A traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue, and its preparation method.

Abstract

This invention discloses a traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and fatigue, and its preparation method. It belongs to the field of traditional Chinese medicine technology. The prebiotic composition comprises the following raw medicinal materials in parts by weight: 2-20 parts of Polygonatum odoratum, 2-20 parts of chicory, 2-20 parts of wolfberry, 3-30 parts of Codonopsis pilosula, 4-40 parts of Astragalus membranaceus, 2-20 parts of Angelica sinensis, 2-20 parts of jujube, and 2-20 parts of turmeric. The composition of this invention can improve the body's aerobic metabolism, enhance cellular oxygen utilization, strengthen high-altitude adaptability, and improve work capacity under hypoxic conditions. Furthermore, this composition helps relieve central and musculoskeletal fatigue, while having no toxic side effects, and exhibits significant anti-fatigue, hypoxia tolerance, and immune-regulating effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to a traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and anti-fatigue, and its preparation method. Specifically, it is a traditional Chinese medicine prebiotic composition that can treat high-altitude hypoxia and simultaneously has anti-fatigue effects, and its preparation method. Background Technology

[0002] Altitude is a major characteristic of plateaus and a crucial factor in their formation. The average altitude of plateau regions ranges from 2,000 to 4,000 meters, with some areas exceeding 5,000 meters. High altitude causes lower temperatures, lower air pressure, and thinner oxygen, creating a unique climatic environment. Areas above 4,000 meters are characterized by thin air, low pressure, low oxygen, low temperatures, large diurnal temperature variations, and strong ultraviolet radiation. Workers operating in this hypoxic environment for extended periods experience a decline in physiological function and adaptability due to the low pressure, low oxygen, intense stress, and excessive physical exertion. This poses a significant challenge to their tolerance to hypoxia and fatigue, increasing the incidence and susceptibility to high-altitude fatigue, and severely impacting their physical and mental health.

[0003] Current research on the above-mentioned problems mainly focuses on drugs or supplements for combating hypoxia and fatigue. According to research statistics, about 20 kinds of traditional Chinese medicinal herbs growing in the Qinghai-Tibet Plateau region have anti-hypoxia activity, including Rhodiola rosea, Ganoderma lucidum, snow lotus, Astragalus membranaceus, Pteris vittata, Angelica sinensis, and Codonopsis pilosula. Traditional Chinese medicine's anti-altitude fatigue treatment shows great research potential. Shengyu Decoction, first recorded in *Lan Shi Mi Cang* (Secret Collection of the Orchid Chamber), is composed of Rehmannia glutinosa (processed), Rehmannia glutinosa (raw), ginseng, Ligusticum chuanxiong, Angelica sinensis, and Astragalus membranaceus. In normobaric hypoxia experiments in mice, Shengyu Decoction significantly prolonged the survival time of mice under hypoxic conditions. Sini Decoction, a classic formula in *Shang Han Lun* (Treatise on Cold Damage), is composed of dried ginger, raw Aconitum carmichaelii, and prepared licorice root. In normobaric hypoxia experiments and ice-water swimming experiments in mice, Sini Decoction significantly prolonged the survival time of mice under normobaric hypoxia and their swimming time at low temperatures. Dang Gui Bu Xue Tang (Angelica Blood-Nourishing Decoction), from *Bianhuo Lun* (Treatise on Differentiation of Internal and External Injuries), consists of Astragalus and Angelica sinensis, and has the effect of tonifying qi and nourishing blood; it can significantly prolong the survival time of mice under normobaric hypoxia experimental conditions. Si Jun Zi Tang (Four Gentlemen Decoction), from *Taiping Huimin Heji Jufang* (Formulary of the Bureau of Imperial Medical Services), consists of Ginseng, Poria cocos, Atractylodes macrocephala, and Glycyrrhiza uralensis; Si Jun Zi Tang can significantly improve the survival time of mice under normobaric hypoxia experimental conditions and increase the swimming time of mice under load, exhibiting anti-hypoxia and anti-fatigue effects. Ban Xia Xie Xin Tang (Pinellia Heart-Clearing Decoction), from *Shang Han Lun* (Treatise on Cold Damage), consists of Ginseng, Pinellia ternata, Glycyrrhiza uralensis, Scutellaria baicalensis, Zingiber officinale, Coptis chinensis, and Ziziphus jujuba; Ban Xia Xie Xin Tang can significantly improve the survival time of mice under normobaric hypoxia experimental conditions.

[0004] Extensive practice has shown that common side effects of existing anti-hypoxia and anti-fatigue drugs or supplements include allergies, palpitations, gastrointestinal discomfort, headaches, and nausea. If high-altitude oxygen inhalation is used to enhance anti-hypoxia, it may cause an increase in oxygen partial pressure, which can damage the function of body cells and cause oxygen poisoning, resulting in a series of symptoms such as headaches, dizziness, nausea, vertigo, and poor mental state.

[0005] Therefore, minimizing the incidence of fatigue in high-altitude work and reducing the harm caused by high-altitude work fatigue are of great significance to ensuring the physical and mental health of high-altitude workers. Summary of the Invention

[0006] Based on the technical problems existing in the prior art, the present invention provides a traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue, and its preparation method; the traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue not only has a clear effect on relieving high-altitude hypoxia, but also has an anti-fatigue effect.

[0007] According to a first aspect of the technical solution of the present invention, a traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue is provided. The traditional Chinese medicine prebiotic composition comprises the following traditional Chinese medicine raw material components in parts by weight: 2-20 parts of Polygonatum odoratum, 2-20 parts of chicory, 2-20 parts of wolfberry, 3-30 parts of Codonopsis pilosula, 4-40 parts of raw Astragalus membranaceus, 2-20 parts of Angelica sinensis, 2-20 parts of jujube, and 2-20 parts of turmeric.

