Compound Fengshi Ning capsule, preparation method and application thereof

Abstract

The application discloses a compound Fengshi Ning capsule and a preparation method thereof, and belongs to the field of traditional Chinese medicine preparations. The capsule is composed of Notopterygium incisum, Angelica pubescens, Saposhnikovia divaricata, Corydalis, Ligusticum chuanxiong, Pheretima, Radix Paeoniae Alba, Dictyophora, and Glycyrrhiza, and is prepared through volatile oil extraction and inclusion, ethanol or water extraction, concentration, granulation, and capsule filling processes. The preparation has high bioavailability and good stability. Experiments show that the dissolution rate of effective components of the preparation is effectively improved compared with traditional preparations, the preparation can enhance the effects of dispelling wind and dampness, promoting blood circulation and relieving pain, and is suitable for treating rheumatoid arthritis, joint pain and other diseases.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine preparations, in particular to a compound Fengshi Ning capsule, a preparation method and an application thereof. BACKGROUND

[0002] Rheumatic arthritis belongs to the category of "arthritis" and other diseases in traditional Chinese medicine, which is a chronic and recurrent acute onset of arthritic disease caused by the body's exposure to wind, cold, dampness, heat, and blood stasis. Its clinical manifestations are muscle and joint pain, heaviness, numbness, or joint flexion, stiffness, swelling, and deformation. Traditional Chinese medicine believes that the moving arthralgia is caused by wind; the painful arthralgia is caused by cold; the arthralgia is caused by dampness; and the hot arthralgia is caused by heat.

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

[0004] Rheumatic arthritis is a common clinical disease that causes great pain to patients and seriously affects the quality of life. At present, there are many treatment methods, but most of the drug treatments have unsatisfactory effects and certain side effects. Traditional Chinese medicine has unique advantages in the treatment of rheumatic diseases, and its multi-target and multi-pathway characteristics can effectively relieve the symptoms of patients and have relatively small side effects. Therefore, it is of great clinical significance to develop a safe and effective traditional Chinese medicine preparation for the treatment of rheumatic arthritis.

[0005] Patent CN115201361A embodiment 1 discloses a compound Fengshi Ning prescription, which is composed of 17 kinds of traditional Chinese medicines such as Notopterygium, Angelica, Sinomenium acutum, Radix Clematidis, Turmeric, Saposhnikovia divaricata, and Licorice. The preparation method is to obtain a total amount of 223g of medicinal materials, add 500mL of water, soak in cold water for 1h, heat and decoct for 1h, filter through four layers of gauze, add 300mL of water to the residue, decoct for 45min, filter through gauze again, combine the two filtrates, and reduce pressure to concentrate. The concentration of crude drugs is 2g / mL. The above preparation adopts the traditional decoction extraction and concentration method. Since the active ingredients of medicinal materials are different, especially some medicinal materials contain volatile oil, there are problems of loss of active ingredients and insufficient stability of the preparation, thereby affecting the curative effect. SUMMARY

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

[0007] The first aspect of the present application provides a compound Fengshi Ning composition, wherein the medicinal materials are:

[0008] Notopterygium 3-9 parts, Angelica 3-9 parts, 4.5-9 parts of wind-preventing, 3-10 parts of Corydalis, 3-9 parts of Chuanxiong, 4.5-9 parts of Earthworm, 5-15 parts of White Peony, 9-15 parts of Yunling, 1.5-9 parts of Licorice.

[0009] Further, the medicinal materials are: Notopterygium 6-9 parts, Angelica 6-9 parts, 6-9 parts of wind-preventing, 5-10 parts of Corydalis, 4-9 parts of Chuanxiong, 5-9 parts of Earthworm, 6-15 parts of White Peony, 10-15 parts of Yunling, 2-9 parts of Licorice.

[0010] Further, the medicinal materials are: Notopterygium 6-9 parts, Angelica 6-9 parts, 6-9 parts of wind-preventing, 5-10 parts of Corydalis, 4-9 parts of Chuanxiong, 5-9 parts of Earthworm, 6-15 parts of White Peony, 10-15 parts of Yunling, 2-9 parts of Licorice.

[0011] Rheumatoid arthritis belongs to systemic connective tissue disease, which is an allergic disease related to hemolytic streptococcus infection. Its characteristics are mainly to invade the large joints of the limbs, and red, swollen, hot, painful or functional disorders appear locally in the joints, which is often seen in humid, cold, and dramatic climate changes. Due to physical weakness, deficiency of yangqi, and emptying of the interstices, combined with living in a humid environment, rain and water, and dramatic climate changes, etc., the wind, cold and dampness and heat are mixed and blocked in the meridians, causing poor blood circulation, and gradually forming the Bi syndrome.

[0012] The Bi syndrome is caused by the partial dominance of wind, cold and dampness, and the clinical symptoms are different. The wind is the most common, the pain is wandering and unpredictable, and it involves multiple joints. The cold is the most painful, the pain is fixed, the disease is more severe, and the joint flexion is not easy. The wet is the most heavy, the skin is numb, and the limbs are heavy. The heat is the most painful, the joint is red and swollen, and the movement is not convenient.

