A shengji yu red ointment, a preparation method thereof and a medicine film adhesive plaster

Abstract

This invention belongs to the field of traditional Chinese medicine adhesive bandage technology, specifically relating to a Shengji Yuhong Ointment, its preparation method, and a medicated film adhesive bandage. The Shengji Yuhong Ointment has a hydrogel structure, comprising raw materials, a gel matrix, and nano-zinc oxide or silver sulfadiazine nanoparticles. The raw materials include the following components by weight: 13-17 parts Angelica dahurica, 34-38 parts Glycyrrhiza uralensis, 58-62 parts Angelica sinensis root, 10-14 parts Dragon's Blood, 4-8 parts Lithospermum erythrorhizon, and 0.2-0.25 parts Musk-β-cyclodextrin inclusion complex powder or Musk nanoliposome powder. The matrix comprises the following components by weight: 245-255 parts sesame oil, 57-63 parts beeswax, 93-103 parts polymer material, 37-43 parts plasticizer, 3-8 parts penetration enhancer, and 0.8-1.2 parts preservative. The Shengji Yuhong Ointment of this invention is used in medicated film adhesive bandages, is convenient to use, and is particularly suitable for chronic, difficult-to-heal ulcers and acute wounds requiring accelerated healing.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine plaster technology, specifically relating to a Shengji Yuhong Ointment, its preparation method, and a medicated film plaster. Background Technology

[0002] The traditional Chinese medicine "Yu Hong Gao" has an outdated dosage form. Its ointment (oil-based base) is greasy, easily stains clothes, is difficult to wash off, and has poor breathability. The drug has insufficient permeability, and the active ingredients mainly remain on the skin surface, resulting in low transdermal absorption efficiency and affecting efficacy.

[0003] In addition, most existing adhesive bandages only have physical isolation and hemostasis functions, lacking "therapeutic" effects such as promoting wound healing, anti-inflammation, and tissue regeneration. Furthermore, they are often backed with non-woven fabric and PE film, which have limited biocompatibility and the ability to create a breathable and moisture-wicking environment.

[0004] In view of this, the present invention is hereby proposed. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art and to propose a regenerating ointment, its preparation method, and a medicated film bandage.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: In a first aspect, the present invention provides a regenerating ointment, wherein the regenerating ointment has a hydrogel structure, comprising an active pharmaceutical ingredient and a matrix, as well as nano-zinc oxide or silver sulfadiazine nanoparticles. The active pharmaceutical ingredient comprises the following ingredients in parts by weight: 13-17 parts Angelica dahurica, 34-38 parts Glycyrrhiza uralensis, 58-62 parts Angelica sinensis, 10-14 parts Dragon's Blood, 4-8 parts Lithospermum erythrorhizon, and 0.2-0.25 parts Musk-β-cyclodextrin inclusion complex powder or Musk nanoliposome powder. The matrix comprises the following components in parts by weight: 245-255 parts sesame oil, 57-63 parts beeswax, 93-103 parts polymer material, 37-43 parts plasticizer, 3-8 parts penetration enhancer, and 0.8-1.2 parts preservative.

[0007] It should be noted that musk is used as a rare additive in very small quantities. It is not a main ingredient, but plays a key role in enhancing the efficacy of the medicine by "guiding the medicine to its fullest extent and promoting blood circulation".

[0008] The traditional method involves adding 1.2 to 1.5 grams of musk (approximately 0.2-0.25 parts) to each pound of the ointment after it has been prepared, and then stirring until homogeneous. This invention, however, involves preparing musk-β-cyclodextrin inclusion complex powder or musk nanoliposome powder, which is then directly added to the raw material.

[0009] It should also be noted that the formula for the Shengji Yuhong Ointment of this invention can be clearly divided into three main parts: 1. Core medicinal ingredients Angelica extract: promotes blood circulation, nourishes blood, reduces swelling and relieves pain, improves local microcirculation, and creates favorable conditions for tissue regeneration.

[0010] Angelica dahurica extract: dispels wind and dampness, reduces swelling and drains pus, and relieves pain. It has strong anti-inflammatory and antibacterial effects.

[0011] Natural musk extract: an extremely precious key ingredient. It promotes blood circulation, relieves pain, reduces swelling, and detoxifies. Its powerful penetrating ability (promoting penetration) and anti-inflammatory effects are remarkably effective for difficult-to-heal wounds. Modern research has confirmed its extremely strong angiogenesis and tissue repair capabilities.

[0012] Comfrey extract: Cools the blood and promotes blood circulation, detoxifies and relieves rashes. It mainly provides antibacterial and anti-inflammatory effects, especially effective against common wound infection bacteria such as Staphylococcus aureus, and can promote granulation tissue growth.

[0013] Dragon's Blood: It invigorates blood circulation, relieves pain, removes blood stasis, stops bleeding, promotes wound healing, and promotes tissue regeneration. It is an important medicine in traditional Chinese medicine for trauma treatment, and can significantly promote wound healing and reduce scar formation.

[0014] Sesame oil (base): moisturizes, detoxifies, and promotes tissue regeneration. As an excipient in traditional plasters, it can protect wounds and dissolve fat-soluble components.

[0015] 2. Pharmaceutical excipients (to achieve "drug film" form) Nano-zinc oxide microparticles: wound care materials. They possess astringent, drying, antibacterial (broad-spectrum), and wound-protective properties. Nano-sizing increases their surface area, enhances their activity, and may also provide better transdermal absorption.

[0016] Polymer materials: These form the framework of the drug film. Commonly used materials include polyvinyl alcohol (PVA), sodium carboxymethyl cellulose (CMC-Na), and sodium alginate. They can form a soft, breathable protective film on the skin.

[0017] Plasticizers, such as glycerin and propylene glycol, increase the flexibility and elasticity of the medicated film, preventing it from drying out and cracking, and making it adhere better to the skin.

[0018] Permeation enhancers (transdermal absorption improvers): such as azone, oleic acid, menthol, etc. These are crucial for transdermal drug delivery systems, helping the active ingredients of drugs (especially lipid-soluble ones) penetrate the stratum corneum of the skin and improving bioavailability. Natural musk itself also has a very strong permeation-enhancing effect.

[0019] Preservatives: such as parabens. Ensure the film is not contaminated by microorganisms during storage and use.

[0020] 3. Dosage Form Innovation It improves upon traditional greasy, difficult-to-wash ointments by transforming them into modern film-like solutions (patch / gel ointments). Advantages include: excellent adherence: it adheres closely to the wound surface, especially suitable for uneven skin; breathable yet waterproof: it maintains a moist healing environment while blocking external bacteria; sustained-release and long-lasting effect: the medication is slowly released from the polymer mesh for prolonged action; and ease of use: it does not stain clothing and is easy to remove.