[0008] Preferably, the traditional Chinese medicine prebiotic composition comprises the following traditional Chinese medicine raw material components in parts by weight: 5-15 parts of Polygonatum odoratum, 5-15 parts of chicory, 5-15 parts of wolfberry, 7-25 parts of Codonopsis pilosula, 8-30 parts of raw Astragalus membranaceus, 5-15 parts of Angelica sinensis, 5-15 parts of jujube, and 5-15 parts of turmeric.

[0009] More preferably, the herbal prebiotic composition includes the following herbal raw material components in parts by weight: 10 parts of Polygonatum odoratum, 10 parts of chicory, 10 parts of wolfberry, 15 parts of Codonopsis pilosula, 20 parts of raw Astragalus membranaceus, 10 parts of Angelica sinensis, 10 parts of jujube, and 10 parts of turmeric.

[0010] According to a second aspect of the present invention, a method for preparing the above-mentioned traditional Chinese medicine prebiotic composition is provided, comprising the following steps:

[0011] Step S1: Weigh out the Chinese medicinal materials according to the mass fractions. The Chinese medicinal materials are Polygonatum odoratum, chicory, wolfberry, codonopsis, raw astragalus, angelica, jujube and turmeric.

[0012] Step S2: Add 5 to 30 times the amount of the Chinese herbal raw materials obtained in step S1 to distilled water, soak, reflux and filter to obtain the first extract and residue;

[0013] Step S3: Combine the filtrates from the residue in step S2 after heating and refluxing with 0.5 to 10 times the amount of distilled water 1 to 3 times to obtain the second extract;

[0014] Step S4: Combine the filtrates from the residue in step S3 after heating and refluxing with 0.5 to 10 times the amount of distilled water 1 to 3 times to obtain the third extract;

[0015] Step S5: Combine the first extract obtained in step S2, the second extract obtained in step S3, and the third extract obtained in step S4 to obtain the aqueous extract of the Chinese herbal prebiotic composition.

[0016] Step S6: Rotary evaporate the aqueous extract of the Chinese herbal prebiotic composition obtained in step S5 to remove excess solvent, thereby obtaining the aqueous extract paste.

[0017] Preferably, in step S2, the mixed Chinese herbal medicine raw materials are soaked in 8 to 25 times the amount of water for 1 to 10 hours.

[0018] More preferably, in step S2, the soaking time is 3 to 5 hours.

[0019] Furthermore, in step S3, the amount of distilled water is 0.8 times the volume; the extraction is carried out by heating and reflux for 1 hour.

[0020] Preferably, in step S3, the dregs are soaked in 0.6 to 5 times the amount of distilled water for 1 to 5 hours.

[0021] According to a third aspect of the technical solution of the present invention, the present invention provides a pharmaceutical preparation made from the above-described traditional Chinese medicine prebiotic composition and a pharmaceutically acceptable carrier, wherein the dosage form is any pharmaceutically acceptable dosage form.

[0022] Preferably, the pharmaceutical preparation dosage form is an oral preparation, selected from tablets, capsules, granules, pills, powders, elixirs, syrups, oral solutions, and oral suspensions.

[0023] According to a fourth aspect of the technical solution of the present invention, the present invention provides the application of the above-mentioned traditional Chinese medicine prebiotic composition in the preparation of a drug for treating high-altitude hypoxia and relieving fatigue.

[0024] Compared with existing technologies, the traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue, and its preparation method, of the present invention have the following beneficial technical effects:

[0025] 1. The herbal prebiotic composition for treating high-altitude hypoxia and fatigue of this invention is based on the theory of food and medicine sharing the same origin. It also utilizes the advantages of traditional Chinese medicine, which is based on food and medicine, in regulating blood pressure through multiple pathways, multiple targets, and comprehensive intervention compared to chemical drugs. Moreover, it is safer and more applicable. Furthermore, this invention offers flexibility in adjusting dosages and individualization for long-term use. This invention enhances the exploration of the treatment of high-altitude hypoxia with traditional Chinese medicine based on food and medicine, and is of great significance for improving acute mountain sickness.

[0026] 2. This invention utilizes prebiotics to develop a traditional Chinese medicine composition that is both food and medicine. At the same time, it develops a traditional Chinese medicine prebiotic composition that also has the effects of resisting high altitude hypoxia and fatigue. It can promote the growth of beneficial bacteria, thereby benefiting intestinal health, and can also purify the intestines, inhibit the growth of harmful bacteria, and increase the number of probiotics, prompting them to produce a series of effects that are beneficial to human health, such as promoting the production of short-chain fatty acids and improving the body's immunity.

[0027] 3. The traditional Chinese medicine prebiotic composition of the present invention for treating high-altitude hypoxia and relieving fatigue can significantly prolong the human body's resistance to normal pressure closed hypoxia, reduce the mortality rate of acute hypoxia, and has a good anti-hypoxia effect.

[0028] 4. The single herbal ingredients in the formula of the Chinese herbal prebiotic composition for treating high-altitude hypoxia and relieving fatigue of the present invention have the best synergistic effect in treating high-altitude hypoxia and relieving fatigue, and the effect is better than the extracts of single herbs and the extracts of some combinations of single herbs.

[0029] 5. The traditional Chinese medicine prebiotic composition of the present invention has the effects of treating high-altitude hypoxia and anti-fatigue, and its good safety characteristics as a food-medicine homology composition support its use in the prevention of the above-mentioned diseases. It has the potential value of shifting the health protection focus forward, managing chronic diseases and promoting national health. Attached Figure Description

[0030] Figure 1 This is a graph showing the test data on the effect of the traditional Chinese medicine prebiotic composition of the present invention on the exercise endurance of mice;

[0031] Figure 2 This is a graph showing experimental test data on the effect of the traditional Chinese medicine prebiotic composition of the present invention on the exercise endurance of mice;

[0032] Figure 3 This is a comparative data graph of mouse running distance under high-altitude hypoxia conditions based on the present invention;

[0033] Figure 4 This is a comparative data graph of respiratory arrest time in mice under hypoxic conditions, based on the present invention. Detailed Implementation

[0034] To make the technical problems solved by this invention, the technical solutions adopted, and the beneficial effects obtained clearer, the invention will be further described in detail below with reference to specific embodiments. The specific embodiments described herein are for illustrative purposes only and are not intended to constitute any limitation on the invention. Unless otherwise defined, all terms used in this invention have the same meaning as commonly used in the art to which this invention pertains.

