Traditional Chinese medicine composition for treating restless leg syndrome as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating restless leg syndrome and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition comprises the following raw medicinal materials: fried rhizoma atractylodis, golden cypress, coix seed, achyranthes root, radix cyathulae, radix stephaniae tetrandrae, yam rhizome, pawpaw, angelica sinensis, rhizoma alismatis, herba siegesbeckiae, radix clematidis, radix paeoniae alba, parasitic loranthus, eucommia ulmoides and honey-fried licorice root. The invention further discloses a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition has the beneficial effects that the traditional Chinese medicine composition has the effects of clearing heat, promoting diuresis, dredging collaterals and calming legs, also can tonify the liver and the kidney, can be used for treating the restless leg syndrome on the basis of the common constitution of patients with the restless leg syndrome due to damp-heat, also has extremely high safety while giving consideration to clinical curative effects, and is worthy of popularization and application. The traditional Chinese medicine is suitable for most restless leg syndrome patients.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular, to a traditional Chinese medicine composition for treating restless legs syndrome, a preparation method thereof, and an application thereof. Background Art

[0002] Restless legs syndrome (RLS), also known as Willis-Ekbom disease, is a sensorimotor disorder. The main clinical manifestation is that patients have a strong sense of discomfort in the limbs when resting (especially at night), and this discomfort is sometimes indescribable, and there is an urgent need to move the limbs to relieve this discomfort. The prevalence rate of RLS in China is between 1.2% and 5%. It is relatively rare in children and more common in the elderly. The prevalence rate in people over 65 years old is 0.96% - 3.5%. At present, the diagnosis of RLS mainly relies on clinical symptoms, and the specific pathogenesis is not yet clear. Referring to the consensus on the newly revised diagnostic criteria released by the International Restless Legs Syndrome Study Group in 2014, the treatment aims to improve clinical symptoms as the primary goal, but there is no specific drug for RLS yet. Currently, commonly used drugs mainly include dopamine receptor agonists, α2-δ calcium channel agonists, opioid preparations, etc. Once the drug is discontinued or used unreasonably, the symptoms may recur, and there are certain adverse reactions and side effects, and there is still a lack of large-sample clinical data research.

[0003] There is no corresponding disease to restless legs syndrome in traditional Chinese medicine ancient books, but there are relevant records of its similar clinical manifestations. According to the relevant symptom records in traditional Chinese medicine ancient books, RLS can be classified into the categories of "Bi disease", "inability to feel", "leg spasm", etc. Currently, most scholars classify this disease as "Bi disease". In traditional Chinese medicine, nowadays people often overindulge in fatty, sweet, thick-flavored foods and cold and raw foods, or due to busy work and irregular diet, the spleen and stomach are damaged, the spleen loses its transportation and transformation function, dampness accumulates and phlegm is generated, and over time, heat is transformed. The damp-heat accumulates in the body, and over time, it blocks the meridians; or overusing bitter-cold drugs can also damage the spleen and stomach and generate damp-heat. Dampness is a tangible pathogen with a heavy and turbid nature and a sticky and stagnant property, and heat is an intangible pathogen that attaches to dampness, so that the pathogen lingers in the zang-fu organs and meridians for a long time, causing symptoms such as burning discomfort, numbness, soreness, and swelling pain in the joints or muscles, and finally developing into Bi disease. Therefore, restless legs syndrome is mostly a type of Bi disease with damp-heat blocking and stagnation, and the treatment should focus on clearing heat and promoting diuresis, and dredging the meridians to calm the legs. However, considering the diversity of the symptoms of this disease, the complexity of the etiology, and the diagnosis and treatment mode of traditional Chinese medicine, there is no recognized traditional Chinese medicine diagnosis and treatment plan yet.

[0004] In view of this, the inventor of the present invention conducted in-depth research on this need, and thus this case was born. Summary of the Invention

[0005] To overcome the problems commonly seen in patients with restless legs syndrome in the prior art, such as limb discomfort, an irresistible desire to move the limbs, and the emergence of mental abnormalities, etc., the present invention provides a traditional Chinese medicine composition for treating restless legs syndrome, its preparation method and application, which can effectively treat restless legs syndrome.

[0006] A traditional Chinese medicine composition for treating restless legs syndrome, comprising the following medicinal material raw materials in parts by mass: stir-fried Atractylodes lancea 10 - 20 parts, Phellodendron amurense 5 - 15 parts, Coix lacryma-jobi 10 - 20 parts, Achyranthes bidentata 10 - 20 parts, Cyathula officinalis 6 - 18 parts, Stephania tetrandra 10 - 20 parts, Dioscorea septemloba 10 - 20 parts, Chaenomeles sinensis 10 - 20 parts, Angelica sinensis 6 - 18 parts, Alisma orientale 6 - 18 parts, Siegesbeckia orientalis 10 - 20 parts, Clematis chinensis 5 - 15 parts, Paeonia lactiflora 10 - 20 parts, Taxillus chinensis 10 - 20 parts, Eucommia ulmoides 10 - 20 parts, and honey-fried Licorice 3 - 9 parts.

[0007] Preferably, it comprises the following medicinal material raw materials in parts by mass: stir-fried Atractylodes lancea 12 - 18 parts, Phellodendron amurense 7 - 13 parts, Coix lacryma-jobi 12 - 18 parts, Achyranthes bidentata 12 - 18 parts, Cyathula officinalis 8 - 16 parts, Stephania tetrandra 12 - 18 parts, Dioscorea septemloba 12 - 18 parts, Chaenomeles sinensis 12 - 18 parts, Angelica sinensis 8 - 16 parts, Alisma orientale 8 - 16 parts, Siegesbeckia orientalis 12 - 18 parts, Clematis chinensis 7 - 13 parts, Paeonia lactiflora 12 - 18 parts, Taxillus chinensis 12 - 18 parts, Eucommia ulmoides 12 - 18 parts, and honey-fried Licorice 4 - 8 parts.

[0008] More preferably, it comprises the following medicinal material raw materials in parts by mass: stir-fried Atractylodes lancea 14 - 16 parts, Phellodendron amurense 9 - 11 parts, Coix lacryma-jobi 14 - 16 parts, Achyranthes bidentata 14 - 16 parts, Cyathula officinalis 10 - 14 parts, Stephania tetrandra 14 - 16 parts, Dioscorea septemloba 14 - 16 parts, Chaenomeles sinensis 14 - 16 parts, Angelica sinensis 10 - 14 parts, Alisma orientale 10 - 14 parts, Siegesbeckia orientalis 14 - 16 parts, Clematis chinensis 9 - 11 parts, Paeonia lactiflora 14 - 16 parts, Taxillus chinensis 14 - 16 parts, Eucommia ulmoides 14 - 16 parts, and honey-fried Licorice 5 - 7 parts.

[0009] The present invention also provides the application of the above traditional Chinese medicine composition for treating restless legs syndrome in the preparation of a drug for treating restless legs syndrome.

[0010] The present invention also provides a drug for treating restless legs syndrome, comprising the above traditional Chinese medicine composition for treating restless legs syndrome and a pharmaceutically acceptable excipient.

[0011] Preferably, the dosage form of the drug is traditional Chinese medicine decoction, decocted agent, granule, pill, capsule, tablet, tea agent, suspension, powder or oral liquid.

