle layer wound was approximately 0.3 cm. After hemostasis, 0.5 ml of Staphylococcus aureus (ATCC6583 10) was applied to the wound. 6 Soak the wound in a solution of CFU / mL for 1 hour, then secure it with Vaseline gauze, dressing, and tape. Feed the wound appropriately after the operation. Remove the covering after 48 hours. If there is purulent discharge or a foul odor from the wound, observe the formation of bacterial biofilm on the wound at 3, 5, and 7 days. The formation of the bacterial biofilm is considered successful when the characteristic structure of the bacterial biofilm is detected.

[0137] 2) Grouping: The successfully modeled rats were divided into 5 groups.

[0138] Group 1: Hydrogel treatment group of the present invention; Treatment method: The traditional Chinese medicine hydrogel composition (product 1) prepared in Example 2 was applied to the wound, covered and fixed with sterile gauze, once a day until the end of the in vivo experiment;

[0139] Group 2: Concentrated Chinese medicine solution treatment group; Treatment method: The concentrated Chinese medicine solution with a concentration of 1g / ml prepared in Example 2 was applied to the wound, covered and fixed with sterile gauze, once a day until the end of the in vivo experiment;

[0140] Group 3: Hydrogel skeleton treatment group; Treatment method: The hydrogel skeleton prepared in Example 2 was applied to the wound, covered and fixed with sterile gauze, once a day until the end of the in vivo experiment;

[0141] Group 4: Classic hydrogel treatment group; Treatment method: The hydrogel (product 2) prepared in Example 3 was applied to the wound, covered and fixed with a dressing, once a day until the end of the in vivo experiment;

[0142] Group 5: Classic Ointment Treatment Group; Treatment Method: The ointment (Product 3) prepared according to the classic formula in Example 4 was applied to the wound, covered and fixed with a dressing, once a day until the end of the in vivo experiment.

[0143] 3) Sampling: All specimens were collected under sterile conditions. After 14 days of treatment, the rats were euthanized by overdose anesthesia.

[0144] The evaluation criteria are as follows:

[0145] (1) Determination of wound healing rate:

[0146] Wound healing was observed on days 3, 7, and 14 post-treatment. ImageJ software was used to measure and compare the changes in wound area before and after treatment in each group. Wound healing on days 7 and 14 post-treatment was analyzed, and the wound healing rate was calculated.

[0147] Wound healing rate (%) = (Original wound area - Unhealed wound area) / Original wound area × 100%

[0148] The results are shown in Table 2 and Figure 8 Show.

[0149] Table 2. Comparison of wound healing rates among different groups in the rat animal model (%)

[0150]

[0151] From Table 2 and Figure 8The results show that the wound healing rate of the herbal hydrogel composition (product 1) and the classic formula hydrogel (product 2) of this invention is better than that of the classic formula ointment (product 3). Moreover, the healing rate of the herbal hydrogel composition (product 1) of this invention is better than that of the classic formula hydrogel (product 2), indicating that the herbal compound of the herbal hydrogel composition of this invention is better than the classic formula, and the hydrogel dosage form is better than the ointment dosage form. In addition, the wound healing rate of the herbal preparation concentrate and the hydrogel skeleton of this invention is not as good as that of the herbal hydrogel composition (product 1), indicating that combining the herbal preparation concentrate with the hydrogel skeleton improves its effect on promoting wound healing.

[0152] (2) Observation of bacterial biofilm:

[0153] Qualitative identification: Tissue samples from the infected wounds of rats were taken on postoperative days 3 and 7, respectively. Biofilm growth was observed under scanning electron microscopy, and statistical comparisons were performed. Columnar or mushroom-shaped structures observed under scanning electron microscopy indicated the formation of a bacterial biofilm. Figure 9 and Figure 10 As shown.

[0154] Biofilm growth was graded as follows: Grade I: Free-floating planktonic cells were visible, adhering to the biofilm; Grade II: Small colonies and cell groups formed; Grade III: Small colonies were interconnected through extracellular matrix fibers, forming spiderweb-like microcolonies (towers); Grade IV: Towers with underground channels and amorphous extracellular material formed, exhibiting a honeycomb structure. Biofilm growth was graded as 1, 2, 3, and 4 respectively. The statistical results are shown in Table 3.

