Compound composition for treating meniscus injury of knee joints and pain in neck, shoulders, waist and legs

Abstract

The invention discloses a compound composition for treating meniscus injury of knee joints and pain in neck, shoulders, waist and legs, and belongs to the technical field of traditional Chinese medicine preparations. The composition comprises 2-15 parts of liquidambar formosana hance, 2-4 parts of Chinese prickly ash, 3-6 parts of yellow mustard seeds, 4-6 parts of ginger powder, 3-15 parts of radix clematidis, 1-8 parts of asarum and 14-16 parts of lycopodium clavatum. All the medicines are combined to achieve the effects of clearing damp and fending off cold, promoting blood circulation to remove blood stasis, relaxing tendons and dredging collaterals, and diminishing inflammation and relieving pain. The composition can be prepared into powder, ointment, tincture and other external dosage forms, and is used for treating knee joint meniscus injury, neck, shoulder, waist, leg and other pains. The traditional Chinese medicine composition is rigorous and scientific in formula, has the advantages of quick response, short treatment course, high cure rate, difficulty in relapse, greenness, safety and no side effect, is low in raw material cost, remarkably relieves the economic burden of patients, and has remarkable clinical application value.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a compound composition for treating knee meniscus injury and neck, shoulder, back and leg pain. Background Technology

[0002] Knee meniscus injury and neck, shoulder, and lower back pain are common clinical conditions, often caused by overuse, trauma, or invasion of wind, cold, and dampness. Symptoms include pain, swelling, and limited mobility; in severe cases, it can lead to joint dysfunction or even disability. Current treatment methods include oral nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy, local injections, and surgery. These methods have limitations: oral medications can easily cause gastrointestinal reactions and liver and kidney damage; physical therapy has a long treatment cycle and unstable effects; and surgical treatment is highly invasive, expensive, and carries a risk of recurrence.

[0003] Traditional Chinese medicine has unique advantages in this field, often employing methods such as dispelling wind and cold, removing dampness and unblocking meridians, promoting blood circulation and removing blood stasis, and reducing swelling and relieving pain. However, many topical Chinese medicine preparations currently on the market have problems such as complex ingredients, slow onset of action, long treatment courses, and uncertain efficacy for single symptoms. Summary of the Invention

[0004] In view of the above-mentioned technical shortcomings, the purpose of this invention is to provide a compound composition for treating knee meniscus injury and neck, shoulder, back and leg pain, solving the problems of slow effectiveness, long treatment course, large side effects and easy recurrence of existing treatment methods.

[0005] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: The present invention provides a compound composition for treating knee meniscus injury and neck, shoulder, back and leg pain, comprising the following raw materials in parts by weight: 2-15 parts of Liquidambar formosana, 2-4 parts of Zanthoxylum bungeanum, 3-6 parts of yellow mustard seed, 4-6 parts of ginger powder, 3-15 parts of Clematis chinensis, 1-8 parts of Asarum heterotropoides, and 14-16 parts of Lycopodium clavatum.

[0006] Preferably, the raw materials are in the following proportions by weight: 2 parts of *Luffa cylindrica*, 2 parts of Sichuan pepper, 3 parts of yellow mustard seeds, 4 parts of ginger powder, 3 parts of *Clematis chinensis*, 1 part of *Asarum heterotropoides*, and 14 parts of *Lycopodium clavatum*.

[0007] Preferably, the raw materials are in the following weight proportions: 15 parts of *Luffa cylindrica*, 4 parts of Sichuan pepper, 6 parts of yellow mustard seeds, 6 parts of ginger powder, 15 parts of *Clematis chinensis*, 8 parts of *Asarum heterotropoides*, and 16 parts of *Lycopodium clavatum*.

[0008] Preferably, the raw materials are in the following proportions by weight: 10 parts of *Luffa cylindrica*, 3 parts of Sichuan pepper, 5 parts of yellow mustard seeds, 5 parts of ginger powder, 10 parts of *Clematis chinensis*, 5 parts of *Asarum heterotropoides*, and 15 parts of *Lycopodium clavatum*.

