Compound Fengshining capsule as well as preparation method and application thereof

Abstract

The invention discloses a compound Fengshining capsule and a preparation method thereof, and belongs to the field of traditional Chinese medicine preparations. The capsule is prepared from notopterygium root, radix angelicae pubescentis, divaricate saposhnikovia root, corydalis tuber, ligusticum wallichii, lumbricus, radix paeoniae alba, poria and liquorice according to a ratio through the processes of volatile oil extraction and inclusion, respective ethanol or water extraction, concentration, granulation, capsule filling and the like. The preparation is high in bioavailability and good in stability, experiments show that the dissolution rate of effective components of the preparation is effectively improved compared with that of a traditional preparation, the effects of dispelling wind, eliminating dampness, promoting blood circulation and relieving pain can be enhanced, and the preparation is suitable for treating rheumatic arthritis, arthralgia and other diseases.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparations, and in particular to a compound Fengshining capsule, a preparation method and application thereof. Background Art

[0002] Rheumatoid arthritis, classified as "bi" in Traditional Chinese Medicine (TCM), is a chronic, recurring arthritis characterized by acute attacks caused by pathogenic factors such as wind, cold, dampness, heat, and blood stasis. Clinical manifestations include muscle and joint pain, heaviness, and numbness, or difficulty flexing and extending the joints, stiffness, swelling, and deformity. TCM considers "wandering bi" to be characterized by wandering pain, a sign of prevalence of wind pathogens; "painful bi" to be characterized by more severe, localized pain, aggravated by cold, a sign of prevalence of cold pathogens; "fixed bi" to be characterized by joint soreness, heaviness, and diffuse swelling, a sign of prevalence of damp pathogens; and "re bi" to be characterized by joint swelling, reddening, burning pain, and a sign of prevalence of heat pathogens.

[0003] The etiology and pathogenesis of rheumatoid arthritis are not yet fully understood. It is generally believed to be related to infection with group A beta-hemolytic streptococci, but it is not directly caused by bacteria. Instead, it is a systemic allergic disease. Its occurrence is related to the body's resistance and reactivity.

[0004] Rheumatoid arthritis is a common clinical disease that causes great pain to patients and seriously affects their quality of life. Currently, there are many treatment methods, but most drug treatments are less than ideal and have certain side effects. Traditional Chinese medicine has unique advantages in the treatment of rheumatic diseases. Its multi-target and multi-pathway characteristics can effectively alleviate patients' symptoms with relatively few side effects. Therefore, the development of a safe and effective traditional Chinese medicine preparation to treat rheumatoid arthritis is of great clinical significance.

[0005] Patent CN115201361A Example 1 discloses a compound rheumatism-relief formula, which is composed of 17 Chinese medicinal herbs such as Notopterygium wilfordii, Angelica dahurica, Cercidiphyllum sinensis, Curcuma longa, Saposhnikovia divaricata, and Licorice root. The preparation method is to purchase 223g of medicinal materials, add 500mL of clean water, soak in cold water for 1h, heat and decoct for 1h, filter through four layers of gauze, add 300mL of clean water to the residue, decoct for 45min, filter through gauze again, combine the two filtrates, and concentrate under reduced pressure to obtain a crude drug concentration of 2g / mL. The above preparation adopts the traditional decoction extraction and concentration method. Due to the different active ingredients of the medicinal materials, especially some medicinal materials contain volatile oils, there will be problems such as loss of active ingredients and insufficient stability of the preparation, thereby affecting the efficacy. Summary of the Invention

[0006] In order to overcome the problems of active ingredient loss and insufficient preparation stability in the prior art, the present invention provides a compound medicine with high active ingredient dissolution rate, good stability and significant therapeutic effect.

[0007] In a first aspect, the present invention provides a compound Fengshining composition, wherein the Chinese medicinal raw materials are:

[0008] 3-9 parts of Notopterygium root, 3-9 parts of Angelica dahurica, 4.5-9 parts of Saposhnikovia root, 3-10 parts of Corydalis yanhusuo, 3-9 parts of Chuanxiong, 4.5-9 parts of earthworm, 5-15 parts of white peony root, 9-15 parts of Poria, and 1.5-9 parts of liquorice.

[0009] Furthermore, the Chinese medicinal raw materials are: 6-9 parts of Notopterygium wilfordii, 6-9 parts of Angelica dahurica, 6-9 parts of Saposhnikovia divaricata, 5-10 parts of Corydalis yanhusuo, 4-9 parts of Chuanxiong, 5-9 parts of earthworm, 6-15 parts of white peony root, 10-15 parts of Poria cocos, and 2-9 parts of liquorice.

[0010] Furthermore, the Chinese medicinal raw materials are: 8-9 parts of Notopterygium wilfordii, 8-9 parts of Angelica dahurica, 6-8 parts of Saposhnikovia divaricata, 6-10 parts of Corydalis yanhusuo, 4-8 parts of Chuanxiong, 5-8 parts of earthworm, 8-15 parts of white peony root, 12-15 parts of Poria cocos, and 3-6 parts of liquorice.

[0011] Rheumatoid arthritis is a systemic connective tissue disease, an allergic reaction associated with hemolytic streptococcal infection. It primarily affects the large joints of the limbs, causing localized redness, swelling, heat, pain, or dysfunction. It is common in damp, cold regions or those experiencing drastic climate changes. Due to physical weakness, insufficient Yang Qi, and loose pores, coupled with damp living conditions, exposure to rain and water, and drastic climate change, a combination of wind, cold, dampness, and heat can invade, blocking the meridians and impeding the smooth flow of Qi and blood, leading to the development of Bi syndrome.

[0012] Bi syndrome presents different clinical symptoms depending on the predominance of wind, cold, and dampness. Predominance of wind pathogens results in wandering pain, affecting multiple joints. Predominance of cold pathogens results in painful bi syndrome, characterized by localized pain and a more severe course, exacerbated by exposure to cold, and difficulty flexing and extending joints. Predominance of dampness pathogens results in fixed bi syndrome, characterized by persistent pain, numbness, and heaviness of the limbs. Heat bi syndrome presents with joint pain, redness, swelling, fever, and difficulty moving.

