A pharmaceutical composition for treating acute soft tissue injury and its preparation method and application

Abstract

The invention discloses a pharmaceutical composition for treating acute soft tissue injury and its preparation method and application, and relates to the field of traditional Chinese medicine. The pharmaceutical composition includes the following raw materials by weight: 9-15 parts of summer no, 9-15 parts of notoginseng, 9-15 parts of gardenia, 9-15 parts of lianqiancao, 9-15 parts of red peony root, 3-6 parts of vinegar cyperus and 3-6 parts of rhubarb. The pharmaceutical composition provided by the present invention pays attention to the pathological characteristics of "stagnation of water and blood" in the treatment of acute soft tissue injury, and on the basis of the conventional prescription of "activating blood circulation and removing blood stasis, promoting qi and relieving pain", by adding "diuretic, diuretic" drugs, the law of "activating blood circulation and removing blood stasis, promoting water and reducing swelling, promoting qi and relieving pain" is formed, which can quickly eliminate swelling in the affected area, and is conducive to the repair and healing of damaged tissue.

Description

Technical Field

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

[0002] Acute soft tissue injury is a common and frequently occurring disease in orthopedics. It is more likely to occur in daily labor, exercise and life, causing great physical and mental pain to patients.

[0003] At present, Western medicine treatments mainly include immobilization, bandaging, local blockade, drugs, physical therapy and other methods, which have poor therapeutic effects, long recovery time, and may also cause adverse reactions.

[0004] For example, the book "Shengji Zonglu·Broken Injury" in traditional Chinese medicine states: "If the meridians are disturbed due to fractures, the blood circulation will not be smooth, and the blood stasis will not be dispersed, resulting in swelling and pain." The treatment method of "activating blood circulation and removing blood stasis" was derived. The syndrome is classified as qi stagnation and blood stasis, and the treatment is suitable for activating blood circulation and removing blood stasis, reducing swelling and relieving pain. After thousands of years of clinical practice, a comprehensive treatment method of "combining dynamic and static, treating both internal and external, and using drugs in stages" has been formed. Because of its relatively reliable efficacy, relatively small toxic and side effects, and a variety of treatment methods, it is suitable for the characteristics of acute soft tissue injuries. Therefore, many doctors have been exploring the effective methods of treating acute soft tissue injuries with traditional Chinese medicine. Traditional Chinese medicine uses syndrome differentiation and treatment, and internal and external treatment, which is more advantageous than the single treatment method of Western medicine.

[0005] In recent years, many experts and scholars have confirmed through modern scientific experiments that Chinese medicine for promoting blood circulation and removing blood stasis, and reducing swelling and relieving pain plays two roles. (1) For swelling and pain that occur in the early stage of injury, blood-activating and blood-stasis-removing drugs can control and slow down the inflammatory response, absorb the exudation, congestion and edema caused by the inflammatory response, repair the soft tissue and blood vessel walls caused by the injury, reduce the concentration of pain-causing substances, reduce the stimulation of free nerve endings, and at the same time increase the pain threshold to reduce swelling and relieve pain; (2) For swelling and pain that occur in the middle and late stages of injury, blood-activating and blood-stasis-removing drugs can dilate capillaries, reduce the pressure of the capillary venous segment, reduce the exudation of white blood cells and other formed elements, and reduce the incidence of necrosis at the injury site. At present, there are many studies on the mechanism of blood-activating and blood-stasis-removing methods.

[0006] The clinical efficacy of traditional Chinese medicine in the treatment of acute soft tissue injuries in China is quite significant. Among them, a large number of clinical reports focus on local external treatments. Its mechanism of action is mainly to improve the microcirculation perfusion of the injured area, relieve microcirculatory disorders, reduce vascular permeability, counteract and eliminate the traumatic inflammatory response, and relax skeletal muscle spasms to achieve the purpose of reducing swelling and relieving pain.

[0007] Oral Chinese medicine is one of the important methods of treating diseases in traditional Chinese medicine. Currently, there are few studies on the treatment of acute soft tissue injuries with oral Chinese medicine, and the treatment is mainly based on promoting blood circulation and removing blood stasis, promoting qi and relieving pain. However, whether it is external treatment or internal treatment, most of them follow the treatment principle of "promoting blood circulation and removing blood stasis first", starting from qi stagnation and blood stasis, and following the three principles of promoting qi and blood circulation, cooling blood and promoting blood circulation, and attacking and removing blood stasis, which has also become the main direction of modern clinical research.

[0008] In view of this, the present invention is proposed. Summary of the invention

[0009] The purpose of the present invention is to provide a simple, safe, effective and economical pharmaceutical composition for treating acute soft tissue injury and its preparation method and application to solve the above technical problems.

