A traditional Chinese medicine composition for treating deficiency syndrome caused by post-illness, post-operation, radiotherapy and chemotherapy and a preparation process thereof

Abstract

This application relates to the technical field of traditional Chinese medicine compositions, specifically disclosing a traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy, and its preparation process. The composition comprises Ganoderma lucidum extract and ginseng powder. The preparation method of the Ganoderma lucidum extract is as follows: Step 1, pulverizing the raw material to obtain Ganoderma lucidum powder; Step 2, extraction: extracting the Ganoderma lucidum powder with a primary liquid-liquid phase solvent for 1.5-2.5 hours, adding non-oxidizing gas nano-bubble water and extracting for 0.5-1.5 hours, then adding acidic gas nano-bubble water and continuing extraction for 0.5-1.5 hours; Step 3, collection: collecting the extract, concentrating, forming a paste, and drying to obtain the Ganoderma lucidum extract; the primary liquid-liquid phase solvent includes an alcohol solution with a volume ratio of (2-5):1 and a non-polar organic solvent, with the alcohol volume percentage in the primary alcohol solution being 65-90%. The composition of this application has a higher content of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes.

Description

Technical Field

[0001] This application relates to the technical field of traditional Chinese medicine compositions, and more specifically, to a traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy, and its preparation process. Background Technology

[0002] Reishi mushroom is a fungus used for both medicinal and edible purposes. Its main bioactive components include polysaccharides, triterpenoids, proteins, amino acids, sterols, and minerals. Among these, polysaccharides are helical compounds composed of three monosaccharide chains, similar in structure to RNA and DNA, with relative molecular weights ranging from hundreds to hundreds of thousands. Related studies have shown that polysaccharides possess various pharmacological effects, including anti-tumor, immunomodulatory, anti-radiation, antibacterial, and antioxidant properties. Due to their excellent medicinal effects, the reishi mushroom industry has experienced rapid development.

[0003] Ginseng is rich in ginsenosides, which have a variety of pharmacological effects, such as enhancing immunity and fighting tumors.

[0004] Based on the medicinal properties of the two substances mentioned above, the following traditional Chinese medicine composition has been developed: a composition with Ganoderma lucidum extract and ginseng powder as the main components. Its main efficacy lies in treating deficiency syndromes caused by illness, surgery, and radiotherapy / chemotherapy. The preparation process of this composition includes the following steps: drying and pulverizing the Ganoderma lucidum fruiting body; extracting, concentrating, and drying the Ganoderma lucidum fruiting body powder using a solvent; and then mixing it with dried ginseng powder according to a specified ratio. Various dosage forms of drugs and health products can be prepared using this composition as a raw material.

[0005] In the above methods, the initial Ganoderma lucidum extract is obtained by directly extracting with water, alcohol, and / or alcohol solutions, which suffers from a low extraction rate of Ganoderma lucidum polysaccharides. Generally, when using hot water at 90-100℃ as a solvent for Ganoderma lucidum polysaccharide extraction, the extraction rate is 0.5-0.8 wt%. However, by further combining "ultrasound + enzyme treatment" to assist hydrothermal extraction, and by further optimizing the extraction temperature, ultrasonic conditions, enzyme dosage, and pH, the extraction rate of Ganoderma lucidum polysaccharides is further increased to approximately 2.5 wt%. The extraction method for Ganoderma lucidum triterpenes generally involves extraction with an ethanol solution, for example, extraction with a 95% ethanol solution under high pressure, resulting in an extraction rate of approximately 0.1 wt%.

[0006] Therefore, it is evident that the Ganoderma lucidum extract obtained using current extraction methods has low contents of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes. In other words, the content of the effective medicinal components in the resulting traditional Chinese medicine composition is not high. Summary of the Invention

[0007] In order to further increase the content of effective medicinal components in the traditional Chinese medicine composition, especially the content of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes, this application provides a traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy and chemotherapy, and its preparation process.

[0008] In the first aspect, this application provides a traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, or radiotherapy and chemotherapy, employing the following technical solution:

[0009] A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, or radiotherapy and chemotherapy, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

[0010] 50-80 parts of Ganoderma lucidum extract, 20-40 parts of ginseng powder;

[0011] The preparation method of the Ganoderma lucidum extract includes the following steps:

[0012] Step 1, Grinding: Dry the fruiting body of Ganoderma lucidum, grind it into powder to obtain Ganoderma lucidum powder;

[0013] Step 2, Extraction: Extract the obtained Ganoderma lucidum powder with the original two-phase solvent for 1.5-2.5h, add non-oxidizing gas nano-bubble water to the original two-phase solvent and extract for 0.5-1.5h, then add acidic gas nano-bubble water and extract for 0.5-1.5h.

[0014] Step 3, Collection: The extract is collected, concentrated, dried, and then the Ganoderma lucidum extract is obtained.

[0015] The original two-phase solvent includes an original alcohol solution and a non-polar organic solvent, wherein the volume percentage of alcohol in the original alcohol solution is 65-90%; the volume ratio of the original alcohol solution to the non-polar organic solvent is (2-5):1; after adding acidic gas nanobubble water and non-oxidizing gas nanobubble water, a modified two-phase solvent is obtained, wherein the modified two-phase solvent includes a modified alcohol solution and a non-polar organic solvent, wherein the volume percentage of alcohol in the modified alcohol solution is 20-50%;

[0016] The acidic gas nanobubble water is selected from any one or two of carbon dioxide nanobubble water and sulfur dioxide nanobubble water; the non-oxidizing gas nanobubble water is selected from any one or more of hydrogen nanobubble water, nitrogen nanobubble water and argon nanobubble water.

[0017] By employing the above-mentioned technical solution, this application combines a "two-phase extraction + nano-bubble water-assisted extraction" method to obtain Ganoderma lucidum extract, thereby improving the extraction rate of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes. Specifically, in this method, Ganoderma lucidum extract is first obtained by extraction with a primary two-phase solvent. The primary alcohol solution has an affinity for both Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes, thus enabling the simultaneous extraction of these two types of substances. When using the original two-phase solvent extraction, the volume ratio of the original alcohol solution to the non-polar organic solvent is (2-5):1, and the volume percentage of alcohol in the original alcohol solution is 65-90%. This means that the extraction system initially tends to extract substances that are compatible with organic solvents, such as Ganoderma triterpenes. After extraction with this system for 1.5-2.5 hours, non-oxidizing gas nanobubble water and acidic gas nanobubble water are added, so that the volume percentage of alcohol in the modified alcohol solution is 20-50%. At this point, a new two-phase extraction system is formed, which tends to extract Ganoderma polysaccharides. That is, by changing the two-phase extraction system, Ganoderma polysaccharides and Ganoderma triterpenes can be extracted simultaneously and with high extraction rates.

