A traditional Chinese medicine composition, preparation and preparation method for treating lumbago

Abstract

The application discloses a traditional Chinese medicine composition for treating lumbago, a preparation and a preparation method. The traditional Chinese medicine composition comprises peach kernel, Sanqi, frankincense, myrrh, safflower, dragon's blood, native copper, human hair, rhizoma sparganii, kochia sieboldii, croton tiglium, radix et rhizoma rhei, sweet cinnamon, radix styrax, cassia, fennel, radix angelicae pubescentis, radix et rhizoma aconiti, elder, radix aconiti, kaempferia rotunda, radix puerariae, radix bupleuri, radix angelicae sinensis, apricot kernel, white mustard seed, rhizoma arisaematis, pinellia ternata, scorpion, gastrodia elata, centipede, borneol, schisandra chinensis, sesame oil, zhangdan and old vinegar. The traditional Chinese medicine composition is prepared into a paste, is externally attached to a lumbago part, can eliminate the edema of the lumbar soft tissue of the governed area caused by the intervertebral disc herniation and the like, improves the pain symptom of the lumbar part, and effectively improves the life quality of patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions, and in particular to a traditional Chinese medicine composition, preparation, and preparation method for treating lower back pain. Background Technology

[0002] Lower back pain refers to pain along the lower rib cage, in the lumbosacral and sacroiliac regions, sometimes accompanied by radiating pain in the lower limbs. Lower back pain is commonly caused by acute or chronic muscle injuries in the lower back, or by conditions such as herniated discs or spinal stenosis. It can also be caused by diseases of nearby internal organs, such as kidney stones. Lower back pain is a prevalent health problem among adults, with an incidence rate as high as 84%, and it shows an increasing trend year by year. In September 2017, the international authoritative journal *The Lancet* reported that with changes in living and working environments and the accelerated pace of society, the incidence of lower back pain increased by 18% between 2006 and 2016.

[0003] Lower back pain is not a disease in itself, but rather a group of symptoms with complex causes. Among the many diseases that cause lower back pain, some still have unknown causes. Common causes include fatigue, injury, local inflammation, and deformities. Certain primary diseases, such as nutritional and metabolic disorders, and tumors, can also present with lower back pain. Treatment for lower back pain should be determined based on the specific cause. Patients with acute lumbar strains or sprains generally do not require medication or surgery and can recover gradually with home treatment and rest. When the pain is more pronounced, appropriate medications can be taken under the guidance of a doctor to relieve symptoms. In addition, traditional therapies such as massage, cupping, and traditional Chinese medicine can also be effective for lower back pain. For those who do not respond to conservative treatment, doctors will develop a treatment plan based on the individual patient's condition, and surgery may be recommended if necessary. Persistent or recurrent severe lower back pain can lead to motor dysfunction and even loss of self-care ability. The vast majority of patients can achieve clinical symptom relief and functional improvement with conservative treatment, but the recurrence rate is high, reaching as high as 24% to 33%. Therefore, the inventors believe that it is of great significance to develop a traditional Chinese medicine composition for treating lower back pain to assist conventional treatments for lower back pain, thereby improving the current treatment effect and ultimately improving the quality of life of patients. Summary of the Invention

[0004] In order to solve the above-mentioned technical problems, the present invention provides a traditional Chinese medicine composition, preparation and preparation method for treating low back pain.

[0005] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating lower back pain, which is achieved by the following technical solution.

[0006] A traditional Chinese medicine composition for treating lower back pain, comprising the following raw materials in parts by weight:

[0007] Angelica pubescens 4-6 parts, peach kernel 2-3 parts, Lycopus lucidus 1-3 parts, kudzu root 1-3 parts, Phellodendron bark 2-3 parts, Sambucus chinensis 4-6 parts, Schisandra chinensis 3-4 parts, Gastrodia elata 2-3 parts, Panax notoginseng 2-3 parts, Aconitum carmichaelii 2-3 parts, Kaempferia galanga 6-8 parts, white mustard seed 3-4 parts, Croton tiglium 0.5-1.5 parts, star anise 2-3 parts, human hair 0.5-1.5 parts, Sparganium stoloniferum 3-4 parts, centipede 1-2 parts, apricot kernel 2-3 parts, rhubarb 3-4 parts, Euphorbia kansui 2-3 parts 1 part each of Aconitum carmichaelii, Citrus aurantium, Citrus aurantium, Scorpio, Arisaema heterophyllum, Pepper, Pinellia ternata, Nardostachys jatamansi, Angelica dahurica, Syzygium aromaticum, Cinnamomum cassia, Cinnamomum cassia, Boswellia carterii, Commiphora myrrha, Carthamus tinctorius, Draconis draco, Pyrite, Borneol, Sesame oil, Litharge, Litharge, and Aged vinegar.

