A traditional Chinese medicine composition, preparation and preparation method for treating acute soft tissue injury

Abstract

The present invention discloses a traditional Chinese medicine composition, preparation, and preparation method for treating acute soft tissue injuries. The composition comprises the following raw materials: Chuanxiong, dried bone drynourish rhizome, clematis root, turmeric, earthworm, calcined copper, Panax notoginseng, Achyranthes bidentata, Zanthoxylum bungeanum, Sappan wood, safflower, vinegar frankincense, vinegar myrrh, dragon's blood, white mustard, borneol, menthol, and liquorice tablets. The composition has the effects of promoting blood circulation, dispersing blood stasis, reducing swelling and relieving pain. It can be applied externally to directly treat the affected area, rapidly penetrates the body, and quickly eliminates swelling and pain. It is an excellent topical analgesic ointment for treating swelling and pain caused by tendon and soft tissue injuries and osteoarthritis.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine compositions, and in particular to a traditional Chinese medicine composition, a preparation and a preparation method for treating acute soft tissue injury. Background Art

[0002] Pain is a common symptom in Traditional Chinese Medicine (TCM). Pain caused by injuries to soft tissues such as tendons, as well as swelling and pain due to osteoarthritis, are particularly common. These conditions significantly impact limb mobility and ultimately health. While their etiology and pathogenesis are complex, they can be summarized as "pain indicates obstruction, and unobstructed circulation eliminates pain." Injury to soft tissues such as tendons, commonly referred to as "tendon injuries," is the most common ailment in trauma. Tendons and other soft tissues are crucial components of joints. "Xizhuo: The Origin and Development of Miscellaneous Diseases" states, "Tendons bind joints and bones, bind flesh and skin, and serve as the nexus of the body, facilitating movement." It also states, "The knee is the central gathering point for tendons." "Lingshu" states, "All tendons belong to the joints." "Flexion and extension are all caused by tendons." Tendons are often the first to be injured in traumatic injuries, presenting the highest risk of injury.

[0003] Clinically, sprains and contusions can cause muscle damage, localized swelling and pain, bruising, and difficulty flexing and extending the joints. In bone injuries, tendons are often injured first because soft tissues such as tendons are attached to the surface, resulting in localized swelling, bruising, and difficulty flexing and extending the joints. The pathogenesis is mostly due to injury and the resulting stagnation of qi and blood, which blocks the meridians and causes pain. If the injury is prolonged, improper treatment, and the bruises do not heal, coupled with improper living habits and the discomfort caused by cold or heat, the condition will worsen, causing persistent swelling and pain, and even affecting the liver and kidneys. Traditional Chinese medicine has accumulated rich experience in treating muscle injuries, swelling, and pain, which can be roughly divided into the following categories: in the acute stage, the main treatment is to promote blood circulation, dissipate blood stasis, and reduce swelling and pain; in chronic injuries, it is advisable to combine warming the meridians, dispelling cold and relieving pain, and promoting qi circulation to relieve stagnation; if the injury does not heal over time, the liver and kidneys should be nourished and the muscles and bones should be strengthened.

[0004] Pain caused by osteoarthritis is also a common pain syndrome. Osteoarthritis encompasses a wide range of conditions, including degenerative bone and joint changes, bone hyperplasia, osteoporosis, rheumatoid arthritis, gout, and joint injuries. Traditional Chinese Medicine (TCM) classifies these conditions as "bi syndrome." The ancients considered "bi" to mean "blockage," referring to the obstruction of the meridians, qi, and blood. The Neijing (Inner Canon of Medicine) states that "the combined presence of wind, cold, and dampness creates bi," a condition characterized by insufficient vital energy, loose pores, and the invasion of external pathogens. The pathogenesis is characterized by blocked meridians, stagnant qi and blood, and poor nutrient and defensive function. Treatment focuses on unblocking the meridians, promoting blood circulation and promoting qi movement, while also using warming and dispersing cold, wind, and dampness. This removes pathogens, unblocks the meridians, and allows qi and blood to circulate, ultimately eliminating swelling and pain.