[0010] The Suwen Yinyang Yingxiang Dalun points out that "injury to qi causes pain, injury to body causes swelling". After injury to tendons, the veins are damaged, qi stagnates, blood overflows from the veins, and stagnates in the skin and pores, causing qi stagnation and pain, obstruction of local qi and blood circulation, abnormal transportation and transformation, and accumulation of water and dampness in the local limbs to produce edema. Chinese medicine has long put forward the view that "unfavorable blood turns into water", "water obstruction prevents blood from flowing", and "stagnation of blood has nowhere to stay... and turns into urine..." Blood and water belong to the same yin fluid. Body fluid enters the veins to become blood, and blood seeps outside the veins to become body fluid; on the other hand, water and dampness stagnate in the body, qi stagnation can cause blood stasis, and blood stasis in the body can cause water stagnation. The two often affect each other and are mutually causal. Since acute soft tissue injury causes stasis first, and water stagnation comes later, water and stasis coexist and block each other, which is an aspect that cannot be ignored in clinical diagnosis and treatment. Therefore, in the treatment of acute soft tissue injuries, attention should be paid to the pathogenesis of "interlocking of blood stasis and water". On the basis of traditional methods of promoting blood circulation and removing blood stasis, promoting qi and relieving pain, adding methods of promoting diuresis will be more conducive to quickly reducing swelling and relieving pain.

[0011] The inventor followed the traditional method of "promoting blood circulation, removing blood stasis, promoting qi and relieving pain", combined his own experience and practical summary of learning Chinese medicine from a teacher and studying national traditional Chinese medicine characteristic technology inheritance tours, and added the method of "diuresis" and corresponding drugs on the basis of "promoting blood circulation, removing blood stasis, promoting qi and relieving pain", and the effect was as good as a drum.

[0012] The present invention is achieved in that:

[0013] In a first aspect, the present invention provides a pharmaceutical composition for treating acute soft tissue injury, comprising the following raw materials in parts by weight: 9-15 parts of summer melon, 9-15 parts of Panax notoginseng, 9-15 parts of Gardenia jasminoides, 9-15 parts of Cyperus rotundus, 9-15 parts of Paeonia lactiflora, 3-6 parts of Cyperus rotundus and 3-6 parts of Rhubarb.

[0014] In view of the fact that existing studies have shown that oral administration of Chinese medicine has an obvious effect on eliminating swelling in acute soft tissue injuries, and the medication is safe. The inventor, through studying the pathogenesis and post-healing outcome of acute soft tissue injuries, believes that the diagnosis and treatment of acute soft tissue injuries should pay attention to the pathogenesis of "intertwining of stasis and water", with "promoting blood circulation and removing blood stasis, promoting diuresis and reducing swelling" as the main method, which can quickly and effectively control and eliminate inflammatory edema, inhibit inflammatory reactions, improve microcirculation, and promote tissue repair and healing. Because "swelling and pain" are the main clinical manifestations, it is determined that "promoting blood circulation and removing blood stasis, promoting diuresis and reducing swelling, and promoting qi and relieving pain" are the basic methods. The self-prepared drug composition for treating acute soft tissue injuries (new injury swelling and pain prescription) has been used clinically in the hospital for more than one year, and has achieved good clinical efficacy and patient satisfaction.

[0015] Traditional Chinese medicine believes that acute soft tissue injury belongs to the category of "tendon injury". The etiology and pathogenesis of this disease is that under the influence of external violence, the tendons and blood vessels are damaged, blood overflows outside the vessels, blood stagnates in local tissues to form hematomas, and blood overflows under the skin, so the skin becomes cyanotic; the local circulation of qi and blood is blocked, and pain occurs when the circulation is blocked. Qi and blood cannot nourish the joints, so common clinical symptoms include local tissue swelling, pain, cyanosis, and poor joint movement.

[0016] The pharmaceutical composition provided by the present invention attaches importance to the pathological characteristics of "intertwining of blood stasis and water" in the treatment of acute soft tissue injuries. On the basis of the conventional prescriptions of "promoting blood circulation and removing blood stasis, promoting qi and relieving pain", by adding "diuretic and diuretic" drugs, the principle of "promoting blood circulation and removing blood stasis, promoting water and reducing swelling, promoting qi and relieving pain" is formed, which can quickly eliminate swelling in the affected area and is beneficial to the repair and healing of damaged tissues.

[0017] Explanation of the prescription of the above-mentioned pharmaceutical composition: This prescription is caused by traumatic injury, internal blood stasis, and stagnation of qi. Symptoms include swelling and pain in the affected area. Chinese medicine proposes that "water is the cause of blood stagnation" and "water stagnation causes blood stagnation". Internal retention of water and poor qi flow can cause blood stasis, while internal stagnation of blood stasis and loss of qi circulation can cause water stagnation. The two often affect each other and are mutually causal, forming a stagnation of water and blood. In addition, qi is the commander of blood, and blood stagnation causes blood stasis when qi flows, and blood stagnation causes blood stasis when qi stagnates. Therefore, the treatment should be to promote blood circulation and dissipate blood stasis, promote diuresis and reduce swelling, and promote qi circulation and relieve pain.