[0035] The following specific embodiments are provided to help understand the present invention. However, it should be understood that the embodiments and test examples listed in the present invention are only for illustrating the present invention and do not constitute any limitation. The actual scope of protection of the present invention is set forth in the claims.

[0036] Through in-depth research, the inventors have developed a traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and fatigue, along with its preparation method. This invention creatively combines medicinal and edible herbs such as Polygonatum odoratum, chicory, wolfberry, Codonopsis pilosula, Astragalus membranaceus, Angelica sinensis, jujube, and turmeric into a formula. This improves the body's aerobic metabolism, enhances cellular oxygen utilization, strengthens high-altitude adaptability, and improves work capacity under hypoxic conditions. Furthermore, this traditional Chinese medicine prebiotic composition exhibits significant anti-fatigue, hypoxia tolerance, and immune-regulating effects.

[0037] The traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue provided by this invention comprises the following traditional Chinese medicine raw material components in parts by weight: 2-20 parts of Polygonatum odoratum, 2-20 parts of chicory, 2-20 parts of wolfberry, 3-30 parts of Codonopsis pilosula, 4-40 parts of raw Astragalus membranaceus, 2-20 parts of Angelica sinensis, 2-20 parts of jujube, and 2-20 parts of turmeric.

[0038] This invention relates to a traditional Chinese medicine prebiotic composition that is effective and safer in treating high-altitude hypoxia. Furthermore, the combined effect of the individual herbs in this composition exhibits optimal synergistic antidepressant activity, superior to extracts of individual herbs or combinations of individual herbs. The raw materials used in this invention—Polygonatum odoratum, Chicory, Lycium barbarum, Codonopsis pilosula, Astragalus membranaceus, Angelica sinensis, Jujube, and Curcuma longa—were purchased from Beijing Tongrentang. The Hongyi capsules used in this invention were purchased from Hubei Kangqin Pharmaceutical Co., Ltd. Mice were purchased from Speford Beijing Experimental Animal Technology Co., Ltd. The mouse treadmill was purchased from Jiangsu Saions Biotechnology Co., Ltd.

[0039] In this invention, "prebiotics" are defined as substrates that are selectively utilized by host microorganisms and have health benefits. Prebiotics utilize the components of the present invention, such as Polygonatum odoratum, chicory, wolfberry, codonopsis, raw astragalus, angelica, jujube, and turmeric, to promote the growth of beneficial bacteria, thereby benefiting intestinal health. For example, herbs such as raw scutellaria, wolfberry, jujube, turmeric, and codonopsis can purify the intestines, inhibit the growth of harmful bacteria, and increase the number of probiotics, thus promoting intestinal health.

[0040] This invention is based on the theory of food and medicine sharing the same origin: the effective components of traditional Chinese medicines such as raw Scutellaria baicalensis, wolfberry, and jujube generally contain glycosides. Because these are not easily digested and absorbed, they can easily reach the colon, where they are broken down into aglycones by probiotics before being absorbed by the human body. This inhibits the growth of pathogenic bacteria in the intestines and selectively ferments beneficial microorganisms, promoting a series of effects beneficial to human health, such as promoting the production of short-chain fatty acids and improving the body's immunity. In addition, raw Scutellaria baicalensis, wolfberry, jujube, and Codonopsis pilosula contain a large amount of polysaccharides. Ginseng polysaccharides have a protective effect on some probiotics and can promote the growth of Lactobacillus spp. and Bacteroides spp. in the intestines.

[0041] Compared with chemical drugs, the traditional Chinese medicine of the present invention has the advantages of multiple pathways, multiple targets and comprehensive intervention in regulating blood pressure. It is also safer and more applicable. In terms of long-term use, it has the characteristics of flexibility in addition and subtraction, individualization and fewer adverse reactions.

[0042] The herbal prebiotic composition of this invention is a compound made from the medicinal and edible herbs Polygonatum odoratum, chicory, wolfberry, codonopsis, raw astragalus, angelica, jujube, and turmeric. It is used to treat high-altitude hypoxia and to combat fatigue. Polygonatum odoratum is a yin-nourishing Chinese herb, primarily used to nourish yin and moisten dryness, promote body fluid production and quench thirst, clear heart heat, and nourish heart yin. It can treat diseases related to lung and stomach yin deficiency, dry throat due to dryness and heat, and internal heat and fluid depletion. Chicory has the effects of clearing heat and detoxifying, promoting diuresis and reducing swelling, and strengthening the stomach. It can be used to treat damp-heat jaundice, nephritis edema, stomach distension and pain, and loss of appetite. Goji berries have various pharmacological effects such as enhancing immunity, delaying aging, resisting liver damage, lowering blood sugar, lowering blood lipids, sex hormone-like effects, and anti-fatigue effects. Codonopsis pilosula has the effects of replenishing qi and blood, strengthening the spleen and lungs, and enhancing immunity. Astragalus membranaceus has the effects of consolidating the exterior and stopping sweating, promoting tissue regeneration and detoxification, and replenishing qi and raising yang. Angelica sinensis has the effects of replenishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. Jujube has the effects of tonifying the spleen and stomach, replenishing qi and promoting body fluid production. Turmeric has various pharmacological effects such as resisting myocardial ischemia, regulating lipids, anti-tumor, anti-pulmonary fibrosis, resisting tissue damage, and regulating immunity.

