Traditional Chinese medicine composition as well as preparation method, application and medicine thereof

Abstract

The invention discloses a traditional Chinese medicine composition as well as a preparation method and application thereof and a medicine, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 3-12 parts of sea cucumber; 8-20 parts of cistanche deserticola; 3-12 parts of ginseng; and 4-10 parts of sipunculus nudus. The traditional Chinese medicine composition disclosed by the invention has the characteristics of multiple targets, relatively small toxic and side effects and the like, and treats and prevents altitude sickness through ways of enhancing anti-hypoxia capability, inhibiting multi-organ edema, blocking an inflammation activation pathway, regulating oxidative stress balance, protecting neurological functions, improving energy metabolism capability and the like.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition, its preparation method and application, and a drug. Background Technology

[0002] Altitude sickness is a syndrome that occurs when a person moves from a low-altitude area to a higher-altitude area due to incomplete or disordered adaptation to the low-oxygen environment.

[0003] Currently, altitude sickness is mainly prevented and treated with Western medicine, including acetazolamide, dexamethasone, and ibuprofen. However, these drugs have problems such as limited applicability and significant side effects. Summary of the Invention

[0004] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a traditional Chinese medicine composition, its preparation method and application, and a drug, aiming to solve the problem of the lack of effective drugs for treating altitude sickness in the existing technology.

[0005] To achieve the above objectives, the present invention proposes a traditional Chinese medicine composition comprising, by weight parts, the following raw material components: 3-12 parts of sea cucumber; 8-20 parts of Cistanche deserticola; 3-12 parts of ginseng; and 4-10 parts of Sipunculus nudus.

[0006] In one embodiment, the traditional Chinese medicine composition further includes American ginseng, jujube, and cardamom, wherein the American ginseng is present in 5-15 parts by weight, the jujube in 4-12 parts by weight, and the cardamom in 5-15 parts by weight.

[0007] In one embodiment, the traditional Chinese medicine composition further includes Polygonatum sibiricum and Poria cocos, wherein the Polygonatum sibiricum is present in 5 to 20 parts by weight and the Poria cocos is present in 5 to 15 parts by weight.

[0008] In one embodiment, the traditional Chinese medicine composition comprises the following raw material components by mass: 4-8 parts sea cucumber; 8-12 parts Cistanche deserticola; 4-10 parts ginseng; 6-12 parts American ginseng; 4-8 parts jujube; 5-10 parts Amomum villosum; 8-12 parts Polygonatum sibiricum; 8-12 parts Poria cocos; and 5-7 parts Sipunculus nudus.

[0009] This invention also provides a method for preparing a traditional Chinese medicine composition, the method comprising the following steps: S1. Mix the decoction of Cistanche deserticola and sea cucumber powder, and dry them to obtain the first powder; S2. Mix the first powder, ginseng powder, and Sipunculus nudus powder with excipients to obtain the traditional Chinese medicine composition.

[0010] In one embodiment, step S1 includes: mixing the decoction of Cistanche deserticola, jujube and Amomum villosum with sea cucumber powder, drying it, and obtaining a first powder; Step S2 includes: mixing the first powder with ginseng powder, star cricket powder, and American ginseng powder to obtain the traditional Chinese medicine composition.

[0011] In one embodiment, step S1 includes: mixing the decoction of Cistanche deserticola, jujube, Amomum villosum, Poria cocos and Polygonatum sibiricum with sea cucumber powder, and drying to obtain a first powder.

[0012] The present invention also provides an application of a traditional Chinese medicine composition in the prevention or treatment of altitude sickness, wherein the traditional Chinese medicine composition includes the aforementioned traditional Chinese medicine composition or a traditional Chinese medicine composition prepared according to the preparation method of the aforementioned traditional Chinese medicine composition.

[0013] The present invention also provides a medicine comprising the aforementioned traditional Chinese medicine composition or a traditional Chinese medicine composition prepared according to the preparation method of the aforementioned traditional Chinese medicine composition.

[0014] In one embodiment, the type of drug includes granules, tablets, capsules, pills, or oral liquids.

[0015] In the technical solution of this invention, the traditional Chinese medicine composition has the effects of greatly replenishing vital energy, promoting blood circulation, nourishing yin and generating fluids, and drying dampness and resolving phlegm. The formula uses sea cucumber, cistanche, and ginseng as the principal herbs to replenish qi and strengthen the foundation. The combination of these three herbs exerts the effects of replenishing qi and raising yang, tonifying the kidneys and replenishing essence, and nourishing yin and blood, effectively strengthening the generation of vital energy in the body and warming and tonifying kidney yang. *Sipunculus nudus*, being cold in nature, is used as an adjuvant to counteract the warming nature of the principal herbs, enhancing the effects of nourishing yin and moistening the lungs, promoting blood circulation and replenishing essence. This traditional Chinese medicine composition has the characteristics of multiple targets and fewer toxic side effects. It effectively prevents and treats altitude sickness by improving anti-hypoxia capacity, inhibiting edema in multiple organs, blocking inflammatory activation pathways, improving antioxidant stress capacity, protecting nerve function, and enhancing the body's energy metabolism. Therefore, the traditional Chinese medicine composition of this invention forms a multi-target prevention and treatment mechanism against altitude sickness through the synergistic effect of multiple components. Detailed Implementation