[0018] In the above-mentioned drug composition, Xiatianwu can promote blood circulation and dissipate blood stasis, promote qi circulation and relieve pain; Panax notoginseng is an important medicine for traumatology, which can disperse blood stasis and stop bleeding, reduce swelling and relieve pain. The two are both monarch drugs. Red peony root can disperse blood stasis and relieve pain; Gardenia can clear the triple energizer, relieve dampness and reduce swelling, and relieve pain; Herba schizonepetae can relieve dampness and reduce swelling, and disperse blood stasis; the combination of the three drugs can dissipate blood stasis and swelling, and the evil can be discharged from the urine, so the pain can be relieved by the meridians, and they are all minister drugs. Vinegar and Cyperus rotundus can promote qi circulation and relieve pain; Rhubarb can remove blood stasis, promote menstruation, relieve dampness and reduce swelling, and guide the stasis and dampness to go out through the stool, and they are all adjuvant drugs. The combination of the three drugs can play the effects of promoting blood circulation and dissipating blood stasis, promoting diuresis and reducing swelling, and promoting qi circulation and relieving pain.

[0019] The medicinal composition has the effects of promoting blood circulation and dispersing blood stasis, promoting diuresis and reducing swelling, promoting qi and relieving pain.

[0020] Clinical application: used for the early stage of trauma, with symptoms such as swelling and pain.

[0021] All the Chinese medicinal pieces in the formula of the pharmaceutical composition provided by the present invention are varieties listed in the "Chinese Pharmacopoeia", and have good drug safety. And the effect of "activating blood circulation and dispersing blood stasis, promoting diuresis and reducing swelling, and promoting qi and relieving pain" in reducing swelling and relieving pain is better than that of simply using blood circulation and removing blood stasis, regulating qi and relieving pain drugs (clinically compared with Dusheng Huoxue Tablets). In addition, the pharmaceutical composition provided by the present invention can be taken orally or applied externally.

[0022] In the above-mentioned pharmaceutical composition, the dried tuber of Coydalis decumbens (Thunb.) Pers. of the Poppy family is used as the summer non-ingredient.

[0023] Panax notoginseng is also known as mountain lacquer, golden ginseng, blood ginseng, ginseng, and panax notoginseng; it is the dried root and rhizome of Panax notoginseng (Burk.) FHChen, a plant of the Araliaceae family. The Panax notoginseng in the raw materials of the pharmaceutical composition of the present invention includes but is not limited to Panax notoginseng powder, Panax notoginseng slices, Panax notoginseng, and cooked Panax notoginseng. Gardenia is also known as yellow gardenia, gardenia, and white toad. It is the dried mature fruit of Gardenia jasminoides Ellis., a plant of the Rubiaceae family, and is a resource for both medicinal and edible purposes. Lianqiancao is the dried aerial part of Glechoma longituba (Nakai) Kupr., a plant of the Lamiaceae family. Red peony is also known as wood peony, red peony, and red peony. It is the dried root of Paeonia lactiflora Pall. or Paeonia veitchii Lynch., a plant of the Ranunculaceae family.

[0024] Vinegar-scented cyperus is also known as: quetouxiang, sedge root, cyperus, thunder god head, three-edged grass root; it is a qi-moving medicine, which is the dried rhizome of sedge (Cyperus rotundus L.) of the Cyperaceae family, cut into thick slices or crushed and then fried dry according to the vinegar roasting method. Rhubarb is also known as: general, Sichuan army, brocade pattern; it is a laxative, which is the dried root and rhizome of palmatum rhubarb (Rheum palmatum L.), Tanguticum rhubarb (Rheum tanguticum Maxim.ex Balf.) or medicinal rhubarb (Rheum officinale Baill.) of the Polygonaceae family.

[0025] In a preferred embodiment of the present invention, the above-mentioned pharmaceutical composition includes the following raw materials in parts by weight: 9 parts of summer wormwood, 9 parts of Panax notoginseng, 9 parts of Gardenia jasminoides, 9 parts of Cyperus rotundus, 9 parts of Paeonia lactiflora, 3 parts of Cyperus rotundus and 3 parts of Rhubarb.

[0026] In a preferred embodiment of the present invention, the dosage form of the pharmaceutical composition includes but is not limited to pills, tablets, powders, capsules, granules, suspensions, lotions, decoctions or ointments. Tablets are, for example, selected from sugar-coated tablets, film-coated tablets or enteric-coated tablets. Capsules are, for example, selected from hard capsules or soft capsules.

[0027] In a second aspect, the present invention also provides a method for preparing a pharmaceutical composition, comprising: decocting Gardenia, Herba Lycopodii, Radix Paeoniae Rubrae, Rhizoma Cyperi and Radix Rhei, and mixing the concentrated solution with Herba Achyranthis Bidentatae and Radix Notoginseng. The above-mentioned preparation method is simple and easy to implement.

[0028] In an optional embodiment, the decoction is performed at least twice, for example, twice, three times or four times.

[0029] In a preferred embodiment of the present invention, the concentrated liquid is mixed with summer powder (100 mesh and above) and Panax notoginseng powder (100 mesh and above).

