Traditional Chinese medicine composition, health wine containing traditional Chinese medicine composition and preparation method and application

Abstract

The application relates to the technical field of medicines, and provides a traditional Chinese medicine composition, a health-care wine containing the traditional Chinese medicine composition, and a preparation method and application of the traditional Chinese medicine composition. The raw material components of the traditional Chinese medicine composition contain, in parts by weight, 50-99 parts of wolfberry, 20-40 parts of Chinese yam, 15-27 parts of raspberry, 10-20 parts of asparagus, 10-20 parts of ophiopogon japonicus, 10-20 parts of longan arillus, 3-9 parts of yizhi, 3-9 parts of radix rehmanniae preparatae, 1-8 parts of radix codonopsis, 1-8 parts of spina date, 1-8 parts of angelica sinensis, 1-8 parts of cistanche, and 1-3 parts of radix ginseng. The components in the traditional Chinese medicine composition can produce significant synergistic effects, so that the traditional Chinese medicine composition has the effects of resisting aging, resisting fatigue, and enhancing male sexual function.

Description

Technical Field

[0001] This application relates to the field of pharmaceutical technology, and in particular to a traditional Chinese medicine composition, a health wine containing the traditional Chinese medicine composition, and its preparation method and application. Background Technology

[0002] Modern biological research indicates that the aging process is closely related to multiple molecular mechanisms, among which mitochondrial dysfunction and cellular energy metabolism disorders are considered core driving factors. As the cell's "energy factory," reduced mitochondrial activity leads to decreased adenine triphosphate (ATP, the "energy currency") production, resulting in decreased cell repair capacity, increased oxidative stress, and ultimately manifested as skin laxity, memory loss, and weakened motor skills. Currently, most anti-aging products on the market rely on single active ingredients, such as simply supplementing with resveratrol, which is insufficient to achieve a multi-target synergistic intervention in the aging mechanism. Furthermore, the fast pace of life and increasing pressure from various aspects have led to a sharp increase in the proportion of people in a sub-healthy state. Fatigue and decreased male sexual function are major manifestations of sub-health, representing a pre-disease state and a pathogenic signal. While existing drug treatments for fatigue and decreased male sexual function can be rapid and effective, the side effects, addiction, and dependence risks associated with conventional drug treatments greatly limit their clinical application. Currently, the components of various anti-aging and anti-fatigue drugs produce effects independently, resulting in single active ingredients and difficulty in regulating physiological functions through multiple pathways. Therefore, it is necessary to develop drugs that combine anti-aging, anti-fatigue, and enhancement of male sexual function, as well as health products that help with anti-oxidation and relieve physical fatigue. Summary of the Invention

[0003] The purpose of this application is to provide a traditional Chinese medicine composition, a health-enhancing wine containing the traditional Chinese medicine composition, a preparation method, and its application. The components of this traditional Chinese medicine composition exhibit significant synergistic effects, thereby possessing anti-aging, anti-fatigue, and male sexual function-enhancing effects. The specific technical solution is as follows:

[0004] The first aspect of this application provides a traditional Chinese medicine composition, wherein the raw material components of the traditional Chinese medicine composition, by weight, include: 50-99 parts by weight of wolfberry, 20-40 parts by weight of yam, 15-27 parts by weight of raspberry, 10-20 parts by weight of asparagus root, 10-20 parts by weight of ophiopogon root, 10-20 parts by weight of longan pulp, 3-9 parts by weight of alpinia oxyphylla, 3-9 parts by weight of rehmannia root, 1-8 parts by weight of codonopsis root, 1-8 parts by weight of jujube seed, 1-8 parts by weight of angelica root, 1-8 parts by weight of cistanche, and 1-3 parts by weight of ginseng.

[0005] In one embodiment of this application, the traditional Chinese medicine composition is made from the following raw material components in parts by weight: 50-99 parts by weight of wolfberry, 20-40 parts by weight of yam, 15-27 parts by weight of raspberry, 10-20 parts by weight of asparagus root, 10-20 parts by weight of ophiopogon root, 10-20 parts by weight of longan pulp, 3-9 parts by weight of alpinia oxyphylla, 3-9 parts by weight of prepared rehmannia root, 1-8 parts by weight of codonopsis root, 1-8 parts by weight of jujube seed, 1-8 parts by weight of angelica root, 1-8 parts by weight of cistanche, and 1-3 parts by weight of ginseng.

[0006] In one embodiment of this application, the raw material components of the traditional Chinese medicine composition, by weight, include: 63-80 parts by weight of wolfberry, 25-35 parts by weight of yam, 17-23 parts by weight of raspberry, 11-17 parts by weight of asparagus root, 11-17 parts by weight of ophiopogon root, 11-17 parts by weight of longan pulp, 3-8 parts by weight of alpinia oxyphylla, 3-8 parts by weight of rehmannia root, 2-5 parts by weight of codonopsis root, 2-5 parts by weight of jujube seed, 2-5 parts by weight of angelica root, 2-6 parts by weight of cistanche, and 1 part by weight of ginseng.

[0007] In one embodiment of this application, the traditional Chinese medicine composition is made from the following raw material components in parts by weight: 63-80 parts by weight of wolfberry, 25-35 parts by weight of yam, 17-23 parts by weight of raspberry, 11-17 parts by weight of asparagus root, 11-17 parts by weight of ophiopogon root, 11-17 parts by weight of longan pulp, 3-8 parts by weight of alpinia oxyphylla, 3-8 parts by weight of rehmannia root, 2-5 parts by weight of codonopsis root, 2-5 parts by weight of jujube seed, 2-5 parts by weight of angelica root, 2-6 parts by weight of cistanche, and 1 part by weight of ginseng.