[0043] Furthermore, the traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue includes the following traditional Chinese medicine raw material components in parts by weight: 5-15 parts of Polygonatum odoratum, 5-15 parts of chicory, 5-15 parts of wolfberry, 7-25 parts of Codonopsis pilosula, 8-30 parts of raw Astragalus membranaceus, 5-15 parts of Angelica sinensis, 5-15 parts of jujube, and 5-15 parts of turmeric. In a preferred embodiment, the traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue includes the following traditional Chinese medicine raw material components in parts by weight: 10 parts of Polygonatum odoratum, 10 parts of chicory, 10 parts of wolfberry, 15 parts of Codonopsis pilosula, 20 parts of raw Astragalus membranaceus, 10 parts of Angelica sinensis, 10 parts of jujube, and 10 parts of turmeric.

[0044] According to a second aspect of the present invention, a method for preparing the traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue as described above is provided, comprising the following steps:

[0045] Step S1: Weigh the raw Chinese medicinal materials according to the specified mass proportions. The raw materials are Polygonatum odoratum, chicory, wolfberry, codonopsis pilosula, raw astragalus membranaceus, angelica sinensis, jujube, and turmeric. Step S1 includes removing all impurities from the raw materials, preferably using a combination of manual and mechanical impurity removal. After removing impurities, quickly wash the surface of the raw materials with clean room temperature water or purified water. Preferably, use flowing water or a water gun with a water pressure between 0.2 MPa and 1.0 MPa for spray cleaning, preferably using a water gun with a water pressure between 0.25 MPa and 0.80 MPa. Experiments have shown that Polygonatum odoratum, wolfberry, codonopsis pilosula, raw astragalus membranaceus, angelica sinensis, and jujube are best cleaned with a water gun at a water pressure of 0.50 MPa, while chicory and turmeric are best cleaned with a water gun at a water pressure of 0.30 MPa.

[0046] Step S2: Add 5 to 30 times the amount of the raw Chinese medicinal materials obtained in Step S1 to distilled water, soak, reflux, and filter to obtain the first extract and residue; in Step S2, clean, whole pieces of medicinal and edible herbs such as Polygonatum odoratum, chicory, wolfberry, codonopsis pilosula, raw astragalus membranaceus, angelica sinensis, jujube, and turmeric can be used for soaking; alternatively, the following steps can be used:

[0047] Step S21 involves rinsing the raw Chinese medicine obtained in step S1 with clean water, and then placing it in a cool room at a temperature of 18 to 25 degrees Celsius to allow it to cool naturally. The cool room must be kept well-ventilated and clean.

[0048] Step S22: In a preferred embodiment, large, clean pieces of traditional Chinese medicine raw materials are pulverized into small particles with a diameter of less than 1 cm, preferably less than 0.5 cm. For example, Polygonatum odoratum, chicory, wolfberry, codonopsis pilosula, raw astragalus membranaceus, angelica sinensis, jujube, and turmeric are cut into small particles. The pulverized and mixed traditional Chinese medicine raw materials are then soaked in 5 to 30 times the amount of water, preferably distilled or purified water, for 1 to 30 hours. In another embodiment, the mixed traditional Chinese medicine raw materials are soaked in 8 to 25 times the amount of water for 1 to 10 hours, preferably 3 to 5 hours.

[0049] Step S23, Heating to Boiling Step: After soaking, the mixture of soaked Chinese herbal raw materials is heated to boiling over a low flame and kept boiling for 15 to 30 minutes, preferably 20 minutes. In this embodiment, the low flame temperature is preferably controlled between 120°C and 260°C, more preferably between 150°C and 180°C. In a preferred embodiment, a low flame of 160°C is used.

[0050] Step S24, gentle boiling heating: Then reduce the heating temperature so that the mixture of soaked Chinese herbal raw materials is kept in a gentle boiling state for 15 to 30 minutes. Preferably, the gentle heating temperature is reduced to any temperature between 80 and 100 degrees Celsius. In a preferred embodiment, gentle heating at 90, 95 or 98 degrees Celsius is used.

[0051] Step S25, reflux extraction step: The heated mixture of Chinese herbal raw materials is extracted using a reflux extraction device to separate the active ingredients from the soaked mixture. A high-temperature condensing reflux device is preferred, and the reflux extraction time is 60 to 180 minutes, preferably 2 hours. This step yields the first extract.

[0052] Furthermore, the concentrated mixture of Chinese herbal raw materials is filtered through a Chinese herbal liquid filter to remove the residue. The residue is filtered using a Chinese herbal liquid filter with a pore size of 100 to 800 mesh; preferably, a Chinese herbal liquid filter with a pore size of 300, 400, or 500 mesh is used to remove the residue, thereby obtaining the first extract (i.e., filtrate) and the residue.

[0053] Step S3: Combine the filtrates from the residue in step S2 after reflux extraction with 0.5 to 10 times the volume of distilled water 1 to 3 times to obtain the second extract; this further includes the following steps:

[0054] Step S31 involves soaking the dregs from step S2 in 0.5 to 10 times the volume of water, preferably distilled or purified water. In another embodiment, the dregs are soaked in 0.6 to 5 times the volume of water for 1 to 5 hours, preferably 2 to 3 hours. In a preferred embodiment, the dregs are soaked in 0.8 times the volume of purified water for 1 to 3 hours, preferably 2 hours.

[0055] Step S32, Heating to Boiling Step: After soaking, the mixture of soaked Chinese herbal raw materials is heated to boiling over a low flame and kept boiling for 15 to 30 minutes, preferably 20 minutes. In this embodiment, the low flame temperature is preferably controlled between 120°C and 260°C, more preferably between 150°C and 180°C. In a preferred embodiment, a low flame of 160°C is used.

[0056] Step S33, gentle boiling heating: Then reduce the heating temperature so that the mixture of soaked Chinese herbal raw materials is kept in a gentle boiling state for 15 to 30 minutes. Preferably, the gentle heating temperature is reduced to any temperature between 80 and 100 degrees Celsius. In a preferred embodiment, gentle heating at 90, 95, or 98 degrees Celsius is used.

