A Chinese medicine composition for treating lateral epicondylitis and / or sterno-clavicular arthritis, a preparation method and application thereof, and a Chinese medicine preparation

Abstract

The present invention relates to a Chinese medicine composition for treating lateral epicondylitis and / or sterno-clavicular arthritis, its preparation method and application, and a Chinese medicine preparation, belonging to the technical field of Chinese medicine. The Chinese medicine composition provided by the present invention is obtained by extracting raw materials including the following components in parts by weight: 5-6 parts of Bupleurum chinense, 3-4 parts of Picrorhizoma Coptidis, 5-7.5 parts of Rhizoma Anemarrhenae, 6-7.5 parts of Carapax Trionycis, 5-6 parts of Artemisia Annua, 5-6 parts of Cortex Lycii, 5-6 parts of Gentiana Macrophyllae, 7.5-15 parts of Morus Ramulus, 6-7.5 parts of Angelica Sinensis, 5-7.5 parts of Paeonia lactiflora, 7.5-15 parts of Salvia miltiorrhiza, 4-5 parts of Carthamus tinctorius, and 3-4 parts of Licorice. The present invention is mainly directed to lateral epicondylitis and sterno-clavicular arthritis caused by chronic strain, and has good therapeutic effect, rapid onset of action, short course of treatment, safe medication, and no obvious toxic and side effects. One prescription can be used for multiple purposes and can effectively treat the above-mentioned two types of arthritis.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition for treating lateral epicondylitis and / or sterno-clavicular arthritis, a preparation method and application thereof, and a traditional Chinese medicine preparation, belonging to the technical field of traditional Chinese medicine. Background Art

[0002] Lateral epicondylitis (commonly known as "tennis elbow") is a chronic overuse disease characterized by localized pain in the lateral epicondyle of the humerus, impairing wrist extension and forearm rotation. According to the book "Traditional Chinese Medicine Traumatology" (New Century, Fifth Edition, China Traditional Chinese Medicine Press), its diagnosis is as follows: It develops slowly, initially with occasional soreness and pain on the lateral side of the elbow during exertion or certain movements, which subsides with rest. As the condition worsens, the pain intensifies with actions such as wringing a towel, sweeping the floor, or pouring water from a kettle, leading to forearm weakness and even the dropping of held objects. Over time, the pain becomes persistent and can radiate to the upper arm and forearm, interfering with limb movement.

[0003] Sternoclavicular arthritis does not have a completely corresponding independent disease name in traditional Chinese medicine theory. It is mainly manifested by pain and tenderness in the sternoclavicular joint area, which worsens with breathing and coughing, especially when the shoulders or upper limbs move.

[0004] In Traditional Chinese Medicine Traumatology (New Century, Fifth Edition, China Traditional Chinese Medicine Press), lateral epicondylitis is classified as a "muscle injury," specifically an "elbow muscle injury" (chronic strain muscle injury). Sternoclavicular arthritis is also included in this category, but the name "sterno-clavicular arthritis" is not directly mentioned in the textbook. A review of the "General Introduction to Muscle Injuries" and its discussion of specific joint injuries reveals only diagnostic criteria for each of these two types of arthritis, without a clear, unified syndrome classification.

[0005] These two types of arthritis should be differentiated from the following diseases: congenital malformations and abnormalities of the anatomical structure; certain chronic inflammations; fractures, joint dislocations; autoimmune diseases; bone tuberculosis, bone tumors and other bone and joint diseases.

[0006] For these two types of arthritis, Western medicine uses oral non-steroidal anti-inflammatory drugs, local blockade or surgical treatment. These methods only treat the symptoms and not the root cause, and may cause gastrointestinal discomfort or increase surgical pain. Some patients with chronic pain that does not heal for a long time are prone to mental problems such as depression and anxiety, and then need to take anti-anxiety and antidepressant drugs.

[0007] Traditional Chinese medicine adopts the following therapies: tendon regulation, fixation, qigong exercises, acupuncture, internal and external medications. Among them, in terms of internal Chinese medicine, "Chinese Orthopedics" (New Century Fifth Edition, China Traditional Chinese Medicine Press): ① In the "Introduction to Tendon Injury", the internal medicines for "tendon injury and chronic tendon injury" are mainly to nourish blood and meridians, nourish the liver and kidneys, strengthen tendons and bones, and dispel wind and relieve numbness. Dahuo Luo Dan, Xiaohuo Luo Dan, Duhuo Jishe Tang, Bushen Zhuangjin Tang, Magui Wenjing Tang, etc. are often used; ② In elbow tendon injuries, the drug treatment for "lateral humeral epicondylitis" is to nourish blood and strengthen tendons, relax tendons and activate meridians, and take Huoxue Tang and Shujin Tang internally.

[0008] A Chinese patent application (publication number CN103611134A) discloses a plaster for treating periostitis. The formula includes the following ingredients: safflower, ginger, scorpion root, silkworm, dipsaci root, acanthopanax bark, Chuanwu root, aconite root, Eupolyphaga sinensis root, Achyranthes bidentata root, frankincense, myrrh, asarum root, borneol, dragon's blood, red peony root, cinnamon bark, phellodendron, Chuanxiong root, Lycium bark, yellow ochre, and sesame oil. The formula focuses on relaxing muscles and promoting blood circulation, reducing swelling and pain, promoting blood circulation and dispersing blood stasis, and dispelling wind and cold. It is a plaster preparation.

