Traditional Chinese medicine composition, preparation method thereof and application of traditional Chinese medicine composition in preparation of health-care wine with kidney deficiency conditioning effect

Abstract

The invention discloses a traditional Chinese medicine composition for conditioning kidney deficiency and application of the traditional Chinese medicine composition. The composition is compatible according to the principle of monarch, minister, assistant and guide, wherein monarch drugs comprise cistanche, herba epimedii and morinda officinalis; the ministerial drugs comprise American ginseng, radix astragali and fructus lycii; the adjuvant drugs comprise eucommia ulmoides, dogwood, prepared rehmannia root, angelica sinensis, cinnamon, liquorice and poria cocos; in addition, dendrobium, loranthus parasiticus and acanthopanax senticosus According to the preparation method, a differential extraction technology is adopted according to the characteristics of different medicine groups: the monarch medicine is steamed and then subjected to enzymolysis; the ministerial drug is subjected to ethanol reflux extraction; and adjuvant drugs are extracted under ultrahigh pressure. When the composition is used for health-care wine, through low-temperature aging, microfiltration, ultrafiltration refining and addition of a stabilizer, the product is high in active ingredient content, good in stability and good in taste, and has remarkable kidney-tonifying and fatigue-resisting effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition and its preparation method, and its application in the preparation of a health wine with the effect of regulating kidney deficiency. Background Technology

[0002] Kidney deficiency syndrome is a common condition in Traditional Chinese Medicine (TCM), often caused by overwork, old age, or prolonged illness leading to depletion of kidney essence. Clinical manifestations include lower back and knee pain, dizziness, tinnitus, fatigue, and decreased sexual function. With increasing work pressure and a rapidly aging population in modern society, the incidence of kidney deficiency syndrome is rising annually, making the development of safe and effective kidney deficiency treatment products of significant market value. Health-promoting wines, as a traditional Chinese medicine dosage form, combine the blood-activating and qi-regulating effects of alcohol with the nourishing and strengthening effects of herbs, giving them a unique advantage in the treatment of kidney deficiency.

[0003] Most kidney-tonifying health tonics on the market currently suffer from the following problems: First, their formulas are mostly based on traditional prescriptions, lacking innovation in the combination of medicinal materials, such as derivatives of Liuwei Dihuang Wan, which fails to meet the diverse needs of modern consumers; second, the extraction of active ingredients from raw medicinal materials is insufficient, and traditional soaking processes are time-consuming, inefficient, and have limited dissolution rates of effective components; third, the products have poor stability, easily developing sediment and turbidity during storage, affecting their appearance and taste; fourth, the formulas lack scientific rigor, with most products simply listing kidney-tonifying herbs without in-depth research on the synergistic effects between the herbs, resulting in unsatisfactory clinical effects.

[0004] In the prior art, CN105838554A discloses a Panax notoginseng, Astragalus membranaceus, and Lycium barbarum wine, which has a certain anti-fatigue effect, but its formula is simple and its efficacy is limited. CN103666959A discloses a health-preserving wine, whose formula contains multiple medicinal materials such as Polygonatum sibiricum and Dendrobium nobile, but it does not conduct in-depth research and verification on the synergistic effects between the medicinal materials. In addition, the preparation processes used in these prior art are relatively traditional, mostly involving simple soaking and filtration, and they fail to use modern extraction techniques to improve the extraction rate of active ingredients and product quality.

[0005] Therefore, there is an urgent need in this field for a traditional Chinese medicine composition with a scientific formulation, advanced preparation process, significant synergistic effect, and good stability, as well as a corresponding method for preparing health wine, to meet the modern market demand for efficient and safe products for treating kidney deficiency. This paper designs a traditional Chinese medicine composition and its preparation method, and its application in the preparation of health wine with the effect of treating kidney deficiency. Summary of the Invention

[0006] In order to overcome the shortcomings of the prior art, a traditional Chinese medicine composition and its preparation method are provided, and its application in the preparation of a health wine with the effect of regulating kidney deficiency is provided.

[0007] To achieve the above objectives, the present invention provides the following technical solution: A traditional Chinese medicine composition, by weight, is composed of the following raw materials in accordance with the principles of monarch, minister, assistant, and guide: Principal herbs: 15-25 parts of Cistanche deserticola, 12-20 parts of Epimedium, and 12-20 parts of Morinda officinalis; Assistant herbs: American ginseng 10-18 parts, astragalus 15-25 parts, wolfberry 12-20 parts; Adjuvant herbs: Eucommia ulmoides 12-18 parts, Cornus officinalis 12-18 parts, Rehmannia glutinosa 15-22 parts, Angelica sinensis 12-18 parts, Chrysanthemum indicum 8-12 parts, Lonicera japonica 8-12 parts; The following herbs are used: 8-12 parts cinnamon, 8-12 parts licorice, and 12-18 parts poria.