[0057] Step S34, reflux extraction step: The heated mixture of Chinese herbal raw materials is extracted using a reflux extraction device to separate the effective components from the soaked mixture of Chinese herbal raw materials, resulting in a second extract. The reflux extraction device is preferably a high-temperature condensing reflux device, and the reflux extraction is performed for 30 to 90 minutes, preferably 1 hour.

[0058] Step S4: Combine the filtrates from the residue in step S3 after reflux extraction with 0.5 to 10 times the volume of distilled water 1 to 3 times to obtain the third extract; this further includes the following steps:

[0059] Step S41 involves soaking the solid obtained after reflux extraction in step S34 in 0.5 to 3 times its volume of water, preferably distilled or purified water. In another embodiment, the mixed Chinese herbal raw materials are soaked in 0.6 to 1.5 times its volume of water for 1 to 5 hours, preferably 2 to 3 hours. In a preferred embodiment, the mixed solid is soaked in 0.8 times its volume of purified water for 1 to 3 hours, preferably 2 hours.

[0060] Step S42, Heating to Boiling Step: After soaking, the mixture of soaked Chinese herbal raw materials is heated to boiling over a low flame and kept boiling for 15 to 30 minutes, preferably 20 minutes. In this embodiment, the low flame temperature is preferably controlled between 120°C and 260°C, more preferably between 150°C and 180°C. In a preferred embodiment, a low flame of 160°C is used.

[0061] Step S43, gentle boiling heating: Then reduce the heating temperature so that the mixture of soaked Chinese herbal raw materials is kept in a gentle boiling state for 15 to 30 minutes. Preferably, the gentle heating temperature is reduced to any temperature between 80 and 100 degrees Celsius. In a preferred embodiment, gentle heating at 90, 95 or 98 degrees Celsius is used.

[0062] Step S44, reflux extraction step: The heated mixture of Chinese herbal raw materials is extracted using a reflux extraction device to separate the effective components from the soaked mixture of Chinese herbal raw materials, resulting in a third extract. The reflux extraction device is preferably a high-temperature condensing reflux device, and the reflux extraction time is 30 to 90 minutes, preferably 1 hour.

[0063] Step S5: Combine the first extract obtained in step S2, the second extract obtained in step S3, and the third extract obtained in step S4 to obtain the aqueous extract of the Chinese herbal prebiotic composition.

[0064] Step S6: Rotary evaporate the aqueous extract of the Chinese herbal prebiotic composition obtained in step S5 to remove excess solvent, thereby obtaining the aqueous extract paste.

[0065] Using the obtained aqueous extract, preparations are made with pharmaceutically acceptable carriers, and the dosage form can be any pharmaceutically acceptable dosage form. Preparations are also made into oral dosage forms, selected from tablets, capsules, granules, pills, powders, elixirs, syrups, oral solutions, and oral suspensions. These preparations can be used to treat altitude sickness, fatigue, and other altitude-related symptoms. Specifically, the herbal prebiotic composition of this invention is a compound formula composed of medicinal and edible herbs such as Polygonatum odoratum, chicory, wolfberry, Codonopsis pilosula, Astragalus membranaceus, Angelica sinensis, jujube, and turmeric, and has the effects of treating altitude sickness and fatigue.

[0066] Furthermore, the Solomon's Seal in this invention is a yin-tonifying traditional Chinese medicine, whose main functions are to nourish yin and moisten dryness, promote body fluid production and quench thirst, clear heart heat and nourish heart yin. It can treat related diseases such as lung and stomach yin deficiency, dry throat due to dryness and heat, and internal heat and fluid deficiency.

[0067] Chicory has the effects of clearing heat and detoxifying, promoting diuresis and reducing swelling, and strengthening the stomach. It can be used to treat damp-heat jaundice, nephritis edema, stomach distension and pain, and loss of appetite. In this patent, Solomon's seal and chicory are used simultaneously, which is one of the innovations of this invention. The simultaneous use of Solomon's seal and chicory in this invention clears heat and detoxifies, nourishes yin and moistens dryness from multiple angles.

[0068] Goji berries have a variety of pharmacological effects, such as enhancing immunity, delaying aging, resisting liver damage, lowering blood sugar, lowering blood lipids, sex hormone-like effects, and anti-fatigue effects, which greatly alleviate patients' fatigue.

[0069] Codonopsis pilosula has the effects of replenishing qi and blood, strengthening the spleen and lungs, and enhancing immunity. Angelica sinensis has the effects of replenishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. Jujube has the effects of tonifying the spleen and stomach, replenishing qi and promoting body fluid production. In this invention, Codonopsis pilosula, Angelica sinensis and jujube are used simultaneously to replenish qi and blood, strengthen the spleen and lungs from multiple perspectives.

[0070] Raw astragalus has the effects of strengthening the exterior and stopping sweating, promoting tissue regeneration and detoxification, and tonifying qi and raising yang. Turmeric has a variety of pharmacological effects, such as anti-myocardial ischemia, lipid regulation, anti-tumor, anti-pulmonary fibrosis, anti-tissue damage, and immune regulation. In this invention, raw astragalus and turmeric are used simultaneously, which can have the effects of invigorating qi and strengthening the stomach, enhancing immunity, anti-aging, and antibacterial and disease prevention.

[0071] The technical solution of the present invention will be further illustrated below through various embodiments.

[0072] Example 1: Preparation of Prebiotic Extract (Concentrate) from Traditional Chinese Medicine

[0073] A traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue is prepared from Polygonatum odoratum, chicory, Codonopsis pilosula, wolfberry, raw Astragalus membranaceus, Angelica sinensis, jujube, and turmeric.