[0009] A Chinese patent (publication number CN101647876A) discloses an antiviral compound Chinese medicine and its preparation. The compound medicine is composed of Aconitum kusnezoffii, Scorpio, Mylabris, Scolopendra, Coptis chinensis, Bombyx batryticatus, and Polygonum multiflorum. The formula has significant effects on lumps, periostitis, breast tumors, carbuncles, and malignant sores, and is especially effective for various carbuncles and malignant sores. According to the "Background Technology" description, most clinical manifestations are redness, swelling, carbuncles, abnormal pain, and yellow-white "pus heads" on the surface of carbuncles. The formula is used to treat a type of excess heat syndrome and superficial symptoms, among which the treatment of periostitis is for the treatment of infectious periostitis.

[0010] A Chinese patent application (publication number CN104000945A) discloses a traditional Chinese medicine for treating sports fatigue periostitis and its preparation method, which includes the following raw materials: white peony root, licorice, motherwort, angelica, ginseng, astragalus, wolfberry, Panax notoginseng, earthworm, silkworm, processed frankincense, processed myrrh, catechu, Achyranthes bidentata, and rhubarb. The formula focuses on nourishing blood, promoting blood circulation, removing blood stasis, unblocking meridians, and relieving pain. The preparation is preferably in the form of pills.

[0011] A Chinese patent application (publication number CN103191211A) discloses a traditional Chinese medicine for treating lateral epicondylitis. The formula is composed of the following raw materials by weight: 10g of Aconite Root, 10g of Herba Lycopodii, 10g of Radix Angelicae Sinensis, 10g of Carthamus Tinctorius, 10g of Herba Coptidis, 10g of Cinnamomum cassiae, 6g of Paeonia lactiflora, 6g of Millettia Spatholobi, 10g of Herba Centipediae, 10g of Pittosporum tobira, 10g of Caulis Trachelospermi, 10g of Caulis Lonicerae, and 10g of Geranium Herba. This formula is intended for treating internal cold syndrome. Summary of the Invention

[0012] In response to the aforementioned problems in the prior art, one of the objectives of the present invention is to provide a traditional Chinese medicine composition for treating lateral epicondylitis and / or sterno-clavicular arthritis. The present invention is primarily directed at treating lateral epicondylitis and sterno-clavicular arthritis caused by chronic strain, and exhibits excellent efficacy with rapid onset, a short treatment course, safe use, and no significant toxic or side effects. This single composition can be used for multiple purposes, effectively treating both types of arthritis.

[0013] A second object of the present invention is to provide a method for preparing a Chinese medicine composition.

[0014] A third object of the present invention is to provide a Chinese medicine composition for use in treating lateral epicondylitis and / or sterno-clavicular arthritis.

[0015] A fourth object of the present invention is to provide a Chinese medicine preparation for treating lateral epicondylitis and / or sterno-clavicular arthritis.

[0016] In order to achieve the above-mentioned objectives, the first aspect of the present invention is to provide a traditional Chinese medicine composition for treating lateral epicondylitis and / or sterno-clavicular arthritis, which is extracted from raw materials including the following components in parts by weight: 5-6 parts of Bupleurum chinense, 3-4 parts of Picrorhizoma Coptidis, 5-7.5 parts of Anemarrhena Rhizoma, 6-7.5 parts of Carapax Trionycis, 5-6 parts of Artemisia annua, 5-6 parts of Rehmannia glutinosa, 5-6 parts of Gentiana macrophylla, 7.5-15 parts of Morus alba, 6-7.5 parts of Angelica sinensis, 5-7.5 parts of Paeonia lactiflora, 7.5-15 parts of Salvia miltiorrhiza, 4-5 parts of Carthamus tinctorius, and 3-4 parts of Licorice.

[0017] In the present invention, lateral epicondylitis and sterno-clavicular arthritis are mainly caused by chronic strain, and are mainly manifested by the following symptoms: localized pain and dysfunction of the joints, accompanied by some symptoms of liver and kidney yin deficiency (such as dry mouth, constipation, irritability, insomnia, soreness of the waist and knees, red tongue with little coating, thin pulse, etc., but without obvious typical yin deficiency symptoms of fever in the five hearts, night heat and morning coolness, and bone steaming and fatigue fever). The course of the disease is relatively long, ranging from more than a month to several months or even years.

[0018] Chronic tendon injuries have a long course, a complex pathogenesis (not a single one), and deep-seated pathogenic factors. This treatment, combined with the holistic approach of "clearing latent heat and nourishing yin fluid" while simultaneously "activating blood circulation, removing blood stasis, dredge menstruation, and alleviating pain," can resolve the condition. This treatment, guided by the principles of "clearing latent heat, nourishing yin fluid, activating blood circulation, removing blood stasis, dredge menstruation, and alleviating pain," falls within the realm of "different treatments for the same disease."

[0019] In the present invention, the pain level adopts the VAS pain scoring standard.

[0020] The VAS (Visual Analog Scale) pain score is a visual assessment method that quantifies pain intensity and is commonly used in clinical practice and research. The core principle is to have the patient mark the degree of pain on a 10-centimeter line (0 = no pain, 10 = excruciating pain). Medical staff then measure the position of the mark and convert it into a specific score, objectively recording the subjective experience.

[0021] The specific operation method is to draw a line on a piece of white paper. The first end of the line is the number 0, which means the patient has no pain; the other end of the line is the number 10, which means severe pain that is unbearable. Ask the patient to make a note on this line according to his or her pain feeling to record the degree of pain. Based on the patient's subjective feelings, the VAS pain scoring standard stipulates the degree of pain as follows:

[0022] 1. 0 points: The patient does not feel any pain.