[0008] The traditional Chinese medicine composition also contains the following auxiliary medicinal materials: 8-15 parts of Dendrobium, 10-16 parts of Taxillus chinensis, and 12-18 parts of Acanthopanax senticosus.

[0009] A method for preparing a traditional Chinese medicine composition, the method comprising the following steps: (1) Raw material pretreatment: The principal medicinal materials: Cistanche deserticola, Epimedium and Morinda officinalis were washed, steamed and dried, and then pulverized through a 60-mesh sieve to obtain the principal medicinal powder; (2) Enzymatic hydrolysis: Add the principal drug powder to 8-10 times the amount of water, adjust the pH value to 5.0-6.0, and carry out the enzymatic hydrolysis reaction to obtain the enzymatic hydrolysate; (3) Extraction of the auxiliary herbs: The auxiliary herbs, namely American ginseng, astragalus and wolfberry, were extracted twice by reflux at 75-80℃ with 60-70% ethanol for 1-2 hours each time. The extracts were combined, filtered, and concentrated to a relative density of 1.12-1.18 to obtain the ethanol extract. (4) Treatment of adjuvant and guiding herbs: The adjuvant herbs (Eucommia ulmoides, Cornus officinalis, Rehmannia glutinosa, Angelica sinensis, Chrysanthemum indicum, Lonicera japonica) and the guiding herbs (Cinnamomum cassia, Glycyrrhiza uralensis, Poria cocos) were mixed and subjected to ultra-high pressure extraction to obtain an aqueous extract. (5) Mixing and concentration: Combine the above-mentioned enzymatic hydrolysate, ethanol extract and water extract, and concentrate them under reduced pressure at 60-65℃ to a thick paste with a relative density of 1.20-1.25. The resulting thick paste is the traditional Chinese medicine composition.

[0010] In step (1), the specific steps of steam drying are as follows: steam is used to steam for 30-40 minutes at a pressure of 0.15-0.20 MPa, and then dried at 50-60℃ until the moisture content is less than 10%.

[0011] In step (2), the specific steps of the enzymatic hydrolysis reaction are as follows: add 0.5-1.0% of the compound enzyme preparation of the principal drug powder and hydrolyze at 45-50℃ for 2-3 hours.

[0012] The compound enzyme preparation is composed of cellulase, pectinase and β-glucosidase in a mass ratio of (2-3):(0.5-1):1.

[0013] In step (4), the specific steps of the ultra-high pressure extraction process are as follows: the adjuvant group (Eucommia ulmoides, Cornus officinalis, Rehmannia glutinosa, Angelica sinensis, Chrysanthemum indicum, Lonicera japonica) and the medicated group (Cinnamomum cassia, Glycyrrhiza uralensis, Poria cocos) are mixed and treated under a pressure of 500-600 MPa for 10-15 minutes. Then, the mixture is soaked twice in 8-10 times the amount of warm water at 50-60℃ for 1-2 hours each time.

[0014] An application of a traditional Chinese medicine composition for preparing a health wine with the effect of regulating kidney deficiency, the health wine comprising the traditional Chinese medicine composition and base wine, wherein the mass ratio of the traditional Chinese medicine composition to the base wine is 1:12-18.

[0015] The preparation method of the health wine includes the following steps: take the traditional Chinese medicine composition and base wine, stir and mix them at 45-50℃ for 2-3 hours to obtain a mixture; let the mixture stand and age at -5 to 0℃ for 24-36 hours, take the supernatant and filter it through a 0.45μm microfiltration membrane to obtain a filtrate; centrifuge the filtrate at 10000-12000 r / min for 15-20 minutes, take the supernatant and refine it using an ultrafiltration membrane system with a membrane molecular weight cutoff of 1000 Da; add 0.2-0.5% gum arabic and 0.1-0.3% sodium citrate, adjust the alcohol content to 38-40 degrees, and bottle and sterilize to obtain the health wine.

[0016] The ultrafiltration membrane system is made of polyethersulfone and operates at a pressure of 0.2-0.4 MPa.

[0017] Compared with the prior art, the advantages and beneficial effects of the present invention are as follows: 1. In terms of formulation design, this invention adopts the principle of principal, assistant, adjuvant, and guide herbs, using Cistanche deserticola, Epimedium, and Morinda officinalis as principal herbs to target the core pathogenesis of kidney deficiency. American ginseng, Astragalus membranaceus, and Lycium barbarum serve as assistant herbs to enhance the tonic effects of the principal herbs. The adjuvant and guide herbs harmonize the effects of the other herbs and guide their efficacy. This structured formulation design allows the herbs to exert synergistic effects, which is more in line with traditional Chinese medicine theory than simply piling up kidney-tonifying herbs, and is expected to improve the overall conditioning effect.