[0013] The inventors have studied and believed that for rheumatoid arthritis, the treatment should be to dispel wind and dampness, and to promote blood circulation and relieve pain. The compound prescription of the present invention includes Notopterygium wilfordii, Angelica dahurica, Saposhnikovia divaricata, Corydalis yanhusuo, Chuanxiong, Earthworm, White Peony Root, Poria cocos, and Licorice. Wherein Notopterygium wilfordii and Angelica dahurica are both pungent, warm and dry products. Their pungent and dispersing properties dispel wind, bitter and dampness-drying properties, and warm and cold-dispersing properties, so they can both dispel wind and dampness and relieve joint pain. Wherein Notopterygium wilfordii is good at dispelling upper rheumatism, while Angelica dahurica is good at dispelling lower rheumatism. The two medicines are combined to dispel rheumatism from head to toe, relieve joint pain and relieve arthralgia. Saposhnikovia divaricata is pungent and warm, and has the functions of dispelling wind and cold, overcoming dampness and relieving pain. Corydalis yanhusuo is pungent, dispersing and warming, and can promote blood circulation, relieve qi stagnation, and relieve blood stasis, so it is specially used to treat all kinds of pain from head to toe, and is a good medicine for promoting blood circulation, promoting qi and relieving pain. Chuanxiong promotes blood circulation and qi circulation, dispels wind and dredges meridians and relieves pain. While the formula contains mostly pungent and warm herbs, the addition of earthworms, known for their cooling properties, provides relief and is effective in dredging meridians and alleviating pain. Poria strengthens the spleen, dispels dampness, and calms the mind, particularly for those suffering from insomnia due to pain. White peony root nourishes yin and blood, while licorice harmonizes the various herbs. Together, the formula dispels wind and dampness, promotes blood circulation, and relieves pain, demonstrating remarkable efficacy in treating rheumatoid arthritis and joint pain.

[0014] The effects of each Chinese medicine component in the present invention are as follows:

[0015] Notopterygium wilfordii

[0016] This is the dried rhizome and root of Notopterygium incisum Ting ex HTChang or Notopterygium franchetii H. de Boiss. (both Umbelliferae). Notopterygium incisum is primarily grown in Sichuan, Yunnan, Qinghai, and Gansu provinces. Notopterygium franchetii is primarily grown in Sichuan, Qinghai, Shaanxi, and Henan provinces. It is harvested in spring and autumn, the fibrous roots and sediment removed, and sun-dried. Sliced and used raw.

[0017]

Properties

[0018] [Effects] Dispels cold, dispels wind and dampness, and relieves pain. Used for colds, headaches, stiff neck, rheumatic pain, and shoulder and back pain.

[0019]

Modern Research

[0020] 1. Chemical composition: This product contains volatile oil, β-sitosterol, coumarin compounds, phenolic compounds, carotene, euphorbia pulegone, organic acids and alkaloids.

[0021] 2. Pharmacological Actions: Qianghuo injection has analgesic and antipyretic effects, and has inhibitory effects on skin fungi and Brucella. The water-soluble portion of Qianghuo has anti-arrhythmic effects in experimental cases. The volatile oil also has anti-inflammatory, analgesic, and antipyretic effects, and can counteract vasopressin-induced myocardial ischemia and increase myocardial nutritive blood flow. It also has an inhibitory effect on delayed hypersensitivity reactions in mice.

[0022] Angelica dahurica

[0023] This is the dried root of Angelica pubescens Maxim.f.biserrata Shan et Yuan, a plant in the Umbelliferae family. It is primarily grown in Sichuan, Hubei, and Anhui provinces. It is harvested in early spring or late autumn, the fibrous roots and sediment removed, and then scalded until partially dry. The roots are then piled for 2-3 days, softened, and then scalded again until fully dry. Slice and use raw.

[0024] [Properties] Pungent, bitter, slightly warm. Enters the kidney and bladder meridians.

[0025] [Effects] Dispel wind and dampness, relieve numbness and relieve pain. Used for wind-cold-dampness arthritis, pain in the waist and knees, headache due to wind in Shaoyin meridians, and headache due to wind-cold and dampness.

[0026]

Modern Research

[0027] 1. Chemical composition: This product contains dihydrocarvacrol and its acetate, carvacrol methyl ether, isoimperatorin, bergamotol, zanthoxylum toxin, dihydrocarvacrol angelate, dihydrocarvacrol glucoside, angelicol, angelicol D, G, B, γ-aminobutyric acid and volatile oil, etc.

[0028] 2. Pharmacological effects: Angelica dahurica has anti-inflammatory, analgesic and sedative effects; it has an inhibitory effect on platelet aggregation; it also has a hypotensive effect, but it is not long-lasting; the bergamot lactones and zanthoxylum toxins it contains have photosensitizing and anti-tumor effects.

[0029] windproof

[0030] This is the dried root of Saposhnikovia divaricata (Turez.) Schischk., a plant in the Umbelliferae family. It's primarily grown in Northeast China and the eastern part of Inner Mongolia Autonomous Region. The roots are harvested in spring and autumn before flowering stems emerge, the fibrous roots and mud are removed, and the roots are sun-dried. Sliced, they can be used raw or roasted for charcoal.

[0031] [Properties] Pungent, sweet, slightly warm. Enters the bladder, liver, and spleen meridians.

[0032] [Effects] Dispel wind and relieve exterior symptoms, overcome dampness and relieve pain, and stop spasms. Used for colds, headaches, rheumatic pain, rubella itching, and tetanus.

[0033]

Modern Research

[0034] 1. Chemical composition: This product contains volatile oil, mannitol, β-sitosterol, bitter glycosides, phenols, polysaccharides and organic acids.

[0035] 2. Pharmacological Actions: This product has antipyretic, anti-inflammatory, sedative, analgesic, anticonvulsant, and anti-allergic effects. Fresh Saposhnikovia divaricata juice has a certain antibacterial effect against Pseudomonas aeruginosa and Staphylococcus aureus, while its decoction has varying degrees of inhibitory effect against Shigella dysenteriae and hemolytic Streptococci. It also enhances the phagocytic function of mouse peritoneal macrophages.

[0036] Corydalis yanhusuo

[0037] This is the dried tuber of Corydalis yanhusuo (a plant in the Poppy family). It's primarily grown in Zhejiang, Jiangsu, Hubei, and Hunan. Whether wild or cultivated, it's harvested in early summer when the stems and leaves wither. The fibrous roots are removed and the tubers are boiled in boiling water until the white core is gone. Remove and sun-dry. Cut into thick slices or mash and use raw or roasted with vinegar.

[0038]

Properties

[0039] [Effects] Promotes blood circulation, promotes qi circulation, and relieves pain. Used for chest, flank, abdominal pain, chest pain, heart pain, amenorrhea, dysmenorrhea, postpartum blood stasis, and swelling and pain caused by falls.

[0040]

Modern Research

[0041] 1. Chemical composition: It mainly contains more than 20 kinds of alkaloids, including corydaline, thiazolinone ...

[0042] 2. Pharmacological effects: Corydalis butyl ester has significant analgesic, hypnotic, sedative and tranquilizer effects. The analgesic effect of terpenoid and uglycine is also more obvious, and they have certain hypnotic, sedative and tranquilizer effects. The alcohol extract can dilate coronary arteries, reduce coronary resistance, increase coronary blood flow, and improve the ability to tolerate hypoxia. The total alkali can fight arrhythmia, myocardial ischemia, dilate peripheral blood vessels, lower blood pressure, and slow down heart rate. The total alkali has anti-ulcer and gastric secretion inhibitory effects. Tetrahydropalmatine and uglycine have muscle relaxant effects.