[0023] 2. Below 3 points: The patient has mild pain, but it is still tolerable.

[0024] 3. 4-6 points: The patient has obvious pain, which affects the quality of sleep, but is still tolerable.

[0025] 4. 7-10 points: The patient experiences severe pain that is unbearable and affects sleep quality and appetite.

[0026] As a preferred solution, when the patient's VAS pain score is 1-4 points, but not including 4 points, the raw materials include the following components by weight: 5-6 parts of Bupleurum chinense, 3-4 parts of Picrorhizoma Coptidis, 5-6 parts of Anemarrhena Rhizoma, 6-7.5 parts of Carapax Trionycis, 5-6 parts of Artemisia annua, 5-6 parts of Lycium bark, 5-6 parts of Gentiana macrophylla, 7.5-10 parts of Morus alba, 6-7.5 parts of Angelica sinensis, 5-6 parts of Red Peony Root, 7.5-10 parts of Salvia miltiorrhiza, 4-5 parts of Carthamus tinctorius, and 3-4 parts of Licorice.

[0027] As a preferred solution, when the patient's VAS pain score is 4-10 points, including 4 points, the dosage of Anemarrhena Rhizoma, Morus Albizia, Paeonia lactiflora and Salvia miltiorrhiza is increased.

[0028] As a more preferred scheme, when the patient's VAS pain score is 4-10 points, including 4 points, the raw materials include the following components by weight: 5-6 parts of Bupleurum chinense, 3-4 parts of Coptis chinensis, 7-7.5 parts of Anemarrhena asphodeloides, 6-7.5 parts of Carapax tricolor, 5-6 parts of Artemisia annua, 5-6 parts of Lycium bark, 5-6 parts of Gentiana macrophylla, 12-15 parts of Morus alba, 6-7.5 parts of Angelica sinensis, 6.5-7.5 parts of Paeonia lactiflora, 12-15 parts of Salvia miltiorrhiza, 4-5 parts of Carthamus tinctorius, and 3-4 parts of Licorice.

[0029] The second aspect of the present invention provides a method for preparing a Chinese medicine composition, comprising the following steps: mixing the raw materials described in the first aspect, soaking them in water, and then decocting and extracting them to obtain a medicinal solution.

[0030] As a preferred solution, when soaking in water, the soaking time is 30 to 50 minutes and the amount of water added is 6 to 8 times the total weight of the Chinese medicine raw materials.

[0031] As a preferred solution, when decocting, bring to a boil over high heat and simmer over low heat for 60 to 70 minutes.

[0032] As a preferred solution, the water decoction is performed 2 to 3 times, with each decoction being performed until the decoction liquid is 180 to 220 mL, and the decoction liquids from each decoction are combined as the medicinal solution.

[0033] The third aspect of the present invention provides use of the traditional Chinese medicine composition described in the first aspect in preparing a traditional Chinese medicine preparation for treating lateral epicondylitis and / or sterno-clavicular arthritis.

[0034] The fourth aspect of the present invention provides a traditional Chinese medicine preparation for treating lateral epicondylitis and / or sterno-clavicular arthritis, comprising the traditional Chinese medicine composition described in the first aspect and pharmaceutically acceptable excipients.

[0035] As a preferred embodiment, the Chinese medicine preparation is in the form of granules, powders, decoctions, pills, tablets, capsules, mixtures or syrups.

[0036] Specifically, the medicinal properties and effects of the raw materials selected in the Chinese medicine composition provided by the present invention are as follows:

[0037] Bupleurum chinense: Sweet, slightly cold. Enters the Liver and Stomach meridians. Benefits: Clears heat from internal organs and relieves malnutrition fever.

[0038] Picrorhizome: Bitter and cold. Enters the Liver, Stomach, and Large Intestine meridians. Benefits: Reduces fever due to deficiency, eliminates malnutrition fever, and clears damp-heat.

[0039] Anemarrhena: Bitter, sweet, and cold. Actively affects the lungs, stomach, and kidneys. Benefits: Clears heat and purges fire, nourishes yin and moistens dryness.

[0040] Turtle Shell: Salty, slightly cold. Enters the Liver and Kidney meridians. Benefits: Nourishes Yin and suppresses Yang, reduces fever, relieves steaming, softens and disperses lumps.

[0041] Artemisia annua: Bitter, pungent, and cold. Enters the Liver and Gallbladder Meridians. Efficacy: Clears heat from internal organs, relieves bone steaming, relieves summer heat, stops malaria, and reduces jaundice.

[0042] Rehmannia root bark: Sweet, cold. Enters the lung, liver, and kidney meridians. Efficacy: Cools blood, eliminates steam, clears the lungs, and reduces internal heat.

[0043] Gentiana macrophylla: Pungent, bitter, neutral. Enters the stomach, liver, and gallbladder meridians. Efficacy: Dispels rheumatism, clears damp heat, relaxes tendons and meridians, relieves pain, and reduces damp heat.

[0044] Mulberry Branch: Slightly bitter, neutral. Enters the Liver Meridian. Benefits: Relieves rheumatism and benefits joints.

[0045] Angelica: Sweet, pungent, and warm. It enters the Liver, Heart, and Spleen meridians. Benefits: tonifies blood, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements.

[0046] Red Peony Root: Bitter, slightly cold. Enters the Liver Meridian. Efficacy: Clears heat, cools blood, disperses blood stasis, and relieves pain.

