Traditional Chinese medicine composition for treating osteoarthritis and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating osteoarthritis and application thereof. The ointment is prepared from the following raw materials in parts by weight: 30 parts of rheum officinale, 30 parts of golden cypress, 30 parts of scutellaria baicalensis, 30 parts of coptis chinensis, 30 parts of bletilla striata, 30 parts of ampelopsis japonica, 30 parts of radix angelicae, 30 parts of sophora flavescens, 15 parts of frankincense, 15 parts of myrrh and 100 parts of sesame oil. The traditional Chinese medicine composition can regulate qi and blood, dredge meridians and collaterals, promote blood circulation to remove blood stasis, clear heat and dry dampness, reduce swelling and promote tissue regeneration to relieve pain, is suitable for patients with qi stagnation and blood stasis syndrome type osteoarthritis caused by trauma or damp-heat, is especially suitable for patients who repeatedly attack for a long time and are difficult to radically cure, and has high clinical application value in the aspect of osteoarthritis treatment.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating osteoarthritis and application thereof. Background Art

[0002] Osteoarthritis is a disease with a high incidence rate and seriously affects the quality of life of patients. It is especially common in the middle-aged and elderly population and manual laborers. Osteoarthritis belongs to the category of "arthralgia" in traditional Chinese medicine. The term "arthralgia" was first seen in "Bian Que Xin Shu·Arthralgia": "Wind, cold and dampness combine to form arthralgia, which causes pain, or stiffness in the arms, waist, feet and knees, and tightness in the elbows. This is because the cold evil gathers between the flesh...Arthralgia is caused by the stagnation of qi and blood, which stays outside the five internal organs and combines to form a disease." "Su Wen·Arthralgia Theory" says that "wind, cold and dampness are mixed together and combine to form arthralgia." It can be seen from this that arthralgia is caused by obstruction, which is caused by tangible real evil; regardless of whether the pathogenesis of knee arthralgia is virtual or real, there is real evil.

[0003] According to TCM theory, the causes of osteoarthritis are complex and diverse, including exogenous wind, cold and dampness, trauma, overstrain and congenital physical weakness. According to the TCM Diagnosis and Treatment Program for Osteoarthritis (2017 Edition), osteoarthritis can be divided into five syndromes: liver and kidney deficiency syndrome, cold and dampness obstruction syndrome, damp-heat obstruction syndrome, phlegm and blood stasis syndrome, and qi and blood deficiency syndrome. Through long-term clinical work, it is found that qi stagnation and blood stasis caused by trauma or dampness and heat are also one of the common pathological mechanisms leading to osteoarthritis. "Yu Ji" says "Injury from hitting a metal blade... must cause blood stasis", and "Su Wen" says "Qi hurts pain, shape hurts swelling". Qi is invisible, blood is visible, and shape hurts swelling, causing invisible qi to gather in the affected area, which is better than visible. Qi stagnation and blood stasis lead to meridian obstruction, which causes pain. Inflammation corresponds to damp-heat evil qi in TCM. Heat evil burns blood in the body, and damp evil blocks the qi mechanism, causing qi stagnation. "Qi is the commander of blood, and blood is the mother of Qi." Stagnation of Qi will result in poor blood circulation, and blood stasis will stagnate in the meridians and joints. If Qi is blocked and blood stasis persists for a long time, blood stasis will easily become heat, and damp heat evil Qi will fight with Qi and blood, thus causing redness and swelling. Osteoarthritis of Qi stagnation and blood stasis syndrome caused by trauma or damp heat is mainly manifested by fixed pain location, pain like needle prick, especially at night, accompanied by local redness and swelling, difficulty in movement, and significantly increased pain when touched. At present, there is a lack of corresponding TCM treatment options for osteoarthritis of Qi stagnation and blood stasis syndrome in clinical practice.