[0012] The present invention also provides a preparation method of the above drug for treating restless legs syndrome. When the drug is a granule, its preparation method is as follows:

[0013] Step 1: Weigh the raw materials according to the parts by weight, conduct cleaning and selection, drying, cutting, pulverizing, sieving, and mix them evenly.

[0014] Step 2: Add water to submerge the raw materials in Step 1 by 3 - 5 cm and soak for 30 - 60 minutes. Then bring to a boil over high heat, and then switch to low heat and continue to decoct for 50 - 70 minutes. Filter using a traditional Chinese medicine sieve to obtain the first filtrate. Then add water to submerge the residue by 1 - 3 cm, bring to a boil over high heat, switch to low heat and continue to decoct for 50 - 70 minutes, and filter out the residue using a traditional Chinese medicine sieve to obtain the second filtrate. Combine the first filtrate and the second filtrate.

[0015] Step 3: Place the combined filtrate in Step 2 in a vacuum dryer and dry at a temperature of 40 - 60 °C and a pressure of 5 - 7 KPa until the weight no longer decreases to obtain the granule.

[0016] The present invention also provides a preparation method of the above - mentioned drug for treating restless legs syndrome. The drug is in pill form, and its preparation method is as follows:

[0017] Step 1: Weigh the raw materials according to the parts by weight, conduct cleaning and selection, drying, cutting, pulverizing, sieving, and mix them evenly.

[0018] Step 2: Add water to submerge the raw materials in Step 1 by 3 - 5 cm and soak for 30 - 60 minutes. Then bring to a boil over high heat, and then switch to low heat and continue to decoct for 50 - 70 minutes. Filter using a traditional Chinese medicine sieve to obtain the first filtrate. Then add water to submerge the residue by 1 - 3 cm, bring to a boil over high heat, switch to low heat and continue to decoct for 50 - 70 minutes, and filter out the residue using a traditional Chinese medicine sieve to obtain the second filtrate. Combine the first filtrate and the second filtrate and place them in a vacuum dryer and dry at a temperature of 40 - 60 °C and a pressure of 5 - 7 KPa until the weight no longer decreases.

[0019] Step 3: Heat the honey to 100 - 120 °C, and then mix it evenly with the dried drug in Step 2, honey, and water in a mass ratio of 1:1.2:2. Simmer over low heat at 100 - 120 °C for 15 - 25 minutes, and then naturally cool to room temperature and add it to a pill - making machine to obtain the pills.

[0020] The present invention also provides a preparation method of the above - mentioned drug for treating restless legs syndrome. The drug is in ointment form, and its preparation method is as follows:

[0021] Step 1: Weigh the raw materials according to the parts by weight, conduct cleaning and selection, drying, cutting, pulverizing, sieving, and mix them evenly.

[0022] Step 2: Add water to submerge the crude drug in Step 1 by 3 - 5 cm and soak for 30 - 60 minutes. Then bring to a boil over high heat, and then switch to low heat and continue to decoct for 50 - 70 minutes. Filter using a traditional Chinese medicine sieve to obtain the first filtrate. Then add water to submerge the drug residue by 1 - 3 cm, bring to a boil over high heat, switch to low heat and continue to decoct for 50 - 70 minutes, and filter out the drug residue using a traditional Chinese medicine sieve to obtain the second filtrate. Combine the first filtrate and the second filtrate and place them in a vacuum dryer. Dry at a temperature of 40 - 60°C and a pressure of 5 - 7 KPa until the weight no longer decreases.

[0023] Step 3: Heat the honey to 100 - 120°C, and then mix it evenly with the dried drug in Step 2, honey, and water according to a mass ratio of 1:1.2:2. Simmer over low heat at 100 - 120°C and stir continuously. When the drug forms a flag shape, pour the paste into a dry container to obtain the paste.

[0024] The beneficial effects of adopting the technical solution of the present invention are as follows:

[0025] In the above traditional Chinese medicine composition, Atractylodes lancea (Thunb.) DC. stir - fried and Phellodendron amurense Rupr. are used as the monarch drugs, jointly exerting the effect of clearing heat and drying dampness, so that dampness is removed and heat has nothing to rely on. Atractylodes lancea (Thunb.) DC. stir - fried is pungent, bitter, and warm, with a dry and strong nature, strengthening the spleen and promoting transportation, dispelling wind and dampness, so that dampness is removed and arthralgia is relieved; Phellodendron amurense Rupr. is cold, bitter, and dry, with a descending nature, being good at dispelling damp - heat in the lower energizer. The two are used in combination as monarch drugs, and they mutually restrict each other's cold, bitter, warm, and dry properties to prevent the risk of damaging the stomach and injuring body fluids. Coix lacryma - jobi L., Stephania tetrandra S. Moore, Dioscorea septemloba Thunb., Chaenomeles sinensis (Thouin) Koehne, Alisma orientale (Sam.) Juz., Siegesbeckia orientalis L., and Clematis chinensis Osbeck are used as ministerial drugs. Among them, Coix lacryma - jobi L. enters only the Yangming meridian, promoting diuresis and dampness - elimination, assisting the monarch drugs in clearing heat and relieving arthralgia; Siegesbeckia orientalis L. dispels wind - dampness, dredges the meridians, and clears heat and detoxifies; Clematis chinensis Osbeck dispels wind and wins over dampness, dredges the collaterals and relieves pain; Alisma orientale (Sam.) Juz. promotes diuresis and dampness - percolation, resolving turbidity and clearing heat; Dioscorea septemloba Thunb. dispels wind and relieves arthralgia, promotes dampness - elimination and turbidity - resolution; Chaenomeles sinensis (Thouin) Koehne relaxes the muscles and tendons, activates collaterals, and harmonizes the stomach to eliminate dampness; Stephania tetrandra S. Moore dispels wind and dampness, relieves pain, and promotes diuresis. The combination of Stephania tetrandra S. Moore, Dioscorea septemloba Thunb., Chaenomeles sinensis (Thouin) Koehne, Alisma orientale (Sam.) Juz., Siegesbeckia orientalis L., and Clematis chinensis Osbeck greatly increases the effect of dispelling wind and dampness, relaxing the muscles and tendons, and jointly assisting Atractylodes lancea (Thunb.) DC. and Phellodendron amurense Rupr. in clearing heat and drying dampness. The monarch and ministerial drugs work together to clear the source, taking both the root cause and the symptoms into consideration. Angelica sinensis (Oliv.) Diels and Paeonia lactiflora Pall. are used as adjuvant drugs to nourish blood and relieve pain, and at the same time prevent the other drugs from damaging yin and blood. Additionally, Taxillus chinensis (DC.) Danser and Eucommia ulmoides Oliv. are used as adjuvant drugs to tonify the liver and kidney, strengthen the waist and knees. Achyranthes bidentata Blume and Cyathula officinalis Kuan are used as guiding drugs. Achyranthes bidentata Blume is good at tonifying the liver and kidney, strengthening the bones and muscles, while Cyathula officinalis Kuan is good at removing blood stasis and dredging the meridians, promoting blood circulation and relaxing joints. Adding the two together with Taxillus chinensis (DC.) Danser and Eucommia ulmoides Oliv. jointly builds the effect of tonifying the liver and kidney, strengthening the bones and muscles, promoting blood circulation and dredging collaterals. Using Achyranthes bidentata Blume as the guiding drug, it guides the medicine downward, assisting the other drugs to directly reach the diseased area in the lower energizer, so that the damp - heat pathogen is removed from below. Additionally, prepared licorice root is used as the guiding drug to invigorate the spleen and harmonize the stomach, reconcile the various drugs, and the combination of Paeonia lactiflora Pall. and prepared licorice root is the Paeoniae Radix Alba - Glycyrrhizae Decoction, further strengthening its effect of soothing the liver, softening the liver, and relieving spasm and pain. The formula has a mild property, without the worry of damaging the stomach due to cold and bitter drugs. The combination of various drugs removes damp - heat, dredges the tendons and meridians, and relieves arthralgia, effectively improving the clinical symptoms of patients with restless legs syndrome of damp - heat obstruction type and significantly enhancing their quality of life.