[0008] Preferably, a traditional Chinese medicine composition for treating lower back pain comprises the following raw materials in parts by weight: Angelica pubescens 5 parts, peach kernel 2.5 parts, Lycopus lucidus 2 parts, kudzu root 2 parts, Phellodendron bark 2.5 parts, Sambucus chinensis 5 parts, Schisandra chinensis 3.5 parts, Gastrodia elata 2.5 parts, Panax notoginseng 2.5 parts, Aconitum carmichaelii 2.5 parts, Kaempferia galanga 7 parts, white mustard seed 3.5 parts, Croton tiglium 0.75 parts, star anise 2.5 parts, human hair 1 part, Sparganium stoloniferum 3.5 parts, centipede 1.5 parts, and apricot kernel. 2.5 parts, rhubarb 3.5 parts, euphorbia kansui 2.5 parts, aconite 1.5 parts, immature bitter orange 2.5 parts, scorpion 1.5 parts, arisaema 1.5 parts, pepper 2.5 parts, pinellia 2.5 parts, nardostachys 1.5 parts, angelica dahurica 7 parts, clove 1 part, cinnamon 3 parts, frankincense 5.5 parts, myrrh 5.5 parts, safflower 12.5 parts, dragon's blood 2 parts, natural copper 1.5 parts, borneol 1 part, sesame oil 20 parts, cinnamon 4.5 parts, aged vinegar 100 parts.

[0009] Traditional Chinese medicine believes that "pain indicates obstruction, and cold causes contraction," and the key to relieving pain lies in "unblocking and warming." This formula is based on this principle, using thirty-nine ingredients including peach kernel, Panax notoginseng, frankincense, myrrh, safflower, dragon's blood, natural copper, human hair, Sparganium, Euphorbia kansui, croton seed, rhubarb, Nardostachys chinensis, Phellodendron amurense, Lycopus lucidus, Citrus aurantium, pepper, clove, cinnamon, fennel, Angelica pubescens, Aconitum carmichaelii, Sambucus chinensis, Aconitum kusnezoffii, Kaempferia galanga, Pueraria lobata, Angelica dahurica, apricot kernel, white mustard seed, Arisaema heterophyllum, Pinellia ternata, scorpion, Gastrodia elata, centipede, borneol, Schisandra chinensis, sesame oil, cinnamon, and aged vinegar. It has the effects of promoting blood circulation and removing blood stasis, promoting diuresis and reducing swelling, and warming and dispersing stagnation. It is suitable for pain caused by acute and chronic lumbar muscle injuries or lumbar disc herniation, lumbar spinal stenosis, and other lesions.

