A traditional Chinese medicine composition for treating rheumatoid arthritis

Abstract

The application discloses a traditional Chinese medicine composition for treating rheumatoid arthritis. The traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: coix seed 50-70 parts, quassia 50-70 parts, siegesbeckia orientalis 25-35 parts, melon seed 25-35 parts, radix rehmanniae 25-35 parts, atractylodes 25-35 parts, raw licorice 8-12 parts and amomum villosum 8-12 parts. The traditional Chinese medicine composition has the effects of clearing heat and removing dampness, dredging collaterals and relieving arthralgia, invigorating the spleen and tonifying the body, nourishing yin and nourishing blood, can significantly improve the clinical symptoms of rheumatoid arthritis patients, has high safety, and is suitable for long-term use.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating rheumatoid arthritis. BACKGROUND

[0002] Rheumatoid arthritis (RA) is an autoimmune disease characterized by symmetrical polyarthritis, which is difficult to cure and can lead to joint deformity. RA belongs to the category of "Bi syndrome" in traditional Chinese medicine, and its core can be summarized as "deficiency of vital qi, invasion of pathogenic factors, mutual accumulation of phlegm and blood stasis, and obstruction of meridians". The key is that the meridians are obstructed by wind, cold and dampness, the circulation of qi and blood is not smooth, the body fluid condenses into phlegm, the blood stagnates into stasis, and the toxins are formed after a long time of deepening into the sinews and bones. The deficiency of liver and kidney essence and blood, and the damage of qi and blood and yin and yang are caused by the long-term consumption of vital qi and the involvement of zang-fu organs.

[0003] Modern medicine often uses non-steroidal anti-inflammatory drugs, glucocorticoids and DMARDs to intervene, which can relieve symptoms in the short term, but long-term use can lead to adverse reactions such as gastrointestinal damage, liver and kidney toxicity, osteoporosis and immunosuppression, seriously affecting the quality of life of patients.

[0004] The current traditional Chinese medicine formula for treating rheumatoid arthritis also has the following technical defects: (1) complex formula, more flavors; (2) containing hormones and toxic ingredients, large toxic and side effects, easy to cause adverse reactions; (3) excessive attack and damage to vital qi; (4) improper combination of cold and heat, which is difficult to adapt to the pathogenesis characteristics of RA with cold and heat. SUMMARY

[0005] Therefore, the purpose of the present application is to provide a traditional Chinese medicine composition for treating rheumatoid arthritis, which overcomes the problems of complex formula, large toxic and side effects, damage to vital qi and improper combination of cold and heat in the prior art.

[0006] In order to achieve the above purpose, the present application adopts the following technical scheme:

[0007] The present application provides a traditional Chinese medicine composition.

[0008] Further, the raw material composition of the traditional Chinese medicine composition comprises: yiyi- ren, xanthoxylum, hawksbeard, muskmelon seed, radix rehmanniae, atractylodes, raw licorice and amomum villosum.

[0009] Further, the traditional Chinese medicine composition is composed of the following raw materials: yiyi- ren 50-70 parts, xanthoxylum 50-70 parts, hawksbeard 25-35 parts, muskmelon seed 25-35 parts, radix rehmanniae 25-35 parts, atractylodes 25-35 parts, raw licorice 8-12 parts and amomum villosum 8-12 parts.

[0010] Furthermore, the traditional Chinese medicine composition is composed of the following raw medicinal materials by weight: 60 parts of coix seed, 60 parts of海州常山, 30 parts of Siegesbeckia orientalis, 30 parts of muskmelon seeds, 30 parts of raw rehmannia root, 30 parts of Atractylodes lancea, 10 parts of raw licorice, and 10 parts of Amomum villosum.