[0047] Salvia miltiorrhiza: Bitter, slightly cold. Enters the Heart and Liver meridians. Benefits: Promotes blood circulation and dispels blood stasis, promotes menstruation and relieves pain, clears the heart and relieves restlessness, cools blood and eliminates carbuncle.

[0048] Safflower: Pungent and warm. Enters the Heart and Liver meridians. Benefits: Promotes blood circulation, dredges meridians, dissipates blood stasis, and relieves pain.

[0049] Licorice: Sweet and neutral. Enters the Heart, Lung, Spleen, and Stomach meridians. Benefits: Tonifies the spleen and replenishes Qi, clears heat and detoxifies, eliminates phlegm and relieves cough, relieves pain, and harmonizes various medicinal ingredients.

[0050] The preparation methods of the above-mentioned medicines are all made in accordance with the 1983 edition of "Hunan Province Traditional Chinese Medicine Processing Standards" compiled by the Hunan Provincial Health Department and published by Hunan Science and Technology Press.

[0051] The principle of medication is as follows:

[0052] Based on the "Diagnostic Key Points" outlined in Traditional Chinese Medicine Traumatology (New Century, Fifth Edition, China Traditional Chinese Medicine Press), this paper innovatively proposes three stages of pathogenesis for lateral epicondylitis, from the most superficial to the most advanced. The first stage involves "Qi stagnation and blood stasis," leading to "pain due to obstruction." This stage presents with a slow onset, characterized by occasional soreness and pain on the lateral side of the elbow during exertion or certain movements. Because the discomfort symptoms in this stage can be relieved after rest, patients tend to ignore the necessity of "seeking medical treatment and taking medicine", and the disease slowly progresses to the next stage; the second stage: "liver and kidney yin deficiency", due to long-term damage, the qi and blood are depleted, leading to liver and kidney deficiency, yin fluid loss, and lack of nourishment of the tendons and veins. On the basis of "pain due to obstruction", "pain due to lack of nourishment" is triggered, and at this stage, the localized pain in the lateral epicondyle of the humerus is aggravated, and the weakness and dysfunction of the forearm are aggravated, accompanied by symptoms such as dry mouth, constipation, irritability, insomnia, soreness of the waist and knees, red tongue with little coating, and thin pulse. If the pathogenesis is not reversed in time, the disease may progress to the next stage; the third stage: "yin-based latent heat, nutrient blood stasis", because the yin fluid is continuously depleted, the virtual heat is endogenous, the heat evil is deeply hidden between the tendons and bones, the stagnation of qi and blood is further aggravated, and the nourishment of the tendons and veins is even more scarce, which makes the localized pain in the lateral epicondyle of the humerus become persistent and can radiate to the upper arm or forearm, affecting limb movement. This type of heat evil often lurks deep, and the symptoms are relatively hidden. To a certain extent, there is a phenomenon of disparity between the pathogenesis and symptoms (such as dry mouth, constipation, irritability, insomnia, soreness of waist and knees, red tongue with little coating, and thin pulse, but no obvious typical symptoms of yin deficiency such as fever in the five hearts, night heat and morning coolness, and bone steaming and fatigue fever. When in this pathogenesis, based on the clinical manifestations of yin deficiency, it is mistakenly believed that the loss of yin fluid is relatively mild, that is, it has not reached the level of "bone steaming and fatigue fever" where yin deficiency internal heat and evil heat are deeply trapped, so the "Six Flavors" are used. The use of "Liuwei Dihuang Decoction" to nourish yin and clear heat has had little effect. In some patients, the condition has even worsened. This is because, in the presence of the coexisting pathogenesis of "qi stagnation and blood stasis" and "latent heat in the yin and stasis of the nutrient blood," "Liuwei Dihuang Decoction" has a nourishing and greasy effect, increasing the viscosity of the blood and hindering the flow of qi and blood. This heat evil has penetrated deeply and is beyond the level that "Liuwei Dihuang Decoction" can resolve. This has caused great trouble for clinical diagnosis and treatment, and is also the "crux" of the disease that makes it difficult to cure.

[0053] The present invention has four innovative points in syndrome differentiation and treatment, which are described as follows in combination with its medication principles:

[0054] (1) Starting from the overall dialectical thinking, we carefully identify the depth of the invasion of pathogenic factors and determine the pathogenesis of "hidden heat in the yin division and stasis of blood circulation", rather than mistakenly thinking that it is only in the state of "initial deficiency of yin fluid and initial generation of deficiency heat" as the manifestation of "liver and kidney yin deficiency". This type of heat evil is often latent and the condition is lingering, and the symptoms are relatively hidden. Although the patient did not have the phenomenon of "bone steaming and fatigue fever", the present invention attempted to use the prescription for treating "bone steaming and fatigue fever" (silver bupleurum, coptis chinensis, anemarrhena, turtle shell, artemisia annua, radix rehmanniae, and gentiana macrophylla) (from "Zhengzhi Zhunsheng") to treat the pathogenic heat problem in this pathogenesis, and achieved good therapeutic effects. After being widely used in clinical practice, its efficacy has been confirmed. The principle of its use is as follows: Because the pathogenic heat has deeply sunk into the yin, only turtle shell can guide the other herbs into the yin, relying on Artemisia annua and Gentiana macrophylla to penetrate the latent heat in the yin. The seven herbs, namely, Bupleurum chinense, Coptis chinensis, Anemarrhena asphodeloides, and Rehmannia root, which all belong to different meridians, work together to clear the deficiency heat from different meridians. This treatment effectively removes the firewood from under the cauldron, protecting the yin fluid from further burns. Simultaneously, turtle shell and Anemarrhena asphodeloides nourish the yin fluid, and in conjunction with the blood-tonifying effect of Angelica sinensis in the present invention, this nourishes the yin fluid, thereby significantly reducing blood viscosity. Gentiana macrophylla also protects against the onset of wind and dampness. These seven herbs work together to resolve the pathogenesis of "latent heat in the yin," and serve as the monarch drug in the entire prescription.

