A topical traditional Chinese medicine composition for treating pain and its preparation method

Abstract

This invention discloses a topical traditional Chinese medicine composition for treating pain and its preparation method. The composition includes Evodia rutaecarpa, Cinnamomum cassia, Carthamus tinctorius, Prunus persica, Smilax glabra, Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, Boswellia carterii, Commiphora myrrha, Clematis armandii, Paris polyphylla, Ephedra sinica, Zingiber officinale, and Achyranthes bidentata. This invention has the effects of warming the meridians and promoting blood circulation, removing blood stasis, dispelling wind and dampness, reducing swelling and relieving pain. It is a safe, non-invasive, and low-cost external treatment method in traditional Chinese medicine, without burdening the liver and kidneys, and is simple to operate. It can effectively alleviate severe pain in patients with lumbar disc herniation, knee synovitis, rheumatoid arthritis, and late-stage ankylosing spondylitis. It also has rapid analgesic and functional recovery effects, improves symptoms such as insomnia and mobility impairment caused by pain, and improves the quality of life of patients.

Description

Technical Field

[0001] This invention relates to a topical traditional Chinese medicine composition for treating pain, specifically to a topical traditional Chinese medicine composition for treating pain, its preparation method, and its application. Background Technology

[0002] In the theoretical system of Traditional Chinese Medicine (TCM), the pathogenesis of pain is complex and multifaceted, primarily attributed to the invasion of wind, cold, and dampness into the meridians, leading to stagnation of qi and blood; or qi stagnation and blood stasis, obstructing the meridians; or deficiency of liver and kidney, resulting in malnourishment of tendons and bones; or accumulation of damp-heat flowing into the joints. This pathogenesis encompasses orthopedic diseases such as cervical spondylosis, frozen shoulder, osteoarthritis, and lumbar disc herniation; it also includes arthralgia such as rheumatoid arthritis and ankylosing spondylitis. Although these diseases vary in location (superficial or deep), they all share common symptoms such as severe localized pain, limited mobility, limb numbness, and even joint deformities, disuse atrophy, or severe colic, significantly impacting the patient's quality of life.

[0003] In current clinical treatments, oral analgesics can temporarily relieve symptoms, but long-term or excessive use can easily damage the spleen and stomach, leading to symptoms of disharmony in the middle jiao (middle burner), such as abdominal distension, nausea, and vomiting. Even worse, the accumulation of drug toxicity can cause dizziness and drowsiness, or deplete the liver and kidney essence and blood, resulting in severe drug-induced damage. Oral administration cannot avoid systemic side effects. While traditional external plasters or patches avoid gastrointestinal irritation, their transdermal penetration is insufficient to reach deep lesions. For example, in patients with lumbar disc herniation, the lesion is deep in the spinal canal, with nerve roots compressed and edematous. Conventional plasters only have a superficial effect and cannot penetrate the layers of fascia and muscles to reach the affected area, resulting in minimal efficacy. For late-stage rheumatoid arthritis with joint deformities and bone destruction, ordinary external medications lack the powerful effects of dispelling wind, clearing the meridians, resolving phlegm, and removing blood stasis, making it difficult to reverse the chronic condition. For intractable insomnia and severe pain associated with cervical and shoulder syndrome due to damp-heat stagnation, current techniques often fall short of addressing both symptoms and lack comprehensive external treatment options for rapid pain relief.

[0004] In summary, existing technologies need to overcome the limitations of traditional topical preparations, such as difficulty in transdermal absorption, shallow penetration, and dissipation of efficacy, to provide a broad-spectrum, rapid-acting, safe, and non-toxic treatment option for various acute and chronic pain. Summary of the Invention

[0005] To address the aforementioned issues, the purpose of this application is to provide a topical Chinese medicine composition for treating pain that is rapidly transdermal and can directly reach deep lesions, as well as a method for its preparation.

[0006] The technical solution of this invention is: a topical traditional Chinese medicine composition for treating pain, comprising the following raw materials in parts by weight:

[0007] Evodia rutaecarpa 25-35 parts, Cinnamomum cassia or litchi seed 25-35 parts, Carthamus tinctorius 25-35 parts, Prunus persica kernel 25-35 parts, Smilax glabra 25-35 parts, Saposhnikovia divaricata 15-25 parts, Notopterygium incisum 15-25 parts, Angelica pubescens 15-25 parts, Boswellia carterii 15-20 parts, Commiphora myrrha 15-20 parts, Clematis armandii 13-17 parts, Paris polyphylla 17-25 parts, Ephedra sinica 10-20 parts, Zingiber officinale 20-30 parts, Achyranthes bidentata 15-20 parts.

[0008] As a preferred embodiment, the traditional Chinese medicine composition further comprises 15-25 parts by weight of excipients, wherein the excipients are at least one of Panax notoginseng and Drynaria fortunei.

[0009] As a preferred embodiment, the traditional Chinese medicine composition, based on parts by weight, comprises: 30 parts of Evodia rutaecarpa, 30 parts of Cinnamomum cassia, 30 parts of Carthamus tinctorius, 30 parts of Prunus persica, 30 parts of Smilax glabra, 20 parts of Panax notoginseng, 20 parts of Saposhnikovia divaricata, 20 parts of Notopterygium incisum, 20 parts of Angelica pubescens, 20 parts of Boswellia carterii, 20 parts of Commiphora myrrha, 30 parts of Zingiber officinale, 20 parts of Ephedra sinica, 25 parts of Paris polyphylla, 17 parts of Clematis armandii, and 20 parts of Achyranthes bidentata.

