Traditional Chinese medicine composition for clearing heat, dispersing blood stasis and treating osteoarthritis as well as preparation method, application and related products of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for clearing heat, dispersing blood stasis and treating osteoarthritis as well as a preparation method, application and related products of the traditional Chinese medicine composition, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition is prepared from rhizoma smilacis glabrae, honeysuckle flowers, radix astragali, fructus gardeniae, rhizoma polygoni cuspidati, radix paeoniae rubra, radix salviae miltiorrhizae, rhizoma atractylodis, vinegar-processed rhizoma curcumae, fructus chaenomelis The rhizoma smilacis glabrae has the effects of detoxifying and promoting diuresis, the honeysuckle has the effects of clearing away heat and toxic materials, and the astragalus membranaceus has the Gardenia, polygonum cuspidatum, radix paeoniae rubra and salvia miltiorrhiza help the monarch drug to clear heat, cool blood, promote blood circulation and dredge collaterals and serve as ministerial drugs; the rhizoma atractylodis has the effects of eliminating dampness and preventing cold and cold obstructing dampness, the vinegar-processed curcuma zedoary has the effects of breaking blood and promoting qi circulation and enhancing the blood activating efficacy, and the pawpaw has the effects of resolving dampness and relaxing tendons and aims at joint, tendon and vessel contracture; gastrodia elata can calm liver wind, dispel wind and dredge collaterals, and introduce the efficacy into meridian joints to serve as a conductant drug. The whole formula has the effects of clearing away heat and toxic materials, promoting diuresis and dredging collaterals, promoting blood circulation to remove blood stasis, tonifying qi and strengthening the body resistance, effectively improves the treatment effect on rheumatoid arthritis, and has the treatment effect on gouty arthritis.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, and relates to a traditional Chinese medicine composition for clearing heat and removing blood stasis and treating osteoarthritis, its preparation method, application and related products. Background Technology

[0002] The traditional Chinese medicine (TCM) name for rheumatoid arthritis (RA) is "Wangbi." The term "Wang" first appeared in Zhang Zhongjing's *Synopsis of Prescriptions of the Golden Chamber* from the Han Dynasty: "Pain in all limbs and joints, and a weak and emaciated body," referring to a state of swollen joints and emaciation. Now, it often means "swollen and deformed joints." As early as the early 1980s, the TCM academic community began scientific research on Bi syndrome.

[0003] Wu Zhen, in his *Treatise on Febrile Diseases: Dampness Syndrome*, discussed damp-heat arthralgia, stating, "Damp-heat causes arthralgia; external invasion of damp-heat evil, combined with the intake of sweet and greasy foods, leads to the accumulation of dampness and heat, which then stagnates in the meridians." He pointed out that damp-heat can cause arthralgia from both external and internal causes. Li Yongcui, in his *Collection of Diagnostic and Treatment Methods*, stated, "Dampness, heat, phlegm, and fire... can all cause numbness and arthralgia." Besides proposing that damp-heat causes arthralgia, he also pointed out that "the onset of dampness syndrome is always accompanied by cold and heat, generally manifested as dark urine and thirst, indicating damp-heat." He used symptoms such as yellow urine and thirst as indicators of damp-heat syndrome. Ye Tianshi proposed that "initially, damp-heat is in the meridians; over time, stagnant heat enters the collaterals," and, considering the characteristics of arthralgia, believed that "there are cases where damp-heat injures the qi, and warm heat enters the blood vessels, resulting in arthralgia." In his *Clinical Guide to Medical Cases: Arthralgia*, he stated, "Damp-heat flows, causing numbness and pain in the limbs." Following this theory, Wu Jutong stated in his "Treatise on Febrile Diseases: Dampness-Heat Syndrome": "Dampness accumulates and heat rises, accumulating in the meridians... causing pain and discomfort in the bones and joints... the disease is called dampness-induced arthralgia." Ye Tianshi and Wu Jutong's discussions on damp-heat transforming into blood stasis and causing arthralgia are particularly relevant to clinical practice and are of great significance for the treatment of damp-heat syndrome in arthralgia.

[0004] The development of arthralgia (Bi syndrome) is invariably due to obstruction of the flow of Qi, blood, and body fluids. Obstruction of the meridians and blockages lead to pain and the development of Bi syndrome. In ancient times, the climate was cold and people's lives were difficult, resulting in a deficiency of vital energy and susceptibility to wind, cold, and dampness, which became the main causes and mechanisms of Bi syndrome. However, people's diets today are vastly different from those of ancient times, and wind and cold pathogens are no longer as rampant. Regarding the characteristics of Bi syndrome, *Danxi's Essentials of Treatment* states: "Swelling and pain in the limbs and joints, pain belongs to fire, swelling belongs to dampness; this is a disease caused by damp-heat." *Clinical Guide to Medical Cases, Volume Seven, Bi Syndrome* states: "Initially, damp-heat is in the meridians; over time, stagnant heat enters the collaterals." *Classified Treatment of Bi Syndrome* also states: "Prolonged Bi syndrome inevitably leads to blood stasis." It is evident that although there was no formal statement in ancient times that the core pathogenesis of RA (rheumatoid arthritis) was "dampness, heat, and stasis," the important role of dampness, heat, and stasis in RA was already clear based on its clinical manifestations.

