A traditional Chinese medicine composition, a preparation method therefor and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition, its preparation method, and its application, belonging to the field of traditional Chinese medicine technology. The traditional Chinese medicine composition comprises the following components in parts by weight: 30-60 parts Astragalus membranaceus granules, 20-40 parts Polygonum cuspidatum granules, 20-40 parts Spatholobus suberectus granules, 20-40 parts Caulis Clematis chinensis granules, 15-30 parts Corydalis yanhusuo granules, and 5-10 parts Asarum sieboldii granules. The traditional Chinese medicine composition of this invention uses Astragalus membranaceus granules as the principal ingredient, Polygonum cuspidatum granules as the assistant ingredient, and Spatholobus suberectus granules, Caulis Clematis chinensis granules, Corydalis yanhusuo granules, and Asarum sieboldii granules as adjuvant ingredients. These ingredients work synergistically to achieve the effects of invigorating qi and nourishing blood, relaxing muscles and tendons, promoting blood circulation and relieving pain. It has good efficacy and high safety in treating post-traumatic ankle arthritis, synovitis, and phlegm-blood stasis obstruction.

Description

Technical Field

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

[0002] The ankle joint is one of the most important weight-bearing joints in the human body, with a complex structure and numerous surrounding ligaments. Even subtle structural changes in the joint can lead to alterations in the biomechanics of the foot and ankle, increasing local stress and accelerating cartilage wear. Post-traumatic ankle arthritis, as the name suggests, refers to ankle joint inflammation caused by various traumatic factors. Trauma is the most common cause of ankle arthritis. Among all ankle arthritis patients, those with traumatic ankle arthritis account for 70%, and these patients are mostly younger and have high activity levels. Clinical manifestations include ankle pain, recurrent swelling, stiffness, and limited range of motion, severely impacting patients' self-care ability and reducing their quality of life.

[0003] In traditional Chinese medicine, traumatic ankle arthritis falls under the category of "bone obstruction." Its pathogenesis involves joint injury, trauma, or overuse leading to poor local blood circulation and blocked meridians. This, coupled with the invasion of external wind and cold, further obstructs blood flow and triggers the disease. Therefore, treatment focuses on tonifying qi and promoting blood circulation, dispelling blood stasis and cold, and unblocking meridians to relieve pain. Traditional Chinese medicine recognizes its etiology and pathogenesis primarily as cold-dampness obstructing the meridians, damp-heat obstructing the meridians, phlegm-blood stasis obstructing the meridians, liver and kidney deficiency, and deficiency of both qi and blood. Treatment principles include dispelling cold and dampness, warming the meridians and unblocking the meridians, clearing heat and nourishing yin, tonifying qi and promoting blood circulation, relaxing muscles and tendons, and tonifying the liver and kidneys.

[0004] Currently, Western medicine offers numerous treatment options for traumatic ankle arthritis. Early treatment generally falls into two categories: conservative and surgical. Conservative treatment includes medication, physical therapy, and biomechanical orthotic braces, which, when combined, can achieve good pain relief and functional recovery. If conservative treatment is ineffective, surgical treatment may be considered, including minimally invasive ankle arthroscopy, ankle osteotomy, ankle replacement, or ankle fusion, depending on the specific situation. For end-stage post-traumatic ankle arthritis, surgery remains the primary treatment, with ankle replacement or ankle fusion chosen based on the specific circumstances. Generally, ankle replacement should be considered first, followed by ankle fusion. Although surgery can alleviate symptoms to some extent, some patients experience poor outcomes and prognoses; therefore, clinical practice needs to optimize treatment methods. With in-depth research into the efficacy of traditional Chinese medicine granules, the application of traditional Chinese medicine in the treatment of traumatic ankle arthritis has shown promising results.