[0016] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Where the manufacturers of reagents or instruments are not specified, they are all conventional products that can be purchased commercially. Furthermore, the meaning of "and / or" throughout the text includes three parallel solutions; for example, "A and / or B" includes solution A, or solution B, or a solution where both A and B are satisfied simultaneously. In addition, the technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0017] Altitude sickness is a syndrome caused by insufficient or impaired adaptation to the low-oxygen environment when a person moves from a low-altitude area to a higher altitude. Low oxygen and low pressure at high altitudes are the main causes, while upper respiratory tract infections, fatigue, cold and dry climates, mental stress, hunger, and pregnancy are contributing factors. The disease mainly includes acute altitude sickness (high-altitude pulmonary edema, high-altitude cerebral edema) and chronic altitude sickness (high-altitude heart disease, high-altitude polycythemia, high-altitude pulmonary hypertension, etc.). Clinical symptoms include dizziness, headache, general weakness, shortness of breath, nausea, loss of appetite, gastrointestinal discomfort, cognitive impairment, sleep disturbances, tachycardia, and cyanosis of the lips and fingers. Acute altitude sickness affects a person's activities and even their health. The higher the altitude, the lower the oxygen partial pressure. When moving from a low-altitude area to a high-altitude area in a short period, the body's blood oxygen saturation decreases, blood flow increases, and oxygen consumption is high, thus affecting the body's aerobic metabolic capacity and impairing organ function.

[0018] Currently, Western medicines used for the prevention and treatment of altitude sickness mainly include three types: ① Acetazolamide is the main drug for preventing acute altitude sickness. It is an inhibitor of carbonic anhydrase. It increases the excretion of bicarbonate by the kidneys, causing mild diuresis and maintaining a state of mild metabolic acidosis, thereby increasing respiratory rate and improving the body's condition. However, acetazolamide is prone to adverse reactions such as numbness in the limbs, fatigue, drowsiness, indigestion, and kidney damage. Therefore, its applicability to patients with altitude sickness is limited. ② Dexamethasone can improve symptoms related to high-altitude cerebral edema and high-altitude pulmonary edema by inhibiting histamine release and reducing vascular permeability. However, adverse reactions associated with hormone drugs, such as gastrointestinal reactions, hyperglycemia, and withdrawal symptoms after discontinuation, limit its application. ③ Ibuprofen is a non-steroidal anti-inflammatory drug that reduces prostaglandin production by inhibiting cyclooxygenase activity, thus relieving headache symptoms in high-altitude environments. Ibuprofen can regulate the body's respiration in high-altitude environments, but it cannot improve the severity of acute altitude sickness. In addition, long-term use of ibuprofen may lead to hemorrhagic gastritis and duodenitis, and the efficacy of nonsteroidal anti-inflammatory drugs may mask the symptoms of acute mountain sickness headache.

[0019] In view of this, the present invention provides a traditional Chinese medicine composition comprising the following raw materials in parts by weight: 3-12 parts sea cucumber; 8-20 parts Cistanche deserticola; 3-12 parts ginseng; and 4-10 parts Sipunculus nudus. That is, the mass fraction of sea cucumber can be 3, 7, or 12 parts; the mass fraction of Cistanche deserticola can be 8, 10, 14, or 20 parts; the mass fraction of ginseng can be 3, 8, or 12 parts; and the mass fraction of Sipunculus nudus can be 4, 6, or 10 parts.

[0020] In this invention, sea cucumber, Cistanche deserticola, and ginseng are used as the principal herbs to replenish qi and strengthen the body's foundation. The combination of these three herbs effectively enhances the generation of vital qi and warms and tonifies kidney yang. *Sipunculus nudus*, being cold in nature, is used as the guiding herb to counteract the warming nature of the principal herbs, enhancing their effects of nourishing yin and moistening the lungs, promoting blood circulation and replenishing essence. This traditional Chinese medicine composition has multiple targets and fewer toxic side effects. It effectively prevents and treats altitude sickness by prolonging the survival time of mice under hypoxia, inhibiting pulmonary edema, blocking inflammatory activation pathways, improving antioxidant stress capacity, protecting nerve function, and enhancing the body's energy metabolism. Through the synergistic effect of multiple components, a multi-target prevention and treatment mechanism is formed.

[0021] In the above formula, the sea cucumber can be *Stichopus japonicus*, an animal belonging to the genus *Stichopus* of the family Stichopustidae. Aposticopus japoniciLs Selenka, Green Sea Cucumber Stichopus chloronotus Brandt, Sea Cucumber S. variegatus One type of sermper. Sea cucumber is sweet and salty in taste, and neutral in nature; it enters the kidney and lung meridians; it has the effects of tonifying the kidney and replenishing essence, nourishing blood and moisturizing dryness, and stopping bleeding.

[0022] Cistanche can be the plant Cistanche deserticola of the Orobanchaceae family. Cistanche deserticola YCMa or Cistanche tubulosa Cistanche tubulosa The dried, fleshy stem with scales and leaves of *Cistanche deserticola*. *Cistanche deserticola* is obtained by digging up the plants in spring when the seedlings have just emerged or in autumn before the soil freezes, removing the stem tips; cutting into sections, and sun-drying. *Cistanche deserticola* is sweet, salty, and warm in nature; it enters the kidney and large intestine meridians; it has the effects of tonifying kidney yang, nourishing essence and blood, and moistening the intestines to relieve constipation.

[0023] Ginseng can be the plant ginseng (Panax ginseng) of the Araliaceae family. Panax ginseng The dried roots and rhizomes of CA Mey. Ginseng is obtained by harvesting in autumn, washing, and then sun-drying or oven-drying. Ginseng is 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, generating fluids and nourishing blood, and calming the mind and improving intelligence.

[0024] Sipunculus repens can be classified as belonging to the family Sipunculidae. The method of obtaining Sipunculus repens is as follows: in summer and autumn, dig them up on the sand at low tide line, remove the internal organs, wash them clean, add water and boil until the insects turn from red to white, then remove them and dry them in the sun. Sipunculus repens is salty and cold in nature; it enters the spleen, lung, and kidney meridians; it has the effects of nourishing yin and reducing fire, clearing the lungs and replenishing deficiency, and promoting blood circulation and strengthening the body.