[0005] Chinese invention patent CN102451428A discloses a traditional Chinese medicine composition for treating rheumatoid arthritis, comprising Smilax glabra, Lonicera japonica, Paeonia lactiflora, Salvia miltiorrhiza, Atractylodes lancea, Phellodendron chinense, Coix lacryma-jobi, Dioscorea hypoglauca, Sinomenium acutum, Curcuma zedoaria, Astragalus membranaceus, Scolopendra subspinipes, and Vespa nidus. Based on this formula, one or more of the following can be added: Gypsum fibrosum, Anemarrhena asphodeloides, Morus alba twigs, and Trachelospermum jasminoides. This formula is effective in treating rheumatoid arthritis.

[0006] The article "Clinical Observation on the Efficacy of Heat-Clearing and Blood-Activating Formula in the Treatment of Active Rheumatoid Arthritis" (Jiang Quan et al., World Journal of Integrated Traditional and Western Medicine, 2010, Vol. 5, No. 7, pp. 588-592) discloses a heat-clearing and blood-activating formula: honeysuckle, smilax glabra, atractylodes lancea, phellodendron chinense, red peony root, salvia miltiorrhiza, raw coix seed, turmeric, dioscorea hypoglauca, sinomenium acutum, and bee honeycomb, etc. Modifications are made according to symptoms: for fever, add 30g of raw gypsum and 12g of anemarrhena asphodeloides; for upper limb joint pain, add 15g of mulberry twig; for lower limb joint pain, add 15g of trachelospermum jasminoides.

[0007] The traditional Chinese medicine prescriptions described in the above-mentioned prior art still have the following problems:

[0008] 1. The treatment efficacy for rheumatoid arthritis, especially the damp-heat obstruction type, needs further improvement.

[0009] 2. The formula uses a variety of drugs, resulting in numerous side effects or potential side effects. The formula in the aforementioned prior art contains the animal-derived medicinal material centipede / animal-derived medicinal material bee honeycomb. Centipedes are poisonous. The prior art, "Clinical Observation on the Efficacy of Heat-Clearing and Blood-Activating Formulas in the Treatment of Active Rheumatoid Arthritis" (Jiang Quan et al., World Journal of Integrated Traditional and Western Medicine, 2010, Vol. 5, No. 7, pp. 588-592), records allergic side effects experienced by some patients due to the presence of *Sinomenium acutum* and *bee honeycomb* in the formula. Summary of the Invention

[0010] The purpose of this invention is to provide a traditional Chinese medicine composition for clearing heat and removing blood stasis and treating osteoarthritis, and related technologies, in order to solve the technical problems of existing traditional Chinese medicine prescriptions, such as the need to further improve efficacy and reduce side effects, or a combination thereof.

[0011] According to the existing book "Dictionary of Traditional Chinese Medicine" (Nanjing University of Traditional Chinese Medicine, Second Edition), the medicinal materials used in the formulation of this invention are as follows: Smilax glabra

Synonyms

[0012] [Origin] It is the rhizome of Smilax glabra, a plant belonging to the genus Smilax in the family Liliaceae.

[0013] [Original Plant] Smilax glabra Smilax glabra Roxb.

[0014] [Harvesting and Processing] Harvest from August to October, soak and bleach, slice and sun-dry; or boil in boiling water for a few minutes, then slice and sun-dry.

[0015] [Medicinal Properties] Sweet, bland, neutral. It enters the liver, kidney, spleen, and stomach meridians.

[0016]

Functions and Indications

[0017] honeysuckle

Synonyms

[0018]

Origin

[0019] [Original Plant] 1. Honeysuckle Japanese honeysuckle Thunb.

[0020] 2. South China Honeysuckle L. confused (Sweet) DC.

[0021] 3. Honeysuckle gland L. hypoglauca Miq.

[0022] 4. Yellow-brown hairy honeysuckle L. fulvotomentosa Hsu et SC Cheng.

[0023] [Harvesting and Processing] Honeysuckle flowers bloom 3-4 years after transplanting, with a concentrated flowering period. Harvesting should be done in batches promptly, generally the first harvest in mid-to-late May and the second in mid-to-late June. Harvesting is most suitable when the upper part of the flower bud swells, turns from green to white, and has not yet opened. Honeysuckle should be dried immediately after harvesting to prevent mold and spoilage. Avoid turning the flowers during drying to prevent them from turning black. The drying temperature should be controlled: initially 30-35℃, then increase to 40℃ after 2 hours and dry for 5-10 hours. Afterward, maintain a room temperature of 45-50℃ for 10 hours, then increase the temperature to 55-60℃ to ensure rapid drying. Avoid turning the flowers during drying or stopping drying before they are completely dry. Drying yields higher quality flowers than air drying.

[0024] [Medicinal Properties] Sweet, cold. Enters the Lung and Stomach meridians.

[0025]

Functions and Indications

[0026] Astragalus:

Synonyms

[0027] [Origin] The roots of Astragalus mongholicus and Astragalus membranaceus, both belonging to the genus Astragalus in the legume family.

[0028]

Original Plant

[0029] 2. Astragalus membranaceus (Fisch.) Bunge.

[0030] [Harvesting and Processing] Harvest 2-3 years after sowing, in September-November or before the winter buds sprout in spring. Dig deep to prevent root breakage, cut off the rhizome, shake off the soil, and sun-dry until semi-dry. Pile up for 1-2 days and sun-dry again until completely dry. Trim off the lateral roots and fibrous roots, and tie them into small bundles to obtain raw Astragalus membranaceus.

