Kidney and spleen tonifying traditional Chinese medicine composition capable of tonifying yin and yang and harmonizing spleen and kidney as well as preparation method and application of kidney and spleen tonifying traditional Chinese medicine composition

Abstract

The invention discloses a kidney-tonifying and spleen-strengthening traditional Chinese medicine composition capable of tonifying yin and yang and harmonizing spleen and kidney and a preparation method and application of the kidney-tonifying and spleen-strengthening traditional Chinese medicine composition, and relates to the technical field of traditional Chinese medicine compositions.The kidney-tonifying and spleen-strengthening traditional Chinese medicine composition comprises monarch drugs, ministerial drugs, adjuvant drugs, conductant drugs and synergistic ingredients, and the composition comprises, by weight, the monarch drugs including 10-20 parts of herba epimedii and 8-15 parts of rhizoma polygonati; ministerial drugs: 12-20 parts of radix astragali, 10-18 parts of prepared rehmannia root and 9-13 parts of semen cuscutae; adjuvant drugs: 8-12 parts of rhizoma atractylodis macrocephalae, 6-10 parts of fructus corni, 10-14 parts of rhizoma dioscoreae and 8-12 parts of fructus lycii; a conductant drug: 5-8 parts of dried orange peel and 3-5 parts of honey-fried licorice root; and synergistic components: 5-7 parts of fructus alpiniae oxyphyllae and 6-8 parts of radix ophiopogonis. Compared with the prior art, the invention has the following beneficial effects: 1, the side effect is significantly reduced; 2, the bioavailability is obviously improved; 3, the curative effect of spleen and kidney regulation is enhanced; 4, the quality controllability and stability are improved; and 5, the application range is widened.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine compositions, in particular to a kidney-tonifying and spleen-nourishing traditional Chinese medicine composition for yin-yang dual supplementation and spleen-kidney coordination, and a preparation method and application thereof. BACKGROUND

[0002] Most existing kidney-tonifying traditional Chinese medicines focus on single yin-yang regulation. Simple yang-warming types (such as Jinkui Shenqi Pill) contain ingredients such as aconite and cassia, which are potent yang-warming components. The incidence of yang-warming causing yin damage is as high as 32% (Chinese Patent Medicine Adverse Reaction Monitoring Report 2022). Symptoms include dry mouth, sore throat, irritability, and insomnia. Yin-nourishing and essence-filling types (such as Liuwei Dihuang Pill) use prepared rehmannia as the core ingredient. The moistening and greasy nature of prepared rehmannia leads to a 28% incidence of abdominal distension in people with weak spleen and stomach. It is often accompanied by problems such as loss of appetite and loose and watery stools. At the same time, the mainstream dosage forms have obvious defects. Decoctions need to be decocted for more than 40 minutes every day, which is cumbersome and the effective components are prone to volatilization. Ordinary capsules have a disintegration time of more than 30 minutes and a bioavailability of only 58%, resulting in poor long-term patient compliance. In addition, existing products generally lack clear multi-dimensional pharmacodynamic substance basis control (such as key components such as icariin and astragaloside A). Only a few detect 1-2 components, which makes it difficult to ensure the stability of the therapeutic effect. Most of them do not take into account the synergistic regulation mechanism of "kidney as the root of the body and spleen as the root of the afterlife", and the therapeutic effect on complex deficiency of the spleen and kidney (such as soreness and weakness of the waist and knees accompanied by abdominal distension, and fatigue accompanied by aversion to cold) is limited, with a total effective rate of less than 60%.

[0003] The present application aims to solve the five core problems of existing kidney-tonifying traditional Chinese medicines: 1) significant side effects of yang-warming causing yin damage or moistening and greasy hindering the stomach; 2) low bioavailability of the dosage form and incomplete absorption of effective components; 3) insufficient synergistic regulation of the spleen and kidney, resulting in poor therapeutic effect on complex deficiency; 4) single pharmacodynamic substance basis and poor quality controllability; and 5) insufficient stability of some components, resulting in a decline in therapeutic effect after long-term storage. The present application further provides a traditional Chinese medicine composition for tonifying the kidney and strengthening the spleen and a preparation method thereof, which are more accurate in balancing yin and yang, more efficient in coordinating the spleen and kidney, have fewer side effects, higher bioavailability, stronger quality stability, and are suitable for a wider range of people. SUMMARY

[0004] The present application aims to provide a traditional Chinese medicine composition for tonifying the kidney and strengthening the spleen and a preparation method thereof, which are more accurate in balancing yin and yang, more efficient in coordinating the spleen and kidney, have fewer side effects, higher bioavailability, stronger quality stability, and are suitable for a wider range of people.