[0043] Chuanxiong

[0044] This is the dried rhizome of Ligusticum chuanxiong Hort., a plant of the Umbelliferae family. It is primarily produced in Sichuan, Guizhou, and Yunnan, with Sichuan-produced varieties being of superior quality. It is cultivated artificially. It is harvested in May, desilted, sun-dried, and the fibrous roots removed. It can be sliced and used raw or roasted with wine.

[0045]

Properties

[0046] [Effects] It promotes blood circulation and qi circulation, dispels wind and relieves pain. It is used for chest pain, heart pain, stabbing pain in the chest and ribs, swelling and pain due to falls, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to lumps, headache, and rheumatic pain.

[0047]

Modern Research

[0048] 1. Chemical composition: This product contains alkaloids (such as ligustrazine), volatile oils (mainly ligustilide, ligustilide, etc.), phenolic substances (such as ferulic acid), visfatin, vitamin A, folic acid, sucrose, sterols, fatty oils, etc.

[0049] 2. Pharmacological effects: Ligustrazine can dilate coronary arteries, increase coronary blood flow, improve myocardial blood oxygen supply, and reduce myocardial oxygen consumption; Ligustrazine can dilate cerebral blood vessels, reduce vascular resistance, significantly increase brain and limb blood flow, and improve microcirculation; it can reduce platelet surface activity, inhibit platelet aggregation, and prevent the formation of thrombus; the neutral component of ferulic acid contained in it promotes uterine smooth muscle in small doses and inhibits it in large doses; the decoction has a sedative effect on the central nervous system of animals and has a significant and lasting antihypertensive effect; it can accelerate the absorption of local hematoma of fractures and promote callus formation; it has anti-vitamin E deficiency effect; it can inhibit a variety of bacteria; it has antihistamine and choleretic effects.

[0050] Earth Dragon

[0051] This refers to the dried body of Pheretima aspergillum (E. Perrier), Pheretima vulgaris Chen, Pheretima guillelmi (Michaelsen), or Pheretima Michaelsen, members of the family Pheretimaidae. The former, commonly known as "Guangdilong," is primarily found in Guangdong and Guangxi Zhuang Autonomous Regions; the latter three, commonly known as "Hudilong," are primarily found in the Shanghai area. Guangdilong is harvested from spring to autumn, while Hudilong is harvested in summer and autumn. The abdomen should be promptly dissected, and the internal organs and mud and sand removed. The body should then be cleaned, sun-dried, or low-temperature dried, and used raw or fresh.

[0052]

Properties

[0053] [Effects] Clears away heat and calms nerves, dredges meridians, relieves asthma, and is a diuretic. Used for high fever, coma, epilepsy, convulsions, joint pain, limb numbness, hemiplegia, lung heat, asthma, cough, edema, and oliguria.

[0054]

Modern Research

[0055] 1. Chemical Composition: This product contains a variety of amino acids, with glutamic acid, aspartic acid, and leucine being the highest in content; trace elements such as iron, zinc, magnesium, copper, and chromium; and organic acids such as arachidonic acid and succinic acid. It also contains earthworm antipyretic base, earthworm alkali, earthworm toxin, xanthine, hypoxanthine, yellow pigment, and enzymes.

[0056] 2. Pharmacological Actions: Earthworm decoctions and earthworm antipyretic alkali have excellent antipyretic effects; hot infusions and alcohol extracts have sedative and anticonvulsant effects in mice and rabbits. The hypoxanthine in Guangdilong has a significant bronchodilating effect and can antagonize the bronchial contraction effects of histamine and pilocarpine. Guangdilong tinctures, dry powder suspensions, hot infusions, and decoctions all have a slow and sustained antihypertensive effect. Earthworm extracts have fibrinolytic and anticoagulant properties. Furthermore, earthworms have immune-enhancing, anti-tumor, antibacterial, diuretic, and uterine and intestinal smooth muscle stimulating effects.

[0057] Poria cocos

[0058] It is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf. It is parasitic on the roots of Pinus densiflora or Pinus massoniana. It is wild or cultivated, and is mainly produced in Yunnan, Anhui, Hubei, Henan, Sichuan and other places. The ones produced in Yunnan are called "Yunling" and are of better quality. They are mostly dug up from July to September. After being dug out, the mud and sand are removed, and after being piled up to "sweat", they are spread out to dry on the surface, and then "sweated" again, and repeated several times until wrinkles appear and most of the internal moisture is lost. After that, they are dried in the shade and are called "Fulingge". After soaking, take it and steam it slightly, slice it in time, and dry it in the sun; or cut the fresh Poria cocos according to different parts, dry it in the shade, and use it raw.

[0059]

Properties

[0060] [Effects] It can promote diuresis and eliminate dampness, strengthen the spleen, and calm the mind. It is used for edema, oliguria, phlegm and fluid retention, dizziness and palpitations, spleen deficiency, poor appetite, loose stools and diarrhea, restlessness, palpitations and insomnia.

[0061]

Modern Research

[0062] 1. Chemical composition: This product contains β-Pachymannan, accounting for about 93% of the dry weight, and also contains Pachymanic acid, protein, fat, lecithin, choline, histidine, ergosterol, etc.

[0063] 2. Pharmacological Actions: Poria cocos decoction, syrup, alcohol extract, and ether extract have diuretic, sedative, anti-tumor, blood sugar-lowering, and myocardial contractility-enhancing effects, respectively. Poria cocos polysaccharides enhance immune function. Poria cocos also protects the liver, reduces gastric secretion, and has an inhibitory effect on gastric ulcers.

[0064] White Peony Root

[0065] This is the dried root of Paeonia lactiflora (Paeonia lactiflora), a plant of the Ranunculaceae family. It is primarily grown in Zhejiang, Anhui, and Sichuan. It is harvested in summer and autumn, cleaned of soil and rootlets, peeled, and soaked in boiling water or briefly boiled until evenly heated. Then, it is sun-dried. Moisten thoroughly and slice before use. It is typically used raw, stir-fried with wine, or stir-fried.

[0066]

Properties

[0067] [Effects] Nourishes blood and regulates menstruation, restrains yin and stops sweating, softens the liver and relieves pain, and suppresses liver yang. Used for blood deficiency, sallow complexion, irregular menstruation, spontaneous sweating, night sweats, flank pain, abdominal pain, cramps in the limbs, headache and dizziness.

[0068]

Modern Research

[0069] 1. Chemical composition: White peony root contains paeoniflorin, peony phenol, paeoniflorin, peony lactone, benzoic acid, etc. In addition, it also contains volatile oil, fatty oil, resin sugar, starch, mucilage, protein and triterpenes.