[0031] [Medicinal Properties] Sweet, warm. Enters the lung and spleen meridians.

[0032]

Functions and Indications

[0033] Gardenia jasminoides

Synonyms

[0034]

Original Source

[0035]

Original Plant

[0036]

Harvesting and Processing

[0037]

Medicinal Properties

[0038]

Functions and Indications

[0039] Polygonum cuspidatum

Synonyms

[0040]

Origin

[0041] [Original Plant] Japanese knotweed Polygonum cuspidatum Sieb. et Zucc.

[0042] [Harvesting and Processing] Harvesting can be done from April to September. It can be used fresh or dried.

[0043] [Medicinal Properties] Bitter, slightly cold. Enters the liver, gallbladder, and lung meridians.

[0044]

Functions and Indications

[0045] Red peony:

Synonyms

[0046] [Origin] The root of Paeonia lactiflora and Paeonia veitchii, plants of the Paeoniaceae family and Paeonia genus.

[0047] [Original plant] 1. Paeonia lactiflora Pall. [P. albiflora Pall.].

[0048] 2. Paeonia lactiflora P. veitchii Lynch.

[0049] [Harvesting and Processing] Harvest in August and September, dry until semi-dry, bundle into small bundles, and dry until fully dry.

[0050] [Medicinal Properties] Bitter, slightly cold. Enters the Liver and Spleen meridians.

[0051]

Functions and Indications

[0052] Salvia miltiorrhiza:

Synonyms

[0053] [Source] The root of Salvia miltiorrhiza, a plant belonging to the genus Salvia in the family Lamiaceae.

[0054] [Original plant] Salvia miltiorrhiza Bunge.

[0055] [Harvesting and Processing] For spring planting and sowing, harvest in the same year; for autumn planting and sowing, dig up the entire plant in October or November of the following year when the above-ground parts wither or before sprouting in the spring of the following year, remove the remaining stems and leaves, spread it out to dry to soften the roots, shake off the mud and sand (avoid washing with water), transport it back and dry it until it is 50-60% dry. Pinch the roots together, dry it again until it is 80-90% dry, pinch it once more to break off all the fibrous roots and dry it completely.

[0056] [Medicinal Properties] Bitter, slightly cold. It enters the Heart, Pericardium, and Liver meridians.

[0057]

Functions and Indications

[0058] Atractylodes lancea

Synonyms

[0059]

Origin

[0060] [Original Plant] 1. Atractylodes lancea Atractylodes lancea (Thunb.)DC.

[0061] 2. Northern Cangshu A. lanceolata (Thunb.) DC. var. Chinese (Bunge)Kitam.

[0062] 3. Guan Cangshu A. japonica Koidz. ex Kitam.

[0063] [Harvesting and Processing] After 2-3 years of cultivation, dig up the rhizomes from early September to early November or from February to March of the following year, remove the remaining stems, dry them in the sun, remove the root hairs, or use them after drying to 90% dryness, or singe off the root hairs and then dry them completely.

[0064] [Medicinal Properties] Pungent, bitter, warm. Enters the spleen, stomach, and liver meridians.

[0065]

Functions and Indications

[0066] Curcuma zedoaria

Synonyms

[0067]

Origin

[0068] [Original Plant] 1. Curcuma zedoaria Curcuma aeruginosa Roxb.

[0069] 2. Curcuma zedoaria from Guangxi C. Kwang-siensis SGLee et CF Liang.

[0070] 3. Wen Yujin C. wenyujin YH Chen et C. Ling.

[0071] [Harvesting and Processing] In mid-to-late December, when the above-ground parts wither, dig up the roots, remove the soil from the rhizomes, steam or boil them in a pot for about 15 minutes, then sun-dry or oven-dry them, and remove the fibrous roots. Alternatively, soak the rhizomes in clean water, take them out, drain the water, moisten them thoroughly, slice them thinly, and sun-dry or oven-dry them.

[0072] [Medicinal Properties] Pungent, bitter, warm. Enters the Liver and Spleen meridians.

[0073]

Functions and Indications

[0074] [Preparation] In this invention, the Curcuma zedoaria used is processed vinegar-processed Curcuma zedoaria.

[0075] The processing method for vinegar-processed turmeric is as follows: Place clean turmeric in a pot, add rice vinegar and an appropriate amount of water to cover it, and boil until the vinegar is absorbed completely. When the turmeric is cut open and there is no white core, remove it, let it dry slightly, cut it into thick slices, and dry it completely. For every 100 kg of turmeric, use 20 kg of rice vinegar. After being processed with vinegar, it mainly enters the liver meridian and blood level, enhancing its effect of dispersing blood stasis and relieving pain.

[0076] pawpaw:

Alternative names

[0077] [Origin] The fruit of the wrinkled-skin papaya, a plant belonging to the genus Chaenomeles in the family Rosaceae.

[0078] [Original plant] Chaenomeles speciosa (Sweet) Nakai [C. lagenaria (Loisel.) Koidz.] [Harvesting and Processing] Harvest papayas in early July or early August when the outer skin is greenish-yellow. Cut them in half with a copper knife, leaving the seeds intact. Dry at low temperature.

[0079] [Medicinal Properties] Sour, warm. Enters the liver, spleen, and stomach meridians.