[0010] As a preferred embodiment, the traditional Chinese medicine composition, based on parts by weight, comprises: 25 parts of Evodia rutaecarpa, 30 parts of Cinnamomum cassia, 30 parts of Carthamus tinctorius, 25 parts of Prunus persica, 25 parts of Smilax glabra, 15 parts of Drynaria fortunei, 20 parts of Saposhnikovia divaricata, 15 parts of Notopterygium incisum, 15 parts of Angelica pubescens, 15 parts of Boswellia carterii, 15 parts of Commiphora myrrha, 25 parts of Zingiber officinale, 10 parts of Ephedra sinica, 18 parts of Paris polyphylla, 13 parts of Achyranthes bidentata, and 17 parts of Achyranthes bidentata.

[0011] As a preferred embodiment, the traditional Chinese medicine composition, based on parts by weight, comprises: 35 parts of Evodia rutaecarpa, 25 parts of Cinnamomum cassia, 25 parts of Carthamus tinctorius, 35 parts of Prunus persica, 35 parts of Smilax glabra, 15 parts of Panax notoginseng, 15 parts of Saposhnikovia divaricata, 20 parts of Notopterygium incisum, 20 parts of Angelica pubescens, 18 parts of Boswellia carterii, 18 parts of Commiphora myrrha, 20 parts of Zingiber officinale, 13 parts of Ephedra sinica, 17 parts of Paris polyphylla, 13 parts of Achyranthes bidentata, and 15 parts of Achyranthes bidentata.

[0012] As a preferred embodiment, the traditional Chinese medicine composition, based on parts by weight, comprises: 30 parts of Evodia rutaecarpa, 35 parts of Litchi chinensis seed, 35 parts of Carthamus tinctorius, 30 parts of Prunus persica kernel, 30 parts of Smilax glabra, 25 parts of Drynaria fortunei, 25 parts of Saposhnikovia divaricata, 25 parts of Notopterygium incisum, 25 parts of Angelica pubescens, 19 parts of Boswellia carterii, 19 parts of Commiphora myrrha, 20 parts of Zingiber officinale, 12 parts of Ephedra sinica, 17 parts of Paris polyphylla, 13 parts of Clematis chinensis, and 15 parts of Achyranthes bidentata.

[0013] 35 parts of Evodia rutaecarpa, 25 parts of Litchi chinensis seed, 25 parts of Carthamus tinctorius, 35 parts of Prunus persica kernel, 35 parts of Smilax glabra, 20 parts of Panax notoginseng, 15 parts of Saposhnikovia divaricata, 20 parts of Notopterygium incisum, 20 parts of Angelica pubescens, 18 parts of Boswellia carterii, 18 parts of Commiphora myrrha, 20 parts of Zingiber officinale, 13 parts of Citrus reticulata, 17 parts of Paris polyphylla, 13 parts of Achyranthes bidentata, and 15 parts of Achyranthes bidentata.

[0014] 25 parts of Evodia rutaecarpa, 30 parts of Litchi chinensis seed, 30 parts of Carthamus tinctorius, 25 parts of Prunus persica kernel, 25 parts of Smilax glabra rhizome, 8 parts of Drynaria fortunei, 13 parts of Panax notoginseng, 20 parts of Saposhnikovia divaricata, 15 parts of Notopterygium incisum, 15 parts of Angelica pubescens, 15 parts of Boswellia carterii, 15 parts of Commiphora myrrha, 25 parts of Zingiber officinale, 10 parts of Citrus reticulata, 18 parts of Paris polyphylla, 13 parts of Achyranthes bidentata, and 17 parts of Achyranthes bidentata.

[0015] This invention relates to a topical Chinese medicine composition with the core treatment principle of warming yang, promoting blood circulation, clearing the channels, and relieving pain, specifically targeting the pathogenesis of cold stagnation and blood stasis. The entire formula uses Evodia rutaecarpa and Cinnamomum cassia for their pungent and warming properties to dispel cold, combined with Carthamus tinctorius and Prunus persica to promote blood circulation and remove blood stasis. These four herbs together form the principal herbs; their warming properties dispel cold stagnation and clear the channels. The warming and clearing effects of Lychee seed are relatively mild. Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, and Smilax glabra are used as assistant herbs to dispel wind and dampness, clear blockages, and relieve pain, assisting the principal herbs in dispelling wind, cold, and dampness in the channels. The adjuvant herbs are combined in two layers: the base layer of the plaster uses Frankincense and Myrrh to remove blood stasis and relieve pain, Dried Ginger to warm the middle and promote circulation, and Achyranthes bidentata to guide the medicine downwards; the powder layer of the plaster uses Smilax china and Ephedra sinica for their strong, penetrating, and pain-relieving properties, combined with Paris polyphylla for its bitter and cold properties to counteract the drying and pungent nature of the warming herbs. These three extremely fine powders are directly sprinkled onto the surface of the plaster, allowing for rapid transdermal penetration and direct access to the affected area. The topical Chinese medicine composition achieves a synergistic effect of sustained warming and penetration of the matrix layer and rapid attack of the powder layer through layered administration. It is suitable for severe cases of cold coagulation and blood stasis caused by wind-cold-dampness arthralgia, blood stasis and obstruction of collaterals, cold pain in the waist and knees, stubborn joint pain, and late stage of traumatic injuries.

[0016] The following are the functions and effects of each component:

[0017] Evodia rutaecarpa: pungent, bitter, and hot; slightly toxic. It enters the liver, spleen, stomach, and kidney meridians. It has the functions of dispelling cold and relieving pain, suppressing nausea and vomiting, and tonifying yang and stopping diarrhea. It is used for Jueyin headache, cold hernia abdominal pain, cold-damp beriberi, menstrual cramps, abdominal distension and pain, vomiting and acid regurgitation, and early morning diarrhea. Studies have shown that evodia rutaecarpa contains erythromycin, which has anti-inflammatory and analgesic effects.