[0008] In one embodiment of this application, the traditional Chinese medicine composition further includes a pharmaceutically acceptable carrier or excipient; preferably, the pharmaceutically acceptable carrier or excipient is selected from at least one of solvents, diluents, disintegrants, precipitation inhibitors, surfactants, flow aids, binders, lubricants, dispersants, suspending agents, isotonic agents, thickeners, emulsifiers, preservatives, stabilizers, hydrating agents, emulsification accelerators, buffers, absorbents, colorants, flavorings, sweeteners, ion exchangers, release agents, coating agents, flavoring agents, and antioxidants.

[0009] In one embodiment of this application, the traditional Chinese medicine composition is formulated as a pharmaceutically acceptable preparation; preferably, the pharmaceutically acceptable preparation is granules, decoction, powder, tablets, capsules, pills, emulsion, suspension, tincture, or alcohol.

[0010] The second aspect of this application provides a health-preserving wine, comprising wine and the traditional Chinese medicine composition provided in the first aspect of this application.

[0011] The third aspect of this application provides a method for preparing the health wine provided in the second aspect of this application, comprising the following steps:

[0012] 1) Weigh the raw material components, mix them evenly, and add the base wine for extraction;

[0013] 2) After extraction, the mixture is filtered to obtain the wine.

[0014] In one embodiment of this application, the preparation method further includes:

[0015] The wine was frozen at a low temperature of -7℃ to -15℃ for 22 to 26 hours.

[0016] Then, fine filtration is performed, and the mixture is left to stand at room temperature for 2 to 4 days. The alcohol content is adjusted, and then fine filtration is performed again to obtain the health wine. The filtration precision of the fine filtration is 0.2µm to 0.5µm.

[0017] The alcohol content of the health wine is 36°~52°.

[0018] In one embodiment of this application, the base liquor has an alcohol content of 50°~60°, and the total mass of the raw material components to the volume ratio of the base liquor is (109~313) g: 1L; the extraction includes closed extraction for 20 to 23 days, with daily circulation for uniform extraction.

[0019] In one embodiment of this application, in step 2), the filtration accuracy is 50µm~180µm.

[0020] The fourth aspect of this application provides the use of the traditional Chinese medicine composition provided in the first aspect of this application in the preparation of medicaments for anti-aging, anti-fatigue, or improving male sexual function.

[0021] The fifth aspect of this application provides the use of the traditional Chinese medicine composition provided in the first aspect of this application in the preparation of health products that help with anti-oxidation and relieve physical fatigue.

[0022] In one embodiment of this application, the health product includes health wine.

[0023] The beneficial effects of this application are:

[0024] This application provides a traditional Chinese medicine composition, a health wine containing the traditional Chinese medicine composition, and its preparation method and application. By using wolfberry, yam, raspberry, asparagus, ophiopogon japonicus, longan pulp, alpinia oxyphylla, rehmannia glutinosa, codonopsis pilosula, jujube seed, angelica sinensis, cistanche deserticola, and ginseng as raw material components, and controlling the amount of each component within the scope of this application, the traditional Chinese medicine composition prepared can produce a significant synergistic effect among the components, thereby having anti-aging, anti-fatigue, and male sexual function enhancement effects.

[0025] Of course, implementing any product or method of this application does not necessarily require achieving all of the advantages described above at the same time. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other embodiments can be obtained based on these accompanying drawings.

[0027] Figure 1 This is a graph showing the results of zebrafish telomerase activity after different sample treatments in an anti-aging experiment.

[0028] Figure 2 The movement trajectory of zebrafish after different sample treatments in the anti-fatigue efficacy test;

[0029] Figure 3 Figure showing the results of zebrafish sperm count after different sample treatments in an experiment to improve male sexual function. Detailed Implementation

[0030] The technical solutions of this application will be clearly and completely described below with reference to the embodiments and accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. All other embodiments obtained by those skilled in the art based on this application are within the scope of protection of this application.

