A Traditional Chinese Medicine Composition for Treating Rheumatoid Arthritis and Its Preparation Method

Abstract

The present invention belongs to the technical field of traditional Chinese medicine compositions and traditional Chinese medicine preparation, and particularly relates to a traditional Chinese medicine combination for treating rheumatic bone diseases and a preparation method thereof. The pharmaceutical composition (Jinyi Juanbi Dan) for treating rheumatic bone diseases provided by the present invention comprises black ants, golden bupleurum root, deer horn glue, tortoise shell glue, clematis root, drynaria rhizome, epimedium, cibot rhizome, taxillus twig, white peony root, ginseng, stir-fried radish seed, achyranthes root, scorpion, vinegar processed Corydalis yanhusuo, salvia miltiorrhiza, amomum villosum, wine processed phellodendron bark, roasted licorice root, tribulus terrestris, eggshell membrane, zedoary, notoginseng powder, processed fleeceflower root, and notopterygium root. The above-mentioned medicinal materials are formulated according to the principle of monarch, minister, assistant, and envoy; the pharmaceutical composition can regulate the spleen and stomach, dredge the governor and conception vessels, balance yin and yang, strengthen the muscles and bones, can not only carry out immune regulation, but also improve joint function, block the progression of the disease, and has small side effects. Compared with decoctions, it is convenient to take medicine and the compliance is increased. The total effective rate of treatment has been increased from 67.6% to 95.8% compared with the conventional control group.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions and traditional Chinese medicine preparation, and particularly relates to a traditional Chinese medicine combination for treating rheumatic bone diseases and a preparation method thereof. Background Art

[0002] Rheumatic bone disease is a disease caused by poor blood circulation due to immune dysfunction and chronic inflammation, resulting in poor nutrition supply to muscles, ligaments, bursae, and fascia, and damage to the corresponding bone and joint tissues.

[0003] Currently, rheumatic bone diseases are mainly treated with drugs, such as western medicine glucocorticoids and non-steroidal anti-inflammatory drugs; however, the use of western medicine glucocorticoids and non-steroidal anti-inflammatory drugs will produce serious adverse reactions, severely damaging the gastrointestinal tract, liver, and kidneys. In particular, although glucocorticoids have an immunosuppressive effect, they severely damage human bone mass; non-steroidal anti-inflammatory drugs have a certain anti-inflammatory and analgesic effect, but they cannot control the progression of the disease, cannot prevent bone and joint damage, and have relatively severe gastrointestinal reactions; while traditional Chinese medicine decoctions are inconvenient to take orally, patients are reluctant to accept them, and the compliance is poor. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a pharmaceutical composition for treating rheumatic bone diseases. Based on the theory of regulating the spleen and transporting qi, and regulating the governor vessel and conception vessel, corresponding prescriptions are formulated, which can regulate the five zang-organs, balance yin and yang, strengthen the muscles and bones, not only can regulate immunity, but also can improve or restore joint function, block the progression of the disease, and have small side effects, small dosage volume, convenient administration, and increased patient compliance.

[0005] In order to achieve the above purpose, the present invention provides the following technical solutions:

[0006] The present invention provides a pharmaceutical composition for treating rheumatic bone diseases, comprising the following components: 100 - 300 parts of black ants, 290 - 600 parts of golden bupleurum root, 12 - 60 parts of deer horn glue, 12 - 60 parts of tortoise shell glue, 30 - 100 parts of clematis root, 30 - 60 parts of drynaria rhizome, 30 - 60 parts of epimedium herb, 30 - 100 parts of cibot rhizome, 30 - 100 parts of taxillus twig, 12 - 60 parts of white peony root, 9 - 30 parts of ginseng, 9 - 30 parts of stir-fried radish seed, 9 - 60 parts of achyranthes root, 6 - 18 parts of scorpion, 12 - 60 parts of vinegar-processed Corydalis tuber, 12 - 60 parts of salvia root, 6 - 12 parts of amomum fruit, 6 - 18 parts of wine-processed phellodendron bark, 6 - 18 parts of roasted licorice root, 12 - 60 parts of puncturevine caltrop fruit, 9 - 30 parts of chicken embryo membrane, 9 - 30 parts of zedoary tuber, 9 - 30 parts of notoginseng powder, 30 - 60 parts of processed fleeceflower root, and 3 - 10 parts of incised notopterygium root.

[0007] The present invention also provides a preparation method of the pharmaceutical composition described in the above scheme, comprising the following steps:

[0008] Mix scorpio, deer horn glue, tortoise shell glue, clematis root, drynaria rhizome, epimedium herb, cibot rhizome, taxillus twig, white peony root, ginseng, stir-fried radish seed, achyranthes root, rhizoma corydalis, salvia root, amomum fruit, wine-processed phellodendron bark, roasted licorice root, puncturevine caltrop fruit, endothelium corneum gigeriae galli, zedoary, notoginseng, processed fleeceflower root, incised notopterygium root and black ant, grind them into powder to obtain medicinal powder;

[0009] Decoct sophora flavescens root, concentrate the obtained decoction to obtain clear extract;

[0010] Mix the medicinal powder and clear extract, make pills and dry them to obtain the pharmaceutical composition.

[0011] Preferably, after grinding into powder, the medicinal powder is further sieved through a 80-mesh sieve.

[0012] Preferably, the decoction includes decocting with 1500 mL of water.

[0013] Preferably, the mass ratio of the medicinal powder to the clear extract is 1:(0.35 - 0.5).

[0014] The present invention also provides the application of the pharmaceutical composition described in the above solution in the preparation of a medicament for treating rheumatic bone diseases.

[0015] The present invention also provides a pharmaceutical combination for treating rheumatic bone diseases, which includes the pharmaceutical composition in the following mass parts of A) or B), and the pharmaceutical composition described in the above solution;

[0016] A): 30 parts of angelica pubescens, 60 parts of wine-processed phellodendron bark, 15 parts of white mustard seed, 15 parts of arisaema cum bile and 9 parts of asarum;

[0017] B): 10 parts of frankincense, 10 parts of myrrh, 30 parts of vinegar-processed winged euonymus, 10 parts of processed kusnezoff monkshood root, 15 parts of arisaema cum bile and 15 parts of mint.

[0018] Preferably, the preparation method of the pharmaceutical composition of A) includes the following steps:

[0019] Mix white mustard seed and wine-processed phellodendron bark with angelica pubescens, arisaema cum bile and asarum, grind them into powder to obtain medicinal powder;

[0020] Mix the medicinal powder and water in a mass ratio of 1:(0.35 - 0.5), make pills and dry them to obtain the pharmaceutical composition of A).

[0021] Preferably, the preparation method of the pharmaceutical composition of B) includes the following steps:

[0022] Mix vinegar-processed winged euonymus with frankincense, myrrh, arisaema cum bile and processed kusnezoff monkshood root, grind them into powder to obtain medicinal powder;

[0023] Mix the medicinal powder with ginger juice at a mass ratio of 1:(0.35 - 0.5), make pills, and dry to obtain the pharmaceutical composition of B).

[0024] Beneficial effects:

[0025] The present invention provides a pharmaceutical composition Jin Yi Juan Bi Dan for treating rheumatic bone diseases, which includes the following components in parts by mass: 100 - 300 parts of black ants, 290 - 600 parts of golden bupleurum root, 12 - 60 parts of deer horn glue, 12 - 60 parts of tortoise shell glue, 30 - 100 parts of clematis root, 30 - 60 parts of drynaria rhizome, 30 - 60 parts of epimedium herb, 30 - 100 parts of cibot rhizome, 30 - 100 parts of taxillus twig, 12 - 60 parts of white peony root, 9 - 30 parts of ginseng, 9 - 30 parts of stir-fried radish seed, 9 - 60 parts of achyranthes root, 6 - 18 parts of scorpio, 12 - 60 parts of vinegar-processed Corydalis tuber, 12 - 60 parts of salvia root, 6 - 12 parts of amomum fruit, 6 - 18 parts of wine-processed phellodendron bark, 6 - 18 parts of roasted licorice root, 12 - 60 parts of puncturevine caltrop fruit, 9 - 30 parts of inner shell of chicken egg, 9 - 30 parts of zedoary, 9 - 30 parts of notoginseng powder, 30 - 60 parts of processed fleeceflower root, and 3 - 10 parts of incised notopterygium rhizome;

