Traditional Chinese medicine composition for treating acute altitude sickness and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating acute altitude sickness. The traditional Chinese medicine composition is prepared from ginseng, astragalus membranaceus, acanthopanax, rhodiola rosea, turnip, salvia miltiorrhiza, dogwood, poria cocos, rhizoma cimicifugae, radix bupleuri, platycodon grandiflorum, aster, elecampane, rhizoma anemarrhenae and liquorice. The traditional Chinese medicine composition disclosed by the invention can be used for treating the acute altitude sickness, remarkably prolonging the load-bearing swimming time of rats, remarkably increasing the arterial oxygen partial pressure and the arterial oxygen saturation of acute altitude sickness model rats and relieving physical fatigue, has obvious effects of resisting anoxia, improving acid-base balance and resisting inflammation, and has obvious curative effects on myocardial injury, liver injury, liver injury and the like. And the kidney injury can be protected.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating acute mountain sickness. BACKGROUND

[0002] Acute mountain sickness (AMS) is prone to occur in people who are native to plains and then quickly move to high altitudes. AMS affects the psychology, emotion, physical activity, work ability and even life and health of people who quickly move to high altitudes. In recent years, due to tourism, business activities and cultural exchanges, the number of people who go to and from high altitudes in inland areas has increased sharply, and therefore the incidence of AMS has increased year by year. AMS is characterized by headache, nausea, vomiting and fatigue, often causes people to lose behavioral ability, and can develop into life-threatening high altitude cerebral edema and high altitude pulmonary edema.

[0003] Although modern medicine has carried out certain drug and physical intervention exploration in the prevention and treatment of high altitude sickness, existing treatment methods are mostly focused on relieving symptoms, such as oxygen inhalation, application of glucocorticoids, and the like, and there is still a lack of systematic comprehensive intervention strategies for the overall stress and multi-system dysfunction of the body under the condition of "quickly moving to high altitudes". Some intervention measures also have problems of interference with acid-base balance, electrolyte disorder or dependence on equipment support, and the like. SUMMARY

[0004] Traditional Chinese medicine has unique advantages and practical potential in overall regulation and multi-target intervention. Traditional Chinese medicine has recognized high altitude sickness early, and Huangdi Neijing has the statement of "high altitude causing panting and gas shortage". Zhang Xichun's Medical Insights into Western Records proposes the theory of "atmospheric depression", which is consistent with the modern pathological mechanism of "oxygen pressure sudden drop leading to disorder of qi movement".

[0005] To solve the above problems, the present application finally screens a traditional Chinese medicine composition capable of treating acute mountain sickness through research on a large number of traditional Chinese medicine prescriptions. The traditional Chinese medicine composition is used for treating and relieving acute mountain sickness and physical discomfort after quickly moving to high altitudes.

[0006] The raw materials of the traditional Chinese medicine composition in the present application are: ginseng, astragalus, acanthopanax, rhodiola, seakale, danshen, cornus, poria cocos, cimicifuga, bupleurum, platycodon, radix araliae, radix ligustici, rhizoma anemarrhenae and licorice.

[0007] The weight parts of the raw materials of the traditional Chinese medicine composition in the present application are: 3-9 weight parts of ginseng, 3-9 weight parts of astragalus, 5-15 weight parts of acanthopanax, 3-9 weight parts of rhodiola, 8-25 weight parts of seakale, 6-24 weight parts of danshen, 3-9 weight parts of cornus, 8-25 weight parts of poria cocos, 1.5-4.5 weight parts of cimicifuga, 3-9 weight parts of bupleurum, 3-9 weight parts of platycodon, 3-9 weight parts of radix ligustici, 3-9 weight parts of radix araliae, 3-9 weight parts of rhizoma anemarrhenae and 3-9 weight parts of licorice.

[0008] Alternatively, the weight parts of each raw material in the Chinese medicine composition of this application are as follows: ginseng 5-8 parts by weight, astragalus 5-8 parts by weight, eleutherococcus senticosus 7-13 parts by weight, rhodiola rosea 5-8 parts by weight, turnip 10-20 parts by weight, salvia miltiorrhiza 8-20 parts by weight, cornus officinalis 5-8 parts by weight, poria cocos 10-20 parts by weight, cimicifuga foetida 2-4 parts by weight, bupleurum chinense 5-8 parts by weight, platycodon grandiflorus 5-8 parts by weight, aster 5-8 parts by weight, costus root 5-8 parts by weight, anemarrhena asphodeloides 5-8 parts by weight, and licorice 5-8 parts by weight.

