Orthopedic plaster as well as preparation method and application thereof

Abstract

The invention provides an orthopedic plaster as well as a preparation method and application thereof, and relates to the technical field of traditional Chinese medicines, the orthopedic plaster comprises frankincense, myrrh, Sichuan notopterygium root, eucommia ulmoides, rhizoma cyperi, ox's teasel root, safflower, angelica sinensis, radix curcumae, rhizoma atractylodis, radix saposhnikoviae, dipsacus root, radix aconiti, radix aconiti agrestis, rhubarb, ephedra, drynaria baronii, semen strychni, catechu, radix sophorae flavescentis, rosin, borneol and dragon's blood. The multiple components cooperatively intervene in multiple pathological links such as inflammatory response, pain conduction and tissue repair through different action ways, the fracture healing period can be shortened, hyperostosis can be treated, the postoperative infection incidence rate can be reduced, muscle atrophy caused by long-term bed lying can be relieved, the joint movement function can be improved, and analgesic drug dependence can be reduced; the method is suitable for treating open wounds with damaged skin integrity.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to an orthopedic plaster, its preparation method, and its application. Background Technology

[0002] In the current medical field, orthopedic diseases, especially fractures, bone hyperplasia, and herniated discs, are extremely common, causing patients great pain and inconvenience. Treatment for these diseases often relies on surgical intervention, aiming to remove or repair damaged bone or cartilage structures. However, surgical treatment is often accompanied by postoperative complications such as infection, bleeding, and nerve damage, and postoperative functional recovery is lengthy, painful, and hinders normal fracture healing. Furthermore, surgical treatment is expensive, placing a heavy financial burden on patients. While traditional Chinese medicine external application therapy has the advantages of fewer side effects and lower cost, existing plasters often suffer from problems such as limited active ingredients and poor penetration, resulting in limited therapeutic effects. This is especially true in complex cases such as open fracture infections and postoperative orthopedic infections, where the therapeutic effect of existing plasters is poor. Summary of the Invention

[0003] The problem this invention addresses is how to solve the issue of poor therapeutic effects of existing plasters.

[0004] To address the above problems, this invention provides an orthopedic plaster, its preparation method, and its application.

[0005] In a first aspect, the present invention provides an orthopedic plaster comprising: frankincense, myrrh, Sichuan pepper, eucommia bark, cyperus rhizome, achyranthes root, safflower, angelica root, turmeric, atractylodes rhizome, saposhnikovia root, dipsacus root, aconite root, aconite tuber, rhubarb, ephedra, ginger, strychnos seed, catechu, sophora root, rosin, borneol, and dragon's blood.

[0006] Optionally, by weight fraction, it includes: 20 to 40 g of frankincense, 20 to 40 g of myrrh, 20 to 40 g of Sichuan pepper, 20 to 40 g of eucommia, 20 to 40 g of cyperus, 20 to 40 g of achyranthes, 20 to 40 g of safflower, 20 to 40 g of angelica, 20 to 40 g of turmeric, 20 to 40 g of atractylodes, 20 to 40 g of saposhnikovia, 20 to 40 g of dipsacus, 20 to 40 g of aconite, 20 to 40 g of aconite root, 20 to 40 g of rhubarb, 20 to 40 g of ephedra, 20 to 40 g of ginger, 20 to 40 g of strychnos nux-vomica, 20 to 40 g of catechu, 20 to 40 g of sophora flavescens, 40 to 60 g of rosin, 180 to 220 g of borneol, and 180 to 220 g of dragon's blood.

[0007] Optionally, the orthopedic plaster may also include an extraction solvent, which may include sesame oil.

[0008] Optionally, by weight fraction, it includes 2000 to 4000 g of sesame oil.

[0009] Secondly, the present invention provides a method for preparing the orthopedic plaster as described above, comprising the following steps: Take frankincense, myrrh, Sichuan ginseng, eucommia bark, cyperus rhizome, achyranthes root, safflower, angelica root, turmeric, atractylodes rhizome, saposhnikovia root, dipsacus root, aconite root, kusnezoffii rhizome, rhubarb, ephedra, ginger, strychnos nux-vomica, catechu, sophora root, rosin, and dragon's blood, place them in an extraction solvent, boil for more than 6 hours, add borneol, and obtain the medicinal liquid.

[0010] Optionally, the extraction solvent may include sesame oil.

[0011] Optionally, the method further includes the step of: Thickening excipients are added to the medicinal liquid, heated until the thickening excipients are completely melted, and then cooled to form a plaster.

[0012] Optionally, the thickening agent includes at least one of red lead, rosin, and petrolatum.

[0013] Optionally, the method further includes the step of: Place the plaster on the backing material, with a thickness of 0.5 to 1 cm; The backing material is one of the following: non-woven fabric, cotton fabric, paper film, and plastic film.

[0014] Thirdly, the present invention provides an application of the orthopedic plaster described above in the fields of conservative treatment of fractures, bone hyperplasia, infection of open fractures, or postoperative infection of orthopedic patients.