[0025] In some embodiments of the present invention, the traditional Chinese medicine composition further includes American ginseng, jujube, and cardamom, wherein the American ginseng is present in parts by weight of 5 to 15, the jujube in parts by weight of 4 to 12, and the cardamom in parts by weight of 5 to 15. That is, the American ginseng can be present in parts by weight of 5, 8, 12, or 15; the jujube in parts by weight of 4, 8, or 12; and the cardamom in parts by weight of 5, 8, 12, or 15.

[0026] In this invention, sea cucumber, Cistanche deserticola, and ginseng are used as the principal herbs to replenish qi and strengthen the body's foundation. The combination of these three herbs effectively enhances the generation of vital energy and warms and tonifies kidney yang. American ginseng and jujube are used as assistant herbs, which replenish qi and nourish yin, nourish blood and calm the mind, clear heat and generate fluids. Combined with the principal herbs, they enhance the effects of replenishing qi and nourishing blood, strengthening the kidneys and consolidating the foundation, and nourishing yin and generating fluids. Amomum villosum is added as an adjuvant herb to replenish lung qi, dry dampness and resolve phlegm, and promote diuresis and eliminate dampness, thus treating cold-damp phlegm. Starworm, being cold in nature, is used as the guiding herb to counteract the warming nature of the principal herbs. Combined with the principal and assistant herbs, it enhances the effects of nourishing yin and moistening the lungs, invigorating blood and replenishing essence. This traditional Chinese medicine composition showed a decreasing trend in water content of myocardial, brain, and lung tissues. It was more effective in prolonging the survival time of mice under hypoxia, blocking inflammatory activation pathways, improving antioxidant stress capacity, protecting nerve function, and enhancing the body's energy metabolism. It also had a better effect in preventing and treating altitude sickness.

[0027] In the above formula, American ginseng can be American ginseng, a plant belonging to the Araliaceae family. Panax quinquefoliumThe dried root of L. American ginseng. American ginseng is obtained by harvesting in autumn, washing, and sun-drying or low-temperature drying. American ginseng has a sweet and slightly bitter taste, and is cool in nature; it enters the heart, lung, and kidney meridians; it has the effects of replenishing qi and nourishing yin, clearing heat and promoting body fluids.

[0028] Jujube can be the fruit of the jujube plant (Ziziphus jujuba) in the Rhamnaceae family. Ziziphus jujube Dried, ripe fruit of Mill. Jujubes are obtained by harvesting them in autumn when they are ripe and then drying them. Jujubes are sweet and warm in nature; they enter the spleen, stomach, and heart meridians; they have the effects of tonifying the middle energizer, replenishing qi, nourishing blood, and calming the mind.

[0029] Amomum villosum can be the ginger family plant Amomum villosum. Woolly amaranth Lour., Green Shell Sand Ammonium villosumLour.var.xanthioides TLWu et Senjen or Hainan Sand Long-leaved amomum TLWu's dried, ripe fruit. Amomum villosum is obtained by harvesting the fruit in summer and autumn when it is ripe, and then sun-drying or low-temperature drying. Amomum villosum is pungent and warm in nature; it enters the spleen, stomach, and kidney meridians; it has the effects of resolving dampness and invigorating the stomach, warming the spleen and stopping diarrhea, regulating qi and calming the fetus.

[0030] In some embodiments of the present invention, the traditional Chinese medicine composition further includes Polygonatum sibiricum and Poria cocos, wherein the mass fraction of Polygonatum sibiricum is 5 to 20 parts, and the mass fraction of Poria cocos is 5 to 15 parts. That is, the mass fraction of Polygonatum sibiricum can be 5 parts, 8 parts, 15 parts, or 20 parts; and the mass fraction of Poria cocos can be 5 parts, 8 parts, 11 parts, or 15 parts.

[0031] In this invention, sea cucumber, Cistanche deserticola, and ginseng are used as the principal herbs to replenish qi and strengthen the body's foundation. The combination of these three herbs enhances their effects of replenishing qi and raising yang, tonifying the kidneys and replenishing essence, and nourishing yin and blood, effectively strengthening the body's vital energy and warming and tonifying kidney yang. American ginseng, jujube, and Polygonatum sibiricum are used as the assistant herbs, which replenish qi and nourish yin, nourish blood and calm the mind, clear heat and moisten the lungs, and strengthen the spleen and kidneys. Combined with the principal herbs, they enhance the effects of replenishing qi and nourishing blood, strengthening the kidneys and consolidating the foundation, and nourishing yin and generating fluids. Amomum villosum and Poria cocos are used as adjuvant herbs to replenish lung qi, dry dampness and resolve phlegm, and promote diuresis and eliminate dampness, thus treating cold-damp phlegm. Starworm, being cold in nature, is used as the guiding herb to counteract the warming nature of the principal herbs. Combined with the principal and assistant herbs, it enhances the effects of nourishing yin and moistening the lungs, promoting blood circulation and replenishing essence. Combined with Poria cocos, it also enhances the effects of promoting diuresis, strengthening the spleen, regulating qi, and clearing the lungs. This traditional Chinese medicine composition is more effective in improving hypoxia resistance, inhibiting edema in multiple organs, blocking inflammatory activation pathways, enhancing antioxidant stress resistance, protecting nerve function, and enhancing the body's energy metabolism. It is also more effective in preventing and treating altitude sickness.

