A traditional Chinese medicine composition for treating lumbar muscle strain, a preparation method thereof and application thereof

Abstract

The application provides a traditional Chinese medicine composition for treating lumbar muscle strain, and raw material formula and proportion of the traditional Chinese medicine composition are as follows: 3-6 parts by weight of Wulingteng, 1-3 parts by weight of Baizhi, 1-3 parts by weight of Sanqi, 5-8 parts by weight of Danggui, 3-6 parts by weight of Xianfengcao, 3-6 parts by weight of Guizhi, 1-3 parts by weight of Tongcao, 3-6 parts by weight of Jixueteng, 1-3 parts by weight of Danshen, 1-3 parts by weight of Wujiapi, 3-6 parts by weight of Mugua, 1-3 parts by weight of Huzhang, 1-3 parts by weight of Rending, 1-3 parts by weight of Yujin, 1-3 parts by weight of Muxiang, 1-3 parts by weight of Zhishouwu, 1-3 parts by weight of Rangguishu, 1-3 parts by weight of Zhuru, and 1-3 parts by weight of Diyu. The traditional Chinese medicine composition has reasonable compatibility, no toxic side effects, simple preparation method, can effectively reduce blood rheology of patients, relieve lumbar pain symptoms, improve lumbar activity, reduce clinical symptoms, has smaller adverse reactions and higher safety.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, specifically to a traditional Chinese medicine composition for treating lumbar muscle strain, its preparation method, and its application. Background Technology

[0002] Lumbar muscle strain, also known as chronic lower back strain or functional low back pain, has complex causes, mostly due to cumulative damage resulting from acute lumbar sprains or repeated adverse stress on the lumbar region. Maintaining poor posture for extended periods can cause passive stretching or contraction of the lumbar muscles, leading to insufficient oxygen supply to local tissues, accumulation of metabolic products, and irritation and inflammation. In severe cases, it can cause local soft tissue hyperplasia, thickening, adhesions, and even degeneration, resulting in recurrent episodes of lower back pain or discomfort. Modern medicine considers the causes of lumbar muscle strain to include chronic strain, improper treatment of acute lumbar sprains, congenital malformations, facet joint dysfunction, fractures, and external stimuli. In Traditional Chinese Medicine (TCM), lumbar muscle strain falls under the categories of "painful obstruction," "muscle injury," and "bone obstruction," and is classified as "lower back pain" and "muscle injury," with the "blood stasis type" being particularly common. The causes of lower back pain are generally due to overexertion, resulting in lumbar injury, meridian obstruction, and blocked blood vessels. Falls, sprains, or improper exertion can cause spinal misalignment, leading to blood stasis and lower back pain. Alternatively, underlying weakness can allow external pathogens to invade, causing lumbar muscle spasms, meridian obstruction, and poor blood circulation, thus resulting in lower back pain. Internal causes are often due to liver and kidney deficiency, old age and weakness, and meridian damage and blood stasis after injury. External causes are often due to the invasion of wind, cold, and dampness. Middle-aged and elderly patients, due to old age and weakness, long-term overexertion, and decreased organ function, experience qi and blood deficiency and weakened defensive qi. Long-term excessive and uneven exertion leads to damage to muscles, ligaments, fascia, and joints, making them susceptible to external wind, cold, and dampness, resulting in meridian obstruction and blood stasis. Currently, there are many medications available in the domestic market for treating this condition, but the main dosage forms are liniments, plasters, and sprays. In modern medicine, oral medications primarily utilize anti-inflammatory and analgesic drugs, including nonsteroidal anti-inflammatory drugs (NSAIDs), steroidal anti-inflammatory drugs (SSAIDs), and anabolic steroids. However, these drugs have significant side effects, including nausea, vomiting, heartburn, abdominal discomfort, abdominal pain, and allergic reactions. In severe cases, they can lead to gastrointestinal perforation, bleeding, shock, and liver and kidney dysfunction. Long-term, high-dose use can affect the function of many organs and systems. Therefore, the use of anti-inflammatory and analgesic drugs is not the best choice for long-term treatment.

[0003] Physiotherapy refers to methods that utilize artificial or natural physical factors to act on the human body, producing beneficial responses to achieve the purpose of preventing and treating diseases. Physiotherapy methods for treating lumbar muscle strain mainly include massage, laser irradiation, and acupuncture. Clinically, physiotherapy is relatively gentle and can play a certain auxiliary role. However, its disadvantages include a long treatment cycle and course, requiring a significant amount of time, and often having limited efficacy and a high recurrence rate.

[0004] With the development of traditional Chinese medicine, there is an increasing amount of research on the treatment of lumbar muscle strain using traditional Chinese medicine. For example, CN201510270494.X discloses a traditional Chinese medicine composition for treating lumbar muscle strain, which is mainly prepared from the following raw materials, all in parts by weight: Bupleurum chinense 12-17, Ratwort 7-12, Taxillus chinensis 9-13, Da Pao Tong 7-14, Akebia quinata 10-15, Gou Er Cha 6-12, Dao Zha Long 8-16, Dioscorea opposita 12-15, Oakleaf cirrhosa 6-13, Da Huo 8-12, Inverted Lotus Root 10-14, Da Bo Gu 7-13, Uncaria rhynchophylla 9-12, Red Boy 10-13, Coix lacryma-jobi 12-16, and Mussel 7-17. For example, CN201510574561.7 discloses a traditional Chinese medicine composition for treating lumbar muscle strain and its preparation method, which includes the following raw materials in parts by weight: 4-12 parts of *Euonymus fortunei*, 2-8 parts of *Clematis chinensis*, 1-5 parts of *Ligusticum striatum*, 2-8 parts of *Eucommia ulmoides*, 3-9 parts of *Cibotium barometz*, 5-10 parts of *Smilax glabra*, 2-8 parts of *Achyranthes bidentata*, 3-9 parts of *Xanthium sibiricum*, 5-10 parts of *Valeriana officinalis*, 1-5 parts of *Caulis Cibotium barometz*, 3-9 parts of *Radix Achyranthis Bidentatae*, and 2-8 parts of *Clematis chinensis*.

[0005] Traditional Chinese medicine is increasingly promising as a treatment for lumbar muscle strain with definite efficacy and high safety. Therefore, it is of great significance to further develop a traditional Chinese medicine composition that is rationally formulated, has no toxic side effects, and has obvious therapeutic effects for the treatment of lumbar muscle strain. Summary of the Invention

[0006] To address the shortcomings of existing technologies, the purpose of this invention is to develop a traditional Chinese medicine composition for treating lumbar muscle strain and its preparation method. The traditional Chinese medicine composition is rationally formulated, has no toxic side effects, and its preparation method is simple. This traditional Chinese medicine composition has better therapeutic effects on lumbar muscle strain, can effectively reduce the patient's blood rheology, alleviate lower back pain symptoms, improve lumbar mobility, reduce clinical symptoms, and has fewer adverse reactions and higher safety.

[0007] The technical solution of this invention is:

[0008] A traditional Chinese medicine composition for treating lumbar muscle strain, comprising the following raw materials and proportions: Clematis chinensis 3-6 parts by weight, Angelica dahurica 1-3 parts by weight, Panax notoginseng 1-3 parts by weight, Angelica sinensis 5-8 parts by weight, Asarum heterotropoides 3-6 parts by weight, Lycopodium clavatum 5-8 parts by weight, Cinnamomum cassia 3-6 parts by weight, Tetrapanax papyriferus 1-3 parts by weight, Spatholobus suberectus 3-6 parts by weight, Salvia miltiorrhiza 1-3 parts by weight, Acanthopanax senticosus 1-3 parts by weight, Chaenomeles speciosa 3-6 parts by weight, Polygonum cuspidatum 1-3 parts by weight, Prunus persica 1-3 parts by weight, Curcuma longa 1-3 parts by weight, Aucklandia lappa 1-3 parts by weight, Polygonum multiflorum 1-3 parts by weight, Drynaria fortunei 1-3 parts by weight, Bambusa textilis 1-3 parts by weight, and Sanguisorba officinalis 1-3 parts by weight.

[0009] Preferably, the raw material formula and proportion are as follows: Clematis chinensis 4 parts by weight, Angelica dahurica 2 parts by weight, Panax notoginseng 2 parts by weight, Angelica sinensis 7 parts by weight, Asarum heterotropoides 4 parts by weight, Lycopodium clavatum 7 parts by weight, Cinnamomum cassia 4 parts by weight, Tetrapanax papyriferus 2 parts by weight, Spatholobus suberectus 4 parts by weight, Salvia miltiorrhiza 2 parts by weight, Acanthopanax senticosus 2 parts by weight, Chaenomeles speciosa 4 parts by weight, Polygonum cuspidatum 2 parts by weight, Prunus persica 2 parts by weight, Curcuma longa 2 parts by weight, Aucklandia lappa 2 parts by weight, Polygonum multiflorum 2 parts by weight, Drynaria fortunei 2 parts by weight, Bambusa textilis 2 parts by weight, and Sanguisorba officinalis 2 parts by weight.