[0018] 2. This invention employs differentiated extraction techniques based on the physicochemical properties of different herbal groups. The principal herbal group is first steamed, a step that helps disrupt cell structure and transform certain components. Subsequently, a compound enzyme preparation is used for enzymatic hydrolysis. Utilizing the synergistic effect of cellulase, pectinase, and β-glucosidase, the plant cell wall structure is effectively disrupted, promoting the release of intracellular active ingredients, thereby improving extraction efficiency.

[0019] 3. For the herbs in the assistant herb group, this invention employs an ethanol reflux extraction method, which has a good extraction effect on polar components such as saponins and polysaccharides. For the adjuvant herbs in the guide herb group, ultra-high pressure extraction technology is used. This technology uses extremely high static pressure to instantly act on the herb cells, altering their cell structure and enhancing permeability. This allows for more complete dissolution of active ingredients during subsequent warm water extraction, while avoiding the damage of heat-sensitive components caused by high temperatures.

[0020] 4. In the preparation process of health wine, this invention, through a phased treatment including low-temperature static aging, precision microfiltration and centrifugal separation, and an ultrafiltration membrane refining system, effectively removes large molecular impurities, colloidal substances, and components that may cause precipitation from the wine, significantly improving the product's clarity and physical stability. The addition of gum arabic and sodium citrate as stabilizers enhances the system's stability, prevents turbidity or precipitation during storage, and maintains the product's good appearance and taste.

[0021] This invention adds wild chrysanthemum and honeysuckle to the original kidney-tonifying and essence-boosting adjuvant herbs. This formulation adjustment reflects the traditional Chinese medicine principles of "tonifying while purging" and "yin-yang balance." Wild chrysanthemum and honeysuckle are sweet, bitter, and slightly cold in nature, possessing excellent heat-clearing, detoxifying, liver-calming, and fire-purging effects. They can effectively counteract the potential warming and drying properties of the principal herbs such as cistanche, epimedium, and morinda root, which are used to tonify kidney yang. This ensures that the entire formula, while powerfully tonifying, is less likely to generate heat, significantly enhancing the safety and applicability of the formula. It is especially suitable for modern people with kidney deficiency constitutions due to fast-paced lifestyles and a tendency to suffer from internal heat, achieving a synergistic effect of clearing the upper body and warming the lower body, and combining tonification and purging. This helps improve the overall comfort of the user and expands the suitable population. Detailed Implementation

[0022] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] In the specific implementation of this application, all raw materials are commercially available pharmaceutical-grade Chinese medicinal herbs.

[0024] The technical solution of this application is as follows: A traditional Chinese medicine composition, by weight, is composed of the following raw materials in accordance with the principles of monarch, minister, assistant, and guide: Principal herbs: 15-25 parts of Cistanche deserticola, 12-20 parts of Epimedium, and 12-20 parts of Morinda officinalis; Assistant herbs: American ginseng 10-18 parts, astragalus 15-25 parts, wolfberry 12-20 parts; Adjuvant herbs: Eucommia ulmoides 12-18 parts, Cornus officinalis 12-18 parts, Rehmannia glutinosa 15-22 parts, Angelica sinensis 12-18 parts, Chrysanthemum indicum 8-12 parts, Lonicera japonica 8-12 parts; The following herbs are used: 8-12 parts cinnamon, 8-12 parts licorice, and 12-18 parts poria.

[0025] The traditional Chinese medicine composition also contains the following auxiliary medicinal materials: 8-15 parts of Dendrobium, 10-16 parts of Taxillus chinensis, and 12-18 parts of Acanthopanax senticosus.