[0018] Cinnamon: pungent, sweet, and very hot in nature. It enters the kidney, spleen, heart, and liver meridians. It has the functions of tonifying fire and assisting yang, guiding fire back to its source, dispelling cold and relieving pain, and warming and unblocking the meridians. It is used for impotence, cold uterus, lower back and knee pain, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, amenorrhea, and dysmenorrhea. Studies have shown that cinnamaldehyde, trans-cinnamaldehyde, 2'-hydroxycinnamaldehyde, and 2'-benzoyloxycinnamaldehyde in cinnamon have anti-inflammatory, antipyretic, and analgesic pharmacological effects.

[0019] Safflower: pungent, warm. It enters the heart and liver meridians. It has the effects of promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain. It is used for amenorrhea, dysmenorrhea, lochia retention, abdominal masses, chest pain, abdominal pain due to blood stasis, hypochondriac pain, traumatic injuries, and sores and swellings. Studies have shown that the flavonoids in safflower have anti-inflammatory and analgesic pharmacological activities.

[0020] Peach kernel: bitter, sweet, and neutral in nature. It enters the heart, liver, and large intestine meridians. It has the functions of promoting blood circulation and removing blood stasis, moistening the intestines and relieving constipation, and relieving cough and asthma. It is used for amenorrhea and dysmenorrhea, abdominal masses, traumatic injuries, constipation due to intestinal dryness, and cough and asthma. Studies have shown that the flavonoids in peach kernels have analgesic effects.

[0021] Smilax glabra: Sweet, bland, and neutral in nature. It enters the liver and stomach meridians. It has detoxifying, dampness-removing, and joint-relieving effects. It is used for limb contractures and muscle and bone pain caused by syphilis and mercury poisoning; damp-heat urinary tract infections, leukorrhea, carbuncles, scrofula, and scabies.

[0022] Saposhnikovia divaricata: pungent, sweet, and slightly warm. It enters the bladder, liver, and spleen meridians. It has the functions of dispelling wind and releasing the exterior, eliminating dampness and relieving pain, and stopping spasms. It is used for colds with headaches, urticaria with itching, rheumatic pain, and tetanus. Studies have shown that the coumarin, polysaccharides, and chromogens in Saposhnikovia divaricata have analgesic effects.

[0023] Notopterygium root: pungent, bitter, and warm. It enters the bladder and kidney meridians. It has the functions of relieving exterior syndromes, dispelling cold, eliminating wind and dampness, and relieving pain. It is used for common cold due to wind-cold, headache and stiff neck, rheumatic pain, and shoulder and back pain. Studies have shown that coumarin compounds and ethyl acetate extracts in Notopterygium root have analgesic effects.

[0024] Angelica pubescens: pungent, bitter, slightly warm. It enters the kidney and bladder meridians. It has the functions of dispelling wind and dampness, relieving pain and numbness. It is used for wind-cold-dampness arthralgia, lower back and knee pain, headache due to latent wind in the Shaoyin meridian, and headache due to wind-cold with dampness. Studies have shown that the coumarin compounds in Angelica pubescens have analgesic effects.

[0025] Frankincense: pungent, bitter, and warm. It enters the heart, liver, and spleen meridians. It has the functions of promoting blood circulation, relieving pain, reducing swelling, and promoting tissue regeneration. It is used for chest pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal masses, rheumatic pain, muscle spasms, traumatic injuries, carbuncles, and sores. Studies have shown that the triterpenoids in Angelica pubescens have the effect of reducing pain sensitivity.

[0026] Myrrh: pungent, bitter, and neutral in nature. It enters the heart, liver, and spleen meridians. It has the functions of dispersing blood stasis, relieving pain, reducing swelling, and promoting tissue regeneration. It is used for chest pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal pain due to masses, rheumatic pain, traumatic injuries, carbuncles, and sores. Studies have shown that quercetin, dihydrocheiloline, stigmasterol, and ellagic acid in myrrh have therapeutic effects on chronic pain.

[0027] *Gynostemma pentaphyllum*: Bitter, pungent, and warm in nature; slightly toxic. It enters the liver meridian. It has the functions of dispelling wind and dampness, dispersing blood stasis and relieving pain, and detoxifying and reducing swelling. It is used for rheumatic pain, stomachache, traumatic bleeding, sprains, and lumbar sprains. Studies have shown that the total saponins in *Gynostemma pentaphyllum* have analgesic effects.

[0028] Paris polyphylla: Bitter, slightly cold; slightly toxic. It enters the liver meridian. It has the functions of clearing heat and detoxifying, reducing swelling and relieving pain, cooling the liver and calming the nerves. It is used for boils and carbuncles, sore throat, snake bites, injuries from falls, and infantile convulsions.

[0029] Hemp seed: pungent, warm; toxic. Enters the lung and liver meridians. It has the functions of promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, and dispelling wind and dampness. Used for traumatic injuries, rheumatic pain, and swelling and pain due to blood stasis.

[0030] Dried ginger: pungent and hot. It enters the spleen, stomach, kidney, heart, and lung meridians. It has the functions of warming the middle jiao and dispelling cold, restoring yang and unblocking the meridians, and warming the lungs and resolving phlegm. It is used for cold pain in the epigastrium and abdomen, vomiting and diarrhea, cold limbs and weak pulse, and cough with cold phlegm.

[0031] Achyranthes bidentata: Sweet, slightly bitter, neutral in nature. It enters the liver and kidney meridians. It has the functions of removing blood stasis and promoting menstruation, facilitating joint movement, and promoting urination. It is used for amenorrhea, retained placenta, injuries from falls, rheumatic pain, weakness and muscle spasms of the feet, and hematuria.

[0032] Panax notoginseng: sweet, slightly bitter, and warm in nature. It enters the liver and stomach meridians. It has the effects of dispersing blood stasis, stopping bleeding, reducing swelling, and relieving pain. It is used for hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic bleeding, chest and abdominal pain, and swelling and pain from falls. Modern research shows that the total saponins in Panax notoginseng have anti-thrombotic, microcirculation-improving, cerebral ischemia-resistant, and myocardial-protective effects.