[0070] 2. Pharmacological effects: When mice were fed with a decoction of white peony root, the percentage of peritoneal macrophages and the phagocytic index were significantly increased compared with the control group. White peony root can promote the phagocytic function of mouse peritoneal macrophages. White peony root decoction can antagonize the inhibitory effect of cyclophosphamide on mouse peripheral T lymphocytes, restoring them to normal levels, indicating that white peony root can restore the cellular immune function that is in a low state to normal. White peony root extract has a significant inhibitory effect on acute inflammatory edema caused by egg white in rats and has an inhibitory effect on the proliferation of cotton ball granulomas. White peony root has a significant analgesic effect on the writhing reaction caused by acetic acid. When used in combination with the methanol complex of licorice, the two have a synergistic analgesic effect on the writhing reaction caused by acetic acid. Paeoniflorin, the main component of peony root, has a good antispasmodic effect.

[0071] Licorice

[0072] This is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., all of the Leguminosae family. It is primarily produced in Inner Mongolia Autonomous Region, Xinjiang Uyghur Autonomous Region, and Gansu Province. It is harvested in spring and autumn, with autumn harvest being preferred. Remove the fibrous roots, sun-dry, and slice into thick slices for use raw or roasted with honey.

[0073]

Properties

[0074] [Effects] Tonifies the spleen and replenishes Qi, clears away heat and detoxifies, eliminates phlegm and relieves cough, relieves pain, and harmonizes various medicines. It is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, abdominal and limb cramps and pain, carbuncle and sore, and relieves drug toxicity and potency.

[0075]

Modern Research

[0076] 1. Chemical composition: This product contains triterpenes (the potassium and calcium salts of the triterpenoid saponin glycyrrhizic acid are glycyrrhizin, which is the sweet component of licorice), flavonoids, alkaloids, polysaccharides and other ingredients.

[0077] 2. Pharmacological effects: Licorice has anti-arrhythmic effects; it has anti-ulcer effects, inhibits gastric acid secretion, relieves gastrointestinal smooth muscle spasms and analgesic effects, and has a synergistic effect with the active ingredient of peony, paeoniflorin; it can promote pancreatic juice secretion; it has obvious antitussive effects, and the expectorant effect is also significant, and it also has a certain anti-asthmatic effect; it has antibacterial, antiviral, anti-inflammatory and anti-allergic effects; it can protect inflamed throat and tracheal mucosa; it has a detoxification effect similar to glucuronic acid on certain poisons; it has an effect similar to adrenal cortex hormone; it also has antidiuretic, lipid-lowering and liver-protecting effects.

[0078] In a second aspect, the present invention provides an oral preparation prepared by encapsulating the composition, wherein the composition is added with conventional excipients and prepared according to a preparation process to obtain a usable oral preparation, wherein the dosage form of the oral preparation is powder, capsule, tablet, pill, granule, solution, emulsion, suspension or oil.

[0079] Furthermore, the present invention provides a compound Fengshi Ning capsule with significant efficacy, safety and reliability. The capsule has the effects of dispelling wind and dampness, promoting blood circulation and relieving pain, and can effectively treat rheumatoid arthritis, joint pain and the like.

[0080] The third aspect of the present invention also provides a method for preparing the compound Fengshi Ning capsule to facilitate drug preparation and quality control. The preparation method comprises the following steps:

[0081] Step 1: soaking Notopterygium wilfordii, Angelica dahurica, Saposhnikovia divaricata, and Ligusticum chuanxiong in water to extract volatile oil, collecting the distilled aqueous solution in another container, setting the medicinal residue aside, collecting the volatile oil, encapsulating the volatile oil with β-cyclodextrin, drying, and grinding into fine powder a;

[0082] Step 2: Combine the above medicinal residues with Corydalis yanhusuo, add ethanol, reflux extract, filter, combine the filtrate and recover ethanol, and concentrate to a thick paste A;

[0083] Step 3: Extract white peony root, Poria cocos, and liquorice with water, filter, combine the filtrates, and concentrate to form a thick paste B;

[0084] Step 4: Take the vinegar-processed earthworm, add water to decoct, filter, combine the filtrate with the distilled aqueous solution, concentrate to a paste, add ethanol to precipitate, refrigerate overnight, filter, recover ethanol from the filtrate, and concentrate to a thick paste C;

[0085] Step 5: Mix the thick pastes A, B, and C, dry them into a dry extract, and then grind them into fine powder b; mix the fine powders a and b, add auxiliary materials, mix evenly, granulate, dry, sieve and shape the granules, and put them into capsules to obtain the product.

[0086] Furthermore, the preparation method comprises the following steps:

[0087] Step 1: Soak the Radix Notopterygii, Radix Angelicae Pubescentis, Radix Saposhnikoviae, and Rhizoma Chuanxiong in 8-10 times water for 1-4 hours, extract the volatile oil for 8-12 hours, collect the distilled aqueous solution in another container, set aside the medicinal residue, collect the volatile oil, incorporate the volatile oil with 6-10 times β-cyclodextrin, dry it at below 45°, and grind it into fine powder a;

[0088] Step 2: Combine the above-mentioned medicinal residues with Corydalis yanhusuo, add 6-10 times of 60-80% ethanol, reflux extract 2-4 times, each time for 1-3 hours, filter, combine the filtrates and recover the ethanol, and concentrate to a thick paste A of 1.25-1.30 (50°C);

[0089] Step 3: Take white peony root, Poria cocos, and liquorice and add 6-10 times water to extract 2-4 times, each time for 1.5-3 hours, filter, combine the filtrates, and concentrate to a thick paste B with a relative density of 1.25-1.30 (50°C);

[0090] Step 4: Take vinegar-processed earthworms, add 6-10 times the amount of water, and boil for 2-4 times, each time for 1-3 hours, filter, combine the filtrate with the distilled aqueous solution, concentrate to a relative density of 1.10-1.15 (50° C.), add ethanol to increase the alcohol content to 55-75%, refrigerate overnight, filter, recover ethanol from the filtrate, and concentrate to a thick paste C with a relative density of 1.20-1.30 (50° C.);

[0091] Step 5: Mix the thick pastes A, B, and C, dry them under reduced pressure below 65°C to form a dry extract, and then grind them into fine powder b; mix the fine powders a and b, add auxiliary materials, mix evenly, granulate, dry, pass through a 40-60 mesh sieve, resize the granules, and put them into capsules to obtain the product.

[0092] Furthermore, the excipients are pharmaceutically acceptable excipients, including fillers, binders, disintegrants, lubricants, glidants, opacifiers, and flavoring agents.

[0093] The fourth aspect of the present invention provides use of the composition or the oral preparation or the drug prepared by the preparation method in treating rheumatoid arthritis and joint pain.

[0094] The present invention has the following beneficial effects:

[0095] (1) Significant therapeutic effect: The compound Fengshi Ning capsule of the present invention has the effects of dispelling wind and dampness, promoting blood circulation and relieving pain through the rational combination of multiple Chinese medicinal materials. It can effectively relieve the symptoms of rheumatoid arthritis, joint pain and other diseases, and improve the quality of life.