[0015] The beneficial effects of the orthopedic plaster of the present invention, its preparation method, and its application are as follows: Frankincense and myrrh, when combined, exert synergistic analgesic and tissue regeneration-promoting effects; as a combination of resinous medicinal materials, frankincense and myrrh can form a network structure to encapsulate active substances, achieving a sustained-release effect; the combination of Sichuan pepper, saposhnikovia root, and atractylodes can increase the blood drug concentration at the lesion site by dilating capillaries, improving local microcirculation disorders; the combination of eucommia bark and dipsacus root promotes osteoblast activity, stimulates osteoblast differentiation, and accelerates callus formation; the combination of aconite, aconitum carmichaelii, and strychnos nux-vomica can block pain nerve conduction through transdermal absorption, achieving local anesthesia. This formula combines blood-activating ingredients to clear local metabolic waste; the combination of angelica, safflower, and dragon's blood accelerates the repair of damaged tissues; the combination of ephedra and ginger relieves muscle spasms, improves tissue oxygenation, and forms an antibacterial barrier with antibacterial components; the combination of sophora flavescens and catechu provides antibacterial and anti-inflammatory effects, preventing wound infection; rosin, as a matrix, enhances the adhesiveness of the ointment, and softens it with body temperature to improve application stability; a penetration enhancer disrupts the lipid structure of the stratum corneum to improve drug bioavailability; borneol, as a penetration enhancer, increases the transdermal drug delivery rate; and the combination of borneol and rosin forms a gradient release system to maintain effective blood drug concentrations. These multiple components synergistically intervene in multiple pathological processes, including inflammatory response, pain transmission, and tissue repair, through different pathways of action. This can shorten the fracture healing period, treat bone hyperplasia, reduce postoperative infection rates, alleviate muscle atrophy caused by prolonged bed rest, improve joint function, and reduce dependence on analgesics, making it suitable for treating open wounds with impaired skin integrity. Attached Figure Description

[0016] Figure 1 This is an imaging examination image of the lumbar vertebrae in the affected area of ​​a patient with untreated lumbar osteophyte in Example 1. Figure 2 This is an imaging examination of the lumbar vertebrae in the patient with lumbar osteophyte who had applied orthopedic plaster in Example 1. Figure 3 This is an image of the heel bone in the affected area of ​​a patient with untreated heel spurs in Example 2. Figure 4 This is an image of the heel bone in the affected area of ​​a patient with heel osteophyte who had applied orthopedic plaster in Example 2. Figure 5 Image of the infection status of the affected area in the patient with untreated forearm fracture postoperative infection in Example 3; Figure 6 Image of the infection status of the patient with a forearm fracture after one day of application of orthopedic plaster in Example 3; Figure 7 Image of the infection status of the patient with a forearm fracture who had an infection after applying orthopedic plaster for two days in Example 3; Figure 8Image of the infection status of the patient with a forearm fracture who had an infection after applying orthopedic plaster for three days in Example 3; Figure 9 Image of the infection status of the patient with a forearm fracture who had an infection after four days of applying orthopedic plaster in Example 3; Figure 10 Image of the infection status of the patient with a forearm fracture who developed an infection after applying orthopedic plaster for five days in Example 3; Figure 11 Image of the infection status of the patient with a forearm fracture who had an infection after applying orthopedic plaster for six days in Example 3; Figure 12 Image of the infection status of the patient with a forearm fracture who underwent surgery and developed an infection after applying orthopedic plaster for seven days in Example 3; Figure 13 Image of the infection status of the patient with a forearm fracture who had an infection after eight days of applying orthopedic plaster in Example 3; Figure 14 This is an image showing the infection status of the affected area in a patient with a forearm fracture who underwent surgery and developed an infection after applying orthopedic plaster for nine days, as described in Example 3. Detailed Implementation

[0017] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Although some embodiments of the present invention are shown in the drawings, it should be understood that the present invention can be implemented in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to provide a more thorough and complete understanding of the present invention. It should be understood that the accompanying drawings and embodiments of the present invention are for illustrative purposes only and are not intended to limit the scope of protection of the present invention.

[0018] Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used in this invention's description is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "comprising" and its variations as used herein are open-ended inclusion, meaning "including but not limited to"; the term "based on" means "at least partially based on"; the term "one embodiment" means "at least one embodiment"; the term "another embodiment" means "at least one additional embodiment"; the term "some embodiments" means "at least some embodiments"; and the term "optionally" means "optional embodiments". Definitions of other terms will be given in the description below.

[0019] This invention provides an orthopedic plaster, its preparation method, and its application.

[0020] An embodiment of the present invention provides an orthopedic plaster comprising: frankincense, myrrh, notopterygium root (also known as Qianghuo), eucommia bark, cyperus rhizome, ox horn product, safflower, angelica root, turmeric, atractylodes rhizome, saposhnikovia root, dipsacus root (also known as Xuduan), aconite root, aconite tuber, rhubarb root (also known as Dahuang), ephedra, ginger, strychnos nux-vomica, catechu, sophora flavescens root, rosin, borneol, and dragon's blood.