[0010] Preferably, the raw material formula and proportion are as follows: Clematis chinensis 6 parts by weight, Angelica dahurica 3 parts by weight, Panax notoginseng 3 parts by weight, Angelica sinensis 8 parts by weight, Asarum heterotropoides 6 parts by weight, Lycopodium clavatum 8 parts by weight, Cinnamomum cassia 6 parts by weight, Tetrapanax papyriferus 3 parts by weight, Spatholobus suberectus 6 parts by weight, Salvia miltiorrhiza 2 parts by weight, Acanthopanax senticosus 2 parts by weight, Chaenomeles speciosa 4 parts by weight, Polygonum cuspidatum 2 parts by weight, Prunus persica 3 parts by weight, Curcuma longa 3 parts by weight, Aucklandia lappa 3 parts by weight, Polygonum multiflorum 3 parts by weight, Drynaria fortunei 2 parts by weight, Bambusa textilis 2 parts by weight, and Sanguisorba officinalis 2 parts by weight.

[0011] Preferably, the preparation method of the traditional Chinese medicine composition includes the following steps:

[0012] (1) Crush Clematis chinensis, Angelica dahurica and Panax notoginseng into fine powder, sterilize with moist heat to obtain fine powder A;

[0013] (2) Angelica sinensis and Asarum sieboldii were crushed, then sterilized by ethanol to obtain fine powder B.

[0014] (3) The remaining 15 herbs, including *Shenjincao*, *Guizhi*, *Tongcao*, *Jixueteng*, *Danshen*, *Wujiapi*, *Mugua*, *Huzhang*, *Tuotaoren*, *Yujin*, *Muxiang*, *Zhiheshouwu*, *Tanggusuibu*, ​​*Zhuru*, and *Diyu*, are decocted 2-3 times with water. The first time, 14-15 times the amount of water is added and the decoction is decocted for 2-3 hours. The second time, 12-14 times the amount of water is added and the decoction is decocted for 1-2 hours. The decoctions are combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.20-1.30 (60℃). The paste is dried, pulverized into fine powder C, and added to the above fine powder A and fine powder B. The mixture is then stirred to obtain the final product.

[0015] More preferably, the moist heat sterilization is controlled at 121℃-125℃ for 15min-20min.

[0016] More preferably, the ethanol soaking sterilization uses ethanol with a concentration of 65%-75%, and the amount used accounts for 25%-30% of the mass of Angelica sinensis and Asarum heterotropoides, with a soaking time of 3-4 hours.

[0017] More preferably, the moisture content of fine powder A and fine powder B is <7%, and the moisture content of fine powder C is <6%.

[0018] More preferably, the particle size of fine powder A, fine powder B and fine powder C is 80 mesh to 100 mesh.

[0019] Further preferably, the pharmaceutical composition is prepared into pills, ointments or tablets by conventional existing methods.

[0020] Use of the traditional Chinese medicine composition of the present invention and the traditional Chinese medicine composition prepared by the method of the present invention in the preparation of a medicament for treating lumbar muscle strain.

[0021] Explanation of the prescription of the present invention:

[0022] This disease is mostly caused by qi stagnation and blood stasis, and obstruction of the tendons and collaterals. There are many clinical complications in this disease, so the basic treatment principle in clinical treatment should be promoting blood circulation to remove blood stasis, dredging collaterals to relieve pain, and relaxing the lumbar muscles. Herba Lycopodii is slightly bitter, pungent and warm. It belongs to the liver, spleen and kidney meridians; it dispels wind and dampness, and relaxes tendons and activates collaterals. Angelica sinensis is sweet, pungent and warm. It belongs to the liver, heart and spleen meridians. It enriches blood and promotes blood circulation. It plays the role of promoting blood circulation and dredging collaterals. The two have the effects of dispelling dampness and activating collaterals, and promoting blood circulation to remove blood stasis, so Herba Lycopodii and Angelica sinensis are used as the monarch drugs together. Cinnamon Twig is a warm drug, warming the meridians, promoting qi transformation by warming yang, and making the body fluids and blood circulation not stagnate. Asarum sieboldii is warm in nature, relieving exterior syndrome by dispelling cold, expelling wind and relieving pain, and promoting qi transformation by warming yang. It can expel cold air and disperse wind pathogens in the upper and lower parts; Caulis Spatholobi promotes blood circulation and relieves pain; Fructus Chaenomelis relieves rheumatism and dredges collaterals. Clematis chinensis is pungent, salty and warm. It belongs to the bladder meridian; it dispels wind and dampness, dredges collaterals and relieves pain, and is mainly used for wind, dampness, phlegm, stagnation in the meridians, resulting in gouty pain, bone joint pain, swelling or numbness. In this formula, Cinnamon Twig, Asarum sieboldii, Caulis Spatholobi, Fructus Chaenomelis and Clematis chinensis are used as ministerial drugs, making up for the deficiency of the monarch drugs in warming yang, dispersing cold and promoting qi movement, and strengthening the effects of the monarch drugs in dispelling wind and dampness and promoting blood circulation and dredging collaterals. Salvia miltiorrhiza clears heat and cools blood, promotes blood circulation and relieves pain; Acanthopanax gracilistylus relieves rheumatism and strengthens bones and muscles; Radix Polygoni Multiflori Preparata and Drynaria fortunei strengthen the liver and kidney, and strengthen bones and muscles; Bamboo茹 and Sanguisorba officinalis cool blood, and Angelica dahurica relieves pain. Aucklandia lappa regulates qi; Polygonum cuspidatum, Persica praeparata, Notoginseng and Curcuma aromatica together play the role of promoting blood circulation to remove blood stasis. Tetrapanax papyriferus dredges collaterals; the above drugs used together with the monarch and ministerial drugs strengthen the effects of the whole formula in dispelling dampness and dredging collaterals, promoting qi movement, promoting blood circulation to remove blood stasis, and strengthening bones and muscles. The various drugs in this formula are combined and used together to play the role of dispelling dampness and dredging collaterals, promoting qi movement, promoting blood circulation to remove blood stasis, so as to remove stasis and relieve congestion, and make the meridians and collaterals smooth and stop low back pain. Looking at the whole formula, the prescription is rigorous and the compatibility is appropriate, and it will definitely have good effects in clinical use.

[0023] The functions of each traditional Chinese medicine are as follows:

[0024] Clematis chinensis: warm in nature, pungent and salty in taste. Dispel wind and dampness, dredge collaterals and relieve pain. Used for wind-cold arthralgia, numbness of the limbs, spasms of tendons and vessels, difficulty in flexion and extension, and obstruction of the throat.

[0025] Angelica dahurica: warm in nature, pungent in taste. Belongs to the lung and stomach meridians. Dispel wind and cold, open the nasal cavity and relieve pain, promote blood circulation and drain pus, promote tissue regeneration and relieve pain, dry dampness and arrest leukorrhea. Used for headache, toothache, nasal sinusitis, intestinal wind and hemorrhoids, leukorrhea with red and white discharge, carbuncles and ulcers, and skin itching.

[0026] Notoginseng: sweet and slightly bitter, warm, promoting blood circulation to remove blood stasis and promoting qi circulation to relieve pain, used for traumatic injuries, stasis and swelling pain, etc.

[0027] Angelica sinensis: Tonifying blood; promoting blood circulation; regulating menstruation and alleviating pain; moistening dryness and lubricating the intestines. It is used for various syndromes of blood deficiency; irregular menstruation; amenorrhea; dysmenorrhea; mass in the abdomen; metrorrhagia and metrostaxis; abdominal pain due to deficiency-cold; flaccidity and paralysis; numbness of the skin and muscles; difficult defecation due to intestinal dryness; tenesmus after dysentery; carbuncles, ulcers and sores; injuries from falls and fractures.

[0028] Asarum sieboldii: Pungent and warm in nature and flavor. Expelling wind, dispelling cold and alleviating pain, warming the lungs and resolving fluid-retention, promoting nasal passage. It is used for treating exogenous wind-cold, headache, toothache, cough due to cold in the lungs, nasal sinusitis and other diseases.

[0029] Lycopodium clavatum: Slightly bitter, pungent, warm. It belongs to the liver, spleen and kidney meridians. Expelling wind and dampness, relaxing muscles and tendons. It is used for joint pain and difficulty in flexion and extension.

