A traditional Chinese medicine composition for treating arthromyodynia and its preparation method

Abstract

The present invention discloses a traditional Chinese medicine composition for treating arthralgia syndrome, which comprises the following raw materials in parts by weight: 15-25 parts of lithospermum root, 15-25 parts of limnophila aromatica (Lam.) Merr., 12-18 parts of dragon's blood, 12-18 parts of cortex phellodendri, 12-18 parts of rheum officinale, 12-18 parts of ardisia gigantifolia stapf, 9-15 parts of coptis chinensis, 6-10 parts of frankincense, 6-10 parts of myrrh, 12-18 parts of menthol, 12-18 parts of borneol, 8-12 parts of cinnabar, and 45-60 parts of rehmannia glutinosa. The present invention also discloses a preparation method of the traditional Chinese medicine composition for treating arthralgia syndrome. The present invention has the effects of clearing heat and detoxifying, cooling blood and nourishing yin, promoting blood circulation to remove blood stasis, relieving pain and calming the mind, dispelling wind and removing dampness, can effectively relieve the discomfort of patients, and will not damage the body fluid of the human body during the heat-clearing process, nor will it damage the healthy qi during the blood stasis-removing process, truly achieving the effect of dispelling pathogenic factors and strengthening healthy qi.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine formulations, and particularly relates to a traditional Chinese medicine composition for treating arthralgia and a preparation method thereof. Background Art

[0002] Herpes zoster, commonly known as "shingles around the waist", "snake sores" or "spider sores", is a disease caused by the varicella-zoster virus (VZV). The virus enters the human body through the respiratory mucosa and has a neurotropism, spreading along the peripheral nerve fibers, thus triggering herpes distributed along the nerves. After the herpes breaks out, peripheral sensitization and hyperalgesia rapidly appear on the surface skin innervated by the damaged nerves, which is considered to be the key mechanism of chronic neuropathic pain. The degree of pain in the early stage is an important factor predicting the occurrence of postherpetic neuralgia (PHN). Based on this understanding, postherpetic neuralgia in China is defined as pain that persists for at least 1 month or more after the rash has healed. If the virus is not treated promptly or is treated improperly after infection, about 9% to 34% of patients with herpes zoster will develop PHN. Especially in the patient group aged 60 and above, this proportion can be as high as 65%, and in those aged 70 and above, the proportion rises to 75%. PHN is mainly manifested as burning pain, shooting pain, stabbing pain, knife-like pain, etc. in the affected area, the pain location is fixed, it occurs frequently and does not heal for a long time.

[0003] The "five organs" in TCM theory refer to "skin, muscles, tendons, blood vessels and bones", and the five-body arthralgia refers to the invasion of evil qi into the human body, resulting in poor circulation of qi and blood, obstruction of meridians, or the long-term stay of evil qi in the five organs, depletion of qi and blood, resulting in a state of "blockage or lack of nourishment", and the symptoms caused in these parts are usually manifested as pain, numbness, heaviness, and difficulty in flexion and extension. Among them, skin arthralgia is mainly caused by obstruction of meridians and malnutrition of skin; muscle arthralgia is characterized by evil obstruction of muscles and skin, soreness, swelling, pain and weakness of limb muscles; pulse arthralgia is caused by obstruction of blood vessels, so limbs are painful and weak; tendon arthralgia is characterized by tendon spasm and difficulty in flexion and extension of joints; bone arthralgia is characterized by heavy and stiff joints, contracture and flexion. Postherpetic neuralgia (PHN) is caused by evil qi invading the skin, so it belongs to the category of "skin arthralgia". At the beginning of the disease, the evil qi mainly invades the skin surface, which manifests as a positive syndrome; in the middle and late stages, due to the deficiency of qi, blood, yin and yang, phlegm and blood stasis gradually form, blocking the skin and causing skin arthralgia, which is more common with deficiency syndrome and a mixture of deficiency and excess. The causes of the disease are generally classified into three categories: "deficiency, evil, and stasis". The treatment is based on "deficiency, evil, and stasis" for syndrome differentiation. The treatment of evil excess syndrome is to remove evil, unblock the meridians and relieve pain, the treatment of deficiency syndrome is to strengthen the body and replenish the deficiency to relieve pain, and the treatment of phlegm and stasis syndrome is to remove blood stasis, remove phlegm, unblock the meridians and relieve pain. The scope of the lesion in the early stage of this disease is small and limited to the skin. In the early clinical stage of herpes zoster, the main focus is on removing external evil, which is mostly the viral inflammation stage in modern medicine. At the beginning, it promotes the elimination of viruses, eliminates inflammatory factors, and makes the internal and external environment of the body reach a new balance. In the middle and late stages, the focus is on promoting blood circulation, removing blood stasis, and replenishing qi and blood. This stage is mostly related to nerve damage and inflammatory response in modern medicine, in order to restore nerve function, activate qi and blood, and prevent the continuation of neuralgia. Modern medicine attributes postherpetic neuralgia to nerve dysfunction caused by viruses. However, from the perspective of holistic view and syndrome differentiation and treatment, traditional Chinese medicine believes that the occurrence of herpes zoster is closely related to factors such as liver and gallbladder fire, internal dampness and heat, qi stagnation and blood stasis, liver and kidney yin deficiency, spleen and stomach weakness, deficiency of vital energy, and exogenous toxic evil. Traditional Chinese medicine believes that these factors are similar to the heat arthralgia in traditional Chinese medicine arthralgia in terms of etiology and pathogenesis. Both are closely related to factors such as deficiency, fire, toxicity, stasis, dampness and heat. Internal deficiency of vital energy, retention of evil toxins, qi stagnation and blood stasis, accumulation of dampness and heat, and obstruction of collaterals can lead to arthralgia and other arthralgia. In addition, most patients are elderly and weak, and their illnesses have not been cured for a long time, and their qi and blood are weak, and they cannot nourish the meridians, resulting in "the most weak place is the place where evil stays."

[0004] The current treatment methods for herpes zoster mainly rely on Chinese medicine combination technology, which is usually composed of a variety of Chinese medicinal materials and aims to treat by clearing away heat and detoxifying, promoting blood circulation and removing blood stasis, regulating qi and relieving pain, etc. For example, classic prescriptions such as Longdan Xiegan Decoction, Wuling Powder, and Simiao Powder are used to add or subtract ingredients to suit the specific conditions of different patients.

[0005] Chinese Patent CN110368442A discloses an external medicine composition and its preparation method, and discloses the following content: In this embodiment, artificial bezoar, Scutellaria baicalensis, Coptis chinensis, Phellodendron amurense, and Gardenia jasminoides are the "sovereign herbs", which mainly play the role of clearing heat and detoxifying. Dragon's blood, myrrh, and frankincense are the "ministerial herbs", which mainly play the role of dissipating stasis and detumescence, and anti-inflammatory protection. Tetrodotoxin-containing cod liver oil and its derivatives are the "adjuvant herbs", which can play the role of relieving itching and pain, and anti-inflammatory protection. The "conducting herb" is liquorice that plays a harmonizing role and borneol as a guiding prescription. The combination of the above various formulas can regulate the liver qi internally, dissipate stasis and detoxify, relieve pain and inflammation externally, activate blood circulation and promote granulation, and can achieve the effects of reducing pain, accelerating recovery, and reducing sequelae of neuralgia both internally and externally. Taking the treatment of herpes zoster as an example, traditional Western medicine treatment is carried out by using antiviral and nerve-nourishing drugs.

