A traditional Chinese medicine composition for osteoarthritis and a preparation method thereof

Abstract

The present application relates to the medical technology field, especially to a kind of traditional Chinese medicine composition for osteoarthritis and preparation method thereof, and the inventor combines the characteristics of TCM syndrome differentiation and treatment and holistic concept, and summarizes a traditional Chinese medicine composition for treating knee osteoarthritis, which is prepared from the following components in parts by mass: angelica 10-14 parts, safflower 8-12 parts, frankincense 4-6 parts, myrrh 4-6 parts, redwood 8-10 parts, borneol 0.2-0.4 parts, and linseed oil 22-30 parts.The traditional Chinese medicine composition can be directly used externally according to the use method of traditional Chinese medicine prescription, and has good efficacy and patient adaptability according to the clinical trials of the inventor, can effectively treat joint pain problems of patients with osteoarthritis, and has no toxic side effects.The process of the present application is simple, and has good operability and wide application prospect.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a traditional Chinese medicine composition for osteoarthritis and its preparation method. Background Technology

[0002] Osteoarthritis (OA) is a common degenerative joint disease among middle-aged and elderly people. The resulting joint swelling, pain, deformity, and limited mobility severely impact patients' quality of life. According to the latest epidemiological data and the 2018 edition of the "Guidelines for the Diagnosis and Treatment of Osteoarthritis," the incidence of symptomatic KOA is approximately 8.1%, with significant regional differences. The incidence is significantly higher in the southwest and northwest regions than in North China and the eastern coastal areas, and higher in rural areas than in urban areas. With the increasing aging of the population, the incidence of this disease is rising year by year, and it is projected to become the fourth leading cause of disability by 2020. Furthermore, since there is currently no cure for OA, conservative treatment can only temporarily relieve symptoms and is prone to recurrence.

[0003] KOA treatment has always been a challenge in clinical practice. The latest guidelines propose a stepwise treatment approach, which will greatly improve the diagnosis and treatment rate for clinicians. However, choosing conservative treatment drugs for KOA remains a challenging task in clinical practice. Most drugs lack specific targets and have significant toxic side effects. Furthermore, most patients cannot adhere to long-term, regular medication, leading to continuous disease progression and ultimately requiring expensive joint replacement surgery, causing immense suffering and financial burden for patients. The new guidelines introduce the use of traditional Chinese medicine (TCM) for KOA treatment for the first time, suggesting that TCM can effectively alleviate symptoms through multiple pathways; however, its mechanism of action and long-term efficacy remain unclear.

[0004] Oral medications for knee osteoarthritis have a clear mechanism of action and definite efficacy, but they are prone to side effects and symptom recurrence in clinical practice. While surgical treatment offers rapid relief, it still inevitably leads to postoperative joint mobility limitations. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for osteoarthritis and its preparation method, so as to solve the technical problems of how to effectively improve the side effects, recurring symptoms and postoperative joint mobility disorders that are prone to occur in clinical practice through traditional Chinese medicine formulas.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0007] This invention provides a traditional Chinese medicine composition for osteoarthritis, which is prepared from the following components in parts by weight: 10-14 parts Angelica sinensis, 8-12 parts Carthamus tinctorius, 4-6 parts Boswellia carterii, 4-6 parts Commiphora myrrha, 8-10 parts Sappanwood, 0.2-0.4 parts Borneol, and 22-30 parts Flaxseed oil.

[0008] Preferably, it is prepared from the following components in parts by weight: 12 parts Angelica sinensis, 10 parts Carthamus tinctorius, 5 parts Boswellia carterii, 5 parts Myrrh, 9 parts Sappanwood, 0.3 parts Borneol, and 26 parts Flaxseed Oil.

[0009] This invention also provides a method for preparing a traditional Chinese medicine composition for osteoarthritis, comprising the following steps:

[0010] 1) Mix angelica, safflower, frankincense, myrrh, sappanwood and borneol to obtain a mixture;

[0011] 2) Grind and sieve the mixture to obtain the undersize material;

[0012] 3) Heat the flaxseed oil and add it to the sieved material obtained in step 2) and stir to obtain a traditional Chinese medicine composition for osteoarthritis.

