Traditional Chinese medicine composition for treating acute soft tissue injury, preparation, preparation method and application

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating acute soft tissue injury, a preparation, a preparation method and application. The traditional Chinese medicine composition is prepared from the following medicinal materials in parts by weight: 25 to 30 parts of radix notoginseng, 15 to 20 parts of herba scutellariae barbatae, 20 to 25 parts of frankincense, 20 to 25 parts of myrrh, 10 to 15 parts of calamine, 10 to 15 parts of herba portulacae, 15 to 20 parts of caulis sargentodoxae, 10 to 15 parts of abelmoschus esculentus, 15 to 20 parts of fructus cnidii, 10 to 15 parts of fructus kochiae, 15 to 20 parts of radix astragali seu hedysari, 5 to 10 parts of cactus and 2 to 5 parts of borneol. The preparation method comprises the following steps: decocting sculellaria barbata, purslane, sargentgloryvine stem, abelmoschus esculentus, fructus cnidii, fructus kochiae and astragalus membranaceus in water, and concentrating under reduced pressure to obtain a Crushing pseudo-ginseng, calamine and borneol into fine powder; adding ethanol into the succulent stem of cactus, frankincense and myrrh, standing overnight, and concentrating the filtrate under reduced pressure to obtain a fluid extract; and mixing the fluid extract and the fine powder with a medically acceptable matrix to obtain the traditional Chinese medicine external preparation. The monarch, minister, assistant and guide medicines are combined to well treat the acute soft tissue injury.

Description

Technical Field:

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition, preparation, preparation method and application for treating acute soft tissue injuries. Background Art:

[0002] Acute soft tissue injury is a very common disease in clinical practice, and its incidence rate remains high. Such injuries are not limited to all aspects of our daily life, but also occupy a significant position in the field of sports medicine. Acute soft tissue injury is caused by external impact, resulting in minor tears or bleeding in soft tissues such as muscles, tendons, and ligaments, causing local inflammatory reactions. These injuries may lead to capillary rupture and bleeding, and edema of the surrounding tissues. Typical manifestations include symptoms such as pain, swelling, congestion, and limited movement. The pain may be severe and accompanied by tenderness, and the swelling is usually accompanied by subcutaneous congestion. When the joint is affected, it will cause joint stiffness.

[0003] Western medicine generally treats soft tissue injuries through methods such as drug treatment, physical therapy, and surgical treatment. Among them, drug treatment can orally administer non-steroidal anti-inflammatory drugs such as ibuprofen, nimesulide, and diclofenac sodium to relieve the pain symptoms of soft tissue injuries. If the local pain symptoms are relatively severe after soft tissue injury, closed treatment can also be used to relieve the local pain symptoms. Physical therapy includes cold compress and hot compress. In the first 24 hours after injury, cold compress treatment should be given to prevent continuous bleeding of capillaries. If it exceeds 24 hours, hot compress treatment can be given to promote the dissipation of congestion. Surgical treatment: If the soft tissue injury is severe, resulting in fracture or soft tissue rupture, generally, it needs to be treated by surgical methods.

[0004] However, although oral medications in Western medicine can achieve a certain degree of relief, they do not have the obvious harmlessness of external treatment methods in traditional Chinese medicine, and the public acceptance is high, and the operation is convenient, which is more in line with the treatment concept of the Chinese people. Compared with Western medicine non-steroidal anti-inflammatory drugs, external use of traditional Chinese medicine shows more obvious curative effects in the treatment of acute soft tissue injuries, and has fewer adverse and allergic reactions, so the acceptance of patients is high. However, the existing external traditional Chinese medicine prescriptions mostly carry out syndrome differentiation and treatment from a single pathogenesis, ignoring the syndrome differentiation essentials starting from multiple pathogeneses, and at the same time lacking the consideration of the synergistic effects of multiple groups of traditional Chinese medicine components. Summary of the Invention:

[0005] In view of the deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition, preparation, preparation method and application for treating acute soft tissue injuries.

[0006] Specifically, the first aspect of the present invention provides a traditional Chinese medicine composition for treating acute soft tissue injuries, which is composed of the following medicinal materials: Panax notoginseng, Scutellaria barbata, Olibanum, Myrrha, Calamine, Portulaca oleracea, Sargentodoxa cuneata, Abelmoschus moschatus, Fructus Cnidii, Kochia scoparia, Astragalus membranaceus, Opuntia dillenii, and Borneol.

[0007] Panax notoginseng: Its nature and flavor are sweet, slightly bitter, and warm. It mainly belongs to the liver meridian and stomach meridian. The main component of Panax notoginseng is notoginsenoside, which has various pharmacological effects. Panax notoginseng can promote blood circulation to remove blood stasis, reduce swelling and relieve pain, and is commonly used to treat traumatic injuries, blood stasis and swelling pain, etc. In addition, Panax notoginseng also has a hemostatic effect and can be used to treat various bleeding symptoms, such as hemoptysis, hematemesis, hematochezia, etc. Modern research shows that Panax notoginseng also has various effects such as reducing blood lipid, reducing blood sugar, anti-fatigue, anti-oxygen deficiency, antioxidant, anti-aging, and improving immunity, so it is widely used in the prevention and treatment of cardiovascular and cerebrovascular diseases.