[0009] The compound composition provided by the present invention can be prepared into clinically acceptable external dosage forms, including but not limited to powders, ointments, tinctures, patches or medicated bath packs.

[0010] Taking the preparation of powder (external poultice powder) as an example, the preparation steps are as follows: S1. Weigh each raw material according to the above-mentioned weight proportions; S2. Wash and dry the following herbs: Lulutong, Sichuan pepper, yellow mustard seeds, Clematis chinensis, and Lycopodium clavatum. S3. Place the dried medicinal materials, ginger powder, and asarum together in a grinder and grind them into 80-120 mesh fine powder. S4. Mix the obtained powder evenly and sterilize it using radiation sterilization or ethylene oxide sterilization. S5. Pack into sterile, moisture-proof packaging bags to obtain the final product.

[0011] The method of use of this invention is for external application. For example, take an appropriate amount of powder, mix it with honey, vinegar, or warm water to form a paste, apply it evenly to the affected area, cover with gauze or plastic wrap, and apply for 4-6 hours each time, once a day, for 7 days as one course of treatment. You can apply a hot compress to the affected area before use to enhance the effect.

[0012] The beneficial effects of this invention are as follows: The formulation of this invention is scientifically sound and synergistically effective: *Lycopodium clavatum* and *Liquidambar formosana* are the principal herbs, used to relax muscles and tendons, dispel wind and dampness; *Clematis chinensis* and *Asarum heterotropoides* are the assistant herbs, used to dispel wind and cold, unblock meridians and relieve pain; *Zanthoxylum bungeanum*, *Mustard Seed*, and ginger powder are the adjuvant herbs, used to warm the middle jiao, dispel cold, relieve pain, and guide the medicine directly to the affected area. The combined effects of these herbs dispel dampness and cold, promote blood circulation and remove blood stasis, relax muscles and tendons, unblock meridians, reduce inflammation and relieve pain, closely addressing the etiology and pathogenesis of the disease.

[0013] The formulation of this invention has significant therapeutic effects: it is used to treat various types of pain such as knee meniscus injury, neck, shoulder, waist and leg pain. This compound has the characteristics of rapid effect, short course of treatment and high cure rate, and can effectively relieve pain, eliminate swelling and restore joint function.

[0014] The formulation of this invention is safe and has no side effects: It is a pure Chinese herbal medicine formulation, applied topically, avoiding damage to the gastrointestinal tract, liver and kidneys. It is green, safe, and has virtually no side effects.

[0015] The formula of this invention removes deep-seated wind-cold-dampness, unblocks meridians, and improves local blood circulation, thus regulating the body from the root cause, resulting in stable efficacy and low recurrence rate.

[0016] The ingredients of this invention are common Chinese herbal medicines, which are inexpensive, easy to prepare, and convenient to use, greatly reducing the economic burden on patients and making them suitable for widespread application. Detailed Implementation

[0017] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0018] Example 1: Weigh out 10g of *Luffa cylindrica*, 3g of Sichuan pepper, 5g of yellow mustard seeds, 5g of ginger powder, 10g of *Clematis chinensis*, 5g of *Asarum heterotropoides*, and 15g of *Lycopodium clavatum*. Prepare an external powder according to the aforementioned method.

[0019] Example 2: Weigh out 2g of *Luffa cylindrica*, 4g of Sichuan pepper, 3g of yellow mustard seeds, 6g of ginger powder, 15g of *Clematis chinensis*, 1g of *Asarum heterotropoides*, and 16g of *Lycopodium clavatum*. Prepare an external powder according to the aforementioned method.