[0004] In modern medicine, the clinical manifestations of Qi stagnation and blood stasis type osteoarthritis are often accompanied by joint inflammation, soft tissue injury, poor local blood flow, etc. Western medicine usually relieves symptoms through nonsteroidal anti-inflammatory drugs (NSAIDs), steroid drugs or physical therapy such as heat therapy and massage. Although these treatments can relieve pain in the short term, long-term use of nonsteroidal anti-inflammatory drugs and steroid drugs will cause adverse reactions in the digestive system, cardiovascular system and kidneys. At the same time, Western medicine treatment focuses more on symptom relief, but cannot fundamentally solve the cause. Therefore, many patients' pain symptoms still recur after treatment and cannot be completely relieved.

[0005] Compared with symptomatic treatment of Western medicine, traditional Chinese medicine has unique advantages in treating osteoarthritis, especially in the treatment of qi stagnation and blood stasis type diseases. "Suwen" says: "Zongjin is the main bone and the organ is also beneficial." Tendons are attached to bones, bones are connected to tendons, muscles and tendons are on the outside, and bones are on the inside. Traditional Chinese medicine emphasizes syndrome differentiation and treatment. Through regulating qi and blood, dredging meridians, promoting blood circulation and removing blood stasis, clearing away heat and dampness, reducing swelling, promoting muscle growth and relieving pain, the treatment of qi stagnation and blood stasis type osteoarthritis can improve the patient's condition. At present, traditional Chinese medicine prescriptions commonly used in clinical practice, such as blood circulation and blood stasis drugs (such as Chuanxiong, Danshen, Safflower, etc.), have achieved certain results in relieving joint pain. However, traditional Chinese medicine prescriptions are mostly based on experience, the drug compatibility is not accurate enough, and the efficacy varies from person to person, and there are still some shortcomings. For example, some prescriptions lack pertinence and cannot effectively improve the pain and functional disorders caused by qi stagnation and blood stasis. In addition, although existing traditional Chinese medicine topical therapies, such as medicated oils, have good local therapeutic effects, they still need to be further improved in terms of drug efficacy persistence and safety. Summary of the invention

[0006] The present invention proposes a Chinese medicine composition (Jingu Zhongtongning) specifically for treating osteoarthritis of qi stagnation and blood stasis type. Through precise drug compatibility and application, it aims to effectively relieve the symptoms such as pain, swelling, and dysfunction of the limb joints caused by qi stagnation and blood stasis. The composition can regulate qi and blood, dredge meridians, promote blood circulation and remove blood stasis, clear away heat and dry dampness, reduce swelling, promote tissue regeneration and relieve pain. It is suitable for osteoarthritis patients of qi stagnation and blood stasis syndrome type caused by trauma or damp heat, especially for patients with long-term repeated attacks and difficult to cure. The present invention provides an innovative treatment method based on traditional Chinese medicine theory and modern pharmacological research.

[0007] The invention provides a traditional Chinese medicine composition for treating qi stagnation and blood stasis type osteoarthritis. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-40 parts by weight of rhubarb, 20-40 parts by weight of phellodendron, 20-40 parts by weight of scutellaria, 20-40 parts by weight of coptis, 20-40 parts by weight of bletilla striata, 20-40 parts by weight of white ampel, 20-40 parts by weight of angelica dahurica, 20-40 parts by weight of sophora flavescens, 10-20 parts by weight of frankincense, 10-20 parts by weight of myrrh and 80-120 parts by weight of sesame oil.

[0008] The Chinese medicine composition for treating qi stagnation and blood stasis type osteoarthritis is prepared from the following raw materials in parts by weight: 30 parts by weight of rhubarb, 30 parts by weight of phellodendron, 30 parts by weight of scutellaria, 30 parts by weight of coptis, 30 parts by weight of bletilla striata, 30 parts by weight of white ampel, 30 parts by weight of angelica dahurica, 30 parts by weight of sophora flavescens, 15 parts by weight of frankincense, 15 parts by weight of myrrh, and 100 parts by weight of sesame oil.

