Traditional Chinese medicine composition and traditional Chinese medicine ointment for preventing and / or treating knee osteoarthritis as well as preparation method and application of traditional Chinese medicine composition and traditional Chinese medicine ointment

By preparing a traditional Chinese medicine ointment, and utilizing the synergistic effect of traditional Chinese medicine ingredients such as camel burdock seed and sheep tail oil, the problems of large side effects and poor compliance in the treatment of knee osteoarthritis have been solved, providing a highly effective, low-toxicity, and widely applicable external treatment solution.

CN120919203APending Publication Date: 2025-11-11XINYUAN COUNTY PEOPLES HOSPITAL
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Patent Information

Application Number
CN202511279183.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-09-09
Publication Date
2025-11-11

AI Technical Summary

Technical Problem

Existing treatments for knee osteoarthritis suffer from problems such as long-term use, significant side effects, high costs, and poor patient compliance. Traditional Chinese medicine external therapies are simple, easy to perform, low in toxicity, and widely applicable, but there is a lack of effective Chinese medicine preparations.

Method used

A traditional Chinese medicine composition, including camel thorn, achyranthes bidentata, safflower, saposhnikovia divaricata, phellodendron chinense, lycopodium clavatum, clematis chinensis, frankincense, and myrrh, is prepared with sheep tail oil to form an ointment. The ointment is made by heating, boiling, and filtering, and is used for external treatment of knee osteoarthritis.

Benefits of technology

Traditional Chinese medicine ointments are highly effective, low in toxicity, and do not cause drug resistance. They have a wide range of applications and are effective in treating bone and joint pain caused by various reasons. They enhance patients' self-repair ability and provide a cheap, simple, and convenient green therapy.

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Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition and traditional Chinese medicine ointment for preventing and / or treating knee osteoarthritis as well as a preparation method and application thereof. The peganum harmala is used as a monarch drug to dispel wind and eliminate dampness, promote blood circulation to arrest pain and relax tendons and activate collaterals; safflower, frankincense and myrrh are used as ministerial drugs for promoting blood circulation to remove blood stasis and stimulating menstrual flow to relieve pain; cortex phellodendri, radix saposhnikoviae and radix achyranthis bidentatae are used as adjuvant drugs to tonify liver and kidney, strengthen muscles and bones, eliminate dampness and treat warm dryness; and the lycopodium clavatum and the garden balsam stem are used as conductant drugs and directly reach the disease site, so that the effect of dredging the bones and tendons of the whole formula is enhanced. The components of the traditional Chinese medicine raw materials have a synergistic effect, the self-repairing capability of human bodies, tissues and organs is enhanced, patients with knee osteoarthritis are gradually recovered, and the traditional Chinese medicine composition has a good curative effect on knee osteoarthritis prevention and treatment and has the advantages of high efficiency, low toxicity, no drug resistance and wide application range. The traditional Chinese medicine composition provided by the invention is prepared into ointment, so that the defects that decoction and use are inconvenient and some rare medicinal materials are wasted are overcome, and the traditional Chinese medicine composition is easy to act.
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Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition, a traditional Chinese medicine ointment, and its preparation method and application for the prevention and / or treatment of knee osteoarthritis. Background Technology

[0002] Knee osteoarthritis (KOA) is a common and refractory osteoarthritis disease, a major cause of limb deformity and disability. Its associated clinical symptoms (joint swelling, pain, and in severe cases, joint deformities) and medical expenses seriously threaten patients' physical and mental health and quality of life. Currently, KOA is primarily treated conservatively with symptomatic relief, but the benefits and risks still need to be weighed: long-term use of various forms of nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with a high incidence of gastrointestinal and cardiovascular adverse events; opioid use (oral or topical) is associated with addiction, nausea, and vomiting; intra-articular injection of corticosteroids can rapidly relieve inflammation, but it also causes rapid degradation of the cartilage matrix, and should not be used more than twice a year; the clinical efficacy of sodium hyaluronate and chitosan remains controversial; intra-articular injection of platelet-rich plasma (PRP) helps cartilage repair and slows disease progression, but its high cost makes it unsuitable for widespread use; exercise training is indeed effective for early and mid-stage KOA, but patient compliance is poor, making it difficult to adhere to.