[0031] The first aspect of this application provides a traditional Chinese medicine composition, the raw material components of which, by weight, include: 50-99 parts by weight of wolfberry, 20-40 parts by weight of yam, 15-27 parts by weight of raspberry, 10-20 parts by weight of asparagus root, 10-20 parts by weight of ophiopogon root, 10-20 parts by weight of longan pulp, 3-9 parts by weight of alpinia oxyphylla, 3-9 parts by weight of prepared rehmannia root, 1-8 parts by weight of codonopsis root, 1-8 parts by weight of jujube seed, 1-8 parts by weight of angelica root, 1-8 parts by weight of cistanche, and 1-3 parts by weight of ginseng. For example, wolfberries can be in the range of 50, 60, 63, 70, 80, 90, or 99 parts by weight, or any two of these values; yam can be in the range of 20, 25, 30, 35, or 40 parts by weight, or any two of these values; raspberries can be in the range of 15, 17, 20, 23, or 27 parts by weight, or any two of these values; asparagus can be in the range of 10, 11, 15, 17, or 20 parts by weight, or any two of these values; ophiopogon japonicus can be in the range of 10, 11, 15, 17, or 20 parts by weight, or any two of these values; longan pulp can be in the range of 10, 11, 15, 17, or 20 parts by weight, or any two of these values. The range of values ​​is as follows: Alpinia oxyphylla can be 3 parts by weight, 6 parts by weight, 8 parts by weight, 9 parts by weight, or any two of these values; Rehmannia glutinosa can be 3 parts by weight, 6 parts by weight, 8 parts by weight, 9 parts by weight, or any two of these values; Codonopsis pilosula can be 1 part by weight, 2 parts by weight, 3 parts by weight, 5 parts by weight, 8 parts by weight, or any two of these values; Ziziphus jujuba var. spinosa can be 1 part by weight, 2 parts by weight, 3 parts by weight, 5 parts by weight, 8 parts by weight, or any two of these values; Angelica sinensis can be 1 part by weight, 2 parts by weight, 3 parts by weight, 5 parts by weight, 8 parts by weight, or any two of these values; Cistanche deserticola can be 1 part by weight, 2 parts by weight, 3 parts by weight, 5 parts by weight, 6 parts by weight, 8 parts by weight, or any two of these values; Panax ginseng can be 1 part by weight, 2 parts by weight, 3 parts by weight, or any two of these values.In the traditional Chinese medicine composition provided in this application, wolfberry, yam, and raspberry are the principal herbs, which tonify the kidneys and replenish essence, strengthen tendons and bones, and focus on tonifying kidney qi and consolidating kidney essence. Codonopsis and ginseng are used together to tonify the middle and replenish qi. Asparagus nourishes yin and moistens dryness, clears heat and generates fluids. Rehmannia and longan are used together to nourish yin and replenish blood, nourish blood and calm the mind, and are the assistant herbs. These five assistant herbs tonify qi, nourish yin and generate fluids, and focus on replenishing kidney yin, while also nourishing heart and lung qi and yin. Cistanche and Alpinia oxyphylla warm the kidneys and consolidate essence, and supplement the kidney yang tonification effect, and are also assistant herbs. The ten principal and assistant herbs are used together to tonify both kidney yin and kidney yang, consolidate kidney essence, and also benefit the body, strengthen the brain and improve intelligence, and tonify kidney qi and liver blood. Angelica sinensis invigorates blood and can prevent the principal and assistant herbs from stagnating blood, and is the adjuvant herb. Ophiopogon japonicus strengthens the yin-nourishing effect and is the adjuvant herb. Ziziphus jujuba nourishes blood and calms the mind, and assists ginseng in calming the mind and improving intelligence, and is the adjuvant guiding herb.

[0032] The inventors discovered that a traditional Chinese medicine composition made from wolfberry, yam, raspberry, asparagus root, ophiopogon root, longan pulp, alpinia oxyphylla, rehmannia root, codonopsis root, jujube seed, angelica root, cistanche, and ginseng can exhibit significant synergistic effects among its components, thereby exerting good anti-aging, anti-fatigue, and male sexual function enhancement effects.

[0033] The raw materials used in this application, such as wolfberry, yam, raspberry, asparagus root, ophiopogon root, longan pulp, alpinia oxyphylla, rehmannia root, codonopsis root, jujube seed, angelica root, cistanche and ginseng, can all be purchased.

[0034] In one embodiment of this application, the traditional Chinese medicine composition is made from the following raw material components in parts by weight: 50-99 parts by weight of wolfberry, 20-40 parts by weight of yam, 15-27 parts by weight of raspberry, 10-20 parts by weight of asparagus root, 10-20 parts by weight of ophiopogon root, 10-20 parts by weight of longan pulp, 3-9 parts by weight of alpinia oxyphylla, 3-9 parts by weight of prepared rehmannia root, 1-8 parts by weight of codonopsis root, 1-8 parts by weight of jujube seed, 1-8 parts by weight of angelica root, 1-8 parts by weight of cistanche, and 1-3 parts by weight of ginseng.

[0035] In one embodiment of this application, the raw material components of the traditional Chinese medicine composition, by weight, include: 63-80 parts by weight of wolfberry, 25-35 parts by weight of yam, 17-23 parts by weight of raspberry, 11-17 parts by weight of asparagus root, 11-17 parts by weight of ophiopogon root, 11-17 parts by weight of longan pulp, 3-8 parts by weight of alpinia oxyphylla, 3-8 parts by weight of rehmannia root, 2-5 parts by weight of codonopsis root, 2-5 parts by weight of jujube seed, 2-5 parts by weight of angelica root, 2-6 parts by weight of cistanche, and 1 part by weight of ginseng. Adjusting the raw material components of the traditional Chinese medicine composition within this range can further enhance its anti-aging, anti-fatigue, and male sexual function-enhancing effects.

[0036] In one embodiment of this application, the traditional Chinese medicine composition is made from the following raw material components in parts by weight: 63-80 parts by weight of wolfberry, 25-35 parts by weight of yam, 17-23 parts by weight of raspberry, 11-17 parts by weight of asparagus root, 11-17 parts by weight of ophiopogon root, 11-17 parts by weight of longan pulp, 3-8 parts by weight of alpinia oxyphylla, 3-8 parts by weight of rehmannia root, 2-5 parts by weight of codonopsis root, 2-5 parts by weight of jujube seed, 2-5 parts by weight of angelica root, 2-6 parts by weight of cistanche, and 1 part by weight of ginseng.

[0037] In one embodiment of this application, the raw material components of the traditional Chinese medicine composition, by weight, include: 75 parts by weight of wolfberry, 30 parts by weight of yam, 20 parts by weight of raspberry, 15 parts by weight of asparagus root, 15 parts by weight of ophiopogon root, 15 parts by weight of longan pulp, 5 parts by weight of alpinia oxyphylla, 5 parts by weight of rehmannia root, 3 parts by weight of codonopsis root, 3 parts by weight of jujube seed, 3 parts by weight of angelica root, 3 parts by weight of cistanche, and 1 part by weight of ginseng. Adjusting the raw material components of the traditional Chinese medicine composition within this range can further enhance its anti-aging, anti-fatigue, and male sexual function-enhancing effects.