[0080]

Functions and Indications

[0081] Gastrodia elata

Synonyms

[0082] [Origin] It is the tuber of Gastrodia elata, a plant belonging to the genus Gastrodia in the family Orchidaceae.

[0083] [Original Plant] Gastrodia elata Gastrodia elata Bl.

[0084] [Harvesting and Processing] Harvesting should be carried out during the dormant period. Harvesting should be done in October-November of the second year after winter planting or March-April of the third year. When harvesting, first collect the fungal material, then collect the Gastrodia elata and sisal for medicinal use, and white hemp and rice hemp for seed. Processing should be done promptly after harvesting. While fresh, remove mud and sand, and grade by size by boiling: 150g or more: 10-15 minutes; 100-150g: 7-10 minutes; less than 100g: 5-8 minutes; and ungraded: 5 minutes. Boil until thoroughly cooked. After boiling, place in a fumigation room and fumigate with sulfur for 20-30 minutes, then bake over a low flame. The initial temperature on the drying rack should be 50-60℃. When it is about 70-80% dry, remove it, flatten it by hand, and continue drying on the rack at around 70℃. Once completely dry, remove it from the rack immediately.

[0085] [Medicinal Properties] Sweet and pungent, neutral. Enters the Liver Meridian.

[0086]

Functions and Indications

[0087] To achieve the objectives of this invention, in a first aspect, this invention provides a traditional Chinese medicine composition for clearing heat and removing blood stasis, and for treating osteoarthritis, wherein the traditional Chinese medicine composition comprises Smilax glabra, Lonicera japonica, Astragalus membranaceus, Gardenia jasminoides, Polygonum cuspidatum, Paeonia lactiflora, Salvia miltiorrhiza, Atractylodes lancea, Curcuma zedoaria (processed with vinegar), Chaenomeles speciosa, and Gastrodia elata.

[0088] Specifically, the traditional Chinese medicine composition comprises, by weight, 20-40 parts of Smilax glabra, 20-40 parts of Lonicera japonica, 28-42 parts of Astragalus membranaceus, 10-20 parts of Gardenia jasminoides, 10-20 parts of Polygonum cuspidatum, 10-20 parts of Paeonia lactiflora, 10-20 parts of Salvia miltiorrhiza, 10-20 parts of Atractylodes lancea, 5-15 parts of Curcuma zedoaria (processed with vinegar), 5-15 parts of Chaenomeles speciosa, and 3-7 parts of Gastrodia elata.

[0089] As a specific embodiment of the present invention, the traditional Chinese medicine composition comprises, by weight, 40 parts of Smilax glabra, 20 parts of Lonicera japonica, 28 parts of Astragalus membranaceus, 10 parts of Gardenia jasminoides, 20 parts of Polygonum cuspidatum, 20 parts of Paeonia lactiflora, 10 parts of Salvia miltiorrhiza, 20 parts of Atractylodes lancea, 15 parts of Curcuma zedoaria (processed with vinegar), 5 parts of Chaenomeles speciosa, and 7 parts of Gastrodia elata.

[0090] As a specific embodiment of the present invention, the traditional Chinese medicine composition comprises, by weight, 20 parts of Smilax glabra, 40 parts of Lonicera japonica, 42 parts of Astragalus membranaceus, 20 parts of Gardenia jasminoides, 10 parts of Polygonum cuspidatum, 10 parts of Paeonia lactiflora, 20 parts of Salvia miltiorrhiza, 10 parts of Atractylodes lancea, 5 parts of Curcuma zedoaria (processed with vinegar), 15 parts of Chaenomeles speciosa, and 3 parts of Gastrodia elata.

[0091] More specifically, the traditional Chinese medicine composition comprises, by weight, 25-35 parts of Smilax glabra, 25-35 parts of Lonicera japonica, 31-39 parts of Astragalus membranaceus, 13-17 parts of Gardenia jasminoides, 13-17 parts of Polygonum cuspidatum, 13-17 parts of Paeonia lactiflora, 13-17 parts of Salvia miltiorrhiza, 13-17 parts of Atractylodes lancea, 7-13 parts of Curcuma zedoaria (processed with vinegar), 7-13 parts of Chaenomeles speciosa, and 4-6 parts of Gastrodia elata.

[0092] As a specific embodiment of the present invention, the traditional Chinese medicine composition comprises, by weight, 35 parts of Smilax glabra, 25 parts of Lonicera japonica, 31 parts of Astragalus membranaceus, 13 parts of Gardenia jasminoides, 17 parts of Polygonum cuspidatum, 17 parts of Paeonia lactiflora, 13 parts of Salvia miltiorrhiza, 17 parts of Atractylodes lancea, 13 parts of Curcuma zedoaria (processed with vinegar), 7 parts of Chaenomeles speciosa, and 6 parts of Gastrodia elata.

[0093] As a specific embodiment of the present invention, the traditional Chinese medicine composition comprises, by weight, 25 parts of Smilax glabra, 35 parts of Lonicera japonica, 39 parts of Astragalus membranaceus, 17 parts of Gardenia jasminoides, 13 parts of Polygonum cuspidatum, 13 parts of Paeonia lactiflora, 17 parts of Salvia miltiorrhiza, 13 parts of Atractylodes lancea, 7 parts of Curcuma zedoaria (processed with vinegar), 13 parts of Chaenomeles speciosa, and 4 parts of Gastrodia elata.