[0005] Therefore, this application is submitted. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the existing technology and provide a traditional Chinese medicine composition, its preparation method and application. The traditional Chinese medicine composition has the effects of invigorating qi and promoting blood circulation, removing blood stasis and dispelling cold, and unblocking collaterals and relieving pain. It has good effects in treating post-traumatic ankle arthritis, synovitis and phlegm and blood stasis obstruction. The traditional Chinese medicine composition is safe and has no side effects.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0008] A traditional Chinese medicine composition comprising the following components in parts by weight: 30-60 parts Astragalus membranaceus granules, 20-40 parts Polygonum cuspidatum granules, 20-40 parts Spatholobus suberectus granules, 20-40 parts Caulis Cimicifugae granules, 15-30 parts Corydalis yanhusuo granules, and 5-10 parts Asarum sieboldii granules.

[0009] The "Technical Requirements for the Research and Formulation of Quality Standards for Chinese Medicine Formula Granules" stipulates that Chinese medicine formula granules are granules made from single Chinese medicinal herbs through water heating extraction, separation, concentration, drying, and granulation. Under the guidance of traditional Chinese medicine theory, they are prepared according to clinical prescriptions of traditional Chinese medicine and then taken by patients.

[0010] This invention creatively combines Astragalus membranaceus granules, Polygonum cuspidatum granules, Spatholobus suberectus granules, Caulis Cimicifugae granules, Corydalis yanhusuo granules, and Asarum sieboldii granules in the above-mentioned specific proportions to obtain a traditional Chinese medicine composition with the effects of invigorating qi and promoting blood circulation, removing blood stasis and dispelling cold, and unblocking collaterals and relieving pain. The traditional Chinese medicine composition is safe and has no side effects, and can effectively solve the problem of limited efficacy in Western medicine clinical practice.

[0011] The traditional Chinese medicine composition uses Astragalus membranaceus granules as the principal ingredient, Polygonum cuspidatum granules as the assistant ingredient, and Spatholobus suberectus granules, Caulis Cimicifugae, Corydalis yanhusuo granules, and Asarum sieboldii granules as adjuvant ingredients. These ingredients work together synergistically to achieve the effects of invigorating qi and nourishing blood, relaxing muscles and tendons, promoting blood circulation and relieving pain. It has good efficacy in treating post-traumatic ankle arthritis, synovitis, and phlegm-blood stasis obstruction, and has high safety.

[0012] In this invention, the sources of Astragalus membranaceus slices, Polygonum cuspidatum slices, Spatholobus suberectus slices, Caulis Spatholobi, Corydalis yanhusuo slices, and Asarum sieboldii slices are not limited, as long as they comply with the relevant requirements and general rules for processing of Chinese medicinal herbs in the current edition of the Chinese Pharmacopoeia.

[0013] The aforementioned Astragalus membranaceus slices, Polygonum cuspidatum slices, Spatholobus suberectus slices, Caulis Spatholobi slices, Corydalis yanhusuo slices, and Asarum sieboldii slices can be purchased at the Qingping Chinese Herbal Medicine Market.

[0014] As a preferred embodiment of the present invention, it comprises the following components in parts by weight: 45-50 parts Astragalus membranaceus granules, 30-35 parts Polygonum cuspidatum granules, 30-34 parts Spatholobus suberectus granules, 30-32 parts Tinospora sinensis granules, 22-25 parts Corydalis yanhusuo granules, and 7-8 parts Asarum sieboldii granules.

[0015] As a preferred embodiment of the present invention, it comprises the following components in parts by weight: 45 parts Astragalus membranaceus granules, 30 parts Polygonum cuspidatum granules, 30 parts Spatholobus suberectus granules, 30 parts Tinospora sinensis granules, 22 parts Corydalis yanhusuo granules, and 7 parts Asarum sieboldii granules.

[0016] As a preferred embodiment of the present invention, the preparation method of the Astragalus formula granules is as follows: Astragalus slices are decocted with water 2 to 3 times, each time adding 15 to 20 times the weight of the Astragalus slices of water, and each decoction is decocted for 20 to 40 minutes. The decoctions are combined, concentrated, dried, and excipients are added. The mixture is then granulated to obtain Astragalus formula granules.