[0013] The inventors believe that for rheumatoid arthritis, the treatment should focus on dispelling wind and dampness, promoting blood circulation, and relieving pain. The compound rheumatoid arthritis formula of this invention includes Notopterygium root, Angelica pubescens root, Saposhnikovia root, Corydalis rhizome, Ligusticum chuanxiong rhizome, Earthworm, White peony root, Poria cocos, and Licorice root. Notopterygium root and Angelica pubescens root are both pungent, bitter, warm, and drying herbs. Their pungent and dispersing properties dispel wind, their bitter taste dries dampness, and their warm nature dispels cold, thus both can dispel wind and dampness and promote joint mobility. Notopterygium root is good at dispelling wind-dampness in the upper body, while Angelica pubescens root is good at dispelling wind-dampness in the lower body. The combination of these two herbs can dispel wind-dampness throughout the body, promote joint mobility, and relieve pain. Saposhnikovia root is pungent and warm, and functions to dispel wind and cold, eliminate dampness, and relieve pain. Corydalis rhizome is pungent, dispersing, and warm, promoting blood circulation and relieving qi stagnation, thus specifically treating various pains throughout the body, making it an excellent medicine for promoting blood circulation, promoting qi, and relieving pain. Ligusticum chuanxiong rhizome promotes blood circulation, promotes qi, dispels wind, unblocks meridians, and relieves pain. With most of the ingredients being pungent and warm in nature, the addition of earthworm, which is cold in nature, helps to moderate the effects and is effective in clearing the channels and relieving pain. Poria cocos strengthens the spleen and eliminates dampness, calms the mind and soothes the nerves, and is especially effective in relieving insomnia caused by pain. White peony root nourishes yin and blood, while licorice root harmonizes the effects of the other ingredients. Together, the formula works to dispel wind and dampness, promote blood circulation and relieve pain, and is used to treat rheumatoid arthritis, joint pain, and other ailments with significant efficacy.

[0014] The effects of each herbal component in this invention are as follows:

[0015] Notopterygium

[0016] This refers to the dried rhizome and roots of *Notopterygium incisum* Ting ex HTChang or *Notopterygium franchetii* H. de Boiss., both belonging to the Apiaceae family. *Notopterygium incisum* is mainly produced in Sichuan, Yunnan, Qinghai, and Gansu provinces. *Notopterygium franchetii* is mainly produced in Sichuan, Qinghai, Shaanxi, and Henan provinces. Harvested in spring and autumn, the fibrous roots and soil are removed, and the roots are sun-dried. Sliced ​​and used raw.

[0017]

Properties

[0018] [Efficacy] Relieves exterior syndromes and dispels cold, eliminates wind and dampness, and relieves pain. Used for common cold due to wind-cold, headache and stiff neck, rheumatic pain, and soreness in the shoulders and back.

[0019] [Modern Research]

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

[0021] 2. Pharmacological effects: Notopterygium root injection has analgesic and antipyretic effects, and inhibits skin fungi and Brucella. The water-soluble fraction of Notopterygium root has anti-experimental arrhythmia effects. The volatile oil also has anti-inflammatory, analgesic, and antipyretic effects, and can counteract myocardial ischemia induced by posterior pituitary extract and increase myocardial nutritional blood flow. It has an inhibitory effect on delayed-type hypersensitivity reactions in mice.

[0022] Angelica pubescens

[0023] This is the dried root of *Angelica pubescens* Maxim. f. biserrata Shan et Yuan, a plant belonging to the Apiaceae family. It is mainly produced in Sichuan, Hubei, and Anhui provinces. Harvested in early spring or late autumn, the fibrous roots and soil are removed, and the root is dried until semi-dry, then piled for 2-3 days to soften before being dried completely. It is then sliced ​​and used raw.

[0024]

Properties

[0025]

Efficacy

[0026] [Modern Research]

[0027] 1. Chemical composition: This product contains dihydroapigenin and its acetate, parsley methyl ether, isoimperatorin, bergapten, xanthotoxin, dihydroapigenin angelic acid ester, dihydroapigenin glucoside, romaine lettuce, angelic alcohol D, G, B, γ-aminobutyric acid and volatile oil, etc.

[0028] 2. Pharmacological effects: Angelica pubescens has anti-inflammatory, analgesic and sedative effects; it has an inhibitory effect on platelet aggregation; and it has a hypotensive effect, but it is not long-lasting; the bergapten, xanthotoxin and other ingredients it contains have photosensitizing and antitumor effects.

[0029] windproof

[0030] This is the dried root of *Saposhnikovia divaricata* (Turez.) Schishk., a plant belonging to the Apiaceae family. It is mainly produced in Northeast China and eastern Inner Mongolia. The roots of plants that have not yet produced flower stalks are harvested in spring and autumn. The fibrous roots and soil are removed, and the roots are sun-dried. They are then sliced ​​and used raw or charred.

[0031]

Properties

[0032] [Efficacy] Dispels wind and releases the exterior, eliminates dampness and relieves pain, stops spasms. Used for colds with headache, rheumatic pain, itchy rashes, and tetanus.

[0033] [Modern Research]

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

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

[0036] Corydalis

[0037] It is the dried tuber of Corydalis yanhusuo WT. Wang, a plant in the Papaveraceae family. It is mainly produced in Zhejiang, Jiangsu, Hubei, and Hunan provinces. It can be wild or cultivated. Harvested in early summer when the stems and leaves wither, the fibrous roots are removed, and the tubers are boiled in boiling water until just past the white core disappears. Then it is sun-dried. It can be sliced ​​thickly or crushed and used raw; or processed with vinegar.

[0038]

Properties

[0039]

Efficacy

[0040] [Modern Research]

[0041] 1. Chemical composition: It mainly contains more than 20 kinds of alkaloids, including corydaline A, B, C, D, G, Oct, Non, Yin, Chou, Zi, etc.