[0018] In this extraction process, the Ganoderma lucidum fruiting body powder undergoes cellular material extraction without additional cell wall disruption. Without the addition of composite nano-bubble water, the original two-phase extraction system tends to extract Ganoderma triterpenes. This process is both an intracellular material extraction process and a cell wall and cell membrane disruption process. The reason for prioritizing the extraction of Ganoderma triterpenes is that they include neutral Ganoderma triterpenes (such as ganoderic acid, ganoderic aldehyde, Ganoderma spore esters, and ganoderic ketones) and acidic Ganoderma triterpenes (such as ganoderic acid, ganoderic acid, ganoderic acid, and ganoderic acid). Acidic Ganoderma triterpenes affect the Ganoderma cell wall and cell membrane, altering their permeability to expedite the release of intracellular, cell wall, and cell membrane substances. After adding acidic gas nanobubble water and non-oxidizing gas nanobubble water, the volume ratio of water in the modified alcohol solution increased from 10-35% to 50-80%, which significantly improved the extraction effect of hydrophilic substances in the two-liquid-phase system. However, both the original two-liquid-phase system and the two-liquid-phase system after adding composite nanobubble water have good ability to extract substances that are compatible with both water and organic solvents, that is, to achieve the simultaneous extraction of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes.

[0019] In this scheme, the addition of acidic gas nanobubble water and non-oxidizing gas nanobubble water has the following effects: as described above, it promotes the extraction of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes by changing the two-liquid-phase system; on the other hand, the nanobubble water itself contains a large number of micro- and nano-bubbles, which have excellent effects on promoting the extraction of substances due to their high specific surface energy.

[0020] In this application, the addition of nano-bubble water does not involve adding only one type of nano-bubble water, but rather the addition of both acidic gas nano-bubble water and non-oxidizing gas nano-bubble water. This is because cells generally contain substances with both positive and negative charges: for example, phospholipids on the cell membrane are negatively charged, and pectin and polysaccharides on the cell wall are negatively charged; protein molecules, containing both carboxyl and amino groups, become positively charged after losing their acidic groups in an acidic environment, and both the cell wall and cell membrane (especially the cell membrane) contain proteins. Therefore, substances such as phospholipids, polysaccharides, and membrane proteins can all affect the dissolution of effective substances in Ganoderma lucidum cells. In this application, the non-oxidizing gas nano-bubble water prepared with non-oxidizing gas has a negatively charged outer surface of the bubbles. The acidic gas nano-bubble water prepared with acidic gas has a positively charged outer surface because its bubbles are adsorbed with a large number of hydrogen ions. This application first adds non-oxidizing gas nanobubble water, which primarily targets positively charged substances in cells, such as membrane proteins; then adds acidic gas nanobubble water, which primarily targets negatively charged substances in cells, such as phospholipids on the cell membrane and polysaccharides on the cell wall. This treatment significantly improves cell permeability, thereby enhancing the extraction efficiency of Ganoderma lucidum triterpenes and polysaccharides. Furthermore, the two types of nanobubble water have different liquid environments, such as pH and the distribution of external charge on the bubbles; therefore, when the two types of nanobubble water are mixed, the interaction between the two types of bubbles causes unstable bubbles to aggregate, rise, and burst, ultimately leaving more stable bubbles with smaller particle sizes. Smaller bubbles have higher surface energy, thus further improving the extraction rate of Ganoderma lucidum polysaccharides and triterpenes. In addition, micro- and nanobubble water inherently contains reactive oxygen species; therefore, compared to oxidizing gas nanobubble water, the addition of non-oxidizing gas nanobubble water can further reduce the reactive oxygen species content in the extraction system, reducing the possibility of active polysaccharides losing their biological activity due to oxidation.

[0021] Optionally, in step S2, the addition ratio of Ganoderma lucidum powder to the original two-phase solvent is 25-35g Ganoderma lucidum powder / L original two-phase solvent.

[0022] Optionally, the volume percentage of alcohol in the original alcohol solution is 70-80%; after adding the acidic gas nanobubble water and the non-oxidizing gas nanobubble water, the volume percentage of alcohol in the obtained modified alcohol solution is 40-50%.

[0023] By adopting the above technical solution, the two-phase extraction system can be further optimized to extract more Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes with the minimum amount of composite nano bubble water added.

[0024] Optionally, the alcohol is selected from one or more of methanol, ethanol, propanol, and butanol; the nonpolar solvent is selected from one or more of n-hexane, petroleum ether, and chloroform.

[0025] Further optionally, the alcohol is ethanol, and the nonpolar solvent is n-hexane.

[0026] Optionally, the acidic gas nanobubble water is sulfur dioxide nanobubble water; the non-oxidizing gas nanobubble water is hydrogen nanobubble water.

[0027] By adopting the above technical solution, sulfur in sulfur dioxide itself has a certain reducing property, and hydrogen is a gas with strong reducing property. Therefore, the above nanobubble water can further reduce the adverse effects of active oxygen in nanobubbles on the bioactivity of the extract.

[0028] Optionally, the preparation method of the acidic gas nanobubble water includes the following steps: acidic gas nanobubble water is prepared by using water and acidic gas as raw materials, and then left to stand for 2-3 days;

[0029] The preparation method of the non-oxidizing gas nanobubble water includes the following steps: non-oxidizing gas nanobubble water is prepared by using non-oxidizing gas and water as raw materials, and then left to stand for 7-10 days.

[0030] The acidic gas nanobubble water and the non-oxidizing gas nanobubble water are added at a volume ratio of 1:(0.4-0.6).

[0031] By employing the above technical solutions, acidic gas nanobubble water is prepared by standing for 2-3 days to obtain stable acidic gas nanobubble water; non-oxidizing gas nanobubble water is prepared by standing for 7-10 days to obtain stable non-oxidizing gas nanobubble water. This application utilizes stable acidic and non-oxidizing gas nanobubble water to further improve the extraction efficiency of Ganoderma lucidum's effective substances.

[0032] Optionally, salt is added to the original two-phase solvent along with the acidic gas nanobubble water, and the amount of salt added is 0.2-0.8 wt% of the original two-phase solvent.

[0033] By adopting the above technical solution, the addition of salt increases the amount of positive charge outside the bubbles formed by acidic gas to a certain extent, increases the repulsive force between bubbles, and makes the bubbles more stable. On the other hand, salt also acts as a partitioning agent, making the hydrophilic phase (i.e., the liquid phase in which the alcohol solution is located) of the two-liquid-phase system more hydrophilic, promoting the partitioning of hydrophilic substances in this phase, so as to further improve the extraction rate of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes.

[0034] Optionally, the salt is selected from any one or more of sodium salts, calcium salts, and aluminum salts.

[0035] Secondly, this application provides a preparation process for the above-mentioned traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy, using the following technical solution:

[0036] A preparation process for a traditional Chinese medicine composition for treating deficiency syndromes caused by post-illness, post-operative, radiotherapy, and chemotherapy involves mixing the Ganoderma lucidum extract and the ginseng powder according to a specified ratio.

[0037] Thirdly, this application provides an application of the above-mentioned traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy, using the following technical solution:

[0038] The traditional Chinese medicine composition is used in the preparation of drugs or health products, and the dosage form of the drugs or health products is selected from any one of capsules, tablets, granules, gels and suspensions.

[0039] Optionally, when the dosage form of the drug is a capsule, the preparation method of the drug includes the following steps: mixing Ganoderma lucidum extract and ginseng powder according to the specified ratio, drying, and mixing to obtain a solid mixture; filling the solid mixture into empty capsules to obtain the drug.

