Externally applied traditional Chinese medicine composition for treating soft tissue injury as well as preparation method and application thereof

Abstract

The invention relates to an externally applied traditional Chinese medicine composition for treating soft tissue injury as well as a preparation method and application of the externally applied traditional Chinese medicine composition, which can radically regulate qi and blood, enable qi and blood to run smoothly and achieve the purpose of curing the soft tissue injury. The traditional Chinese medicine is prepared from the following raw material medicines by weight: 4-20 g of lycopodium clavatum, 4-20 g of garden balsam stem, 2-10 g of folium artemisiae argyi, 1.8-9 g of safflower, 2-10 g of notopterygium root, 2-10 g of radix angelicae pubescentis, 3-15 g of raw frankincense, 3-15 g of raw myrrh, 10-50 g of radix clematidis, 4-20 g of fried semen brassicae, 4-20 g of raw pinellia ternate, 3-15 g of raw gardenia, 3-15 g of wine-treated rhubarb, 4-20 g of radix aconiti preparata and 10-50 g of honey. The traditional Chinese medicine composition is free of toxic and side effects, short in treatment period and not prone to relapse and is innovative externally applied medicine for treating soft tissue

Description

1. Technical Field

[0001] The present invention relates to the field of medicine, in particular to an external application Chinese medicinal composition for treating soft tissue injuries, and a preparation method and application thereof. 2. Background Technology

[0002] Soft tissue injury refers to damage to soft tissues such as muscles, tendons, ligaments, and joint capsules caused by external forces or improper exercise. Clinical manifestations include local pain, swelling, limited movement, and congestion, and in severe cases, functional impairment. Soft tissue injury is a common sports injury, especially during sports activities, high-intensity exercise in daily life, and sudden external forces, which can easily lead to varying degrees of injury. Depending on the type and severity of the injury, soft tissue injuries can be divided into mild, moderate, and severe injuries. Mild injuries are generally painful and recover quickly, while severe injuries may involve deeper tissue damage and may even require surgical treatment, with a longer recovery time. In traditional Chinese medicine, the external manifestations of soft tissue injury can be classified as "contusion" or "trauma", where the concept of "trauma" includes all types of soft tissue injuries caused by external forces, such as muscle strains and ligament sprains.

[0003] The Huangdi Neijing describes the pathological mechanism of soft tissue injuries: "Nutrient Qi is blocked, defensive Qi flows alone, blood and Qi are out of harmony, and tendons and bones are out of sync. This causes pain in the body and pain in the head, neck, shoulders, and back." Such injuries often occur in the limbs. External forces such as compression, tearing, and impact can cause symptoms such as localized tissue stasis, edema, and pain. Traditional Chinese Medicine (TCM) theory posits that soft tissue injuries are often related to "Qi stagnation and blood stasis." External forces can obstruct the flow of Qi and blood, leading to blood retention and disharmony, resulting in swelling or pain. Common clinical manifestations include localized pain, swelling, and congestion, accompanied by limited mobility. Furthermore, the pathogenesis of soft tissue injuries is not solely due to Qi stagnation and blood stasis. Localized injuries are often accompanied by underlying weaknesses such as Qi and blood deficiency, which slow tissue repair and predispose to the development of chronic lesions. When Qi and blood are deficient, the driving force of Qi is weakened, blood flow is impaired, and blood stasis is difficult to return to the injured area. Over time, this stasis accumulates, Qi and blood are insufficient, and repair is delayed. Professor Yang Bin's unique "Qi and Blood Co-treatment Theory" emphasizes regulating Qi and blood to promote the body's self-healing and improve the healing process of soft tissue injuries. Qi deficiency leads to obstructed blood circulation, and blood stasis prevents the injured area from receiving timely nutrients and oxygen, slowing repair. Blood deficiency, on the other hand, weakens cellular repair capacity and impairs tissue regeneration. The Qi and Blood Co-treatment Theory aims to promote the repair of soft tissue injuries by replenishing Qi and nourishing blood, unblocking Qi and blood, and stimulating the body's potential.

[0004] In clinical treatment, the commonly adopted therapeutic methods are promoting blood circulation to remove blood stasis and replenishing qi and nourishing blood. By regulating qi and blood, reducing swelling and alleviating pain, and accelerating tissue repair. When necessary, external treatment methods such as acupuncture and massage can be supplemented to further promote the circulation of qi and blood and enhance the rehabilitation effect. The treatment of soft tissue injuries should not only focus on reducing swelling and alleviating pain, but more importantly, pay attention to the regulation of treating both qi and blood to achieve a more long-term therapeutic effect. Wang Qingren in the Qing Dynasty mentioned in the book "Corrections of Medical Errors": "If qi circulates and blood is active, what disease cannot be cured?" Therefore, the treatment methods for soft tissue injuries are not only to relieve pain and reduce swelling, but more fundamentally, to harmonize qi and blood, make qi and blood circulate smoothly, and achieve the purpose of cure. III. Summary of the Invention

[0005] In view of the above situation, to solve the deficiencies of the prior art, the purpose of the present invention is to provide an external application traditional Chinese medicine composition for treating soft tissue injuries, its preparation method and application, which can fundamentally harmonize qi and blood, make qi and blood circulate smoothly, and achieve the purpose of curing soft tissue injuries.

[0006] One of the technical solutions provided by the present invention is an external application traditional Chinese medicine composition for treating soft tissue injuries, which is made from the following raw medicinal materials by weight: 4 - 20 g of Lycopodium clavatum, 4 - 20 g of Speranskia tuberculata, 2 - 10 g of Artemisia argyi, 1.8 - 9 g of Carthamus tinctorius, 2 - 10 g of Notopterygium incisum, 2 - 10 g of Angelica pubescens, 3 - 15 g of Boswellia carterii, 3 - 15 g of Commiphora myrrha, 10 - 50 g of Clematis chinensis, 4 - 20 g of stir-fried Semen Sinapis Albae, 4 - 20 g of Pinellia ternata, 3 - 15 g of Gardenia jasminoides, 3 - 15 g of Rheum palmatum, 4 - 20 g of Radix Aconiti Carmichaeli Preparata, and 10 - 50 g of honey.

[0007] Preferably, the traditional Chinese medicine composition is made from the following raw medicinal materials by weight: 4 g of Lycopodium clavatum, 4 g of Speranskia tuberculata, 2 g of Artemisia argyi, 1.8 g of Carthamus tinctorius, 2 g of Notopterygium incisum, 2 g of Angelica pubescens, 3 g of Boswellia carterii, 3 g of Commiphora myrrha, 10 g of Clematis chinensis, 4 g of stir-fried Semen Sinapis Albae, 4 g of Pinellia ternata, 3 g of Gardenia jasminoides, 3 g of Rheum palmatum, 4 g of Radix Aconiti Carmichaeli Preparata, and 10 g of honey.

[0008] Preferably, the traditional Chinese medicine composition is made from the following raw medicinal materials by weight: 8 g of Lycopodium clavatum, 8 g of Speranskia tuberculata, 4 g of Artemisia argyi, 3.6 g of Carthamus tinctorius, 4 g of Notopterygium incisum, 4 g of Angelica pubescens, 6 g of Boswellia carterii, 6 g of Commiphora myrrha, 20 g of Clematis chinensis, 8 g of stir-fried Semen Sinapis Albae, 8 g of Pinellia ternata, 6 g of Gardenia jasminoides, 6 g of Rheum palmatum, 8 g of Radix Aconiti Carmichaeli Preparata, and 20 g of honey.