[0003] Traditional Chinese medicine (TCM) treatment for this disease boasts numerous methods, effectiveness, low toxicity, and the potential for long-term application, making it a hot topic in clinical research. Modern studies indicate that externally applied medications, in addition to directly entering the bloodstream to exert therapeutic effects, also regulate the function of systemic organs and the body's immune system, thus exerting an indirect therapeutic effect. Because TCM external therapies offer simple and convenient administration routes, avoiding the irritation caused by gastrointestinal administration and reducing drug toxicity and side effects, they are easily accepted by patients, thus possessing excellent development potential. Clinically, there is a greater need and an urgent need to research and develop a TCM preparation with proven efficacy for knee osteoarthritis. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition, ointment, preparation method and application for the prevention and / or treatment of knee osteoarthritis. It has the advantages of high efficiency, low toxicity, no drug resistance and wide applicability. It has a good curative effect on the prevention and treatment of knee osteoarthritis and has a good curative effect on bone and joint pain caused by various reasons.

[0005] This invention provides a traditional Chinese medicine composition for the prevention and / or treatment of knee osteoarthritis, comprising a first ingredient, a second ingredient, and sheep tail oil; The mass ratio of the first raw material to the second raw material is (1~4):1; The total mass ratio of the first raw material and the second raw material to the mass ratio of mutton tail fat is 1:(2.5~5); The first raw material includes 1 to 50 parts by weight of each of Camel's Wort, Achyranthes bidentata, Carthamus tinctorius, Saposhnikovia divaricata, Phellodendron chinense, Lycopodium clavatum, and Clematis chinensis; The second raw material includes the following parts by weight: 1-2 parts frankincense and 1-2 parts myrrh.

[0006] Preferably, the first raw material comprises 5 to 30 parts by weight of each of Camel's Wort, Achyranthes bidentata, Carthamus tinctorius, Saposhnikovia divaricata, Phellodendron chinense, Lycopodium clavatum, and Clematis chinensis.

[0007] Preferably, the first raw material comprises the following parts by weight: 1 part of Achyranthes bidentata, 1 part of Carthamus tinctorius, 1 part of Saposhnikovia divaricata, 1 part of Phellodendron chinense, 1 part of Lycopodium clavatum, 1 part of Clematis chinensis, and 3 parts of Camel's Wort.

[0008] Preferably, the second raw material comprises the following parts by weight: 2 parts frankincense and 2 parts myrrh.

[0009] The present invention also provides the application of the traditional Chinese medicine composition described above in the preparation of a medicament for the prevention and / or treatment of knee osteoarthritis.

[0010] Preferably, the drug includes a topical drug.

[0011] Preferably, the dosage form of the topical medicine includes an ointment.

[0012] This invention also provides a method for preparing a traditional Chinese medicine ointment for the prevention and / or treatment of knee osteoarthritis, comprising the following steps: The first and second raw materials in the traditional Chinese medicine composition described in the above technical solution are pulverized to obtain the first solid material and the second solid material. The sheep tail oil in the traditional Chinese medicine composition described in the above technical solution is heated to 90~120℃, the first solid material is added, and the mixture is simmered over low heat for 1.5 hours. Then the second solid material is added, and the mixture is simmered over low heat for 0.5 hours to obtain the decoction. The decoction is passed through a sieve with a diameter of less than 4 mm to obtain the permeate, and then cooled and solidified to obtain the traditional Chinese medicine ointment.

[0013] Preferably, the sieve passing through 4mm or less is a sieve passing through 100~400μm.

[0014] The present invention also provides a traditional Chinese medicine ointment for the prevention and / or treatment of knee osteoarthritis obtained by the preparation method described above.

[0015] Beneficial effects: This invention provides a traditional Chinese medicine composition for the prevention and / or treatment of knee osteoarthritis, comprising a first ingredient, a second ingredient, and sheep tail oil; the mass ratio of the first ingredient and the second ingredient is (1~4):1; the mass ratio of the total mass of the first ingredient and the second ingredient to the mass of sheep tail oil is 1:(2.5~5); the first ingredient comprises 1~50 parts by mass of each of *Camelella asiatica*, *Achyranthes bidentata*, safflower, *Saposhnikovia divaricata*, *Phellodendron chinense*, *Lycopodium clavatum*, and *Clematis chinensis*; the second ingredient comprises the following parts by mass: 1~2 parts of frankincense and 1~2 parts of myrrh. The traditional Chinese medicine composition of this invention uses *Camelella asiatica* as the principal ingredient, which dispels wind and dampness, invigorates blood circulation and relieves pain, and relaxes muscles and tendons; safflower, frankincense, and myrrh are the assistant ingredients, which invigorate blood circulation, remove blood stasis, and relieve pain; *Phellodendron chinense*, *Saposhnikovia divaricata*, and *Achyranthes bidentata* are the adjuvant ingredients, which tonify the liver and kidneys, strengthen muscles and bones, and dry dampness, while also counteracting the warming and drying properties of other herbs; *Lycopodium clavatum* and *Clematis chinensis* are the guiding ingredients, which directly reach the affected area, enhancing the overall effect of the formula in penetrating bones and tendons. The synergistic effect of the Chinese herbal raw materials in this invention maximizes the therapeutic effect of the drug, enhances the self-repair ability of the human body, tissues and organs, and enables patients with knee osteoarthritis to gradually recover. It has a very good therapeutic effect on the prevention and treatment of knee osteoarthritis, and has the advantages of high efficiency, low toxicity, no drug resistance and wide applicability. It also has a good therapeutic effect on bone and joint pain caused by various reasons.