[0020] Example 3: Weigh out 15g of *Luffa cylindrica*, 2g of Sichuan pepper, 6g of yellow mustard seeds, 4g of ginger powder, 3g of *Clematis chinensis*, 8g of *Asarum heterotropoides*, and 14g of *Lycopodium clavatum*. Prepare an external tincture according to the aforementioned method (after pulverizing each herb, soak it in 75% ethanol for 2 weeks, and then filter it).

[0021] Comparison Example 1 (Commercially Available Comparison): A commercially available blood-activating and pain-relieving plaster (main ingredients: Angelica sinensis, Ligusticum chuanxiong, borneol, menthol, etc.) was used as a control.

[0022] Control Example 2 (Component Missing Control): Weigh out 10g of *Luffa cylindrica*, 3g of Sichuan pepper, 5g of yellow mustard seeds, 5g of ginger powder, 10g of *Clematis chinensis*, and 15g of *Lycopodium clavatum* (omitting *Asarum heterotropoides*). Prepare the powder using the same method.

[0023] Comparative Example 3 (Single Herb Comparison): When using *Lycopodium clavatum* alone, grind it into powder of uniform fineness.

[0024] Experimental Example 1: Study on the anti-inflammatory and analgesic effects of adjuvant-induced arthritis in rats Animal grouping: Sixty healthy SD rats were randomly divided into 6 groups: blank control group (physiological saline), model control group, positive control group (diclofenac ointment), Example 1 of this invention, control group 2, and control group 3, with 10 rats in each group.

[0025] Model establishment: Except for the blank group, rats in the other groups were injected subcutaneously with 0.1 ml of Freund's complete adjuvant in the right hind foot to establish an adjuvant-induced arthritis model.

[0026] Administration method: Administration began on day 7 after modeling. Each test drug was evenly applied to the swollen area of ​​the rat's right posterior ankle joint, approximately 0.5g once daily for 14 consecutive days. The control group and model group received the same amount of matrix.

[0027] Observation indicators and procedures: Foot swelling measurement: Before administration (D0) and on days 3, 7, 10 and 14 after administration, the volume of the right hind paw of the rat was measured using a toe volume measuring instrument, and the swelling degree was calculated (swelling degree = volume after administration - volume before administration).

[0028] Pain threshold determination: On day 14 after administration, the pain threshold latency (seconds) of rats licking their hind paws or jumping was determined using a hot plate tester.

[0029] Joint inflammation score: After the administration of medication, observe the redness, swelling and deformity of the joints and score them from 0 to 4.

[0030] Experimental results (table): Table 1: Effect of Example 1 of the present invention on paw swelling in rats (x±s, n=10) Note: ^△△ P < 0.01 compared with the blank group; P < 0.05 compared with the model group; ** P < 0.01 compared with the model group*.

[0031] Conclusion: Example 1 of the present invention can significantly inhibit paw swelling in arthritic rats. Its anti-inflammatory effect is better than that of the positive control drug and the component-deficient / single-herb control, and the effect continues to increase over time.

[0032] Experimental Example 2: Study on the analgesic effect on the writhing response in mice Animal grouping: 60 Kunming mice were grouped as in Experiment 1.

[0033] Administration method: After shaving the abdomen of each group of mice, apply the corresponding drug (0.2g / mouse) once a day for 3 consecutive days.

[0034] Experimental procedure: One hour after the last administration, each mouse was intraperitoneally injected with 0.2 ml of 0.6% glacial acetic acid solution. The number of times the mice exhibited writhing responses (abdominal contraction and hind limb extension) within 15 minutes after injection was observed and recorded.

[0035] Experimental results (table): Table 2: Effect of Example 1 of the present invention on acetic acid-induced writhing response in mice (x±s, n=10) Note: P < 0.05 compared to the model group; ** P < 0.01 compared to the model group.

[0036] Conclusion: Example 1 of the present invention has a significant analgesic effect, and its analgesic effect is significantly better than that of the control drug.