[0010] The formula uses Angelica pubescens and Sambucus as the principal herbs. Angelica pubescens is pungent and warm, and is good at treating lower back and knee pain caused by wind, cold and dampness. Sambucus is an important herb for promoting blood circulation and healing injuries, and has the functions of dispelling wind and dampness, promoting blood circulation and stopping bleeding. Angelica pubescens combined with Sambucus can dispel wind and dampness, dredge the meridians, and have a strong analgesic effect. The formula is composed of Aconitum carmichaelii, Aconitum kusnezoffii, Kaempferia galanga, Prunus persica, Panax notoginseng, Boswellia carterii, Commiphora myrrha, Carthamus tinctorius, Dragon's blood, natural copper, human hair, and Sparganium stoloniferum as assistant herbs. Among them, Aconitum carmichaelii dispels wind and dampness, relieves pain, and is good at treating muscle spasms and joint stiffness; Kaempferia galanga warms the middle jiao, removes dampness, and relieves pain; Prunus persica and Panax notoginseng resolve blood stasis, stop bleeding, reduce swelling, and relieve pain; Carthamus tinctorius, Commiphora myrrha, and Boswellia carterii are excellent for treating muscle injuries, with the functions of promoting blood circulation, removing blood stasis, relaxing muscles and tendons, reducing swelling, and relieving pain, and are suitable for pain caused by stagnation of qi and blood; Dragon's blood promotes blood circulation, relieves pain, resolves blood stasis, stops bleeding, promotes tissue regeneration, and heals sores; Natural copper, human hair, and Sparganium stoloniferum break up blood stasis, promote qi circulation, eliminate stagnation, and relieve pain. The above twelve herbs assist the principal herbs in benefiting blood vessels and reducing swelling and pain, and also dispel wind and dampness to relieve pain. Scorpion, centipede, and gastrodia elata relieve wind, stop spasms, unblock meridians, and relieve pain; apricot kernel, arisaema, and pinellia resolve phlegm and dissipate nodules; euphorbia kansui, croton seed, rhubarb, nardostachys chinensis, phellodendron bark, and eupatorium fortunei promote diuresis and reduce swelling; immature bitter orange, pepper, clove, cinnamon, and fennel warm and unblock the meridians; kudzu root and angelica dahurica relieve exterior syndromes and dispel cold; schisandra chinensis astringes, consolidates, replenishes qi, and generates fluids. These twenty herbs assist the principal herb in enhancing its effects of warming the middle jiao, reducing swelling, dissipating nodules, and relieving pain, serving as adjuvant herbs. White mustard seed dissipates nodules and reduces swelling; borneol, a crystal of borneol, effectively penetrates the meridians, dissipates pain, and serves as guiding herbs, directing the medicine directly to the affected area and enhancing the efficacy of the other herbs. In summary, the formula is rationally formulated and appropriately used, achieving the effects of promoting blood circulation, removing blood stasis, promoting diuresis, reducing swelling, warming and unblocking, and dissipating nodules. It is an excellent external formula for relieving pain, reducing swelling, and dissipating nodules.

[0011] Secondly, the present invention provides a traditional Chinese medicine preparation for treating lower back pain, which is achieved by the following technical solution.

[0012] A pharmaceutically acceptable preparation made from the above-mentioned traditional Chinese medicine composition.

[0013] Furthermore, the preparation is a plaster.

[0014] Thirdly, the present invention provides a method for preparing a traditional Chinese medicine preparation for treating lower back pain, which is achieved by the following technical solution.

[0015] A method for preparing the above-mentioned formulation includes the following steps:

[0016] S1. Preparation of Clear Oil Ointment: Circulate a specified amount of raw sesame oil at 310℃~330℃ for 40~60 hours until the raw sesame oil turns reddish-black. After cooling, take half the amount of cooked sesame oil, heat it to 310℃~330℃ and then stop heating. Add a specified amount of Zhangdan (a type of medicinal ingredient), stir for 10~15 minutes, and when there is no smoke, pour the mixture of the two ingredients into water. After cooling and solidification, remove the water to obtain clear oil ointment.

[0017] S2. Preparation method of vinegar extract: Place the specified amounts of Angelica pubescens, peach kernel, Lycopus lucidus, Pueraria lobata, Phellodendron chinense, Sambucus chinensis, Schisandra chinensis, Gastrodia elata, Panax notoginseng, Aconitum carmichaelii, Kaempferia galanga, Sinapis alba, Croton tiglium, Illicium verum, human hair, Sparganium stoloniferum, Scolopendra subspinipes, apricot kernel, rhubarb, Euphorbia kansui, Aconitum carmichaelii, Citrus aurantium, and scorpion into the specified amount of aged vinegar, seal the container and soak for 5 to 7 months, then open the container, filter, concentrate the filtrate, cool it, and filter it again to obtain vinegar extract;

[0018] S3. Preparation of fine powder: Take the specified amounts of Arisaema heterophyllum, pepper, Pinellia ternata, Nardostachys jatamansi, Angelica dahurica, clove, cinnamon, frankincense, myrrh, safflower, dragon's blood, and natural copper, grind them into a fine powder of 100 mesh, and mix them thoroughly to obtain the powder.

[0019] S4. Preparation of finished plaster: Take the clear oil ointment, crush it, heat and melt it, add vinegar extract, melt until it clumps, stir thoroughly, cool to 65℃~75℃, add group powder, stir thoroughly, cool to 55℃~65℃, add borneol, stir evenly, spread it on cloth or paper to make a back pain plaster, pack it into a bag and seal it to get the finished product.