[0011] The analysis of the therapeutic principles of the raw medicinal materials used in the present invention is as follows:

[0012] King drug: In the formula of the present invention, coix seed is sweet and light in flavor, cool in nature, and belongs to the spleen, stomach, and lung meridians. It strengthens the spleen, promotes diuresis to eliminate dampness, clears heat and relieves arthralgia, relaxes the tendons and alleviates spasm.海州常山 is pungent and dispersing, bitter and descending, neutral in nature, and belongs to the liver, gallbladder, and spleen meridians. It is good at dispelling wind-dampness and heat pathogens between the muscles and bones, dredging collaterals to relieve pain, and penetrating pathogenic factors, taking both the root cause and symptoms into consideration. Coix seed mainly strengthens the spleen and promotes diuresis to eliminate dampness, while海州常山 mainly dispels wind and dredges collaterals. The two together serve as the king drug, combining reinforcement and reduction, and taking both the root cause and symptoms into consideration.

[0013] Ministerial drug: Siegesbeckia orientalis is pungent, bitter, and cold in nature, and belongs to the liver and kidney meridians. It dispels wind-dampness, benefits joints, clears heat and detoxifies, and is good at treating wind-dampness arthralgia and weakness of muscles and bones. Muskmelon seeds are sweet and cold in flavor, and belong to the lung and stomach meridians. They resolve phlegm, disperse stasis, dredge collaterals, promote diuresis and reduce swelling, and are sweet, cold, and moistening, which can counteract the adverse effect of the bitter cold of Siegesbeckia orientalis on yin. Siegesbeckia orientalis helps the king drug clear damp-heat and dredge collaterals, while muskmelon seeds resolve phlegm stasis and moisten dryness and stasis. The two together serve as the ministerial drug.

[0014] Assistant drug: Raw rehmannia root is sweet, bitter, and cold in nature, and belongs to the heart, liver, and kidney meridians. It nourishes yin to control dryness, clears heat and promotes fluid production, and prevents the dampness-removing drugs from damaging yin. Atractylodes lancea is pungent, bitter, and warm in nature, and belongs to the spleen and stomach meridians. It dries dampness and strengthens the spleen, and together with coix seed, "one promotes diuresis and one dries dampness" to disperse damp pathogens separately. It is pungent and warm to dispel wind and cold, and also restrains the cold nature in the formula. Amomum villosum is pungent and warm in flavor, and belongs to the spleen, stomach, and kidney meridians. It promotes qi circulation by eliminating dampness, awakens the spleen and harmonizes the stomach, helps coix seed strengthen the spleen function, and also prevents the cold-natured drugs from damaging the middle jiao. The three together serve as the assistant drug.

[0015] Guiding drug: Raw licorice, known as the "national elder", is sweet in flavor and neutral in nature, and belongs to the twelve meridians. It is good at harmonizing various drugs, relieving spasm and pain, and also replenishing qi and regulating the middle jiao, tonifying deficiency and detoxifying. It serves as the guiding drug.

[0016] The whole formula: The whole formula clears heat and removes dampness, dredges collaterals and relieves arthralgia, strengthens the spleen and consolidates the root, nourishes yin and blood, eliminates pathogenic factors and strengthens healthy qi simultaneously, and jointly achieves the effects of combining reinforcement and reduction, balancing cold and heat, and treating both the root cause and symptoms.

[0017] In the present invention, parts by weight refer to any unit of weight, such as grams (g), kilograms (kg), etc.

[0018] In the above composition, the weight of the medicine is calculated based on crude drugs, and the proportion is in weight parts. During production, the proportion can be increased or decreased, such as in large-scale production, the unit can be kilogram or ton, and in small-scale production, the unit can be gram or milligram. The weight can be increased or decreased, but the proportion of the weight of the crude drugs of each component remains unchanged. The above proportion is obtained through scientific screening. For special patients, such as severe or mild patients, obese or small patients, the proportion of the amount of the composition can be adjusted accordingly, and the increase or decrease is not more than 100%, and the drug efficacy remains unchanged.

[0019] Further, the dosage form of the traditional Chinese medicine composition includes ointments, powders, decoctions, tinctures, films, and oil agents.

[0020] Further, the dosage form of the traditional Chinese medicine composition is a decoction.

[0021] Further, the type of the raw medicine includes dry medicinal materials, fresh medicinal materials, crude medicinal materials, cooked medicinal materials, processed medicinal materials, whole-plant medicinal materials, effective parts of whole-plant medicinal materials, or combinations thereof.