[0074] The preparation method includes the following steps:

[0075] Step S1: Weigh the following Chinese herbal raw material components according to the mass fractions: 2-20 parts of Polygonatum odoratum, 2-20 parts of chicory, 2-20 parts of wolfberry, 3-30 parts of Codonopsis pilosula, 4-40 parts of raw Astragalus membranaceus, 2-20 parts of Angelica sinensis, 2-20 parts of jujube, and 2-20 parts of turmeric. Step S1 includes removing all impurities from the Chinese herbal raw materials, preferably using a combination of manual and mechanical impurity removal methods. After removing impurities, the surface of the above-mentioned Chinese herbal raw materials is quickly washed with clean room temperature water or purified water. It is preferable to use flowing water for washing, or to use a water spray gun with a water pressure between 0.5MPa and 1.0MPa for spraying and cleaning, preferably using a water spray gun with a water pressure between 0.6MPa and 0.80MPa. Experiments have verified that Polygonatum odoratum, wolfberry, Codonopsis pilosula, Astragalus membranaceus, Angelica sinensis, and jujube are cleaned by spraying with a water gun with a water pressure of 0.80MPa, while chicory and turmeric are cleaned by spraying with a water pressure of 0.60MPa.

[0076] Step S2: Add 8 to 15 times the amount of the Chinese herbal raw materials from step S1 (1:10, m:V) to distilled water, soak for 8 to 24 hours, then heat and reflux to extract for 1 to 2 hours, filter to obtain the first extract and residue;

[0077] Step S3: The residue from step S2 is heated and refluxed with 0.6 to 1.2 times the amount of distilled water for 1 to 1.5 hours. The extraction is repeated twice. The filtrates are collected and combined to obtain the second extract.

[0078] Step S4: For the filter residue obtained after step S3, heat and reflux with 0.6 to 1.2 times the amount of distilled water to extract for 1 hour to 1.5 hours. Repeat the heat and reflux extraction twice. Collect the filtrates and combine them to obtain the third extract.

[0079] Step S5: Combine the first extract from step S2, the second extract from step S3, and the third extract from step S4 to obtain the aqueous extract of the traditional Chinese medicine prebiotic composition.

[0080] Step S6: Concentrate the aqueous extract of the Chinese herbal prebiotic composition from step S5 under reduced pressure to obtain an aqueous extract of Chinese herbal prebiotics.

[0081] Example 2: Preparation of Prebiotic Extract (Concentrate) from Traditional Chinese Medicine

[0082] A traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue is prepared from Polygonatum odoratum, chicory, Codonopsis pilosula, wolfberry, raw Astragalus membranaceus, Angelica sinensis, jujube, and turmeric.

[0083] The preparation method includes the following steps:

[0084] Step S1: Weigh out 10g of Polygonatum odoratum, 10g of chicory, 10g of Codonopsis pilosula, 15g of wolfberry, 20g of raw Astragalus membranaceus, 10g of Angelica sinensis, 10g of jujube, and 10g of turmeric according to the weight proportions.

[0085] Step S2: Add 10 times the amount of the Chinese herbal raw materials from step S1 (1:10, m:V) to distilled water, soak for 12 hours, then heat under reflux for 2 hours, and filter to obtain the first extract and residue.

[0086] Step S3: Heat and reflux the residue from step S2 with 0.8 times the amount of distilled water for 1 hour, repeat the heating and reflux extraction twice, collect the filtrates and combine them to obtain the second extract;

[0087] Step S4: For the filter residue obtained after step S3, heat and reflux with 0.8 times the amount of distilled water for 1 hour, and repeat the heating and reflux extraction twice. Collect the filtrates and combine them to obtain the third extract.

[0088] Step S5: Combine the first extract from step S2, the second extract from step S3, and the third extract from step S4 to obtain the aqueous extract of the traditional Chinese medicine prebiotic composition.

[0089] Step S6: Concentrate the aqueous extract of the Chinese herbal prebiotic composition from step S5 under reduced pressure to obtain 35.9g of aqueous extract, with an extraction rate of 35.9g / 95g = 37.4%.

[0090] Test Example 1: Evaluation of the anti-fatigue effect of prebiotic extracts from traditional Chinese medicine.

[0091] This test case uses a weighted swimming experiment in mice to evaluate the anti-fatigue effect of the drug of the present invention.

[0092] Laboratory animals: C57 mice, male, 18-22g, purchased from Spaford Beijing Laboratory Animal Technology Co., Ltd.

[0093] Test sample: The extract of the Chinese herbal prebiotic composition prepared in Example 1 was weighed according to the extraction rate and the dosage of the medicinal materials. The corresponding dose of the Chinese herbal prebiotic composition extract was added to distilled water to make a solution for gavage.

[0094] Experimental apparatus: mouse swimming apparatus, glass container with a diameter of 14cm and a height of 19cm.

[0095] Experimental Methods: Mice were acclimatized after purchase and randomly divided into four groups of eight mice each: a blank control group, a positive control group (Hongyi Capsules, 0.22 g / kg), a low-dose group (15 g / kg) of traditional Chinese medicine prebiotic composition, and a high-dose group (20 g / kg) of traditional Chinese medicine prebiotic composition. Administered via gavage (20 ml / kg orally) for 14 consecutive days. One hour after the last administration, a weight-bearing swimming test was conducted. A piece of lead wire, representing 5% of the mouse's body weight, was tied to the mouse's tail. The mouse's fur was sprayed with water, and the mouse was placed in a bucket of water 40–50 cm deep at a temperature maintained at 22–26°C. The mouse was allowed to swim until exhaustion. Exhaustion swimming was defined as the inability to resurface for 7 seconds after sinking. This time was recorded as the exhaustion swimming time. Prolonged swimming time was considered to have an anti-fatigue effect.

[0096] Experimental results: See Figure 1 . Figure 1 This is a graph showing the test data on the effect of a traditional Chinese medicine prebiotic composition on the exercise endurance of mice, based on... Figure 1 The results of the weight-bearing swimming experiment in mice showed that low doses of the traditional Chinese medicine composition could increase the swimming time of mice under weight, with a significant difference compared to the control group (P < 0.05). The positive control drug, Hongyi capsules, could increase the swimming distance of mice, but there was no significant difference compared to the control group. These results suggest that the traditional Chinese medicine prebiotic composition has an anti-fatigue effect, and its effect is superior to that of Hongyi capsules.

