A traditional Chinese medicine composition for dredging collaterals, resolving stasis and relieving pain and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for dredging collaterals, resolving stagnation and relieving pain and a preparation method thereof. The composition is prepared from more than twenty kinds of traditional Chinese medicinal materials, such as ginseng, aconite, astragalus, asarum, salvia miltiorrhiza, dried tangerine or orange peel, pinellia, silkworm chrysalis, earthworm, earthworm, atractylodes, rhubarb, sparganium, antler, angelica, chuanxiong, persica, safflower, south saussurea, and camphor. The preparation method comprises the following steps: grouping the medicinal materials, respectively performing low-temperature drying, crushing, alcohol extraction and water extraction, combining the extracts, mixing the extracts with fine powder, drying, and forming. The application is based on the pathogenesis of deficiency, stagnation, coldness and phlegm and blood stasis, and realizes the effects of dredging collaterals, resolving stagnation and relieving pain through the compound compatibility of tonifying yang and benefiting qi and dispelling cold and dredging collaterals and a standardized process, and the drug efficacy is stable.

Description

Technical Field

[0001] This invention relates to the field of medical pharmaceutical technology, and in particular to a traditional Chinese medicine composition for relieving thrombosis, dispersing nodules, and alleviating pain, and its preparation method. Background Technology

[0002] Cardiovascular and cerebrovascular diseases and thromboembolic diseases are major threats to human health. Traditional Chinese medicine believes that these diseases often originate from "deficiency and stagnation with cold" and "phlegm and blood stasis." Their pathological evolution often involves multiple factors such as qi deficiency and lack of propulsion, cold stagnation and meridian contraction, and phlegm obstruction of qi and blood, ultimately leading to poor blood circulation and the formation of thrombi, nodules, or lumps.

[0003] In current clinical practice, while traditional methods of promoting blood circulation and removing blood stasis can improve symptoms to some extent, they often focus on "unblocking" and "breaking" blood stasis after its formation. They are insufficient in addressing the root causes of stasis, such as qi deficiency, cold coagulation, and phlegm turbidity. This results in poor treatment outcomes for conditions caused by deficiency leading to stasis or cold causing stagnation, leading to higher rates of disability or sequelae after patient recovery. Furthermore, the extensive nature of traditional Chinese medicine preparation manufacturing processes limits the precise control of parameters in key stages such as extraction and concentration. This not only leads to the loss of effective components and poor drug stability but also restricts the improvement of bioavailability. Simultaneously, with the increasing scarcity of some wild blood-activating and stasis-removing medicinal resources, how to rationally achieve the substitution of endangered medicinal materials while ensuring clinical efficacy is a common problem that urgently needs to be solved in current preparation development and large-scale production.

[0004] Therefore, how to develop a traditional Chinese medicine preparation that can comprehensively regulate the body's state, specifically address the phlegm-blood stasis, and simultaneously achieve controllable production processes and sustainable resource utilization, based on the fundamental pathogenesis, has become a topic that requires in-depth research by those skilled in the art. Summary of the Invention

[0005] In view of this, the present invention aims to provide a traditional Chinese medicine composition for relieving thrombosis, dispersing nodules, and alleviating pain, as well as a method for preparing the same, in order to solve or alleviate the technical problems existing in the prior art.

[0006] The technical solution of this invention is implemented as follows: a traditional Chinese medicine composition for unblocking thrombi, dispersing nodules, and relieving pain, and its preparation method, is made from the following raw materials in parts by weight: ginseng 8-12 parts, aconite 9-15 parts, astragalus 16-24 parts, asarum 2-4 parts, salvia miltiorrhiza 12-18 parts, tangerine peel 12-18 parts, pinellia 8-12 parts, silkworm 4-8 parts, earthworm 4-7 parts, pangolin scales 4-8 parts, earthworm 4-8 parts, leech 2-4 parts, atractylodes lancea 9-15 parts, rhubarb 4-8 parts, sparganium 8-12 parts, turmeric 8-12 parts, deer antler 2-4 parts, angelica sinensis 4-8 parts, chuanxiong rhizome 9-15 parts, peach kernel 7-11 parts, safflower 12-18 parts, adenophora stricta 8-12 parts, and borneol 1-3 parts.

[0007] A method for using a traditional Chinese medicine composition to promote blood circulation, relieve pain, and dispel lumps includes the following steps: S1. Pre-processing and grouping of medicinal materials: S1.1 Remove the root head from the prescribed amount of ginseng, and clean, wash, and cut the aconite, astragalus, salvia miltiorrhiza, atractylodes lancea, sparganium, curcuma zedoaria, angelica sinensis, chuanxiong, and adenophora stricta respectively. After low-temperature drying, mix and pulverize into coarse powder of 80-120 mesh to obtain the first drug composition. S1.2 Stir-fry the prescribed amount of leeches with talcum powder until they puff up, let them cool, and then crush them; S1.3 The prescribed amount of pangolin scales is scalded with sand, and the silkworm is stir-fried with wheat bran and cooled; S1.4 The medicinal materials processed in steps S1.2 and S1.3 are cleaned and selected separately with the prescribed amounts of Asarum, Citrus reticulata peel, Pinellia ternata, Eupolyphaga sinensis, Pheretima aspergillum, Deer antler, Prunus persica kernel, and Carthamus tinctorius. After mixing, they are pulverized into a fine powder of 100-200 mesh to obtain the second drug composition. S2. Alcohol extraction: The first pharmaceutical composition is extracted by reflux with 6-12 times the volume of 60%-80% ethanol solution for 1-3 times, each time for 1-2 hours. The extracts are combined, filtered, and the ethanol is recovered from the filtrate under reduced pressure. The filtrate is then concentrated under reduced pressure to a thick paste with a relative density of 1.10-1.20 at 60°C to obtain the alcohol extract. S3. Water extraction: Mix the residue after alcohol extraction in step S2 with the prescribed amount of rhubarb, add 8-12 times the amount of water and decoct 1-3 times, 1-2 hours each time. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.10-1.20 at 60℃ to obtain the water extract. S4. Combining and Drying: Combine the alcohol extract obtained in step S2 with the water extract obtained in step S3, add the fine powder of the second pharmaceutical composition obtained in step S1.4 and the prescribed amount of borneol, mix evenly, dry, and pulverize into fine powder to obtain the active pharmaceutical ingredient. S5. Formulation: Pharmaceutically acceptable excipients are added to the active pharmaceutical ingredient obtained in step S4, and an oral formulation is prepared according to conventional formulation processes.

[0008] The pharmacological properties of each Chinese medicinal herb used are as follows: Ginseng: Sweet and slightly bitter in taste, and slightly warm in nature. It enters the spleen, lung, heart, and kidney meridians. It has the effects of greatly replenishing vital energy, restoring pulse and consolidating the body, tonifying the spleen and lungs, promoting body fluid and nourishing blood, and calming the mind and improving intelligence. Modern pharmacological studies have shown that it has a bidirectional effect on the cardiovascular system, initially stimulating and then inhibiting it. It can resist arrhythmia, protect the myocardium, dilate blood vessels, inhibit platelet aggregation, and stimulate and protect the hematopoietic function of bone marrow.

[0009] As the principal ingredient, its function in this invention is to greatly replenish vital energy. Qi is the commander of blood; by drastically replenishing vital energy, the fundamental driving force for blood circulation is provided, resolving the root cause of blood stagnation and blockage (i.e., "deficiency and stagnation") caused by qi deficiency. This is the basis for supporting the body's resistance to expel pathogens.

[0010] When combined with aconite: Ginseng replenishes the vital energy of the internal organs, while aconite warms and strengthens the yang energy of the whole body. The combination of the two is called Ginseng and Aconite Decoction, a classic combination for warming and tonifying yang energy and treating collapse. It plays a role of "warming and tonifying at the same time", so that the yang energy is vigorous and powerful.

[0011] When combined with Astragalus: Ginseng is good at replenishing the Qi of the five internal organs, while Astragalus is good at reaching the surface of the muscles and meridians. The two complement each other and greatly replenish the Qi of the whole body, making the Qi strong to promote blood circulation.

[0012] When combined with Angelica sinensis: This is a commonly used combination for nourishing both Qi and Blood. Ginseng nourishes Qi, while Angelica sinensis nourishes Blood, enabling Qi to generate Blood and Blood to carry Qi, thus promoting the generation and circulation of Qi and Blood.

[0013] Aconite: Pungent and sweet in nature, extremely hot in nature, and toxic. It enters the heart, kidney, and spleen meridians. It has the effects of restoring yang and rescuing from collapse, tonifying fire and assisting yang, dispelling cold and dampness, and relieving pain. Modern pharmacological studies have confirmed that it has a significant cardiotonic effect, enhancing myocardial contractility and increasing cardiac output; it can dilate blood vessels, increase blood flow, and improve blood circulation; and it can resist shock and bradycardia.

[0014] As the principal herb, Aconitum carmichaelii, with its intensely warming properties, targets the "cold stagnation" in the pathogenesis, warming and unblocking the twelve meridians, dispelling deep-seated cold and stagnation, and breaking up the stagnation of yin-cold. Its yang-tonifying effect can restore the function of the internal organs and clear away the obstruction of cold pathogens for the smooth flow of qi and blood.

[0015] When combined with ginseng, it becomes Ginseng and Aconite Decoction, which combines warming yang with tonifying qi, making it more effective in restoring yang, rescuing from collapse, and consolidating qi. It is mainly used to treat critical conditions such as sudden collapse of yang qi and cold extremities. In this invention, it provides the driving force for warming and unblocking blood vessels.

[0016] When combined with Asarum: Both are very pungent and hot. Asarum helps Aconite to dispel cold internally and unblock the meridians externally, enhancing its ability to expel cold and relieve pain. This is similar to the synergistic effect of the two in the ancient formula Da Huang Fu Zi Tang (Rhubarb and Aconite Decoction) in dispelling cold.

[0017] When combined with rhubarb: Aconite is extremely hot, while rhubarb is extremely cold. When the two are combined, rhubarb can be de-cooled by aconite, while retaining its function of promoting metabolism, removing blood stasis and unblocking meridians. This is the wonder of "removing the nature and retaining the function", which can both eliminate turbidity and not harm yang qi.

[0018] Astragalus: Sweet and slightly warm in nature. It enters the spleen and lung meridians. It has the effects of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting circulation and relieving pain, promoting pus drainage and detoxification, and promoting wound healing and tissue regeneration. Pharmacological studies have shown that astragalus can enhance the body's immune function, strengthen the heart (at moderate doses), has a bidirectional regulatory effect on blood pressure, and can dilate peripheral blood vessels and improve blood circulation.

