External black plaster for treating soft tissue pain and osteoarticular diseases and preparation method thereof

Abstract

The invention discloses an external black plaster for treating soft tissue pain and osteoarticular diseases as well as a preparation method and application of the external black plaster. The black plaster is prepared from fineleaf schizonepeta herb, divaricate saposhnikovia root, garden balsam stem, dahurian angelica root, safflower, medicinal cyathula root, red peony root, Chinese angelica, dried orange peel, frankincense, myrrh, common duckweed herb, dried river shrimp, minium and sesame oil according to a specific ratio. The preparation method comprises the steps of material frying, oil refining, pellet feeding, fire toxin removing, spreading and the like. Based on the theory of treating different diseases at the same time in traditional Chinese medicine, aiming at the core pathogenesis of qi stagnation, blood stasis and meridian obstruction, the traditional Chinese medicine composition is scientific in formula and has the effects of promoting blood circulation to remove blood stasis, relieving swelling and pain, dispelling wind and eliminating dampness and clearing and activating the channels and collaterals. Clinical application proves that the plaster has remarkable curative effects on soft tissue pain such as mastitis and hyperplasia of mammary glands and osteoarticular diseases such as lumbar disc herniation, arthritis and cervical spondylosis, is safe and convenient to use and has important clinical application value.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine external preparation technology, specifically relating to a topical black plaster based on the TCM theory of "treating different diseases with the same method", used to treat soft tissue injuries and bone and joint diseases caused by qi stagnation and blood stasis and meridian obstruction, as well as its preparation method and application. Background Technology

[0002] The information disclosed in this background section is intended only to enhance some understanding of the overall background of the invention and is not necessarily to be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art.

[0003] Soft tissue injuries (such as acute and chronic mastitis, breast hyperplasia, various sprains and falls) and bone and joint diseases (such as lumbar disc herniation, cervical spondylosis, arthritis, and lumbar muscle strain) are common and frequently occurring diseases in modern society. Clinically, they mainly manifest as local pain, swelling, stiffness, and functional impairment, causing great suffering to patients.

[0004] Currently, Western medicine treatments often involve oral nonsteroidal anti-inflammatory drugs (NSAIDs), hormones, or surgical intervention, which carry risks such as gastrointestinal irritation, liver and kidney damage, and high surgical risks. Traditional Chinese medicine external therapies, especially traditional black plasters, are favored for their direct targeting of the affected area, long-lasting effects, ease of use, and minimal side effects. However, existing black plasters often have limited efficacy (focusing on analgesia or blood circulation) or complex formulas lacking specificity, making it difficult to achieve comprehensive and effective treatment for various pain syndromes involving multiple pathogenic mechanisms such as wind, cold, dampness, blood stasis, and stagnation. Furthermore, there are few commercially available topical compound preparations that can simultaneously and effectively target both breast diseases and neck, shoulder, back, and leg pain, while also embodying the principle of "treating different diseases with the same method."

[0005] Therefore, there is an urgent need to develop a traditional Chinese medicine black plaster with a refined formula, scientific compatibility, definite efficacy, and clear scope of application to meet the clinical demand for safe, effective, and convenient topical analgesics. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to overcome the shortcomings of the prior art and provide a topical black plaster with a unique formula, mature preparation process, significant curative effect and wide applicability to various pain diseases caused by qi stagnation and blood stasis.

[0007] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: In a first aspect, the present invention provides a topical traditional Chinese medicine composition, which is prepared from the following raw materials in parts by weight: 4-6 parts of Schizonepeta tenuifolia, 4-6 parts of Saposhnikovia divaricata, 4-6 parts of Clematis chinensis, 4-6 parts of Angelica dahurica, 4-6 parts of Carthamus tinctorius, 4-6 parts of Achyranthes bidentata, 4-6 parts of Paeonia lactiflora, 4-6 parts of Angelica sinensis, 4-6 parts of Citrus reticulata peel, 4-6 parts of Boswellia carterii, 4-6 parts of Commiphora myrrha, 2-8 parts of Lemna minor, 2-8 parts of dried river shrimp, 30-40 parts of Litharge, and 70-90 parts of sesame oil.

[0008] Preferably, the raw materials and their weight parts of the external application traditional Chinese medicine composition are as follows: 5 parts of Schizonepeta tenuifolia, 5 parts of Saposhnikovia divaricata, 5 parts of Clematis chinensis, 5 parts of Angelica dahurica, 5 parts of Carthamus tinctorius, 5 parts of Achyranthes bidentata, 5 parts of Paeonia lactiflora, 5 parts of Angelica sinensis, 5 parts of Citrus reticulata peel, 5 parts of Boswellia carterii, 5 parts of Commiphora myrrha, 3-5 parts of Lemna minor, 3-5 parts of dried river shrimp, 35 parts of Litharge, and 80 parts of sesame oil.

[0009] Secondly, the present invention provides a topical black plaster prepared from the traditional Chinese medicine composition described in the first aspect.

[0010] Thirdly, the present invention provides a method for preparing the topical black plaster described in the second aspect, comprising the following steps: (1) Prepare medicinal oil: Place Schizonepeta, Saposhnikovia divaricata, Clematis armandii, Angelica dahurica, Carthamus tinctorius, Achyranthes bidentata, Paeonia lactiflora, Angelica sinensis, Citrus reticulata, Boswellia carterii, Commiphora myrrha, Lemna minor, and dried river shrimp in sesame oil and fry over low heat until the herbs are golden brown. Filter out the dregs to obtain medicinal oil. Refining the oil and adding the cinnabar to form the ointment: Continue to simmer the filtered medicinal oil over a low flame until it sinks into a round bead when dropped into cold water and becomes hard to the touch (i.e., "dropping water forms a bead"), then add the cinnabar and stir continuously until a black and shiny ointment is formed. (3) Remove heat toxins: Eliminate irritating components through cold water soaking process; (4) Spreading and shaping: Heat the plaster after removing the fire poison and melt it, then spread it on the backing material to obtain the finished external black plaster.

[0011] Fourthly, the present invention provides the application of the aforementioned external Chinese medicine composition or external black plaster in the preparation of a medicine for treating painful diseases caused by qi stagnation and blood stasis and meridian obstruction.

[0012] Preferably, the painful conditions include soft tissue injuries and / or osteoarthritis.

[0013] More preferably, the soft tissue injury includes mastitis, breast hyperplasia, acute sprains, and bruises.

[0014] More preferably, the osteoarthritis includes lumbar disc herniation, lumbar sprain, lumbar muscle strain, arthritis, and cervical spondylosis (including cervical stiffness and pain).