[0020] Furthermore, in step S4, the mass ratio of the clear oil extract, vinegar extract, and powder is (12.8–19.2):(0.4–0.6):(1.2–1.8).

[0021] This application has the following beneficial effects.

[0022] (1) The prescription of this invention uses aged vinegar. Since vinegar contains acetic acid, it has an astringent effect, which can not only inhibit bacterial growth but also kill bacteria. At the same time, the prescription herbs are soaked in aged vinegar for 5 to 7 months, which can dissolve their fat-soluble and water-soluble active ingredients, thus increasing the efficacy of this ointment.

[0023] (2) The plaster of this invention has a dark brown surface, an oily and delicate texture, and is suitable for all ages. It has the effects of reducing swelling, relieving pain, promoting blood circulation, removing blood stasis, dispelling wind and dampness, and promoting tissue regeneration. It is used as an adjunct treatment for lower back pain symptoms, and can eliminate edema of the soft tissues in the lumbar region caused by herniated discs and other reasons, thereby improving lower back pain symptoms. Attached Figure Description

[0024] Figure 1 This is a comparison chart of the overall therapeutic effects of the treatment group and the control group of this invention;

[0025] Figure 2 This is a comparison chart of the lumbar spine comprehensive scores of the treatment group and the control group of this invention. Detailed Implementation

[0026] The present patent application will be further described below with reference to the embodiments.

[0027] Unless otherwise specified, the experimental methods used in the following preparation examples and embodiments are conventional methods; the materials and reagents used in the following preparation examples and embodiments are commercially available unless otherwise specified.

[0028] Example

[0029] A plaster for treating lower back pain is prepared as follows:

[0030] ① Preparation of clear oil paste: Place 20kg of raw sesame oil in an iron pot, circulate the oil using a hydraulic pump, heat at 320℃ until the color turns reddish-black, about 48 hours, then cool it down and pump it into a storage tank for later use; take 10kg of cooked sesame oil from the above storage tank, put it into the iron pot, heat it to 320℃, stop heating, add 4.5kg of cinnabar, stir for 15 minutes, and when there is no smoke, pour it into a box containing cold water to remove the fire toxicity. After cooling and solidification, remove the water to obtain clear oil paste;

[0031] ② Preparation method of vinegar extract: Place 5kg of Angelica pubescens, 2.5kg of peach kernel, 2kg of Lycopus lucidus, 2kg of Pueraria lobata, 2.5kg of Phellodendron chinense, 5kg of Sambucus chinensis, 3.5kg of Schisandra chinensis, 2.5kg of Gastrodia elata, 2.5kg of Panax notoginseng, 2.5kg of Aconitum carmichaelii, 7kg of Kaempferia galanga, 3.5kg of Sinapis alba, 0.75kg of Croton tiglium, 2.5kg of Illicium verum, 1kg of human hair, 3.5kg of Sparganium stoloniferum, 1.5kg of Scolopendra subspinipes, 2.5kg of apricot kernel, 3.5kg of rhubarb, 2.5kg of Euphorbia kansui, 1.5kg of Aconitum carmichaelii, 2.5kg of Citrus aurantium, and 1.5kg of Buthus martensii into 100kg of aged vinegar, seal the container and soak for 6 months, then open the container, filter out the impurities, concentrate the filtrate, cool it, filter it again and seal it for storage. The amount of vinegar extract added to each batch is 0.5kg.

[0032] ③ Preparation of fine powder: Grind the following thirteen Chinese medicinal herbs into a fine powder of 100 mesh: 1.5 kg of Arisaema heterophyllum, 2.5 kg of pepper, 2.5 kg of Pinellia ternata, 1.5 kg of Nardostachys jatamansi, 7 kg of Kaempferia galanga, 7 kg of Angelica dahurica, 1 kg of clove, 3 kg of cinnamon, 5.5 kg of frankincense, 5.5 kg of myrrh, 12.5 kg of safflower, 2 kg of dragon's blood, and 1.5 kg of natural copper. Mix them thoroughly and evenly for later use. The amount of the above powder added to each batch is 1.7 kg.