[0005] Currently, there are many traditional Chinese medicine compositions for treating swelling and pain caused by tendon and soft tissue injuries and bone and joint diseases, but the therapeutic effects are general and cannot meet clinical needs well. Summary of the Invention

[0006] In order to solve the above technical problems, the present invention provides a Chinese medicine composition, preparation and preparation method for treating acute soft tissue injuries (including joint sprains and soft tissue contusions).

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating acute soft tissue injury, which is achieved by adopting the following technical solution.

[0008] A traditional Chinese medicine composition for treating acute soft tissue injury, comprising the following raw materials in parts by weight:

[0009] 1000-1400 parts of Chuanxiong, 1000-1400 parts of scalded Drynaria fortunei, 1000-1400 parts of Clematidis, 1000-1400 parts of Curcuma longa, 600-1000 parts of Eupolyphaga sinensis, 1000-1400 parts of calcined natural copper, 200-600 parts of Panax notoginseng, 600-1000 parts of Achyranthes bidentata, 600-1000 parts of Zanthoxylum bungeanum, 600-1000 parts of Sappan wood, 600-1000 parts of Carthamus tinctorius, 600-1000 parts of vinegar frankincense, 600-1000 parts of vinegar myrrh, 20-60 parts of Sanguisorba officinalis, 100-300 parts of white mustard seeds, 108-148 parts of borneol, 108-148 parts of menthol, and 100-300 parts of liquorice tablets.

[0010] Preferably, a traditional Chinese medicine composition for treating acute soft tissue injury comprises the following raw materials in parts by weight:

[0011] 1100-1300 parts of Chuanxiong, 1100-1300 parts of scalded Drynaria fortunei, 1100-1300 parts of Clematidis, 1100-1300 parts of Curcuma longa, 700-900 parts of Eupolyphaga sinensis, 1100-1300 parts of calcined natural copper, 300-500 parts of Panax notoginseng, 700-900 parts of Achyranthes bidentata, 700-900 parts of Zanthoxylum bungeanum, 700-900 parts of Sappan wood, 700-900 parts of Carthamus tinctorius, 700-900 parts of vinegar frankincense, 700-900 parts of vinegar myrrh, 30-50 parts of Sanguisorba officinalis, 150-250 parts of white mustard seeds, 118-138 parts of borneol, 118-138 parts of menthol, and 150-250 parts of liquorice tablets.

[0012] More preferably, a traditional Chinese medicine composition for treating acute soft tissue injury comprises the following raw materials in parts by weight:

[0013] 1200 parts of Chuanxiong, 1200 parts of scalded Drynaria Rhizoma, 1200 parts of Clematidis, 1200 parts of Curcuma longa, 800 parts of Eupolyphaga sinensis, 1200 parts of calcined natural copper, 400 parts of Panax notoginseng, 800 parts of Achyranthes bidentata, 800 parts of Zanthoxylum bungeanum, 800 parts of Sappan wood, 800 parts of Carthamus tinctorius, 800 parts of vinegar frankincense, 800 parts of vinegar myrrh, 40 parts of Sanguisorba officinalis, 200 parts of white mustard seeds, 128 parts of borneol, 128 parts of menthol, and 200 parts of liquorice tablets.

[0014] Traditional Chinese Medicine believes that "pain is caused by obstruction, and unblocked circulation relieves pain." The key to pain relief lies in "unblocking circulation." This prescription is based on this principle, utilizing 18 herbs: Chuanxiong, Drynaria fortunei, Clemati radix, Curcuma longa, Eupolyphaga sinensis, Copper stalk, Panax notoginseng, Achyranthes bidentata, Zanthoxylum bungeanum, Sappan wood, Carthamus tinctorius, Frankincense, Myrrh, Sanguisorba officinalis, Sinapis alba, Borneolum, Mentha, and Licorice. It promotes blood circulation, removes blood stasis, dredges meridians, and relieves swelling and pain. It is suitable for pain and swelling caused by sprains and contusions, as well as those due to osteoarthritis. The formula is formulated according to established principles, with appropriate herbal ingredients, rigorous compatibility, and a well-balanced combination of monarch and ministerial ingredients, meticulously tailored to the underlying pathogenesis.