[0009] Preferably, the traditional Chinese medicine composition is made from the following raw medicinal materials by weight: 12 g of Lycopodium clavatum, 12 g of Speranskia tuberculata, 6 g of Artemisia argyi, 5.4 g of Carthamus tinctorius, 6 g of Notopterygium incisum, 6 g of Angelica pubescens, 9 g of Boswellia carterii, 9 g of Commiphora myrrha, 30 g of Clematis chinensis, 12 g of stir-fried Semen Sinapis Albae, 12 g of Pinellia ternata, 9 g of Gardenia jasminoides, 9 g of Rheum palmatum, 12 g of Radix Aconiti Carmichaeli Preparata, and 30 g of honey.

[0010] The second technical solution provided by the present invention is a preparation method of an external application traditional Chinese medicine composition for treating soft tissue injuries, comprising the following steps:

[0011] 1) Add the raw medicinal materials except honey into a crusher and break them up;

[0012] 2) Grind the broken medicinal materials into traditional Chinese medicine powder, pass through an 80-110 mesh sieve, and set aside;

[0013] 3) Place the honey in a container, add pure water with a weight of 1 / 2 - 3 / 4 of the honey, then heat it over a slow fire, skim the floating foam on the surface of the honey, filter out the impurities with a sieve, put the filtered honey back into the pot, and heat and concentrate it again. When the honey reaches a viscous state with a slight draw, let it stand for use;

[0014] 4) Add the honey prepared in step 3) to the traditional Chinese medicine powder sieved in step 2), adjust it into a paste, and evenly apply it on the dressing.

[0015] The third technical solution provided by the present invention is the application of the external application traditional Chinese medicine composition for treating soft tissue injuries described in the present invention in the preparation of drugs for treating soft tissue injuries.

[0016] The beneficial technical effects of the present invention are as follows:

[0017] 1) In the formula of the present invention, Clematis Root is used as the monarch drug to mainly promote blood circulation and remove blood stasis, and is combined with adjuvant drugs such as Herba Lycopodii, Herba Speranskiae tuberculatae, Safflower, Radix Aconiti Carmichaeli, etc. to enhance the curative effects of promoting blood circulation, dispelling wind-dampness, and relieving pain due to cold. At the same time, through drugs such as Frankincense, Myrrh, and Notopterygium Root, the qi and blood are comprehensively regulated, blood circulation is promoted, and pain symptoms caused by wind-damp-cold are relieved.

[0018] 2) The raw materials of the present invention are rich, the components are scientifically and reasonably formulated according to the monarch, minister, assistant, and guide principles, it is convenient to take, has an immediate effect, no toxic and side effects, a short treatment period, is not easy to relapse, and is an innovation in external drugs for treating soft tissue injuries. IV. Specific Embodiments

[0019] The following further elaborates on the specific embodiments of the present invention with reference to examples.

[0020] Example 1

[0021] An external application traditional Chinese medicine composition for treating soft tissue injuries is made from the following raw medicinal materials by weight: Herba Lycopodii 4g, Herba Speranskiae tuberculatae 4g, Folium Artemisiae Argyi 2g, Safflower 1.8g, Notopterygium Root 2g, Angelica Pubescens Root 2g, Raw Frankincense 3g, Raw Myrrh 3g, Clematis Root 10g, Stir-fried Semen Sinapis Albae 4g, Raw Pinellia Tuber 4g, Raw Fructus Gardeniae 3g, Rheum Officinale 3g, Radix Aconiti Carmichaeli Preparata 4g, and honey 10g.

[0022] The preparation method comprises the following steps:

[0023] 1) Add the raw drugs except honey into a crusher and break them up;

[0024] 2) Continue to grind the broken drugs into traditional Chinese medicine powder, pass through an 80-mesh sieve, and set aside;

[0025] 3) Place the honey in a container, add pure water equal to 1 / 2 of the weight of the honey, then heat it over low heat, skim the foam on the surface of the honey, filter out the impurities with a sieve, put the filtered honey back into the pot, and heat and concentrate it again. When the honey reaches a viscous and slightly drawable state, set it aside for use;

[0026] 4) Add the honey prepared in step 3) to the traditional Chinese medicine powder sieved in step 2), adjust it into a paste, and evenly apply it on the dressing.

[0027] Example 2

[0028] An externally applied traditional Chinese medicine composition for treating soft tissue injuries is made from the following raw drugs by weight: 8 g of Lycopodium clavatum, 8 g of Speranskia tuberculata, 4 g of Artemisia argyi, 3.6 g of Carthamus tinctorius, 4 g of Notopterygium incisum, 4 g of Angelica pubescens, 6 g of raw Olibanum, 6 g of raw Myrrha, 20 g of Clematis chinensis, 8 g of stir-fried Semen Sinapis Albae, 8 g of raw Pinellia ternata, 6 g of raw Gardenia jasminoides, 6 g of Rheum palmatum L. var. tanguticum Maxim. ex Regel, 8 g of Radix Aconiti Carmichaeli Preparata, and 20 g of honey.

[0029] The preparation method includes the following steps:

[0030] 1) Add the raw drugs except honey into a crusher and break them up;

[0031] 2) Continue to grind the broken drugs into traditional Chinese medicine powder, pass through a 100-mesh sieve, and set aside;

[0032] 3) Place the honey in a pot, add pure water equal to 1 / 2 of the weight of the honey, then heat it over low heat, skim the foam on the surface of the honey, filter out the impurities with a sieve, put the filtered honey back into the pot, and heat and concentrate it again. When the honey reaches a viscous and slightly drawable state, set it aside for use;

[0033] 4) Add the honey prepared in step 3) to the traditional Chinese medicine powder sieved in step 2), adjust it into a paste, and evenly apply it on the dressing.

[0034] Example 3

[0035] An externally applied traditional Chinese medicine composition for treating soft tissue injuries is made from the following raw drugs by weight: 12 g of Lycopodium clavatum, 12 g of Speranskia tuberculata, 6 g of Artemisia argyi, 5.4 g of Carthamus tinctorius, 6 g of Notopterygium incisum, 6 g of Angelica pubescens, 9 g of raw Olibanum, 9 g of raw Myrrha, 30 g of Clematis chinensis, 12 g of stir-fried Semen Sinapis Albae, 12 g of raw Pinellia ternata, 9 g of raw Gardenia jasminoides, 9 g of Rheum palmatum L. var. tanguticum Maxim. ex Regel, 12 g of Radix Aconiti Carmichaeli Preparata, and 30 g of honey.

[0036] The preparation method includes the following steps:

[0037] 1) Add the raw drugs except honey to a crusher and break them up.

[0038] 2) Grind the broken drugs into traditional Chinese medicine powder, pass through a 110-mesh sieve, and set aside.

[0039] 3) Place the honey in a container, add pure water equal to 3 / 4 of the weight of the honey, then heat it over a slow fire, skim the foam on the surface of the honey, filter out the impurities with a sieve, put the filtered honey back into the pot, and heat and concentrate it again. When the honey reaches a viscous and slightly stringy state, let it stand and set aside.

[0040] 4) Add the honey prepared in step 3) to the traditional Chinese medicine powder sieved in step 2), adjust it into a paste, and evenly apply it on the dressing.