[0015] Compared with the related technologies known to the inventors, one of the technical solutions of the present invention has the following beneficial effects: The formula is refined and scientifically formulated, embodying the principle of "treating different diseases with the same method": This invention targets the core pathogenesis of "qi stagnation and blood stasis, and meridian obstruction," integrating methods such as dispelling wind and cold, promoting blood circulation and removing blood stasis, clearing the meridians and collaterals, and expelling pathogens. In particular, the unique combination of duckweed and dried river shrimp achieves a synergistic effect of deep medicinal penetration and external dissipation of pathogens, enabling the same preparation to effectively treat breast diseases and bone and joint diseases with the same pathogenesis but different locations.

[0016] It has a definite curative effect and takes effect quickly: for pain caused by diseases such as lumbar disc herniation and mastitis, applying 3-6 patches can achieve significant improvement or even make the symptoms basically disappear.

[0017] Wide range of applications: Based on precise treatment of the core pathogenesis, this plaster can be widely used for various soft tissue and bone and joint pain caused by qi stagnation and blood stasis and meridian blockage, covering multiple parts such as the breast, lumbar spine, cervical spine, and joints.

[0018] Safe and convenient to use: Pure Chinese herbal medicine for external application, absorbed through the skin, with a long-lasting and gentle effect. It is also treated with a "detoxification" process, resulting in minimal skin irritation and high patient compliance.

[0019] The process is mature and stable: the key steps of the preparation process are clearly defined, the quality is controllable, and it is easy to standardize production. Attached Figure Description

[0020] The accompanying drawings, which form part of this specification, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an improper limitation of the invention.

[0021] Figure 1 This image is from the page in "Chinese Materia Medica" that records the medicinal properties, flavors, meridian tropism, and functions of shrimp.

[0022] Figure 2 This is the external black plaster prepared in Example 1.

[0023] Figure 3 This is the external black plaster prepared in Example 2. Detailed Implementation

[0024] It should be noted that the following detailed descriptions are exemplary and intended to provide further illustration of the invention. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0025] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of exemplary embodiments according to the invention. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, and / or combinations thereof.

[0026] The formulation principle and theoretical basis of this invention (I) Core theoretical foundation: "treating different diseases with the same method" and the theory of "arthralgia"

[0027] Breast diseases (such as breast hyperplasia and mastitis) and neck, shoulder, back and leg pain (such as cervical spondylosis and osteoarthritis) may seem to be internal and external, but in traditional Chinese medicine theory, their core pathogenesis can indeed be unified under "qi stagnation and blood stasis, and meridian obstruction". The theoretical root can be traced back to the classic Chinese medicine text, "Huangdi Neijing".

[0028] 1. Shared theoretical foundation: The theory of "Bi syndrome" in the Yellow Emperor's Inner Classic The Inner Canon of Medicine believes that the core meaning of "Bi" is the blockage of Qi, blood and meridians.

[0029] “Bi” means “blockage”: the “Bi” discussed in the book specifically refers to the pathogenesis of “obstruction and stagnation”. As stated in the opening of “Suwen·Bi Lun”: “When wind, cold and dampness come together, they combine to form Bi.” Although it refers to external pathogens, the ultimate outcome of Bi syndrome is that it leads to stagnation of Qi and blood circulation and blockage of meridian channels.

[0030] The complex pathogenesis of "interplay between old and new": The occurrence of arthralgia is often not due to a single cause, but rather "interplay between old and new"—that is, the combination of pre-existing pathogenic factors (such as qi stagnation, blood stasis, phlegm turbidity, and emotional trauma) with newly acquired pathogenic factors such as wind, cold, and dampness from the outside world, leading to the onset of the disease. This indicates that internal imbalance of qi and blood is an important basis for the occurrence of arthralgia.

[0031] Conclusion: Whether the pain is caused by external wind-cold-dampness directly "blocking" the meridians of the limbs, or by internal emotional distress and dysfunction of the internal organs leading to stagnation of qi and blood and "blocking" the mammary meridians to form lumps, both are consistent with the definition of "Bi" in the "Neijing" (Inner Canon of Medicine) - the final pathological state is the stagnation of qi and blood and obstruction of meridians.

[0032] 2. Breast diseases: Initially caused by liver stagnation, leading to blood stasis in the collaterals. The core issue in breast diseases is liver qi stagnation. The Foot Jueyin Liver Meridian runs through the hypochondrium and breasts; the liver governs the free flow of qi and regulates its movement. If emotions are not smooth, liver qi stagnates, then: Qi stagnation: When the flow of Qi is obstructed, it first leads to breast swelling and pain, which is localized (migratory). This is closely related to emotions and the menstrual cycle.

[0033] Blood stasis: Qi is the commander of blood. When Qi stagnates, blood circulation is obstructed, eventually leading to blood stasis. Blood stasis, combined with Qi stagnation and phlegm accumulation, can form a relatively hard, tender, and fixed breast lump.

[0034] Phlegm accumulation: Liver stagnation can invade the spleen, and when the spleen fails to function properly, dampness accumulates and phlegm forms. The mutual binding of phlegm and blood stasis makes the mass more stubborn.

[0035] The pathogenesis chain is as follows: emotional distress → stagnation of liver qi (qi stagnation) → poor blood circulation (blood stasis) → impaired distribution of body fluids (phlegm accumulation) → qi, phlegm, and blood stasis intertwine, obstructing the mammary collaterals → forming mastopathy (hyperplasia) or breast cancer (tumor). Therefore, breast diseases are a typical manifestation of the pathogenesis of "qi stagnation and blood stasis, and obstruction of meridians" in the internal organs and meridians (especially the liver and stomach meridians).

[0036] 3. Neck, shoulder, lower back and leg pain: caused by external pathogens and overexertion, resulting in obstruction of the meridians. In Traditional Chinese Medicine (TCM), neck, shoulder, lower back, and leg pain often fall under the categories of "muscle and tendon pain" and "bone and tendon pain." Its pathogenesis also begins with "obstruction of flow." External pathogenic factors obstructing the flow of qi and blood: The neck, shoulders, waist, and legs are on the surface of the body and are easily invaded by external pathogenic factors such as wind, cold, and dampness. When these pathogenic factors invade the meridians, they obstruct the flow of qi and blood, causing pain due to blockage. Symptoms include soreness, pain, numbness, and heaviness in the joints and muscles.

[0037] Strain leading to blood stasis: Long-term improper posture or chronic strain can cause "external injury" to local muscles and bones. The Ling Shu·Zei Feng states, "If one falls or falls, the stagnant blood remains inside and does not go away." Coupled with exposure to wind and cold, this will lead to "blood and qi stagnation," resulting in cold bi syndrome. This directly corresponds to common chronic musculoskeletal diseases in modern times, one of the core pathogenesis of which is "qi and blood stagnation."