[0155] Table 3. Comparison of biofilm growth in different groups of rat animal models (P25, P75)

[0156]

[0157] As shown in Table 3, compared to the classic formula ointment of Product 3, both the herbal hydrogel composition of this invention (Product 1) and the classic formula hydrogel (Product 2) exhibit better inhibitory effects on bacterial biofilms, and the inhibitory effect of the herbal hydrogel composition of this invention (Product 1) is superior to that of the classic formula hydrogel (Product 2). This indicates that the herbal compound of the herbal hydrogel composition of this invention is superior to the classic formula, and the hydrogel dosage form is superior to the ointment dosage form. Furthermore, the antibacterial effects of the concentrated herbal preparation and the hydrogel framework of this invention are both inferior to those of the herbal hydrogel composition (Product 1), indicating that combining the concentrated herbal preparation with the hydrogel framework enhances its antibacterial effect and effectively prevents the formation of bacterial biofilms.

[0158] (3) Pathological observation of granulation tissue in the wound:

[0159] On postoperative days 7 and 14, newly formed granulation tissue, approximately 0.5cm x 0.5cm in size, was collected from the wound edge to the center. Immediately after successful collection, the tissue was fixed in 4% paraformaldehyde solution for 24 hours, followed by routine dehydration and clearing, paraffin embedding, and 4μm serial sectioning for pathological observation. The growth of capillaries and fibroblasts in the granulation tissue of different rat animal models was compared. Figure 11 As shown in the figure, the herbal hydrogel composition of this invention has the best effect in inhibiting inflammatory response and promoting wound healing compared with concentrated herbal liquid, hydrogel framework and classic formula hydrogel. This proves the advantages of the herbal hydrogel composition of this invention in promoting the growth of capillaries and fibroblasts in granulation tissue and promoting wound healing.

[0160] Simultaneously, granulation tissue from near the wound edge was collected, fixed in Carnoy's solution for 45 minutes, embedded in paraffin, sectioned, and subjected to routine HE staining for observation under a light microscope. Figures 12 to 14 As shown in Tables 4 and 5. Specifically, the capillaries and fibroblasts in the granulation tissue of rat animal models were statistically analyzed using light microscopy and the MPIAS-400 computer-aided color pathological image analysis system. The specific procedures were as follows: ① General observation; ② Observation of 5 fields of view for each specimen, counting the number of fibroblasts in the granulation tissue, and calculating the mean (number of fibroblasts / average per field of view); ③ Observation of 3 fields of view for each specimen, counting the number of newly formed capillaries, and calculating the average value per field of view.

[0161] Table 4. Comparison of capillary vessels in granulation tissue of wounds in different groups of rat animal models (x±s)

[0162]

[0163] As shown in Table 4, the granulation tissue capillary growth of the herbal hydrogel composition (Product 1) and the classic formula hydrogel (Product 2) of this invention is superior to that of the classic formula ointment (Product 3). Furthermore, the granulation tissue capillary growth of the herbal hydrogel composition (Product 1) of this invention is superior to that of the classic formula hydrogel (Product 2). This indicates that the herbal compound of the herbal hydrogel composition of this invention is superior to the classic formula, and the hydrogel dosage form is superior to the ointment dosage form. In addition, the granulation tissue capillary growth of both the concentrated herbal preparation and the hydrogel framework of this invention is inferior to that of the herbal hydrogel composition (Product 1), indicating that combining the concentrated herbal preparation with the hydrogel framework enhances its ability to promote granulation tissue capillary growth.

[0164] In addition, the results of light microscopy observations Figures 12 to 14 This also demonstrates the superior therapeutic effects of the herbal hydrogel of the present invention, wherein... Figure 12 For wounds treated with classic ointments, there is wound infection, tissue necrosis, and destruction of tissue structure. Figure 13 The wound, treated with a classic hydrogel, was infected and infiltrated by a large number of inflammatory cells. Figure 14 The wound treated with the hydrogel of this invention exhibits reduced inflammatory cell infiltration and good capillary growth in granulation tissue.