[0030] In a preferred embodiment of the present invention, the concentrated liquid is mixed with summer-nourished powder and Panax notoginseng powder to prepare pills.

[0031] In a third aspect, the present invention also provides a method for preparing a pharmaceutical composition, comprising: decocting Rhizoma Achyranthis Bidentatae, Gardenia Fructus, Herba Lycopodiellae, Radix Paeoniae Rubrae, Rhizoma Cyperi and Radix Rhei, and mixing the concentrated solution with Radix Notoginseng, and decocting for at least two times.

[0032] The main ingredient of summerwort is alkaloids, and the extraction effect is better with hydrochloric acid, which can dissolve more effective ingredients.

[0033] In a preferred embodiment of the present invention, the pharmaceutical composition is a decoction.

[0034] In a fourth aspect, the present invention also provides an application of a pharmaceutical composition in the preparation of a new medicine for injuries, swellings and pains.

[0035] In a preferred embodiment of the present invention, the drug further comprises a pharmaceutically acceptable carrier. The pharmaceutically acceptable carrier includes, but is not limited to, one or a combination of polyvinyl pyrrolidone and its derivatives, polyvinyl alcohol and its derivatives, methyl cellulose and its derivatives, ethyl cellulose and its derivatives, hydroxypropyl cellulose and its derivatives, starch and its derivatives, polyethylene glycol and its derivatives, lactose, sucrose, mannitol, trehalose, sorbitol, dextrin, microcrystalline cellulose, acrylic resin, calcium hydrogen phosphate, calcium stearate, sodium stearyl fumarate, silicon dioxide, titanium dioxide, talc, and indigo.

[0036] The excipients include at least one polar organic solvent and at least one thickening agent.

[0037] The diluent is, for example, selected from pharmaceutically acceptable water or salt.

[0038] The present invention has the following beneficial effects:

[0039] (1) In the pharmaceutical composition provided by the present invention, Xia Tian Wu, which can promote blood circulation and dissipate blood stasis, promote qi circulation and relieve pain; Panax notoginseng, which is an important medicine for traumatology, can disperse blood stasis and stop bleeding, reduce swelling and relieve pain, and the two are both monarch medicines. Red peony root, which can disperse blood stasis and relieve pain; Gardenia, which can clear the triple energizer, relieve dampness and relieve swelling, and relieve pain; Herba schizonepetae, which can relieve dampness and relieve swelling, and disperse blood stasis; the three medicines are used together to dissipate blood stasis and swelling, and the evil is discharged through urine, so the meridians are unblocked and the pain is relieved, and they are all minister medicines. Vinegar-scented cyperus, which can promote qi circulation and relieve pain; Rhubarb, which can remove blood stasis, promote menstruation, relieve dampness and relieve swelling, and guide the stasis and dampness to be discharged through the stool, is a total adjuvant. The combination of these medicines can play the effects of promoting blood circulation and dissipating blood stasis, promoting diuresis and reducing swelling, and promoting qi circulation and relieving pain.

[0040] (2) The present invention pays attention to the pathological characteristics of "intertwining of blood stasis and water" in the treatment of acute soft tissue injuries. On the basis of the conventional prescriptions of "promoting blood circulation and removing blood stasis, promoting qi and relieving pain", by adding "diuretic and diuretic" drugs, the principle of "promoting blood circulation and removing blood stasis, promoting water and reducing swelling, promoting qi and relieving pain" is formed, which can quickly eliminate swelling in the affected area and facilitate the repair and healing of damaged tissues.

[0041] (3) The synergistic effects of Rhizoma Cibotii, Radix Notoginseng, Gardenia, Herba Lycopodiellae, Radix Paeoniae Rubrae, Rhizoma Cyperi, and Radix Rhei can effectively improve clinical symptoms such as pain, swelling, functional impairment, and ecchymosis caused by qi stagnation and blood stasis. Clinical observations show that the efficacy is better than that of simply using drugs that "activate blood circulation and remove blood stasis, regulate qi and relieve pain". In addition, the raw materials in the pharmaceutical composition provided by the present invention are all traditional Chinese medicines included in the Chinese Pharmacopoeia. DETAILED DESCRIPTION

[0042] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0043] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0044] Example 1

[0045] This embodiment provides a pharmaceutical composition for treating acute soft tissue injury, which includes the following raw materials: 9 grams of summer osmanthus, 9 grams of Panax notoginseng, 9 grams of Gardenia jasminoides, 9 grams of Cyperus rotundus, 9 grams of Paeonia lactiflora, 3 grams of Cyperus rotundus, and 3 grams of Rhubarb.

[0046] Preparation of New Shangzhongtong Pills

[0047] Preparation method: Except for Xiatianwu and Panax notoginseng, which are ground into fine powder, the other five herbs are decocted twice, and the concentrated liquid is taken. Add Xiatianwu fine powder and Panax notoginseng fine powder, mix and make pills (0.7 cm mold), and set aside.