[0032] In the above formula, Polygonatum can be Polygonatum yunnanensis, a plant belonging to the Liliaceae family. Polygonatum kingianum Coll. etHemsl., Polygonatum Siberian Polygonum Red. or Polygonatum multiflorum Polygonatum cyrtonemaThe dried rhizome of *Polygonatum sibiricum*. The method of obtaining *Polygonatum sibiricum* is as follows: harvested in spring and autumn, fibrous roots removed, washed, briefly blanched in boiling water or steamed until thoroughly cooked, and then dried. *Polygonatum sibiricum* is sweet and neutral in nature; it enters the spleen, lung, and kidney meridians; it has the effects of tonifying qi and nourishing yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys.

[0033] Poria cocos can be a fungus belonging to the Polyporaceae family. Poria cocos The dried sclerotium of (Schw.) Wolf. Poria cocos is sweet, bland, and neutral in nature; it enters the heart, lung, spleen, and kidney meridians; it has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind.

[0034] In some embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 4-8 parts sea cucumber; 8-12 parts Cistanche deserticola; 4-10 parts ginseng; 6-12 parts American ginseng; 4-8 parts jujube; 5-10 parts Amomum villosum; 8-12 parts Polygonatum sibiricum; 8-12 parts Poria cocos; and 5-7 parts Sipunculus nudus.

[0035] In the technical solution of the present invention, the traditional Chinese medicine composition has a better effect in preventing and treating altitude sickness.

[0036] This invention also provides a method for preparing a traditional Chinese medicine composition, the method comprising the following steps: S1. Mix the decoction of Cistanche deserticola and sea cucumber powder, and dry them to obtain the first powder; S2. The first powder is mixed with ginseng powder, star cricket powder and excipients to obtain the traditional Chinese medicine composition.

[0037] In the technical solution of this invention, water decoction is used to fully retain the medicinal substances, without water extraction or alcohol precipitation to remove impurities. Dry granulation reduces the amount of excipients, ensures the filling volume, and simplifies the process. The excipients can be at least one selected from mannitol, starch, sucrose, dextrin, lactose, and microcrystalline cellulose.

[0038] In some embodiments of the present invention, the preparation method of the traditional Chinese medicine composition includes the following steps: Step S1 includes: mixing the decoction of Cistanche deserticola, jujube and Amomum villosum with sea cucumber powder, drying to obtain a first powder; Step S2 includes: mixing the first powder with ginseng powder, Starworm powder, American ginseng powder and excipients to obtain the traditional Chinese medicine composition.

[0039] In some embodiments of the present invention, the preparation method of the traditional Chinese medicine composition includes the following steps: Step S1 includes: mixing the decoction of Cistanche deserticola, jujube, Amomum villosum, Poria cocos and Polygonatum sibiricum with sea cucumber powder, drying to obtain a first powder.

[0040] This invention also provides an application of a traditional Chinese medicine composition in the prevention or treatment of altitude sickness. The traditional Chinese medicine composition includes the aforementioned traditional Chinese medicine composition or a traditional Chinese medicine composition prepared according to the aforementioned preparation method. The application encompasses all the technical solutions of the aforementioned pharmaceutical composition and therefore possesses all the beneficial effects brought about by the above solutions, which will not be elaborated upon here.

[0041] This invention also provides a medicine comprising the aforementioned traditional Chinese medicine composition or a traditional Chinese medicine composition prepared according to the aforementioned method for preparing the traditional Chinese medicine composition. The medicine includes all the technical solutions of the aforementioned traditional Chinese medicine composition and therefore possesses all the beneficial effects brought about by the above solutions, which will not be elaborated upon here. It should be noted that the traditional Chinese medicine composition of this invention can be formulated into granules, tablets, capsules, pills, or oral liquids.

[0042] The technical solution of the present invention will be further described in detail below with reference to specific embodiments. It should be understood that the following embodiments are only used to explain the present invention and are not intended to limit the present invention.

[0043] Example 1 A traditional Chinese medicine composition comprising 5g sea cucumber, 12g Cistanche deserticola, 5g ginseng, and 6g Sipunculus nudus; the traditional Chinese medicine composition is prepared by the following steps: Ginseng and Sipunculus nudus powder were prepared by removing impurities, washing, drying, and grinding them into powder through a 100-mesh sieve. Dried sea cucumbers were soaked in pure water for 2 days, changing the water 2-3 times daily until fully expanded. The head and tail were removed, and the sea cucumbers were cut into small pieces. Eight times their weight of pure water were added, and the mixture was brought to a boil over high heat, then simmered over low heat for 30 minutes until softened. The sea cucumbers were removed, cooled, and then crushed evenly. Cistanche deserticola was sliced, soaked in eight times their weight of water for 4 hours, and then decocted twice under pressure for 60 minutes each time. The decoctions were combined, filtered through a 200-mesh sieve, and the filtrate was concentrated under reduced pressure to a suitable volume. The crushed sea cucumber powder was added, mixed well, spray-dried, and pulverized into a fine powder. Ginseng powder, Sipunculus nudus powder, and appropriate excipients were added to the fine powder and mixed thoroughly to obtain the aforementioned traditional Chinese medicine composition.

[0044] Example 2 A traditional Chinese medicine composition comprising 5g sea cucumber, 12g Cistanche deserticola, 5g ginseng, 8g American ginseng, 5g jujube, 6g Amomum villosum, and 6g Sipunculus nudus; the traditional Chinese medicine composition is prepared by the following steps: Ginseng, Sipunculus nudus, and American ginseng were cleaned, dried, and powdered, then passed through a 100-mesh sieve to prepare ginseng powder, Sipunculus nudus powder, and American ginseng powder for later use. Dried sea cucumbers were soaked in pure water for 2 days, changing the water 2-3 times daily until fully expanded. The heads and tails were removed, and the sea cucumbers were cut into small pieces. Eight times their weight of pure water were added, and the mixture was brought to a boil over high heat, then simmered over low heat for 30 minutes until softened. The sea cucumbers were removed, cooled, and then crushed evenly. Cistanche deserticola was sliced, jujubes were pitted, and Amomum villosum was crushed. These were added to eight times their weight of water, soaked for 4 hours, and then decocted twice under pressure for 60 minutes each time. The decoctions were combined, filtered through a 200-mesh sieve, and the filtrate was concentrated under reduced pressure to a suitable volume. The crushed sea cucumber powder was added, mixed well, spray-dried, and pulverized into a fine powder. Ginseng powder, Sipunculus nudus powder, American ginseng powder, and appropriate excipients were added to the fine powder and mixed thoroughly to obtain the aforementioned traditional Chinese medicine composition.

