A traditional Chinese medicine preparation for treating acute and chronic closed soft tissue injury and a preparation method thereof

Abstract

This invention discloses a traditional Chinese medicine preparation for treating acute and chronic closed soft tissue injuries and its preparation method. The preparation includes Dipsacus asper, Drynaria fortunei, Eupolyphaga sinensis, natural copper, Angelica sinensis, Paeonia lactiflora, Ligusticum chuanxiong, Carthamus tinctorius, Boswellia carterii, Commiphora myrrha, Paeonia suffruticosa, Verbena officinalis, Piper kadsura, Lycopodium clavatum, Luffa cylindrica, Clematis chinensis, Trachelospermum jasminoides, Buthus martensii, Scolopendra subspinipes, Cinnamomum cassia, Asarum heterotropoides, Salvia miltiorrhiza, and Gleditsia sinensis. This preparation possesses the effects of healing injuries and promoting tendon healing, invigorating blood circulation and relaxing collaterals, reducing swelling and relieving pain, dispelling wind and dampness, and warming the meridians and dispersing cold. It can be used simultaneously for the treatment of acute and chronic closed soft tissue injuries, such as ankle sprains and contusions, knee sprains and contusions, wrist sprains and contusions, small joint sprains and contusions of the hands and feet, lumbar sprains, cervical sprains, and stiff neck. The preparation process utilizes traditional Chinese medicine fermentation technology. While the method is relatively traditional, it embodies the concept of enhancing efficacy through fermentation, fully leveraging the advantages of fermentation to enhance therapeutic effects and resulting in more prominent clinical efficacy.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically, it relates to a traditional Chinese medicine preparation for treating acute and chronic closed soft tissue injuries and its preparation method. Background Technology

[0002] Closed soft tissue injury refers to a condition where the skin or mucous membrane is intact, without any opening to the outside, and the bleeding accumulates within the tissue. It is a type of soft tissue injury, and the bleeding accumulates within the tissue. It is commonly seen in symptoms such as rheumatic bone pain, sprains and strains, frozen shoulder, cervical spondylosis, lumbar disc herniation, sciatica, lumbar muscle strain, bone hyperplasia, rheumatism, rheumatoid arthritis, joint effusion, arthritis, and joint swelling.

[0003] In treatment, approximately 30% of patients with soft tissue injuries each year choose conservative treatment or postoperative rehabilitation. This type of treatment is primarily conducted in Traditional Chinese Medicine (TCM) wards. The underlying pathogenesis mainly focuses on damage to the meridians and blood vessels, and blood stasis outside the vessels. The medications used for treatment based on TCM theory vary, and their effectiveness differs. TCM compositions for closed soft tissue injuries are constantly being explored and improved. Therefore, based on clinical practice, we have developed a simple, convenient, inexpensive, and effective external application formula of TCM. Summary of the Invention

[0004] The technical problem to be solved by this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine preparation for treating acute and chronic closed soft tissue injuries and its preparation method. To solve the above technical problem, the basic concept of the technical solution adopted by this invention is as follows:

[0005] This invention provides a traditional Chinese medicine composition for treating acute and chronic closed soft tissue injuries, comprising the following parts by weight of traditional Chinese medicine raw materials: 15-30 parts of Dipsacus asper, 15-30 parts of Drynaria fortunei, 10-15 parts of Eupolyphaga sinensis, 6-10 parts of natural copper, 6-10 parts of Angelica sinensis, 6-10 parts of Paeonia lactiflora, 3-6 parts of Ligusticum chuanxiong, 3-6 parts of Carthamus tinctorius, 3-6 parts of Boswellia carterii, 3-6 parts of Commiphora myrrha, 6-10 parts of Paeonia suffruticosa, 6-10 parts of Verbena officinalis, 10-15 parts of Piper kadsura, 10-15 parts of Lycopodium clavatum, 10-15 parts of Luffa cylindrica, 10-15 parts of Clematis chinensis, 10-15 parts of Trachelospermum jasminoides, 2-6 parts of Buthus martensii, 2-6 parts of Scolopendra subspinipes, 6-10 parts of Cinnamomum cassia, 2-6 parts of Asarum heterotropoides, 2-6 parts of Salvia miltiorrhiza, and 2-6 parts of Gleditsia sinensis.