[0040] In summary, this application has the following beneficial effects:

[0041] 1. This application uses a "two-phase solvent + nano-bubble water" technology to extract Ganoderma lucidum extract, which significantly increases the content of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes in the extract. In this technology, the original two-phase solvent is used for extraction first, and then acidic gas nano-bubble water and non-oxidizing gas nano-bubble water are added sequentially to form a new two-phase extraction system. With the help of nano-bubbles, the extraction rate of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes is significantly improved at the same time.

[0042] 2. This application further optimizes the original two-phase extraction solvent and the modified two-phase solvent, so that the volume ratio of alcohol in the original alcohol solution is 70-80%, and the volume ratio of alcohol in the modified alcohol solution after adding acidic gas nano bubble water and non-oxidizing gas nano bubble water is 40-50%, so as to ensure that the extraction rate of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes is further improved with a lower amount of nano bubble water added.

[0043] 3. This application adds salt while adding acidic gas nanobubbles, in order to improve the extraction rate of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes by stabilizing the acidic gas nanobubbles. Detailed Implementation

[0044] The following detailed description of this application is provided in conjunction with the embodiments. It should be noted that: unless otherwise specified, the conditions in the following embodiments are performed under conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, the raw materials used in the following embodiments are all from commercially available sources.

[0045] This application uses Ganoderma lucidum fruiting bodies as an example to illustrate this solution, where the fruiting bodies are obtained through commercial sales.

[0046] Example

[0047] Example 1

[0048] A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy is obtained by mixing Ganoderma lucidum extract and ginseng powder in a weight ratio of 5:2.

[0049] The traditional Chinese medicine composition is dispersed in water to obtain a suspension.

[0050] Among them, ginseng powder is made by pulverizing dried ginseng to the micro-nano level, and then sieving it to obtain powder of 0.5-500μm, which can be used for later use.

[0051] The preparation method of Ganoderma lucidum extract is as follows:

[0052] Step 1, Grinding: Dry the fruiting body of Ganoderma lucidum, then grind it with a grinder to obtain Ganoderma lucidum powder.

[0053] Step 2, Extraction: Take 2.5g of Ganoderma lucidum powder, add 100mL of the original two-phase solvent, and extract at 100rpm for 2.5h at room temperature; add 43mL of non-oxidizing gas nano-bubble water to the two-phase solvent and continue extraction at 100rpm for 0.5h; then add 107mL of acidic gas nano-bubble water and continue extraction at 100rpm for 0.5h. The total amount of non-oxidizing gas nano-bubble water and acidic gas nano-bubble water added is 150mL, with a volume ratio of 1:0.5. After adding the two types of nano-bubble water, a modified two-phase solvent is obtained. This modified two-phase solvent is obtained by mixing petroleum ether and a modified alcohol solution, with a methanol content of 20Vol.%.

[0054] The original two-phase extraction solvent was prepared by mixing 65 mL of anhydrous methanol and 35 mL of water to obtain the original alcohol solution; and by mixing 66.7 mL of the original alcohol solution and 33.3 mL of petroleum ether to obtain the original two-phase solvent.

[0055] The preparation method of non-oxidizing gas nanobubble water is as follows: using nitrogen and water as raw materials, non-oxidizing gas nanobubble water is prepared using an ultra-micron bubble generator (produced by Yunnan Xiazhichun Environmental Protection Technology Co., Ltd., model XZCP-K-1.1), and can be used immediately after standing for 7 days.

[0056] The preparation method of acidic gas nanobubble water is as follows: acidic gas nanobubble water is prepared using water and carbon dioxide as raw materials and an ultra-micro bubble generator (produced by Yunnan Xiazhichun Environmental Protection Technology Co., Ltd., model XZCP-K-1.1). It can be used immediately after standing for 2 days.

[0057] Step 3, Collection: Collect the extract and concentrate it to a relative density of 1.30 (60℃) to obtain a thick paste. After drying the thick paste, you will get Ganoderma lucidum extract.

[0058] Example 2

[0059] A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy is obtained by mixing Ganoderma lucidum extract and ginseng powder in a weight ratio of 6.5:3.

[0060] After filling the traditional Chinese medicine composition into an empty capsule, a capsule-type drug is obtained.

[0061] Among them, ginseng powder is made by pulverizing dried ginseng to the micro-nano level, and then sieving it to obtain powder of 0.5-500μm, which can be used for later use.

[0062] The preparation method of Ganoderma lucidum extract is as follows:

[0063] Step 1, Grinding: Dry the fruiting body of Ganoderma lucidum, then grind it with a grinder to obtain Ganoderma lucidum powder.

[0064] Step 2, Extraction: Take 3.0g of Ganoderma lucidum powder, add 100mL of the original two-phase solvent, and extract at 150rpm for 2.0h at room temperature; add 33.3mL of non-oxidizing gas nano-bubble water to the two-phase solvent and continue extraction at 150rpm for 1.0h; then add 66.7mL of acidic gas nano-bubble water and continue extraction at 150rpm for 1.0h. The total amount of non-oxidizing gas nano-bubble water and acidic gas nano-bubble water added is 100mL, and the acidic gas nano-bubble water and non-oxidizing gas nano-bubble water are added at a volume ratio of 1:0.5. After adding the two types of nano-bubble water, a modified two-phase solvent is obtained. This modified two-phase solvent is obtained by mixing n-hexane and a modified alcohol solution, and the alcohol content in the modified alcohol solution is 35Vol.%.

[0065] The original two-phase extraction solvent was prepared as follows: 80 mL of anhydrous ethanol and 20 mL of water were mixed to obtain the original alcohol solution. 77.8 mL of the original alcohol solution was then mixed with 22.2 mL of n-hexane to obtain the original two-phase solvent.

[0066] The preparation method of non-oxidizing gas nanobubble water is as follows: using water and sulfur dioxide as raw materials, non-oxidizing gas nanobubble water is prepared using an ultra-micron bubble generator (produced by Yunnan Xiazhichun Environmental Protection Technology Co., Ltd., model XZCP-K-1.1), and can be used immediately after standing for 8.5 days.

[0067] The preparation method of acidic gas nano bubble water is as follows: using hydrogen and water as raw materials, acidic gas nano bubble water is prepared using an ultra-micro bubble generator (produced by Yunnan Xiazhichun Environmental Protection Technology Co., Ltd., model XZCP-K-1.1), and can be used immediately after standing for 2.5 days.

[0068] Step 3, Collection: Collect the extract and concentrate it to a relative density of 1.20 (60℃) to obtain a thick paste, which is the Ganoderma lucidum extract.

[0069] Example 3

[0070] A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy is obtained by mixing Ganoderma lucidum extract and ginseng powder in a weight ratio of 2:1.

[0071] After filling the traditional Chinese medicine composition into an empty capsule, a capsule-type drug is obtained.

[0072] Among them, ginseng powder is made by pulverizing dried ginseng to the micro-nano level, and then sieving it to obtain powder of 0.5-500μm, which can be used for later use.

[0073] The preparation method of Ganoderma lucidum extract is as follows:

[0074] Step 1, Grinding: Dry the fruiting body of Ganoderma lucidum, then grind it with a grinder to obtain Ganoderma lucidum powder.