[0033] Drynaria fortunei: Bitter, warm. It enters the liver and kidney meridians. It has the functions of healing injuries and relieving pain, tonifying the kidneys and strengthening bones, and dispelling wind and removing blemishes. It is used for falls and sprains, fractures, kidney deficiency and lower back pain, weakness of muscles and bones, tinnitus and deafness, and loose teeth. Studies have shown that naringin, drynaria dihydroflavonoid glycosides, and drynaria acid in Drynaria fortunei have the effects of promoting fracture healing, resisting osteoporosis, anti-inflammatory and analgesic properties.

[0034] The traditional Chinese medicine composition of the present invention can also be formulated into conventional pharmaceutical preparations, which preferably include plasters or gel patches.

[0035] Another object of the present invention is to provide a method for preparing the aforementioned topical Chinese medicine composition for treating pain, wherein the composition is prepared as a plaster or gel patch:

[0036] The preparation of plasters includes the following steps:

[0037] 1) Accurately weigh all raw medicinal materials according to the weight proportions of each of the above formulas;

[0038] 2) After cleaning and drying, take the golden iron lock, Paris polyphylla and hemp grass, grind them into powder using a Chinese medicine powder grinder, pass them through a 100-200 mesh sieve to make an extremely fine powder, and seal it for later use.

[0039] 3) Take Evodia rutaecarpa, cinnamon or litchi seed, safflower, peach kernel, Smilax glabra, Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, frankincense, myrrh, dried ginger, and Achyranthes bidentata. Mix them evenly and then pulverize them using a Chinese medicine pulverizer to make coarse powder of 10-50 mesh for later use.

[0040] 4) Put the coarse powder into a pot, add sesame oil in 2-5 times its weight, and soak for 72 hours;

[0041] 5) Simmer over low heat, stirring constantly, until the dregs are dry and float on the surface of the oil. Filter to remove the dregs and continue simmering until the liquid forms beads when dripped.

[0042] 6) Add 30 parts by weight of red lead to every 1000 parts by weight of sesame oil; after adding the red lead, continue stirring and simmer over low heat until it becomes a thick paste, and stop simmering when the paste is soft and firm to the touch, can be pulled into threads without breaking, and is not sticky.

[0043] 7) Continue stirring until the fumes from the paste dissipate. Pour the paste into cold water and soak for 7 days, changing the cold water once a day to remove the fire toxins from the paste.

[0044] 8) Place the cleaned ointment in a pot and heat it over a low flame until it melts and dehydrates until no more bubbles are produced to form an ointment matrix. When the temperature of the ointment matrix drops to 60℃-80℃, add the very fine powder of *Imperata cylindrica*, *Paris polyphylla* and *Hedyotis diffusa* prepared in step 2 and stir thoroughly.

[0045] 9) Apply the above-mentioned paste matrix loaded with extremely fine powder onto the backing material, cut it into shape, and the finished plaster is obtained.

[0046] The preparation of gel patches includes the following steps:

[0047] 1) Weigh all the raw medicinal materials accurately according to the weight proportions of each of the above formulas, and mix them evenly;

[0048] 2) After cleaning and drying, take the herbs *Imperata cylindrica*, *Paris polyphylla*, and *Hedyotis diffusa*, then grind them into a fine powder using a Chinese medicine powder grinder, pass them through a 200-mesh sieve, and seal them for later use.

[0049] 3) Take the remaining Evodia rutaecarpa, cinnamon or litchi seed, safflower, peach kernel, Smilax glabra, Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, frankincense, myrrh, dried ginger, and Achyranthes bidentata from the prescription and mix them evenly;

[0050] 4) Add 6-10 times the amount of 50% ethanol to the mixed medicinal materials in step 3, extract 1-3 times, each extraction lasting 1-2 hours, filter 2-3 times after extraction, and collect the clear filtrate;

[0051] 5) Recover ethanol from the clarified filtrate under reduced pressure, concentrate to an extract with a relative density of 1.20-1.30 (60℃), and seal for later use;

[0052] 6) Take the humectant, add it to the skeleton material, stir until completely dissolved and mixed evenly, and set aside as the oil phase;

[0053] 7) Take the crosslinking agent, crosslinking regulator, and thickener, add them to purified water, and stir until completely dissolved. Use this as the aqueous phase for later use.

[0054] 8) Add the extract prepared in step 5 to the oil phase in step 6 and stir until homogeneous to form an oil phase-extract mixture;

[0055] 9) Under vacuum stirring conditions, the aqueous phase prepared in step 7 is slowly added to the oil phase-extract mixture obtained in step 8 above. After stirring evenly, an ointment matrix is ​​formed. The fine powders of *Gynostemma pentaphyllum*, *Paris polyphylla* and *Hypericum perforatum* prepared in step 2 are added to form an ointment.

[0056] 10) Apply the paste containing extremely fine powder onto the backing material, cover with an anti-stick film, and after curing and shaping, cut and seal to obtain the finished gel patch.

[0057] In the preparation method, the ultrafine powder is mixed into the paste matrix and then coated, or the paste matrix is ​​coated and then the ultrafine powder is sprinkled on the surface and pressed in.

[0058] Advantages of this invention:

[0059] 1. The topical Chinese medicine composition for treating pain of the present invention has the effects of warming the meridians and dispelling cold, promoting blood circulation and removing blood stasis, dispelling wind and dampness, clearing heat and detoxifying and reducing swelling.

[0060] 2. This invention provides a topical traditional Chinese medicine composition for treating pain, suitable for common clinical pain conditions such as cervical spondylosis, frozen shoulder, osteoarthritis, lumbar disc herniation, tenosynovitis, myositis, synovitis, and dysmenorrhea. It is particularly effective for joint pain caused by ankylosing spondylitis, rheumatoid arthritis, and other arthritis. It is also applicable to pain caused by wind-cold invasion, poor blood circulation, and limb numbness. It also has rapid analgesic and functional recovery effects, further improving symptoms such as insomnia and limited mobility caused by pain, thus improving the patient's quality of life.