[0006] Furthermore, the herbal raw materials include the following parts by weight: 30 parts of Dipsacus asper, 30 parts of Drynaria fortunei, 15 parts of Eupolyphaga sinensis, 10 parts of natural copper, 10 parts of Angelica sinensis, 10 parts of Paeonia lactiflora, 6 parts of Ligusticum chuanxiong, 6 parts of Carthamus tinctorius, 6 parts of Boswellia carterii, 6 parts of Commiphora myrrha, 10 parts of Paeonia suffruticosa, 10 parts of Verbena officinalis, 15 parts of Piper kadsura, 15 parts of Lycopodium clavatum, 15 parts of Luffa cylindrica, 15 parts of Clematis chinensis, 15 parts of Trachelospermum jasminoides, 6 parts of Buthus martensii, 6 parts of Scolopendra subspinipes, 10 parts of Cinnamomum cassia, 6 parts of Asarum heterotropoides, 6 parts of Salvia miltiorrhiza, and 6 parts of Gleditsia sinensis.

[0007] In another aspect, the present invention provides a formulation made from the above-mentioned traditional Chinese medicine composition for treating acute and chronic closed soft tissue injuries.

[0008] Furthermore, the formulation is in the form of an ointment.

[0009] In another aspect, this invention also provides a method for preparing a traditional Chinese medicine preparation for treating acute and chronic closed soft tissue injuries, comprising the following process steps:

[0010] Step 1: Mix all the ingredients according to the specified proportions and grind them into powder.

[0011] Step 2: Mix the medicinal powder obtained in Step 1 with an appropriate amount of honey and dry yeast to form a medicinal paste, ferment for 40-60 minutes at a fermentation temperature of 30-36℃, and obtain the medicinal paste; wherein the mass ratio of medicinal powder to honey and dry yeast is 200:160~250:0.5~1.5;

[0012] Step 3: Make the medicated mud into a medicated cake suitable for the affected area, with a thickness of 1.5-2mm, and the preparation is obtained.

[0013] In Traditional Chinese Medicine (TCM), closed soft tissue injuries fall under the category of "tendon and muscle injuries" in the Department of Orthopedics and Traumatology, and are rarely directly recorded in TCM classics. Regarding their etiology, TCM believes that in addition to direct violence, indirect violence, and chronic strain, they are closely related to the strength of one's constitution. For example, the *Suwen* (Plain Questions) states, "The waist is the residence of the kidneys; if it cannot turn and sway, the kidneys are exhausted." The *Zhubing Yuanhou Lun* (Treatise on the Origins and Symptoms of Various Diseases) also points out, "The kidneys govern the waist and legs," and "When the kidneys are strained, the meridians are injured, and one is also invaded by wind and cold, causing blood and qi to stagnate, hence the lower back pain. Those with yang energy cannot bend forward, and those with yin energy cannot bend backward; when both yin and yang are affected by pathogenic factors, it causes lower back pain and the inability to bend or straighten." This indicates that some lower back and leg pain is related to both "strain" and "injury," as well as kidney deficiency. Traditional Chinese medicine also believes that after a sprain, the local qi and blood are disrupted, and blood circulation is sluggish. Wind, cold and dampness will inevitably take advantage of the weakness and invade. The "Essentials of Orthopedics" in the "Golden Mirror of Medicine" states: "If one is accustomed to wind, cold and dampness, and then suffers a fall or injury, blood stasis will congeal, swelling and hardening of the tendons will occur." This indicates that when there is injury and blood stasis combined with numbness, the meridians lose their warmth, blood stasis is difficult to resolve, and the muscles become more stiff and weak, making the recovery of sprains slow, the course of the disease longer, and it may even become chronic and difficult to improve.