[0026] A method for preparing a traditional Chinese medicine composition, the method comprising the following steps: (1) Raw material pretreatment: The principal medicinal materials: Cistanche deserticola, Epimedium and Morinda officinalis were washed, steamed and dried, and then pulverized through a 60-mesh sieve to obtain the principal medicinal powder; (2) Enzymatic hydrolysis: Add the principal drug powder to 8-10 times the amount of water, adjust the pH value to 5.0-6.0, and carry out the enzymatic hydrolysis reaction to obtain the enzymatic hydrolysate; (3) Extraction of the auxiliary herbs: The auxiliary herbs, namely American ginseng, astragalus and wolfberry, were extracted twice by reflux at 75-80℃ with 60-70% ethanol for 1-2 hours each time. The extracts were combined, filtered, and concentrated to a relative density of 1.12-1.18 to obtain the ethanol extract. (4) Treatment of adjuvant and guiding herbs: The adjuvant herbs (Eucommia ulmoides, Cornus officinalis, Rehmannia glutinosa, Angelica sinensis, Chrysanthemum indicum, Lonicera japonica) and the guiding herbs (Cinnamomum cassia, Glycyrrhiza uralensis, Poria cocos) were mixed and subjected to ultra-high pressure extraction to obtain an aqueous extract. (5) Mixing and concentration: Combine the above-mentioned enzymatic hydrolysate, ethanol extract and water extract, and concentrate them under reduced pressure at 60-65℃ to a thick paste with a relative density of 1.20-1.25. The resulting thick paste is the traditional Chinese medicine composition.

[0027] In step (1), the specific steps of steam drying are as follows: steam is used to steam for 30-40 minutes at a pressure of 0.15-0.20 MPa, and then dried at 50-60℃ until the moisture content is less than 10%.

[0028] In step (2), the specific steps of the enzymatic hydrolysis reaction are as follows: add 0.5-1.0% of the compound enzyme preparation of the principal drug powder and hydrolyze at 45-50℃ for 2-3 hours.

[0029] The compound enzyme preparation is composed of cellulase, pectinase and β-glucosidase in a mass ratio of (2-3):(0.5-1):1.

[0030] In step (4), the specific steps of the ultra-high pressure extraction process are as follows: the adjuvant group (Eucommia ulmoides, Cornus officinalis, Rehmannia glutinosa, Angelica sinensis, Chrysanthemum indicum, Lonicera japonica) and the medicated group (Cinnamomum cassia, Glycyrrhiza uralensis, Poria cocos) are mixed and treated under a pressure of 500-600 MPa for 10-15 minutes. Then, the mixture is soaked twice in 8-10 times the amount of warm water at 50-60℃ for 1-2 hours each time.

[0031] An application of a traditional Chinese medicine composition for preparing a health wine with the effect of regulating kidney deficiency, the health wine comprising the traditional Chinese medicine composition and base wine, wherein the mass ratio of the traditional Chinese medicine composition to the base wine is 1:12-18.

[0032] The preparation method of the health wine includes the following steps: take the traditional Chinese medicine composition and base wine, stir and mix them at 45-50℃ for 2-3 hours to obtain a mixture; let the mixture stand and age at -5 to 0℃ for 24-36 hours, take the supernatant and filter it through a 0.45μm microfiltration membrane to obtain a filtrate; centrifuge the filtrate at 10000-12000 r / min for 15-20 minutes, take the supernatant and refine it using an ultrafiltration membrane system with a membrane molecular weight cutoff of 1000 Da; add 0.2-0.5% gum arabic and 0.1-0.3% sodium citrate, adjust the alcohol content to 38-40 degrees, and bottle and sterilize to obtain the health wine.

[0033] The ultrafiltration membrane system is made of polyethersulfone and operates at a pressure of 0.2-0.4 MPa.

[0034] This invention, through scientific formula design, advanced extraction technology, and refined preparation process, provides a traditional Chinese medicine composition and its health wine product with more complete component extraction, more significant synergistic effect, and better stability, in order to meet the market demand for efficient and stable kidney deficiency conditioning products.

[0035] The technical solutions of the present invention are further illustrated below through examples and comparative examples, but the scope of protection of the present invention is not limited thereto.

[0036] Example 1 This embodiment provides a traditional Chinese medicine composition and its preparation method, as well as its application in health tonics. The raw material composition of the traditional Chinese medicine composition, by weight, is as follows: Chief herbs: 25 parts Cistanche deserticola, 20 parts Epimedium, and 20 parts Morinda officinalis; The following ingredients are used as a supplement: American ginseng 10 parts, astragalus 15 parts, and wolfberry 12 parts. Adjuvant herbs: Eucommia ulmoides 18 parts, Cornus officinalis 18 parts, Rehmannia glutinosa 22 parts, Angelica sinensis 18 parts, Chrysanthemum indicum 12 parts, Lonicera japonica 12 parts; Ingredients: 12 parts cinnamon, 12 parts licorice, 18 parts poria cocos; Auxiliary medicinal materials: Dendrobium 8 parts, Taxillus chinensis 10 parts, Acanthopanax senticosus 12 parts.

