A traditional Chinese medicine composition for treating high altitude polycythemia, a preparation method and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine composition for treating high-altitude polycythemia, its preparation method, and its application. The active ingredients of the traditional Chinese medicine composition are made from the following raw materials in parts by weight: Trichosanthes kirilowii 5-15 parts, Allium macrostemon 5-15 parts, Schisandra chinensis 10-20 parts, Panax quinquefolius 5-15 parts, Ziziphus jujuba peel 15-25 parts, Cinnamomum cassia twig 5-15 parts, Citrus aurantium (fried) 10-20 parts, and Salvia miltiorrhiza 5-15 parts. The aim is to enhance myocardial contractility and increase cardiac output, thereby effectively improving oxygen perfusion in peripheral tissues (especially the kidneys). By eliminating hypoxia signals at the source and downregulating the HIF-2α / EPO hematopoietic pathway, a stable and sustained decrease in red blood cell levels is achieved, avoiding a retaliatory increase in red blood cell count.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine composition for treating high-altitude polycythemia, its preparation method, and its application. Background Technology

[0002] High Altitude Polycythemia (HAPC), a common type of Chronic Mountain Sickness (CMS), is a clinical syndrome characterized by abnormal erythrocyte proliferation and significantly increased blood viscosity, resulting from incomplete adaptation to chronic low-pressure hypoxia caused by migration or long-term residence at high altitudes (usually above 2500 meters). Under prolonged hypoxic conditions, the degradation of hypoxia-inducible factor-2α (HIF-2α) decreases and accumulates in large quantities within cells, regulating the transcription of downstream target genes and promoting abnormal secretion of erythropoietin (EPO), which in turn drives excessive proliferation of bone marrow erythroid cells. More importantly, abnormally elevated hematocrit (HCT) and hemoglobin (HGB) lead to a hypercoagulable state, slowed blood flow, and systemic microcirculatory disturbances. HAPC patients exhibit significant chronic systemic oxidative stress and persistent inflammatory responses. Ischemia, hypoxia, and blood stasis lead to cellular lipid peroxidation and induce the release of large amounts of pro-inflammatory factors (such as TNF-α). This cascading inflammatory response not only exacerbates vascular endothelial damage but also leads to substantial damage to vital organs such as the heart, lungs, liver, and kidneys. Therefore, effectively controlling the abnormal proliferation of red blood cells while alleviating the accompanying inflammatory response is a key technical challenge in mitigating HAPC.

[0003] Existing traditional Chinese medicine treatments for altitude sickness mainly focus on improving microcirculation, using large amounts of pure blood-activating and stasis-removing single herbs or compound formulas such as Rhodiola rosea, Salvia miltiorrhiza, and Ligusticum chuanxiong. These treatments have a weak effect on downregulating significantly abnormally elevated red blood cell counts, have long treatment cycles, and are difficult to reverse multi-organ damage in patients with severe high altitude sickness-related pulmonary artery disease (HAPC). Summary of the Invention

[0004] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine composition for treating high-altitude polycythemia and its preparation method.

[0005] A traditional Chinese medicine composition for treating high-altitude polycythemia, wherein the active ingredients of the traditional Chinese medicine composition are made from the following raw materials in parts by weight: Trichosanthes kirilowii 5 parts, Allium macrostemon 5 parts, Schisandra chinensis 10 parts, Panax quinquefolius 5 parts, Ziziphus jujuba 15 parts, Cinnamomum cassia 5 parts, Citrus aurantium 10 parts, and Salvia miltiorrhiza 5 parts.

[0006] This invention adopts the overall formulation approach of "promoting Yang and relieving pain, invigorating Qi and astringing the lungs, promoting blood circulation and unblocking the meridians, and tonifying the liver and kidneys" to improve the state of chest and lung dysfunction, Qi and Yin depletion, poor blood circulation and chronic depletion under the low oxygen environment of high altitude.