[0014] Through in-depth study of traditional Chinese medicine classics and literature review, summarizing the views of physicians from the Han Dynasty to the present, and combining long-term clinical practice, the inventor innovated while inheriting tradition, believing that the pathogenesis of closed soft tissue injuries is mainly due to kidney deficiency as the internal cause, and direct violence, indirect violence and chronic strain as the external factors. At the same time, after the injury, local blood circulation is sluggish, and wind, cold and dampness take advantage of the deficiency to invade. This characteristic is precisely why many soft tissue injuries in clinical practice, despite timely treatment in the acute phase, still develop into chronic injuries and are difficult to heal.

[0015] Based on the etiology and pathogenesis of closed soft tissue injuries, and the characteristics of pathological transformation at different stages of the disease, and adhering to the principles of "treating based on evidence," "prescribing based on principles," and "the principles of external treatment are the principles of internal treatment, and the medicines used in external treatment are the medicines used in internal treatment; the only difference is the method," the inventors pioneered the following treatment principles for closed soft tissue injuries: 1. Regardless of whether it is the acute or chronic phase, adhere to the principle of continuous treatment; 2. Tonify the kidneys and strengthen the tendons as the foundation, and promote blood circulation, remove blood stasis, reduce swelling, and relieve pain as the key. Given that soft tissue injuries are easily invaded by wind, cold, and dampness, the importance of dispelling wind and dampness, warming the meridians, and dispersing cold is emphasized. Based on the principle of "prescribing based on principles," and adhering to the theory of "principal, assistant, adjuvant, and guide," we fully utilize the advantages of traditional Chinese medicine in "multiple effects of one medicine" and "synergistic effects," and have formulated specific formulation schemes. Through more than 10 years of clinical practice and continuous exploration and optimization, we have formed the traditional Chinese medicine composition scheme of this invention.

[0016] The self-developed external application formula of traditional Chinese medicine in this invention consists of: Dipsacus asper, Drynaria fortunei, Eupolyphaga sinensis, natural copper, Angelica sinensis, Paeonia lactiflora, Ligusticum chuanxiong, Carthamus tinctorius, Boswellia carterii, Commiphora myrrha, Paeonia suffruticosa, Verbena officinalis, Piper kadsura, Lycopodium clavatum, Luffa cylindrica, Clematis chinensis, Trachelospermum jasminoides, Buthus martensii, Scolopendra subspinipes, Cinnamomum cassia, Asarum heterotropoides, Salvia miltiorrhiza, and Gleditsia sinensis.