[0009] Alternatively, use 3 parts by weight of ginseng, 3 parts by weight of astragalus, 5 parts by weight of Acanthopanax senticosus, 3 parts by weight of rhodiola rosea, 8 parts by weight of turnip, 6 parts by weight of salvia miltiorrhiza, 3 parts by weight of cornus officinalis, 8 parts by weight of poria cocos, 1.5 parts by weight of cimicifuga foetida, 3 parts by weight of bupleurum chinense, 3 parts by weight of platycodon grandiflorus, 3 parts by weight of aster tataricus, 3 parts by weight of costus root, 3 parts by weight of anemarrhena asphodeloides, and 3 parts by weight of licorice.

[0010] Alternatively, use 9 parts by weight of ginseng, 9 parts by weight of astragalus, 15 parts by weight of Acanthopanax senticosus, 9 parts by weight of rhodiola rosea, 25 parts by weight of turnip, 24 parts by weight of salvia miltiorrhiza, 9 parts by weight of cornus officinalis, 25 parts by weight of poria cocos, 4.5 parts by weight of cimicifuga foetida, 9 parts by weight of bupleurum chinense, 9 parts by weight of platycodon grandiflorus, 9 parts by weight of aster tataricus, 9 parts by weight of costus root, 9 parts by weight of anemarrhena asphodeloides, and 9 parts by weight of licorice.

[0011] Alternatively, the weight parts of each raw material in the Chinese medicine composition of this application are as follows: ginseng 5 parts, astragalus 5 parts, eleutherococcus senticosus 7 parts, rhodiola rosea 5 parts, turnip 10 parts, salvia miltiorrhiza 8 parts, cornus officinalis 5 parts, poria cocos 10 parts, cimicifuga foetida 2 parts, bupleurum chinense 5 parts, platycodon grandiflorus 5 parts, aster 5 parts, costus root 5 parts, anemarrhena asphodeloides 5 parts, and licorice 5 parts.

[0012] Alternatively, the weight parts of each raw material in the Chinese medicine composition of this application are as follows: ginseng 8 parts by weight, astragalus 8 parts by weight, Acanthopanax senticosus 13 parts by weight, Rhodiola rosea 8 parts by weight, turnip 20 parts by weight, Salvia miltiorrhiza 20 parts by weight, Cornus officinalis 8 parts by weight, Poria cocos 20 parts by weight, Cimicifuga foetida 4 parts by weight, Bupleurum chinense 8 parts by weight, Platycodon grandiflorus 8 parts by weight, Aster tataricus 8 parts by weight, Aucklandia lappa 8 parts by weight, Anemarrhena asphodeloides 8 parts by weight, and Glycyrrhiza uralensis 8 parts by weight.

[0013] Alternatively, the weight parts of each raw material in the Chinese medicine composition of this application are: 6 parts ginseng, 6 parts astragalus, 10 parts Acanthopanax senticosus, 6 parts rhodiola rosea, 15 parts turnip, 12 parts salvia miltiorrhiza, 6 parts cornus officinalis, 15 parts poria cocos, 3 parts cimicifuga foetida, 6 parts bupleurum chinense, 6 parts platycodon grandiflorus, 6 parts aster tataricus, 6 parts costus root, 6 parts anemarrhena asphodeloides, and 6 parts licorice.

[0014] The raw materials and ingredients of the traditional Chinese medicine composition in this application are as follows:

[0015] Ginseng is the dried root and rhizome of Panax ginseng CAMey., a plant belonging to the Araliaceae family. It is mostly harvested in autumn, washed, and then sun-dried or oven-dried.

[0016] Astragalus is the dried root of *Astragalus membranaceus* (Fisch.) Bge. var. *mongholicus* (Bge.) Hsiao or *Astragalus membranaceus* (Fisch.) Bge., belonging to the legume family. It is harvested in spring and autumn, with the fibrous roots and root heads removed before being sun-dried.

[0017] Acanthopanax senticosus (Rupr. et Maxim.) Harms, a plant belonging to the Araliaceae family, is known as the dried root, rhizome, or stem. It is harvested in spring and autumn, washed, and dried.

[0018] Rhodiola crenulata (Hook.f.et Thoms.) H.Ohba, a plant in the Crassulaceae family, is a plant that is harvested in autumn after the flower stalks have withered. The outer bark is removed, the roots are washed, and the roots are dried.

[0019] Turnips are the dried tuberous roots of Brassica rapa L., a plant in the Brassicaceae family. The tubers are harvested in autumn, washed, and then air-dried or sun-dried; or washed, sliced ​​while fresh, and then air-dried or sun-dried.

[0020] Danshen is the dried root and rhizome of *Salvia miltiorrhiza* Bge., a plant in the Lamiaceae family. It is harvested in spring and autumn, cleaned of mud and sand, and then dried.