[0026] The traditional Chinese medicine composition of the present invention has the effects of clearing away heat and promoting diuresis, dredging collaterals and calming the legs, and can also tonify the liver and kidney. Based on the common damp-heat constitution of patients with restless legs syndrome, it can be used for the treatment of restless legs syndrome, has extremely high safety while taking into account the clinical efficacy, and is suitable for the vast majority of patients with restless legs syndrome. Moreover, the present invention also provides a pharmaceutical preparation (granules, pills, ointments) for the treatment of restless legs syndrome. While ensuring the efficacy, it can facilitate patients to choose the corresponding dosage form according to their own conditions, enhance the convenience of taking the medicine, facilitate patients to adhere to the drug treatment, and enhance the curative effect. Detailed Embodiments

[0027] To make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Therefore, the following detailed description of the embodiments provided by the present invention is not intended to limit the scope of the claimed invention, but merely represents the selected embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0028] In this embodiment, a traditional Chinese medicine composition for the treatment of restless legs syndrome, its preparation method and application are invented by fully analyzing the common problems of limb discomfort, irresistible desire to move the limbs and mental abnormal symptoms in patients with restless legs syndrome in the prior art. The raw material medicinal materials include: stir-fried Atractylodes lancea, Phellodendron amurense, Coix lacryma-jobi, Achyranthes bidentata, Cyathula officinalis, Stephania tetrandra, Dioscorea septemloba, Chaenomeles sinensis, Angelica sinensis, Alisma orientale, Siegesbeckia orientalis, Clematis chinensis, Paeonia lactiflora, Taxillus chinensis, Eucommia ulmoides, and roasted Licorice.

[0029] In the traditional Chinese medicine composition for the treatment of vascular dementia provided by the present application:

[0030] Stir-fried Atractylodes lancea: It is the rhizome of Atractylodes lancea (Thunb.) DC. of the Compositae family. It is pungent and bitter in taste, warm in nature, and belongs to the spleen, stomach and liver meridians. It has the effects of drying dampness and strengthening the spleen, expelling wind and cold, and improving eyesight. It is commonly used to treat symptoms such as abdominal distension, vomiting, diarrhea, wind-cold-damp arthralgia, and swelling and pain of the feet and knees caused by dampness obstruction in the middle-jiao.

[0031] Phellodendron amurense: It is the dried bark of Phellodendron chinense Schneid. of the Rutaceae family. It is bitter in taste, cold in nature, and belongs to the kidney and bladder meridians. It has the effects of clearing away heat and drying dampness, purging fire and removing steaming, and detoxifying and treating sores. It is commonly used to treat symptoms such as damp-heat diarrhea, jaundice with red urine, leukorrhea with itching in the vagina, heat strangury with pain, beriberi with flaccidity, bone-steaming fever, night sweats, spermatorrhea, sores and boils, and eczema and damp sores.

[0032] Coix Seed: The dried and matured semen of Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf, Gramineae. Sweet, light, cool in nature, attributive to the spleen, stomach and lung meridians. It has the effects of promoting diuresis to eliminate dampness, strengthening the spleen to stop diarrhea, dispelling impediment, expelling pus, detoxifying and dissipating nodules. It is commonly used to treat edema, beriberi, dysuria, diarrhea due to spleen deficiency, damp impediment with contracture, lung abscess, intestinal abscess; verruca, cancer and other symptoms.

[0033] Radix Achyranthis Bidentatae: The dried root of Achyranthes bidentata Blume, Amaranthaceae. Sweet, sour, bitter, neutral in nature, attributive to the liver and kidney meridians. It has the effects of tonifying the liver and kidney, strengthening the bones and muscles, dredging the meridians, and dispersing stasis. It is commonly used to treat cold-dampness, pain in the waist and knees, weakness of the waist and knees, contracture of the limbs, irregular menstruation, abdominal pain due to postpartum stasis, bloody stranguria, traumatic injury and knee flexion impairment, etc. It is one of the commonly used drugs for dredging collaterals and activating blood circulation in traditional Chinese medicine prescriptions.

[0034] Radix Cyathulae: The dried root of Cyathula officinalis Kuan, Amaranthaceae. Sweet, slightly bitter, neutral in nature, attributive to the liver and kidney meridians. It has the effects of removing blood stasis and dredging menstruation, promoting joint movement, and inducing diuresis for treating stranguria. It is commonly used to treat amenorrhea and mass in the abdomen, retention of the placenta, traumatic injury, rheumatic arthralgia, flaccidity of the feet and spasms of the tendons, hematuria and bloody stranguria, etc.

[0035] Stephania Tetrandra Root: The dried root of Stephania tetrandra S. Moore, Menispermaceae. Pungent, bitter, cold in nature, attributive to the bladder and lung meridians. It has the effects of expelling wind and relieving pain, promoting diuresis and reducing edema. It is commonly used to treat rheumatic arthralgia, edema and beriberi, dysuria, eczema and sores, etc.

[0036] Rhizoma Dioscoreae Hypoglaucae: The dried rhizome of Dioscorea septemloba Thunb. and Dioscorea hypoglauca Palibin, Dioscoreaceae. Bitter, flat in nature, attributive to the kidney and stomach meridians. It has the effects of promoting diuresis to remove turbidity, expelling wind and relieving impediment. It is commonly used to treat chyluria, leukorrhagia, excessive leucorrhea, rheumatic arthralgia, joint discomfort, pain in the waist and knees, etc.

[0037] Fructus Chaenomelis: The dried nearly mature fruit of Chaenomeles speciosa (Sweet) Nakai, Rosaceae. Sour, warm in nature, attributive to the liver and spleen meridians. It has the effects of relaxing tendons and activating collaterals, regulating the stomach and resolving dampness. It is commonly used to treat damp impediment with contracture, soreness and pain in the waist and knee joints, vomiting and diarrhea due to summer heat and dampness, spasm and pain of the muscles due to cramps, edema of beriberi, etc.

[0038] Radix Angelicae Sinensis: The dried root of Angelica sinensis (Oliv.) Diels, Umbelliferae. Sweet, pungent, warm in nature, attributive to the liver, heart and spleen meridians. It has the effects of enriching blood and promoting blood circulation, regulating menstruation and relieving pain, moistening the intestine and relaxing bowel. It is commonly used to treat sallow complexion due to blood deficiency, dizziness and palpitation, irregular menstruation, amenorrhea and dysmenorrhea, cold pain in the abdomen, rheumatic arthralgia, traumatic injury, carbuncle and ulcer, constipation due to intestinal dryness, etc.