[0061] 3. The composition of the present invention, as a topical plaster, is a safe, non-invasive, non-hepatic, and low-cost external treatment method in traditional Chinese medicine. Detailed Implementation

[0062] The present invention will be further described in detail below with reference to specific embodiments, but this is not intended to limit the present invention.

[0063] Example 1:

[0064] 30 parts of Evodia rutaecarpa, 30 parts of Cinnamomum cassia, 30 parts of Carthamus tinctorius, 30 parts of Prunus persica, 30 parts of Smilax glabra, 20 parts of Panax notoginseng, 20 parts of Saposhnikovia divaricata, 20 parts of Notopterygium incisum, 20 parts of Angelica pubescens, 20 parts of Boswellia carterii, 20 parts of Commiphora myrrha, 30 parts of Zingiber officinale, 20 parts of Achyranthes bidentata, 17 parts of Iron Lock, 25 parts of Paris polyphylla, and 20 parts of Hemp scabra.

[0065] The preparation of plasters includes the following steps:

[0066] 1) Accurately weigh all raw medicinal materials according to the weight proportions of each of the above formulas;

[0067] 2) After cleaning and drying, take the herbs *Imperata cylindrica*, *Paris polyphylla*, and *Hedyotis diffusa*, then grind them into a fine powder using a Chinese medicine powder grinder, pass them through a 200-mesh sieve, and seal them for later use.

[0068] 3) Take Evodia rutaecarpa, cinnamon, safflower, peach kernel, Smilax glabra, Panax notoginseng, Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, frankincense, myrrh, dried ginger, and Achyranthes bidentata. Mix them evenly and then pulverize them using a Chinese medicine pulverizer to make 50-mesh coarse powder for later use.

[0069] 4) Put the coarse powder into a pot, add sesame oil five times the weight of the coarse powder, and soak for 72 hours;

[0070] 5) Simmer over low heat, stirring constantly, until the dregs are dry and float on the surface of the oil. Filter to remove the dregs and continue simmering until the liquid forms beads when dripped.

[0071] 6) Add 30 parts by weight of red lead to every 1000 parts by weight of sesame oil; after adding the red lead, continue stirring and simmer over low heat until it becomes a thick paste, and stop simmering when the paste is soft and firm to the touch, can be pulled into threads without breaking, and is not sticky.

[0072] 7) Continue stirring until the fumes from the paste dissipate. Pour the paste into cold water and soak for 7 days, changing the cold water once a day to remove the fire toxins from the paste.

[0073] 8) Place the cleaned ointment in a pot and heat it over a low flame until it melts and dehydrates until no more bubbles are produced. When the temperature of the ointment drops to 60°C, add the very fine powder of *Imperata cylindrica*, *Paris polyphylla* and *Hedyotis diffusa* prepared in step 2 and stir thoroughly.

[0074] 9) Take the above-mentioned well-mixed paste and apply it to the backing material while it is still hot, with a thickness of 1.5 cm. Then cut it into a circle with a diameter of 9 cm to obtain the finished plaster.

[0075] Instructions for use: Apply externally to the affected area once a day for 6 days as one course of treatment.

[0076] Example 2:

[0077] 25 parts of Evodia rutaecarpa, 30 parts of Cinnamomum cassia, 30 parts of Carthamus tinctorius, 25 parts of Prunus persica, 25 parts of Smilax glabra, 15 parts of Drynaria fortunei, 20 parts of Saposhnikovia divaricata, 15 parts of Notopterygium incisum, 15 parts of Angelica pubescens, 15 parts of Boswellia carterii, 15 parts of Commiphora myrrha, 25 parts of Zingiber officinale, 17 parts of Achyranthes bidentata, 13 parts of Lysimachia christinae, 18 parts of Paris polyphylla, and 10 parts of Citrus reticulata.

[0078] The preparation of gel patches includes the following steps:

[0079] 1) Accurately weigh all raw medicinal materials according to the weight proportions of each of the above formulas;

[0080] 2) After cleaning and drying, take the herbs *Imperata cylindrica*, *Paris polyphylla*, and *Hedyotis diffusa*, then grind them into a fine powder using a Chinese medicine powder grinder, pass them through a 200-mesh sieve, and seal them for later use.

[0081] 3) Take the remaining Evodia rutaecarpa, Cinnamomum cassia, Carthamus tinctorius, Prunus persica, Smilax glabra, Drynaria fortunei, Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, Boswellia carterii, Commiphora myrrha, Zingiber officinale, and Achyranthes bidentata from the prescription and mix them evenly;

[0082] 4) Add 6-10 times the amount of 50% ethanol to the mixed medicinal materials in step 3, extract 3 times, 1 hour each time, filter twice after extraction, and collect the clear filtrate.

[0083] 5) Recover ethanol from the clarified filtrate under reduced pressure, concentrate to a paste with a relative density of 1.20 (60℃), and seal for later use;

[0084] 6) Take the humectant, add it to the skeleton material, stir until completely dissolved and mixed evenly, and set aside as the oil phase;

[0085] 7) Take the crosslinking agent, crosslinking regulator, and thickener, add them to purified water, and stir until completely dissolved. Use this as the aqueous phase for later use.

[0086] 8) Add the extract prepared in step 5 to the oil phase in step 6 and stir until homogeneous to form an oil phase-extract mixture;

[0087] 9) Slowly add the aqueous phase prepared in step 7 to the oil phase-extract mixture prepared in step 8 above, stir evenly to form an ointment matrix, and add the fine powder of *Gynostemma pentaphyllum*, *Paris polyphylla* and *Hypericum perforatum* prepared in step 2 to make an ointment.