[0041] Example 4

[0042] An externally applied traditional Chinese medicine composition for treating soft tissue injuries is made from the following raw drugs by weight: 16 g of Lycopodium clavatum, 16 g of Speranskia tuberculata, 6 g of Artemisia argyi, 7.2 g of Carthamus tinctorius, 8 g of Notopterygium incisum, 8 g of Angelica pubescens, 12 g of raw Olibanum, 12 g of raw Myrrha, 40 g of Clematis chinensis, 16 g of stir-fried Semen Sinapis Albae, 16 g of raw Pinellia ternata, 12 g of raw Gardenia jasminoides, 12 g of Rheum officinale processed with wine, 16 g of Radix Aconiti Carmichaeli Preparata, and 40 g of honey.

[0043] Example 5

[0044] An externally applied traditional Chinese medicine composition for treating soft tissue injuries is made from the following raw drugs by weight: 20 g of Lycopodium clavatum, 20 g of Speranskia tuberculata, 10 g of Artemisia argyi, 9 g of Carthamus tinctorius, 10 g of Notopterygium incisum, 10 g of Angelica pubescens, 15 g of raw Olibanum, 15 g of raw Myrrha, 50 g of Clematis chinensis, 20 g of stir-fried Semen Sinapis Albae, 20 g of raw Pinellia ternata, 15 g of raw Gardenia jasminoides, 15 g of Rheum officinale processed with wine, 20 g of Radix Aconiti Carmichaeli Preparata, and 50 g of honey.

[0045] In the formula of the present invention:

[0046] Lycopodium clavatum: pungent, bitter, warm. It belongs to the liver and kidney meridians. It has the functions of promoting blood circulation to remove blood stasis, relaxing tendons and activating collaterals, and detoxifying and relieving pain. It is used for treating rheumatoid arthritis, various traumatic injuries, muscle soreness, numbness of muscles and bones, and sores and ulcers with toxic swelling.

[0047] Pharmacological studies have shown that Lycopodium clavatum contains rich volatile oils (such as geraniol, cineole), flavonoids (such as quercetin, kaempferol), triterpenoids (such as lycoclavanol), and polysaccharide components. These components have anti-inflammatory, analgesic, microcirculation-improving, and blood circulation-promoting effects. Specifically, they have the following effects: 1. It has good anti-inflammatory effects. The flavonoid compounds in Lycopodium clavatum can reduce the inflammatory response and joint swelling and pain by inhibiting the expression of cyclooxygenase-2 (COX-2) and prostaglandin E2 (PGE2). 2. The polysaccharide components it contains can enhance the phagocytosis of macrophages, improve the body's immunity, and have a certain regulatory effect on chronic rheumatic diseases. 3. The volatile oil inhibits the growth by destroying the cell membrane structure of bacteria and fungi to achieve antibacterial effects, and reduces the inflammatory response by inhibiting inflammatory mediators and signaling pathways (such as NF-κB). 4. Triterpenoid components reduce the inflammatory response by inhibiting the release of inflammatory mediators and regulating the functions of immune cells (such as macrophages, T cells), enhance the activity of immune cells, and improve the body's immune response.

[0048] Speranskia tuberculata: Bitter, pungent, warm. It belongs to the liver and kidney meridians. It has the functions of dredging collaterals and promoting blood circulation, reducing swelling and relieving pain. It is commonly used to treat diseases such as rheumatic arthralgia, traumatic injury, amenorrhea and dysmenorrhea.

[0049] Pharmacological studies have shown that Speranskia tuberculata contains a variety of alkaloids (such as tuberculatine, pyrrolizidine alkaloids), flavonoids (such as quercetin, kaempferol), and volatile oils (such as limonene, eucalyptol). These components have anti-inflammatory and analgesic effects. It has the following effects: 1. The extract of Speranskia tuberculata can inhibit the inflammatory cascade reaction and reduce joint swelling by downregulating the expression of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). 2. Its active ingredients can also improve local blood flow and promote the secretion of synovial fluid in joints by increasing the activity of nitric oxide synthase (NOS), thereby relieving joint stiffness and pain. 3. Tuberculatine inhibits the activities of cyclooxygenase (COX) and lipoxygenase (LOX), reduces the generation of inflammatory mediators such as prostaglandin (PGE2) and leukotrienes (LTs), regulates the pain signal transduction in the central and peripheral nervous systems, and inhibits the activity of pain-related receptors (such as TRPV1) to achieve analgesic effects. 4. Flavonoids reduce oxidative stress by scavenging free radicals (such as ROS) and enhancing the activities of antioxidant enzymes (such as SOD, GSH-Px). Kaempferol inhibits the release of inflammatory mediators and signaling pathways (such as NF-κB, MAPK), thereby reducing inflammation.

[0050] Artemisia argyi: Pungent, bitter, warm. It belongs to the spleen, liver and kidney meridians. It has the functions of warming the meridians and relieving pain, dispelling cold and dampness, and regulating qi and blood. It is used to treat diseases such as irregular menstruation, threatened abortion, rheumatic arthritis, and soreness of the waist and legs.

[0051] Pharmacological studies have shown that Artemisia argyi contains rich volatile oils (such as α-thujone, pinene), flavonoid compounds (such as quercetin, rutin) and sesquiterpene components. It has the following effects: 1. The extract of Artemisia argyi can reduce the release of inflammatory factors by inhibiting the production of PGE2, thereby achieving anti-inflammatory and analgesic effects. 2. The sesquiterpene substances it contains have significant antioxidant capacity, can reduce free radical damage, and improve the soft tissue repair ability. Clinical studies have shown that Artemisia argyi can improve the pathological state of cold-damp arthritis by promoting local blood circulation and increasing the tissue oxygen supply level. 3. Volatile oils can relieve pain by activating cold receptors (TRPM8 receptors) and inhibiting pain signal conduction, and can also inhibit the release and signal pathways of inflammatory mediators (such as NF-κB), reducing the inflammatory response. 4. α-Thujone reduces the production of inflammatory mediators such as prostaglandin (PGE2) and leukotrienes (LTs) by inhibiting the activities of cyclooxygenase (COX) and lipoxygenase (LOX).

[0052] Carthamus tinctorius: pungent, warm. It belongs to the heart and liver meridians. It has the effects of promoting blood circulation to remove blood stasis, dredging meridians to relieve pain, and promoting blood circulation. It is used for irregular menstruation, traumatic injury, postpartum blood stasis, abdominal blood stasis, and sores and ulcers.

[0053] Pharmacological studies have shown that Carthamus tinctorius is rich in flavonoid compounds (such as safflower yellow pigment A, safflower yellow pigment B) and alkaloids (such as safflorine). It has the following effects: 1. Safflower yellow pigment can inhibit platelet aggregation, reduce the deposition of fibrin, improve microcirculation, and promote local blood flow. 2. The extract of Carthamus tinctorius can achieve antithrombotic effects by regulating the ratio of thromboxane A2 (TXA2) and prostacyclin (PGI2). 3. Its anti-inflammatory effect is mainly achieved by reducing the expression of inflammatory mediators such as TNF-α and IL-1β. The components in Carthamus tinctorius can regulate the functions of immune cells and reduce the inflammatory response. For example, HSYA can reduce the inflammatory response, reduce synovial inflammation, and improve joint function by regulating the balance of Th1 / Th2 cytokines. 4. The flavonoid and phenolic acid components in Carthamus tinctorius have significant antioxidant capacity, can scavenge free radicals, reduce the damage of oxidative stress to cells, and thus indirectly play an anti-inflammatory role. For example, the extract of Carthamus tinctorius can reduce inflammatory damage by inhibiting the oxidative stress response. The components in Carthamus tinctorius can inhibit the activity of matrix metalloproteinases (MMPs) and reduce the destruction of chondrocytes, thereby protecting joints.