[0038] The root cause is deficiency and the manifestation is excess: In the later stages of the disease or in elderly patients, there is often a deficiency of liver and kidney and insufficient qi and blood, which leads to malnourishment of tendons and bones; at the same time, there is an excess of wind, cold and dampness, blood stasis and phlegm, which obstruct the meridians, forming a complex situation of mixed deficiency and excess.

[0039] The pathogenesis chain is as follows: external invasion of wind, cold, and dampness / chronic strain → obstruction of the flow of qi and blood in the meridians (qi stagnation and blood stasis) → local malnutrition, and pain due to obstruction → manifested as pain, numbness, and limited movement in the limbs and joints. Therefore, neck, shoulder, waist, and leg pain is a direct manifestation of the pathogenesis of "qi stagnation and blood stasis, and obstruction of the meridians" in the muscles, bones, and meridians of the body surface.

[0040] 4. Comparison of similarities and differences and clinical significance To more clearly understand the connection and differences between the two, a detailed comparison is as follows:

[0041] This common theoretical core: It explains the treatment of different diseases with the same method: Based on the principle of "pain due to obstruction, relief from pain when the obstruction is removed", whether it is the distending pain in the breast or the stabbing pain in the joints, as long as the syndrome differentiation belongs to qi stagnation and blood stasis, the treatment can focus on the word "removing obstruction", such as soothing the liver and regulating qi, promoting blood circulation to remove stasis, resolving phlegm and dissipating nodules, dredging collaterals and relieving pain, etc.

[0042] It reveals the disease association: People with long-term emotional depression (liver qi stagnation) are not only prone to breast hyperplasia, but also often more likely to be invaded by external pathogens or suffer from strain due to qi stagnation and blood stasis, and weakness in defending the exterior, which can induce pain in the neck, shoulders, waist and legs, forming a complex situation of internal and external diseases coexisting.

[0043] Generally speaking, breast diseases and pain in the neck, shoulders, waist and legs, one internal and one external, one is caused by emotional injury leading to qi and blood stagnation in the breast collaterals, and the other is caused by external pathogens and strain leading to qi and blood obstruction in the muscles and bones. Their symptoms and disease locations are very different, but tracing back to the essence of their pathogenesis, they both do not deviate from the core of the "bi" syndrome in "Huangdi Neijing" which is "qi and blood stagnation, collaterals obstruction", and they are manifestations of the same pathological mechanism in different parts.

[0044] (2) Analysis of the compatibility of the formula 1. Compatibility of monarch, minister, assistant and courier drugs The formula of this invention strictly follows the compatibility principle of "monarch, minister, assistant and courier drugs" in traditional Chinese medicine. Each drug has a clear role and works synergistically to treat the syndrome of "qi stagnation and blood stasis, collaterals obstruction".

[0045] 1) Schizonepeta tenuifolia Briq., Saposhnikovia divaricata (Turcz.) Schischk., Herba Speranskiae tuberculatae, Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav. These four herbs are the monarch drugs in the formula, jointly achieving the effects of dispelling wind and cold, and penetrating the muscles and bones. Schizonepeta tenuifolia Briq. and Saposhnikovia divaricata (Turcz.) Schischk. are used in combination, opening the pores, dispersing wind-cold, and expelling pathogenic factors outside. Herba Speranskiae tuberculatae specializes in treating pain due to bone and muscle obstruction, leading the medicinal power deep into the affected area. Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav. is pungent, warm and fragrant, dispersing cold and relieving pain, especially good at opening the orifices. The four herbs work together to break the external attack of wind-cold-damp pathogens and pave the way for the whole formula.

[0046] 2) Flos Carthami, Cyathula officinalis Kuan, Radix Paeoniae Rubra, Angelica sinensis (Oliv.) Diels. These four herbs are the minister drugs, mainly promoting blood circulation to remove stasis and dredging channels to relieve pain. Flos Carthami breaks blood stasis and promotes qi movement, Radix Paeoniae Rubra cools blood and reduces swelling, and the two herbs promote blood circulation without being dry. Angelica sinensis (Oliv.) Diels. nourishes blood and promotes blood circulation, and also moistens the tendons and vessels. Cyathula officinalis Kuan guides blood downward, strengthens the muscles and bones, and dredges the joints. The combination of the monarch and minister drugs not only disperses external pathogens but also resolves internal stasis, conforming to the pathogenesis of "bi syndrome with more stasis".

[0047] 3) Pericarpium Citri Reticulatae, Olibanum, Myrrha, Herba Desmodii Styracifolii, dried river shrimp. These five herbs are the assistant drugs. Pericarpium Citri Reticulatae: regulates qi and strengthens the spleen, preventing the plaster from being sticky and obstructing the stomach, and promoting qi movement so as to promote blood circulation. Olibanum, Myrrha: This pair of herbs is essential for treating traumatic injuries, assisting the minister drugs to enhance the power of promoting blood circulation to relieve pain, promoting tissue regeneration and reducing swelling.

[0048] Herba Desmodii Styracifolii: floating and ascending, assisting the monarch drugs to disperse exterior pathogens, and also promoting diuresis and resolving dampness. Dried river shrimp is used as a drug guide: dried river shrimp is salty, warm and enters the kidney, commonly used to warm and dredge channels, strengthen yang and dissipate nodules, assisting in removing deep-lying cold and dampness. This group of herbs takes into account both qi and blood, with a combination of dispersing and promoting, making the whole formula dispel pathogenic factors without harming healthy qi.

[0049] 4) Sesame oil and red lead are used as guiding ingredients. Sesame oil serves as the base for the ointment; its moisturizing properties nourish the skin, allowing the medicinal effects to penetrate, while also detoxifying and moisturizing. Red lead, pungent and slightly cold in nature, has the effects of drawing out toxins, promoting tissue regeneration, and astringing sores. When combined with the oil to form an ointment, it is shaped and molded, allowing the medicinal effects to be released slowly and for a longer duration. These two ingredients, one gentle and one strong, work together as guiding ingredients, carrying the other medicines directly to the affected area and securing the medicinal effects at the site of infection.