[0042] 2. Pharmacological effects: Corydaline B has significant analgesic, hypnotic, sedative and tranquilizing effects; Corydaline A and Corydaline B also have relatively obvious analgesic effects, and have certain hypnotic, sedative and tranquilizing effects; the alcohol extract can dilate coronary arteries, reduce coronary artery resistance, increase coronary blood flow, and improve hypoxia tolerance; the total alkaloids can counteract arrhythmia, resist myocardial ischemia, dilate peripheral blood vessels, lower blood pressure, and slow heart rate; the total alkaloids have anti-ulcer and gastric secretion inhibitory effects; Corydaline B and Corydaline B have muscle relaxant effects.

[0043] Chuanxiong

[0044] This is the dried rhizome of *Ligusticum chuanxiong* Hort., a plant belonging to the Apiaceae family. It is mainly produced in Sichuan, Guizhou, and Yunnan provinces, with the Sichuan variety being of superior quality. It is artificially cultivated. Harvested in May, the soil and sand are removed, and the rhizome is sun-dried and then oven-dried, with the fibrous roots removed. It is used raw in slices or processed with wine.

[0045]

Properties

[0046]

Efficacy

[0047] [Modern Research]

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

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

[0050] earth dragon

[0051] This refers to the dried bodies of several species of the family Pheretima, including *Pheretima aspergillum* (E. Perrier), *Pheretima vulgaris* Chen, *Pheretima guillelmi* (Michaelsen), and *Pheretima pumil* Michaelsen. The former is commonly known as "Guangdong earthworm" and is mainly produced in Guangdong and Guangxi Zhuang Autonomous Regions; the latter three are commonly known as "Shanghai earthworm" and are mainly produced in the Shanghai area. Guangdong earthworms are harvested from spring to autumn, while Shanghai earthworms are harvested in summer and autumn. The abdomen is promptly dissected, the internal organs and mud removed, and the earthworms are washed, sun-dried, or dried at low temperature. They can be used raw or fresh.

[0052]

Properties

[0053]

Efficacy

[0054] [Modern Research]

[0055] 1. Chemical Composition: This product contains various amino acids, with glutamic acid, aspartic acid, and leucine being the most abundant; it also contains trace elements such as iron, zinc, magnesium, copper, and chromium; and organic acids such as arachidonic acid and succinic acid. Furthermore, it contains earthworm antipyretic alkaloids, earthworm toxins, earthworm toxicity, xanthine, hypoxanthine, yellow pigments, and enzymes.

[0056] 2. Pharmacological effects: Earthworm decoction and earthworm antipyretic alkaloids have good antipyretic effects; hot extract and alcohol extract have sedative and anticonvulsant effects on mice and rabbits; earthworm hypoxanthine has a significant bronchodilatory effect and can antagonize the bronchodilatory effects of histamine and pilocarpine; earthworm tincture, dry powder suspension, hot extract, and decoction all have a slow and sustained hypotensive effect; earthworm extract has fibrinolytic and anticoagulant effects. In addition, earthworm also has immune-enhancing, antitumor, antibacterial, diuretic, and uterine and intestinal smooth muscle stimulating effects.

[0057] Poria

[0058] It is the dried sclerotium of the fungus *Poria cocos* (Schw.) Wolf, belonging to the Polyporaceae family. It parasitizes the roots of pine trees such as *Pinus tabuliformis* or *Pinus massoniana*. It can be found wild or cultivated, mainly in Yunnan, Anhui, Hubei, Henan, and Sichuan provinces. The Yunnan variety is called "Yunling" and is considered to be of superior quality. It is mostly harvested from July to September. After being dug up, the soil and sand are removed, and the fungus is piled up to "sweat," then spread out to dry until the surface is dry. This process of "sweating" is repeated several times until wrinkles appear and most of the internal moisture is lost. Finally, it is air-dried, resulting in "Fuling pieces." Alternatively, it can be soaked, slightly steamed, sliced ​​promptly, and sun-dried; or fresh Fuling can be cut according to different parts, air-dried, and used raw.

[0059] [Properties] Sweet, bland, neutral. Enters the heart, lung, spleen, and kidney meridians.

[0060] [Efficacy] Promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. Used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations and insomnia.

[0061] [Modern Research]

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

[0063] 2. Pharmacological effects: Poria cocos decoction, syrup, alcohol extract, and ether extract have diuretic, sedative, antitumor, hypoglycemic, and myocardial contractility-enhancing effects, respectively. Poria cocos polysaccharides enhance immune function. Poria cocos has hepatoprotective effects, can reduce gastric acid secretion, and inhibits gastric ulcers.

[0064] White peony root

[0065] It is the dried root of Paeonia lactiflora apall., a plant in the Ranunculaceae family. It is mainly produced in Zhejiang, Anhui, and Sichuan provinces. Harvested in summer and autumn, the roots are cleaned of soil and lateral roots, peeled, soaked in boiling water or briefly boiled until evenly heated, and then sun-dried. When used, it is moistened thoroughly and sliced. It is generally used raw, stir-fried with wine, or simply stir-fried.

[0066] [Properties] Bitter, sour, slightly cold. Enters the liver and spleen meridians.

[0067]

Efficacy

[0068] [Modern Research]

[0069] 1. Chemical composition: White peony contains paeoniflorin, paeonol, paeoniflorin glycoside, as well as paeoniflorin lactone, benzoic acid, etc. In addition, it also contains volatile oil, fatty oil, resin sugar, starch, mucilage, protein and triterpenoids.