[0039] Rhizoma Alismatis: The dried tuber of Alisma orientale (Sam.) Juzep., Alismataceae. Sweet, light, cold in nature, attributive to the kidney and bladder meridians. It has the effects of promoting diuresis to eliminate dampness, clearing heat, and reducing turbidity and lipid. It is commonly used to treat dysuria, edema and fullness, diarrhea with scanty urine, dizziness due to phlegm retention, stranguria with pain, hyperlipidemia, etc.

[0040] Siegesbeckia herb: The dried above-ground part of Siegesbeckia pubescens, Siegesbeckia virgaurea or Siegesbeckia glabrescens, which are plants of the Compositae family. It is bitter, pungent, and cold in nature, and belongs to the liver and kidney meridians. It has the effects of dispelling wind-dampness, promoting joint movement, and detoxifying. It is commonly used to treat symptoms such as wind-damp arthralgia, weak muscles and bones, soreness and weakness of the waist and knees, limb paralysis, hemiplegia, rubella, and damp sores.

[0041] Clematis root: The dried root and rhizome of Clematis chinensis, Clematis hexapetala or Clematis manshurica, which are plants of the Ranunculaceae family. It is pungent, salty, and warm in nature, and belongs to the bladder meridian. It has the effects of dispelling wind-dampness and dredging the channels. It is commonly used to treat symptoms such as wind-damp arthralgia, limb numbness, muscle contracture, and limited flexion and extension.

[0042] White peony root: The dried root of Paeonia lactiflora, which is a plant of the Ranunculaceae family. It is bitter, sour, and slightly cold in nature, and belongs to the liver and spleen meridians. It has the effects of nourishing blood and regulating menstruation, astringing yin and stopping sweating, soothing the liver and relieving pain, and suppressing liver yang. It is commonly used to treat symptoms such as sallow complexion due to blood deficiency, irregular menstruation, spontaneous sweating, night sweating, hypochondriac pain, abdominal pain, limb contracture pain, headache, and dizziness.

[0043] Taxillus twig: The dried leafy stem branch of Taxillus chinensis, which is a plant of the Loranthaceae family. It is bitter, sweet, and neutral in nature, and belongs to the liver and kidney meridians. It has the effects of dispelling wind-dampness, tonifying the liver and kidney, strengthening muscles and bones, and preventing miscarriage. It is commonly used to treat symptoms such as wind-damp arthralgia, soreness and weakness of the waist and knees, weak muscles and bones, metrorrhagia and menorrhagia, threatened abortion, fetal movement restlessness, and dizziness.

[0044] Eucommia bark: The bark of Eucommia ulmoides, which is a plant of the Eucommiaceae family. It is sweet, slightly pungent, and warm in nature, and belongs to the liver and kidney meridians. It has the effects of tonifying the liver and kidney, strengthening muscles and bones, and preventing miscarriage. It is commonly used to treat symptoms such as lumbar and spinal pain, weakness of the feet and knees, residual urine, itching in the perineum, threatened abortion, fetal movement restlessness, and hypertension.

[0045] Prepared licorice root: The processed product of the dried root and rhizome of Glycyrrhiza uralensis, Glycyrrhiza inflata or Glycyrrhiza glabra, which are plants of the Leguminosae family. That is, put honey in a pot and heat it to medium honey, then change to a slow fire and add raw licorice root slices and stir-fry evenly. Take it out of the pot after 3 - 5 minutes, place it in a baking room or oven and bake until it is not sticky to the hand, then take it out and let it cool. It is sweet in taste, neutral in nature, and belongs to the heart, lung, spleen, and stomach meridians. It has the effects of invigorating the spleen and stomach, and replenishing qi and restoring the pulse. It is commonly used to treat symptoms such as weakness of the spleen and stomach, lassitude and weakness, palpitations, and intermittent pulse.

[0046] As a preferred embodiment, it includes the following medicinal material raw materials in parts by mass: fried Atractylodes lancea 10 - 20 parts, Phellodendron amurense 5 - 15 parts, Coix lacryma-jobi 10 - 20 parts, Achyranthes bidentata 10 - 20 parts, Cyathula officinalis 6 - 18 parts, Stephania tetrandra 10 - 20 parts, Dioscorea septemloba 10 - 20 parts, Chaenomeles speciosa 10 - 20 parts, Angelica sinensis 6 - 18 parts, Alisma orientale 6 - 18 parts, Siegesbeckia herb 10 - 20 parts, Clematis root 5 - 15 parts, White peony root 10 - 20 parts, Taxillus twig 10 - 20 parts, Eucommia bark 10 - 20 parts, Prepared licorice root 3 - 9 parts.

[0047] As a preferred embodiment, it includes the following medicinal material raw materials in parts by mass: stir-fried Atractylodes lancea 12 - 18 parts, Phellodendron amurense 7 - 13 parts, Coix lacryma-jobi 12 - 18 parts, Achyranthes bidentata 12 - 18 parts, Cyathula officinalis 8 - 16 parts, Stephania tetrandra 12 - 18 parts, Dioscorea hypoglauca 12 - 18 parts, Chaenomeles sinensis 12 - 18 parts, Angelica sinensis 8 - 16 parts, Alisma orientale 8 - 16 parts, Siegesbeckia orientalis 12 - 18 parts, Clematis chinensis 7 - 13 parts, Paeonia lactiflora 12 - 18 parts, Taxillus chinensis 12 - 18 parts, Eucommia ulmoides 12 - 18 parts, roasted Glycyrrhiza uralensis 4 - 8 parts.

[0048] As a preferred embodiment, it includes the following medicinal material raw materials in parts by mass: stir-fried Atractylodes lancea 14 - 16 parts, Phellodendron amurense 9 - 11 parts, Coix lacryma-jobi 14 - 16 parts, Achyranthes bidentata 14 - 16 parts, Cyathula officinalis 10 - 14 parts, Stephania tetrandra 14 - 16 parts, Dioscorea hypoglauca 14 - 16 parts, Chaenomeles sinensis 14 - 16 parts, Angelica sinensis 10 - 14 parts, Alisma orientale 10 - 14 parts, Siegesbeckia orientalis 14 - 16 parts, Clematis chinensis 9 - 11 parts, Paeonia lactiflora 14 - 16 parts, Taxillus chinensis 14 - 16 parts, Eucommia ulmoides 14 - 16 parts, roasted Glycyrrhiza uralensis 5 - 7 parts.

[0049] The present invention also provides the application of the above traditional Chinese medicine composition for treating restless legs syndrome in the preparation of a drug for treating restless legs syndrome.

[0050] The present invention also provides a drug for treating restless legs syndrome, which includes the above traditional Chinese medicine composition for treating restless legs syndrome and pharmaceutically acceptable excipients.

[0051] As a preferred embodiment, the dosage form of the drug is traditional Chinese medicine decoction, decocted medicine, granule, pill, capsule, tablet, tea, suspension, powder or oral liquid.