[0075] Step 2, Extraction: Take 3.5g of Ganoderma lucidum powder, add 100mL of the original two-phase solvent, and extract at 200rpm for 1.5h at room temperature; add 25mL of non-oxidizing gas nano-bubble water to the two-phase solvent and continue extraction at 200rpm for 1.5h; then add 41.6mL of acidic gas nano-bubble water and continue extraction at 200rpm for 1.5h. The total amount of non-oxidizing gas nano-bubble water and acidic gas nano-bubble water added is 66.6mL, with a volume ratio of 1:0.6. After adding the two types of nano-bubble water, a modified two-phase solvent is obtained. This modified two-phase solvent is obtained by mixing chloroform and a modified alcohol solution, with the isopropanol content in the modified alcohol solution being 50Vol.%.

[0076] The original two-phase extraction solvent was prepared as follows: 90 mL of isopropanol and 10 mL of water were mixed to obtain the original alcohol solution. 83.3 mL of the original alcohol solution was then mixed with 16.7 mL of chloroform to obtain the original two-phase solvent.

[0077] The preparation method of non-oxidizing gas nanobubble water is as follows: using water and sulfur dioxide as raw materials, non-oxidizing gas nanobubble water is prepared using an ultra-micron bubble generator (produced by Yunnan Xiazhichun Environmental Protection Technology Co., Ltd., model XZCP-K-1.1), and can be used immediately after standing for 10 days.

[0078] The preparation method of acidic gas nanobubble water is as follows: using hydrogen and water as raw materials, acidic gas nanobubble water is prepared by an ultra-micro bubble generator (produced by Yunnan Xiazhichun Environmental Protection Technology Co., Ltd., model XZCP-K-1.1), and can be used immediately after standing for 3 days.

[0079] Step 3, Collection: Collect the extract and concentrate it to a relative density of 1.25 (60℃) to obtain a thick paste, which is the Ganoderma lucidum extract.

[0080] Example 4

[0081] The difference between this embodiment and Embodiment 2 lies in the different original two-phase solvents and the modified two-phase solvents, as detailed below:

[0082] A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, or radiotherapy and chemotherapy, with the specific components being the same as in Example 2. The preparation method of the capsule-type drug is the same as in Example 2.

[0083] The preparation method of Ganoderma lucidum extract is as follows:

[0084] Step 1, Grinding: The specific steps are the same as in Example 2, to obtain Ganoderma lucidum powder.

[0085] Step 2, Extraction: Take 3.0g of Ganoderma lucidum powder, add 100mL of the original two-phase solvent, and extract at 150rpm for 2.0h at room temperature; add 19.5mL of non-oxidizing gas nano-bubble water to the two-phase solvent and continue extraction at 150rpm for 1.0h; then add 38.9mL of acidic gas nano-bubble water and continue extraction at 150rpm for 1.0h. The total amount of non-oxidizing gas nano-bubble water and acidic gas nano-bubble water added is 58.4mL, and the acidic gas nano-bubble water and non-oxidizing gas nano-bubble water are added at a volume ratio of 1:0.5. After adding the two types of nano-bubble water, a modified two-phase solvent is obtained. This modified two-phase solvent is obtained by mixing n-hexane and a modified alcohol solution, and the alcohol content in the modified alcohol solution is 40Vol.%.

[0086] The original two-phase extraction solvent was prepared as follows: 70 mL of anhydrous ethanol and 30 mL of water were mixed to obtain the original alcohol solution. 77.8 mL of the original alcohol solution was then mixed with 22.2 mL of n-hexane to obtain the original two-phase solvent.

[0087] The preparation methods for non-oxidizing gas nanobubble water and acidic gas nanobubble water are the same as in Example 2.

[0088] Step 3, Collection: The specific steps are the same as in Example 2, to obtain Ganoderma lucidum extract.

[0089] Example 5

[0090] The difference between this embodiment and Embodiment 2 lies in the different original two-phase solvents and the modified two-phase solvents, as detailed below:

[0091] A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, or radiotherapy and chemotherapy, with the specific components being the same as in Example 2. The preparation method of the capsule-type drug is the same as in Example 2.

[0092] The preparation method of Ganoderma lucidum extract is as follows:

[0093] Step 1, Grinding: The specific steps are the same as in Example 2, to obtain Ganoderma lucidum powder.

[0094] Step 2, Extraction: Take 30g of Ganoderma lucidum powder, add 100mL of the original two-phase solvent, and extract at 150rpm for 2.0h at room temperature; add 17.3mL of non-oxidizing gas nano-bubble water to the two-phase solvent and continue extraction at 150rpm for 1.0h; then add 34.6mL of acidic gas nano-bubble water and continue extraction at 150rpm for 1.0h. The total amount of non-oxidizing gas nano-bubble water and acidic gas nano-bubble water added is 51.9mL, with a volume ratio of 1:0.5. After adding the two types of nano-bubble water, a modified two-phase solvent is obtained. This modified two-phase solvent is obtained by mixing n-hexane and a modified alcohol solution, with an alcohol content of 45Vol.%.

[0095] The original two-phase extraction solvent was prepared as follows: 75 mL of anhydrous ethanol and 25 mL of water were mixed to obtain the original alcohol solution. 77.8 mL of the original alcohol solution was then mixed with 22.2 mL of n-hexane to obtain the original two-phase solvent.

[0096] The preparation methods for non-oxidizing gas nanobubble water and acidic gas nanobubble water are the same as in Example 2.

[0097] Step 3, Collection: The specific steps are the same as in Example 2, to obtain Ganoderma lucidum extract.

[0098] Example 6

[0099] The difference between this embodiment and Embodiment 2 lies in the different original and modified two-phase solvents, as follows: A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, or radiotherapy and chemotherapy, with the same specific components as in Embodiment 2. The preparation method of the capsule-type drug is the same as in Embodiment 2.

[0100] The preparation method of Ganoderma lucidum extract is as follows:

[0101] Step 1, Grinding: The specific steps are the same as in Example 2, to obtain Ganoderma lucidum powder.

[0102] Step 2, Extraction: Take 3.0g of Ganoderma lucidum powder, add 100mL of the original two-phase solvent, and extract at 150rpm for 2.0h at room temperature; add 15.6mL of non-oxidizing gas nano-bubble water to the two-phase solvent and continue extraction at 150rpm for 1.0h; then add 31.1mL of acidic gas nano-bubble water and continue extraction at 150rpm for 1.0h. The total amount of non-oxidizing gas nano-bubble water and acidic gas nano-bubble water added is 46.7mL, with a volume ratio of 1:0.5. After adding the two types of nano-bubble water, a modified two-phase solvent is obtained. This modified two-phase solvent is obtained by mixing n-hexane and a modified alcohol solution, with an alcohol content of 50vol.%.

[0103] The original two-phase extraction solvent was prepared as follows: 80 mL of anhydrous ethanol and 20 mL of water were mixed to obtain the original alcohol solution. 77.8 mL of the original alcohol solution was then mixed with 22.2 mL of n-hexane to obtain the original two-phase solvent.

[0104] The preparation methods for non-oxidizing gas nanobubble water and acidic gas nanobubble water are the same as in Example 2.

[0105] Step 3, Collection: The specific steps are the same as in Example 2, to obtain Ganoderma lucidum extract.