[0048] Dosage and administration: Oral administration. Take 25 pills at a time (equivalent to 12.75 grams of crude drug in theory), with warm water, 3 times a day.

[0049] Example 2

[0050] This embodiment provides a pharmaceutical composition for treating acute soft tissue injury, which includes the following raw materials: 9 grams of summer osmanthus, 9 grams of Panax notoginseng, 9 grams of Gardenia jasminoides, 9 grams of Cyperus rotundus, 9 grams of Paeonia lactiflora, 3 grams of Cyperus rotundus, and 3 grams of Rhubarb.

[0051] Preparation of New Injury and Swelling Decoction

[0052] Preparation method: Except for the finely powdered Panax notoginseng, boil the other 6 herbs in water until the amount reaches 450 ml.

[0053] Dosage and Administration: 1 dose per day, taken warm after breakfast, lunch and dinner, 150 ml each time. Add fine powder of Panax notoginseng to the liquid medicine for oral administration.

[0054] Comparative Example

[0055] Dusheng Huoxue Tablets (Specifications: core weight 0.4 g, 36 tablets / box; Approval number: National Medicine Standard Z51020241; Manufacturer: Taiji Group Sichuan Mianyang Pharmaceutical Co., Ltd.), Usage and Dosage: Oral. 3 tablets at a time, 3 times a day. 14 days is a course of treatment, and the efficacy and safety are evaluated after 1 course of treatment.

[0056] Dusheng Huoxue Tablets are made up of Panax notoginseng, Cyperus rotundus (roasted in four parts), Angelica sinensis, Corydalis yanhusuo (roasted in vinegar), Millettia reticulata, Rhubarb, and Licorice. Its functions and indications are: promoting blood circulation and reducing swelling, regulating qi and relieving pain. It is used for dysmenorrhea caused by traumatic injuries, blood stasis and swelling, and qi stagnation and blood stasis.

[0057] Experimental Example 1

[0058] Name: Li Li, Gender: Female, Age: 23 years old. Clinical diagnosis: Acute right ankle sprain; TCM syndrome differentiation: Qi stagnation and blood stasis syndrome.

[0059] Current medical history: One hour ago, the patient accidentally sprained his right ankle while walking, resulting in pain, swelling, and dysfunction of the right ankle.

[0060] Physical examination: right ankle lateral ankle joint swelling, normal skin color, slightly higher skin temperature, local tenderness, limited mobility. Red tongue, thin white fur, stringy pulse.

[0061] Treatment: The patient was given braking, rest, and neutral position support board fixation. The pharmaceutical composition for treating acute soft tissue injury prepared in Example 1 (ie, Xinshangzhongtong Pills) was taken orally, 3 times a day, 25 pills each time, for 6 days.

[0062] The patient re-examined 6 days later: physical examination showed slight swelling of the right ankle joint, normal skin color, normal skin temperature, no obvious tenderness in the local area, and normal activity function. The tongue was pale red, the coating was thin and white, and the pulse was stringy. Treatment: Remove the support board and ask the patient to avoid excessive walking and strenuous exercise. Oral Xinshangzhongtong Pills were given again, 3 times a day, 25 pills each time * 6 days; the patient re-examined 6 days later: no obvious swelling and tenderness in the right ankle joint, and the activity function was normal.

[0063] Experimental Example 2

[0064] Name: Wang Li, gender: male, age: 19. Clinical diagnosis: acute right knee sprain; TCM syndrome differentiation: Qi stagnation and blood stasis syndrome.

[0065] Current medical history: 3 days ago, the patient accidentally sprained his right knee while playing basketball, causing swelling and pain in the right knee joint. After treatment outside the hospital, there was no relief, so he came to our hospital for diagnosis and treatment. (The specific treatment outside the hospital is unknown).

[0066] Physical examination: right knee joint swelling, normal skin color, slightly higher skin temperature, local tenderness. Floating patella test (+), grinding test (-), drawer test (-), lateral stress test (-), extension and flexion dysfunction. Dark red tongue, thin yellow fur, sluggish pulse.

[0067] Auxiliary examination: B-ultrasound of our hospital showed: the soft tissue layers of the right knee joint were clear, and a liquid dark area was found in the suprapatellar bursa and the medial and lateral joint spaces, with a maximum depth of about 1.6 cm. The internal sound transmission was poor, synovial hyperplasia was seen, no obvious blood flow signal was seen, and no obvious abnormality was found in the articular cartilage. The deep infrapatellar bursa of the right knee was widened, with a liquid dark area of ​​about 0.4 cm deep and a little synovial hyperplasia.

[0068] Treatment: After routine disinfection, perform right knee joint puncture and draw out about 30 ml of dark red blood. Immobilize the patient and fix the knee joint with a support plate in the straight position. Orally take the pharmaceutical composition prepared in Example 2 (i.e., Xinshangzhongtong Decoction), for a total of 7 doses. One dose per day, take warm after breakfast, lunch and dinner, 150 ml each time, add Panax notoginseng fine powder into the liquid medicine when taking orally.