[0038] In one embodiment of this application, the traditional Chinese medicine composition further includes a pharmaceutically acceptable carrier or excipient; preferably, the pharmaceutically acceptable carrier or excipient is selected from at least one of solvents, diluents, disintegrants, precipitation inhibitors, surfactants, flow aids, binders, lubricants, dispersants, suspending agents, isotonic agents, thickeners, emulsifiers, preservatives, stabilizers, hydrating agents, emulsification accelerators, buffers, absorbents, colorants, flavorings, sweeteners, ion exchangers, release agents, coating agents, flavoring agents, and antioxidants.

[0039] In one embodiment of this application, the traditional Chinese medicine composition is formulated as a pharmaceutically acceptable preparation; preferably, the pharmaceutically acceptable preparation is granules, decoction, powder, tablets, capsules, pills, emulsion, suspension, tincture, or alcohol.

[0040] Those skilled in the art will understand that the weight proportions of the aforementioned Chinese medicinal materials are relative, and the amount of one or more of the medicinal materials can be reasonably adjusted based on traditional Chinese medicine theory and actual needs. All obvious variations of such reasonably adjusted formulations are within the scope of this application.

[0041] The second aspect of this application provides a health-preserving wine, comprising wine and the traditional Chinese medicine composition provided in the first aspect of this application.

[0042] The third aspect of this application provides a method for preparing the health wine provided in the second aspect of this application, comprising the following steps:

[0043] 1) Weigh the raw material components, mix them evenly, and add the base wine for extraction;

[0044] 2) After extraction, the mixture is filtered to obtain the wine.

[0045] In one embodiment of this application, the preparation method further includes:

[0046] The wine was frozen at a low temperature of -7℃ to -15℃ for 22 to 26 hours.

[0047] Then, fine filtration is performed, and the mixture is left to stand at room temperature for 2 to 4 days. The alcohol content is adjusted, and then fine filtration is performed again to obtain the health wine. The filtration precision of the fine filtration is 0.2µm to 0.5µm.

[0048] The alcohol content of the health wine is 36°~52°.

[0049] For example, the freezing temperature can be -7℃, -8℃, -10℃, -12℃, -15℃, or any two of these values; the freezing time can be 22h, 23h, 24h, 25h, 26h, or any two of these values; the room temperature settling time can be 2 days, 3 days, 4 days, or any two of these values; the filtration precision of the fine filtration can be 0.2µm, 0.3µm, 0.4µm, 0.5µm, or any two of these values; and the alcohol content of the health wine can be 36°, 42°, 52°, or any two of these values.

[0050] In one embodiment of this application, the base liquor has an alcohol content of 50°~60°, and the total mass ratio of the raw material components to the volume ratio of the base liquor is (109~313) g:1L, preferably (150~250) g:1L, more preferably (180~200) g:1L. For example, the total mass ratio of the raw material components to the volume ratio of the base liquor can be 109g:1L, 150g:1L, 180g:1L, 200g:1L, 250g:1L, 313g:1L, or any two of these values. This application controls the amount of base liquor within the above range, which is beneficial for better extraction of the effective components in the raw materials.

[0051] In one embodiment of this application, the extraction includes a closed extraction for 20 to 23 days, with daily circulation for uniform extraction. For example, the extraction period can be 20 days, 21 days, 22 days, 23 days, or a range of any two of these values.

[0052] In this application, uniform circulation can be achieved by opening the bottom outlet valve and the top return valve of the extraction tank, starting the circulation pump, drawing out the wine from the bottom of the tank, and spraying it back from the top of the tank through a pipeline, forming a closed-loop circulation of bottom-out and top-back, driving the overall flow of the wine inside the tank. For example, circulation can be performed twice a day, each time lasting 10-30 minutes. In this application, uniform circulation can also be achieved by shaking.

[0053] In this application, the base liquor is selected from fermented baijiu and contains 50-60 wt% ethanol, 38-48 wt% water, and 1-2 wt% trace flavor substances (lipids, acids, etc.).

[0054] In this application, the temperature range of "normal temperature" is 20~30℃.

[0055] In this application, the alcohol content can be adjusted as needed. For example, when the base wine has an alcohol content of 52°, take 1 part of the finely filtered extract, add about 0.24 parts of purified water, circulate it thoroughly and let it stand, and you will get the target alcohol content of 42°±1°.

[0056] In one embodiment of this application, in step 2), the filtration accuracy is 50µm to 180µm. For example, the filtration accuracy can be 50µm, 80µm, 100µm, 150µm, 180µm, or a range consisting of any two of these values.

[0057] The fourth aspect of this application provides the use of the traditional Chinese medicine composition provided in the first aspect of this application in the preparation of medicaments for anti-aging, anti-fatigue, or improving male sexual function.

[0058] The fifth aspect of this application provides the use of the traditional Chinese medicine composition provided in the first aspect of this application in the preparation of health products that help with anti-oxidation and relieve physical fatigue.

[0059] In one embodiment of this application, the health product includes health wine.

[0060] The "health products" in this application may also exist or be provided in the form of functional foods, food, food additives, etc.

[0061] The sixth aspect of this application provides the use of the health wine provided in the second aspect of this application or the health wine prepared according to the preparation method provided in the third aspect of this application in the preparation of health products that help with anti-oxidation and relieve physical fatigue.

[0062] Those skilled in the art will understand that, based on the description herein, the applicable active extracts and preparations of traditional Chinese medicines used in this application can be prepared using appropriate traditional Chinese medicinal materials, alone or in mixtures thereof, through conventional methods of pulverization, extraction, and separation in the art, such as soaking, percolation, liquid-liquid extraction, water extraction with alcohol precipitation, alcohol extraction with water precipitation, and dialysis. Alternatively, one or more active extracts of the traditional Chinese medicines used in this application can be purchased commercially and then combined with extracts of other traditional Chinese medicines to obtain the active extracts of traditional Chinese medicines used in this application. These variations of traditional Chinese medicine compositions and preparations are all within the scope of this application.