[0026] The spleen and stomach are the central axes of the five zang-organs. When the middle jiao functions smoothly, the five zang-organs are at peace. When the meridians are smooth and qi and blood are harmonious, all diseases will not occur. The spleen is in charge of transportation and transformation. When the spleen is healthy, damp pathogens will not be generated. The kidney is the innate foundation, nourishing primordial yin and primordial yang, and is in charge of bones and marrow production. The liver governs the tendons. The liver and kidney share the same origin. When the liver and kidney functions are normal, the essence and blood of the liver and kidney are sufficient. The Governor Vessel runs along the midline of the back of the human body, governing the yang qi of the human body. The Conception Vessel runs along the midline of the abdomen of the human body, being the sea of yin meridians, and governing the yin qi of the human body in general. When the Governing Vessel and the Conception Vessel are in smooth communication and the yin and yang are in harmony and balance, the bone marrow, tendons, and bones are nourished, the bones are straight, the tendons are soft, and the joints are soft and powerful. Therefore, regulating the middle energizer and activating the spleen, and regulating the Governing Vessel and the Conception Vessel are the keys to treating rheumatic arthralgia. The treatment of rheumatic bone diseases (such as rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, etc.) is based on the theory of regulating the middle energizer and activating the spleen, and regulating the Governing Vessel and the Conception Vessel as the formula principle, to regulate the five zang-organs and the yin and yang of the Governing Vessel and the Conception Vessel, smooth the meridians, and regulate the ascending and descending, entering and exiting of qi movement, so as to restore the balance of qi, blood, yin, and yang of the human body's zang-fu organs, and stubborn arthralgia can be cured. Therefore, in the formula, Pueraria lobata var. thomsonii is selected to strengthen the spleen and replenish qi, and firmly guard the middle jiao. Polyrhachis vicina Roger is used to tonify the liver and kidney, dispel wind and dampness, relieve arthralgia and dredge collaterals. One of the two herbs guards the middle and harmonizes the middle, and the other activates the middle. Considering both the acquired and the congenital, they are the sovereign herbs in the formula together. Moreover, Pueraria lobata var. thomsonii has a certain immunosuppressive effect and can regulate calcium and phosphorus metabolism. Polyrhachis vicina Roger has a certain dual-directional immunomodulatory effect. In addition, Colla Cornus Cervi and Colla Plastri Testudinis tonify the liver and kidney, replenish essence and generate marrow. Colla Cornus Cervi and Colla Plastri Testudinis are glue masses decocted from concentrated antlers and turtle shells respectively. Among them, the deer has the most complete yang qi between heaven and earth and has a long lifespan, and is good at dredging the Governing Vessel; the turtle has the most complete yin qi and lies dormant with a long lifespan, and is good at dredging the Conception Vessel. The combination of the two herbs and adjusting the proportion of the two herbs can regulate the Governing Vessel and the Conception Vessel, and harmonize yin and yang to regulate the ascending and descending, opening and closing; Clematis chinensis Osbeck can pass through the twelve regular meridians, dispel wind and dampness, relieve arthralgia and dredge collaterals, and communicate the interior and exterior, and when combined with the turtle and deer, it can harmonize yin and yang and dredge the meridians, and is also the sovereign herb in the formula; Polyrhachis vicina Roger and Pueraria lobata var. thomsonii are a pair of herbs; Colla Cornus Cervi, Colla Plastri Testudinis, and Clematis chinensis Osbeck are a corner of herbs; the two groups of herbs reflect the compatibility characteristics of yin and yang, ascending and descending, movement and stillness, opening and closing. Additionally, Radix Polygoni Multiflori Preparata, Epimedium brevicornum Maxim., Drynaria fortunei (Kunze) J. Sm., Taxillus chinensis (DC.) Danser, Paeonia lactiflora Pall., Cibotium barometz (L.) J. Sm., and Achyranthes bidentata Blume are selected to tonify the liver and kidney, benefit the marrow and strengthen the bones, nourish the blood and nourish the tendons; Ginseng and Amomum villosum Lour. replenish qi and tonify the yuan, regulate qi and harmonize the middle; Corydalis yanhusuo W. T. Wang, Salvia miltiorrhiza Bunge, and Panax notoginseng activate blood circulation to dissipate stasis, dredge collaterals and relieve pain as ministerial herbs; Scorpio searches for wind and dredges collaterals; Rhizoma Zedoariae and Membrana Funiculi Vesicalis activate blood circulation and tonify bones, and can also protect the stomach and the middle energizer; Tribulus terrestris L. soothes the liver and extinguishes wind; Phellodendron chinense Schneid. clears heat and strengthens yin; Semen Raphani promotes digestion and resolves phlegm as adjuvant herbs in the formula; Notopterygium incisum Ting ex H. T. Chang disperses wind and dampness, opens the profound and dredges the Governing Vessel, and Radix Glycyrrhizae Preparata harmonizes all the herbs as the guiding herb in the formula; The above-mentioned herbs acting together can achieve the effects of regulating the middle energizer and activating the spleen, regulating the Governing Vessel and the Conception Vessel, strengthening the bones and muscles, and immunomodulation.

[0027] In addition, the pharmaceutical composition for treating rheumatic bone diseases provided by the present invention can regulate the middle energizer and activate the spleen, regulate the Governing Vessel and the Conception Vessel, balance yin and yang, strengthen the bones and muscles, can not only carry out immunomodulation, but also improve joint function, block the progression of the disease, and has small side effects, increasing the compliance of patients.

[0028] Furthermore, the present invention also provides a preparation method of the pharmaceutical composition for treating rheumatic bone diseases, with simple process and low cost.

[0029] Moreover, the present invention also provides a drug combination for treating rheumatic bone diseases, including the drug composition described in the above solution and two other drug formulations, which can treat rheumatic bone diseases with concurrent damp-heat symptoms or concurrent cold-damp obstruction symptoms. According to the operation of the middle jiao in the patient's condition, it is combined with the main formula to assist the main formula to correct the deficiency of the operation of the middle jiao. Detailed implementation mode

[0030] The present invention provides a drug composition for treating rheumatic bone diseases, which, by mass parts, includes the following components: 100 - 300 parts of black ants, 290 - 600 parts of golden bupleurum root, 12 - 60 parts of deer horn glue, 12 - 60 parts of tortoise shell glue, 30 - 100 parts of clematis root, 30 - 60 parts of drynaria rhizome, 30 - 60 parts of epimedium herb, 30 - 100 parts of cibot rhizome, 30 - 100 parts of taxillus twig, 12 - 60 parts of white peony root, 9 - 30 parts of ginseng, 9 - 30 parts of stir-fried radish seed, 9 - 60 parts of achyranthes root, 6 - 18 parts of scorpion, 12 - 60 parts of vinegar-processed Corydalis tuber, 12 - 60 parts of salvia root, 6 - 12 parts of amomum fruit, 6 - 18 parts of wine-processed phellodendron bark, 6 - 18 parts of roasted licorice root, 12 - 60 parts of puncturevine caltrop fruit, 9 - 30 parts of inner shell of chicken egg, 9 - 30 parts of zedoary, 9 - 30 parts of notoginseng powder, 30 - 60 parts of processed fleece-flower root, and 3 - 10 parts of incised notopterygium root.

[0031] By mass parts, the drug composition provided by the present invention includes 100 - 300 parts of black ants, preferably 100 - 150 parts, and more preferably 150 parts.

[0032] Based on the mass parts of the black ants, the drug composition provided by the present invention includes 290 - 600 parts of golden bupleurum root, further preferably 350 - 600 parts, and more preferably 600 parts.

[0033] Based on the mass parts of the black ants, the drug composition provided by the present invention includes 12 - 60 parts of deer horn glue. For the deficiency of the operation of the middle jiao in yang deficiency syndrome, it is preferably 36 - 60 parts, and more preferably 60 parts; for yin deficiency, it is preferably 12 - 36 parts, and more preferably 30 parts; for those with no obvious symptoms of cold and heat, or those with concurrent damp-heat obstruction or concurrent cold-damp obstruction, it is preferably 36 parts to regulate the governor vessel and conception vessel to harmonize yin and yang.