[0008] Scutellaria barbata: Its nature and flavor are pungent, bitter, and cold. It belongs to the lung meridian, liver meridian, and kidney meridian. It has the effects of clearing heat and detoxifying, promoting blood circulation to remove stasis and diuresis, and can be used to treat furuncles, carbuncles, sore throats, traumatic injuries, edema, jaundice, and snake and insect bites, etc. Scutellaria barbata mainly contains flavonoid components, such as scutellarin, carthamin, etc. Modern pharmacological research shows that Scutellaria barbata has anti-tumor effects, as well as anti-pathogenic microorganism and antipyretic effects, etc. Scutellaria barbata can be taken orally or externally. When used externally, dry products are selected and mashed appropriately and applied externally to the affected area. If there are snake and insect bites or carbuncles and sores, it can be applied to the swollen and painful area of the skin.

[0009] Olibanum: It has the effects of promoting blood circulation to activate qi and relieve pain, reducing swelling and promoting granulation. Its fragrance can penetrate, internally it can dredge the qi and blood of the zang-fu organs, and externally it can penetrate the meridians. It can be used for traumatic injuries, sores and carbuncles, etc. When treating traumatic injuries, it is often used in combination with Myrrha, which can effectively promote the local qi and blood circulation, play the role of activating collaterals and tendons, reducing swelling and relieving pain.

[0010] Myrrha: Its efficacy is to disperse stasis and relieve pain, reduce swelling and promote granulation. It has similar effects to Olibanum, and the two are often used in combination. It has good curative effects on pain caused by blood stasis blocking the meridians, muscle spasms, etc. It can be used for traumatic blood stasis and swelling pain, rheumatic arthralgia, etc., which can improve local blood circulation, relieve pain, and restore the normal function of the tendons and meridians.

[0011] Calamine: The nature and flavor of calamine are sweet and flat, and it is only for external use. It can not only detoxify, improve eyesight and remove nebula, but also astringe dampness, relieve itching and astringe sores. Externally, calamine has the effects of inhibiting bacteria and accelerating the healing of skin wounds, and can be used in dermatological medications. Calamine can also be used in ophthalmic medications, such as Zhenzhu Babao Eye Drops, Shezhu Mingmu Eye Drops, Bayun Powder Eye Drops, Fenghuo Eye Drops, E'mao Guan Eye Drops, etc.

[0012] Purslane: Nature, flavor, and meridian tropism: Sour, cold. It pertains to the liver and large intestine meridians. Functions and indications: Clearing heat and detoxifying, cooling the blood and stopping bleeding, relieving dysentery. It is used for dysentery due to heat-toxin, carbuncles and sores, eczema, erysipelas, snake and insect bites, hematochezia, hemorrhoids bleeding, metrorrhagia and metrostaxis.

[0013] Sargentgloryvine: Sargentgloryvine is bitter and neutral in nature and flavor, and pertains to the liver and large intestine meridians. Sargentgloryvine has the effects of clearing heat and detoxifying, promoting blood circulation, expelling wind, and relieving pain. It can be used to treat appendicitis with abdominal pain, heat-toxin sores, traumatic injuries, rheumatic arthralgia, amenorrhea and dysmenorrhea, etc. Sargentgloryvine is a common traditional Chinese medicine, with the effects of opening orifices and dredging meridians, strengthening the healthy qi and eliminating pathogenic factors. It can quickly penetrate into the meridian vessels and expel stasis and turbid yin out of the body.

[0014] Abelmoschus moschatus: Nature, flavor: Slightly sweet in taste, cool in nature; Meridian tropism: Heart and lung meridians; Efficacy: Clearing heat and detoxifying, detumescence and pain relief. It is the root or leaf of the plant Abelmoschus moschatus in the Malvaceae family. The extract of Abelmoschus moschatus in the Abelmoschus moschatus capsule has the effect of scavenging free radicals, can effectively counteract oxidative stress reactions, and play a certain antioxidant effect. The extract of Abelmoschus moschatus can inhibit the production and release of inflammatory mediators, reduce tissue damage and edema, and thus play an anti-inflammatory role. The extract of Abelmoschus moschatus can also enhance the regenerative ability of liver cells, promote the repair of damaged liver cells and restore normal physiological functions, achieving the effect of protecting the liver.

[0015] Cnidium monnieri: The nature, flavor, and meridian tropism of Cnidium monnieri are mainly manifested as bitter, pungent, and warm. The bitter taste has the effects of clearing heat and detoxifying, purging fire; the pungent taste can disperse wind-cold, promote qi and activate blood circulation; the warm nature helps to warm yang and dispel cold. Cnidium monnieri can remove dampness in the body and has good curative effects on diseases such as rheumatic bone pain and arthritis. It can be taken orally or topically. When taken orally, it is usually combined with other drugs. When used topically, it can be decocted for fumigation and washing or ground into powder for dressing.