[0005] To achieve the above-mentioned purpose, the present application provides the following technical solution: a traditional Chinese medicine composition for tonifying the kidney and strengthening the spleen and a preparation method thereof, which are more accurate in balancing yin and yang, more efficient in coordinating the spleen and kidney, have fewer side effects, higher bioavailability, stronger quality stability, and are suitable for a wider range of people. The composition includes monarch drugs, ministerial drugs, auxiliary drugs, guide drugs, and synergistic components. The compatibility follows the principle of "yin and yang are mutually rooted, the spleen and kidney are homologous, supplementation without stagnation, and warming without dryness". The composition includes the following components by weight:

[0006] Monarch drug: Herba Epimedii 10-20 parts (warm kidney yang, contain icariin ≥0.5%), Rhizoma Polygonati 8-15 parts (nourish yin and essence, contain rhizoma polygonati polysaccharide ≥15%), accurately balance yin and yang, avoid the disadvantages of single warming yang or nourishing yin;

[0007] Minister drug: Radix Astragali 12-20 parts (tonifying qi and ascending yang, invigorating spleen and consolidating exterior, contain astragaloside IV ≥0.08%), Radix Rehmanniae Preparata 10-18 parts (nourishing yin and blood, tonifying essence and marrow, contain catalpol ≥0.1%), Semen Taxilli 9-13 parts (tonifying kidney and essence, nourishing liver and eyesight, contain taxillus glycoside ≥0.07%), taking into account tonifying qi and nourishing blood, Semen Taxilli synergizes with monarch drug to enhance the effect of tonifying kidney, and at the same time, it takes into account liver yin, achieving "tonifying liver and kidney together";

[0008] Assistant drug: Rhizoma Atractylodis Macrocephalae 8-12 parts (invigorating spleen and drying dampness, benefiting qi and invigorating spleen, contain atractylodes lactone I ≥0.05%), Fructus Corni 6-10 parts (tonifying liver and kidney, astringing and contracting, contain loganin ≥0.2%), Rhizoma Dioscoreae 10-14 parts (tonifying spleen and stomach, generating fluid and benefiting lung, contain dioscorea polysaccharide ≥12%), Fructus Lycii 8-12 parts (nourishing liver and kidney, essence and eyesight, contain lycium polysaccharide ≥15%), strengthening spleen and kidney, Rhizoma Dioscoreae synergizes with Rhizoma Atractylodis Macrocephalae to invigorate spleen, and at the same time, it relieves the property of Radix Rehmanniae Preparata of causing greasiness, Fructus Lycii synergizes with Fructus Corni to nourish liver and kidney, forming "spleen and kidney-liver and kidney" double regulation network;

[0009] Minister drug: Chenpi 5-8 parts (regulating qi and harmonizing center, preventing greasiness), Radix Glycyrrhizae 3-5 parts (harmonizing various drugs, benefiting qi and tonifying center);

[0010] Synergistic component: Fructus Evodiae 5-7 parts (warming kidney and tonifying essence, warming spleen and stopping diarrhea, containing evodiamine ≥0.04%), Radix Ophiopogonis 6-8 parts (nourishing yin and generating fluid, moistening lung and clearing heart, containing radix ophiopogonis polysaccharide ≥10%), Fructus Evodiae taking into account spleen and kidney, enhancing the effects of warming kidney and stopping diarrhea and astringing, Radix Ophiopogonis synergizing with Rhizoma Polygonati to nourish yin, relieving possible slight dryness, and at the same time, improving dry mouth symptoms;

[0011] In the compatibility, the dosage ratio of Herba Epimedii to Rhizoma Polygonati is 1.2:1 (taking into account yang and yin), the dosage ratio of Radix Astragali to Rhizoma Atractylodis Macrocephalae is 1.5:1 (strengthening spleen and kidney), and the dosage of Chenpi is ≤8 parts (avoiding consuming qi).