[0017] In the formula of the present invention, Dipsaci Radix has the property of acrid-warm dispersing, good at activating blood and removing blood stasis; with the tonifying effect of sweet-warm property, it can also strengthen bones and tendons, so it has the effects of connecting tendons and bones, and healing injuries and fractures. Rhizoma Drynariae, as its name suggests, can not only activate blood and heal injuries, but also tonify the kidney and strengthen bones. Eupolyphaga Steleophaga, with salty-cold property entering blood, mainly enters the liver meridian, and is good at walking and dredging. It can activate blood, reduce swelling, relieve pain, connect tendons and bones, and heal injuries. The combination of these three medicines gives full play to the effects of tonifying the kidney, connecting tendons and bones, activating blood, reducing swelling and relieving pain, and all of them serve as monarch medicines; Pyritum is acrid in flavor and dispersing, entering the blood part of liver meridian, functioning in activating blood and dispersing blood stasis, and connecting tendons and bones. Angelicae Sinensis Radix is acrid in moving and warm in unblocking, and is a key medicine for activating blood, removing blood stasis and relieving pain. Paeoniae Radix Rubra is bitter and cold in nature, entering the blood part of liver meridian, and has the effects of activating blood, dispersing blood stasis and relieving pain. Chuanxiong Rhizoma is acrid in dispersing and warm in unblocking, which can not only activate blood and resolve blood stasis, but also move qi and relieve pain. It is known as "qi medicine in blood" and can also dispel wind, dredge collaterals and relieve pain. Carthami Flos is good at unblocking blood vessels, reducing swelling and relieving pain, and is a key medicine for treating injuries from falls and injuries, and stasis swelling and pain. Olibanum and Myrrha are core herb pairs for treating tendon injury diseases in literature retrieval. Olibanum is bitter in flavor, dredging and entering blood, which can not only dispel blood stasis and relieve pain, but also activate blood and reduce swelling. Myrrha is used in combination with Olibanum. Moutan Cortex can clear heat, cool blood, activate blood and remove blood stasis. Verbenae Herba can activate blood and remove blood stasis. The combination of these nine medicines assists the monarch medicines in connecting tendons and bones, nourishing blood and removing blood stasis, reducing swelling and relieving pain, and all of them serve as minister medicines; Piperis Kadsurae Caulis can not only dispel wind-damp, but also dredge collaterals and relieve pain. Lycopodii Herba is acrid in dispersing, bitter in drying and warm in unblocking, can dispel wind-damp, enters liver meridian and is especially good at unblocking collaterals, and is better at relaxing tendons and activating collaterals, reducing swelling and relieving pain. Luffae Cirrhosus Retinervus can dispel wind, dredge collaterals and activate blood. Clematidis Radix et Rhizoma is acrid in dispersing and warm in unblocking, with fierce property good at walking, and unblocking the twelve meridians. It can not only dispel wind-damp, but also dredge collaterals and relieve pain. Trachelospermi Caulis et Folium can not only dispel wind, dredge collaterals and relieve pain, but also cool blood, reduce swelling and relieve pain; Scorpio and Scolopendra are used in combination, both entering liver meridian, good at walking and dredging, dispersing wind-cold-damp pathogens in meridians, and dredging collaterals to relieve pain. Modern pharmacology also shows that they have good anti-inflammatory and analgesic effects. Cinnamomi Ramulus enters lung and bladder meridians, can not only induce sweating to release muscles, but also warm and unblock meridians. Asari Radix et Rhizoma can not only dispel cold pathogens in the kidney meridian of foot-shaoyin to activate yang and resolve stagnation, but also search for wind-damp between muscles and bones to eliminate bi-syndrome and relieve pain. These nine medicines focus on dispelling wind and eliminating dampness, warming meridians and dispersing cold, addressing the characteristic that after soft tissue injury, local blood circulation is sluggish, and wind-cold-damp pathogens invade by taking advantage of the deficiency, which also reflects the importance attached by the team of the present invention to the understanding that wind-cold-damp pathogens invade by taking advantage of the deficiency. They can also unblock meridians and activate collaterals, which is the focus of the later treatment of tendon injury diseases, and all of them serve as assistant medicines. Aesculi Semen is the mature seed of *Aesculus chinensis* or *Aesculus wilsonii*, which is rich in triterpenoid saponins according to modern pharmacology. Gleditsiae Fructus, when used externally, has the effect of dispersing stagnation and reducing swelling, and also contains triterpenoid saponins according to modern pharmacology. Escin can be isolated from both of them, which has the effects of anti-inflammation, anti-exudation, increasing venous tension, improving blood circulation and the like. At the same time, it has good surface activity, which is conducive to the penetration of the medicine through the stratum corneum of the skin, and then directly reaches the affected area to exert the therapeutic effect. Both of them serve as guide medicines.

[0018] After adopting the above technical scheme, the present invention has the following beneficial effects compared with the prior art.

[0019] The self-developed traditional Chinese medicine external application formula provided by this invention has the effects of healing injuries and tendons, promoting blood circulation and relaxing collaterals, reducing swelling and relieving pain, dispelling wind and dampness, and warming the meridians and dispersing cold. It can be used simultaneously for the treatment of acute and chronic closed soft tissue injuries, such as ankle sprains and contusions, knee sprains and contusions, wrist sprains and contusions, small joint sprains and contusions of the hands and feet, lumbar sprains, neck sprains, and stiff neck. Its preparation process uses traditional Chinese medicine fermentation technology. While the method of use is relatively traditional, it embodies the concept of enhancing efficacy through fermentation, fully leveraging the advantages of fermentation to enhance therapeutic effects and making clinical efficacy more prominent.