[0016] Kochia scoparia: It is cold in nature, sweet and bitter in taste, and has the efficacy of clearing heat and promoting diuresis, expelling wind and relieving itching. The main active ingredients of Kochia scoparia include alkaloids, flavonoids, saponins, etc. Among them, alkaloids such as ephedrine and isoephedrine have antipyretic and analgesic effects; flavonoids have antioxidant, anti-allergic and other effects; saponin compounds have antibacterial, antiviral and other effects.

[0017] Astragalus membranaceus: Sweet in taste, slightly warm in nature, it pertains to the spleen and lung meridians. Astragalus membranaceus can replenish qi and raise yang, and is applicable to spleen qi deficiency syndrome and lung qi deficiency syndrome. Secondly, Astragalus membranaceus has the effect of consolidating the exterior and stopping sweating, and can treat spontaneous sweating due to deficiency of the exterior. In addition, it can promote diuresis and reduce swelling, treat edema, and generate body fluid and nourish blood, treat qi and blood deficiency syndrome. Astragalus membranaceus also has the efficacy of promoting pus discharge from sores, and is applicable to the situation where sores do not ulcerate for a long time or do not heal for a long time after ulceration.

[0018] Cactus: Bitter in taste and cold in nature, it pertains to the stomach, lung, and large intestine meridians. It has the effects and functions of promoting qi and activating blood circulation, cooling blood and stopping bleeding, detoxifying and detumescence, etc. Cactus contains rich components such as vitamins, proteins, trace elements, polysaccharides, triterpenoid compounds, malic acid, and resins. Modern pharmacology has confirmed that it has the effects of delaying aging and enhancing resistance; regulating blood sugar; regulating blood lipids and anti-atherosclerosis; losing weight; having a significant anti-inflammatory effect; inhibiting gastric acid secretion and protecting the gastric mucosa; promoting cell regeneration and wound healing.

[0019] Borneol: Slightly cold in nature, pungent and bitter in taste, it pertains to the heart, spleen, and lung meridians. It has the effects of resuscitating the consciousness and clearing heat and relieving pain, and can be used to treat febrile disease with coma, convulsion, stroke with phlegm syncope, sudden syncope due to qi stagnation, syncope due to pestilence, chest impediment with heart pain, red eyes, oral ulcers, sore throat, and ear discharge, etc. Borneol is a processed product of the resin of the evergreen arbor Dryobalanops aromatica Gaertn. f. in the family Dipterocarpaceae, or the crystal obtained by distillation and cooling of the trunk of Dryobalanops aromatica Gaertn. f., called borneol camphor, also known as borneol. Modern pharmacological research shows that borneol has the effect of anti-myocardial ischemia, can promote the growth of glial cells, and has the effects of relieving pain, antiseptic, and anti-inflammatory.

[0020] Modern traditional Chinese medicine theory believes that the main pathological mechanism of acute soft tissue injury lies in qi stagnation and blood stasis, and the meridians are blocked. According to the etiology and pathogenesis of qi stagnation and blood stasis, and blocked meridians in acute soft tissue injury. The main treatment principle of this invention for soft tissue injury is positioned as promoting blood circulation to remove blood stasis and detumescence and relieve pain. At the same time, considering the common inflammatory reactions related to soft tissue injury in modern medicine, anti-inflammatory and antibacterial components are added, and the synergistic effects among various drugs are considered to make the effects of each flavor of monarch, minister, assistant, and courier reach the best. In addition, this formula also considers the symptoms of heat pathogen caused by external pathogen invasion and imbalance between yin and yang, and treats them with clearing heat, drying dampness, and purging fire. The spleen governs the muscles and four limbs. If the spleen and stomach function normally, the limbs are not easily damaged, and the symptoms of heat pathogen are likely to cause spleen damage. Therefore, this formula also adds a formula for invigorating qi and ascending yang. By promoting qi movement locally to dredge the local qi mechanism, and then using the formula for invigorating qi and ascending yang to make its efficacy better. Finally, each drug penetrates through the skin and pores to directly reach the diseased site.

[0021] Among the ingredients: Notoginseng and Scutellaria barbata are the monarch drugs, promoting blood circulation to remove blood stasis, detumescence and pain relief, clearing heat and detoxifying; Frankincense, Myrrh, Calamine, and Portulaca oleracea are the ministerial drugs. The combination of Frankincense and Myrrh can activate blood circulation, promote qi flow, relieve pain, and dredge collaterals; Calamine can resist bacteria and astringe dampness, while Portulaca oleracea can reduce inflammation and swelling, clear heat and cool blood. The addition of Calamine and Portulaca oleracea enables the ministerial drugs to jointly achieve the effects of dredging meridians and anti-inflammatory and antibacterial; Sargentodoxa cuneata, Abelmoschus moschatus, Fructus Cnidii, and Kochia scoparia are the adjuvant drugs. Among them, Sargentodoxa cuneata can assist Notoginseng to further achieve the purpose of expelling stasis and turbid yin, while Abelmoschus moschatus can further enhance the detoxifying and detumescence effect of the monarch drugs. The combination of Fructus Cnidii and Kochia scoparia can clear heat and dry dampness, purge fire and detoxify; Astragalus membranaceus, Opuntia dillenii, and Borneol are the envoy drugs. The combination of Opuntia dillenii and Borneol can promote qi flow and cool blood, further assisting the ministerial drugs to dredge meridians, and at the same time can also promote the dredging of local qi movement. Astragalus membranaceus has the effects of tonifying qi and lifting yang, strengthening the spleen and replenishing the middle, and in addition, Borneol can also assist each drug to penetrate through the skin and reach the affected area directly.