[0013] Preferably, the grinding speed in step 2) is 2200-2600 rpm.

[0014] Preferably, the grinding time in step 2) is 2 to 4 minutes.

[0015] Preferably, in step 2), the mesh size of the sieve is 280-320 mesh, and the sieve is passed twice.

[0016] Preferably, the heating temperature in step 3) is 58–62°C.

[0017] Based on long-term clinical practice and combining the characteristics of traditional Chinese medicine's syndrome differentiation and treatment and holistic approach, the inventors of this invention have developed a traditional Chinese medicine composition (Liu Sheng Qu Tong Gao) for treating knee osteoarthritis. This composition can be applied directly externally according to the usage instructions of traditional Chinese medicine prescriptions. According to the inventors' clinical trials, its efficacy is definite and it is well-tolerated by patients. Specifically, this invention provides a traditional Chinese medicine composition for knee osteoarthritis, made from the following raw materials:

[0018] Angelica sinensis (Latin: ANGELICA SINENSIS; Part: This product is the dried root of Angelica sinensis (Oliv.) Diels, a plant of the Apiaceae family. Processing method: Remove the fibrous roots and dirt, after the moisture has evaporated slightly, bundle them into small bunches, put them on a rack, and slowly dry them with smoke, then slice them thinly; used raw or processed with wine.) is the principal herb, with a sweet, pungent, and warm taste; it nourishes and invigorates blood, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements. The Compendium of Materia Medica records: "It treats headaches, various pains in the heart and abdomen, moistens the intestines, stomach, muscles, bones, and skin, treats carbuncles, drains pus and relieves pain, and harmonizes and nourishes blood."

[0019] Safflower (Latin: CARTHAMUS TINCTORIUS L., Part: This product is the dried flower of Carthamus tinctorius L., a plant of the Asteraceae family. Harvested in summer when the flowers turn from yellow to red, and dried in the shade or sun. Processing method: This product has a slightly fragrant odor and a slightly bitter taste. The best quality is characterized by its bright red-yellow color and soft texture. Used raw.) It is an assistant herb, pungent and warm; it invigorates blood circulation, promotes menstruation, disperses blood stasis, and relieves pain.

[0020] Frankincense (Latin: BOSWELLIA SACRA; Part: This product is the resin exuded from the bark of Boswellia carterii Birdw and its related species Boswellia bhawdajian Birdw., belonging to the Burseraceae family. Processing method: Cut the bark of the trunk sequentially from bottom to top to allow the resin to exudate. After several days, it will solidify and can then be harvested. It can be crushed and used raw; for internal use, it is mostly stir-fried.) It is an assistant herb, pungent, bitter, and warm in nature. It invigorates blood circulation, relieves pain, reduces swelling, and promotes tissue regeneration. The *Compendium of Materia Medica* records: "Frankincense is a medicine that invigorates blood circulation, dispels wind, relaxes muscles, and relieves pain… It is also commonly used for falls, injuries, and postpartum pain due to blood stasis and abdominal pain."

[0021] Myrrh (Latin: COMMIPHORA MYRRHA, part: the dried resin of the Burseraceae plant Commiphora amyrrha Engl. or Commiphora molmol Engl.. Preparation method: Collect the oleoresin that has seeped into the air from cracks in the bark, turning into reddish-brown hard lumps, remove impurities, crush, and roast with vinegar before use.) It is an assistant herb, pungent, bitter, and neutral; it disperses blood stasis, relieves pain, reduces swelling, and promotes tissue regeneration. The *Introduction to Medicine* records: "This herb promotes the elimination of old blood stasis, thus breaking up stagnant blood, reducing swelling, and relieving pain; it is a remarkable medicine for sores."

