A traditional Chinese medicine composition for treating tennis leg, and a preparation method and application thereof

Abstract

This invention relates to a traditional Chinese medicine composition for treating tennis leg, its preparation method, and its application. The composition comprises 6-12 parts of Schizonepeta tenuifolia, 6-12 parts of Saposhnikovia divaricata, 6-12 parts of Perilla frutescens, 9-15 parts of Clematis chinensis, 6-12 parts of Curcuma longa, 9-15 parts of Dipsacus asper, 6-12 parts of Broussonetia papyrifera, 9-15 parts of Dendrobium nobile, and 9-15 parts of Clematis armandii. This invention not only rapidly reduces swelling and relieves pain, but also strengthens tendons and bones, repairs muscle damage, and enhances tendon and vein resilience, fundamentally reducing the recurrence rate of tennis leg. Furthermore, the medicinal properties of each ingredient are mild, with no obvious toxic side effects, avoiding the problems of gastrointestinal irritation and increased burden on the liver and kidneys caused by existing anti-inflammatory drugs, thus possessing outstanding clinical application value.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition for treating tennis leg, its preparation method and application, and is applicable to the field of traditional Chinese medicine technology. Background Technology

[0002] Tennis leg is a sports medicine term that has been introduced in recent years. It refers to injuries or tears in the calf muscles, such as the gastrocnemius, soleus, and plantar muscles, caused by various reasons. It is common among athletes who play tennis, badminton, sprint, and jumping, and is also frequently seen in people who suddenly exert force after a long period of inactivity. Tennis leg is named after tennis players, whose first common occurrence is in tennis players. Its typical symptoms include sudden, tearing pain in the inner lower leg, local swelling, tenderness, and limited ability to tiptoe and walk. If left untreated or mistreated, it can easily become a chronic strain injury, with recurring dull pain and stiffness, seriously affecting athletic ability and daily activities.

[0003] Modern medicine typically treats tennis leg by applying ice, compression, and immobilization during the acute phase, followed by anti-inflammatory and analgesic drugs, physical therapy (ultrasound, infrared), and rehabilitation training during the recovery period. However, this approach has significant limitations: firstly, long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) can easily cause gastrointestinal irritation and burden on liver and kidney function; secondly, physical therapy has a long treatment cycle and limited efficacy, making it difficult to quickly repair damaged tissue; and thirdly, there is a lack of effective methods for targeted repair of the tendon-muscle fiber transition zone, resulting in a high recurrence rate.

[0004] Traditional Chinese medicine (TCM) categorizes tennis leg as a condition of "tendon injury" or "traumatic injury." According to records in texts such as the *Huangdi Neijing* and *Xuezheng Lun*, the core pathogenesis of this condition is acute injury leading to stagnation of qi and blood, and obstruction of meridians, resulting in pain due to blockage. In the chronic phase, it is accompanied by liver and kidney deficiency, and malnourishment of the tendons and vessels, leading to pain due to lack of nourishment. Traditional TCM treatments often employ single blood-activating and stasis-removing formulas (such as Taohong Siwu Tang) or general-purpose external plasters for soft tissue injuries. While these can relieve pain, the formulas lack specificity and fail to achieve the therapeutic goals of rapid swelling and pain reduction in the acute phase, strengthening tendons and repairing muscles during recovery, and preventing recurrence. Therefore, developing a highly targeted TCM composition with effects such as activating blood circulation, removing blood stasis, reducing swelling and pain, relaxing tendons and activating collaterals, and tonifying the liver and kidneys, while being safe and without side effects, has significant clinical value and application prospects in the treatment of tennis leg. Summary of the Invention

[0005] To address the shortcomings of the existing technology, this invention proposes a traditional Chinese medicine composition for treating tennis leg, its preparation method, and its application.

[0006] The technical solution adopted by the present invention is as follows: On the one hand, the present invention provides a traditional Chinese medicine composition for treating tennis leg, which is made from the following raw materials in parts by weight: 6-12 parts of Schizonepeta tenuifolia, 6-12 parts of Saposhnikovia divaricata, 6-12 parts of Perilla frutescens, 9-15 parts of Clematis chinensis, 6-12 parts of Curcuma longa, 9-15 parts of Dipsacus asper, 6-12 parts of Broussonetia papyrifera, 9-15 parts of Dendrobium nobile, and 9-15 parts of Clematis armandii.

[0007] On the other hand, the present invention provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating tennis leg.

[0008] Furthermore, the drug comprises a traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0009] Furthermore, the dosage forms of the drug include decoctions, tablets, capsules, granules, powders, water pills, honey pills, drop pills, and oral liquid preparations.