[0106] Example 7

[0107] The difference between this embodiment and Embodiment 5 lies in the preparation methods of non-oxidizing gas nanobubble water and acidic gas nanobubble water, as detailed below:

[0108] In this embodiment, the preparation method of non-oxidizing gas nanobubble water is as follows: using water and sulfur dioxide as raw materials, non-oxidizing gas nanobubble water is prepared using an ultra-micron bubble generator (produced by Yunnan Xiazhichun Environmental Protection Technology Co., Ltd., model XZCP-K-1.1) and can be used immediately.

[0109] The preparation method of acidic gas nanobubble water is as follows: using hydrogen and water as raw materials, acidic gas nanobubble water is prepared using an ultra-micron bubble generator (produced by Yunnan Xiazhichun Environmental Protection Technology Co., Ltd., model XZCP-K-1.1) and then used immediately.

[0110] Examples 8-9

[0111] The difference between the following examples and Example 5 is that the proportions of acidic gas nanobubble water and non-oxidizing gas nanobubble water added are different, as detailed below:

[0112] In Example 8, the amount of non-oxidizing gas nanobubble water added was 8.6 mL, and the amount of acidic gas nanobubble water added was 43.3 mL; the total amount of non-oxidizing gas nanobubble water and acidic gas nanobubble water added was 51.9 mL, and the acidic gas nanobubble water and non-oxidizing gas nanobubble water were added at a volume ratio of 1:0.2.

[0113] In Example 9, the amount of non-oxidizing gas nanobubble water added was 23.1 mL, and the amount of acidic gas nanobubble water added was 28.8 mL; the total amount of non-oxidizing gas nanobubble water and acidic gas nanobubble water added was 51.9 mL, and the acidic gas nanobubble water and non-oxidizing gas nanobubble water were added at a volume ratio of 1:0.8.

[0114] Example 10

[0115] The difference between this embodiment and embodiment 5 is that sodium chloride is added along with acidic gas nanobubble water to the original two-phase solvent. The amount of sodium chloride added is 0.8 wt% of the original two-phase solvent.

[0116] Example 11

[0117] The difference between this embodiment and embodiment 5 is that, in addition to adding acidic gas nanobubble water to the original two-phase solvent, aluminum chloride is also added, and the amount of aluminum chloride added is 0.2 wt% of the original two-phase solvent.

[0118] Comparative Example 1

[0119] A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy, prepared by taking 295g of Ganoderma lucidum and 290g of ginseng.

[0120] The above-mentioned Ganoderma lucidum were extracted with water to obtain Ganoderma lucidum extract. The preparation method of Ganoderma lucidum extract is as follows: the fruiting body of Ganoderma lucidum was dried and pulverized, and decocted with 1L of water for 2 hours; then filtered, and 1L of water was added to the residue and decocted for 1.5 hours; then filtered again, and 1L of water was added to the residue and decocted for 1 hour; the decoctions extracted from the three decoctions were combined. The combined decoction was filtered, and the filtrate was concentrated to a clear extract with a relative density of 1.25 (60℃).

[0121] Wash all the ginseng thoroughly, chop it, dry it at 60℃, then grind it into powder and pass it through a 60-mesh sieve to obtain the final product.

[0122] After thoroughly mixing the ginseng powder and Ganoderma lucidum extract obtained above, the mixture is sieved and dried. The dried mixture is then filled into empty capsules to obtain the capsule-type drug.

[0123] Comparative Example 2

[0124] A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy, prepared by taking 505g of Ganoderma lucidum and 498g of ginseng.

[0125] All the above-mentioned Ganoderma lucidum were extracted with water to obtain Ganoderma lucidum extract. The preparation method of Ganoderma lucidum extract is as follows: the fruiting body of Ganoderma lucidum is dried and pulverized, and then decocted three times with water, with the specific steps being the same as in Comparative Example 1; the decoctions extracted from the three decoctions are combined. The combined decoction is filtered and the filtrate is concentrated to a clear extract with a relative density of 1.26 (60℃).

[0126] The ginseng was processed using the same method as in Comparative Example 1 to obtain ginseng powder.

[0127] After thoroughly mixing the ginseng powder and Ganoderma lucidum extract obtained above, the mixture is sieved and dried. The dried mixture is then filled into empty capsules to obtain the capsule-type drug.

[0128] Comparative Example

[0129] Comparative Example 1

[0130] The difference between this comparative example and Example 10 lies in step 2 of the preparation of the Ganoderma lucidum extract, as detailed below:

[0131] In this comparative example, the preparation method of Ganoderma lucidum extract is as follows:

[0132] Step 1, Grinding: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum powder.

[0133] Step 2, Extraction: Take 3.0 g of Ganoderma lucidum powder, add 100 mL of the original two-phase solvent, and extract at 150 rpm for 2.0 h at room temperature; add 17.3 mL of water to the two-phase solvent and continue extraction at 150 rpm for 1.0 h; then add 34.6 mL of water and continue extraction at 150 rpm for 1.0 h. After the two additions of water, the alcohol content in the alcohol solution is 45 Vol.%.

[0134] The preparation method of the original two-phase extraction solvent is the same as in Example 10.

[0135] Step 3, Collection: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum extract.

[0136] Comparative Example 2

[0137] The difference between this comparative example and Example 10 lies in step 2 of the preparation of the Ganoderma lucidum extract, as detailed below:

[0138] In this comparative example, the preparation method of Ganoderma lucidum extract is as follows:

[0139] Step 1, Grinding: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum powder.

[0140] Step 2, Extraction: Take 3.0g of Ganoderma lucidum powder, add 100mL of the original two-phase solvent, and extract at 150rpm for 2.0h at room temperature; add 17.3mL of non-oxidizing gas nano-bubble water to the two-phase solvent and continue extraction at 150rpm for 1.0h; then add 34.6mL of non-oxidizing gas nano-bubble water and continue extraction at 150rpm for 1.0h. The total amount of non-oxidizing gas nano-bubble water added is 51.9mL. After adding the non-oxidizing gas nano-bubble water, a modified two-phase solvent is obtained. This modified two-phase solvent is obtained by mixing n-hexane and a modified alcohol solution, with an alcohol content of 45Vol.%.

[0141] The original two-phase extraction solvent and the preparation method of non-oxidizing gas nanobubble water are the same as in Example 10.

[0142] Step 3, Collection: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum extract.

[0143] Comparative Example 3

[0144] The difference between this comparative example and Example 10 lies in step 2 of the preparation of the Ganoderma lucidum extract, as detailed below:

[0145] In this comparative example, the preparation method of Ganoderma lucidum extract is as follows:

[0146] Step 1, Grinding: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum powder.

[0147] Step 2, Extraction: Take 3.0g of Ganoderma lucidum powder, add 100mL of the original two-phase liquid solvent, and extract at 150rpm for 2.0h at room temperature; add 17.3mL of non-oxidizing gas nano-bubble water to the two-phase liquid solvent and continue extraction at 150rpm for 1.0h; then add 34.6mL of water and continue extraction at 150rpm for 1.0h. The total amount of non-oxidizing gas nano-bubble water and water added is 51.9mL. After addition, a modified two-phase liquid solvent is obtained, which is obtained by mixing n-hexane and a modified alcohol solution with an alcohol content of 45Vol.%.