[0054] Notopterygium incisum: pungent, bitter, warm. It belongs to the bladder and kidney meridians. It has the effects of dispelling wind and dampness, relieving pain, and dredging collaterals. It is used to treat wind-cold colds, rheumatoid arthritis, headache, shoulder and back pain, and traumatic injury, etc.

[0055] Pharmacological studies have shown that Notopterygium incisum contains volatile oils (such as eugenol, β-pinene) and alkaloids (such as notopterygine). It has the following effects: 1. The volatile oils in Notopterygium incisum can reduce the release of inflammatory factors by regulating the NF-κB signaling pathway, thereby inhibiting the rheumatic inflammatory response. 2. The extract of Notopterygium incisum has an inhibitory effect on the expression of COX-2, can reduce the synthesis of prostaglandins, and plays an analgesic and anti-inflammatory role. 3. Its volatile oil components can also relieve joint stiffness by dilating microvessels and improving local blood circulation. 4. The coumarin compounds (such as nodakenin) in Notopterygium incisum can prevent the infiltration of inflammatory cells, reduce the inflammatory response at the inflammatory site, and inhibit the infiltration of inflammatory cells. The flavonoid and phenolic acid components (such as diosmin, ferulic acid) in Notopterygium incisum have significant antioxidant capacity, can scavenge free radicals, reduce oxidative stress damage, and thus indirectly play an anti-inflammatory role. 5. The active ingredients in Notopterygium incisum can inhibit the activity of matrix metalloproteinases (MMPs), reduce the damage of chondrocytes, and at the same time promote the proliferation of chondrocytes and the synthesis of type II collagen, thereby protecting joints and cartilage. The coumarin components (such as notopterol, isoimperatorin) in Notopterygium incisum can inhibit the abnormal proliferation of synovial fibroblasts, reduce synovial tissue inflammation and joint destruction.

[0056] Angelica pubescens: pungent, bitter, warm. It acts on the bladder and kidney meridians. It has the functions of dispelling wind and dampness, relieving pain, and relaxing tendons and activating collaterals. It is used to treat rheumatoid arthritis, wind-cold cold, lumbar and knee soreness, headache, traumatic injury, etc.

[0057] Pharmacological studies have shown that Angelica pubescens contains volatile oils (such as linalool, borneol), alkaloids (such as angelicine) and phenolic compounds (such as chlorogenic acid). It has the following effects: 1. Its anti-rheumatic effect is mainly achieved by the volatile oil inhibiting the expression of TNF-α and IL-6, thereby reducing the inflammatory response. 2. The extract of Angelica pubescens can also inhibit the transmission of pain signals by regulating the TRPV1 receptor, thereby achieving an analgesic effect. Experimental studies have shown that Angelica pubescens can improve joint lubrication function and enhance joint mobility by increasing the secretion of synovial fluid. 3. The extract of Angelica pubescens can significantly inhibit the generation of inflammatory mediators, such as tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-6 (IL-6) and prostaglandin E2 (PGE2), etc. In addition, the active ingredients in Angelica pubescens can also inhibit the activity of inflammation-related enzymes, such as cyclooxygenase-2 (COX-2) and inducible nitric oxide synthase (iNOS), thereby reducing the generation of inflammatory mediators. 4. The extract of Angelica pubescens can regulate the function of immune cells, such as inhibiting the activation of T cells and reducing the secretion of pro-inflammatory cytokines (such as IL-17, IL-23). In addition, the extract of Angelica pubescens may also inhibit the migration of inflammatory cells by regulating the expression of adhesion molecules (such as ICAM-1 and VCAM-1) on the surface of immune cells.

[0058] Clematis chinensis: pungent, bitter, warm. It acts on the bladder, liver and kidney meridians. It has the functions of promoting blood circulation to dispel wind, dredging collaterals to relieve pain, and relaxing tendons and activating collaterals. It is used to treat joint pain and swelling caused by rheumatoid arthritis, various traumatic injuries, and soreness of the waist and knees.

[0059] Pharmacological studies have shown that Clematis chinensis is rich in alkaloids (such as clematine), saponins (such as clematis saponin) and organic acids (such as ferulic acid). It has the following effects: 1. The extract of Clematis chinensis can relieve rheumatoid arthritis by regulating the levels of inflammatory factors (IL-1β, IL-6), inhibiting leukocyte infiltration and inflammatory reactions. 2. Its effect of promoting blood circulation and removing blood stasis is mainly achieved by enhancing the activity of fibrinolytic enzyme, promoting blood circulation, accelerating the absorption of blood stasis, and reducing local inflammatory edema. 3. Total saponins of Clematis chinensis can reduce the expression of Janus kinase 2 (JAK2) and signal transducer and activator of transcription 3 (STAT3), and decrease their phosphorylation levels, thereby inhibiting inflammatory reactions and reducing the expression of pro-inflammatory cytokines by inhibiting the activation of the NF-κB pathway. 4. Total saponins of Clematis chinensis may play an anti-inflammatory role by down-regulating the expression of long non-coding RNA (lncRNA) OIP5-AS1 and regulating the miR-410-3p / Wnt7b signaling axis and Wnt signaling pathway.

[0060] Radix Aconiti Lateralis Preparata: pungent, hot, toxic. It acts on the heart, liver and spleen meridians. It has the functions of warming the channels to relieve pain, dispelling cold and dampness, and promoting blood circulation to remove blood stasis. It is used to treat wind-cold-damp arthralgia, cold hernia pain, various cold pains, traumatic injuries, etc.

[0061] Pharmacological studies have shown that Aconitum carmichaelii mainly contains diester alkaloids (such as aconitine and hypaconitine), and these components can inhibit nerve conduction through sodium ion channel blockade, thereby exerting a strong analgesic effect. It has the following effects: 1. The extract of Aconitum carmichaelii can relieve rheumatoid arthritis by inhibiting the expression of COX-2 and PGE2 and reducing the release of inflammatory factors. 2. Aconitum carmichaelii also has the effects of promoting blood circulation and improving the local microenvironment, and can accelerate the absorption of joint cavity effusion in patients with rheumatoid arthritis. 3. The anti-inflammatory mechanism of processed Aconitum carmichaelii involves the regulation of inflammation-related signaling pathways. For example, the components in processed Aconitum carmichaelii can inhibit the activation of the MAPK pathway, thereby reducing the activation of inflammatory cells and the release of inflammatory mediators. The alkaloids in processed Aconitum carmichaelii can inhibit the activation of the NF-κB pathway and reduce the expression of pro-inflammatory cytokines (such as TNF-α, IL-1β). The components in processed Aconitum carmichaelii can play antioxidant and anti-inflammatory roles by upregulating the expression of Nrf2 and its downstream antioxidant enzymes (such as HO-1, NQO1). 4. Processed Aconitum carmichaelii can reduce the infiltration of inflammatory cells (such as neutrophils) and alleviate the inflammatory response at the inflammatory site. For example, in a carrageenan-induced inflammation model, processed Aconitum carmichaelii significantly reduced the level of PGE2 in the inflammatory exudate. In addition, the components in processed Aconitum carmichaelii have antioxidant properties, can scavenge free radicals, reduce oxidative stress damage, and thus indirectly alleviate the inflammatory response.