[0037] Experimental Example 3: Clinical observation of the therapeutic effect of treating meniscus injuries of the knee joint Case selection: 120 patients with knee meniscus injuries (grade I-II) meeting the diagnostic criteria were randomly divided into a treatment group (Example 1 of this invention) and a control group (Control Case 1, commercially available blood-activating and pain-relieving plaster), with 60 patients in each group. There were no statistically significant differences between the two groups in terms of age, gender, disease duration, and disease severity.

[0038] Treatment methods: The treatment group used the powder of this invention mixed with water to make a paste for external application, once a day for 6 hours each time. The control group used commercially available blood-activating and pain-relieving plasters, which were changed once a day. The treatment course for both groups was 4 weeks.

[0039] Efficacy evaluation criteria: Refer to the "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine".

[0040] Cure: Pain and swelling disappeared, joint movement returned to normal, and MRI showed that the meniscus signal was basically normal.

[0041] Significant effect: Pain and swelling have basically disappeared, and joint movement is only slightly restricted.

[0042] Effective: Reduces pain and swelling, and improves joint mobility.

[0043] Ineffective: Symptoms and signs do not improve or worsen.

[0044] Observation indicators: VAS pain score, Lysholm knee function score, joint swelling degree, and improvement in MRI imaging before and after treatment.

[0045] Clinical Outcomes (Table): Table 3: Comparison of clinical efficacy between the two groups of patients (cases) Statistical analysis showed that the total effective rate and cure rate of the treatment group were significantly higher than those of the control group (P<0.05).

[0046] Conclusion: The compound composition of the present invention has a definite clinical efficacy in treating meniscus injuries of the knee joint. It is superior to commonly used commercial products in relieving pain, improving joint function, and promoting tissue repair, and has a higher cure rate.

[0047] In summary, the compound composition provided by this invention, through rigorous and scientific formulation, achieves comprehensive effects of dispelling dampness and cold, promoting blood circulation and removing blood stasis, relaxing muscles and tendons, and relieving inflammation and pain. It has shown significant advantages in animal experiments and clinical trials, including rapid onset of action, short treatment course, high cure rate, safety and economy, and has good application prospects.

[0048] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A compound composition for treating knee meniscus injury and neck, shoulder, back and leg pain, characterized in that, The ingredients include the following parts by weight: 2-15 parts of *Luffa cylindrica*, 2-4 parts of Sichuan pepper, 3-6 parts of yellow mustard seeds, 4-6 parts of ginger powder, 3-15 parts of *Clematis chinensis*, 1-8 parts of *Asarum heterotropoides*, and 14-16 parts of *Lycopodium clavatum*.

2. The compound composition for treating knee meniscus injury and neck, shoulder, back and leg pain as described in claim 1, characterized in that, The ingredients include the following parts by weight: 2 parts of *Luffa cylindrica*, 2 parts of Sichuan pepper, 3 parts of yellow mustard seeds, 4 parts of ginger powder, 3 parts of *Clematis chinensis*, 1 part of *Asarum heterotropoides*, and 14 parts of *Lycopodium clavatum*.

3. The compound composition for treating knee meniscus injury and neck, shoulder, back and leg pain as described in claim 1, characterized in that, The ingredients include the following parts by weight: 15 parts of *Luffa cylindrica*, 4 parts of Sichuan pepper, 6 parts of yellow mustard seeds, 6 parts of ginger powder, 15 parts of *Clematis chinensis*, 8 parts of *Asarum heterotropoides*, and 16 parts of *Lycopodium clavatum*.

4. The compound composition for treating knee meniscus injury and neck, shoulder, back and leg pain as described in claim 1, characterized in that, The ingredients include the following parts by weight: 10 parts of *Luffa cylindrica*, 3 parts of Sichuan pepper, 5 parts of yellow mustard seeds, 5 parts of ginger powder, 10 parts of *Clematis chinensis*, 5 parts of *Asarum heterotropoides*, and 15 parts of *Lycopodium clavatum*.

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