[0016] Furthermore, the traditional Chinese medicine composition provided by this invention can be made into an ointment, which overcomes the inconvenience of traditional decoction and use, as well as the waste caused by some precious medicinal materials. It is easy to use and provides a cheap, convenient and effective green therapy for the majority of patients with knee osteoarthritis. Detailed Implementation

[0017] This invention provides a traditional Chinese medicine composition for the prevention and / or treatment of knee osteoarthritis, comprising a first ingredient, a second ingredient, and sheep tail oil; The mass ratio of the first raw material to the second raw material is (1~4):1; The total mass ratio of the first raw material and the second raw material to the mass ratio of mutton tail fat is 1:(2.5~5); The first raw material includes 1 to 50 parts by weight of each of Camel's Wort, Achyranthes bidentata, Carthamus tinctorius, Saposhnikovia divaricata, Phellodendron chinense, Lycopodium clavatum, and Clematis chinensis; The second raw material includes the following parts by weight: frankincense (1~2) parts and myrrh (1~2) parts.

[0018] As one embodiment, the method for preparing sheep tail oil according to the present invention includes: frying fresh sheep tail fat tissue over low heat until cooked, rendering the oil, and then filtering.

[0019] In one embodiment, the first raw material of the present invention comprises 5-30 parts by weight of each of *Camelella asiatica*, *Achyranthes bidentata*, safflower, saposhnikovia divaricata, phellodendron chinense, *Lycopodium clavatum*, and *Clematis chinensis*. In another embodiment, the first raw material of the present invention comprises 10-20 parts by weight of each of *Camelella asiatica*, *Achyranthes bidentata*, safflower, saposhnikovia divaricata, phellodendron chinense, *Lycopodium clavatum*, and *Clematis chinensis*. In yet another embodiment, the first raw material of the present invention comprises 15 parts by weight of each of *Camelella asiatica*, *Achyranthes bidentata*, safflower, saposhnikovia divaricata, phellodendron chinense, *Lycopodium clavatum*, and *Clematis chinensis*. In one embodiment, the first raw material of the present invention is composed of the following parts by weight: 1 part of *Achyranthes bidentata*, 1 part of safflower, 1 part of saposhnikovia divaricata, 1 part of phellodendron chinense, 1 part of *Lycopodium clavatum*, 1 part of *Clematis chinensis*, and 3 parts of *Camelella asiatica*.

[0020] In one embodiment, the second raw material of the present invention comprises the following parts by weight: 2 parts of roasted frankincense and 2 parts of roasted myrrh. In one embodiment, the frankincense used in the present invention is roasted frankincense. In one embodiment, the myrrh used in the present invention is roasted myrrh.

[0021] The traditional Chinese medicine composition of this invention uses *Camel's Footprint* as the principal ingredient, which dispels wind and dampness, invigorates blood circulation, relieves pain, and relaxes muscles and tendons; safflower, frankincense, and myrrh are the assistant ingredients, which invigorate blood circulation, remove blood stasis, and relieve pain; phellodendron bark, saposhnikovia root, and achyranthes root are the adjuvant ingredients, which tonify the liver and kidneys, strengthen tendons and bones, and dry dampness, while also counteracting the warming and drying properties of other herbs; and *Lycopodium clavatum* and *Clematis chinensis* are the guiding ingredients, which directly target the affected area and enhance the overall effect of the formula in penetrating bones and tendons. The synergistic effect of the medicinal ingredients in this invention maximizes the therapeutic efficacy, enhances the body's self-repair capabilities, and promotes gradual recovery in patients with knee osteoarthritis. It has excellent efficacy in the prevention and treatment of knee osteoarthritis, and possesses the advantages of high efficiency, low toxicity, no drug resistance, and wide applicability. It also shows good efficacy for bone and joint pain caused by various reasons.