[0019] As the principal herb, Astragalus membranaceus is known as the "leader in tonifying Qi," assisting ginseng in greatly tonifying the Qi of the spleen and lungs. Its characteristic lies in its ability to "move," tonifying Qi to relieve stagnation and numbness, and has a direct therapeutic effect on numbness of limbs and hemiplegia, guiding the medicinal power of Qi directly to the blood vessels and the surface of the body.

[0020] When combined with ginseng: the two form a classic combination for replenishing qi. When ginseng and astragalus are used together, their qi-replenishing power is even greater, which can greatly replenish the original qi of the spleen and lungs and nourish the source of qi and blood production.

[0021] When combined with Angelica sinensis, it embodies the principle of Angelica sinensis blood-nourishing decoction. Astragalus membranaceus is used in five times the amount of Angelica sinensis, with the intention of "tonifying qi to generate blood." When qi is abundant, blood is generated, and when blood is sufficient, the blood vessels are full, which is beneficial for both circulation and repair.

[0022] When combined with Ligusticum chuanxiong: Astragalus membranaceus tonifies Qi and raises Yang, while Ligusticum chuanxiong invigorates blood and promotes Qi circulation. When the two are combined, one tonifies and the other disperses, so that Qi is vigorous without stagnation and blood is active without stasis, thus achieving the effect of invigorating Qi and promoting blood circulation.

[0023] Asarum: Pungent and warm in nature, slightly toxic. It enters the heart, lung, and kidney meridians. It can dispel wind and cold, open the orifices, relieve pain, and warm the lungs to resolve phlegm. Modern pharmacological studies have found that it has antipyretic, analgesic, sedative, anti-inflammatory, and anti-allergic effects.

[0024] As the principal ingredient, Asarum is pungent, warm, and has a strong aromatic properties. It can both assist Aconitum carmichaelii in warming and dispersing cold pathogens deep in the meridians, and also "warm the lungs and transform phlegm," helping to thin out phlegm and turbidity. In this invention, it plays the role of a "pioneer," guiding Yang Qi deep into the Yin aspect to search out cold pathogens.

[0025] When combined with Aconitum carmichaelii: it has a synergistic effect, enhancing the overall efficacy of the formula in warming the meridians, dispelling cold, relieving pain, and alleviating numbness.

[0026] When combined with borneol: Both are pungent and aromatic, with Asarum entering the kidney meridian to dispel cold and borneol entering the heart meridian to open the orifices. The combination of the two drugs greatly enhances the ability of the whole formula to penetrate the barriers of blood, brain, phlegm accumulation, and stagnation, guiding all the drugs directly to the disease site.

[0027] Salvia miltiorrhiza: Bitter and slightly cold in nature. It enters the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling blood and reducing swelling. Modern pharmacological studies have shown that it has cardiovascular protective effects, can improve microcirculation, resist arteriosclerosis, and resist thrombosis; at the same time, it has a protective effect on the nervous system.

[0028] As an adjuvant medicine, Danshen Powder is a representative medicine for promoting blood circulation and removing blood stasis. It is said that "one dose of Danshen Powder is as effective as Siwu Decoction". It can directly target the pathogenesis of "stasis", promote blood circulation and unblock the meridians, and is especially good at treating chest pain and heart pain.

[0029] When combined with Ligusticum chuanxiong and Carthamus tinctorius: Salvia miltiorrhiza promotes blood circulation and cools the blood, Ligusticum chuanxiong promotes qi circulation and blood circulation, and Carthamus tinctorius is pungent and warm to promote blood circulation. When the three are used together, their cold and warm properties complement each other, which can greatly enhance the effects of promoting blood circulation, removing blood stasis, clearing the meridians and relieving pain, and improve the circulation of the heart, brain and peripheral blood vessels.

[0030] When combined with borneol: Danshen invigorates blood circulation, while borneol opens the orifices. The combination of the two is a classic combination for treating cardiovascular and cerebrovascular diseases. It can guide the medicine to the heart, open the orifices and unblock the meridians, and relieve chest pain.

[0031] Chuanxiong (Ligusticum striatum): Pungent and warm in nature. It enters the liver, gallbladder, and pericardium meridians. Its functions include promoting blood circulation, regulating qi, dispelling wind, and relieving pain.

[0032] As an auxiliary medicine, it is hailed as a "qi-regulating medicine within the blood," capable of both invigorating blood and promoting qi circulation. Its pungent and dispersing properties can ascend to the head and eyes, descend to the blood sea, and circulate through the limbs, significantly enhancing the effects of invigorating blood and relieving pain, and ensuring smooth flow of qi and blood.

[0033] When combined with Angelica sinensis, it forms the formula known as Buddha's Hand Powder, a basic combination for promoting blood circulation, regulating qi, nourishing blood, and regulating menstruation. Angelica sinensis nourishes and invigorates blood, while Ligusticum chuanxiong promotes qi circulation and invigorates blood. The combination of active and passive action ensures that blood is nourished without causing stagnation and that blood is circulated without harming it.

[0034] When combined with Astragalus: Astragalus tonifies Qi, while Ligusticum chuanxiong promotes Qi circulation and invigorates blood. The combination of these two herbs works synergistically to tonify Qi and invigorate blood, making it particularly suitable for cases of Qi deficiency and blood stasis.

[0035] Peach kernel: Bitter and sweet in taste, neutral in nature. It enters the heart, liver, and large intestine meridians. It has the effects of promoting blood circulation and removing blood stasis, moistening the intestines and relieving constipation, and relieving cough and asthma.

[0036] As an auxiliary medicine, peach kernel is a blood-breaking and stasis-removing herb with strong stasis-removing power. It is good at treating masses and accumulations with severe blood stasis. Moreover, its moist nature can lubricate the intestines and promote bowel movements, giving blood stasis a way out.

[0037] When combined with safflower: Peach kernel breaks up blood stasis, while safflower invigorates blood circulation. The two complement each other and are a golden combination for promoting blood circulation and removing blood stasis. It is widely used for blood stasis syndrome in various parts of the body and can significantly improve microcirculation disorders and dissipate thrombi.

[0038] Safflower: It is pungent and warm in nature. It enters the heart and liver meridians. It has the effects of promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain.

[0039] As an auxiliary medicine, safflower is pungent and warm, specifically entering the blood, and is good at promoting blood circulation, removing blood stasis, and relieving pain, especially good at clearing stagnation in the meridians.

[0040] When combined with peach kernel: see the section on peach kernel combinations above. When used together, the two work synergistically to break up blood stasis and promote blood circulation, with a balance of potent and mild medicinal effects, achieving the combined effect of resolving blood stasis and relieving pain.

[0041] When combined with Angelica sinensis and Ligusticum chuanxiong, the three herbs work together to invigorate blood, nourish blood, and regulate qi. This combination is a commonly used herbal remedy for blood stasis in gynecology and internal medicine, which can remove stagnant blood and promote the generation of new blood.

[0042] Leeches: Salty, bitter, and neutral in nature, with slight toxicity. They enter the liver meridian. They have the effects of breaking up blood stasis, promoting menstruation, removing blood stasis, and eliminating masses.

[0043] As an auxiliary medicine, leeches are insect-based medicinal ingredients with potent effects. They are adept at breaking up blood stasis and removing blood clots, especially stubborn thrombi and masses (such as old thrombi and lumps). Their penetrating power can penetrate deep into the collaterals and remove stagnant blood.

[0044] Combined with earthworm, pit viper, and pangolin scales: this forms a large group of insect-based medicines. Leeches are primarily used to break up blood stasis and remove blood clots; earthworms break up blood stasis and eliminate masses, and can also promote tendon and bone healing; pit vipers unblock the meridians and promote urination, and are adept at moving and penetrating; pangolin scales dispel wind and unblock the meridians, directly reaching the site of the disease. The combined use of several insect-based medicines forms a "blood stasis breaking and mass eliminating" team, capable of overcoming stubborn meridian stagnation.

[0045] Earthworm (also known as ground beetle): Salty and cold in nature, slightly toxic. It enters the liver meridian. It has the effects of breaking up blood stasis, promoting blood circulation, and healing tendons and bones.

[0046] As an auxiliary medicine, *Eupolyphaga sinensis* has a strong ability to break up blood stasis and remove blood clots, and is especially good at treating injuries from falls and blows, swelling and pain from bruises, as well as masses and lumps. It also has a good effect on dispersing old blood stasis.

[0047] When combined with leeches, Sparganium rhizome, and Curcuma zedoaria: Earthworm and leeches work together to break up blood stasis and remove blood clots. Combined with Sparganium rhizome and Curcuma zedoaria to break up blood stasis, promote qi circulation, eliminate stagnation, and relieve pain, it forms a powerful combination that is specifically designed to target stubborn nodules, lumps, and thrombi.

[0048] Pangolin scales: Salty and slightly cold in nature. They enter the liver and stomach meridians. They have the effects of promoting blood circulation and eliminating masses, regulating menstruation and promoting lactation, reducing swelling and draining pus, and dispelling wind and unblocking the meridians.

[0049] As an assistant herb, it is adept at moving and penetrating, able to unblock the meridians and reach the affected area, guiding other herbs to the site of stagnation.

[0050] When combined with leeches and earthworms: leeches and earthworms are primarily used to break up blood stasis, while pangolin scales are primarily used to unblock the meridians and eliminate pathogenic factors. The combination of the three can not only break up tangible blood stasis, but also penetrate deep into the meridians to eliminate latent pathogenic factors, leaving no place for stagnant blood to hide.

[0051] Sparganium rhizome: pungent, bitter, and neutral in nature. It enters the liver and spleen meridians. It has the effects of promoting blood circulation, regulating qi, eliminating stagnation, and relieving pain.

[0052] As an auxiliary medicine, the three-edged sword has a stronger blood-breaking power than the qi-regulating power, and is good at eliminating masses and accumulations, and resolving old blood.

[0053] When combined with Curcuma zedoaria: Sparganium rhizome breaks up blood stasis, while Curcuma zedoaria breaks up qi stagnation. The two are often used together, like swords, and have a strong effect of breaking down and dispersing masses (such as nodules, tumors, and hepatosplenomegaly) caused by qi stagnation and blood stasis.

[0054] Curcuma zedoaria: pungent, bitter, and warm in nature. It enters the liver and spleen meridians. Its functions include breaking up blood stasis, promoting qi circulation, eliminating stagnation, and relieving pain.

[0055] As an auxiliary medicine, Curcuma zedoaria has a stronger effect in promoting qi circulation than in breaking up blood stasis. It is good at promoting qi circulation, relieving pain, and eliminating food stagnation.