[0020] The specific embodiments of the present invention will be described in further detail below. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments will be clearly and completely described below. The following embodiments are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0022] Example 1: Traditional Chinese Medicine Ointment for Treating Acute and Chronic Closed Soft Tissue Injuries

[0023] (1) Mix all the Chinese herbal raw materials evenly according to the proportions shown in Example 1 in Table 1, and then grind them into powder.

[0024] (2) Mix the medicinal powder obtained in step (1) with honey and dry yeast to form a medicinal paste and ferment for 40-60 minutes at a temperature of 30-36℃. The mass ratio of medicinal powder to honey and dry yeast is 200:160:1 (a ratio of 200:160 to 250:0.5 to 1.5 is acceptable).

[0025] (3) The fermented medicinal mud obtained in step (2) is made into a medicinal cake suitable for the affected area, with a thickness of 1.5-2mm, thus obtaining the ointment.

[0026] Example 2: Formulation

[0027] Same as Example 1, except that the proportions of each Chinese herbal raw material are shown in Example 2 in Table 1.

[0028] Example 3: Formulation

[0029] Same as Example 1, except that the proportions of each Chinese herbal raw material are shown in Example 3 in Table 1.

[0030] Table 1. Ingredient Combinations for Each Example

[0031]

[0032]

[0033] The clinical effects of Examples 1-3 are not significantly different, and all can exert the following effects: healing injuries and tendons, promoting blood circulation and relaxing collaterals, reducing swelling and relieving pain, dispelling wind and dampness, and warming the meridians and dispelling cold.

[0034] Effect verification

[0035] This invention has been under development since 2009, undergoing annual clinical validation. Adhering to the principle of identifying and solving problems, and incorporating new clinical experience and discoveries, the version has been continuously optimized. By 2019, it had undergone three updates and iterations, resulting in the current version of the traditional Chinese medicine composition. The clinical effects of these three versions have become increasingly prominent, with each generation showing a higher efficacy rate. The clinical observation data are as follows.

[0036] 1. First generation version

[0037] 1.1 By weight, the traditional Chinese medicine composition includes the following components: 30 parts of Dipsacus asper, 30 parts of Drynaria fortunei, 15 parts of Eupolyphaga sinensis, 10 parts of natural copper, 10 parts of Angelica sinensis, 10 parts of Paeonia lactiflora, 6 parts of Ligusticum chuanxiong, 6 parts of Carthamus tinctorius, 10 parts of Paeonia suffruticosa, 10 parts of Verbena officinalis, 15 parts of Piper kadsura, 15 parts of Lycopodium clavatum, 15 parts of Luffa cylindrica, 15 parts of Clematis chinensis, 15 parts of Trachelospermum jasminoides, 6 parts of Buthus martensii, 6 parts of Scolopendra subspinipes, 10 parts of Cinnamomum cassia, and 6 parts of Asarum heterotropoides.

[0038] 1.2 Statistical Period

[0039] October 2009 - October 2012

[0040] 1.3 Statistical Objects (hereinafter the same):

[0041] Patients who visited the outpatient and inpatient departments of the Department of Traditional Chinese Medicine at the Seventh Medical Center of the PLA General Hospital during the aforementioned period, whose diagnoses included acute closed soft tissue injury and chronic closed soft tissue injury, and who used this external application of traditional Chinese medicine.

[0042] 1.4 Criteria and methods for evaluating efficacy (hereinafter the same):

[0043] 1.4.1 In the acute group, pain, swelling, joint function, and clinical efficacy were assessed on days 1, 3, 5, and 7 after treatment. Adverse reactions were statistically analyzed, and patients were followed up once a month later.