[0062] (Raw) Frankincense: pungent, bitter, warm. Acting on the heart and liver meridians. It has the functions of promoting blood circulation to remove blood stasis, dredging collaterals to relieve pain, dissipating swelling and resolving masses. It is used for the treatment of traumatic injuries, wind-cold-damp arthralgia, sores and ulcers, chest pain, and bone and muscle pain, etc.

[0063] Pharmacological studies have shown that frankincense is rich in triterpenoids (such as boswellic acid, β-caryophyllene), flavonoids, polysaccharides and volatile oils (such as boswellene). It has the following effects: 1. Frankincense extract can reduce joint inflammation by inhibiting the expression of inflammatory factors such as TNF-α, IL-1β, and PGE2, and reducing leukocyte infiltration. 2. Its volatile oil components can dilate microvessels, increase local blood flow, and improve microcirculation, thus enhancing the effect of promoting blood circulation and removing blood stasis. 3. The triterpenoids in frankincense have immunomodulatory effects, can enhance anti-inflammatory ability, and improve the soft tissue repair speed, and are applicable to diseases such as rheumatoid arthritis and osteoarthritis. The active ingredients in frankincense (such as β-boswellic acid, 11-keto-β-boswellic acid, and acetyl-11-keto-β-boswellic acid) can significantly inhibit the generation of inflammatory mediators. These components can reduce the release of leukotrienes, prostaglandin E2 (PGE2), and nitric oxide (NO). Leukotrienes are key mediators in the inflammatory response and are closely related to chronic inflammations such as asthma and rheumatoid arthritis. 4. The boswellic acid compounds in frankincense can inhibit inflammation-related signaling pathways, such as the 5-lipoxygenase (5-LOX) and cyclooxygenase (COX) pathways. In addition, boswellic acid can also inhibit the activation of nuclear factor-κB (NF-κB), thereby reducing the expression of pro-inflammatory cytokines (such as TNF-α and IL-1β). 5. Frankincense can inhibit the infiltration of inflammatory cells (such as neutrophils) and reduce the aggregation of inflammatory cells at the inflammatory site. For example, in a carrageenan-induced rat pleurisy model, frankincense significantly reduced the contents of total protein, NO, and PGE2 in the pleural effusion.

[0064] (Raw) myrrh: pungent, bitter, warm. It acts on the heart and liver meridians. It has the functions of promoting blood circulation and removing blood stasis, dredging collaterals and relieving pain, and detumescence and promoting granulation. It is used to treat traumatic injuries, sores and ulcers, dysmenorrhea, and bone and muscle pain, etc.

[0065] Pharmacological studies have shown that myrrh is rich in volatile oils (such as bisabolol, myrrh esters), triterpenoids (such as myrrholic acid), flavonoids and polysaccharide components. It has the following effects: 1. Myrrh extract can reduce the synthesis of prostaglandins and leukotrienes by regulating the activities of COX-2 and LOX enzymes, thereby reducing the inflammatory response and relieving pain. 2. Its anti-inflammatory effect is mainly achieved by inhibiting the NF-κB signaling pathway and reducing the expression of inflammatory factors such as IL-6 and TNF-α. 3. Myrrh can promote the proliferation of fibroblasts, accelerate the repair process of damaged tissues, improve the proliferation ability of synoviocytes, and enhance joint lubrication function. 4. α-Bisabolol in myrrh can significantly inhibit the expression of inflammatory factors such as TNF-α, IL-1β and IL-6. These inflammatory factors play a key role in the inflammatory response, and the reduction of their expression can directly reduce the level of inflammation. α-Bisabolol can inhibit the activation of NF-κB, p38 and JNK signaling pathways. These pathways play a key role in the inflammatory response, and their inhibition can reduce the activation of inflammatory cells and the release of inflammatory mediators. In a lipopolysaccharide (LPS)-induced inflammation model, the active ingredients in myrrh can significantly reduce the phosphorylation levels of ERK1 / 2, JNK and p38 proteins. 5. The active ingredients in myrrh have antioxidant properties, can scavenge free radicals, and reduce oxidative stress damage. For example, α-Bisabolol can correct lysosomal dysfunction and impaired autophagy flux by inhibiting the activity of NLRP3 inflammasome and TLR4 / NF-κB / MAPK signaling pathway, thereby reducing oxidative stress and inflammatory response.

[0066] Fried semen sinapis albae: Pungent, hot, and toxic. It belongs to the lung and large intestine meridians. It has the effects of promoting qi flow in the airway, detoxifying and reducing swelling. It is used to treat cold-phlegm cough, asthma, chest and hypochondrium distending pain, joint swelling and pain, phlegm nodes, scrofula, and sores and ulcers with toxin.

[0067] Pharmacological studies have shown that semen sinapis albae mainly contains glucosinolates (such as sinapine), volatile oils (such as heliene) and alkaloids. It has the following effects: 1. After hydrolysis, its glucosinolates can produce isothiocyanates, which have significant anti-inflammatory and circulatory-stimulating effects. These degradation products have significant anti-inflammatory activities. They can reduce the inflammatory response by inhibiting the mRNA expression of inflammatory mediators such as TNF-α, IL-6 and IL-1β. In addition, glucosinolates and their degradation products can also play an anti-inflammatory role by regulating the inflammatory signaling pathway. 2. The extract of semen sinapis albae can relieve joint swelling and stiffness by promoting local blood circulation, enhancing capillary permeability, and accelerating the clearance of inflammatory metabolites. 3. The alkaloids in semen sinapis albae can promote the regulation of the cholinergic nervous system, improve nerve conduction function, and help relieve muscle spasms and neuropathic pain. 4. The alkaloids and their hydrolysis products in semen sinapis albae have antibacterial activities. Isothiocyanate compounds have inhibitory effects on a variety of bacteria, fungi and yeasts, and the effective antibacterial concentration against Gram-negative or positive bacteria is 1:102 -3×10 2 5. The alkaloids and their hydrolysis products in white mustard seeds have antibacterial activity. Isothiocyanate compounds have inhibitory effects on various bacteria, fungi and yeasts, and the effective antibacterial concentration against Gram-negative or Gram-positive bacteria is 1:10 2 -3×10 2 。

[0068] Raw Pinellia ternata: pungent, warm, toxic. It acts on the spleen and stomach meridians. It has the functions of drying dampness and resolving phlegm, and lowering adverse qi and stopping vomiting. It is used to treat phlegm-damp cough, vomiting, stuffiness and fullness in the chest and epigastrium, phlegm nodules, scrofula, and sores and ulcers.

[0069] Pharmacological studies have shown that Pinellia ternata is rich in alkaloids (such as pinelline, β-benzylamine), volatile oils (such as pinellol), and saponin compounds. It has the following effects: 1. The extract of Pinellia ternata can reduce gastrointestinal dysfunction by regulating the activity of cholinergic receptors, and reduce the inflammatory response by inhibiting the expression of TNF-α and IL-6. 2. Its anti-inflammatory effect is mainly achieved by inhibiting the synthesis of COX-2 and PGE2, reducing synovial inflammation, and thus relieving joint inflammation. 3. Pinellia ternata can also enhance the regulatory ability of the nervous system, reduce neurogenic inflammation, and improve the anti-inflammatory and analgesic effects. 4. The alkaloids of Pinellia ternata can inhibit the activation of extracellular signal-regulated kinase (ERK), p38 mitogen-activated protein kinase (p38-MAPK), and c-Jun N-terminal kinase (JNK), which play key roles in the inflammatory response. It can also inhibit the activation of inflammatory cells and the release of inflammatory factors by regulating the phosphatidylinositol 3-kinase (PI3K) / protein kinase B (Akt) pathway. 5. The saponins of Pinellia ternata can significantly inhibit the production and release of inflammatory mediators, such as interleukin-1β (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and prostaglandin E2 (PGE2). These inflammatory mediators are key factors in the inflammatory response, and their reduced release can effectively reduce inflammation.