[0021] Secondly, the present invention also provides a regenerating ointment, wherein the regenerating ointment has a hydrogel structure, comprising a raw material, a gel matrix and a chitosan quaternary ammonium salt, and nano-zinc oxide or silver sulfadiazine nanoparticles. The active pharmaceutical ingredient comprises the following ingredients in parts by weight: 13-17 parts Angelica dahurica, 34-38 parts Glycyrrhiza uralensis, 58-62 parts Angelica sinensis, 10-14 parts Dragon's Blood, 4-8 parts Lithospermum erythrorhizon, 0.2-0.25 parts Musk-β-cyclodextrin inclusion complex powder or Musk nanoliposome powder, and 0.5-5 parts Berberine hydrochloride extract; The matrix comprises the following components in parts by weight: 245-255 parts sesame oil, 57-63 parts beeswax, 93-103 parts polymer material, 37-43 parts plasticizer, 3-8 parts penetration enhancer, and 0.8-1.2 parts preservative.

[0022] Thirdly, the present invention also provides a regenerating ointment, wherein the regenerating ointment has a hydrogel structure, comprising a raw material, a gel matrix and a chitosan quaternary ammonium salt, and nano-zinc oxide or silver sulfadiazine nanoparticles. The active pharmaceutical ingredient comprises the following ingredients in parts by weight: 13-17 parts Angelica dahurica, 34-38 parts Glycyrrhiza uralensis, 58-62 parts Angelica sinensis root, 10-14 parts Dragon's Blood, 4-8 parts Lithospermum erythrorhizon, 0.2-0.25 parts Musk-β-cyclodextrin inclusion complex powder or Musk nanoliposome powder, and 1-5 parts lidocaine-ion exchange resin complex; it also includes recombinant human epidermal growth factor, which accounts for less than 1% of the total weight of the active pharmaceutical ingredient; The matrix comprises the following components in parts by weight: 245-255 parts sesame oil, 57-63 parts beeswax, 93-103 parts polymer material, 37-43 parts plasticizer, 3-8 parts penetration enhancer, and 0.8-1.2 parts preservative.

[0023] Furthermore, the mass ratio of the active pharmaceutical ingredient to the matrix is ​​0.15~1:10.6~70.

[0024] Furthermore, the nano-zinc oxide or silver sulfadiazine nanoparticles account for 1% to 2% of the total mass of Shengji Yuhong Ointment.

[0025] The function of nano-zinc oxide or silver sulfadiazine nanoparticles is as highly effective antibacterial agents. Nano-zinc oxide has broad-spectrum antibacterial and healing-promoting effects; silver sulfadiazine is a burn antibacterial agent, and its nano-sizing enhances its efficacy and may reduce silver ion toxicity (because silver has extremely high antibacterial efficiency, the dosage must be strictly controlled to avoid cytotoxicity). Nanomaterials have a large specific surface area, and even small amounts can exert a powerful effect. Excessive proportions may lead to the risk of aggregation, affect membrane transparency, or produce toxicity.

[0026] Furthermore, the chitosan quaternary ammonium salt accounts for 1% to 2% of the total mass of Shengji Yuhong Ointment.

[0027] The preparation process of the musk-β-cyclodextrin inclusion complex powder is as follows: Furthermore, the musk extract was mixed with β-cyclodextrin, then sheared or ultrasonically dispersed, and finally sprayed or freeze-dried. Among them, the molecular weight of β-cyclodextrin is 1135 g / mol, the molar ratio of muscone to β-cyclodextrin in musk extract is 1:1.2, and the encapsulation efficiency is verified to be ≥85%.

[0028] The preparation process of the musk nanoliposome powder is as follows: Musk extract was mixed with phospholipids, followed by shear dispersion or ultrasonic dispersion, and finally spray-dried or freeze-dried. The mass ratio of muscone to phospholipids in the musk extract was 1:2.

[0029] The shearing dispersion process involves high-speed shearing in a digital display high-speed shearing disperser. First, coarse dispersion is performed at 1000 rpm for 3 minutes, followed by fine shearing at 2500-3000 rpm for 8-12 minutes. During the shearing process, the temperature is controlled within ≤35℃.

[0030] Furthermore, the polymer material is any one or more selected from polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), sodium carboxymethyl cellulose (CMC-Na), sodium alginate, carbomer 980, sodium hyaluronate, and superabsorbent polymer (SAP). The plasticizer is used to reduce the rigidity between the molecular chains of the polymer material (matrix), increase the flexibility and plasticity of the membrane, and prevent the membrane from becoming brittle after drying. It includes glycerol, propylene glycol, polyethylene glycol 400, or sorbitol solution. The penetration enhancer is used to temporarily and reversibly alter the structure of the skin or wound biological barrier, promoting the penetration and absorption of active pharmaceutical ingredients (especially lipid-soluble or macromolecular components).

[0031] Specifically, these include azones (lauropentazones or azones), alcohols (menthol), organic acids (oleic acid), or natural products (borneol or terpenoids (leaf oil or eugenol)). The preservative prevents the growth of microorganisms (bacteria, fungi) during production and storage, ensuring the microbiological safety of the formulation during its shelf life. For aseptically manufactured, single-use wound dressings, this may be omitted. However, it must be added to reusable packaging.

[0032] Specifically, these include parabens (methylparaben or propylparaben), alcohols (phenoxyethanol or benzyl alcohol), organic acids (sorbic acid (potassium)) or compound systems (Germa series (such as Germa-115) or pentylene glycol).

[0033] Fourthly, the present invention also provides a medicated film bandage based on Shengji Yuhong Ointment. Based on the Shengji Yuhong Ointment as described above, the medicated film bandage includes a backing layer, a medicated film layer is provided in the top middle area of ​​the backing layer, an adhesive layer is provided on the top of the backing layer and on both sides of the medicated film layer, and an absorbent pad is provided on the top of the medicated film layer. The medicated film layer has a hydrogel structure and contains Shengji Yuhong Ointment.

[0034] Fifthly, the present invention also provides a method for preparing a medicated film bandage based on Shengji Yuhong Ointment. Based on the medicated film bandage described above, the preparation process of the medicated film bandage includes: uniformly coating Shengji Yuhong Ointment on the central area of ​​the backing layer using a precision coating machine, then laminating an absorbent pad online, and then drying it through a low-temperature hot air circulating oven to form a medicated film of a set thickness and strength. Subsequently, the film is cut, covered with anti-stick release paper, sealed and packaged, and finally sterilized.

[0035] Furthermore, the low-temperature hot air circulation adopts a variable temperature program of 36~40℃, wind speed 1.2~1.6 m / s (42~46min) → 30~34℃, wind speed 0.8~1.1 m / s (150~180min) → 26~29℃, wind speed 0.4~0.7 m / s (50~60min); the set thickness of the drug film is 100~500μm, and the strength is 0.5~5.0 MPa.