[0007] The formula uses Trichosanthes kirilowii and Allium macrostemon as the principal herbs. Trichosanthes kirilowii relieves chest congestion, resolves phlegm, and promotes lung qi circulation, while Allium macrostemon promotes yang, disperses stagnation, and regulates qi. The two herbs work together to target the underlying pathogenesis of chest yang deficiency, lung qi stagnation, chest tightness, and shortness of breath caused by long-term high-altitude hypoxia. They play a core role in opening up the chest and lungs, promoting yang, and regulating qi circulation, making them the main herbs used in the entire formula to treat high-altitude polycythemia.

[0008] With cinnamon twig, American ginseng, schisandra fruit, and salvia miltiorrhiza as assistant herbs, cinnamon twig warms and invigorates the heart yang, assisting yang in transforming qi, and combined with trichosanthes fruit and allium macrostemon to further enhance the effects of widening the chest, invigorating yang, and promoting the smooth flow of qi. American ginseng tonifies qi and nourishes yin, replenishing the qi and yin depleted by the body under chronic hypoxia. Schisandra fruit astringes the lungs, consolidates qi, generates fluids, and calms the mind; combined with American ginseng, they work together to tonify qi and nourish yin, astringe the lungs, and consolidate the body's ability to adapt to hypoxia. Salvia miltiorrhiza invigorates blood, removes blood stasis, and promotes blood circulation, addressing the pathological conditions of high-altitude polycythemia, such as increased red blood cells, increased blood viscosity, and microcirculatory disorders, improving poor blood flow and stasis. These assistant herbs assist the principal herbs in improving the obstruction of qi in the chest and lungs, and enhance the overall effect of the formula in intervening in high-altitude hypoxia damage from the perspectives of tonifying qi and nourishing yin, and invigorating blood and unblocking the meridians.

[0009] With Citrus aurantium and Cornus officinalis as adjuvant herbs, Citrus aurantium promotes qi circulation, relieves stagnation, and helps to open up blockages and promote the flow of qi in the chest and diaphragm. It can also prevent the tonifying herbs from being too cloying and affecting the flow of qi. Cornus officinalis tonifies the liver and kidneys and consolidates essence and qi. When combined with Schisandra chinensis, it can improve the liver and kidney deficiency and essence and qi depletion caused by long-term chronic hypoxia. This allows the whole formula to promote yang and blood circulation while also supporting the body's resistance and consolidating its foundation.

[0010] Cinnamon twig also serves as a guiding herb. Its warming and unblocking properties, as well as its ability to promote the flow of Yang energy, can guide other herbs to the chest and lungs and promote blood circulation. It can also coordinate the effects of herbs that promote Yang, regulate Qi, benefit Qi, and invigorate blood, allowing the entire formula to reach the chest, lungs, and blood vessels.

[0011] In summary, the principal herb in this invention focuses on opening the chest and promoting Yang, and dispersing lung Qi; the assistant herb focuses on tonifying Qi and nourishing Yin, astringing the lungs and consolidating Qi, and invigorating blood and unblocking the meridians; the adjuvant herb focuses on regulating Qi and opening blockages, tonifying the liver and kidneys and preventing stagnation; and the guiding herb focuses on warming and harmonizing, and guiding the medicine to the affected area. After the combination of these herbs, they together form a holistic intervention system of "improving chest and lung Qi mechanism, enhancing hypoxia adaptation, improving blood circulation, and alleviating chronic depletion," which can be used for the prevention and treatment of high-altitude polycythemia.

[0012] A method for preparing the aforementioned traditional Chinese medicine composition includes the following steps: Weigh out Trichosanthes kirilowii, Allium macrostemon, Schisandra chinensis, Panax quinquefolius, Ziziphus jujuba peel, Cinnamomum cassia, stir-fried Citrus aurantium and Salvia miltiorrhiza, remove impurities, wash and dry to obtain raw materials; Mix the raw materials with water at a mass ratio of 1:6 to 12, soak, decoct, filter, and collect the filtrate. The resulting filtrate is concentrated to 1 / 10 to 1 / 5 of its original volume at a concentration temperature of 70 to 80°C.

[0013] Preferably, the soaking time is 20 to 60 minutes.

[0014] Preferably, it is decocted 1 to 3 times, each time for 0.5 to 2 hours.

[0015] The application of the aforementioned traditional Chinese medicine composition in the preparation of a drug for treating high-altitude polycythemia.