[0063] All drugs involved in this application, except for ginseng, are traditional Chinese medicine raw materials listed in the "List of Substances That Are Traditionally Both Food and Chinese Medicinal Materials" (including newly added varieties in 2024) published by the State, and have no toxic side effects. Ginseng is a new food raw material as specified in the "Announcement on Approving Ginseng (Artificial Cultivation) as a New Resource Food," which stipulates that it has no toxic side effects within the prescribed dosage range.

[0064] The health tonic and pharmaceutical preparations of this application can be formulated in unit dose form. The term "unit dose form" means a physically dispersed unit suitable for use as a unit dose for human subjects and other mammals, each unit containing a predetermined amount of the health tonic, pharmaceutical preparation of this application, and suitable pharmaceutically acceptable excipients calculated to produce the desired therapeutic effect.

[0065] The actual dosage level and administration time of the traditional Chinese medicine composition or the active ingredient in the traditional Chinese medicine composition of this application can be adaptively changed so that the amount of the active ingredient can effectively achieve the desired therapeutic response for a specific test individual, composition and administration method, without toxicity to the test individual.

[0066] Unless otherwise specified or defined, the terms used in this application shall have their general meanings known to those skilled in the art.

[0067] Example

[0068] The embodiments and comparative examples provided below illustrate the implementation of this application in more detail. Various tests and evaluations were conducted according to the methods described below. Furthermore, unless otherwise specified, "parts" and "%" are quality standards.

[0069] Example 1

[0070] 1) Weigh the following raw materials separately: 75g of wolfberry, 30g of yam, 20g of raspberry, 15g of asparagus root, 15g of ophiopogon root, 15g of longan pulp, 5g of alpinia oxyphylla, 5g of rehmannia root, 3g of codonopsis root, 3g of jujube seed, 3g of angelica root, 3g of cistanche, and 1g of ginseng (artificially cultivated for less than 5 years). Mix them evenly. Add 1L of baijiu (52°) for extraction (the total mass of the raw materials: the volume ratio of the base liquor is 193g:1L). Seal and extract for 21 days. During this period, shake the liquor daily to ensure even circulation, once in the morning and once in the afternoon, for 10-30 minutes each time.

[0071] 2) After the maceration period, the wine is coarsely filtered at room temperature with a filtration precision of 100µm to obtain coarsely filtered wine.

[0072] 3) Freeze the coarsely filtered wine at -10℃ for 24 hours;

[0073] 4) After freezing, the wine is finely filtered with a precision of 0.35µm to obtain finely filtered wine. The finely filtered wine is left to stand at room temperature for 3 days, and the alcohol content is adjusted. After mixing evenly, it is finely filtered again with a precision of 0.35µm to obtain a health wine with an alcohol content of 48°.

[0074] Examples 2-5, Comparative Examples 1-16

[0075] Except for adjusting the dosage of each raw material component or the selection of medicinal ingredients as shown in Table 1, the rest is the same as in Example 1; wherein, in Comparative Example 14, wolfberry is replaced with privet fruit; in Comparative Example 15, yam is replaced with poria cocos; and in Comparative Example 16, raspberry is replaced with mulberry.

[0076] Table 1. Raw material components of each embodiment and comparative example

[0077] The following zebrafish efficacy test will illustrate that the health tonics in the various embodiments and comparative examples of this application have anti-aging, anti-fatigue, and male sexual function-improving effects.

[0078] I. Anti-aging efficacy test

[0079] 1. Sample preparation

[0080] The health wine stock solution prepared by taking the examples and comparative examples of this application can be used directly.

[0081] Positive control: Resveratrol, white powder, batch number F2121344, Shanghai Aladdin Biochemical Technology Co., Ltd., solvent is dimethyl sulfoxide (DMSO).

[0082] 2. Laboratory animals

[0083] Zebrafish were raised in aquarium water at 28℃ (water quality: 200 mg of readily soluble sea salt added per 1 L of reverse osmosis water, conductivity 450~550 μS / cm; pH 6.5~8.5; hardness 50~100 mg / L CaCO3), provided by the applicant's aquarium breeding center. The laboratory animal use license number is: SYXK (Zhejiang) 2022-0004. The husbandry and management met the requirements of international AAALAC certification (certification number: 001458), and the IACUC ethics review number is: IACUC-2024-10521-01.

[0084] 3. Instruments, consumables and reagents

[0085] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, USA); 6-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China); Fully automated rapid sample grinder (JXFSTPRP-24L, Shanghai Jingxin Laboratory Equipment Technology Department, China); High-speed refrigerated centrifuge (Heraeus Fresco17, ThermoFisher, Germany); Multifunctional microplate reader (SPARK, TECAN, Austria); 96-well plate (Nest Biotech, China).

[0086] Hydrogen peroxide solution (batch number G2023089, Shanghai Aladdin Biochemical Technology Co., Ltd., China); dimethyl sulfoxide (DMSO, batch number BCCD8942, Sigma, Switzerland); Zebra fish TE ELISA KIT (telomerase activity kit, batch number 202410, Shanghai Hengyuan Biotechnology Co., Ltd., China).

[0087] 4. Testing methods and results

[0088] (1) Maximum Detection Concentration (MTC)

[0089] Wild-type AB strain zebrafish, 6 hours post-fertilization (6 hpf), were randomly selected and encapsulated in 6-well plates, with 30 zebrafish treated in each well. The samples were administered in water (concentrations shown in Table 2). A normal control group and a model control group were also included, with a volume of 3 mL per well. Except for the normal control group, all other groups were treated with water-soluble hydrogen peroxide to establish a zebrafish aging model, with the medium changed daily. After 6 days of treatment at 28℃, the MTC of the samples in the model zebrafish was measured.