[0097] Test Example 2: Evaluation of the anti-fatigue effect of prebiotic extracts from traditional Chinese medicine.

[0098] This test case uses a mouse rotarod experiment to evaluate the anti-fatigue effect of the herbal prebiotic extract of this invention.

[0099] Laboratory animals: C57 mice, male, 18-22g, purchased from Spaford Beijing Laboratory Animal Technology Co., Ltd.

[0100] Test sample: The extract of the Chinese herbal prebiotic composition prepared in Example 1 was weighed according to the extraction rate and the dosage of the medicinal materials. The corresponding dose of the Chinese herbal prebiotic composition extract was added to distilled water to make a solution for gavage.

[0101] Experimental apparatus: Mouse treadmill, Jiangsu Saions Biotechnology Co., Ltd.

[0102] Experimental Methods: Mice were acclimatized after purchase and randomly divided into four groups of eight mice each: a blank control group, a positive control group (Hongyi Capsules, 0.22 g / kg), a low-dose group (15 g / kg) of traditional Chinese medicine prebiotic composition, and a high-dose group (20 g / kg) of traditional Chinese medicine prebiotic composition. Administered via gavage (20 ml / kg orally) for 14 consecutive days. A rotundus test was conducted one hour after the last administration. Before testing, mice were acclimatized to the test environment for 1-2 days, during which time they were introduced into the testing device and subjected to some trials to familiarize themselves with the rotundus and reduce errors. Each training session lasted 5-10 minutes. For the formal test, the mice were placed on the rotundus, and the time from when the mouse stepped onto the rotundus was recorded, stopping the time after the mouse fell off. The time for each mouse was repeated to determine the average. The movement time of the mice on the rotundus was statistically analyzed to assess their motor ability.

[0103] Experimental results: See Figure 2 . Figure 2 This is a graph showing experimental test data on the effect of a traditional Chinese medicine prebiotic composition on the exercise endurance of mice. Based on... Figure 2 The results of the rotarod experiment on mice showed that low doses of the traditional Chinese medicine composition increased the movement time of mice, with a significant difference compared to the control group (P < 0.05). The positive control drug, Hongyi capsules, increased the movement time of mice, but there was no significant difference compared to the control group. These results suggest that the traditional Chinese medicine prebiotic composition has an anti-fatigue effect, and its effect is superior to that of Hongyi capsules.

[0104] Test Example 3: Evaluation of the anti-fatigue effect of prebiotic extracts from traditional Chinese medicine.

[0105] This test case uses a mouse treadmill test to evaluate the anti-altitude hypoxia fatigue effect of the traditional Chinese medicine prebiotic extract of this invention.

[0106] Laboratory animals: C57 mice, male, 18-22g, purchased from Spaford Beijing Laboratory Animal Technology Co., Ltd.

[0107] Test sample: The extract of the Chinese herbal prebiotic composition prepared in Example 1 was weighed according to the extraction rate and the dosage of the medicinal materials. The corresponding dose of the Chinese herbal prebiotic composition extract was added to distilled water to make a solution for gavage.

[0108] Experimental apparatus: Mouse treadmill, Jiangsu Saions Biotechnology Co., Ltd.

[0109] Experimental Methods: After purchase, mice were acclimatized and randomly divided into four groups of eight mice each: a blank control group, a high-altitude hypoxia group, a positive control group (Hongyi Capsule, 0.22 g / kg), a low-dose group (15 g / kg) of traditional Chinese medicine prebiotic composition, and a high-dose group (20 g / kg) of traditional Chinese medicine prebiotic composition. Mice were administered the drugs via gavage (20 ml / kg orally) for 14 consecutive days. Afterward, except for the blank control group, the mice in the other groups were placed in a low-pressure, low-oxygen animal experimental chamber simulating a high altitude of 5500 m for 3 consecutive days. One hour after the last administration, a treadmill test was conducted. Mice were placed on different tracks and allowed to explore and adapt on the unused tracks for 5 minutes. Then, the start button and the current buttons for each track were pressed. The mice were observed for signs of fatigue, such as rapid breathing, lying prone in the latter third of the track, and failing to move forward after five attempts when their tails were lightly touched. The track where the fatigued mouse was located was then stopped, and the running distance on that track was recorded. Increasing the treadmill distance is believed to have an anti-fatigue effect.

[0110] Experimental results: See Figure 3 The results showed that high doses of the traditional Chinese medicine composition increased the running distance of mice, with a significant difference compared to the high-altitude hypoxia group (P < 0.05). The positive control drug, Hongyi capsules, showed no significant difference compared to the hypoxia group. These results suggest that the traditional Chinese medicine prebiotic composition has an anti-high-altitude hypoxia fatigue effect, and its effect is superior to that of Hongyi capsules.

[0111] Test Example 4: Evaluation of the Anti-hypoxia Effect of Traditional Chinese Medicine Prebiotic Compositions

[0112] This test case uses a normal pressure closed hypoxia experiment to evaluate the anti-hypoxia effect of a traditional Chinese medicine prebiotic composition.

[0113] Laboratory animals: C57 mice, male, 18-22g, purchased from Spaford Beijing Laboratory Animal Technology Co., Ltd.

[0114] Test sample: The extract of the Chinese herbal prebiotic composition prepared in Example 1 was weighed according to the extraction rate and the dosage of the medicinal materials. The corresponding dose of the Chinese herbal prebiotic composition extract was added to distilled water to make a solution for gavage.

[0115] Experimental apparatus: Mouse treadmill, Jiangsu Saions Biotechnology Co., Ltd.

[0116] Experimental Methods: After purchase, mice were acclimatized and randomly divided into four groups of eight mice each: a blank control group, a positive control group (Hongyi Capsules, 0.22 g / kg), a low-dose group (15 g / kg) of traditional Chinese medicine prebiotic composition, and a high-dose group (20 g / kg) of traditional Chinese medicine prebiotic composition. Mice were administered the drugs via gavage (20 ml / kg orally) for 14 consecutive days. One hour after the last administration, each group of mice was placed in a 250 mL wide-mouth bottle containing 15 g of soda lime (one mouse per bottle). The bottles were quickly sealed and inverted in water to prevent air from entering. The respiratory rate and depth of the mice were timed and observed. Survival time was measured when respiration ceased. The survival time of the mice was calculated to assess their resistance to hypoxia.