[0096] (2) High safety: It uses natural Chinese medicinal materials as raw materials, which have relatively few side effects and are suitable for long-term use.

[0097] (3) Reasonable preparation process: The preparation process of the present invention classifies and processes the medicinal materials, can effectively extract the active ingredients in the Chinese medicinal materials, improve the stability, quality and efficacy of the drugs, and facilitate industrial production. DETAILED DESCRIPTION

[0098] To better illustrate the objectives, technical solutions, and advantages of the present invention, the present invention will be further described below with reference to specific embodiments. However, the present invention is not limited thereto. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without inventive effort are intended to fall within the scope of protection of the present invention.

[0099] A compound Fengshining composition 1, characterized in that its Chinese medicinal raw materials are:

[0100] 6 parts of Notopterygium root, 6 parts of Angelica dahurica, 6 parts of Saposhnikovia root, 5 parts of Corydalis yanhusuo, 4 parts of Chuanxiong, 5 parts of earthworm, 6 parts of white peony root, 10 parts of Poria, and 2 parts of liquorice.

[0101] A compound Fengshining composition 2, characterized in that its Chinese medicinal raw materials are:

[0102] 8 parts of Notopterygium root, 8 parts of Angelica dahurica, 6 parts of Saposhnikovia root, 6 parts of Corydalis yanhusuo, 4 parts of Chuanxiong, 5 parts of earthworm, 8 parts of white peony root, 12 parts of Poria, and 3 parts of liquorice.

[0103] A compound Fengshining composition 3, characterized in that its Chinese medicinal raw materials are:

[0104] 9 parts of Notopterygium root, 9 parts of Angelica dahurica, 9 parts of Saposhnikovia root, 10 parts of Corydalis yanhusuo, 9 parts of Chuanxiong, 9 parts of earthworm, 12 parts of white paeonia lactiflora, 15 parts of Poria, and 4 parts of liquorice.

[0105] A compound Fengshining composition 4, characterized in that the Chinese medicinal raw materials are:

[0106] 9 parts of Notopterygium root, 9 parts of Angelica dahurica, 8 parts of Saposhnikovia root, 10 parts of Corydalis yanhusuo, 8 parts of Chuanxiong, 8 parts of earthworm, 15 parts of white paeonia lactiflora, 15 parts of Poria, and 5 parts of liquorice.

[0107] Any one of the compositions 1-4 is added with conventional excipients and prepared according to the preparation process to obtain a usable oral preparation, which is in the form of powder, capsule, tablet, pill, granule, solution, emulsion, suspension or oil.

[0108] The preparation method of any one of compositions 1-4 may comprise the following steps:

[0109] Step 1: Soak the Radix Notopterygii, Radix Angelicae Pubescentis, Radix Saposhnikoviae, and Rhizoma Chuanxiong in 8-10 times water for 1-4 hours, extract the volatile oil for 8-12 hours, collect the distilled aqueous solution in another container, set aside the medicinal residue, collect the volatile oil, incorporate the volatile oil with 6-10 times β-cyclodextrin, dry it at below 45°, and grind it into fine powder a;

[0110] Step 2: Combine the above-mentioned medicinal residues with Corydalis yanhusuo, add 6-10 times of 60-80% ethanol, reflux extract 2-4 times, each time for 1-3 hours, filter, combine the filtrates and recover the ethanol, and concentrate to a thick paste A of 1.25-1.30 (50°C);

[0111] Step 3: Take white peony root, Poria cocos, and liquorice and add 6-10 times water to extract 2-4 times, each time for 1.5-3 hours, filter, combine the filtrates, and concentrate to a thick paste B with a relative density of 1.25-1.30 (50°C);

[0112] Step 4: Take vinegar-processed earthworms, add 6-10 times the amount of water, and boil for 2-4 times, each time for 1-3 hours, filter, combine the filtrate with the distilled aqueous solution, concentrate to a relative density of 1.10-1.15 (50° C.), add ethanol to increase the alcohol content to 55-75%, refrigerate overnight, filter, recover ethanol from the filtrate, and concentrate to a thick paste C with a relative density of 1.20-1.30 (50° C.);

[0113] Step 5: Mix the thick pastes A, B, and C, dry them under reduced pressure below 65°C to form a dry extract, and then grind them into fine powder b; mix the fine powders a and b, add auxiliary materials, mix evenly, granulate, dry, pass through a 40-60 mesh sieve, resize the granules, and put them into capsules to obtain the product.

[0114] Example 1:

[0115] A compound Fengshining capsule, characterized in that its Chinese medicinal raw materials are:

[0116] 8 parts of Notopterygium root, 8 parts of Angelica dahurica, 6 parts of Saposhnikovia root, 6 parts of Corydalis yanhusuo, 4 parts of Chuanxiong, 5 parts of earthworm, 8 parts of white peony root, 12 parts of Poria, and 3 parts of liquorice.

[0117] The preparation method comprises the following steps:

[0118] Step 1: soaking Notopterygium wilfordii, Angelica dahurica, Saposhnikovia divaricata, and Ligusticum chuanxiong in 10 times water for 1 hour, extracting volatile oil for 8 hours, collecting the distilled aqueous solution in another container, setting aside the medicinal residue, collecting the volatile oil, encapsulating the volatile oil with 7 times β-cyclodextrin, drying below 45°, and grinding into fine powder a;

[0119] Step 2: Combine the above medicinal residues with Corydalis yanhusuo, add 10 times of 60-80% ethanol, reflux and extract twice, each time for 1 hour, filter, combine the filtrates and recover the ethanol, and concentrate to a thick paste A of 1.25 (50°C);

[0120] Step 3: Take white peony root, Poria cocos, and liquorice and extract them twice with 10 times water, each time for 1.5 hours, filter, combine the filtrates, and concentrate to a thick paste B with a relative density of 1.25 (50°C);

[0121] Step 4: Take vinegar-processed earthworms, add 10 times the amount of water, and boil twice for 1 hour each time. Filter, combine the filtrate with the distilled aqueous solution, and concentrate to a relative density of 1.10 (50° C.). Add ethanol to increase the alcohol content to 60%, refrigerate overnight, filter, recover ethanol from the filtrate, and concentrate to a thick paste C with a relative density of 1.30 (50° C.);

[0122] Step 5: Mix the thick pastes A, B, and C, dry them under reduced pressure below 65°C to form a dry extract, and then grind them into fine powder b; mix the fine powders a and b, add excipients, mix evenly, granulate, dry, pass through a 50-mesh sieve, and shape the granules, and put them into capsules to obtain the product.

[0123] Example 2

[0124] A compound Fengshining capsule, characterized in that its Chinese medicinal raw materials are:

[0125] 9 parts of Notopterygium root, 9 parts of Angelica dahurica, 9 parts of Saposhnikovia root, 10 parts of Corydalis yanhusuo, 9 parts of Chuanxiong, 9 parts of earthworm, 12 parts of white paeonia lactiflora, 15 parts of Poria, and 4 parts of liquorice.