[0036] Optionally, the absorbent pad is made of sterile nonwoven fabric or ultra-thin spunlace nonwoven fabric; the adhesive layer is made of medical-grade acrylic pressure-sensitive adhesive. The backing layer + adhesive layer is made of polyurethane (PU) breathable membrane with edge pressure-sensitive adhesive; the backing layer + adhesive layer can also be a foam pad backing with edge pressure-sensitive adhesive.

[0037] Compared with the prior art, the present invention has the following beneficial effects: 1. **Innovative Formulation:** This innovative formula transforms Shengji Yuhong Ointment from an oil-based ointment into a hydrogel film, offering a refreshing, breathable, invisible, and aesthetically pleasing result without staining clothing. **Technological Innovation:** Utilizing cyclodextrin / nanoliposome technology to process musk solves the stability and transdermal absorption challenges of traditional formulations and modern hydrogels, achieving "highly effective musk-containing" results. **Enhanced Efficacy:** Musk, as a potent penetration enhancer, allows Shengji Yuhong Ointment to promote blood circulation and tissue regeneration more quickly and significantly. **Dressing Material (nano-zinc oxide microparticles or silver sulfadiazine nanoparticles)** Provides a better moist healing environment. **Convenient Use:** Apply directly without mixing or application. **Painless Dressing Changes:** Does not adhere to the wound surface, minimizes bleeding during changes, and does not damage newly formed tissue. **Aesthetically pleasing and Comfortable:** Thin, invisible, and breathable, without affecting daily activities. This invention addresses the three major pain points of traditional ointments: greasiness, staining clothing, and inconvenient dressing changes.

[0038] Advantages compared to traditional ointments / gauze Early use (1-3 days). Rapid pain relief: Blood-activating ingredients take effect, reducing local burning and throbbing pain. Control of exudate: Absorbs a small amount of exudate, keeping the wound moist and preventing ulceration. Anti-inflammatory and swelling reduction: Reduces the area of ​​redness and swelling around the wound. Superior: The medicated film adheres tightly, allowing the active ingredients to work continuously; while ointments are easily diluted and lost by exudate.

[0039] Mid-term use (3-7 days). Removal of necrotic tissue and regeneration of new tissue: Pus decreases, and necrotic tissue gradually separates and sloughs off. Promotion of granulation tissue: Fresh, rosy granulation tissue begins to grow, filling the wound. Improved odor: Infection is controlled, and wound odor is reduced. Significant advantages: The "moist environment" of the film-like treatment can non-invasively soften and remove necrotic tissue, avoiding painful mechanical debridement. Traditional gauze tends to stick to the wound, making dressing changes painful.

[0040] Later application (1-2 weeks later). Epithelial creep: The wound edges begin to contract, and epidermal cells grow from the periphery towards the center. Accelerated healing: Overall healing time is expected to be 30%-50% shorter than conventional dry exposure methods. Scar improvement: Due to milder inflammation and faster healing, hypertrophic scar formation may be reduced. Superior: Continuous moisturizing and drug supply provide an ideal environment for cell migration. Traditional methods easily form dry scabs, hindering epithelial cell movement.

[0041] The Shengji Yuhong Medicated Film Bandage is a culmination of traditional Chinese medicine wisdom and modern pharmaceutical technology. Through its comprehensive effects of sustained release, moisturizing, isolation, and promoting repair, it delivers the "removing necrotic tissue, promoting tissue regeneration, invigorating blood circulation, and relieving pain" benefits of the Shengji Yuhong formula to the wound surface in a more efficient, comfortable, and convenient manner. It is particularly suitable for chronic, difficult-to-heal ulcers and acute wounds requiring accelerated healing, aiming to achieve "painless healing and rapid repair" in clinical practice. It is a highly promising innovative product in the field of trauma care and wound management. Attached Figure Description

[0042] The accompanying drawings are incorporated in and form part of this specification, and together with the description serve to explain the principles of the invention.

[0043] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0044] Figure 1 Images of the patient before treatment in Example 2; Figure 2 This is a photo taken on the 7th day after treatment with the Shengji Yuhong Ointment or medicated film bandage of the present invention in Example 2; Figure 3 This is a photo taken on the 14th day after treatment with the Shengji Yuhong Ointment or medicated film bandage of the present invention in Example 2; Figure 4 This is a photograph taken on the 28th day after treatment with the Shengji Yuhong Ointment or medicated film bandage of the present invention in Example 2; Figure 5 These are photos of the patient before and after debridement in Example 3; Figure 6 This is a photo taken on the third day after treatment with the Shengji Yuhong Ointment or medicated film bandage of the present invention in Example 3; Figure 7 This is a photo taken on the 7th day after treatment with the Shengji Yuhong Ointment or medicated film bandage of the present invention in Example 3; Figure 8 This is a photo taken on the 14th day after treatment with the Shengji Yuhong Ointment or medicated film bandage of the present invention in Example 3. Detailed Implementation

[0045] Exemplary embodiments will now be described in detail. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Rather, they are merely examples consistent with some aspects of the invention as detailed in the appended claims.

[0046] Example 1 (Applied to clinical trial batches) This embodiment provides a regenerating ointment called Shengji Yuhong Ointment, which has a hydrogel structure and includes an active pharmaceutical ingredient, a matrix, and nano-zinc oxide. Drug components: Angelica dahurica 15 parts (Angelica dahurica extract content ≥80%), Glycyrrhiza uralensis 36 parts (Glycyrrhizic acid extract content ≥90%), Angelica sinensis 60 parts (Angelica sinensis extract content ≥80%), Dragon's blood powder 12 parts (passed through a 200-mesh sieve), Lithospermum erythrorhizon 6 parts (Lithospermum erythrorhizon extract content ≥80%), Musk-β-cyclodextrin inclusion complex powder or Musk nanoliposome powder 0.22 parts; Nano zinc oxide accounts for 1.5% of the total mass of Shengji Yuhong Cream.

[0047] Gel matrix: 250 parts sesame oil, 60 parts beeswax, 100 parts polymer material, 40 parts plasticizer, 6 parts penetration enhancer, and 1 part preservative; Specifically, the ingredients are: 250 parts sesame oil; 60 parts beeswax; 50 parts sodium carboxymethyl cellulose (CMC-Na, medium viscosity); 30 parts polyvinylpyrrolidone K30 (PVP K30); 20 parts sodium alginate; 40 parts glycerin; 6 parts azone; 1 part potassium sorbate; and purified water to a total solids content of approximately 30%.