[0021] In this embodiment, frankincense and myrrh are combined to exert synergistic analgesic and tissue regeneration-promoting effects. As a combination of resinous medicinal materials, frankincense and myrrh can form a network structure to encapsulate the active substances, achieving a sustained-release effect. The combination of Sichuan pepper, saposhnikovia root, and atractylodes can increase the blood drug concentration at the lesion site by dilating capillaries and improve local microcirculation disorders. The combination of eucommia bark and dipsacus root promotes osteoblast activity, stimulates osteoblast differentiation, and accelerates callus formation. The combination of aconite root, aconitum carmichaelii root, and strychnos nux-vomica can block the transmission of pain nerves through transdermal absorption to achieve local anesthesia, combined with the removal of blood-activating components. Local metabolic waste; the combination of Angelica sinensis, safflower, and dragon's blood can accelerate the repair of damaged tissues; the combination of ephedra and ginger can relieve muscle spasms, improve tissue oxygenation, and form an antibacterial barrier with antibacterial components; the combination of Sophora flavescens and catechu can have antibacterial and anti-inflammatory effects and prevent wound infection; rosin as a matrix can enhance the adhesion of the ointment, and softening it with body temperature can enhance the stability of the application; the penetration enhancer disrupts the lipid structure of the stratum corneum to improve drug bioavailability; borneol as a penetration enhancer can increase the transdermal drug delivery rate; the combination of borneol and rosin forms a gradient release system that can maintain an effective blood drug concentration. Multiple components synergistically intervene in multiple pathological processes such as inflammatory response, pain transmission, and tissue repair through different pathways of action, which can shorten the fracture healing period, treat bone hyperplasia, reduce the incidence of postoperative infection, alleviate muscle atrophy caused by prolonged bed rest, improve joint function, and reduce dependence on analgesics. It is suitable for the treatment of open wounds with impaired skin integrity.

[0022] To address the inherent contradiction between surgical trauma and drug penetration efficiency, a multi-component synergistic traditional Chinese medicine compound system was considered. Analysis of the pathological mechanisms of orthopedic diseases revealed pain, inflammation, impaired bone repair, and poor local circulation as key therapeutic targets. Based on the theory of traditional Chinese medicine compatibility, a combination of medicinal materials with the effects of promoting blood circulation, removing blood stasis, dispelling wind and dampness, and strengthening tendons and bones was selected. A matrix system was constructed that combines transdermal absorption promotion and long-lasting sustained release, forming a non-invasive comprehensive therapeutic plaster. Through the synergistic effect of more than twenty traditional Chinese medicine components such as frankincense, myrrh, and Sichuan pepper, it can effectively improve the problems of traditional plasters with single ingredients and poor permeability, possessing the advantages of strong synergistic effects of active ingredients, good permeability, and long-lasting effects.

[0023] Specifically, the combination of frankincense and myrrh refers to a combination of resinous medicinal materials, which can be directly mixed to exert synergistic analgesic and tissue regeneration-promoting effects. The combination of Sichuan pepper, saposhnikovia root, and atractylodes refers to a group of wind-dispelling and dampness-removing medicinal materials, which can be extracted using sesame oil to improve local microcirculation disorders. The combination of eucommia bark and dipsacus root refers to liver- and kidney-tonifying medicinal materials, which can be extracted using sesame oil to promote osteoblast activity. The combination of aconite root, aconitum carmichaelii root, and nux vomica refers to alkaloid-containing medicinal materials, which can be extracted using sesame oil for transdermal absorption to achieve local anesthesia. The combination of angelica root, safflower, and dragon's blood refers to a group of blood-activating and stasis-removing medicinal materials, which can be extracted using sesame oil to accelerate the repair of damaged tissues. The combination of ephedra and ginger refers to warming and dispersing cold medicinal materials, which can be extracted using sesame oil to relieve muscle spasms. The combination of sophora flavescens and catechu refers to antibacterial and anti-inflammatory components, which can be extracted using sesame oil to prevent wound infection. Rosin, as a matrix, refers to a natural resin material. Specifically, it can be extracted by boiling sesame oil to enhance the adhesiveness of the ointment. Borneol, as a penetration enhancer, refers to borneol-like substances. Specifically, borneol can be added after boiling sesame oil to enhance the transdermal drug delivery rate.

[0024] Resin-based components form a network structure to encapsulate active substances, achieving a sustained-release effect. Wind-dispelling and dampness-removing components increase blood drug concentration at the lesion site by dilating capillaries, while liver- and kidney-tonifying components stimulate osteoblast differentiation and accelerate callus formation. Alkaloids block pain nerve transmission and, in conjunction with blood-activating components, clear local metabolic waste. Warming and cold-dispersing components improve tissue oxygenation, and antibacterial components form an antibacterial barrier. The matrix system softens with body temperature to enhance patch stability, and penetration enhancers disrupt the lipid structure of the stratum corneum to improve drug bioavailability. These multiple components synergistically intervene in multiple pathological processes—inflammatory response, pain transmission, and tissue repair—through different pathways of action.

[0025] Optionally, by weight fraction, the orthopedic plaster comprises: frankincense 20 to 40 g, myrrh 20 to 40 g, Sichuan pepper 20 to 40 g, eucommia 20 to 40 g, cyperus rotundus 20 to 40 g, achyranthes bidentata 20 to 40 g, safflower 20 to 40 g, angelica sinensis 20 to 40 g, turmeric 20 to 40 g, atractylodes lancea 20 to 40 g, saposhnikovia divaricata 20 to 40 g, dipsacus asper 20 to 40 g, aconite 20 to 40 g, aconitum carmichaelii 20 to 40 g, rhubarb 20 to 40 g, ephedra 20 to 40 g, ginger 20 to 40 g, strychnos nux-vomica 20 to 40 g, catechu 20 to 40 g, sophora flavescens 20 to 40 g, rosin 40 to 60 g, borneol 180 to 220 g, and dragon's blood 180 to 220 g.