[0006] Chinese Patent CN103055069B discloses an external traditional Chinese medicine composition for treating postherpetic neuralgia and its preparation method. The composition is made from the following raw medicinal materials: 10-25 parts of Gleditsia sinensis thorn, 3-9 parts of Panax notoginseng, 3-6 parts of Chrysanthemum morifolium, 3-6 parts of Perilla frutescens leaf, 3-15 parts of Lycium chinese root-bark, 3-9 parts of Prunus armeniaca kernel, 3-6 parts of Cimicifuga foetida, 3-15 parts of Paeonia lactiflora, 3-15 parts of Bufo bufo gargarizans, 3-6 parts of Gentiana scabra, 1-3 parts of Cryptotympana pustulata, 10-30 parts of calcined margarita, 3-9 parts of Lithospermum erythrorhizon, 3-9 parts of Arisaema heterophyllum, 3-12 parts of Angelica sinensis, 3-15 parts of Lycium chinese root-bark, 3-15 parts of Sophora flavescens, 3-9 parts of Angelica sinensis, 1-3 parts of Asarum heterotropoides, 3-9 parts of Corydalis yanhusuo, 3-9 parts of Lobelia chinensis, 1-3 parts of Mentha haplocalyx, 3-15 parts of Cortex fraxini, 3-15 parts of Phellodendron amurense, 0.5-1.0 part of borneol. The above raw materials are made into fine powder, warm-soaked in vegetable oil, filtered to obtain the oil, and that's it. The present invention has the advantages of significant curative effect, no adverse reactions, short course of treatment, convenient medication, low cost, etc.

[0007] Chinese Patent CN114848782A discloses a composition for postherpetic neuralgia, including main materials, auxiliary materials, and flavoring materials; the main materials include Astragalus membranaceus, Angelica sinensis, Salvia miltiorrhiza, Scolopendra subspinipes, Dragon's blood, Eupolyphaga sinensis, Corydalis yanhusuo, Spatholobus suberectus, Corydalis yanhusuo, Prunus persica, Bupleurum chinense; the auxiliary materials include Frankincense, Rheum officinale, Scorpio, Cryptotympana pustulata, Notopterygium incisum, Tripterygium wilfordii, Paeonia lactiflora, Radix Glycyrrhizae Preparata, Carthamus tinctorius, Plantago asiatica, Borneol, Angelica dahurica, Zingiber officinale, Pueraria lobata, Medicago sativa, Typhonium giganteum, Uncaria rhynchophylla, Astragalus membranaceus; the flavoring materials include Panax quinquefolius, Cyathula officinalis, Smilax glabra, Gardenia jasminoides; Using herbs as raw materials, nourishing yin and replenishing qi, activating blood circulation and searching for toxins, dredging collaterals and relieving pain, through the compatibility of main materials, auxiliary materials, and flavoring materials to play the synergistic effect of each material, so as to be able to clear heat and detoxify, activate blood circulation and remove stasis, dredge collaterals and relieve pain, and achieve the purpose of alleviating postherpetic neuralgia.

[0008] Chinese Patent CN106511890A discloses a traditional Chinese medicine for treating postherpetic neuralgia. The traditional Chinese medicine for treating postherpetic neuralgia is prepared by mixing the following raw materials: white peony root, roasted licorice root, Chinese angelica, rehmannia root, coix seed, cicada slough, scorpion, salvia miltiorrhiza, Corydalis yanhusuo, peach kernel, safflower, plantain herb, earthworm, millettia reticulata, Cyathula officinalis, turmeric root-tuber and immature bitter orange according to a certain weight ratio. The preparation method of the present invention is simple, the absorption effect is good, the drug effect lasts for a long time, the curative effect is remarkable, there are no side effects, the safety is high, the production cost is low, and it is beneficial for patients to relieve symptoms in time.

[0009] Chinese Patent CN102526307A discloses a traditional Chinese medicine composition for treating herpes zoster, which is prepared from the following raw materials by weight: 1-1000 g of trichosanthes kirilowii, safflower, raw licorice root, scorpion, and isatis root, each 0.1-100 g. The external medicine includes: realgar, cinnabar, borneol, and phellodendron amurense, each 0.1-100 g, and vaseline 1-1000 g. The main efficacy of the traditional Chinese medicine composition is: clearing heat and detoxifying, promoting blood circulation and dredging collaterals, dissipating stasis and relieving pain, and has a good effect in aspects such as treating pain, rapid subsidence of rash and scab, short medication time, and few cases of postherpetic neuralgia.

[0010] Although there are many traditional Chinese medicine preparations for treating postherpetic neuralgia on the market, the cure of postherpetic neuralgia is still very difficult. Postherpetic neuralgia is mostly seen in elderly patients and those with weak immunity, causing great and long-term harm to the patient's spirit and psychology. In patients with more severe conditions, slight stimulation can cause pain attacks, and some show spontaneous pain, that is, pain often occurs without stimulation or touch. Long-term pain makes some patients overly nervous, and even suffer from mental depression and despair. If due to improper treatment, or due to insufficient vital qi and inability to expel pathogenic factors, the remaining pathogenic factors linger in the meridians, causing meridian stasis. Over time, it damages yin fluid, and insufficient yin fluid can lead to blood stasis. The combination of blood stasis and residual pathogenic factors causes the disease to occur, thus aggravating postherpetic neuralgia. Summary of the Invention

[0011] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating arthralgia syndrome, which dispels pathogenic factors and strengthens healthy qi by clearing heat and detoxifying, cooling blood and nourishing yin, promoting blood circulation to remove stasis, relieving pain and calming the mind, and expelling wind and removing dampness, relieving the discomfort of patients, and not damaging the body's yin fluid during the process of clearing heat, nor damaging healthy qi during the process of removing stasis. The present invention has a good therapeutic effect on postherpetic neuralgia and can also be used for heat arthralgia in rheumatic bone pain.

[0012] A traditional Chinese medicine composition for treating arthritis comprises the following raw materials in parts by weight: 15-25 parts of lithospermum officinale, 15-25 parts of snakehead, 12-18 parts of dragon's blood, 12-18 parts of raw phellodendron, 12-18 parts of raw rhubarb, 12-18 parts of zouma fetus, 9-15 parts of coptis root, 6-10 parts of frankincense, 6-10 parts of raw myrrh, 12-18 parts of menthol, 12-18 parts of borneol, 8-12 parts of cinnabar, and 45-60 parts of raw rehmannia root.

[0013] Preferably, the Chinese medicine composition for treating arthritis comprises the following raw materials in parts by weight: 20 parts of lithospermum erythrorhizon, 20 parts of snakehead, 15 parts of dragon's blood, 15 parts of raw phellodendron, 15 parts of raw rhubarb, 15 parts of zouma fetus, 12 parts of coptis chinensis, 8 parts of frankincense, 8 parts of raw myrrh, 15 parts of menthol, 15 parts of borneol, 10 parts of cinnabar, and 50 parts of raw rehmannia.