[0015] In the prescription, Chuanxiong and Drynaria are selected as the main drugs. Chuanxiong is pungent, dispersing, warming and unblocking. It is a blood Qi drug that is good at promoting blood circulation and qi, dispelling wind and relieving pain. It is often used to treat various pain syndromes caused by blood stasis and qi stagnation; Drynaria is an important drug for promoting blood circulation and healing injuries. It has the functions of promoting blood circulation and healing injuries and relieving pain, and nourishing the kidney and strengthening bones; Chuanxiong is combined with Drynaria to promote the circulation of qi and blood, dredge the meridians, and have strong analgesic effect. It is combined with Clematis chinensis, Curcuma longa, Natural Copper, Eupolyphaga sinensis, Panax notoginseng, Achyranthes bidentata, and Zanthoxylum bungeanum as auxiliary drugs. Among them, Clematis chinensis can dispel rheumatism, relieve arthritis and pain, and is good at treating tendon spasms and joint flexion and extension problems; Curcuma longa can break blood circulation and promote qi, dredge menstruation and relieve pain, and treat bruises and pain caused by falls; Natural Copper and Eupolyphaga sinensis can disperse blood stasis and relieve pain, and connect tendons and bones; Panax notoginseng is an important drug for treating falls and injuries. It has the functions of dispersing blood stasis, stopping bleeding, reducing swelling and relieving pain, and has the characteristics of stopping bleeding without leaving blood stasis, reducing swelling and relieving pain; Achyranthes bidentata can promote blood circulation and remove blood stasis. , guiding blood downward, nourishing the liver and kidneys, and strengthening the tendons and bones. Its benefits for joints and downward movement of the waist and knees make it commonly used for sprains and contusions of the waist and legs, as well as swollen tendons and soreness. Liangmianzhen (two-sided needle) is a highly effective analgesic with a wide range of effects. It promotes blood circulation, dissipates blood stasis, promotes qi and unblocks the meridians, dispels wind and relieves pain, making it particularly suitable for pain caused by wind-cold arthritis, numbness of the limbs, joint flexion and extension difficulties, and injuries from falls. The above seven herbs either assist the monarch to promote blood circulation and reduce swelling and pain, or dissipate blood stasis to relieve pain. Su Mu (sappanwood), Safflower, Myrrh, and Frankincense are excellent for treating tendon injuries, promoting blood circulation, dissipating blood stasis, relaxing tendons and activating meridians, reducing swelling and relieving pain. They are suitable for pain caused by qi and blood stagnation. Xuejie (blood clotting herb) promotes blood circulation, relieves pain, dissipates blood stasis, stops bleeding, and promotes tissue regeneration and sores. The above five herbs primarily dissipate blood stasis, reduce swelling, and enter the meridians to relieve pain. Together, they assist the monarch to enhance the effects of promoting blood circulation, dispersing blood stasis, and relieving pain, and serve as adjuvants. White mustard seeds dissipate lumps and reduce swelling, borneol is a crystal of camphor, which is good at penetrating into the meridians, dispersing and relieving pain, and menthol promotes skin absorption. These three herbs act as guiding drugs, guiding the drugs directly to the affected area and helping the other drugs to exert their efficacy. Licorice harmonizes the other drugs.

[0016] Looking at the whole prescription, the combination is reasonable and the medication is appropriate, which can work together to dredge the meridians, promote blood circulation and disperse blood stasis, reduce swelling and relieve pain. It is a good prescription for external use to treat injuries, reduce swelling and relieve pain.