[0010] Furthermore, tennis leg injuries include damage or tears at the junction of the plantar muscles, gastrocnemius, soleus, and the medial head tendon of the gastrocnemius.

[0011] On the other hand, the present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising: S1. Weigh each raw material according to the weight proportions, wash them and mix them together; S2. Add water and boil, then collect the first decoction. S3. Add water to the dregs after decoction and decoct again, then collect the second decoction. S4. Combine the first decoction and the second decoction, and concentrate them to obtain the traditional Chinese medicine composition.

[0012] Further, in step S2, add water equal to 8 times the total weight of the raw materials, soak for 30 minutes, and then decoct.

[0013] Furthermore, in step S2, the decoction is first brought to a boil over high heat, then simmered over low heat for 25-35 minutes, and filtered to obtain the first decoction.

[0014] Further, in step S3, add water again at a ratio of 6 times the total weight of the raw materials, bring to a boil over high heat, then simmer over low heat for 15-25 minutes, and filter to obtain the second decoction.

[0015] Further, in step S4, the combined first and second decoctions are concentrated to a relative density of 1.1~1.25 at 60°C to obtain the traditional Chinese medicine composition.

[0016] Solution: The herbal composition of this invention adopts the principle of "treating both the exterior and interior, and dispersing and draining" to target the pathogenesis of tennis leg syndrome, which involves stagnation of the exterior, obstruction of the internal meridians, and damage to the tendons and vessels. The nine herbs are divided into three groups: 1. Principal herbs: Schizonepeta tenuifolia, Saposhnikovia divaricata, and Perilla frutescens. Schizonepeta tenuifolia has the effect of relieving exterior wind and effectively dispelling wind-evil from the skin surface; Saposhnikovia divaricata is a "wind-dispelling and moisturizing agent," dispelling wind without causing dryness, relieving muscle spasms, and promoting qi circulation to help disperse blood stasis; Perilla frutescens is aromatic and promotes qi circulation, guiding the medicinal power towards the affected area of ​​the lower limbs. These three herbs relieve exterior symptoms and open the pores, are pungent and warm in nature, and work synergistically to open the stagnant pores, dispel external evil, and once the exterior qi is unblocked, blood stasis and edema can be dispersed, paving the way for subsequent treatment. 2. Assistant Herbs: Clematis chinensis, Curcuma longa, and Dipsacus asper; Clematis chinensis, being pungent and salty, penetrates and disperses, unblocking the twelve meridians, dispelling wind and dampness, and relieving pain; Curcuma longa breaks up blood stasis and promotes qi circulation, moving horizontally through the limbs, working in tandem with Clematis chinensis to clear stagnation in the calf meridians; Dipsacus asper tonifies the liver and kidneys, strengthens tendons and bones, and promotes healing of fractures, directly promoting repair of tears at the tendon-to-muscle junction. These three herbs unblock the meridians and strengthen tendons, working together to eliminate internal stagnation, unblock the meridians externally, and repair tendons. 3. Adjuvant Herbs: Broussonetia papyrifera, Dendrobium nobile, and Clematis armandii; Broussonetia papyrifera nourishes the kidneys and clears the liver, promotes diuresis and reduces swelling, guiding the medicine downwards to the posterior side of the calf; Dendrobium nobile nourishes yin and generates fluids, mitigating the dryness and heat of the pungent and warm herbs, while modern research confirms that it can promote the repair of skeletal muscle damage; Clematis armandii clears heat and detoxifies, reduces swelling and relieves pain, specifically treating local redness, heat, swelling, and pain, and also has the function of dispelling wind and promoting blood circulation. This traditional Chinese medicine combination first opens the exterior, then clears the interior, and is supplemented with diuretics and yin-nourishing herbs, so that the external pathogens are dispersed, the internal stagnation is eliminated, the tendons and veins are restored, and the swelling and pain are relieved. Together, they achieve the effects of relieving muscle tension, clearing the meridians, removing blood stasis, strengthening tendons and muscles, reducing swelling and relieving pain.