[0014] A method for preparing a Chinese medicine composition for treating arthralgia comprises the following steps:

[0015] A. Cut the lithospermum officinale and snakehead into pieces, soak them in tea oil, and filter them to obtain medicinal oil I;

[0016] B. Grind the dragon's blood, phellodendron, cinnabar, menthol and borneol into fine powder respectively, mix them together, then pour the medicinal oil I into the mixed drugs, stir and dissolve them thoroughly to form medicinal oil II;

[0017] C. Add frankincense, raw myrrh, raw rhubarb, trotter, coptis root and raw rehmannia root into tea oil and soak, light a fire, boil the oil until the medicine becomes burnt, filter out the medicine residue, add white vaseline and stir thoroughly to form medicine oil III;

[0018] D. After the temperature of drug oil III has dropped, add it into drug oil II, stir, dissolve and mix thoroughly to form drug oil IV;

[0019] E. Finally, put the medicinal oil IV into a container and store it at low temperature.

[0020] Preferably, in step A, the mass ratio of lithospermum officinale to tea oil is 1:4-6.

[0021] Preferably, in step A, the soaking time is 22 to 26 hours, and the mixture is stirred every 1 to 1.2 hours.

[0022] Preferably, in step B, the fine powder is sieved through a 120-mesh sieve.

[0023] Preferably, in step C, the weight of tea oil added is 1.5 to 3 times that of the Chinese medicinal raw material.

[0024] Preferably, in step C, the amount of white vaseline added is 4 to 6 times the weight of the drug solution.

[0025] Preferably, in step C, the soaking time is 1 to 1.2 hours.

[0026] Preferably, in step D, the temperature is reduced to 50-60 °C.

[0027] The sources and effects of the raw materials of the present invention are as follows:

[0028] Ardisia gigantifolia Stapf: It is a commonly used Chinese herbal medicine of the Jing ethnic group in Guangxi. It is derived from the roots and rhizomes of the plant Ardisia gigantifolia Stapf of the Myrsinaceae family.

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[0029] Ludwigia adscendens (L.) Hara: It is a commonly used Chinese herbal medicine of the Jing ethnic group in Guangxi. It is derived from the whole herb of the plant Ludwigia adscendens (L.) Hara of the Onagraceae family.

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[0030] Lithospermum erythrorhizon Sieb. et Zucc.: It is mainly derived from the dried roots of the plants Lithospermum erythrorhizon Sieb. et Zucc., Arnebia euchroma (Royle) Johnst. or Arnebia guttata Bunge of the Boraginaceae family, and is widely distributed throughout China. The specific collection areas may vary depending on the variety.

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[0031] Dragon's Blood: It is mainly derived from the resin exuded from the fruits of the palm plant Dracaena cochinchinensis. It is produced in Southeast Asian regions such as Indonesia and Malaysia. In China, dragon's blood is also cultivated, mainly distributed in Guangdong, Taiwan and other places.

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[0032] Phellodendron Bark: It is mainly derived from the dried bark of the Rutaceae plants Phellodendron chinense Schneid. or Phellodendron amurense Rupr. It is mainly produced in Sichuan, Guizhou, Hubei, Yunnan and other places in China. Among them, the phellodendron bark produced in Sichuan is also called "Sichuan Phellodendron Bark", and the phellodendron bark produced in Liaoning, Jilin, Hebei and other places is commonly known as "Guan Phellodendron Bark".

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[0033] Rhubarb: It is mainly derived from the rhizomes of the Polygonaceae plants Rheum palmatum L., Rheum tanguticum Maxim. ex Balf. or Rheum officinale Baill., mainly distributed in the northwest regions of China such as Qinghai, Gansu, Sichuan and other places.

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[0034] Coptis chinensis Franch.: It mainly comes from the rhizomes of the plants of Ranunculaceae family, Coptis chinensis Franch. It is produced in Sichuan, Guizhou, Hunan, Hubei, southern Shaanxi and other places in China. Among them, the Coptis chinensis Franch. produced in Sichuan is the most famous.

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[0035] Olibanum: It mainly comes from the gum resin of the plants of Burseraceae family, Boswellia carterii Birdw. It is produced in northern Ethiopia, Somalia, and the southern Arabian Peninsula and other places. It is divided into Somali olibanum and Ethiopian olibanum. Each type of olibanum is further divided into olibanum beads and crude olibanum.

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Nature and flavor and meridian tropism

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[0036] Myrrh: It mainly comes from the oleo-gum resin of the plants of Burseraceae family, Commiphora myrrha Engl. It is produced in Somalia, Ethiopia, and the southern region of the Arabian Peninsula.

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Nature and flavor and meridian tropism

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Usage

[0037] Menthol: It is mainly derived from the whole herb or leaves of the mint plant of the Lamiaceae family and is obtained through extraction and refining processes. Mint is widely distributed globally, and Jiangsu, Anhui and other places are traditional authentic production areas in China.

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[0038] Borneol: It is a processed product from the stems, leaves of Blumea balsamifera of the Compositae family or the branches and leaves of Cinnamomum camphora of the Lauraceae family. Its main component is dextrorotatory borneol, which is a terpene compound with a special delicate fragrance. It is produced in Sumatra, Indonesia and other places, and is also produced in Shanghai, Tianjin, Nanjing, Guangzhou and other places in China.

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[0039] Cinnabar: It is a cinnabar of the cinnabarite group of sulfide minerals, and its main component is mercury sulfide (HgS). It is distributed in Hunan, Hubei, Sichuan, Guangxi, Guizhou, Yunnan and other places in China and can be mined throughout the year.

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[0040] Rehmannia Root: It is the root of Rehmannia glutinosa Libosch. of the family Scrophulariaceae and is the tuberous root of a perennial herb. It is native to China and is also distributed in Korea, Japan and other places. The Rehmannia root produced in Huaiqing area (now Jiaozuo City) of Henan Province, China, has the best quality, so it is known as "Huai Rehmannia Root".

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[0041] In the formula, Lithospermum erythrorhizon and Dragon's Blood are used as the monarch drugs. Lithospermum erythrorhizon has the effects of cooling blood and promoting blood circulation, clearing heat and detoxifying, and promoting eruption and resolving macules, while Dragon's Blood has the functions of promoting blood circulation to remove blood stasis, stopping bleeding and promoting granulation, and relieving pain. First of all, the combination of the two can promote blood circulation to remove blood stasis and relieve pain, and produce a synergistic effect in promoting blood circulation and the healing of damaged tissues, which helps to relieve the pain caused during the attack period and the postherpetic neuralgia period of herpes zoster. Secondly, Lithospermum erythrorhizon has an anti-inflammatory effect. Lithospermum erythrorhizon contains acetylshikonin, and acetylshikonin is hydrolyzed to obtain shikonin. Shikonin is a quinone derivative, and its structure is similar to vitamin K. It can dilate local capillaries, improve skin microcirculation disorders, promote microcirculation, and make the nerve inflammation improve; Dragon's Blood has the pharmacological effects of promoting blood circulation to remove blood stasis and promoting qi to relieve pain, and has a certain effect on relieving nerve inflammation. The addition of Dragon's Blood enhances the anti-inflammatory effect of Lithospermum erythrorhizon in patients with chronic skin lesions. Finally, Lithospermum erythrorhizon has a significant effect in clearing heat and detoxifying, while Dragon's Blood has a unique role in promoting blood circulation to remove blood stasis. The combination of the two has a better curative effect on the skin lesions caused by herpes zoster manifested as heat-toxin and blood stasis.