[0009] The preparation method of the Chinese medicine composition comprises:

[0010] Step 1: Grind rhubarb, phellodendron, scutellaria, coptis root, bletilla striata, white peony root, angelica dahurica and sophora flavescens into fine powder and set aside;

[0011] Step 2: Heat sesame oil to 120℃, fry myrrh and frankincense over low heat until the herbs turn golden yellow, filter and remove the residue;

[0012] Step 3: Mix the powder obtained in step 1 with the oil in step 2, stir evenly to make a paste, and seal and store after cooling for later use.

[0013] The application of the traditional Chinese medicine composition in preparing medicine for treating qi stagnation and blood stasis type osteoarthritis.

[0014] Cool the mixed ointment to room temperature, place it in a sealed container, seal it and keep it for later use. The ointment needs to be kept away from light, high temperature and humidity to ensure the stability of the efficacy.

[0015] The Chinese medicine composition can be prepared as an external ointment, which can be directly applied to the painful area once a day, and appropriate massage can be performed after each application to promote absorption.

[0016] Usage: Apply an appropriate amount of ointment to the affected area daily and massage for 5-10 minutes each time to promote drug absorption. Continuous use for 2 to 4 weeks will significantly improve symptoms.

[0017] The present invention follows the principle of TCM syndrome differentiation and treatment and is adapted from the "Wanjin Paste" in "Zhengti Leiyao". The meridian entry, function, main treatment and mechanism of action of the above-mentioned Chinese medicines are as follows: it has the effects of regulating qi and blood, dredging meridians, promoting blood circulation and removing blood stasis, clearing away heat and dampness, reducing swelling, promoting tissue regeneration and relieving pain, and can promote the circulation of qi and blood, remove blood stasis, eliminate dampness, promote the regeneration of tissues around joints, and restore the normal function of joints.

[0018] Rhubarb: bitter in taste, cold in nature, enters the spleen, stomach, large intestine, liver, and heart meridians. "Shennong's Herbal Classic" states: "It is used to treat blood stasis, lower blockage, cold and heat, break up accumulation of tumors, retain food and drink, cleanse the intestines and stomach, remove the old and bring in the new, clear the water and food channels, regulate the middle and digest food, and calm the five internal organs." "Jingyue Complete Works" states: "It clears away solid phlegm, guides blood stasis, clears the water channels, removes dampness and heat, and relieves dryness and constipation." As the main drug, rhubarb directly enters the blood, has a powerful effect of promoting blood circulation and removing blood stasis, and removing blood stasis. At the same time, rhubarb also has the function of clearing heat and purging, and can lead heat downward. In this prescription, it plays a major role in promoting the dissolution of blood stasis and clearing dampness and heat.

[0019] Huangbai: bitter, cold in nature, enters the kidney, bladder, and large intestine meridians. "Yao Xing Fu": "It can purge the hidden dragon fire in the lower Jiao, calm the roundworms in the upper Jiao, and can eliminate the pain below the navel by simply treating it. It can replenish the kidney deficiency by using it raw, and it is indispensable in the medicine for removing dampness and dampness." Huangqin: bitter, cold in nature, enters the lung, stomach, gallbladder, and large intestine meridians. "Yi Xue Qi Yuan": "Huangqin is a must-use medicine for treating damp heat in the lungs, swelling and redness in the eyes due to upper heat, and blood stasis. Huanglian: bitter, cold in nature, enters the heart, liver, stomach, and large intestine meridians. "Zhenzhu Nang": "It has six uses: purging heart fire, one; removing damp heat in the middle Jiao, two; must be used for all sores, three; removing rheumatism, four; treating red eye outbreaks, five; stopping bleeding in the middle, six. "The three together as ministerial drugs can clear damp heat from the upper, middle and lower three burners, reduce fire with bitter and cold properties, and are particularly suitable for joint swelling and pain caused by qi stagnation and blood stasis caused by damp heat. They can effectively relieve local inflammatory reactions and reduce symptoms such as redness, swelling, heat and pain. At the same time, they assist rhubarb in enhancing the effects of clearing heat, cooling blood, reducing swelling and relieving pain.