[0026] In this optional embodiment, the precise ratio range of each component is defined to maximize the efficacy of multiple medicinal herbs through synergistic effects, while controlling toxic components within safe thresholds and reducing reliance on surgical treatment. This solves the problem of unstable efficacy caused by imprecise component ratios in traditional orthopedic plasters, ensuring analgesic and anti-inflammatory effects while reducing skin irritation, and shortening the recovery period by enhancing transdermal absorption, providing a non-surgical treatment option for bone hyperplasia and postoperative infection.

[0027] Specifically, *Aconitum carmichaelii* and *Aconitum kusnezoffii* refer to alkaloid-containing medicinal materials, and their use can be controlled by limiting the dosage below the toxicity threshold for analgesia and antirheumatism. Borneol and dragon's blood are components with transdermal penetration-promoting, hemostatic, and tissue-regenerating effects, which can be achieved by increasing their proportion in the formula to accelerate drug penetration and wound repair. The dosage of frankincense, myrrh, and *Aconitum carmichaelii* and *Aconitum kusnezoffii* is limited to 20-40 g to balance the ratio of blood-activating and analgesic components, avoiding skin irritation caused by excessive aconitine while maintaining anti-swelling and analgesic effects. The dosage of rosin is controlled at 40-60 g to ensure the ointment forms a moderately adhesive film on the skin surface while avoiding excessive viscosity that could affect breathability. The dosage of borneol and dragon's blood is increased to 180-220 g to increase transdermal absorption efficiency, allowing active ingredients to act on deeper tissues more quickly and shortening the onset time. The dosage of medicinal materials containing toxic alkaloids, such as *Strychnos nux-vomica*, is strictly limited to the upper limit to reduce toxicity risks through synergistic effects with other components.

[0028] Optionally, the orthopedic plaster may also include an extraction solvent, which may include sesame oil.

[0029] In this optional embodiment, sesame oil serves as a natural solvent, ensuring the full dissolution of the active ingredients in the medicinal materials while avoiding damage to the patient's skin from residual organic solvents. This achieves efficient extraction of the fat-soluble components of the medicinal materials, enhances the transdermal penetration ability of the active pharmaceutical ingredients, and eliminates potential skin allergic reactions caused by chemical solvents.

[0030] Specifically, the extraction solvent refers to the liquid medium used to dissolve the active ingredients of medicinal materials. Natural oils can be used, and their function is to promote the dissolution of fat-soluble active substances and form a stable drug carrier. Sesame oil, in particular, refers to vegetable oil obtained from sesame seeds through a pressing process, and refined sesame oil can be used. Its viscosity and permeability can balance the dissolution efficiency of the medicinal ingredients with the skin absorption rate.

[0031] During the decoction process, sesame oil is used as a solvent and heated together with frankincense, myrrh, and other medicinal materials. The polarity of the oil dissolves the fat-soluble alkaloids and terpenoids in the herbs. As the temperature rises, the cell walls of the herbs rupture under the permeation of the oil, releasing the active ingredients into the oil phase. After decoction, the sesame oil forms a miscible system with rosin and borneol, which solidifies to form a matrix layer that serves both as a drug carrier and for transdermal absorption.

[0032] Optionally, by weight fraction, it includes 2000 to 4000 g of sesame oil.

[0033] In this optional embodiment, by optimizing the range of extraction solvent dosage, the problems of loss of effective components or excessively thin paste caused by mismatch between the volume of extraction solvent and the amount of medicinal materials are solved. This achieves efficient extraction of the effective components of the medicinal materials while ensuring stable adhesion and drug release performance of the plaster during application, avoiding process defects caused by excessive or insufficient extraction solvent during preparation.

[0034] Specifically, this is achieved by adjusting the ratio of the total amount of extraction solvent, sesame oil, to the amount of medicinal materials, thus balancing the dissolution efficiency of the active ingredients and the viscosity of the paste. The amount of sesame oil is controlled within the range of 2000 to 4000 grams, ensuring that the medicinal materials are completely immersed in the solvent and avoiding component destruction caused by uneven heating in certain areas. When the amount of sesame oil is below the lower limit, insufficient immersion of the medicinal materials may lead to a decrease in the extraction rate of active ingredients; when the amount exceeds the upper limit, excessive solvent will dilute the concentration of active ingredients and reduce the adhesion of the paste. By limiting this range, the full release of active substances in the medicinal materials is ensured, and a suitable physical state basis is provided for the subsequent addition of thickening excipients.

[0035] Another embodiment of the present invention provides a method for preparing the orthopedic plaster as described above, comprising the following steps: Take frankincense, myrrh, Sichuan ginseng, eucommia bark, cyperus rhizome, achyranthes root, safflower, angelica root, turmeric, atractylodes rhizome, saposhnikovia root, dipsacus root, aconite root, kusnezoffii rhizome, rhubarb, ephedra, ginger, strychnos nux-vomica, catechu, sophora root, rosin, and dragon's blood, place them in an extraction solvent, boil for more than 6 hours, add borneol, and obtain the medicinal liquid.