[0088] 10) Apply the paste containing extremely fine powder onto the backing material, cover with an anti-stick film, and after curing and shaping, cut and seal to obtain the finished gel patch.

[0089] Instructions for use: During treatment, peel off the protective film from the gel patch and apply it to the affected area, leaving it on for 24 hours.

[0090] Example 3:

[0091] Evodia rutaecarpa 35 parts, Cinnamomum cassia 25 parts, Carthamus tinctorius 25 parts, Prunus persica 35 parts, Smilax glabra 35 parts, Panax notoginseng 15 parts, Saposhnikovia divaricata 15 parts, Notopterygium incisum 20 parts, Angelica pubescens 20 parts, Boswellia carterii 18 parts, Commiphora myrrha 18 parts, Zingiber officinale 20 parts, Achyranthes bidentata 15 parts, Sophora flavescens 13 parts, Paris polyphylla 17 parts, Citrus reticulata 13 parts.

[0092] The preparation and usage methods are as described in Example 1.

[0093] In step 3, Panax notoginseng is ground into coarse powder.

[0094] Example 4:

[0095] 30 parts of Evodia rutaecarpa, 35 parts of Litchi chinensis seed, 35 parts of Carthamus tinctorius, 30 parts of Prunus persica kernel, 30 parts of Smilax glabra, 25 parts of Drynaria fortunei, 25 parts of Saposhnikovia divaricata, 25 parts of Notopterygium incisum, 25 parts of Angelica pubescens, 19 parts of Boswellia carterii, 19 parts of Commiphora myrrha, 20 parts of Zingiber officinale, 15 parts of Achyranthes bidentata, 13 parts of Clematis armandii, 17 parts of Paris polyphylla, and 12 parts of Citrus reticulata.

[0096] The preparation and usage methods are as described in Example 1.

[0097] In step 3, Drynaria fortunei is ground into coarse powder.

[0098] Example 5:

[0099] 35 parts of Evodia rutaecarpa, 25 parts of Litchi chinensis seed, 25 parts of Carthamus tinctorius, 35 parts of Prunus persica kernel, 35 parts of Smilax glabra, 20 parts of Panax notoginseng, 15 parts of Saposhnikovia divaricata, 20 parts of Notopterygium incisum, 20 parts of Angelica pubescens, 18 parts of Boswellia carterii, 18 parts of Commiphora myrrha, 20 parts of Zingiber officinale, 13 parts of Citrus reticulata, 17 parts of Paris polyphylla, 13 parts of Achyranthes bidentata, and 15 parts of Achyranthes bidentata.

[0100] The preparation and usage methods are as described in Example 3.

[0101] Example 6:

[0102] 25 parts of Evodia rutaecarpa, 30 parts of Litchi chinensis seed, 30 parts of Carthamus tinctorius, 25 parts of Prunus persica kernel, 25 parts of Smilax glabra rhizome, 8 parts of Drynaria fortunei, 13 parts of Panax notoginseng, 20 parts of Saposhnikovia divaricata, 15 parts of Notopterygium incisum, 15 parts of Angelica pubescens, 15 parts of Boswellia carterii, 15 parts of Commiphora myrrha, 25 parts of Zingiber officinale, 10 parts of Citrus reticulata, 18 parts of Paris polyphylla, 13 parts of Achyranthes bidentata, and 17 parts of Achyranthes bidentata.

[0103] The preparation and usage methods are as described in Example 4.

[0104] In step 3, lychee seeds, Panax notoginseng, and Drynaria fortunei are ground into coarse powder.

[0105] Preliminary foundation

[0106] This herbal combination has been used to treat approximately 3,000 patients with pain. The range of pain treated includes cervical spondylosis, frozen shoulder, osteoarthritis, lumbar disc herniation, tenosynovitis, myositis, synovitis, dysmenorrhea, and other pain caused by trauma, inflammation, blockage, cold, rheumatism, and rheumatoid arthritis. It also includes pain caused by wind-cold invasion, poor blood circulation, and numbness of limbs.

[0107] Table 1 shows the number of patients and the effectiveness rate of this traditional Chinese medicine composition in treating the main types of pain.

[0108] disease Number of examples efficiency Cervical spondylosis 150 90% frozen shoulder 300 97% Osteoarthritis 130 90% Lumbar disc herniation 200 97% Tenosynovitis 300 95% Myositis 300 95% Synovitis 300 95% Menstrual cramps 100 90% rheumatoid arthritis 200 93%

[0109] Case

[0110] Case 1

[0111] Ms. Wang, 36 years old, presented with a chief complaint of lumbar disc herniation. At the time of consultation, she was experiencing severe lower back pain, rendering her unable to walk or drive normally. An MRI of the lumbar spine at the hospital's orthopedic department revealed L3 / 4 and L4 / 5 disc herniation, moderate tenderness (++) lateral to the affected segment, and severe tenderness (++) along the sciatic nerve pathway, particularly at the sciatic exit point. Pressure on this area elicited radiating pain in the ipsilateral lower limb, accompanied by numbness. The patient had sought treatment at multiple hospitals within the past year with unsatisfactory results. After applying the plaster described in Example 1 of this invention for two consecutive courses of treatment, the patient's lower back pain and numbness disappeared, and she was able to walk normally again.

[0112] Case 2

[0113] Ms. Peng, 75 years old. Chief complaint: "Severe deformity of both knee joints accompanied by intense pain." Upon presentation, the patient was unable to walk independently and was carried to the clinic by a family member. The patient reported a history of knee pain for many years, which had worsened to the point of severely affecting her sleep at night. After treatment with the plaster described in Example 1 of this invention, and completing one course of treatment, the patient was able to walk independently with the aid of crutches, and the pain essentially disappeared when not standing.