[0020] Bletilla striata: bitter, cold in nature, enters the lung, stomach, and liver meridians. "Ben Cao Jing Bai Zhong Lu" states: "Bletilla striata has a mild and peaceful smell, but its body is smooth and extremely sticky. It enters the tendons and bones, can nourish and soften, and harmonize with the positive energy, so that the minor evils will retreat." It makes rhubarb and other blood-activating drugs activate blood but not too much. Bletilla striata: bitter, slightly cold in nature, enters the heart and stomach meridians. "Ben Cao Zheng Yi" states: "In addition to "Ben Jing" and "Bie Lu", it has an additional meaning of cooling blood, breaking blood, removing blood stasis and promoting new blood." Angelica dahurica: pungent in taste, warm in nature, enters the lung and stomach meridians. "Ri Hua Zi Ben Cao" states: "It can treat red eyes, pterygium, and repair abortion, break old blood, replenish new blood, breast abscess, back hair, scrofula, intestinal wind, hemorrhoids, fistula, discharge pus, sores, scabies, relieve pain, promote tissue regeneration, and remove facial wrinkles and scars." It can enter the Chong meridian. The Qi of Yangming is directed to Chongmai, the blood of Chongmai is regulated to follow Yangming, the turbidity of Yangming is removed, and the Chongmai is clear and harmonious. As adjuvants, these drugs have good effects of reducing swelling, promoting tissue regeneration, relieving pain, promoting blood circulation and removing blood stasis, and can promote soft tissue repair and reduce local pain and swelling. At the same time, these drugs have a positive effect on accelerating tissue regeneration and promoting blood circulation, and are especially suitable for patients with osteoarthritis of Qi stagnation and blood stasis type.

[0021] Sophora flavescens: bitter, cold in nature, enters the heart, liver, stomach, large intestine, and bladder meridians. As an adjuvant, it has the effects of clearing away heat and dampness, dispelling wind and relieving pain. It is suitable for numbness and stiffness associated with joint pain. Frankincense: pungent, bitter, warm in nature, enters the heart, liver, and spleen meridians. It is the blood of the tree, its color is yellow-white and transparent, it has wood energy and fire. The fragrance is penetrating, so it is good at penetrating the orifices to regulate qi, and it can enter all the twelve meridians. It is yang, ascending, penetrating and dispersing. Because it is similar to the blood of the human body, it can enter the five internal organs of the spleen, lungs, heart, liver, and kidneys, can ward off evil qi, can make qi and blood mutually active, so that qi does not block blood, and blood is not blocked by qi, qi and blood are harmonious and can make true qi grow; and if the tendons of ordinary people are not stretched, it is appropriate to add frankincense to the compress, which can stretch the tendons. Myrrh: pungent, bitter, flat in nature, enters the heart, liver, and spleen meridians. It is also the body fluid of the tree, and its color is brown, just like the color of blood. It is born with the Qi of metal and water, and is yin, descending, and dispersing. "New Compendium of Materia Medica": "It can reduce swelling, ulcers, carbuncles, ulcers, and rot, and it is very effective in breaking blood and relieving pain. It is especially effective in treating falls and injuries." "Compendium of Materia Medica": "Frankincense can promote blood circulation, and myrrh can disperse blood. Both can relieve pain, reduce swelling, and promote tissue regeneration, so the two medicines are often used together." These two medicines complement each other. One is best at regulating qi, and the other is best at removing blood stasis. They treat qi and blood at the same time, and have the effects of promoting blood circulation, removing blood stasis, and relieving pain. As a guiding drug, it guides the above-mentioned drugs to play their strengths, unblocking blood vessels, and dispersing blood stasis.

[0022] Sesame oil: As a drug carrier, sesame oil can not only improve the permeability of drugs, but also moisturize the skin. At the same time, it provides a good solvent environment for medicinal ingredients and enhances the local absorption effect of drugs.

[0023] The compatibility of various medicinal materials in this combination has strict principles, which not only embodies the "monarch, minister, assistant and envoy" compatibility concept of traditional Chinese medicine, but also combines the specific functional research of drugs in modern medicine:

[0024] Rhubarb: It can increase plasma osmotic pressure, transfer tissue blood into blood vessels, reduce blood viscosity, and promote blood circulation. Physcion in rhubarb inhibits the TGF-β / NF-κB / MAPK pathway and regulates the expression of inflammatory cytokines, thereby achieving the effect of treating arthritis.