[0048] This embodiment also provides a medicated film bandage based on Shengji Yuhong Ointment. The medicated film bandage includes a backing layer, a medicated film layer is laid in the top middle area of ​​the backing layer, an adhesive layer is provided on the top of the backing layer and on both sides of the medicated film layer, and an absorbent pad is provided on the top of the medicated film layer. The medicated film layer has a hydrogel structure and contains Shengji Yuhong Ointment.

[0049] The specific preparation process is as follows: Step 1, Pretreatment: Prepare musk-β-cyclodextrin inclusion complex powder according to the molar ratio of musk ketone:β-cyclodextrin = 1:1.2, and verify that the encapsulation rate is ≥85%; Then, the extracts of Angelica dahurica, Lithospermum erythrorhizon, glycyrrhizic acid, and Angelica sinensis were dissolved in an appropriate amount of ethanol (60% by volume of aqueous ethanol solution) for later use.

[0050] Step 2, preparation of the gel: Phase A (aqueous matrix): CMC-Na and sodium alginate were dispersed in purified water at 60℃ and allowed to swell overnight. PVP K30, glycerol, potassium sorbate, and azone were added, and the mixture was subjected to high-speed shearing (3000 rpm, 10 minutes, temperature controlled <40℃) to obtain a homogeneous and transparent gel A.

[0051] Phase B (drug phase): Add the prepared solution obtained in step 1, dragon's blood powder, and nano zinc oxide to a portion of colloid A under low-speed stirring (500 rpm) (the drug phase should be completely dissolved in colloid A), and sonicate homogenize (ice bath, 300W pulse, 2 minutes in total) to obtain drug-containing colloid B.

[0052] Step 3, Mixing and Degassing: Slowly add colloid B to the remaining colloid A while stirring at low speed (400 rpm) for 30 minutes. Transfer to a planetary mixer for degassing and degas for 15 minutes under a vacuum of -0.09 MPa.

[0053] Step 4: Add musk-β-cyclodextrin inclusion complex powder: Cool the defoamed solution from Step 3 to below 30°C, and slowly add the musk-β-cyclodextrin inclusion complex powder while stirring at 200 rpm. Stir for 20 minutes to obtain the final drug-containing solution.

[0054] Step 5, Coating and Drying: First, using an automatic coating machine, the drug-containing adhesive from Step 4 is evenly coated onto the central area of ​​the backing to achieve a wet film thickness of 350 μm. Immediately afterward, sterile nonwoven fabric is laminated online. Then, the film is placed in a low-temperature hot air circulating drying oven and subjected to a three-stage temperature program: Stage 1: 38℃, air velocity 1.5 m / s, time 40 minutes (rapid removal of surface moisture). Stage 2: 33℃, air velocity 1.0 m / s, humidity control <50%RH, time 150 minutes (core drying period). Stage 3: 28℃, air velocity 0.5 m / s, time 50 minutes (equilibrium curing). The final result is a target drug-containing film with a moisture content ≤10% and a dry film thickness of 180±20 μm.

[0055] Step 6, Slitting and Packaging: Slit the dried medicated film from Step 5 into sizes (e.g., 7cm × 10cm). The backing layer uses a breathable polyurethane (PU) membrane with pressure-sensitive adhesive at the edges, with the medicated film in the center. Cover the medicated film layer and the pressure-sensitive adhesive with glassine silicone release paper, seal in an aluminum-plastic bag, and sterilize by cobalt-60 irradiation to obtain the medicated film bandage based on Shengji Yuhong Ointment.

[0056] The absorbent layer is integrated on top of the medicated film layer and uses sterile non-woven fabric to quickly absorb small amounts of exudate and keep the wound surface clean.

[0057] Furthermore, the inventors conducted a quality inspection on the adhesive bandage of this embodiment, and the inspection results are as follows: Appearance: The film is uniform, dark red, and has a flexible texture; Mechanical properties (universal testing machine): tensile strength 1.8 MPa; elongation at break 125%; Content determination (HPLC): Muscone: 0.95 mg per patch, 95.0% of the labeled amount. Licorice extract: 1.38 mg per patch, 92.0% of the labeled amount.

[0058] In vitro release (Franz diffusion cell): The cumulative drug release rate reaches over 80% within 8 hours, demonstrating excellent sustained-release characteristics.

[0059] The results of the clinical trials include the following: Study Methods: 1. Design: Randomized, single-blind, parallel-controlled. 2. Subjects: A total of 120 patients with chronic lower extremity venous ulcers were included and randomly assigned to the experimental group (using Shengji Yuhong dressing) and the control group (using standard alginate dressing), with 60 patients in each group. There were no statistically significant differences between the two groups in terms of age, sex, ulcer area, and disease duration. 3. Treatment regimen: Both groups received routine debridement and pressure therapy. The experimental group used this product as a dressing, while the control group used standard alginate dressing. Dressings were changed every 1-2 days depending on the amount of exudate, and the treatment course was 4 weeks. 4. Evaluation indicators: These included the primary endpoint (percentage reduction in ulcer area after 4 weeks of treatment) and secondary endpoints (complete healing rate, granulation tissue coverage (score), change in VAS pain score, infection control (negative bacterial culture rate), and incidence of adverse reactions).

[0060] Research findings: Table 1 shows that the Shengji Yuhong Medicated Film Bandage is significantly more effective than conventional alginate dressings in promoting the healing of chronic lower extremity ulcers, accelerating granulation tissue growth, relieving wound pain, and controlling infection. Its "removing necrotic tissue and promoting tissue regeneration" effect is manifested in its more effective cleaning of the wound and promotion of healthy granulation tissue growth; its "promoting blood circulation and relieving pain" effect is manifested in its significant and rapid reduction of patient pain. The product is safe to use; the main adverse reaction is mild local irritation in a very small number of patients, with an incidence rate no different from that of conventional dressings, and the symptoms subside after discontinuation of the medication.

[0061] Example 2 (Special type for diabetic foot ulcers) This embodiment provides a regenerating ointment called Shengji Yuhong Ointment, which has a hydrogel structure and includes an active pharmaceutical ingredient, a matrix, and nano-zinc oxide. Drug components: Enhanced antibacterial and penetration-enhancing: 3 parts berberine hydrochloride (berberine hydrochloride extract content ≥97%) (enhanced antibacterial and penetration-enhancing) + 34 parts licorice (glycyrrhizic acid extract content ≥90%) + 4 parts lithospermum (lithospermicin extract content ≥80%). The three have a synergistic effect in enhancing the anti-G+ bacteria (such as Staphylococcus aureus).