[0045] Example 3 A traditional Chinese medicine composition comprising 5g sea cucumber, 12g Cistanche deserticola, 5g ginseng, 8g American ginseng, 5g jujube, 10g Polygonatum sibiricum, 10g Poria cocos, 6g Amomum villosum, and 6g Sipunculus nudus; the traditional Chinese medicine composition is prepared by the following steps: Ginseng, Sipunculus nudus, and American ginseng were cleaned, dried, and powdered, then passed through a 100-mesh sieve to prepare ginseng powder, Sipunculus nudus powder, and American ginseng powder for later use. Dried sea cucumbers were soaked in pure water for 2 days, changing the water 2-3 times daily until fully expanded. The heads and tails were removed, and the sea cucumbers were cut into small pieces. Eight times their weight of pure water were added, and the mixture was brought to a boil over high heat, then simmered over low heat for 30 minutes until softened. The sea cucumbers were then removed, cooled, and crushed evenly. Cistanche deserticola was sliced, jujubes were pitted, Amomum villosum was crushed, Polygonatum sibiricum was sliced, and Poria cocos was sliced. These were added to eight times their weight of water, soaked for 4 hours, and then decocted twice under pressure for 60 minutes each time. The decoctions were combined, filtered through a 200-mesh sieve, and the filtrate was concentrated under reduced pressure to a suitable volume. The crushed sea cucumber powder was added, mixed well, spray-dried, and pulverized into a fine powder. Ginseng powder, Sipunculus nudus powder, American ginseng powder, and appropriate excipients were added to the fine powder and mixed thoroughly to obtain the aforementioned traditional Chinese medicine composition.

[0046] Performance testing I. Atmospheric Pressure Hypoxia Experiment 1. Experimental Materials Animals: SPF (Specific Pathogen Free) grade ICR (Institute of Cancer Research) mice, male, 6-8 weeks old, weighing 20±2g; housing environment: temperature 22-25℃, humidity 45%-60%, 12h light-dark cycle, acclimatization for 3 days before starting the experiment.

[0047] Drugs: The traditional Chinese medicine compositions from Examples 1, 2, and 3 were prepared into a solution with a concentration of 10 mg / mL (mass of the traditional Chinese medicine composition / volume of pure water) using pure water, resulting in solution 1, solution 2, and solution 3.

[0048] 2. Animal grouping, drug administration, and model establishment Grouping: The mice were randomly divided into 4 groups according to their body weight, with 12 mice in each group. The groups were: blank control group, Example 1 group, Example 2 group, and Example 3 group.

[0049] Administration: Once daily for 7 consecutive days, with administration time fixed at 9:00 AM each day. The drug types administered to groups 1, 2, and 3 corresponded to drug solution 1, drug solution 2, and drug solution 3, respectively, with a dose of 360 mg / kg per administration. The blank control group received the same volume of physiological saline as the aforementioned drug solutions.

[0050] Modeling: One hour after the last administration, according to the test method for improving hypoxia tolerance in the functional evaluation test method of the "Technical Specifications for Inspection and Evaluation of Functional Foods" (2003 edition), each group of mice was placed in a 160mL wide-mouth bottle containing 5g of soda lime, one mouse per bottle, and then the bottle cap was sealed with Vaseline.

[0051] 3. Detection indicators: After sealing the bottle cap with Vaseline, the survival time of the mice was recorded.

[0052] 4. Experimental Results 4.1 Using mortality as an indicator, the time of death in each group was recorded. The survival time of mice under hypoxia is shown in Table 1.

[0053] Table 1 Comparison of survival time under hypoxia at normal pressure (±sem, n=12)

[0054] In Table 1, * indicates a significant difference compared to the blank control group (P<0.05); ** indicates a highly significant difference compared to the blank control group (P<0.01). represents the mean of the data within the group; n represents the sample size within the group; SEM represents the standard error of the mean; s represents the standard deviation.

[0055] The results showed that all treatment groups significantly prolonged the survival time of mice under hypoxia, indicating that the traditional Chinese medicine composition has an anti-hypoxic effect and can prevent and treat hypoxia-induced diseases. Compared with the blank control group, the anti-hypoxic effects of groups 1-3 were significant, and the prolongation of survival time was greatly affected by the ratio of the traditional Chinese medicine composition, with group 3 showing the best effect.

[0056] II. Acute decompression and hypoxia test 1. Experimental Materials Animals: SPF-grade male Sprague-Dawley SD rats, 6-8 weeks old, weighing 200-220g, were selected. Housing environment: temperature 22-25℃, humidity 45%-60%, 12h light-dark cycle, acclimatization for 5 days before starting the experiment.

[0057] Drugs: The traditional Chinese medicine compositions in Examples 1, 2 and 3 were prepared into a solution with a concentration of 300 mg / mL (mass of traditional Chinese medicine composition / volume of pure water) using pure water, resulting in solution 1, solution 2 and solution 3.

[0058] 2. Animal grouping, model establishment, and drug administration Grouping: SD rats were randomly divided into five groups using a random number table: blank control group, model control group, Example 1 group, Example 2 group, and Example 3 group; 12 rats in each group, for a total of 5 groups.