[0036] In this embodiment, extending the decoction time to over 6 hours significantly improves the concentration and stability of active substances in the medicinal solution. This enables non-surgical local treatment of orthopedic diseases, allowing the drug components to continuously act on the affected area through transdermal absorption, reducing tissue damage and infection risks associated with surgery. The thorough dissolution and stable binding of the effective components during preparation give the plaster long-lasting analgesic and bone-repair-promoting functions, shortening the recovery period required for traditional treatments.

[0037] Specifically, the extraction solvent refers to the liquid medium used to dissolve and extract the effective components of traditional Chinese medicine (TCM) herbs. This can be achieved using sesame oil, which helps to fully extract the fat-soluble active ingredients from the herbs. The decoction time of over 6 hours refers to the process conditions where continuous heating ensures full contact between the herbs and the solvent. This can be achieved through segmented temperature control or constant temperature decoction, ensuring the full dissolution of heat-stable components and the formation of a stable medicinal solution. The herbal combination refers to a specific blend of 23 TCM herbs, including frankincense and myrrh, which works by synergistically producing a comprehensive effect of promoting blood circulation, removing blood stasis, reducing inflammation and pain, and promoting tissue repair.

[0038] The herbal combination contains aconite and aconitum carmichaelii, which contain alkaloids that combine with the oil solvent during decoction to form transdermal absorption carriers. Rosin and borneol act as natural penetration enhancers, increasing the skin permeability of the medicinal components. The active ingredients in dragon's blood and safflower are released at high temperatures and fuse with the solvent to form a complex with tissue repair functions. By controlling the decoction time, the heat-sensitive components in the herbs are gradually released while avoiding activity loss due to high temperatures. In the oil solvent, the lipid-soluble components and some water-soluble components form a microemulsion system, giving the final medicinal solution both sustained-release and rapid-onset properties.

[0039] Optionally, the extraction solvent may include sesame oil.

[0040] In this optional embodiment, sesame oil, as a natural solvent, leaves no toxic residue, and its permeability promotes the transdermal absorption of medicinal components. Furthermore, organic solvents may destroy heat-sensitive components during high-temperature boiling, while the high boiling point of sesame oil reduces such decomposition. This solves the problems of low extraction efficiency of active ingredients and insufficient solvent safety in traditional preparation processes, achieving efficient release and stable preservation of the active ingredients of the medicinal materials, while avoiding skin irritation from solvent residues, thus improving the safety and therapeutic effect of the plaster.

[0041] Specifically, sesame oil refers to natural plant oil, such as sesame oil or peanut oil. It possesses excellent permeability and stability, capable of dissolving fat-soluble active ingredients in medicinal materials, such as resinous substances, while preventing the decomposition of active ingredients during high-temperature boiling. By choosing sesame oil as a solvent, the release efficiency of drug components can be improved, while reducing the risk of skin irritation from solvent residue.

[0042] In the preparation process, sesame oil is used as a solvent to boil together with the medicinal materials. Its high boiling point and thermal stability maintain the stability of the medicinal liquid under prolonged high-temperature conditions. The fat-soluble active ingredients are fully dissolved in the sesame oil, forming a homogeneous medicinal matrix, which provides the foundation for the subsequent plaster formation. Furthermore, sesame oil has high skin compatibility, avoiding allergic or toxic reactions that may be caused by traditional organic solvents.

[0043] Optionally, the method further includes the step of: Thickening excipients are added to the medicinal liquid, heated until the thickening excipients are completely melted, and then cooled to form a plaster.

[0044] In this optional embodiment, the phase change process is controlled in stages, and the rheological properties of the ointment are precisely regulated by utilizing the physical properties of the thickening excipients while maintaining the effective components of the drug. During the heating and melting stage, rosin and the drug solution are fully integrated, preserving drug activity while avoiding excessively high local concentrations. This solves the problem of difficulty in ointment formation caused by excessive fluidity of the drug solution, ensuring the ointment maintains a stable shape during application and enhancing adhesion to the skin surface, preventing displacement and detachment due to movement or sweat. The three-dimensional network structure formed within the ointment effectively carries the drug components, ensuring continuous release of therapeutic substances to the affected area.

[0045] Specifically, thickening excipients refer to substances used to adjust the viscosity of the drug solution. These can be achieved using at least one of red lead, rosin, and petrolatum, forming a three-dimensional network structure through intermolecular forces to reduce the system's fluidity. Heating to complete melting refers to ensuring thorough mixing of the thickening excipient and the drug solution through temperature control. This can be achieved by maintaining a constant temperature of 60-80°C for 30 minutes using a constant temperature heating device, eliminating crystallization defects and ensuring uniform component distribution. Cooling to form a plaster refers to inducing a phase change in the mixture through cooling. This can be achieved by natural cooling or forced air cooling at 25°C for 2 hours, transforming the liquid mixture into a viscoelastic semi-solid plaster.