[0055] (2) The present invention adopts a two-pronged treatment method that takes into account both "clearing away latent heat and nourishing yin fluid" and "activating blood circulation, removing blood stasis, promoting menstruation and relieving pain", thereby solving the pathogenesis of "pain due to lack of nourishment" and "pain due to obstruction" at the same time. The prescription for treating "bone steaming and fatigue fever" not only clears latent heat and nourishes yin fluid, but also utilizes angelica root to replenish blood and activate blood circulation; red peony root to clear heat, cool blood, dissipate blood stasis and relieve pain; safflower to activate blood circulation and dredge collaterals, dissipate blood stasis and relieve pain; and mulberry branch to guide the herbs upward to the upper limbs and effectively open up the meridians and joints. Building on these blood-activating, blood-stasis-removing, and menstrual-unblocking properties, to further boost blood circulation, salvia miltiorrhiza is used. Its slightly cold nature enters the heart and liver, and its nature is good for circulation. As the "heart governs blood vessels," it increases the driving force behind blood circulation and improves systemic blood circulation. It also clears the heart, cools blood, relieves restlessness and calms the mind, making it very beneficial for patients with restlessness and insomnia. The synergy of these herbs effectively "activates blood circulation, dispels pain, unblocks menstruation and relieves pain." These five herbs serve as assistant herbs in the prescription. Licorice harmonizes the other herbs.

[0056] (3) The formula uses two meridian-guiding herbs, "mulberry branch" and "turtle shell." Mulberry branch can guide the herbs to the upper limbs, while turtle shell guides the herbs into the yin part. These two meridian-guiding herbs, each performing their own functions and coordinating with each other, allow the herbs to reach the affected area directly and exert their maximum efficacy. These two herbs serve as adjuvants in the formula.

[0057] (4) The present invention can be used for multiple purposes and treat different diseases with the same prescription. This is mainly because: ① Lateral epicondylitis and sterno-clavicular arthritis both belong to the category of "chronic tendon injury". The movement of the upper limbs affects the movement of these two joints at the same time. However, the sternoclavicular joint is a micro-motion joint, and its incidence of arthritis is much lower than that of lateral epicondylitis. ② According to meridian differentiation: a. "Where the meridian passes, the main treatment is reached". The lateral epicondylitis is where the large intestine meridian and the lung meridian pass through, and the lung meridian passes through the supraclavicular fossa. b. According to the theories of "the liver governs the tendons, the kidney governs the bones, the liver stores blood, the kidney stores essence, and the liver and kidney are of the same origin" and "the liver and gallbladder are exterior and interior", these two types of arthritis have great similarities in the selection of the meridians of the drugs. For example, most of the drugs selected by the present invention belong to the lung, large intestine, liver, gallbladder, and kidney meridians. In summary, the present invention has laid a solid theoretical foundation for using the same prescription to treat these two types of arthritis under the same etiology and pathogenesis. DETAILED DESCRIPTION

[0058] The endpoints of the ranges and any values ​​disclosed herein are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoints of each range, the endpoints of each range and individual point values, and the individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered to be specifically disclosed herein.

[0059] The present invention is further described below with reference to specific embodiments, but the scope of protection of the present invention is not limited to the following specific embodiments. Obviously, the embodiments described below are only a part of the embodiments, and all other embodiments obtained by professionals in this field without making creative efforts are still within the scope of protection of the present invention.

[0060] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0061] Example 1 (VAS pain score: 1-4 points, excluding 4 points)

[0062] Prescription: Bupleurum chinense 12g, Coptis chinensis 8g, Anemarrhena asphodeloides 12g, Carapax tricolor 15g, Artemisia annua 12g, Rehmannia root bark 12g, Gentiana macrophylla 12g, Morus alba 15g, Angelica sinensis 15g, Paeonia lactiflora 12g, Salvia miltiorrhiza 20g, Carthamus tinctorius 10g, Licorice root 6g.

[0063] Preparation method: Mix the above raw materials, add cold water (7 times the total weight of the raw materials), soak for 30 minutes, bring to a boil over high heat, simmer for 60-70 minutes, and when the liquid is reduced to 200 mL, pour out the resulting decoction. Then, add the residue back to cold water (7 times the total weight of the original raw materials), soak for 30 minutes, bring to a boil over high heat, simmer for 60-70 minutes, and when the liquid is reduced to 200 mL, pour out the resulting decoction. Combine the two decoctions to prepare the medicinal solution. Avoid eating amaranth when taking this medicine.

[0064] Example 2 (VAS pain score: 4-10 points, including 4 points)

[0065] Prescription: Bupleurum chinense 12g, Coptis chinensis 8g, Anemarrhena asphodeloides 15g, Carapax tricolor 15g, Artemisia annua 12g, Rehmannia root bark 12g, Gentiana macrophylla 12g, Morus alba 30g, Angelica sinensis 15g, Paeonia lactiflora 15g, Salvia miltiorrhiza 30g, Carthamus tinctorius 10g, Licorice root 8g.