[0050] Synergistic effects of this formula: It treats both internal and external ailments, addressing both the exterior and the interior. 1) The combination of dispersing cold from the surface (Schizonepeta, Saposhnikovia, Duckweed) and penetrating deep into the muscles and bones (Clematis chinensis, Achyranthes bidentata) leaves no place for evil to hide; 2) Combining blood-activating and stasis-removing herbs (safflower, red peony root, frankincense and myrrh) with qi-regulating and stagnation-relieving herbs (tangerine peel, angelica root) to regulate both qi and blood; 3) The warming and dispersing properties (Angelica dahurica, river shrimp) are balanced with the blood-cooling and swelling-reducing properties (Paeonia lactiflora), resulting in a warming effect without causing dryness; 4) With oil as the base, the properties of various medicines can be absorbed into the meridians through the skin, which can be used to treat chronic muscle and bone pain and old injuries from falls and blows.

[0051] This formula can be used for joint swelling and pain caused by wind-cold-dampness, traumatic injuries, and difficulty in flexion and extension, or for carbuncles in their early stages before ulceration.

[0052] 2. Three-dimensional treatment strategy: "Open the door to expel the enemy, penetrate deep into the enemy camp, break through the blockage pathways, and warm and consolidate the defenses." The core condition treated by this formula is "wind, cold, and dampness invading the muscles and meridians, leading to stagnation of qi and blood, and pain due to obstruction." It is commonly seen in "bi syndrome" characterized by cold pain and limited flexibility in joints, or breast pain and meridian blockage in women caused by anger, or swelling and pain resulting from old injuries or falls. Therefore, the general principle of this formula is: "Open the gates to expel the enemy, penetrate deep into the enemy camp, break up the stagnation and obstruct the pathways, and warm and consolidate the defenses."

[0053] Below, this principle of formulation will be broken down into four progressive strategic steps: Step 1: Opening the Door to Expel the Invaders (Solving the Pathogenic Factors) Wind, cold, and dampness are the first external pathogens to invade the body. They block the skin and pores (the body's gateways), causing internal imbalances in Qi and blood. The first step in treatment is not to directly attack the internal organs, but to expel these external pathogens, giving them a "way out." Use Schizonepeta, Saposhnikovia, Angelica dahurica, and Duckweed. These herbs are light and ascending, like opening a window. Schizonepeta and Saposhnikovia are good at dispersing wind and cold, releasing the surface constriction; Angelica dahurica is pungent and fragrant, able to open the orifices and relieve pain, especially good at expelling wind and cold from the head, face, and skin; Duckweed is light and ascending, able to disperse wind and heat and promote urination, helping dampness to be expelled through sweat or urination. These four herbs work together to disperse the wind, cold, and dampness entrenched on the surface, thus "giving the pathogens a way out."

[0054] Step 2: Penetrate the enemy camp and directly attack the seat of the disease (solve the location of pathogenic factors). If the pathogenic factors are only on the body surface, sweating will do. However, the pain of arthromyodynia and old injuries lies in that the pathogenic qi has penetrated deep into the bones, joints, and muscles, the "deep enemy camps". Ordinary medicinal power is difficult to reach. Use speranskia tuberculata, cyathula officinalis, and dried river shrimps. This is the subtlety of this prescription. Speranskia tuberculata, as its name implies, can lead the medicinal power into the bone marrow; cyathula officinalis can not only activate blood circulation but also lead blood and medicine downward, directly reaching the deep joints below the waist and knees; dried river shrimps take their salty and warm nature of running around, drilling through the stagnation in the meridians like swimming shrimps in water. These three herbs form a "special force", leading the medicinal power of the whole prescription to the deepest and most painful focus.

[0055] Step 3: Break up stasis and clear the path, clean the battlefield (solve the core pathology). The invasion of exogenous pathogens and the long-term non-healing will inevitably lead to poor local qi and blood circulation, forming "stasis of blood". Stasis of blood is the direct cause of pain, swelling, and limited movement. Only expelling pathogenic factors without removing stasis of blood makes it difficult to remove the root cause of the disease. Use safflower, red peony root, angelica sinensis, frankincense, myrrh, and dried tangerine peel. This is a powerful "troop for promoting blood circulation and removing stasis". Safflower and red peony root are the main forces for breaking up stasis and promoting blood circulation, directly attacking blood stasis clots. Angelica sinensis is the "saint medicine in blood", which can both enrich blood and activate blood circulation. Adding angelica sinensis to a large number of blood-activating herbs is to make the blood-activating effect without damaging blood, with the subtlety of "increasing water to facilitate the movement of the boat". Frankincense and myrrh are important herbs for traumatic injuries. Used in combination, they can not only activate blood circulation but also promote qi movement, relieve pain, and promote granulation, having a special effect on the severe pain caused by stasis of blood and swelling.

[0056] Dried tangerine peel regulates qi. Traditional Chinese medicine believes that "qi is the commander of blood", and when qi moves, blood moves. Dried tangerine peel is like a commander on the battlefield, mobilizing the qi and blood to move, helping the stasis-removing herbs to play a better role. At the same time, it also prevents the plaster from being too greasy.

[0057] Step 4: Warm and dredge for consolidation, long-term slow attack (solve the problems of dosage form and long-lasting medicinal power). All the above-mentioned herbs need a carrier to "stick" them to the affected area and let the medicinal power penetrate slowly, continuously, and gently. This is the essence of the black plaster dosage form (based on oil and red lead).

[0058] Use sesame oil and red lead. Sesame oil: It has a moist nature, can nourish the skin, and prevent the pungent and dry herbs from burning the skin. As a matrix, it can fully extract the effective components of all herbs. Red lead: When combined with oil through high-temperature refining, it forms a plaster. It can make the medicinal properties become "stable", changing from "swift" to "lasting", transforming the pungent-dispersing and blood-activating power of various herbs into a gentle and continuous "warming and dredging" power, acting on the affected area for a long time like hot compress, slowly melting the deep cold-dampness and stasis of blood.

[0059] Summary of the principle: The compatibility of this prescription is not a simple superposition of medicinal effects but a complete "three-dimensional combat" plan: 1. Eliminate pathogens from the exterior and interior: Use wind herbs (schizonepeta and ledebouriella) to expel pathogenic factors from the body surface and use herbs for leading through the bones (speranskia tuberculata and achyranthes bidentata) to attack pathogenic factors from the inside.

[0060] 2. Regulating Qi and Blood: It uses blood-activating herbs (red peony root, peony root, angelica root) to treat blood stasis, and qi-regulating herbs (tangerine peel, frankincense and myrrh) to promote qi circulation, which conforms to the ancient saying "Treat wind by first treating blood stasis, and when blood circulates smoothly, wind will naturally subside".

[0061] 3. Combination of activity and stillness: A large number of pungent and volatile active ingredients (such as angelica, myrrh, and river shrimp) are "active" and used to attack pathogens; while the ointment base made from cinnamon oil is "still" and used to retain and slow-release the medicine. This combination of activity and stillness ensures that the medicinal effect is long-lasting and gentle.