[0017] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art: This invention relates to a traditional Chinese medicine composition for treating tennis leg, its preparation method, and its application. The raw materials in the formula conform to the principle of "principal, assistant, adjuvant, and guide" in traditional Chinese medicine formulation. The principal herb disperses pathogenic factors on the skin surface, clears blocked pores, and disperses blood stasis and edema. The assistant herbs internally eliminate stagnation, externally unblock meridians, and promote the repair of tendons and vessels. Simultaneously, the adjuvant herbs assist in tonifying the liver and kidneys, strengthening tendons and bones, promoting muscle repair, and invigorating blood circulation to reduce swelling. The combined formula not only rapidly reduces swelling and relieves pain but also strengthens tendons and bones, repairs muscle damage, and enhances tendon and vessel resilience, fundamentally reducing the recurrence rate of tennis leg. Furthermore, the raw materials are mild in nature and have no obvious toxic side effects, avoiding the problems of gastrointestinal irritation and increased burden on the liver and kidneys associated with existing anti-inflammatory drugs, thus possessing outstanding clinical application value. Detailed Implementation

[0018] The technical solution of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, 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.

[0019] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0020] Example 1 On one hand, this embodiment provides a traditional Chinese medicine composition for treating tennis leg, which is made from the following raw materials in parts by weight: 6-12 parts of Schizonepeta tenuifolia, 6-12 parts of Saposhnikovia divaricata, 6-12 parts of Perilla frutescens, 9-15 parts of Clematis chinensis, 6-12 parts of Curcuma longa, 9-15 parts of Dipsacus asper, 6-12 parts of Broussonetia papyrifera, 9-15 parts of Dendrobium nobile, and 9-15 parts of Clematis armandii.

[0021] On the other hand, this embodiment also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating tennis leg.

[0022] In a more preferred embodiment, the drug comprises a traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0023] In a more preferred embodiment, the dosage form of the drug includes decoctions, tablets, capsules, granules, powders, water pills, honey pills, drop pills, and oral liquid preparations.

[0024] In a more preferred embodiment, the tennis leg includes damage or tearing at the junction of the plantar muscles, gastrocnemius, soleus, and medial head tendon of the gastrocnemius.

[0025] On the other hand, this embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine composition, including: S1. Weigh each raw material according to the weight parts, wash and mix them. The weight parts of each raw material are: 9 parts of Schizonepeta tenuifolia, 9 parts of Saposhnikovia divaricata, 9 parts of Perilla frutescens, 12 parts of Clematis chinensis, 9 parts of Curcuma longa, 12 parts of Dipsacus asper, 9 parts of Broussonetia papyrifera, 12 parts of Dendrobium nobile, and 12 parts of Clematis armandii. S2. Add water equal to 8 times the total weight of the raw materials, soak for 30 minutes, bring to a boil over high heat and then simmer over low heat for 30 minutes. Filter to obtain the first decoction. S3. Add water to the dregs after decoction, which is 6 times the total weight of the raw materials. Bring to a boil over high heat, then simmer over low heat for 20 minutes. Filter to obtain the second decoction. S4. After combining the first decoction and the second decoction, the mixture is concentrated until the relative density is 1.18 at 60°C, thus obtaining the traditional Chinese medicine composition. The concentration process is carried out by atmospheric pressure boiling concentration, reduced pressure heating concentration, or thin film concentration.

[0026] Example 2: Granule Preparation The traditional Chinese medicine composition obtained in Example 1 was further concentrated into a thick paste or dry extract, and then dextrin was added for granulation and drying to obtain granules containing the above-mentioned traditional Chinese medicine composition.

[0027] Example 3: Tablet Preparation The traditional Chinese medicine composition obtained in Example 1 is further concentrated into a thick paste or dry extract, then dextrin is added for granulation and drying, and then disintegrants and lubricants are added to the granules, and then the mixture is compressed into tablets to obtain tablets containing the above-mentioned traditional Chinese medicine composition.

[0028] Example 4: Effect Evaluation 1. Clinical Data Thirty patients with acute tennis leg who met the criteria were selected, including 19 males and 11 females. The patients' ages ranged from 22 to 59 years, with a mean age of 38.7 years. The shortest duration of illness was 4 hours and the longest was 68 hours. Patient information is shown in the table below.

[0029] Table 1: Patient Information and Disease Progress 2. Diagnostic criteria (1) Western medicine diagnostic criteria (refer to the Clinical Practice Guidelines - Orthopedics and related literature on "tennis leg") There is a clear history of acute or subacute strain of the calf muscles (medial head of the gastrocnemius, soleus, etc.), which often occurs during running, jumping or pushing off the ground. At the moment of injury, a "tearing sound" is often heard or a "stick-like" sensation is felt, followed by sharp pain in the back of the calf and limited mobility; Physical examination: There is significant tenderness on the posteromedial or posterolateral aspect of the lower leg, and local swelling and muscle tension can be felt. The plantar flexion resistance test is positive, and traction movements such as straight leg raises can induce pain. Imaging examinations: Ultrasound or MRI may indicate partial tearing of muscle fibers or hematoma at tendon junction.