[0022] As a further illustration of the present invention, the traditional Chinese medicine composition is composed of the following medicinal materials in parts by weight: 25-30 parts of Notoginseng, 15-20 parts of Scutellaria barbata, 20-25 parts of Frankincense, 20-25 parts of Myrrh, 10-15 parts of Calamine, 10-15 parts of Portulaca oleracea, 15-20 parts of Sargentodoxa cuneata, 10-15 parts of Abelmoschus moschatus, 15-20 parts of Fructus Cnidii, 10-15 parts of Kochia scoparia, 15-20 parts of Astragalus membranaceus, 5-10 parts of Opuntia dillenii, and 2-5 parts of Borneol.

[0023] As a further illustration of the present invention, the traditional Chinese medicine composition is composed of the following medicinal materials in parts by weight: 28 parts of Notoginseng, 17 parts of Scutellaria barbata, 23 parts of Frankincense, 23 parts of Myrrh, 12 parts of Calamine, 12 parts of Portulaca oleracea, 18 parts of Sargentodoxa cuneata, 13 parts of Abelmoschus moschatus, 18 parts of Fructus Cnidii, 13 parts of Kochia scoparia, 18 parts of Astragalus membranaceus, 7 parts of Opuntia dillenii, and 3 parts of Borneol.

[0024] The second aspect of the present invention provides the application of the above traditional Chinese medicine composition in the preparation of a drug for treating acute soft tissue injury.

[0025] The third aspect of the present invention provides a preparation method of the above traditional Chinese medicine composition, and the method comprises the following steps: S1: Add 6-12 times the amount of water to Scutellaria barbata, Portulaca oleracea, Sargentodoxa cuneata, Abelmoschus moschatus, Fructus Cnidii, Kochia scoparia, and Astragalus membranaceus, decoct for 1-3 times, 1-2 hours each time, filter the decoction, combine the filtrates, and concentrate under reduced pressure to a flow extract with a relative density of 1.1-1.2 (60 °C) for standby; S2: Powder Notoginseng, Calamine, and Borneol into fine powder for standby; S3: Powder the fleshy stem of Opuntia dillenii, Frankincense, and Myrrh into fine powder, add 6-12 times the amount of 95% ethanol, let stand overnight, filter, and concentrate the filtrate under reduced pressure to a flow extract with a relative density of 1.1-1.2 (60 °C) for standby; S4: Mix the extract obtained in step S1 and step S3, the fine powder obtained in step S2 with a medically acceptable matrix to obtain the traditional Chinese medicine external preparation.

[0026] As a further illustration of the present invention, the traditional Chinese medicine external preparation is an ointment, liniment, paint, film agent, tincture, patch or plaster.

[0027] The fourth aspect of the present invention provides a method for preparing a traditional Chinese medicine ointment for treating acute soft tissue injuries, and the method includes the following steps: S1: Add 6 - 12 times the amount of water to Scutellaria barbata, Portulaca oleracea, Sargentodoxa cuneata, Abelmoschus moschatus, Fructus Cnidii, Kochia scoparia, and Astragalus membranaceus, decoct for 1 - 3 times, 1 - 2 hours each time, filter the decoction, combine the filtrates, and concentrate under reduced pressure to a fluid extract with a relative density of 1.1 - 1.2 (60 °C) for standby; S2: Crush Panax notoginseng, Calamine, and Borneol into fine powder for standby; S3: Crush the fleshy stem of Opuntia dillenii, Olibanum, and Myrrha into fine powder, add 6 - 12 times the amount of 95% ethanol, let stand overnight, filter, and concentrate the filtrate under reduced pressure to a fluid extract with a relative density of 1.1 - 1.2 (60 °C) for standby; S4: Mix the fluid extracts obtained in step S1 and step S3, the fine powder obtained in step S2 with an ointment matrix to obtain the traditional Chinese medicine external preparation.

[0028] As a further illustration of the present invention, the ointment matrix is a mixture of liquid paraffin and petrolatum.

[0029] As a further illustration of the present invention, the mass ratio of the liquid paraffin, the petrolatum and the traditional Chinese medicine components is (1 - 3):(6 - 8):(0.5 - 1.5), wherein the traditional Chinese medicine components are a mixture of the fluid extract obtained in step S1, the fluid extract obtained in step S3 and the fine powder obtained in step S2.