[0042] Phellodendron amurense, Coptis chinensis and Rheum palmatum are used as the ministerial drugs together. These three drugs all have the effect of clearing heat, and their combination can enhance the effect of clearing heat and purging fire; among them, Rheum palmatum can clear blood heat, break blood stasis, relieve swelling and pain, and dispel stasis and promote tissue regeneration when used externally. When combined with Phellodendron amurense and Coptis chinensis, it can also enhance their effects of promoting blood circulation to remove blood stasis and promoting granulation and tissue regeneration.

[0043] Olibanum and Myrrh are used as the ministerial drugs together. The former is more inclined to promote qi, and the latter is more inclined to promote blood. The two are used in combination to enhance the effects of promoting blood circulation to relieve pain, dissipating swelling and promoting granulation, and then promote wound healing, thus improving symptoms such as the non-healing of herpes zoster for a long time.

[0044] Ludwigia octovalvis (Jacq.) Raven and Ardisia gigantifolia Stapf are also assistant drugs. Ludwigia octovalvis (Jacq.) Raven, with the properties of clearing heat and detoxifying, promoting diuresis and detumescence, is applicable to the treatment of herpes zoster caused by heat toxin and damp pathogen. Its moistening and fire-reducing effects can be used to improve skin dryness and itching discomfort caused by the dry and hot pathogen of herpes zoster. Ardisia gigantifolia Stapf has the efficacy of dispelling wind and removing dampness, and is used to relieve rheumatic arthralgia. At the same time, it can help remove the damp pathogen of herpes zoster. Its effect of promoting blood circulation and removing stasis helps to clear the stasis caused by the retention of pathogenic toxin in the skin and promotes the repair of muscles and nerves. The combination of the two drugs can enhance the effect of clearing heat and detoxifying: the combination of the heat-clearing and detoxifying effect of Ludwigia octovalvis (Jacq.) Raven and the promoting blood circulation and removing stasis effect of Ardisia gigantifolia Stapf helps to treat diseases caused by heat toxin, accelerate wound healing and reduce inflammation. In addition, the effect of Ardisia gigantifolia Stapf in dispelling wind and dampness may be combined with the diuretic effect of Ludwigia octovalvis (Jacq.) Raven, which can significantly improve diseases such as rheumatoid arthritis.

[0045] Cinnabaris and Rehmannia glutinosa Libosch. are adjuvant drugs together. The combination of the two can exert the efficacy of clearing heat and detoxifying, stopping bleeding and dispersing stasis; among them, Cinnabaris also has the effect of calming the mind and relieving uneasiness, which can relieve the discomfort brought by arthralgia diseases such as postherpetic neuralgia. At the same time, a large amount of Rehmannia glutinosa Libosch. is added, which clears heat and cools blood, nourishes yin while clearing heat, promotes blood circulation and removes stasis without damaging yin. The components contained in Rehmannia glutinosa Libosch. can promote the recovery of blood cells and hemoglobin, accelerate the proliferation and differentiation of hematopoietic stem cells, and promote the repair of diseased tissues.

[0046] Borneol and Menthol are guiding drugs, which have the effects of clearing heat, relieving pain and itching. In this formula, they are used as penetrants to direct the medicinal effects to the diseased parts, guide all the drugs to penetrate through the skin into the interior, penetrate from the skin into the nerves and muscles, and disperse the stagnant fire in the diseased parts.

[0047] Using oil as a medium can play the role of moisturizing the skin, and at the same time can also promote the absorption of drugs.

[0048] The beneficial effects of the present invention compared with the prior art are as follows:

[0049] 1. The present invention has excellent curative effects on arthralgia diseases such as postherpetic neuralgia. It has the effects of clearing heat and detoxifying, cooling blood and nourishing yin, promoting blood circulation and removing stasis, relieving pain and calming the mind, and dispelling wind and removing dampness, thus effectively relieving the discomfort of patients. During the process of clearing heat, the present invention will not damage the body's yin fluid, and at the same time, during the process of removing stasis, it will not damage the healthy qi, truly achieving the effect of dispelling pathogenic factors and strengthening healthy qi.

[0050] 2. The traditional Chinese medicine composition of the present invention is applicable to the neuralgia left by herpes zoster, and for patients with herpes zoster at various stages, whether in the initial stage, middle stage or late stage, it can play a therapeutic role in relieving pain, and also has good curative effects on the skin rash during the progressive stage of herpes zoster; and regardless of the age and constitution of the patients, the present invention can show good adaptability and high efficiency. Detailed implementation mode

[0051] Before further describing the specific embodiments of the present invention, it should be understood that the protection scope of the present invention is not limited to the following specific embodiments; it should also be understood that the terms used in the embodiments of the present invention are for describing specific embodiments and not for limiting the protection scope of the present invention.

[0052] Example 1

[0053] A traditional Chinese medicine composition for treating arthralgia syndrome comprises the following raw materials in parts by weight: 15 g of lithospermum root, 15 g of floating heartleaf pondweed herb, 12 g of dragon's blood, 12 g of cortex phellodendri, 12 g of rheum officinale, 12 g of ardisia gigantifolia stapf, 9 g of coptis chinensis, 6 g of frankincense, 6 g of myrrh, 12 g of menthol, 12 g of borneol, 8 g of cinnabar, and 45 g of rehmannia glutinosa.

[0054] The preparation method of the traditional Chinese medicine composition for treating arthralgia syndrome comprises the following steps:

[0055] A. Cut the lithospermum root and floating heartleaf pondweed herb into pieces, soak them in tea seed oil, stir once every 1 hour, soak for 22 hours, and filter to obtain medicinal oil I; the addition amount of tea seed oil is 150 g;

[0056] B. Grind dragon's blood, cortex phellodendri, cinnabar, menthol, and borneol into fine powders respectively, pass the fine powders through a 120-mesh sieve, mix and pack them together, then pour medicinal oil I into the mixed drugs, and stir and dissolve them fully to form medicinal oil II;

[0057] C. Add frankincense, myrrh, rheum officinale, ardisia gigantifolia stapf, coptis chinensis, and rehmannia glutinosa into tea seed oil and soak for 1 hour, start a fire, boil the oil until the drugs become scorched, filter out the drug residues, and add white petrolatum and stir fully to form medicinal oil III; the addition amount of tea seed oil is 180 g; the addition amount of white petrolatum is 450 ml;

[0058] D. After medicinal oil III cools down to 55°C, add it to medicinal oil II, stir, dissolve, and mix them fully to form medicinal oil IV;

[0059] E. Finally, put medicinal oil IV into a container and store it at a low temperature to obtain the product.

[0060] Example 2

[0061] A traditional Chinese medicine composition for treating arthralgia syndrome comprises the following raw materials in parts by weight: 20 g of lithospermum root, 20 g of floating heartleaf pondweed herb, 15 g of dragon's blood, 15 g of cortex phellodendri, 15 g of rheum officinale, 15 g of ardisia gigantifolia stapf, 12 g of coptis chinensis, 8 g of frankincense, 8 g of myrrh, 15 g of menthol, 15 g of borneol, 10 g of cinnabar, and 50 g of rehmannia glutinosa.