[0022] In the present application, "raw material" is synonymous with "raw medicine", which refers to traditional Chinese medicinal materials capable of exerting active functions in the present application. The traditional Chinese medicinal materials include various forms, specifically including dry medicinal materials, fresh medicinal materials, crude medicinal materials, cooked medicinal materials, processed medicinal materials, whole-plant medicinal materials, effective parts of whole-plant medicinal materials, or combinations thereof, but are not limited thereto. In some embodiments, the raw material further comprises main active ingredients extracted from the raw material, which are all proven ingredients in the prior art.

[0023] In some embodiments, the traditional Chinese medicine composition further comprises effective components or pharmaceutically acceptable salts of effective components of coicis semen, acokanthera, siegesbeckia orientalis, melon seed, radix rehmanniae, atractylodes, radix glycyrrhizae, and amomum villosum.

[0024] In some embodiments, the pharmaceutically acceptable salt includes an acid addition salt, a base addition salt.

[0025] The term "pharmaceutically acceptable salt" as used herein includes phosphates of ammonium, metal salts, salts with amino acids, salts with amines, and salts with other bases such as piperidine or morpholine. The term "pharmaceutically acceptable salt" includes mono- or di-salts. Specific embodiments include ammonium, sodium, calcium, magnesium, cesium, lithium, potassium, barium, zinc, aluminum, lysine, arginine, histidine, methylamine, ethylamine, t-butylamine, cyclohexylamine, N-methylglucamine, ethylenediamine, glycine, procaine, benzathene, diethanolamine, triethanolamine, piperidine, and morpholine.

[0026] In some embodiments, the term "pharmaceutically acceptable salt" can also include hydrates of pharmaceutically acceptable salts of the effective ingredients of the present application. Exemplary salts include, but are not limited to, sulfate, citrate, acetate, oxalate, chloride, hydrochloride, bromide, hydrobromide, iodide, nitrate, bisulfate, acid phosphate, acid citrate, tartrate, oleate, tannate, pantothenate, bitartrate, ascorbate, gentisinate, gluconate, glucaronate, saccharate, formate, benzoate, glutamate, methanesulfonate, ethanesulfonate, benzenesulfonate, p-toluenesulfonate, camphorsulfonate, naphthalenesulfonate, propionate, succinate, fumarate, maleate, malonate, mandelate, malate, palmitate, aspartate, phthalate, and pamoate.

[0027] The second aspect of the present application provides a pharmaceutical preparation.

[0028] Further, the effective ingredient of the pharmaceutical preparation is the traditional Chinese medicine composition of the first aspect of the present application.

[0029] Further, the pharmaceutical preparation further comprises a pharmaceutically acceptable buffer, carrier and / or excipient.

[0030] Further, the buffer comprises phosphate, carbonate, acetate, citrate, glycolate, lactate, borate, tartrate or cacodylate.

[0031] Further, the buffer further comprises Trizma, Bicine, Tricine, MOPS, MOPSO, MOBS, Tris, Hepes, HEPBS, MES, ACES, ADA, AMP, AMPD, AMPSO, BES, CABS, CHES, DIPSO, EPPS, ethanolamine, glycine, HEPPSO, imidazole, imidazole lactate, PIPES, SSC, SSPE, POPSO, TAPS, TABS, TAPSO, TES.

[0032] Further, the carrier comprises an isotonic agent, antioxidant, suspending agent, dispersing agent, emulsifying agent, chelating agent, thickening agent or solubilizing agent.

[0033] Further, the excipient comprises a carbohydrate, polymer, lipid or mineral.

[0034] Further, the dosage form of the pharmaceutical preparation comprises granules, tablets, pills, capsules, injections, oral liquids, tinctures, suppositories, mixtures, powders, lotions, films or dripping pills.

[0035] Further, the pharmaceutically acceptable buffers, carriers and / or excipients are described in detail in Remington's Pharmaceutical Sciences (19th ed., 1995), and these substances are used as needed to assist in the stability of the drug or to help increase the activity of the active ingredient in the drug, and the active ingredient that can be used in this pharmaceutical composition can be in the form of the original compound itself, or optionally in the form of other pharmaceutically acceptable forms thereof, and the pharmaceutical composition thus formulated can be administered to the drug composition in any appropriate manner known to those skilled in the art as needed.