[0022] The present invention also provides the application of the traditional Chinese medicine composition described above in the preparation of a medicament for the prevention and / or treatment of knee osteoarthritis.

[0023] In one embodiment, the drug of the present invention includes a topical drug. In another embodiment, the dosage form of the topical drug of the present invention includes an ointment.

[0024] This invention also provides a method for preparing a traditional Chinese medicine ointment for the prevention and / or treatment of knee osteoarthritis, comprising the following steps: The first and second raw materials in the traditional Chinese medicine composition described in the above technical solution are pulverized to obtain the first solid material and the second solid material. The sheep tail oil in the traditional Chinese medicine composition described in the above technical solution is heated to 90~120℃, the first solid material is added, and the mixture is simmered over low heat for 1.5 hours. Then the second solid material is added, and the mixture is simmered over low heat for 0.5 hours to obtain the decoction. The decoction is passed through a sieve with a diameter of less than 4 mm to obtain the permeate, and then cooled and solidified to obtain the traditional Chinese medicine ointment.

[0025] As one implementation method, the sieve described in this invention that passes through a sieve smaller than 4 mm is a sieve that passes through a sieve of 100~400 μm.

[0026] The first ingredient in the traditional Chinese medicine composition of this invention is a Kazakh specialty medicinal material, which has the effects of dispelling wind and dampness, relaxing muscles and tendons and promoting blood circulation. This invention uses sheep tail oil to process it into an ointment, so as to achieve the synergistic effect of the ingredients and exert the highest efficacy of the drug. It has a very good effect on the prevention and treatment of the above-mentioned bone tissue diseases.

[0027] This invention also provides a traditional Chinese medicine ointment prepared by the method described above. The ointment prepared from the traditional Chinese medicine composition provided by this invention overcomes the inconvenience of traditional decoction and application, as well as the waste caused by certain precious medicinal materials. It is easy to use and provides a cheap, convenient, and effective green therapy for patients with knee osteoarthritis.

[0028] To further illustrate the present invention, the following detailed description, in conjunction with embodiments, provides a traditional Chinese medicine composition, a traditional Chinese medicine ointment, and its preparation method and application for the prevention and / or treatment of knee osteoarthritis provided by the present invention, but these should not be construed as limiting the scope of protection of the present invention.

[0029] Example 1 1. Prepare materials according to the following mass proportions. 3 parts of camel burdock, 1 part of achyranthes bidentata, 1 part of safflower, 1 part of saposhnikovia divaricata, 1 part of phellodendron chinense, 1 part of lycopodium clavatum, 1 part of clematis chinensis, 2 parts of roasted frankincense, 2 parts of roasted myrrh, and 32.5 parts of sheep tail oil.

[0030] 2. Crush camel thorn, achyranthes bidentata, safflower, saposhnikovia divaricata, phellodendron chinense, lycopodium clavatum, and clematis chinensis into strips or granules less than 1 cm, mix them together to obtain solid material A; grind frankincense and myrrh into 0.2 cm granules, mix them together to obtain solid material B; Heat the sheep tail fat to 90-120℃ and maintain a gentle simmer. Add solid ingredient A and stir constantly until well combined. After simmering for 1.5 hours, add solid ingredient B and continue heating for another 0.5 hours, stirring constantly until well combined. Sieve the permeate through a sieve smaller than 4mm. The residue larger than 4mm after filtration is the dregs. After cooling, it can be applied topically. The permeate will solidify after cooling to obtain a traditional Chinese medicine ointment, which can be applied topically in appropriate amounts.

[0031] Comparative Example 1 Same as Example 1, except that the raw materials do not contain camel husk.

[0032] Application Example 1 1. Materials and Methods This embodiment included 79 patients with knee osteoarthritis (KOA) who visited the outpatient department of Xinyuan County People's Hospital. They were randomly divided into a treatment group and a control group, with 40 and 39 patients respectively. SPSS 23.0 software was used to statistically analyze the gender, age, ethnicity, and duration of disease in the two groups. Quantitative data were expressed as mean and standard deviation, and categorical data were expressed as rates or proportions. Statistical methods included t-tests, ANOVA, and chi-square tests. The significance level was set at 0.05, i.e., when... P A value <0.05 was considered statistically significant. The results are shown in Table 1.