[0062] 4. Outward and inward journey: Give external pathogens an "outward journey" (dispersion), give internal medicine an "inward journey" (guiding to the meridians), give stagnant blood a "pathway" (blood circulation), and finally use plaster to "secure" all the power to the lesion.

[0063] In this way, the formula forms a complete therapeutic loop, from the skin to the bones and muscles, from the Qi to the blood, and from rapid dispersion to long-lasting warming and unblocking. This is a vivid manifestation of the philosophical thought of "principal, assistant, adjuvant, and guide" in traditional Chinese medicine compound prescriptions, working synergistically to achieve the desired effect.

[0064] (III) The unique effects of key medicinal materials 1. The mechanism and basis of action of duckweed: a "light cavalry" that opens the pores and draws pathogens to the surface. In this formula, duckweed plays the role of a guiding herb that "reaches the exterior from the interior," and its function is unique and irreplaceable.

[0065] (1) Core function and ancient text basis: Duckweed is pungent and cold in nature, light and floating, and good at opening the pores. According to Li Shizhen's "one leaf grows into several leaves overnight" and "Correct Interpretation of Materia Medica", its growth characteristic is "one leaf grows into several leaves overnight", which means it is full of vitality and is considered to be "a yang energy rising from cold water", so it is good at expelling pathogenic factors.

[0066] Sweating without harming the body's vital energy: Unlike strong diaphoretics such as ephedra, the "Correct Interpretation of Materia Medica" points out that duckweed, "although said to induce sweating, is not warm in nature, and there is no risk of excessive sweating." This is especially important for plasters that need to be applied for a long time, as it can avoid excessive depletion of the body's surface fluids.

[0067] It can also dispel wind, relieve itching, and promote diuresis: It can also dispel wind and relieve itching, and use its diuretic properties to guide the dampness between the skin out.

[0068] (2) Unique value in this case: The formula already contains herbs like Schizonepeta and Saposhnikovia, which dispel wind and cold. However, the addition of Duckweed enhances its ability to penetrate the skin horizontally. It can guide the "stasis" and "dampness" resolved by the blood-activating and stasis-removing herbs in the formula (such as Safflower, Frankincense, and Myrrh), as well as the "latent evil" deeply penetrated by Clematis chinensis, from the levels of muscles and meridians to the surface of the skin, truly achieving "giving the evil a way out".

[0069] 2. The Mechanism of Action of Dried River Shrimp and Supporting Evidence from Classical Texts: "Sailing Engineers" that penetrate deep into saline-temperature environments. Dried river shrimp is a unique folk remedy, its core function being "to unblock" or "clear."

[0070] (1) Core function and ancient text basis: According to historical records on the "commonality" of river shrimp, based on a synthesis of multiple ancient texts, the "commonality" of river shrimp is mainly reflected in: Promoting lactation: The Compendium of Materia Medica Supplement records that it can "promote lactation". Relieving stagnation and eliminating toxins: It can be used for "measles with poor eruption, carbuncles, and malignant nodules", meaning it has the effect of expelling and clearing internal toxins.

[0071] Tongyangdao: The Compendium of Materia Medica records that it can "strengthen the yang meridian". This "strengthening the yang meridian" is not just a simple warming and tonifying, but also includes the meaning of unblocking the kidney meridian and invigorating the circulation of yang energy.

[0072] The physical properties of shrimp as a medium for "unblocking meridians": Shrimp live in water and are adept at swimming and burrowing. Their nature is salty and warm. Saltiness can soften hardened masses and disperse lumps, while warmth can promote blood circulation. Traditional Chinese medicine, using analogy and metaphor, believes that shrimp possess the ability to penetrate and move, especially adept at reaching deep into the gaps between muscles and bones, and areas of stagnation in the meridians, thus achieving the effect of unblocking meridians and dispersing lumps. This is reflected in the medicinal experience of many regions.

[0073] (2) The unique value of this formula: Although the formula contains Achyranthes bidentata to guide the medicine downwards and Clematis chinensis to penetrate the muscles and bones, the addition of dried river shrimp is like sending out an engineering corps skilled in working in narrow places. With its salty and warm properties, it can enhance the formula's ability to penetrate deep obstructions and resolve long-standing stagnation. Its "unblocking" property is especially crucial for joint stiffness and difficulty in flexion and extension caused by long-term illness.

[0074] Summary of Collaborative Relationships: Constructing a Three-Dimensional Pathway for "Separation and Elimination of Internal and External Factors" These two adjuvant herbs work synergistically with the entire formula to form a sophisticated "internal and external differentiation and elimination" strategy: Duckweed penetrates the exterior to expel pathogenic factors, opens the pores, and promotes urination from the interior (muscles, meridians) to the exterior (skin), dispersing outwards and upwards. Li Shizhen discussed its vitality; *Ben Cao Zheng Yi* states that it promotes sweating in a mild way. It acts as an "exit" guide, ultimately expelling the "pathological products" of internalized blood stasis and dampness to the body surface. Dried river shrimp clears the meridians and disperses stagnation; its salty and warm properties allow it to penetrate deep into the muscles, bones, and joints, reaching deep into areas of stagnation. *Ben Cao Gang Mu* records its "yang-strengthening" properties; *Ben Cao Gang Mu Shi Yi* records its "lactation-promoting" properties, demonstrating its "unblocking" nature. It acts as a "deep-penetrating" agent, enhancing the ability of prescriptions to penetrate deep and long-standing pathogenic factors.

[0075] In simple terms, dried river shrimp helps to "get things in," addressing the problem of pathogens being "deeply hidden," while duckweed helps to "get things out," addressing the problem of pathological products having "narrow exit routes." The two, one deep and one shallow, one inside and one outside, together ensure the perfect execution of the overall strategy of "opening the door to expel the enemy, penetrating deep into the enemy camp, and breaking through the blockages."

[0076] Among them, dried river shrimp (hereinafter referred to as "shrimp") is used medicinally, and its "penetrating" properties are clearly recorded in the authoritative national pharmacopoeia of traditional Chinese medicine, *Zhonghua Bencao*. The properties, flavors, meridian tropism, and indications of dried river shrimp are recorded in […]. Figure 1 .

[0077] To enable those skilled in the art to better understand the technical solution of the present invention, the technical solution of the present invention will be described in detail below with reference to specific embodiments.

[0078] Example 1: Preparation of Black Plaster Prescription: Schizonepeta tenuifolia 50g, Saposhnikovia divaricata 50g, Clematis chinensis 50g, Angelica dahurica 50g, Carthamus tinctorius 50g, Achyranthes bidentata 50g, Paeonia lactiflora 50g, Angelica sinensis 50g, Citrus reticulata 50g, Boswellia carterii 50g, Commiphora myrrha 50g, Lemna minor 40g, Dried river shrimp 40g, Litharge 350g, Sesame oil 800g.