[0036] Further, the pharmaceutically acceptable buffers, carriers and / or excipients can additionally contain liquids such as water, physiological saline, glycerol and ethanol. In addition, auxiliary substances such as wetting or emulsifying agents or pH buffering substances can be present in the pharmaceutical composition. These carriers enable the pharmaceutical composition to be formulated into granules, tablets, pills, capsules, injections, oral liquids, tinctures, mixtures, powders, lotions, films, dripping pills, etc. to be ingested by the patient.

[0037] As a non-limiting example, the preparation of the dosage form of the pharmaceutical preparation is as follows:

[0038] Granules: The traditional Chinese medicine composition of the first aspect of the present application is used as the active ingredient, and pharmaceutical excipients are added, mixed, granulated, dried, and packaged to obtain a traditional Chinese medicine granule containing the traditional Chinese medicine composition of the first aspect of the present application.

[0039] Tablets: The traditional Chinese medicine composition of the first aspect of the present application is used as the active ingredient, dried, and then pharmaceutical excipients are added, mixed, granulated, dried, and compressed to obtain a traditional Chinese medicine tablet containing the traditional Chinese medicine composition of the first aspect of the present application. The tablet can be an uncoated tablet or a coated tablet such as a sugar-coated tablet, a gastric-soluble tablet, an enteric-soluble tablet, etc.

[0040] Capsules: The traditional Chinese medicine composition of the first aspect of the present application is used as the active ingredient, dried, and then pharmaceutical excipients are added, mixed, granulated, dried, and packaged to obtain a traditional Chinese medicine capsule containing the traditional Chinese medicine composition of the first aspect of the present application. The capsule can be a hard capsule formulation or a soft capsule.

[0041] Oral liquid: The traditional Chinese medicine composition of the first aspect of the present application is used as the active ingredient, water is added and stirred to mix, and then pharmaceutical excipients are added, stirred, filtered, filled and sealed, sterilized, and packaged to obtain a traditional Chinese medicine oral liquid containing the traditional Chinese medicine composition of the first aspect of the present application.

[0042] Pills: Using the traditional Chinese medicine composition described in the first aspect of the present invention as the active ingredient, after drying and pulverizing, pharmaceutical excipients are added, the mixture is placed in a sugar coating pan, a polar solvent is added while rotating the sugar coating machine, the mixture is stirred, formed into pills, dried, coated, and packaged to obtain traditional Chinese medicine pills containing the traditional Chinese medicine composition described in the first aspect of the present invention.

[0043] Droplets: Using the traditional Chinese medicine composition described in the first aspect of this invention as the active ingredient, after drying and pulverizing, pharmaceutical excipients are added, mixed evenly, heated and melted, stirred evenly, made into pills, washed, dried, and packaged to obtain traditional Chinese medicine droplets containing the traditional Chinese medicine composition described in the first aspect of this invention.

[0044] The third aspect of the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect of the present invention.

[0045] Furthermore, the method includes the following steps: weigh the raw materials according to the above-mentioned proportions of Chinese herbal medicines, soak them, decoct them in water to extract the raw materials, and filter the extract to obtain the final product.

[0046] Furthermore, the soaking time is 1 hour.

[0047] Furthermore, the water decoction extraction time is 45 minutes.

[0048] Furthermore, when decocting the herbs, add the cardamom last, and after the remaining herbs have been soaked, decoct for 40 minutes, then add the cardamom and continue decocting for another 5 minutes.

[0049] The fourth aspect of the present invention provides the use of the traditional Chinese medicine composition described in the first aspect of the present invention in the preparation of a medicament for the prevention and / or treatment of rheumatoid arthritis.

[0050] The fifth aspect of the present invention provides the use of the pharmaceutical preparation described in the second aspect of the present invention in the preparation of a medicament for the prevention and / or treatment of rheumatoid arthritis.