[0022] Sappanwood (Latin: CAESALPINIA SAPPAN; Part: This product is the dried heartwood of Caesalpinia sappan L., a plant of the Fabaceae family. Processing method: Remove the white sapwood, dry. Saw into sections about 3cm long, then split into pieces or grind into coarse powder, used raw.) is used as an adjuvant medicine; sweet, salty, and neutral; it invigorates blood circulation, removes blood stasis, reduces swelling, and relieves pain. The *Rihuazi Materia Medica* records: "It drains pus, relieves pain, reduces carbuncles and swelling, and replenishes blood stasis."

[0023] Borneol (Latin: Dryobalanops aromatica Gaertn.f., Part: This product is a processed product of the resin of Dryobalanops aromatica Gaertn.f., a plant of the Dipterocarpaceae family, or crystals obtained by distillation and cooling of the trunk and branches of the Dryobalanops tree. Processing method: Grind into powder for use.) It is used as an adjuvant medicine; it is pungent, bitter, and slightly cold; it opens the orifices and awakens the mind, clears heat and relieves pain. The *Yilin Zuanyao* records: "Borneol mainly disperses stagnant heat, can penetrate bone heat, treats convulsions, phlegm obstruction, sore throat, tongue swelling, toothache, deafness... However, it disperses and is easily depleted, ultimately returning to a cold nature."

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] Conservative treatments for knee osteoarthritis lack effective external medications to improve pain symptoms and joint mobility. This invention summarizes a combination of external Chinese medicines that can be used to improve the clinical symptoms of patients with knee osteoarthritis through long-term clinical practice. It can be applied directly to the affected area according to the usage instructions of Chinese medicine prescriptions. According to the inventors' clinical trials, it has definite efficacy and good patient adaptability. Detailed Implementation

[0026] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0027] Example 1

[0028] A method for preparing and using a traditional Chinese medicine composition for osteoarthritis, comprising the following steps:

[0029] I. Formula: Angelica sinensis 100g, safflower 80g, frankincense 40g, myrrh 40g, sappanwood 80g, borneol 2g is one dose.

[0030] II. Preparation method:

[0031] (2) After mixing all the above raw materials evenly, use Zhizhong Chinese medicine pulverizer at 2200 rpm for 4 minutes;

[0032] (3) After grinding evenly, sieve twice through a 280-mesh sieve to remove residue;

[0033] (4) Heat 220g of flaxseed oil to 58℃ and pour it into 342g of raw material. Stir until it becomes a paste to obtain Liusheng Pain Relief Paste.

[0034] (5) Pack into a dry sterilized container.

[0035] III. Instructions for use:

[0036] (1) Position selection: When applying Liusheng Qutong Gao, fully expose the affected area and adopt an appropriate position so that the medicine can be fixed securely.

[0037] (2) Preparation of local skin: Perform routine disinfection on the area where topical medication is to be applied, as the skin may become red, blistered, and broken due to drug irritation, making it prone to infection. Before application, usually wash the area with warm water and then begin application.

[0038] (3) Fixation of the medication: In order to ensure the efficacy of the medication, the topical medication should be fixed to prevent it from moving or falling off. The fixation method is to cover it with gauze or oil paper and then fix it with adhesive tape.

[0039] (4) Application time: The application time of Liusheng Pain Relief Plaster is 6 hours. For the elderly, children and those with weak constitution, the application time can be appropriately shortened. If skin allergies, itching or pain that is difficult to tolerate occur during the application time, the application should be stopped immediately.

[0040] (5) Application method: Apply Liusheng Pain Relief Ointment evenly to the affected area, covering the entire affected area with a thickness of about 1cm. Use once a day.

[0041] Example 2

[0042] A method for preparing and using a traditional Chinese medicine composition for osteoarthritis, comprising the following steps:

[0043] I. Formula: Angelica sinensis 140g, safflower 120g, frankincense 60g, myrrh 60g, sappanwood 100g, borneol 4g constitute one dose.