[0016] Preferably, the drug is used to relieve erythrocyte stasis and diffuse congestion caused by the hypoxic environment at high altitudes.

[0017] Preferably, the drug is used to relieve significant thickening of alveolar septa, accompanied by extensive inflammatory cell infiltration and vascular congestion caused by high-altitude hypoxic environment.

[0018] Preferably, the drug is used to relieve interstitial edema and focal rupture caused by the hypoxic environment at high altitudes.

[0019] Compared with the prior art, the beneficial effects of the present invention are as follows: This invention provides a drug regimen with a definite cardiotonic effect, aiming to enhance myocardial contractility and increase cardiac output, thereby effectively improving oxygen perfusion in peripheral tissues (especially the kidneys). By eliminating hypoxia signals at the source and downregulating the HIF-2α / EPO hematopoietic pathway, it achieves a stable and sustained decrease in red blood cell levels, preventing a retaliatory increase in red blood cell count. Furthermore, addressing the technical challenge of existing Western and traditional Chinese medicine preparations failing to effectively reverse the chronic systemic inflammation associated with hypererythrocyte hyperplasia, this invention aims to simultaneously inhibit the HIF-1α-mediated inflammatory cascade response through the synergistic action of multiple components, significantly reducing the levels of pro-inflammatory factors in the body, thereby protecting against organ damage caused by high blood viscosity and hypoxia. Attached Figure Description

[0020] Figure 1 The comparison of the indicators between Example 1 and Comparative Examples 1-4 is shown, where A represents HGB, B represents HCT, and C represents RBC; the data are expressed as mean ± SD (n=6).

[0021] Figure 2 These are blood routine indicators, where A is HGB, B is HCT, C is RBC, D is RDS-SD, and E is MCV.

[0022] Figure 3The figures show the expression levels of EPO and HIF2-α in the kidneys and the expression levels of inflammatory factors in the serum. In this figure, A represents the expression level of EPO and HIF2-α mRNA in the kidneys, and B represents the expression level of IL-6 in the serum.

[0023] Figure 4 HE staining of spleen tissue.

[0024] Figure 5 HE staining of lung tissue.

[0025] Figure 6 HE staining of kidney tissue.

[0026] Figure 7 HE staining of liver tissue.

[0027] Figure 8 HE staining of cardiac tissue. Detailed Implementation

[0028] The specific embodiments of the present invention are described in detail below, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention. Unless otherwise specified, the experimental methods described in the embodiments of the present invention are conventional methods.

[0029] High-altitude polycythemia is a chronic disease that develops under long-term hypoxic conditions at high altitudes. It manifests not only as abnormally elevated levels of red blood cells, hemoglobin, and hematocrit, but also as symptoms such as chest tightness, shortness of breath, palpitations, headache, and fatigue, exhibiting characteristics of chest pain syndrome. This further leads to increased blood viscosity, microcirculatory disturbances, and insufficient tissue oxygenation. This disease is not simply a hypoxic reaction, nor does it differ from ordinary cardiovascular diseases. Instead, it combines multiple pathological features caused by hypoxia, including insufficient Yang energy in the chest, depletion of Qi and Yin, blood stasis, impaired Qi flow, and long-term kidney involvement. This invention employs a holistic approach of "treating chest pain simultaneously with heart and lung function, tonifying Qi and astringing the lungs, promoting blood circulation and unblocking the meridians, and nourishing the liver and kidneys." Among them, Trichosanthes kirilowii, Allium macrostemon, and Cinnamomum cassia broaden the chest, promote Yang, and regulate Qi, thereby improving symptoms such as chest tightness and shortness of breath caused by long-term hypoxia; American ginseng and Schisandra chinensis tonify Qi and nourish Yin, astringe the lungs and consolidate Qi, thereby improving the body's ability to adapt to low-oxygen environments; Salvia miltiorrhiza invigorates blood and unblocks the meridians, thereby improving blood viscosity and circulatory disorders caused by high red blood cell counts; Citrus aurantium regulates Qi and relieves stagnation, promoting the ascending and descending of Qi; Cornus officinalis and Schisandra chinensis tonify the liver and kidneys and consolidate essence and Qi, thereby improving the body's depletion state caused by long-term chronic hypoxia. Each component targets different stages of the disease's development, together forming a holistic intervention system of "improving chest and lung function—enhancing hypoxia adaptation—improving blood rheology—alleviating chronic depletion."