[0033] ④ Preparation of the finished plaster: The ingredients and methods for each batch are as follows: Take 16kg of clear oil paste, crush it, put it into a pot, heat and melt it, add 0.5kg of vinegar extract, melt it until it clumps, stir it thoroughly, pour it into a small pot, cool it down to 70℃, add the powder, the amount of powder added to each batch is 1.7kg, stir it thoroughly, cool it down to 60℃, add borneol, the amount of borneol added to each batch is 0.75kg, stir it evenly, spread it on cloth or fire paper to make the back pain plaster, pack it into bags and seal it to obtain the finished product.

[0034] Clinical efficacy

[0035] 1. Clinical Data

[0036] 1.1 General Information 144 inpatients admitted to the Department of Orthopedics of a tertiary hospital in Tianjin from August 2020 to August 2022 were randomly divided into a treatment group and a control group, with 72 patients in each group.

[0037] Table 1 Comparison of gender, age, and disease duration between the two groups

[0038]

[0039] There were no statistically significant differences in gender, age, and disease duration between the two groups (P>0.05), indicating they were comparable.

[0040] 1.2 Diagnostic criteria

[0041] 1.2.1 The diagnostic criteria for Western medicine were formulated with reference to the "Research Progress in Diagnosis and Treatment of Chronic Low Back Pain" and the "Guidelines for Diagnosis and Treatment of Lumbar Disc Herniation". (1) The chief complaint is pain or discomfort in the lower back, sacrum, and buttocks; (2) The motor and sensory functions of both lower limbs are normal; (3) The duration of symptoms exceeds 3 months; (4) Exclusion of spinal pain diseases with clear "danger signals" such as infection, tumor, fracture, and cauda equina syndrome.

[0042] 1.2.2 The TCM diagnostic criteria were formulated with reference to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine". (1) Primary symptoms: lower back pain radiating to the buttocks and lower limbs, with increased abdominal pressure aggravating the pain; scoliosis, loss of the physiological curvature of the lumbar spine, tenderness in the paravertebral region of the lesion, radiating to the lower limbs, and limited lumbar movement. (2) Secondary symptoms: weakness in the lower limbs, soreness or stabbing pain in the lower back, which is aggravated by exertion and weakened by lying down. Pale face, cold hands and feet, cold waist and legs, impotence and premature ejaculation, deep and hesitant pulse, and a purplish-dark tongue or ecchymosis.

[0043] 1.3 Inclusion criteria (1) Meets the above Western medicine diagnostic criteria; (2) Meets the TCM syndrome differentiation criteria; (3) 50 years old ≤ age ≤ 75 years old; (4) Has not taken NSAIDs or other drugs for treating this disease within 3 days of visiting the clinic.

[0044] 1.4 Exclusion criteria (1) Pregnant or lactating women; (2) Allergic constitution or allergy to the drugs observed in this study; (3) Recurrent lumbar disc herniation after surgery; (4) No lumbar disc herniation, non-disc-related low back and leg pain, lumbar disc herniation combined with cauda equina syndrome or conus medullaris syndrome; (5) Lumbar disc herniation syndrome combined with lumbar tumors or tuberculosis, grade II or higher spondylolisthesis, ankylosing spondylitis, or severe osteoporosis; (6) Lumbar disc herniation syndrome combined with severe hypertension, heart disease, or other systemic or organ primary diseases, or mental illness; (7) Meeting the surgical indications.

[0045] 2 Treatment methods

[0046] 2.1 The control group used Compound Arisaema Analgesic Ointment externally for 2 weeks as per the instructions.

[0047] 2.2 The treatment group received external application of the lumbar patch according to the embodiment of the present invention. One patch was applied daily for 7 days as one course of treatment. Two courses of treatment were administered.

[0048] 3. Observation of therapeutic effects

[0049] 3.1 Observational Indicator: Lumbar Spine Functional Impairment Index (ODI): This index assesses the degree of functional impairment in patients and understands the impact of low back pain on their daily lives. It consists of 9 questions, including pain intensity, self-care ability, lifting heavy objects, walking, sitting, standing, sleep, social life, and travel. Each question has 6 options, and scores range from 0 to 5. Higher scores indicate more severe functional impairment.

[0050] 3.2 The efficacy criteria were formulated with reference to the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases" and "Lumbar Disc Herniation". Marked effect: Disappearance of low back and leg pain, complete disappearance of symptoms and signs, ability to return to original work, straight leg raise test ≥75° but <85°; Effective: Improvement of low back and leg pain, improvement of lumbar mobility, partial disappearance or reduction of symptoms and signs, straight leg raise test improved compared to before treatment but <70°; Ineffective: No improvement in symptoms and signs, or worsening of symptoms and signs.