[0062] 0.2 parts of musk-β-cyclodextrin inclusion complex (1.0 mg / g calculated as musk ketone) optimized analgesia, and its strong blood-activating and meridian-clearing effects are crucial for improving microcirculatory disorders and neuralgia in diabetic foot. Angelica dahurica 13 parts (Angelica dahurica extract content ≥80%); Angelica sinensis 58 parts (Angelica sinensis total phenolic acid extract content ≥50%); Dragon's blood powder 10 parts (passed through a 200-mesh sieve). Chitosan quaternary ammonium salt and nano zinc oxide each account for 1% of the total mass of Shengji Yuhong Ointment.

[0063] Gel matrix: Sesame oil 245 parts, beeswax 57 parts, polymer material 93 parts, plasticizer 37 parts, penetration enhancer 3 parts, preservative 0.8 parts; Specifically, the formula consists of 245 parts sesame oil; 57 parts beeswax; 50 parts sodium carboxymethyl cellulose (CMC-Na, medium viscosity); 30 parts polyvinylpyrrolidone K30 (PVP K30); 13 parts carbomer 980; 37 parts sorbitol solution; 3 parts menthol; and 0.8 parts methylparaben. The addition of carbomer 980 to the matrix improves the gel's absorbency, swelling properties, and tissue adhesion, making it suitable for active areas such as the soles of the feet.

[0064] This embodiment also provides a medicated film bandage based on Shengji Yuhong Ointment, the specific preparation process of which is as follows: Step 1, Pretreatment: Prepare musk-β-cyclodextrin inclusion complex powder according to the molar ratio of musk ketone:β-cyclodextrin = 1:1.2, and verify that the encapsulation rate is ≥85%; Then, the extracts of Angelica dahurica, shikonin, glycyrrhizic acid, and total phenolic acid extract of Angelica sinensis were dissolved in an appropriate amount of ethanol (60% by volume of aqueous ethanol solution) for later use.

[0065] Step 2, Preparation of the colloid: Phase A (aqueous matrix): CMC-Na was dispersed in purified water at 60℃ and swollen overnight. Simultaneously, Carbomer 980 was pre-swollen separately in purified water. PVP K30, menthol, methylparaben, and sorbitol solution were added to the pre-swollen Carbomer 980 colloid. High-speed shearing (3000 rpm, 10 minutes, temperature controlled <40℃) was performed, and the CMC-Na swollen colloid was added during the high-speed shearing stage to obtain a homogeneous, transparent colloid A.

[0066] Phase B (drug phase): The prepared solution obtained in step 1, dragon's blood powder, berberine hydrochloride, chitosan quaternary ammonium salt, and nano zinc oxide were added to colloid A under low-speed stirring (500 rpm) and ultrasonically homogenized (ice bath, 300W pulse, for a total of 2 minutes) to obtain drug-containing colloid B.

[0067] Step 3, Mixing and Degassing: Slowly add colloid B to the remaining colloid A while stirring at low speed (400 rpm) for 30 minutes. Transfer to a planetary mixer for degassing and degas for 15 minutes under a vacuum of -0.09 MPa.

[0068] Step 4: Add musk-β-cyclodextrin inclusion complex powder: Cool the defoamed solution from Step 3 to below 30°C, and slowly add the musk-β-cyclodextrin inclusion complex powder while stirring at 200 rpm. Stir for 20 minutes to obtain the final drug-containing solution.

[0069] Step 5, Coating and Drying: First, using an automatic coating machine, the medicated adhesive solution from Step 4 is evenly coated onto the central area of ​​the backing; then, an ultra-thin spunlace nonwoven fabric is immediately laminated online, followed by the drying process. This process ensures a tight bond between the absorbent layer and the medicated film layer, preventing displacement.

[0070] The drying process involved slightly extending the drying time due to the increased total thickness. A variable temperature program was used: 36℃ (45 min) → 32℃ (180 min) → 28℃ (60 min).

[0071] Step 6, Slitting and Packaging: Slit the dried medicated film from Step 5 into sizes (e.g., 7cm × 10cm); the backing layer uses a foam pad with pressure-sensitive adhesive at the edges, with the medicated film in the center. Cover the medicated film layer and the pressure-sensitive adhesive with glassine silicone release paper, seal in an aluminum-plastic bag, and sterilize by cobalt-60 irradiation to obtain the medicated film bandage based on Shengji Yuhong Ointment.

[0072] Foam provides cushioning and reduces foot pressure, while pressure-sensitive adhesive ensures a secure fit during foot activity.

[0073] The absorbent layer is integrated on top of the medicated film layer and laminated with an ultra-thin spunlace nonwoven fabric (25g / m²) to quickly absorb small amounts of exudate and keep the wound surface clean.

[0074] Furthermore, the inventors conducted a quality inspection on the adhesive bandage of this embodiment, and the inspection results are as follows: Appearance: The central medicated film area is dark red, while the surrounding foam pad is skin-colored.

[0075] Absorbability: Absorption of physiological saline ≥ 5 g / 100cm².

[0076] Adhesion: It has moderate peel strength to stainless steel sheets, allowing it to adhere firmly yet be easily removed.

[0077] Antibacterial properties (in vitro): The diameter of the inhibition zone against Staphylococcus aureus and Pseudomonas aeruginosa is >8 mm.

[0078] The results of the clinical trials include the following: Patient Information: Mr. Zhang, male, 68 years old. Diagnosis: 15-year history of type 2 diabetes, diabetic foot (right foot, Wagner grade 2). Wound condition: Upon admission, an ulcer had formed on the first metatarsal head of the right foot for more than 2 months, which had not responded well to routine outpatient dressing changes (iodine disinfection, Vaseline gauze coverage). The ulcer area was approximately 2.5 cm × 2.0 cm, extending to the subcutaneous fascia. Approximately 30% yellowish-white necrotic tissue was visible at the base of the wound, with moderate exudate, redness and swelling of the surrounding tissue, elevated skin temperature, and a VAS pain score of 6 (rest pain). Culture of wound secretions showed: Staphylococcus aureus (+). General condition: Fasting blood glucose 9.8 mmol / L, glycated hemoglobin 8.5%. Ultrasound of the lower extremities showed: thickening of the intima with plaque formation in the anterior and posterior tibial arteries, with unobstructed blood flow.

[0079] Treatment plan: 1. Basic treatment: adjust insulin regimen to control fasting blood glucose at 7.0-8.5 mmol / L; oral mecobalamin to nourish nerves; patient education to reduce foot weight-bearing.

[0080] 2. Local wound treatment, initial stage (days 1-3): Sharp debridement is performed in the operating room to remove significant necrotic tissue. "Shengji Yuhong Medicated Film Bandage (Diabetic Foot Special Type)" is started 24 hours post-surgery.

[0081] Dressing change procedure: Gently rinse the wound daily with sterile saline solution, and pat the surrounding skin dry with sterile gauze. Cut an appropriate size medicated film according to the shape of the ulcer, apply it to the wound, ensuring complete coverage and extending approximately 1 cm beyond the edges. Secure the outer layer with sterile gauze.