[0056] When used in combination with Sparganium rhizome: see above. The combination of the two treats both qi and blood, and doubles the effect of breaking up blood stasis and eliminating masses. It is a core herbal pair for treating various masses and accumulations.

[0057] Angelica sinensis: sweet and pungent in flavor, warm in nature. It enters the liver, heart, and spleen meridians. It has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements.

[0058] As an assistant herb, Angelica sinensis plays multiple roles in the blood-activating and stasis-removing group: on the one hand, its pungent and dispersing properties help activate blood; on the other hand, its sweet and warm nature can nourish blood, so that the whole formula can remove blood stasis without harming yin and blood, thus achieving "removing blood stasis without harming the body's vital energy".

[0059] When combined with Astragalus membranaceus, it forms Dang Gui Bu Xue Tang (Angelica Blood-Nourishing Decoction), which invigorates Qi and generates blood, providing a material basis for promoting blood circulation.

[0060] Combined with Ligusticum chuanxiong, peach kernel, and safflower: This is the core structure of Taohong Siwu Decoction, which nourishes blood, invigorates blood, regulates qi, and removes blood stasis, so that blood stasis is removed and new blood is generated.

[0061] Pinellia ternata: pungent, warm, and toxic in nature. It enters the spleen, stomach, and lung meridians. It has the effects of drying dampness and resolving phlegm, relieving nausea and vomiting, and dissipating lumps and nodules.

[0062] As an adjuvant medicine, Pinellia ternata targets the pathological factors of "phlegm," drying dampness and resolving phlegm, especially effective in resolving phlegm and turbidity in the internal organs and meridians, and can also eliminate lumps and nodules, having a direct dissipating effect on tangible phlegm (such as nodules).

[0063] When combined with dried tangerine peel: This is the core of Er Chen Tang (Two-Ingredient Decoction), which is based on the fundamental structure of drying dampness, resolving phlegm, regulating qi, and harmonizing the middle jiao (digestive system). Pinellia ternata resolves phlegm, while dried tangerine peel promotes qi circulation; when qi flows smoothly, phlegm dissipates.

[0064] When combined with silkworm: Pinellia resolves phlegm and dissipates nodules, while silkworm dispels wind, resolves phlegm, and dissipates nodules. The combination of the two enhances the effect of resolving phlegm, softening hardness, and dissipating nodules, and is specifically used to treat phlegm nodules and scrofula (such as nodules and lymph node tuberculosis).

[0065] Dried tangerine peel: pungent, bitter, and warm in nature. It enters the spleen and lung meridians. It has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm.

[0066] As an adjuvant, dried tangerine peel is pungent and warm, effectively promoting the flow of Qi in the spleen and stomach. When Qi flows smoothly, phlegm, dampness, and blood stasis are resolved. Its function is to regulate the Qi mechanism of the middle Jiao, preventing the heavy and cloying nature of tonifying herbs from hindering the stomach, while also assisting Pinellia ternata in resolving phlegm.

[0067] When combined with Astragalus and Ginseng: Tangerine peel regulates Qi and harmonizes the stomach, so that the tonifying effects of ginseng and astragalus are not stagnant, and the tonifying herbs can be better digested and absorbed.

[0068] Silkworm pupae: Salty and pungent in flavor, neutral in nature. It enters the liver, lung, and stomach meridians. It has the effects of calming wind and stopping spasms, dispelling wind and relieving pain, and resolving phlegm and dissipating nodules.

[0069] As an adjuvant medicine, silkworm can dispel wind, unblock the meridians, and relieve pain, as well as resolve phlegm, soften hardness, and dissipate nodules. It is particularly effective for headaches and phlegm nodules caused by wind-phlegm obstructing the meridians.

[0070] When combined with Pinellia ternata: it enhances the ability to resolve phlegm and dissipate nodules.

[0071] When combined with insect-based blood-activating drugs: Silkworm, with its ability to resolve phlegm and dissipate nodules, can be combined with leeches, earthworms, and other blood-breaking and stasis-removing drugs to achieve the simultaneous treatment of phlegm and blood stasis. This approach addresses the complex pathogenesis of phlegm and blood stasis by comprehensively dismantling pathological products.

[0072] Southern ginseng: Sweet and slightly cold in nature. It enters the lung and stomach meridians. It has the effects of nourishing yin and clearing the lungs, benefiting the stomach and promoting body fluids, resolving phlegm, and replenishing qi.

[0073] As an adjuvant, it is added to the formula containing a large number of warming, drying, and blood-activating herbs, with a sweet and cold yin-nourishing herb. The purpose is to "increase fluids and thin phlegm"—to dilute the thick phlegm and blood stasis, making them easier to dissolve and expel. At the same time, it prevents the warming and drying herbs from depleting yin fluids.

[0074] When combined with Aconitum carmichaelii, Asarum sieboldii, and Pinellia ternata (the principal and adjuvant herbs): this embodies the idea of ​​"removing the nature while retaining the function" -4. The "moistening" nature of Adenophora stricta restrains the "warming and drying" nature of Aconitum carmichaelii, Asarum sieboldii, and Pinellia ternata, but retains their effects of warming yang, dispelling cold, resolving phlegm, and dissipating nodules. This makes the whole formula warm without being drying and moist without being greasy. They complement each other and work together to achieve the effect of "water and fire balance".

[0075] Atractylodes lancea: pungent, bitter, and warm in nature. It enters the spleen, stomach, and liver meridians. It has the effects of drying dampness and strengthening the spleen, dispelling wind and cold, and improving eyesight.

[0076] As an adjuvant herb, Atractylodes lancea, with its pungent, warm, and drying properties, strengthens the spleen, dries dampness, aids digestion, and eliminates the source of phlegm. Its ability to dispel wind and cold also helps the principal and assistant herbs to dispel cold and unblock the meridians.

[0077] When combined with dried tangerine peel and pinellia: the three ingredients work together to greatly enhance the effects of drying dampness and resolving phlegm, regulating qi and harmonizing the stomach, thus controlling the production of phlegm and turbidity from the source.

[0078] When combined with Astragalus: Astragalus tonifies Qi, while Atractylodes dries dampness. The combination of tonifying Qi and strengthening the spleen makes the tonification not cloying and the strengthening not harmful.

[0079] Deer antler: Sweet and salty in taste, warm in nature. It enters the kidney and liver meridians. It has the effects of strengthening kidney yang, nourishing essence and blood, strengthening tendons and bones, regulating the Chong and Ren meridians, and promoting the healing of sores and carbuncles.

[0080] As an adjuvant medicine, deer antler is a substance rich in blood and flesh, which powerfully replenishes essence and blood. In this invention, its significance lies in two aspects: first, seeking yang within yin, using essence and blood as a foundation to support and promote yang energy (the effects of aconite and ginseng), ensuring a source for the generation of yang energy; second, tonifying the liver and kidneys, strengthening muscles and bones, and promoting the repair of blood vessels and nerves.

[0081] When combined with aconite: aconite warms the kidney yang to aid qi transformation, while deer antler replenishes essence and blood to strengthen the foundation. The combination of these two allows yang to be assisted by yin, resulting in inexhaustible generation of qi and blood, achieving the effect of warming yang and replenishing essence, especially beneficial for those with severe deficiency.

[0082] Rhubarb: Bitter and cold in nature. It enters the spleen, stomach, large intestine, liver, and pericardium meridians. It has the effects of purging and eliminating stagnation, clearing heat and purging fire, cooling blood and detoxifying, removing blood stasis and promoting menstruation, and promoting diuresis and relieving jaundice.

[0083] As an adjuvant, rhubarb in this invention is not primarily used for purgation. Firstly, it is used to dispel blood stasis and promote menstruation, assisting the adjuvant herbs in activating blood and removing blood stasis; secondly, its bitter and cold nature is used to counteract the overall pungent, warm, and drying properties of the formula, preventing excessive warming and tonifying; thirdly, it promotes the elimination of stagnation and heat, guiding the stagnant heat downwards and providing an outlet for pathogenic factors.

[0084] When combined with Aconitum carmichaelii and Asarum sieboldii, rhubarb's cold nature is countered by the warmth of Aconitum carmichaelii and Asarum sieboldii, while its function of clearing stagnation and purging turbidity remains. Together, they exert the effects of warming and purging cold accumulation and promoting blood circulation. This is the concentrated embodiment of the "removing the nature and retaining the function" formulation concept of this invention.

[0085] Borneol: It is pungent, bitter, and slightly cold in nature. It enters the heart, spleen, and lung meridians. It has the effects of opening the orifices and refreshing the mind, clearing heat and relieving pain.

[0086] As an adjuvant, borneol, with its pungent and aromatic properties, can penetrate everywhere and has a strong guiding effect. It can guide the medicinal power of the whole prescription to quickly penetrate various physiological barriers (such as the blood-brain barrier) and reach the lesions deep in the heart, brain and meridians. Especially in the emergency treatment of cerebral infarction, its function of opening the orifices and restoring consciousness is crucial.

[0087] When combined with Danshen and Chuanxiong: Borneol guides the blood-activating drugs to the heart and brain, opens the orifices and unblocks the meridians, and has a synergistic effect on acute conditions such as chest pain, stroke and coma.

[0088] When combined with Asarum: Both are pungent and aromatic herbs that can penetrate and spread, one enters the Lesser Yin meridian and the other enters the Heart meridian. Together, they act as "guides" for the entire formula, allowing the medicinal power to reach the affected area directly.

[0089] Compared with existing technologies, this invention has the following advantages: It is not limited to the superficial treatment of simply promoting blood circulation and removing blood stasis, but rather addresses the root cause of the pathogenesis of deficiency, stagnation, cold coagulation, and phlegm-blood stasis. Through a compound treatment principle of tonifying Yang and Qi, increasing fluids and dissolving phlegm, and dispelling cold and unblocking thrombi, it improves the problems of thrombus and nodule formation. Simultaneously, through standardized production processes and refined parameter control, this invention effectively solves the defects of traditional preparations, such as easy loss of effective components and poor drug stability. It also proposes feasible alternatives for endangered medicinal materials, improving clinical cure rates and reducing the risk of disability while ensuring synergistic efficacy and bioavailability. Detailed Implementation

[0090] The invention will be more readily understood by referring to the following detailed description of preferred embodiments and included examples. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the definitions in this specification shall prevail.

[0091] As used herein, the terms “prepared from” and “comprising” are synonymous. The terms “comprising,” “including,” “having,” “containing,” or any other variations thereof, as used herein, are intended to cover non-exclusive inclusion. For example, a composition, step, method, article, or apparatus that includes the listed elements is not necessarily limited to those elements, but may include other elements not expressly listed or elements inherent to such composition, step, method, article, or apparatus.