[0037] The preparation method includes the following steps: (1) Raw material pretreatment: After washing the medicinal materials of the principal drug group, Cistanche deserticola, Epimedium and Morinda officinalis, steam them for 30 minutes under a steam pressure of 0.15 MPa, take them out and dry them at 50℃ until the moisture content is less than 10%, pulverize them and pass them through a 60-mesh sieve to obtain the principal drug powder; (2) Enzymatic hydrolysis: Add the principal drug powder to 10 times the amount of water, adjust the pH value to 6.0, add 1.0% of the principal drug powder of a compound enzyme preparation, which is composed of cellulase, pectinase and β-glucosidase in a mass ratio of 3:1:1, and enzymatically hydrolyze at 50°C for 3 hours to obtain the enzymatic hydrolysate; (3) Extraction of the auxiliary herbs: American ginseng, astragalus and wolfberry were extracted twice with 70% ethanol at 80°C for 2 hours each time. The extracts were combined, filtered and concentrated to a relative density of 1.18 to obtain ethanol extract. (4) Treatment of adjuvant and guiding herbs: The adjuvant herbs Eucommia ulmoides, Cornus officinalis, Rehmannia glutinosa, Angelica sinensis and guiding herbs Cinnamomum cassia, Glycyrrhiza uralensis and Poria cocos were mixed and treated under ultra-high pressure at 600 MPa for 15 minutes. Then, they were extracted twice with 10 times the amount of 60℃ warm water for 2 hours each time, and the water extracts were combined. (5) Mixing and concentration: The enzymatic hydrolysate, ethanol extract and water extract are combined and concentrated under reduced pressure at 60°C to a thick paste with a relative density of 1.20 to obtain the traditional Chinese medicine composition.

[0038] The traditional Chinese medicine composition was used to prepare a health-promoting wine, wherein the mass ratio of the traditional Chinese medicine composition to the base wine was 1:18. The traditional Chinese medicine composition and the base wine were stirred and mixed at 50°C for 3 hours to obtain a mixture. The mixture was then allowed to stand and age at 0°C for 36 hours. The supernatant was filtered through a 0.45 μm microfiltration membrane. The filtrate was centrifuged at 12000 r / min for 20 minutes. The supernatant was then purified using a polyethersulfone ultrafiltration membrane system with a molecular weight cutoff of 1000 Da and an operating pressure of 0.4 MPa. 0.5% gum arabic and 0.3% sodium citrate were added to adjust the alcohol content to 40 degrees. The wine was then bottled and sterilized to obtain the finished health-promoting wine.

[0039] Example 2 In this embodiment, the similarities to those in Embodiment 1 will not be repeated, and the differences are as follows: This embodiment provides another traditional Chinese medicine composition and its preparation method, as well as its application in health tonics. The raw material composition of the traditional Chinese medicine composition, by weight, is as follows: Chief herbs: 15 parts Cistanche deserticola, 12 parts Epimedium, and 12 parts Morinda officinalis; The following ingredients were used: American ginseng 18 parts, astragalus 25 parts, and wolfberry 20 parts. Adjuvant herbs: Eucommia ulmoides 15 parts, Cornus officinalis 15 parts, Rehmannia glutinosa 18 parts, Angelica sinensis 15 parts, Chrysanthemum indicum 10 parts, Lonicera japonica 10 parts; Ingredients: 8 parts cinnamon, 8 parts licorice, 12 parts poria cocos; Auxiliary medicinal materials: Dendrobium 12 parts, Taxillus chinensis 13 parts, Acanthopanax senticosus 15 parts.

[0040] The preparation method includes the following steps: (1) Raw material pretreatment: After washing the main medicinal materials Cistanche deserticola, Epimedium and Morinda officinalis, steam them for 40 minutes under a steam pressure of 0.20 MPa. After taking them out, dry them at 60℃ until the moisture content is less than 10%. Then, pulverize them and pass them through a 60-mesh sieve to obtain the main medicinal powder. (2) Enzymatic hydrolysis: Add the principal drug powder to 8 times the amount of water, adjust the pH value to 5.0, add 0.5% of the principal drug powder of a compound enzyme preparation, which is composed of cellulase, pectinase and β-glucosidase in a mass ratio of 2:0.5:1, and enzymatically hydrolyze at 45℃ for 2 hours to obtain the enzymatic hydrolysate; (3) Extraction of the auxiliary herbs: American ginseng, astragalus and wolfberry were extracted twice with 65% ethanol at 78°C for 1.5 hours each time. The extracts were combined, filtered and concentrated to a relative density of 1.15 to obtain ethanol extract. (4) Treatment of adjuvant and guiding herbs: The adjuvant herbs Eucommia ulmoides, Cornus officinalis, Rehmannia glutinosa, Angelica sinensis and guiding herbs Cinnamomum cassia, Glycyrrhiza uralensis and Poria cocos were mixed and treated under ultra-high pressure at 500 MPa for 10 minutes. Then, they were extracted twice with 8 times the amount of 50℃ warm water for 1 hour each time, and the water extracts were combined. (5) Mixing and concentration: The enzymatic hydrolysate, ethanol extract and water extract are combined and concentrated under reduced pressure at 65°C to a thick paste with a relative density of 1.25 to obtain the traditional Chinese medicine composition.