[0030] Cinnamomum cassia: Pungent, sweet, warm in nature. It belongs to the heart, lungs and bladder meridians. Inducing sweating and releasing the exterior, warming the channels and promoting blood circulation, assisting yang to transform qi. It is used for exterior syndrome of wind-cold, various pain syndromes due to cold congealing and blood stasis, phlegm-fluid retention syndrome, fluid-retention syndrome.

[0031] Tetrapanax papyriferus: Sweet, light, slightly cold in nature. Clearing heat and promoting diuresis, promoting lactation. It is used for stranguria with pain, dysuria, edema, jaundice, damp-warm disease, scanty and red urine, less milk after childbirth, amenorrhea, leukorrhea.

[0032] Millettia reticulata: Bitter, sweet, warm in nature and flavor. Tonifying blood, promoting blood circulation, dredging collaterals. It is used for irregular menstruation, sallow complexion due to blood deficiency, numbness, paralysis, rheumatic pain.

[0033] Salvia miltiorrhiza: Bitter in taste, slightly cold in nature. It belongs to the heart and liver meridians. Promoting blood circulation to remove blood stasis, dredging channels and alleviating pain, clearing the heart and relieving vexation, cooling blood and dissipating carbuncles. It is used for chest pain, epigastric and hypochondriac pain, mass in the abdomen, pain of heat arthralgia, restlessness and insomnia, irregular menstruation, dysmenorrhea, amenorrhea, swelling and pain of sores and ulcers.

[0034] Acanthopanax gracilistylus: Pungent, bitter, warm in nature. It belongs to the liver and kidney meridians. Expelling wind-dampness, tonifying the liver and kidney, strengthening muscles and bones, promoting diuresis to alleviate edema. It is used for rheumatic arthralgia, flaccidity of muscles and bones, slow walking of children, physical weakness, edema, beriberi.

[0035] Chaenomeles sinensis: Warm in nature, sour in taste; it belongs to the spleen, liver and stomach meridians. Strengthening the spleen and promoting digestion, relaxing muscles and tendons, relieving fatigue and pain, removing dampness and turbidity. It is used for rheumatic arthralgia, heaviness of limbs, cramps of muscles and tendons, vomiting and diarrhea with cramps, beriberi edema and other diseases.

[0036] Reynoutria japonica: Slightly bitter, slightly cold in nature. It belongs to the liver, gallbladder and lung meridians. Expelling wind and dampness, removing stasis and alleviating pain, relieving cough and resolving phlegm. It is used for arthralgia, damp-heat jaundice, amenorrhea, mass in the abdomen, scalds from fire and water, injuries from falls and fractures, carbuncles, ulcers and sores, cough with profuse phlegm and other symptoms.

[0037] Semen Persicae Praeparatum: Sweet, flat, bitter in taste. It enters the lung, liver and large intestine meridians. Promoting blood circulation to remove blood stasis, moistening the intestines and relaxing bowel movements. It is used for amenorrhea, dysmenorrhea, mass in the abdomen, injuries from falls and fractures, constipation due to intestinal dryness.

[0038] Turmeric: Pungent, bitter, and cool in nature. Enters the heart, lung, and liver meridians. It promotes qi circulation and relieves stagnation, cools the blood and breaks up blood stasis. Used for various pains in the chest, abdomen, and hypochondrium; mental instability and mania; delirium due to fever; hematemesis; epistaxis; hematuria; urinary tract infection; retrograde menstruation; and jaundice.

[0039] Costus root: pungent, bitter, warm. It enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. It promotes qi circulation and relieves pain, strengthens the spleen and aids digestion. It is used for spleen and stomach qi stagnation, abdominal, chest and rib distension and pain, jaundice, hernia pain and distension, indigestion, loss of appetite, and tenesmus after diarrhea.

[0040] Prepared Polygonum multiflorum: Bitter, sweet, astringent, slightly warm. It enters the liver, heart, and kidney meridians. It nourishes the liver and kidneys, replenishes essence and blood, darkens hair, strengthens tendons and bones, and clears turbidity and lowers lipids. It is used for blood deficiency and chlorosis, dizziness and tinnitus, premature graying of hair, soreness and weakness of the lower back and knees, numbness of the limbs, metrorrhagia and leukorrhea, hyperlipidemia, sores and carbuncles, scrofula, urticaria and itching, chronic malaria with weakness, and constipation due to intestinal dryness.

[0041] *Drynaria fortunei* (literally "Bone-Piercing Drynaria"): Bitter, warm. Enters the liver and kidney meridians. Promotes blood circulation, heals wounds, relieves pain, tonifies the kidneys and strengthens bones; externally used to dispel wind and remove blemishes. Used for falls, sprains, fractures, kidney deficiency causing lower back pain, weakness of muscles and bones, tinnitus, deafness, loose teeth, chronic diarrhea, alopecia areata, and vitiligo.

[0042] Bamboo shavings: Sweet, slightly cold. Enters the lung, stomach, heart, and gallbladder meridians. Clears heat and resolves phlegm, relieves irritability, and stops vomiting. Used for cough with phlegm-heat, phlegm due to gallbladder fire, palpitations, restlessness, and insomnia.

[0043] Sanguisorba officinalis: Bitter, sour, and astringent; slightly cold. It enters the liver and large intestine meridians. It cools the blood and stops bleeding, detoxifies and astringes sores. It is used for bloody stools due to blood heat, hemorrhoidal bleeding, bloody dysentery, metrorrhagia, burns, carbuncles, boils, and eczema.

[0044] Compared with the prior art, the advantages of the present invention are:

[0045] 1. Pharmacokinetic studies have shown that the traditional Chinese medicine composition of this invention has a good therapeutic effect on rats with qi stagnation and blood stasis, can significantly reduce whole blood viscosity (low shear, medium shear, high shear) and plasma viscosity, and has a significant improvement effect on blood rheological parameters of rats with qi stagnation and blood stasis; it has a significant inhibitory effect on the number of torsional responses induced by acetic acid in mice; and it significantly increases the pain threshold of mice.

[0046] 2. Clinical efficacy has proven that patients treated with the herbal composition of this invention showed significant improvement in blood rheology, VAS, and ODI. It is effective in treating lumbar muscle strain, effectively reducing blood rheology, alleviating lower back pain symptoms, improving lumbar mobility, and reducing clinical symptoms. It also has fewer adverse reactions and high safety. The effective rate after clinical treatment can reach over 98%, demonstrating significant effects.

[0047] 3. Repeated-dose toxicity test and single-dose toxicity test of the traditional Chinese medicine composition of the present invention administered orally to rats for 3 months showed that the traditional Chinese medicine composition of the present invention has high safety and no toxic side effects.

[0048] 4. The preparation method of the traditional Chinese medicine composition of the present invention is simple and has a high efficacy rate in clinical trials.

[0049] 5. Compared with the comparative formulation, the drug synergistic effect between the drugs in the traditional Chinese medicine composition of the present invention is stronger and the therapeutic effect is better.

[0050] Through years of tireless efforts and incorporating modern pharmacological research findings, the applicant has conducted extensive clinical and experimental research, accumulating rich experience in treating this condition. Through long-term clinical practice, the applicant has continuously optimized and adjusted the formula, focusing on the core pathological aspects of this type of disease, resulting in a traditional Chinese medicine composition for treating lumbar muscle strain. This formula has proven effective and has a solid foundation for clinical application, benefiting thousands of patients.

[0051] The detailed structure of the present invention will be further described below with reference to the accompanying drawings and specific embodiments. Attached Figure Description

[0052] Figure 1 This is a flowchart of the preparation process of Example 1 of the present invention. Detailed Implementation

[0053] Example 1: A traditional Chinese medicine composition, the raw material formula and proportion are as follows: Clematis chinensis 4 parts by weight, Angelica dahurica 2 parts by weight, Panax notoginseng 2 parts by weight, Angelica sinensis 7 parts by weight, Asarum heterotropoides 4 parts by weight, Lycopodium clavatum 7 parts by weight, Cinnamomum cassia 4 parts by weight, Tetrapanax papyriferus 2 parts by weight, Spatholobus suberectus 4 parts by weight, Salvia miltiorrhiza 2 parts by weight, Acanthopanax senticosus 2 parts by weight, Chaenomeles speciosa 4 parts by weight, Polygonum cuspidatum 2 parts by weight, Prunus persica 2 parts by weight, Curcuma longa 2 parts by weight, Aucklandia lappa 2 parts by weight, Polygonum multiflorum 2 parts by weight, Drynaria fortunei 2 parts by weight, Bambusa textilis 2 parts by weight, Sanguisorba officinalis 2 parts by weight.