[0021] Cornus officinalis is the dried, ripe pulp of the plant Cornus officinalis Sieb. et Zucc., belonging to the Cornaceae family. The fruit is harvested in late autumn or early winter when the peel turns red. After being dried over a low heat or briefly blanched in boiling water, the pits are removed promptly, and the fruit is then dried.

[0022] Poria cocos is the dried sclerotium of the fungus Poria cocos (Schw.) Wolf, belonging to the Polyporaceae family. It is mostly harvested from July to September. After being dug up, the mud and sand are removed, and the fungus is piled up to "sweat". It is then spread out to dry until the surface is dry, and then "sweat" again. This process is repeated several times until wrinkles appear and most of the internal moisture is lost. Finally, it is dried in the shade and called "Poria cocos pieces". Alternatively, fresh Poria cocos can be cut into different parts and dried in the shade, which are called "Poria cocos chunks" and "Poria cocos slices" respectively.

[0023] Cimicifuga is the dried rhizome of Cimicifuga heracleifolia Kom., Cimicifuga dahurica (Turcz.) Maxim., or Cimicifuga foetida L., all belonging to the Ranunculaceae family. It is harvested in autumn, the soil and sand are removed, and the rhizomes are sun-dried until the fibrous roots are dry. The fibrous roots are then singed off or removed, and the rhizomes are dried further.

[0024] Bupleurum is the dried root of Bupleurum chinense DC. or Bupleurum corzonerifolium Willd., both belonging to the Apiaceae family. Based on their different characteristics, they are commonly referred to as "Northern Bupleurum" and "Southern Bupleurum," respectively. It is harvested in spring and autumn, and the stems, leaves, and soil are removed before drying.

[0025] Platycodon grandiflorum (Jacq.) A.DC., a plant in the Campanulaceae family, is a dried root. It is harvested in spring and autumn, washed, and the fibrous roots are removed. While still fresh, the outer skin is peeled off, or left on, and then dried.

[0026] Aster is the dried root and rhizome of Aster tataricus Lf, a plant in the Asteraceae family. It is harvested in spring and autumn, and the jointed rhizomes (commonly known as "mother roots") and mud are removed. The roots are then braided and dried in the sun, or simply dried directly.

[0027] Inula helenium L., a plant in the Asteraceae family, is a dried root. It is harvested in autumn, cleaned of mud and sand, and then sun-dried.

[0028] Anemarrhena asphodeloides Bge., a plant in the Liliaceae family, is a dried rhizome. It is harvested in spring and autumn, and the fibrous roots and soil are removed before it is dried in the sun. This is commonly known as "hairy Anemarrhena"; alternatively, the outer skin can be removed before drying.

[0029] Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflate Bat., or Glycyrrhiza glabra L., all belonging to the legume family. It is harvested in spring and autumn, the fibrous roots are removed, and it is then sun-dried.

[0030] This application presents a traditional Chinese medicine composition based on the principles of TCM syndrome differentiation and treatment, using "tonifying qi and lifting prolapsed qi" as its therapeutic principle. Ginseng and astragalus are the principal herbs, focusing on greatly tonifying primordial qi, supporting the lungs and spleen, and serving as the foundation for the generation of vital qi. Ginseng, with its sweet and neutral properties, greatly tonifies primordial qi, benefits the lungs and spleen, making it the first choice for tonifying qi. Astragalus tonifies qi, raises yang, consolidates the exterior, and expels toxins, especially effective in lifting the middle qi. Combined with ginseng, it addresses both internal and external factors, achieving the effect of tonifying qi and preventing collapse. The combined use of these two herbs establishes the foundation for preventing "qi collapse" and supporting "vital qi." The main ingredients are Acanthopanax senticosus, Rhodiola rosea, turnip, Salvia miltiorrhiza, Cornus officinalis, and Poria cocos. Among them, Acanthopanax senticosus benefits the kidneys and strengthens the will, assisting ginseng in replenishing the innate vital energy; Rhodiola rosea invigorates the spleen, benefits qi, and promotes blood circulation; turnip nourishes and oxygenates, and promotes appetite and eliminates dampness; Salvia miltiorrhiza invigorates blood, promotes menstruation, and relieves pain; Cornus officinalis is astringent and consolidates the body, preventing qi from dissipating; and Poria cocos invigorates the spleen and eliminates dampness. This formula embodies the principle of "tonifying the middle while astringing, regulating both qi and blood, consolidating the body while eliminating dampness". In this formula, Cimicifuga rhizome raises the Yangming Qi, while Bupleurum root relieves the stagnation of the Shaoyang Qi, thus lifting the Qi mechanism and reversing the downward sinking of Qi, aligning with Zhang Xichun's Shengxian Decoction's principle of "lifting the Qi." Platycodon root acts as a "boat and oar," guiding the other herbs upwards to the chest, forming a "guiding within raising" combination with Cimicifuga and Bupleurum, both raising the Qi mechanism and clearing the lung channels, relieving chest tightness and shortness of breath. Aster root moistens the lungs and stops coughing, promoting lung Qi, reflecting the formula's approach of "tonifying lung Qi and clearing the upper burner." Bupleurum root soothes the liver and relieves stagnation, raising the clear Yang Qi, and when combined with Cimicifuga rhizome, synergistically lifts the sinking Qi and regulates the Qi mechanism. Aucklandia root promotes Qi circulation and relieves pain, achieving a balance between rising and falling, and coordinating ascending, descending, entering, and exiting. Combined with Cornus officinalis, it astringes the liver, embodying the principle of "using both dispersing and astringing" to regulate the liver. Anemarrhena rhizome clears heat and generates fluids, addressing coughs caused by dryness in the lungs at high altitudes, combining tonification and sedation, reflecting the principle of "tonifying within clearing and clearing within tonifying." Licorice root harmonizes the other herbs. The entire formula closely adheres to the core principle of "tonifying qi and lifting sunken qi," while also taking into account the lungs, spleen, and liver. It tonifies without causing stagnation, and lifts while lowering, thus both rescuing those with qi depletion and regulating the normal flow of qi.