[0094] More specifically, and as a specific embodiment of the present invention, the traditional Chinese medicine composition comprises, by weight, 30 parts of Smilax glabra, 30 parts of Lonicera japonica, 35 parts of Astragalus membranaceus, 15 parts of Gardenia jasminoides, 15 parts of Polygonum cuspidatum, 15 parts of Paeonia lactiflora, 15 parts of Salvia miltiorrhiza, 15 parts of Atractylodes lancea, 10 parts of Curcuma zedoaria (processed with vinegar), 10 parts of Chaenomeles speciosa, and 5 parts of Gastrodia elata.

[0095] Secondly, the present invention provides a medicine made from the above-mentioned traditional Chinese medicine composition as raw material.

[0096] Specifically, the dosage forms of the drug include decoctions, powders, pills, tablets, lozenges, ointments, suspensions, granules, and capsules.

[0097] Specifically, the drug also includes pharmaceutically acceptable excipients.

[0098] Specifically, the drug is a medicine for clearing heat and removing blood stasis, and for treating osteoarthritis.

[0099] Thirdly, the present invention provides a method for preparing the above-mentioned drug, comprising the following steps: mixing the traditional Chinese medicine composition with water and decocting it.

[0100] Fourthly, the present invention provides the application of the above-mentioned traditional Chinese medicine composition or the above-mentioned drug in the preparation of a drug for clearing heat and removing blood stasis and treating osteoarthritis.

[0101] Furthermore, the osteoarthritis is rheumatoid arthritis and / or gouty arthritis.

[0102] The solution of this invention is as follows: Smilax glabra (Tufuling) detoxifies and promotes diuresis, while Lonicera japonica (Jinyinhua) assists in clearing heat and detoxifying, and Astragalus membranaceus (Huangqi) strengthens the body and removes toxins; together they are the principal herbs. Gardenia jasminoides (Zhizi), Polygonum cuspidatum (Huzhang), Paeonia lactiflora (Chishao), and Salvia miltiorrhiza (Danshen) assist the principal herbs in clearing heat, cooling the blood, and promoting blood circulation; these are the assistant herbs. Atractylodes lancea (Cangzhu) dries dampness and prevents coldness from hindering dampness; Curcuma zedoaria (Zhezhu) (processed with vinegar) breaks up blood stasis and promotes qi circulation, enhancing the blood-activating effect; Chaenomeles speciosa (Mugua) resolves dampness and relaxes muscles, targeting joint and muscle contractures; these three are the adjuvant herbs. Gastrodia elata (Tianma) calms the liver, extinguishes wind, dispels wind, and unblocks the meridians, guiding the medicinal power into the meridians and joints; this is the guiding herb. The entire formula works synergistically to clear heat and detoxify, promote diuresis and unblock the meridians, activate blood circulation and remove blood stasis, and strengthen the body's resistance and qi.

[0103] Compared with the prior art, the present invention has the following beneficial effects: 1. The traditional Chinese medicine composition of the present invention has the following characteristics: (1) The whole formula uses both cold and warm herbs to treat damp heat.

[0104] The formula includes both cold-natured herbs such as honeysuckle, gardenia, and polygonum cuspidatum, and warm-natured herbs such as atractylodes lancea, papaya, and turmeric (processed with vinegar). Dampness is a yin evil that cannot be transformed without warmth; heat is a yang evil that cannot be cleared without cold. If only cold herbs are used, although heat can be cleared, the dampness will be "hidden" by the cold, making it even more difficult to remove. The formula uses the warming and drying properties of atractylodes lancea to strengthen the spleen and remove dampness, and the warming and unblocking properties of turmeric (processed with vinegar) to promote qi and blood circulation. Combined with papaya to resolve dampness and relax muscles, this formula can prevent cold herbs from hindering the removal of dampness, thus better decomposing damp-heat evils.

[0105] (2) The whole formula combines attack and supplementation, eliminating evil without harming the body's vital energy.

[0106] The formula includes herbs such as Smilax glabra, Lonicera japonica, Curcuma zedoaria, and Paeonia lactiflora, which have the function of "attacking pathogens" (clearing heat, removing dampness, and promoting blood circulation), belonging to the "purging method"; while Astragalus membranaceus is a powerful qi-tonifying herb, belonging to the "tonifying method". In complex chronic diseases, patients often have "deficient vital energy and still strong pathogenic factors". If one only attacks the pathogenic factors, it will damage the body's vital energy, leading to prolonged illness. Adding Astragalus membranaceus can enhance the patient's own disease resistance and recovery ability, support vital energy, and promote the flow of qi, water and blood, thus assisting the dampness-removing and blood-activating herbs to exert better effects.

[0107] (3) The toxic centipede and the succulent pine and bee honeycomb used in similar prescriptions in the prior art have been removed, which are prone to causing allergic reactions, thus reducing the side effects of the drug; at the same time, Gastrodia elata is used as the guiding drug to guide the medicinal power into the meridians and joints, thereby improving the therapeutic effect of osteoarthritis.

[0108] 2. Compared with existing technologies, the traditional Chinese medicine composition provided by this invention can better enhance the therapeutic effect of rheumatoid arthritis. Mouse experiments show that the traditional Chinese medicine composition provided by this invention can reduce the joint swelling score and type II collagen antibody level in rheumatoid arthritis.