[0054] Preparation process: According to the above proportions, Clematis chinensis, Angelica dahurica, and Panax notoginseng are pulverized into fine powder and sterilized by moist heat; Angelica sinensis and Asarum heterotropoides are pulverized into fine powder and sterilized by ethanol moistening; the remaining 15 herbs, including Lycopodium clavatum, Cinnamomum cassia, Tetrapanax papyriferus, Spatholobus suberectus, Salvia miltiorrhiza, Acanthopanax senticosus, Chaenomeles speciosa, Polygonum cuspidatum, Prunus persica, Curcuma longa, Aucklandia lappa, processed Polygonum multiflorum, Drynaria fortunei, Bambusa textilis, and Sanguisorba officinalis, are decocted twice with water. The first time, 14 times the amount of water is added and decocted for 2 hours. The second time, 12 times the amount of water is added and decocted for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.20-1.30 (60℃). The paste is dried, pulverized into fine powder, and then mixed with the above-mentioned fine powders of Clematis chinensis and Angelica sinensis. The mixture is then made into pills, dried, and the final product is obtained.

[0055] Table 1 Detailed Description of Preparation Process

[0056]

[0057]

[0058] Comparative Example 1:

[0059] By weight, the ingredients are: 4 parts Clematis chinensis, 3 parts Angelica dahurica, 3 parts Panax notoginseng, 6 parts Spatholobus suberectus, 2 parts Salvia miltiorrhiza, 2 parts Polygonum cuspidatum, 3 parts Curcuma longa, 3 parts processed Polygonum multiflorum, and 2 parts Drynaria fortunei. Preparation process: According to the above proportions, Clematis chinensis, Angelica dahurica, and Panax notoginseng are pulverized into fine powder and sterilized by moist heat. The remaining Spatholobus suberectus, Salvia miltiorrhiza, Polygonum cuspidatum, Curcuma longa, processed Polygonum multiflorum, and Drynaria fortunei are decocted twice with water. The first time, 14 times the amount of water is added, and the decoction is decocted for 2 hours. The second time, 12 times the amount of water is added, and the decoction is decocted for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.20–1.30 (60℃). The paste is dried, pulverized into fine powder, added to the above fine powder, mixed well, made into pills, and dried to obtain the final product.

[0060] Comparative Example 2:

[0061] By weight, the ingredients are: Clematis chinensis 4 parts, Angelica dahurica 2 parts, Panax notoginseng 2 parts, Angelica sinensis 7 parts, Lycopodium clavatum 7 parts, Cinnamomum cassia 4 parts, Spatholobus suberectus 4 parts, Salvia miltiorrhiza 2 parts, Chaenomeles speciosa 4 parts, Polygonum cuspidatum 2 parts, Prunus persica 2 parts, Curcuma longa 2 parts, Polygonum multiflorum 2 parts, and Drynaria fortunei 2 parts. Preparation process: According to the above proportions, Clematis chinensis, Angelica dahurica, and Panax notoginseng are pulverized into fine powder and sterilized by moist heat; Angelica sinensis is pulverized into fine powder and sterilized by ethanol moistening; the remaining Lycopodium clavatum, Cinnamomum cassia, Spatholobus suberectus, Salvia miltiorrhiza, Chaenomeles speciosa, Polygonum cuspidatum, Prunus persica 2 parts, Curcuma longa, Polygonum multiflorum 2 parts, and Drynaria fortunei are decocted twice with water. The first time, 14 times the amount of water is added and decocted for 2 hours. The second time, 12 times the amount of water is added and decocted for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.20-1.30 (60℃). The paste is dried, pulverized into fine powder, and the above-mentioned fine powders of Clematis chinensis and Angelica sinensis are added, mixed well, made into pills, and dried to obtain the final product.

[0062] Example 2: Single-dose toxicity test of the herbal pills prepared in Example 1 administered orally to rats.

[0063] This study was conducted in accordance with national GLP standards. It observed the acute toxic reactions and mortality of SD rats after three oral administrations of the traditional Chinese medicine composition pills prepared in Example 1 within 24 hours, providing reference data for repeated-dose toxicity tests.

[0064] Forty SPF-grade SD rats (half male and half female) that passed quarantine were used in the experiment. They were housed in cages measuring 475mm × 350mm × 200mm, with five rats per cage. The animals were housed according to the international (GB14925-2010) requirements for SPF-grade laboratory animal environmental conditions, and underwent quarantine and environmental acclimatization for five days. This experiment observed the acute toxicity test response of the traditional Chinese medicine composition pills prepared in Example 1 via oral gavage in SD rats. Forty SD rats (half male and half female), weighing 180.1–198.9g, were randomly divided into two groups according to sex and weight: a blank control group and a group containing the traditional Chinese medicine composition pills prepared in Example 1 (67.8g of medicinal slices / kg), with 20 rats in each group. Before the experiment, the animals were fasted for at least 12 hours but allowed free access to water. Then, they were administered pure water and the traditional Chinese medicine pills prepared in Example 1 via oral gavage at a dose of 20 mL / kg. The administration was repeated three times on the day of administration (with a 6-hour interval between doses). After each administration, the animals were closely observed and recorded for 0-4 hours, noting the characteristics of poisoning, the onset and recovery time of toxic reactions, and mortality. Observations were then conducted twice daily, once in the morning and once in the afternoon, for 14 consecutive days. The animals were weighed before administration and on days 4, 7, 10, and 14 after administration, and changes in weight and mortality were recorded.

[0065] Experimental Results: Effects on general activity, symptoms of poisoning in experimental animals, and mortality: Within 0-4 hours after each oral administration, no significant abnormalities were observed in the spontaneous activity, mental state, and diet of rats in both the blank control group and the group treated with the traditional Chinese medicine composition pills prepared in Example 1. No related toxic reactions or animal deaths were observed. After 14 days of continuous observation following administration, no significant abnormalities were observed in the spontaneous activity, mental state, and diet of rats in both the blank control group and the group treated with the traditional Chinese medicine composition pills prepared in Example 1. No related toxic reactions or animal deaths were observed.

[0066] Effects on body weight: Experimental animals were weighed before administration on the day of administration and on days 4, 7, 10, and 14 after administration. No statistically significant difference in body weight was observed between the group of experimental animals treated with the traditional Chinese medicine pills prepared in Example 1 and the blank control group during the same period, and the weight gain was within the normal range. This indicates that oral administration of the traditional Chinese medicine pills prepared in Example 1 to SD rats had no significant effect on the rats' body weight gain.

[0067] At the end of the experiment, gross anatomical observation of SD rats showed no obvious abnormalities on the surface and cut surfaces of any organs.

[0068] Conclusion: Under the conditions of this experiment, rats were orally administered the traditional Chinese medicine composition pills prepared in Example 1 at a volume of 20 mL / kg, three times a day (with a 6-hour interval between two administrations), with a cumulative dose of 67.8 g of medicinal slices / kg, which is equivalent to 98 times the clinically intended dose per kilogram of body weight for adults. No related toxic reactions or deaths were observed in the experimental animals.

[0069] Table 2. Effects of the traditional Chinese medicine composition pills prepared in Example 1 on the body weight of SD rats (n=20, )

[0070]

[0071] Table 3. Effects of the traditional Chinese medicine composition pills prepared in Example 1 on the body weight of female SD rats (n=10, )

[0072]

[0073] Table 4. Effects of the traditional Chinese medicine composition pills prepared in Example 1 on the body weight of male SD rats (n=10, )

[0074]

[0075] Example 3: Toxicity test of rats after oral administration of the traditional Chinese medicine composition pills prepared in Example 1 for 3 months.

[0076] Objective: This study was conducted in accordance with national GLP standards to observe the toxic reactions of SD rats after oral administration of different doses of the traditional Chinese medicine composition pills prepared in Example 1, and to predict the possible adverse clinical reactions caused by the traditional Chinese medicine composition pills prepared in Example 1. This study aims to provide a reference for the monitoring and treatment of toxic reactions in clinical trials, as well as for clinical trials and clinical drug use.

[0077] Experimental method: Eighty qualified SD rats, half male and half female, weighing 178.5-221.8g and measuring 475×350×200mm, were selected. 3 Five rats were housed in cages. They were raised according to the SPF-grade laboratory animal environmental conditions required by the national standard (GB14925-2010), and underwent quarantine and environmental acclimatization for 7 days. They were randomly divided into four groups according to sex and weight: a blank control group, and low, medium, and high dose groups of the traditional Chinese medicine composition pills prepared in Example 1 (8.52, 16.95, and 33.90 g of medicinal slices / kg, respectively), with 20 animals in each group. All groups received the medication by gavage at a volume of 15 mL / kg for 3 consecutive months, followed by a 2-week recovery period. At the end of the treatment period (week 13) and the end of the recovery period (week 15), 40 rats (half male and half female) were dissected as planned. Examinations included: general clinical observation; weight and food intake measurements; hematological parameters, blood biochemistry, coagulation, and organ coefficient measurements; and histopathological examination.