[0044] (1) Pain assessment: The visual analog scale (VAS) was used to assess the patient's pain level. VAS assessment criteria: no pain 0-1 points; mild pain 2-4 points; moderate pain 5-7 points; severe pain 8-9 points; extreme pain 10 points. Data were recorded before treatment and on days 1, 3, 5, and 7 after treatment. (2) Swelling assessment: Using the healthy side as a reference, no swelling was 0 points; mild swelling, below the bony prominence of the adjacent joint, was 2 points; moderate swelling, level with the bony prominence of the adjacent joint, was 4 points; severe swelling, significantly exceeding the bony prominence of the adjacent joint, was 8 points. Data were recorded before treatment and on days 1, 3, 5, and 7 after treatment. (3) Joint function assessment: no impairment was 0 points; mild impairment, with slight restriction of adjacent joints but not affecting daily life, was 2 points; moderate impairment, with movement of adjacent joints affecting work but able to complete daily life, was 4 points; severe impairment, with loss of daily living ability, was 8 points. Record patient data before and during treatment. (4) Efficacy evaluation criteria: Cured: Symptoms and signs completely disappeared, and the patient returned to work. VAS score was 0-1, and total score for swelling and joint function was 0-1. Significantly effective: Symptoms basically disappeared or mostly disappeared, and the patient could return to work or only felt mild discomfort after exertion. VAS score was 2-4, and total score for swelling and joint function was 2-4. Improved: Clinical symptoms improved. VAS score was 5-7, and total score for swelling and joint function was 5-8. Ineffective: Symptoms did not improve. VAS score was 8-10, and total score for swelling and joint function was 9-16. Total effective rate = (number of cured cases + number of significantly effective cases + number of improved cases) / total number of cases × 100%. Cure rate = number of cured cases / total number of cases × 100%.

[0045] 1.4.2 In the chronic group, clinical treatment effects, VAS pain scores, Oswestry scores, and quality of life scores were analyzed at 7, 14, 21, and 28 days after treatment. Adverse reactions were statistically analyzed. Patients were followed up once a month for six months.

[0046] (1) Clinical efficacy evaluation criteria: Cured: The patient's pain and clinical signs completely disappeared after treatment, and the joint movement was normal; Significantly effective: The patient's pain and clinical signs basically disappeared after treatment, and the joint movement was normal; Effective: The patient's pain and other symptoms basically disappeared after treatment, and the joint was slightly restricted; Ineffective: The patient's pain and clinical signs did not improve or even worsened after treatment, and the joint was significantly restricted. (2) VAS pain score and Oswestry score: VAS pain score evaluation: Select on the vernier caliper, where 0 points is defined as no pain and 10 points is defined as the most severe pain. Oswestry score: The assessment items include pain intensity (0-5 points), lifting objects (0-5 points), daily living ability (0-5 points), standing (0-5 points), sleep (0-5 points), travel (0-5 points), sexual life (0-5 points), and social activities (0-5 points). (3) Quality of life score, including five items: psychological domain score, independence domain score, social relationship score, environmental domain score, and physical domain score. Overall effective rate = (Number of cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases × 100%. Cure rate = Number of cured cases / Total number of cases × 100%.

[0047] 1.5. Usage Instructions (same below)

[0048] Prepare the medicated cake according to the preparation method of Example 1 and the proportion of the first-generation version of the drug combination. Apply the prepared medicated cake to the injured area, with the area of ​​the medicated cake slightly larger than the area of ​​the injured area, and then wrap it with plastic wrap. The plastic wrap has three functions: (1) fixation, so that it can continue to exert its effect in the same place and prevent it from getting contaminated elsewhere; (2) moisturizing, so that the medicated cake is kept moist, which is more conducive to its continued therapeutic effect; (3) promoting secondary fermentation. The human body temperature is 36-37℃. The plastic wrap fixes the medicated cake to the affected area, so that the medicated cake can be kept at 30-36℃, which promotes secondary fermentation during the use of the medicated cake, which is more conducive to the drug penetrating the stratum corneum of the skin and exerting a better therapeutic effect. Remove the plastic wrap and medicated cake after 8-10 hours of application, and rinse off the residue of the medicated cake with warm water. Repeat the above operation at the same time every day. The treatment course for the acute group is 7 days, and the treatment course for the chronic group is 28 days.

[0049] 1.6. Precautions (the same applies below)

[0050] (1) It is only for closed injuries. It is contraindicated for open injuries and for injuries with skin lesions (eczema, dermatitis, boils, furuncles, etc.).