[0079] Preparation method: (1) Prepare medicinal oil: Place Schizonepeta, Saposhnikovia divaricata, Clematis armandii, Angelica dahurica, Carthamus tinctorius, Achyranthes bidentata, Paeonia lactiflora, Angelica sinensis, Citrus reticulata, Boswellia carterii, Commiphora myrrha, Lemna minor, and dried river shrimp in sesame oil and fry over low heat until the herbs are golden brown. Filter out the dregs to obtain medicinal oil. (2) Refining oil and adding cinnabar to form ointment: Continue to simmer the filtered medicinal oil over a low flame until it sinks into cold water as a round bead and becomes hard to the touch (i.e., "dropping water forms a bead"), then add cinnabar and stir continuously until a black and shiny ointment is formed. (3) Remove heat toxins: Eliminate irritating components through cold water soaking process; (4) Spreading and shaping: The plaster, after being detoxified, is heated and melted, and then spread onto cotton cloth to obtain the finished external black plaster, such as... Figure 2 .

[0080] Example 2: Preparation of Black Plaster Prescription: Schizonepeta tenuifolia 45g, Saposhnikovia divaricata 45g, Clematis chinensis 60g, Angelica dahurica 45g, Carthamus tinctorius 45g, Achyranthes bidentata 45g, Paeonia lactiflora 45g, Angelica sinensis 45g, Citrus reticulata 45g, Boswellia carterii 45g, Commiphora myrrha 45g, Lemna minor 30g, Dried river shrimp 30g, Litharge 320g, Sesame oil 750g.

[0081] The preparation method is the same as in Example 1, and the resulting external black plaster is as follows: Figure 3 .

[0082] Example 3: Preparation of Black Plaster Prescription: Schizonepeta tenuifolia 55g, Saposhnikovia divaricata 55g, Clematis chinensis 40g, Angelica dahurica 55g, Carthamus tinctorius 60g, Achyranthes bidentata 55g, Paeonia lactiflora 60g, Angelica sinensis 55g, Citrus reticulata 55g, Boswellia carterii 55g, Commiphora myrrha 55g, Lemna minor 50g, Dried river shrimp 50g, Litharge 380g, Sesame oil 850g.

[0083] The preparation method is the same as in Example 1.

[0084] Clinical application observation and typical cases To preliminarily verify the clinical applicability and safety of the black plaster of this invention, the inventors conducted a retrospective summary of their experience with the product prepared according to Example 1. It should be noted that this observation was not a rigorously designed randomized controlled clinical trial, and its results are intended to provide preliminary reference for the stated efficacy.

[0085] I. Observation Methods and Case Details In clinical application, a group of patients who met the TCM diagnostic criteria of "qi stagnation and blood stasis, meridian obstruction" and had a clear Western medical diagnosis (confirmed by imaging examination) were selected for topical treatment. The diseases involved mainly included soft tissue injuries (such as mastitis, breast hyperplasia, acute and chronic sprains) and bone and joint diseases (such as lumbar disc herniation, cervical spondylosis, and osteoarthritis). All patients used the black plaster prepared in Example 1 of this invention, applying it to the area of ​​significant pain after cleaning the skin, changing one plaster every 3 days, and using it continuously.

[0086] During treatment, close attention should be paid to changes in the patient's subjective pain perception, improvement of local symptoms, and whether skin irritation or other reactions occur.

[0087] II. Observation Results Based on the overall observations, the following initial impressions were obtained: Symptom relief trend: Most patients experience varying degrees of relief from local pain, swelling, and other symptoms after starting to use the patches (usually within 1-3 patches). With prolonged use (e.g., continuous use for 1-2 weeks), some patients experience more significant symptom improvement.

[0088] Safety impression: The plaster was generally well tolerated. During the observation period, a very small number of patients experienced transient and mild skin redness and itching at the application site, which resolved spontaneously after the plaster was removed. No serious skin allergies or systemic adverse reactions were observed.

[0089] Typical case: To illustrate the application more specifically, the following are brief descriptions of representative cases: Case 1: Acute mastitis during lactation Patient information: Ms. Zhang, female, 28 years old, married, farmer, with redness, swelling and pain in her right breast for 3 days.

[0090] Diagnosis: Acute lactational mastitis (right side).

[0091] Treatment: Apply the plaster prepared in Example 1 to the area of ​​most severe pain on the right side of the breast. Apply one plaster every 3 days and change it every 72 hours. Applying the plaster does not affect breastfeeding.

[0092] Results: After applying one patch, the swelling and pain were significantly relieved; breast milk was discharged normally; after applying three patches, the pain symptoms basically disappeared.

[0093] Case 2: Non-lactational mastitis Patient Information: Ms. Li, female, 35 years old, married, office worker, presented with a lump and pain in her left breast for 2 weeks. Diagnosis: Non-lactational mastitis (left side, abscess formation).

[0094] Treatment: Apply the plaster prepared in Example 1 to the area on the left side of the breast where the pain is most pronounced. Apply one plaster every 3 days and change it every 72 hours.

[0095] Results: After applying 2 patches, the pain was significantly relieved; after applying 3 patches, the swelling gradually disappeared and the pain symptoms were significantly improved; after applying 6 patches, the above symptoms basically disappeared.

[0096] Case 3: Mild breast hyperplasia Patient Information: Ms. Wang, female, 30 years old, married, teacher, experiencing bilateral breast tenderness for 3 months. Diagnosis: Breast hyperplasia (bilateral, mild).

[0097] Treatment: Apply the plaster prepared in Example 1 to the areas of most severe pain on both sides of the breast. Apply one plaster every 3 days and change it every 72 hours.

[0098] Results: After applying 2 patches, the pain was significantly relieved; after applying 4 patches, the swelling and pain symptoms basically disappeared.

[0099] Case 4: Moderate breast hyperplasia with nodule formation Patient Information: Ms. Zhao, female, 42 years old, married, farmer. She has had a lump and pain in her left breast for 6 months. Diagnosis: Breast hyperplasia (bilateral, moderate); hyperplastic nodules in the left breast. Treatment: Apply the plaster prepared in Example 1 to the area of ​​most severe pain in the left breast. Apply one plaster every 3 days and change it every 72 hours.

[0100] Results: After applying 3 patches, the swelling and pain were significantly relieved; after applying 6 patches, the pain symptoms were significantly relieved, and the patient reported that the nodules felt better.