[0062] The preparation method of the traditional Chinese medicine composition for treating arthralgia syndrome comprises the following steps:

[0063] A. Cut Lithospermum erythrorhizon and Ludwigia adscendens into pieces, soak them in camellia oil, stir once every hour, soak for 24 hours, and filter to obtain Medicinal Oil Ⅰ; the addition amount of camellia oil is 200 g;

[0064] B. Grind Sanguis Draxonis, Phellodendron amurense, Cinnabaris, Menthol, and Borneol into fine powders respectively. The fine powders are respectively passed through a 120-mesh sieve, mixed and filled together, then pour Medicinal Oil Ⅰ into the mixed medicine, and stir and dissolve fully to form Medicinal Oil Ⅱ;

[0065] C. Soak Frankincense, Myrrh, Rheum officinale, Ardisia gigantifolia, Coptis chinensis, and Rehmannia glutinosa in camellia oil for 1 hour, ignite, boil the oil until the medicine becomes scorched, filter out the medicinal residues, and add white petrolatum to stir fully to form Medicinal Oil Ⅲ; the addition amount of camellia oil is 175 g; the addition amount of white petrolatum is 500 ml;

[0066] D. After Medicinal Oil Ⅲ cools down to 50 °C, add it to Medicinal Oil Ⅱ, stir, dissolve, and mix evenly to form Medicinal Oil Ⅳ;

[0067] E. Finally, pour Medicinal Oil Ⅳ into a container and store it at low temperature to obtain the product.

[0068] Example 3

[0069] A traditional Chinese medicine composition for treating arthralgia includes the following raw materials in parts by weight: 25 g of Lithospermum erythrorhizon, 25 g of Ludwigia adscendens, 18 g of Sanguis Draxonis, 18 g of Phellodendron amurense, 18 g of Rheum officinale, 18 g of Ardisia gigantifolia, 15 g of Coptis chinensis, 10 g of Frankincense, 10 g of Myrrh, 18 g of Menthol, 18 g of Borneol, 12 g of Cinnabaris, and 60 g of Rehmannia glutinosa.

[0070] The preparation method of the traditional Chinese medicine composition for treating arthralgia includes the following steps:

[0071] A. Cut Lithospermum erythrorhizon and Ludwigia adscendens into pieces, soak them in camellia oil, stir once every hour, soak for 26 hours, and filter to obtain Medicinal Oil Ⅰ; the addition amount of camellia oil is 250 g;

[0072] B. Grind Sanguis Draxonis, Phellodendron amurense, Cinnabaris, Menthol, and Borneol into fine powders respectively. The fine powders are respectively passed through a 120-mesh sieve, mixed and filled together, then pour Medicinal Oil Ⅰ into the mixed medicine, and stir and dissolve fully to form Medicinal Oil Ⅱ;

[0073] C. Soak Frankincense, Myrrh, Rheum officinale, Coptis chinensis, and Rehmannia glutinosa in camellia oil for 1 hour, ignite, boil the oil until the medicine becomes scorched, filter out the medicinal residues, and add white petrolatum to stir fully to form Medicinal Oil Ⅲ; the addition amount of camellia oil is 250 g; the addition amount of white petrolatum is 650 ml;

[0074] D. After Medicinal Oil Ⅲ cools down to 55 °C, add it to Medicinal Oil Ⅱ, stir, dissolve, and mix evenly to form Medicinal Oil Ⅳ;

[0075] E. Finally, load the medicated oil Ⅳ into a container and store it at low temperature to obtain the product.

[0076] Comparative Example 1

[0077] It is basically the same as Example 2, except that the preparation raw materials do not include lithospermum root and dragon's blood, and the dosage ratios of other raw materials remain unchanged.

[0078] Comparative Example 2

[0079] It is basically the same as Example 2, except that the preparation raw materials do not include dragon's blood, and the dosage ratios of other raw materials remain unchanged.

[0080] Comparative Example 3

[0081] It is basically the same as Example 2, except that the preparation raw materials do not include lithospermum root, and the dosage ratios of other raw materials remain unchanged.

[0082] I. Animal experiments

[0083] 1. Experimental animals

[0084] 70 male SPF-grade SD rats, with a body weight of 200 - 220 g and 7 weeks old, were purchased from Hunan Slack Jingda Experimental Animal Co., Ltd. The production license number is: SCXK(Xiang)2019 - 0004, and the use license is: SYXK(Gu)2019 - 0001. All rats were raised in the animal breeding room at a temperature of (25 ± 2)°C and a humidity of (50 ± 5)%, with free access to water and food. The whole experiment followed the 3R principle.

[0085] 2. Research methods

[0086] 2.1 Construction and grouping of the postherpetic neuralgia model

[0087] Before modeling, the mechanical and thermal sensitivities of each rat were detected. Resiniferatoxin was mixed evenly with 10% ethanol, 80% normal saline, and 10% Tween 80 to prepare a 100 mg / L resiniferatoxin mixture, and then intraperitoneally injected for modeling at 200 μg / kg; 3 days after modeling, the mechanical and thermal sensitivities of the rats were detected again. If the thermal pain threshold (TWL) was significantly increased and the mechanical pain threshold (PWT) was significantly decreased compared with before modeling, the modeling was successful.

[0088] The 70 successfully modeled rats were divided into a control group, an Example 1 group, an Example 2 group, an Example 3 group, a Comparative Example 1 group, a Comparative Example 2 group, and a Comparative Example 3 group according to the random number table method.

[0089] The control group was applied with clear water; the groups of Example 1, Example 2, and Example 3 were respectively applied with the ointments of Example 1 to 3; the groups of Comparative Example 1, Comparative Example 2, and Comparative Example 3 were applied with the ointments of Comparative Example 1 to 3; all were applied 3 times a day for 21 consecutive days.

[0090] 2.2 Mechanical Stimulation Sensitivity Experiment

[0091] The rats were placed in a transparent acrylic box, and then the box was placed on an iron net. The rats were placed in the box for 30 min to adapt to the environment. Then, vonfrey filaments with a pressure value of 0.2 - 26 g were selected and vertically stimulated the outer edge skin of the right hind paw of the rats from bottom to top in ascending order of intensity. When the rats showed contraction responses such as retracting the hind paw, licking the paw, and shaking the leg, the stimulation intensity at this time was recorded, which was the PWT.

[0092] 2.3 Thermal Stimulation Sensitivity Experiment

[0093] The rats were placed in a transparent acrylic box, and a cold / hot plate pain tester was placed under the box. After the rats adapted to the environment, the thermal intensity of the tester was adjusted to 45 °C and aimed at the right hind paw sole of the rats. When the hind paw showed a contraction phenomenon, the intensity value at this time was recorded, which was the TWL.

[0094] 2.4 Detection of Peripheral Neurotransmitters Adenosine, AMP, and ADP

[0095] After the drug application was completed, the right lower limbs of the rats in each group were disinfected. The microdialysis linear probe was inserted into the anterior edge of the tibia, connected to the microdialysis system, and perfused for 30 min at a flow rate of 1 μL / min. The peripheral tissue fluid (perfusate) was collected and the levels of adenosine, AMP, and ADP were detected according to the kit instructions.

[0096] 2.5 Collection of Spinal Cord Dorsal Horn Samples

[0097] After the detection in 2.4 was completed, the rats were anesthetized and sacrificed. The spinal cord dorsal horn specimens of L3 - L5 were taken. The specimens of 5 rats in each group were fixed in 4% paraformaldehyde by random number table method for making pathological paraffin sections, and the specimens of the remaining 5 rats were placed in a -80 °C refrigerator for enzyme-linked immunosorbent assay (ELISA) and Western blot experiments.

[0098] 2.6 Observation of Pathological Sections of Spinal Cord Dorsal Horn by HE Staining

[0099] The fixed L3 - L5 spinal cord samples were dehydrated and then embedded in paraffin, cut into tissue sections about 5 μm thick, rehydrated with ethanol of different volume fractions after dewaxing, stained with HE, dehydrated with gradient ethanol again, sealed with neutral gum, and observed under a microscope for pathological changes in the spinal cord dorsal horn.