[0051] (2) This product is contraindicated for those who are allergic to any of the ingredients in the external application formula of this invention, as well as to honey, dry yeast, etc.

[0052] (3) If contact dermatitis occurs during use, discontinue use and treat the symptoms.

[0053] (4) The normal usage time is 8-10 hours. Children and the elderly should shorten the usage time appropriately.

[0054] 1.7. Statistical Analysis of Clinical Outcome Data

[0055] The treatment outcomes for acute closed soft tissue injuries are shown in Table 2:

[0056] Table 2

[0057]

[0058] The results of chronic closed soft tissue injuries are shown in Table 3:

[0059] Table 3

[0060]

[0061] Note: The results above show that the efficacy of the formula in treating acute closed soft tissue injuries is lower than that in treating chronic closed soft tissue injuries. Acute cases are characterized by significant local tissue exudation, requiring stronger anti-swelling and analgesic effects. Therefore, the first-generation formula was further optimized by adding frankincense and myrrh to enhance blood circulation, reduce swelling, and relieve pain, resulting in the second-generation version.

[0062] 2. Second generation version

[0063] 2.1 By weight, the traditional Chinese medicine composition comprises the following components: 30 parts of Dipsacus asper, 30 parts of Drynaria fortunei, 15 parts of Eupolyphaga sinensis, 10 parts of natural copper, 10 parts of Angelica sinensis, 10 parts of Paeonia lactiflora, 6 parts of Ligusticum chuanxiong, 6 parts of Carthamus tinctorius, 6 parts of Boswellia carterii, 6 parts of Commiphora myrrha, 10 parts of Paeonia suffruticosa, 10 parts of Verbena officinalis, 15 parts of Piper kadsura, 15 parts of Lycopodium clavatum, 15 parts of Luffa cylindrica, 15 parts of Clematis chinensis, 15 parts of Trachelospermum jasminoides, 6 parts of Buthus martensii, 6 parts of Scolopendra subspinipes, 10 parts of Cinnamomum cassia, and 6 parts of Asarum heterotropoides.

[0064] 2.2 Statistical Period

[0065] October 2012 - July 2019

[0066] 2.3 Statistical subjects (same as above):

[0067] Patients who visited the outpatient and inpatient departments of the Department of Traditional Chinese Medicine at the Seventh Medical Center of the PLA General Hospital during the aforementioned period, whose diagnoses included acute closed soft tissue injury and chronic closed soft tissue injury, and who used this external application of traditional Chinese medicine.

[0068] 2.4 Efficacy assessment criteria and methods (same as above):

[0069] 2.5. Usage method (same as above)

[0070] 2.6. Precautions (same as above)

[0071] 2.7. Statistical Analysis of Clinical Outcome Data

[0072] The treatment outcomes for acute closed soft tissue injuries are shown in Table 4:

[0073] Table 4

[0074]

[0075] The results of chronic closed soft tissue injuries are shown in Table 5:

[0076] Table 5

[0077]

[0078] Note: After optimization to the second-generation traditional Chinese medicine composition, the overall effective rate for both acute and chronic closed soft tissue injuries improved, with a more significant improvement in the acute group, suggesting that enhancing the anti-swelling and analgesic effects during the acute phase can improve the effective rate. No serious adverse reactions were observed during treatment; only one case of skin redness occurred, which subsided spontaneously after discontinuation of the medication. Clinical practice revealed that the key challenges hindering further improvement in drug efficacy were reducing vascular permeability to decrease exudation and increasing the drug's ability to penetrate the stratum corneum. After reviewing literature and screening, *Salvia miltiorrhiza* and *Gleditsia sinensis* were selected as adjuvants to address these two challenges, resulting in the third-generation version, namely the traditional Chinese medicine composition of this invention.

[0079] 3. Third generation version

[0080] 3.1 The third-generation version is the combination ratio in Example 1.