[0033] Table 1 Comparison of clinical data between the treatment group and the control group

[0034] As shown in Table 1, the two groups of patients showed good balance in terms of gender, age, ethnicity, and duration of disease, with no significant differences. P >0.05).

[0035] 2. Western Medicine Diagnostic Criteria (1) The Western medical diagnostic criteria for KOA were formulated with reference to the "Guidelines for the Diagnosis and Treatment of Osteoarthritis" of the Joint Surgery Group of the Chinese Orthopaedics Branch in 2018.

[0036] a. Recurrent knee pain within the past month; b. X-ray (standing or weight-bearing position) shows narrowing of the joint space, subchondral bone sclerosis and / or cystic changes, and osteophyte formation at the joint margins; c. Age ≥ 50 years; d. Morning stiffness duration ≤ 30 min; e. Bone crepitus is felt during activity; Note: KOA can be diagnosed if the diagnostic criteria a+b, a+d+e, or a+c+d+e are met.

[0037] (2) The internationally accepted radiological standard for osteoarthritis is the Kellgren-Lawrence classification (Table 2), in which grade II and above can be diagnosed as KOA.

[0038] Table 2 Kellgren-Lawrence Classification Criteria

[0039] 3. Traditional Chinese Medicine Diagnostic Criteria: The diagnostic criteria for knee osteoarthritis were based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine".

[0040] (1) It often begins after the joints are exposed to cold or after excessive activity; (2) The onset is slow, with initial dull pain, aversion to cold, and difficulty in movement. It gradually worsens and may be accompanied by joint swelling, joint locking, and clicking sound during movement. (3) Persistent pain, joint deformity, and lingering pain in the later stages; (4) X-ray shows changes in osteoarthritis.

[0041] 4. Inclusion criteria (1) Those who meet the diagnostic criteria for knee osteoarthritis after examination; (2) Those aged 50 or older; (3) Patients with mild to moderate knee osteoarthritis who are KL grade I, II or III and whose ISOA < 14); (4) The patient has signed an informed consent form; (5) Those who have not taken any health care and treatment measures for knee osteoarthritis in the past week.

[0042] 5. Exclusion Criteria (1) Individuals who have been diagnosed with metabolic bone disease or neurogenic arthropathy; (2) Those with acute trauma, loose bodies in the joint, acute synovitis, or severe joint deformities; (3) Those with serious primary diseases of the cardiovascular and cerebrovascular system and endocrine system.

[0043] 6. Observation Indicators (1) VAS (Visual Analogue Scale): This is a psychological measurement response scale that uses objective scoring data to reflect subjective pain perception. The 10cm scale represents a score of 0-10, with the two ends representing "no pain" and "severe pain" respectively. A score below 3 indicates mild pain; 4-6 indicates moderate pain; and 7-10 indicates severe pain. Patients mark an appropriate score based on their own pain level.

[0044] (2) WOMAC (Western University McMaster University Osteoarthritis Index Visualization Scale): It includes 24 questions covering pain, stiffness and physical function, and is one of the longest-used indicators for assessing osteoarthritis.

[0045] 7. Treatment methods The treatment group received the herbal ointment obtained in Example 1 for massage; the control group received the herbal ointment obtained in Comparative Example 1 for massage. The herbal ointment was packaged in individual 50ml bottles; each application consisted of 10ml, 10 times per course of treatment. Two courses of treatment were administered, with a two-day interval between courses.

[0046] Specific application method: The patient lies supine. The practitioner first applies an appropriate amount of herbal plaster evenly around the patella, then applies rubbing and kneading techniques with moderate pressure until a warming sensation is felt, for 2 minutes. Use the plaster once daily, 10ml per application, for 10 applications per course of treatment, with a 2-day interval between courses. Efficacy is assessed after two courses of treatment.

[0047] 8. Efficacy evaluation criteria Calculated according to the nimodipine score calculation formula. Syndrome score ratio = (Total score before treatment - Total score after treatment) / Total score before treatment × 100% Overall effective rate = (cured + significantly effective + effective) / total number of cases × 100% (1) Cured: All symptoms disappeared after treatment, and the syndrome score decreased by 90%; (2) Significant effect: After treatment, all symptoms were significantly reduced, with 70% < syndrome score < 90%; (3) Effective: Symptoms were alleviated after treatment, with 30% < syndrome score < 70%; (4) Ineffective: No relief or worsening of symptoms after treatment, and syndrome score <30%.