[0030] Compared with the prior art, the present invention has the following beneficial technical effects: In the formula of the present invention, Panax notoginseng and Scutellaria barbata are monarch drugs, promoting blood circulation to remove blood stasis, detumescence and pain relief, clearing heat and detoxifying; Frankincense, Myrrh, Calamine, and Portulaca oleracea are ministerial drugs. The combination of Frankincense and Myrrh can promote blood circulation, activate qi and relieve pain, dredge collaterals and tendons; Calamine can antibacterial and astringe dampness; Portulaca oleracea can reduce inflammation and swelling, clear heat and cool blood. The addition of Calamine and Portulaca oleracea enables the ministerial drugs to jointly achieve the effects of dredging meridians and anti-inflammatory and bactericidal; Sargentodoxa cuneata, Abelmoschus moschatus, Fructus Cnidii, and Kochia scoparia are adjuvant drugs. Among them, Sargentodoxa cuneata can assist Panax notoginseng to further achieve the purpose of discharging stasis and turbid yin, while Abelmoschus moschatus can further enhance the detoxifying and detumescence effect of the monarch drug. The combination of Fructus Cnidii and Kochia scoparia can clear heat and dry dampness, purge fire and detoxify; Astragalus membranaceus, Opuntia dillenii, and Borneol are guiding drugs. The combination of Opuntia dillenii and Borneol can promote qi and cool blood, further assisting the ministerial drugs to dredge meridians, and at the same time can also promote the dredging of local qi movement. Astragalus membranaceus can tonify qi and lift yang, strengthen the spleen and replenish the middle, and in addition, Borneol can also assist each drug to reach the diseased site directly through the skin and pores. Brief Description of the Drawings:

[0031] Figure 1 It is the HE staining diagram of the muscle tissues of rats in each group provided by the present invention. Among them, (a) is the staining result of the rats in the blank group, (b) is the staining result of the rats in the model group, (c) is the staining result of the rats in the low-dose group of Example 1, and (d) is the staining result of the rats in the high-dose group of Example 1. Detailed Embodiments:

[0032] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0033] Example 1 A traditional Chinese medicine composition for treating acute soft tissue injuries, which is composed of the following medicinal materials in parts by weight: 28 parts of Panax notoginseng, 17 parts of Scutellaria barbata, 23 parts of Frankincense, 23 parts of Myrrh, 12 parts of Calamine, 12 parts of Portulaca oleracea, 18 parts of Sargentodoxa cuneata, 13 parts of Abelmoschus moschatus, 18 parts of Fructus Cnidii, 13 parts of Kochia scoparia, 18 parts of Astragalus membranaceus, 7 parts of Opuntia dillenii, and 3 parts of Borneol.

[0034] Example 2 A traditional Chinese medicine composition for treating acute soft tissue injuries, which is composed of the following medicinal materials in parts by weight: 27 parts of Panax notoginseng, 18 parts of Scutellaria barbata, 22 parts of Frankincense, 22 parts of Myrrh, 13 parts of Calamine, 13 parts of Portulaca oleracea, 17 parts of Sargentodoxa cuneata, 12 parts of Abelmoschus moschatus, 17 parts of Fructus Cnidii, 12 parts of Kochia scoparia, 17 parts of Astragalus membranaceus, 8 parts of Opuntia dillenii, and 4 parts of Borneol.

[0035] Example 3 A traditional Chinese medicine composition for treating acute soft tissue injuries, which is composed of the following medicinal materials in parts by weight: 25 parts of notoginseng, 15 parts of scutellaria barbata, 20 parts of frankincense, 20 parts of myrrh, 10 parts of calamine, 10 parts of portulaca oleracea, 15 parts of caulis sargentodoxae, 10 parts of abelmoschus moschatus, 15 parts of fructus cnidii, 10 parts of fructuskochiae scopariae, 15 parts of astragalus membranaceus, 5 parts of opuntia dillenii, and 2 parts of borneol.

[0036] Example 4 A traditional Chinese medicine composition for treating acute soft tissue injuries, which is composed of the following medicinal materials in parts by weight: 30 parts of notoginseng, 20 parts of scutellaria barbata, 25 parts of frankincense, 25 parts of myrrh, 15 parts of calamine, 15 parts of portulaca oleracea, 20 parts of caulis sargentodoxae, 15 parts of abelmoschus moschatus, 20 parts of fructus cnidii, 15 parts of fructuskochiae scopariae, 20 parts of astragalus membranaceus, 10 parts of opuntia dillenii, and 5 parts of borneol.

[0037] Comparative Example 1: A traditional Chinese medicine composition for treating acute soft tissue injuries, which is different from Example 1 in that: scutellaria barbata in the formula is removed.

[0038] Comparative Example 2: A traditional Chinese medicine composition for treating acute soft tissue injuries, which is different from Example 1 in that: calamine and portulaca oleracea in the formula are removed.

[0039] Comparative Example 3: A traditional Chinese medicine composition for treating acute soft tissue injuries, which is different from Example 1 in that: caulis sargentodoxae and abelmoschus moschatus in the formula are removed.

[0040] Comparative Example 4: A traditional Chinese medicine composition for treating acute soft tissue injuries, which is different from Example 1 in that: caulis sargentodoxae and abelmoschus moschatus in the formula are respectively replaced by rhizoma corydalis and dandelion.

[0041] Comparative Example 5: A traditional Chinese medicine composition for treating acute soft tissue injuries, which is different from Example 1 in that: astragalus membranaceus and opuntia dillenii in the formula are removed.

[0042] The traditional Chinese medicine compositions provided in the above examples and comparative examples can be made into traditional Chinese medicine external preparations for verifying their specific therapeutic effects on acute soft tissue injuries. The made traditional Chinese medicine external preparations are external preparations such as ointments, liniments, paints, film-forming agents, tinctures, patches or cataplasms.