[0052] The present invention also provides a preparation method of the above drug for treating restless legs syndrome. The drug is a granule, and its preparation method is as follows:

[0053] Step 1, weigh the raw medicinal materials according to the weight ratio, perform cleaning and selection, drying, cutting, pulverizing, sieving, and mix evenly;

[0054] Step 2, add water to submerge the raw medicinal materials in Step 1 by 3 - 5 cm and soak for 30 - 60 minutes, then bring to a boil over high heat, and then continue to decoct over low heat for 50 - 70 minutes. Filter with a traditional Chinese medicine sieve to obtain the first filtrate; then add water to submerge the medicinal residues by 1 - 3 cm, bring to a boil over high heat, change to low heat and continue to decoct for 50 - 70 minutes, filter out the medicinal residues with a traditional Chinese medicine sieve to obtain the second filtrate; combine the first filtrate and the second filtrate;

[0055] Step 3, place the combined filtrate in Step 2 in a vacuum dryer, and dry at a temperature of 40 - 60 °C and a pressure of 5 - 7 KPa until the weight no longer decreases to obtain the granule.

[0056] The present invention also provides a preparation method of the above-mentioned drug for treating restless legs syndrome. The drug is in pill form, and its preparation method is as follows:

[0057] Step 1: Weigh the raw materials according to the weight ratio, perform cleaning, drying, cutting, pulverizing, sieving, and mix them evenly.

[0058] Step 2: Add water to submerge the raw materials in Step 1 by 3 - 5 cm and soak for 30 - 60 minutes. Then bring to a boil over high heat, and then switch to low heat and continue to decoct for 50 - 70 minutes. Filter with a traditional Chinese medicine sieve to obtain the first filtrate. Then add water to submerge the residue by 1 - 3 cm, bring to a boil over high heat, switch to low heat and continue to decoct for 50 - 70 minutes, and filter out the residue with a traditional Chinese medicine sieve to obtain the second filtrate. Combine the first filtrate and the second filtrate and place them in a vacuum dryer. Dry at a temperature of 40 - 60°C and a pressure of 5 - 7 KPa until the weight no longer decreases.

[0059] Step 3: Heat the honey to 100 - 120°C, and then mix it evenly with the dried drug in Step 2, honey, and water according to a mass ratio of 1:1.2:2. Simmer over low heat at 100 - 120°C for 15 - 25 minutes. Then naturally cool to room temperature and add it to a pill-making machine to obtain pills.

[0060] The present invention also provides a preparation method of the above-mentioned drug for treating restless legs syndrome. The drug is in ointment form, and its preparation method is as follows:

[0061] Step 1: Weigh the raw materials according to the weight ratio, perform cleaning, drying, cutting, pulverizing, sieving, and mix them evenly.

[0062] Step 2: Add water to submerge the raw materials in Step 1 by 3 - 5 cm and soak for 30 - 60 minutes. Then bring to a boil over high heat, and then switch to low heat and continue to decoct for 50 - 70 minutes. Filter with a traditional Chinese medicine sieve to obtain the first filtrate. Then add water to submerge the residue by 1 - 3 cm, bring to a boil over high heat, switch to low heat and continue to decoct for 50 - 70 minutes, and filter out the residue with a traditional Chinese medicine sieve to obtain the second filtrate. Combine the first filtrate and the second filtrate and place them in a vacuum dryer. Dry at a temperature of 40 - 60°C and a pressure of 5 - 7 KPa until the weight no longer decreases.

[0063] Step 3: Heat the honey to 100 - 120°C, and then mix it evenly with the dried drug in Step 2, honey, and water according to a mass ratio of 1:1.2:2. Simmer over low heat at 100 - 120°C and stir continuously. When the drug shows the "hanging flag" phenomenon, pour the ointment into a dry container to obtain the ointment.

[0064] The following further elaborates the present invention with specific embodiments:

[0065] Example 1

[0066] A drug for treating restless legs syndrome, and the raw materials of the traditional Chinese medicine formula are taken by the following mass parts: 10 parts of stir-fried Atractylodes lancea, 5 parts of Phellodendron amurense, 10 parts of Coix lacryma-jobi, 10 parts of Achyranthes bidentata, 6 parts of Cyathula officinalis, 10 parts of Stephania tetrandra, 10 parts of Dioscorea septemloba, 10 parts of Chaenomeles sinensis, 6 parts of Angelica sinensis, 6 parts of Alisma orientale, 10 parts of Siegesbeckia orientalis, 5 parts of Clematis chinensis, 10 parts of Paeonia lactiflora, 10 parts of Taxillus chinensis, 10 parts of Eucommia ulmoides, and 3 parts of roasted licorice root. Embodiment 1 also provides a preparation method of the drug for treating restless legs syndrome. The drug is a granule, and the preparation method is as follows:

[0067] Step 1: Weigh the raw materials according to the weight ratio, perform cleaning, drying, cutting, pulverizing, sieving, and mix them evenly;

[0068] Step 2: Add water to submerge the raw materials in Step 1 by 5 cm and soak for 40 minutes, then bring to a boil over high heat, and then switch to low heat and continue to decoct for 60 minutes. Filter with a traditional Chinese medicine sieve to obtain the first filtrate; then add water to submerge the medicinal residues by 3 cm, bring to a boil over high heat, switch to low heat and continue to decoct for 60 minutes, and filter out the medicinal residues with a traditional Chinese medicine sieve to obtain the second filtrate; combine the first filtrate and the second filtrate;

[0069] Step 3: Place the combined filtrate in Step 2 in a vacuum dryer, and dry it at a temperature of 50 °C and a pressure of 6 KPa until the weight no longer decreases to obtain the granule.

[0070] Embodiment 2

[0071] A drug for treating restless legs syndrome, and the raw materials of the traditional Chinese medicine formula are taken by the following mass parts: 12 parts of stir-fried Atractylodes lancea, 7 parts of Phellodendron amurense, 12 parts of Coix lacryma-jobi, 12 parts of Achyranthes bidentata, 8 parts of Cyathula officinalis, 12 parts of Stephania tetrandra, 12 parts of Dioscorea septemloba, 12 parts of Chaenomeles sinensis, 8 parts of Angelica sinensis, 8 parts of Alisma orientale, 12 parts of Siegesbeckia orientalis, 7 parts of Clematis chinensis, 12 parts of Paeonia lactiflora, 12 parts of Taxillus chinensis, 12 parts of Eucommia ulmoides, and 4 parts of roasted licorice root. The preparation method of the drug for treating restless legs syndrome in this Embodiment 2 is the same as that in Embodiment 1.

[0072] Embodiment 3

[0073] A drug for treating restless legs syndrome, and the raw materials of the traditional Chinese medicine formula are taken by the following mass parts: 14 parts of stir-fried Atractylodes lancea, 9 parts of Phellodendron amurense, 14 parts of Coix lacryma-jobi, 14 parts of Achyranthes bidentata, 10 parts of Cyathula officinalis, 14 parts of Stephania tetrandra, 14 parts of Dioscorea septemloba, 14 parts of Chaenomeles sinensis, 10 parts of Angelica sinensis, 10 parts of Alisma orientale, 14 parts of Siegesbeckia orientalis, 9 parts of Clematis chinensis, 14 parts of Paeonia lactiflora, 14 parts of Taxillus chinensis, 14 parts of Eucommia ulmoides, and 5 parts of roasted licorice root. The preparation method of the drug for treating restless legs syndrome in this Embodiment 3 is the same as that in Embodiment 1.