[0090] The experimental results are shown in Table 2.

[0091] Table 2 Results of the concentration exploration experiment for anti-aging efficacy of samples (n=30)

[0092] Note: "-" indicates that it does not exist or is not shown.

[0093] Under the above experimental conditions, the MTC of the zebrafish used in the health wine prepared in Example 1 of this application for anti-aging effects was 15.6 μL / mL.

[0094] (2) Evaluation of anti-aging efficacy (telomerase activity)

[0095] Six hpf wild-type AB strain zebrafish were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well. Samples were administered via water-soluble solution (concentrations shown in Table 3). A positive control of resveratrol at a concentration of 20.0 μg / mL was used. Normal control and model control groups were also included. Each well contained 3 mL of sample. Except for the normal control group, all other groups were treated with water-soluble hydrogen peroxide to establish a zebrafish aging model. The medium was changed daily, and the experiment was repeated three times. After 6 days of treatment at 28℃, zebrafish samples were collected from each experimental group. Telomerase activity was detected using a telomerase activity kit to evaluate the anti-aging efficacy of the samples. Statistical results are expressed as mean ± SE. Statistical analysis was performed using statistical software; p < 0.05 indicated statistical significance. Experimental results are shown in Table 3 and... Figure 1 As shown.

[0096] Table 3. Experimental results evaluating the anti-aging efficacy of the samples (n=3)

[0097] Note: Compared with the model control group, "-" indicates that it does not exist or is not shown.

[0098] The results above show that the health tonics prepared in the embodiments of this application all have good anti-aging effects. Comparison of the results of Examples 1-5 and Comparative Examples 1-16 reveals that when some raw material components of the health tonics are not within the scope of this application, the telomerase activity of zebrafish is significantly reduced, indicating a weakened anti-aging effect. These results demonstrate that the components in the traditional Chinese medicine composition provided in this application can produce a significant synergistic effect, thereby achieving the purpose of anti-aging.

[0099] II. Anti-fatigue efficacy test

[0100] 1. Sample preparation information

[0101] The health wine stock solution prepared by taking the examples and comparative examples of this application can be used directly.

[0102] 2. Laboratory animals

[0103] Zebrafish were raised in aquarium water at 28℃ (water quality: 200 mg of readily soluble sea salt added per 1 L of reverse osmosis water, conductivity 450~550 μS / cm; pH 6.5~8.5; hardness 50~100 mg / L CaCO3), provided by the applicant's aquarium breeding center. The laboratory animal use license number is: SYXK (Zhejiang) 2022-0004. The husbandry and management met the requirements of international AAALAC certification (certification number: 001458), and the IACUC ethics review number is: IACUC-2024-10521-01.

[0104] 3. Instruments, consumables and reagents

[0105] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, USA); 6-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China); 96-well plate (Nest Biotech, China); Behavioral analyzer (Zebra Lab 3.22.3.31, Viewpoint, France); Multifunctional microplate reader (SPARK, TECAN, Austria); 96-well microplate (Costar, China).

[0106] Anhydrous sodium sulfite (batch number I1428128, Shanghai Aladdin Biochemical Technology Co., Ltd., China).

[0107] 4. Detection methods and results

[0108] 4.1. MTC

[0109] Wild-type AB strain zebrafish, 4 days post-fertilization (4 dpf), were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). Water-soluble samples were administered (concentrations shown in Table 4), and a normal control group and a model control group were also included, with a volume of 3 mL per well. After treatment at 28℃ for 1 day, except for the normal control group, all other experimental groups were given anhydrous sodium sulfite to establish a zebrafish fatigue model. Treatment continued at 28℃ for another 1 h, and the MTC of the samples on the model zebrafish was measured.

[0110] The experimental results are shown in Table 4.

[0111] Table 4 Results of the concentration exploration experiment on the anti-fatigue efficacy of samples at different concentrations (n=30)

[0112] Note: "-" indicates that it does not exist.

[0113] Under the above experimental conditions, the MTC of the zebrafish used to prepare the health wine in Example 1 of this application for combating fatigue was 15.6 μL / mL.

[0114] 4.2. Evaluation of anti-fatigue efficacy (total exercise distance)

[0115] Wild-type AB strain zebrafish (4 dpf) were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). Samples were administered in water (concentrations shown in Table 5). A normal control group and a model control group were established, with a volume of 3 mL per well. After treatment at 28℃ for 1 day, except for the normal control group, all other experimental groups were given anhydrous sodium sulfite in water to establish a zebrafish fatigue model. After further treatment at 28℃ for 1 h, 10 zebrafish from each experimental group were randomly selected and placed in 96-well plates. The total movement distance of the zebrafish was measured using a behavior analyzer. The anti-fatigue efficacy of the samples was evaluated based on the statistical analysis results of this index. Statistical results are expressed as mean ± SE. Statistical analysis was performed using statistical software, and p < 0.05 was considered statistically significant.

[0116] The experimental results are shown in Table 5. Figure 2 As shown. Among them, Figure 2 The black line represents the distance traveled at slow speed, the green line represents the distance traveled at medium speed, and the red line represents the distance traveled at fast speed.

[0117] Table 5. Experimental results of the anti-fatigue efficacy evaluation of the samples (n=10)

[0118] Note: Compared with the model control group, ; "-" indicates that it does not exist.

[0119] As shown in Table 5, the health tonics prepared in the embodiments of this application all have anti-fatigue effects, specifically by increasing the total movement distance. Comparison of the results of Examples 1-5 and Comparative Examples 1-16 reveals that when some raw material components of the health tonics are not within the scope of this application, the total movement distance of the zebrafish is shortened to varying degrees, indicating a weakening of the anti-fatigue effect. The above results indicate that the components in the traditional Chinese medicine composition provided in this application can produce a significant synergistic effect, thereby achieving the purpose of anti-fatigue.