[0034] Based on the mass parts of the black ants, the drug composition provided by the present invention includes 12 - 60 parts of tortoise shell glue. For the excessive operation of the middle jiao in yin deficiency syndrome, it is preferably 12 - 60 parts, further preferably 36 - 60 parts, and more preferably 60 parts; for yang deficiency syndrome, it is preferably 12 - 60 parts, further preferably 30 - 60 parts, and more preferably 30 parts; for those with no obvious symptoms of cold and heat, or those with concurrent damp-heat obstruction or concurrent cold-damp obstruction, it is preferably 36 parts to regulate the governor vessel and conception vessel to harmonize yin and yang.

[0035] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 30 - 100 parts of Clematis chinensis Osbeck, more preferably 40 - 50 parts, and even more preferably 45 parts.

[0036] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 30 - 60 parts of Drynaria fortunei (Kunze) J. Sm., preferably 30 - 36 parts, and even more preferably 36 parts.

[0037] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 30 - 60 parts of Epimedium brevicornum Maxim., preferably 30 - 55 parts, 45 parts for the syndrome of yang deficiency and cold deficiency, 30 parts for the syndrome of yin deficiency and heat deficiency, and 36 parts for those with no obvious symptoms of cold or heat, or those with damp - heat obstruction or cold - damp obstruction.

[0038] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 30 - 100 parts of Cibotium barometz (L.) J. Sm., preferably 30 - 75 parts, 60 parts for yang deficiency and cold arthralgia, 55 parts for yin deficiency and heat arthralgia, and 45 parts for those with no obvious symptoms of cold or heat, or those with damp - heat obstruction or cold - damp obstruction.

[0039] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 30 - 100 parts of Taxillus chinensis (DC.) Danser, preferably 45 - 55 parts, and even more preferably 45 parts.

[0040] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 12 - 60 parts of Paeonia lactiflora Pall., preferably 36 - 45 parts, and even more preferably 36 parts.

[0041] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 9 - 30 parts of Panax ginseng C. A. Mey., preferably 12 - 25 parts, more preferably 16 - 24 parts, and even more preferably 18 parts.

[0042] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 9 - 30 parts of Semen Raphani preparatum, preferably 10 - 30 parts, more preferably 20 - 28 parts, and even more preferably 24 parts.

[0043] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 9 - 60 parts of Achyranthes bidentata Blume, preferably 15 - 55 parts, more preferably 20 - 36 parts, and even more preferably 36 parts.

[0044] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 6 - 18 parts of Scorpio, preferably 6 - 12 parts, more preferably 9 - 11 parts, and even more preferably 9 parts.

[0045] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 12 - 60 parts of Corydalis yanhusuo, preferably 20 - 55 parts, more preferably 30 - 40 parts, and even more preferably 36 parts.

[0046] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 12 - 60 parts of Salvia miltiorrhiza, preferably 15 - 55 parts, more preferably 25 - 40 parts, and even more preferably 36 parts.

[0047] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 6 - 12 parts of Amomum villosum, preferably 6 - 11 parts, more preferably 9 - 10 parts, and even more preferably 10 parts.

[0048] Based on the parts by mass of the black ants, for the yin deficiency with heat syndrome, the pharmaceutical composition provided by the present invention comprises 6 - 18 parts of Phellodendron chinense var. glabriusculum processed with wine, preferably 12 - 18 parts, more preferably 15 - 18 parts, and even more preferably 18 parts; for the yang deficiency with cold syndrome, it is preferably 6 parts; for those with no obvious symptoms of cold or heat, or those with concurrent damp - heat arthralgia obstruction, or those with concurrent cold - damp arthralgia obstruction, it is preferably 9 parts.

[0049] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 6 - 18 parts of Glycyrrhiza uralensis Fisch. processed with honey, preferably 15 - 18 parts, more preferably 9 - 12 parts, and even more preferably 9 parts.

[0050] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 12 - 60 parts of Tribulus terrestris L., preferably 45 - 55 parts, more preferably 36 - 45 parts, and even more preferably 36 parts.

[0051] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 9 - 30 parts of Endothelium Corneum Galli Domestici, preferably 10 - 25 parts, more preferably 15 - 25 parts, and even more preferably 18 parts.

[0052] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 9 - 30 parts of Curcuma zedoaria (Christm.) Rosc., preferably 10 - 25 parts, more preferably 15 - 25 parts, and even more preferably 18 parts.

[0053] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 9 - 30 parts of Panax notoginseng powder, preferably 15 - 25 parts, and even more preferably 18 parts.

[0054] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 30 - 60 parts of Polygonum multiflorum Thunb. processed, preferably 36 - 55 parts, and even more preferably 36 parts.

[0055] Based on the parts by mass of the black ants, the pharmaceutical composition provided by the present invention comprises 3 - 10 parts of Notopterygium incisum Ting ex H. T. Chang, preferably 5 - 9 parts, more preferably 6 - 9 parts, and even more preferably 9 parts.

[0056] In the present invention, the black ants have the effects of nourishing the liver and kidney, dispelling wind and dampness, and relieving numbness and unblocking the meridians. The golden broom root has the effects of strengthening the spleen and replenishing qi, and defending the middle jiao. The black ants and golden broom root can protect the middle and harmonize the middle, and can move the middle; the deer antler glue and tortoise shell glue are respectively made of glue blocks made by decocting deer antlers and tortoise shells, wherein the deer obtains the most complete yang energy of heaven and earth and lives a long life, and is good at opening the governor vessel, and the tortoise obtains the most complete yin energy and rests a long life, and is good at opening the conception vessel. The combination of the two medicines and adjusting the ratio of the two medicines can regulate the governor vessel and regulate yin and yang, so as to regulate the rise and fall, opening and closing, and has the effects of nourishing the liver and kidney, replenishing essence and producing marrow; the clematis can pass through the twelve meridians, has the effects of dispelling wind and dampness, relieving numbness and unblocking the meridians, and promoting the flow of internal and external, and can be used together with the tortoise and deer glue to harmonize yin and yang and promote the flow of meridians; the above-mentioned drugs are used together as the monarch drugs in the pharmaceutical composition.

[0057] In the present invention, the processed Polygonum multiflorum, epimedium, drynaria, mistletoe, white peony root, Cibotium barometz, and Rhizoma Cynoglossi have the effects of nourishing the liver and kidney, strengthening the marrow and bones, nourishing blood and strengthening the tendons; the ginseng and Amomum villosum have the effects of invigorating qi and replenishing the essence, regulating qi and harmonizing the middle; the vinegar-containing Corydalis, Salvia miltiorrhiza, and Panax notoginseng have the effects of promoting blood circulation, removing blood stasis, unblocking meridians and relieving pain; the above drugs are collectively used as the adjuvant drugs in the pharmaceutical composition.

[0058] In the present invention, the whole scorpion has the effect of clearing wind and unblocking meridians; the Curcuma zedoaria and Phoenix odorata have the effects of promoting blood circulation, strengthening bones, protecting the stomach and the middle; the Tribulus terrestris has the effect of soothing the liver and extinguishing wind; the Phellodendron chinense has the effect of clearing heat and strengthening yin; the radish seeds have the effect of digesting food and resolving phlegm; the above drugs are used together as adjuvants in the pharmaceutical composition.

[0059] In the present invention, Notopterygium wilfordii dispels wind and dampness, opens the mind and clears the orifices, and the roasted licorice has the function of harmonizing the above-mentioned medicinal materials, and they are the guiding drugs in the pharmaceutical composition.

[0060] The components of the pharmaceutical composition provided by the present invention are matched according to the principle of monarch, minister, assistant and guiding, and have the effects of harmonizing the spleen, regulating the Ren and Du meridians, strengthening the muscles and bones, and regulating immunity, which embodies the principle of combining traditional Chinese medicine theory with modern Chinese medicine pharmacology.

[0061] The present invention also provides a method for preparing the pharmaceutical composition described in the above scheme, comprising the following steps:

[0062] Mix scorpion, antler glue, tortoise shell glue, clematis root, bone drynaria, epimedium, dog spine, mistletoe, white peony root, ginseng, stir-fried radish seed, Chinese rhizome, vinegar corydalis, salvia miltiorrhiza, amomum, wine phellodendron, roasted liquorice, tribulus, phoenix hairy clothes, zedoaria, panax notoginseng, processed polygonum multiflorum, notopterygium and black ant, grind into powder, and obtain medicinal powder;

[0063] The root of goldenrod is decocted, and the decoction obtained is concentrated to obtain a clear paste;

[0064] Mix the medicinal powder and the clear extract, make pills, and dry to obtain the pharmaceutical composition.