[0070] 2. Pharmacological effects: Feeding mice with a decoction of Paeonia lactiflora significantly increased the percentage of peritoneal macrophages and the phagocytic index compared to the control group. Paeonia lactiflora can promote the phagocytic function of peritoneal macrophages in mice. The decoction of Paeonia lactiflora can antagonize the inhibitory effect of cyclophosphamide on peripheral T lymphocytes in mice, restoring them to normal levels, indicating that Paeonia lactiflora can restore impaired cellular immune function. Paeonia lactiflora extract has a significant inhibitory effect on egg white-induced acute inflammatory edema in rats and inhibits the proliferation of cotton pellet granulomas. Paeonia lactiflora has a significant analgesic effect on acetic acid-induced writhing; when used in combination with the methanol complex of licorice, the two have a synergistic analgesic effect on acetic acid-induced writhing. Paeoniflorin, the main component of Paeonia lactiflora, has a good antispasmodic effect.

[0071] licorice

[0072] This refers to the dried roots and rhizomes of *Glycyrrhiza uralensis* Fisch., *Glycyrrhiza inflata* Bat., or *Glycyrrhiza glabra* L., all belonging to the Fabaceae family. It is mainly produced in Inner Mongolia Autonomous Region, Xinjiang Uygur Autonomous Region, and Gansu Province. Harvesting takes place in spring and autumn, with autumn harvest being considered the best. The fibrous roots are removed, and the roots are sun-dried into thick slices, used raw or honey-processed.

[0073] [Properties] Sweet, neutral. Enters the heart, lung, spleen, and stomach meridians.

[0074] [Efficacy] Tonifies the spleen and replenishes qi, clears heat and detoxifies, eliminates phlegm and relieves cough, alleviates spasms and pain, and harmonizes the effects of other medicines. Used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of other medicines.

[0075] [Modern Research]

[0076] 1. Chemical composition: This product contains triterpenoids (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 components.

[0077] 2. Pharmacological effects: Licorice has antiarrhythmic effects; it has anti-ulcer effects, inhibits gastric acid secretion, relieves gastrointestinal smooth muscle spasms and has analgesic effects, and has a synergistic effect with paeoniflorin, the effective component of peony; it can promote pancreatic juice secretion; it has significant antitussive and expectorant effects, and also has a certain antiasthmatic effect; it has antibacterial, antiviral, anti-inflammatory and anti-allergic effects; it can protect inflamed pharyngeal and tracheal mucosa; it has a detoxification effect similar to glucuronic acid on certain poisons; it has an effect similar to adrenocortical hormones; it also has antidiuretic, lipid-lowering and hepatoprotective effects.

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

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

[0080] In a third aspect, this invention also provides a method for preparing the compound rheumatism-relieving capsules, facilitating drug preparation and quality control. The preparation method includes the following steps:

[0081] Step 1: Soak Notopterygium root, Angelica pubescens root, Saposhnikovia root, and Ligusticum chuanxiong root in water to extract volatile oil. Collect the distilled aqueous solution separately and set aside the residue. Collect the volatile oil, encapsulate it with β-cyclodextrin, dry it, and pulverize it into fine powder a.

[0082] Step 2: Combine the above-mentioned dregs with Corydalis rhizome, add ethanol, reflux to extract, filter, combine the filtrates and recover the ethanol, and concentrate to thick paste A;

[0083] Step 3: Take white peony root, poria cocos, and licorice root, add water to extract, filter, combine the filtrates, and concentrate into a thick paste B;

[0084] Step 4: Take the vinegar-processed earthworm, add water and boil, filter, combine the filtrate with the above distilled aqueous solution, concentrate to a paste, add ethanol for precipitation, refrigerate overnight, filter, recover the 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 pulverize them into fine powder b; mix fine powders a and b, add excipients, mix evenly, granulate, dry, sieve and granulate, and fill into capsules to obtain the final product.

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

[0087] Step 1: Soak Qianghuo, Duhuo, Fangfeng, and Chuanxiong in 8-10 times the amount of water for 1-4 hours, extract the volatile oil for 8-12 hours, collect the distilled aqueous solution separately, keep the residue for later use, collect the volatile oil, encapsulate the volatile oil with 6-10 times the amount of β-cyclodextrin, dry it below 45°C, and pulverize it into fine powder a;

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

[0089] Step 3: Take white peony root, poria cocos, and licorice root, add 6-10 times the amount of water and extract 2-4 times, 1.5-3 hours each time. Filter, combine the filtrates, and concentrate to a thick paste B with a relative density of 1.25-1.30 (50℃).

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

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

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

[0093] In a fourth aspect, the present invention provides the use of the composition, the oral formulation, or the drug prepared by the preparation method in the treatment of rheumatoid arthritis and joint pain.

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

[0095] (1) Significant therapeutic effect: The compound rheumatism relief capsule of the present invention has the effects of dispelling wind and dampness, promoting blood circulation and relieving pain through the rational combination of various 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, with relatively few side effects, and is suitable for long-term use.

[0097] (3) Reasonable preparation process: The preparation process of the present invention classifies and processes medicinal materials, which can effectively extract the effective components in Chinese medicinal materials, improve the stability, quality and efficacy of the drug, and facilitate industrial production. Detailed Implementation

[0098] To better illustrate the objectives, technical solutions, and advantages of this invention, the invention will be further described below in conjunction with specific embodiments. However, this invention is not limited thereto. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without inventive effort are within the scope of protection of this invention.

[0099] A compound rheumatism-relieving composition 1, characterized in that its medicinal raw materials are:

[0100] Notopterygium root 6 parts, Angelica pubescens root 6 parts, Saposhnikovia divaricata root 6 parts, Corydalis yanhusuo root 5 parts, Ligusticum chuanxiong rhizome 4 parts, Pheretima aspergillum root 5 parts, Paeonia lactiflora root 6 parts, Poria cocos 10 parts, Glycyrrhiza uralensis root 2 parts.