[0017] The Astragalus membranaceus slices were soaked in water before being decocted.

[0018] As a preferred embodiment of the present invention, the preparation method of the Polygonum cuspidatum formula granules is as follows: Polygonum cuspidatum slices are decocted with water 2 to 3 times, each time adding 15 to 20 times the mass of Polygonum cuspidatum slices of water, and each decoction is decocted for 20 to 40 minutes. The decoctions are combined, concentrated, dried, and excipients are added. The mixture is then granulated to obtain Polygonum cuspidatum formula granules.

[0019] As a preferred embodiment of the present invention, the preparation method of the chicken blood vine formula granules is as follows: the chicken blood vine slices are decocted with water 2 to 3 times, each time adding 15 to 30 times the weight of the chicken blood vine slices of water, and each decoction is decocted for 20 to 50 minutes. The decoctions are combined, concentrated, dried, and excipients are added. The mixture is then granulated to obtain the chicken blood vine formula granules.

[0020] As a preferred embodiment of the present invention, the preparation method of the *Tinospora sinensis* formula granules is as follows: *Tinospora sinensis* slices are decocted with water 2-3 times, each time adding 10-15 times the mass of *Tinospora sinensis* slices of water, each time decocting for 20-50 minutes, the decoctions are combined, concentrated, dried, excipients are added, and granulated to obtain *Tinospora sinensis* formula granules.

[0021] As a preferred embodiment of the present invention, the preparation method of the Corydalis formula granules is as follows: Corydalis slices are decocted with water 2 to 3 times, each time adding 15 to 20 times the mass of Corydalis slices of water, and each decoction is decocted for 20 to 50 minutes. The decoctions are combined, concentrated, dried, and excipients are added. The mixture is then granulated to obtain Corydalis formula granules.

[0022] As a preferred embodiment of the present invention, the preparation method of the Asarum formula granules is as follows: Asarum slices are decocted with water 2 to 3 times, each time adding 10 to 15 times the mass of Asarum slices of water, and each decoction is decocted for 30 to 50 minutes. The decoctions are combined, concentrated, dried, and excipients are added. The mixture is then granulated to obtain Asarum formula granules.

[0023] In this invention, concentration refers to concentrating the decoction to a solid content (by weight percentage) of 30% to 50%.

[0024] In this invention, the excipients mentioned include at least one of starch, β-cyclodextrin, magnesium stearate, lactose, and maltodextrin.

[0025] In this invention, there are no special restrictions on the amount of excipients added, as long as they meet the requirements for the amount of excipients in the "Technical Requirements for the Research and Formulation of Quality Standards for Chinese Herbal Formula Granules".

[0026] This invention also provides a method for preparing a traditional Chinese medicine composition, comprising the following steps:

[0027] Mix Astragalus membranaceus granules, Polygonum cuspidatum granules, Spatholobus suberectus granules, Caulis Cimicifugae granules, Corydalis yanhusuo granules, and Asarum heterotropoides granules according to the specified ratio to obtain a mixture. Add 10 to 30 times the mass of the mixture to water and decoct to obtain a traditional Chinese medicine composition.

[0028] The present invention also provides the application of a traditional Chinese medicine composition in the preparation of drugs for treating ankle arthritis, synovitis or phlegm-blood stasis syndrome.