[0051] 3.3 Statistical methods: SPSS 26.0 software was used for statistical processing. Comparisons of count data were performed using the chi-square test (XPS). 2 Tests were conducted; continuous data were expressed as (x±s), and the comparison of two groups of continuous data was performed using the two independent samples t-test. A p-value < 0.05 was considered statistically significant.

[0052] 4. Treatment Results

[0053] 4.12 Comparison of overall efficacy: The total effective rate was 87.5% in the treatment group and 81.9% in the control group. The difference between the two groups was statistically significant. (See Table 2 and...) Figure 1 )

[0054] 4.2 Comparison of Lumbar Spine Comprehensive Scores Before and After Treatment in Groups The differences in lumbar spine comprehensive scores before and after treatment within both groups and between groups after treatment were statistically significant. (See Table 3 and...) Figure 2 )

[0055] Table 2 Comparison of overall therapeutic effects between the two groups [n(%)]

[0056]

[0057] Note: Compared with the control group, P<0.05.

[0058] Table 3. Comparison of lumbar spine comprehensive scores before and after treatment in the two groups (x±s, points)

[0059]

[0060] Note: Compared with the pre-treatment level in this group, P<0.05; compared with the control group, P<0.05.

[0061] Typical Cases

[0062] Case 1

[0063] Mr. Pang, male, 46 years old, occupation: network worker, with 20 years of work experience. Due to long hours working in front of a computer, he experienced stiffness and intermittent lower back pain, especially worsening in the morning. Treatment period: April 7, 2023 to April 22, 2023. He used a back pain relief plaster prepared as described above, applying it once a day according to the instructions. After 14 applications, he recovered completely. Currently, his lower back is no longer stiff, and the pain symptoms have completely disappeared, greatly improving his quality of life.

[0064] Case 2

[0065] Ms. Wu, 34 years old, occupation: office copywriter, suffered a sprained back pain 2 days ago. Treatment period: March 21, 2023 to March 26, 2023. She used a back pain plaster made in the above manner. She applied the plaster once a day according to the above method. She recovered after 6 applications. During a 3-month follow-up, she did not experience any back pain symptoms.

[0066] Case 3

[0067] Ms. Ji, 39 years old, had a history of lumbar disc herniation for more than 10 years before treatment. Treatment period: January 26, 2023 to February 10, 2023. She used a back pain plaster made in the above manner. She applied the plaster once a day according to the above method. After 14 applications, she recovered and her back pain symptoms have not recurred to this day.

[0068] Case 4

[0069] Ms. Li, 70 years old, had a history of lumbar spinal stenosis for over 20 years. She frequently experienced lower back pain and soreness, and needed to rest after walking about 500 meters. Treatment period: February 7, 2023 to February 21, 2023. She was treated with a lumbar pain patch prepared as described above. The patch was applied once a day according to the above instructions. After 14 applications, her lower back pain and soreness disappeared. She was followed up for 3 months without recurrence.

[0070] The embodiments described herein are preferred embodiments of the present invention and are not intended to limit the scope of protection of the present invention. Therefore, all equivalent changes made in accordance with the structure, shape, and principle of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating lower back pain, characterized in that: Composed of the following parts by weight of active pharmaceutical ingredient: Angelica pubescens 4-6 parts, peach kernel 2-3 parts, Lycopus lucidus 1-3 parts, kudzu root 1-3 parts, Phellodendron bark 2-3 parts, elderberry 4-6 parts, Schisandra chinensis 3-4 parts, Gastrodia elata 2-3 parts, Panax notoginseng 2-3 parts, Aconitum carmichaelii 2-3 parts, Kaempferia galanga 6-8 parts, white mustard seed 3-4 parts, Croton tiglium 0.5-1.5 parts, star anise 2-3 parts, human hair 0.5-1.5 parts, Sparganium stoloniferum 3-4 parts, centipede 1-2 parts, apricot kernel 2-3 parts, rhubarb 3-4 parts, Euphorbia kansui 2-3 parts 1 part each of Aconitum carmichaelii, Citrus aurantium, Scorpio, Arisaema heterophyllum, Pepper, Pinellia ternata, Nardostachys jatamansi, Angelica dahurica, Syzygium aromaticum, Cinnamomum cassia, Cinnamomum cassia, Boswellia carterii, Commiphora myrrha, Carthamus tinctorius, Draconis draco, Pyrite, Borneol, Sesame oil, Limonene scabra, Limonene scabra, and Aged vinegar.