[0012] As a preferred technical scheme of the present application, the method comprises the following steps:

[0013] Step one:

[0014] Preprocessing: remove impurities and clean all traditional Chinese medicine raw materials, slice Herba Epimedii, Rhizoma Polygonati, Radix Rehmanniae Preparata, Semen Taxilli and Fructus Lycii, crush Radix Astragali, Rhizoma Atractylodis Macrocephalae, Fructus Corni, Rhizoma Dioscoreae, Fructus Evodiae, Radix Ophiopogonis to coarse powder, and crush Chenpi and Radix Glycyrrhizae to fine powder, and reserve them for use.

[0015] Step two:

[0016] Fractionated extraction:

[0017] Take Epimedium, Polygonatum, Rehmannia glutinosa, Dodder Fruit, add 60% ethanol, reflux extraction, filter, combine the filtrate, get the fat-soluble extract; use 60% ethanol to optimize extraction, improve the dissolution rate of icariin, dodder glycoside and other fat-soluble components;

[0018] Take Astragalus, Atractylodes, Cornus, Dioscorea, Yizhi Ren, Ophiopogon, add water, first boil with strong fire, then simmer twice with gentle fire, filter, combine the filtrate, get the water-soluble extract; extend the first decoction time, improve the extraction efficiency of astragaloside A, Dioscorea polysaccharide and other water-soluble components.

[0019] Take dried tangerine peel powder, extract tangerine peel volatile oil by supercritical CO2 extraction method, reserve; avoid the loss of volatile oil caused by traditional decoction, enhance the effect of regulating qi and middle.

[0020] Step three:

[0021] Concentration and purification: reduce the pressure of the fat-soluble extract obtained in step two to concentrate to a relative density of 1.18-1.22 (58-62℃), get the fat-soluble concentrated paste;

[0022] Filter the water-soluble extract obtained in step two first with ceramic membrane, pore size is 100nm, remove macromolecular impurities, then reduce the pressure to concentrate to a relative density of 1.12-18 (58-62℃), get the water-soluble concentrated paste; increase the membrane filtration step, improve product purity, reduce potential discomfort such as abdominal distension.

[0023] Step four:

[0024] Mix granulation: mix the fat-soluble concentrated paste obtained in step three and the water-soluble concentrated paste evenly, add tangerine peel volatile oil obtained in step two, fried licorice powder obtained in step one and dextrin 9-11 parts, stir evenly to make soft material, dextrin auxiliary material can improve the flowability of granules;

[0025] Pass the above soft material through a 16-mesh sieve to granulate, place it in a vacuum drying oven, turn the material over 2 times during the period to ensure uniform drying, get dry granules, vacuum drying reduces the oxidation of active ingredients, improves stability;

[0026] Pass the dry granules through a 20-mesh sieve to granulate, remove fine powder and large particles, get uniform granules;

[0027] Step five: capsule filling: fill the uniform granules after granulation in step four into capsules, each capsule contains 0.5g, the capsule shell is an enteric type hollow capsule, which avoids the destruction of active ingredients by stomach acid and ensures precise release in the intestine.

[0028] As a preferred technical solution of the present invention, in step one, the thickness of the slices of Epimedium, Polygonatum, Rehmannia glutinosa, Cuscuta chinensis, and Lycium barbarum is 2-4 mm; the coarse powder of Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Dioscorea opposita, Alpinia oxyphylla, and Ophiopogon japonicus is 15-25 mesh; and the fine powder of Citrus reticulata and Glycyrrhiza uralensis is 75-85 mesh.

[0029] As a preferred embodiment of the present invention, in step two, reflux extraction is performed twice, each time for 110-130 minutes. The amount of water added in step two is 1:10 of the material to the liquid. Then, the mixture is simmered twice, the first time for 90-110 minutes and the second time for 70-90 minutes. In step two, the extraction pressure is 30-32 MPa, the extraction temperature is 40-45℃, and the extraction time is 110-130 minutes.

[0030] As a preferred embodiment of the present invention, in step four, the temperature of the soft material placed in the vacuum drying oven is 58-62°C and the time is 180-200 minutes.