[0066] Preparation method: Mix the above raw materials, add cold water (7 times the total weight of the raw materials), soak for 30 minutes, bring to a boil over high heat, simmer for 60-70 minutes, and when the liquid is reduced to 200 mL, pour out the resulting decoction. Then, add the residue back to cold water (7 times the total weight of the original raw materials), soak for 30 minutes, bring to a boil over high heat, simmer for 60-70 minutes, and when the liquid is reduced to 200 mL, pour out the resulting decoction. Combine the two decoctions to prepare the medicinal solution. Avoid eating amaranth when taking this medicine.

[0067] Test example

[0068] 1. From October 2014 to March 2025, 152 patients with lateral epicondylitis were admitted, aged between 28 and 60 years, including 98 males and 54 females; 20 patients with sterno-clavicular arthritis were admitted, aged between 28 and 60 years, including 15 males and 5 females.

[0069] 2. Diagnostic criteria

[0070] According to the "Key Points of Diagnosis" outlined in Traditional Chinese Medicine Traumatology (New Century, Fifth Edition, China Traditional Chinese Medicine Press), lateral epicondylitis develops slowly, initially with occasional soreness and pain on the lateral elbow during exertion or certain movements, which subsides with rest. As the condition worsens, the pain intensifies with actions such as wringing a towel, sweeping the floor, or pouring water from a pot. The forearm becomes weak, and even objects may fall. Over time, the pain becomes persistent, radiating to the upper arm and forearm, interfering with limb movement. For lateral epicondylitis, the wrist extensor tension test and Milner's sign are positive.

[0071] ② Sternoclavicular arthritis does not have a completely corresponding independent disease name in traditional Chinese medicine theory. It is mainly manifested by pain and tenderness in the sternoclavicular joint area, which worsens with breathing and coughing, especially when the shoulders or upper limbs move.

[0072] ③ Both types of arthritis have a long course of illness, ranging from more than a month to several months or even years. Most patients are between 28 and 60 years old, and are generally accompanied by some symptoms of liver and kidney yin deficiency (such as dry mouth, constipation, irritability, insomnia, soreness of waist and knees, red tongue with little coating, thin pulse, etc., but without obvious typical symptoms of yin deficiency such as fever in the five hearts, night heat and morning coolness, and bone steaming and fatigue fever).

[0073] ④ There are obvious tender points in the joints, but generally there is no obvious redness, swelling, heat, or cold (or the pain is aggravated by cold). However, a few people have slight swelling in the sternoclavicular joint, but no redness, heat, or cold (or the pain is aggravated by cold).

[0074] ⑤ Since the present invention is only aimed at the treatment of patients with lateral epicondylitis and sterno-clavicular arthritis caused mainly by chronic strain and accompanied by some symptoms of liver and kidney yin deficiency, it should be differentiated from the following diseases: those with congenital malformations and abnormalities in the anatomical structure; certain chronic inflammations; fractures, joint dislocations; autoimmune diseases; bone tuberculosis, bone tumors and other bone and joint diseases.

[0075] 3. Treatment methods

[0076] Take one dose daily, decocting each dose twice. Mix the decoctions and take warm once in the morning and evening. A course of treatment consists of 7-10 doses. Avoid eating amaranth while taking this medicine.

[0077] 4. Efficacy evaluation criteria

[0078] (1) Cured: Local pain disappears, corresponding functional activities return to normal, and muscle atrophy is recovering. Wrist extensor tension test is negative, Mill sign is negative, and VAS pain score is 0.

[0079] (2) Effective: Local pain is relieved and functional activities are improved. The wrist extensor tension test and Mill sign are positive, but the VAS pain score is reduced.

[0080] (3) Ineffective: There is no improvement in local pain and functional activities, or even aggravation. The wrist extensor tension test is positive, the Mill sign is positive, and the VAS pain score is unchanged or increases.

[0081] (4) Total effective rate = (number of cured + effective) cases / total number of cases × 100%.

[0082] (5) Therapeutic effect: 152 patients with lateral epicondylitis and 20 patients with sterno-clavicular arthritis took the drug for one course of treatment, a small number took two courses, and a very few took three courses. The treatment results are as follows: the total effective rate of lateral epicondylitis was 96%, and the cure rate was 90.7%; the total effective rate of sterno-clavicular arthritis was 95%, and the cure rate was 90%.

[0083] Typical case data

[0084] 1. Liu xx, male, 52 years old, teacher, living in Changsha, usually likes to play tennis; on November 8, 2019, the first visit, complained of pain in the lateral side of the right elbow joint, which was aggravated by wrist extension and forearm rotation, which had lasted for more than two months. The right forearm muscles were slightly atrophied. Recently, due to the death of his mother, excessive grief and fatigue, the pain aggravated and he was unable to hold objects, which seriously affected his sleep; local examination showed no obvious redness, swelling, or heat, but obvious tenderness (VAS pain score was 8 points), wrist extensor tension test and Mill sign were positive, BP150 / 100mmHg, red tongue with little fur, and thin pulse. He was given 10 doses of the second prescription of Example 2 of the present invention; on November 22, 2019, the above-mentioned pain symptoms were reduced by half (VAS pain score was 4 points), irritability and insomnia were improved, wrist extensor tension test and Mill sign were positive, and he continued to take 10 doses of the original prescription. The patient was re-examined on December 5, 2019, and complained that the aforementioned pain symptoms had been relieved (VAS pain score was 2 points), but there was still dull pain in wrist extension and forearm rotation, and local mild tenderness. He was given 10 doses of the first prescription of Example 1 of the present invention. On January 10, 2020, the patient was re-examined and complained that the local pain had healed, and the wrist extension and forearm rotation functions were free, but the muscle atrophy had not fully recovered, the wrist extensor tension test was negative, and the Mill sign was negative. He was informed of the precautions and corresponding protective functional exercises.