[0070] Raw Gardenia jasminoides: bitter, cold. It acts on the heart, liver and gallbladder meridians. It has the functions of clearing heat and detoxifying, cooling blood and stopping bleeding, and reducing fire and promoting defecation. It is used to treat fever due to febrile diseases, bleeding due to blood heat, damp-heat jaundice, poisonous sores, red and swollen eyes, and restlessness and insomnia.

[0071] Pharmacological studies have shown that Gardenia jasminoides Ellis contains flavonoids (such as genipin-1-gentiobioside), organic acids (such as geniposidic acid), iridoid glycosides (such as geniposide), polysaccharides and alkaloids. It has the following effects: 1. Gardenia jasminoides Ellis extract can reduce the expression of IL-1β and IL-6, lower the level of oxidative stress and reduce inflammatory damage by down-regulating the NF-κB signaling pathway. 2. Flavonoids (such as quercetin, rutin, etc.) in raw Gardenia jasminoides Ellis have significant antioxidant activity. These compounds protect cells from oxidative damage by scavenging free radicals, inhibiting the oxidative stress response and reducing the generation of reactive oxygen species (ROS). Geniposidic acid has significant antioxidant effects, can scavenge superoxide anion free radicals, reduce the damage of inflammatory factors to chondrocytes and improve joint function. 3. Geniposide can improve blood viscosity, enhance microcirculation and the repair ability of inflamed tissues. Geniposide can inhibit oxidative stress and inflammatory responses and reduce nerve cell damage. 4. Organic acid components (such as chlorogenic acid) in raw Gardenia jasminoides Ellis have significant antioxidant activity. These components can protect against oxidative stress damage by scavenging free radicals and inhibiting lipid peroxidation reactions. Organic acid components play an anti-inflammatory role by inhibiting the production of inflammatory mediators and regulating the inflammatory response. For example, organic acids such as chlorogenic acid can inhibit the release of pro-inflammatory cytokines and reduce the inflammatory response.

[0072] Wine-processed Rheum palmatum L.: Bitter, cold. It acts on the large intestine meridian. It has the effects of purging fire and relieving constipation, clearing heat and detoxifying. It is used to treat constipation due to heat accumulation, bleeding due to blood heat, blood stasis blockage, damp-heat jaundice, pyogenic infections and dysentery, etc.

[0073] Pharmacological studies have shown that wine-processed Rheum palmatum L. is rich in anthraquinone compounds (such as emodin, chrysophanol, rhein), flavonoids and organic acids. It has the following effects: 1. Wine-processed Rheum palmatum L. extract can reduce systemic inflammatory responses by promoting intestinal peristalsis, enhancing the ability to regulate intestinal flora and accelerating the excretion of inflammatory factors. 2. Emodin can reduce the expression of inflammatory mediators IL-1β and TNF-α, lower the oxidative stress response, inhibit cartilage degradation and reduce synovial inflammation by regulating the MAPK signaling pathway. Its laxative effect can reduce the recurrence rate of damp-heat arthropathy and improve the pathogenesis of rheumatic pain. 3. Anthraquinone components in wine-processed Rheum palmatum L. can play an anti-inflammatory role by inhibiting the release of pro-inflammatory factors (such as TNF-α, IL-6). The wine-processing process can enhance the blood-activating effect of Rheum palmatum L., and its active ingredients may promote blood circulation by improving hemorheological indexes. 4. Studies have shown that flavonoid components (such as quercetin-3-O-glucoside, etc.) in Rheum palmatum L. can play an antioxidant role by scavenging free radicals and inhibiting the oxidative stress response. This antioxidant ability is related to the phenolic hydroxyl groups in its chemical structure, and these groups can effectively capture free radicals, thus protecting cells from oxidative damage. Flavonoids can play an anti-inflammatory role by inhibiting the release of inflammatory mediators and the activation of inflammatory signaling pathways.

[0074] Honey: Sweet, neutral. It acts on the lung, spleen, and large intestine meridians. It has the functions of tonifying the middle-jiao, moistening dryness, relieving pain, and detoxifying. It is used to treat dry cough due to lung dryness, constipation due to intestinal dryness, epigastric pain, nasal sinusitis, oral ulcers, scalds and burns caused by hot liquids, and to detoxify aconite poisoning.

[0075] Pharmacological studies have shown that honey contains abundant glucose, fructose, a small amount of sucrose, as well as water, vitamins, various inorganic salts, enzymes, and organic acids, etc. It has the following effects: 1. High-quality honey has good antibacterial properties. Its physical properties such as high osmotic pressure, viscosity, and acidity make the antibacterial effect stronger. The glucose oxidase in honey decomposes glucose to produce hydrogen peroxide, which has natural antibacterial activity. Non-peroxide substances such as phenolic compounds, flavonoids, coumarins, and volatile substances have a certain inhibitory effect on microorganisms. 2. Antioxidant property. Most scholars believe that the phenolic acids, flavonoids, amino acids, and Maillard products it contains have an inhibitory effect on lipid peroxidation and superoxide anion radicals. The water extract of honey is rich in phenolic acid compounds, which can effectively quench hydrogen peroxide radicals, increase the activity of superoxide dismutase in rat serum, reduce the content of malondialdehyde in serum and lipofuscin in the liver, and have an anti-aging effect on the rat brain. In addition, the ether extraction method is more conducive to the removal of ferricyanide outside human red blood cells by cell membrane redox enzymes. 3. Promote tissue regeneration and treat wounds. It can promote wound healing through multiple ways such as providing wound nutrition, controlling wound infection, anti-inflammatory, removing necrotic tissue, and regulating cytokines related to wound healing, and has become an effective measure for treating chronic infectious wounds clinically. 4. Moisten the lung and relieve cough. Clinically, it is combined with other drugs to prepare cough suppressants, which can significantly relieve cough symptoms and improve sleep quality. 4. Promote digestion and relieve constipation. Rich in fructose, it has a regulatory effect on gastrointestinal function, can make gastric acid secretion normal, make stomach pain and gastric burning sensation disappear, increase the number of red blood cells and hemoglobin, enhance intestinal peristalsis, and can significantly shorten the defecation time. 5. Protect the cardiovascular system. Due to factors such as rich vitamins, antioxidant and antibacterial properties, two-way regulation of blood pressure and blood sugar, and promotion of liver fat metabolism, as a food without side effects, it has a good preventive and therapeutic effect on coronary heart disease.

[0076] The formula of the present invention as a whole adopts the compatibility method of "sovereign, ministerial, adjuvant, and guiding herbs", and mainly treats joint pain, muscle soreness, etc. caused by rheumatism and cold-dampness by promoting blood circulation to dredge collaterals, dispelling wind-dampness, and expelling cold and relieving pain. Specifically as follows:

[0077] Sovereign herb: Clematis chinensis

[0078] Clematis chinensis Osbeck is used as the monarch drug in this formula, which has a significant effect of promoting blood circulation and removing blood stasis. It can dredge the meridians, promote blood circulation, and eliminate blood stasis. It is especially suitable for joint pain, muscle soreness caused by wind-damp cold-dampness. By promoting blood circulation and removing blood stasis, warming and dredging the meridians, and dispelling cold-dampness, it can relieve pain and restore function. At the same time, Clematis chinensis Osbeck can also improve local blood supply, reduce the negative impact of blood stasis and slow blood flow on joints and muscles, and promote the recovery of damaged parts.