[0078] Experimental results:

[0079] General clinical observation: During the administration and recovery periods, compared with the control group, no abnormalities related to drug toxicity were observed in the appearance, behavior, secretions and excretions of the animals in each dosage group of the traditional Chinese medicine pills prepared in Example 1. During the experiment, all animals were euthanized as planned, and no abnormal deaths occurred.

[0080] Body weight: Compared with the blank control group at the same time, no abnormalities in body weight of each dose group of the traditional Chinese medicine composition pills prepared in Example 1 were observed that were of toxicological significance.

[0081] Food intake: Compared with the blank control group at the same time, no abnormalities were found in the average food intake of each dose group of the traditional Chinese medicine composition pills prepared in Example 1 that were toxicologically significant.

[0082] Routine hematological examination: Compared with the blank control group at the same time, no abnormalities with toxicological significance were found in the hematological indicators of each dosage group of the traditional Chinese medicine composition pills prepared in Example 1.

[0083] Blood biochemistry tests: Compared with the blank control group at the same time, no abnormalities with toxicological significance were found in the blood biochemistry indicators of each dose group of the traditional Chinese medicine composition pills prepared in Example 1.

[0084] Coagulation test: Compared with the blank control group at the same time, no abnormalities with toxicological significance were found in the coagulation indicators of each dose group of the traditional Chinese medicine composition pills prepared in Example 1.

[0085] Organ coefficient: Compared with the blank control group at the same time, no abnormalities with toxicological significance were found in the organ coefficient index of each dosage group of the traditional Chinese medicine composition pills prepared in Example 1.

[0086] Conclusion: Under the conditions of this experiment, the no obvious adverse reaction dose (NOAEL) of SD rats after oral administration of the traditional Chinese medicine composition pills prepared in Example 1 for 3 months was 33.90 g of medicinal slices / kg (approximately equivalent to 7.8 times (based on body surface area) and 49 times (based on body weight) of the clinically intended dose for a 70 kg adult).

[0087] Table 5. Effects of the traditional Chinese medicine composition pills prepared in Example 1 on animal body weight (g). )

[0088]

[0089]

[0090] Note: There were no statistically significant differences among the dose groups compared with the blank control group.

[0091] Table 6. Effect of the traditional Chinese medicine composition pills prepared in Example 1 on the average feed intake of animals (g / animal / day). )

[0092]

[0093] Note: There were no statistically significant differences among the dose groups compared with the blank control group.

[0094] Table 7. Effects of the traditional Chinese medicine pills prepared in Example 1 on animal hematology.

[0095]

[0096]

[0097] Note: Compared with the blank control group, * P<0.05, ** P<0.01.

[0098] Table 8. Effects of the traditional Chinese medicine pills prepared in Example 1 on animal blood biochemical indicators.

[0099]

[0100]

[0101] Note: Compared with the blank control group, * P<0.05, ** P<0.01.

[0102] Table 9. Effects of the traditional Chinese medicine pills prepared in Example 1 on animal coagulation.

[0103]

[0104] Note: Compared with the blank control group, * P<0.05.

[0105] Table 10. Effects of the traditional Chinese medicine composition pills prepared in Example 1 on animal organ coefficients ( mg / g

[0106]

[0107]

[0108] Note: Compared with the blank control group, ** P<0.01.

[0109] Example 4: Pharmacokinetic Study Data of the Formulation in Example 1

[0110] Experiment 1: Effect of the formulation in Example 1 on a rat model of qi stagnation and blood stasis

[0111] 1. Experimental Objective

[0112] This experiment used a qi stagnation and blood stasis model and administered the herbal composition solutions of Example 1, Comparative Example 1, and Comparative Example 2 to rats by gavage. The effects of the herbal composition solutions of Example 1, Comparative Example 1, and Comparative Example 2 on the blood rheology of rats with qi stagnation and blood stasis were observed, providing a pharmacological basis for clinical application.

[0113] 2.1 Test Materials

[0114] Test substance (test sample): The traditional Chinese medicine composition of Example 1, Comparative Example 1, and Comparative Example 2 (Guyitang (Hunan) Health Technology Co., Ltd.), 1g extract contains 2.51g of raw medicinal materials, ointment, proposed clinical dosage: 48.5g of raw medicinal materials / day, proposed route of administration: oral, one packet at a time, each packet containing 5g (equivalent to 16.17g of raw medicinal materials), three times a day, proposed course of treatment: 1 month, positive control drug, name: Yaoxitong Capsules, specification: 0.3g per capsule, manufacturer: Hebei Wansui Pharmaceutical Co., Ltd., experimental animals: 60 SPF-grade male SD rats, weight range: 180-220g; (Hunan Slack Jingda Experimental Animal Co., Ltd.)

[0115] Main reagent: epinephrine hydrochloride injection, specification: 1mL / vial, manufacturer: Shanghai Quanyu Biotechnology (Zhumadian) Animal Pharmaceutical Co., Ltd.

[0116] 3.1 Test Methods

[0117] Grouping and Dosing

[0118] Sixty qualified SD rats were randomly divided into six groups (n=10 per group) according to sex and weight: a blank control group, a model control group, Example 1 group (4.37 g of medicinal slices / kg), Comparative Example 1 group (4.37 g of medicinal slices / kg), Comparative Example 2 group (4.37 g of medicinal slices / kg), and a positive control group (0.32 g / kg of Yaoxitong capsules). These were equivalent to 1, 1, and 1 times the rat's equivalent dose (calculated based on body surface area), respectively. Except for the blank control group, the other groups underwent modeling using alternating fasting, swimming, and tail clamping stimuli for 28 consecutive days. Drug administration was performed concurrently with modeling, with the corresponding dose administered by gavage at 10 mL / kg. The blank control group received an equal volume of pure water by gavage. Administering drugs once daily. Starting from day 22 of modeling, each model group received a subcutaneous injection of 1 mL / kg of epinephrine hydrochloride after the morning administration of the drug (the blank control group received subcutaneous saline).

[0119] Dosage design of test sample and control sample

[0120] The clinically intended dosage of the traditional Chinese medicine compositions in Example 1, Comparative Examples 1 and 2 was 48.5 g of medicinal slices / day. According to the conversion table of body surface area for equivalent doses between animal species in *Pharmacological Experimental Methodology*, 4th edition, edited by Wei Wei, the equivalent dose for rats was 48.5 g of medicinal slices / day × 0.018 ÷ 0.2 kg = 4.37 g of medicinal slices / kg (adult dose). The clinically intended dosage of Yaoxitong capsules (positive control) was 1.8 g / day, which, converted to the equivalent dose for rats using the body surface area method, was 1.8 × 0.018 ÷ 0.2 = 0.16 g / kg.

[0121] Table 11 Dosage Design for Each Group

[0122]

[0123] Drug preparation:

[0124] Traditional Chinese medicine compositions of Example 1, Comparative Example 1, and Comparative Example 2: Weigh the traditional Chinese medicine compositions of Example 1, Comparative Example 1, and Comparative Example 2, add pure water and stir to mix well, and prepare medicinal solutions of 0.174 g extract / mL, 0.174 g extract / mL, and 0.174 g extract / mL respectively. Take once a day and stir well before use.

[0125] Yaoxitong Capsules (positive control group): Take the contents of Yaoxitong Capsules, add pure water and stir well to prepare a 0.016g / mL solution. Take once a day and stir well before use.

[0126] 4.1 Detection Indicators

[0127] One hour after the last injection of epinephrine hydrochloride, the animals were anesthetized with isoflurane, and blood was collected from the abdominal aorta to determine the hemorheological parameters of the rats.

[0128] Data processing and statistical analysis

[0129] SPSS 16.0 software was used for data analysis. Experimental data are expressed as mean ± standard deviation. This indicates that when comparing multiple groups with homogeneous variances, normality and homogeneity of variance tests are performed. If normality is satisfied (P>0.05), one-way ANOVA is used for statistical analysis, and either LSD+Dunnet (homogeneous variance) or Tamhane's T2 (non-homogeneous variance) is selected for comparison based on the homogeneity of variance. If normality is not satisfied (P<0.05), the Kruskal-Wallis test is used, and pairwise comparisons are performed using the Mann-Whitney test. Statistical results are presented with α=0.05 as the test limit, where P<0.05 is considered statistically significant, and its biological significance is considered during evaluation.