[0085] 2. Xiao xx, female, 35 years old. A patient from Shuangjiang, Loudi, had 3 pregnancies, 2 deliveries, and 1 abortion. She was first diagnosed on March 5, 2020, and complained of pain in the right sternoclavicular joint for more than 3 years. The pain was aggravated by breathing, coughing, and right forearm movement. There was a little local swelling, no redness, no heat, no cold (or aggravated by cold), and obvious tenderness (VAS pain score of 3 points). The wrist extensor tension test and Mill's sign were positive. She had a lot of housework, difficulty falling asleep, dry mouth, and dry stool (once every 2-3 days), normal urine flow, normal blood pressure, red tongue with little coating, and a thready pulse. She was given 10 doses of the first prescription of Example 1 of the present invention, and was advised to rest and not to drink cold water. She was re-examined on March 18, 2020, and complained of significant improvement in local pain (VAS pain score of 1 point). The wrist extensor tension test and Mill's sign were weakly positive. She occasionally felt dull pain when taking a deep breath and coughing, and had mild local tenderness. She was given 10 doses of the original prescription. A follow-up call one month later showed that she was cured.

[0086] 3. Zhu xx, male, 42 years old, from Loudi, living in Sunshui Mingzhu, a construction worker, complained of pain in the lateral bone and joint of the right elbow for half a year, with no obvious history of trauma. It was dull pain at first, and the pain worsened in the past two months, especially when holding objects, which significantly affected his work and sleep. Examination showed obvious local tenderness (VAS pain score of 6 points), positive wrist extensor tension test and Mill's sign, no obvious redness and swelling, positive wrist extensor tension test and Mill's sign, frequent sexual intercourse, often staying up late, like spicy food, impatient temper, normal blood pressure, red tongue with little coating, and thready pulse. He was given 10 doses of the second prescription of the present invention; after a follow-up visit 10 days later, the pain was significantly relieved (VAS pain score of 3 points), and functional activities were enhanced. He was given 10 doses of the first prescription of the present invention, and was advised to rest for one month. A follow-up call was made one and a half months later, and the patient was cured.

[0087] Clinical application:

[0088] Formula A: "Liuwei Dihuang Decoction", 6-7.5 parts of Chinese Angelica, 5-7.5 parts of Red Peony Root, 4-5 parts of Carthamus Tinctorius, 7.5-15 parts of Morus Alpiniae, 7.5-15 parts of Salvia Miltiorrhiza, and 3-4 parts of Licorice;

[0089] The formula of Liuwei Dihuang Decoction: 6-8 parts of cooked rehmannia, 5-6 parts of cornus officinalis, 6-10 parts of Chinese yam, 6-8 parts of poria, 5-6 parts of oriental water plantain, and 5-6 parts of moutan bark.

[0090] Formula B: 5-6 parts of Bupleurum chinense, 3-4 parts of Picrorhizoma Coptidis, 5-7.5 parts of Rhizoma Anemarrhenae, 6-7.5 parts of Carapax Trionycis, 5-6 parts of Artemisia Annua, 5-6 parts of Cortex Lycii, 5-6 parts of Gentiana Macrophylla, 7.5-15 parts of Morus Ramulus, 6-7.5 parts of Angelica Sinensis, 5-7.5 parts of Paeonia lactiflora, 7.5-15 parts of Salvia miltiorrhiza, 4-5 parts of Carthamus tinctorius, and 3-4 parts of Licorice.

[0091] Formula C: 5-6 parts of Bupleurum chinense, 3-4 parts of Picrorhizoma Coptidis, 5-7.5 parts of Anemarrhena Rhizoma, 6-7.5 parts of Carapax Trionycis, 5-6 parts of Artemisia annua, 5-6 parts of Lycium bark, 5-6 parts of Gentiana macrophylla, and 3-4 parts of Licorice root;

[0092] Formula D: 6-7.5 parts of Chinese Angelica, 5-7.5 parts of Red Peony Root, 4-5 parts of Carthamus tinctorius, 7.5-15 parts of Morus alba, 7.5-15 parts of Salvia miltiorrhiza, and 3-4 parts of Licorice.

[0093] Each serving represents 2g.

[0094] Weigh Formula A proportionally, add 7 times the total weight of the Chinese medicinal raw materials in cold water, soak in cold water for 30 minutes, bring to a boil over high heat, simmer for 60-70 minutes, and when the liquid is reduced to 200 mL, pour out the resulting decoction. Then, add the residue back to 7 times the total weight of the original Chinese medicinal raw materials in cold water, soak in cold water for 30 minutes, bring to a boil over high heat, simmer for 60-70 minutes, and when the liquid is reduced to 200 mL, pour out the resulting decoction. Combine the two decoctions to prepare the medicinal solution. Avoid eating amaranth when taking this medicine.

[0095] The preparation methods of formulations B, C and D are the same as formulation A.

[0096] The results of many years of clinical application are shown in Table 1.

[0097] Table 1

[0098]

[0099] Through SPSS operation, with ɑ=0.0083 ( Where k is the total number of treatment groups = 4) is the test level. When comparing the effective rates, we can get the difference between treatment A and treatment B (χ2 A&B =37.581, P<0.001, treatment method B and treatment method C (χ2 B&C =13.659, P<0.001, treatment method B and treatment method D (χ2 B&D =34.525, P<0.001). The above shows that the effectiveness of treatment method B is better than that of treatment methods A, C, and D, and the differences in effectiveness are statistically significant.