[0092] The conjunction "composed of..." excludes any unspecified elements, steps, or components. If used in a claim, this phrase makes the claim closed, excluding materials other than those described, except for conventional impurities associated with them. When the phrase "composed of..." appears in a clause of the body of a claim rather than immediately following it, it limits only the elements described in that clause; other elements are not excluded from the claim as a whole.

[0093] When a quantity, concentration, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper and lower preferred values, this should be understood as specifically disclosing all ranges formed by any pair of any upper or preferred value with any lower or preferred value, regardless of whether the range is disclosed individually. For example, when the range “1 to 5” is disclosed, the described range should be interpreted as including ranges “1 to 4”, “1 to 3”, “1 to 2”, “1 to 2 and 4 to 5”, “1 to 3 and 5”, etc. When numerical ranges are described herein, unless otherwise stated, the range... Furthermore, the indefinite articles “a” and “an” preceding the elements or components of this invention do not impose any limitation on the quantity (i.e., number of times) of the elements or components. Therefore, “an” or “a” should be interpreted as including one or at least one, and the singular form of an element or component also includes the plural form, unless the quantity clearly refers to the singular form.

[0094] Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention. The preferred embodiments and materials described herein are for illustrative purposes only and do not limit the scope of this application.

[0095] Unless otherwise specified, the experimental methods used in the following examples are conventional methods; unless otherwise specified, the experimental materials and test strains used in the following examples were purchased from commercial channels. Example 1

[0096] A traditional Chinese medicine composition for relieving thrombosis, dispersing nodules, and alleviating pain, and its preparation method, is made from the following raw materials in parts by weight: ginseng 8 parts, aconite 9 parts, astragalus 16 parts, asarum 2 parts, salvia miltiorrhiza 12 parts, tangerine peel 12 parts, pinellia 8 parts, silkworm 4 parts, earthworm 4 parts, pangolin scales 4 parts, earthworm 4 parts, leech 2 parts, atractylodes 9 parts, rhubarb 4-8 parts, sparganium 8 parts, turmeric 8 parts, deer antler 2 parts, angelica 4 parts, chuanxiong 9 parts, peach kernel 7 parts, safflower 12 parts, glehnia littoralis 8 parts, and borneol 1 part.

[0097] A method for using a traditional Chinese medicine composition to promote blood circulation, relieve pain, and dispel lumps includes the following steps: S1. Pre-processing and grouping of medicinal materials: S1.1 Remove the root head from the prescribed amount of ginseng, and clean, wash, and cut the aconite, astragalus, salvia miltiorrhiza, atractylodes lancea, sparganium, curcuma zedoaria, angelica sinensis, chuanxiong, and adenophora stricta respectively. After low-temperature drying, mix and pulverize into coarse powder of 80 mesh to obtain the first drug composition. Specifically, the temperature for the low-temperature drying is 40°C.

[0098] S1.2 Stir-fry the prescribed amount of leeches with talcum powder until they puff up, let them cool, and then crush them; S1.3 The prescribed amount of pangolin scales is scalded with sand, and the silkworm is stir-fried with wheat bran and cooled; S1.4 The medicinal materials processed in steps S1.2 and S1.3 are cleaned and selected separately with the prescribed amounts of Asarum, Citrus reticulata peel, Pinellia ternata, Eupolyphaga sinensis, Pheretima aspergillum, Deer antler, Prunus persica kernel, and Carthamus tinctorius. After mixing, they are pulverized into a fine powder of 100 mesh to obtain the second drug composition. S2. Alcohol extraction: The first pharmaceutical composition is refluxed once with 6-12 times the volume of 60% ethanol solution for 1 hour each time. The extracts are combined, filtered, and the ethanol is recovered from the filtrate under reduced pressure. The filtrate is then concentrated under reduced pressure to a thick paste with a relative density of 1.10 at 60°C to obtain the alcohol extract. Specifically, the vacuum degree of the vacuum concentration is controlled at -0.08MPa, and the temperature is controlled at 50℃.

[0099] S3. Water extraction: Mix the residue after alcohol extraction in step S2 with the prescribed amount of rhubarb, add 8 times the amount of water and decoct once, for 1 hour each time. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.10 at 60°C to obtain the water extract. Specifically, the vacuum degree of the vacuum concentration is controlled at -0.08MPa, and the temperature is controlled at 50℃.

[0100] S4. Combining and Drying: Combine the alcohol extract obtained in step S2 with the water extract obtained in step S3, add the fine powder of the second pharmaceutical composition obtained in step S1.4 and the prescribed amount of borneol, mix evenly, dry, and pulverize into fine powder to obtain the active pharmaceutical ingredient. Specifically, the drying is vacuum drying at a temperature of 40°C and a vacuum degree of 0.07 MPa, until the moisture content is ≤5%.

[0101] S5. Formulation: Pharmaceutically acceptable excipients are added to the active pharmaceutical ingredient obtained in step S4, and an oral formulation is prepared according to conventional formulation processes.

[0102] The present invention also provides a traditional Chinese medicine composition for relieving thrombosis, dispersing nodules, and alleviating pain, wherein the traditional Chinese medicine composition comprises the above-mentioned traditional Chinese medicine composition or other pharmaceutically acceptable physical forms.

[0103] The traditional Chinese medicine composition is in the form of tablets, capsules, granules, pills, ointments, or oral liquids.

[0104] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine that can treat thrombotic nodules and painful lumps. Example 2

[0105] A traditional Chinese medicine composition for relieving thrombosis, dispersing nodules, and alleviating pain, and its preparation method, is made from the following raw materials in parts by weight: 10 parts ginseng, 12 parts aconite, 20 parts astragalus, 3 parts asarum, 15 parts salvia miltiorrhiza, 15 parts tangerine peel, 10 parts pinellia, 6 parts silkworm, 5 parts earthworm, 6 parts pangolin scales, 6 parts earthworm, 3 parts leech, 12 parts atractylodes lancea, 6 parts rhubarb, 10 parts sparganium, 10 parts turmeric, 3 parts deer antler, 6 parts angelica sinensis, 12 parts chuanxiong rhizome, 9 parts peach kernel, 15 parts safflower, 10 parts southern ginseng, and 2 parts borneol.

[0106] A method for using a traditional Chinese medicine composition to promote blood circulation, relieve pain, and dispel lumps includes the following steps: S1. Pre-processing and grouping of medicinal materials: S1.1 Remove the root head from the prescribed amount of ginseng, and clean, wash, and cut the aconite, astragalus, salvia miltiorrhiza, atractylodes lancea, sparganium, curcuma zedoaria, angelica sinensis, chuanxiong, and adenophora stricta respectively. After low-temperature drying, mix and pulverize into 100-mesh coarse powder to obtain the first drug composition. Specifically, the temperature for the low-temperature drying is 50°C.

[0107] S1.2 Stir-fry the prescribed amount of leeches with talcum powder until they puff up, let them cool, and then crush them; S1.3 The prescribed amount of pangolin scales is scalded with sand, and the silkworm is stir-fried with wheat bran and cooled; S1.4 The medicinal materials processed in steps S1.2 and S1.3 are cleaned and selected separately with the prescribed amounts of Asarum, Citrus reticulata peel, Pinellia ternata, Eupolyphaga sinensis, Pheretima aspergillum, Deer antler, Prunus persica kernel, and Carthamus tinctorius. After mixing, they are pulverized into a fine powder of 150 mesh to obtain the second drug composition. S2. Alcohol extraction: The first pharmaceutical composition was refluxed twice with 9 times the volume of 70% ethanol solution for 1.5 hours each time. The extracts were combined, filtered, and the ethanol was recovered from the filtrate under reduced pressure. The filtrate was then concentrated under reduced pressure to a thick paste with a relative density of 1.15 at 60°C to obtain the alcohol extract. Specifically, the vacuum degree of the vacuum concentration is controlled at -0.07 MPa, and the temperature is controlled at 60°C.

[0108] S3. Water extraction: Mix the residue after alcohol extraction in step S2 with the prescribed amount of rhubarb, add 10 times the amount of water and decoct twice, 1.5 hours each time. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.15 at 60°C to obtain the water extract. Specifically, the vacuum degree of the vacuum concentration is controlled at -0.07 MPa, and the temperature is controlled at 60°C.

[0109] S4. Combining and Drying: Combine the alcohol extract obtained in step S2 with the water extract obtained in step S3, add the fine powder of the second pharmaceutical composition obtained in step S1.4 and the prescribed amount of borneol, mix evenly, dry, and pulverize into fine powder to obtain the active pharmaceutical ingredient. Specifically, the drying is vacuum drying at a temperature of 50°C and a vacuum degree of 0.08 MPa, until the moisture content is ≤5%.

[0110] S5. Formulation: Pharmaceutically acceptable excipients are added to the active pharmaceutical ingredient obtained in step S4, and an oral formulation is prepared according to conventional formulation processes.

[0111] The present invention also provides a traditional Chinese medicine composition for relieving thrombosis, dispersing nodules, and alleviating pain, wherein the traditional Chinese medicine composition comprises the above-mentioned traditional Chinese medicine composition or other pharmaceutically acceptable physical forms.

[0112] The traditional Chinese medicine composition is in the form of tablets, capsules, granules, pills, ointments, or oral liquids.

[0113] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine that can treat thrombotic nodules and painful lumps. Example 3

[0114] The technical solution of this invention is implemented as follows: a traditional Chinese medicine composition for relieving thrombosis, dispersing nodules, and alleviating pain, and its preparation method, is made from the following raw materials in parts by weight: 12 parts ginseng, 15 parts aconite, 24 parts astragalus, 4 parts asarum, 18 parts salvia miltiorrhiza, 18 parts tangerine peel, 12 parts pinellia, 8 parts silkworm, 7 parts earthworm, 8 parts pangolin scales, 8 parts earthworm, 4 parts leech, 15 parts atractylodes lancea, 8 parts rhubarb, 12 parts sparganium, 12 parts turmeric, 4 parts deer antler, 8 parts angelica sinensis, 15 parts chuanxiong rhizome, 11 parts peach kernel, 18 parts safflower, 12 parts southern ginseng, and 3 parts borneol.

[0115] A method for using a traditional Chinese medicine composition to promote blood circulation, relieve pain, and dispel lumps includes the following steps: S1. Pre-processing and grouping of medicinal materials: S1.1 Remove the root head from the prescribed amount of ginseng, and clean, wash, and cut the aconite, astragalus, salvia miltiorrhiza, atractylodes lancea, sparganium, curcuma zedoaria, angelica sinensis, chuanxiong, and adenophora stricta respectively. After low-temperature drying, mix and pulverize into coarse powder of 120 mesh to obtain the first drug composition. Specifically, the temperature for the low-temperature drying is 60°C.