[0101] Case 5: Acute mastitis with abscess Patient Information: Ms. Liu, female, 25 years old, married, farmer. She has experienced swelling and pain in her left breast for 5 days.

[0102] Diagnosis: Acute lactational mastitis (left side); left breast abscess Treatment: Apply the plaster prepared in Example 1 to the area of ​​most severe pain in the left breast. Apply one plaster every 3 days and change it every 72 hours.

[0103] Results: After applying one patch, the swelling and pain were significantly relieved; after applying six patches, the pain symptoms basically disappeared, and the signs of abscess gradually decreased.

[0104] Case 6: Breast hyperplasia Patient Information: Ms. Chen, female, 38 years old, married, accountant. She has experienced bilateral breast tenderness for one year.

[0105] Diagnosis: Breast hyperplasia (bilateral); Treatment: Apply the plaster prepared in Example 1 to the areas of most severe pain on both sides of the breast. Apply one plaster every 3 days and change it every 72 hours.

[0106] Results: After applying 2 patches, the pain was significantly relieved; after applying 6 patches, the swelling and pain symptoms basically disappeared.

[0107] Case 7: Chronic mastitis Patient Information: Ms. Zhou, female, 45 years old, married, farmer. She has had a lump in her right breast with dull pain for one year.

[0108] Diagnosis: Chronic mastitis (right side) Treatment: Apply the plaster prepared in Example 1 to the area of ​​most severe pain in the right breast. Apply one plaster every 3 days and change it every 72 hours.

[0109] Results: After applying 3 patches, the swelling and pain were significantly relieved; after applying 6 patches, the pain symptoms basically disappeared and the lump signs were significantly reduced.

[0110] Case 8: Severe fibrocystic breast disease with significant breast tenderness Patient Information: Ms. Wu, female, 35 years old, married, farmer. She has experienced persistent bilateral breast tenderness for 2 years, affecting her daily life.

[0111] Diagnosis: Breast hyperplasia (bilateral, severe) Treatment: Apply the plaster prepared in Example 1 to the areas of most severe pain on both sides of the breast. Apply one plaster every 3 days and change it every 72 hours.

[0112] Results: After applying 3 patches, the pain was relieved; after applying 8 patches, the swelling and pain symptoms were significantly reduced.

[0113] Case 9: Acute mastitis Patient Information: Ms. Zheng, female, 32 years old, farmer. She has experienced redness, swelling, and pain in her right breast for 4 days, and fever for 2 days.

[0114] Diagnosis: Acute mastitis Treatment: Apply the plaster prepared in Example 1 to the area of ​​most severe pain on the right side of the breast. Apply one plaster every 3 days and change it every 72 hours.

[0115] Results: After applying 2 patches, the pain was significantly relieved; after applying 4 patches, the redness, swelling and pain symptoms basically disappeared.

[0116] Case 10: Lumbar disc herniation Patient Information: Zhao, male, 38 years old, construction worker. A few days ago, he suddenly experienced lower back pain after lifting heavy objects, accompanied by radiating pain in his right lower limb for 5 days.

[0117] Diagnosis: Lumbar disc herniation (L4-L5, right side, acute phase) Treatment: Apply the plaster prepared in Example 1 to the tender points beside the spinous processes of L4 / L5 and the Huantiao acupoint on the lower back. Apply one plaster every 3 days and change it every 72 hours.

[0118] Results: After applying 3 patches, the lower back and leg pain was significantly reduced; after applying 6 patches consecutively, the pain symptoms basically disappeared, and mobility was restored. No recurrence was observed during a one-month follow-up.

[0119] Case 11: Acute lumbar sprain Patient Information: Ms. Sun, female, 26 years old. The patient accidentally missed a step while going down the stairs in high heels, and suddenly experienced severe, stabbing pain in her lower back. She was unable to bend over or turn around, and needed assistance to stand and walk. After 3 hours of lower back pain, her mobility was limited.

[0120] Diagnosis: Acute lumbar sprain (left paraspinal muscle injury) Treatment: Apply the plaster prepared in Example 1 to the most painful area of ​​the lower back. Apply one plaster every 3 days and change it every 72 hours.

[0121] Results: After applying 2 patches, the lower back pain was significantly reduced; after applying 4 patches consecutively, the pain symptoms basically disappeared, and the patient could move freely.

[0122] Case 12: Chronic lumbar muscle strain Patient Information: Zhou, male, 45 years old, truck driver. He has experienced recurrent lower back pain for 2 years.

[0123] Diagnosis: Chronic lumbar muscle strain; Treatment: Apply the plaster prepared in Example 1 to the most painful area of ​​the lower back. Apply one plaster every 3 days and change it every 72 hours.

[0124] Results: After applying 3 patches, the lower back pain was significantly reduced; after applying 7 patches consecutively, the pain symptoms basically disappeared, and daily activity ability was significantly improved.

[0125] Case 13: Knee osteoarthritis (moderate to severe) Patient Information: Ms. Chen, 62 years old. Bilateral knee pain for 3 years, limited mobility for 6 months.

[0126] Diagnosis: Bilateral knee osteoarthritis Treatment: Apply the plaster prepared in Example 1 to the painful areas of both knees. Apply one plaster every 3 days and change it every 72 hours.

[0127] Results: After applying 5 patches, the pain was significantly reduced; after applying 9 patches consecutively, the pain symptoms were significantly reduced.

[0128] Case 14: Neck stiffness and pain Patient information: Ms. Li, 32 years old, has been experiencing stiffness and pain in her neck and shoulders for 1 month and limited head turning for 3 days.

[0129] Diagnosis: Myofascitis of the neck and shoulder; Treatment: Apply the plaster prepared in Example 1 to the area of ​​neck pain. Apply one plaster every 3 days and change it every 72 hours.

[0130] Results: After applying 2 patches, the pain was significantly reduced; after applying 6 patches consecutively, the pain symptoms basically disappeared.

[0131] Case 15: Acute ankle sprain Patient Information: Wang, male, 19 years old, student. The patient sprained his right ankle while playing basketball. His right ankle was swollen and painful for 4 hours after the sprain, and his mobility was limited.

[0132] Diagnosis: Acute sprain of the right ankle joint Treatment: Apply the plaster prepared in Example 1 to the sprained and painful area of ​​the right ankle. Apply one plaster every 3 days and change it every 72 hours.

[0133] Results: After applying 3 patches, the pain was significantly reduced; after applying 6 patches consecutively, the pain symptoms basically disappeared.

[0134] Case 16: Lumbar muscle strain complicated by lumbar disc herniation (chronic phase) Patient information: Zhang, male, 52 years old, farmer, has suffered from lower back pain for 5 years and numbness in his left lower limb for 3 months.