[0120] III. Efficacy Trial for Improving Male Sexual Function

[0121] 1. Sample preparation information

[0122] The health wine stock solution prepared by taking the examples and comparative examples of this application can be used directly.

[0123] 2. Laboratory animals

[0124] Zebrafish were raised in aquarium water at 28℃ (water quality: 200 mg of readily soluble sea salt added per 1 L of reverse osmosis water, conductivity 450~550 μS / cm; pH 6.5~8.5; hardness 50~100 mg / L CaCO3), provided by the applicant's aquarium breeding center. The laboratory animal use license number is: SYXK (Zhejiang) 2022-0004. The husbandry and management met the requirements of international AAALAC certification (certification number: 001458), and the IACUC ethics review number is: IACUC-2024-10521-01.

[0125] 3. Instruments, consumables and reagents

[0126] Dissecting microscope (SZX7, OLYMPUS, Japan); motorized focusing continuous zoom fluorescence microscope (AZ100, Nikon, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, USA); Multifunctional microplate reader (SPARK, TECAN, Austria); Ultrasonic cleaner (JP-010T, Shenzhen Jiemeng Cleaning Equipment Co., Ltd., China); Fully automatic rapid sample grinder (JXFSTPRP-24L, Shanghai Jingxin Experimental Equipment Technology Department, China); High-speed refrigerated centrifuge (Heraeus Fresco17, ThermoFisher, Germany); 96-well plate (Nest Biotech, China).

[0127] Cyclophosphamide (batch number A2203038, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Dimethyl sulfoxide (DMSO, batch number BCCD8942, Sigma, Switzerland); Sperm motility fluorescence staining kit (batch number 1-426511-1, Shanghai Jiemei Gene Pharmaceutical Technology Co., Ltd., China); Zebrafish T ELISA KIT (testosterone kit, batch number 202410, Shanghai Enzyme-Linked Biotechnology Co., Ltd., China); 0.9% sodium chloride injection (batch number S21091609, Hunan Kelun Pharmaceutical Co., Ltd., China).

[0128] 4. Detection methods and results

[0129] 4.1. MTC Measurement

[0130] Six-month-old (6 mpf) wild-type AB strain male zebrafish were randomly selected and placed in culture tanks, with eight zebrafish treated in each tank (experimental group). Water-soluble samples were administered (concentrations shown in Table 6). A normal control group and a model control group were also included, with each tank having a volume of 1 L. After 8 days of sample treatment, except for the normal control group, all other experimental groups were given water-soluble cyclophosphamide to establish a zebrafish oligospermia model. All experimental groups continued treatment with cyclophosphamide for 16 days, and the MTC of the samples in the oligospermia model zebrafish was measured.

[0131] The experimental results are shown in Table 6.

[0132] Table 6 Results of the concentration exploration experiment on the efficacy of different concentrations of samples in improving male sexual function (n=8)

[0133] Note: "-" indicates that it does not exist or is not shown.

[0134] Under the above experimental conditions, the MTC of the health wine prepared in Example 1 of this application for evaluating the efficacy of improving male sexual function in zebrafish was 7.81 μL / mL.

[0135] 4.2. Efficacy in improving male sexual function

[0136] Six mpf wild-type AB strain male zebrafish were randomly selected and placed in culture tanks, with eight zebrafish treated in each tank (experimental group). Samples were administered in water (concentrations shown in Table 7). A normal control group and a model control group were set up, with each tank having a volume of 1 L. After 8 days of sample treatment, except for the normal control group, all other experimental groups were given cyclophosphamide in water to establish a zebrafish oligospermia model. All experimental groups continued treatment with cyclophosphamide for up to 16 days: 1) Eight zebrafish were randomly selected from each experimental group, and sperm were stained using a sperm motility fluorescence staining kit. After staining, the sperm were photographed under a fluorescence microscope, and the data were analyzed and collected using ImageJ advanced image processing software. The sperm count was analyzed, and the statistical analysis results of this indicator were used to evaluate the efficacy of the sample in improving male sexual function; 2) Three zebrafish were randomly selected from each experimental group, and the testosterone content in the zebrafish was detected using a zebrafish testosterone kit via a multi-functional microplate reader. The statistical analysis results of this indicator were used to evaluate the efficacy of the sample in improving male sexual function. Statistical results are expressed as mean ± SE. Statistical analysis using statistical software showed that p < 0.05 indicated a statistically significant difference.

[0137] The experimental results are shown in Table 7. Figure 3 As shown. Among them, Figure 3 In the image, the blue particles represent sperm.

[0138] Table 7. Experimental results evaluating the efficacy of the samples in improving male sexual function (n=3)

[0139] Note: "-" indicates non-existence; compared with the model control group, .

[0140] The results above show that the health tonics prepared in the embodiments of this application all have good effects on improving male sexual function. Comparison of the results of Examples 1-5 and Comparative Examples 1-16 reveals that when some raw material components of the health tonic are not within the scope of this application, the zebrafish testosterone content and sperm count decrease to varying degrees, indicating a decline in the efficacy in improving male sexual function. These results indicate that the components in the health tonic provided by this application can produce a significant synergistic effect, thereby achieving the purpose of improving male sexual function.