[0043] In the following animal experiments, the traditional Chinese medicine external preparation used is an ointment, and its specific preparation process is as follows: S1: Weigh Scutellaria barbata, Portulaca oleracea, Sargentodoxa cuneata, Abelmoschus moschatus, Cnidium monnieri, Kochia scoparia, and Astragalus membranaceus in the above-mentioned examples and comparative examples according to the proportion, add 10 times the amount of water, decoct 3 times, each time for 1.5 hours. Filter the decoction, combine the filtrates, and concentrate under reduced pressure to a flow extract with a relative density of 1.1 (60 °C) for standby. S2: Pulverize Panax notoginseng, Calamine, and Borneol into fine powders for standby. S3: Pulverize the fleshy stem of Opuntia dillenii, Frankincense, and Myrrh into fine powders, add 10 times the amount of 95% ethanol, let it stand overnight, filter, and concentrate the filtrate under reduced pressure to a flow extract with a relative density of 1.1 (60 °C) for standby. S4: Mix the flow extracts obtained in steps S1 and S3 and the fine powder obtained in step S2 to obtain the traditional Chinese medicine components, and then add the ointment base and continue to mix evenly to obtain the traditional Chinese medicine ointment. Among them, the ointment base is a mixture of liquid paraffin and petrolatum, and the mass ratio of liquid paraffin, petrolatum, and the traditional Chinese medicine components is 2:7:1.

[0044] Experimental Example: 1. Animal Experiment: 1.1 Experimental Medicaments and Animals: Medicaments: Voltaren Ointment, Novartis Pharma AG (China); Traditional Chinese medicine ointments prepared from the traditional Chinese medicine formulas provided in Example 1 and Comparative Examples 1-5 above.

[0045] Experimental Animals: 110 male SD rats (body weight: 180 - 220 g) were sourced from the Experimental Animal Center of Heilongjiang University of Chinese Medicine. After the rats were purchased, they were placed under SPF conditions and adaptively raised for one week before the experiment.

[0046] 1.2 Administration and Modeling: Grouping: Randomly divide the 110 rats into the low-dose group of Example 1, the medium-dose group of Example 1, the high-dose group of Example 1, the high-dose groups of Comparative Examples 1-5, the positive control group, the blank group, and the model group.

[0047] Modeling: For the rats in groups other than the blank group, depilate the left hind leg. After 24 hours of depilation, anesthetize the rats intraperitoneally with 7 mg / 100 g of Zoletil. Then fix the left hind leg of the rat with the knee extended and the back flexed at a right angle. Let a 200 g weight freely fall from the upper end of a vertical plastic cylinder to strike the biceps femoris of the left hind limb of the rat 12 times continuously (pad two layers of gauze for the last 6 times to prevent serious skin lesions caused by the impact). When ecchymosis and obvious swelling appear at the striking site, and there is no fracture or dislocation, and the skin is not damaged and there is no other abnormal situation, it is determined that the modeling is successful.

[0048] Administration: Start administering the drugs 24 hours after the successful modeling. Except for the blank group and the model group, apply the ointment to the soft tissue injury of the left hind limb of the rats at the following doses, once in the morning and once in the evening, for a continuous week.

[0049] The dosage of each administration for each group of rats is as follows: low-dose group of Example 1: 2.5 g / kg of the traditional Chinese medicine ointment prepared with the traditional Chinese medicine formula provided in Example 1; medium-dose group of Example 1: 5 g / kg of the traditional Chinese medicine ointment prepared with the traditional Chinese medicine formula provided in Example 1; high-dose group of Example 1: 10 g / kg of the traditional Chinese medicine ointment prepared with the traditional Chinese medicine formula provided in Example 1; high-dose groups of Comparative Examples 1-5: 10 g / kg of the traditional Chinese medicine ointment prepared with the traditional Chinese medicine formula provided in Comparative Examples 1-5; positive control group: 10 g / kg of Voltaren ointment.

[0050] 1.3 Observation indicators: 2 h after the last administration, the rats were sacrificed, the muscle tissues at the impacted sites of the rats were taken, and physiological saline was injected into the tissues. When the homogenate was ground evenly in a homogenizer until the homogenate became a uniform suspension, the supernatant was taken after centrifugation, and an IL-6 and TNF-α kit was used to measure the inflammatory factors.

[0051] The muscle tissues at the impacted sites of the rats were taken, fixed with 4% paraformaldehyde, routinely paraffin-embedded, washed successively with xylene solution, ethanol and pure water, stained in hematoxylin stain for 8 min, and then the floating stain was washed off. Then, differentiation with a differentiating solution, staining with a bluing solution and washing with ethanol for dehydration were carried out in sequence. Next, staining with eosin staining solution was carried out for 2 min. The sections were dehydrated and washed in absolute ethanol, soaked in xylene solution, and then neutral gum was dropped at the center position of the sections. After the xylene volatilized, a cover glass was covered for sealing.