[0148] The original two-phase extraction solvent and the preparation method of non-oxidizing gas nanobubble water are the same as in Example 10.

[0149] Step 3, Collection: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum extract.

[0150] Comparative Example 4

[0151] The difference between this comparative example and Example 10 lies in step 2 of the preparation of the Ganoderma lucidum extract, as detailed below:

[0152] In this comparative example, the preparation method of Ganoderma lucidum extract is as follows:

[0153] Step 1, Grinding: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum powder.

[0154] Step 2, Extraction: Take 3.0 g of Ganoderma lucidum powder, add 100 mL of the original two-phase liquid solvent, and extract at 150 rpm for 2.0 h at room temperature; add 17.3 mL of acidic gas nano-bubble water to the two-phase liquid solvent and continue extraction at 150 rpm for 1.0 h; then add 34.6 mL of acidic gas nano-bubble water and 0.8 wt% sodium chloride of the original two-phase liquid solvent and continue extraction at 150 rpm for 1.0 h. The total amount of acidic gas nano-bubble water added in both steps is 51.9 mL. After addition, a modified two-phase liquid solvent is obtained, which is obtained by mixing n-hexane and a modified alcohol solution with an alcohol content of 45 vol.%.

[0155] The preparation methods of the original two-phase extraction solvent and acidic gas nanobubble water are the same as in Example 10.

[0156] Step 3, Collection: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum extract.

[0157] Comparative Example 5

[0158] The difference between this comparative example and Example 10 lies in step 2 of the preparation of the Ganoderma lucidum extract, as detailed below:

[0159] In this comparative example, the preparation method of Ganoderma lucidum extract is as follows:

[0160] Step 1, Grinding: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum powder.

[0161] Step 2, Extraction: Take 3.0 g of Ganoderma lucidum powder, add 100 mL of the original two-phase liquid solvent, and extract at 150 rpm for 2.0 h at room temperature; add 17.3 mL of water to the two-phase liquid solvent and continue extraction at 150 rpm for 1.0 h; then add 34.6 mL of acidic gas nano-bubble water and 0.8 wt% sodium chloride of the original two-phase liquid solvent and continue extraction at 150 rpm for 1.0 h. The total amount of acidic gas nano-bubble water and water added is 51.9 mL. After addition, a modified two-phase liquid solvent is obtained, which is obtained by mixing n-hexane and a modified alcohol solution with an alcohol content of 45 vol.%.

[0162] The preparation methods of the original two-phase extraction solvent and acidic gas nanobubble water are the same as in Example 10.

[0163] Step 3, Collection: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum extract.

[0164] Comparative Example 6

[0165] The difference between this comparative example and Example 10 lies in step 2 of the preparation of the Ganoderma lucidum extract, as detailed below:

[0166] In this comparative example, the preparation method of Ganoderma lucidum extract is as follows:

[0167] Step 1, Grinding: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum powder.

[0168] Step 2, Extraction: Take 3.0g of Ganoderma lucidum powder, add 100mL of water at 85℃, and extract at 85℃ for 4.0h.

[0169] Step 3, Collection: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum extract.

[0170] Comparative Example 7

[0171] The difference between this comparative example and Example 10 lies in step 2 of the preparation of the Ganoderma lucidum extract, as detailed below:

[0172] In this comparative example, the preparation method of Ganoderma lucidum extract is as follows:

[0173] Step 1, Grinding: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum powder.

[0174] Step 2, Extraction: Take 3.0g of Ganoderma lucidum powder, add 100mL of water at 85℃, and extract in an 85℃ water bath for 2.0h; after cooling, add 17.3mL of non-oxidizing gas nano-bubble water and continue to extract by stirring at 150rpm for 1.0h; then add 34.6mL of acidic gas nano-bubble water and continue to extract by stirring at 150rpm for 1.0h.

[0175] The preparation methods for non-oxidizing gas nanobubble water and acidic gas nanobubble water are the same as in Example 10.

[0176] Step 3, Collection: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum extract.

[0177] Comparative Example 8

[0178] The difference between this comparative example and Example 10 lies in step 2 of the preparation of the Ganoderma lucidum extract, as detailed below:

[0179] In this comparative example, the preparation method of Ganoderma lucidum extract is as follows:

[0180] Step 1, Grinding: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum powder.

[0181] Step 2, Extraction: Take 3.0g of Ganoderma lucidum powder, add 100mL of 95% ethanol solution, and extract under pressure of 350MPa for 10min, then extract under normal pressure for 2.0h. The 95% ethanol solution is prepared by mixing 95mL of anhydrous ethanol and 5mL of water to obtain 100mL of 95% ethanol solution.

[0182] Step 3, Collection: The specific steps are the same as in Example 10, to obtain Ganoderma lucidum extract.

[0183] Performance testing

[0184] 1. Detection of Ganoderma lucidum polysaccharides in Ganoderma lucidum extract

[0185] The polysaccharide content of the obtained Ganoderma lucidum extract was determined by the phenol-sulfuric acid method. The specific method is as follows:

[0186] 1.1. Draw the standard curve

[0187] Prepare a 100 μg / mL glucose solution and dilute it with deionized water to create concentration gradients (10, 20, 30, 40, and 50 μg / mL). Then, add 0.5 mL of 6% phenol solution (g / mL) to each group, shake well, and then add 3 mL of concentrated sulfuric acid. Incubate the mixture in a humidified water bath at 30°C for 30 min. After the reaction, take 150 μL for detection, specifically measuring the absorbance at 490 nm using a microplate reader.

[0188] The resulting regression equation is: y1 = 0.10562 + 0.01594x1, R1 2 =0.9994; where x1 refers to the polysaccharide concentration (μg / mL) and y1 refers to the absorbance at 490nm.

[0189] 1.2 Detection of Ganoderma lucidum polysaccharides in Ganoderma lucidum extract

[0190] Ganoderma lucidum extract was diluted with water to a sugar content below 50 μg / mL, then 0.5 mL of phenol solution (phenol content 6 wt%) was added. After shaking and mixing, 3 mL of concentrated sulfuric acid was added, and the mixture was reacted in a constant humidity water bath at 30℃ for 30 min. After the reaction, 150 μL was taken for detection, specifically, absorbance was measured at 490 nm using an ELISA reader. The absorbance value was substituted into the regression equation obtained in 1.1 to calculate the polysaccharide concentration (μg / mL). Furthermore, the extraction rate (%) of Ganoderma lucidum polysaccharides was calculated based on the weight of the Ganoderma lucidum fruiting body. The formula for calculating the extraction rate of Ganoderma lucidum polysaccharides is shown below, and the specific results are shown in Table 1.

[0191] Ganoderma lucidum polysaccharide extraction rate (%) = (C1×V1 / m1)×100%;

[0192] Wherein, C1 refers to the concentration of Ganoderma lucidum polysaccharides (g / mL), V1 refers to the volume of Ganoderma lucidum extract after adding water (mL), and m1 refers to the weight of Ganoderma lucidum fruiting body (g).

[0193] Table 1. Extraction rate (%) of Ganoderma lucidum polysaccharides from different Ganoderma lucidum extracts

[0194]

[0195]

[0196] Comparing the data results of Examples 1-11 and Comparative Examples 1-7 in Table 1, it was found that the extraction method of this application can significantly increase the content of Ganoderma lucidum polysaccharides in Ganoderma lucidum extract.