[0031] The method for preparing the traditional Chinese medicine composition in this application includes:

[0032] Take the above-mentioned raw materials in the specified weight proportions, add 6-10 times the amount of water, decoct for 1-3 hours, decoct 2-4 times, filter the decoction (200 mesh), combine the decoctions, and concentrate the above filtrate under reduced pressure; the vacuum degree is 0.06-0.09 MPa, and the concentration temperature is 60-80℃. After concentrating to a relative density of approximately 1.10-1.15 (60℃), release the extract. Place the above-mentioned filtered extract in a feeding tank, stir and preheat to about 50℃, keep warm, turn on the spray dryer, set the inlet temperature and outlet temperature, collect the spray-dried powder, and add pharmaceutically acceptable excipients to prepare a traditional Chinese medicine composition.

[0033] The dosage form of the traditional Chinese medicine composition in this application is granules, tablets, capsules, oral liquids, or injections, etc.

[0034] Pharmaceutically acceptable excipients include xylitol, sucrose powder, sucralose, and magnesium stearate. Specifically, xylitol is pulverized, passed through an 80-mesh sieve, and set aside for dry granulation. The excipients are sucrose powder, sucralose (0.3%), and magnesium stearate (0.5%), mixed for approximately 30 minutes (until homogeneous), and then dry granulated.

[0035] The use of the traditional Chinese medicine composition in the preparation of products for treating acute mountain sickness, as described in this application, is that the traditional Chinese medicine composition can resist fatigue, significantly increase arterial oxygen partial pressure and arterial oxygen saturation in blood gas, improve acid-base balance, protect against myocardial damage, liver damage, and kidney damage, and has anti-inflammatory and anti-hypoxic effects. It can effectively relieve adverse physical reactions such as chest tightness, shortness of breath, wheezing, loss of appetite, fatigue, cough, and headache caused by rapid ascent to high altitudes.

[0036] The use of the traditional Chinese medicine composition in the preparation of products that relieve physical fatigue is described in this application.

[0037] The product mentioned therein is the traditional Chinese medicine composition, drug or adjuvant drug or other traditional Chinese medicine related product described in this application.

[0038] The technical solution of this application will be illustrated below through specific embodiments. Detailed Implementation

[0039] Example 1:

[0040] A traditional Chinese medicine composition, the raw materials and dosages of which are: ginseng 3g, astragalus 3g, eleutherococcus senticosus 5g, rhodiola rosea 3g, turnip 8g, salvia miltiorrhiza 6g, cornus officinalis 3g, poria cocos 8g, cimicifuga foetida 1.5g, bupleurum chinense 3g, platycodon grandiflorus 3g, aster tataricus 3g, costus root 3g, anemarrhena asphodeloides 3g, and licorice 3g.

[0041] The preparation method is as follows: Weigh the above-mentioned raw materials according to the above-mentioned traditional Chinese medicine composition, add 6 times the amount of water, decoct for 1 hour, decoct twice, filter the decoction, combine the decoctions, and concentrate the above filtrate under reduced pressure; the vacuum degree is 0.06-0.09 MPa, and the concentration temperature is 60-80℃. After concentrating to a relative density of about 1.10-1.15 (60℃), release the extract. Place the above-mentioned filtered extract in a feeding tank, stir and preheat to about 50℃, keep warm, turn on the spray dryer, set the inlet temperature and outlet temperature, collect the spray-dried powder, and add pharmaceutically acceptable excipients to prepare granules.