[0046] The medicinal liquid exhibits high fluidity after boiling, making it prone to dripping and uneven thickness when applied directly. By introducing thickening excipients, these excipients are uniformly dispersed in the medicinal liquid under heating conditions, and the molecular chains cross-link during cooling to form a stable structure. For example, petrolatum, when mixed with the medicinal liquid in a molten state, gradually solidifies as the temperature decreases, restricting liquid flow and making it suitable for application to open wounds, maintaining its intended shape. Similarly, red lead, when mixed with the medicinal liquid in a molten state, gradually forms a crystalline network as the temperature decreases, further restricting liquid flow. Rosin, through its resin components, increases the cohesive force of the system, further enhancing the mechanical strength of the plaster. Therefore, the plaster maintains its intended shape during application, preventing it from falling off due to limb movement or skin surface tension.

[0047] Optionally, the thickening agent includes at least one of red lead, rosin, and petrolatum.

[0048] In this optional embodiment, the complementary temperature response characteristics of red lead and rosin, combined with the plasticity-regulating effect of petrolatum, achieve a dynamic balance in the rheological properties of the paste, allowing for control of the paste thickness and shape without relying on complex equipment during the molding process. This ensures the paste maintains plasticity within a processing temperature range of 40 to 60°C and maintains a set thickness of 0.5-1 cm at an ambient temperature of 25°C, while preventing paste deformation due to gravity during storage. The stability of the paste's internal structure also allows for the uniform distribution of drug components within the carrier matrix, enabling continuous release.

[0049] Specifically, red lead refers to a natural waxy substance extracted from honeycomb, which can be achieved using refined red lead. Its hydrophobic properties enhance the structural strength of the ointment and maintain the stability of the drug components. Rosin refers to the solid substance obtained by distilling pine resin to remove volatile oils, and can be achieved using food-grade rosin. Its thermoplastic properties allow it to form a three-dimensional network structure upon cooling, enhancing the ointment's spreadability. Petrolatum refers to a mixture of mineral oil and paraffin wax, and can be achieved using medical-grade petrolatum. Its semi-solid properties regulate the ointment's softness and form a sealing and moisturizing layer.

[0050] During the high-temperature cooking stage, red lead and rosin are uniformly dispersed in the liquid while molten, maintaining appropriate fluidity for easy processing. As the temperature drops to room temperature, the crystallization of red lead and the network cross-linking of rosin synergistically solidify the paste structure, while petrolatum fills the gaps between materials to buffer mechanical stress. This phase transition process ensures the paste is processable during preparation and maintains a stable form in the finished product, preventing dripping or cracking due to insufficient viscosity. Optionally, the method further includes the step of: Place the plaster on the backing material, with a thickness of 0.5 to 1 cm; The backing material is one of the following: non-woven fabric, cotton fabric, paper film, and plastic film.

[0051] In this optional embodiment, by limiting the type of backing material and the range of plaster thickness, the problems of low drug release efficiency and poor application comfort in traditional methods are solved. This achieves structural stability during plaster application, ensuring continuous drug release at the lesion site. Simultaneously, by adapting to different backing materials, it meets the diverse needs of clinical applications for waterproofing, breathability, or high fit, thereby reducing reliance on surgical treatment and shortening the recovery period.

[0052] Specifically, the backing material refers to the base layer used to support the plaster and adhere to the skin. It can be made of non-woven fabric, cotton cloth, paper film, or plastic film, with different materials utilizing their physical properties to meet the application requirements. The plaster thickness refers to the vertical height range of the drug layer on the backing material, which can be controlled within the range of 0.5 to 1 cm by adjusting the drug coating process to balance drug load and skin breathability.

[0053] By combining the medicated plaster layer with a backing material, the backing material provides physical support to the plaster, preventing the medication from falling off or deforming due to external forces. The plaster thickness is limited to 0.5 to 1 cm to ensure that the medicated layer has sufficient drug loading to maintain the continuous release of active ingredients, while avoiding reduced skin breathability or discomfort due to excessive thickness. The choice of backing material is adapted according to different clinical needs: for example, non-woven fabric can improve flexibility and fit during application, cotton fabric can enhance moisture absorption and perspiration wicking, and plastic film is used in scenarios requiring waterproof performance.

[0054] Specifically, the plaster layer can be uniformly coated onto the surface of a nonwoven fabric using a hot-melt process, and then pressed into the desired thickness using a mold. For example, when using cotton fabric as a backing, the plaster layer can be covered with a breathable protective film after coating to prolong drug activity.

[0055] Another embodiment of the present invention provides the application of the orthopedic plaster described above in the fields of conservative treatment of fractures, bone hyperplasia, open fracture infection, or postoperative infection in orthopedics.

[0056] In this embodiment, the plaster is applied directly to the infected site through local application, avoiding invasive procedures. Simultaneously, the synergistic effect of multiple components in the traditional Chinese medicine compound reduces the probability of resistance to single antibiotics. For postoperative infections, the sustained-release properties of the plaster maintain a longer-lasting antibacterial effect compared to conventional disinfectants. It can effectively control orthopedic infections without surgical intervention, shorten the wound healing period, reduce the frequency of postoperative antibiotic use, and accelerate the self-repair of damaged bone tissue by promoting local microcirculation.