[0065] In the present invention, scorpion, deer horn glue, tortoise shell glue, clematis root, drynaria rhizome, epimedium herb, cibot rhizome, taxillus twig, white peony root, ginseng, stir-fried radish seed, achyranthes root, vinegar-processed Corydalis tuber, salvia root, amomum fruit, wine-processed phellodendron bark, roasted licorice root, puncturevine caltrop fruit, embryo of chicken egg membrane, zedoary, notoginseng, processed polygonum multiflorum, notopterygium root and black ant are mixed and ground into powder to obtain the medicinal powder. The black ant in the present invention is preferably the dried black ant, and the drying temperature is preferably 80-95°C, more preferably 80°C. The present invention has no special limitation on the grinding method, and the conventional grinding method in the art can be used. After grinding into powder, the present invention preferably further includes passing the medicinal powder through an 80-mesh sieve, that is, the particle size of the medicinal powder is preferably less than or equal to 80 mesh, and the 80-mesh medicinal powder has the effect of enhancing gastrointestinal absorption.

[0066] Meanwhile, in the present invention, the root of Lespedeza cuneata is decocted to obtain the decoction. The present invention preferably performs decoction twice, and preferably adds 1500 mL of water for each decoction, and combines the decoction obtained from the two decoctions to obtain the decoction.

[0067] After obtaining the decoction, the present invention concentrates the decoction to obtain the clear extract.

[0068] After obtaining the medicinal powder and the clear extract, the present invention preferably mixes the medicinal powder and the clear extract, makes pills, and dries to obtain the pharmaceutical composition. The medicinal powder and the clear extract in the present invention are preferably mixed in a mass ratio of 1:(0.35-0.5), more preferably 1:0.4. The pill making in the present invention preferably adopts the pan pelletization method. The drying temperature in the present invention is preferably 80°C-100°C, more preferably 95°C. The present invention has no special limitation on the drying equipment, and the conventional drying equipment in the art can be used.

[0069] The preparation method of the above-mentioned pharmaceutical composition provided by the present invention has simple process, low cost, can be produced on a large scale, and the prepared pharmaceutical composition can harmonize the middle energizer and strengthen the spleen, dredge the governor and conception vessels, balance yin and yang, strengthen the muscles and bones, can not only perform immune regulation, but also improve joint function, block the progression of the disease, and has small side effects.

[0070] Based on the above advantages, the present invention also provides the application of the pharmaceutical composition described in the above solution in the preparation of a drug for treating rheumatic bone disease.

[0071] The present invention also provides a drug combination for treating rheumatic bone disease, which includes the pharmaceutical composition in the following mass parts of A) or B), and the pharmaceutical composition described in the above solution;

[0072] A): 30 parts of angelica pubescens, 60 parts of wine-processed phellodendron bark, 15 parts of white mustard seed, 15 parts of arisaema cum bile and 9 parts of asarum;

[0073] B): 10 parts of frankincense, 10 parts of myrrh, 30 parts of vinegar-processed winged euonymus, 10 parts of processed kusnezoff monkshood, 15 parts of arisaema cum bile, and 15 parts of mint.

[0074] The pharmaceutical composition A) of the present invention, in combination with angelica pubescens, wine-processed phellodendron, white mustard seed, arisaema cum bile, and asarum with the pharmaceutical composition described in the above scheme, can treat rheumatic bone diseases with damp-heat symptoms.

[0075] The preparation method of the pharmaceutical composition A) of the present invention preferably includes the following steps:

[0076] Mix white mustard seed and wine-processed phellodendron with angelica pubescens, arisaema cum bile, and asarum, and grind them into powder to obtain medicinal powder;

[0077] Mix the medicinal powder and water in a mass ratio of 1:(0.35 - 0.5), make pills, and dry to obtain the pharmaceutical composition A).

[0078] In the present invention, it is preferred to mix white mustard seed, wine-processed phellodendron, angelica pubescens, arisaema cum bile, and asarum and grind them into powder to obtain medicinal powder. In the present invention, the white mustard seed is preferably stir-fried with ginger juice and bamboo juice. The advantage of such stir-frying is to enhance the effect of resolving phlegm, and at the same time, it can protect the stomach and regulate the middle energizer; the mass ratio of the white mustard seed, the volume of ginger juice, and the volume of bamboo juice is preferably (10 - 15) g:(0.4 - 0.5) mL:(0.4 - 0.5) mL, and more preferably 10 g:0.5 mL:0.5 mL. In the present invention, the preparation method of the wine-processed phellodendron preferably includes stir-frying phellodendron with yellow rice wine. The advantage of such stir-frying is to reduce the bitter-cold property of phellodendron, and the pungent opening and bitter descending can enhance the effect of clearing heat and removing dampness; the mass ratio of phellodendron and the volume of yellow rice wine is preferably (10 - 15) g:(0.8 - 1) mL, and more preferably 10 g:1 mL. The present invention does not have any special limitation on the grinding method, and the conventional grinding method in the art can be used. After grinding into powder in the present invention, it is also preferred to pass the medicinal powder through an 80-mesh sieve.

[0079] After obtaining the medicinal powder, in the present invention, it is preferred to mix the medicinal powder and water in a mass ratio of 1:(0.35 - 0.5), make pills, and dry to obtain the pharmaceutical composition A). In the present invention, it is preferred to mix the medicinal powder and water in a mass ratio of 1:(0.35 - 0.5), and more preferably in a mass ratio of 1:0.4. In the present invention, the pill-making preferably adopts the pan-pilling method, and the pills are preferably made into the size of mung beans. The drying temperature in the present invention is preferably 80°C - 100°C, and more preferably 95°C. The present invention does not have any special limitation on the drying equipment, and the conventional drying equipment in the art can be used.

[0080] The pharmaceutical composition B) of the present invention is formulated with frankincense, myrrh, vinegar-processed flying squirrel feces, processed kusnezoff monkshood, bile arisaema, and mint in combination with the pharmaceutical composition described in the above scheme, and can treat rheumatic bone diseases with symptoms of cold-damp obstruction.

[0081] The preparation method of the pharmaceutical composition B) of the present invention preferably includes the following steps:

[0082] Mix vinegar-processed flying squirrel feces with frankincense, myrrh, bile arisaema, and processed kusnezoff monkshood, and grind them into powder to obtain medicinal powder;

[0083] Mix the medicinal powder with ginger juice in a mass ratio of 1:(0.35 - 0.5), make pills, and dry to obtain the composition B).

[0084] In the present invention, preferably, vinegar-processed flying squirrel feces are mixed with frankincense, myrrh, bile arisaema, and processed kusnezoff monkshood and ground into powder to obtain medicinal powder. In the present invention, the preparation method of the vinegar-processed flying squirrel feces preferably includes stir-frying flying squirrel feces with red vinegar, and the mass ratio of the flying squirrel feces to the volume of red vinegar is preferably (10 - 15) g:(1 - 1.5) mL, more preferably 10 g:1 mL. The present invention has no special limitation on the grinding method, and any conventional grinding method in the art can be used. After grinding into powder in the present invention, it is further preferred to pass the medicinal powder through an 80-mesh sieve.

[0085] After obtaining the medicinal powder, in the present invention, preferably, the medicinal powder is mixed with ginger juice in a mass ratio of 1:(0.35 - 0.5), made into pills, and dried to obtain the pharmaceutical composition B). Preferably, the medicinal powder and ginger juice are mixed in a mass ratio of 1:(0.35 - 0.5), and more preferably in a mass ratio of 1:0.4. The pill-making in the present invention preferably adopts the pan-pilling method, and the pills are preferably made into the size of mung beans. The drying temperature in the present invention is preferably 80°C - 100°C, and more preferably 95°C.

[0086] The pharmaceutical composition provided by the present invention can be used in combination with the pharmaceutical compositions A) - B) described in the above scheme according to the syndrome differentiation of cold, heat, deficiency, and excess of rheumatic bone bi, so as to achieve the effect of relieving symptoms of damp-heat and cold-damp obstruction.

[0087] If there is no special limitation, the medicinal materials involved in the present invention above can all adopt conventional commercially available products in the art.

[0088] To further illustrate the present invention, the following examples describe in detail the pharmaceutical composition for treating rheumatic bone diseases provided by the present invention, but they should not be construed as limiting the protection scope of the present invention.