[0029] The beneficial effects of the present invention are as follows: (1) The traditional Chinese medicine composition of the present invention uses Astragalus membranaceus granules as the principal drug, Polygonum cuspidatum granules as the assistant drug, and Spatholobus suberectus granules, Caulis buergerianum granules, Corydalis yanhusuo granules, and Asarum sieboldii granules as adjuvant drugs. They are combined and synergistically enhanced to achieve the effects of invigorating qi and nourishing blood, relaxing muscles and tendons, promoting blood circulation and relieving pain. It has a good effect on treating post-traumatic ankle arthritis, synovitis, and phlegm-blood stasis obstruction, and is highly safe. (2) The traditional Chinese medicine composition of the present invention uses Astragalus membranaceus granules as the principal drug, Polygonum cuspidatum granules as the assistant drug, and Spatholobus suberectus granules, Caulis buergerianum granules, Corydalis yanhusuo granules, and Asarum sieboldii granules as adjuvant drugs. They are combined and synergistically enhanced to achieve the effects of invigorating qi and nourishing blood, relaxing muscles and tendons, promoting blood circulation and relieving pain. It has a good effect on treating post-traumatic ankle arthritis, synovitis, and phlegm-blood stasis obstruction, and is highly safe. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions in the embodiments of this application will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0031] In this application, the technical features described in an open-ended manner include both closed technical solutions consisting of the listed features and open technical solutions that include the listed features.

[0032] In this application, numerical ranges are referred to as continuous unless otherwise specified, and include the minimum and maximum values ​​of the range, as well as every value between the minimum and maximum values. Furthermore, when the range refers to integers, it includes every integer between the minimum and maximum values ​​of the range. Additionally, when multiple ranges are provided to describe a feature or characteristic, the ranges may be merged. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges to which they are incorporated.

[0033] In this application, there are no particular restrictions on the specific dispersion and mixing methods.

[0034] Unless otherwise specified, all components, raw materials, or instruments used in the embodiments and comparative examples of this invention are commercially available, and the same type of components and raw materials are used in each parallel experiment.

[0035] The preparation methods of the formulation particles used in the examples and comparative examples are as follows:

[0036] The preparation method of Astragalus formula granules is as follows: Soak Astragalus slices in water for 30 minutes, decoct twice with water, adding 18 times the weight of Astragalus slices of water each time, and decoct for 30 minutes each time. Combine the decoctions, concentrate, dry, and obtain the dried product. Add starch, granulate, and obtain Astragalus formula granules.

[0037] The preparation method of Polygonum cuspidatum formula granules is as follows: Polygonum cuspidatum slices are decocted twice with water, each time adding 18 times the mass of Polygonum cuspidatum slices of water, and each decoction is decocted for 30 minutes. The decoctions are combined, concentrated, and dried to obtain dried product. Starch is added, and the product is granulated to obtain Polygonum cuspidatum formula granules.

[0038] The preparation method of chicken blood vine formula granules is as follows: add water to chicken blood vine slices and decoct twice, adding 20 times the weight of chicken blood vine slices of water each time, and decoct for 35 minutes each time. Combine the decoctions, concentrate, dry, and obtain dried product. Add starch, granulate, and obtain chicken blood vine formula granules.

[0039] The preparation method of the Kuanjinteng formula granules is as follows: Kuanjinteng slices are decocted twice with water, each time adding 12 times the mass of Kuanjinteng slices of water, and each decoction is 30 minutes. The decoctions are combined, concentrated, and dried to obtain the dried product. Starch is added, and the product is granulated to obtain Kuanjinteng formula granules.

[0040] The preparation method of Corydalis formula granules is as follows: Corydalis slices are decocted twice with water, each time adding 18 times the weight of Corydalis slices of water, and each decoction is decocted for 35 minutes. The decoctions are combined, concentrated, dried, and excipients are added. The mixture is then granulated to obtain Corydalis formula granules.

[0041] The preparation method of Asarum formula granules is as follows: Asarum slices are decocted with water 3 times, each time adding 12 times the mass of Asarum slices of water, and each decoction is 45 minutes. The decoctions are combined, concentrated, and dried to obtain dried product. Starch is added and granulated to obtain Asarum formula granules.

[0042] The preparation method of earthworm decoction granules is as follows: earthworm decoction slices are decocted twice with water, each time adding 12 times the mass of earthworm decoction slices of water, and each decoction is decocted for 30 minutes. The decoctions are combined, concentrated, and dried to obtain dried product. Starch is added, and the product is granulated to obtain earthworm decoction granules.