[0074] Embodiment 4

[0075] A drug for treating restless legs syndrome, the raw materials of the traditional Chinese medicine formula are taken according to the following parts by mass: stir-fried Atractylodes lancea 15 parts, Phellodendron amurense 10 parts, Coix lacryma-jobi 15 parts, Achyranthes bidentata 15 parts, Cyathula officinalis 12 parts, Stephania tetrandra 15 parts, Dioscorea septemloba 15 parts, Chaenomeles sinensis 15 parts, Angelica sinensis 12 parts, Alisma orientale 12 parts, Siegesbeckia orientalis 15 parts, Clematis chinensis 10 parts, Paeonia lactiflora 15 parts, Taxillus chinensis 15 parts, Eucommia ulmoides 15 parts, and roasted Glycyrrhiza uralensis 6 parts. The preparation method of the drug for treating restless legs syndrome in this Example 4 is the same as that in Example 1.

[0076] Example 5

[0077] A drug for treating restless legs syndrome, the raw materials of the traditional Chinese medicine formula are taken according to the following parts by mass: stir-fried Atractylodes lancea 16 parts, Phellodendron amurense 11 parts, Coix lacryma-jobi 16 parts, Achyranthes bidentata 16 parts, Cyathula officinalis 14 parts, Stephania tetrandra 16 parts, Dioscorea septemloba 16 parts, Chaenomeles sinensis 16 parts, Angelica sinensis 14 parts, Alisma orientale 14 parts, Siegesbeckia orientalis 16 parts, Clematis chinensis 11 parts, Paeonia lactiflora 16 parts, Taxillus chinensis 16 parts, Eucommia ulmoides 16 parts, and roasted Glycyrrhiza uralensis 7 parts. The preparation method of the drug for treating restless legs syndrome in this Example 5 is the same as that in Example 1.

[0078] Example 6

[0079] A drug for treating restless legs syndrome, the raw materials of the traditional Chinese medicine formula are taken according to the following parts by mass: stir-fried Atractylodes lancea 18 parts, Phellodendron amurense 13 parts, Coix lacryma-jobi 18 parts, Achyranthes bidentata 18 parts, Cyathula officinalis 16 parts, Stephania tetrandra 18 parts, Dioscorea septemloba 18 parts, Chaenomeles sinensis 18 parts, Angelica sinensis 16 parts, Alisma orientale 16 parts, Siegesbeckia orientalis 18 parts, Clematis chinensis 13 parts, Paeonia lactiflora 18 parts, Taxillus chinensis 18 parts, Eucommia ulmoides 18 parts, and roasted Glycyrrhiza uralensis 8 parts. The preparation method of the drug for treating restless legs syndrome in this Example 6 is the same as that in Example 1.

[0080] Example 7

[0081] A drug for treating restless legs syndrome, the raw materials of the traditional Chinese medicine formula are taken according to the following parts by mass: stir-fried Atractylodes lancea 20 parts, Phellodendron amurense 15 parts, Coix lacryma-jobi 20 parts, Achyranthes bidentata 20 parts, Cyathula officinalis 18 parts, Stephania tetrandra 20 parts, Dioscorea septemloba 20 parts, Chaenomeles sinensis 20 parts, Angelica sinensis 18 parts, Alisma orientale 18 parts, Siegesbeckia orientalis 20 parts, Clematis chinensis 15 parts, Paeonia lactiflora 20 parts, Taxillus chinensis 20 parts, Eucommia ulmoides 20 parts, and roasted Glycyrrhiza uralensis 9 parts. The preparation method of the drug for treating restless legs syndrome in this Example 7 is the same as that in Example 1.

[0082] In order to verify the efficacy of this application, the drug prepared in the preferred Example 4 was used for experimental identification of the efficacy of the present invention on patients with restless legs syndrome:

[0083] 1. Source of cases

[0084] All the cases included in this study were from the patients who visited the Encephalopathy Department of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from December 2018 to November 2024. A total of 70 patients were admitted successively, among which 59 patients met the diagnostic criteria and inclusion criteria of restless legs syndrome.

[0085] 2. Diagnostic Criteria

[0086] 2.1 Western Medicine Diagnostic Criteria

[0087] Referring to the 6 diagnostic criteria formulated in the "Consensus on the Diagnostic Criteria of Restless Legs Syndrome" issued by the International Restless Legs Syndrome Study Group (IRLSSG) for the diagnosis of RLS in 2014, the specific criteria are as follows:

[0088] (1) A strong desire to move the legs, accompanied by discomfort in the legs;

[0089] (2) A strong desire to move, accompanied by discomfort or aggravation when at rest;

[0090] (3) After moving the legs, the discomfort and the desire to move are relieved or disappear;

[0091] (4) The discomfort and the desire to move appear or worsen in the evening or at night;

[0092] (5) Accompanied by sleep disorders and mood swings;

[0093] (6) The above manifestations cannot be solely explained by another disease or phenomenon, such as habitual foot tapping, myalgia, lower limb edema, etc.

[0094] 2.2 Traditional Chinese Medicine Diagnostic Criteria

[0095] Referring to the "Diagnostic Criteria for the Efficacy of Traditional Chinese Medicine Syndromes" (2012 edition), "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (the third volume), and "Internal Medicine of Traditional Chinese Medicine" (the second edition), the diagnostic criteria for the type of damp-heat obstruction are formulated as follows:

[0096] (1) Main symptoms: The skin feels burning and uncomfortable, relieved by getting cool, sour, distending pain, numbness, heaviness of the limbs, especially at night;

[0097] (2) Concurrent symptoms: Skin itching, thirst or dry mouth but not willing to drink, fullness and distension or burning pain in the epigastric and abdominal regions, loose stools;

[0098] Tongue and pulse: The tongue is red or dark red, the tongue coating is yellow or thick yellow and greasy, and the pulse is slippery and rapid or string-taut and slippery;

[0099] The basis for diagnosis is: 1 main symptom, 2 or more concurrent symptoms, and comprehensive diagnosis combined with tongue and pulse.

[0100] 3. Inclusion and Exclusion Criteria

[0101] 3.1 Inclusion Criteria

[0102] (1) Patients who meet the Western medicine diagnostic criteria for restless legs syndrome and whose syndrome type is damp-heat obstruction and blockage;

[0103] (2) Gender is not limited, aged between 18 and 80 years old;

[0104] (3) Patients without obvious sleep disorders, anxiety, depression and other mood disorders before suffering from RLS;

[0105] (4) Have not participated in other drug trials within 3 months;

[0106] (5) IRLS score > 10 points;

[0107] (6) Sign the informed consent form.

[0108] 3.2 Exclusion criteria

[0109] (1) Patients with moderate to severe depression, or stress, personality disorders, or sleep disorders caused by organic diseases or psychiatric drugs;

[0110] (2) Patients with diseases that may secondary RLS symptoms, such as diabetes, uremia, iron deficiency anemia, etc.;

[0111] (3) Women in pregnancy or lactation;

[0112] (4) Patients who have taken any drugs that may affect the research results, such as antidopaminergic drugs, sedatives, antiepileptic drugs, hypnotics, benzodiazepines, anti-anxiety drugs, ferrous salts, vitamin B12, etc. within 2 weeks before the start of this study;

[0113] (5) Patients with allergic symptoms to the drugs used in this study.

