Traditional Chinese medicine composition for treating muscular neuropathic pain and preparation method of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating muscular neuropathic pain and a patch thereof, and the traditional Chinese medicine composition is prepared from the following raw materials: ligusticum wallichii, salvia miltiorrhiza, frankincense, myrrh, dandelion, bunge corydalis herb, corydalis tuber and folium mori. In the formula, Ligusticum wallichii and Salvia miltiorrhiza are monarch drugs for regulating qi and promoting blood circulation to remove blood stasis, frankincense and myrrh are ministerial drugs for assisting the monarch drugs for promoting blood circulation to remove blood stasis and cooling blood to dispel wind, dandelion and Corydalis bungeana are used for clearing away heat and toxic materials and cooling blood to relieve pain, corydalis tuber and mulberry leaf are used for promoting blood circulation to remove blood stasis and relieving swelling and pain and are used as adjuvant drugs, and all the drugs are combined and synergistically act to achieve the effects of clearing away heat and toxic materials and regulating qi and promoting blood circulation, so that the neuromuscular pain symptom is effectively improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating muscle nerve pain and a patch thereof. Background Art

[0002] Neuropathic pain is pain caused by lesions or diseases of the somatic sensory nervous system, including central neuropathic pain: such as pain caused by spinal cord or brain injury, post-stroke pain, and pain associated with multiple sclerosis, and peripheral neuropathic pain such as: trigeminal neuralgia, post-herpetic neuralgia, and diabetic peripheral neuropathy, etc.

[0003] Currently, the clinical solutions for treating neuropathic pain can be systemic treatment and local treatment. For example, gabapentin-like drugs, tricyclic antidepressants, and selective serotonin-norepinephrine reuptake inhibitors, these are all systemic treatments and are usually regarded as first-line treatments, but Western medicines have side effects such as drowsiness, dizziness, peripheral nerve swelling, and blurred vision. Lidocaine and capsaicin patches are used for local treatment of neuropathic pain, but the application of patches containing capsaicin is carried out under the guidance of a doctor, and there is often a burning sensation on the skin.

[0004] In traditional Chinese medicine, neuropathic pain belongs to the category of "pain syndrome" or "bi syndrome". Its occurrence is closely related to constitutional factors, climatic conditions, diet, and living environment, etc. The basic pathogenesis can be summarized as the mutual binding of pathogenic factors such as wind, phlegm, and stasis, resulting in the blockage of the meridians. Therefore, the treatment is always carried out with the principle of "unblocking". As the medical expert Li Dongyuan said in "Medical Inventions": "When it is unblocked, there is no pain; when there is pain, it is blocked. The pain decreases with dredging. When the meridians are dredged, the pain will go away." According to the pathogenesis characteristics of the mutual binding of pathogenic factors, blocking the meridians, and pain due to blockage, traditional Chinese medicine treatment can mainly dispel pathogenic factors, dredge the collaterals, and relieve pain, and be combined with drugs for promoting blood circulation to remove stasis, clearing heat and detoxifying, and calming endogenous wind.

[0005] External treatment with traditional Chinese medicine refers to applying traditional Chinese medicine preparations to the surface of the affected area. It is a traditional Chinese medicine therapy through skin penetration and is an important part of traditional Chinese medicine treatment in our country. Based on the theory of traditional Chinese medicine, combining overall syndrome differentiation and local syndrome differentiation, different types of drugs are selected to make patches and applied on the body surface and its corresponding acupoints and tissue sites. Through the penetration and absorption of various drugs by the skin and the stimulation of various drugs on the acupoints and skin, it helps to regulate and improve the functions of qi and blood, replenish body fluids, and meridians and zang-fu organs in the human body, achieving the main purpose of preventing diseases and treating various diseases.

[0006] Currently, there is an urgent need for effective topical drugs for neuropathic pain in the prior art to achieve a safe and effective analgesic effect on neuropathic pain. Summary of the Invention

[0007] To solve the above technical problems, the object of the present invention is to provide a traditional Chinese medicine composition for treating muscle and nerve pain with rigorous prescription, scientific compatibility and remarkable curative effect, and its patch. The traditional Chinese medicine composition of the present invention has a remarkable external analgesic effect, especially for neuropathic pain and postoperative incision pain, and provides a better solution for the treatment of muscle and nerve pain.

[0008] To achieve the above object, the present invention provides the following technical solutions:

[0009] The first object of the present invention is to provide a traditional Chinese medicine composition for treating muscle and nerve pain.

[0010] The second object of the present invention is to provide a preparation method of the above traditional Chinese medicine composition for treating muscle and nerve pain.

[0011] The third object of the present invention is to provide the use of the above traditional Chinese medicine composition for treating muscle and nerve pain.

[0012] To achieve the first object, the technical solution adopted by the present invention is:

[0013] The present invention provides a traditional Chinese medicine composition for treating muscle and nerve pain, which is made of Ligusticum chuanxiong, Salvia miltiorrhiza, Olibanum, Myrrha, Taraxacum mongolicum, Viola yedoensis, Corydalis yanhusuo and Morus alba leaves.