[0100] Through SPSS operation, with ɑ=0.0083 ( Where k is the total number of treatment groups = 4) is the test level. When comparing the cure rates, we can get the difference between treatment A and treatment B (χ2 A&B =57.376, P<0.001, treatment method B and treatment method C (χ2 B&C =45.784, P<0.001, treatment method B and treatment method D (χ2 B&D =71.095, P<0.001). The above shows that the cure rate of treatment method B is better than that of treatment methods A, C, and D, and the differences in cure rates are statistically significant.

[0101] Statistical analysis methods:

[0102] The original data were recorded truthfully, accurately and completely. The database was established and data were entered using Excel. SPSS statistical analysis software was used to perform statistical analysis on the database. The measurement data were described as mean ± standard deviation (normal distribution) or median (interquartile range / non-normal distribution), and the count data were described as rate or constituent ratio. The continuous variable (age) was analyzed by variance analysis, and P < 0.05 was used as the statistical significance level. The comparison of categorical variables (gender) was performed by multi-row and multi-column χ2 test or Fisher's exact test, and P < 0.05 was used as the statistical significance level. Before analyzing the data, the researchers confirmed the homogeneity of variance and normality of each group. The multi-group sample rate pairwise χ2 test (effectiveness and cure rate) was performed with ɑ = 0.0083 ( Where k is the total number of treatment groups = 4) as the test level, and P < 0.0083 was used as the statistical significance level.

[0103] The preferred embodiments of the present invention have been described in detail above, but the present invention is not limited thereto. Within the technical concept of the present invention, various simple variations of the technical solution of the present invention may be made, including combining the various technical features in any other appropriate manner. These simple variations and combinations should also be regarded as disclosed in the present invention and fall within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating lateral epicondylitis and / or sterno-clavicular arthritis, characterized in that: The product is extracted from the following raw materials in parts by weight: 5-6 parts of Bupleurum chinense, 3-4 parts of Picrorhizoma Coptidis, 5-7.5 parts of Rhizoma Anemarrhenae, 6-7.5 parts of Carapax Trionycis, 5-6 parts of Artemisia annua, 5-6 parts of Cortex Lycii, 5-6 parts of Gentiana macrophylla, 7.5-15 parts of Morus truncatula, 6-7.5 parts of Angelica sinensis, 5-7.5 parts of Paeonia lactiflora, 7.5-15 parts of Salvia miltiorrhiza, 4-5 parts of Carthamus tinctorius, and 3-4 parts of Licorice.

2. A Chinese medicine composition for treating lateral epicondylitis and / or sterno-clavicular arthritis according to claim 1, characterized in that: When the patient's VAS pain score is 1-4 points, but does not include 4 points, the raw materials are composed of the following components in parts by weight: 5-6 parts of Bupleurum chinense, 3-4 parts of Coptis chinensis, 5-6 parts of Anemarrhena asphodeloides, 6-7.5 parts of Carapax tricolor, 5-6 parts of Artemisia annua, 5-6 parts of Rehmannia glutinosa, 5-6 parts of Gentiana macrophylla, 7.5-10 parts of Morus alba, 6-7.5 parts of Angelica sinensis, 5-6 parts of Paeonia lactiflora, 7.5-10 parts of Salvia miltiorrhiza, 4-5 parts of Carthamus tinctorius, and 3-4 parts of Licorice.

3. A Chinese medicine composition for treating lateral epicondylitis and / or sterno-clavicular arthritis according to claim 1, characterized in that: When the patient's VAS pain score is 4-10 points, including 4 points, the raw materials are composed of the following components in parts by weight: 5-6 parts of Bupleurum chinense, 3-4 parts of Picrorhizoma Coptidis, 7-7.5 parts of Rhizoma Anemarrhenae, 6-7.5 parts of Carapax Trionycis, 5-6 parts of Artemisia annua, 5-6 parts of Cortex Lycii, 5-6 parts of Gentiana macrophylla, 12-15 parts of Morus alba, 6-7.5 parts of Angelica sinensis, 6.5-7.5 parts of Paeonia lactiflora, 12-15 parts of Salvia miltiorrhiza, 4-5 parts of Carthamus tinctorius, and 3-4 parts of Licorice.

4. A method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The following steps are involved: The raw materials according to any one of claims 1 to 3 are mixed, soaked in water, and then boiled and extracted to obtain a medicinal solution.

5. The preparation method according to claim 4, characterized in that: When adding water for soaking, the soaking time is 30 to 50 minutes and the amount of water added is 6 to 8 times the total weight of the Chinese medicine raw materials.

6. The preparation method according to claim 4 or 5, characterized in that: When decocting in water, bring to a boil over high heat and then simmer over low heat for 60-70 minutes.

7. The preparation method according to claim 6, characterized in that: The water decoction extraction is performed 2 to 3 times, and each decoction is performed until the decoction liquid is 180 to 220 mL. The decoction liquids from each decoction are combined as the medicinal solution.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a traditional Chinese medicine preparation for treating lateral epicondylitis and / or sterno-clavicular arthritis.

9. A Chinese medicine preparation for treating lateral epicondylitis and / or sterno-clavicular arthritis, characterized by: The invention comprises the traditional Chinese medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

10. The Chinese medicine preparation according to claim 9, characterized in that: The Chinese medicine preparation is in the form of granules, powders, decoctions, pills, tablets, capsules, mixtures or syrups.

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