[0043] The preparation method of Fangfeng formula granules is as follows: Fangfeng medicinal slices are decocted twice with water, each time adding 20 times the weight of Fangfeng medicinal slices of water, and each decoction is 35 minutes. The decoctions are combined, concentrated, and dried to obtain dried product. Starch is added and granulated to obtain Fangfeng formula granules.

[0044] The preparation method of Psoralea corylifolia formula granules is as follows: Psoralea corylifolia slices are decocted twice with water, each time adding 18 times the weight of Psoralea corylifolia slices of water, and each decoction is decocted for 30 minutes. The decoctions are combined, concentrated, and dried to obtain dried product. Starch is added, and the product is granulated to obtain Psoralea corylifolia formula granules.

[0045] In the preparation of Astragalus membranaceus formula granules, Polygonum cuspidatum formula granules, Spatholobus suberectus formula granules, Tinospora sinensis formula granules, Corydalis yanhusuo formula granules, Asarum sieboldii formula granules, Pheretima aspergillum formula granules, Saposhnikovia divaricata formula granules, and Psoralea corylifolia formula granules, the mass ratio of dried matter to starch is 1:1.5.

[0046] Examples and Comparative Examples

[0047] The formulations of Examples 1-4 and Comparative Examples 1-7 are shown in Table 1.

[0048] The preparation methods of the traditional Chinese medicine compositions in the examples and comparative examples are as follows: Mix the granules of each traditional Chinese medicine formula evenly according to the ratio, add 15 times the mass of water of the mixture and decoct for 2 hours to obtain the traditional Chinese medicine composition.

[0049] Table 1

[0050]

[0051] Test case

[0052] I. Toxicity test: Adult female Kunming rats were provided by the Experimental Animal Center of Shandong University.

[0053] (1) Acute toxicity: 110 female Kunming rats were divided into 11 groups of 10 rats each. The traditional Chinese medicine compositions of the examples and comparative examples were administered to the rats respectively. The dosage was 132 times the clinical dosage for humans (50 kg). 24 hours and 7 days after administration, no abnormalities were observed in the activity of the Kunming rats. Their fur was glossy and their stools were normal, indicating that the traditional Chinese medicine composition of this application is relatively safe.

[0054] (2) Long-term toxicity: Another 99 female Kunming rats were divided into 33 groups of 3 rats each. The traditional Chinese medicine compositions of each example and comparative example were administered to the Kunming rats at 3 times, 2 times, and 1 times the equivalent of the clinical dose for humans (50 kg), respectively, for 60 consecutive days. After 60 days, no abnormalities were found in the white blood cell count, alanine aminotransferase (ALT), post-traumatic ankle arthritis, phlegm-blood stasis syndrome, and blood urea nitrogen in the Kunming rats of each group. Routine pathological microscopy also revealed no drug-related pathological changes, indicating that the traditional Chinese medicine compositions of this application have no significant toxic effects with long-term use.

[0055] II. Clinical Trials

[0056] 1. Experimental materials: Traditional Chinese medicine compositions of the examples and comparative examples.

[0057] 2. Experimental Basis: The experimental protocol was developed based on the "Regulations for Drug Registration Management", "Good Clinical Practice for Drug Clinical Trials", "Regulations for the Reporting and Monitoring of Adverse Drug Reactions", "Advances in Pharmacology and Clinical Research of Traditional Chinese Medicine" (Volume 8, edited by Zhang Yongxiang and Zhou Wenxia), "Practical Orthopedics" (4th edition, edited by Xu Shaoting, Ge Baofeng, and Lu Shibi), "Internal Medicine of Traditional Chinese Medicine" (10th edition, edited by Zhang Boli and Wu Mianhua), "Traditional Chinese Medicine Orthopedics and Traumatology" (10th edition, edited by Huang Guicheng and Wang Yongjun), and relevant pharmacological and toxicological experimental and clinical research data of Astragalus membranaceus formula granules.