[0101] A compound rheumatism-relieving composition 2, characterized in that its medicinal raw materials are:

[0102] 8 parts of Notopterygium root, 8 parts of Angelica pubescens root, 6 parts of Saposhnikovia root, 6 parts of Corydalis rhizome, 4 parts of Ligusticum chuanxiong rhizome, 5 parts of earthworm, 8 parts of white peony root, 12 parts of Poria cocos, and 3 parts of licorice root.

[0103] A compound rheumatism-relieving composition 3, characterized in that its medicinal raw materials are:

[0104] Notopterygium root 9 parts, Angelica pubescens root 9 parts, Saposhnikovia divaricata root 9 parts, Corydalis yanhusuo root 10 parts, Ligusticum chuanxiong rhizome 9 parts, Pheretima aspergillum root 9 parts, Paeonia lactiflora root 12 parts, Poria cocos root 15 parts, Glycyrrhiza uralensis root 4 parts.

[0105] A compound rheumatism-relieving composition 4, characterized in that its medicinal raw materials are:

[0106] Notopterygium root 9 parts, Angelica pubescens root 9 parts, Saposhnikovia divaricata root 8 parts, Corydalis yanhusuo root 10 parts, Ligusticum chuanxiong rhizome 8 parts, Pheretima aspergillum root 8 parts, Paeonia lactiflora root 15 parts, Poria cocos root 15 parts, Glycyrrhiza uralensis root 5 parts.

[0107] Add any one of the compositions 1-4 to conventional excipients and prepare a usable oral formulation according to the preparation process. The dosage form of the oral formulation is powder, capsule, tablet, pill, granule, solution, emulsion, suspension or oil.

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

[0109] Step 1: Soak Qianghuo, Duhuo, Fangfeng, and Chuanxiong in 8-10 times the amount of water for 1-4 hours, extract the volatile oil for 8-12 hours, collect the distilled aqueous solution separately, keep the residue for later use, collect the volatile oil, encapsulate the volatile oil with 6-10 times the amount of β-cyclodextrin, dry it below 45°C, and pulverize it into fine powder a;

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

[0111] Step 3: Take white peony root, poria cocos, and licorice root, add 6-10 times the amount of water and extract 2-4 times, 1.5-3 hours each time. Filter, combine the filtrates, and concentrate to a thick paste B with a relative density of 1.25-1.30 (50℃).

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

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

[0114] Example 1:

[0115] A compound rheumatism-relieving capsule, characterized in that its medicinal raw materials are:

[0116] 8 parts of Notopterygium root, 8 parts of Angelica pubescens root, 6 parts of Saposhnikovia root, 6 parts of Corydalis rhizome, 4 parts of Ligusticum chuanxiong rhizome, 5 parts of earthworm, 8 parts of white peony root, 12 parts of Poria cocos, and 3 parts of licorice root.

[0117] Its preparation method includes the following steps:

[0118] Step 1: Soak Qianghuo, Duhuo, Fangfeng, and Chuanxiong in 10 times the amount of water for 1 hour, extract the volatile oil for 8 hours, collect the distilled aqueous solution separately, keep the residue for later use, collect the volatile oil, encapsulate the volatile oil with 7 times the amount of β-cyclodextrin, dry it below 45°C, and pulverize it into fine powder a;

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

[0120] Step 3: Take white peony root, poria cocos, and licorice root, add 10 times the amount of water and extract twice, 1.5 hours each time. Filter, combine the filtrates, and concentrate to a thick paste B with a relative density of 1.25 (50℃).

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

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

[0123] Example 2

[0124] A compound rheumatism-relieving capsule, characterized in that its medicinal raw materials are:

[0125] Notopterygium root 9 parts, Angelica pubescens root 9 parts, Saposhnikovia divaricata root 9 parts, Corydalis yanhusuo root 10 parts, Ligusticum chuanxiong rhizome 9 parts, Pheretima aspergillum root 9 parts, Paeonia lactiflora root 12 parts, Poria cocos root 15 parts, Glycyrrhiza uralensis root 4 parts.

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

[0127] Example 3

[0128] A compound rheumatism-relieving capsule, characterized in that its medicinal raw materials are:

[0129] Notopterygium root 9 parts, Angelica pubescens root 9 parts, Saposhnikovia divaricata root 8 parts, Corydalis yanhusuo root 10 parts, Ligusticum chuanxiong rhizome 8 parts, Pheretima aspergillum root 8 parts, Paeonia lactiflora root 15 parts, Poria cocos root 15 parts, Glycyrrhiza uralensis root 5 parts.

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

[0131] Comparative Example 1

[0132] Take the following herbs according to the weight ratio in Example 1: Notopterygium root, Angelica pubescens root, Saposhnikovia root, Corydalis rhizome, Ligusticum chuanxiong rhizome, Pheretima root, Paeonia lactiflora root, Poria cocos, and Glycyrrhiza root. Add 10 times the weight of the mixed herbs to water, soak in cold water for 1 hour, heat and decoct for 1 hour, and filter through four layers of gauze. Add 4 times the weight of water to the dregs, decoct for 45 minutes, filter through gauze again, combine the two filtrates, and concentrate under reduced pressure to a crude herb concentration of 1.30 g / mL.

[0133] Comparative Example 2

[0134] According to the weight ratio of Notopterygium root, Angelica pubescens root, Saposhnikovia root, Corydalis rhizome, Ligusticum chuanxiong rhizome, Pheretima root, Paeonia lactiflora root, Poria cocos, and Glycyrrhiza root in Example 1, add 10 times the weight of water to the mixed herbs, soak in cold water for 1 hour, heat and decoct for 1 hour, filter with gauze, repeat the decoction process twice, combine the two filtrates, concentrate under reduced pressure to a relative density of 1.1, add ethanol to achieve an alcohol content of 60%, refrigerate overnight, filter, recover the ethanol from the filtrate, and concentrate to a thick paste with a relative density of 1.20 (50°C). Dry the thick paste under reduced pressure below 65°C to obtain a dry extract, then pulverize it into a fine powder, add excipients, mix evenly, granulate, dry, pass through a 50-mesh sieve and granulate, and fill into capsules to obtain the final product.