[0135] Diagnosis: Lumbar disc herniation; Treatment: Apply the plaster prepared in Example 1 to the tender points beside the spinous processes of L4 / L5 and the Huantiao acupoint on the lower back. Apply one plaster every 3 days and change it every 72 hours.

[0136] Results: After applying 6 patches, the pain in the lower back and legs was significantly reduced; after applying 9 patches consecutively, the pain symptoms were effectively relieved and the limitation of movement was significantly improved.

[0137] Case 17: Periarthritis of the shoulder (frozen shoulder) Patient Information: Ms. Wu, female, 55 years old. She has experienced right shoulder pain for 6 months, which worsens at night (affecting her sleep). Diagnosis: Periarthritis of the right shoulder (painful phase) Treatment: Apply the plaster prepared in Example 1 to the painful area of ​​the right shoulder joint. Apply one plaster every 3 days and change it every 72 hours.

[0138] Results: After applying 2 patches, the pain was significantly reduced; after applying 6 patches consecutively, the pain symptoms basically disappeared.

[0139] Case 18: Knee synovitis (with joint swelling and pain) Patient Information: Zhao, male, 28 years old. The patient experienced swelling and pain in his left knee after accidentally impacting it while playing basketball, which worsened after activity.

[0140] Diagnosis: Traumatic synovitis of the left knee joint Treatment: Apply the plaster prepared in Example 1 to the painful area of ​​the right knee joint. Apply one plaster every 3 days and change it every 72 hours.

[0141] Results: After applying 3 patches, the pain was significantly reduced; after applying 6 patches consecutively, the pain symptoms basically disappeared.

[0142] Case 19: Lumbar disc herniation Patient Information: Mr. Yang, male, 42 years old. He has a history of lower back pain with radiating pain in his right lower extremity for one year, due to long-term manual labor. MRI showed L4 / L5 disc herniation.

[0143] Diagnosis: Lumbar disc herniation (Qi stagnation and blood stasis type).

[0144] Treatment: Apply the plaster prepared in Example 1 to the tender points beside the spinous processes of L4 / L5 and the Huantiao acupoint on the lower back. Apply one plaster every 3 days and change it every 72 hours.

[0145] Results: After applying 3 patches, the lower back and leg pain was significantly reduced; after applying 6 patches consecutively, the pain symptoms were significantly relieved, and the limitation of movement was significantly improved. No recurrence was observed during the follow-up one month later.

[0146] Case 20: Chronic mastitis Patient Information: Ms. Li, female, 35 years old. She has experienced bilateral breast swelling and stabbing pain for 1.5 years due to emotional distress, with nodules palpable. Ultrasound showed chronic mastitis. Diagnosis: Mastitis (liver qi stagnation, blood stasis obstructing the collaterals type).

[0147] Treatment: Apply the plaster prepared in Example 1 to the area of ​​most severe pain in both breasts. Apply one plaster every 3 days and change it every 72 hours.

[0148] Results: After applying one patch, the swelling and pain were relieved; after applying three patches, the pain symptoms were significantly relieved, and the patient reported that the nodules felt better to the touch.

[0149] The above embodiments are preferred embodiments of the present invention, but the embodiments of the present invention are not limited to the above embodiments. Any changes, modifications, substitutions, combinations, or simplifications made without departing from the spirit and principle of the present invention shall be considered equivalent substitutions and shall be included within the protection scope of the present invention.

Claims

1. A topical traditional Chinese medicine composition, characterized in that, Made from the following ingredients in parts by weight: 4-6 parts of Schizonepeta tenuifolia, 4-6 parts of Saposhnikovia divaricata, 4-6 parts of Clematis chinensis, 4-6 parts of Angelica dahurica, 4-6 parts of Carthamus tinctorius, 4-6 parts of Achyranthes bidentata, 4-6 parts of Paeonia lactiflora, 4-6 parts of Angelica sinensis, 4-6 parts of Citrus reticulata peel, 4-6 parts of Boswellia carterii, 4-6 parts of Commiphora myrrha, 2-8 parts of Lemna minor, 2-8 parts of dried river shrimp, 30-40 parts of Litharge, and 70-90 parts of sesame oil.

2. The topical traditional Chinese medicine composition according to claim 1, characterized in that, Made from the following ingredients in parts by weight: 5 parts of Schizonepeta tenuifolia, 5 parts of Saposhnikovia divaricata, 5 parts of Clematis armandii, 5 parts of Angelica dahurica, 5 parts of Carthamus tinctorius, 5 parts of Achyranthes bidentata, 5 parts of Paeonia lactiflora, 5 parts of Angelica sinensis, 5 parts of Citrus reticulata peel, 5 parts of Boswellia carterii, 5 parts of Commiphora myrrha, 3-5 parts of Lemna minor, 3-5 parts of dried river shrimp, 35 parts of red lead, and 80 parts of sesame oil.

3. A topical black plaster, characterized in that, It is prepared from the traditional Chinese medicine composition according to claim 1 or 2.

4. The method for preparing the external black plaster according to claim 3, characterized in that, The method includes the following steps: (1) Prepare medicinal oil: Place Schizonepeta, Saposhnikovia divaricata, Clematis armandii, Angelica dahurica, Carthamus tinctorius, Achyranthes bidentata, Paeonia lactiflora, Angelica sinensis, Citrus reticulata, Boswellia carterii, Commiphora myrrha, Lemna minor, and dried river shrimp in sesame oil and fry over low heat until the herbs are golden brown. Filter out the dregs to obtain medicinal oil. (2) Refining oil and adding cinnabar to form ointment: Continue to simmer the filtered medicinal oil over a low flame until it sinks into cold water in the form of round beads and feels hard to the touch. Then add cinnabar and stir continuously until a black and shiny ointment is formed. (3) Remove heat toxins: Eliminate irritating components through cold water soaking process; (4) Spreading and shaping: Heat the plaster after removing the fire poison and melt it, then spread it on the backing material to obtain the finished external black plaster.

5. The use of the external Chinese medicine composition of claim 1 or the external black plaster of claim 3 in the preparation of a medicine for treating painful diseases caused by qi stagnation and blood stasis and meridian obstruction.

6. The application according to claim 5, characterized in that, The disease is soft tissue injury or bone and joint disease.

7. The application according to claim 6, characterized in that, The soft tissue injury is selected from mastitis, breast hyperplasia, acute sprain, or sprain.

8. The application according to claim 6, characterized in that, The bone and joint diseases mentioned are selected from lumbar disc herniation, lumbar sprain, lumbar muscle strain, arthritis or cervical spondylosis.

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