[0069] The patient was re-examined 7 days later: there was no obvious swelling and tenderness in the right knee joint, normal skin color, normal skin temperature, and acceptable activity function. Floating patella test (-). Ultrasound showed: the soft tissue layers of the right knee joint were clear, and a liquid dark area was detected in the suprapatellar bursa and the medial and lateral joint spaces, with a maximum depth of about 0.2 cm. The internal sound transmission was poor, synovial hyperplasia was seen, no obvious blood flow signals were seen, and no obvious abnormalities were found in the articular cartilage. The deep infrapatellar bursa of the right knee was widened, with a liquid dark area of ​​about 0.1 cm deep, and a small amount of synovial hyperplasia was seen. The patient was advised to rest, avoid strenuous exercise, avoid standing or walking for a long time, and squat (90° knee flexion is recommended).

[0070] Experimental Example 3

[0071] Name: Xu Rong, Gender: Female, Age: 36. Clinical diagnosis: right elbow joint injury; TCM syndrome differentiation: Qi stagnation and blood stasis syndrome.

[0072] Current medical history: The patient reported that he was hit by a falling heavy object 5 days ago, causing pain and swelling in the right elbow joint. After treatment outside the hospital, there was no significant relief, so he came to our hospital for diagnosis and treatment. (The specific treatment outside the hospital is unknown).

[0073] Physical examination: right elbow swelling, purple bruises, slightly higher skin temperature, obvious local tenderness and percussion pain, joint dysfunction. Dark red tongue, a few petechiae scattered under the tongue, thin yellow fur, stringy pulse.

[0074] Auxiliary examination: DR showed: no obvious fracture of the right elbow joint, and local soft tissue swelling.

[0075] Treatment: Immobilize and rest. Take Xinshangzhongtong Decoction orally, 7 doses in total. 1 dose per day, take warm in the morning, noon and evening after meals, 150 ml each time, add Panax notoginseng powder into the liquid when taking orally.

[0076] 7 days later, the patient was re-examined: the pain and swelling of the right elbow joint improved, and the activity function was acceptable. The tongue was red, the coating was thin and white, and the pulse was sluggish. Treatment: Oral administration of the new injury and swelling pills prepared in Example 1, 3 times a day, 25 pills each time * 5 days. The patient was re-examined 5 days later: the right elbow joint function was normal, and there was no obvious swelling, no bruise, and no tenderness locally.

[0077] Experimental Example 4

[0078] Name: Xu Mengli, Gender: Female, Age: 35. Clinical diagnosis: Acute soft tissue injury; TCM syndrome differentiation: Qi stagnation and blood stasis syndrome.

[0079] Current medical history: The patient accidentally fell from a height 6 days ago and landed on his back, causing back pain and bruises. After examination at another hospital, he was diagnosed with subcutaneous hemorrhage. Because the pain was worse at night, he came to our hospital for further treatment.

[0080] Physical examination: No obvious swelling on the back, purple bruises and slight burning sensation, local tenderness, and good mobility from the lower edge of the scapula to the 10th thoracic vertebra on both sides. The tongue is dark purple, with yellow fur, and the pulse is slow and sluggish.

[0081] Auxiliary examination: Chest CT showed no fractures or internal bleeding.

[0082] Treatment: Take Xinshangzhongtong Decoction orally, 7 doses in total. 1 dose per day, take warm in the morning, noon and evening after meals, 150 ml each time, add Panax notoginseng powder into the liquid when taking orally.

[0083] The patient was re-examined 7 days later: the bruise on the back improved, the skin temperature was normal, and there was no obvious tenderness in the local area. The patient was again given the new injury swelling and pain soup prepared in Example 2 for oral administration, for a total of 3 doses. One dose per day, taken warm after breakfast, lunch and dinner, 150 ml each time, and fine powder of Panax notoginseng was added to the medicine solution during oral administration. The patient was re-examined 3 days later: the bruise disappeared, there was no tenderness in the local area, and the skin was normal.

[0084] Experimental Example 5

[0085] Name: Wang Jing, Gender: Female, Age: 31. Clinical diagnosis: right foot soft tissue injury; TCM syndrome differentiation: Qi stagnation and blood stasis syndrome.

[0086] Current medical history: The patient was hit by a heavy object on the dorsum of his right foot 2 hours ago, followed by swelling, pain, and dysfunction of movement, so he came to our hospital for treatment.

[0087] Physical examination: swelling of the anterior part of the right dorsum, normal skin color, slightly higher temperature, tenderness, and functional impairment. The tongue is red, with a thin white coating, and the pulse is tight and astringent.

[0088] Auxiliary examination: DR showed: no obvious fracture, and swelling of surrounding soft tissue.

[0089] Treatment: immobilization, rest, raising the affected limb. Orally take the new injury swelling and pain decoction prepared in Example 2, a total of 5 doses. One dose per day, take warm after breakfast, lunch and dinner, 150 ml each time, add Panax notoginseng fine powder into the medicine solution when taking orally.