[0081] 3.2 Statistical Period

[0082] August 2019 - October 2023

[0083] 3.3 Statistical Objects:

[0084] Patients who visited the outpatient and inpatient departments of the Department of Traditional Chinese Medicine at the Seventh Medical Center of the PLA General Hospital during the aforementioned period, whose diagnoses included acute closed soft tissue injury and chronic closed soft tissue injury, and who used this external application of traditional Chinese medicine.

[0085] 3.4 Efficacy assessment criteria and methods (same as above):

[0086] 3.5. Usage method (same as above)

[0087] 3.6. Precautions (same as above)

[0088] 3.7. Statistical Analysis of Clinical Outcome Data

[0089] The treatment outcomes for acute closed soft tissue injuries are shown in Table 6:

[0090] Table 6

[0091]

[0092] The treatment outcomes for chronic closed soft tissue injuries are shown in Table 7:

[0093] Table 7

[0094]

[0095] Note: After 11 years of continuous practice and optimization, the third-generation traditional Chinese medicine composition (i.e., the composition of this invention) and its preparation and use have achieved satisfactory clinical effects.

[0096] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-described technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating acute and chronic closed soft tissue injuries, characterized in that, It is composed of the following Chinese medicinal materials in parts by weight: Dipsacus asperoides 15-30 parts, Drynaria fortunei 15-30 parts, Eupolyphaga sinensis 10-15 parts, natural copper 6-10 parts, Angelica sinensis 6-10 parts, Paeonia lactiflora 6-10 parts, Ligusticum chuanxiong 3-6 parts, Carthamus tinctorius 3-6 parts, Boswellia carterii 3-6 parts, Commiphora myrrha 3-6 parts, Paeonia suffruticosa 6-10 parts, Verbena officinalis 6-10 parts, Piper kadsura 10-15 parts, Lycopodium clavatum 10-15 parts, Luffa cylindrica 10-15 parts, Clematis chinensis 10-15 parts, Trachelospermum jasminoides 10-15 parts, Buthus martensii 2-6 parts, Scolopendra subspinipes 2-6 parts, Cinnamomum cassia 6-10 parts, Asarum heterotropoides 2-6 parts, Salvia miltiorrhiza 2-6 parts, and Gleditsia sinensis 2-6 parts.

2. The traditional Chinese medicine composition for treating acute and chronic closed soft tissue injuries according to claim 1, characterized in that, It is composed of the following Chinese medicinal materials in parts by weight: Dipsacus asperoides 30 parts, Drynaria fortunei 30 parts, Eupolyphaga sinensis 15 parts, natural copper 10 parts, Angelica sinensis 10 parts, Paeonia lactiflora 10 parts, Ligusticum chuanxiong 6 parts, Carthamus tinctorius 6 parts, Boswellia carterii 6 parts, Commiphora myrrha 6 parts, Paeonia suffruticosa 10 parts, Verbena officinalis 10 parts, Piper kadsura 15 parts, Lycopodium clavatum 15 parts, Luffa cylindrica 15 parts, Clematis chinensis 15 parts, Trachelospermum jasminoides 15 parts, Buthus martensii 6 parts, Scolopendra subspinipes 6 parts, Cinnamomum cassia 10 parts, Asarum heterotropoides 6 parts, Salvia miltiorrhiza 6 parts, and Gleditsia sinensis 6 parts.

3. A formulation, characterized in that, It is made from the traditional Chinese medicine composition for treating acute and chronic closed soft tissue injuries as described in claim 1 or 2.

4. The method for preparing the formulation according to claim 3, characterized in that, The process includes the following steps: Step 1: Mix all the ingredients according to the specified proportions and grind them into powder. Step 2: Mix the medicinal powder obtained in Step 1 with an appropriate amount of honey and dry yeast to form a medicinal paste, ferment for 40-60 minutes at a fermentation temperature of 30-36℃, and obtain the medicinal paste; wherein the mass ratio of medicinal powder to honey and dry yeast is 200:160~250:0.5~1.5; Step 3: Make the medicated mud into a medicated cake suitable for the affected area, with a thickness of 1.5-2mm, and the preparation is obtained.

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