[0041] The traditional Chinese medicine composition was used to prepare a health-promoting wine, wherein the mass ratio of the traditional Chinese medicine composition to the base wine was 1:15. The traditional Chinese medicine composition and the base wine were stirred and mixed at 48℃ for 2.5 hours to obtain a mixture. The mixture was then allowed to stand and age at -2℃ for 30 hours. The supernatant was filtered through a 0.45 μm microfiltration membrane. The filtrate was centrifuged at 11000 r / min for 18 minutes. The supernatant was then purified using a polyethersulfone ultrafiltration membrane system with a molecular weight cutoff of 1000 Da and an operating pressure of 0.3 MPa. 0.35% gum arabic and 0.2% sodium citrate were added to adjust the alcohol content to 39 degrees. The wine was then bottled and sterilized to obtain the finished health-promoting wine.

[0042] Example 3 In this embodiment, the similarities to those in Embodiment 1 will not be repeated, and the differences are as follows: This embodiment provides another traditional Chinese medicine composition and its preparation method, as well as its application in health tonics. The raw material composition of the traditional Chinese medicine composition, by weight, is as follows: Chief herbs: 20 parts of Cistanche deserticola, 16 parts of Epimedium, and 16 parts of Morinda officinalis; The following ingredients were used as a supplement: American ginseng 14 parts, astragalus 20 parts, and wolfberry 16 parts. Adjuvant herbs: Eucommia ulmoides 12 parts, Cornus officinalis 12 parts, Rehmannia glutinosa 15 parts, Angelica sinensis 12 parts, Chrysanthemum indicum 8 parts, Lonicera japonica 8 parts; Ingredients: 10 parts cinnamon, 10 parts licorice, 15 parts poria cocos; Auxiliary medicinal materials: Dendrobium 15 parts, Taxillus chinensis 16 parts, Acanthopanax senticosus 18 parts.

[0043] The preparation method includes the following steps: (1) Raw material pretreatment: After washing the medicinal materials of the principal drug group, Cistanche deserticola, Epimedium and Morinda officinalis, steam them for 35 minutes under a steam pressure of 0.18 MPa, take them out and dry them at 55℃ until the moisture content is less than 10%, pulverize them and pass them through a 60-mesh sieve to obtain the principal drug powder; (2) Enzymatic hydrolysis: Add the principal drug powder to 9 times the amount of water, adjust the pH value to 5.5, add 0.8% of the principal drug powder of a compound enzyme preparation, which is composed of cellulase, pectinase and β-glucosidase in a mass ratio of 2.5:0.8:1, and enzymatically hydrolyze at 48℃ for 2.5 hours to obtain the enzymatic hydrolysate; (3) Extraction of the auxiliary herbs: American ginseng, astragalus and wolfberry were extracted twice with 60% ethanol at 75°C for 1 hour each time. The extracts were combined, filtered and concentrated to a relative density of 1.12 to obtain ethanol extract. (4) Treatment of adjuvant and guiding herbs: The adjuvant herbs Eucommia ulmoides, Cornus officinalis, Rehmannia glutinosa, Angelica sinensis and guiding herbs Cinnamomum cassia, Glycyrrhiza uralensis and Poria cocos were mixed and treated under ultra-high pressure at 550 MPa for 12 minutes. Then, they were extracted twice with 9 times the amount of 55℃ warm water for 1.5 hours each time, and the water extracts were combined. (5) Mixing and concentration: The enzymatic hydrolysate, ethanol extract and water extract are combined and concentrated under reduced pressure at 63°C to a thick paste with a relative density of 1.22 to obtain the traditional Chinese medicine composition.

[0044] The traditional Chinese medicine composition was used to prepare a health-promoting wine, wherein the mass ratio of the traditional Chinese medicine composition to the base wine was 1:12. The traditional Chinese medicine composition and the base wine were stirred and mixed at 45°C for 2 hours to obtain a mixture. The mixture was then allowed to stand and age at -5°C for 24 hours. The supernatant was filtered through a 0.45 μm microfiltration membrane. The filtrate was centrifuged at 10,000 r / min for 15 minutes. The supernatant was then purified using a polyethersulfone ultrafiltration membrane system with a molecular weight cutoff of 1000 Da and an operating pressure of 0.2 MPa. 0.2% gum arabic and 0.1% sodium citrate were added to adjust the alcohol content to 38 degrees. The wine was then bottled and sterilized to obtain the finished health-promoting wine.