[0141] Example 6

[0142] Weigh the following raw materials separately: 75g of wolfberry, 30g of yam, 20g of raspberry, 15g of asparagus root, 15g of ophiopogon root, 15g of longan pulp, 5g of alpinia oxyphylla, 5g of rehmannia root, 3g of codonopsis root, 3g of jujube seed, 3g of angelica root, 3g of cistanche, and 1g of ginseng (artificially cultivated for less than 5 years). Mix them evenly. Add 8 times the amount of purified water to the above herbal composition, heat and reflux twice, 1.5 hours each time, filter and combine the filtrates. Concentrate the filtrate under reduced pressure (60-70℃, -0.08MPa) to a relative density of 1.15~1.25. The thick paste was dried under reduced pressure and pulverized through an 80-mesh sieve to obtain a dry extract powder. The dry extract powder was then mixed with microcrystalline cellulose, lactose, and silicon dioxide in a mass ratio of 1:0.4:0.2:0.05. A suitable amount of 75% ethanol was added as a binder to form a soft mass. Granulation was performed using a 16-mesh sieve, dried at 60℃, and granulated using a 14-mesh sieve. 0.5% magnesium stearate by weight of the dry granules was added and mixed thoroughly. The mixture was then compressed into tablets (0.5g / tablet) using a single-punch tablet press, film-coated, and packaged to obtain the tablet product.

[0143] Example 7

[0144] Weigh the following raw materials separately: 75g of wolfberry, 30g of yam, 20g of raspberry, 15g of asparagus root, 15g of ophiopogon root, 15g of longan pulp, 5g of alpinia oxyphylla, 5g of rehmannia root, 3g of codonopsis root, 3g of jujube seed, 3g of angelica root, 3g of cistanche, and 1g of ginseng (artificially cultivated for less than 5 years). Mix them evenly. Add 8 times the amount of purified water to the above herbal composition, heat and reflux twice, extracting for 1.5 hours each time. Combine the extracts. The extract was filtered to obtain a filtrate. The filtrate was concentrated under reduced pressure (60℃, -0.08MPa) to a clear extract with a relative density of 1.08~1.12. An appropriate amount of dextrin and lactose (clear extract:dextrin:lactose = 1:0.3:0.2 by mass) were added to the clear extract and mixed evenly. An appropriate amount of purified water was added to obtain a soft material. The material was granulated using a 16-mesh sieve, dried with hot air at 65℃, granulated using a 10-mesh sieve, and packaged to obtain granules.

[0145] In summary, the traditional Chinese medicine composition provided in this application has good anti-aging, anti-fatigue, and male sexual function enhancement effects. It can be used to prepare drugs for anti-aging, anti-fatigue, or improvement of male sexual function, or to prepare health products that help with anti-oxidation and relieve physical fatigue.

[0146] The above description is only a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition is made from the following raw material components in parts by weight: 50-99 parts of wolfberry, 20-40 parts of yam, 15-27 parts of raspberry, 10-20 parts of asparagus root, 10-20 parts of ophiopogon root, 10-20 parts of longan pulp, 3-9 parts of alpinia oxyphylla, 3-9 parts of prepared rehmannia root, 1-8 parts of codonopsis root, 1-8 parts of jujube seed, 1-8 parts of angelica root, 1-8 parts of cistanche, and 1-3 parts of ginseng. Preferably, the traditional Chinese medicine composition is made from the following raw material components in parts by weight: 63-80 parts by weight of wolfberry, 25-35 parts by weight of yam, 17-23 parts by weight of raspberry, 11-17 parts by weight of asparagus root, 11-17 parts by weight of ophiopogon root, 11-17 parts by weight of longan pulp, 3-8 parts by weight of alpinia oxyphylla, 3-8 parts by weight of prepared rehmannia root, 2-5 parts by weight of codonopsis root, 2-5 parts by weight of jujube seed, 2-5 parts by weight of angelica root, 2-6 parts by weight of cistanche, and 1 part by weight of ginseng.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition also includes pharmaceutically acceptable carriers or excipients; Preferably, the pharmaceutically acceptable carrier or excipient is selected from at least one of solvents, diluents, disintegrants, precipitation inhibitors, surfactants, flow aids, binders, lubricants, dispersants, suspending agents, isotonic agents, thickeners, emulsifiers, preservatives, stabilizers, hydrating agents, emulsification accelerators, buffers, absorbents, colorants, flavorings, sweeteners, ion exchangers, release agents, coating agents, flavoring agents, and antioxidants.

3. The traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, The traditional Chinese medicine composition is formulated into a pharmaceutically acceptable preparation; preferably, the pharmaceutically acceptable preparation is granules, decoction, powder, tablets, capsules, pills, emulsion, suspension, tincture or alcohol.

4. A health-enhancing wine, characterized in that, Includes alcohol and the traditional Chinese medicine composition according to any one of claims 1-3.

5. A method for preparing the health wine according to claim 4, characterized in that, Includes the following steps: 1) Weigh the raw material components, mix them evenly, and add the base wine for extraction; 2) After extraction, the mixture is filtered to obtain the wine; Preferably, the filtration accuracy is 50µm to 180µm.

6. The preparation method according to claim 5, characterized in that, The preparation method further includes: The wine was frozen at a low temperature of -7℃ to -15℃ for 22 to 26 hours. Then, fine filtration is performed, and the mixture is left to stand at room temperature for 2 to 4 days. The alcohol content is adjusted, and then fine filtration is performed again to obtain the health wine. The filtration precision of the fine filtration is 0.2µm to 0.5µm. The alcohol content of the health wine is 36°~52°.

7. The preparation method according to claim 5, characterized in that, The base liquor has an alcohol content of 50°~60°, and the total mass of the raw material components to the volume ratio of the base liquor is (109~313) g: 1L; the extraction includes closed extraction for 20 to 23 days, with daily circulation for uniform extraction.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicine for anti-aging, anti-fatigue or improving male sexual function.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of health products that help with anti-oxidation and relieve physical fatigue.

10. The application according to claim 9, characterized in that, The health products mentioned include health wines.

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