[0165] Table 5. Comparison of fibroblasts in granulation tissue of wounds in different groups of rat animal models (x±s)

[0166]

[0167] As shown in Table 5, the granulation tissue fibroblast growth of the herbal hydrogel composition (Product 1) and the classic formula hydrogel (Product 2) of this invention is superior to that of the classic formula ointment (Product 3). Furthermore, the granulation tissue fibroblast growth of the herbal hydrogel composition (Product 1) of this invention is superior to that of the classic formula hydrogel (Product 2). This indicates that the herbal compound of the herbal hydrogel composition of this invention is superior to the classic formula, and the hydrogel dosage form is superior to the ointment dosage form. In addition, the granulation tissue fibroblast growth of both the concentrated herbal preparation and the hydrogel framework of this invention is inferior to that of the herbal hydrogel composition (Product 1), indicating that combining the concentrated herbal preparation with the hydrogel framework enhances its ability to promote granulation tissue fibroblast growth.

[0168] from Figures 12 to 14 (These three images are pathological sections of granulation tissue from the wound 7 days post-surgery.) It can also be seen that the wound treated with the classic ointment was infiltrated by inflammatory cells, with extensive tissue necrosis. Figure 12 Wounds treated with classic hydrogels also became infected, with necrotic tissue and bacterial colonization present. Figure 13 ); and the granulation tissue of the wound treated with the hydrogel of this invention grows well ( ); Figure 14 This further demonstrates that the herbal hydrogel composition (product 1) of the present invention can inhibit bacterial infection of wounds, prevent the formation of biofilm by wound bacteria, and promote the growth of granulation tissue and capillaries in wounds, thus promoting wound healing.

[0169] Example 6

[0170] This embodiment examines the effects of the selection and dosage of the gel skeleton in the herbal hydrogel composition of the present invention on the molding properties, mechanical stability, and drug efficacy of the composition. Details are as follows:

[0171] This embodiment uses the herbal hydrogel composition (product 1) prepared in Example 2 as the basis for investigation. The only differences between the various gel compositions investigated and product 1 are the selection and dosage of the gel skeleton material and the preparation method of the hydrogel skeleton. All other components, dosages, and preparation processes are consistent with those in Example 2.

[0172] The selection and dosage of gel skeleton materials in the various Chinese herbal hydrogel compositions used for the investigation are shown in Table 6.

[0173] Table 6. Materials (g) of the gel skeleton in various traditional Chinese medicine hydrogel compositions

[0174]

[0175] In this example, the hydrogel frameworks of Products 4 and 5 were prepared by dissolving non-crosslinked sodium hyaluronate and carboxymethyl chitosan in 1000 mL of distilled water, heating to 60°C to fully dissolve the drugs, obtaining a 70 mg / mL gel framework solution, and then loading the drugs onto it. The preparation methods of the remaining products were the same as in Example 2, except that the carboxymethyl chitosan was replaced with other appropriate materials. Additionally, this example also includes a comparison of the preparation of a traditional Chinese medicine compound hydrogel (Product 12) according to Example 1 disclosed in Chinese Patent Document CN110624054B.

[0176] In this embodiment, the molding performance and mechanical stability of the product composition were evaluated by assessing the shaping ability and shape retention time of the prepared herbal hydrogel composition. The pharmacological effect of the product composition was evaluated by observing the bacterial biofilm on rat wounds. The process for evaluating the pharmacological effect of the product composition was the same as in Example 5. The experiments on the shaping ability and shape retention time of the product composition are as follows:

[0177] Each herbal hydrogel composition was filled into a mold and shaped into a column with a diameter of 1 cm and a height of 2 cm. The column was then placed in an environment of 36℃ to observe whether each herbal hydrogel composition could be molded and the shape retention time of each column. Shape retention time refers to the time required for complete spreading and drying at 36℃. The results are shown in Table 7.