[0045] Comparative Example 1 In this comparative example, the similarities with Example 1 will not be repeated, and the differences are as follows: Instead of using compound enzyme preparations to treat the principal herb group, the traditional water extraction method was used.

[0046] Comparative Example 2 In this comparative example, the similarities with Example 2 will not be repeated, and the differences are as follows: The adjuvant and guide herbs were not processed using ultra-high pressure extraction technology, but instead were processed using conventional water decoction.

[0047] Comparative Example 3 In this comparative example, the similarities with Example 3 will not be repeated, and the differences are as follows: The purification process was not carried out using an ultrafiltration membrane system, but only using conventional filtration methods.

[0048] Comparative Example 4 In this comparative example, the similarities with Example 1 will not be repeated, and the differences are as follows: The traditional Chinese medicine composition formula does not include auxiliary medicinal materials such as Dendrobium, Taxillus chinensis, and Acanthopanax senticosus.

[0049] Comparative Example 5 In this comparative example, the similarities with Example 1 will not be repeated, and the differences are as follows: No gum arabic or sodium citrate was added as stabilizers.

[0050] Performance Test Results and Analysis To verify the efficacy of the herbal composition and its health-enhancing wine of this invention, multiple performance tests were conducted on the products of three embodiments and five comparative examples. The main test indicators included active ingredient content, stability, in vitro antioxidant activity, and anti-fatigue effect in animal experiments. Specific test methods are as follows: 1. Determination of active ingredient content: The contents of icariin, astragaloside A and wolfberry polysaccharide in the health wine were determined by high performance liquid chromatography.

[0051] 2. Stability test: The sample was placed under accelerated testing conditions of 40℃ and 75% relative humidity for 3 months, and the precipitation and changes in clarity were observed.

[0052] 3. In vitro antioxidant activity: The antioxidant capacity of the samples was evaluated by DPPH free radical scavenging rate.

[0053] 4. Anti-fatigue effect in animal experiments: A weighted swimming experiment was conducted on mice, and the time it took to swim to exhaustion was recorded.

[0054] The results were tested, and the specific test results are shown in Table 1.

[0055] Table 1 Analysis of Test Results

[0056] As shown in Table 1, the contents of icariin, astragaloside A, and Lycium barbarum polysaccharides in the three examples were significantly higher than those in the comparative examples, indicating that the differentiated extraction process used in this invention effectively improved the dissolution rate of active ingredients. In Comparative Example 1, the cell walls of the principal herb group were not sufficiently broken down due to the lack of enzymatic hydrolysis, resulting in insufficient extraction of active ingredients. In Comparative Example 2, the lack of ultra-high pressure extraction led to insufficient release of components from the adjuvant herb group. In Comparative Example 4, the lack of auxiliary herbs weakened the overall synergistic effect, and the content of active ingredients also decreased.

[0057] The precipitation amounts in Examples 1-3 were all lower than those in the comparative example, indicating that the preparation process and stabilizer addition of the present invention effectively improved the physical stability of the product. Comparative Example 3 did not use ultrafiltration refining, and large molecular impurities in the wine were not effectively removed, resulting in a significant increase in precipitation. Comparative Example 5 did not add a stabilizer, and a large amount of precipitation occurred in the accelerated testing.

[0058] In vitro antioxidant activity and animal anti-fatigue experiments showed that the example groups were superior to the comparative groups, further verifying the synergistic effect of the traditional Chinese medicine composition of the present invention achieved through scientific formulation and advanced preparation process. Comparative Examples 1, 2, and 4, due to insufficient extraction or incomplete formulation, had insufficient pharmacodynamic material basis, resulting in decreased antioxidant and anti-fatigue effects.

[0059] In summary, this invention, through a rational combination of principal, assistant, and adjuvant ingredients and modern extraction and refining technologies, significantly improves the content of active ingredients, product stability, and bioactivity in health tonics, effectively meeting the modern market demand for products for treating kidney deficiency.

[0060] The above description represents the preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, By weight, this traditional Chinese medicine composition is composed of the following raw materials in accordance with the principles of monarch, minister, assistant, and guide: Principal herbs: 15-25 parts of Cistanche deserticola, 12-20 parts of Epimedium, and 12-20 parts of Morinda officinalis; Assistant herbs: American ginseng 10-18 parts, astragalus 15-25 parts, wolfberry 12-20 parts; Adjuvant herbs: Eucommia ulmoides 12-18 parts, Cornus officinalis 12-18 parts, Rehmannia glutinosa 15-22 parts, Angelica sinensis 12-18 parts, Chrysanthemum indicum 8-12 parts, Lonicera japonica 8-12 parts; The following herbs are used: 8-12 parts cinnamon, 8-12 parts licorice, and 12-18 parts poria.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition also contains the following auxiliary medicinal materials: 8-15 parts of Dendrobium, 10-16 parts of Taxillus chinensis, and 12-18 parts of Acanthopanax senticosus.