[0014] In some preferred embodiments of the present invention, the traditional Chinese medicine composition for treating muscle and nerve pain is made of the following raw materials by weight: 10-15 parts of Ligusticum chuanxiong, 10-15 parts of Salvia miltiorrhiza, 10-15 parts of Olibanum, 7-10 parts of Myrrha, 15-18 parts of Taraxacum mongolicum, 10-15 parts of Viola yedoensis, 25-30 parts of Corydalis yanhusuo and 10-15 parts of Morus alba leaves.

[0015] In a preferred embodiment of the present invention, the traditional Chinese medicine composition for treating muscle and nerve pain is made of the following raw materials by weight: 12 parts of Ligusticum chuanxiong, 12 parts of Salvia miltiorrhiza, 12 parts of Olibanum, 8 parts of Myrrha, 16 parts of Taraxacum mongolicum, 12 parts of Viola yedoensis, 28 parts of Corydalis yanhusuo and 12 parts of Morus alba leaves.

[0016] In a preferred embodiment of the present invention, the traditional Chinese medicine composition for treating muscle and nerve pain is made of the following raw materials by weight: 10 parts of Ligusticum chuanxiong, 15 parts of Salvia miltiorrhiza, 15 parts of Olibanum, 7 parts of Myrrha, 15 parts of Taraxacum mongolicum, 15 parts of Viola yedoensis, 25 parts of Corydalis yanhusuo and 15 parts of Morus alba leaves.

[0017] In a preferred embodiment of the present invention, the traditional Chinese medicine composition for treating muscle and nerve pain is made of the following raw materials by weight: 15 parts of Ligusticum chuanxiong, 10 parts of Salvia miltiorrhiza, 10 parts of Olibanum, 10 parts of Myrrha, 18 parts of Taraxacum mongolicum, 10 parts of Viola yedoensis, 30 parts of Corydalis yanhusuo and 10 parts of Morus alba leaves.

[0018] To achieve the second object, the technical solution adopted by the present invention is as follows:

[0019] The preparation method of the traditional Chinese medicine composition for treating muscle and nerve pain of the present invention is as follows: Weigh each raw material by weight, add water for decoction, filter to obtain the decoction, and concentrate it under vacuum to obtain an extract.

[0020] In some preferred embodiments of the present invention, the preparation method of the present invention is as follows: Weigh each raw material by weight, add 8 - 10 times the amount of water, decoct for 1 - 2 hours, filter out the decoction; then add 8 - 10 times the amount of water, decoct for 1.5 - 2.5 hours, filter out the decoction, combine the two decoctions, and concentrate under vacuum to remove the aqueous solution to obtain an extract.

[0021] In a preferred embodiment of the present invention, the preparation method of the present invention is as follows: Weigh each raw material by weight, add 8 times the amount of water, decoct for 2 hours, filter out the decoction; then add 8 times the amount of water, decoct for 2.5 hours, filter out the decoction, combine the two decoctions, and concentrate under vacuum to remove the aqueous solution to obtain an extract.

[0022] Furthermore, the dosage form of the traditional Chinese medicine composition for treating muscle and nerve pain is an oral preparation or an external preparation.

[0023] Preferably, the dosage form of the traditional Chinese medicine composition for treating muscle and nerve pain is an external preparation.

[0024] In some preferred embodiments of the present invention, the dosage form of the external preparation is a lotion, a patch, a paste, an ointment, a gel, a film - forming agent or a cataplasm.

[0025] In a preferred embodiment of the present invention, the dosage form of the external preparation is a patch.

[0026] Furthermore, the preparation method of the patch is as follows: Take glycerin, sodium carboxymethylcellulose, sodium polyacrylate and purified water, mix them evenly to form a matrix, add the extract, borneol, menthol, azone and liquid paraffin to the matrix, stir evenly to form a patch coating, let it stand for 1.5 - 2 hours, evenly coat the prepared patch coating on a waterproof square medical adhesive tape, and dry it to make a patch.

[0027] To achieve the third object, the technical solution adopted by the present invention is as follows:

[0028] The present invention provides the use of the traditional Chinese medicine composition for treating muscle and nerve pain in the preparation of a drug for preventing or treating neuropathic pain.

[0029] In a preferred embodiment of the present invention, the neuropathic pain is neuropathic pain caused by peripheral nerve injury.

[0030] In a more preferred embodiment of the present invention, the neuropathic pain is neuropathic pain caused by sciatic nerve injury.

[0031] The present invention provides the use of the traditional Chinese medicine composition for treating muscle and nerve pain in the preparation of a medicament for preventing or treating postoperative incision pain.