[0117] Experimental results: see Figure 4 ,in accordance with Figure 4 The test results showed that high doses of the traditional Chinese medicine composition increased the survival time of mice, with a significant difference compared to the control group (P < 0.01). The positive control drug, Hongyi capsules, increased the movement time of mice, with a significant difference compared to the control group (P < 0.05). These results suggest that the traditional Chinese medicine prebiotic composition has an anti-hypoxia effect, and its effect is superior to that of Hongyi capsules.

[0118] The above description of the technical solution of the present invention further illustrates the beneficial effects of the present invention. The present invention aligns the traditional Chinese medicine concept of "preventing disease before it occurs, preventing disease progression after it occurs, and preventing recurrence after recovery" with the treatment principle of "early detection and early treatment" for diseases. It also leverages the multi-target, multi-system holistic regulatory characteristics of traditional Chinese medicine, and can be widely applied in the prevention and treatment of depression, anxiety, and various types of fatigue.

[0119] The formula of this invention thoroughly implements the concept of "medicine and food from the same source," which means that the medicine can be used as both medicine and food. The formulation of traditional Chinese medicines from the same source in this invention can further reduce the safety risks of long-term medication and improve patient compliance.

[0120] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details of the above embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solutions of the present invention. These simple modifications all fall within the protection scope of the present invention. It should also be noted that the various specific technical features described in the above embodiments can be combined in any way without contradiction. To avoid unnecessary repetition, the present invention will not describe the various possible combinations separately. Furthermore, various different embodiments of the present invention can also be arbitrarily combined, as long as they do not violate the spirit of the present invention, they should also be considered as the content disclosed by the present invention.

Claims

1. A traditional Chinese medicine prebiotic composition for treating high-altitude hypoxia and relieving fatigue, characterized in that, The Chinese herbal prebiotic composition consists of the following Chinese herbal raw materials in parts by weight: 2-20 parts of Polygonatum odoratum, 2-20 parts of chicory, 2-20 parts of wolfberry, 3-30 parts of Codonopsis pilosula, 4-40 parts of raw Astragalus membranaceus, 2-20 parts of Angelica sinensis, 2-20 parts of jujube, and 2-20 parts of turmeric.

2. The traditional Chinese medicine prebiotic composition according to claim 1, characterized in that, The Chinese herbal prebiotic composition consists of the following Chinese herbal raw materials in parts by weight: 5-15 parts of Polygonatum odoratum, 5-15 parts of chicory, 5-15 parts of wolfberry, 7-25 parts of Codonopsis pilosula, 8-30 parts of raw Astragalus membranaceus, 5-15 parts of Angelica sinensis, 5-15 parts of jujube, and 5-15 parts of turmeric.

3. The traditional Chinese medicine prebiotic composition according to claim 1, characterized in that, The Chinese herbal prebiotic composition consists of the following Chinese herbal raw materials in parts by weight: 10 parts Polygonatum odoratum, 10 parts chicory, 10 parts wolfberry, 15 parts Codonopsis pilosula, 20 parts raw Astragalus membranaceus, 10 parts Angelica sinensis, 10 parts jujube, and 10 parts turmeric.

4. A method for preparing the traditional Chinese medicine prebiotic composition according to any one of claims 1-3, characterized in that, Includes the following steps: Step S1: Weigh out the Chinese medicinal materials according to the mass fractions. The Chinese medicinal materials are Polygonatum odoratum, chicory, wolfberry, codonopsis, raw astragalus, angelica, jujube and turmeric. Step S2: Add 5 to 30 times the amount of the Chinese herbal raw materials obtained in step S1 to distilled water, soak, reflux and filter to obtain the first extract and residue; Step S3: Combine the filtrates from the residue in step S2 after heating and refluxing with 0.5 to 10 times the amount of distilled water 1 to 3 times to obtain the second extract; Step S4: Combine the filtrates from the residue in step S3 after heating and refluxing with 0.5 to 10 times the amount of distilled water 1 to 3 times to obtain the third extract; Step S5: Combine the first extract obtained in step S2, the second extract obtained in step S3, and the third extract obtained in step S4 to obtain the aqueous extract of the Chinese herbal prebiotic composition. Step S6: Rotary evaporate the aqueous extract of the Chinese herbal prebiotic composition from step S5 to remove excess solvent, thereby obtaining the aqueous extract paste.

5. The method for preparing the traditional Chinese medicine prebiotic composition according to claim 4, characterized in that, In step S2, the mixed Chinese herbal medicine raw materials are soaked in 8 to 25 times the amount of water for 1 to 10 hours.

6. The method for preparing the traditional Chinese medicine prebiotic composition according to claim 4, characterized in that, In step S2, the raw Chinese medicine is soaked in 1 to 20 times the amount of distilled water for 12 to 24 hours; then refluxed for 2 hours.

7. The method for preparing the traditional Chinese medicine prebiotic composition according to claim 4, characterized in that, In step S3, the amount of distilled water is 0.8 times the volume; the extraction is carried out by heating and reflux for 1 hour.

8. A pharmaceutical preparation, characterized in that, It is made from the traditional Chinese medicine prebiotic composition according to any one of claims 1-2 and a pharmaceutically acceptable carrier, and the dosage form is any pharmaceutically acceptable dosage form.

9. The pharmaceutical preparation according to claim 8, characterized in that, The pharmaceutical preparation dosage form is an oral preparation, selected from tablets, capsules, granules, pills, powders, elixirs, syrups, oral solutions, and oral suspensions.

10. The use of the traditional Chinese medicine prebiotic composition according to any one of claims 1-2 in the preparation of a drug for treating high-altitude hypoxia and relieving fatigue.

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