[0042] Example 2:

[0043] A traditional Chinese medicine composition, the raw materials and dosages of which are: ginseng 9g, astragalus 9g, Acanthopanax senticosus 15g, Rhodiola rosea 9g, turnip 25g, Salvia miltiorrhiza 24g, Cornus officinalis 9g, Poria cocos 25g, Cimicifuga foetida 4.5g, Bupleurum chinense 9g, Platycodon grandiflorus 9g, Aster tataricus 9g, Aucklandia lappa 9g, Anemarrhena asphodeloides 9g, and Glycyrrhiza uralensis 9g.

[0044] The preparation method is as follows: Weigh the above-mentioned raw materials according to the above-mentioned traditional Chinese medicine composition, add 8 times the amount of water, decoct for 2 hours, decoct twice, filter the decoction, combine the decoctions, and concentrate the above filtrate under reduced pressure; the vacuum degree is 0.06-0.09 MPa, and the concentration temperature is 60-80℃. After concentrating to a relative density of about 1.10-1.15 (60℃), release the extract. Place the above-mentioned filtered extract in a feeding tank, stir and preheat to about 50℃, keep warm, turn on the spray dryer, set the inlet temperature and outlet temperature, collect the spray-dried powder, and add pharmaceutically acceptable excipients to prepare tablets.

[0045] Example 3:

[0046] A traditional Chinese medicine composition, the raw materials and dosages of which are: ginseng 5g, astragalus 5g, eleutherococcus senticosus 7g, rhodiola rosea 5g, turnip 10g, salvia miltiorrhiza 8g, cornus officinalis 5g, poria cocos 10g, cimicifuga foetida 2g, bupleurum chinense 5g, platycodon grandiflorus 5g, aster tataricus 5g, costus root 5g, anemarrhena asphodeloides 5g, and licorice 5g.

[0047] The preparation method is as follows: Weigh the above-mentioned raw materials according to the above-mentioned traditional Chinese medicine composition, add 10 times the amount of water, decoct for 3 hours, decoct 3 times, filter the decoction, combine the decoctions, and concentrate the above filtrate under reduced pressure; the vacuum degree is 0.06-0.09Mpa, and the concentration temperature is 60-80℃. After concentrating to a relative density of about 1.10-1.15 (60℃), release the extract. Place the above-mentioned filtered extract in a feeding tank, stir and preheat to about 50℃, keep warm, turn on the spray dryer, set the inlet temperature and outlet temperature, collect the spray-dried powder, and add pharmaceutically acceptable excipients to prepare capsules.

[0048] Example 4:

[0049] A traditional Chinese medicine composition, the raw materials and dosages of which are: ginseng 8g, astragalus 8g, Acanthopanax senticosus 13g, rhodiola rosea 8g, turnip 20g, salvia miltiorrhiza 20g, cornus officinalis 8g, poria cocos 20g, cimicifuga foetida 4g, bupleurum chinense 8g, platycodon grandiflorus 8g, aster tataricus 8g, costus root 8g, anemarrhena asphodeloides 8g, and licorice 8g.

[0050] The preparation method is as follows: Weigh the above-mentioned raw materials according to the above-mentioned traditional Chinese medicine composition, add 10 times the amount of water, decoct for 3 hours, decoct 3 times, filter the decoction, combine the decoctions, and concentrate the above filtrate under reduced pressure; the vacuum degree is 0.06-0.09Mpa, and the concentration temperature is 60-80℃. After concentrating to a relative density of about 1.10-1.15 (60℃), release the extract. Place the above-mentioned filtered extract in a feeding tank, stir and preheat to about 50℃, keep warm, turn on the spray dryer, set the inlet temperature and outlet temperature, collect the spray-dried powder, and add a carrier acceptable to traditional Chinese medicine to prepare an oral liquid.

[0051] Example 5:

[0052] A traditional Chinese medicine composition, the raw materials and dosages of which are: ginseng 6g, astragalus 6g, Acanthopanax senticosus 10g, rhodiola rosea 6g, turnip 15g, salvia miltiorrhiza 12g, cornus officinalis 6g, poria cocos 15g, cimicifuga foetida 3g, bupleurum chinense 6g, platycodon grandiflorus 6g, aster tataricus 6g, costus root 6g, anemarrhena asphodeloides 6g, and licorice 6g.

[0053] The preparation method is as follows: Weigh the above-mentioned raw materials according to the above-mentioned traditional Chinese medicine composition, add 10 times the amount of water, decoct for 1 hour, decoct 3 times, filter the decoction, combine the decoctions, and concentrate the above filtrate under reduced pressure; the vacuum degree is 0.06-0.09Mpa, and the concentration temperature is 60-80℃. After concentrating to a relative density of about 1.10-1.15 (60℃), release the extract. Place the above-mentioned filtered extract in a feeding tank, stir and preheat to about 50℃, keep warm, turn on the spray dryer, set the inlet temperature and outlet temperature, collect the spray-dried powder, and after drying, add appropriate amounts of sucrose powder, sucralose, and magnesium stearate, mix well, granulate, and make granules.