[0082] Change frequency: For the first two weeks, change the dressing every 24 hours due to the large amount of exudate; from the third week onwards, when the exudate decreases, change the dressing every 48 hours.

[0083] Treatment process and results observation and analysis (text and images): Before treatment (e.g.) Figure 1 The wound measures 2.5 x 2.0 cm, with a yellowish-white base and significant redness and swelling. The patient experiences significant resting pain (VAS score of 6) and difficulty walking. Thorough debridement is the first step in initiating healing.

[0084] Day 7 of treatment (e.g.) Figure 2 The ulcer area shrank to 2.0 × 1.5 cm. Necrotic tissue had largely sloughed off, the base had turned red, and scattered fresh granulation tissue was visible. Exudate became clear. Redness and swelling significantly subsided. Pain was significantly reduced (VAS score decreased to 3), with only slight stinging during dressing changes. The "anti-corrosion" effect of the medicated film was evident, painlessly softening and promoting the separation of necrotic tissue. Its "blood-activating and anti-inflammatory" effect reduced surrounding inflammation.

[0085] Day 14 of treatment (e.g.) Figure 3The ulcer area is 1.2 × 0.8 cm. Granulation tissue is well-filled, with a reddish and dense color. Exudate is minimal. Resting pain has disappeared (VAS 1 point), and the patient can walk slowly over short distances. The ulcer has entered the "tissue regeneration" stage. The moist environment and continuous blood-activating components provided by the medicated film stimulate rapid and healthy granulation tissue growth.

[0086] Day 28 of treatment (e.g.) Figure 4 The ulcer has completely healed. New epithelium covers the area, the skin is slightly reddish, and it is flush with the surrounding tissue. There is no pain, and the patient can walk normally with shoes. Clinical healing has been achieved. The protective effect of the drug film and its epithelial growth-promoting effect completed the final step of the repair process.

[0087] Case Summary and Discussion: 1. Evaluation of therapeutic effect In this case, the diabetic foot ulcer (Wagner grade 2) healed completely within 4 weeks after using this product, a healing rate better than expected with conventional treatment for ulcers of this grade (usually requiring 6-12 weeks). During treatment, pain was rapidly and effectively controlled, granulation tissue grew healthily, and no reinfection occurred.

[0088] 2. Mechanism of Action Analysis Debridement stage: The blood-activating and stasis-removing ingredients (angelica, dragon's blood, musk) in this formula work synergistically with trace antibacterial components (nano zinc oxide, chitosan) to improve the microcirculation at the wound edge and enhance the local immune clearance ability, thereby achieving "non-invasive" biological debridement.

[0089] During the tissue regeneration stage: Muscone has been shown to promote the proliferation of vascular endothelial cells and fibroblasts, which manifested in this case as reddish granulation tissue and rapid growth. The moist environment maintained by the gel matrix is ​​the optimal physical environment for granulation tissue growth.

[0090] Comprehensive anti-infection treatment: Targeting the susceptibility of diabetic foot to infection, the prescription integrates glycyrrhizic acid, shikonin, berberine hydrochloride, and chitosan to form a broad-spectrum antibacterial combination, effectively controlling Staphylococcus aureus infection and preventing wound deterioration.

[0091] 3. Security Throughout the 28-day treatment, the patient did not experience any adverse reactions such as local allergies or irritant dermatitis. The skin around the wound remained intact. Monitoring of liver and kidney function showed no abnormalities, indicating that the topical application was safe.

[0092] 4. Revelation This case demonstrates that "Shengji Yuhong Medicated Film Bandage," through modern pharmaceutical technology, transforms the traditional Chinese medicine theories of "soothing pus and promoting tissue regeneration" and "removing necrotic tissue and promoting tissue regeneration" into quantifiable and repeatable clinical efficacy. It is particularly suitable for chronic wounds with complex etiologies and poor responses to conventional treatments, such as diabetic foot, showcasing the unique advantages of integrating traditional Chinese and Western medicine in wound management. (Note: This is a single successful case; the efficacy requires further verification through larger-sample randomized controlled trials.) Example 3 (Burn Repair Type) This embodiment provides a regenerating ointment called Shengji Yuhong Ointment, which has a hydrogel structure and includes an active pharmaceutical ingredient, a matrix, and nano-zinc oxide. Drug components: Enhanced analgesia and penetration: 0.25 parts of musk-β-cyclodextrin inclusion complex (1.2 mg / g calculated as musk ketone): Increased dosage enhances the core effects of promoting blood circulation, reducing swelling, clearing the channels, and relieving pain.

[0093] Lidocaine-ion exchange resin complex (2 parts): Provides rapid, long-lasting, and safe local surface anesthesia through resin sustained-release technology, achieving "immediate pain relief".

[0094] Enhanced anti-inflammatory and scar prevention: Recombinant human epidermal growth factor (rh-EGF) 100,000 IU accounts for less than 1% of the total weight of the active pharmaceutical ingredient: directly promotes epithelial cell proliferation, accelerates healing, and reduces scarring; Eight parts of Lithospermum erythrorhizon (Lithospermum erythrorhizon extract content ≥80%): Increase the dosage to enhance its anti-inflammatory, anti-exudative and granulation tissue growth-promoting properties; Licorice 38 parts (glycyrrhizic acid extract content ≥90%): Increased dosage, synergistic anti-inflammatory and anti-allergic effects; 14 parts of dragon's blood powder (passed through a 200-mesh sieve); 62 parts of angelica (total phenolic acid extract content ≥50%); 17 parts of angelica dahurica (angelica dahurica extract content ≥80%).

[0095] Optimized antibacterial properties: Silver sulfadiazine nanoparticles account for 2% of the total mass of Shengji Yuhong Ointment. As a first-line broad-spectrum antibacterial agent for burn wounds, it has both anti-infection and exudation control effects.

[0096] Chitosan quaternary ammonium salt accounts for 2% of the total mass of Shengji Yuhong Ointment, which helps to fight bacteria and form a physical barrier.

[0097] Gel matrix: Sesame oil 255 parts, beeswax 63 parts, polymer material 103 parts, plasticizer 43 parts, penetration enhancer 8 parts, preservative 1.2 parts.

[0098] Specifically, the formula contains 255 parts sesame oil, 63 parts beeswax, 40 parts superabsorbent polymer (SAP) resin (which has strong absorbency and water-locking properties to cope with the large amount of exudate in the early stage of burns), 40 parts sodium alginate (which provides better biocompatibility, breathability and wound adhesion), and 23 parts sodium hyaluronate (which maintains wound moisture and promotes cell migration).

[0099] 43 parts polyethylene glycol 400; 8 parts oleic acid; 1.2 parts phenoxyethanol.