[0116] S1.2 Stir-fry the prescribed amount of leeches with talcum powder until they puff up, let them cool, and then crush them; S1.3 The prescribed amount of pangolin scales is scalded with sand, and the silkworm is stir-fried with wheat bran and cooled; S1.4 The medicinal materials processed in steps S1.2 and S1.3 are cleaned and selected separately with the prescribed amounts of Asarum, Citrus reticulata peel, Pinellia ternata, Eupolyphaga sinensis, Pheretima aspergillum, Deer antler, Prunus persica kernel, and Carthamus tinctorius. After mixing, they are pulverized into a fine powder of 200 mesh to obtain the second drug composition. S2. Alcohol extraction: The first pharmaceutical composition was refluxed three times with 12 times the volume of 80% ethanol solution for 2 hours each time. The extracts were combined, filtered, and the ethanol was recovered from the filtrate under reduced pressure. The filtrate was then concentrated under reduced pressure to a thick paste with a relative density of 1.20 at 60°C to obtain the alcohol extract. Specifically, the vacuum degree of the vacuum concentration is controlled at -0.06 MPa, and the temperature is controlled at 70°C.

[0117] S3. Water extraction: Mix the residue after alcohol extraction in step S2 with the prescribed amount of rhubarb, add 12 times the amount of water and decoct 3 times, 2 hours each time. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.20 at 60°C to obtain the water extract. Specifically, the vacuum degree of the vacuum concentration is controlled at -0.06 MPa, and the temperature is controlled at 70°C.

[0118] S4. Combining and Drying: Combine the alcohol extract obtained in step S2 with the water extract obtained in step S3, add the fine powder of the second pharmaceutical composition obtained in step S1.4 and the prescribed amount of borneol, mix evenly, dry, and pulverize into fine powder to obtain the active pharmaceutical ingredient. Specifically, the drying is vacuum drying at a temperature of 60°C and a vacuum degree of 0.09 MPa, until the moisture content is ≤5%.

[0119] S5. Formulation: Pharmaceutically acceptable excipients are added to the active pharmaceutical ingredient obtained in step S4, and an oral formulation is prepared according to conventional formulation processes.

[0120] The present invention also provides a traditional Chinese medicine composition for relieving thrombosis, dispersing nodules, and alleviating pain, wherein the traditional Chinese medicine composition comprises the above-mentioned traditional Chinese medicine composition or other pharmaceutically acceptable physical forms.

[0121] The traditional Chinese medicine composition is in the form of tablets, capsules, granules, pills, ointments, or oral liquids.

[0122] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine that can treat thrombotic nodules and painful lumps.

[0123] Experimental Example 1: Antithrombotic and Blood-activating Effects Experiment 1. Experimental objective: By establishing an acute blood stasis model in rats and a bleeding / coagulation model in mice, the effects of the traditional Chinese medicine composition of this invention on platelet aggregation, in vitro thrombosis, blood rheological parameters and bleeding and clotting time were observed, and its pharmacological effects of "unblocking thrombosis" and "promoting blood circulation and removing blood stasis" were evaluated.

[0124] 2. Experimental materials: Test drug: The traditional Chinese medicine composition extract powder prepared in Example 2 of this invention was prepared into a suspension of the required concentration with 0.5% sodium carboxymethyl cellulose (CMC-Na) before use.

[0125] Positive control drug: Xuesaitong soft capsules (main ingredient: total saponins of Panax notoginseng, specification: 100mg per capsule) are used for platelet aggregation and blood rheology experiments. They should be prepared as a 5mg / mL suspension before use.

[0126] Enteric-coated aspirin tablets (specification: 100mg / tablet) are used for clotting time experiments in mice. They should be prepared as a 10mg / mL suspension before use.

[0127] Laboratory animals: SD rats, SPF grade, male, weighing 200±20g, a total of 60 rats.

[0128] KM mice, SPF grade, male, weighing 18-22g, 50 in total.

[0129] Main reagents and instruments: Reagents: epinephrine hydrochloride injection (1 mg / mL), adenosine diphosphate (ADP), sodium citrate, sodium heparin.

[0130] Instruments: Platelet aggregator (LBY-NJ4), blood rheometer (SA-6000), in vitro thrombosis analyzer (WTP-A1), capillary glass tube (1mm inner diameter), stopwatch.

[0131] 3. Experimental methods and detailed procedures: 3.1 Effects on platelet aggregation rate and in vitro thrombosis in rats: Grouping and administration: Sixty SD rats were randomly divided into 6 groups of 10 rats each, according to their body weight: Blank control group: administered an equal volume of 0.5% CMC-Na solution by gavage.

[0132] Model control group: administered an equal volume of 0.5% CMC-Na solution by gavage.

[0133] Positive drug group (Xuesaitong): Xuesaitong suspension was administered by gavage at a dose of 50 mg / kg (equivalent to the clinically equivalent dose).

[0134] High-dose group of test drug: The test drug suspension was administered by gavage at a dose of 10g crude drug / kg (equivalent to twice the clinical equivalent dose).

[0135] Medium-dose group of test drug: oral administration of test drug suspension at a dose of 5g crude drug / kg (equivalent to clinical equivalent dose).

[0136] Low-dose group of test drug: The test drug suspension was administered by gavage at a dose of 2.5 g crude drug / kg (equivalent to 0.5 times the clinically equivalent dose).

[0137] Each group was administered gavage once daily for 7 consecutive days, with a gavage volume of 10 mL / kg.

[0138] Modeling method (acute blood stasis model): One hour after the last administration, except for the blank control group, rats in all other groups were subcutaneously injected with epinephrine hydrochloride (0.8 mg / kg) twice, with an interval of 4 hours. Two hours after the first injection, the rats were immersed in ice water (0~2℃) for 5 minutes. After modeling, the rats were kept on a fasting but not water-dependent basis, and the indicators were measured on the second day (day 8).

[0139] Specimen collection and testing: Platelet aggregation rate assay: Rats were anesthetized by intraperitoneal injection of 10% chloral hydrate (3 mL / kg). 5 mL of blood was collected from the abdominal aorta and anticoagulated with 3.8% sodium citrate (1:9), then gently mixed. The mixture was centrifuged at 800 rpm for 10 minutes, and the supernatant platelet-rich plasma (PRP) was collected. The remaining blood was centrifuged at 3000 rpm for 10 minutes, and the supernatant platelet-poor plasma (PPP) was collected. Using PPP as the zeroing point, 200 μL of PRP was added to a turbidity test tube, and ADP (final concentration 10 μmol / L) was added to induce aggregation. The maximum aggregation rate within 5 minutes was recorded.

[0140] In vitro thrombosis assay: Take 1 mL of non-anticoagulated blood and quickly inject it into a siliconized plastic ring. Place the ring on the rotating ring of the in vitro thrombosis apparatus and rotate it at 17 r / min for 15 minutes to form a thrombus. Gently remove the thrombus with tweezers, lay it flat on filter paper to absorb the surface blood, and measure the length of the thrombus. Weigh the wet weight using an electronic balance. Place the thrombus in a 60℃ oven to dry for 24 hours until constant weight, and weigh the dry weight.

[0141] 3.2 Effects on blood rheology in rats with blood stasis model: Take 2 mL of heparin-anticoagulated blood from section "3.1" (and another tube of blood, anticoagulated with sodium heparin), and use a blood rheometer to measure the whole blood viscosity at different shear rates (10 / s, 60 / s, 150 / s). Centrifuge the remaining whole blood at 3000 r / min for 10 minutes, and measure the plasma viscosity (shear rate 100 / s). Each sample was measured three times, and the average value was taken.

[0142] 3.3 Effects on coagulation time and bleeding time in mice: Grouping and drug administration: Fifty KM mice were randomly divided into 5 groups of 10 mice each, according to their body weight. Blank control group: administered an equal volume of 0.5% CMC-Na solution by gavage.

[0143] Positive drug group (aspirin): Aspirin suspension was administered by gavage at a dose of 100 mg / kg (equivalent to the clinically equivalent dose).

[0144] High, medium, and low dose groups of the test drug: The test drug suspension was administered by gavage at doses of 15 g crude drug / kg, 7.5 g crude drug / kg, and 3.75 g crude drug / kg (equivalent to 1.5 times the rat dose based on body surface area). The gavage volume was 20 mL / kg for all groups.

[0145] Each group was given gavage once a day for 7 consecutive days.

[0146] Bleeding time determination (tail amputation method): One hour after the last administration, the mouse was fixed and the tip of its tail was cut off by 1 mm with surgical scissors. The bleeding was allowed to flow out on its own, and the timing was started immediately. Every 30 seconds, a drop of blood was gently absorbed with filter paper (taking care not to touch the wound) until the bleeding stopped naturally (no bloodstains were left on the filter paper). The bleeding time was then recorded.

[0147] Clotting Time Measurement (Capillary Glass Tube Method): After measuring bleeding time, fix the mouse and insert a 1mm inner diameter capillary glass tube into the retrocanal venous plexus of the mouse to a depth of approximately 4-5mm. Gently rotate the tube to puncture the blood vessel. Once the tube is filled with blood, remove it and place it flat on a table. Every 30 seconds, break off a small section (approximately 5mm) of the capillary tube and slowly pull it back to observe for any blood streaks. Record the time from when the capillary tube fills with blood to when blood streaks appear; this is the clotting time.

[0148] 4. Experimental Results: Table 1-1 Effects of the test drugs on platelet aggregation rate and in vitro thrombosis in rats (n=10, ) Note: Compared with the model control group, * ,** Compared with the blank control group, ## .

[0149] Table 1-2 Effects of the test drugs on hemorheology in rats with blood stasis model (n=10, ) Note: Compared with the model control group, * ,** Compared with the blank control group, ## .

[0150] Table 1-3 Effects of the test drugs on coagulation time and bleeding time in mice (n=10, ) Note: Compared with the blank control group, * ,** .

[0151] 5. Experimental Conclusion: Inhibition of platelet aggregation and thrombus formation: As shown in Table 1-1, compared with the blank control group, the platelet aggregation rate of rats in the model control group was significantly increased ( This indicates that the acute blood stasis model was successfully established. After administration of the test drug, the platelet aggregation rate decreased in a dose-dependent manner in all dose groups, with the high-dose group decreasing to 35.6%, close to the level of the blank control group, and showing a highly significant difference compared with the model control group. In terms of in vitro thrombosis markers, the high, medium, and low dose groups of the test drug all significantly shortened thrombus length and reduced thrombus wet and dry weight. or The high-dose group showed slightly better efficacy than the positive control drug, Xuesaitong. This indicates that the herbal composition of this invention can effectively inhibit platelet activation, reduce thrombus formation, and has a clear "thrombus-clearing" effect.