[0030] (2) Traditional Chinese Medicine diagnostic criteria Main symptoms: Severe pain and swelling on the back of the calf, with elevated or normal skin temperature, and limited mobility; Secondary symptoms: local skin tension, tenderness and reluctance to touch, or chills, anhidrosis, and heaviness in the limbs; Tongue and pulse: The tongue is pale red or dark, with a thin white or greasy white coating, and the pulse is floating, tight, or hesitant; Diagnosis: The exterior is blocked, the collaterals are obstructed, and the tendons and vessels are damaged.

[0031] 3. Inclusion criteria (1) Meets the above Western medicine diagnosis and traditional Chinese medicine syndrome differentiation; (2) Age 18-65 years old; (3) Damage time ≤ 72 hours; (4) No other systemic treatment or drug discontinuation washout has been received within 3 days; (5) The subject signed an informed consent form.

[0032] 4. Exclusion criteria (1) Cases that do not meet the inclusion criteria; (2) Patients with concomitant fibular fracture, complete Achilles tendon rupture, or requiring surgery; (3) Severe heart, liver and kidney dysfunction or coagulation disorders; (4) Pregnant or breastfeeding women; (5) Allergic to any component of this Chinese medicine composition.

[0033] 5. Treatment methods The herbal composition obtained in Example 1 was used, one dose per day, taken twice daily after meals, warm, for 7 days as one course of treatment, with two consecutive courses. During treatment, the affected limb was immobilized and elevated, and no other oral or topical medications, physical therapy, or nerve blocks were used.

[0034] 6. Evaluation Criteria (1) Main therapeutic indicators Pain visual analog scale (VAS): 0 (no pain) to 10 (severe pain), recorded before treatment, on day 3, day 7 and day 14 of treatment; Calf swelling circumference: The circumference of the thickest part of the calf (usually the belly of the gastrocnemius muscle) is compared with that of the healthy side to calculate the swelling difference.

[0035] (2) Secondary efficacy indicators Ankle range of motion (AROM): active dorsiflexion and plantarflexion range; Traditional Chinese Medicine syndrome score: scored as 0, 2, 4, and 6 points respectively for none, mild, moderate, and severe symptoms, including pain, swelling, limited mobility, local tenderness, and aversion to cold.

[0036] (3) Comprehensive efficacy evaluation criteria (modified based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines") Cure: Pain and swelling disappear, movement is free, VAS=0, ankle joint range of motion returns to normal (≥70°), and syndrome score decreases by ≥95%; Significant effect: Pain is significantly reduced, swelling is basically subsided, VAS is reduced by ≥70%, ankle joint range of motion is improved by more than 20°, and syndrome score is reduced by ≥70%; Effective: Pain and swelling are relieved, movement is slightly limited, VAS is reduced by ≥30%, ankle range of motion is improved by more than 10°, and syndrome score is reduced by ≥30%; Ineffective: Symptoms and signs do not improve significantly or worsen, and VAS decreases by <30%.

[0037] 7. Treatment Results As shown in the table below, the 30 patients with acute tennis leg who met the criteria showed significant overall therapeutic effects after 14 days of standardized treatment. Among them, 15 cases were cured, 9 cases showed significant improvement, 5 cases showed improvement, and 1 case showed no effect, with a total effective rate of 96.7%, demonstrating that the above-mentioned traditional Chinese medicine composition has excellent comprehensive therapeutic effects on acute tennis leg. Regarding pain improvement, the average VAS score before treatment was 7.26, the average VAS score on day 3 of treatment was 5.01, it decreased to 2.51 on day 7, and further decreased to 0.97 on day 14, with statistically significant differences (P < 0.01), proving that the above-mentioned traditional Chinese medicine composition can quickly and continuously relieve pain at the affected area. Regarding the reduction of calf swelling, the average difference in calf swelling circumference gradually decreased from 1.53 cm before treatment to 0.53 cm on day 7, and then to 0.13 cm on day 14, demonstrating that with continuous treatment with the above-mentioned traditional Chinese medicine composition, calf swelling was significantly absorbed and improved. Regarding ankle joint mobility, the range of motion in recovered patients all increased to over 70°, indicating that muscle stiffness and limited mobility were completely relieved. Patients with significant and effective results also showed marked improvement in joint function compared to before treatment, alleviating some degree of restriction in mobility. Only one ineffective patient showed no significant improvement in ankle joint mobility. Overall, this demonstrates that the aforementioned traditional Chinese medicine composition effectively relieves muscle spasms, improves tendon contractures, and restores limb mobility. Changes in TCM syndrome scores also effectively prove the significant improvement effect of the aforementioned traditional Chinese medicine composition on tennis leg and its remarkable effect on alleviating clinical symptoms.