[0197] The results of Examples 2 and 4-6 demonstrate that even with the addition of less nano-bubble water—specifically, a scheme where the volume percentage of alcohol in the original alcohol solution is 70-80%, and after adding nano-bubble water, the volume percentage of alcohol in the modified alcohol solution is 40-50%—a high-ganoderma lucidum polysaccharide extract can still be obtained. Therefore, from a cost perspective, this scheme is preferred in actual production. Furthermore, the scheme in Example 5, where the volume percentage of alcohol in the original alcohol solution is 75%, and after adding nano-bubble water, the volume percentage of alcohol in the modified alcohol solution is 45%, yields a relatively higher level of ganoderma lucidum polysaccharides. This may be because, in this system, the solvent causes a greater degree of damage to the ganoderma lucidum fruiting body cells, leading to the release of more polysaccharides from the cells, further increasing the solubility of the polysaccharides in the solvent.

[0198] Compared to Example 7, Example 7 adjusted the preparation methods of non-oxidizing gas nanobubble water and acidic gas nanobubble water. Specifically, unlike Example 2, the prepared non-oxidizing gas nanobubble water and acidic gas nanobubble water were not subjected to a standing treatment and were used directly. The results showed that the Ganoderma lucidum polysaccharide content in the Ganoderma lucidum extract obtained in Example 7 was reduced. This may be because the freshly prepared non-oxidizing gas nanobubble water and acidic gas nanobubble water have poor bubble stability, with many bubbles still aggregating, rising, and / or bursting. The average bubble size is large, and the surface energy is small, resulting in poor extraction of Ganoderma lucidum polysaccharides. Therefore, compared to Example 5, the Ganoderma lucidum polysaccharide content in the Ganoderma lucidum extract prepared in Example 7 was reduced.

[0199] Examples 5 and 8-9 investigated the effect of the addition ratio of acidic gas nanobubble water and non-oxidizing gas nanobubble water on the results. The results showed that the recommended volume ratio of acidic gas nanobubble water to non-oxidizing gas nanobubble water is 1:(0.4-0.6). Exceeding this ratio (Example 9) will adversely affect the extraction effect of Ganoderma lucidum polysaccharides. The bubbles in acidic gas nanobubble water are positively charged, exhibiting good adsorption for negatively charged substances such as intracellular phospholipids and polysaccharides (pectin, polyuronic acid, etc.), promoting their dissolution. Conversely, the bubbles in non-oxidizing gas nanobubble water are negatively charged, exhibiting good adsorption for intracellular proteins (membrane proteins, etc.), also promoting their dissolution. Therefore, it is necessary to control the addition ratio of acidic gas nanobubble water and non-oxidizing gas nanobubble water to regulate the dissolution capacity of substances on the cell membrane and cell wall, resulting in a higher degree of damage to Ganoderma lucidum cells and thus extracting more Ganoderma lucidum polysaccharides. However, in Example 8, because the cell wall and cell membrane contain different substances, even though the bubbles in the acidic gas nanobubble water have a good adsorption effect on pectin, other substances on the cell wall and cell membrane (phospholipids, proteins, etc.) will hinder the dissolution of polysaccharides. Therefore, the content of Ganoderma lucidum polysaccharides in the Ganoderma lucidum extract obtained in Example 8 is not high.

[0200] Examples 10 and 11 further investigated the effect of adding salt while adding acidic gas nanobubble water on the results. The results showed that adding different salts (sodium chloride in Example 10 and aluminum chloride in Example 11) could improve the extraction rate of Ganoderma lucidum polysaccharides to a certain extent.

[0201] In Comparative Example 1, using only a two-phase solvent to extract Ganoderma lucidum polysaccharides resulted in a significantly reduced extraction rate. Comparative Examples 2-5 explored the extraction effects of both two-phase solvents and a single type of nano-bubble water, finding that the extraction rates were significantly lower in both cases. This indicates that only extraction using a combination of two-phase solvents and two types of nano-bubble water can yield a high-polysaccharide extract. Comparative Example 6 used a conventional hydrothermal extraction method, achieving an extraction rate of only 0.75%. Comparative Example 7 further explored extraction using only a two-phase extractant, showing a significantly higher extraction rate compared to the conventional hydrothermal method, but still significantly lower than the extraction rates achieved in the example solutions.

[0202] 2. Detection of Ganoderma lucidum triterpenes

[0203] The polysaccharide content of the obtained Ganoderma lucidum extract was determined by the vanillin-ursolic acid-perchloric acid method. The specific method is as follows:

[0204] 2.1. Draw the standard curve

[0205] Prepare a 0.2 mg / mL ursolic acid solution by measuring 0.2 mL, 0.4 mL, 0.6 mL, 0.8 mL, and 1.0 mL of ursolic acid stock solution, and evaporate the solutions to dryness in a 100℃ water bath. Add 0.4 mL of freshly prepared 5% vanillin-glacial acetic acid solution (i.e., glacial acetic acid with a vanillin mass fraction of 5%) and 1.0 mL of perchloric acid. Heat in a 65℃ water bath for 15 min, then place in a cold water bath for 5 min. Add 5 mL of ethyl acetate and shake well. After standing for 15 min, measure the absorbance at a wavelength of 542 nm.

[0206] The resulting regression equation is: y² = 0.00621 + 0.0432x², R² 2 =0.9991; where x2 refers to the concentration of Ganoderma lucidum triterpenes (μg / mL) and y2 refers to the absorbance at 542nm.

[0207] 2.2 Detection of Ganoderma triterpenes in Ganoderma extract

[0208] The Ganoderma lucidum extract was diluted with water to an appropriate concentration. After evaporating the solvent, 0.4 mL of a freshly prepared 5% vanillin-glacial acetic acid solution (i.e., 5% vanillin by mass in glacial acetic acid) and 1.0 mL of perchloric acid were added. The mixture was heated in a 65°C water bath for 15 min, then placed in a cold water bath for 5 min. 5 mL of ethyl acetate was added and the mixture was shaken well. After standing for 15 min, the absorbance was measured at 542 nm. The absorbance value was substituted into the regression equation obtained in section 2.1 to calculate the concentration of Ganoderma lucidum triterpenes (μg / mL). Furthermore, the extraction rate (%) of Ganoderma lucidum triterpenes was calculated based on the weight of the Ganoderma lucidum fruiting body. The formula for calculating the extraction rate of Ganoderma lucidum triterpenes is shown below, and the specific results are shown in Table 2.

[0209] Ganoderma lucidum triterpenoid extraction rate (%) = (C2×V2 / m2)×100%;

[0210] Wherein, C2 refers to the concentration of Ganoderma triterpenes (g / mL), V2 refers to the volume of Ganoderma extract after adding water (mL), and m2 refers to the weight of Ganoderma fruiting body (g).

[0211] Table 2. Extraction rate (%) of Ganoderma triterpenes in different Ganoderma extracts

[0212]

[0213] Comparing the data results of Examples 1-11, Comparative Examples 1-5, and Comparative Example 8 in Table 1, it was found that the extraction method of this application can significantly increase the content of Ganoderma triterpenes in Ganoderma extract.