[0052] Pathological scoring: After sealing with neutral gum after the above hematoxylin-eosin staining, observation and scoring were carried out using an optical microscope. The scoring criteria are as follows: no inflammatory cell infiltration, no necrosis of muscle tissue, uniform and regular arrangement of muscle fibers, score 0; a small amount of inflammatory cell infiltration, small-area necrosis of muscle tissue, irregular arrangement of a small part of muscle fibers, and a small amount of inflammatory edema in the intermuscular connective tissue, score 1; a large amount of inflammatory cell infiltration, large-area necrosis of muscle tissue, irregular arrangement of most muscle fibers, and a large amount of inflammatory edema in the intermuscular connective tissue, score 2.

[0053] 1.4 Statistical methods: For measurement data, t-test was used, and for count data, χ 2 test was used. All measurement data were expressed in and the data were processed using SPSS 19.0 version of statistical software.

[0054] 1.5 Experimental results: 1.5.1 Comparison of inflammatory index levels of each group of rats.

[0055] Table 1 Changes in TNF-α and IL-6 levels in muscle tissues of each group of rats

[0056] Note: Compared with the blank group, # P < 0.05, ## P < 0.01; compared with the model group, 、 ; compared with the high-dose group of Example 1, 、 。

[0057] It can be seen from Table 1 that, compared with the rats in the model group, the levels of TNF-α and IL-6 in the muscle tissues of the rats in the positive group, the low, medium, and high-dose groups of Example 1 were significantly decreased, indicating that the traditional Chinese medicine composition provided by the present invention can effectively improve TNF-α and IL-6 in the muscle tissues of rats, and also indicating that the traditional Chinese medicine preparation provided by the present invention has a good effect on improving the inflammation at the injury site of rats. In addition, compared with the high-dose groups of Comparative Examples 1-5, the levels of TNF-α and IL-6 in the muscle tissues of the rats in the high-dose group of Example 1 of the present application were decreased more significantly, and there was a statistically significant difference in the improvement effect between the high-dose groups of Comparative Examples 1-5 and the high-dose group of Example 1 of the present application, indicating that the traditional Chinese medicine preparation provided by the present application is superior to the traditional Chinese medicine preparations provided by Comparative Examples 1-5 in improving the levels of TNF-α and IL-6 in the muscle tissues of rats, and also indicating that each of the monarch, minister, assistant, and envoy herbs in the traditional Chinese medicine composition provided by the present invention performs its own functions, synergizes with each other, and is indispensable.

[0058] 1.5.2 Comparison of muscle tissues of rats in each group.

[0059] Figure 1 The HE staining diagrams of the muscle tissues of the rats in the blank group, the model group, the low and high-dose groups of Example 1 are shown. It can be seen from the figures that there was no obvious infiltration of inflammatory cells, no obvious necrosis of muscle tissue, and the arrangement of muscle fibers was relatively neat in the muscle tissues of the rats in the blank group. A large number of inflammatory cells infiltrated, extensive necrosis of muscle tissue occurred, the intervals between muscle fibers were chaotic, and a large amount of inflammatory edema of the intermuscular connective tissue was visible in the muscle tissues of the rats in the model group. Compared with the rats in the model group, there was a small amount of infiltration of inflammatory cells in the muscle tissues of the rats in the low-dose group of Example 1, but it was significantly reduced, the necrotic area of muscle tissue was reduced, the arrangement of muscle fibers was significantly orderly, and the inflammatory edema of the intermuscular connective tissue was alleviated. Compared with the rats in the model group, there was basically no infiltration of inflammatory cells, no obvious pathological necrosis of muscle tissue, and the arrangement of muscle fibers was relatively neat in the muscle tissues of the rats in the high-dose group of Example 1.

[0060] Table 2 Pathological scoring of muscle tissues of rats in each group

[0061] Note: Compared with the blank group, # P < 0.05, ## P < 0.01; compared with the model group, 、 ; Compared with the high-dose group of Example 1, , .

[0062] It can be seen from Table 2 that compared with the rats in the blank group, the pathological score of the muscle tissue of the rats in the model group was significantly higher. While compared with the rats in the model group, the pathological scores of the muscle tissue of the rats in the positive group, the low, medium, and high-dose groups of Example 1 were all significantly decreased, indicating that the traditional Chinese medicine composition provided by the present invention can effectively improve the muscle tissue of rats and has an obvious improvement effect on the muscle tissue lesions caused by acute soft tissue injury. In addition, compared with the high-dose groups of Comparative Examples 1-5, the pathological score of the muscle tissue of the rats in the high-dose group of Example 1 of the present application was decreased more significantly, and the difference was statistically significant, indicating that the traditional Chinese medicine preparation provided by the present application has a better improvement level for the muscle tissue lesions of rats than the traditional Chinese medicine preparations provided by Comparative Examples 1-5, and also indicating that each of the monarch, minister, assistant, and envoy herbs in the traditional Chinese medicine composition provided by the present invention performs its own functions, cooperates with each other, and is indispensable.

[0063] Based on the above analysis, it can be seen that whether replacing or removing each of the monarch, minister, assistant, and envoy herbs in the present application will significantly reduce the effect of the traditional Chinese medicine composition. Thus, it can be seen that the monarch, minister, assistant, and envoy herbs in the present application complement each other and are all indispensable parts of this traditional Chinese medicine formula. Without or replacing some of the traditional Chinese medicine formulations, the best therapeutic effect on acute soft tissue injury in rats cannot be achieved.