[0057] Specifically, orthopedic plasters refer to external patches prepared from specific traditional Chinese medicine formulas. These plasters may combine blood-activating and stasis-removing ingredients such as frankincense and myrrh with antibacterial ingredients such as borneol and dragon's blood, acting on the affected area through transdermal absorption. Osteophyte formation refers to degenerative lesions characterized by abnormal proliferation at the edges of bones and joints; local treatment can be achieved using active ingredients that inhibit inflammatory responses and promote cartilage repair. Open fracture infection refers to complications caused by bacterial invasion of the fracture wound; wound disinfection can be achieved using traditional Chinese medicine ingredients with antibacterial activity, such as sophora flavescens and strychnine. Postoperative orthopedic infection refers to bacterial infection occurring around the incision or implant after bone surgery; sustained-release matrix containing ingredients such as borneol and dragon's blood can provide continuous antibacterial protection.

[0058] This orthopedic plaster relieves pain caused by bone hyperplasia through the anti-inflammatory and analgesic effects of frankincense and myrrh, while inhibiting bacterial proliferation in open fracture wounds using the antibacterial properties of borneol and dragon's blood. For postoperative infections in orthopedic surgeries, excipients such as rosin and red lead in the plaster form a sustained-release matrix, allowing ingredients like nux vomica and sophora flavescens to continuously act on the surgical incision area, blocking bacterial colonization. During treatment, ingredients such as angelica and safflower promote local blood circulation and accelerate bone tissue repair, while the analgesic effects of aconite and aconitum carmichaelii reduce patients' dependence on oral analgesics.

[0059] The present invention will be further described below with reference to specific embodiments.

[0060] Example 1: Preparation of orthopedic plaster.

[0061] 1. Take 30g of frankincense, 30g of myrrh, 30g of Sichuan ginseng, 30g of eucommia bark, 30g of cyperus rhizome, 30g of achyranthes root, 30g of safflower, 30g of angelica root, 30g of turmeric, 30g of atractylodes rhizome, 30g of saposhnikovia root, 30g of dipsacus root, 30g of aconite root, 30g of aconite root, 30g of rhubarb, 30g of ephedra, 30g of ginger, 30g of strychnos nux-vomica, 30g of catechu, 30g of sophora flavescens root, 50g of rosin, and 200g of dragon's blood. Place them in 3000g of sesame oil and simmer for 6 hours. Add 200g of borneol to obtain the medicinal liquid.

[0062] 2. Add red lead to the medicinal solution, heat until the red lead is completely melted, cool, and a plaster is formed.

[0063] 3. Place the plaster on a non-woven fabric. The thickness of the plaster should be 1 cm to obtain the orthopedic plaster.

[0064] Select patients with lumbar spondylosis, and perform imaging examinations of the affected lumbar vertebrae as follows: Figure 1 As shown, in cases of bone hyperplasia with unclear skeletal contours, the orthopedic plaster prepared in Example 1 was applied to the affected area of ​​the patient with lumbar bone hyperplasia. The plaster was changed every three days. After applying nine plasters, the imaging examination of the lumbar vertebrae at the affected area was as follows after 28 days. Figure 2 As shown, the bone outline is clear, and the bone hyperplasia has been absorbed, demonstrating that this orthopedic plaster can effectively and quickly treat bone hyperplasia.

[0065] Example 2: Preparation of orthopedic plaster.

[0066] 1. Take 20g of frankincense, 20g of myrrh, 20g of Sichuan pepper, 20g of eucommia bark, 20g of cyperus rhizome, 20g of achyranthes root, 20g of safflower, 20g of angelica root, 20g of turmeric, 20g of atractylodes rhizome, 20g of saposhnikovia root, 20g of dipsacus root, 20g of aconite root, 20g of aconite root, 20g of rhubarb, 20g of ephedra, 20g of ginger, 20g of strychnos seed, 20g of catechu, 20g of sophora root, 40g of rosin, and 180g of dragon's blood. Place them in 2000g of sesame oil and simmer for 6 hours. Add 180g of borneol to obtain the medicinal liquid.

[0067] 2. Add red lead to the medicinal solution, heat until the red lead is completely melted, cool, and a plaster is formed.

[0068] 3. Place the plaster on a cotton cloth, making the plaster 1 cm thick, to obtain the orthopedic plaster.

[0069] Select patients with heel spurs, and perform imaging examinations of the affected heel bones as follows: Figure 3 As shown, the circled area indicates the location of the osteophyte formation, specifically heel bone hyperplasia. The orthopedic plaster prepared in Example 2 was applied to the affected area of ​​the patient with heel bone hyperplasia. The plaster was changed every three days. After applying nine plasters, the imaging examination of the heel bone at the affected area was performed 30 days later. Figure 4 As shown, the circled area indicates the location of the bone hyperplasia. The bone outline is clear, the hyperplasia has shrunk, and it has been absorbed. This demonstrates that the orthopedic plaster can effectively and quickly treat bone hyperplasia.

[0070] Example 3: Preparation of orthopedic plaster.