[0030] A traditional Chinese medicine composition for treating high-altitude polycythemia, wherein the active ingredients of the traditional Chinese medicine composition are made from the following raw materials in parts by weight: Trichosanthes kirilowii 5 parts, Allium macrostemon 5 parts, Schisandra chinensis 10 parts, Panax quinquefolius 5 parts, Ziziphus jujuba 15 parts, Cinnamomum cassia 5 parts, Citrus aurantium 10 parts, and Salvia miltiorrhiza 5 parts.

[0031] Preparation method: ①Weigh out the following ingredients according to the prescription: Trichosanthes kirilowii, Allium macrostemon, Schisandra chinensis, American ginseng, jujube peel, cinnamon twig, stir-fried Citrus aurantium, and Salvia miltiorrhiza. Remove impurities, wash, and dry them for later use. ② Add the raw materials to the extraction tank, add water in a volume of 6-12 times the total weight of the raw materials, soak for 20-60 minutes, heat and decoct 1-3 times, each time for 0.5-2 hours, filter, and combine the filtrates; ③ The resulting filtrate is concentrated to one-eighth of its original volume at a concentration temperature of 70-80℃.

[0032] Example 1 A traditional Chinese medicine composition for treating high-altitude polycythemia, wherein the active ingredients of the traditional Chinese medicine composition are made from the following raw materials in parts by weight: Trichosanthes kirilowii 10g, Allium macrostemon 10g, Schisandra chinensis 15g, Panax quinquefolius 10g, Ziziphus jujuba peel 20g, Cinnamomum cassia 20g, Citrus aurantium 15g, and Salvia miltiorrhiza 10g.

[0033] Example 2 A traditional Chinese medicine composition for treating high-altitude polycythemia, wherein the active ingredients of the traditional Chinese medicine composition are made from the following raw materials in parts by weight: Trichosanthes kirilowii 5g, Allium macrostemon 5g, Schisandra chinensis 10g, Panax quinquefolius 5g, Ziziphus jujuba peel 15g, Cinnamomum cassia twig 5g, Citrus aurantium 10g, and Salvia miltiorrhiza 5g.

[0034] Example 3 A traditional Chinese medicine composition for treating high-altitude polycythemia, wherein the active ingredients of the traditional Chinese medicine composition are made from the following raw materials in parts by weight: Trichosanthes kirilowii 15g, Allium macrostemon 15g, Schisandra chinensis 20g, Panax quinquefolius 15g, Ziziphus jujuba peel 25g, Cinnamomum cassia 15g, Citrus aurantium 20g, and Salvia miltiorrhiza 15g.

[0035] Example 4 A method for preparing a traditional Chinese medicine composition includes the following steps: Weigh out the following raw materials from Examples 1-3: Trichosanthes kirilowii, Allium macrostemon, Schisandra chinensis, Panax quinquefolius, Ziziphus jujuba peel, Cinnamomum cassia, Citrus aurantium (fried), and Salvia miltiorrhiza. Remove impurities, wash, and dry them for later use. Add the raw materials to the extraction tank, add water with a total weight of 10 times the raw materials, soak for 45 minutes, heat and decoct 3 times, 1 hour each time, filter, and combine the filtrates; The resulting filtrate was concentrated to one-eighth of its original volume at a concentration temperature of 75°C.

[0036] Comparative Example 1 The difference between Comparative Example 1 and Example 1 is that Danshen was not added in Comparative Example 1, while the other raw materials, dosages and preparation methods are the same as in Example 1.

[0037] Specifically, 10g of Trichosanthes kirilowii, 10g of Allium macrostemon, 15g of Schisandra chinensis, 10g of Panax quinquefolius, 20g of Ziziphus jujuba peel, 10g of Cinnamomum cassia twig, and 15g of Citrus aurantium were weighed out, without adding Salvia miltiorrhiza, and the traditional Chinese medicine composition of Comparative Example 1 was prepared according to the method described in Example 1.