[0031] As a preferred technical solution of the present invention, the traditional Chinese medicine composition is used in the treatment of tonifying the spleen and kidneys by simultaneously nourishing yin and yang and regulating the spleen and kidneys.

[0032] Compared with the prior art, the beneficial effects of the present invention are:

[0033] 1. Significantly reduced side effects: By combining "Epimedium-Polygonatum-Ophiopogon japonicus" to nourish Yin and Yang, replacing the pure warming Yang combination of Aconitum carmichaelii-Cinnamomum cassia, a clinical observation of 100 patients showed that the incidence of Yin deficiency due to heat and dryness (dry mouth, sore throat) was reduced to 3% (compared to 32% in existing products). The volatile oil of Citrus reticulata peel was purified by membrane filtration, and the incidence of abdominal distension due to greasiness was reduced to 5% (compared to 28% in existing products). There were no new side effects such as loss of appetite or loose stools.

[0034] 2. Significantly improved bioavailability: By adopting fractional extraction (60% ethanol + water extraction), supercritical extraction, and enteric-coated capsule technology, the disintegration time is shortened to less than 3 minutes (compared to more than 30 minutes for existing capsules); pharmacokinetic studies in rats show that the in vivo absorption rate of icariin, astragaloside A, and Lycium barbarum polysaccharides is increased by 60%, and the bioavailability reaches 86% (compared to 58% for existing products).

[0035] 3. Enhanced efficacy in regulating both spleen and kidney: Combined with Astragalus membranaceus, Atractylodes macrocephala, Cuscuta chinensis, Dioscorea opposita, and Alpinia oxyphylla, and with the addition of other herbs, a multi-dimensional conditioning system is formed that tonifies Qi, nourishes the kidney, strengthens the spleen, and nourishes the liver. The overall effective rate for the complex syndrome of kidney Yang deficiency combined with spleen Qi deficiency and liver and kidney insufficiency reaches 96%. The time for improvement of clinical symptoms is shortened, and the average relief time for symptoms such as soreness and weakness of the waist and knees, abdominal distension, and fatigue is shortened from 10 days to 7 days.

[0036] 4. Improved quality controllability and stability: An HPLC fingerprint was established, containing 8 characteristic peaks including icariin, astragaloside A, loganin, cuscutoside, and Lycium barbarum polysaccharide, with a similarity of ≥0.99, which is superior to existing products (which only detect 1-2 components); through vacuum drying and enteric encapsulation, the product can be stored at room temperature for 24 months with an effective ingredient content decay rate of ≤5% (the decay rate of existing products is 15%).

[0037] 5. Expanded applicable population: Due to reduced side effects and synergistic regulation of the spleen, kidneys and liver, it is not only suitable for adults with spleen and kidney deficiency and yin-yang imbalance, but also for daily health care of middle-aged and elderly people (such as preventing osteoporosis and improving sleep quality), as well as for regulating spleen and kidney function in patients during postoperative recovery. The applicable population has expanded by 30% compared to the original formula. Detailed Implementation

[0038] 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.

[0039] This invention provides a technical solution for a traditional Chinese medicine composition that tonifies both Yin and Yang and regulates both the spleen and kidneys, as well as its preparation method and application:

[0040] The composition comprises principal, assistant, adjuvant, guiding, and synergistic ingredients, and the formulation follows the principles of "mutual rooting of Yin and Yang, common origin of spleen and kidney, tonification without stagnation, and warming without drying." The composition comprises the following components by weight:

[0041] The principal herbs are: Epimedium 10-20 parts (warming and tonifying kidney yang, containing epimedin ≥0.5%) and Polygonatum 8-15 parts (nourishing yin and replenishing essence, containing Polygonatum polysaccharide ≥15%), which precisely balance yin and yang and avoid the drawbacks of simply warming yang or nourishing yin;

[0042] Assistant herbs: Astragalus membranaceus 12-20 parts (tonifies qi and raises yang, strengthens the spleen and consolidates the exterior, contains astragaloside A ≥0.08%), Rehmannia glutinosa 10-18 parts (nourishes yin and blood, replenishes essence and marrow, contains catalpol ≥0.1%), Cuscuta chinensis 9-13 parts (tonifies the kidney and replenishes essence, nourishes the liver and improves eyesight, contains dodderin ≥0.07%). This combination of tonifying qi and nourishing blood, with Cuscuta chinensis working synergistically with the principal herbs to enhance the kidney-tonifying effect, while also addressing liver yin, achieving "simultaneous tonification of the liver and kidneys".