[0054] Animal experiments:

[0055] The efficacy test of the traditional Chinese medicine composition for the prevention and treatment of acute mountain sickness in a hypoxic animal experiment (simulated altitude 7000m) using a hypoxic simulated chamber:

[0056] The traditional Chinese medicine composition of this application was tested in a low-pressure, low-oxygen chamber (simulating an altitude of 7000 meters).

[0057] 1. Animal grouping, model establishment, and drug administration

[0058] Grouping: Wistar rats, SPF grade, male, were randomly divided into 3 groups according to body weight: normoxic control group, hypoxia model group, and the herbal composition of this application (5.18 g / kg, calculated as crude drug, which is the herbal composition of Example 1), with 10 rats in each group.

[0059] Modeling and drug administration: After the adaptation period, rats in each group were continuously administered drugs outside the chamber for 7 days according to their group. Specifically, the normoxic blank group and the hypoxic model group were administered sterile water for injection by gavage. The traditional Chinese medicine composition group of this application was administered by gavage according to the corresponding dose. After gavage administration on the 7th day, except for the normoxic blank group, the animals in the other groups were placed in a large plateau low-pressure hypoxia simulation chamber (simulated altitude 7000m) and continuously exposed to hypoxia for 72 hours. The drugs were administered continuously inside the chamber for 3 days. One hour after the last administration, a swimming experiment was first conducted, followed by anesthesia, blood collection, and dissection of the animals.

[0060] 2. Detection indicators

[0061] 2.1 Measure the time spent swimming with added weight;

[0062] 2.2 Blood gas analysis;

[0063] 2.3 Blood was collected, centrifuged, serum was separated, and serum biochemical indicators were detected;

[0064] 2.4 Detection of inflammatory factors in lung tissue: nuclear factor Toll-like receptor 4 (TLR4), pro-inflammatory factor interleukin-1β (IL-1β), and tumor necrosis factor-α (TNF-α);

[0065] 2.5 Detection of cytokines such as hypoxia-inducible factor-1α (HIF-1α) and hypoxia-inducible factor-1β (HIF-1β) in lung tissue.

[0066] 3. Data Statistical Analysis

[0067] Experimental data were analyzed using SPSS software. Measurement data were expressed as mean ± standard deviation. The data is presented in the table. One-way ANOVA was used for comparisons among multiple groups. For groups conforming to a normal distribution, if the variances were homogeneous, the LSD test was used; if the variances were unequal, the Games-Howell test was used. For other groups not conforming to a normal distribution, the Kruskal-Wallis test was used. A p-value < 0.05 was considered statistically significant.

[0068] 4. Experimental Results

[0069] 4.1 Anti-fatigue effect of the traditional Chinese medicine composition in this application

[0070] (1) Swimming time with weight

[0071] Compared with the normoxic control group, the swimming time of the hypoxic control group was significantly reduced; the swimming time of the traditional Chinese medicine composition group in this application was significantly increased, indicating that the traditional Chinese medicine composition in this application has an anti-fatigue effect. The results are shown in Table 1.

[0072] Table 1 Comparison of swimming time among rats in each group (M(Q1, Q3))

[0073]

[0074] Note: Compared with the normoxic control group, ** P < 0.01; compared with the hypoxic control group, # P < 0.05.

[0075] 4.2 The traditional Chinese medicine composition of this application has the effects of increasing blood oxygen saturation and oxygen partial pressure, and improving acid-base balance.

[0076] (1) Compared with the normoxic control group, the pH, PaO2, PaCO2, SaO2, HCO3-act, HCO3-std, BE(ecf), and BE(b) of the hypoxia model group were significantly reduced, indicating that metabolic acidosis occurred in the hypoxia model group.

[0077] (2) The herbal composition group in this application showed a significant increase in both PaO2 and SaO2, which was significantly different from the hypoxia model group;

[0078] (3) The herbal composition of this application can significantly improve pH value and PaCO2 level, and improve acid-base balance indicators HCO3-act, HCO3-std, BE(ecf), and BE(b), indicating that the herbal composition of this application can correct metabolic acidosis. The results are shown in Table 2.

[0079] Table 2 Comparison of blood gas parameters in rats of different groups

[0080]

[0081] Note: Compared with the normoxic control group, ** P < 0.01; compared with the hypoxia model group, ## P < 0.01;

[0082] 4.3 The traditional Chinese medicine composition of this application has a protective effect against myocardial injury, liver injury, and kidney injury.