[0038] Comparative Example 2 The difference between Comparative Example 2 and Example 1 is that American ginseng was not added in Comparative Example 2, while the other raw materials, dosages and preparation methods were the same as in Example 1.

[0039] Specifically, 10g of Trichosanthes kirilowii, 10g of Allium macrostemon, 15g of Schisandra chinensis, 20g of Ziziphus jujuba peel, 10g of Cinnamomum cassia, 15g of stir-fried Citrus aurantium, and 10g of Salvia miltiorrhiza were weighed out, without adding American ginseng, and the traditional Chinese medicine composition of Comparative Example 2 was prepared according to the method described in Example 1.

[0040] Comparative Example 3 The difference between Comparative Example 3 and Example 1 is that Trichosanthes kirilowii and Allium macrostemon were not added in Comparative Example 3, while the other raw materials, dosages and preparation methods were the same as in Example 1.

[0041] Specifically, 15g of Schisandra chinensis, 10g of American ginseng, 20g of jujube peel, 10g of cinnamon twig, 15g of stir-fried Citrus aurantium, and 10g of Salvia miltiorrhiza were weighed out, without adding Trichosanthes kirilowii and Allium macrostemon, and the traditional Chinese medicine composition of Comparative Example 3 was prepared according to the method described in Example 1.

[0042] Comparative Example 4 The difference between Comparative Example 4 and Example 1 is that the proportion of each active pharmaceutical ingredient used in Comparative Example 4 exceeds the limits of this invention, while the other preparation methods are the same as those in Example 1.

[0043] Specifically, 3g of Trichosanthes kirilowii, 3g of Allium macrostemon, 25g of Schisandra chinensis, 3g of Panax quinquefolius, 30g of Ziziphus jujuba peel, 3g of Cinnamomum cassia, 25g of Citrus aurantium (fried), and 3g of Salvia miltiorrhiza were weighed and prepared according to the method described in Example 1 to obtain the traditional Chinese medicine composition of Comparative Example 4.

[0044] Experimental Example: Interventional Effects of Different Traditional Chinese Medicine Combinations on High Altitude Polycythemia To verify the therapeutic effect of the traditional Chinese medicine composition of this invention on high-altitude polycythemia and the synergistic effect among the raw materials, SPF-grade C57BL / 6 mice were placed in a hypobaric chamber at an altitude of 5500 meters to establish an animal model of high-altitude polycythemia. The successfully modeled animals were randomly divided into a model group, Example 1 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and Comparative Example 4 group, with a normal control group. Example 1 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and Comparative Example 4 group served as the treatment groups, and each group was administered the traditional Chinese medicine composition prepared in Example 1 and Comparative Examples 1-4, respectively. After 6 weeks of continuous administration, changes in red blood cell count, hemoglobin content, hematocrit, blood viscosity, and blood oxygen saturation were measured in each group.

[0045] The experimental results showed that, compared with the normal control group, the model group animals had significantly higher red blood cell count, hemoglobin content, and hematocrit, as well as increased blood viscosity, indicating that the high-altitude polycythemia model was successfully established.

[0046] Compared with the model group, the Example 1 group was able to reduce red blood cell count, hemoglobin content and hematocrit, improve blood viscosity, and alleviate tissue damage to the heart, lungs, spleen and other tissues caused by the high-altitude hypoxic environment, indicating that the traditional Chinese medicine composition of the present invention has a good therapeutic effect on high-altitude polycythemia.

[0047] Compared with Example 1, Comparative Example 1, due to the removal of Salvia miltiorrhiza, had a weakened effect in reducing blood viscosity, improving hematocrit, and alleviating microcirculation disorders, indicating that Salvia miltiorrhiza plays an important role in improving blood viscosity and blood stasis caused by high-altitude polycythemia in the composition of the present invention.

[0048] Compared with Example 1, Comparative Example 2, due to the removal of American ginseng, had a weakened effect in improving hypoxia tolerance and regulating compensatory erythrocyte proliferation caused by high-altitude hypoxia. This was reflected in the fact that the improvement in red blood cell count, hemoglobin content, and hematocrit was lower than that in Example 1. This indicates that American ginseng in the composition of the present invention has the effect of enhancing the body's hypoxia tolerance and reducing abnormal erythrocyte proliferation caused by hypoxia stimulation.