[0032] Analysis of each single herb in the traditional Chinese medicine composition of the present invention:

[0033] Chuanxiong (Rhizoma Chuanxiong): Pungent in taste, warm in nature, attributing to the liver and gallbladder meridians, promoting qi circulation to relieve depression, dispelling wind, dampness and cold, activating blood circulation to relieve pain; mainly treating wind-cold headache and dizziness, hypochondriac pain and abdominal pain, cold arthralgia with muscle spasm, amenorrhea, dystocia, postpartum stasis and mass pain, carbuncle and sore; used for irregular menstruation, amenorrhea and dysmenorrhea, abdominal mass pain, chest and hypochondriac stabbing pain, traumatic injury and swelling pain, headache, rheumatic arthralgia.

[0034] Danshen (Salvia Miltiorrhiza): Bitter in taste, slightly cold in nature, attributing to the heart and liver meridians, removing stasis to relieve pain, activating blood circulation to dredge meridians, clearing the heart and relieving vexation; used for irregular menstruation, amenorrhea and dysmenorrhea, mass accumulation, chest and abdomen stabbing pain, heat arthralgia pain, swelling and pain of sores and ulcers, restlessness and insomnia, hepatosplenomegaly, angina pectoris.

[0035] Ruxiang (Olibanum): Pungent and bitter in taste, slightly warm in nature, attributing to the heart, liver and spleen meridians, promoting blood circulation and qi movement, dredging meridians to relieve pain, detumescence and promoting granulation; used for heart and abdominal pain, rheumatic arthralgia, amenorrhea and dysmenorrhea, traumatic injury and stasis pain, carbuncle and swelling toxin, intestinal abscess, non-healing sore; treating qi and blood stasis, heart and abdominal pain, carbuncle and sore toxin, traumatic injury, dysmenorrhea, postpartum stasis and stabbing pain.

[0036] Moyao (Myrrha): Pungent and bitter in taste, flat in nature, attributing to the heart, liver and spleen meridians, removing stasis to arrest pain, detumescence and promoting granulation; used for treatment of chest impediment pain, epigastric pain, dysmenorrhea and amenorrhea, postpartum stasis, abdominal mass pain, rheumatic arthralgia, traumatic injury, carbuncle and swelling sores and other diseases.

[0037] Pugongying (Dandelion): Bitter and sweet in taste, cold in nature, attributing to the liver and stomach meridians, clearing heat and detoxifying, diuretic and dissipating binds; used for acute mastitis, lymphadenitis, scrofula, furuncle and sore, acute conjunctivitis, common cold and fever, acute tonsillitis, acute bronchitis, gastritis, hepatitis, cholecystitis, urinary tract infection.

[0038] Didin (Viola Yedoensis): Bitter in taste, cold in nature, attributing to the heart and liver meridians, clearing heat and promoting diuresis, detoxifying and detumescence; treating furuncle, carbuncle, scrofula, jaundice, dysentery, diarrhea, red eyes, sore throat, snake bite.

[0039] Yanhusuo (Rhizoma Corydalis): Pungent and bitter in taste, warm in nature, attributing to the liver and spleen meridians, promoting blood circulation, qi movement and pain relief; used for chest and hypochondriac pain, epigastric pain, chest impediment pain, amenorrhea and dysmenorrhea, postpartum stasis, traumatic injury and swelling pain.

[0040] Sangye (Folium Mori): Sweet and bitter in taste, cold in nature, attributing to the lung and liver meridians, dispersing wind-heat, moistening the lung and dryness, clearing the liver and improving eyesight; used for treating wind-heat cold, dry cough due to lung heat, dizziness and headache, red eyes and dim vision.

[0041] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0042] Traditional Chinese medicine believes that "pain is caused by obstruction" and "pain is caused by deficiency of nourishment". Qi stagnation and blood stasis are one of the basic pathological conditions of inflammation. In traditional Chinese medicine, "inflammation" means "heat". Therefore, the main treatment principles for inflammatory pain in traditional Chinese medicine are clearing heat and detoxifying, regulating qi and activating blood circulation to remove stasis. When the blood circulates smoothly, the medicine can easily penetrate into the lesion. When the qi is normal, it is easy to clear the pathogenic factors inside or expel them outside. In the formula of the present invention, Chuanxiong (Rhizoma Chuanxiong) and Danshen (Radix Salviae Miltiorrhizae) are the monarch drugs, regulating qi, activating blood circulation and removing stasis. Ruxiang (Olibanum) and Muyao (Myrrha) are the minister drugs, assisting the monarch drug to promote blood circulation to remove stasis, cool the blood and dispel wind. Pugongying (Herba Taraxaci) and Diding (Herba Violae) clear heat and detoxify, cool the blood and relieve pain. Yanhusuo (Rhizoma Corydalis) and Sangye (Folium Mori) promote blood circulation to remove stasis, reduce swelling and relieve pain, and they are all adjuvant drugs. All the drugs are used in combination, synergistically enhancing the effect, and jointly achieving the effects of clearing heat and detoxifying, regulating qi and activating blood circulation, effectively improving the symptoms of neuromuscular pain.