[0100] This embodiment also provides a medicated film bandage based on Shengji Yuhong Ointment, the specific preparation process of which differs from that of Embodiment 1 as follows: Step 1: Prepare a base gel that does not contain the rh-EGF and lidocaine complex.

[0101] Step 2: Cool the base gel to below 25°C, and while stirring at low speed, add rh-EGF solution (pre-dissolved with a small amount of buffer) and lidocaine resin complex powder in sequence. After stirring and mixing, immediately proceed to the coating process to maximize the protection of biological activity.

[0102] Step 3, Low-temperature cryogelation: After coating, the sodium alginate system is first passed through a 4°C cold air tunnel (10 minutes) to allow it to initially gel and set, preventing it from flowing, before proceeding to the main drying process.

[0103] Step 4, Gentle Drying Program: Perform a low-temperature drying program of 32℃ (60min) → 28℃ (180min) → 25℃ (60min), with humidity strictly controlled at <40% RH throughout the process.

[0104] Backing layer: A semi-permeable polyurethane (PU) film with pressure-sensitive adhesive on the edges is used, which has an extremely high water vapor permeability (>2000 g / m² / 24h), which can promptly remove water vapor formed by a large amount of exudate and avoid immersion.

[0105] Structure: It is a "sandwich" structure: PU film backing → highly absorbent mixed gel film layer → ultra-thin porous non-woven fabric (contact layer, to prevent the gel from adhering to the new granulation tissue).

[0106] Furthermore, the inventors conducted a quality inspection on the adhesive bandage of this embodiment, and the inspection results are as follows: Appearance: The film layer is a semi-transparent dark red gel with a soft and elastic texture.

[0107] Absorption performance: Absorption capacity of simulated exudate (containing protein) ≥ 15 g / 100cm², and extremely low reverse osmosis under pressure.

[0108] Water vapor transmission rate: >1800 g / m² / 24h.

[0109] Onset time of analgesia (in vitro transdermal test): ≤20 minutes.

[0110] Aseptic assurance: Final irradiation sterilization is performed, and the aseptic test is passed.

[0111] The results of the clinical trials include the following: Patient Information: Ms. Li, 35 years old. Diagnosis: Scalds (right forearm and back of hand, superficial second-degree to deep second-degree). Wound Condition: Upon admission (2 hours after injury), a wound approximately 8 cm × 6 cm in size was visible on the right forearm and back of the hand. The base was red and swollen, with scattered blisters of varying sizes. Some blisters had ruptured, exposing a red and white base. The wound was tender to the touch. There was significant exudate. The wound was relatively clean, with no severe contamination. The VAS pain score was 8.

[0112] Overall condition: Vital signs are stable, with no signs of shock.

[0113] Treatment plan: 1. Emergency treatment: Under sedation and analgesia, perform "debridement and blister fluid aspiration". Preserve the unruptured loose blister skin, remove the ruptured blister skin, and rinse the wound with normal saline and mild disinfectant.

[0114] 2. Local wound treatment: After debridement, immediately spray a growth factor solution, then smoothly apply a "Shengji Yuhong Medicated Film Bandage (Burn Repair Type)". Because the wound is located at a joint, use a mesh elastic bandage for slight fixation, allowing moderate movement.

[0115] Change frequency: Depending on the exudation, change the dressing every 24 hours initially; after the peak of exudation (around day 3-4), change it every 48-72 hours. Handle the dressing gently during changes. If the inner non-woven fabric contact layer is dry and not sticky, it can be retained; only the outer medicated film needs to be replaced.

[0116] 3. Adjunctive treatment: tetanus antitoxin injection, oral nonsteroidal anti-inflammatory drugs for pain relief (only for the first 3 days), and enhanced nutritional support.

[0117] Observation of treatment process and results: Before treatment (after debridement) (e.g.) Figure 5 The wound measures 8×6 cm, with a red and white base showing a visible capillary network and active exudation. The patient experiences severe pain (VAS score of 8) and a pronounced burning sensation. Early application aims to provide rapid pain relief, reduce exudation, and prevent infection.

[0118] Day 3 of treatment (e.g.) Figure 6Exudation was significantly reduced, and wound swelling subsided. The base color turned a uniform bright red. The medicated film slightly expanded after absorbing exudate and adhered well to the wound. There was no purulent discharge. Pain was significantly relieved (VAS score decreased to 3). The patient reported minimal pain during dressing changes, and the medicated film did not adhere to the wound. The synergistic effect of lidocaine sustained release and musk's blood-activating properties achieved excellent analgesia. SAP and silver sulfadiazine effectively controlled exudation and the risk of infection.

[0119] Day 7 of treatment (e.g.) Figure 7 A pinkish epithelialized area, approximately 2 mm wide, was visible creeping inwards from the wound edge. The basal granulation tissue was reddish, flat, and without edema. The wound area shrank to approximately 7 × 5 cm. There was only occasional slight itching, with no pain. Joint mobility had largely recovered. The wound had entered the epithelialization stage. The moist environment, rh-EGF, and components such as comfrey jointly promoted rapid and orderly epithelial regeneration.

[0120] Day 14 of treatment (e.g.) Figure 8 The wound has completely healed through epithelialization. The new skin is smooth, slightly reddish in color, and shows no signs of hypertrophic scarring or contracture. Only mild pigmentation remains. There is no discomfort, and skin sensation gradually returns. High-quality physiological healing has been achieved. The protective film prevents dryness and crusting, which is key to scar prevention.

[0121] Case Summary and Discussion: 1. Overall efficacy evaluation: Excellent analgesic effect: Patients experience significant pain relief within 30 minutes of application, an advantage that traditional burn ointments cannot match, greatly improving treatment compliance.

[0122] Highly efficient exudation management: The highly absorbent composite gel system successfully copes with peak exudation periods, maintaining the ideal state of "moist but not soaked" wound surface and avoiding frequent dressing changes.

[0123] Zero infection: The wound remained clean and showed no signs of infection throughout the two-week treatment period, demonstrating the effectiveness of the prescribed antimicrobial system.

[0124] High healing quality: Complete healing of mixed-degree burns, mainly deep second-degree burns, is achieved within 14 days, with smooth and soft skin and unimpaired joint function after healing, achieving the dual goal of cosmetic and functional restoration.

[0125] 2. Mechanism of action and advantages: This product creatively combines four elements: "immediate analgesia (Western medicine sustained-release technology)," "full-process anti-infection (silver sulfadiazine)," "active repair promotion (rh-EGF and traditional Chinese medicine blood-activating and tissue-regenerating components)," and "ideal healing environment (modern functional dressing technology)."

[0126] Compared with traditional silver sulfadiazine cream, it not only has antibacterial properties, but also actively regulates the wound microenvironment, significantly relieves pain, and positively promotes tissue regeneration, achieving an upgrade from "passive coverage" to "active repair".