[0130] 5. Experimental Results

[0131] The results are shown in Tables 1-2: Compared with the blank control group, the whole blood viscosity (low shear, medium shear, high shear) and plasma viscosity of rats in the model control group were significantly increased (P<0.05 or P<0.01); compared with the model control group, the whole blood viscosity (low shear, medium shear, high shear) and plasma viscosity of rats in Comparative Example 1, Comparative Example 2, Example 1 and positive control group were significantly decreased (P<0.01); compared with Comparative Example 1, Example 1 had a more obvious effect (P<0.05); compared with Comparative Example 2, Example 1 had a better effect, but there was no significant difference (P>0.05); compared with Comparative Example 2, Comparative Example 2 had a better effect, but there was no significant difference (P>0.05). The results are shown in Table 12.

[0132] Table 12 Effects on acute blood stasis model rats ( n=10)

[0133]

[0134] Note: Compared with the blank control group, "*" indicates P<0.05, and "**" indicates P<0.01; compared with the model control group, " ΔΔ "#" indicates P < 0.01; compared with Comparative Example 1, "#" indicates P < 0.05.

[0135] 6. Experimental Conclusions

[0136] Experimental results showed that under the experimental conditions, when rats with qi stagnation and blood stasis model were administered the doses of Example 1, Comparative Example 1, and Comparative Example 2 (4.37, 4.37, 4.37 g of medicinal slices / kg) and the positive control (Yaoxitong capsules, 0.16 g / kg), whole blood viscosity (low shear, medium shear, and high shear) and plasma viscosity were significantly reduced (P<0.05 or P<0.01). This indicates that Example 1, Comparative Example 1, and Comparative Example 2 have a significant improving effect on the hemorheological parameters of rats with qi stagnation and blood stasis model. Compared with Comparative Example 1 and Comparative Example 2, Example 1 has a better effect.

[0137] Experiment 2 Analgesia Test (Acetic Acid Writhing Test)

[0138] 1. Research Objectives

[0139] This experiment involved administering the traditional Chinese medicine compositions of Example 1, Comparative Examples 1 and 2 to mice via gavage to observe their effects on acetic acid-induced writhing in mice, providing experimental evidence for clinical application.

[0140] 2.1 Test Materials

[0141] Test substance (sample): The traditional Chinese medicine composition of Example 1, Comparative Example 1, and Comparative Example 2 (Guyitang (Hunan) Health Technology Co., Ltd.), 1g extract contains 2.51g of raw medicinal materials, ointment, proposed clinical dosage: 48.5g of raw medicinal materials / day, proposed route of administration: oral, one packet at a time, each packet containing 5g (equivalent to 16.17g of raw medicinal materials), three times a day, proposed course of treatment: 1 month.

[0142] Positive control drug, name: Aspirin enteric-coated tablets, specification: 100 tablets / bottle, manufacturer: Hunan Xinhui Pharmaceutical Co., Ltd.

[0143] Laboratory animals: 50 SPF-grade ICR mice, half male and half female, with a weight range of 18–22g; (Hunan Silek Jingda Laboratory Animal Co., Ltd.)

[0144] Main reagent: Acetic acid, specification: 500mL, manufacturer: Sinopharm Chemical Reagent Co., Ltd.

[0145] 3. Experimental Methods

[0146] Grouping and Dosing

[0147] Fifty qualified ICR mice (half male and half female) were randomly divided into five groups (n=10 per group) according to sex and weight: a blank control group, the dosage groups of Example 1, Comparative Example 1, and Comparative Example 2 (6.31, 6.31, 6.31 g of medicinal slices / kg), and a positive control group (enteric-coated aspirin tablets, 234 mg / kg). These dosages were equivalent to 1, 1, and 1 times the rat equivalent dose (calculated based on body surface area), respectively. Each group was administered the corresponding dose of drug via gavage at 20 mL / kg, while the blank control group was administered an equal volume of purified water via gavage. The drugs were administered once daily for seven consecutive days.

[0148] Dosage setting

[0149] Dosage design of test sample and control sample

[0150] The clinically intended dosage of the traditional Chinese medicine compositions in Example 1, Comparative Examples 1 and 2 is 48.5g of medicinal slices / day, based on the conversion table of equivalent doses and body surface area between animal species in *Pharmacological Experimental Methodology*, 4th edition, edited by Wei Wei.

[0151] The equivalent clinical dose for mice calculated based on body surface area is calculated as follows: Adult dose 48.5g of decoction pieces / day × 0.0026 ÷ 0.02kg = 6.31g of decoction pieces / kg. The proposed clinical dose of enteric-coated aspirin tablets (positive control drug) is 1800mg / day. The equivalent dose for mice calculated based on body surface area is 1800mg × 0.0026 ÷ 0.02 = 234mg / kg, as shown in Table 13.

[0152] Table 13 Experimental Dosage and Group Design

[0153]

[0154] Drug preparation

[0155] Traditional Chinese medicine compositions of Example 1, Comparative Example 1, and Comparative Example 2: Weigh the traditional Chinese medicine compositions of Example 1, Comparative Example 1, and Comparative Example 2, add pure water and stir to mix well, and prepare medicinal solutions of 0.126 g extract / mL, 0.126 g extract / mL, and 0.126 g extract / mL respectively. Take once a day and stir well before use.

[0156] Aspirin enteric-coated tablets (positive control group): Grind aspirin enteric-coated tablets into powder, weigh the powder, add pure water and stir well to prepare a solution of 11.7 mg / mL. Take once a day and stir well before use.

[0157] 4. Detection indicators

[0158] Thirty minutes after the last administration, mice in each group were intraperitoneally injected with 0.6% acetic acid saline at a dose of 0.1 mL / 10 g. The number of writhing responses (abdominal contraction and inward concavity, extension of hind limbs, raising of buttocks, accompanied by peristalsis) in mice within 15 minutes after the injection of acetic acid was observed and recorded.

[0159] Data processing and statistical analysis

[0160] SPSS 16.0 software was used for statistical analysis. Experimental data are expressed as mean ± standard deviation (x ± s). Normality and homogeneity of variance tests were performed when comparing multiple groups to ensure homogeneity of variance. If normality was satisfied (P > 0.05), one-way ANOVA was used for statistical analysis, and LSD+Dunnet (homogeneous variance) or Tamhane's T2 (non-homogeneous variance) was selected for comparison based on the homogeneity of variance. If normality was not satisfied (P < 0.05), the Kruskal-Wallis test was used, and the Mann-Whitney test was used for pairwise comparisons. The statistical results were set with α = 0.05 as the test limit, where P < 0.05 was considered statistically significant, and its biological significance was considered during evaluation.

[0161] 5. Experimental Results

[0162] The results are shown in Table 3-2: Compared with the blank control group, the number of writhing movements in mice in each drug administration group was significantly reduced (P<0.01); Compared with Comparative Example 1 and Comparative Example 2, Example 1 showed a more significant effect (P<0.05 or P<0.01); Compared with Comparative Example 1, Comparative Example 2 showed a more significant effect (P<0.05). The results are shown in Table 14.

[0163] Table 14 Effects on the number of writhing movements in mice ( n=10)

[0164]

[0165] Note: Compared with the blank control group, "**" indicates P<0.01; compared with Comparative Example 1, "#" indicates P<0.05, "##" indicates P<0.01; compared with Comparative Example 2, "▲" indicates P<0.05.

[0166] 6. Experimental Conclusions

[0167] Under the conditions of this experiment, ICR mice were administered Example 1, Comparative Example 1, Comparative Example 2, and a positive control by gavage. The number of writhing movements in the mice was significantly reduced, indicating that Example 1, Comparative Example 1, and Comparative Example 2 had an inhibitory effect on the number of writhing responses induced by acetic acid in mice. Compared with Comparative Example 1 and Comparative Example 2, the effect of Example 1 was more significant (P<0.05 or P<0.01).

[0168] Experiment 3 Analgesia Test (Hot Plate Test)

[0169] 1. Research Objectives

[0170] This experiment involved administering the traditional Chinese medicine compositions of Example 1, Comparative Examples 1 and 2 to mice via gavage to observe their effects on hot plate-induced pain in mice, providing experimental evidence for clinical application.

[0171] 2.1 Test Materials

[0172] Test substance (sample): The traditional Chinese medicine composition of Example 1, Comparative Example 1, and Comparative Example 2 (Guyitang (Hunan) Health Technology Co., Ltd.), 1g extract contains 2.51g of raw medicinal materials, ointment, proposed clinical dosage: 48.5g of raw medicinal materials / day, proposed route of administration: oral, one packet at a time, each packet containing 5g (equivalent to 16.17g of raw medicinal materials), three times a day, proposed course of treatment: 1 month.