[0059] Modeling: An experimental chamber was used to simulate high-altitude, low-pressure, and low-oxygen conditions. SD rats in the model control group, Example 1 group, Example 2 group, and Example 3 group were placed in the experimental chamber for 7 days of high-altitude, low-pressure, and low-oxygen treatment. Experimental chamber parameters were set as follows: simulated altitude 7000m, ascent / descent rate 10m / s, chamber pressure 56kPa, chamber oxygen pressure 8.6kPa, chamber temperature 22.5℃, and chamber humidity 25%RH (relative humidity). The experimental chamber operated for 23 hours per day, with a day / night ratio of 12 hours / 12 hours. The blank control group was kept in a standard feeding environment without hypoxia treatment; all other procedures were the same as the model group.

[0060] Administration: Feed, drinking water, and bedding were changed for one hour daily between 9-10 AM. The treatment groups were administered the medication via gavage for seven consecutive days. The medication types for groups 1, 2, and 3 were drug solution 1, drug solution 2, and drug solution 3, respectively. The dosage was 250 mg / kg once daily for 7 consecutive days. The model control group received an equal volume of physiological saline via gavage once daily for 7 consecutive days. The blank control group received an equal volume of physiological saline via gavage once daily for 7 consecutive days.

[0061] 3. Index determination: After the animals completed the experiment and left the chamber, blood was collected, and they were euthanized by cervical dislocation. The intact heart, brain tissue and lung tissue were then removed.

[0062] (1) Take lung tissue, brain tissue and myocardial tissue from 6 animals in each group, and use the wet-dry weight method to determine the water content and evaluate the edema of organs and tissues.

[0063] (2) Take lung tissue from 6 animals in each group and use enzyme-linked immunosorbent assay (ELISA) to detect superoxide dismutase (SOD) activity, malondialdehyde (MDA) content and glutathione peroxidase (GSH-Px) activity to evaluate antioxidant stress capacity.

[0064] (3) Serum from 12 cases in each group was collected and the levels of inflammatory factors tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β) were detected by ELISA.

[0065] (4) Take brain tissue from 12 animals in each group and detect the levels of brain-derived neurotrophic factor (BDNF) and glial cell-derived neurotrophic factor (GDNF) by ELISA; take serum from 12 animals in each group and detect the level of neuron-specific enolase (NSE) by ELISA to evaluate the neuroprotective level.

[0066] (5) The serum lactate dehydrogenase (LDH) and brain tissue adenosine triphosphate (ATP) levels of 12 patients in each group were detected by ELISA to evaluate energy metabolism.

[0067] 4. Experimental Results 4.1 Detection of tissue water content in each group of rats In high-altitude environments, hypoxia stress can trigger pathological edema in tissues, leading to damage to multiple organs and causing various pathological manifestations such as impaired vascular barrier function, fluid metabolism disorders, and respiratory distress.

[0068] After the animals completed the experiment and exited the chamber, blood was collected, and they were euthanized by cervical dislocation. Intact heart, brain, and lung tissues were harvested. Lung, brain, and myocardial tissues were collected from six animals in each group, and water content was determined using the wet-dry weight method to evaluate organ tissue edema. The results are shown in Table 2.

[0069] Table 2. Water content of rat organs in each group (±sem, n=12)

[0070] In Table 2, # indicates a significant difference compared to the blank control group (P<0.05); ## indicates a highly significant difference compared to the blank control group (P<0.01); * indicates a significant difference compared to the model control group (P<0.05); and ** indicates a highly significant difference compared to the model control group (P<0.01). represents the mean of the data within the group; n represents the sample size within the group; SEM represents the standard error of the mean; s represents the standard deviation.

[0071] The results showed that under acute hypobaric and hypoxic conditions, the myocardial, brain, and lung tissues of rats in the model control group all exhibited varying degrees of edema. Compared to the model control group, the water content of the myocardial, brain, and lung tissues of rats in each treatment group showed a decreasing trend, indicating that the traditional Chinese medicine composition has a certain therapeutic or protective effect on organ edema and organ damage caused by acute altitude sickness. The anti-organ edema effects of groups 2-3 were significant, and the reduction in organ water content was greatly influenced by the ratio of the traditional Chinese medicine composition. Group 3 showed the best effect, indicating that this formula has a therapeutic effect on organ edema or damage caused by acute altitude sickness.

[0072] 4.2 Expression of serum inflammatory factors in rats of each group Hypoxic environments can activate inflammatory pathways in the body, releasing excessive amounts of pro-inflammatory factors such as TNF-α, IL-6, and IL-1β, which can exacerbate vascular damage, tissue edema, and organ dysfunction.

[0073] After the animals completed the experiment and exited the chamber, blood was collected, and they were euthanized by cervical dislocation. Intact heart, brain, and lung tissues were harvested. Serum samples from 12 animals in each group were collected to detect the levels of TNF-α, IL-6, and IL-1β. The results are shown in Table 3. Table 3. Serum inflammatory factor levels in rats of each group (±sem, n=12)

[0074] In Table 3, # indicates a significant difference compared to the blank control group (P<0.05); ## indicates a highly significant difference compared to the blank control group (P<0.01); * indicates a significant difference compared to the model control group (P<0.05); and ** indicates a highly significant difference compared to the model control group (P<0.01). represents the mean of the data within the group; n represents the sample size within the group; SEM represents the standard error of the mean; s represents the standard deviation.