[0044] II. Preparation method:

[0045] (1) After mixing all the above raw materials evenly, use Zhizhong Chinese medicine pulverizer at 2600 rpm for 2 minutes;

[0046] (3) After grinding evenly, use a 320-mesh sieve to sieve twice to remove residue;

[0047] (4) Take 300g of flaxseed oil, heat it to 62℃, pour it into 484g of raw material, stir until it becomes a paste, and obtain Liusheng Pain Relief Paste;

[0048] (5) Pour into a dry sterilized container

[0049] III. Instructions for use:

[0050] (1) Position selection: When applying Liusheng Qutong Gao, fully expose the affected area and adopt an appropriate position so that the medicine can be fixed securely.

[0051] (2) Preparation of local skin: Perform routine disinfection on the area to which the topical medication is applied, as the skin may become red, blistered, and broken due to drug irritation, making it prone to infection. Disinfect the area with a 75% ethanol cotton ball before application.

[0052] (3) Fixation of the medication: In order to ensure the efficacy of the medication, the topical medication should be fixed to prevent it from moving or falling off. The fixation method is to cover it with gauze or oil paper and then fix it with adhesive tape.

[0053] (4) Application time: The application time of Liusheng Pain Relief Plaster is 4 hours. For the elderly, children and those with weak constitution, the application time can be appropriately shortened. If skin allergies, itching or pain that is difficult to tolerate occurs during the application time, the application should be stopped immediately.

[0054] (5) Application method: Apply Liusheng Pain Relief Ointment evenly to the affected area, covering the entire affected area with a thickness of about 1cm. Use once a day.

[0055] Example 3

[0056] A method for preparing and using a traditional Chinese medicine composition for osteoarthritis, comprising the following steps:

[0057] I. Formula: Angelica sinensis 120g, safflower 100g, frankincense 50g, myrrh 50g, sappanwood 90g, borneol 3g is one dose.

[0058] II. Preparation method:

[0059] (1) After mixing all the above raw materials evenly, use Zhizhong Chinese medicine pulverizer at 2500 rpm for 3 minutes;

[0060] (3) After grinding evenly, sieve twice through a 300-mesh sieve to remove residue;

[0061] (4) Heat 260g of flaxseed oil to 60℃ and pour it into 413g of raw material. Stir until it becomes a paste to obtain Liusheng Pain Relief Paste.

[0062] (5) Pour into a dry sterilized container

[0063] The usage method is the same as in Example 2.

[0064] Application Example 1

[0065] Specific examples:

[0066] Ms. Pan, medical record number: XXX782, 68 years old.

[0067] Chief complaint: Pain in both knees with limited mobility for 3 years, with the left knee worsening for 2 months.

[0068] Present Illness: The patient reported experiencing dull pain in both knees after exertion 3 years ago, accompanied by limited joint flexion and extension, especially when climbing stairs, and difficulty squatting. At the time, the patient did not pay much attention to it, and the symptoms were relieved by rest and physical therapy. For the past 3 years, the patient has experienced recurrent pain in both knees, which worsens after prolonged walking and exertion. The patient has not sought systematic medical treatment. Two months ago, the patient experienced increased pain in the left knee, accompanied by limited joint movement. Seeking further systematic treatment, the patient came to our hospital and was admitted to our department with a diagnosis of "bilateral knee osteoarthritis." Admission findings: The patient is alert but lethargic; complains of stabbing pain in both knees, with a fixed location, severe pain at night, weakness in the lower back, and limited joint movement, especially when climbing stairs and squatting, making it difficult to bear weight for extended periods; poor sleep, normal appetite, and regular bowel movements.

[0069] Specialist examination: The shape of both knee joints is generally normal, with no obvious swelling. There is tenderness in the medial joint space and patellofemoral joint. The range of motion of both knee joints is: flexion 120 degrees, extension 0 degrees, rotation 0 degrees. Patellar tapping test (-), patellar extension test (+), drawer test (-), Lachmann test (-), lateral stress test (-), gyrocompression test (+), McMurray sign (+), axis shift test (-).

[0070] Western medical diagnosis: Osteoarthritis of both knees

[0071] Traditional Chinese Medicine Diagnosis: Knee Bi Syndrome - Liver and Kidney Deficiency Syndrome

[0072] Treatment: Tonifying the liver and kidneys. After one month of treatment with the medication described in Example 3 of this invention, the knee pain symptoms were significantly relieved, and no recurrence has been observed to date. To ensure patient privacy, the patient's identity is not disclosed here. The patient's identity information and medical record number are archived at the Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital and are available for review.