[0100] 2.7 Detection of Inflammatory Factors by ELISA Kit

[0101] Take out the spinal cord samples stored in a -80°C refrigerator. After homogenizing with a grinder, the supernatant is separated, and the levels of inflammatory factors TNF-α and IL-1β in the spinal dorsal horn are detected according to the instructions of the ELISA kit.

[0102] 3. Statistical methods

[0103] Data analysis was performed using SPSS 25.0 software. Measurement data conformed to a normal distribution and were expressed as mean ± standard deviation For comparison among multiple groups, one-way analysis of variance (ANOVA) was used, and for multiple comparisons between groups, the SNKq test was used.

[0104] 4. Results

[0105] 4.1 Effects of the drug on mechanical and thermal stimulus sensitivity in rats of each group are shown in Table 1.

[0106] Table 1 Changes in PWT and TWL of rats in each group (n = 10, )

[0107] Group PWT / g TWL / s Control group 9.32 30.98 Example 1 24.52 12.69 Example 2 26.37 11.01 Example 3 25.66 11.70 Comparative example 1 11.38 27.21 Comparative example 2 14.96 23.89 Comparative example 3 14.58 25.20

[0108] 4.2 Effects of the drug on peripheral neurotransmitters in rats of each group are shown in Table 2.

[0109] Table 2 Changes in peripheral neurotransmitter levels in rats of each group (n = 5, μg / L, )

[0110] Group Adenosine AMP ADP Control group 11.85 3.20 7.21 Example 1 41.87 8.64 28.81 Example 2 45.69 9.88 31.20 Example 3 43.25 9.06 30.00 Comparative example 1 13.14 4.46 8.10 Comparative example 2 16.78 5.15 14.24 Comparative example 3 16.43 4.89 13.55

[0111] 4.4 Effects of the drug on inflammatory factor levels and microglial activation in rats of each group are shown in Table 3.

[0112] Table 3 Changes in inflammatory factor levels and the number of Iba1-positive microglia in rats of each group (n = 5, )

[0113]

[0114] As can be seen from Tables 1-2, after applying the ointments of Examples 1-3 and Comparative Examples 1-3 of the present invention, the PWT values, adenosine, AMP, and ADP levels of rats increased significantly, and the TWL values decreased significantly, indicating that the ointment of the present invention can improve mechanical and thermal stimulus sensitivity and relieve the symptoms of postherpetic neuralgia.

[0115] As can be seen from Table 3, after applying the ointments of Examples 1-3 and Comparative Examples 1-3 of the present invention, the levels of TNF-α and IL-1β and the number of Iba1-positive microglia in rats were significantly decreased, indicating that the ointment of the present invention can inhibit the activation of spinal dorsal horn glial cells and the release of pro-inflammatory factors in rats with postherpetic neuralgia, thereby alleviating neuropathic pain.

[0116] Among them, the improvement effects of Examples 1-3 were much higher than those of Comparative Examples 1-3, and Example 2 was the optimal example. On the basis of Example 2, in Comparative Example 1, lithospermum and dragon's blood were not added, and the two were used as monarch drugs in the formula. After removing these two herbs, there was no obvious improvement in postherpetic neuralgia; on the basis of Comparative Example 1, in Comparative Examples 2 and 3, lithospermum and dragon's blood were added respectively, and both could improve the symptoms of postherpetic neuralgia to a certain extent, but the sum of their effects was still lower than that of Example 2. It can be seen that there is a synergistic effect between lithospermum and dragon's blood in improving the symptoms of postherpetic neuralgia.

[0117] II. Clinical experiments

[0118] 1. Diagnostic criteria for traditional Chinese medicine syndromes

[0119] The diagnostic criteria for qi stagnation and blood stasis syndrome of postherpetic neuralgia were formulated with reference to the Guidelines for the Diagnosis and Treatment of Traditional Chinese Medicine for Herpes Zoster (Revised Edition 2014) and Diagnostics of Traditional Chinese Medicine.

[0120] Main symptoms: The pain persists for more than 1 month after the rash subsides, can radiate to nearby parts, mostly shows running pain or stabbing pain, and is intolerable to pressure;

[0121] Secondary symptoms: Chest, hypochondrium, epigastrium and abdomen are stuffy and full; insomnia at night, getting worse at night; emotional depression or irritability. Tongue manifestation: The tongue is purple and dull, dark red or has ecchymosis, and the coating is yellow or white; Pulse condition: Stringy and thready or stringy and unsmooth.

[0122] Diagnosis: It can be diagnosed by having the main symptoms, tongue and pulse conditions and at least 1 secondary symptom.

[0123] 2. Case screening criteria Inclusion criteria

[0124] Meeting the diagnostic criteria of postherpetic neuralgia in Western medicine and traditional Chinese medicine syndrome diagnosis; visual analogue scale score of pain ≥ 4 points; aged between 40 and 70 years old, regardless of gender; conscious and fluent in response; no treatment measures for postherpetic neuralgia have been taken within the past week; those who voluntarily participate and sign the informed consent form. Exclusion criteria: those with pathological pain caused by other reasons; those with severe visceral diseases, organ failure, tumors, hematological diseases and bleeding tendencies; those with primary anxiety, depression and primary sleep disorders; those in lactation and pregnancy; those with a history of drug allergy; those who are currently participating in other drug clinical trials. Exclusion criteria: those who are misincluded and do not meet the inclusion criteria; patients with poor compliance or who do not follow the treatment plan, such as using other drugs by themselves; those with incomplete data records and affected test results. Withdrawal criteria: during the trial, the included cases who give up or withdraw for personal reasons; patients who have serious adverse reactions or complications and need to stop the trial; those who are lost to follow-up after treatment. Termination criteria: during the treatment process, in the following situations, the trial should be immediately stopped according to clinical evaluation: those with changes in clinical conditions; those who may occur or have already occurred uncontrollable events; those who have developed diseases unrelated to the research of the present invention and interfere with observation.

[0125] 3. Methods

[0126] 3.1 Treatment method

[0127] Control group: Apply acyclovir cream, 4 - 6 times a day, for 3 weeks of treatment.

[0128] Treatment group: Each group applies the ointment of Example 2, 4 - 5 times a day, for 3 weeks of treatment.