[0114] Case 3

[0115] Mr. Duan, male, 32 years old. Chief complaint: "Rheumatoid arthritis". At his first visit, the patient's bilateral upper limbs and finger joints were severely deformed, accompanied by intense pain. The patient reported that due to joint deformities and severe pain, he had lost the ability to live independently. He was treated with the plaster described in Example 1 of this invention. After five courses of treatment, at his follow-up visit, the patient's clinical symptoms had completely disappeared, all joints in both upper limbs and fingers had returned to normal, all pain had disappeared, and the patient had regained the ability to live independently.

[0116] Case 4

[0117] Mr. Li, male, 41 years old. Chief complaint: ankylosing spondylitis. The patient was unable to bend over, experienced significant numbness in the spinal region, and was unable to sit up independently after lying flat. He had sought medical treatment at various hospitals for 7 years, but his condition continued to progress without significant improvement. Before seeking medical attention, his condition had progressed from initial pain to spinal ankylosis. Imaging examination confirmed late-stage ankylosing spondylitis, which posed a high risk of paralysis without timely and effective intervention. Treatment with the plaster described in Example 1 of this invention was administered. After 5 days of treatment, the spinal compression and numbness were significantly reduced, he could sit up independently after lying flat, and his walking ability also improved.

[0118] Case 5

[0119] Mr. Huang, male, 61 years old, presented with "synovitis of the right knee joint." Upon consultation, the patient was unable to walk on his right leg, and his right knee joint was severely swollen and accompanied by intense pain. The plaster described in Example 1 of this invention was applied for treatment. After 3 days of treatment, the joint inflammation and swelling disappeared.

[0120] Case 6

[0121] Ms. Yang, 50 years old. At initial consultation, the patient presented with severely limited neck movement, unable to rotate voluntarily, accompanied by intense pain. She reported experiencing insomnia for one month due to the pain. Traditional Chinese medicine diagnosis identified it as cervical and shoulder syndrome of the damp-heat stagnation type. The plaster described in Example 1 of this invention was applied for treatment. After two courses of treatment, the pain disappeared, her neck and shoulders returned to normal, and her sleep resumed.

[0122] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the basic principles of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A topical traditional Chinese medicine composition for treating pain, characterized in that, Based on parts by weight, the traditional Chinese medicine composition includes 25-35 parts of Evodia rutaecarpa, 25-35 parts of Cinnamomum cassia or Litchi chinensis seed, 25-35 parts of Carthamus tinctorius, 25-35 parts of Prunus persica kernel, 25-35 parts of Smilax glabra, 15-25 parts of Saposhnikovia divaricata, 15-25 parts of Notopterygium incisum, 15-25 parts of Angelica pubescens, 15-20 parts of Boswellia carterii, 15-20 parts of Commiphora myrrha, 20-30 parts of Zingiber officinale, 15-20 parts of Achyranthes bidentata, 13-17 parts of Clematis chinensis, 17-25 parts of Paris polyphylla, and 10-20 parts of Ephedra sinica.

2. The topical traditional Chinese medicine composition for treating pain according to claim 1, characterized in that, Based on parts by weight, it also includes 15-25 parts of excipients, wherein the excipients are at least one of Panax notoginseng and Drynaria fortunei.

3. The topical traditional Chinese medicine composition for treating pain according to claim 2, characterized in that, Based on parts by weight, the ingredients include 30 parts of Evodia rutaecarpa, 30 parts of Cinnamomum cassia, 30 parts of Carthamus tinctorius, 30 parts of Prunus persica, 30 parts of Smilax glabra, 20 parts of Panax notoginseng, 20 parts of Saposhnikovia divaricata, 20 parts of Notopterygium incisum, 20 parts of Angelica pubescens, 20 parts of Boswellia carterii, 20 parts of Commiphora myrrha, 30 parts of Zingiber officinale, 20 parts of Achyranthes bidentata, 17 parts of Clematis armandii, 25 parts of Paris polyphylla, and 20 parts of Citrus reticulata.

4. The topical traditional Chinese medicine composition for treating pain according to claim 2, characterized in that, Based on weight, the ingredients include 25 parts of Evodia rutaecarpa, 30 parts of Cinnamomum cassia, 30 parts of Carthamus tinctorius, 25 parts of Prunus persica, 25 parts of Smilax glabra, 15 parts of Drynaria fortunei, 20 parts of Saposhnikovia divaricata, 15 parts of Notopterygium incisum, 15 parts of Angelica pubescens, 15 parts of Boswellia carterii, 15 parts of Commiphora myrrha, 25 parts of Zingiber officinale, 17 parts of Achyranthes bidentata, 13 parts of Clematis armandii, 18 parts of Paris polyphylla, and 10 parts of Citrus reticulata.

5. The topical traditional Chinese medicine composition for treating pain according to claim 2, characterized in that, Based on parts by weight, the ingredients include 35 parts of Evodia rutaecarpa, 25 parts of Cinnamomum cassia, 25 parts of Carthamus tinctorius, 35 parts of Prunus persica, 35 parts of Smilax glabra, 15 parts of Panax notoginseng, 15 parts of Saposhnikovia divaricata, 20 parts of Notopterygium incisum, 20 parts of Angelica pubescens, 18 parts of Boswellia carterii, 18 parts of Commiphora myrrha, 20 parts of Zingiber officinale, 15 parts of Achyranthes bidentata, 13 parts of Clematis armandii, 17 parts of Paris polyphylla, and 13 parts of Citrus reticulata.