[0043] Pharmacodynamic studies have shown that the traditional Chinese medicine composition of the present invention significantly reduces the PWT value and TWL value of neuropathic pain caused by sciatic nerve injury, reduces the PWT value of the postoperative pain model, and has a positive therapeutic effect on neuropathic pain and postoperative incision pain, providing a better treatment plan for the treatment of muscle nerve pain. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Figure 1 The effect of the traditional Chinese medicine composition patch of the present invention on the PWT value of rats. Different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0045] Figure 2 The effect of the traditional Chinese medicine composition patch of the present invention on the TWL value of rats. Different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05). DETAILED DESCRIPTION OF THE INVENTION

[0046] The following further details the content of the present invention through specific embodiments, but it should not be understood that the scope of the above-mentioned subject matter of the present invention is limited to the following embodiments. The following embodiments are used to illustrate the technical solutions of the present invention rather than to limit the protection scope of the present invention. Those of ordinary skill in the art who modify or equivalently replace the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention still fall within the protection scope of the present invention.

[0047] Example 1

[0048] Chuanxiong (Rhizoma Chuanxiong) 12 g, Danshen (Radix Salviae Miltiorrhizae) 12 g, Ruxiang (Olibanum) 12 g, Muyao (Myrrha) 8 g, Pugongying (Herba Taraxaci) 16 g, Diding (Herba Violae) 12 g, Yanhusuo (Rhizoma Corydalis) 28 g, and Sangye (Folium Mori) 12 g.

[0049] The excipients are: borneol 2.5 parts, menthol 3.5 parts, glycerol 12 parts, azone 6.5 parts, sodium polyacrylate 15 parts, sodium carboxymethylcellulose 2.0 parts, and liquid paraffin 4.5 parts.

[0050] The preparation method is as follows: Weigh each raw material by weight parts, add 8 times the amount of water, decoct for 2 hours, and filter out the decoction; then add 8 times the amount of water again, decoct for 2.5 hours, filter out the decoction, combine the two decoctions, concentrate under reduced pressure in a vacuum, and remove the aqueous solution to obtain an extract.

[0051] Take glycerol, sodium carboxymethylcellulose, sodium polyacrylate and purified water, mix them evenly to form a matrix, add the extract, borneol, menthol, azone and liquid paraffin to the matrix, stir evenly to make a patch coating, let it stand for 2 hours, evenly coat the prepared patch coating on a waterproof square medical adhesive tape, and dry it in the sun to make a patch.

[0052] Example 2

[0053] 10 g of Ligusticum chuanxiong, 15 g of Salvia miltiorrhiza, 15 g of Olibanum, 7 g of Myrrha, 15 g of Taraxacum mongolicum, 15 g of Viola philippica, 25 g of Corydalis yanhusuo and 15 g of Morus alba leaves.

[0054] The auxiliary materials are: 2.0 parts of borneol, 4.0 parts of menthol, 10 parts of glycerol, 5.5 parts of azone, 20 parts of sodium polyacrylate, 3.0 parts of sodium carboxymethylcellulose, and 5.0 parts of liquid paraffin.

[0055] The preparation method is as follows: Weigh each raw material by weight parts, add 10 times the amount of water, decoct for 2 hours, and filter out the decoction; then add 8 times the amount of water again, decoct for 1.5 hours, filter out the decoction, combine the two decoctions, concentrate under reduced pressure in a vacuum, and remove the aqueous solution to obtain an extract.

[0056] Take glycerol, sodium carboxymethylcellulose, sodium polyacrylate and purified water, mix them evenly to form a matrix, add the extract, borneol, menthol, azone and liquid paraffin to the matrix, stir evenly to make a patch coating, let it stand for 2 hours, evenly coat the prepared patch coating on a waterproof square medical adhesive tape, and dry it in the sun to make a patch.

[0057] Example 3

[0058] 15 g of Ligusticum chuanxiong, 10 g of Salvia miltiorrhiza, 10 g of Olibanum, 10 g of Myrrha, 18 g of Taraxacum mongolicum, 10 g of Viola philippica, 30 g of Corydalis yanhusuo and 10 g of Morus alba leaves.

[0059] The auxiliary materials are: 2.0 parts of borneol, 4.0 parts of menthol, 10 parts of glycerol, 5.5 parts of azone, 20 parts of sodium polyacrylate, 3.0 parts of sodium carboxymethylcellulose, and 5.0 parts of liquid paraffin.

[0060] The preparation method is as follows: Weigh each raw material by weight parts, add 10 times the amount of water, decoct for 1.5 hours, and filter out the decoction; then add 9 times the amount of water again, decoct for 2 hours, filter out the decoction, combine the two decoctions, concentrate under reduced pressure in a vacuum, and remove the aqueous solution to obtain an extract.

[0061] Take glycerol, sodium carboxymethyl cellulose, sodium polyacrylate and purified water, mix them evenly to form a matrix. Add the extract, borneol, menthol, azone and liquid paraffin to the matrix, stir evenly to form a patch coating, let it stand for 1.5 h, evenly coat the prepared patch coating on a waterproof square medical adhesive tape, and dry it in the sun to make a patch.

[0062] Example 4

[0063] 12 g of Ligusticum chuanxiong, 15 g of Salvia miltiorrhiza, 10 g of Olibanum, 8 g of Myrrha, 15 g of Taraxacum mongolicum, 10 g of Viola philippica, 25 g of Corydalis yanhusuo and 15 g of Morus alba leaves.