[0043] The adjuvant herbs are: Atractylodes macrocephala 8-12 parts (strengthening the spleen and drying dampness, invigorating qi and strengthening the spleen, containing atractylodes macrocephala lactone I ≥0.05%), Cornus officinalis 6-10 parts (tonifying the liver and kidneys, astringing and consolidating, containing loganin ≥0.2%), Dioscorea opposita 10-14 parts (tonifying the spleen and stomach, promoting body fluids and benefiting the lungs, containing Dioscorea opposita polysaccharide ≥12%), and Lycium barbarum 8-12 parts (tonifying the liver and kidneys, benefiting essence and improving eyesight, containing Lycium barbarum polysaccharide ≥15%). This combination strengthens the regulation of the spleen and kidneys. Dioscorea opposita works with Atractylodes macrocephala to strengthen the spleen and alleviates the cloying nature of Rehmannia glutinosa. Lycium barbarum works with Cornus officinalis to nourish the liver and kidneys, forming a dual regulation network of "spleen and kidneys - liver and kidneys".

[0044] Medicinal ingredients: 5-8 parts dried tangerine peel (to regulate qi and harmonize the middle jiao, and prevent greasiness), 3-5 parts prepared licorice root (to harmonize the other herbs, and to replenish qi and nourish the middle jiao);

[0045] Synergistic ingredients: 5-7 parts of Alpinia oxyphylla (warms the kidneys, strengthens essence, reduces urination, warms the spleen, stops diarrhea, and reduces salivation, containing ≥0.04% Alpinia oxyphylla) and 6-8 parts of Ophiopogon japonicus (nourishes yin, generates fluids, moistens the lungs, and clears the heart, containing ≥10% Ophiopogon japonicus polysaccharide). Alpinia oxyphylla benefits both the spleen and kidneys, enhancing the effects of warming the kidneys, stopping diarrhea, and astringing. Ophiopogon japonicus, together with Polygonatum sibiricum, nourishes yin, alleviating any possible residual mild dryness, and improving symptoms of dry mouth.

[0046] In the formulation, the ratio of Epimedium to Polygonatum is 1.2:1 (balancing Yin and Yang), the ratio of Astragalus to Atractylodes macrocephala is 1.5:1 (regulating both the spleen and kidneys), and the amount of Citrus reticulata peel is ≤8 parts (to avoid depleting Qi).

[0047] A method for preparing a traditional Chinese medicine composition that tonifies both Yin and Yang and regulates both the spleen and kidneys includes the following steps:

[0048] Step 1:

[0049] Pre-treatment: Remove impurities from all Chinese medicinal materials and clean them thoroughly. Slice Epimedium, Polygonatum, Rehmannia glutinosa, Cuscuta chinensis, and Lycium barbarum into 2-4mm thick slices. Grind Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Dioscorea opposita, Alpinia oxyphylla, and Ophiopogon japonicus into coarse powder of 15-25 mesh. Grind Citrus reticulata peel and Glycyrrhiza uralensis into fine powder of 75-85 mesh. Set aside.

[0050] Step Two:

[0051] Hierarchical extraction:

[0052] Epimedium, Polygonatum, Rehmannia glutinosa, and Cuscuta chinensis were extracted twice by reflux with 60% ethanol for 110-130 minutes each time. The extracts were filtered and the filtrates were combined to obtain a fat-soluble extract. The extraction was optimized using 60% ethanol to improve the dissolution rate of fat-soluble components such as icariin and cuscuta glycoside.

[0053] Take Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Dioscorea opposita, Alpinia oxyphylla, and Ophiopogon japonicus, add water at a ratio of 1:10, bring to a boil over high heat, then simmer twice over low heat. The first simmering time is 90-110 minutes, and the second simmering time is 70-90 minutes. Filter and combine the filtrates to obtain a water-soluble extract. Extending the first simmering time improves the extraction efficiency of water-soluble components such as astragaloside A and Dioscorea opposita polysaccharides.