[0178] Table 7. Molding effect and antibacterial biofilm effect of various Chinese herbal hydrogel compositions

[0179]

[0180] As shown in Table 7, all products were successfully molded into drug columns, but the shaping time varied. Regarding the natural polymer materials described in this invention, the product using a combination of non-crosslinked sodium hyaluronate and carboxymethyl chitosan as the framework material exhibited the longest shaping time and the best inhibitory effect on wound biofilm growth. While product 12, prepared according to patent document CN110624054B, also showed good shaping and excellent shaping ability, its inhibitory effect on wound biofilm growth was relatively poor, inferior to any of the herbal hydrogel composition products of this invention. This further illustrates the superior performance of the herbal hydrogel composition of this invention.

[0181] Example 7

[0182] This embodiment investigates the effect of the amount of glycerin, the encapsulating agent, in the herbal hydrogel composition of the present invention on the stability of the composition and the efficacy of the drug. Details are as follows:

[0183] This embodiment also uses the herbal hydrogel composition (product 1) prepared in Example 2 as the basis for investigation. The only difference between the various hydrogel compositions used in the investigation and product 1 is the amount of glycerol used. All other components, amounts, and preparation processes are the same as in Example 2. The amount of glycerol used in each herbal hydrogel composition used for investigation is shown in Table 8.

[0184] Table 8. Glycerin content (%) in various traditional Chinese medicine hydrogel compositions

[0185]

[0186] Product 13 does not use glycerin, meaning there is no oil-encapsulation process; the drug can be directly cooled to room temperature after loading.

[0187] In this embodiment, the stability of the prepared herbal hydrogel composition was evaluated by its water loss rate, and the drug efficacy was evaluated by observing the bacterial biofilm on rat wounds. Similarly, the bacterial biofilm observation experiment was conducted in the same manner as in Example 5. The water loss experiment of the composition is as follows:

[0188] Each herbal hydrogel composition was filled into a mold and shaped into a short column with a diameter of 3cm and a height of 2cm. The column was placed on multiple layers of filter paper and left to stand for 5 minutes at 36℃. The weight of each column (excluding the filter paper) was measured before and after standing, and the water loss rate was calculated. A water loss rate of less than 50% was considered acceptable.

[0189] Water loss rate (%) = (Weight before water loss - Weight after water loss) / Weight before water loss × 100%;

[0190] The results of the investigation are shown in Table 9.

[0191] Table 9. Water loss rate and antibacterial biofilm effect of various Chinese herbal hydrogel compositions

[0192]

[0193] As shown in Table 9, the water loss rate of each herbal hydrogel composition first decreased and then increased with the increase of glycerol dosage. The composition had the lowest water loss rate when the glycerol dosage was 9% of the total mass of the hydrogel matrix. When the glycerol dosage was 8-10% of the total mass of the hydrogel matrix, the water loss rate was less than 50%, and all were qualified products. When the glycerol dosage was less than 8% or greater than 10% of the total mass of the hydrogel matrix, the water loss rate of the composition was greater than 50%. This is because when the glycerol dosage was too low, it could not form a good sealing effect on the herbal liquid in the gel skeleton, resulting in the loss of medicine and water. When the glycerol dosage was too high, it would lead to poor shape retention of the composition, causing the medicine column to collapse, and thus causing the loss of water and medicine.

[0194] Furthermore, the inhibition of biofilm growth on wounds by various hydrogel compositions showed a strong correlation with their water loss rate. Insufficient glycerol dosage resulted in the gel skeleton failing to properly encapsulate the herbal liquid, leading to unsatisfactory therapeutic and antibacterial effects. Conversely, excessive glycerol dosage may reduce the stability of the hydrogel, causing the three-dimensional network structure of the hydrogel to be disrupted during drug administration, resulting in a sudden drug release and further unsatisfactory therapeutic and antibacterial effects. In other words, both excessive and insufficient glycerol dosage can lead to rapid drug release, failing to achieve the expected sustained-release effect, which is detrimental to the treatment of anorectal surgical wounds, which require long-term stable drug release.

[0195] Example 8

[0196] This embodiment aims to verify the clinical efficacy of the traditional Chinese medicine hydrogel composition for preventing postoperative wound infection of anorectal surgery according to the present invention. The products used in this embodiment for comparison are the traditional Chinese medicine hydrogel composition (product 1) prepared in Example 2 and the classic formula ointment prepared in Example 4.