[0135] Content determination

[0136] The volatile oil was determined according to the method for determination of volatile oil (Chinese Pharmacopoeia General Chapter 2204).

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

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

[0139]

[0140] [Pharmacological Efficacy Experiment]

[0141] Adjuvant-induced arthritis model rat experiment

[0142] I. Experimental Materials

[0143] 1. Laboratory animals

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

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

[0146] 2. Reagents

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

[0148] (2) 10% chloral hydrate: Dissolve 10g of chloral hydrate in 100mL of physiological saline, and store it for later use after it is fully dissolved.

[0149] (3) Physiological saline.

[0150] 3. Experimental Samples

[0151] Compound Rheumatoid Capsules in Examples 1-3, and Traditional Chinese Medicine Preparations in Comparative Examples 1-2.

[0152] 4. Equipment

[0153] 0.1% electronic balance

[0154] Electric constant temperature water bath

[0155] Vernier calipers

[0156] syringe

[0157] rat gavage injection

[0158] II. Experimental Methods

[0159] 1. Modeling

[0160] Rats were randomly divided into two groups: a model group and a drug administration group (Examples 1-3, Comparative Examples 1-2), with 10 rats in each group. The model group and the drug administration group were subjected to modeling treatment according to the following modeling method.

[0161] (1) Immunization: On day 0, rats were anesthetized with 10% chloral hydrate at a dose of 400 μL / 100g. 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 rats' body weight and joint changes. When the rats lose weight and show symptoms such as redness and swelling in their limbs, and their clinical scores also increase significantly, the animal model can be judged to be successful.

[0163] Criteria Score No redness and swelling of the joints 0 Mild redness and swelling at the ankle or wrist joint 1 Moderate redness and swelling at the ankle or wrist joint 2 Moderate redness and swelling at the ankle and mid bone or wrist and palm 3 Severe redness and even stiffness of the entire forelimb or hind limb 4

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

[0165] 2. Administration

[0166] (1) Administration method: Start gavage administration 6 days after inflammation, once a day for 18 consecutive days.

[0167] (2) Dosage:

[0168] The model group was given an equal volume of physiological saline by gavage, 10 mL / kg.

[0169] The treatment groups were administered 70 mg / kg via gavage to Examples 1-3 and Comparative Examples 1-2, respectively.

[0170] During this period, provide regular feed and water.

[0171] 3. Observation indicators

[0172] The severity of lesions in rats was monitored, with a focus on swelling. Ankle circumference was measured every 3 days, and the degree of swelling and swelling inhibition rate were calculated. Scores were given at the same time point each time according to standard criteria. Inflammatory factor levels were measured the day before the end of the experiment.

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

[0174] Swelling inhibition rate (%) = (Average swelling degree of model group - Average swelling degree of treatment group) / Average swelling degree of model group × 100%

[0175] 4. Results

[0176] Table 2. Therapeutic effects of each group on adjuvant-induced 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 in Examples 1-3 of this invention had a significant inhibitory effect on adjuvant-induced arthritis in rats, with a highly significant difference compared with the model group (P < 0.01). Among them, the swelling inhibition rate of the Example 1-3 groups was significantly better than that of the Comparative Example 1-2 groups.

[0180] TNF-α is an important pro-inflammatory cytokine in the pathogenesis of rheumatoid arthritis. In patients with rheumatoid arthritis, synovial cells 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 and cartilage and bone tissue destruction. Therefore, detecting TNF-α levels can directly reflect the activity level of local joint inflammation; higher TNF-α levels generally indicate higher disease activity and potentially more severe joint damage.

[0181] By detecting TNF-α levels, we can directly understand the inhibitory effect of drugs on inflammatory responses. If a drug significantly reduces TNF-α levels in a rheumatoid arthritis efficacy study, it suggests that the drug may alleviate inflammation by inhibiting TNF-α production or action, thus having a therapeutic effect on rheumatoid arthritis. This provides an objective and quantitative indicator for evaluating drug efficacy, helping to determine drug effectiveness and optimal dosage. Detecting TNF-α levels helps to further explore the mechanisms of action of drugs in treating rheumatoid arthritis. If a drug can reduce TNF-α levels, further research can be conducted to determine whether it exerts its effects by inhibiting TNF-α gene transcription and translation, blocking the binding of TNF-α to its receptor, or affecting downstream signaling pathways of TNF-α. This is of great significance for identifying drug targets, optimizing drug design, and developing more targeted treatment methods.

[0182] High levels of TNF-α before treatment often indicate a more severe condition, potentially faster joint damage progression, and a relatively poor prognosis. However, during pharmacodynamic studies, continuous monitoring of TNF-α levels reveals that a gradual decrease and maintenance of low TNF-α levels generally indicates better disease control, potentially slower joint damage progression, and a better prognosis. Therefore, TNF-α levels can serve as an important indicator for predicting the prognosis of rheumatoid arthritis patients, providing a basis for adjusting clinical treatment plans and guiding patient rehabilitation.