[0173] Positive control drug, name: Aspirin enteric-coated tablets, specification: 100 tablets / bottle, manufacturer: Hunan Xinhui Pharmaceutical Co., Ltd.

[0174] Laboratory animals: 50 SPF-grade female ICR mice, weighing between 18 and 22 g; (Hunan Silek Jingda Laboratory Animal Co., Ltd.)

[0175] 3. Experimental Methods

[0176] Grouping and Dosing

[0177] ICR female mice that passed quarantine were selected. The pain threshold (time from placement on a hot plate to licking the hind paw) of each female mouse was measured and recorded twice. Mice that frequently jumped were excluded. The interval between each measurement was at least 5 minutes. Fifty female mice with an average pain threshold of 5-30 seconds were selected and randomly divided into 5 groups of 10 mice each, according to their body weight: a blank control group, comparative example 1, comparative example 2, the dosage group of Example 1 (6.31, 6.31, 6.31 g of medicinal material / kg), and a positive control group (enteric-coated aspirin tablets, 234 mg / kg). These dosages were equivalent to 1, 1, and 1 times the effective dose (calculated based on body surface area) for mice, respectively. Each group was administered the corresponding dose of drug by gavage at 20 mL / kg. The blank control group was administered an equal volume of pure water by gavage. The drugs were administered once daily for 7 consecutive days. The pain threshold of each mouse was measured and recorded at 30 min, 1 h, and 2 h after the last administration.

[0178] Dosage setting

[0179] Dosage design of test sample and control sample

[0180] The clinically intended dosage of the traditional Chinese medicine compositions in Example 1, Comparative Examples 1 and 2 is 48.5g of medicinal slices / day, based on the conversion table of equivalent doses and body surface area between animal species in *Pharmacological Experimental Methodology*, 4th edition, edited by Wei Wei.

[0181] The equivalent clinical dose for mice calculated based on body surface area is calculated as follows: Adult dose 48.5g of decoction pieces / day × 0.0026 ÷ 0.02kg = 6.31g of decoction pieces / kg. The proposed clinical dose of enteric-coated aspirin tablets (positive control drug) is 1800mg / day. The equivalent dose for mice calculated based on body surface area is 1800mg × 0.0026 ÷ 0.02 = 234mg / kg, as shown in Table 15.

[0182] Table 15 Experimental Dosage and Group Design

[0183]

[0184] Drug preparation

[0185] Traditional Chinese medicine compositions of Example 1, Comparative Example 1, and Comparative Example 2: Weigh the traditional Chinese medicine compositions of Example 1, Comparative Example 1, and Comparative Example 2, add pure water and stir to mix well, and prepare medicinal solutions of 0.126 g extract / mL, 0.126 g extract / mL, and 0.126 g extract / mL respectively. Take once a day and stir well before use.

[0186] Aspirin enteric-coated tablets (positive control group): Grind aspirin enteric-coated tablets into powder, weigh the powder, add pure water and stir well to prepare a solution of 11.7 mg / mL. Take once a day and stir well before use.

[0187] 4 detection indicators

[0188] The pain threshold of each mouse was measured at 30 min, 1 h and 2 h after the last administration.

[0189] Data processing and statistical analysis

[0190] SPSS 16.0 software was used for data analysis. Experimental data are expressed as mean ± standard deviation. This indicates that when comparing multiple groups with homogeneous variances, normality and homogeneity of variance tests are performed. If normality is satisfied (P>0.05), one-way ANOVA is used for statistical analysis, and either LSD+Dunnet (homogeneous variance) or Tamhane's T2 (non-homogeneous variance) is selected for comparison based on the homogeneity of variance. If normality is not satisfied (P<0.05), the Kruskal-Wallis test is used, and pairwise comparisons are performed using the Mann-Whitney test. Statistical results are presented with α=0.05 as the test limit, where P<0.05 is considered statistically significant, and its biological significance is considered during evaluation.

[0191] 5. Experimental Results

[0192] The results are shown in Table 16: Compared with the blank control group, 30 min after the last administration, the pain threshold of mice in Example 1 was significantly increased (P<0.05); 1 h after the last administration, the pain threshold of mice in Example 1, Comparative Example 2, and the positive control group was significantly or substantially increased (P<0.05 or P<0.01); 2 h after administration, the pain threshold of mice in Example 1, Comparative Example 1, Comparative Example 2, and the positive control group was significantly or substantially increased (P<0.05 or P<0.01); the pain threshold of mice in other administration groups increased at all time points after administration, but no statistical difference was observed; 1 h after the last administration, there was a statistical difference between Example 1 and Comparative Example 1 and Comparative Example 2 (P<0.05 or P<0.01), and between Example 2 and Comparative Example 1 (P<0.05); 2 h after the last administration, there was a statistical difference between Example 1 and Comparative Example 1 and Comparative Example 2 (P<0.05).

[0193] Table 16 Effects on pain threshold in mice ( n=10)

[0194]

[0195] Note: Compared with the blank control group, "*" indicates P<0.05, "**" indicates P<0.01; compared with Comparative Example 1, "#" indicates P<0.05; compared with Comparative Example 2, "▲" indicates P<0.05.

[0196] 6. Experimental Conclusions

[0197] Under the conditions of this experiment, ICR mice were administered via gavage to Example 1, Comparative Example 1, and Comparative Example 2 (6.31, 6.31, 6.31 g of medicinal slices / kg), and the positive control group (enteric-coated aspirin tablets, 234 mg / kg). The pain threshold of the mice increased in all cases, with statistically significant differences at some time points. Compared with Comparative Example 1 and Comparative Example 2, Example 1 showed better efficacy.

[0198] Example 4: Clinical analysis data of the traditional Chinese medicine composition of Example 1 of this invention

[0199] 144 patients with lumbar muscle strain (blood stasis type) were selected for observation and randomly divided into Example 1 and a control group. Example 1 included 42 male and 30 female patients, aged 28–67 years (mean age 58.22±7.35 years), with a disease duration of 5 months–8 years (mean 4.76±1.45 years). The control group included 39 male and 33 female patients, aged 26–65 years (mean age 56.28±6.85 years), with a disease duration of 7 months–9 years (mean 4.51±1.37 years). There were no significant differences in age and disease duration between the two groups (P>0.05).

[0200] The diagnostic criteria meet the diagnostic criteria for chronic lumbar muscle strain in the "Latest Diagnosis and Treatment of Low Back and Leg Pain"; and meet the diagnostic criteria for blood stasis syndrome in the "Traditional Chinese Medicine Diagnosis and Treatment Plan for 104 Diseases in 24 Specialties": stabbing pain in the lower back, with a fixed location, mild pain making it difficult to bend forward or backward, and severe pain preventing turning over, aversion to pressure, purplish-dark tongue, and wiry pulse.

[0201] Inclusion criteria include meeting the diagnostic criteria for "lumbar muscle strain" and the syndrome differentiation criteria for "blood stasis type"; being aged 25-70 years with a disease duration of 1-8 years; not having an allergic constitution; having no coagulation system diseases; having a pain visual analog scale (VAS) score ≥3 points; and being able to cooperate with relevant intervention measures and complete various examinations.

[0202] Women who are breastfeeding or pregnant are excluded; those with lumbar disc herniation, lumbar transverse process syndrome or other low back pain conditions; those with low back pain caused by chronic pelvic inflammatory disease, chronic prostatitis or other conditions; those with severe organ dysfunction; and those with mental disorders.

[0203] The efficacy evaluation criteria were based on the relevant standards in the "Traditional Chinese Medicine Diagnosis and Treatment Plan for 104 Diseases in 24 Specialties," and were assessed according to the patient's scores before and after treatment. Cure: All lower back pain symptoms disappeared, lumbar function returned to its physiological state, and the improvement rate was [missing information].

[0204] ≥75%; Markedly effective: Most lower back pain symptoms disappear, lumbar mobility is basically normal, improvement rate ≥50%, and <75%; Effective: Lower back pain symptoms are reduced, lumbar mobility is improved, improvement rate ≥25%, and <50%; Ineffective: Lower back pain symptoms and mobility do not show significant improvement, improvement rate <25%. Effective rate = (Cure + Markedly effective + Effective) ÷ Total number of cases × 100%.

[0205] Pain score: The Visual Analogue Scale (VAS) was used to assess pain intensity, with scores ranging from 0 to 10. 0 represents no pain, and 10 represents the most severe pain. Higher scores indicate more severe pain. Lumbar spine dysfunction score: The Oswestry Disability Index (ODI) questionnaire was used to assess lumbar spine dysfunction. It consists of 10 items with a maximum score of 50. Higher scores indicate more severe lumbar spine dysfunction. Fasting venous blood samples were collected from both groups of patients before and after treatment to measure plasma viscosity, erythrocyte aggregation index, platelet aggregation rate (PAG), and fibrinogen (Fib) levels.