[0064] The auxiliary materials are: 2.5 parts of borneol, 3.5 parts of menthol, 12 parts of glycerol, 6.5 parts of azone, 15 parts of sodium polyacrylate, 2.0 parts of sodium carboxymethyl cellulose and 4.5 parts of liquid paraffin.

[0065] The preparation method is as follows: Weigh each raw material according to the parts by weight, add 10 times the amount of water, decoct for 1 h, filter out the decoction; then add 8 times the amount of water, decoct for 1.5 h, filter out the decoction, combine the two decoctions, concentrate under vacuum and reduce pressure, and remove the aqueous solution to obtain an extract.

[0066] Take glycerol, sodium carboxymethyl cellulose, sodium polyacrylate and purified water, mix them evenly to form a matrix. Add the extract, borneol, menthol, azone and liquid paraffin to the matrix, stir evenly to form a patch coating, let it stand for 2 h, evenly coat the prepared patch coating on a waterproof square medical adhesive tape, and dry it in the sun to make a patch.

[0067] Example 5

[0068] 10 g of Ligusticum chuanxiong, 12 g of Salvia miltiorrhiza, 12 g of Olibanum, 10 g of Myrrha, 18 g of Taraxacum mongolicum, 12 g of Viola philippica, 30 g of Corydalis yanhusuo and 10 g of Morus alba leaves.

[0069] The auxiliary materials are: 2.0 parts of borneol, 4.0 parts of menthol, 10 parts of glycerol, 5.5 parts of azone, 20 parts of sodium polyacrylate, 3.0 parts of sodium carboxymethyl cellulose and 5.0 parts of liquid paraffin.

[0070] The preparation method is as follows: Weigh each raw material according to the parts by weight, add 8 times the amount of water, decoct for 1 h, filter out the decoction; then add 8 times the amount of water, decoct for 2.5 h, filter out the decoction, combine the two decoctions, concentrate under vacuum and reduce pressure, and remove the aqueous solution to obtain an extract.

[0071] Take glycerol, sodium carboxymethyl cellulose, sodium polyacrylate and purified water, mix them evenly to form a matrix. Add the extract, borneol, menthol, azone and liquid paraffin to the matrix, stir evenly to form a patch coating, let it stand for 2 h, evenly coat the prepared patch coating on a waterproof square medical adhesive tape, and dry it in the sun to make a patch.

[0072] Example 6

[0073] 10 g of Ligusticum wallichii, 10 g of Salvia miltiorrhiza, 12 g of Olibanum, 7 g of Myrrha, 16 g of Taraxacum mongolicum, 15 g of Viola philippica, 28 g of Corydalis yanhusuo, and 12 g of Morus alba

[0074] The adjuvants are: 2.5 parts of borneol, 3.5 parts of menthol, 12 parts of glycerol, 6.5 parts of azone, 15 parts of sodium polyacrylate, 2.0 parts of sodium carboxymethylcellulose, and 4.5 parts of liquid paraffin.

[0075] The preparation method is as follows: Weigh each raw material according to the parts by weight, add 10 times the amount of water, decoct for 2 h, and filter out the decoction; then add 8 times the amount of water, decoct for 1.5 h, filter out the decoction, combine the two decoctions, concentrate under vacuum and decompression, and remove the aqueous solution to obtain an extract.

[0076] Take glycerol, sodium carboxymethylcellulose, sodium polyacrylate and purified water, mix them evenly to form a matrix, add the extract, borneol, menthol, azone, and liquid paraffin to the matrix, stir evenly to form a patch coating, let it stand for 1.5 h, evenly coat the prepared patch coating on a waterproof square medical adhesive tape, and dry it to make a patch.

[0077] Example 7

[0078] 10 g of Ligusticum wallichii, 15 g of Salvia miltiorrhiza, 12 g of Olibanum, 10 g of Myrrha, 15 g of Taraxacum mongolicum, 12 g of Viola philippica, 25 g of Corydalis yanhusuo, and 15 g of Morus alba

[0079] The adjuvants are: 2.5 parts of borneol, 3.5 parts of menthol, 12 parts of glycerol, 6.5 parts of azone, 15 parts of sodium polyacrylate, 2.0 parts of sodium carboxymethylcellulose, and 4.5 parts of liquid paraffin.

[0080] The preparation method is as follows: Weigh each raw material according to the parts by weight, add 8 times the amount of water, decoct for 2 h, and filter out the decoction; then add 8 times the amount of water, decoct for 2.5 h, filter out the decoction, combine the two decoctions, concentrate under vacuum and decompression, and remove the aqueous solution to obtain an extract.

[0081] Take glycerol, sodium carboxymethylcellulose, sodium polyacrylate and purified water, mix them evenly to form a matrix, add the extract, borneol, menthol, azone, and liquid paraffin to the matrix, stir evenly to form a patch coating, let it stand for 1.5 h, evenly coat the prepared patch coating on a waterproof square medical adhesive tape, and dry it to make a patch.