[0152] Improvement of abnormal blood rheology: Table 1-2 shows that the whole blood viscosity (low, medium, and high shear) and plasma viscosity of the model control group rats were significantly higher than those of the blank control group. This reflects a state of high blood viscosity. All doses of the test drug reduced whole blood and plasma viscosity to varying degrees, exhibiting a dose-dependent effect. The high-dose group showed particularly significant effects, reducing whole blood viscosity at all shear rates to near-normal levels, with a highly significant difference compared to the model control group. This indicates that the compound can improve the "thick, viscous, and coagulated" state of blood and promote blood circulation, which is a direct manifestation of its "blood-activating and stasis-removing" effect.

[0153] Prolonged clotting time: Table 1-3 data show that, compared with the blank control group, both the high- and medium-dose groups of the test drug significantly prolonged the clotting time and bleeding time in mice. The low-dose group also had a prolonged effect. Furthermore, the high-dose group showed stronger effects than aspirin-positive drugs. This result suggests that the compound may exert its anticoagulant effect by affecting the intrinsic coagulation pathway, thus helping to prevent thrombosis. However, it also indicates that the risk of bleeding should be considered during clinical application.

[0154] 6. Summary: This experimental study systematically evaluated the antithrombotic and blood-activating effects of the herbal composition of this invention using a rat acute blood stasis model and a mouse hemostasis model. Data from Tables 1-1, 1-2, and 1-3 show that the compound significantly inhibits ADP-induced platelet aggregation, reduces in vitro thrombus formation, lowers whole blood and plasma viscosity, and moderately prolongs hemostasis and clotting time, exhibiting a clear dose-dependent effect. Its efficacy at high doses is comparable to or slightly superior to that of the positive control drug XueSaiTong or aspirin, and no significant adverse reactions were observed. These results provide a reliable pharmacological basis for the clinical treatment of thrombotic diseases (such as cerebral infarction, coronary heart disease, deep vein thrombosis, etc.) and pain in nodules and masses caused by blood stasis.

[0155] Experimental Example 2: Anti-inflammatory and Analgesic Effect Experiment 1. Experimental objective: By establishing chemical and thermal stimulation-induced pain models, the inhibitory effect of the herbal composition of this invention on pain response was observed; by establishing an acute inflammation model, its inhibitory effect on inflammatory swelling was observed, thereby evaluating its "analgesic" and "anti-inflammatory" pharmacological effects.

[0156] 2. Experimental materials: Test drug: The traditional Chinese medicine composition extract powder prepared in Example 2 of this invention was prepared into a suspension of the required concentration with 0.5% sodium carboxymethyl cellulose (CMC-Na) before use.

[0157] Positive control drug: Ibuprofen sustained-release capsules (specification: 300mg / capsule) are used for the acetic acid writhing test and mouse ear swelling test. They should be prepared as a 10mg / mL suspension before use.

[0158] Tramadol hydrochloride tablets (specification: 50mg / tablet) are used in the hot plate analgesia test. They should be prepared as a 5mg / mL suspension before use.

[0159] Laboratory animals: KM mice, SPF grade, half male and half female, weighing 18-22g, totaling 180 mice.

[0160] Main reagents and instruments: Reagents: glacial acetic acid (analytical grade), xylene (analytical grade), physiological saline.

[0161] Instruments: Hot plate analgesia tester (RB-200), electronic balance (accuracy 0.0001g), hole punch (diameter 8mm), stopwatch.

[0162] 3. Experimental methods and detailed procedures: 3.1 Effects on acetic acid-induced writhing response in mice (peripheral analgesia): Experimental principle: Intraperitoneal injection of acetic acid causes extensive and persistent chemical pain stimulation deep in the peritoneum, leading to a "writhing" response in mice, characterized by abdominal retraction, trunk twisting, and hind limb extension. This model is primarily used to evaluate the peripheral analgesic effect of drugs.

[0163] Grouping and drug administration: Sixty KM mice (half male and half female) were randomly divided into 6 groups of 10 mice each, according to their body weight: Blank control group (model group): administered an equal volume of 0.5% CMC-Na solution by gavage.

[0164] Positive drug group (ibuprofen): Ibuprofen suspension was administered by gavage at a dose of 100 mg / kg (equivalent to the clinically equivalent dose).

[0165] High-dose group of test drug: The test drug suspension was administered by gavage at a dose of 15g crude drug / kg (equivalent to twice the clinical equivalent dose based on body surface area).

[0166] Medium-dose group of test drug: oral administration of test drug suspension at a dose of 7.5 g crude drug / kg (equivalent to clinical equivalent dose).

[0167] Low-dose group of test drug: The test drug suspension was administered by gavage at a dose of 3.75 g crude drug / kg (equivalent to 0.5 times the clinically equivalent dose).

[0168] Each group was administered gavage once daily, with a gavage volume of 20 mL / kg, for 7 consecutive days.

[0169] Experimental steps: One hour after the last administration, mice in each group were intraperitoneally injected with 0.6% glacial acetic acid solution (prepared fresh for use), with an injection volume of 0.1 mL / 10 g body weight.

[0170] Immediately after injection, mice were placed in a transparent observation box, and the number of writhing responses in each group was recorded within 5-20 minutes (15 minutes in total). The writhing response criteria were: abdominal concavity, trunk twisting, hind limb extension, and buttock elevation.

[0171] Calculate the analgesia rate: Analgesia rate (%) = (Average number of writhing movements in the model group - Average number of writhing movements in the drug treatment group) / Average number of writhing movements in the model group × 100%.

[0172] 3.2 Effects on pain induced by the hot plate test in mice (central analgesic effect): Experimental principle: Mice are placed on a heated plate at a constant temperature. Heat stimulation induces a pain response in the mice, causing them to lick their hind paws. The time from placement on the heated plate to the licking of the hind paws is recorded as the pain threshold. This model is primarily used to evaluate the central analgesic effect of drugs.

[0173] Pre-experiment screening: Before the experiment, the hot plate analgesia meter was preheated and maintained at 55±0.5℃.

[0174] Female mice were placed on a hot plate one by one (male mice have varying scrotal drooping sensitivity to heat, which can easily lead to errors), and the time from placement to the appearance of licking the hind paws was recorded (pain threshold).

[0175] Selection criteria: Mice with a pain threshold between 5 and 30 seconds were included in the experiment. Mice with a pain threshold less than 5 seconds (overly sensitive) or greater than 30 seconds (sluggish response) were excluded. Each mouse was tested only once to avoid thermal damage.

[0176] A total of 60 qualified mice were screened and randomly divided into 6 groups of 10 mice each according to their pain threshold. The grouping and administration were the same as in "3.1".

[0177] Experimental steps: Each group was administered the medication by gavage according to the above protocol, once daily for 7 consecutive days.

[0178] Before the last administration, the baseline pain threshold of each group of mice was measured (as the pre-administration value).

[0179] The pain threshold of mice in each group was measured at 30, 60, 90 and 120 minutes after the last administration.

[0180] Precautions: To prevent foot burns, if the mouse does not lick its feet after 60 seconds on the hot plate, it should be removed immediately. The pain threshold is calculated based on 60 seconds.

[0181] 3.3 Effects of xylene on mouse ear swelling (anti-inflammatory effect): Experimental principle: Xylene applied to the auricle of mice stimulates local capillary dilation and increased permeability, causing acute inflammatory swelling. The anti-inflammatory effect of the drug can be evaluated by measuring the degree of swelling in the ear.

[0182] Grouping and administration: Sixty male KM mice (to avoid the influence of the estrogen cycle on the inflammatory response) were randomly divided into 6 groups of 10 mice each according to their body weight. The grouping and administration were the same as in "3.1".

[0183] Experimental steps: Each group was administered the medication by gavage according to the above protocol, once daily for 7 consecutive days.

[0184] One hour after the last administration, 20 μL of xylene was pipetted and evenly applied to both the front and back of the right auricle of each mouse to induce inflammation. The left ear was left untreated as a control.

[0185] Thirty minutes after the inflammation was induced, the mice were euthanized by cervical dislocation, and both ears were cut off along the auricular baseline.

[0186] Use an 8mm diameter punch to make circular ear pieces at the same location on both ears, and immediately weigh them using an electronic balance.

[0187] Calculate ear swelling degree and swelling inhibition rate: Ear swelling (mg) = Weight of right earpiece - Weight of left earpiece; Swelling inhibition rate (%) = (average swelling degree of model group - average swelling degree of drug treatment group) / average swelling degree of model group × 100%.

[0188] 4. Experimental Results: Table 2-1 Effects of the test drugs on acetic acid-induced writhing response in mice (n=10, ) Note: Compared with the model control group, * ,** .

[0189] Table 2-2 Effects of test drugs on pain threshold induced by hot plate test in mice (n=10, ) Note: Compared with the model control group at the same time point, * ,** .

[0190] Table 2-3 Effects of the test drugs on xylene-induced ear swelling in mice (n=10, ) Note: Compared with the model control group, * ,** .

[0191] 5. Experimental Conclusion: Significant peripheral analgesic effect: As shown in Table 2-1, mice in the model control group exhibited typical writhing responses after intraperitoneal injection of acetic acid, with an average of 42.6 writhing repetitions. After administration of the test drug, the number of writhing repetitions decreased in a dose-dependent manner in all dose groups. The high-dose group showed an average writhing repetition count reduced to 13.8, with an analgesic rate reaching 67.6%, which was significantly different from the model control group. Furthermore, its analgesic effect is slightly better than that of the positive control drug ibuprofen (analgesia rate of 61.5%). This indicates that the herbal composition of the present invention has a strong inhibitory effect on pain caused by chemical stimulation, and its mechanism of action may be related to blocking the release of peripheral inflammatory mediators (such as prostaglandins and histamine) or acting directly on pain receptors.

[0192] Significant central analgesic effect: As shown in Table 2-2, there was no significant difference in the baseline pain threshold among the groups of mice. Following administration of the test drug, the pain threshold increased at all time points in the high, medium, and low dose groups, exhibiting a dose-time dependent relationship. The high-dose group reached its peak pain threshold at 60 minutes post-administration (40.8 seconds), significantly higher than the model control group (15.8 seconds), and comparable to the effect of the positive control drug tramadol. Even 120 minutes after administration, the pain threshold in the high-dose group (28.9 seconds) remained significantly higher than that in the model control group. This indicates that the compound can act on the central nervous system, increase the pain threshold, and has a clear central analgesic effect.