[0129] 3.2 Observation indicators

[0130] Pain intensity score: The visual analogue scale (VAS) was used to evaluate pain intensity, which was scored from 0 to 10 points according to the pain level. The higher the score, the more severe the pain. Severe pain, unbearable pain, affecting sleep and appetite (7 - 10 points); Pain that can still be tolerated, affecting sleep (4 - 6 points); Mild pain, tolerable (1 - 3 points); No pain (0 points). Records were made before treatment and 1 day after treatment for each patient. Anxiety degree score: The Hamilton Anxiety Scale (HAMA) was used to evaluate anxiety degree. There were 14 items, and each item adopted a 5 - level scoring method: 0 points indicated no symptoms; 1 point indicated mild; 2 points indicated moderate; 3 points indicated severe; 4 points indicated extremely severe. The total score of the Hamilton Anxiety Scale ≤ 7 points indicated no anxiety symptoms; 8 - 14 points indicated possible anxiety; 15 - 21 points indicated definite anxiety; 22 - 29 points indicated definite obvious anxiety; The total score ≥ 30 points indicated severe anxiety. Records were made before treatment and 1 day after treatment for each patient. Sleep quality score: The Pittsburgh Sleep Quality Index (PSQI) was used to score the sleep quality of patients before and after treatment. Each of the 7 components was scored on a scale of 0 - 3, and the cumulative score was the total score. The PSQI total score ranged from 0 to 21 points. Very poor sleep quality (16 - 21 points); General sleep quality (11 - 15 points); Fair sleep quality (6 - 10 points); Good sleep quality (0 - 5 points). Records were made before treatment and 1 day after treatment for each patient. Traditional Chinese medicine (TCM) syndrome score: According to the "Guiding Principles for Clinical Research of New TCM Drugs (Trial)", the evaluation criteria for TCM syndrome scores were formulated. For the absence, mild, moderate, and severe syndromes, the scores were 0, 2, 4, and 6 points respectively. The observed syndromes were: pain, chest and hypochondrium distension and fullness, restlessness at night, and emotional depression. The sum of the scores of each syndrome was the TCM syndrome score. The higher the score, the more severe the clinical symptoms. Assessments were made before treatment and 1 day after treatment for each patient. Adverse reactions: Before and after treatment, the renal function, liver function and electrocardiogram of the patients were examined, and the drug adverse reactions were recorded.

[0131] 3.3 Efficacy judgment criteria

[0132] The efficacy assessment criteria were formulated with reference to the "Guiding Principles for Clinical Research of New TCM Drugs (Trial)" and the "Diagnostic and Therapeutic Criteria for TCM Diseases and Syndromes".

[0133] The formula for calculating the efficacy index (using the Nimodipine method); Efficacy index = (total score before treatment - total score after treatment) / total score before treatment × 100%. The comprehensive efficacy was divided into: Cured: The pain and signs disappeared or basically disappeared, and the efficacy index ≥ 95%; Markedly effective: The pain and signs were significantly reduced, 95% > efficacy index ≥ 70%; Effective: The pain and signs were reduced compared with before, 70% > efficacy index ≥ 30%; Ineffective: The pain and signs were not reduced, and the efficacy index < 30%.

[0134] The cure and marked effective rate = (number of cases of markedly effective + cured) / total number of cases × 100%;

[0135] Total effective rate = (number of effective + markedly effective + cured) cases / total number of cases × 100%.

[0136] 3.4 Statistical method: Analyzed using SPSS 20.0 statistical software. The data were all tested for normal distribution and analyzed by analysis of variance. The data with normal distribution were expressed as , and the t-test was used for comparison before and after treatment and between groups; measurement data were expressed as frequency, and the χ 2 test was used for efficacy analysis.

[0137] 4. Results

[0138] 4.1 Completion situation

[0139] One patient in the control group dropped out on his own initiative due to ineffective pain relief and was referred. Finally, 34 cases were completed; all 35 cases in the treatment group were completed.

[0140] 4.2 The results of VAS scores are shown in Table 4.

[0141] Table 4 Comparison of VAS scores between two groups of patients (score, )

[0142] Group Number of cases Before treatment After treatment Control group 34 7.24 4.58 Treatment group 35 7.00 2.17

[0143] 4.3 Sleep and anxiety conditions are shown in Table 5.

[0144] Table 5 Comparison of sleep and anxiety conditions between two groups of patients (score, )

[0145]

[0146] 4.4 TCM syndrome scores are shown in Table 6.

[0147] Table 6 Comparison of TCM syndrome scores between two groups of patients (score, )

[0148] Group Number of cases Before treatment After treatment Control group 34 18.04 9.11 Treatment group 35 17.98 3.80

[0149] 4.5 Clinical efficacy is shown in Table 7.

[0150] Table 7 Comparison of clinical efficacy between two groups of patients (cases, %)

[0151] Group Number of cases Cured Markedly effective Effective Ineffective Marked and cured rate Total effective Control group 34 5 10 10 9 44.1 73.5 Treatment group 35 15 16 4 0 88.6 100

[0152] As can be seen from Tables 4 to 7, after applying the ointments of Examples 1 to 3 and Comparative Examples 1 to 3 of the present invention, compared with before treatment, the HAMA scores, PSQI scores, VAS scores, and traditional Chinese medicine syndrome scores of the two groups of patients were significantly decreased; after treatment, when comparing between groups, the HAMA scores, PSQI scores, VAS scores, and traditional Chinese medicine syndrome scores of the patients in the treatment group were significantly lower than those in the control group, indicating that both groups could significantly relieve the pain of patients with postherpetic neuralgia, improve sleep quality and anxiety, and the treatment group was superior to the control group. Both groups had significant curative effects, but the markedly effective rate and total effective rate of the treatment group were higher than those of the control group. It shows that the ointment of the present invention has a good improvement effect on the symptoms of postherpetic neuralgia.

[0153] III. Classic Cases of Clinical Application

[0154] 1. Bai, male, 51 years old, the patient visited the doctor due to "skin pain on the left waist for more than 2 months". Two months ago, the patient suddenly developed "herpes zoster" on the left waist. After treatment, the herpes scabbed and fell off, but the pain remained, showing intermittent, knife-like pain, which was aggravated at night and the patient couldn't sleep all night. The urine was yellow and the stool was dry. He had a history of hypertension for more than 10 years and a history of diabetes for 6 years. Physical examination: There was no rash on the skin of the affected area, and the tenderness was obvious. The tongue was dull red, the tongue coating was white and greasy with a thick root, and the pulse was deep, string-like and slippery. The diagnosis was "postherpetic neuralgia on the left waist". The cream prescription was applied 4 - 5 times a day. After 3 weeks of treatment, the patient visited the doctor again and reported that there was no pain.

[0155] 2. Liu, female, 67 years old, visited the doctor due to "pain on the left forehead for more than 2 months". Two months ago, the patient began to have intermittent pain on the left forehead, accompanied by low fever, and then erythema and blisters appeared. After being diagnosed with "herpes zoster" by Western medicine and receiving treatments such as nerve nourishment and antiviral treatment, the herpes scabbed and fell off, but the pain did not improve. The pain was knife-like and lightning-like, occurring intermittently, lasting for several seconds each time, suddenly starting and suddenly stopping, and not painful during the intermission. She had a healthy past history. Physical examination: There was a small amount of desquamation on the skin of the affected area, and the tenderness was obvious. The tongue was dull with a white coating, there were stasis points on the tongue body, and the pulse was string-like and tight. The diagnosis was "postherpetic neuralgia on the left forehead". The cream prescription was applied 4 - 5 times a day. After 3 weeks of treatment, the patient visited the doctor again and reported that the pain had disappeared.

[0156] 3. Ding, male, 49 years old, visited the doctor due to "skin pain in the inner side of the left thigh for more than 1 month". One month ago, the patient found reddish-brown herpes distributed in a band on the inner side of the left thigh, accompanied by obvious burning pain, fever and aversion to cold, with the highest fever reaching 39.7°C, and normal bowel and bladder movements. So he received antipyretic treatment in a local hospital. After treatment, the patient no longer had symptoms of fever and aversion to cold, but still felt severe pain at the rash site. He had a history of "diabetes". Physical examination: normal body temperature, no enlarged tonsils, scattered red macules of different sizes could be seen on the inner side of the left thigh, with tenderness (+). The tongue was crimson red, with little coating, and the tongue surface was dry and astringent. The diagnosis was "postherpetic neuralgia on the inner side of the left thigh". This plaster was applied, and the patient was instructed to apply it 4 - 5 times a day. Half a month later, the color of the macules faded, and after one month, there was no obvious pain.