[0073] Application Example 2

[0074] Specific examples:

[0075] Mr. Mai, male, medical record number: XXX946, 52 years old.

[0076] Chief complaint: Bilateral knee pain and discomfort with limited range of motion for more than one year, which has worsened in the past week.

[0077] Present Illness: The patient reported experiencing dull pain in both knees after exertion one year ago, accompanied by limited joint mobility, especially when climbing stairs and squatting. At the time, the patient did not pay much attention to the symptoms, which were relieved by rest and physical therapy. For the past year, the patient has experienced recurrent pain in both knees, which worsens after prolonged walking or exertion. The patient has not sought systematic medical treatment. One week ago, the patient experienced increased pain in both knees, accompanied by limited joint mobility. Seeking further systematic treatment, the patient came to our hospital and was admitted to our department with a diagnosis of "bilateral knee osteoarthritis." Admission Findings: The patient is alert but lethargic; complains of stabbing pain in both knees, with a fixed location, worse at night; weakness in the lower back; limited joint mobility, especially when climbing stairs and squatting; difficulty bearing weight for extended periods; poor sleep; normal appetite and bowel movements.

[0078] Specialist examination: The shape of both knee joints is generally normal, with no obvious swelling. There is tenderness in the medial joint space and patellofemoral joint. The range of motion of both knee joints is: flexion 120 degrees, extension 0 degrees, rotation 0 degrees. Patellar tapping test (-), patellar extension test (+), drawer test (-), Lachmann test (-), lateral stress test (-), gyrocompression test (+), McMurray sign (+), axis shift test (-).

[0079] Western medicine diagnosis: Bilateral knee osteoarthritis

[0080] Traditional Chinese Medicine Diagnosis: Knee Bi Syndrome - Liver and Kidney Deficiency Syndrome

[0081] Treatment: Nourishing the liver and kidneys. After one month of treatment with the drug obtained in Example 3 of this invention, the knee pain symptoms were significantly relieved, and no recurrence has been observed to date. To ensure patient privacy, the patient's identity is not disclosed here. The patient's identity information and medical record number are archived at the Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital and are available for review.

[0082] Application Example 3

[0083] Specific examples:

[0084] Ms. Li, medical record number: XXX722, 71 years old.

[0085] Chief complaint: Pain in both knees with limited mobility for 4 years, with the right knee worsening in the past 2 months.

[0086] Present Illness: The patient reported experiencing dull pain in both knees four years ago after exertion, accompanied by limited joint mobility, especially when climbing stairs and squatting. At the time, the patient did not pay much attention to the symptoms, which were relieved by rest and physical therapy. For the past four years, the patient has experienced recurrent pain in both knees, which worsens after prolonged walking or exertion. The patient has not sought systematic medical treatment. Two months ago, the patient experienced increased pain in the right knee, accompanied by limited joint mobility. Seeking further systematic treatment, the patient came to our hospital and was admitted to our department with a diagnosis of "bilateral knee osteoarthritis." Admission Examination: The patient was alert but lethargic; complained of stabbing pain in both knees, with a fixed location, severe pain at night, weakness in the lower back, and limited joint mobility, especially when climbing stairs and squatting, difficulty bearing weight for extended periods, and poor sleep. Appetite was good, and bowel movements were normal.

[0087] Specialist examination: The shape of both knee joints is generally normal, with no obvious swelling. There is tenderness in the medial joint space and patellofemoral joint. The range of motion of both knee joints is: flexion 120 degrees, extension 0 degrees, rotation 0 degrees. Patellar tapping test (-), patellar extension test (+), drawer test (-), Lachmann test (-), lateral stress test (-), gyrocompression test (+), McMurray sign (+), axis shift test (-).