[0071] 1. Take 40g of frankincense, 40g of myrrh, 40g of Sichuan pepper, 40g of eucommia bark, 40g of cyperus rhizome, 40g of achyranthes root, 40g of safflower, 40g of angelica root, 40g of turmeric, 40g of atractylodes rhizome, 40g of saposhnikovia root, 40g of dipsacus root, 40g of aconite root, 40g of aconite root, 40g of rhubarb, 40g of ephedra, 40g of ginger, 40g of strychnos seed, 40g of catechu, 40g of sophora root, 60g of rosin, and 220g of dragon's blood. Place them in 4000g of sesame oil and simmer for 6 hours. Add 220g of borneol to obtain the medicinal liquid.

[0072] 2. Add red lead to the medicinal solution, heat until the red lead is completely melted, cool, and a plaster is formed.

[0073] 3. Place the plaster on a cotton cloth, making the plaster 0.5 cm thick, to obtain the orthopedic plaster.

[0074] Select patients with postoperative infection following forearm fracture surgery, and imagery of the infection site is shown. Figure 5 As shown, the postoperative infection was severe. The orthopedic plaster prepared in Example 3 was applied to the affected area, and the plaster was changed every day. Nine plasters were applied, and the image of the infection status of the affected area after one day of application is shown. Figure 6 As shown in the image, the infection status of the affected area after two days of application is as follows. Figure 7As shown in the image, the infection status of the affected area after three days of application is as follows. Figure 8 As shown in the image, the infection status of the affected area after four days of application is as follows. Figure 9 As shown in the image, the infection status of the affected area after five days of application is as follows. Figure 10 As shown in the image, the infection status of the affected area after six days of application is as follows: Figure 11 As shown in the image, the infection status of the affected area after seven days of application is as follows: Figure 12 As shown in the image, the infection status of the affected area after eight days of application is as follows. Figure 13 As shown in the image, the infection status of the affected area after nine days of application is as follows: Figure 14 As shown, this orthopedic plaster can effectively and quickly intervene in inflammatory responses and tissue repair, reduce the incidence of postoperative infection, and is suitable for the treatment of open wounds with impaired skin integrity.

[0075] While the present invention has been disclosed above, its scope of protection is not limited thereto. Those skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention, and all such changes and modifications will fall within the scope of protection of the present invention.

Claims

1. An orthopedic plaster, characterized in that, include: Frankincense, myrrh, Sichuan pepper, eucommia, cyperus, atractylodes, safflower, angelica, turmeric, atractylodes, saposhnikovia, dipsacus, aconite, aconitum carmichaelii, rhubarb, ephedra, ginger, strychnos nux-vomica, catechu, sophora flavescens, rosin, borneol, and dragon's blood.

2. The orthopedic plaster according to claim 1, characterized in that, By weight fraction, it includes: frankincense 20 to 40 g, myrrh 20 to 40 g, Sichuan pepper 20 to 40 g, eucommia 20 to 40 g, cyperus rotundus 20 to 40 g, atractylodes macrocephala 20 to 40 g, safflower 20 to 40 g, angelica sinensis 20 to 40 g, turmeric 20 to 40 g, atractylodes lancea 20 to 40 g, saposhnikovia divaricata 20 to 40 g, dipsacus asper 20 to 40 g, aconite 20 to 40 g, aconitum carmichaelii 20 to 40 g, rhubarb 20 to 40 g, ephedra 20 to 40 g, ginger 20 to 40 g, strychnos nux-vomica 20 to 40 g, catechu 20 to 40 g, sophora flavescens 20 to 40 g, rosin 40 to 60 g, borneol 180 to 220 g, and dragon's blood 180 to 220 g.

3. The orthopedic plaster according to claim 2, characterized in that, It also includes an extraction solvent, which includes sesame oil.

4. The orthopedic plaster according to claim 3, characterized in that, By weight fraction, it includes 2000 to 4000g of sesame oil.

5. A method for preparing an orthopedic plaster as described in any one of claims 1-4, characterized in that, Includes the following steps: Take frankincense, myrrh, Sichuan ginseng, eucommia bark, cyperus rhizome, achyranthes root, safflower, angelica root, turmeric, atractylodes rhizome, saposhnikovia root, dipsacus root, aconite root, kusnezoffii rhizome, rhubarb, ephedra, ginger, strychnos nux-vomica, catechu, sophora root, rosin, and dragon's blood, place them in an extraction solvent, boil for more than 6 hours, add borneol, and obtain the medicinal liquid.

6. The method for preparing the orthopedic plaster according to claim 5, characterized in that, The extraction solvent includes sesame oil.

7. The method for preparing the orthopedic plaster according to claim 5, characterized in that, It also includes the following steps: Thickening excipients are added to the medicinal liquid, heated until the thickening excipients are completely melted, and then cooled to form a plaster.

8. The method for preparing the orthopedic plaster according to claim 7, characterized in that, The thickening agent includes at least one of red lead, rosin, and petrolatum.

9. The method for preparing the orthopedic plaster according to claim 7, characterized in that, It also includes the following steps: The plaster is placed on a backing material, and the thickness of the plaster is 0.5 to 1 cm; The backing material is one of non-woven fabric, cotton fabric, paper film, and plastic film.

10. The application of an orthopedic plaster as described in any one of claims 1-4 in the fields of conservative treatment of fractures, bone hyperplasia, infection of open fractures, or postoperative infection of orthopedic patients.

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