[0079] Ministerial drugs: Lycopodium clavatum L., Speranskia tuberculata (Bunge) Baill.

[0080] Lycopodium clavatum L. and Speranskia tuberculata (Bunge) Baill. are used as ministerial drugs in combination, which have a strong effect of dispelling wind-dampness and promoting blood circulation and dredging collaterals, enhancing the therapeutic effect of Clematis chinensis Osbeck, especially obvious in the stretching of joints and muscles and pain relief.

[0081] Assistant drugs: Carthamus tinctorius L., Aconitum carmichaelii Debx.

[0082] Carthamus tinctorius L. and Aconitum carmichaelii Debx. are assistant drugs. Carthamus tinctorius L. has the effects of promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, while Aconitum carmichaelii Debx. has a strong effect of dispelling cold and relieving pain. The combination of the two can enhance the effect of promoting blood circulation and relieving pain, and also helps to eliminate cold-dampness.

[0083] Guiding drugs: Olibanum, Myrrha, Notopterygium incisum Ting ex H. T. Chang, Angelica pubescens Maxim. f. biserrata Shan et Yuan, Artemisia argyi Levl. et Vant., Semen Sinapis Albae, Pinellia ternata (Thunb.) Breit., Gardenia jasminoides Ellis, Rheum officinale Baill. var. tanguticum Maxim. ex Regel, Honey

[0084] Olibanum and Myrrha are used as guiding drugs, which have the effects of promoting blood circulation and removing blood stasis, relieving pain, and promoting wound healing. Notopterygium incisum Ting ex H. T. Chang, Angelica pubescens Maxim. f. biserrata Shan et Yuan, Artemisia argyi Levl. et Vant., and Semen Sinapis Albae help to relax tendons and activate collaterals, dispel cold and relieve pain, and have an obvious relieving effect on pain caused by wind-dampness and cold-dampness. Pinellia ternata (Thunb.) Breit. can harmonize the spleen and stomach, honey can harmonize various drugs, protect healthy qi, protect liver metabolism, and Gardenia jasminoides Ellis and Rheum officinale Baill. var. tanguticum Maxim. ex Regel help to clear heat and purge fire, remove damp-heat, and play a role in clearing damp-heat and blood stasis for the whole formula.

[0085] Generally speaking, the formula of this invention is dominated by Clematis chinensis Osbeck as the monarch drug to promote blood circulation and remove blood stasis, and is combined with ministerial and assistant drugs such as Lycopodium clavatum L., Speranskia tuberculata (Bunge) Baill., Carthamus tinctorius L., and Aconitum carmichaelii Debx. to enhance the effects of promoting blood circulation, dispelling wind-dampness, and dispelling cold and relieving pain. At the same time, through drugs such as Olibanum, Myrrha, and Notopterygium incisum Ting ex H. T. Chang, it comprehensively regulates qi and blood, promotes blood circulation, and relieves pain caused by wind-dampness and cold-dampness. It can be effectively used for the treatment of soft tissue injuries, has no toxic and side effects, has a short treatment cycle, a high effective rate, and no recurrence. The relevant test data are as follows:

[0086] I. Diagnostic criteria for soft tissue injuries

[0087] 1. Clinical manifestations

[0088] Soft tissue injuries are common in athletes or after trauma, especially in areas such as joints, muscles, and tendons. Patients usually present with local swelling, pain, bruising, and limited mobility. In the initial stage of the injury, the local skin shows acute reactions of redness, swelling, heat, and pain, followed by the appearance of congestion and bruising, and gradually develops into lymphedema or muscle induration. As the injury heals, symptoms such as local pain, stiffness, and limited mobility may occur. Depending on the type of injury, the symptoms vary in severity. Common injury types include muscle strains, ligament injuries, joint capsule injuries, bursitis, and fascia injuries.

[0089] 2. Auxiliary Examinations

[0090] X-ray examination: Used to exclude skeletal injuries such as fractures. Soft tissue injuries themselves are difficult to show on X-ray films, but it can provide important information for accompanying skeletal injuries.

[0091] Ultrasound examination: Can clearly show the injury conditions of soft tissues such as muscles, ligaments, and tendons, especially soft tissue contusions, tears, and other injuries.

[0092] MRI examination: Is the most sensitive for the diagnosis of ligament, muscle, and articular cartilage injuries, and can evaluate the degree and scope of the injuries.

[0093] Blood test: Through routine blood tests, it can be observed whether there is an inflammatory reaction, such as an increase in white blood cell count, an increase in the level of C-reactive protein (CRP), etc.

[0094] II. Classification Criteria

[0095] Soft tissue injuries can be classified into the following types according to the injury site and severity:

[0096] Mild injury (Grade I injury): Only local muscle fiber strain or minor rupture, with symptoms of mild pain, occasional swelling, and slightly limited mobility, and a relatively fast recovery.

[0097] Moderate injury (Grade II injury): Partial tear of muscle or ligament, with obvious pain, relatively obvious local swelling and congestion, obvious limitation of movement, and a slower recovery.

[0098] Severe injury (Grade III injury): Complete rupture or tear of muscle or ligament, accompanied by severe local swelling, congestion, and loss of function, requiring a long time to recover and may require surgical intervention.

[0099] III. Inclusion Criteria

[0100] The patient meets the clinical manifestations of soft tissue injury, such as local swelling, pain, limited mobility, etc.

[0101] Imaging examinations show local soft tissue injuries, excluding skeletal injuries such as fractures.

[0102] Adults aged between 18 and 65 years old.

[0103] Conscious and with the ability of independent judgment.

[0104] The patient voluntarily participates in the treatment research and signs the informed consent form.

[0105] IV. Exclusion Criteria

[0106] Patients with underlying diseases such as severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, etc.

[0107] Combined with other severe systemic diseases, such as diabetes, immune system diseases, etc.

[0108] Patients with fractures or visceral injuries other than soft tissue injuries.

[0109] Pregnant women, lactating women, patients with allergic constitution or patients allergic to drugs.

[0110] V. Withdrawal and Exclusion Criteria

[0111] Patients who experience severe adverse reactions or complications during the treatment and cannot continue the treatment.

[0112] Patients who do not take the medicine as prescribed and whose curative effects cannot be evaluated.

[0113] Patients with incomplete data or who do not meet the inclusion criteria.

[0114] Patients whose conditions change or who withdraw from the treatment research voluntarily.

[0115] Patients whom the researcher deems unsuitable for continued treatment.

[0116] VI. Treatment Plan

[0117] The patient receives the drug of the present invention for application to the affected area, once a day, 4 - 6 hours each time. 14 days of treatment is one course, and two courses are continuously treated. The curative effect is statistically analyzed according to the soft tissue recovery after treatment.

[0118] VII. Curative Effect Judgment Criteria

[0119] Cured: Swelling subsides, pain disappears, the normal range of motion is restored, imaging examination shows that the soft tissue has completely recovered, and there is no recurrence after 6 - month follow - up.

[0120] Markedly effective: Swelling is significantly reduced, pain is significantly relieved, limited activity is alleviated, and imaging shows that the injury has recovered by more than 50%.

[0121] Effective: Swelling and pain are somewhat relieved, activity is slightly improved, imaging examination shows that the degree of injury has improved, but does not reach the markedly effective standard.