[0090] The patient was re-examined 5 days later: the physical examination showed no obvious swelling on the dorsum of the right foot, a little bruise under the skin, no obvious tenderness, and the activity function was acceptable. He was given oral Xinshangzhongtong Decoction again, for a total of 5 doses. One dose per day, taken warm after breakfast, lunch and dinner, 150 ml each time, add Panax notoginseng powder into the medicine solution when taking it orally. Re-examination 5 days later: the bruise disappeared, and the skin color returned to normal.

[0091] Experimental Example 6

[0092] Name: Liu Yongtao, Gender: Female, Age: 39. Clinical diagnosis: right ankle sprain; TCM syndrome differentiation: Qi stagnation and blood stasis syndrome.

[0093] Current medical history: The patient reported that he accidentally sprained his right ankle joint when he was walking down the stairs 1 day ago. He felt slight pain, no obvious swelling, and normal mobility, but he did not pay much attention to it at that time. The next morning, he felt swelling, pain, and dysfunction of the right ankle joint, so he came to our hospital for further treatment.

[0094] Physical examination: right ankle lateral ankle joint swelling, local tenderness, and functional impairment. Red tongue, thin white fur, and tight and astringent pulse.

[0095] Auxiliary examination: DR showed: no fracture, slight swelling of surrounding soft tissue.

[0096] Treatment: immobilization, rest, elevation of the affected limb. Oral administration of the new injury and swelling pills prepared in Example 1, 3 times a day, 25 pills each time, for 7 days.

[0097] The patient was re-examined 7 days later: there was no obvious swelling in the right lateral ankle joint, the mobility was still good, and there was no obvious tenderness in the local area.

[0098] Experimental Example 7

[0099] From January 2022 to February 2023, 80 cases were observed in the outpatient clinic of Chengdu Pidu District Orthopedic Hospital. The report is as follows:

[0100] 1. Basic clinical information

[0101] Outpatients were diagnosed with qi stagnation and blood stasis according to TCM diagnosis. Clinical symptoms included swelling, pain (persistent, occasional tingling), tingling, pain in a fixed location, limited movement of the affected limb, or local cyanosis (or large hematoma), dark purple tongue or ecchymosis, stringy and astringent pulse, etc. A total of 80 cases were observed, including 40 cases in the treatment group: 19 males aged 19-50 years old, 5 cases ≥50 years old; 13 females aged 20-50 years old, 3 cases ≥50 years old. Control group (40 cases): 20 males aged 20-50 years old, 5 cases ≥50 years old; 11 females aged 20-50 years old, 4 cases ≥50 years old. The course of disease was 1-7 days.

[0102] 2. Treatment and observation methods

[0103] The cases were grouped and observed by an open, randomized, and controlled method. The treatment group took the new injury swelling and pain pills prepared in Example 1 (prescription: 9 grams of summer nut, 9 grams of notoginseng, 9 grams of gardenia, 9 grams of lianqiancao, 9 grams of red peony root, 3 grams of vinegar cyperus, and 3 grams of rhubarb; preparation method: except for summer nut and notoginseng, the remaining 5 herbs are decocted twice, the concentrated liquid is taken, and the summer nut powder and notoginseng powder are added to mix and make pills. The traditional Chinese medicine prescription processing of the new injury swelling and pain pills is completed by the traditional Chinese medicine prescription processing room of the Orthopedic Hospital of Pidu District, Chengdu), usage and dosage: oral. 25 pills at a time (theoretically equivalent to 12.75 grams of crude drug), taken with warm water, 3 times a day.

[0104] The control group took Dusheng Huoxue Tablets in the comparative example, and the dosage was oral. 3 tablets each time, 3 times a day. 14 days was a course of treatment, and the efficacy and safety were evaluated after one course of treatment.

[0105] During the trial, except for routine physical treatments such as routine immobilization, local ice compress, plaster splint external fixation and elevation of the affected limb, no diagnostic and therapeutic drugs that have a therapeutic effect on acute soft tissue injuries shall be used.

[0106] 3. Efficacy evaluation criteria

[0107] 3.1 TCM syndrome efficacy evaluation criteria: (1) Cured: pain, swelling, ecchymosis and other symptoms and signs completely disappeared, no tenderness, local function completely restored to normal, joint movement reached the normal range, and the score after treatment was reduced by ≥95% compared with that before treatment; (2) Markedly effective: pain, swelling, ecchymosis and other symptoms and signs basically disappeared, there was slight tenderness in the affected area, joint function and movement were not restricted, and the score after treatment was reduced by ≥70% but <95% compared with that before treatment; (3) Improved: pain, swelling, ecchymosis and other symptoms and signs were significantly alleviated, tenderness still existed in the affected area, joint function and movement were improved compared with that before treatment, and the score after treatment was reduced by ≥30% but <70% compared with that before treatment; (4) Ineffective: there was no significant improvement in the symptoms and signs compared with that before treatment, and the score after treatment was reduced by <30% compared with that before treatment.