[0051] Advantages and beneficial effects of the present invention:

[0052] The traditional Chinese medicine composition of the present invention has a concise formula, uses few ingredients, has a specific effect, is rationally combined, has a clear curative effect, dispels wind and dampness, relieves pain, does not forget to protect the spleen and stomach, and nourishes yin fluids. It has universality and high safety, and is suitable for long-term use. Attached Figure Description

[0053] Figure 1 Figure showing the proliferation of osteoblasts in different groups as detected by the CCK8 assay;

[0054] Figure 2 Figure showing the expression of the osteoblast marker ATF4 in different groups as detected by immunofluorescence.

[0055] Figure 3Figure for immunofluorescence detection of expression of osteoblast marker BALP, ALP in different groups;

[0056] Figure 4 Figure for immunofluorescence detection of expression of osteoblast marker PINP, RUNX2 in different groups;

[0057] Figure 5 Figure for RT-qRCR detection of expression of osteoblast marker related genes in different groups; wherein, Figure 5 A is a figure for expression of ALP gene in different groups; Figure 5 B is a figure for expression of ATF4 gene in different groups; Figure 5 C is a figure for expression of BALP gene in different groups; Figure 5 D is a figure for expression of RUNX2 gene in different groups; Figure 5 E is a figure for expression of PINP gene in different groups;

[0058] Figure 6 Figure for Western blotting detection of expression of osteoblast marker related proteins in different groups and related statistical result figure; wherein, Figure 6 A is a figure for Western blotting detection of expression of ALP, ATF4, BALP and RUNX2 proteins in different groups; Figure 6 B- Figure 6 E are respectively statistical result figures of expression of ALP, ATF4, BALP and RUNX2 proteins in different groups. DETAILED DESCRIPTION

[0059] In order to make the purpose, technical scheme and beneficial effects of the embodiments of the present application more clear, the technical scheme in the embodiments of the present application will be clearly and completely described below. The specific conditions not mentioned in the embodiments are carried out according to the conventional conditions or the conditions suggested by the manufacturer. The reagents or instruments not mentioned by the manufacturer are all conventional products that can be purchased in the market.

[0060] Preparation of the Chinese medicine composition in Example 1

[0061] The Chinese medicine composition for treating rheumatoid arthritis comprises the following raw materials by weight: Coix seed 60g, Croton 60g, Herba siegesbeckiae 30g, Muskmelon seed 30g, Radix rehmanniae 30g, Atractylodes 30g, Raw licorice 10g, Amomum villosum 10g.

[0062] The preparation method of the Chinese medicine composition for treating rheumatoid arthritis comprises the following steps:

[0063] 1) Pretreatment: wash and cut each raw material for standby;

[0064] 2) Soaking: add 10 times cold water and soak for 60 minutes;

[0065] 3) Decoction: add amomum after soaking the rest of the medicine, then boil with a strong fire and change to a weak fire to decoct for 40 minutes, add amomum and continue to decoct for 5 minutes, filter the juice through three layers of gauze to obtain the filtrate.

[0066] Application of the traditional Chinese medicine composition in example 2 in treating rheumatoid arthritis

[0067] 1. Experimental materials

[0068] Mouse bone marrow mononuclear cells; mouse osteoblast (OB) precursor cell line MC3T3-E1 cells (Guangzhou Huiyuan Yuan Pharmaceutical Effectiveness Company).

[0069] 2. Experimental method

[0070] (1) Cell culture: mouse OB precursor cell line MC3T3-E1 cells were cultured in α-MEN medium containing 10% FBS, 25 cm 2 cell culture bottles were selected, gently shaken uniformly, and then placed in a constant temperature incubator for culture, maintained at 37℃, 5% CO2 and 95% saturated humidity, and the medium was changed every 2-3 days.

[0071] (2) Osteoclast induction system: mouse bone marrow mononuclear cells were cultured for 3 days, the supernatant was discarded, and α-MEN complete culture medium was used for continuous induction for 14 days, and the culture medium was changed every 2-3 days.

[0072] (3) Osteogenic induction (OC) system: MC3T3-E1 cells were induced with osteogenic induction medium for 14 days, and the medium was changed every 2-3 days.

[0073] (4) Construction of co-culture system: MC3T3-E1 cells were inoculated in the lower chamber of Transwell at a cell density of 5×10 5 cells per well, and mouse bone marrow mononuclear cells were inoculated in the upper chamber of Transwell at a cell density of 5×10 5 cells per well, and different culture media were used for continuous induction for 14 days. After 14 days of induction, the upper and lower chambers of Transwell were exchanged, and co-culture was performed for 48 hours.