[0183] In summary, detecting TNF-α levels in rheumatoid arthritis pharmacodynamic experiments can reflect disease activity, assess drug efficacy, explore drug mechanisms of action, and predict disease prognosis, providing important evidence for drug development and clinical diagnosis and treatment. Therefore, TNF-α was selected for this experiment. The results show that the drugs in Examples 1-3 of this invention can significantly reduce TNF-α levels, showing a highly significant difference compared to the model group (P < 0.01), and are also superior to comparative examples 1-2.

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

[0185] Volatile oils are a class of aromatic natural drugs with strong activity, making their proper extraction essential for use in traditional Chinese medicine. For classic formulas containing a high amount of volatile components, such as Qianghuo Shengshi Decoction, which includes seven herbs: Qianghuo, Duhuo, Gaoben, Fangfeng, Gancao, Chuanxiong, and Manjingzi, among which Qianghuo, Gaoben, Fangfeng, and Manjingzi are diaphoretics, and Duhuo and Chuanxiong also contain volatile components. The ancient method for this formula records "using two cups of water to boil down to one cup," indicating a long boiling time (approximately 6 hours) during which a significant amount of volatile components are lost. Studies have shown that component analysis of the aqueous extract obtained by the decoction method reveals only trace amounts of volatile oil due to the escape of volatile oils with the steam caused by boiling water, which are not condensed and recovered. However, the extract is rich in non-volatile components such as polysaccharides and saponins. Therefore, the decoction method is suitable for extracting water-soluble components. For the water extraction and alcohol precipitation method, the alcohol precipitation step causes low-polarity volatile oils to precipitate or be adsorbed, thus reducing the volatile oil content, but retaining some of the more polar volatile components, making it suitable for impurity removal and purification.

[0186] In modern production processes, extraction tanks are generally used, resulting in relatively less loss of volatile components. Given the pungent and warm properties of aromatic components, corresponding to their effects of dispelling wind and cold, clearing the channels, and relieving pain, the traditional method of prolonged decoction seems unsuitable. The inventors, in the extraction and preparation of medicinal materials, considered extracting highly active volatile oil components separately and then encapsulating them in the medicine, and conducted in-depth research on the dispersion state and content of volatile oils. Volatile oils in traditional Chinese medicine generally have low boiling points and are easily oxidized; care must be taken during extraction to avoid adverse effects on the extract. Furthermore, for the volatile active ingredients in traditional Chinese medicine volatile oils, encapsulation technology is used to create volatile oil inclusion compounds, which can effectively prevent the loss of active ingredients and ensure the quality and efficacy of the preparation.

[0187] This invention's formula also contains earthworm, an animal-derived medicine with a certain fishy odor. Appropriate processing methods, such as vinegar processing, can effectively enhance the medicinal properties of earthworm and remove its fishy smell, improving medication adherence. Furthermore, the activity of earthworm is related to various amino acids and enzymes; the extraction process affects the amino acid content in the extract, thus influencing efficacy. Fully extracting the active ingredients of earthworm is crucial for improving therapeutic efficacy. Currently, the clinical use of earthworm is generally by decoction, which leads to significant individual differences and poor treatment adherence. The inventors discovered in their research that water extraction and alcohol precipitation of earthworm is a more effective extraction method than traditional decoction, and the extract has better stability. Capsules can mask the fishy smell and better exert the medicinal effect.

[0188] 5. Conclusion

[0189] This invention relates to a compound rheumatoid arthritis remedy composed of traditional Chinese medicines such as Notopterygium incisum, Angelica pubescens, Saposhnikovia divaricata, and Corydalis yanhusuo. It possesses the effects of dispelling wind and dampness, promoting blood circulation, and relieving pain, and is used to treat rheumatoid arthritis, joint pain, and other symptoms. The preparation process, through the classification and processing of medicinal materials, effectively extracts the active ingredients from the herbs, improving the stability, quality, and efficacy of the drug, and facilitating industrial production. Experiments have shown that the compound rheumatoid arthritis remedy has a significant therapeutic effect.

[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 modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A compound Fengshi Ning capsule, characterized in that, The Chinese medicinal materials are: Notopterygium 3-9 parts, Angelica pubescens 3-9 parts, Saposhnikovia 4.5-9 parts, Corydalis 3-10 parts, Szechwan lovage 3-9 parts, Earthworm 4.5-9 parts, Radix Paeoniae Alba 5-15 parts, Dictyophora 9-15 parts, and Licorice 1.5-9 parts. The preparation method comprises the following steps: Step one: Notopterygium, Angelica pubescens, Saposhnikovia, and Szechwan lovage are soaked in water, and volatile oil is extracted, and the water solution after distillation is collected in another container, and the residue is reserved for later use, and the volatile oil is collected, and the volatile oil is wrapped with β-cyclodextrin, dried, and crushed into fine powder a; Step two: the above residue and Corydalis are combined, and ethanol is added, and reflux extraction is performed, and filtration is performed, and the filtrate is combined, and ethanol is recovered, and concentrated to thick paste A; Step three: Radix Paeoniae Alba, Dictyophora, and Licorice are added with water for extraction, and filtration is performed, and the filtrate is combined, and concentrated to thick paste B; Step four: vinegar-prepared Earthworm is added with water for decoction, and filtration is performed, and the filtrate is combined with the water solution after distillation, and concentrated to paste, and ethanol is added for alcohol precipitation, and refrigerated overnight, and filtration is performed, and the filtrate is recovered for ethanol, and concentrated to thick paste C; Step five: thick pastes A, B, and C are mixed, dried into dry extract, and crushed into fine powder b; fine powders a and b are mixed, and excipients are added, and mixed evenly, and granulated, and dried, and sieved and granulated, and filled into capsules, and the preparation is obtained.