[0197] The verification process is as follows:

[0198] The cases were from patients who underwent open drainage of anal fistula surgical wounds at the Department of Anorectal Surgery, Zhenjiang Municipal Hospital of Traditional Chinese Medicine, between January 2022 and December 2023. This clinical trial underwent ethical review by the ethics committee, and informed consent was obtained from the patients.

[0199] Patients who underwent anal fistula surgery were randomly divided into a treatment group (treated with the herbal hydrogel composition of this invention) and a control group (treated with the classic ointment). One course of treatment lasted 7 days, with continuous treatment, observation, and follow-up until healing. Patients were followed up for 6 months. This embodiment used wound healing speed, secretions, granulation tissue growth, and pain index as efficacy observation indicators to evaluate the clinical efficacy of the herbal compound hydrogel. The differences between the herbal compound hydrogel and traditional therapies in wound healing status and postoperative recurrence rate were statistically analyzed. The method for observing granulation tissue growth was the same as in Example 5. Since postoperative wound infection in clinical anorectal surgery is often treated with surgical debridement, postoperative wound sampling does not jeopardize healing; granulation tissue near the incision edge can be taken for examination. Wound healing speed was compared based on postoperative wound healing time.

[0200] The survey results showed that in the group of patients treated with the herbal hydrogel composition of this invention, all wounds underwent complete epithelialization, with no poor healing or formation of chronic ulcer sinus tracts. Follow-up for 6 months showed no recurrence. In contrast, in the control group, 5 patients, despite continuous outpatient dressing changes for over 2 months, still failed to achieve complete epithelialization and were clinically diagnosed with chronic ulcer sinus tracts (poor healing rate 10%). Figure 15 As shown in Table 10, patients with complete wound epithelialization were followed up for 6 months, and 3 cases relapsed (recurrence rate 6.7%). Patients with poor healing or recurrence underwent reoperation after consultation, and recovered after receiving the treatment regimen. Statistical results showed that the wound healing time in the treatment group was 27-36 days, with an average of (28.31±2.54) days, while it was 31-43 days, with an average of (31.52±3.35) days, in the control group. The healing time in the treatment group was significantly shorter than that in the control group (P<0.05). The granulation tissue growth, cure rate, and effectiveness rate in the treatment group were all superior to those in the control group, with statistically significant differences (P<0.05).

[0201] Table 10. Comparison of granulation tissue growth scores between the two groups of patients (x±s)

[0202]

[0203] As can be seen from the results in Table 10, the granulation tissue capillary growth in the treatment group using the herbal hydrogel composition of the present invention (product 1) was better than that in the control group using the classic ointment (product 3). This proves that the herbal hydrogel composition of the present invention can indeed promote the growth of granulation tissue in the patient's wound.

[0204] Granulation tissue samples were taken from the wound margins of both groups of patients at 7 and 14 days for examination. The results are as follows: Figure 16 and Figure 17 As shown. Figure 16The images show bacterial smears from surgical wounds of patients after anorectal surgery. The top image represents the control group: Staphylococcus and Streptococcus are observed to grow in clusters in the gaps between tissue fragments, exhibiting characteristics of complex bacterial biofilm growth and formation. The bottom image represents the treatment group: No significant bacterial growth or aggregation was observed after treatment with the traditional Chinese medicine compound hydrogel. Figure 16 The images show pathological sections of the anorectal postoperative infection wound. The left image represents the control group: the pathological section of the anorectal postoperative infection wound shows extensive inflammatory cell infiltration, sparse fibroblasts, and poor capillary growth. The right image represents the treatment group: after intervention with the traditional Chinese medicine hydrogel composition, inflammatory cell infiltration decreased, and fibroblast and capillary growth improved.

[0205] The evaluation criteria for the treatment effect on patients were as follows: Cured: complete epithelialization of the wound, no recurrence of ulceration after 1 week of observation, and a symptom score reduction of >90% compared to before treatment; Significantly effective: wound shrinkage ≥75%, and a symptom score reduction of 70%–90%; Effective: wound shrinkage ≥25%, and a symptom score reduction of 30%–70%; Ineffective: no change or enlargement of the wound, and a symptom score reduction of less than 30%. The results are shown in Table 11.