6. The topical traditional Chinese medicine composition for treating pain according to claim 2, characterized in that, Based on parts by weight, the ingredients include 30 parts of Evodia rutaecarpa, 35 parts of Litchi chinensis seed, 35 parts of Carthamus tinctorius, 30 parts of Prunus persica kernel, 30 parts of Smilax glabra, 25 parts of Drynaria fortunei, 25 parts of Saposhnikovia divaricata, 25 parts of Notopterygium incisum, 25 parts of Angelica pubescens, 19 parts of Boswellia carterii, 19 parts of Commiphora myrrha, 20 parts of Zingiber officinale, 15 parts of Achyranthes bidentata, 13 parts of Clematis armandii, 17 parts of Paris polyphylla, and 12 parts of Citrus reticulata.

7. The topical traditional Chinese medicine composition for treating pain according to claim 2, characterized in that, Based on weight, the ingredients include 35 parts of Evodia rutaecarpa, 25 parts of Litchi chinensis seed, 25 parts of Carthamus tinctorius, 35 parts of Prunus persica kernel, 35 parts of Smilax glabra, 20 parts of Panax notoginseng, 15 parts of Saposhnikovia divaricata, 20 parts of Notopterygium incisum, 20 parts of Angelica pubescens, 18 parts of Boswellia carterii, 18 parts of Commiphora myrrha, 20 parts of Zingiber officinale, 13 parts of Citrus reticulata, 17 parts of Paris polyphylla, 13 parts of Achyranthes bidentata, and 15 parts of Achyranthes bidentata.

8. The topical traditional Chinese medicine composition for treating pain according to claim 2, characterized in that, Based on parts by weight, the ingredients include 25 parts of Evodia rutaecarpa, 30 parts of Litchi chinensis seed, 30 parts of Carthamus tinctorius, 25 parts of Prunus persica kernel, 25 parts of Smilax glabra, 8 parts of Drynaria fortunei, 13 parts of Panax notoginseng, 20 parts of Saposhnikovia divaricata, 15 parts of Notopterygium incisum, 15 parts of Angelica pubescens, 15 parts of Boswellia carterii, 15 parts of Commiphora myrrha, 25 parts of Zingiber officinale, 10 parts of Citrus reticulata, 18 parts of Paris polyphylla, 13 parts of Achyranthes bidentata, and 17 parts of Achyranthes bidentata.

9. The topical traditional Chinese medicine composition for treating pain according to any one of claims 1-8, characterized in that, It also includes the formulation of conventional pharmaceutical preparations, including plasters or gel patches.

10. A method for preparing the topical traditional Chinese medicine composition for treating pain as described in claim 9, characterized in that, Prepared into plasters or gel patches; The preparation of the plaster includes the following steps: 1) Accurately weigh all raw medicinal materials according to the weight proportions of each of the above formulas; 2) Take the golden iron lock, Paris polyphylla and hemp grass, clean and dry them, then crush them and pass them through a 100-200 mesh sieve to make an extremely fine powder. Seal and store for later use. 3) Take Evodia rutaecarpa, cinnamon or litchi seed, safflower, peach kernel, Smilax glabra, Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, frankincense, myrrh, dried ginger, and Achyranthes bidentata, mix them evenly and then grind them into coarse powder of 10-50 mesh for later use. 4) Add sesame oil, which is 2-5 times the weight of the coarse powder, to the coarse powder and soak for 72 hours; 5) Stir continuously during the decoction process until the dregs are dry and float on the surface of the oil. Filter to remove the dregs and continue to decoct until the water droplets form beads. 6) Add 30 parts by weight of red lead at 25℃ to every 1000 parts by weight of sesame oil, stir continuously, and cook until it becomes a thick paste. Stop cooking when the paste is soft and firm to the touch, can be pulled into threads without breaking, and is not sticky. 7) Continue stirring until the fumes from the paste dissipate. Pour the paste into cold water and soak for 7 days, changing the cold water once a day to remove the fire toxins from the paste. 8) Heat the detoxified ointment over a low flame until it melts and dehydrates until no more bubbles are produced. When the temperature of the ointment drops to 60℃-80℃, add the very fine powder of *Imperata cylindrica*, *Paris polyphylla* and *Hedyotis diffusa* prepared in step 2, and stir thoroughly until evenly mixed. 9) Apply the above-mentioned uniformly mixed paste to the backing material while it is still hot, cut it into shape, and you will get the finished plaster. The preparation of the gel patch includes the following steps: 1) Accurately weigh all raw medicinal materials according to the weight proportions of each of the above formulas; 2) After cleaning and drying, take Jin Tie Suo, Chong Lou and Pi Ma Cao, pulverize them with a Chinese medicine pulverizer, pass them through a 100-200 mesh sieve to make an extremely fine powder, and seal them for later use. 3) Take the remaining Evodia rutaecarpa, cinnamon or litchi seed, safflower, peach kernel, Smilax glabra, Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, frankincense, myrrh, dried ginger, and Achyranthes bidentata from the prescription and mix them evenly. 4) Add 6-10 times the amount of 50% ethanol to the mixed medicinal materials in step 3, extract 1-3 times, each extraction lasting 1-2 hours, filter 2-3 times after extraction, and collect the clear filtrate; 5) Recover ethanol from the clarified filtrate under reduced pressure, concentrate to an extract with a relative density of 1.20-1.30, and seal for later use; 6) Take the moisturizer, add it to the skeleton material, stir until completely dissolved and mixed evenly, and set aside as the oil phase; 7) Take the crosslinking agent, crosslinking regulator, and thickener, add them to purified water, and stir until completely dissolved. Use this as the aqueous phase for later use. 8) Add the extract prepared in step 5 to the oil phase in step 6 and stir evenly to form the oil phase-extract mixture prepared in step 8. 9) Slowly add the aqueous phase prepared in step 7 to the above oil phase-extract mixture, stir evenly to form an ointment matrix, and add the fine powder of *Isodon japonicus*, *Paris polyphylla* and *Hedyotis diffusa* prepared in step 2 to make an ointment; 10) Apply the paste containing the fine powder to the backing material, cover with an anti-stick film, and after curing and molding, cut and seal to obtain the finished gel patch.