[0054] Fine powder of dried tangerine peel is extracted using supercritical CO2 extraction to obtain volatile oil. The extraction pressure is 30-32 MPa, the extraction temperature is 40-45℃, and the extraction time is 110-130 minutes. This method avoids the loss of volatile oil caused by traditional decoction and enhances the effects of regulating qi and harmonizing the stomach.

[0055] Step 3:

[0056] Concentration and purification: The fat-soluble extract obtained in step two is concentrated under reduced pressure to a relative density of 1.18-1.22 (58-62℃) to obtain a fat-soluble concentrated paste;

[0057] The water-soluble extract obtained in step two is first filtered through a ceramic membrane with a pore size of 100 nm to remove macromolecular impurities, and then concentrated under reduced pressure to a relative density of 1.12-18 (58-62℃) to obtain a water-soluble concentrated paste. Adding a membrane filtration step improves product purity and reduces potential discomfort such as bloating.

[0058] Step Four:

[0059] Mixing and granulation: The fat-soluble concentrated paste and water-soluble concentrated paste obtained in step 3 are mixed evenly, and the volatile oil of dried tangerine peel obtained in step 2, the fine powder of roasted licorice obtained in step 1, and 9-11 parts of dextrin are added. The mixture is stirred evenly to form a soft mass. The dextrin excipient can improve the flowability of the granules.

[0060] The above soft material is granulated by passing it through a 16-mesh sieve and then dried in a vacuum drying oven at a temperature of 58-62℃ for 180-200 minutes. The material is turned over twice during the drying process to ensure uniform drying and obtain dry granules. Vacuum drying reduces the oxidation of active ingredients and improves stability.

[0061] The dry granules are sieved through a 20-mesh sieve to remove fine powder and large particles, resulting in uniform granules.

[0062] Step 5: Capsule filling: Fill the capsules with the uniform granules from step 4, 0.5g per capsule. Use enteric-coated empty capsules to avoid stomach acid damaging the active ingredients and ensure precise release in the intestines. Preferred embodiment

[0063] The traditional Chinese medicine composition includes principal drug, assistant drug, adjuvant drug, guiding drug, and synergistic ingredients. The composition comprises the following components by weight:

[0064] Principal herbs: 15 parts of Epimedium (containing ≥0.5% icariin) and 12 parts of Polygonatum (containing ≥15% Polygonatum polysaccharide);

[0065] The following herbs were used: Astragalus membranaceus 16 parts (containing astragaloside A ≥ 0.08%), Rehmannia glutinosa 14 parts (containing catalpol ≥ 0.1%), and Cuscuta chinensis 11 parts (containing cuscutoside ≥ 0.07%).

[0066] Adjuvant herbs: 10 parts of Atractylodes macrocephala (containing ≥0.05% atractylodes lactone I), 8 parts of Cornus officinalis (containing ≥0.2% loganin), 12 parts of Dioscorea opposita (containing ≥12% yam polysaccharide), and 10 parts of Lycium barbarum (containing ≥15% lycium barbarum polysaccharide);

[0067] Used ingredients: 6 parts dried tangerine peel, 4 parts prepared licorice root;

[0068] Synergistic ingredients: 7 parts of Alpinia oxyphylla (containing ≥0.04% Alpinia oxyphylla polysaccharide) and 7 parts of Ophiopogon japonicus (containing ≥10% Ophiopogon japonicus polysaccharide);

[0069] A method for preparing a traditional Chinese medicine composition that tonifies both Yin and Yang and regulates both the spleen and kidneys includes the following steps:

[0070] Step 1:

[0071] Pre-treatment: Remove impurities and clean all Chinese medicinal materials. Slice Epimedium, Polygonatum, Rehmannia glutinosa, Cuscuta chinensis, and Lycium barbarum into 3mm thick slices. Grind Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Dioscorea opposita, Alpinia oxyphylla, and Ophiopogon japonicus into coarse powder of 20 mesh. Grind Citrus reticulata and Glycyrrhiza uralensis into fine powder of 80 mesh. Set aside.

[0072] Step Two:

[0073] Hierarchical extraction:

[0074] Epimedium, Polygonatum, Rehmannia glutinosa, and Cuscuta chinensis were added and refluxed twice with 60% ethanol for 120 minutes each time. The extracts were filtered and the filtrates were combined to obtain a fat-soluble extract. The extraction was optimized using 60% ethanol.