[0075] The results showed that under acute hypobaric and hypoxic conditions, the levels of pro-inflammatory factors TNF-α, IL-6, and IL-1β in the model control group were significantly increased compared to the blank control group. Compared to the model control group, the serum levels of TNF-α, IL-6, and IL-1β in the treated rats showed a decreasing trend, indicating that the traditional Chinese medicine composition had a certain therapeutic effect on the inflammatory response and damage caused by acute altitude sickness after drug treatment. The anti-inflammatory effects of groups 2-3 were more significant, and the reduction of inflammatory factors was greatly affected by the ratio of the traditional Chinese medicine composition; group 3 showed the best effect. This suggests that the formula has a therapeutic effect on the inflammatory response induced by acute altitude sickness.

[0076] 4.3 Oxidative stress in rats of each group Low-pressure, low-oxygen environments lead to the generation of large amounts of reactive oxygen species (ROS) in the body, triggering oxidative stress and damaging biomembranes and biomolecules. Superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) are core antioxidant enzymes in the body, and their activities reflect antioxidant capacity; malondialdehyde (MDA) is a lipid peroxidation product, and its content reflects the degree of oxidative damage.

[0077] After the animals completed the experiment and exited the chamber, blood was collected, and they were euthanized by cervical dislocation. Intact heart, brain, and lung tissues were harvested. Lung tissues from six animals in each group were collected to detect SOD activity, MDA content, and GSH-Px activity, evaluating their antioxidant stress capacity. The results are shown in Table 4.

[0078] Table 4. Levels of oxidative stress factors in rats of each group (±sem, n=12)

[0079] In Table 4, # indicates a significant difference compared to the blank control group (P<0.05); ## indicates a highly significant difference compared to the blank control group (P<0.01); * indicates a significant difference compared to the model control group (P<0.05); and ** indicates a highly significant difference compared to the model control group (P<0.01). represents the mean of the data within the group; n represents the sample size within the group; SEM represents the standard error of the mean; s represents the standard deviation.

[0080] The results showed that compared with the blank control group, the model group had significantly decreased GSH-Px activity in lung tissue and significantly increased serum SOD activity, while serum MDA content was significantly increased. This indicates that acute hypobaric and hypoxic environments lead to oxidative damage in the body. After drug intervention, compared with the model control group, the drug-treated rats showed significantly increased GSH-Px activity in lung tissue and significantly decreased serum MDA content. This indicates that after drug treatment, the traditional Chinese medicine composition exerts an anti-oxidative damage effect by regulating oxidative stress balance and reducing hypoxia induction. The anti-oxidative stress effect was more significant in groups 2-3, with group 3 showing the best effect. This suggests that the formula can regulate oxidative stress balance, reduce hypoxia induction, and decrease oxidative damage in acute mountain sickness.

[0081] 4.4 Expression of neuroprotective factors in rat brains of different groups Neuron-specific enolase (NSE) is a specific marker of neuronal damage. Hypoxia-induced cerebral edema and oxidative stress can trigger neuronal damage and increase serum NSE levels. Brain-derived neurotrophic factor (BDNF) and glial cell-derived neurotrophic factor (GDNF) can promote neuronal survival and repair neuronal damage. Decreased levels of these substances can exacerbate altitude sickness-related cognitive impairment and neurological dysfunction.

[0082] After the animals completed the experiment and exited the chamber, blood was collected, and they were euthanized by cervical dislocation. Intact heart, brain, and lung tissues were harvested. Brain tissue from 6 animals in each group was used to detect BDNF and GDNF levels; serum from 12 animals in each group was used to detect NSE levels to evaluate neuroprotective effects. The results are shown in Table 5.

[0083] Table 5. Levels of neuroprotective factors in rat brains of each group (±sem, n=12)

[0084] In Table 5, # indicates a significant difference compared to the blank control group (P<0.05); ## indicates a highly significant difference compared to the blank control group (P<0.01); * indicates a significant difference compared to the model control group (P<0.05); and ** indicates a highly significant difference compared to the model control group (P<0.01). represents the mean of the data within the group; n represents the sample size within the group; SEM represents the standard error of the mean; s represents the standard deviation.

[0085] The results showed that, compared with the blank control group, the model control group had significantly increased serum NSE levels and significantly decreased brain tissue BDNF and GDNF contents, indicating that acute hypobaric and hypoxic environments can lead to brain nerve damage. After drug intervention, compared with the model control group, the serum NSE levels of the rats in each drug-treated experimental group were significantly reduced, and the brain tissue BDNF and GDNF contents were significantly increased, indicating that the traditional Chinese medicine composition has a therapeutic or protective effect on brain nerve damage caused by acute mountain sickness. The neuroprotective effect of groups 2-3 was more significant, and the reduction of neuroprotective factors was greatly affected by the ratio of the traditional Chinese medicine composition, with group 3 showing the best effect.

[0086] 4.5 Energy Metabolism In high-altitude, low-pressure, hypoxic environments, insufficient oxygen supply leads to systemic metabolic disorders. Hypoxia inhibits mitochondrial aerobic respiration and remodels metabolic pathways, resulting in insufficient energy production, accumulation of metabolic products, and damage to target organ function, ultimately manifesting as clinical symptoms such as headache, nausea, cerebral edema, and pulmonary edema. ATP is the core substance of cellular energy metabolism, and the brain is the most oxygen- and energy-intensive organ in the body, consuming 25% of the body's total ATP. Brain ATP is mainly generated through mitochondrial oxidative phosphorylation (95%), with only a small amount generated through anaerobic glycolysis; therefore, the brain is extremely sensitive to hypoxia. During high-altitude hypoxia, mitochondrial oxidative phosphorylation is inhibited, leading to insufficient ATP production in the brain. LDH is a key enzyme catalyzing the interconversion of lactate and pyruvate, its core function being to regulate the balance between anaerobic glycolysis and aerobic metabolism. In high-altitude environments, tissue hypoxia induces activation of anaerobic glycolysis and cell membrane damage, resulting in the release of intracellular enzymes and elevated serum LDH levels.