[0109] 3. Compared with existing technologies, the indications of this invention are broader, and it also has a good therapeutic effect on gouty arthritis. Mouse experiments show that the traditional Chinese medicine composition provided by this invention can reduce the ankle joint circumference in mice with acute gout attacks and reduce joint swelling caused by inflammation. Detailed Implementation

[0110] Terminology and Declarations of this Invention: 1. Articles “a,” “a kind,” and “the”: These include plural objects unless otherwise explicitly specified as a single (kind) object.

[0111] 2. Numerical Range: Unless otherwise expressly stated, all ranges or ratios disclosed herein shall be construed as including any and all subranges or subratios contained herein. For example, a stated range or ratio of 1 to 30 shall be considered to be included between the minimum value of 1 and the maximum value of 30, and includes any subranges or subratios, integers, decimals, or subranges or subratios consisting of integers or decimals, including endpoints.

[0112] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0113] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all chemical reagents used in the embodiments of the present invention were obtained through conventional commercial means. Unless otherwise specified, all contents mentioned below are mass contents. Unless otherwise specified, it is understood that the process was carried out at room temperature.

[0114] Examples 1-3 provide a traditional Chinese medicine composition, the weight ratio of its components is shown in Table 1 below.

[0115] Table 1

[0116] Comparative Examples 1-3 provide a traditional Chinese medicine composition, the weight ratio of its components is shown in Table 2 below ("-" indicates that the substance is not present).

[0117] Table 2

[0118] Comparative Example 4 The existing technology CN102451428A provides a traditional Chinese medicine composition. The specific formulation is as follows: Smilax glabra 30g, Lonicera japonica 30g, Atractylodes lancea 15g, Phellodendron chinense 10g, Paeonia lactiflora 15g, Salvia miltiorrhiza 15g, Coix lacryma-jobi 20g, Curcuma zedoaria 10g, Dioscorea hypoglauca 15g, Sinomenium acutum 30g, Astragalus membranaceus 30g, Scolopendra subspinipes 2 pieces, Vespa nidus 5g.

[0119] Comparative Example 5 A traditional Chinese medicine composition, the specific formula of which is as follows: Smilax glabra 30g, Lonicera japonica 30g, Atractylodes lancea 15g, Phellodendron chinense 10g, Paeonia lactiflora 15g, Salvia miltiorrhiza 15g, Coix lacryma-jobi 20g, Curcuma zedoaria 10g, Dioscorea hypoglauca 15g, Sinomenium acutum 30g, Vespa nidus 5g.

[0120] Comparative Example 6 A traditional Chinese medicine composition, the specific formula of which is as follows: Smilax glabra 30g, Lonicera japonica 30g, Atractylodes lancea 15g, Phellodendron chinense 10g, Paeonia lactiflora 15g, Salvia miltiorrhiza 15g, Coix lacryma-jobi 20g, Curcuma zedoaria 10g, Dioscorea hypoglauca 15g, Sinomenium acutum 30g, Vespa nidus 5g, Morus alba 15g, Trachelospermum jasminoides 15g, Gypsum fibrosum 30g, Anemarrhena asphodeloides 12g.

[0121] Comparative Example 7 Compared to Example 1, the only difference is that the weight parts of each component in the traditional Chinese medicine composition are different; all other aspects are the same. Specifically, the traditional Chinese medicine composition consists of the following components by weight: Smilax glabra 15 parts, Lonicera japonica 15 parts, Astragalus membranaceus 15 parts, Gardenia jasminoides 45 parts, Polygonum cuspidatum 30 parts, Paeonia lactiflora 15 parts, Salvia miltiorrhiza 5 parts, Atractylodes lancea 5 parts, Curcuma zedoaria (processed with vinegar) 30 parts, Chaenomeles speciosa 30 parts, and Gastrodia elata 2 parts.

[0122] Comparative Example 8 A traditional Chinese medicine composition, comprising the following components in parts by weight: 12 parts of kudzu root, 12 parts of gardenia, 12 parts of Japanese knotweed, 12 parts of mulberry, 9 parts of wild chrysanthemum, 9 parts of cassia seed, 9 parts of green plum, 9 parts of plantain seed, 12 parts of Sichuan achyranthes root, 12 parts of evodia fruit, 12 parts of papaya, 12 parts of angelica root, 12 parts of smilax glabra, 12 parts of atractylodes lancea, 12 parts of polygonatum odoratum, 9 parts of hawthorn, 12 parts of lotus leaf, and 7 parts of prepared licorice root.

[0123] Preparation example: The preparation methods of the traditional Chinese medicine compositions of Examples 1-5 and Comparative Examples 1-8 are as follows.

[0124] Mix the traditional Chinese medicine composition according to the weight ratio, pulverize it, and add water at a ratio of 1g of traditional Chinese medicine composition to 5mL of water. Decoction, filter and retain the filtrate. Repeat the decoction 3 times. Combine the filtrates and concentrate under reduced pressure to a density of 1.18-1.21g / mL to obtain the traditional Chinese medicine composition (concentrated solution) for later use.

[0125] Effect evaluation 1. Evaluation of the therapeutic effect of traditional Chinese medicine composition on rheumatoid arthritis.

[0126] The following is information regarding the medication used: Freund's complete adjuvant and Freund's incomplete adjuvant were purchased from Beyotime (50 mL). Bovine type II collagen solution was purchased from AmyJet Scientific (Bovine Type II Collagen-Solution, catalog number: 1220-02S, protein content: 0.5 mg). Glacial acetic acid was from Shanghai Testing, GR, ≥99.8%.