[0126] The preparation method is the same as that of Example 1.

[0127] Example 3

[0128] A compound Fengshining capsule, characterized in that its Chinese medicinal raw materials are:

[0129] 9 parts of Notopterygium root, 9 parts of Angelica dahurica, 8 parts of Saposhnikovia root, 10 parts of Corydalis yanhusuo, 8 parts of Chuanxiong, 8 parts of earthworm, 15 parts of white paeonia lactiflora, 15 parts of Poria, and 5 parts of liquorice.

[0130] The preparation method is the same as that of Example 1.

[0131] Comparative Example 1

[0132] According to the weight ratio of Example 1, take Notopterygium root, Angelica dahurica, Saposhnikovia divaricata, Corydalis yanhusuo, Chuanxiong, earthworm, white peony root, Poria, and liquorice, add 10 times the weight of water of the mixed drug, soak in cold water for 1 hour, heat and decoct for 1 hour, and filter through four layers of gauze; add 4 times the water to the residue, decoct for 45 minutes, filter through gauze again, combine the two filtrates, and concentrate under reduced pressure to a crude drug concentration of 1.30 g / mL.

[0133] Comparative Example 2

[0134] According to the weight ratio of Example 1, take Notopterygium root, Angelica dahurica, Saposhnikovia root, Corydalis yanhusuo, Chuanxiong, Earthworm, White Peony Root, Poria, and Licorice root, add 10 times the weight of the mixed medicine in water, soak in cold water for 1 hour, heat and decoct for 1 hour, filter through gauze, repeat the operation and decoct 2 times, combine the 2 filtrates, concentrate under reduced pressure to a relative density of 1.1, add ethanol to make the alcohol content reach 60%, refrigerate overnight, filter, recover ethanol from the filtrate, and concentrate to a thick paste with a relative density of 1.20 (50° C.). The thick paste is dried under reduced pressure below 65° C. to form a dry extract, then pulverized into fine powder, added with auxiliary materials, mixed evenly, granulated, dried, sieved through a 50-mesh sieve, granulated, and encapsulated to obtain the product.

[0135]

Assay

[0136] Determined according to the volatile oil determination method (Chinese Pharmacopoeia General Chapter 2204).

[0137] Determined according to high performance liquid chromatography (Chinese Pharmacopoeia General Chapter 0512).

[0138] Table 1 Comparison of appearance and effective parts of each group

[0139]

[0140]

Efficacy experiment

[0141] Adjuvant-induced arthritis model rat experiment

[0142] 1. Experimental Materials

[0143] 1. Experimental Animals

[0144] SD rats, 6-8 weeks old, female, 180-220 g.

[0145] Laboratory environment: relative humidity 45%-55%, temperature 20-22℃.

[0146] 2. Reagents

[0147] (1) Complete Freund's adjuvant (CFA): BCG (concentration: 10 mg / mL), stored at 4°C.

[0148] (2) 10% chloral hydrate: Dissolve 10 g of chloral hydrate in 100 mL of normal saline and store until fully dissolved.

[0149] (3) Normal saline.

[0150] 3. Experimental samples

[0151] The compound Fengshi Ning capsules of Examples 1-3 and the traditional Chinese medicine preparations of Comparative Examples 1-2.

[0152] 4. Equipment

[0153] Thousandth electronic balance

[0154] Electric constant temperature water bath

[0155] Vernier caliper

[0156] syringe

[0157] Rat gavage injection

[0158] 2. Experimental Methods

[0159] 1. Modeling

[0160] The rats were randomly divided into groups including a model group and a drug-treated group (Examples 1-3 and Comparative Examples 1-2), with 10 rats in each group. The model group and the drug-treated group were treated with the following modeling method.

[0161] (1) Immunization: On day 0, rats were anesthetized with 10% chloral hydrate (400 μL / 100 g). 100 μL of CFA containing 5 mg / mL attenuated BCG was injected intradermally at multiple points at the base of the rat's tail.

[0162] (2) Monitoring: Starting from day 1, monitor the weight and joint changes of the rats. When the rats lose weight and develop symptoms such as redness and swelling in their limbs, and the clinical score also increases significantly, it can be judged that the animal modeling is successful.

[0163] standard Score No erythema or swelling in the joints 0 Mild redness or swelling in the ankle or wrist 1 Moderate redness or swelling in the ankle or wrist 2 Moderate redness and swelling of the ankle and mid-skull area or the wrist and palm 3 Severe redness, swelling, or even stiffness of the entire forelimb or hindlimb 4

[0164] Note: Each rat has four joints, and each joint is scored from 0 to 4, so the maximum score for each rat is 16 points.

[0165] 2. Administer medication

[0166] (1) Administration: Administer the drug by gavage 6 days after induction of inflammation, once a day for 18 consecutive days.

[0167] (2) Dosage:

[0168] The model group was gavaged with an equal volume of normal saline, 10 mL / Kg;

[0169] The drug-dosing groups were gavaged with Examples 1-3 and Comparative Examples 1-2, 70 mg / Kg.

[0170] During this period, regular feed and drinking water were given.

[0171] 3. Observation indicators

[0172] The severity of the rat lesions was monitored, with a focus on swelling. Ankle circumference was measured every three days, and the degree of swelling and swelling inhibition rate were calculated. Scoring was performed according to the standard at the same time point each time. Inflammatory factor levels were measured one day before the end of the experiment.

[0173] Swelling (cm) = ankle circumference after inflammation - ankle circumference before inflammation

[0174] Swelling inhibition rate (%) = (average swelling degree of model group - average swelling degree of drug-treated group) / average swelling degree of model group × 100%

[0175] 4. Results

[0176] Table 2 The therapeutic effects of each group on adjuvant arthritis in rats (M±SD)

[0177]

[0178] Compared with the model group, *P<0.05, **P<0.01.

[0179] The results showed that the drugs of Examples 1-3 of the present invention had a significant inhibitory effect on adjuvant arthritis in rats, with a highly significant difference compared with the model group (P < 0.01). Among them, the swelling inhibition rate of Example 1-3 group was significantly better than that of Comparative Example 1-2 group.

[0180] TNF-α is a key proinflammatory cytokine in the pathogenesis of rheumatoid arthritis. In patients with rheumatoid arthritis, synoviocytes and macrophages secrete large amounts of TNF-α, which further induces the release of other inflammatory mediators, such as interleukin-1 and interleukin-6, leading to pathological changes such as synovial inflammation, cartilage, and bone tissue destruction. Therefore, measuring TNF-α levels directly reflects the activity of local joint inflammation. Higher TNF-α levels generally indicate greater disease activity and potentially more severe joint damage.