[0108] Note: The calculation formula (nimodipine method) is: [(score before treatment - score after treatment) ÷ score before treatment] × 100%.

[0109] 3.2 Evaluation criteria for the efficacy of a single symptom: (1) Clinical cure: symptoms disappear and the score drops to 0 points; (2) Marked effect: symptoms are significantly improved and the score drops by 2 levels; (3) Effective: symptoms are improved and the score drops by 1 level; (4) Ineffective: symptoms are not improved or worsen, and the score does not decrease or increases.

[0110] 3.3 Effectiveness indicators

[0111] Table 1 TCM syndrome observation score

[0112]

[0113] 3.4 Safety indicators:

[0114] Level 1: Safe, without any adverse reactions.

[0115] Level 2: Relatively safe. If any adverse reaction occurs, no treatment is required and medication can continue.

[0116] Level 3: There are safety issues and moderate adverse reactions, but the drug can continue to be administered after treatment.

[0117] Grade 4: The trial was terminated due to adverse reactions.

[0118] 4. Treatment results

[0119] 4.1 The overall efficacy results are shown in Table 2;

[0120] Table 2 Overall efficacy evaluation results

[0121] Group Number of cases get well Significant effect efficient invalid Total effective rate% Treatment Group 40 25 12 2 1 97.50 Control group 40 12 13 7 8 80.00

[0122] The above table shows that the therapeutic effect of the treatment group is significantly better than that of the control group, and the difference in the total effective rate between the treatment group and the control group is statistically significant (P<0.05).

[0123] 4.2 Safety evaluation results

[0124] During clinical observation, no adverse reactions were found and the drug was safe.

[0125] According to Table 2, the new Shangzhongtong Pills provided in the embodiment of the present invention have a good therapeutic effect on acute soft tissue injury (Qi stagnation and blood stasis syndrome), with a total effective rate of 97.50%, which is better than the Dusheng Huoxue Tablets control group.

[0126] In summary, the present invention uses the method of "promoting blood circulation and dispersing blood stasis, promoting diuresis and reducing swelling, and promoting qi and relieving pain" to formulate a prescription for new injuries and swelling and pain, and can effectively improve clinical symptoms such as pain, swelling, dysfunction, and ecchymosis caused by qi stagnation and blood stasis through the synergistic effects of summer nectar, notoginseng, gardenia, schizonepeta, red peony root, vinegar cyperus, and rhubarb. Clinical observations show that the efficacy is better than that of simply using drugs that "promote blood circulation and remove blood stasis, regulate qi and relieve pain". And the above raw materials are all traditional Chinese medicines included in the "Chinese Pharmacopoeia".

[0127] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A pharmaceutical composition for treating acute soft tissue injury, It is characterized in that In terms of weight, the raw materials are: 9-15 parts of summer ginseng, 9-15 parts of Panax notoginseng, 9-15 parts of Gardenia jasminoides, 9-15 parts of Cyperus rotundus, 9-15 parts of Paeonia lactiflora, 3-6 parts of Cyperus rotundus and 3-6 parts of Rhubarb.

2. The pharmaceutical composition according to claim 1, It is characterized in that In terms of weight, the raw materials are: 9 parts of summer nut, 9 parts of Panax notoginseng, 9 parts of Gardenia jasminoides, 9 parts of Cyperus rotundus, 9 parts of Paeonia lactiflora, 3 parts of Cyperus rotundus and 3 parts of Rhubarb.

3. The pharmaceutical composition according to claim 1, It is characterized in that The dosage form of the pharmaceutical composition is pills, tablets, powders, capsules, granules, suspensions or decoctions.

4. A method for preparing the pharmaceutical composition according to any one of claims 1 to 3, It is characterized in that It includes: Decoction gardenia, smilax china, red peony root, vinegar-soaked cyperus and rhubarb, take the concentrated liquid and mix it with summer clover and Panax notoginseng.

5. The preparation method according to claim 4, It is characterized in that Decoction should be performed at least twice.

6. The preparation method according to claim 4, It is characterized in that Take the concentrated liquid and mix it with summer powder and Panax notoginseng powder.

7. The preparation method according to claim 6, It is characterized in that Take the concentrated liquid and mix it with summer powder and Panax notoginseng powder to make pills.

8. A method for preparing the pharmaceutical composition according to any one of claims 1 to 3, It is characterized in that It includes: Decoction summer clover, gardenia, smilax glabra, red peony root, vinegar-scented cyperus and rhubarb, take the concentrated liquid and mix it with Panax notoginseng.

9. The method for preparing the pharmaceutical composition according to claim 8, It is characterized in that Decoction should be performed at least twice.

10. The method for preparing the pharmaceutical composition according to claim 8, It is characterized in that The pharmaceutical composition is a decoction.

11. Use of the pharmaceutical composition according to any one of claims 1 to 3 in the preparation of a drug for treating new wounds, swellings and pains.

12. The use according to claim 11, It is characterized in that The medicament further includes a pharmaceutically acceptable carrier.

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