[0127] Bovine type II collagen emulsion is prepared from bovine type II collagen solution, glacial acetic acid, and Freund's adjuvant. The preparation method is as follows: glacial acetic acid is mixed with deionized water to obtain a 0.05M acetic acid solution. The bovine type II collagen solution is then mixed with the 0.05M acetic acid solution to prepare a 2 mg / mL bovine type II collagen solution. Under ice bath conditions, Freund's complete adjuvant or Freund's incomplete adjuvant is repeatedly mixed with the 2 mg / mL bovine type II collagen solution at a 1:1 volume ratio until homogeneous, removing air bubbles to obtain the bovine type II collagen emulsion. This emulsion should be injected into mice within 1 hour of preparation. The emulsion obtained using Freund's complete adjuvant is designated as Emulsion 1; the emulsion obtained using Freund's incomplete adjuvant is designated as Emulsion 2.

[0128] Animal modeling and drug administration: Experimental animals: 7-8 week old male DBA / 1J mice, acclimatized for one week.

[0129] Animal modeling methods: (1) First injection on day 0: Emulsion 1 (100 μg of bovine type II collagen per mouse) was injected subcutaneously into the tail of the mouse.

[0130] (2) Enhanced injection on day 21: Emulsion 2 was injected subcutaneously into the tail of the mice (the dosage of bovine type II collagen per mouse was 100 μg, and the injection site was different from the first injection).

[0131] (3) From day 29 to 37, the mice showed symptoms of redness and swelling of the skin of the paw joints and swelling of the toes, indicating that the mouse CIA model was successfully established. Due to the reduced activity of the mice, sterile water and food were placed in the cage for easy feeding.

[0132] On day 38, animals were grouped: mice that successfully modeled the virus were randomly divided into groups of 7. Mice from the same batch that did not model the virus were also grouped into groups of 7. The specific groupings are as follows: Blank control group: DBA / 1J mice that have not been modeled by CIA and have normal diet and water intake.

[0133] Model control group: DBA / 1J mice modeled by CIA were administered 100 μL of sterile saline solution by gavage daily.

[0134] Positive control group: DBA / 1J mice modeled by CIA were injected intraperitoneally every 2 days with 0.5 mg / L methotrexate saline solution (containing as little as possible of the solubilizer Tween 80 to ensure complete drug dissolution), with an injection volume of 3 mL / kg mouse body weight.

[0135] Each example group and comparative example group: The traditional Chinese medicine composition prepared in each example group and comparative example group was administered by gavage once a day (the dosage was 15g / kg mouse body weight per day based on the weight of the raw drug).

[0136] The above-mentioned model control group, positive control group, each example group, and comparative group were administered the drug for a total of 16 days. During the drug administration period, the body weight of the mice was monitored, and the severity of rheumatoid arthritis symptoms was scored. After the drug administration was completed, venous blood was collected from the fundus venous plexus of the mice, and the levels of antibodies and biomarkers in the serum were detected.

[0137] Arthritis scoring test: Starting from day 21, the degree of swelling in the mice's paws and joints was assessed every two days. The scoring criteria are shown in Table 3 below: Table 3

[0138] Each mouse's four paws were scored individually, and the scores were summed. Therefore, each mouse's score ranged from 0 to 16 points per assessment, and each group consisted of 7 mice. The scores for paw and joint swelling on days 21, 41, and 51 are shown in Table 4 below (n=7, mean ± standard deviation, rounded to one decimal place, unit: points): Table 4

[0139] As can be seen, on day 51, the embodiments provided by the present invention can significantly reduce the symptom scores of rheumatoid arthritis, especially the group of embodiments 1, which has the best effect.

[0140] Detection of serum anti-type II collagen antibody levels in mice.

[0141] The level of anti-type II collagen antibody in mouse serum was detected according to the detection method provided in the kit instructions (Mouse Anti-type II Collagen Antibody Kit, Fein Biotech, EM0837-96T). The results are shown in Table 5 below (mean ± standard deviation, n=7, unit μg / mL): Table 5

[0142] in, This indicates that there are significant differences between the remaining embodiments and comparative example groups and Example 1 group, with p < 0.01; This indicates that there are significant differences between the remaining embodiments and comparative example groups and Example 1 group, with p < 0.001; This indicates that there are significant differences between the other embodiments and comparative example groups and Example 1 group, with p < 0.0001.

[0143] It is evident that the Panlongqi extract obtained in the various embodiments provided by the present invention has a better effect on reducing the level of anti-type II collagen antibodies compared with each comparative group.

[0144] 2. Evaluation of the therapeutic effect of traditional Chinese medicine composition on gouty arthritis.

[0145] The experiment was conducted using the modeling method provided in the existing technology "Establishment of Animal Model of Acute Gouty Arthritis and Related Basic Research" (Master's Thesis, Inner Mongolia Medical University, Deng Lichao, 2024.5).

[0146] Experimental animals: SD rats, 6-8 weeks old, weighing 200±20g.

[0147] Preparation of experimental reagents.

[0148] Preparation of sodium urate crystal suspension: Take 1g of sodium urate crystals, grind them into powder, sterilize by ultraviolet irradiation, add 4mL of Tween 80, slowly add sterile physiological saline, heat and stir to prepare a 25mg / mL sodium urate crystal suspension. After autoclaving, store at 4℃ and shake well before use.