[0049] Compared with Example 1, Comparative Example 3, due to the removal of Trichosanthes kirilowii and Allium macrostemon, had a weakened effect on improving pathological changes caused by impaired blood circulation, chest yang deficiency, and poor blood and qi circulation under hypoxia. This was manifested in the higher retention of red blood cells in the tissue compared to Example 1. This indicates that Trichosanthes kirilowii and Allium macrostemon have the effects of promoting yang and dispersing stagnation, relieving chest tightness and regulating qi, and promoting blood and qi circulation in the composition of the present invention, and can work with other drugs to improve the pathological state of high altitude polycythemia.

[0050] Compared with Example 1, although Comparative Example 4 contains the same types of active pharmaceutical ingredients as Example 1, its effect on improving red blood cell count, hemoglobin content, hematocrit and blood viscosity is weaker than that of Example 1 because the proportion of each active pharmaceutical ingredient exceeds the limits of this invention. This indicates that the therapeutic effect of the Chinese medicine composition of this invention depends not only on the combined use of each active pharmaceutical ingredient, but also on the proportion of each active pharmaceutical ingredient.

[0051] The above results indicate that the herbal composition of this invention can exert a comprehensive regulatory effect on the pathological aspects of high-altitude polycythemia, including hypoxia, abnormal increase in red blood cells, increased blood viscosity, and tissue hypoxia damage. The ingredients—Trichosanthes kirilowii, Allium macrostemon, Schisandra chinensis, American ginseng, Ziziphus jujuba peel, Cinnamomum cassia, Citrus aurantium (fried), and Salvia miltiorrhiza—exert synergistic effects through multiple mechanisms, including tonifying qi and nourishing yin, warming and invigorating qi and blood, regulating qi and relieving chest congestion, promoting blood circulation and removing blood stasis, improving hypoxia tolerance, and alleviating abnormal blood rheology. The deletion or alteration of any key ingredient will weaken the therapeutic effect on high-altitude polycythemia to varying degrees, indicating that the composition and dosage ratio of the herbal composition of this invention have a synergistic effect.

[0052] Animal experiments: SPF-grade C57BL / 6 mice were randomly divided into two groups: a HAPC saline group and a drug administration group (Example 1 of this invention), with four mice in each group. Except for the control group, all other groups of mice were placed in a hypobaric chamber at a temperature of 5500 meters to induce the hypoxia model. Simultaneously with model initiation, the drug administration group received 220 μl of the drug via gavage every other day for six consecutive weeks.

[0053] like Figure 2 As shown, after continuous administration to the model mice, peripheral blood erythrocyte count (RBC), hemoglobin concentration (HGB), and hematocrit (HCT) all showed extremely significant decreases, and the expression levels of EPO in serum and tissues were also downregulated, demonstrating its hematopoietic inhibitory intervention ability. Compared with the untreated model group, the serum inflammatory factor IL-6 was also decreased, such as... Figure 3 As shown.

[0054] H&E staining results of spleen as follows Figure 4 As shown, the results indicated that the splenic red pulp region of mice in the untreated HAPC model group exhibited severe erythrocyte stasis and diffuse congestion, confirming the abnormal erythrocyte proliferation and microcirculatory disturbances caused by persistent hypoxia. However, after intervention with the herbal composition of this invention, the abnormal aggregation of erythrocytes in the splenic red pulp of mice was significantly cleared, the congestion was greatly alleviated, and the tissue morphology was well restored. These pathological results directly confirm the definite efficacy of the composition of this invention in reducing erythrocyte load and improving blood hyperviscosity.

[0055] like Figure 5As shown, the lung tissue of the model group mice showed obvious pathological damage, including significant thickening of alveolar septa, accompanied by a large number of inflammatory cell infiltrations and vascular congestion. The lung structure of the mice in the drug group of the present invention was significantly protected, the alveolar septa were thinned, the inflammatory cell infiltration was greatly reduced, and the alveolar cavity was restored to permeability.