[0083] Compared with the normoxic control group, the levels of serum central function, liver function, and kidney function-related indicators CKMB, LDH2, AST, and CRE in the hypoxia model group rats were significantly increased (P<0.01).

[0084] Compared with the hypoxia model group, the contents of CKMB, LDH2, AST and CRE in the herbal composition group of this application were significantly reduced, indicating that the herbal composition of this application has a protective effect against myocardial injury, liver injury and kidney injury.

[0085] The results are shown in Table 3.

[0086] Table 3 Comparison of serum CKMB, LDH2, AST, and CRE levels in rats from different groups

[0087]

[0088] Note: Compared with the blank group, ** P < 0.01; compared with the hypoxia model group, ## P < 0.01, # P < 0.05

[0089] 4.4 Anti-inflammatory effect of the traditional Chinese medicine composition in this application

[0090] Compared with the normoxic control group, the levels of TLR4, pro-inflammatory factors IL-1β, and TNF-α in the lung tissue of rats in the hypoxia model group were significantly increased (P<0.01); compared with the hypoxia model group, the levels of TLR4, IL-1β, and TNF-α in the herbal composition group of this application were significantly decreased (P<0.01). The specific results are shown in Table 4.

[0091] Table 4 Comparison of TLR4, IL-1β, and TNF-α levels in lung tissue of rats in different groups

[0092]

[0093] Note: Compared with the normal group, * P < 0.05 ** P < 0.01; compared with the hypoxia model group, ## P < 0.01.

[0094] 4.5 Anti-hypoxia effect of the traditional Chinese medicine composition in this application

[0095] Compared with the normoxic control group, the levels of HIF-1α and HIF-1β in the lung tissue of rats in the hypoxia model group were significantly increased (P<0.01); compared with the hypoxia model group, the levels of HIF-1α and HIF-1β in the herbal composition group of this application were significantly decreased (P<0.01 or P<0.05). The specific results are shown in Table 5.

[0096] Table 5 Comparison of HIE-1α and HIF-1β contents in lung tissue of rats in different groups

[0097]

[0098] Note: Compared with the normal group, ** P < 0.01; compared with the model group, # P < 0.05 ## P < 0.01.

[0099] In summary, the traditional Chinese medicine composition of this application has the effects of anti-fatigue, improving blood oxygen saturation, increasing oxygen partial pressure, and improving acid-base balance. It also has a protective effect against myocardial damage, liver damage, and kidney damage, and has anti-inflammatory and anti-hypoxic effects. Through the above effects, it can be used to treat acute mountain sickness and can effectively relieve adverse physical reactions such as chest tightness, shortness of breath, wheezing, fatigue, cough, headache, and loss of appetite caused by rapid ascent to high altitudes.

Claims

1. A traditional Chinese medicine composition for treating acute mountain sickness, comprising the following raw materials and their weight parts: ginseng 3-9 parts by weight, astragalus 3-9 parts by weight, eleutherococcus senticosus 5-15 parts by weight, rhodiola rosea 3-9 parts by weight, turnip 8-25 parts by weight, salvia miltiorrhiza 6-24 parts by weight, cornus officinalis 3-9 parts by weight, poria cocos 8-25 parts by weight, cimicifuga foetida 1.5-4.5 parts by weight, bupleurum chinense 3-9 parts by weight, platycodon grandiflorus 3-9 parts by weight, aster tataricus 3-9 parts by weight, costus root 3-9 parts by weight, anemarrhena asphodeloides 3-9 parts by weight, and licorice 3-9 parts by weight.

2. The traditional Chinese medicine composition for treating acute mountain sickness as described in claim 1, wherein the raw materials and their weight parts are: ginseng 5-8 parts by weight, astragalus 5-8 parts by weight, eleutherococcus senticosus 7-13 parts by weight, rhodiola rosea 5-8 parts by weight, turnip 10-20 parts by weight, salvia miltiorrhiza 8-20 parts by weight, cornus officinalis 5-8 parts by weight, poria cocos 10-20 parts by weight, cimicifuga foetida 2-4 parts by weight, bupleurum chinense 5-8 parts by weight, platycodon grandiflorus 5-8 parts by weight, aster 5-8 parts by weight, costus root 5-8 parts by weight, anemarrhena asphodeloides 5-8 parts by weight, and licorice 5-8 parts by weight.

3. The traditional Chinese medicine composition for treating acute mountain sickness as described in claim 1, wherein the raw materials and their weight parts are: ginseng 3 parts by weight, astragalus 3 parts by weight, eleutherococcus senticosus 5 parts by weight, rhodiola rosea 3 parts by weight, turnip 8 parts by weight, salvia miltiorrhiza 6 parts by weight, cornus officinalis 3 parts by weight, poria cocos 8 parts by weight, cimicifuga foetida 1.5 parts by weight, bupleurum chinense 3 parts by weight, platycodon grandiflorus 3 parts by weight, aster tataricus 3 parts by weight, costus root 3 parts by weight, anemarrhena asphodeloides 3 parts by weight, and licorice 3 parts by weight.