[0017] In a second aspect, the present invention provides a traditional Chinese medicine preparation for treating acute soft tissue injury, which is achieved by adopting the following technical solution.

[0018] A pharmaceutically acceptable preparation made from the above-mentioned traditional Chinese medicine composition.

[0019] Specifically, the preparation is a plaster.

[0020] In a third aspect, the present invention provides a method for preparing a traditional Chinese medicine preparation for treating acute soft tissue injury, which is achieved by adopting the following technical solution.

[0021] A method for preparing the above preparation comprises the following steps:

[0022] S1. Preparation of fine powder: Take the prescribed amount of the drug calcined natural copper, Panax notoginseng, vinegar frankincense, vinegar myrrh, dragon's blood powder raw material powder into a 100 mesh fine powder and mix well;

[0023] S2. Preparation of clear paste: Take the prescribed amount of drugs Chuanxiong, scalded drynaria, clematis, turmeric, Eupolyphaga, Achyranthes, Zanthoxylum bungeanum, Sappan wood, safflower, white mustard, licorice slices and decocted twice with water, the first time for 2-3 hours, the second time for 1-1.5 hours, the decoction was combined, filtered, and the filtrate was concentrated to a relative density of 1.05-1.10 (65 ° C) of the clear paste; add the fine powder obtained in step S1 and mix well;

[0024] S3. Preparation of matrix: Take 1000g of carbomer, 900g of gelatin and 5000g of glycerol, stir at 60-70°C to prepare a matrix;

[0025] S4. The mixture of step S2, borneol, menthol and potassium sorbate 15g was added to the matrix obtained in step S3, stirred at a constant temperature of 55-65 ℃ for 2-3 hours, and stirred until cold to prepare a coating;

[0026] S5. Apply the coating obtained in step S4 on a non-woven fabric, dry it, and cut it; apply each patch on a breathable tape to make 1000 patches (each patch containing 12.69g of crude drug), bag it and seal it to obtain the finished product.

[0027] This application has the following beneficial effects.

[0028] The prescription of the present invention integrates the methods of promoting blood circulation, dispersing blood stasis, warming the body, promoting the circulation of qi, and dredging the meridians and activating the collaterals into one prescription, with "unblocking" as the main effect, so that cold and dampness are dispersed, the meridians are unblocked, and the qi and blood flow to achieve "no pain when the meridians are unblocked". It has the effects of promoting blood circulation, dispersing blood stasis, reducing swelling and relieving pain. It can be directly used to treat local diseased areas, the medicinal power penetrates quickly, and the swelling and pain are quickly eliminated. It is a good external analgesic ointment for treating swelling and pain caused by tendon soft tissue injuries and bone and joint diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a comparison chart of the VAS scores of the first diagnosis and the 1st, 3rd, and 7th days of medication of the present invention;

[0030] Figure 2 This is a comparison chart of the tenderness scores of the present invention at the initial diagnosis and on the 1st, 3rd, and 7th days of medication;

[0031] Figure 3 This is a comparison chart of the swelling degree scores for the initial diagnosis and the 1st, 3rd, and 7th medications of the present invention;

[0032] Figure 4 This is a comparison chart of swelling rates on the 1st, 3rd, and 7th days after taking the medication of the present invention;

[0033] Figure 5 This is a comparison chart of ecchymosis scores at the initial diagnosis and on the 1st, 3rd, and 7th days of medication of the present invention;

[0034] Figure 6 This is a comparison chart of the functional impairment scores of the present invention at the initial diagnosis and on the 1st, 3rd and 7th days after medication. DETAILED DESCRIPTION

[0035] The present patent application is further described below with reference to the embodiments.

[0036] Unless otherwise specified, the experimental methods used in the following preparation examples and examples are conventional methods; the materials, reagents, etc. used in the following preparation examples and examples are all commercially available unless otherwise specified.