[0214] The results of Examples 2 and 4-6 show that "the volume percentage of alcohol in the original alcohol solution is 70-80%; after adding nano-bubble water, the volume percentage of alcohol in the modified alcohol solution is 40-50%." Even with a low total amount of nano-bubble water added, a Ganoderma lucidum extract with high levels of Ganoderma lucidum triterpenes can still be obtained. Therefore, from a cost perspective, this approach is preferred in actual production.

[0215] Compared to Example 7, Example 5 showed a higher content of ganoderic triterpenes in the Ganoderma lucidum extract prepared in Example 5. This may be because, as mentioned above, the bubbles in the freshly prepared nanobubble water have poor stability, a larger average particle size, and lower surface energy, which reduces their effectiveness in promoting the extraction of ganoderic triterpenes, thus leading to a decrease in the content of ganoderic triterpenes in the obtained Ganoderma lucidum extract.

[0216] Examples 5 and 8-9 investigated the effect of the addition ratio of acidic gas nanobubble water and non-oxidizing gas nanobubble water on the results. The results showed that the recommended volume ratio of acidic gas nanobubble water to non-oxidizing gas nanobubble water is 1:(0.4-0.6). Exceeding this ratio (Examples 8 and 9) will adversely affect the extraction effect of Ganoderma lucidum triterpenes. The specific reasons are as described above: the positively charged bubbles in the acidic gas nanobubble water have good adsorption properties for negatively charged substances in cells (such as phospholipids, pectin, polysaccharides, uronic acids, etc.), promoting the dissolution of these substances; while the negatively charged bubbles in the non-oxidizing gas nanobubble water have good adsorption properties for positively charged proteins in cells, promoting the dissolution of these substances. Therefore, by controlling the addition ratio of acidic gas nanobubble water and non-oxidizing gas nanobubble water, sufficient dissolution of substances on the cell membrane and cell wall can be achieved, thereby obtaining more Ganoderma lucidum triterpenes. When the ratio of acidic gas nanobubble water to non-oxidizing gas nanobubble water is not appropriate, it will affect the dissolution of a certain type of substance, resulting in a low extraction rate of Ganoderma lucidum triterpenes.

[0217] Examples 10 and 11 show that adding different salts (sodium chloride in Example 10 and aluminum chloride in Example 11) not only helps in the extraction of Ganoderma lucidum polysaccharides, but also increases the extraction rate of Ganoderma lucidum triterpenes.

[0218] In Comparative Example 1, using only a two-phase solvent to extract Ganoderma lucidum triterpenes resulted in a significantly reduced extraction rate. Comparative Examples 2-5 explored the extraction effects of both two-phase solvents and a single type of nano-bubble water, finding that the extraction rates were significantly lower in all cases. This indicates that only extraction using a combination of two-phase solvents and two types of nano-bubble water can yield a Ganoderma lucidum extract with a high Ganoderma lucidum triterpenes content. Comparative Example 8, using conventional high-pressure extraction with ethanol solution, achieved an extraction rate of only 0.15%.

[0219] This specific embodiment is merely an explanation of this application and is not intended to limit it. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they fall within the scope of the claims of this application.

Claims

1. A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, or radiotherapy and chemotherapy, characterized in that, The traditional Chinese medicine composition is made from the following components in parts by weight: 50-80 parts of Ganoderma lucidum extract, 20-40 parts of ginseng powder; The preparation method of the Ganoderma lucidum extract includes the following steps: Step 1, Grinding: Dry the fruiting body of Ganoderma lucidum, grind it into powder to obtain Ganoderma lucidum powder; Step 2, Extraction: Extract the obtained Ganoderma lucidum powder with the original two-phase solvent for 1.5-2.5h, add non-oxidizing gas nano-bubble water to the original two-phase solvent and extract for 0.5-1.5h, then add acidic gas nano-bubble water and extract for 0.5-1.5h. Step 3, Collection: The extract is collected, concentrated, dried, and then the Ganoderma lucidum extract is obtained. The original two-phase solvent is an original alcohol solution and a non-polar organic solvent, wherein the volume percentage of alcohol in the original alcohol solution is 65-90%; the volume ratio of the original alcohol solution to the non-polar organic solvent is (2-5):1; after adding acidic gas nanobubble water and non-oxidizing gas nanobubble water, a modified two-phase solvent is obtained, wherein the modified two-phase solvent includes a modified alcohol solution and a non-polar organic solvent, wherein the volume percentage of alcohol in the modified alcohol solution is 20-50%; The alcohol is selected from any one or more of methanol, ethanol, and propanol; the nonpolar solvent is selected from any one or more of n-hexane, petroleum ether, and chloroform. The acidic gas nanobubble water is selected from any one or two of carbon dioxide nanobubble water and sulfur dioxide nanobubble water; the non-oxidizing gas nanobubble water is selected from at least one of hydrogen nanobubble water and nitrogen nanobubble water. The acidic gas nanobubble water and the non-oxidizing gas nanobubble water are added at a volume ratio of 1:(0.4-0.6).

2. The traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy according to claim 1, characterized in that, The volume percentage of alcohol in the original alcohol solution is 70-80%; after adding the acidic gas nanobubble water and the non-oxidizing gas nanobubble water, the volume percentage of alcohol in the modified alcohol solution is 40-50%.

3. The traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy according to claim 1, characterized in that, The acidic gas nanobubble water is sulfur dioxide nanobubble water; the non-oxidizing gas nanobubble water is selected from hydrogen nanobubble water.

4. The traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, and chemotherapy according to claim 1, characterized in that, The preparation method of the acidic gas nanobubble water includes the following steps: acidic gas nanobubble water is prepared by using water and acidic gas as raw materials, and then left to stand for 2-3 days; The preparation method of the non-oxidizing gas nanobubble water includes the following steps: non-oxidizing gas nanobubble water is prepared by using non-oxidizing gas and water as raw materials, and then left to stand for 7-10 days.

5. A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, or chemotherapy according to claim 1, characterized in that, The acidic gas nanobubble water was added to the original two-phase solvent along with salt, the amount of salt added being 0.2-0.8 wt% of the original two-phase solvent.

6. A traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, radiotherapy, or chemotherapy according to claim 5, characterized in that, The salt is selected from at least one of sodium salts and calcium salts.

7. A preparation process of a traditional Chinese medicine composition for treating deficiency syndromes caused by illness, surgery, or radiotherapy / chemotherapy as described in any one of claims 1-6, characterized in that, The Ganoderma lucidum extract and the ginseng powder are mixed according to the specified ratio to obtain the final product.

8. The application of a traditional Chinese medicine composition according to any one of claims 1-6 for treating deficiency syndromes caused by illness, surgery, or radiotherapy and chemotherapy, characterized in that, The traditional Chinese medicine composition is used in the preparation of drugs or health products, and the dosage form of the drugs or health products is selected from any one of capsules, tablets, granules, gels and suspensions.

9. The application of the traditional Chinese medicine composition according to claim 8 for treating deficiency syndromes caused by post-illness, post-operative, or radiotherapy / chemotherapy conditions, characterized in that, When the dosage form of the drug is a capsule, the preparation method of the drug includes the following steps: filling the composition into an empty capsule to obtain the drug.

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