[0088] Western medicine diagnosis: Bilateral knee osteoarthritis

[0089] Traditional Chinese Medicine Diagnosis: Knee Bi Syndrome - Liver and Kidney Deficiency Syndrome

[0090] Treatment: Nourishing the liver and kidneys. After one month of treatment with the drug obtained in Example 3 of this invention, the knee pain symptoms were significantly relieved, and no recurrence has been observed to date. To ensure patient privacy, the patient's identity is not disclosed here. The patient's identity information and medical record number are archived at the Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital and are available for review.

[0091] Application Example 4

[0092] Specific examples:

[0093] Ms. A, medical record number: XXX967, 71 years old.

[0094] Chief complaint: Pain in both knees with limited mobility for 10 years, with the right knee worsening in the past 5 months.

[0095] Present Illness: The patient reported experiencing dull pain in both knees 10 years ago after exertion, accompanied by limited joint mobility, especially when climbing stairs and squatting. At the time, the patient did not pay much attention to it, and the symptoms were relieved by rest and physical therapy. For the past 10 years, the patient has experienced recurrent pain in both knees, which worsens after prolonged walking or exertion. The patient has not sought systematic medical treatment. Five months ago, the patient experienced increased pain in the left knee, accompanied by limited joint mobility. Seeking further systematic treatment, the patient came to our hospital and was admitted to our department with a diagnosis of "bilateral knee osteoarthritis." Admission Findings: The patient was alert but lethargic; complained of stabbing pain in both knees, with a fixed location, worse at night; weakness in the lower back; limited joint mobility, especially when climbing stairs and squatting; difficulty bearing weight for extended periods; poor sleep; normal appetite and bowel movements.

[0096] Specialist examination: The shape of both knee joints is generally normal, with no obvious swelling. There is tenderness in the medial joint space and patellofemoral joint. The range of motion of both knee joints is: flexion 120 degrees, extension 0 degrees, rotation 0 degrees. Patellar tapping test (-), patellar extension test (+), drawer test (-), Lachmann test (-), lateral stress test (-), gyrocompression test (+), McMurray sign (+), axis shift test (-).

[0097] Western medical diagnosis: Osteoarthritis of both knees

[0098] Traditional Chinese Medicine Diagnosis: Knee Bi Syndrome - Liver and Kidney Deficiency Syndrome

[0099] Treatment: Nourishing the liver and kidneys. After one month of treatment with the drug obtained in Example 3 of this invention, the knee pain symptoms were significantly relieved, and no recurrence has been observed to date. To ensure patient privacy, the patient's identity is not disclosed here. The patient's identity information and medical record number are archived at the Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital and are available for review.

[0100] Experimental Example 1: Clinical trial of the efficacy of the traditional Chinese medicine composition of the present invention.

[0101] To demonstrate the effectiveness of this invention in improving the symptoms of osteoarthritis, the following therapeutic trials were conducted.

[0102] 1. Basic Experimental Design

[0103] Sixty-six patients with osteoarthritis were observed. The treatment group consisted of 33 patients, including 6 males and 33 females, with an average disease duration of 3 years. The control group consisted of 33 patients, including 9 males and 24 females, aged 40 to 89 years, with a disease duration of 1 to 10 years.

[0104] The diagnostic criteria were based on the 2022 NICE guidelines "Diagnosis and Management of Osteoarthritis in Individuals Over 16 Years of Age (NG.226)". The efficacy evaluation was based on the 2019 "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine". The trial was conducted at the Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital (a tertiary-level Class A hospital). To ensure patient privacy, patient identities will not be disclosed here. Patient identity information and medical records are archived in the archives of the Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital and are available for review.

[0105] 2. Diagnostic criteria and efficacy evaluation criteria for osteoarthritis

[0106] 2.1 Diagnostic criteria were based on the 2022 NICE guidelines, "Diagnosis and Management of Osteoarthritis in Individuals Over 16 Years of Age (NG.226)":

[0107] (1) Persistent use-related joint pain in one or more joints;

[0108] (2) Age 45 or older;

[0109] (3) Morning stiffness lasts less than or equal to 30 minutes.