[0122] Invalid: The symptoms did not improve, swelling and pain persisted, movement was restricted, and imaging examinations showed no improvement or aggravation of the injury.

[0123] VIII. Statistical Analysis

[0124] In this study, a total of 150 patients with soft tissue injuries were included and treated with the drug of the present invention. After statistical analysis of the treatment results, it was shown that: 78 patients were cured, 40 patients had marked improvement, 20 patients had effective results, and 12 patients were ineffective. The total effective rate was 92%. No obvious adverse reactions or toxic side effects were observed during the treatment process, and during the 2-year follow-up, no recurrence or long-term sequelae were found.

[0125] IX. Classic Cases

[0126] 1. Zhang, male, 45 years old, from Luoyang City, Henan Province, suffered from right knee soft tissue injury for 2 months.

[0127] The patient was injured during sports and received a heavy blow to the right knee. Initially, there was only slight swelling and local pain. As time passed, the swelling worsened, movement was restricted, and there were symptoms of congestion. Examination found that the soft tissues of the right knee were significantly swollen, with obvious tenderness, and no change in local warmth. Imaging examinations showed no fracture, and MRI showed damage to the ligaments and muscle tissues around the knee joint. After treatment with the drug of the present invention, the swelling significantly subsided after 3 weeks, the pain was reduced, the range of movement returned to normal, and a complete recovery was achieved after 6 weeks. No recurrence was found during the 3-month follow-up.

[0128] 2. Li, female, 32 years old, from Xinxiang City, Henan Province, suffered from shoulder soft tissue injury for 1 month.

[0129] The patient strained the shoulder muscles due to excessive force during weightlifting training. Initially, there was no obvious swelling, only discomfort in the shoulder, and pain during movement. As time passed, the shoulder pain intensified, with mild swelling and restricted movement. When touching the shoulder, there was obvious tenderness, and the shoulder movement was restricted. MRI examination showed a mild tear in the shoulder muscles. After treatment with the drug combination of the present invention, the pain significantly reduced after 1 month, and normal activities were restored after 2 months, with no obvious residual symptoms. No recurrence was found during the 6-month follow-up.

[0130] 3. Wang, male, 28 years old, from Zhumadian City, Henan Province, suffered from left calf soft tissue injury for 3 weeks.

[0131] The patient was accidentally hit by the opponent during a football game, resulting in soft tissue injury on the outer side of the left calf. Initially, only mild swelling and congestion occurred and were not taken seriously. One week later, the symptoms worsened, the calf was significantly swollen, movement was restricted, obvious induration and tenderness could be felt during palpation, and the skin showed purplish-red congestion. Ultrasonic examination showed partial damage to the muscle tissues on the outer side of the calf, and no obvious ligament rupture was found. After treatment with the drug of the present invention, the swelling significantly decreased after 2 weeks, the pain was reduced after 3 weeks, and movement recovered. No recurrence occurred during the 3-month follow-up.

[0132] Although the embodiments of the present invention have been disclosed as above, they are not limited to the applications listed in the specification and the embodiments. It can be fully applied to various fields suitable for the present invention. For those skilled in the art, additional modifications can be easily made. Therefore, without departing from the general concept defined by the claims and the equivalent scope, the present invention is not limited to specific details.

Claims

1. An externally applied traditional Chinese medicine composition for treating soft tissue injuries, characterized in that, It is made from the following crude drugs by weight: Lycopodium clavatum L. 4 - 20 g, Speranskia tuberculata (Bge.) Baill. 4 - 20 g, Folium Artemisiae Argyi 2 - 10 g, Flos Carthami 1.8 - 9 g, Rhizoma seu Radix Notopterygii 2 - 10 g, Heracleum hemsleyanum Diels 2 - 10 g, Olibanum 3 - 15 g, Myrrha 3 - 15 g, Clematis chinensis Osbeck 10 - 50 g, Semen Sinapis Albae stir-fried 4 - 20 g, Pinellia ternata (Thunb.) Breit. 4 - 20 g, Fructus Gardeniae 3 - 15 g, Rheum officinale Baill. processed with wine 3 - 15 g, Aconitum carmichaelii Debx. processed 4 - 20 g, and Mel 10 - 50 g.

2. The external application traditional Chinese medicine composition for treating soft tissue injury according to claim 1, wherein The traditional Chinese medicine composition is made from the following crude drugs by weight: Lycopodium clavatum L. 4 g, Speranskia tuberculata (Bge.) Baill. 4 g, Folium Artemisiae Argyi 2 g, Flos Carthami 1.8 g, Rhizoma seu Radix Notopterygii 2 g, Heracleum hemsleyanum Diels 2 g, Olibanum 3 g, Myrrha 3 g, Clematis chinensis Osbeck 10 g, Semen Sinapis Albae stir-fried  4 g, Pinellia ternata (Thunb.) Breit. 4 g, Fructus Gardeniae 3 g, Rheum officinale Baill. processed with wine 3 g, Aconitum carmichaelii Debx. processed 4 g, and Mel 10 g.

3. The external application traditional Chinese medicine composition for treating soft tissue injury according to claim 1, wherein The traditional Chinese medicine composition is made from the following crude drugs by weight: Lycopodium clavatum L. 8 g, Speranskia tuberculata (Bge.) Baill. 8 g, Folium Artemisiae Argyi 4 g, Flos Carthami 3.6 g, Rhizoma seu Radix Notopterygii 4 g, Heracleum hemsleyanum Diels 4 g, Olibanum 6 g, Myrrha 6 g, Clematis chinensis Osbeck 20 g, Semen Sinapis Albae stir-fried 8 g, Pinellia ternata (Thunb.) Breit. 8 g, Fructus Gardeniae 6 g, Rheum officinale Baill. processed with wine 6 g, Aconitum carmichaelii Debx. processed 8 g, and Mel 20 g.

4. The external application traditional Chinese medicine composition for treating soft tissue injury according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following crude drugs by weight: Lycopodium clavatum L. 12 g, Speranskia tuberculata (Bge.) Baill. 12 g, Folium Artemisiae Argyi 6 g, Flos Carthami 5.4 g, Rhizoma seu Radix Notopterygii 6 g, Heracleum hemsleyanum Diels 6 g, Olibanum 9 g, Myrrha 9 g, Clematis chinensis Osbeck 30 g, Semen Sinapis Albae stir-fried 12 g, Pinellia ternata (Thunb.) Breit. 12 g, Fructus Gardeniae 9 g, Rheum officinale Baill. processed with wine 9 g, Aconitum carmichaelii Debx. processed 12 g, and Mel 30 g.

5. The preparation method of the externally applied traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, including the following steps: 1) Add the crude drugs except Mel into a crusher and break them up; 2) Grind the broken drugs into traditional Chinese medicine powder, sieve it through a 80 - 110 mesh sieve, and reserve it for future use; 3) Place Mel in a container, add pure water which is 1 / 2 - 3 / 4 of the weight of Mel, then heat it with gentle fire, remove the floating foam on the surface of Mel, filter out the impurities with a sieve, put the filtered Mel back into the pot, heat and concentrate it again. Wait until the Mel reaches a viscous state with a slight draw and then set it aside for future use; 4) Add the Mel prepared in step 3) to the traditional Chinese medicine powder sieved in step 2), mix it into a paste, and evenly apply it on the dressing.

6. Use of the external application traditional Chinese medicine composition according to any one of claims 1 - 5 in the preparation of a drug for treating soft tissue injuries.