[0048] 9. Statistical Methods SPSS 23.0 software was used for statistical processing of the data. Quantitative data were expressed as mean and standard deviation, while categorical data were expressed as rates or proportions. Statistical methods included t-test, ANOVA, and chi-square test. The significance level was set at 0.05, i.e., when... P A value <0.05 was considered statistically significant. The results are shown in Tables 3 and 4.

[0049] Table 3 Comparison of WOMAC scores between the two groups of patients ( ±s)

[0050] Table 4 Comparison of VAS scores between the two groups of patients ( ±s)

[0051] As shown in Tables 3 and 4, in a horizontal comparison, both the treatment group and the control group showed a significant decrease in WOMAC scores before and after treatment, indicating that both treatment methods were effective. In a longitudinal comparison, there was no significant difference in WOMAC scores between the two groups before treatment, suggesting that the severity of their illness was similar before treatment. However, after treatment, the scores decreased significantly. P A significance level of <0.01 indicates a difference in efficacy between the two treatment methods at the 0.01 significance level. Furthermore, the mean of the treatment group was lower than that of the control group, suggesting that the treatment method used in the treatment group was more effective. Both groups showed a significant decrease in WOMAC scores after treatment.P <0.01, the decrease in susceptibility in the treatment group was greater than that in the control group ( P <0.05); VAS scores decreased significantly in both groups after treatment ( P <0.01, the decrease in susceptibility in the treatment group was greater than that in the control group ( P <0.05).

[0052] As can be seen from the above, the traditional Chinese medicine composition provided by this invention can treat and prevent knee osteoarthritis, with reliable clinical efficacy, and is worthy of clinical promotion and application.

[0053] Although the above embodiments have provided a detailed description of the present invention, they are only some embodiments of the present invention, and not all embodiments. People can obtain other embodiments based on these embodiments without creative effort, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for the prevention and / or treatment of knee osteoarthritis, characterized in that, Includes the first ingredient, the second ingredient, and sheep tail fat; The mass ratio of the first raw material to the second raw material is (1~4):1; The total mass ratio of the first raw material and the second raw material to the mass ratio of mutton tail fat is 1:(2.5~5); The first raw material includes 1 to 50 parts by weight of each of Camel's Wort, Achyranthes bidentata, Carthamus tinctorius, Saposhnikovia divaricata, Phellodendron chinense, Lycopodium clavatum, and Clematis chinensis; The second raw material includes the following parts by weight: 1-2 parts frankincense and 1-2 parts myrrh.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The first raw material includes 5 to 30 parts by weight of each of Camel's Wort, Achyranthes bidentata, Carthamus tinctorius, Saposhnikovia divaricata, Phellodendron chinense, Lycopodium clavatum, and Clematis chinensis.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The first raw material comprises the following parts by weight: 1 part of Achyranthes bidentata, 1 part of Carthamus tinctorius, 1 part of Saposhnikovia divaricata, 1 part of Phellodendron chinense, 1 part of Lycopodium clavatum, 1 part of Clematis chinensis, and 3 parts of Camel's Wort.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The second raw material comprises the following parts by weight: 2 parts frankincense and 2 parts myrrh.

5. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for the prevention and / or treatment of knee osteoarthritis.

6. The application according to claim 5, characterized in that, The medicines include topical medicines.

7. The application according to claim 6, characterized in that, The dosage form of the topical medication includes ointments.

8. A method for preparing a traditional Chinese medicine ointment for the prevention and / or treatment of knee osteoarthritis, characterized in that, Includes the following steps: The first raw material and the second raw material in the traditional Chinese medicine composition according to any one of claims 1 to 4 are respectively pulverized to obtain the first solid material and the second solid material; The sheep tail oil in the traditional Chinese medicine composition according to any one of claims 1 to 4 is heated to 90 to 120°C, the first solid material is added, and the mixture is simmered over a low flame for 1.5 hours. Then the second solid material is added, and the mixture is simmered over a low flame for 0.5 hours to obtain the decoction. The decoction is passed through a sieve of less than 4 mm, and the permeate is collected, cooled and solidified to obtain the traditional Chinese medicine ointment.

9. The preparation method according to claim 8, characterized in that, The sieve that passes through less than 4 mm is a sieve that passes through 100~400 μm.

10. The traditional Chinese medicine ointment for the prevention and / or treatment of knee osteoarthritis obtained by the preparation method according to claim 8 or 9.