[0127] Compared to simple biological dressings, it also has a clear pharmacological therapeutic effect.

[0128] 3. Safety: No local or systemic adverse reactions were observed during treatment. Silver sulfadiazine is bound in the gel in nanoparticle form, allowing for controlled release of silver ions and eliminating the risk of local pigmentation or systemic silver poisoning.

[0129] 4. Clinical Significance: This case demonstrates that through the deep integration of traditional Chinese and Western medicine theories and techniques, the "Shengji Yuhong Medicated Film Bandage" can be successfully extended to the field of acute burns and scalds, providing an integrated solution that offers "powerful analgesia, efficient anti-permeability, and scar prevention and healing promotion," demonstrating significant clinical advantages and social value. (Note: This case is a typical example; large-scale application requires adherence to relevant clinical guidelines and the accumulation of more evidence.) The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention.

[0130] It should be understood that the present invention is not limited to the content already described above, and various modifications and changes can be made without departing from its scope. The scope of the present invention is limited only by the appended claims.

Claims

1. A skin-regenerating ointment, characterized in that, The Shengji Yuhong Ointment has a hydrogel structure, comprising the active pharmaceutical ingredient and a gel matrix, as well as nano-zinc oxide or silver sulfadiazine nanoparticles. The active pharmaceutical ingredient comprises the following ingredients in parts by weight: 13-17 parts Angelica dahurica, 34-38 parts Glycyrrhiza uralensis, 58-62 parts Angelica sinensis, 10-14 parts Dragon's Blood, 4-8 parts Lithospermum erythrorhizon, and 0.2-0.25 parts Musk-β-cyclodextrin inclusion complex powder or Musk nanoliposome powder. The matrix comprises the following components in parts by weight: 245-255 parts sesame oil, 57-63 parts beeswax, 93-103 parts polymer material, 37-43 parts plasticizer, 3-8 parts penetration enhancer, and 0.8-1.2 parts preservative.

2. A skin-regenerating ointment, characterized in that, The Shengji Yuhong Ointment has a hydrogel structure, comprising the active pharmaceutical ingredient, a gel matrix, a chitosan quaternary ammonium salt, and nano-zinc oxide or silver sulfadiazine nanoparticles. The active pharmaceutical ingredient comprises the following ingredients in parts by weight: 13-17 parts Angelica dahurica, 34-38 parts Glycyrrhiza uralensis, 58-62 parts Angelica sinensis, 10-14 parts Dragon's Blood, 4-8 parts Lithospermum erythrorhizon, 0.2-0.25 parts Musk-β-cyclodextrin inclusion complex powder or Musk nanoliposome powder, and 0.5-5 parts Berberine hydrochloride. The matrix comprises the following components in parts by weight: 245-255 parts sesame oil, 57-63 parts beeswax, 93-103 parts polymer material, 37-43 parts plasticizer, 3-8 parts penetration enhancer, and 0.8-1.2 parts preservative.

3. A skin-regenerating ointment, characterized in that, The Shengji Yuhong Ointment has a hydrogel structure, comprising the active pharmaceutical ingredient, a gel matrix, a chitosan quaternary ammonium salt, and nano-zinc oxide or silver sulfadiazine nanoparticles. The active pharmaceutical ingredient comprises the following ingredients in parts by weight: 13-17 parts Angelica dahurica, 34-38 parts Glycyrrhiza uralensis, 58-62 parts Angelica sinensis root, 10-14 parts Dragon's Blood, 4-8 parts Lithospermum erythrorhizon, 0.2-0.25 parts Musk-β-cyclodextrin inclusion complex powder or Musk nanoliposome powder, and 1-5 parts lidocaine-ion exchange resin complex; it also includes recombinant human epidermal growth factor, which accounts for less than 1% of the total weight of the active pharmaceutical ingredient; The matrix comprises the following components in parts by weight: 245-255 parts sesame oil, 57-63 parts beeswax, 93-103 parts polymer material, 37-43 parts plasticizer, 3-8 parts penetration enhancer, and 0.8-1.2 parts preservative.

4. The Shengji Yuhong Ointment according to any one of claims 1 to 3, characterized in that, The mass ratio of the active pharmaceutical ingredient to the gel matrix is ​​0.15~1:10.6~70.

5. The Shengji Yuhong Ointment according to any one of claims 1 to 3, characterized in that, The nano-zinc oxide or silver sulfadiazine nanoparticles account for 1% to 2% of the total mass of Shengji Yuhong Ointment.

6. The Shengji Yuhong Ointment according to claim 2 or 3, characterized in that, The chitosan quaternary ammonium salt accounts for 1% to 2% of the total mass of Shengji Yuhong Ointment.

7. The Shengji Yuhong Ointment according to any one of claims 1 to 3, characterized in that, The preparation process of the musk-β-cyclodextrin inclusion complex powder is as follows: Musk extract was mixed with β-cyclodextrin, then sheared or ultrasonically dispersed, and finally sprayed or freeze-dried. The preparation process of the musk nanoliposome powder is as follows: Musk extract is mixed with phospholipids, then subjected to high-speed shearing or ultrasonic treatment, and finally sprayed or freeze-dried.

8. The Shengji Yuhong Ointment according to any one of claims 1 to 3, characterized in that, The polymer material is any one or more of polyvinylpyrrolidone, polyvinyl alcohol, sodium carboxymethyl cellulose, sodium alginate, carbomer 980, sodium hyaluronate, and superabsorbent resin. The plasticizer includes glycerin, propylene glycol, polyethylene glycol 400, or sorbitol solution; The penetration enhancers include azones, alcohols, organic acids, or natural products; The preservatives include parabens, alcohols, organic acids, or a combination thereof.

9. A medicated adhesive bandage based on Shengji Yuhong Ointment, characterized in that, Based on the Shengji Yuhong Ointment according to any one of claims 1 to 8, the medicated film bandage includes a backing layer, a medicated film layer is provided in the top middle area of ​​the backing layer, an adhesive layer is provided on the top of the backing layer and on both sides of the medicated film layer, and an absorbent pad is provided on the top of the medicated film layer. The medicated film layer has a hydrogel structure and contains Shengji Yuhong Ointment.

10. A method for preparing a medicated adhesive bandage based on Shengji Yuhong Ointment, characterized in that, The medicated film bandage according to claim 9 includes uniformly coating the Shengji Yuhong Ointment onto the central area of ​​the backing layer using a precision coating machine, then laminating an absorbent pad online, and then drying it through a low-temperature hot air circulating oven to form a medicated film of a set thickness and strength. Subsequently, it is cut, covered with anti-stick release paper, sealed and packaged, and finally sterilized.

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