[0089] Example 1

[0090] A pharmaceutical composition for treating rheumatic bone diseases, with deficiency of liver and kidney and deficiency-cold of kidney qi, and insufficient transportation in the middle jiao, has the following formula:

[0091] 150 g of black ants, 600 g of golden bupleurum root, 60 g of deer horn glue, 30 g of tortoise shell glue, 45 g of clematis root, 36 g of drynaria rhizome, 45 g of epimedium herb, 60 g of cibot rhizome, 45 g of taxillus twig, 36 g of white peony root, 18 g of ginseng, 24 g of stir-fried radish seed, 36 g of achyranthes root, 9 g of scorpion, 36 g of vinegar-processed Corydalis tuber, 36 g of salvia root, 10 g of amomum fruit, 6 g of wine-processed phellodendron bark, 9 g of roasted licorice root, 36 g of puncturevine caltrop fruit, 18 g of chick embryo membrane, 18 g of zedoary, 18 g of notoginseng powder, 36 g of processed fleeceflower root, 9 g of incised notopterygium rhizome.

[0092] The preparation method of the above drug composition is as follows:

[0093] 1) Take black ants and dry them at 80 °C;

[0094] 2) Mix the black ants dried in step 1) with scorpion, deer horn glue, tortoise shell glue, clematis root, drynaria rhizome, epimedium herb, cibot rhizome, taxillus twig, white peony root, ginseng, stir-fried radish seed, achyranthes root, Corydalis tuber, salvia root, amomum fruit, wine-processed phellodendron bark, roasted licorice root, puncturevine caltrop fruit, chick embryo membrane, zedoary, notoginseng, processed fleeceflower root, incised notopterygium rhizome, grind them into powder, and pass through an 80-mesh sieve to obtain medicinal powder;

[0095] 3) Decoct golden bupleurum root with water twice, adding 1500 mL of water each time. Mix the decoction juices obtained from the two decoctions and concentrate to obtain an ointment;

[0096] 4) Mix the medicinal powder obtained in step 2) and the clear ointment obtained in step 3) at a mass ratio of 1:0.4, and use the pan-making method to make pills the size of mung beans;

[0097] 5) Put the pills obtained in step 4) into an oven and dry them at 95 °C for standby.

[0098] Example 2

[0099] A drug composition for treating rheumatic bone diseases, with yin deficiency and internal heat due to deficiency of the liver and kidney, and excessive transportation in the middle jiao. The formula is as follows:

[0100] 150 g of black ants, 600 g of golden bupleurum root, 30 g of deer horn glue, 60 g of tortoise shell glue, 45 g of clematis root, 36 g of drynaria rhizome, 30 g of epimedium herb, 55 g of cibot rhizome, 45 g of taxillus twig, 36 g of white peony root, 18 g of ginseng, 24 g of stir-fried radish seed, 36 g of achyranthes root, 9 g of scorpion, 36 g of vinegar-processed Corydalis tuber, 36 g of salvia root, 10 g of amomum fruit, 18 g of wine-processed phellodendron bark, 9 g of roasted licorice root, 36 g of puncturevine caltrop fruit, 18 g of chick embryo membrane, 18 g of zedoary, 18 g of notoginseng powder, 36 g of processed fleeceflower root, 9 g of incised notopterygium rhizome

[0101] The preparation method of the above drug composition is as follows:

[0102] 1) Take black ants and dry them at 80 °C;

[0103] 2) Mix the black ants dried in step 1) with scorpion, deer horn glue, tortoise shell glue, Clematis chinensis, Drynaria rhizome, Epimedium brevicornu, Cibotium barometz, Taxillus chinensis, Paeonia lactiflora, ginseng, stir-fried radish seed, Achyranthes bidentata, Corydalis yanhusuo, Salvia miltiorrhiza, Amomum villosum, wine-processed Phellodendron amurense, roasted licorice root, Tribulus terrestris, membrane of chicken egg, Rhizoma zedoariae, Panax notoginseng, processed Polygonum multiflorum, and Notopterygium incisum, grind them into powder, and sieve through a 80-mesh sieve to obtain medicinal powder;

[0104] 4) Decoct the Cleyera japonica roots twice with 1500 mL of water each time, mix the decoction obtained from the two decoctions, and concentrate to obtain an ointment;

[0105] 7) Mix the medicinal powder obtained in step 2) and the clear paste obtained in step 3) at a mass ratio of 1:0.4, and use the pan-making method to make pills the size of mung beans;

[0106] 10) Put the pills obtained in step 4) into an oven and dry at 95 °C for standby.

[0107] Example 3

[0108] A pharmaceutical composition for treating rheumatic bone diseases, with no obvious symptoms of cold or heat due to liver and kidney deficiency, and the formula is as follows:

[0109] 150 g of black ants, 600 g of Cleyera japonica roots, 36 g of deer horn glue, 36 g of tortoise shell glue, 45 g of Clematis chinensis, 36 g of Drynaria rhizome, 36 g of Epimedium brevicornu, 45 g of Cibotium barometz, 45 g of Taxillus chinensis, 36 g of Paeonia lactiflora, 18 g of ginseng, 24 g of stir-fried radish seed, 36 g of Achyranthes bidentata, 9 g of scorpion, 36 g of Corydalis yanhusuo processed with vinegar, 36 g of Salvia miltiorrhiza, 10 g of Amomum villosum, 9 g of Phellodendron amurense processed with wine, 9 g of roasted licorice root, 36 g of Tribulus terrestris, 18 g of membrane of chicken egg, 18 g of Rhizoma zedoariae, 18 g of Panax notoginseng powder, 36 g of processed Polygonum multiflorum, and 9 g of Notopterygium incisum.

[0110] The preparation method of the above-mentioned pharmaceutical composition is as follows:

[0111] 1) Take the black ants and dry them at 80 °C;

[0112] 2) Mix the black ants dried in step 1) with scorpion, deer horn glue, tortoise shell glue, Clematis chinensis, Drynaria rhizome, Epimedium brevicornu, Cibotium barometz, Taxillus chinensis, Paeonia lactiflora, ginseng, stir-fried radish seed, Achyranthes bidentata, Corydalis yanhusuo, Salvia miltiorrhiza, Amomum villosum, wine-processed Phellodendron amurense, roasted licorice root, Tribulus terrestris, membrane of chicken egg, Rhizoma zedoariae, Panax notoginseng, processed Polygonum multiflorum, and Notopterygium incisum, grind them into powder, and sieve through a 80-mesh sieve to obtain medicinal powder;

[0113] 3) Decoct the Cleyera japonica roots twice with 1500 mL of water each time, mix the decoction obtained from the two decoctions, and concentrate to obtain an ointment;

[0114] 4) Mix the medicinal powder obtained in step 2) and the clear paste obtained in step 3) at a mass ratio of 1:0.4, and use the pan-making method to make pills the size of mung beans;

[0115] 5) Put the pills obtained in step 4) into an oven and dry them at 95 °C for later use.

[0116] Example 4

[0117] A drug combination for treating rheumatic bone diseases with liver and kidney deficiency syndrome and damp-heat syndrome, the formula is as follows:

[0118] Main formula: The drug composition obtained in Example 3

[0119] Auxiliary formula: A drug composition consisting of 30 g of Angelica pubescens, 60 g of wine-processed Phellodendron amurense, 15 g of Semen sinapis alba, 15 g of Arisaema cum Bile, and 9 g of Asarum sieboldii.

[0120] The preparation method of the drug composition of the auxiliary formula in the above drug combination is as follows:

[0121] 1) Take ginger and squeeze out the juice to obtain ginger juice;

[0122] 2) Roast fresh bamboo to drain out the juice to obtain bamboo juice;

[0123] 3) Mix the ginger juice obtained in step 1) and the bamboo juice obtained in step 2) in equal volume (1:1) to obtain a mixed juice;

[0124] 4) Stir-fry Semen sinapis alba with the mixed juice obtained in step 3) to obtain dried Semen sinapis alba, wherein the mass ratio of Semen sinapis alba to the volume of the mixed juice is 10 g:1 mL;

[0125] 5) Stir-fry Phellodendron amurense with yellow rice wine to obtain dried Phellodendron amurense, wherein the mass ratio of Phellodendron amurense to the volume of yellow rice wine is 10 g:1 mL;

[0126] 6) Mix the dried Semen sinapis alba obtained in step 4) and the dried Phellodendron amurense obtained in step 5) with Angelica pubescens, Arisaema cum Bile, and Asarum sieboldii, grind them into powder, and pass through an 80-mesh sieve to obtain medicinal powder;

[0127] 7) Mix the medicinal powder obtained in step 6) and clear water in a mass ratio of 1:0.4 and mix evenly until it can be bonded. After mixing, use the pan-pelleting method to make pills the size of mung beans;

[0128] 8) Put the pills obtained in step 7) into an oven and dry them at 95 °C for later use.