2. Capsule according to claim 1, characterized in that The Chinese medicinal materials are: Notopterygium 6-9 parts, Angelica pubescens 6-9 parts, Saposhnikovia 6-9 parts, Corydalis 5-10 parts, Szechwan lovage 4-9 parts, Earthworm 5-9 parts, Radix Paeoniae Alba 6-15 parts, Dictyophora 10-15 parts, and Licorice 2-9 parts.

3. The capsule according to claim 1, characterized in that, The Chinese medicinal materials are: Notopterygium 8-9 parts, Angelica pubescens 8-9 parts, Saposhnikovia 6-8 parts, Corydalis 6-10 parts, Szechwan lovage 4-8 parts, Earthworm 5-8 parts, Radix Paeoniae Alba 8-15 parts, Dictyophora 12-15 parts, and Licorice 3-6 parts.

4. The compound Fengshi Ning capsule of any one of claims 1-3, characterized in that, The preparation method comprises the following steps: Step one: Notopterygium, Angelica pubescens, Saposhnikovia, and Szechwan lovage are soaked in water for 1-4 hours, and volatile oil is extracted for 8-12 hours, and the water solution after distillation is collected in another container, and the residue is reserved for later use, and the volatile oil is collected, and the volatile oil is wrapped with 6-10 times of β-cyclodextrin, and dried at 45° or below, and crushed into fine powder a; Step two: the above residue and Corydalis are combined, and 6-10 times of 60-80% ethanol is added, and reflux extraction is performed for 2-4 times, each time for 1-3 hours, and filtration is performed, and the filtrate is combined, and ethanol is recovered, and concentrated to thick paste A with a relative density of 1.25-1.30 at 50°C; Step three: Radix Paeoniae Alba, Dictyophora, and Licorice are added with 6-10 times of water for extraction for 2-4 times, each time for 1.5-3 hours, and filtration is performed, and the filtrate is combined, and concentrated to thick paste B with a relative density of 1.25-1.30 at 50°C; Step four: vinegar-prepared Earthworm is added with 6-10 times of water for decoction for 2-4 times, each time for 1-3 hours, and filtration is performed, and the filtrate is combined with the water solution after distillation, and concentrated to paste with a relative density of 1.10-1.15 at 50°C, and ethanol is added to make the alcohol content 55-75%, and refrigerated overnight, and filtration is performed, and the filtrate is recovered for ethanol, and concentrated to thick paste C with a relative density of 1.20-1.30 at 50°C; Step five: mix thick paste A, B, C, dry into dry extract under reduced pressure below 65℃, then crush into fine powder b; mix fine powder a, b, add excipient, mix evenly, granulate, dry, sieve and granulate, fill into capsules, and you get the capsules.

5. A method for preparing Compound Fengshen Ning Capsule, characterized in that, The traditional Chinese medicine raw material of any one of claims 1-3, and the preparation method comprises the following steps: Step one: soak Notopterygium, Angelica pubescens, Saposhnikovia divaricata and Rhizoma Chuanxiong in water, extract volatile oil, collect the water solution after distillation in another container, and reserve the residue for later use, collect the volatile oil, and package it with β-cyclodextrin, dry, and crush into fine powder a; Step two: combine the residue with Corydalis, add ethanol, reflux extract, filter, combine the filtrate, and recover ethanol, and concentrate to thick paste A; Step three: extract Paeonia lactiflora, Grifola and Glycyrrhiza in water, filter, combine the filtrate, and concentrate to thick paste B; Step four: decoct Vine snake with water, filter, combine the filtrate with the water solution after distillation, concentrate to paste, add ethanol for alcohol precipitation, refrigerate overnight, filter, recover ethanol from the filtrate, and concentrate to thick paste C; Step five: mix thick paste A, B, C, dry into dry extract under reduced pressure below 65℃, then crush into fine powder b; mix fine powder a, b, add excipient, mix evenly, granulate, dry, sieve and granulate, fill into capsules, and you get the capsules.

6. The production method according to claim 5, wherein The following steps are included: Step one: soak Notopterygium, Angelica pubescens, Saposhnikovia divaricata and Rhizoma Chuanxiong in 8-10 times water for 1-4 hours, extract volatile oil for 8-12 hours, collect the water solution after distillation in another container, reserve the residue for later use, collect the volatile oil, and package it with 6-10 times β-cyclodextrin, dry below 45°, and crush into fine powder a; Step two: combine the residue with Corydalis, add 6-10 times 60-80% ethanol, reflux extract for 2-4 times, each time for 1-3 hours, filter, combine the filtrate, and recover ethanol, and concentrate to thick paste A with a relative density of 1.25-1.30 at 50℃; Step three: extract Paeonia lactiflora, Grifola and Glycyrrhiza in 6-10 times water for 2-4 times, each time for 1.5-3 hours, filter, combine the filtrate, and concentrate to thick paste B with a relative density of 1.25-1.30 at 50℃; Step four: decoct Vine snake in 6-10 times water for 2-4 times, each time for 1-3 hours, filter, combine the filtrate with the water solution after distillation, concentrate to thick paste C with a relative density of 1.10-1.15 at 50℃, add ethanol to make the alcohol content 55-75%, refrigerate overnight, filter, recover ethanol from the filtrate, and concentrate to thick paste C with a relative density of 1.20-1.30 at 50℃; Step five: mix thick paste A, B, C, dry into dry extract under reduced pressure below 65℃, then crush into fine powder b; mix fine powder a, b, add excipient, mix evenly, granulate, dry, sieve and granulate, fill into capsules, and you get the capsules.

7. The use of the compound Fengshineng capsules of any one of claims 1-4 in the preparation of a drug for treating rheumatoid arthritis.

Images