[0064] It should be noted that in this article, terms such as "including", "comprising" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not expressly listed, or also includes elements inherent to such process, method, article or device.

[0065] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating acute soft tissue injury, characterized in that, The traditional Chinese medicine composition is composed of the following medicinal materials: Panax notoginseng, Scutellaria barbata, Olibanum, Myrrha, Calamine, Portulaca oleracea, Sargentodoxa cuneata, Abelmoschus moschatus, Fructus Cnidii, Kochia scoparia, Astragalus membranaceus, Opuntia dillenii, Borneol.

2. The traditional Chinese medicine composition for treating acute soft tissue injury according to claim 1, wherein, The traditional Chinese medicine composition is composed of the following medicinal materials by weight: 25 - 30 parts of Panax notoginseng, 15 - 20 parts of Scutellaria barbata, 20 - 25 parts of Olibanum, 20 - 25 parts of Myrrha, 10 - 15 parts of Calamine, 10 - 15 parts of Portulaca oleracea, 15 - 20 parts of Sargentodoxa cuneata, 10 - 15 parts of Abelmoschus moschatus, 15 - 20 parts of Fructus Cnidii, 10 - 15 parts of Kochia scoparia, 15 - 20 parts of Astragalus membranaceus, 5 - 10 parts of Opuntia dillenii, 2 - 5 parts of Borneol.

3. The traditional Chinese medicine composition for treating acute soft tissue injury according to claim 1, wherein, The traditional Chinese medicine composition is composed of the following medicinal materials by weight: 28 parts of Panax notoginseng, 17 parts of Scutellaria barbata, 23 parts of Olibanum, 23 parts of Myrrha, 12 parts of Calamine, 12 parts of Portulaca oleracea, 18 parts of Sargentodoxa cuneata, 13 parts of Abelmoschus moschatus, 18 parts of Fructus Cnidii, 13 parts of Kochia scoparia, 18 parts of Astragalus membranaceus, 7 parts of Opuntia dillenii, 3 parts of Borneol.

4. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a drug for treating acute soft tissue injury.

5. A preparation method of the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The method includes the following steps: S1: Add 6 - 12 times the amount of water to Scutellaria barbata, Portulaca oleracea, Sargentodoxa cuneata, Abelmoschus moschatus, Fructus Cnidii, Kochia scoparia, and Astragalus membranaceus, decoct for 1 - 3 times, 1 - 2 hours each time, filter the decoction, combine the filtrates, and concentrate under reduced pressure to a flow extract with a relative density of 1.1 - 1.2 (60 °C) for standby; S2: Powder Panax notoginseng, Calamine, and Borneol into fine powder for standby; S3: Powder the fleshy stem of Opuntia dillenii, Olibanum, and Myrrha into fine powder, add 6 - 12 times the amount of 95% ethanol, let stand overnight, filter, and concentrate the filtrate under reduced pressure to a flow extract with a relative density of 1.1 - 1.2 (60 °C) for standby; S4: Mix the flow extracts obtained in steps S1 and S3, the fine powder obtained in step S2, and a medically acceptable matrix to obtain a traditional Chinese medicine external preparation.

6. The preparation method of the traditional Chinese medicine composition according to claim 5, characterized in that, The traditional Chinese medicine external preparation is an ointment, liniment, paint, film - forming agent, tincture, patch, or plaster.

7. A preparation method of a traditional Chinese medicine ointment for treating acute soft tissue injuries, characterized in that, The method includes the following steps: S1: Add 6 - 12 times the amount of water to Scutellaria barbata, Portulaca oleracea, Sargentodoxa cuneata, Abelmoschus moschatus, Fructus Cnidii, Kochia scoparia, and Astragalus membranaceus, decoct for 1 - 3 times, 1 - 2 hours each time, filter the decoction, combine the filtrates, and concentrate under reduced pressure to a flow extract with a relative density of 1.1 - 1.2 (60 °C) for standby; S2: Powder Panax notoginseng, Calamine, and Borneol into fine powder for standby; S3: Powder the fleshy stem of Opuntia dillenii, Olibanum, and Myrrha into fine powder, add 6 - 12 times the amount of 95% ethanol, let stand overnight, filter, and concentrate the filtrate under reduced pressure to a flow extract with a relative density of 1.1 - 1.2 (60 °C) for standby; S4: Mix the flow extracts obtained in steps S1 and S3, the fine powder obtained in step S2, and an ointment matrix to obtain a traditional Chinese medicine external preparation.

8. The preparation method of the traditional Chinese medicine ointment for treating acute soft tissue injury according to claim 7, wherein, The ointment matrix is a mixture of liquid paraffin and petrolatum.

9. The preparation method of the traditional Chinese medicine ointment for treating acute soft tissue injuries according to claim 8, characterized in that, The mass ratio of the liquid paraffin, the petrolatum, and the traditional Chinese medicine components is (1 - 3):(6 - 8):(0.5 - 1.5), where the traditional Chinese medicine components are a mixture of the flow extract obtained in step S1, the flow extract obtained in step S3, and the fine powder obtained in step S2.

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