[0037] Example

[0038] A plaster for treating acute soft tissue injury, comprising the following steps:

[0039] Calcined natural copper 1200g, Panax notoginseng 400g, vinegar frankincense 800g, vinegar myrrh 800g, Sanguisorba officinalis 40g crushed into fine powder, set aside; Borneol 128g, menthol 128g blended, the blended material set aside; the rest Chuanxiong 1200g, scalded Drynaria 1200g, Clematidis 1200g, Curcuma 1200g, Eupolyphaga sinensis 800g, Achyranthes bidentata 800g, Zanthoxylum bungeanum 800g, Sappan wood 800g, Safflower 800g, White mustard seeds 200g, Licorice slices 20g 0g of the herb is decocted twice with water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.05-1.10 (65°C). The above-mentioned fine powder is added and mixed thoroughly. 1000g of carbomer, 900g of gelatin, and 5000g of glycerin are stirred at 60°C to form a matrix. The above mixture, the eutectic, and 15g of potassium sorbate are added to the matrix and stirred at 60°C for 2 hours. The coating is then cooled by continuous stirring to form a coating. The coating is evenly applied to non-woven fabric, dried, and cut into pieces. Each patch is applied to a breathable tape, making 1000 patches (each containing 12.69g of the herb).

[0040] Objective: To observe the clinical efficacy of prepared plaster in treating acute soft tissue injury of ankle joint.

[0041] Methods: Patients with acute soft tissue injury of the ankle joint were randomly divided into a trial group and a control group, 36 cases in each group. All patients met the clinical diagnostic criteria for acute soft tissue injury of the ankle joint, including a VAS pain score of 3 ≤ ≤ 7, and no heart, liver, or kidney disease or infectious diseases. Exclusion criteria included patients with serious primary cardiovascular, cerebrovascular, liver, kidney, or hematopoietic diseases, psychiatric conditions, bone tumors, tuberculosis, rheumatoid arthritis, ankylosing spondylitis, pregnant or lactating women, and allergies to the study drugs. The control group received a 12g topical application of Qili Powder, with dressing changes daily. The trial group received a plaster prepared in this application example, applied daily. Both groups received topical application for 7 consecutive days. Patients were observed at the initial visit, on the first day of treatment, on the third day, and on the seventh day of treatment for local pain, tenderness, swelling, ecchymosis, and functional activity. Allergies and adverse reactions were also monitored.

[0042] Results: The VAS, tenderness, swelling, ecchymosis, and functional impairment scores of the two groups of patients decreased, and the swelling improvement rate score increased, and the differences were statistically significant; the VAS, tenderness, swelling, and swelling improvement rate scores of the experimental group were higher than those of the control group, and the functional impairment was significantly lower than that of the control group, and the differences were statistically significant; there was no statistical significance in the ecchymosis score compared with the control group, see Table 1-6 for details.

[0043] Table 1 Comparison of VAS scores between the two groups of patients ( point)

[0044] Table 2 Comparison of tenderness scores between the two groups of patients ( point) Table 3 Comparison of swelling scores between the two groups of patients ( point) Table 4 Comparison of swelling improvement rate between the two groups of patients

[0045] Table 5 Comparison of ecchymosis scores between the two groups of patients ( point)

[0046]

[0047] Table 6 Comparison of functional impairment scores between the two groups of patients ( point)

[0048]

[0049] Conclusion: Both dosage forms have good effects on the treatment of acute soft tissue injury of ankle joint, but the prepared plaster is more effective in improving and relieving pain, tenderness, swelling and functional impairment.