[0129] Example 5

[0130] A drug combination for treating rheumatic bone diseases with liver and kidney deficiency syndrome and cold-damp obstruction syndrome, the formula is as follows:

[0131] Main formula: The drug composition obtained in Example 3

[0132] Auxiliary formula: A pharmaceutical composition composed of 10 g of frankincense, 10 g of myrrh, 30 g of vinegar-processed flying squirrel feces, 10 g of processed kusnezoff monkshood, 15 g of arisaema cum bile, and 15 g of mint.

[0133] The preparation method of the pharmaceutical composition of the auxiliary formula in the above pharmaceutical combination is as follows:

[0134] 1) Take ginger and decoct it to obtain ginger juice;

[0135] 2) Stir-fry flying squirrel feces with red vinegar to obtain dried flying squirrel feces, where the mass ratio of flying squirrel feces to the volume of red vinegar is 10 g: 1 mL;

[0136] 3) Mix the dried flying squirrel feces obtained in step 2) with frankincense, myrrh, arisaema cum bile, and processed kusnezoff monkshood, grind them into powder, and sieve through an 80-mesh sieve to obtain medicinal powder;

[0137] 4) Mix the medicinal powder obtained in step 4) with the ginger juice obtained in step 1) at a mass ratio of 1: 0.4 until it can be bonded, and after mixing, use the pan-pelleting method to make pills the size of mung beans;

[0138] 5) Put the pills obtained in step 5) into an oven and dry them at 95 °C for standby.

[0139] Comparative Example 1

[0140] A pharmaceutical composition for treating rheumatic bone diseases has the following formula:

[0141] Deficiency of the liver and kidney with deficiency-cold of the kidney qi, and insufficient transportation in the middle jiao, the formula is as follows:

[0142] 60 g of deer horn glue, 30 g of tortoise shell glue, 45 g of clematis root, 36 g of drynaria rhizome, 45 g of epimedium, 60 g of cibot rhizome, 45 g of taxillus twig, 36 g of white peony root, 18 g of ginseng, 24 g of stir-fried radish seed, 36 g of achyranthes root, 9 g of scorpion, 36 g of vinegar-processed Corydalis tuber, 36 g of salvia root, 10 g of amomum fruit, 6 g of wine-processed phellodendron bark, 9 g of roasted licorice root, 36 g of tribulus terrestris, 18 g of phoenix eggshell membrane, 18 g of zedoary, 18 g of notoginseng powder, 36 g of processed polygonum multiflorum, and 9 g of incised notopterygium rhizome.

[0143] The preparation method of the above pharmaceutical composition is as follows:

[0144] 1) Mix scorpion, deer horn glue, tortoise shell glue, clematis root, drynaria rhizome, epimedium, cibot rhizome, taxillus twig, white peony root, ginseng, stir-fried radish seed, achyranthes root, Corydalis tuber, salvia root, amomum fruit, wine-processed phellodendron bark, roasted licorice root, tribulus terrestris, phoenix eggshell membrane, zedoary, notoginseng, processed polygonum multiflorum, and incised notopterygium rhizome obtained in step 1), grind them into powder, and sieve through an 80-mesh sieve to obtain medicinal powder;

[0145] 2) Mix the medicinal powder obtained in step 1) with clear water at a mass ratio of 1: 0.4, and use the pan-pelleting method to make pills the size of mung beans;

[0146] 3) Put the pills obtained in step 3) into an oven and dry them at 95 °C for later use.

[0147] Comparative Example 2

[0148] A pharmaceutical composition for treating rheumatic bone diseases, with yin deficiency and internal heat due to liver and kidney deficiency, and excessive transportation in the middle jiao. The formula is as follows:

[0149] Colla Corii Cervi 30g, Colla Plastri Testudinis 60g, Clematis Chinensis 45g, Drynaria Rhizome 36g, Epimedium 30g, Cibotium Barometz 55g, Taxillus Chinensis 45g, White Peony Root 36g, Ginseng 18g, Stir-fried Raphanus Sativus Seed 24g, Achyranthes Bidentata Root 36g, Scorpio 9g, Corydalis Yanhusuo 36g, Salvia Miltiorrhiza 36g, Amomum Villosum 10g, Wine-processed Phellodendron Chinense 18g, Honey-fried Licorice Root 9g, Tribulus Terrestris 36g, Membrane of Chicken's Egg 18g, Rhizoma Zedoariae 18g, Panax Notoginseng Powder 18g, Prepared Polygonum Multiflorum 36g, Notopterygium Root 9g

[0150] The preparation method of the above pharmaceutical composition is as follows:

[0151] 1) Take Scorpio, Colla Corii Cervi, Colla Plastri Testudinis, Clematis Chinensis, Drynaria Rhizome, Epimedium, Cibotium Barometz, Taxillus Chinensis, White Peony Root, Ginseng, Stir-fried Raphanus Sativus Seed, Achyranthes Bidentata Root, Corydalis Yanhusuo, Salvia Miltiorrhiza, Amomum Villosum, Wine-processed Phellodendron Chinense, Honey-fried Licorice Root, Tribulus Terrestris, Membrane of Chicken's Egg, Rhizoma Zedoariae, Panax Notoginseng, Prepared Polygonum Multiflorum, and Notopterygium Root in step 1), mix them, grind them into powder, and pass through an 80-mesh sieve to obtain medicinal powder;

[0152] 2) Mix the medicinal powder obtained in step 1) with clear water in a mass ratio of 1:0.4, and use the pan-making method to make pills the size of mung beans;

[0153] 3) Put the pills obtained in step 4) into an oven and dry them at 95 °C for later use.

[0154] Comparative Example 3

[0155] A pharmaceutical composition for treating rheumatic bone diseases, with no obvious signs of cold or heat due to liver and kidney deficiency. The formula is as follows:

[0156] Colla Corii Cervi 36g, Colla Plastri Testudinis 36g, Clematis Chinensis 45g, Drynaria Rhizome 36g, Epimedium 36g, Cibotium Barometz 45g, Taxillus Chinensis 45g, White Peony Root 36g, Ginseng 18g, Stir-fried Raphanus Sativus Seed 24g, Achyranthes Bidentata Root 36g, Scorpio 9g, Corydalis Yanhusuo 36g, Salvia Miltiorrhiza 36g, Amomum Villosum 10g, Wine-processed Phellodendron Chinense 9g, Honey-fried Licorice Root 9g, Tribulus Terrestris 36g, Membrane of Chicken's Egg 18g, Rhizoma Zedoariae 18g, Panax Notoginseng Powder 18g, Prepared Polygonum Multiflorum 36g, and Notopterygium Root 9g.

[0157] The preparation method of the above pharmaceutical composition is as follows:

[0158] 1) Take whole scorpion, deer horn glue, tortoise shell glue, clematis root, drynaria rhizome, epimedium herb, cibot rhizome, taxillus twig, white peony root, ginseng, stir-fried radish seed, achyranthes root, rhizoma corydalis, salvia root, amomum fruit, wine-processed phellodendron bark, roasted licorice root, puncturevine caltrop fruit, chicken embryo membrane, zedoary tuber, notoginseng root, processed fleece-flower root, and notopterygium root, mix them, grind into powder, and sieve through 80-mesh sieve to obtain medicinal powder;

[0159] 2) Mix the medicinal powder obtained in step 2) with clear water at a mass ratio of 1:0.4, and use the pan-pelleting method to make pills the size of mung beans;

[0160] 3) Put the pills obtained in step 4) into an oven and dry at 95 °C for standby.

[0161] Control group 4

[0162] A drug combination for treating rheumatic bone diseases with liver and kidney deficiency syndrome and damp-heat syndrome, the formula is as follows:

[0163] Main prescription: The drug composition obtained in control group 3, with damp-heat obstruction and insufficient transportation in the middle jiao.