[0038] Table 2: VAS Score Statistics Table Table 3: Statistics of Difference in Lower Leg Swelling Values Table 4: Statistical Table of Secondary Therapy and Overall Therapy Evaluation 8. Safety Observation During treatment, blood routine tests, liver and kidney function tests, and electrocardiograms were monitored, and no obvious abnormalities were found. Two patients experienced mild loose stools after the first dose of medication, which disappeared after the first decoction time was adjusted to simmer over low heat for 25 minutes, and the treatment was not interrupted.

[0039] In summary, after 14 days of treatment, all observed indicators of the 30 patients with tennis leg showed significant improvement. The comprehensive efficacy evaluation results showed that 15 cases (50.0%) were cured, 9 cases (30.0%) showed significant improvement, 5 cases (16.7%) showed improvement, and 1 case (3.3%) showed no effect, with a total effective rate of 96.7%. These results indicate that the traditional Chinese medicine composition of this invention has a significant therapeutic effect on acute tennis leg, effectively improving patients' clinical symptoms and restoring limb function. It has a rapid onset of action, stable efficacy, and no obvious adverse reactions, demonstrating good clinical application prospects and promotional value.

[0040] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art: This invention relates to a traditional Chinese medicine composition for treating tennis leg, its preparation method, and its application. The raw materials in the formula conform to the principle of "principal, assistant, adjuvant, and guide" in traditional Chinese medicine formulation. The principal herb disperses pathogenic factors on the skin surface, clears blocked pores, and disperses blood stasis and edema. The assistant herbs internally eliminate stagnation, externally unblock meridians, and promote the repair of tendons and vessels. Simultaneously, the adjuvant herbs assist in tonifying the liver and kidneys, strengthening tendons and bones, promoting muscle repair, and invigorating blood circulation to reduce swelling. The combined formula not only rapidly reduces swelling and relieves pain but also strengthens tendons and bones, repairs muscle damage, and enhances tendon and vessel resilience, fundamentally reducing the recurrence rate of tennis leg. Furthermore, the raw materials are mild in nature and have no obvious toxic side effects, avoiding the problems of gastrointestinal irritation and increased burden on the liver and kidneys associated with existing anti-inflammatory drugs, thus possessing outstanding clinical application value.

[0041] The above embodiments are only for illustrating the technical concept and features of the present invention. Their purpose is to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be used to limit the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating tennis leg, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 6-12 parts of Schizonepeta tenuifolia, 6-12 parts of Saposhnikovia divaricata, 6-12 parts of Perilla frutescens, 9-15 parts of Clematis chinensis, 6-12 parts of Curcuma longa, 9-15 parts of Dipsacus asper, 6-12 parts of Broussonetia papyrifera, 9-15 parts of Dendrobium nobile, and 9-15 parts of Clematis armandii.

2. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicament for treating tennis leg.

3. The application according to claim 2, characterized in that: The drug includes the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

4. The application according to claim 2, characterized in that: The dosage forms of the drugs include decoctions, tablets, capsules, granules, powders, water pills, honey pills, drop pills, and oral liquid preparations.

5. The application according to claim 2, characterized in that: The tennis leg injury or tear includes damage or tearing at the junction of the plantar muscles, gastrocnemius, soleus, and the medial head tendon of the gastrocnemius.

6. A method for preparing a traditional Chinese medicine composition according to any one of claims 1 to 5, characterized in that, include: S1. Weigh each raw material according to the weight proportions, wash them and mix them together; S2. Add water and boil, then collect the first decoction. S3. Add water to the dregs after decoction and decoct again, then collect the second decoction. S4. Combine the first decoction and the second decoction, and concentrate them to obtain the Chinese herbal composition.

7. The preparation method according to claim 6, characterized in that: In step S2, add water equal to 8 times the total weight of the raw materials, soak for 30 minutes, and then decoct.

8. The preparation method according to claim 6, characterized in that: In step S2, the decoction is first brought to a boil over high heat, then simmered over low heat for 25-35 minutes, and then filtered to obtain the first decoction.

9. The preparation method according to claim 6, characterized in that: In step S3, add water again, which is 6 times the total weight of the raw materials. Bring to a boil over high heat, then simmer over low heat for 15-25 minutes. Filter to obtain the second decoction.

10. The preparation method according to claim 6, characterized in that: In step S4, the combined first and second decoctions are concentrated to a relative density of 1.1 to 1.25 at 60°C to obtain the traditional Chinese medicine composition.

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