[0181] Measuring TNF-α levels provides a direct understanding of a drug's inhibitory effect on the inflammatory response. If a drug significantly reduces TNF-α levels in a rheumatoid arthritis efficacy study, it suggests that the drug may be treating rheumatoid arthritis by inhibiting the production or action of TNF-α, thereby reducing the inflammatory response. This provides an objective, quantitative metric for evaluating drug efficacy, helping to determine drug effectiveness and optimal dosage. Measuring TNF-α levels can further explore the mechanism of action of drugs used to treat rheumatoid arthritis. If a drug can reduce TNF-α levels, further investigation can be conducted to determine whether it works by inhibiting TNF-α gene transcription and translation, blocking TNF-α binding to its receptor, or affecting TNF-α downstream signaling pathways. This is crucial for identifying drug targets, optimizing drug design, and developing more targeted treatments.

[0182] High levels of TNF-α before treatment often indicate a more severe condition, potentially more rapid progression of joint damage, and a relatively poor prognosis. However, during efficacy trials, TNF-α levels are continuously monitored. If TNF-α levels gradually decrease and remain at low levels, this generally indicates better disease control, potentially slowed progression of joint damage, and a better prognosis. Therefore, TNF-α levels can serve as an important indicator for predicting the prognosis of patients with rheumatoid arthritis, providing a basis for adjusting clinical treatment plans and providing patient rehabilitation guidance.

[0183] In summary, detecting TNF-α levels in rheumatoid arthritis efficacy experiments can reflect disease activity, evaluate drug efficacy, explore drug mechanisms, and predict disease prognosis, providing an important basis for drug development and clinical diagnosis and treatment. Therefore, TNF-α was selected for this experiment. The results showed that the drugs in Examples 1-3 of the present invention significantly reduced TNF-α levels, with a highly significant difference compared to the model group (P < 0.01), and were superior to the comparative examples 1-2 groups.

[0184] Based on the analysis of Tables 1-2, Examples 1-3 of the present invention have achieved good technical effects.

[0185] Volatile oils are a class of naturally occurring aromatic medicinal herbs with strong activity, making their rational extraction essential for use in traditional Chinese medicine. Classical prescriptions containing a high number of volatile components, such as Qianghuo Shengshi Decoction, contain seven herbs: Qianghuo, Angelica dahurica, Ligusticum chuanxiong, Saposhnikovia divaricata, Licorice root, Chuanxiong rhizome, and Vitex mangzi. Qianghuo, Ligusticum chuanxiong, Saposhnikovia divaricata, and Vitex mangzi are antipyretics, while Angelica dahurica and Ligusticum chuanxiong also contain volatile components. The ancient recipe for this recipe states, "Use two cups of water to decoct one cup." Decoctioning the herb until its volume is reduced to half takes a long time, approximately six hours, resulting in significant loss of volatile components. Studies have shown that compositional analysis of aqueous extracts obtained by decoction reveals that only trace amounts of volatile oils are detected, as the boiling water causes the volatile oils to escape with the vapor and are not condensed for recovery. However, the extract is rich in non-volatile components such as polysaccharides and saponins, making decoction a suitable method for extracting water-soluble components. For the water extraction and alcohol precipitation method, since the alcohol precipitation step causes the low-polarity volatile oil to precipitate or be adsorbed, the volatile oil content is reduced, but some volatile components with higher polarity can be retained, which is suitable for impurity removal and purification.

[0186] In modern production processes, extraction tanks are generally used, and the loss of volatile components is relatively small. Based on the pungent and warm effects of aromatic ingredients, which correspond to the effects of dispelling wind and cold, unblocking meridians and relieving pain, it seems inappropriate to follow the ancient method of decocting for a long time. In the extraction of medicinal materials and preparation of preparations, the inventors considered extracting the volatile oil components with strong active effects separately and then encapsulating them into medicine, and conducted in-depth research on the dispersion state and inclusion amount of the volatile oil. The volatile oils in Chinese medicinal materials generally have a low boiling point and are easily oxidized. Care should be taken during extraction to avoid adverse effects on the extracts. Furthermore, for the volatile active ingredients of Chinese medicine volatile oils, the inclusion technology is used to prepare volatile oil inclusion compounds, which can effectively prevent the loss of active ingredients and ensure the quality and efficacy of the preparations.

[0187] The present invention also contains earthworms in its prescription, which belong to animal medicines and have a certain fishy smell. Suitable processing methods such as vinegar processing can effectively enhance the medicinal properties of earthworms, remove their fishy smell, and improve medication compliance. In addition, the activity of earthworms is relevant to multiple amino acids and enzymes, and the extraction process can affect the content of amino acids in the extract, thereby affecting drug efficacy. Fully extracting the active ingredients of earthworms is of great significance to improving therapeutic effect. Currently, the clinical use of earthworms is generally to take after decocting, and individual operation differences are large, resulting in poor treatment compliance. The inventors have found in research that water extraction and alcohol precipitation of earthworms is a more effective extraction method than traditional water decoction, and the extract is more stable. Making capsules can conceal the fishy smell and can better play drug efficacy.

[0188] 5. Conclusion

[0189] The present invention provides a compound Fengshi Ning, which is composed of Chinese medicinal herbs such as Notopterygium wilfordii, Angelica dahurica, Saposhnikovia divaricata, and Corydalis yanhusuo. It has the effects of dispelling wind and dampness, promoting blood circulation and relieving pain, and is used to treat rheumatoid arthritis, joint pain, and the like. The preparation process, by classifying and processing the medicinal herbs, can effectively extract the active ingredients from the medicinal herbs, thereby improving the stability, quality, and efficacy of the drug and facilitating industrial production. Experiments have shown that the compound Fengshi Ning has a significant therapeutic effect on rheumatoid arthritis.

[0190] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A compound Fengshining composition, characterized in that: The Chinese medicine raw materials are: 3-9 parts of Notopterygium root, 3-9 parts of Angelica dahurica, 4.5-9 parts of Saposhnikovia root, 3-10 parts of Corydalis yanhusuo, 3-9 parts of Chuanxiong, 4.5-9 parts of earthworm, 5-15 parts of white peony root, 9-15 parts of Poria, and 1.5-9 parts of liquorice.

2. The composition according to claim 1, characterized in that The Chinese medicine raw materials are: 6-9 parts of Notopterygium root, 6-9 parts of Angelica dahurica, 6-9 parts of Saposhnikovia root, 5-10 parts of Corydalis yanhusuo, 4-9 parts of Chuanxiong, 5-9 parts of earthworm, 6-15 parts of white peony root, 10-15 parts of Poria, and 2-9 parts of liquorice.

3. The composition according to claim 1, characterized in that The Chinese medicine raw materials are: 8-9 parts of Notopterygium root, 8-9 parts of Angelica dahurica, 6-8 parts of Saposhnikovia root, 6-10 parts of Corydalis yanhusuo, 4-8 parts of Chuanxiong, 5-8 parts of earthworm, 8-15 parts of white peony root, 12-15 parts of Poria, and 3-6 parts of liquorice.