4. The traditional Chinese medicine composition for treating acute mountain sickness as described in claim 1, wherein the raw materials and their weight parts are: ginseng 9 parts by weight, astragalus 9 parts by weight, eleutherococcus senticosus 15 parts by weight, rhodiola rosea 9 parts by weight, turnip 25 parts by weight, salvia miltiorrhiza 24 parts by weight, cornus officinalis 9 parts by weight, poria cocos 25 parts by weight, cimicifuga foetida 4.5 parts by weight, bupleurum chinense 9 parts by weight, platycodon grandiflorus 9 parts by weight, aster 9 parts by weight, costus root 9 parts by weight, anemarrhena asphodeloides 9 parts by weight, and licorice 9 parts by weight.

5. The traditional Chinese medicine composition for treating acute mountain sickness as described in claim 1, wherein the raw materials and their weight parts are: ginseng 5 parts by weight, astragalus 5 parts by weight, eleutherococcus senticosus 7 parts by weight, rhodiola rosea 5 parts by weight, turnip 10 parts by weight, salvia miltiorrhiza 8 parts by weight, cornus officinalis 5 parts by weight, poria cocos 10 parts by weight, cimicifuga foetida 2 parts by weight, bupleurum chinense 5 parts by weight, platycodon grandiflorus 5 parts by weight, aster 5 parts by weight, costus root 5 parts by weight, anemarrhena asphodeloides 5 parts by weight, and licorice 5 parts by weight.

6. The traditional Chinese medicine composition for treating acute mountain sickness as described in claim 1, wherein the raw materials and their weight parts are: ginseng 8 parts by weight, astragalus 8 parts by weight, eleutherococcus senticosus 13 parts by weight, rhodiola rosea 8 parts by weight, turnip 20 parts by weight, salvia miltiorrhiza 20 parts by weight, cornus officinalis 8 parts by weight, poria cocos 20 parts by weight, cimicifuga foetida 4 parts by weight, bupleurum chinense 8 parts by weight, platycodon grandiflorus 8 parts by weight, aster 8 parts by weight, costus root 8 parts by weight, anemarrhena asphodeloides 8 parts by weight, and licorice 8 parts by weight.

7. The traditional Chinese medicine composition for treating acute mountain sickness as described in claim 1, wherein the raw materials and their weight parts are: 6 parts ginseng, 6 parts astragalus, 10 parts Acanthopanax senticosus, 6 parts Rhodiola rosea, 15 parts turnip, 12 parts Salvia miltiorrhiza, 6 parts Cornus officinalis, 15 parts Poria cocos, 3 parts Cimicifuga foetida, 6 parts Bupleurum chinense, 6 parts Platycodon grandiflorus, 6 parts Aster tataricus, 6 parts Aucklandia lappa, 6 parts Anemarrhena asphodeloides, and 6 parts Glycyrrhiza uralensis.

8. The method for preparing the traditional Chinese medicine composition for treating acute mountain sickness as described in any one of claims 1-7, characterized in that... The method includes: taking the above-mentioned raw materials in the specified weight proportions, adding 6-10 times the amount of water, decocting for 1-3 hours, decocting 2-4 times, filtering the decoction, combining the decoctions, and concentrating the above filtrate under reduced pressure; the vacuum degree is 0.06-0.09 MPa, the concentration temperature is 60-80℃, and after concentration to a relative density of 1.10-1.15 at 60℃, the extract is released. The above-mentioned filtered extract is placed in a feeding tank, stirred and preheated to about 50℃, kept warm, and the spray dryer is turned on, the inlet temperature and outlet temperature are set, the spray-dried powder is collected, and pharmacologically acceptable excipients are added to prepare a traditional Chinese medicine composition.

9. The traditional Chinese medicine composition for treating acute mountain sickness as described in any one of claims 1-7, wherein the dosage form is granules, tablets, capsules, oral liquid or injection.

10. The use of the traditional Chinese medicine composition for treating acute mountain sickness as described in any one of claims 1-7 in the preparation of a medicament for treating acute mountain sickness.

11. The application as described in claim 10, wherein the traditional Chinese medicine composition significantly increases arterial oxygen partial pressure and arterial oxygen saturation in blood gas, improves acid-base balance, and has anti-inflammatory, anti-hypoxic effects, as well as protective effects against myocardial damage, liver damage, and kidney damage.

12. The use of the traditional Chinese medicine composition for treating acute mountain sickness as described in any one of claims 1-7 in the preparation of an anti-fatigue medicament.

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