[0025] Scutellaria baicalensis, Phellodendron chinense, and Coptis chinensis: have anti-inflammatory, antioxidant, and antibacterial effects.

[0026] Bletilla striata, White Ampelopsis Root, Angelica dahurica: have anti-inflammatory, antioxidant, analgesic and cartilage protective effects.

[0027] Sophora flavescens, frankincense, and myrrh: Sophora flavescens can play the role of immunosuppression and anti-local skin allergy, making the present invention more suitable for patients. Frankincense contains frankincense, which can increase multinuclear leukocytes in the blood to attack the problem of blood stasis and relieve inflammation. Myrrh contains myrrh oil, resin, gum, etc., which can preserve life, resist inflammation and reduce swelling. Frankincense and myrrh block the release of inflammatory factors related to pain by immune cells, and play the role of peripheral analgesia.

[0028] The Chinese medicine composition is particularly suitable for patients with Qi stagnation and blood stasis type osteoarthritis, and can relieve the following symptoms: fixed pain site, pain like acupuncture, difficulty in movement, especially aggravated at night, increased pain when pressing the painful site, local redness and swelling. It is particularly suitable for patients with long-term and recurrent Qi stagnation and blood stasis type joint pain, and continuous use can relieve pain, improve joint function, and reduce the possibility of recurrence.

[0029] The composition is applied externally, avoiding adverse gastrointestinal reactions caused by oral medications, and has high safety and good patient compliance.

[0030] The Chinese medicine composition of the present invention has been verified by clinical trials, showing that it has significant efficacy in treating arthralgia of qi stagnation and blood stasis type. In the experiment, the patients' pain was significantly relieved, the range of motion of the joints was improved, and the quality of daily life was significantly improved by continuous use of the ointment of the composition. Especially for those patients who have used non-steroidal anti-inflammatory drugs for a long time but have poor efficacy, the present invention provides an effective alternative therapy with higher safety and fewer side effects.

[0031] The present invention not only has a solid foundation in traditional Chinese medicine theory, but also combines the research results of modern pharmacology and long-term clinical practice to prove its effects in regulating qi and blood, dredging meridians, promoting blood circulation and removing blood stasis, clearing away heat and dampness, reducing swelling, promoting tissue regeneration and relieving pain. The preparation process of the present invention is simple, the raw materials are easily available, the cost is low, and it is suitable for large-scale promotion and application. The Chinese medicine composition provides a safe and effective treatment option for patients with qi stagnation and blood stasis type osteoarthritis, and has a wide range of clinical application prospects. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solution and advantages of the embodiment of the present invention clearer, the technical solution of the embodiment of the present invention is clearly and completely described below. Obviously, the described embodiment is a part of the embodiment of the present invention, not all of the embodiments. Based on the described embodiment of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] Embodiment 1: Take 30g of rhubarb, 30g of phellodendron, 30g of scutellaria, 30g of coptis root, 30g of bletilla striata, 30g of white peony root, 30g of angelica root, 30g of sophora flavescens, 15g of frankincense, 15g of myrrh, and 100g of sesame oil, and the preparation steps are as follows: ① pulverizing medicinal materials: pulverize rhubarb, phellodendron, scutellaria, coptis root, bletilla striata, white peony root, angelica root, and sophora flavescens into fine powder, sieve for standby use. ② Sesame oil treatment: take 100g of sesame oil, put it in a container and heat it to 120°C, keep constant temperature, add frankincense and myrrh, continue heating and stirring until the efficacy of frankincense and myrrh is fully released and the oil body is golden yellow, filter to remove the residue, and leave the medicinal oil for standby use. ③ Mixing and stirring: fully mix the medicinal material powder obtained in step 1 with the medicinal oil in step 2, and stir evenly until a uniform paste is formed. ④Cooling and packaging: Cool the mixed ointment to room temperature, place it in a sealed container, seal it and keep it for later use. The ointment needs to be kept away from light, high temperature and humid environment to ensure the stability of the efficacy.