[0050] The embodiments of this specific implementation method are all preferred embodiments of the present invention and are not intended to limit the scope of protection of the present invention. Therefore, any equivalent changes made based on the structure, shape, and principle of the present invention should be included in the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for external use in treating acute soft tissue injury, characterized in that: It is composed of the following raw materials in parts by weight: 1000-1400 parts of Chuanxiong, 1000-1400 parts of scalded Drynaria fortunei, 1000-1400 parts of Clematidis, 1000-1400 parts of Curcuma longa, 600-1000 parts of Eupolyphaga sinensis, 1000-1400 parts of calcined natural copper, 200-600 parts of Panax notoginseng, 600-1000 parts of Achyranthes bidentata, 600-1000 parts of Zanthoxylum bungeanum, 600-1000 parts of Sappan wood, 600-1000 parts of Carthamus tinctorius, 600-1000 parts of vinegar frankincense, 600-1000 parts of vinegar myrrh, 20-60 parts of Sanguisorba officinalis, 100-300 parts of white mustard seeds, 108-148 parts of borneol, 108-148 parts of menthol, and 100-300 parts of liquorice tablets.

2. A Chinese medicine composition for external use for treating acute soft tissue injury according to claim 1, characterized in that: It is composed of the following raw materials in parts by weight: 1100-1300 parts of Chuanxiong, 1100-1300 parts of scalded Drynaria Rhizome, 1100-1300 parts of Clematidis, 1100-1300 parts of Curcuma longa, 700-900 parts of Eupolyphaga sinensis, 1100-1300 parts of calcined natural copper, 300-500 parts of Panax notoginseng, 700-900 parts of Achyranthes bidentata, 700-900 parts of Zanthoxylum bungeanum, 700-900 parts of Sappan wood, 700-900 parts of Carthamus tinctorius, 700-900 parts of vinegar frankincense, 700-900 parts of vinegar myrrh, 30-50 parts of Sanguisorba officinalis, 150-250 parts of white mustard seeds, 118-138 parts of borneol, 118-138 parts of menthol, and 150-250 parts of liquorice tablets.

3. A Chinese medicine composition for external use for treating acute soft tissue injury according to claim 1, characterized in that: It is composed of the following raw materials in parts by weight: 1200 parts of Chuanxiong, 1200 parts of scalded Drynaria Rhizoma, 1200 parts of Clematidis, 1200 parts of Curcuma longa, 800 parts of Eupolyphaga sinensis, 1200 parts of calcined natural copper, 400 parts of Panax notoginseng, 800 parts of Achyranthes bidentata, 800 parts of Zanthoxylum bungeanum, 800 parts of Sappan wood, 800 parts of Carthamus tinctorius, 800 parts of vinegar frankincense, 800 parts of vinegar myrrh, 40 parts of Sanguisorba officinalis, 200 parts of white mustard seeds, 128 parts of borneol, 128 parts of menthol, and 200 parts of liquorice tablets.

4. A pharmaceutically acceptable preparation prepared from the Chinese medicine composition according to any one of claims 1 to 3.

5. The preparation according to claim 4, characterized in that: The preparation is a plaster.

6. A method for preparing the preparation according to claim 5, characterized in that: The following steps are involved: S1. Preparation of fine powder: Take the prescribed amount of the drug calcined natural copper, Panax notoginseng, vinegar frankincense, vinegar myrrh, dragon's blood powder raw material powder into a 100 mesh fine powder and mix well; S2. Preparation of clear paste: Take the prescribed amount of drugs Chuanxiong, scalding drynaria, clematis, turmeric, Eupolyphaga, Achyranthes, Zanthoxylum bungeanum, Sappan wood, safflower, white mustard, licorice slices and decocted twice with water, the first time for 2-3 hours, the second time for 1-1.5 hours, the decoction was combined, filtered, and the filtrate was concentrated to a relative density of 1.05-1.10 clear paste; add the fine powder obtained in step S1 and mix well; S3. Preparation of matrix: Take 1000g of carbomer, 900g of gelatin and 5000g of glycerol, stir at 60-70°C to prepare a matrix; S4. The mixture of step S2, borneol, menthol and potassium sorbate 15g was added to the matrix obtained in step S3, stirred at a constant temperature of 55-65 ℃ for 2-3 hours, and stirred until cold to prepare a coating; S5. Apply the coating obtained in step S4 on non-woven fabric, dry it, and cut it; apply it on a breathable tape, bag it and seal it to obtain the finished product.

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