[0074] (5) Grouping: MC3T3 group (control group), OB+OC group (model group), OB+OC+traditional Chinese medicine group (2 g / ml), OB+OC+MTX (1 mg / ml) group.

[0075] (6) CCK8 method to detect the proliferation of osteoblasts: inverted microscope to observe cell morphology and growth, select the growth state of good logarithmic growth period of cells, trypsin digestion for single cell suspension, cell counting plate; 100 μL of cell suspension was inoculated in each well of 96-well plate, 24 hours later, add traditional Chinese medicine formula (2 g / ml), MTX (1 mg / ml), the culture plate was placed in the incubator, incubated for 48 hours; 10 μL of CCK8 solution was added to each well, and then the culture plate was placed in the incubator, incubated for 2 hours; the absorbance at 450 nm was measured by enzyme marker instrument, repeated 3 times.

[0076] (7) Using immunofluorescence detection, Western blotting technology to detect the effect of traditional Chinese medicine formula on the expression of related proteins in OB and OC in the co-culture system, RT-qRCR technology to detect the effect of traditional Chinese medicine formula on the expression of related genes in OB and OC in the co-culture system.

[0077] 3、Experimental results

[0078] (1) The proliferation of osteoblasts: as shown in Figure 1 , the CCK8 detection results showed that in the osteoblasts of the co-culture model, compared with the MC3T3 control group, the proliferation ability of the OB+OC model group was weakened, and the difference was statistically significant (P<0.001). Compared with the OB+OC group, the proliferation ability of the traditional Chinese medicine treatment group and the MTX treatment group (MTX is methotrexate, which is a basic treatment drug for rheumatoid arthritis) was enhanced, and the difference was statistically significant (P<0.001), and the proliferation of osteoblasts in the traditional Chinese medicine treatment group was better than that in the MTX treatment group (P<0.001). Among them, *** represents p<0.001 compared with the control group, ### represents p<0.001 compared with the model group, and &&& represents p<0.001 compared with the MTX treatment group.

[0079] (2) Immunofluorescence detection results: in the co-culture system, ATF4, BALP, ALP, PINP proteins were expressed in the cytoplasm and nucleus, and RUNX2 protein was mainly expressed in the nucleus. Compared with the MC3T3 control group of osteoblasts, the fluorescence intensity of the OB+OC group of osteoblast markers ATF4 Figure 2 , BALP Figure 3 , ALP Figure 3 , PINP Figure 4 , RUNX2 Figure 4 was weakened; compared with the OB+OC model group, the corresponding fluorescence intensity of the OB+OC+traditional Chinese medicine group and the OB+OC+MTX group was enhanced, as shown in the accompanying Figures 2-4 , and the expression content of ATF4 in the OB+OC+traditional Chinese medicine group was more obvious than that in the OB+OC+MTX group.

[0080] (3) RT-qPCR results: In the co-culture system, compared with osteoblasts composed of MC3T3, osteoblasts composed of OB+OC had significantly higher ALP levels ( Figure 5 A), ATF4 ( Figure 5 B), RUNX2 Figure 5 D), PINP Figure 5 E) mRNA levels were downregulated, with statistically significant differences in ALP (P<0.001) and RUNX2 (P<0.05) mRNA levels. Compared with osteoblasts composed of MC3TC, osteoblasts composed of OB+OC showed elevated BALP mRNA levels, although the difference was not statistically significant. Compared with osteoblasts composed of OB+OC, osteoblasts composed of OB+OC+TCM showed elevated ALP mRNA (P<0.001) and ATF4 mRNA (P<0.05) levels, which were higher than those in the OB+OC+MTX group. Compared with osteoblasts composed of OB+OC, osteoblasts composed of OB+OC+TCM showed elevated BALP (P<0.001) and ATF4 mRNA levels. Figure 5 C) The levels of mRNA (P<0.05), RUNX2 mRNA (P<0.01), and PINP mRNA (P<0.01) were elevated, and the differences were statistically significant.