[0164] Adjuvant prescription: A drug composition composed of 30 g of angelica pubescens, 60 g of wine-processed phellodendron bark, 15 g of white mustard seed, 15 g of arisaema cum bile, and 9 g of asarum.

[0165] The preparation method of the drug composition of the adjuvant prescription in the above drug combination is as follows:

[0166] 1) Extract ginger juice to obtain ginger juice;

[0167] 2) Roast fresh bamboo to extract juice to obtain bamboo juice;

[0168] 3) Mix the ginger juice obtained in step 1) and the bamboo juice obtained in step 2) in equal volume to obtain mixed juice (the ratio of ginger juice to bamboo juice is 1:1);

[0169] 4) Stir-fry white mustard seed with the mixed juice obtained in step 3) to obtain stir-fried and dried white mustard seed, where the mass ratio of white mustard seed to the volume of the mixed juice is 10 g:1 mL;

[0170] 5) Stir-fry phellodendron bark with yellow rice wine to obtain stir-fried and dried phellodendron bark, where the mass ratio of phellodendron bark to the volume of yellow rice wine is 10 g:1 mL;

[0171] 6) Mix the stir-fried and dried white mustard seed obtained in step 4) and the stir-fried and dried phellodendron bark obtained in step 5) with angelica pubescens, arisaema cum bile, and asarum, grind into powder, and sieve through 80-mesh sieve to obtain medicinal powder;

[0172] 7) Mix the medicinal powder obtained in step 6) with clear water at a mass ratio of 1:0.4 and mix evenly until it can be bonded, and then use the pan-pelleting method to make pills the size of mung beans;

[0173] 8) Put the pills obtained in step 7) into an oven and dry them at 95 °C for later use.

[0174] Comparative Example 5

[0175] A drug combination for treating rheumatic bone diseases with liver and kidney deficiency syndrome and cold-dampness arthralgia syndrome has the following formula:

[0176] Main formula: The drug composition obtained in Comparative Example 3, with cold-dampness arthralgia and insufficient transportation in the middle jiao.

[0177] Auxiliary formula: A drug composition consisting of 10 g of frankincense, 10 g of myrrh, 30 g of vinegar-processed winged euonymus, 10 g of prepared kusnezoff monkshood, 15 g of arisaema cum bile, and 15 g of mint.

[0178] The preparation method of the drug composition of the auxiliary formula in the above drug combination is as follows:

[0179] 1) Take ginger and decoct it to obtain ginger juice.

[0180] 2) Stir-fry winged euonymus with red vinegar to obtain stir-fried dry winged euonymus, where the mass ratio of winged euonymus to the volume of red vinegar is 10 g∶1 mL.

[0181] 3) Mix the stir-fried dry winged euonymus obtained in step 2) with frankincense, myrrh, arisaema cum bile, and prepared kusnezoff monkshood, grind them into powder, and sieve through an 80-mesh sieve to obtain medicinal powder.

[0182] 4) Mix the medicinal powder obtained in step 4) with the ginger juice obtained in step 1) in a mass ratio of 1:0.4 until it can be bonded. After mixing, use the pan-pilling method to make pills the size of mung beans.

[0183] 6) Put the pills obtained in step 5) into an oven and dry them at 95 °C for later use.

[0184] Application Example 1

[0185] 1) Sample acquisition

[0186] Select 139 patients with rheumatic bone diseases who visited the traditional Chinese medicine outpatient department of Xincai Moon Bay Hospital (Xincai Orthopedic Hospital) from June 2020 to June 2023.

[0187] The disease information of patients with rheumatic bone arthralgia is as follows:

[0188] Diagnostic criteria (1987 American College of Rheumatology diagnostic criteria for rheumatoid arthritis)

[0189] ① Morning stiffness is not less than 1 hour and lasts for more than 6 weeks.

[0190] ② Swelling of 3 or more joints, lasting for not less than 6 weeks.

[0191] ③ Swelling of the wrist, metacarpophalangeal or proximal interphalangeal joints, lasting for not less than 6 weeks.

[0192] ④Symmetric joint swelling and pain for no less than 6 weeks;

[0193] ⑤X-ray findings.

[0194] ⑥Subcutaneous nodules;

[0195] ⑦Positive rheumatoid factor, titer > 1:32.

[0196] Meeting 4 or more of the above criteria can diagnose a patient with rheumatic bone disease.

[0197] Exclusion criteria

[0198] ①Severe abnormalities in heart, liver, and kidney functions and hematopoietic function; ②Patients with severe joint deformities; ③Severe gastrointestinal diseases; ④Patients who have been using glucocorticoids for a long time; ⑤Patients who have not been treated according to the course of treatment and have interrupted treatment.

[0199] Traditional Chinese medicine syndrome differentiation and typing criteria

[0200] According to the clinical symptoms and signs of the patients, the treatment group differentiates syndromes and types: The main syndrome of liver and kidney deficiency type has related symptoms of rheumatoid arthritis accompanied by dizziness, tinnitus, soreness and weakness of the waist and knees, listlessness or forgetfulness, or impotence, premature ejaculation, spermatorrhea in men, or irregular menstruation in women, etc.; Those with liver and kidney deficiency and partial yin deficiency have tidal fever and night sweats, restlessness in the heart, tender and red tongue, and thready, rapid and weak pulse; Those with liver and kidney deficiency and partial yang deficiency are afraid of cold, have clear and long urine, pale tongue, thin and white coating, and deep, slow and weak pulse; Those with liver and kidney deficiency complicated with damp-heat have unapparent fever, bitter taste in the mouth, dry mouth, yellow and greasy tongue coating, slippery and rapid pulse, or soggy and slippery pulse; Those with liver and kidney deficiency complicated with cold coagulation and cold-dampness have joint contracture pain, fear of cold, clear urine, pale and purple tongue, thin and white coating, or watery and slippery coating, deep and slow pulse, or string-like pulse.

[0201] 2) Sample grouping

[0202] Group A: 68 patients (28 males and 40 females), including 15 cases of liver and kidney deficiency complicated with kidney qi deficiency and cold, 8 cases of liver and kidney deficiency complicated with internal heat due to yin deficiency, 12 cases of liver and kidney deficiency with damp-heat obstruction of collaterals, 12 cases of liver and kidney deficiency with cold-damp obstruction of collaterals, and 21 cases with no obvious signs of cold and heat of liver and kidney deficiency. They were administered the pharmaceutical compositions of Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4, and Comparative Example 5; The main prescription dosages of Comparative Example 1, 2, 3 and Comparative Example 4, 5 were 6 - 8 grams each time, 3 times a day, taken with warm water. The auxiliary prescriptions of the compositions of Comparative Example 4 and 5 were 1.5 - 3 grams respectively; 1.5 - 3 grams, 3 times a day, taken with warm water.

[0203] Group B: There were 71 patients (23 males and 48 females). Among them, 16 had deficiency of both liver and kidney with deficiency-cold of kidney qi, 10 had deficiency of both liver and kidney with internal heat due to yin deficiency, 15 had deficiency of both liver and kidney with damp-heat blocking collaterals, 10 had deficiency of both liver and kidney with cold-damp blocking collaterals, and 20 had no obvious cold or heat symptoms with deficiency of both liver and kidney. The drug compositions of Example 1, Example 2, Example 3, Example 4, and Example 5 were administered. The main prescription dosages of Example 1, 2, 3 and Example 4, 5 were 6 - 8 grams each time, 3 times a day, taken with warm boiled water. The combined auxiliary prescription dosages of Example 4 and 5 were 1.5 - 3 grams respectively; 1.5 - 3 grams, 3 times a day, taken with warm boiled water.

[0204] The above Group A and Group B were administered for 3 months as a treatment course.

[0205] Meanwhile, 111 patients who met the above diagnostic criteria and took decoctions in the outpatient department and 90 patients in the Jinyi Juanbi Dan group (including Group B) were collected respectively to observe the compliance of the two groups of patients. Among the 90 patients, 71 patients in Group B who met the diagnostic criteria and exclusion criteria were included.

[0206] 3) Index Observation

[0207] After one treatment course, the main symptoms and signs were observed. Overall pain intensity: The pain intensity was quantified using the visual analogue scale; Signs: The number of joint swellings, the improvement of the number of joint pains, and relevant laboratory test indexes such as erythrocyte sedimentation rate (ESR), C-reactive protein, interleukin-6 (IL-6), tumor necrosis factor α (TNF-α) by enzyme-linked immunosorbent assay, etc., and the effective rate.