[0193] Significant anti-inflammatory effect: As shown in Table 2-3, after applying xylene to the right ear of mice in the model control group, the ear swelling reached 14.5 mg, indicating that the acute inflammation model was successfully established. All doses of the tested drug significantly reduced xylene-induced ear swelling, with the high-dose group showing a swelling level of only 4.8 mg, and a swelling inhibition rate of 66.9%, which was highly significant compared to the model control group. Furthermore, its anti-inflammatory effect is superior to that of ibuprofen (inhibition rate 55.9%). This indicates that the herbal composition of the present invention can inhibit the increase in vascular permeability and tissue edema in the early stage of inflammation, which is a direct manifestation of its "anti-inflammatory" effect and provides a basis for its treatment of inflammatory pain.

[0194] 6. Summary: This experiment systematically evaluated the anti-inflammatory and analgesic effects of the herbal composition of this invention using three classic models: the acetic acid writhing test, the hot plate test, and the xylene ear swelling test.

[0195] Based on the data in Tables 2-1, 2-2, and 2-3, this compound has the following characteristics: Dual analgesic mechanism: It can significantly reduce the writhing response caused by peripheral chemical stimulation (Table 2-1) and significantly increase the central pain threshold caused by thermal stimulation (Table 2-2), indicating that it has dual analgesic effects on both the peripheral and central sides. This is consistent with the properties of the collaterals-clearing and pain-relieving components such as Asarum, Ligusticum chuanxiong, and Borneol in the formula, as well as the wind-dispelling and pain-relieving properties of insect-derived drugs.

[0196] Clear anti-inflammatory effect: It can significantly inhibit acute inflammatory swelling caused by xylene (Table 2-3), indicating that it can inhibit the early inflammatory response and reduce inflammatory exudation. This is related to the anti-inflammatory components in the formula, such as danshen, rhubarb, and silkworm.

[0197] Dose dependence: All indicators showed a clear dose-response relationship, with the high-dose group showing particularly prominent effects and outperforming the positive control drug in multiple indicators.

[0198] Advantages of efficacy: This compound combines "anti-inflammatory" and "analgesic" effects, and has a synergistic therapeutic advantage, especially for inflammatory pain and neuropathic pain caused by pathological products such as thrombi and nodules.

[0199] Experimental Example 3: Preliminary Experiment on Anti-nodule and Anti-tumor Effects 1. Experimental objective: By establishing a mouse H22 hepatocellular carcinoma xenograft model, the inhibitory effect of the traditional Chinese medicine composition of this invention on the growth of solid tumors was observed. By detecting immune organ indices, serum cytokine levels and the expression of apoptosis-related genes in tumor tissue, the mechanism of its "dispersing nodules" (inhibiting tumor growth) was preliminarily explored, and its "strengthening the body's resistance and eliminating pathogenic factors" formulation characteristics were verified.

[0200] 2. Experimental materials: Test drug: The traditional Chinese medicine composition extract powder prepared in Example 2 of this invention was prepared into a suspension of the required concentration with 0.5% sodium carboxymethyl cellulose (CMC-Na) before use.

[0201] Positive control drug: Compound cyclophosphamide tablets (specification: 50mg / tablet, batch number: 230425), used as a positive control drug for chemotherapy, and prepared into a 2mg / mL solution with physiological saline before use.

[0202] Cell line: Mouse hepatocellular carcinoma H22 cell line, purchased from the Cell Bank of the Chinese Academy of Sciences Type Culture Collection Committee, was passaged in the peritoneum of mice after routine passage.

[0203] Experimental animals: KM mice, SPF grade, male, weighing 18-22g, a total of 80 mice.

[0204] Main reagents and instruments: RPMI-1640 medium, fetal bovine serum, penicillin and streptomycin antibiotics.

[0205] Mouse tumor necrosis factor-α (TNF-α), interferon-gamma (IFN-γ), and interleukin-2 (IL-2) ELISA kit.

[0206] Trizol total RNA extraction reagent, reverse transcription kit, and real-time quantitative PCR kit (SYBR Green method).

[0207] Bax, Bcl-2, Caspase-3 and GAPDH primers were synthesized by Sangon Biotech (Shanghai) Co., Ltd.

[0208] Electronic balance (accuracy 0.0001g), low-temperature high-speed centrifuge, real-time fluorescence quantitative PCR instrument (ABI7500), microplate reader, paraffin microtome, optical microscope.

[0209] 3. Experimental methods and detailed procedures: 3.1 Establishment of the H22 tumor-bearing mouse model: Cell preparation: After thawing frozen H22 cells, they were inoculated into RPMI-1640 medium containing 10% fetal bovine serum and cultured in a 37°C, 5% CO2 incubator.

[0210] Collect cells in the logarithmic growth phase and adjust the cell concentration to 1×10⁻⁶. 7 Ascites fluid was passaged by intraperitoneal injection of 0.2 mL / mouse into KM mice.

[0211] Seven to ten days after passage, the mice showed obvious abdominal distension. Ascites fluid was collected under aseptic conditions, and the number of viable cells was counted using trypan blue staining (viability >95%). The cell concentration was adjusted to 1×10⁻⁶ cells with physiological saline. 7 Quantity / mL, for later use.

[0212] Model building: KM mice were injected subcutaneously into the right anterior axilla with 0.2 mL of H22 cell suspension per mouse (containing 2 × 10⁻⁶ cells). 6 (Number of mice). After inoculation, observe the mice's condition. After about 5-7 days, a solid tumor the size of a grain of rice can be felt, indicating that the model has been successfully established.

[0213] 3.2 Grouping and Dosing: Grouping: 24 hours after inoculation, mice were randomly divided into 6 groups of 10 mice each, based on their body weight. Blank control group: 10 animals, which were not inoculated with tumors and were given only an equal volume of physiological saline.

[0214] Model control group: Inoculated with tumor cells and administered an equal volume of 0.5% CMC-Na solution by gavage.

[0215] Positive drug group (cyclophosphamide): tumors were inoculated and cyclophosphamide solution was injected intraperitoneally at a dose of 20 mg / kg (administered every other day for a total of 3 times to avoid severe immunosuppression).

[0216] High-dose group of test drug: The tumor was inoculated and the test drug suspension was administered by gavage at a dose of 15g crude drug / kg (equivalent to twice the clinical equivalent dose).

[0217] Medium-dose group of the test drug: The tumor was inoculated and the test drug suspension was administered by gavage at a dose of 7.5 g crude drug / kg (equivalent to the clinical equivalent dose).

[0218] Low-dose group of test drug: The tumor was inoculated and the test drug suspension was administered by gavage at a dose of 3.75 g crude drug / kg (equivalent to 0.5 times the clinical equivalent dose).

[0219] Dosage regimen: All groups (except the control group and the positive control group) were administered the drug once daily by gavage, with a gavage volume of 20 mL / kg, for 14 consecutive days. The positive control group was administered the drug intraperitoneally every other day (on days 1, 3, and 5), for a total of 3 times. During the experiment, the mice's mental state, coat color, diet, and activity were observed daily, and their body weight was measured twice a week, with dosage adjusted according to body weight.

[0220] 3.3 Specimen Collection and Testing Indicators: Tumor tissue collection: Twenty-four hours after the last administration, mice were weighed, blood was collected from the orbital venous plexus, and the mice were euthanized by cervical dislocation. The tumor was carefully dissected, connective tissue removed, rinsed with physiological saline, blotted dry with filter paper, and the tumor weight was recorded. The tumor inhibition rate was calculated. Tumor inhibition rate (%) = (average tumor weight in the model group - average tumor weight in the treatment group) / average tumor weight in the model group × 100%; Immune organ index measurement: After euthanizing the mice, the thymus and spleen were immediately separated, rinsed with physiological saline, blotted dry with filter paper, and weighed. Organ indices were calculated. Thymus index (mg / g) = thymus weight (mg) / body weight (g); Spleen index (mg / g) = spleen weight (mg) / body weight (g); Serum cytokine detection: Blood was collected from the orbital venous plexus, allowed to stand at room temperature for 30 minutes, centrifuged at 3000 rpm for 10 minutes, and the serum was separated and stored at -80℃ for later use. The levels of TNF-α, IFN-γ, and IL-2 in the serum were measured according to the ELISA kit instructions.

[0221] HE staining observation of tumor tissue: A portion of tumor tissue was taken, fixed in 10% neutral formalin, routinely embedded in paraffin, sectioned (4μm), stained with hematoxylin and eosin (HE), and observed under a light microscope for morphological changes in tumor cells (such as cell necrosis, nuclear pyknosis, nuclear fragmentation, etc.).

[0222] Detection of apoptosis-related gene expression in tumor tissue (RT-qPCR): RNA extraction: Take about 50 mg of tumor tissue, add 1 mL of Trizol, homogenize, and extract total RNA according to the instructions. Measure the RNA concentration and purity (A260 / A280 between 1.8 and 2.0).

[0223] Reverse transcription: Take 1 μg of total RNA and synthesize cDNA according to the reverse transcription kit instructions.

[0224] Real-time quantitative PCR: Primer sequences (synthesized by Sangon Biotech): Bax: Upstream 5'-TGGAGCTGCAGAGGATGATT-3', Downstream 5'-CCAGTTGAAGTTGCCGTCAG-3'; Bcl-2: Upstream 5'-GAGTACCTGAACCGGCATCT-3', Downstream 5'-GGTATGCACCCAGAGTGATG-3'; Caspase-3: upstream 5'-TGGTGATGAAGGGGTCATTT-3', downstream 5'-TTCCACTGTCTGTCTCAATACC-3'; GAPDH (internal reference): Upstream 5'-AGGTCGGTGTGAACGGATTTG-3', Downstream 5'-TGTAGACCATGTAGTTGAGGTCA-3'; PCR reaction system (20 μL): 10 μL SYBR Green Mix, 0.4 μL each of forward and reverse primers, 2 μL cDNA template, and ddH2O to 20 μL.

[0225] Reaction conditions: 95℃ pre-denaturation for 30 seconds; 95℃ denaturation for 5 seconds; 60℃ annealing for 34 seconds, for a total of 40 cycles.

[0226] Results Analysis: Using The relative expression level of the target gene was calculated using a method with the model control group as the calibration sample (expression level set to 1), and the changes in gene expression levels in each drug administration group were compared.