[0081] (4) WB results: In the co-culture system, compared with the MC3T3 control osteoblasts, the protein levels of ALP, ATF4, BALP, and RUNX2 in the OB+OC osteoblasts decreased, consistent with the RT-qPCR results. Figure 6 Compared with osteoblasts composed of OB+OC, the protein levels of ALP (P<0.001), ATF4 (P<0.001), BALP (P<0.01), and RUNX2 (P<0.001) in osteoblasts after traditional Chinese medicine intervention were significantly increased, and the differences were statistically significant. The levels of the four proteins in the OB+OC+MTX group also increased. Figure 6 Compared with the OB+OC+MTX group, the levels of ALP, ATF4, and RUNX2 in the traditional Chinese medicine group were significantly elevated, with RUNX2 protein showing a statistically significant increase (P<0.01). *** represents p<0.001 compared to the control group, ** represents p<0.01, * represents p<0.05; ### represents p<0.001 compared to the model group, ## represents p<0.01, # represents p<0.05; && represents p<0.01 compared to the MTX treatment group.

[0082] In summary, the above results show that the pharmaceutical composition of the present application can promote the proliferation of osteoblasts in the osteoblast-osteoclast co-culture system, increase the mRNA level of bone formation markers, increase the expression of corresponding proteins, especially the protein content of ATF4 (which acts as a transcriptional regulator of OB genes and plays an important role in OB proliferation and differentiation), and thus plays a role in treating rheumatoid arthritis.

[0083] The above description of the embodiments is only for understanding the method of the present application and its core idea. It should be noted that, for those skilled in the art, without departing from the principles of the present application, the present application can be modified and changed in several ways, and these modifications and changes will also fall within the scope of protection of the claims of the present application.

Claims

1. A traditional Chinese medicine composition for treating rheumatoid arthritis, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: 60 parts of coix seed, 60 parts of hydroxycitronellal, 30 parts of siegesbeckia, 30 parts of melon seed, 30 parts of rehmannia, 30 parts of atractylodes, 10 parts of raw licorice, and 10 parts of amomum villosum.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition includes ointment, powder, decoction, tincture, and oil.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The dosage form of the traditional Chinese medicine composition is decoction.

4. A pharmaceutical preparation, characterized by, The effective component of the pharmaceutical preparation is the traditional Chinese medicine composition according to any one of claims 1-3.

5. The pharmaceutical preparation according to claim 4, characterized in that, The pharmaceutical preparation further comprises a pharmaceutically acceptable buffer.

6. The pharmaceutical preparation according to claim 4, characterized in that, The pharmaceutical preparation further comprises a pharmaceutically acceptable carrier and / or excipient.

7. The pharmaceutical preparation according to claim 5, characterized in that, The buffer comprises phosphate, carbonate, acetate, citrate, or borate.

8. The pharmaceutical preparation according to claim 6, characterized in that, The carrier comprises isotonic agent, antioxidant, suspending agent, dispersing agent, emulsifying agent, chelating agent, thickening agent, or solubilizing agent.

9. The pharmaceutical preparation according to claim 6, characterized in that, The excipient comprises carbohydrate, polymer, lipid, or mineral.

10. The pharmaceutical preparation according to any one of claims 4 to 9, characterized in that, The dosage form of the pharmaceutical preparation includes granules, tablets, pills, capsules, oral liquid, tincture, mixture, powder, lotion, or dripping pills.

11. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The method comprises the following steps: weighing the raw medicinal materials according to the above-mentioned raw medicinal material ratio of the traditional Chinese medicine composition, soaking, and then water decocting and extracting, filtering the extract, and obtaining the traditional Chinese medicine composition.

12. The method of claim 11, wherein, The soaking time is 1 h.

13. The method of claim 11, wherein, The water decocting and extracting time is 45 min.

14. The method of claim 11, wherein, The amomum villosum is added after the soaking of the remaining medicinal materials, and the decocting time is 40 min, and the amomum villosum is added and decocted for 5 min.

15. Use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicine for treating rheumatoid arthritis.

16. Use of the pharmaceutical preparation according to any one of claims 4-10 in the preparation of a medicine for treating rheumatoid arthritis.

Images