[0034] Embodiment 2: Take 20g of rhubarb, 40g of phellodendron, 20g of scutellaria, 40g of coptis root, 20g of bletilla striata, 40g of white peony root, 20g of angelica root, 40g of sophora flavescens, 10g of frankincense, 20g of myrrh, and 80g of sesame oil, and the preparation steps are as follows: ① pulverizing medicinal materials: pulverize rhubarb, phellodendron, scutellaria, coptis root, bletilla striata, white peony root, angelica root, and sophora flavescens into fine powder, sieve for standby use. ② Sesame oil treatment: take 100g of sesame oil, put it in a container and heat it to 120°C, keep constant temperature, add frankincense and myrrh, continue heating and stirring until the efficacy of frankincense and myrrh is fully released and the oil body is golden yellow, filter to remove the residue, and leave the medicinal oil for standby use. ③ Mixing and stirring: fully mix the medicinal material powder obtained in step 1 with the medicinal oil in step 2, and stir evenly until a uniform paste is formed. ④Cooling and packaging: Cool the mixed ointment to room temperature, place it in a sealed container, seal it and keep it for later use. The ointment needs to be kept away from light, high temperature and humid environment to ensure the stability of the efficacy.

[0035] Embodiment 3: Take 40g of rhubarb, 20g of phellodendron, 40g of scutellaria, 20g of coptis root, 40g of bletilla striata, 20g of white peony root, 40g of angelica root, 20g of sophora flavescens, 20g of frankincense, 10g of myrrh, and 120g of sesame oil, and the preparation steps are as follows: ① pulverizing medicinal materials: pulverize rhubarb, phellodendron, scutellaria, coptis root, bletilla striata, white peony root, white peony root, and sophora flavescens into fine powder, sieve for standby use. ② Sesame oil treatment: take 100 parts by weight of sesame oil, put it in a container and heat it to 120°C, keep constant temperature, add frankincense and myrrh, continue heating and stirring until the efficacy of frankincense and myrrh is fully released and the oil body is golden yellow, filter to remove the residue, and leave the medicinal oil for standby use. ③ Mixing and stirring: fully mix the medicinal material powder obtained in step 1 with the medicinal oil in step 2, and stir evenly until a uniform paste is formed. ④Cooling and packaging: Cool the mixed ointment to room temperature, place it in a sealed container, seal it and keep it for later use. The ointment needs to be kept away from light, high temperature and humid environment to ensure the stability of the efficacy.

[0036] Example 4: Clinical study

[0037] This clinical study selected patients with osteoarthritis of qi stagnation and blood stasis type from the Department of Orthopedics of Suzhou Traditional Chinese Medicine Hospital from January 2024 to August 2024, who met the inclusion and exclusion criteria, and the patients agreed to participate in this clinical observation. A total of 50 cases were collected, and the Chinese medicine ointment prepared by the Chinese medicine composition of the present invention was used for treatment, and the relevant indicators of Chinese medicine symptoms and related signs scores were observed.

[0038] 1. Diagnosis and inclusion criteria

[0039] 1.1 Western medicine diagnostic criteria The following criteria are formulated with reference to the diagnostic criteria for osteoarthritis in the Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition): ① Most patients have chronic strain trauma; ② Often occur in middle-aged and elderly people; ③ Chronic, gradually worsening joint pain, usually accompanied by aggravation after activity and relief after rest; ④ Morning stiffness (joint stiffness) usually lasts no more than 30 minutes; ⑤ Limited range of motion of joints, joint swelling and tenderness, especially weight-bearing joints such as knees, hips, and finger joints; ⑥ Imaging examination: Common features of joint X-ray examination include narrowing of the joint space, osteophyte formation, subchondral bone sclerosis and cystic changes. In advanced cases, joint deformities and extensive degenerative changes of cartilage may be seen; ⑦ Laboratory examination: Laboratory examinations for osteoarthritis are usually non-specific, and inflammatory indicators such as blood routine and serum are generally normal.