3. A method for preparing the traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, The method includes the following steps: (1) Raw material pretreatment: The principal medicinal materials: Cistanche deserticola, Epimedium and Morinda officinalis were washed, steamed and dried, and then pulverized through a 60-mesh sieve to obtain the principal medicinal powder; (2) Enzymatic hydrolysis: Add the principal drug powder to 8-10 times the amount of water, adjust the pH value to 5.0-6.0, and carry out the enzymatic hydrolysis reaction to obtain the enzymatic hydrolysate; (3) Extraction of the auxiliary herbs: The auxiliary herbs, namely American ginseng, astragalus and wolfberry, were extracted twice by reflux at 75-80℃ with 60-70% ethanol for 1-2 hours each time. The extracts were combined, filtered, and concentrated to a relative density of 1.12-1.18 to obtain the ethanol extract. (4) Treatment of adjuvant and guiding herbs: The adjuvant herbs (Eucommia ulmoides, Cornus officinalis, Rehmannia glutinosa, Angelica sinensis, Chrysanthemum indicum, Lonicera japonica) and the guiding herbs (Cinnamomum cassia, Glycyrrhiza uralensis, Poria cocos) were mixed and subjected to ultra-high pressure extraction to obtain an aqueous extract. (5) Mixing and concentration: Combine the above-mentioned enzymatic hydrolysate, ethanol extract and water extract, and concentrate them under reduced pressure at 60-65℃ to a thick paste with a relative density of 1.20-1.

25. The resulting thick paste is the traditional Chinese medicine composition.

4. The method for preparing a traditional Chinese medicine composition according to claim 1, characterized in that, In step (1), the specific steps of steam drying are as follows: steam is used to steam for 30-40 minutes at a pressure of 0.15-0.20 MPa, and then dried at 50-60℃ until the moisture content is less than 10%.

5. The method for preparing a traditional Chinese medicine composition according to claim 1, characterized in that, In step (2), the specific steps of the enzymatic hydrolysis reaction are as follows: add 0.5-1.0% of the compound enzyme preparation of the principal drug powder and hydrolyze at 45-50℃ for 2-3 hours.

6. The method for preparing a traditional Chinese medicine composition according to claim 5, characterized in that, The compound enzyme preparation is composed of cellulase, pectinase and β-glucosidase in a mass ratio of (2-3):(0.5-1):

1.

7. The method for preparing a traditional Chinese medicine composition according to claim 1, characterized in that, In step (4), the specific steps of the ultra-high pressure extraction process are as follows: the adjuvant group (Eucommia ulmoides, Cornus officinalis, Rehmannia glutinosa, Angelica sinensis, Chrysanthemum indicum, Lonicera japonica) and the medicated group (Cinnamomum cassia, Glycyrrhiza uralensis, Poria cocos) are mixed and treated under a pressure of 500-600 MPa for 10-15 minutes. Then, the mixture is soaked twice in 8-10 times the amount of warm water at 50-60℃ for 1-2 hours each time.

8. An application of the traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, This traditional Chinese medicine composition is used to prepare a health wine with the effect of regulating kidney deficiency. The health wine includes the traditional Chinese medicine composition and base wine, wherein the mass ratio of the traditional Chinese medicine composition to the base wine is 1:12-18.

9. The application of the traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the health wine includes the following steps: take the traditional Chinese medicine composition and base wine, stir and mix them at 45-50℃ for 2-3 hours to obtain a mixture; let the mixture stand and age at -5 to 0℃ for 24-36 hours, take the supernatant and filter it through a 0.45μm microfiltration membrane to obtain a filtrate; centrifuge the filtrate at 10000-12000 r / min for 15-20 minutes, take the supernatant and refine it using an ultrafiltration membrane system with a membrane molecular weight cutoff of 1000 Da; add 0.2-0.5% gum arabic and 0.1-0.3% sodium citrate, adjust the alcohol content to 38-40 degrees, and bottle and sterilize to obtain the health wine.

10. The application of the traditional Chinese medicine composition according to claim 9, characterized in that, The ultrafiltration membrane system is made of polyethersulfone and operates at a pressure of 0.2-0.4 MPa.

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