[0114] 3.3 Exclusion criteria and withdrawal criteria

[0115] (1) During the treatment process, the compliance is poor, seriously affecting the effective evaluation;

[0116] (2) Adverse reactions occur during the trial, not suitable for continuing treatment;

[0117] (3) During the treatment process, the clinical symptoms change significantly;

[0118] (4) The subjects failed to implement the treatment as required during the treatment period and the curative effect could not be determined;

[0119] (5) Other drugs or methods are used to treat restless legs syndrome during the trial;

[0120] (6) Withdraw from the trial due to adverse drug reactions or poor treatment effects;

[0121] (7) Suffering from serious adverse events, complications, etc., and being unsuitable for continued treatment.

[0122] Drop - out cases: Record in detail the reasons for dropping out; for patients who drop out due to drug allergy or adverse reactions, provide corresponding treatment measures; all relevant trial materials of drop - out cases should be properly preserved for future reference.

[0123] 4. Observation indicators

[0124] Examination using the International Restless Legs Syndrome Severity Rating Scale (IRLS), Pittsburgh Sleep Quality Index (PSQI), and Hamilton Anxiety Scale (HAMA).

[0125] 5. Data analysis

[0126] Statistical analysis was performed using SPSS 25.0. Measurement data were expressed as mean ± standard deviation. For data that conformed to a normal distribution, t - test (for homogeneous variances) or corrected t - test (for heterogeneous variances) was used for analysis; for data that did not conform to a normal distribution, non - parametric tests were used, and the Wilcoxon rank - sum test was used between groups. P < 0.05 was considered statistically significant.

[0127] 6. Research plan

[0128] Among the 59 patients who met the diagnostic criteria and were included, they were randomly divided into a treatment group (30 cases) and a control group (29 cases).

[0129] (1) Control group: Conventional treatment with Pramipexole Dihydrochloride Tablets (Boehringer Ingelheim Shanghai), taken orally once every night before bedtime, 0.125 mg each time, for 4 weeks. The dose could be gradually increased or decreased according to the condition, with the maximum dose not exceeding 0.75 mg per day.

[0130] (2) Treatment group: The drug prepared in Example 4 of this application, the granules prepared in Example 4 were taken on an empty stomach once in the morning and once in the evening, 1 portion each time, dissolved in 150 mL of warm water. At the same time, Pramipexole Dihydrochloride Tablets (Boehringer Ingelheim Shanghai) 0.125 mg were taken orally once every night before bedtime, for 4 weeks.

[0131] 7. Research results

[0132] 7.1 Baseline comparison of clinical data between groups

[0133] Table 1 Comparison of IRLS scores between two groups of patients before treatment (unit: points)

[0134]

[0135] Note: Before treatment, after the normality test, it did not conform to the normal distribution. The IRLS scores of the two groups of patients were detected by the rank sum test, P = 0.790 > 0.05. Therefore, there was no significant difference in the IRLS scores of the two groups before treatment, and they were comparable.

[0136] Table 2 Comparison of PSQI scores of two groups of patients before treatment (unit: points)

[0137]

[0138]

[0139] Note: The PSQI scores of the two groups of patients before treatment were evaluated by the rank sum test, P = 0.598 > 0.05. Therefore, before treatment, there was no significant difference in the PSQI scores of the two groups of patients, and they were comparable.

[0140] Table 3 Comparison of HAMA scores of two groups of patients before treatment (unit: points)

[0141]

[0142] Note: The scores of the Hamilton Anxiety Scale (HAMA) of the two groups of patients before treatment were evaluated by the t-test, P = 0.421 > 0.05. Therefore, there was no significant difference in the HAMA scores of the two groups of patients before treatment, and they were comparable.

[0143] 7.2 Efficacy study after treatment

[0144] Table 4 IRLS scores of two groups before and after treatment (unit: points)

[0145]

[0146] Note: After the end of the 4th week of treatment, for the IRLS scores of the two groups, there was P < 0.001 in the within-group comparison, showing a significant difference and statistical significance; in the between-group comparison, P = 0.047 < 0.05, and the difference between groups was statistically significant.

[0147] Table 5 PSQI scores of two groups before and after treatment (unit: points)

[0148]

[0149] Note: After the end of the 4th week of treatment, for the PSQI scores of the two groups, there was P < 0.001 in the within-group comparison, showing significant differences and statistical significance in the comparisons; in the between-group comparison, P = 0.034 < 0.05, and the difference between groups was statistically significant.

[0150] Table 6 HAMA scores of two groups before and after treatment (unit: points)

[0151]

[0152] Note: After the end of the 4th week of treatment, when comparing within each group in terms of the HAMA score, P < 0.001 in both groups, indicating significant differences and statistical significance in the comparison. When comparing between groups, P = 0.211 > 0.05, indicating that there is no statistical significance in the differences between groups.

[0153] As can be seen from the above table, after treatment, the degrees of limb discomfort, sleep quality, and anxiety status of the patients in both groups were significantly lower than before, and there was statistical significance compared with before treatment, indicating that pramipexole hydrochloride tablets have definite curative effects in improving the clinical manifestations and sleep quality of patients. When comparing between the two groups after treatment, there was no obvious difference in the anxiety status score, indicating that the combination of traditional Chinese and Western medicines is equivalent to pure Western medicines in improving the anxiety mood of patients and has not shown an obvious synergistic effect, which may be related to the treatment course. In terms of the degree of limb discomfort and sleep quality assessment, the curative effect of the traditional Chinese medicine composition for treating restless legs syndrome of the present invention combined with pramipexole hydrochloride tablets is better than that of pure Western medicines, indicating that the combination of traditional Chinese and Western medicines has a more obvious effect in improving the clinical manifestations and sleep quality of patients, highlighting the advantages of traditional Chinese medicine in improving the clinical symptoms of patients. The comparison before and after shows that the traditional Chinese medicine composition for treating restless legs syndrome of the present invention can better improve the clinical symptoms of patients with restless legs syndrome than using pure Western medicines alone, has a definite curative effect on treating restless legs syndrome, and can be used to prepare drugs for treating restless legs syndrome.

[0154] Typical case:

[0155] Case 1: Zhang XX, male, 51 years old, first diagnosis on January 25, 2022. Chief complaint: Discomfort in both knees for 1 month. The patient had discomfort, distending pain, burning heat in both knees and hands joints, which occurred easily during sleep and relieved after activities. Dizziness occurred occasionally when the neck was extended. The patient was irritable, the joints ached when exposed to cold, felt nauseous and wanted to vomit when smelling thick and greasy food, the stool was slightly dry and difficult to defecate smoothly. The tongue was pale and dark, the tongue coating was yellow and thick, and the pulse was deep, thin and slippery. Western diagnosis: Restless legs syndrome; Traditional Chinese medicine diagnosis: Bi syndrome, syndrome of damp-heat blocking collaterals. Treatment principle: Clearing heat and promoting diuresis, dredging collaterals and calming the legs. Oral administration of the granule prepared in Example 4 provided by the present invention, 1 dose per day, taken in 2 times. After taking the medicine for two weeks, the patient's condition improved significantly. The discomfort, distending pain, and burning heat in both hands and knees disappeared, and only mild discomfort in the hands was felt during sleep. The patient had normal appetite, aversion to greasy food, normal sleep, normal bowel movements and urination. The tongue was light red, the tongue coating was yellow and greasy, and the pulse was deep, thin and slippery.