[0056] like Figure 6 As shown, the HAPC model mice in the saline group exhibited extremely severe microcirculatory disturbances, with a large number of bright red erythrocytes severely congested in the peritubular capillaries and renal interstitium. This localized severe congestion exacerbated the parenchymal hypoxia of the kidneys, thereby continuously triggering the abnormal release of EPO. However, after intervention with the composition of this invention, the large accumulation of abnormal erythrocytes in the renal interstitium and capillaries was significantly cleared, microcirculation was restored, and the renal tubular structure remained intact.

[0057] like Figure 7 As shown, both groups showed an increase in stellate cells, but the treatment group did not show significant large-area cell necrosis or large-area inflammation, indicating that this preparation did not show significant toxicity.

[0058] like Figure 8 As shown, the untreated HAPC model group mice showed significant tissue damage, with disordered and loose muscle fiber arrangement, obvious interstitial edema and focal rupture, confirming that long-term hypoxia and hyperviscosity syndrome caused excessive strain on the muscles. After intervention with the composition of the present invention, the interstitial edema of the muscle tissue was significantly eliminated, and the muscle fibers were restored to a dense and continuous parallel arrangement.

[0059] Comprehensive experimental data show that the traditional Chinese medicine composition prepared in the embodiments of the present invention can improve the abnormally elevated HIF-2α activity and RBC indicators in HAPC mice to a certain extent, and significantly reduce the release of HIF-1α-mediated inflammatory factors, which has extremely high clinical value.

[0060] Existing bloodletting therapies can only temporarily remove redundant peripheral red blood cells, which can actually exacerbate tissue ischemia and trigger hematopoietic rebound. The herbal composition of this invention, through multi-component synergy, directly intervenes in the body's hypoxia-sensing pathway, effectively inhibiting the abnormal accumulation of hypoxia-inducible factor (HIF-2α) and reducing the excessive secretion of erythropoietin (EPO) at its source. This intervention from the "upstream" of hematopoiesis results in a stable and sustained decrease in red blood cell levels. As a herbal composition, this invention focuses on the long-term, stable regulation and repair of the body's internal environment.

[0061] It should be noted that when numerical ranges are mentioned in the claims of this invention, it should be understood that the two endpoints of each numerical range and any value between the two endpoints can be selected. To avoid redundancy, the present invention describes preferred embodiments.

[0062] Although preferred embodiments of the invention have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the appended claims are intended to be interpreted as including both the preferred embodiments and all changes and modifications falling within the scope of the invention.

[0063] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition for treating high-altitude polycythemia, characterized in that, The active ingredients of the traditional Chinese medicine composition are made from the following raw materials in parts by weight: Trichosanthes kirilowii 5 parts, Allium macrostemon 5 parts, Schisandra chinensis 10 parts, American ginseng 5 parts, jujube peel 15 parts, cinnamon twig 5 parts, stir-fried Citrus aurantium 10 parts, and Salvia miltiorrhiza 5 parts.

2. A method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, Includes the following steps: Weigh out Trichosanthes kirilowii, Allium macrostemon, Schisandra chinensis, Panax quinquefolius, Ziziphus jujuba peel, Cinnamomum cassia, stir-fried Citrus aurantium and Salvia miltiorrhiza, remove impurities, wash and dry to obtain raw materials; Mix the raw materials with water at a mass ratio of 1:6 to 12, soak, decoct, filter, and collect the filtrate. The resulting filtrate is concentrated to 1 / 10 to 1 / 5 of its original volume at a concentration temperature of 70-80℃.

3. The preparation method according to claim 2, characterized in that, Soaking time is 20-60 minutes.

4. The preparation method according to claim 2, characterized in that, Boil 1-3 times, 0.5-2 hours each time.

5. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicament for treating high-altitude polycythemia.

6. The application according to claim 5, characterized in that, The drug is used to relieve erythrocyte stasis and diffuse congestion caused by the low oxygen environment at high altitudes.

7. The application according to claim 5, characterized in that, The drug is used to alleviate significant thickening of alveolar septa, accompanied by extensive inflammatory cell infiltration and vascular congestion caused by the high-altitude hypoxic environment.

8. The application according to claim 5, characterized in that, The drug is used to relieve interstitial edema and focal rupture caused by the low oxygen environment at high altitudes.

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