[0082] Comparative Example 1

[0083] 24 g of Salvia miltiorrhiza, 12 g of Olibanum, 8 g of Myrrha, 16 g of Taraxacum mongolicum, 12 g of Viola philippica, 28 g of Corydalis yanhusuo, and 12 g of Morus alba

[0084] Compared with Example 1, the difference is that it does not contain Ligusticum wallichii and the dosage of Salvia miltiorrhiza is increased.

[0085] The preparation method refers to Example 1.

[0086] Comparative Example 2

[0087] 12 g of Ligusticum chuanxiong, 12 g of Salvia miltiorrhiza, 12 g of Olibanum, 8 g of Myrrha, 16 g of Taraxacum mongolicum, 40 g of Corydalis yanhusuo, and 12 g of Morus alba

[0088] Compared with Example 1, the difference is that it does not contain Viola philippica and the dosage of Corydalis yanhusuo is increased.

[0089] The preparation method refers to Example 1.

[0090] Comparative Example 3

[0091] 12 g of Ligusticum chuanxiong, 12 g of Salvia miltiorrhiza, 12 g of Olibanum, 24 g of Myrrha, 12 g of Viola philippica, 28 g of Corydalis yanhusuo, and 12 g of Morus alba

[0092] Compared with Example 1, the difference is that it does not contain Taraxacum mongolicum and the dosage of Myrrha is increased.

[0093] The preparation method refers to Example 1.

[0094] Comparative Example 4

[0095] 20 of Ligusticum chuanxiong, 10 g of Salvia miltiorrhiza, 20 g of Olibanum, 15 g of Myrrha, 10 g of Taraxacum mongolicum, 8 g of Viola philippica, 20 g of Corydalis yanhusuo, and 8 g of Morus alba

[0096] Compared with Example 1, the difference is that the dosages of each component are different.

[0097] The preparation method refers to Example 1.

[0098] Comparative Example 5

[0099] 12 g of Ligusticum chuanxiong, 12 g of Salvia miltiorrhiza, 16 g of Taraxacum mongolicum, 12 g of Viola philippica, 28 g of Corydalis yanhusuo, and 12 g of Morus alba

[0100] Compared with Example 1, the difference is that it does not contain Olibanum and Myrrha.

[0101] The preparation method refers to Example 1.

[0102] Comparative Example 6

[0103] 12 g of Ligusticum chuanxiong, 12 g of Salvia miltiorrhiza, 12 g of Olibanum, 8 g of Myrrha, 16 g of Taraxacum mongolicum, 12 g of Viola philippica, 28 g of Corydalis yanhusuo, and 12 g of Morus alba

[0104] Compared with Example 1, the difference is that it does not contain Ligusticum chuanxiong and Salvia miltiorrhiza.

[0105] The preparation method refers to Example 1.

[0106] Comparative Example 7

[0107] 12 g of Ligusticum chuanxiong, 12 g of Salvia miltiorrhiza, 12 g of Olibanum, 8 g of Myrrha, 28 g of Corydalis yanhusuo, and 12 g of Morus alba leaf.

[0108] Compared with Example 1, the difference is that it does not contain Taraxacum mongolicum and Viola philippica.

[0109] The preparation method refers to Example 1.

[0110] Comparative Example 8

[0111] 12 g of Ligusticum chuanxiong, 12 g of Salvia miltiorrhiza, 12 g of Olibanum, 8 g of Myrrha, 16 g of Taraxacum mongolicum, and 12 g of Viola philippica.

[0112] Compared with Example 1, the difference is that it does not contain Corydalis yanhusuo and Morus alba leaf.

[0113] The preparation method refers to Example 1.

[0114] Pharmacodynamic Example 1 Study on the effect of the traditional Chinese medicine composition of the present invention on rats with postoperative pain

[0115] 1. Experimental method

[0116] Forty-eight male SD rats, weighing 180 - 220 g, were purchased and fed adaptively for 7 days for quarantine.

[0117] The rats were intraperitoneally injected with 50 mg / kg of 2% pentobarbital for anesthesia. A cut about 1 cm long was made at the proximal 0.5 cm of the left hind paw of the rats towards the toe direction. The skin and fascia were incised, and the plantar muscles were picked up with ophthalmic forceps and longitudinally cut. The integrity of the muscle origin, insertion, and attachment was maintained throughout the process. Hemostasis was performed, the skin was sutured, and the incision was rinsed with penicillin to prevent infection. After the operation, the rats were placed in a quiet and light-avoiding environment to recover.

[0118] The rats were divided into 8 groups according to the random number method, with 6 rats in each group, namely the model control group, experimental group 1, experimental group 2, control group 1, control group 2, control group 3, control group 4, and control group 5. The experimental grouping and dosing regimens are shown in Table 1.