4. A preparation comprising the composition according to any one of claims 1 to 3, wherein the preparation is in the form of powder, capsule, tablet, pill, granule, solution, emulsion, suspension or oil.

5. A compound Fengshining capsule, characterized in that: The preparation method is prepared from the Chinese medicinal raw material according to any one of claims 1 to 3, and the preparation method comprises the following steps: Step 1: soaking Notopterygium wilfordii, Angelica dahurica, Saposhnikovia divaricata, and Ligusticum chuanxiong in water to extract volatile oil, collecting the distilled aqueous solution in another container, setting the medicinal residue aside, collecting the volatile oil, encapsulating the volatile oil with β-cyclodextrin, drying, and grinding into fine powder a; Step 2: Combine the above medicinal residues with Corydalis yanhusuo, add ethanol, reflux extract, filter, combine the filtrate and recover ethanol, and concentrate to a thick paste A; Step 3: Extract white peony root, Poria cocos, and liquorice with water, filter, combine the filtrates, and concentrate to form a thick paste B; Step 4: Take the vinegar-processed earthworm, add water to decoct, filter, combine the filtrate with the distilled aqueous solution, concentrate to a paste, add ethanol to precipitate, refrigerate overnight, filter, recover ethanol from the filtrate, and concentrate to a thick paste C; Step 5: Mix the thick pastes A, B, and C, dry them into a dry extract, and then grind them into fine powder b; mix the fine powders a and b, add auxiliary materials, mix evenly, granulate, dry, sieve and shape the granules, and put them into capsules to obtain the product.

6. The compound Fengshining capsule according to claim 5, characterized in that The preparation method comprises the following steps: Step 1: Soak the Radix Notopterygii, Radix Angelicae Pubescentis, Radix Saposhnikoviae, and Rhizoma Chuanxiong in 8-10 times water for 1-4 hours, extract the volatile oil for 8-12 hours, collect the distilled aqueous solution in another container, set aside the medicinal residue, collect the volatile oil, incorporate the volatile oil with 6-10 times β-cyclodextrin, dry it at below 45°, and grind it into fine powder a; Step 2: Combine the above-mentioned medicinal residues with Corydalis yanhusuo, add 6-10 times of 60-80% ethanol, reflux and extract 2-4 times, each time for 1-3 hours, filter, combine the filtrates and recover the ethanol, and concentrate to a thick paste A of 1.25-1.30 (50°C); Step 3: Take white peony root, Poria cocos, and liquorice and add 6-10 times water to extract 2-4 times, each time for 1.5-3 hours, filter, combine the filtrates, and concentrate to a thick paste B with a relative density of 1.25-1.30 (50°C); Step 4: Take vinegar-processed earthworms, add 6-10 times the amount of water, and boil for 2-4 times, each time for 1-3 hours, filter, combine the filtrate with the distilled aqueous solution, concentrate to a relative density of 1.10-1.15 (50° C.), add ethanol to increase the alcohol content to 55-75%, refrigerate overnight, filter, recover ethanol from the filtrate, and concentrate to a thick paste C with a relative density of 1.20-1.30 (50° C.); Step 5: Mix the thick pastes A, B, and C, dry them under reduced pressure below 65°C to form a dry extract, and then grind them into fine powder b; mix the fine powders a and b, add auxiliary materials, mix evenly, granulate, dry, pass through a 40-60 mesh sieve, resize the granules, and put them into capsules to obtain the product.

7. A method for preparing Fufang Fengshining Capsule, characterized in that: The Chinese medicinal material according to any one of claims 1 to 3 is used, and the preparation method comprises the following steps: Step 1: soaking Notopterygium wilfordii, Angelica dahurica, Saposhnikovia divaricata, and Ligusticum chuanxiong in water to extract volatile oil, collecting the distilled aqueous solution in another container, setting the medicinal residue aside, collecting the volatile oil, encapsulating the volatile oil with β-cyclodextrin, drying, and grinding into fine powder a; Step 2: Combine the above medicinal residues with Corydalis yanhusuo, add ethanol, reflux extract, filter, combine the filtrate and recover ethanol, and concentrate to a thick paste A; Step 3: Extract white peony root, Poria cocos, and liquorice with water, filter, combine the filtrates, and concentrate to form a thick paste B; Step 4: Take the vinegar-processed earthworm, add water to decoct, filter, combine the filtrate with the distilled aqueous solution, concentrate to a paste, add ethanol to precipitate, refrigerate overnight, filter, recover ethanol from the filtrate, and concentrate to a thick paste C; Step 5: Mix the thick pastes A, B, and C, dry them into a dry extract, and then grind them into fine powder b; mix the fine powders a and b, add auxiliary materials, mix evenly, granulate, dry, sieve and shape the granules, and put them into capsules to obtain the product.

8. The preparation method according to claim 7, characterized in that The following steps are involved: Step 1: Soak the Radix Notopterygii, Radix Angelicae Pubescentis, Radix Saposhnikoviae, and Rhizoma Chuanxiong in 8-10 times water for 1-4 hours, extract the volatile oil for 8-12 hours, collect the distilled aqueous solution in another container, set aside the medicinal residue, collect the volatile oil, incorporate the volatile oil with 6-10 times β-cyclodextrin, dry it at below 45°, and grind it into fine powder a; Step 2: Combine the above-mentioned medicinal residues with Corydalis yanhusuo, add 6-10 times of 60-80% ethanol, reflux and extract 2-4 times, each time for 1-3 hours, filter, combine the filtrates and recover the ethanol, and concentrate to a thick paste A of 1.25-1.30 (50°C); Step 3: Take white peony root, Poria cocos, and liquorice and add 6-10 times water to extract 2-4 times, each time for 1.5-3 hours, filter, combine the filtrates, and concentrate to a thick paste B with a relative density of 1.25-1.30 (50°C); Step 4: Take vinegar-processed earthworms, add 6-10 times the amount of water, and boil for 2-4 times, each time for 1-3 hours, filter, combine the filtrate with the distilled aqueous solution, concentrate to a relative density of 1.10-1.15 (50° C.), add ethanol to increase the alcohol content to 55-75%, refrigerate overnight, filter, recover ethanol from the filtrate, and concentrate to a thick paste C with a relative density of 1.20-1.30 (50° C.); Step 5: Mix the thick pastes A, B, and C, dry them under reduced pressure below 65°C to form a dry extract, and then grind them into fine powder b; mix the fine powders a and b, add auxiliary materials, mix evenly, granulate, dry, pass through a 40-60 mesh sieve, resize the granules, and put them into capsules to obtain the product.

9. The preparation method according to claim 7 or 8, characterized in that The auxiliary materials include fillers, binders, disintegrants, lubricants, glidants, opacifiers and flavoring agents.

10. Use of the composition according to any one of claims 1 to 3, the preparation according to claim 4, the capsule according to any one of claims 5 to 6, or the capsule prepared by the preparation method according to any one of claims 7 to 9 in the preparation of a medicament for treating rheumatoid arthritis.

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