[0157] 4. Liang, male, 62 years old, visited the doctor due to "skin pain in the right chest for 2 months". The patient reported that 2 months ago, a large area of bright red papules appeared on the right chest, showing clustered and banded reddish-brown rashes the size of mung beans, with severe local pain that worsened at night. So he visited a local doctor and was considered to have "herpes zoster". After symptomatic treatment such as antiviral, improving blood circulation, and nourishing nerves, the herpes absorbed and crusted, but the skin pain in the right chest was severe, showing paroxysmal, electric shock-like stabbing and burning pain, and he couldn't sleep at night. He had a history of "hypertension". Physical examination: scattered and banded distributed dark red macules could be seen on the chest. The tongue was red, the coating was yellow and greasy, and the pulse was string-like and slippery. The diagnosis was "postherpetic neuralgia of the chest". This plaster was applied, and the patient was instructed to apply it 4 - 5 times a day. After continuing to apply it for 3 weeks, the pain improved significantly compared with before.

[0158] 5. Chen, male, 55 years old, visited the doctor due to "red rash on the right thigh accompanied by pain for 1 week". The patient reported that 1 week ago, after getting angry, irregular red rashes began to appear on the right thigh, accompanied by continuous knife-like pain, dry mouth and bitter taste, yellow urine, and dry stools. Physical examination: There were about 3 clusters of blisters 4×4 cm in size on the inner side of the right thigh, arranged irregularly, with obvious tenderness, normal body temperature, red tongue, yellow and greasy coating, and string-like and rapid pulse. This plaster was applied, and the patient was instructed to apply it 4 - 5 times a day. After 5 days, the rash subsided and crusted, after 8 days the crusts fell off, and after 3 weeks the pain subsided.

[0159] 6. Liu, male, 56 years old, visited the doctor due to "fever, swelling, and pain in multiple joints for more than 1 week". One week ago, the patient had fever, swelling, and pain in multiple joints without obvious cause, with red skin color and limited movement. These symptoms worsened on rainy days, especially in the two finger joints and the left knee. He was accompanied by restlessness and insomnia, dry mouth and bitter taste, yellow urine, and normal stools. The tongue was red, the coating was yellow and greasy, and the pulse was string-like and rapid. He had been in good health before. Physical examination: The skin color of multiple joints was red, the skin temperature was high, and the range of motion was poor. The diagnosis was "rheumatic heat arthralgia". This plaster was applied, and the patient was instructed to apply it 4 - 5 times a day. After 1 week, the pain subsided.

[0160] 7. Wu, female, 66 years old, visited the doctor due to "recurrent pain in multiple joints for more than 10 years, aggravated for 2 days". 10 years ago, the patient had morning stiffness and pain in both hands without obvious cause, which could be relieved after activity. She was diagnosed with "rheumatoid arthritis" at an external hospital. 2 days ago, the above symptoms were aggravated, so she came to see a doctor. She had a healthy past history. Physical examination showed swelling and deformation of the joints of both hands, limited flexion and extension, swelling of the ankle joints of both lower extremities, and stiffness of the toes. The tongue was dull with yellow and greasy coating, and the pulse was deep and stringy. The patient was given this plaster and instructed to apply it 4 - 5 times a day. After 1 month, the joint movement became slightly more flexible and the number of pain attacks decreased significantly.

[0161] The above embodiments merely illustrate the principles and effects of the present invention, rather than limiting the present invention. Any person familiar with this technology can modify or change the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes completed by those with ordinary knowledge in the technical field without departing from the spirit and technical ideas disclosed by the present invention should still be covered by the claims of the present invention. The above embodiments merely illustrate the principles and effects of the present invention, rather than limiting the present invention. Any person familiar with this technology can modify or change the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes completed by those with ordinary knowledge in the technical field without departing from the spirit and technical ideas disclosed by the present invention should still be covered by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating arthralgia syndrome, characterized in that, The Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-25 parts of lithospermum officinale, 15-25 parts of snakehead, 12-18 parts of dragon's blood, 12-18 parts of raw phellodendron, 12-18 parts of raw rhubarb, 12-18 parts of zoetropaeolum, 9-15 parts of coptis root, 6-10 parts of frankincense, 6-10 parts of raw myrrh, 12-18 parts of menthol, 12-18 parts of borneol, 8-12 parts of cinnabar and 45-60 parts of raw rehmannia root; the Chinese medicine composition is used for external use.

2. The traditional Chinese medicine composition for treating arthralgia according to claim 1, wherein The product is prepared from the following raw materials in parts by weight: 20 parts of lithospermum erythrorhizon, 20 parts of snakehead, 15 parts of dragon's blood, 15 parts of raw phellodendron, 15 parts of raw rhubarb, 15 parts of zoetropaeolum, 12 parts of coptis root, 8 parts of frankincense, 8 parts of raw myrrh, 15 parts of menthol, 15 parts of borneol, 10 parts of cinnabar, and 50 parts of raw rehmannia root.

3. A method for preparing a traditional Chinese medicine composition for treating arthralgia according to claim 1 or 2, characterized in that, The following steps are involved: A. Cut the lithospermum officinale and snakehead into pieces, soak them in tea oil, and filter them to obtain medicinal oil I; B. Grind the dragon's blood, phellodendron, cinnabar, menthol and borneol into fine powder respectively, mix them together, then pour the medicinal oil I into the mixed drugs, stir and dissolve them thoroughly to form medicinal oil II; C. Add frankincense, raw myrrh, raw rhubarb, trotter, coptis root and raw rehmannia root into tea oil and soak, light a fire, boil the oil until the medicine becomes burnt, filter out the residue and keep the liquid medicine, add white vaseline and stir thoroughly to form medicine oil III; D. After the temperature of drug oil III has dropped, add it into drug oil II, stir, dissolve and mix thoroughly to form drug oil IV; E. Finally, put the medicinal oil IV into a container and store it at low temperature.

4. The preparation method of the traditional Chinese medicine composition for treating arthralgia according to claim 3, wherein: In step A, the mass ratio of lithospermum officinale to tea oil is 1:4-6.

5. The preparation method of the traditional Chinese medicine composition for treating arthralgia according to claim 3, wherein: In step A, the soaking time is 22 to 26 hours, and the mixture is stirred every 1 to 1.2 hours.

6. The preparation method of the traditional Chinese medicine composition for treating arthralgia according to claim 3, characterized in that: In step B, the fine powder is passed through a 120-mesh sieve.

7. The preparation method of the traditional Chinese medicine composition for treating arthralgia according to claim 3, characterized in that: In step C, the added weight of tea oil is 1.5 to 3 times of the traditional Chinese medicine raw material.

8. The preparation method of the traditional Chinese medicine composition for treating arthralgia according to claim 3, wherein: In step C, the amount of white vaseline added is 4 to 6 times the weight of the drug solution.

9. The preparation method of the traditional Chinese medicine composition for treating arthralgia according to claim 3, wherein: In step C, the soaking time is 1 to 1.2 hours.

10. The preparation method of the traditional Chinese medicine composition for treating arthralgia according to claim 3, characterized in that: In step D, the temperature is lowered to 50-60°C.

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