[0227] 4. Experimental Results: Table 3-1 Effects of the test drugs on tumor weight and tumor inhibition rate in H22 tumor-bearing mice (n=10, ) Note: Compared with the model control group, * ,** .

[0228] Table 3-2 Effects of the test drugs on the immune organ index of H22 tumor-bearing mice (n=10, ) Note: Compared with the model control group, * ,** Compared with the blank control group, ## Compared with the high-dose group of the test drug, .

[0229] Table 3-3 Effects of the test drugs on serum cytokine levels in H22 tumor-bearing mice (n=10, ) Note: Compared with the model control group, * ,** Compared with the blank control group, # , ## .

[0230] Table 3-4 Effects of the test drugs on the expression of apoptosis-related genes in tumor tissues of H22 tumor-bearing mice (n=6, ) Note: Compared with the model control group, * ,** .

[0231] 5. Experimental Conclusion: Significant in vivo tumor-suppressing effect: As shown in Table 3-1, the subcutaneous transplanted tumors in the model control group mice grew well, with an average tumor weight of 1.86g. After administration of the test drug, the tumor weight decreased in a dose-dependent manner in all dose groups. The high-dose group had an average tumor weight of 0.67g and a tumor inhibition rate of 64.0%, which was highly significant compared with the model control group. The efficacy was comparable to that of the positive control drug cyclophosphamide group (tumor inhibition rate 68.8%). This indicates that the herbal composition of the present invention can effectively inhibit the growth of solid tumors in vivo, which is a direct manifestation of its "nodule-dispersing" effect.

[0232] Immunomodulatory effects (supportive function): As shown in Table 3-2, compared with the blank control group, the thymus index of mice in the model control group was significantly reduced ( ), spleen index significantly increased ( The results suggest that tumor-bearing mice exhibit immune dysfunction (thymic atrophy and compensatory splenomegaly). While the positive control drug cyclophosphamide inhibited tumor growth, it further led to a significant decrease in the thymus and spleen indices. This demonstrates the immunosuppressive effect of chemotherapy drugs. The high-dose group of the test drug significantly increased the thymus index (…). This brought the level of the formula close to that of the blank control group; at the same time, it normalized the spleen index of the enlarged spleen. This indicates that the compound has a "strengthening" effect and can improve the immune function of tumor-bearing organisms, which is consistent with the combination of tonifying herbs such as ginseng, astragalus, and deer antler in the formula.

[0233] Regulation of serum cytokine levels: As shown in Table 3-3, the serum levels of the pro-inflammatory factor TNF-α were significantly increased in the model control group mice ( ), while the immunomodulatory factors IFN-γ and IL-2 were significantly reduced ( or This suggests the presence of an inflammatory microenvironment and immunosuppression in tumor-bearing organisms. The high-dose group of the test drug significantly reduced TNF-α levels (…). ), while significantly increasing IFN-γ and IL-2 levels ( This brought the levels close to those of the blank control group. This indicates that the compound can regulate the cytokine balance in the tumor microenvironment, reduce inflammatory responses, and enhance the body's anti-tumor immune response.

[0234] Molecular mechanisms of tumor cell apoptosis induction: As shown in Tables 3-4, the high-dose group of the test drug significantly upregulated the mRNA expression of pro-apoptotic genes Bax and Caspase-3. ), significantly downregulated the mRNA expression of the anti-apoptotic gene Bcl-2 ( The Bax / Bcl-2 ratio increased from 1.00 in the model group to 6.97, higher than the 5.53 in the positive control group. The increase in the Bax / Bcl-2 ratio is a key indicator of mitochondrial apoptosis pathway activation, suggesting that this compound may induce tumor cell apoptosis by activating the mitochondrial apoptosis pathway, which provides molecular evidence for its "dispersing nodules" (eliminating tumor masses) effect.

[0235] 6. Summary: This experiment systematically evaluated the antitumor effect and preliminary mechanism of the traditional Chinese medicine composition of the present invention using an H22 tumor-bearing mouse model.

[0236] Based on the above data, this compound has the following characteristics: Clear anti-tumor effects: It can significantly inhibit the growth of H22 solid tumors, with a tumor inhibition rate of 64.0% in the high-dose group, which is comparable to that of the chemotherapy drug cyclophosphamide (Table 3-1).

[0237] Unique "strengthening" advantage: Unlike cyclophosphamide, which causes immunosuppression, this compound can increase the thymus index, regulate the spleen index, and improve cytokine levels (Tables 3-2 and 3-3), demonstrating the "strengthening" effect of the tonifying herbs in the formula.

[0238] Molecular mechanism of apoptosis induction: By upregulating Bax / Caspase-3 and downregulating Bcl-2 expression, the mitochondrial apoptosis pathway is activated (Table 3-4), which is the molecular basis of its "nodule-dispersing" effect.

[0239] Advantages of the compound formula that treats both phlegm and blood stasis: This compound formula integrates the functions of promoting blood circulation and removing blood stasis (leech, earthworm, sparganium, turmeric), resolving phlegm and dissipating nodules (pillaria, tangerine peel, silkworm), and strengthening the body's resistance (ginseng, astragalus, deer antler), which embodies the formulation idea of ​​"treating both phlegm and blood stasis and strengthening the body's resistance and eliminating pathogens", and is in line with the basic principles of TCM treatment of masses and accumulations (tumors, nodules).

[0240] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the technical scope disclosed in the present invention, and these should all be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A traditional Chinese medicine composition for dispersing thrombi, resolving lumps, and relieving pain, characterized in that, Made from the following ingredients in parts by weight: ginseng 8-12 parts, aconite 9-15 parts, astragalus 16-24 parts, asarum 2-4 parts, salvia miltiorrhiza 12-18 parts, tangerine peel 12-18 parts, pinellia 8-12 parts, silkworm 4-8 parts, earthworm 4-7 parts, pangolin scales 4-8 parts, earthworm 4-8 parts, leech 2-4 parts, atractylodes lancea 9-15 parts, rhubarb 4-8 parts, sparganium 8-12 parts, turmeric 8-12 parts, deer antler 2-4 parts, angelica sinensis 4-8 parts, chuanxiong rhizome 9-15 parts, peach kernel 7-11 parts, safflower 12-18 parts, adenophora stricta 8-12 parts, and borneol 1-3 parts.

2. The traditional Chinese medicine composition for relieving thrombosis, dispersing nodules, and alleviating pain according to claim 1, and its preparation method, characterized in that, It is made from the following ingredients in parts by weight: 10 parts ginseng, 12 parts aconite, 20 parts astragalus, 3 parts asarum, 15 parts salvia miltiorrhiza, 15 parts tangerine peel, 10 parts pinellia, 6 parts silkworm, 5 parts earthworm, 6 parts pangolin scales, 6 parts earthworm, 3 parts leech, 12 parts atractylodes lancea, 6 parts rhubarb, 10 parts sparganium, 10 parts turmeric, 3 parts deer antler, 6 parts angelica sinensis, 12 parts chuanxiong rhizome, 9 parts peach kernel, 15 parts safflower, 10 parts southern ginseng, and 2 parts borneol.

3. A method for preparing a traditional Chinese medicine composition for relieving thrombosis, dispersing nodules, and alleviating pain as described in claim 1 or 2, characterized in that, Includes the following steps: S1. Pre-processing and grouping of medicinal materials: S1.1 Remove the root head from the prescribed amount of ginseng, and clean, wash, and cut the aconite, astragalus, salvia miltiorrhiza, atractylodes lancea, sparganium, curcuma zedoaria, angelica sinensis, chuanxiong, and adenophora stricta respectively. After low-temperature drying, mix and pulverize into coarse powder of 80-120 mesh to obtain the first drug composition. S1.2 Stir-fry the prescribed amount of leeches with talcum powder until they puff up, let them cool, and then crush them; S1.3 The prescribed amount of pangolin scales is scalded with sand, and the silkworm is stir-fried with wheat bran and cooled; S1.4 The medicinal materials processed in steps S1.2 and S1.3 are cleaned and selected separately with the prescribed amounts of Asarum, Citrus reticulata peel, Pinellia ternata, Eupolyphaga sinensis, Pheretima aspergillum, Deer antler, Prunus persica kernel, and Carthamus tinctorius. After mixing, they are pulverized into a fine powder of 100-200 mesh to obtain the second drug composition. S2. Alcohol extraction: The first pharmaceutical composition is extracted by reflux with 6-12 times the volume of 60%-80% ethanol solution for 1-3 times, each time for 1-2 hours. The extracts are combined, filtered, and the ethanol is recovered from the filtrate under reduced pressure. The filtrate is then concentrated under reduced pressure to a thick paste with a relative density of 1.10-1.20 at 60°C to obtain the alcohol extract. S3. Water extraction: Mix the residue after alcohol extraction in step S2 with the prescribed amount of rhubarb, add 8-12 times the amount of water and decoct 1-3 times, 1-2 hours each time. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.10-1.20 at 60℃ to obtain the water extract. S4. Combining and Drying: Combine the alcohol extract obtained in step S2 with the water extract obtained in step S3, add the fine powder of the second pharmaceutical composition obtained in step S1.4 and the prescribed amount of borneol, mix evenly, dry, and pulverize into fine powder to obtain the active pharmaceutical ingredient. S5. Formulation: Pharmaceutically acceptable excipients are added to the active pharmaceutical ingredient obtained in step S4, and an oral formulation is prepared according to conventional formulation processes.

4. The preparation method according to claim 3, characterized in that, In step S1, the temperature for low-temperature drying is 40-60℃.

5. The preparation method according to claim 3, characterized in that, In steps S2 and S3, the vacuum degree of the reduced pressure concentration is controlled at -0.06 to -0.08 MPa, and the temperature is controlled at 50 to 70°C.

6. The preparation method according to claim 3, characterized in that, The drying described in step S4 is vacuum drying, with a temperature of 40-60℃ and a vacuum degree of 0.07-0.09MPa, until the moisture content is ≤5%.

7. A traditional Chinese medicine composition for relieving thrombosis, dispersing nodules, and alleviating pain, wherein the traditional Chinese medicine composition comprises the traditional Chinese medicine composition according to any one of claims 1-2 or the traditional Chinese medicine composition obtained by the preparation method according to claims 3-6, or other pharmaceutically acceptable physical forms.

8. The traditional Chinese medicine composition according to claim 7, characterized in that, The traditional Chinese medicine composition is in the form of tablets, capsules, granules, pills, ointments, or oral liquids.

9. Use of the traditional Chinese medicine composition according to any one of claims 1-2 or the traditional Chinese medicine composition obtained by the preparation method according to claims 3-6 in the preparation of a medicament capable of treating thrombotic nodules and painful lumps.

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