[0119] Table 1 Dosing regimens for rats in each group

[0120] Group Drug Model control group Blank matrix Experimental group 1 Traditional Chinese medicine composition patch of Example 1 Experimental group 2 Traditional Chinese medicine composition patch of Example 2 Control group 1 Traditional Chinese medicine composition patch of Comparative Example 1 Control group 2 Traditional Chinese medicine composition patch of Comparative Example 2 Control group 3 Traditional Chinese medicine composition patch of Comparative Example 3 Control group 4 Traditional Chinese medicine composition patch of Comparative Example 4 Control group 5 Traditional Chinese medicine composition patch of Comparative Example 5

[0121] Apply once a day. Before surgery and on the second day after surgery, the mechanical withdrawal threshold (PWT) of the surgical paw of the rats was measured using von Frey filaments.

[0122] The specific method is as follows: The rats were placed in a glass box with a metal mesh wire base, and the skin between the 3rd and 4th toes near the incision of the left hind paw of the rats was vertically stimulated with von Frey filaments of different strengths. The rats showing foot withdrawal, foot licking, and foot lifting behaviors were regarded as positive reactions.

[0123] Start measuring from 2g. If the stimulus of this intensity does not cause a positive reaction, apply a stimulus of the next higher intensity; if a positive reaction occurs, apply a stimulus of the next lower intensity. Continue this way until the first straddle between positive and negative reactions appears, and then measure continuously 3 more times. The maximum intensity is 26g, and when it is >26g, it is recorded as 26g. The interval between each stimulus is 15s.

[0124] The pain intensity assessment was carried out after the animals were fully awake, could stand, had no movement disorders, and the righting reflex was restored.

[0125] 2. Statistical methods

[0126] GraphPad Prism 7.0 software was used for data processing. Measurement data were expressed as , one-way ANOVA was used for comparison between groups, LSD-t test was used for pairwise comparison between groups, and P < 0.05 was considered statistically significant.

[0127] 3. Experimental results

[0128] 3.1 Effects on PWT values

[0129] Compared with the model control group, the PWT values of rats in experimental groups 1 and 2 increased. Compared with control groups 1 - 5, there were significant differences in increasing PWT values between experimental groups 1 and 2. The results are shown in Table 2.

[0130] Table 2 Comparison of PWT values of rats in each group (x±s, n = 6, g)

[0131]

[0132] Note: Different lowercase letters in the same column indicate significant differences between different groups (P < 0.05).

[0133] After applying the traditional Chinese medicine composition patch of the present invention to the postoperative pain model rats, the PWT values of the rats increased significantly, indicating that the traditional Chinese medicine composition patch of the present invention has a significant analgesic effect.

[0134] Pharmacodynamic Example 2 Study on the effect of the traditional Chinese medicine composition of the present invention on rats with sciatic nerve injury

[0135] 1. Experimental methods

[0136] Forty-two male SD rats, weighing 200 - 240g, were purchased and fed adaptively for 7 days of quarantine. Six rats were randomly selected as the sham operation group.

[0137] Except for the sham operation group, sciatic nerve injury models were established in rats of other groups. The specific method was as follows: Rats were anesthetized by intraperitoneal injection of 2% pentobarbital at 50 mg / kg. The sciatic nerve on the posterior medial side of the left femur was exposed, the surrounding tissues were dissected, and the sciatic nerve was ligated 4 times with catgut at intervals of 1 mm, and the skin was sutured. After the operation, the paw withdrawal response threshold and paw withdrawal latency of the rats decreased, indicating the successful establishment of the sciatic nerve injury model. After the operation, the rats were placed in a quiet environment away from strong light to recover. The sham operation group only received the treatment of exposing the sciatic nerve on the posterior medial side of the left femur, without ligation, and the incision was sutured.

[0138] The successfully modeled rats were divided into 6 groups of 6 rats each according to the random number method, namely the model control group, experimental group 1, experimental group 3, control group 1, control group 2, and control group 3. The experimental grouping and dosing regimens are shown in Table 2.

[0139] Table 2 Dosing regimens for rats in each group

[0140] Group Drug Sham operation group Blank matrix Model control group Blank matrix Experimental group 1 Traditional Chinese medicine composition patch of Example 1 Experimental group 3 Traditional Chinese medicine composition patch of Example 3 Control group 1 Traditional Chinese medicine composition patch of Comparative Example 6 Control group 2 Traditional Chinese medicine composition patch of Comparative Example 7 Control group 3 Traditional Chinese medicine composition patch of Comparative Example 8

[0141] It was applied once a day. On the third day after the operation, the mechanical paw withdrawal threshold (PWT) of the operated paw of the rats was measured using von Frey filaments. The specific method for measuring the PWT value was the same as that in Pharmacodynamic Example 1.

[0142] The plantar surface of the rat's foot was irradiated with thermal radiation at an intensity of 20 IR. When the rat showed paw withdrawal, licking paw, or lifting paw behavior, the irradiation was immediately stopped, and the irradiation time was recorded, which was the thermal withdrawal latency (TWL).

[0143] 2. Statistical methods

[0144] GraphPad Prism 7.0 software was used for data processing. Measurement data were expressed as , one-way analysis of variance was used for comparison between groups, and LSD-t test was used for pairwise comparison between groups. A P < 0.05 was considered statistically significant.