[0040] 1.2 TCM diagnostic criteria: Refer to the diagnostic criteria of Qi stagnation and blood stasis syndrome in the "TCM Disease Diagnosis and Efficacy Criteria" and the "International Guidelines for the Diagnosis of Blood Stasis Syndrome": History of trauma, tingling, pulling pain in the joints, or severe pain with a fixed location. Or accompanied by limb numbness, and bruises can be seen in the joints and surrounding areas. The tongue is dark purple or has petechiae and ecchymosis, the tongue coating is white and greasy, and the pulse is stringy or astringent.

[0041] 1.3 Case inclusion criteria: ① Aged between 35 and 80 years old, regardless of gender; ② Diagnosed with Qi stagnation and blood stasis type osteoarthritis; ③ No other related treatments (such as long-term use of hormone drugs and non-steroidal anti-inflammatory drugs) in the past 3 months; ④ Voluntarily participate in this study and sign the informed consent form.

[0042] 1.4 Exclusion criteria: ① Patients with other serious diseases, such as rheumatoid arthritis, gouty arthritis, etc.; ② Patients with serious cardiovascular disease, liver and kidney dysfunction or tumor history; ③ Pregnant or lactating women; ④ Patients with a history of severe skin allergies or allergies to Chinese medicine ingredients; ⑤ Patients with mental illness or unable to cooperate with the trial.

[0043] 1.5 Case dropout and exclusion criteria: ① Subjects with poor compliance and unable to adhere to treatment; ② Subjects with more serious adverse reactions, such as abnormal neurological function; ③ Subjects with more serious other diseases during the clinical trial; ④ Subjects with effective treatment but unable to determine the efficacy when other treatments are added.

[0044] 2. Evaluation indicators

[0045] The efficacy was observed after two weeks and four weeks, mainly the VAS score, osteoarthritis index (WOMAC) and joint range of motion of the patients on days 14 and 28. Efficacy evaluation: According to the efficacy standards established in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis", the clinical efficacy of the patients after treatment was evaluated and the efficacy was divided into the following categories:

[0046] Cured: pain disappears, joint range of motion returns to normal, daily activities are restored, and WOMAC score decreases by more than 80%; markedly effective: pain is significantly relieved, joint range of motion is significantly improved, and WOMAC score decreases by 50%-80%; effective: pain is relieved, joint function is improved, and WOMAC score decreases by 20%-50%; ineffective: no significant improvement in symptoms before and after treatment, and WOMAC score decreases by less than 20%. Efficacy index = (VAS score before treatment - VAS score after treatment) / VAS score before treatment × 100%.

[0047] Results: The 50 patients with Qi stagnation and blood stasis type osteoarthritis were given the Chinese medicine ointment prepared by Example 1 of the present invention on the first day after seeing the doctor. An appropriate amount of the ointment was applied to the affected area every day, and massaged for 5 to 10 minutes each time to promote drug absorption. The ointment was used continuously for 2 to 4 weeks. The results showed that 5 cases of TCM syndrome were cured, 22 cases were markedly effective, 15 cases were effective, 8 cases were ineffective, and the total effective rate was 84%.

[0048] 3. Typical Cases

[0049] Case 1: Chen, female, Suzhou Traditional Chinese Medicine Hospital, clinic number: G709155572. The main reason for "left elbow pain and discomfort for 2 months" was to see a doctor. The patient had pain and discomfort in the left elbow joint without obvious causes 2 months ago, with slightly limited activities, aggravated pain when lifting heavy objects, obvious pain at night, no obvious history of trauma, no numbness of the upper arm, so he came to our hospital for treatment. During the course of the disease, the patient's appetite and sleep were good, his bowel movements were regular, his tongue was dark purple, his tongue coating was white and greasy, and his pulse was stringy. Physical examination: tenderness and percussion pain in the lateral epicondyle of the left humerus, limited rotational activity, and reflexes of the biceps tendon and triceps tendon were present. X-rays of the right elbow showed: degenerative changes in the left elbow. Diagnosed as left elbow osteoarthritis, Chinese medicine diagnosed as bone arthralgia-qi stagnation and blood stasis syndrome, the Chinese medicine ointment prepared in Example 1 of the present invention was applied once a day, massaged for 5-10 minutes each time, and treated for 14 days. After treatment, the patient's left elbow pain and range of motion were significantly improved, and the above treatment was continued. After 28 days, the above symptoms completely disappeared.