[0087] After the animals completed the experiment and exited the chamber, blood was collected, and they were euthanized by cervical dislocation. Intact heart, brain, and lung tissue were harvested. Serum LDH and brain tissue ATP levels were measured in each group, and the results of energy metabolism evaluation are shown in Table 6.

[0088] Table 6. Energy metabolism levels in rats of each group (±sem, n=12)

[0089] In Table 6, # indicates a significant difference compared to the blank control group (P<0.05); ## indicates a highly significant difference compared to the blank control group (P<0.01); * indicates a significant difference compared to the model control group (P<0.05); and ** indicates a highly significant difference compared to the model control group (P<0.01). represents the mean of the data within the group; n represents the sample size within the group; SEM represents the standard error of the mean; s represents the standard deviation.

[0090] The results showed that, compared with the blank control group, the model control group had significantly higher serum LDH levels and significantly lower brain ATP content, indicating that acute hypobaric and hypoxic environments lead to impaired aerobic respiration and insufficient energy production. After drug intervention, compared with the model control group, the rats in each drug-treated experimental group had significantly lower serum LDH levels and significantly higher brain ATP content, indicating that the traditional Chinese medicine composition has the effects of repairing hypoxia-induced energy metabolism disorders, improving energy metabolism, and protecting tissue integrity. The neuroprotective effect of groups 2-3 was more significant, and the increase in energy metabolism level was greatly affected by the ratio of the traditional Chinese medicine composition, with group 3 showing the best effect.

[0091] In summary, the traditional Chinese medicine composition provided by this invention has good therapeutic effects on normobaric hypoxia mouse model and acute decompression hypoxia rat model: (1) Enhances anti-hypoxia ability: The traditional Chinese medicine composition of this invention can significantly prolong the survival time of mice tolerating hypoxia and enhance the body's oxygen uptake capacity; (2) Inhibits multi-organ edema: The traditional Chinese medicine composition of this invention can significantly reduce the water content of the myocardium, lungs and brain of the model rats and improve organ damage in the model rats; (3) Blocks inflammatory activation pathways: The traditional Chinese medicine composition of this invention can inhibit the release of TNF-α, IL-6 and IL-1β, exert anti-inflammatory effects, and reduce the body's inflammation. Damage; (3) Regulation of oxidative stress balance: The traditional Chinese medicine composition of the present invention can significantly increase the activity of SOD and GSH-Px, reduce the level of MDA, regulate the balance of oxidative stress, reduce hypoxia induction, and reduce oxidative damage; (4) Protection of nerve function: The traditional Chinese medicine composition of the present invention can significantly reduce the level of NSE, increase the level of BDNF and GDNF, and has a repairing or protective effect on the brain nerve damage of model rats; (5) Improvement of energy metabolism capacity: The traditional Chinese medicine composition of the present invention can significantly reduce the serum LDH, increase the ATP content of brain tissue, and improve energy metabolism to protect tissue integrity.

[0092] The above are merely preferred embodiments of the present invention and do not limit the patent scope of the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the patent protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition comprises the following raw material components in parts by weight: 3-12 parts of sea cucumber; 8-20 parts of Cistanche deserticola; 3-12 parts of ginseng; and 4-10 parts of Sipunculus nudus.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition also includes American ginseng, jujube, and cardamom, wherein the American ginseng is present in 5-15 parts by weight, the jujube in 4-12 parts by weight, and the cardamom in 5-15 parts by weight.

3. The traditional Chinese medicine composition as described in claim 2, characterized in that, The traditional Chinese medicine composition also includes Polygonatum sibiricum and Poria cocos, wherein the Polygonatum sibiricum is present in a mass fraction of 5 to 20 parts and the Poria cocos is present in a mass fraction of 5 to 15 parts.

4. The traditional Chinese medicine composition as described in claim 3, characterized in that, The traditional Chinese medicine composition comprises the following raw material components in parts by weight: Sea cucumber 4-8 parts; Cistanche deserticola 8-12 parts; ginseng 4-10 parts; American ginseng 6-12 parts; jujube 4-8 parts; Amomum villosum 5-10 parts; Polygonatum sibiricum 8-12 parts; Poria cocos 8-12 parts; and Sipunculus nudus 5-7 parts.

5. A method for preparing a traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that, The preparation method of the traditional Chinese medicine composition includes the following steps: S1. Mix the decoction of Cistanche deserticola and sea cucumber powder, and dry them to obtain the first powder; S2. Mix the first powder, ginseng powder, and Sipunculus nudus powder with excipients to obtain the traditional Chinese medicine composition.

6. The method for preparing the traditional Chinese medicine composition as described in claim 5, characterized in that, Step S1 includes: mixing the decoction of Cistanche deserticola, jujube and Amomum villosum with sea cucumber powder, drying it to obtain the first powder; Step S2 includes: mixing the first powder with ginseng powder, star cricket powder, American ginseng powder and excipients to obtain the traditional Chinese medicine composition.

7. The method for preparing the traditional Chinese medicine composition according to claim 6, characterized in that, Step S1 includes: mixing the decoction of Cistanche deserticola, jujube, Amomum villosum, Poria cocos and Polygonatum sibiricum with sea cucumber powder, drying it, and obtaining the first powder.

8. The application of a traditional Chinese medicine composition in the prevention or treatment of altitude sickness, characterized in that, The traditional Chinese medicine composition includes the traditional Chinese medicine composition as described in any one of claims 1 to 4 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 5 to 7.

9. A drug, characterized in that, The drug includes the traditional Chinese medicine composition as described in any one of claims 1 to 4 or the traditional Chinese medicine composition prepared by the method described in any one of claims 5 to 7.

10. The medicament as claimed in claim 9, characterized in that, The types of drugs include granules, tablets, capsules, pills, or oral liquids.

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