[0206] Table 11. Comparison of overall efficacy between the two groups of patients (n / %)

[0207]

[0208] As shown in Table 11, among the 30 patients in the treatment group using the herbal hydrogel composition of the present invention, 26 were cured, with no cases of ineffective treatment, resulting in a cure rate of 87% and an effective rate of 100%. In contrast, among the 30 patients in the control group, 20 were cured, and 5 were ineffective, resulting in a cure rate of 62% and an effective rate of 82.8%. In comparison, the overall effective rate of treatment using the herbal hydrogel composition of the present invention was increased by nearly 17.2%, and the cure rate was increased by 25%, demonstrating significant efficacy.

[0209] Therefore, in general, this invention is based on classic Chinese medicine ointments and powders, combined with clinical experience, and modified and optimized to form a Chinese medicine compound. A temperature-sensitive in-situ hydrogel is prepared using natural hydrogel polymer material as the framework, and glycerin is used as an encapsulating agent to encapsulate the concentrated medicinal liquid of the compound, forming a stable drug delivery system. This achieves the combination of Chinese medicine preparation and hydrogel, effectively solving the shortcomings of traditional ointments and powders such as oil stains, poor formability, and inconvenience of use, as well as the problems of easy contamination, bacterial colonization and growth, and bacterial biofilm formation in open drainage incisions after anorectal surgery. Clinical application has proven that the herbal hydrogel composition of this invention can directly act on the lesion site. The thermosensitive in-situ hydrogel is simple to prepare and convenient to use, with good adhesion and tissue compatibility. It can prolong the retention time of the drug at the application site and improve bioavailability. The effective components of the herbal compound can effectively prevent the formation of bacterial biofilm on the anorectal wound. The thermosensitive herbal compound in-situ hydrogel can form a moist protective film on the anorectal postoperative wound, creating a microenvironment conducive to wound healing. It exerts anti-inflammatory, analgesic, anti-swelling, blood-activating, and tissue-regenerating effects, thereby inhibiting infection, relieving symptoms such as swelling, pain, bleeding, and exudation, promoting recovery, and effectively reducing patient suffering. It has important medical value.

[0210] Finally, it should be noted that, for those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and that the present invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered exemplary and not restrictive in all respects. Furthermore, it should be understood that although this specification describes embodiments, it does not encompass only one technical solution. This descriptive method is merely for clarity, and those skilled in the art should consider the specification as a whole. The technical solutions in the embodiments can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection in anorectal surgery, the composition comprising a traditional Chinese medicine compound and a hydrogel matrix, characterized in that: The traditional Chinese medicine compound preparation comprises the following 12 herbs in parts by weight. composition: Principal herbs: Coptis chinensis 12-36 parts, Scutellaria baicalensis 12-36 parts. Assistant herbs: Forsythia suspensa 12-36 parts, Phellodendron chinense 12-36 parts, Rheum palmatum 9-27 parts. Adjuvant herbs: Turmeric 12-36 parts, Angelica sinensis 18-54 parts, Rehmannia glutinosa 36-108 parts, Lithospermum erythrorhizon 9-27 parts, Sophora flavescens 12-36 parts, Portulaca oleracea 12-36 parts. Used ingredient: 2-6 parts borneol; The hydrogel matrix includes a gel skeleton and an encapsulating agent; The gel skeleton is a natural hydrogel polymer material; The encapsulating agent is glycerin; The amount of glycerol used is 8-10% of the total mass of the hydrogel matrix.

2. The traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery according to claim 1, characterized in that: The hydrogel matrix gel skeleton is any one or a combination of several of the following: hyaluronic acid, alginate, water-soluble chitosan, cellulose, gelatin, agarose, silk protein, and collagen.

3. The traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery according to claim 2, characterized in that: The gel matrix has a gel skeleton composed of hyaluronic acid and water-soluble chitosan in a mass ratio of 2-4:3-5.

4. The traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery according to claim 3, characterized in that: The hyaluronic acid is non-crosslinked sodium hyaluronate with a molecular weight of 1,000,000 to 1,800,000 Da; The water-soluble chitosan is carboxymethyl chitosan with a molecular weight of 150–250 kDa and a degree of carboxymethyl substitution of 35–45%.