[0058] 3. Experimental objective: To evaluate the safety and efficacy of the traditional Chinese medicine compositions in the examples and comparative examples for treating bone arthritis (post-traumatic ankle arthritis, phlegm and blood stasis obstruction).

[0059] 4. Experimental Design: Ten adults aged 18–50 years were included in each of the experimental, comparative, and control groups. The experimental and comparative groups had the same diet. The experimental, comparative, and control groups took 10g of the traditional Chinese medicine composition twice a day, morning and evening. The control group took one tablet of etoricoxib (120mg / tablet) orally daily. To reduce interference factors, the experimental, comparative, and control groups were not allowed to take other medications during the experiment. At the same time, the experimental, comparative, and control groups underwent the same degree of functional exercise and were followed up regularly.

[0060] 5. Selection of subjects

[0061] 5.1 Diagnostic criteria

[0062] 5.1.1 Diagnostic criteria for bone pain: formulated based on "Internal Medicine of Traditional Chinese Medicine" (10th edition, edited by Zhang Boli and Wu Mianhua) and "Orthopedics and Traumatology of Traditional Chinese Medicine" (10th edition, edited by Huang Guicheng and Wang Yongjun).

[0063] (1) Pain, soreness, numbness, heaviness in the limbs, joints, and muscles; difficulty in flexion and extension; or wandering pain; or even severe joint pain, swelling, stiffness, deformity, and movement disorders.

[0064] (2) The onset and severity of the disease are often related to congenital endowment, fatigue, cold climate, damp environment, and improper diet.

[0065] 5.1.2 Diagnostic criteria for post-traumatic ankle arthritis

[0066] 1. Medical History: History of chronic cumulative joint injury or significant trauma; 2. Clinical Manifestations: The main clinical symptoms are joint stiffness, swelling, decreased joint range of motion, local inflammation, and increased pain with increased activity. In severe cases, limping may occur. 3. Imaging: X-ray or CT scans show narrowing of the ankle joint space, subchondral articular surface sclerosis, osteophyte formation, and loose bodies within the joint; MRI shows ankle ligament injury, subchondral edema, and cartilage damage.

[0067] 5.1.3 Traditional Chinese Medicine Differentiation Criteria for Phlegm-Blood Stasis and Arthralgia

[0068] Based on "Internal Medicine of Traditional Chinese Medicine" (10th edition, edited by Zhang Boli and Wu Mianhua) and "Orthopedics and Traumatology of Traditional Chinese Medicine" (1st edition, edited by Huang Guicheng and Wang Yongjun), the TCM diagnostic criteria and syndrome scoring criteria for phlegm-stasis obstruction syndrome are proposed.

[0069] (1) Main symptoms: ① Stabbing pain in joints and muscles, fixed and unmoving; ② Dark purple and swollen skin around joints, which feels hard when pressed.

[0070] (2) Secondary symptoms: ① numbness and heaviness in the limbs; ② stiffness and deformity of the joints, difficulty in flexion and extension; ③ nodules or ecchymosis; ④ chest tightness and excessive phlegm.

[0071] (3) The tongue is dark purple or has ecchymosis, and the tongue is white and greasy.

[0072] (4) The pulse is wiry, slippery, or hesitant.

[0073] If the above primary symptoms are present, along with two or more secondary symptoms, and the tongue and pulse signs are combined, a diagnosis can be established.

[0074] 5.1.4 Pain and joint function assessment: The assessment should be conducted weekly after medication and the results should be recorded.

[0075] The AOFAS ankle-hindfoot score was used: regular follow-up examinations were conducted after clinical fracture healing, and lower leg joint function was assessed. Pain, walking ability, gait, lower leg joint range of motion, ankle stability, and joint alignment were evaluated separately, with a full score of 100 points and a score of 75 or above considered excellent.