[0050] Case 2: Sun, female, Suzhou Traditional Chinese Medicine Hospital, clinic number: G706670654. The main reason for "left knee pain with poor activity for more than 1 month" was to see a doctor. The patient had pain and discomfort in the left knee joint without obvious inducement more than 1 month ago, limited activity, aggravated pain after standing for a long time, unable to move for a long time, difficulty going up and down stairs, obvious pain at night, no obvious history of trauma, no numbness of lower limbs, so he came to our hospital for treatment. During the course of the disease, the patient's appetite and sleep were normal, the two bowel movements were regular, the tongue was dark purple, the tongue coating was white and greasy, and the pulse was stringy. Physical examination: the left knee was slightly red and swollen, local tenderness was positive, especially on the inside, lateral test, drawer test (-), hyperextension and hyperflexion test (+), and the knee joint range of motion was 0-90°. Check the left knee X-ray: osteophyte formation around the left knee joint. Diagnosed as left knee osteoarthritis, Chinese medicine diagnosis of bone arthralgia-qi stagnation and blood stasis syndrome, given the Chinese medicine ointment prepared in Example 1 of the present invention, once a day, massage for 5-10 minutes each time, and treated for 14 days. After treatment, the patient's left knee pain and range of motion were significantly improved, and the above treatment was continued. After 28 days, the above symptoms completely disappeared.

[0051] In summary, the Chinese medicine composition for treating osteoarthritis of the present invention is used to treat osteoarthritis caused by qi stagnation and blood stasis, has the effects of promoting blood circulation and removing blood stasis, promoting qi and relieving pain, and significantly improves the clinical symptoms of traditional Chinese medicine.

[0052] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. A Chinese medicine composition for treating Qi stagnation and blood stasis type osteoarthritis, characterized in that: The Chinese medicine composition is prepared from the following raw materials by weight: 20-40 parts by weight of rhubarb, 20-40 parts by weight of phellodendron, 20-40 parts by weight of scutellaria, 20-40 parts by weight of coptis, 20-40 parts by weight of bletilla striata, 20-40 parts by weight of white ampel, 20-40 parts by weight of angelica dahurica, 20-40 parts by weight of sophora flavescens, 10-20 parts by weight of frankincense, 10-20 parts by weight of myrrh, and 80-120 parts by weight of sesame oil.

2. A Chinese medicine composition for treating Qi stagnation and blood stasis type osteoarthritis according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials by weight: 30 parts by weight of rhubarb, 30 parts by weight of phellodendron, 30 parts by weight of scutellaria, 30 parts by weight of coptis, 30 parts by weight of bletilla striata, 30 parts by weight of white ampel, 30 parts by weight of angelica dahurica, 30 parts by weight of sophora flavescens, 15 parts by weight of frankincense, 15 parts by weight of myrrh, and 100 parts by weight of sesame oil.

3. The Chinese medicine composition according to claim 1, characterized in that The preparation method comprises: Step 1: Grind rhubarb, phellodendron, scutellaria, coptis root, bletilla striata, white peony root, angelica dahurica and sophora flavescens into fine powder and set aside; Step 2: Heat sesame oil to 120℃, fry myrrh and frankincense over low heat until the herbs turn golden yellow, filter and remove the residue; Step 3: Mix the powder obtained in step 1 with the oil in step 2, stir evenly to make a paste, and seal and store after cooling for later use.

4. Use of the Chinese medicine composition according to claim 1 in preparing a drug for treating Qi stagnation and blood stasis type osteoarthritis.