[0156] Case 2: Guo XX, female, 50 years old, first visit on March 26, 2024. Chief complaint: Legs have been sore and uncomfortable for 1 month. The patient reported that her legs were sore and uncomfortable, which occurred easily during sleep, with a strong discomfort that could cause awakening and was relieved after knocking and moving. It occurred 7-8 times every night, resulting in poor sleep, difficulty falling asleep, light sleep and easy awakening, early awakening, normal appetite, normal bowel and bladder movements, normal menstruation, pale red tongue, white and thick greasy coating, and deep, thready and slippery pulse. Western medicine diagnosis: Restless legs syndrome; Traditional Chinese medicine diagnosis: Bi syndrome, damp-heat obstruction syndrome. Treatment principle: Clear heat and promote diuresis, dredge collaterals and soothe the legs. Orally take the granule prepared in Example 4 provided by the present invention, 1 dose per day, taken in 2 times. After taking the medicine for two weeks, the patient's condition improved significantly. During the medicine-taking period, the discomfort in the calves did not occur, but it was still difficult to fall asleep. The appetite was normal, the bowel and bladder movements were normal, the tongue was pale red, the coating was thin and white, and the pulse was deep, thready and fine.

[0157] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention can have various changes and modifications. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating restless legs syndrome, characterized in that: The invention comprises the following medicinal raw materials in proportion by weight: 10-20 parts of stir-fried atractylodes, 5-15 parts of phellodendron, 10-20 parts of coix seeds, 10-20 parts of cyperus rotundus, 6-18 parts of cyperus rotundus, 10-20 parts of stephania tetrandra, 10-20 parts of radix polygoni multiflori, 10-20 parts of papaya, 6-18 parts of angelica sinensis, 6-18 parts of orientalis, 10-20 parts of siegesbeckia herb, 5-15 parts of clematis, 10-20 parts of white peony root, 10-20 parts of mistletoe, 10-20 parts of eucommia bark, and 3-9 parts of roasted liquorice.

2. The Chinese medicine composition for treating restless legs syndrome according to claim 1, characterized in that: The invention comprises the following medicinal raw materials in proportions by weight: 12-18 parts of stir-fried atractylodes, 7-13 parts of phellodendron, 12-18 parts of coix seeds, 12-18 parts of cyperus rotundus, 8-16 parts of cyperus rotundus, 12-18 parts of stephania tetrandra, 12-18 parts of radix polygoni multiflori, 12-18 parts of papaya, 8-16 parts of angelica sinensis, 8-16 parts of orientalis, 12-18 parts of siegesbeckia herb, 7-13 parts of clematis, 12-18 parts of white peony root, 12-18 parts of viburnum parasiticum, 12-18 parts of eucommia bark, and 4-8 parts of roasted liquorice.

3. The Chinese medicine composition for treating restless legs syndrome according to claim 1, characterized in that: The invention comprises the following medicinal raw materials in proportions by weight: 14-16 parts of stir-fried atractylodes, 9-11 parts of phellodendron, 14-16 parts of coix seeds, 14-16 parts of cyperus rotundus, 10-14 parts of cyperus rotundus, 14-16 parts of stephania tetrandra, 14-16 parts of radix polygoni multiflori, 14-16 parts of papaya, 10-14 parts of angelica sinensis, 10-14 parts of orientalis, 14-16 parts of siegesbeckia herb, 9-11 parts of clematis, 14-16 parts of white peony root, 14-16 parts of villous herb, 14-16 parts of eucommia bark, and 5-7 parts of roasted liquorice.

4. Use of the Chinese medicinal composition for treating restless legs syndrome according to any one of claims 1 to 3 in the preparation of a medicament for treating restless legs syndrome.

5. A drug for treating restless legs syndrome, characterized in that: The invention comprises the Chinese medicine composition for treating restless legs syndrome as claimed in any one of claims 1 to 3 and pharmaceutically acceptable excipients.

6. The drug for treating restless legs syndrome according to claim 5, characterized in that: The dosage form of the medicine is Chinese medicine decoction, decoction, granules, pills, capsules, tablets, tea, suspension, powder or oral solution.

7. The method for preparing the drug for treating restless legs syndrome according to claim 6, characterized in that: The medicine is a granule, and its preparation method is as follows: Step 1, weighing the raw materials according to the weight ratio, cleaning, drying, cutting, crushing, sieving, and mixing evenly; Step 2: adding water to cover the raw material medicine of step 1 by 3 to 5 cm and soaking for 30 to 60 minutes, then boiling with high heat, then changing to low heat and continuing to decoct for 50 to 70 minutes, filtering with a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the residue by 1 to 3 cm, boiling with high heat, changing to low heat and continuing to decoct for 50 to 70 minutes, filtering out the residue with a Chinese medicine sieve to obtain a second filtrate; combining the first filtrate and the second filtrate; Step 3: Place the combined filtrate in step 2 in a vacuum dryer and dry at a temperature of 40-60° C. and a pressure of 5-7 KPa until the weight no longer decreases, thereby obtaining granules.

8. The method for preparing the drug for treating restless legs syndrome according to claim 5 or 6, characterized in that: The medicine is a pill, and its preparation method is as follows: Step 1, weighing the raw materials according to the weight ratio, cleaning, drying, cutting, crushing, sieving, and mixing evenly; Step 2: adding water to cover the raw material medicine of step 1 by 3 to 5 cm and soaking for 30 to 60 minutes, then boiling with high heat, then changing to low heat and continuing to decoct for 50 to 70 minutes, filtering with a Chinese medicine sieve to obtain a first filtrate; then adding water to the residue to cover the residue by 1 to 3 cm, boiling with high heat, changing to low heat and continuing to decoct for 50 to 70 minutes, filtering out the residue with a Chinese medicine sieve to obtain a second filtrate; combining the first filtrate and the second filtrate, placing in a vacuum dryer, and drying at a temperature of 40 to 60° C. and a pressure of 5 to 7 KPa until the weight no longer decreases; Step three, heating the honey to 100-120° C., then mixing the dried medicine in step two with honey and water in a mass ratio of 1:1.2:2, simmering over low heat at 100-120° C. for 15-25 minutes, then naturally cooling to room temperature before adding into a pill-making machine to obtain pills.

9. The method for preparing the drug for treating restless legs syndrome according to claim 5 or 6, characterized in that: The medicine is an ointment, and its preparation method is as follows: Step 1, weighing the raw materials according to the weight ratio, cleaning, drying, cutting, crushing, sieving, and mixing evenly; Step 2: adding water to cover the raw material medicine of step 1 by 3 to 5 cm and soaking for 30 to 60 minutes, then boiling with high heat, then changing to low heat and continuing to decoct for 50 to 70 minutes, filtering with a Chinese medicine sieve to obtain a first filtrate; then adding water to the residue to cover the residue by 1 to 3 cm, boiling with high heat, changing to low heat and continuing to decoct for 50 to 70 minutes, filtering out the residue with a Chinese medicine sieve to obtain a second filtrate; combining the first filtrate and the second filtrate, placing in a vacuum dryer, and drying at a temperature of 40 to 60° C. and a pressure of 5 to 7 KPa until the weight no longer decreases; Step three, heat the honey to 100-120° C., then mix it evenly with the dry medicine in step two, honey and water in a mass ratio of 1:1.2:2, simmer over low heat at 100-120° C. and stir continuously, and when the medicine is cooked, pour the ointment into a dry container to obtain an ointment.

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