[0110] 2.2 The efficacy evaluation criteria were based on the 2019 "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine":

[0111] Cured: Swelling and pain disappeared, knee joint movement returned to normal, walking and squatting were painless, and there was no recurrence. Improved: Swelling and pain lessened, but pain persisted after overexertion; knee joint movement was essentially normal. Not cured: Swelling recurred frequently, and knee pain did not subside.

[0112] 3. Treatment Plan

[0113] Treatment group: The drug obtained in Example 3 was used for treatment, and the treatment time was 10-12 days per person;

[0114] Control group: treated with conventional heat therapy (acupoint application therapy);

[0115] 4. Statistical methods:

[0116] SPSS 26.0 was used for data processing and statistical analysis. Chi-square test was used for count data, and normality test was first used to check whether the continuous data were normally distributed. If the data between groups conformed to a normal distribution, an independent samples t-test was used, and the statistical significance was analyzed by checking whether the probability p-value was less than 0.05.

[0117] 5. Results

[0118] 5.1 General Information

[0119] According to the proposed research protocol, the treatment group consisted of 33 people, including 6 males and 27 females, while the control group consisted of 33 people, including 9 males and 24 females.

[0120] Statistical analysis revealed a chi-square test result of 0.387, indicating no statistically significant difference in gender between the treatment and control groups. An independent samples t-test for age showed t = 1.353 (P = 0.181), indicating no statistically significant difference in age between the treatment and control groups. Similarly, an independent samples t-test for VAS scores showed a statistically significant difference between the treatment and control groups before and after treatment: t = 3.349 (P = 0.001) for the treatment group and t = 2.181 (P = 0.033) for the control group. See Tables 1, 2, and 3 for more details.

[0121] Table 1. Comparison of gender between the treatment group and the control group.

[0122]

[0123] Table 2 Comparison of ages between the treatment group and the control group

[0124]

[0125] Table 3 Comparison of VAS scores between the treatment group and the control group

[0126]

[0127] As shown in Table 3, the VAS score decreased by 1.63 in the treatment group and by 1.00 in the control group. The VAS score of the treatment group was significantly lower than that of the control group. Therefore, the traditional Chinese medicine composition for osteoarthritis obtained by the method of this invention has excellent technical efficacy in treating osteoarthritis.

[0128] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for osteoarthritis, characterized in that, The Chinese medicine composition for treating bone joint inflammation is prepared from the following components in mass fraction: Angelica 10-14 parts, safflower 8-12 parts, frankincense 4-6 parts, myrrh 4-6 parts, red sandalwood 8-10 parts, borneol 0.2-0.4 parts, and linseed oil 22-30 parts.

2. The traditional Chinese medicine composition for osteoarthritis according to claim 1, characterized in that, The Chinese medicine composition for treating bone joint inflammation is prepared from the following components in mass fraction: Angelica 12 parts, safflower 10 parts, frankincense 5 parts, myrrh 5 parts, red sandalwood 9 parts, borneol 0.3 parts, and linseed oil 26 parts.

3. The preparation method of the traditional Chinese medicine composition for osteoarthritis according to claim 1 or 2, characterized in that, The method comprises the following steps: 1) mixing Angelica, safflower, frankincense, myrrh, red sandalwood and borneol to obtain a mixture; 2) grinding and sieving the mixture to obtain undersize; 3) adding heated linseed oil into the undersize obtained in step 2) and stirring to obtain the Chinese medicine composition for treating bone joint inflammation.

4. The preparation method of the traditional Chinese medicine composition for osteoarthritis according to claim 3, characterized in that, The rotating speed of grinding in step 2) is 2200-2600 revolutions per minute.

5. The method for preparing a traditional Chinese medicine composition for osteoarthritis according to claim 3, characterized in that, The grinding time in step 2) is 2-4 minutes.

6. The method for preparing a traditional Chinese medicine composition for osteoarthritis according to claim 3, characterized in that, The mesh number of sieving in step 2) is 280-320 meshes, and the sieving times is 2 times.

7. The method for preparing a traditional Chinese medicine composition for osteoarthritis according to claim 3, characterized in that, The heating temperature in step 3) is 58-62 ℃.

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