5. A method for preparing a traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery as described in any one of claims 1-4, characterized in that: Includes the following steps: 1) Extraction and preparation of concentrated Chinese medicine liquid: Weigh the raw materials of the Chinese medicine compound, except for borneol, wash the other raw materials with water and decoct them for concentration, and finally add borneol to prepare concentrated Chinese medicine liquid; 2) Preparation of hydrogel framework: Weigh a quantitative amount of the hydrogel matrix's gel framework, dissolve it in an appropriate amount of water, and prepare the hydrogel framework; 3) Drug loading: The concentrated Chinese medicine solution prepared in step 1) is added to the hydrogel framework prepared in step 2) while it is still hot, and stirred to disperse the concentrated Chinese medicine solution in the gaps of the hydrogel framework to form a hydrogel drug loading system. 4) Oil-encapsulation: Add glycerin and stir at an appropriate speed to form an oil film on the gaps of the hydrogel skeleton, encapsulating the concentrated Chinese medicine liquid in the gaps of the hydrogel skeleton to form a stable temperature-sensitive in-situ hydrogel drug delivery system. Then cool to room temperature to obtain the Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery.

6. The method for preparing the traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery according to claim 5, characterized in that: In step 1), the specific process for extracting and preparing concentrated traditional Chinese medicine solution is as follows: Weigh out the raw materials of the traditional Chinese medicine compound preparation in quantitative terms. Except for borneol, wash the remaining raw materials with water and soak them for 30 minutes. For the first decoction, add 5 times the amount of water, simmer over low heat for 60 minutes, filter the original liquid, and keep the filtrate for later use. Continue simmering, add 4 times the amount of water, simmer over low heat for 45 minutes, filter the original liquid, and keep the filtrate for later use. Add 3 times the amount of water and simmer over low heat for 30 minutes. Filter the original liquid and keep the filtrate for later use. The filtrates from the three decoctions were combined and concentrated at a constant temperature of 60℃ to prepare a concentrated Chinese herbal medicine stock solution with a concentration of 1g / ml. Then add ethanol to a concentration of 70%, let stand for 24 hours, filter, and distill the filtrate at a constant temperature of 60℃ under reduced pressure to remove alcohol, and obtain the concentrated alcohol-precipitated Chinese herbal compound solution. Take the concentrated alcohol-precipitated Chinese herbal medicine, add 4 times the amount of purified water, heat in a 60°C water bath, filter the precipitate with defatted cotton while hot, concentrate under reduced pressure, and add borneol to obtain a concentrated Chinese herbal medicine solution with a concentration of 1g / ml.

7. The method for preparing the traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery according to claim 5, characterized in that: In step 2), the specific process for preparing the hydrogel framework is as follows: Weigh out non-crosslinked sodium hyaluronate and carboxymethyl chitosan according to the mass ratio, add them separately to distilled water, and prepare a 30 mg / mL sodium hyaluronate solution and a 40 mg / mL carboxymethyl chitosan solution at 60°C. Carboxymethyl chitosan solution was slowly added to sodium hyaluronate solution at a volume ratio of 1:1, and stirred at 200-300 rpm to mix them thoroughly to obtain a hydrogel framework.

8. The method for preparing the traditional Chinese medicine hydrogel composition for preventing and treating postoperative wound infection of anorectal surgery according to claim 5, characterized in that: In step 3), the volume ratio of the concentrated traditional Chinese medicine solution to the hydrogel skeleton during drug loading is 5 to 10:

1. The temperature of the concentrated Chinese medicine solution is 60℃, and the stirring speed after adding the hydrogel framework is 200-300 rpm; In step 4), the oil-encapsulation involves cooling the hydrogel drug delivery system to 35-40°C, adding glycerin, and controlling the stirring speed of the encapsulation to 50-150 rpm.

9. The application of the traditional Chinese medicine hydrogel composition according to any one of claims 1-4, characterized in that: Its application in the preparation of drugs for preventing and treating infections of various anorectal surgical wounds, including the preparation of drugs to prevent the formation of bacterial biofilms in various anorectal surgical wounds and to promote wound healing.

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