[0149] In this experiment, the maintenance diet used was a complete maintenance diet for adult mice, purchased from Shuyu Biotechnology. The high uric acid model diet was prepared as follows: by weight percentage, 3% potassium oxonate, 15% yeast extract (brand: Adamas Life), and the remaining maintenance diet powder were mixed, and then re-pressed.

[0150] Experimental grouping: Rats were randomly divided into groups of 7 (n=7).

[0151] Control group: Rats had free access to maintenance feed and normal drinking water, and were given 1.5 mL of physiological saline by gavage every other day. After 6 weeks of continuous feeding, 0.2 mL of physiological saline was injected into the right ankle joint space of the rats. The feeding method remained unchanged before and after the injection.

[0152] Model group: Rats were allowed free access to a high-uric acid model diet and normal drinking water, and were given 1.5 mL of physiological saline by gavage every other day. After 6 weeks of continuous feeding, 0.2 mL of prepared sodium urate crystal suspension was injected into the right ankle joint space of the rats. The feeding method remained unchanged before and after the injection.

[0153] Each example and comparative group: Rats were allowed free access to a high uric acid model diet and normal drinking water. Every other day, each group was administered 1.5 mL of physiological saline solution (10 g / kg rat body weight / glucose dose of raw herbal composition) of the prepared herbal composition. After 6 weeks of continuous feeding, 0.2 mL of prepared sodium urate crystal suspension was injected into the right ankle joint space of the rats. Feeding methods remained unchanged before and after injection.

[0154] The ankle circumference of rats was measured using vernier calipers before injection of fluid into the ankle joint space, 4 hours after injection, 24 hours after injection, 48 hours after injection, and 72 hours after injection. The experimental results are shown in Table 6 below (unit: cm, mean ± standard deviation, n=7): Table 6

[0155] in, This indicates that the data in the same column are significantly different from the model group, with p < 0.05; This indicates that the data in the same column are significantly different from the model group, and p < 0.01; The data in the same column showed a significant difference compared to the model group, with p < 0.001. This indicates that the data in the same column are significantly different from the model group, with p < 0.0001.

[0156] As shown in the table above, 4 hours after injection, the joint circumference of each group did not differ significantly. This is due to the volume change caused by the injection of a certain volume of fluid into the joint cavity. However, at 24, 48, and 72 hours after injection, the joint circumference of the model group was significantly larger than that of the blank control group. This is because sodium urate crystals produced an inflammatory reaction in the joint cavity, leading to joint swelling. At 24, 48, and 72 hours after injection, the joint circumference of each embodiment group was lower than that of the model group, and the average reduction was greater than that of the comparative groups. Therefore, compared with the comparative groups, the traditional Chinese medicine composition provided in each embodiment of the present invention is more effective in reducing ankle swelling during acute gout attacks.

[0157] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for clearing heat and removing blood stasis, and treating osteoarthritis, characterized in that, The traditional Chinese medicine composition comprises, by weight, 20-40 parts of Smilax glabra, 20-40 parts of Lonicera japonica, 28-42 parts of Astragalus membranaceus, 10-20 parts of Gardenia jasminoides, 10-20 parts of Polygonum cuspidatum, 10-20 parts of Paeonia lactiflora, 10-20 parts of Salvia miltiorrhiza, 10-20 parts of Atractylodes lancea, 5-15 parts of Curcuma zedoaria (processed with vinegar), 5-15 parts of Chaenomeles speciosa, and 3-7 parts of Gastrodia elata.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises, by weight, 25-35 parts of Smilax glabra, 25-35 parts of Lonicera japonica, 31-39 parts of Astragalus membranaceus, 13-17 parts of Gardenia jasminoides, 13-17 parts of Polygonum cuspidatum, 13-17 parts of Paeonia lactiflora, 13-17 parts of Salvia miltiorrhiza, 13-17 parts of Atractylodes lancea, 7-13 parts of Curcuma zedoaria (processed with vinegar), 7-13 parts of Chaenomeles speciosa, and 4-6 parts of Gastrodia elata.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition consists of 30 parts by weight of Smilax glabra, 30 parts of Lonicera japonica, 35 parts of Astragalus membranaceus, 15 parts of Gardenia jasminoides, 15 parts of Polygonum cuspidatum, 15 parts of Paeonia lactiflora, 15 parts of Salvia miltiorrhiza, 15 parts of Atractylodes lancea, 10 parts of Curcuma zedoaria (processed with vinegar), 10 parts of Chaenomeles speciosa, and 5 parts of Gastrodia elata.

4. A drug, characterized in that, It is prepared using the traditional Chinese medicine composition described in any one of claims 1-3 as a raw material.

5. The drug according to claim 4, characterized in that, The dosage forms of the drugs include decoctions, powders, pills, tablets, lozenges, ointments, suspensions, granules, and capsules.

6. The drug according to claim 4, characterized in that, The drug also includes pharmaceutically acceptable excipients.

7. A method for preparing the drug according to any one of claims 4-6, characterized in that, Includes the following steps: Mix the Chinese herbal medicine composition with water and decoct.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-3 or the drug according to any one of claims 4-6 in the preparation of a drug for clearing heat and removing blood stasis and / or treating osteoarthritis.

9. The application according to claim 8, characterized in that, The osteoarthritis mentioned is rheumatoid arthritis.

10. The application according to claim 8, characterized in that, The osteoarthritis mentioned is gouty arthritis.

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