2. The traditional Chinese medicine composition for treating lower back pain according to claim 1, characterized in that: The formula consists of the following raw materials in parts by weight: Angelica pubescens 5 parts, peach kernel 2.5 parts, Lycopus lucidus 2 parts, kudzu root 2 parts, Phellodendron bark 2.5 parts, Sambucus chinensis 5 parts, Schisandra chinensis 3.5 parts, Gastrodia elata 2.5 parts, Panax notoginseng 2.5 parts, Aconitum carmichaelii 2.5 parts, Kaempferia galanga 7 parts, white mustard seed 3.5 parts, Croton tiglium 0.75 parts, star anise 2.5 parts, human hair 1 part, Sparganium stoloniferum 3.5 parts, centipede 1.5 parts, apricot kernel 2.5 parts, rhubarb 3 parts. 0.5 parts, Euphorbia kansui 2.5 parts, Aconitum carmichaelii 1.5 parts, Citrus aurantium 2.5 parts, Buthus martensii 1.5 parts, Arisaema heterophyllum 1.5 parts, pepper 2.5 parts, Pinellia ternata 2.5 parts, Nardostachys jatamansi 1.5 parts, Angelica dahurica 7 parts, clove 1 part, cinnamon 3 parts, frankincense 5.5 parts, myrrh 5.5 parts, safflower 12.5 parts, dragon's blood 2 parts, natural copper 1.5 parts, borneol 1 part, sesame oil 20 parts, cinnamon 4.5 parts, aged vinegar 100 parts.

3. A pharmaceutically acceptable formulation made from the traditional Chinese medicine composition of claim 1 or 2.

4. The formulation according to claim 3, characterized in that: The preparation is a plaster.

5. A method for preparing the formulation according to claim 4, characterized in that: Includes the following steps: S1. Preparation of Clear Oil Ointment: Circulate a specified amount of raw sesame oil at 310℃~330℃ for 40~60 hours until the raw sesame oil turns reddish-black. After cooling, take half the amount of cooked sesame oil, heat it to 310℃~330℃ and then stop heating. Add a specified amount of Zhangdan (a type of medicinal ingredient), stir for 10~15 minutes, and when there is no smoke, pour the mixture of the two ingredients into water. After cooling and solidification, remove the water to obtain clear oil ointment. S2. Preparation method of vinegar extract: Place the specified amounts of Angelica pubescens, peach kernel, Lycopus lucidus, Pueraria lobata, Phellodendron chinense, Sambucus chinensis, Schisandra chinensis, Gastrodia elata, Panax notoginseng, Aconitum carmichaelii, Kaempferia galanga, Sinapis alba, Croton tiglium, Illicium verum, human hair, Sparganium stoloniferum, Scolopendra subspinipes, apricot kernel, rhubarb, Euphorbia kansui, Aconitum carmichaelii, Citrus aurantium, and scorpion into the specified amount of aged vinegar, seal the jar and soak for 5-7 months, then open the jar, filter, concentrate the filtrate, cool it, and filter it again to obtain vinegar extract; S3. Preparation of fine powder: Take the specified amounts of Arisaema heterophyllum, pepper, Pinellia ternata, Nardostachys jatamansi, Angelica dahurica, clove, cinnamon, frankincense, myrrh, safflower, dragon's blood, and natural copper, grind them into a fine powder of 100 mesh, and mix them thoroughly to obtain the powder. S4. Preparation of finished plaster: Take the clear oil ointment, crush it, heat and melt it, add vinegar extract, melt until it clumps, stir thoroughly, cool to 65℃~75℃, add group powder, stir thoroughly, cool to 55℃~65℃, add borneol, stir evenly, spread it on cloth or fire paper to make a back pain plaster, pack it into a bag and seal it to get the finished product.

6. The method for preparing the formulation according to claim 5, characterized in that: In step S4, the mass ratio of clear oil extract, vinegar extract and powder is (12.8~19.2):(0.4~0.6):(1.2~1.8).

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