[0208] Result Judgment Criteria

[0209] Marked effect: The improvement of the main clinical symptoms, signs and laboratory indexes was ≥75%; Effective: The improvement of the main clinical symptoms, signs and laboratory indexes was ≥30% and <75%; Ineffective: The improvement of the main clinical symptoms, signs and laboratory indexes was <30%. The two groups of patients were instructed to regularly (once a month) check their liver and kidney functions and blood routine to understand the conditions of their liver and kidney functions and blood routine.

[0210] The Excel 2010 software was used to statistically analyze the drug effective rates, the changes in physical sign indexes before and after treatment, and the changes in laboratory indexes of Group A patients and Group B. All measurement data were analyzed using the t-test, and the count data were analyzed using χ 2 test. A P < 0.05 was considered statistically significant. And the comparison of compliance between the decoction group and Group B. The results are shown in Tables 1 - 4.

[0211] Table 1 Comparative Study on the Compliance of Patients in the Decoction Group and the Jinyi Juanbi Dan Group

[0212] Group Taste factor (number of cases) Adverse reactions (number of cases) Economic factor (number of cases) Decoction group 111(36) 111(8) 111(2) Jinyi Juanbi Dan group 90(2) 90(3) 90(1)

[0213] Note: The number of patients with interrupted treatment is compared in the brackets.

[0214] Table 2 Comparison of the total effective rates of patients in Group A and Group B

[0215] Group Number of cases Marked effect (cases, %) Effective (cases, %) Ineffective (cases, %) Total effective rate (cases, %) Group A 68 25(36.8％) 21(30.9％) 22(32.4％) 46(67.6％) Group B 71 45(63.4％) 23(32.4％) 3(4.2％) 68(95.8％)

[0216] As can be seen from Table 2, the total effective rate of the patients (Group B) who received the pharmaceutical composition of Example 1 was 95.8%, which was significantly higher than the total effective rate (67.6%) of the patients (Group A) who received the pharmaceutical composition of Comparative Example 1.

[0217] Table 3 Comparison of the changes in physical signs of patients in Group A and Group B before and after treatment (cases)

[0218]

[0219]

[0220] Note: Compared with before treatment in this group, 1) P < 0.05; compared Group B after treatment with Group A, 2) P < 0.05

[0221] Table 4 Comparison of the changes in laboratory indexes of patients in Group A and Group B before and after treatment (cases)

[0222]

[0223] Note: Compared with before treatment in this group, 1) P < 0.05; compared Group B after treatment with Group A after treatment, 2) P < 0.05

[0224] As can be seen from Table 3 and Table 4, the clinical symptoms, physical signs and laboratory test results of the patients (Group B) who received the pharmaceutical composition of Example 1 were significantly improved compared with those before treatment, and the improvement effect of the treatment group that received the pharmaceutical compositions of Example 1, Example 2, Example 3, Example 4, and Example 5 was better than that of the treatment group that received the pharmaceutical compositions of Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4, and Comparative Example 5.

[0225] As can be seen from the above examples, the pharmaceutical composition for treating rheumatic bone diseases provided by the present invention can regulate the spleen and stomach, dredge the governor vessel and conception vessel, balance yin and yang, strengthen the muscles and bones, not only can carry out immune regulation, but also can improve joint function, block the progression of the disease, and has small side effects, and the compliance of patients is increased compared with taking oral decoctions.

[0226] Although the above examples have described the present invention in detail, they are only a part of the embodiments of the present invention, rather than all embodiments. People can also obtain other embodiments based on these embodiments without creative efforts, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A pharmaceutical composition for treating rheumatoid arthritis, characterized in that: The components are as follows by weight: 100-300 parts of black ants, 290-600 parts of golden broom roots, 12-60 parts of antler glue, 12-60 parts of tortoise shell glue, 30-100 parts of clematis, 30-60 parts of drynaria, 30-60 parts of epimedium, 30-100 parts of dog spine, 30-100 parts of mistletoe, 12-60 parts of white peony root, 9-30 parts of ginseng, 9-30 parts of stir-fried radish seeds, 9-60 parts of Chinese rhizoma cyperi, 6-18 parts of whole scorpion, 12-60 parts of vinegar Corydalis, 12-60 parts of Salvia miltiorrhiza, 6-12 parts of Amomum villosum, 6-18 parts of wine Phellodendron, 6-18 parts of roasted Licorice root, 12-60 parts of Tribulus terrestris, 9-30 parts of Phoenix skin, 9-30 parts of Curcuma, 9-30 parts of Panax notoginseng powder, 30-60 parts of processed Polygonum multiflorum, and 3-10 parts of Notopterygium wilfordii.

2. The method for preparing the pharmaceutical composition according to claim 1, characterized in that , comprising the following steps: Mix scorpion, antler glue, tortoise shell glue, clematis root, bone drynaria, epimedium, dog spine, mistletoe, white peony root, ginseng, stir-fried radish seed, Chinese rhizome, vinegar corydalis, salvia miltiorrhiza, amomum, wine phellodendron, roasted liquorice, tribulus, phoenix vine, zedoaria, panax notoginseng, processed polygonum multiflorum, black ant and notopterygium root, grind into powder to obtain medicinal powder; decoct golden broom root, concentrate the decoction to obtain clear paste; The medicine powder and the clear paste are mixed, pelletized and dried to obtain the medicine composition.

3. The preparation method according to claim 2, characterized in that: The method further comprises passing the powder through an 80-mesh sieve after the powder is ground into powder.

4. The preparation method according to claim 2, characterized in that: The decocting comprises decocting with water.

5. The preparation method according to claim 2, characterized in that: The mass ratio of the medicine powder to the clear paste is 1:(0.35-0.5).

6. The preparation method according to claim 2, characterized in that: The drying temperature is 80°C to 100°C.

7. Use of the pharmaceutical composition according to claim 1 or the pharmaceutical composition prepared by the preparation method according to any one of claims 2 to 6 in the preparation of a medicament for treating rheumatoid arthritis.

8. A drug combination for treating rheumatoid arthritis, characterized in that: The drug combination comprises the drug composition of the mass fractions as described in A) or B), and the drug composition as described in claim 1 or the drug composition prepared by the preparation method as described in any one of claims 2 to 6; A): 30 parts of Angelica dahurica, 60 parts of Cortex Phellodendri, 15 parts of Sinapis alba, 15 parts of Arisaema cinerea and 9 parts of Asarum; the Sinapis alba is stir-fried with ginger juice and bamboo juice; the ratio of the mass of the Sinapis alba, the volume of ginger juice and the volume of bamboo juice is 10-15g: 0.4-0.5mL: 0.4-0.5mL; B): 10 parts of frankincense, 10 parts of myrrh, 30 parts of vinegar-scented aconite, 10 parts of processed aconite, 15 parts of gallbladder arisaema and 15 parts of mint.

9. The pharmaceutical combination according to claim 8, characterized in that The method for preparing the pharmaceutical composition of A) comprises the following steps: 1) Squeeze ginger to obtain ginger juice; 2) Roast fresh bamboo and drain the juice to obtain bamboo juice; 3) mixing the ginger juice obtained in step 1) and the bamboo juice obtained in step 2) in an equal volume ratio of 1:1 to obtain a mixed juice; 4) stir-frying white mustard seeds with the mixed juice obtained in step 3) to obtain stir-fried white mustard seeds, wherein the mass ratio of the white mustard seeds to the volume ratio of the mixed juice is 10 g: 1 mL; 5) stir-frying the Phellodendron amurense with rice wine to obtain stir-fried Phellodendron amurense, wherein the mass ratio of the Phellodendron amurense to the volume of the rice wine is 10 g: 1 mL; 6) mixing the stir-fried dried white mustard seeds obtained in step 4) and the stir-fried dried phellodendron chinense obtained in step 5) with angelica dahurica, radix aconiti lobatae, and asarum, grinding them into powder, and passing through an 80-mesh sieve to obtain a medicinal powder; 7) mixing the powder obtained in step 6) with clean water at a mass ratio of 1:0.4 to a certain degree of adhesion, and after mixing, making mung bean-sized pills by a panning method; 8) The pills obtained in step 7) are placed in an oven and dried at 95° C. for later use.

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