[0145] 3. Experimental results

[0146] 3.1 Effects on PWT value

[0147] Compared with the sham operation group, the PWT value of the rats in the model control group decreased.

[0148] Compared with the model control group, the PWT values of the rats in experimental groups 1 and 2 increased. Compared with control groups 1 - 3, there were significant differences in increasing the PWT value between experimental groups 1 and 3. The results are shown in Figure 1 .

[0149] 3.2 Effects on TWL value

[0150] Compared with the sham operation group, the TWL value of the rats in the model control group decreased.

[0151] Compared with the model control group, the TWL values of the rats in experimental groups 1 and 2 increased. Compared with control groups 1-3, there were significant differences in increasing the TWL values in experimental groups 1 and 3. The results are shown in Figure 2 .

[0152] After applying the traditional Chinese medicine composition patch of the present invention to the rats with sciatic nerve injury model, the PWT value and TWL value of the rats increased significantly, indicating that the traditional Chinese medicine composition patch of the present invention has a significant analgesic effect.

[0153] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but will be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A traditional Chinese medicine composition for treating muscle and nerve pain, characterized in that, The traditional Chinese medicine composition for treating muscle and nerve pain is prepared from the following raw materials in parts by weight: 10-15 parts of Ligusticum chuanxiong, 10-15 parts of Salvia miltiorrhiza, 10-15 parts of frankincense, 7-10 parts of myrrh, 15-18 parts of Taraxacum mongolicum, 10-15 parts of Viola philippica, 25-30 parts of Corydalis yanhusuo, and 10-15 parts of Morus alba leaf.

2. The traditional Chinese medicine composition for treating muscle and nerve pain according to claim 1, wherein, The traditional Chinese medicine composition for treating muscle and nerve pain is prepared from the following raw materials in parts by weight: 12 parts of Ligusticum chuanxiong, 12 parts of Salvia miltiorrhiza, 12 parts of frankincense, 8 parts of myrrh, 16 parts of Taraxacum mongolicum, 12 parts of Viola philippica, 28 parts of Corydalis yanhusuo, and 12 parts of Morus alba leaf.

3. The traditional Chinese medicine composition for treating muscle and nerve pain according to claim 1, wherein, The traditional Chinese medicine composition for treating muscle and nerve pain is prepared from the following raw materials in parts by weight: 10 parts of Ligusticum chuanxiong, 15 parts of Salvia miltiorrhiza, 15 parts of frankincense, 7 parts of myrrh, 15 parts of Taraxacum mongolicum, 15 parts of Viola philippica, 25 parts of Corydalis yanhusuo, and 15 parts of Morus alba leaf.

4. The traditional Chinese medicine composition for treating muscle and nerve pain according to claim 1, wherein, The traditional Chinese medicine composition for treating muscle and nerve pain is prepared from the following raw materials in parts by weight: 15 parts of Ligusticum chuanxiong, 10 parts of Salvia miltiorrhiza, 10 parts of frankincense, 10 parts of myrrh, 18 parts of Taraxacum mongolicum, 10 parts of Viola philippica, 30 parts of Corydalis yanhusuo, and 10 parts of Morus alba leaf.

5. The traditional Chinese medicine composition for treating muscle and nerve pain according to any one of claims 1-4, characterized in that, The dosage form of the traditional Chinese medicine composition for treating muscle and nerve pain is an external preparation, and the external preparation is a lotion, a patch, a paste, an ointment, a gel, a film-forming agent or a cataplasm.

6. The traditional Chinese medicine composition for treating muscle and nerve pain according to any one of claims 1-4, characterized in that, The preparation method of the traditional Chinese medicine composition for treating muscle and nerve pain is as follows: Weigh each raw material according to the parts by weight, add 8-10 times the amount of water, decoct for 1-2 h, filter out the decoction; then add 8-10 times the amount of water, decoct for 1.5-2.5 h, filter out the decoction, combine the two decoctions, concentrate under reduced pressure in vacuo, and remove the aqueous solution to obtain an extract.

7. The traditional Chinese medicine composition for treating muscle and nerve pain according to claim 6, wherein The preparation method of the traditional Chinese medicine composition for treating muscle and nerve pain is as follows: Weigh each raw material according to the parts by weight, add 8 times the amount of water, decoct for 2 h, filter out the decoction; then add 8 times the amount of water, decoct for 2.5 h, filter out the decoction, combine the two decoctions, concentrate under reduced pressure in vacuo, and remove the aqueous solution to obtain an extract.

8. Use of the traditional Chinese medicine composition for treating muscle and nerve pain according to any one of claims 1-4 in the preparation of a drug for preventing or treating neuropathic pain.

9. The use according to claim 8, wherein The neuropathic pain is neuropathic pain caused by sciatic nerve injury.

10. Use of the traditional Chinese medicine composition for treating muscle and nerve pain according to any one of claims 1-4 in the preparation of a drug for preventing or treating postoperative incision pain.

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