[0076] The AOFAS ankle-hindfoot score was used: the visual analog scale consists of a 100mm straight line. The left end of the line is marked as no pain and the right end as severe pain. The pain is less severe as it is further to the left and more severe as it is further to the right. Patients mark the point on the line where they can best reflect their pain level with an intersecting line. The length from the left end of the line to the mark is then measured with a ruler to obtain the patient's pain score.

[0077] For detailed scoring rules, please refer to the AOFAS ankle-hindfoot score and AOFAS ankle-hindfoot score.

[0078] Table 2

[0079]

[0080] 5.1.5 Traditional Chinese Medicine Syndrome Scoring Standard

[0081] Table 3 Standards for TCM Syndrome Scoring

[0082]

[0083]

[0084] 5.2.1 Inclusion Criteria

[0085] (1) Meets the diagnostic criteria of Western medicine for traumatic post-ankle arthritis, traditional Chinese medicine for bone arthritis, and traditional Chinese medicine for phlegm-blood stasis syndrome.

[0086] (2) Adults aged 18-50.

[0087] (3) Actively cooperate with treatment and follow-up.

[0088] (4) Those who voluntarily sign the informed consent form.

[0089] 5.2.2 Exclusion Criteria

[0090] (1) Those who do not meet the inclusion criteria.

[0091] (2) Individuals with joint infections such as osteomyelitis or suppurative arthritis.

[0092] (3) Patients with serious primary diseases of vital organs such as the heart, lungs, liver, and kidneys.

[0093] (4) Individuals with endocrine disorders such as thyroid disease or adrenal gland disease.

[0094] (5) Those with mental illness who cannot cooperate with treatment and follow-up.

[0095] (6) Individuals with allergic constitution or allergy to any of the ingredients in this product.

[0096] (7) Women who are pregnant or have plans to become pregnant within the next 3 months, and women who are breastfeeding.

[0097] (8) Those who have received other treatments or medications within the past 3 months, or who have participated in other clinical trials within the past month.

[0098] 5.2.3 Case Exclusion Criteria

[0099] Cases already enrolled but meeting one of the following criteria should be excluded:

[0100] (1) Those who were included even though they did not meet the inclusion criteria.

[0101] (2) Those who fail to take medication as prescribed, making it impossible to determine the efficacy, or whose incomplete data affects the assessment of efficacy or safety.

[0102] 5.2.4 Criteria for Subject Dropout and Withdrawal

[0103] All participants who have completed the informed consent form and passed the screening process have the right to withdraw from the trial at any time. Regardless of when they withdraw, as long as they have not completed the entire clinical trial, they are considered dropouts.

[0104] (1) Researcher's decision to withdraw

[0105] For enrolled participants, researchers may decide to withdraw them from the experiment if any of the following situations occur during the study.

[0106] ① Those who terminated the trial due to serious adverse reactions during the trial period.

[0107] ② Assessment of other diseases that occur in the subjects during the trial and affect the efficacy and adverse events.

[0108] ③ The researchers believe that the subject is not suitable to continue receiving the study drug.

[0109] (2) Withdrawal by the subject

[0110] ① The subject withdrew the informed consent form.

[0111] ②Those who have poor treatment results, are unwilling to continue the trial treatment, or whose symptoms worsen and are unable to complete the trial.

[0112] ③ Adverse events that cannot be tolerated.

[0113] (3) Other reasons

[0114] 5.2.5 Handling of Dropout Cases

[0115] (1) After the subjects fall off the test, the researchers should contact the subjects as much as possible by means of telephone, appointment, follow-up, etc., and ask for the reasons, record the last time of medication, and complete the assessment items that can be completed.

[0116] (2) For subjects who withdraw from or interrupt the study, the final evaluation (treatment end visit) should be completed as much as possible. The evaluation process, results, and description of the reasons for subject withdrawal must be recorded in detail in the original data and case report form.

[0117] 5.2.6 Test Termination Criteria

[0118] (1) The ethics committee, sponsor or investigator believes that the investigational drug poses a significant safety risk.

[0119] (2) Sponsors may terminate the study for any scientific, medical or ethical reason, but must take into full account the rights, safety and health of the participants in the study.