[0206] Treatment

[0207] The control group was given oral etoricoxib (0.1g x 10 tablets, Jiangsu Hengrui Medicine Co., Ltd.), one tablet twice a day; the traditional Chinese medicine group was given the traditional Chinese medicine composition in Example 1, one sachet, 5g per sachet (equivalent to 16.17g of decoction pieces), three times a day; both groups of patients were treated continuously for one month.

[0208] Statistical methods: SPSS 16.0 statistical software was used for data processing and analysis in this study. The t-test was used to compare continuous data, and the chi-square test was used to compare categorical data. P < 0.05 was considered statistically significant.

[0209] Table 17. VAS, ODI scores, and TCM clinical symptom scores of patients in the two groups before and after treatment.

[0210]

[0211] Note: Compared with pre-treatment levels in this group, "*" indicates P<0.05, and "**" indicates P<0.01; compared with the control group after treatment, "#" indicates P<0.05.

[0212] Table 18 Comparison of blood rheology between the two groups of patients

[0213]

[0214] Note: Compared with pre-treatment levels in this group, "*" indicates P<0.05, and "**" indicates P<0.01; compared with the control group after treatment, "#" indicates P<0.05.

[0215] Table 19 Comparison of treatment efficacy between the two groups of patients [cases (%), number outside parentheses is the total number of patients, percentage inside parentheses]

[0216]

[0217] Note: Compared with the control group, "*" indicates P<0.05

[0218] Table 20 Comparison of adverse reaction incidence between the two groups of patients [n(%)]

[0219]

[0220] Note: Compared with the control group, "*" indicates P<0.05

[0221] Example 1 group showed significantly better efficacy than the control group: Comparison of blood rheology, VAS, and ODI before and after treatment in both groups showed improvement (P<0.05 or P<0.01), with Example 1 group showing significantly better efficacy than the control group (P<0.05). Example 1 group also had a lower adverse reaction rate than the control group (P<0.05). This indicates that Example 1 is more effective in treating lumbar muscle strain, effectively reducing blood rheology, alleviating low back pain symptoms, improving lumbar mobility, reducing clinical symptoms, and exhibiting fewer adverse reactions and higher safety.

[0222] Example 5

[0223] A traditional Chinese medicine composition for treating lumbar muscle strain, comprising the following raw material ratios: Clematis chinensis 6 parts by weight, Angelica dahurica 3 parts by weight, Panax notoginseng 3 parts by weight, Angelica sinensis 8 parts by weight, Asarum heterotropoides 6 parts by weight, Lycopodium clavatum 8 parts by weight, Cinnamomum cassia 6 parts by weight, Tetrapanax papyriferus 3 parts by weight, Spatholobus suberectus 6 parts by weight, Salvia miltiorrhiza 2 parts by weight, Acanthopanax senticosus 2 parts by weight, Chaenomeles speciosa 4 parts by weight, Polygonum cuspidatum 2 parts by weight, Prunus persica 3 parts by weight, Curcuma longa 3 parts by weight, Aucklandia lappa 3 parts by weight, Polygonum multiflorum 3 parts by weight, Drynaria fortunei 2 parts by weight, Bambusa textilis 2 parts by weight, and Sanguisorba officinalis 2 parts by weight. Prepared according to the method of Example 1. Experiments have shown no toxic side effects and it can treat lumbar muscle strain. Specific experimental data are similar to those in Example 1 and will not be repeated here.

[0224] The above description is a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and concept of the present invention, should be covered within the scope of protection of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating lumbar muscle strain, characterized in that, The raw material formula and proportions are as follows: Clematis chinensis 3-6 parts by weight, Angelica dahurica 1-3 parts by weight, Panax notoginseng 1-3 parts by weight, Angelica sinensis 5-8 parts by weight, Asarum heterotropoides 3-6 parts by weight, Lycopodium clavatum 5-8 parts by weight, Cinnamomum cassia 3-6 parts by weight, Tetrapanax papyriferus 1-3 parts by weight, Spatholobus suberectus 3-6 parts by weight, Salvia miltiorrhiza 1-3 parts by weight, Acanthopanax senticosus 1-3 parts by weight, Chaenomeles speciosa 3-6 parts by weight, Polygonum cuspidatum 1-3 parts by weight, Prunus persica 1-3 parts by weight, Curcuma longa 1-3 parts by weight, Aucklandia lappa 1-3 parts by weight, Polygonum multiflorum 1-3 parts by weight, Drynaria fortunei 1-3 parts by weight, Bambusa textilis 1-3 parts by weight, and Sanguisorba officinalis 1-3 parts by weight.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw material formula and proportions are as follows: Clematis chinensis 4 parts by weight, Angelica dahurica 2 parts by weight, Panax notoginseng 2 parts by weight, Angelica sinensis 7 parts by weight, Asarum heterotropoides 4 parts by weight, Lycopodium clavatum 7 parts by weight, Cinnamomum cassia 4 parts by weight, Tetrapanax papyriferus 2 parts by weight, Spatholobus suberectus 4 parts by weight, Salvia miltiorrhiza 2 parts by weight, Acanthopanax senticosus 2 parts by weight, Chaenomeles speciosa 4 parts by weight, Polygonum cuspidatum 2 parts by weight, Prunus persica 2 parts by weight, Curcuma longa 2 parts by weight, Aucklandia lappa 2 parts by weight, Polygonum multiflorum 2 parts by weight, Drynaria fortunei 2 parts by weight, Bambusa textilis 2 parts by weight, and Sanguisorba officinalis 2 parts by weight.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw material formula and proportions are as follows: Clematis chinensis 6 parts by weight, Angelica dahurica 3 parts by weight, Panax notoginseng 3 parts by weight, Angelica sinensis 8 parts by weight, Asarum heterotropoides 6 parts by weight, Lycopodium clavatum 8 parts by weight, Cinnamomum cassia 6 parts by weight, Tetrapanax papyriferus 3 parts by weight, Spatholobus suberectus 6 parts by weight, Salvia miltiorrhiza 2 parts by weight, Acanthopanax senticosus 2 parts by weight, Chaenomeles speciosa 4 parts by weight, Polygonum cuspidatum 2 parts by weight, Prunus persica 3 parts by weight, Curcuma longa 3 parts by weight, Aucklandia lappa 3 parts by weight, Polygonum multiflorum 3 parts by weight, processed Polygonum multiflorum 3 parts by weight, Drynaria fortunei 2 parts by weight, Bambusa textilis 2 parts by weight, and Sanguisorba officinalis 2 parts by weight.

4. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: (1) Grind Clematis chinensis, Angelica dahurica and Panax notoginseng into fine powder, sterilize with moist heat to obtain fine powder A; (2) Angelica sinensis and Asarum heterotropoides are crushed, then sterilized by soaking in ethanol to obtain fine powder B; (3) The remaining 15 herbs, including *Shenjincao*, *Guizhi*, *Tongcao*, *Jixueteng*, *Danshen*, *Wujiapi*, *Mugua*, *Huzhang*, *Tuotaoren*, *Yujin*, *Muxiang*, *Zhiheshouwu*, *Tanggusuibu*, ​​*Zhuru*, and *Diyu*, are decocted 2-3 times with water. The first time, 14-15 times the amount of water is added and the decoction is decocted for 2-3 hours. The second time, 12-14 times the amount of water is added and the decoction is decocted for 1-2 hours. The decoctions are combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.20-1.30 at 60°C. The paste is dried, pulverized into fine powder C, and then mixed with the above fine powder A and fine powder B.

5. The method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, The moist heat sterilization is controlled at 121℃-125℃ for 15-20 minutes.

6. The method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, The ethanol-based sterilization process uses 65%-75% ethanol, with an amount accounting for 25%-30% of the weight of Angelica sinensis and Asarum heterotropoides, and a soaking time of 3-4 hours.

7. The method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, The moisture content of fine powder A and fine powder B is <7%, and the moisture content of fine powder C is <6%.

8. The method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, The particle size of fine powder A, fine powder B and fine powder C is 80-100 mesh.

9. The method for preparing the traditional Chinese medicine composition according to any one of claims 4-8, characterized in that, The pharmaceutical composition is prepared into pills, ointments or tablets using conventional existing methods.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-3 and the traditional Chinese medicine composition prepared by the method according to claims 4-9 in the preparation of a medicament for treating lumbar muscle strain.

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