[0120] (3) Other reasons why the sponsor or researcher deems it inappropriate to continue the experiment.

[0121] 6. Test Results

[0122] As shown in Table 4.

[0123] Table 4

[0124]

[0125] As can be seen from Table 4, the traditional Chinese medicine composition of the present invention has the effects of invigorating qi and promoting blood circulation, removing blood stasis and dispelling cold, and unblocking collaterals and relieving pain. It has a good effect on treating post-traumatic ankle arthritis, synovitis, and phlegm and blood stasis obstruction. The traditional Chinese medicine composition is safe and has no side effects.

[0126] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, It is prepared from the following components in parts by weight: 30-60 parts Astragalus membranaceus granules, 20-40 parts Polygonum cuspidatum granules, 20-40 parts Spatholobus suberectus granules, 20-40 parts Tinospora sinensis granules, 15-30 parts Corydalis yanhusuo granules, and 5-10 parts Asarum sieboldii granules.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is prepared from the following components in parts by weight: 45-50 parts Astragalus membranaceus granules, 30-35 parts Polygonum cuspidatum granules, 30-34 parts Spatholobus suberectus granules, 30-32 parts Tinospora sinensis granules, 22-25 parts Corydalis yanhusuo granules, and 7-8 parts Asarum sieboldii granules.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the Astragalus formula granules is as follows: Astragalus slices are decocted with water 2-3 times, each time adding 15-20 times the weight of the Astragalus slices of water, and each decoction is 20-40 minutes. The decoctions are combined, concentrated, dried, and excipients are added. The mixture is then granulated to obtain Astragalus formula granules.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the Polygonum cuspidatum formula granules is as follows: Polygonum cuspidatum slices are decocted with water 2-3 times, each time adding 15-20 times the weight of Polygonum cuspidatum slices of water, and each decoction is 20-40 minutes. The decoctions are combined, concentrated, dried, and excipients are added. The mixture is then granulated to obtain Polygonum cuspidatum formula granules.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the chicken blood vine formula granules is as follows: add water to the chicken blood vine slices and decoct 2-3 times, adding 15-30 times the weight of the chicken blood vine slices of water each time, and decoct for 20-50 minutes each time. Combine the decoctions, concentrate, dry, add excipients, and granulate to obtain chicken blood vine formula granules.

6. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the *Vitis thunbergii* formula granules is as follows: *Vitis thunbergii* slices are decocted with water 2-3 times, each time adding 10-15 times the weight of *Vitis thunbergii* slices of water, and each decoction is 20-50 minutes. The decoctions are combined, concentrated, dried, and excipients are added. The mixture is then granulated to obtain *Vitis thunbergii* formula granules.

7. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the Corydalis formula granules is as follows: Corydalis slices are decocted with water 2-3 times, each time adding 15-20 times the weight of the Corydalis slices of water, and each decoction is decocted for 20-50 minutes. The decoctions are combined, concentrated, dried, and excipients are added. The mixture is then granulated to obtain Corydalis formula granules.

8. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the Asarum formula granules is as follows: Asarum slices are decocted with water 2-3 times, each time adding 10-15 times the weight of the Asarum slices of water, and each decoction is 30-50 minutes. The decoctions are combined, concentrated, dried, and excipients are added. The mixture is then granulated to obtain Asarum formula granules.

9. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 8, characterized in that, Includes the following steps: Mix Astragalus membranaceus granules, Polygonum cuspidatum granules, Spatholobus suberectus granules, Caulis Cimicifugae granules, Corydalis yanhusuo granules, and Asarum heterotropoides granules according to the specified ratio to obtain a mixture. Add 10 to 30 times the mass of the mixture to water and decoct to obtain a traditional Chinese medicine composition.

10. The use of the traditional Chinese medicine composition according to any one of claims 1 to 8 in the preparation of a medicine for treating ankle arthritis, synovitis, or phlegm-blood stasis syndrome.

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