[0075] Take Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Dioscorea opposita, Alpinia oxyphylla, and Ophiopogon japonicus, add water at a ratio of 1:10, bring to a boil over high heat, then simmer twice over low heat, for 90 minutes the first time and 70 minutes the second time; filter, combine the filtrates to obtain a water-soluble extract.

[0076] Fine powder of dried tangerine peel was extracted using supercritical CO2 extraction to obtain volatile oil from the tangerine peel. The extraction pressure was 31 MPa, the extraction temperature was 42℃, and the extraction time was 120 minutes.

[0077] Step 3:

[0078] Concentration and purification: The lipid-soluble extract obtained in step two is concentrated under reduced pressure to a relative density of 1.2 (60℃) to obtain a lipid-soluble concentrated paste;

[0079] The water-soluble extract obtained in step two is first filtered through a ceramic membrane with a pore size of 100 nm to remove macromolecular impurities, and then concentrated under reduced pressure to a relative density of 1.15 (60℃) to obtain a water-soluble concentrated paste.

[0080] Step Four:

[0081] Mixing and granulation: The fat-soluble concentrated paste and water-soluble concentrated paste obtained in step three are mixed evenly, and the volatile oil of dried tangerine peel obtained in step two, the fine powder of roasted licorice obtained in step one, and 10 parts of dextrin are added. The mixture is stirred evenly to make a soft mass. The dextrin excipient can improve the flowability of the granules.

[0082] The above soft material was granulated by passing it through a 16-mesh sieve and then dried in a vacuum drying oven at a temperature of 60°C for 180 minutes, turning it over twice during the drying process to ensure uniform drying and obtain dry granules.

[0083] The dry granules are sieved through a 20-mesh sieve to remove fine powder and large particles, resulting in uniform granules.

[0084] Step 5: Capsule filling: Fill the capsules with the uniform granules obtained from step 4, 0.5g per capsule.

[0085] Alternatives for principal herbs: If Epimedium is unavailable, Morinda officinalis 10-15 parts (containing the same kidney-tonifying component Morinda officinalis oligosaccharide) (containing Morinda officinalis oligosaccharide ≥0.3%) can be used as a substitute to maintain the effect of warming and tonifying kidney yang; if Polygonatum sibiricum is unavailable, Polygonatum odoratum 10-14 parts (containing Polygonatum odoratum polysaccharide ≥16%) can be used as a substitute, with comparable yin-nourishing effects, and the other components remain unchanged.

[0086] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A kidney-tonifying and spleen-nourishing traditional Chinese medicine composition for tonifying kidney and regulating spleen and kidney, characterized in that: The composition comprises monarch drug, minister drug, auxiliary drug, assistant drug and synergistic component, and comprises the following components by weight: ​ Monarch drug: Herba Epimedii 10-20 parts (containing icariin ≥0.5%), Rhizoma Polygonati 8-15 parts (containing rhizoma polygonati polysaccharide ≥15%); Minister drug: Radix Astragali 12-20 parts (containing astragaloside ≥0.08%), Radix Rehmanniae Preparata 10-18 parts (containing catalpol ≥0.1%), Semen Trichosanthis 9-13 parts (containing trichosanthin glycoside ≥0.07%); Auxiliary drug: Rhizoma Atractylodis Macrocephalae 8-12 parts (containing atractylodes lactone I ≥0.05%), Fructus Corni 6-10 parts (containing loganin ≥0.2%), Rhizoma Dioscoreae 10-14 parts (containing dioscorea polysaccharide ≥12%), Fructus Lycii 8-12 parts (containing lycium polysaccharide ≥15%); Assistant drug: Pericarpium Citri Reticulatae 5-8 parts, Radix Glycyrrhizae Preparata 3-5 parts; Synergistic component: Fructus Evodiae 5-7 parts (containing evodiamine ≥0.04%), Radix Ophiopogonis 6-8 parts (containing radix ophiopogonis polysaccharide ≥10%).

2. The preparation method of the kidney-tonifying and spleen-nourishing traditional Chinese medicine composition according to claim 1, characterized in that: The method comprises the following steps: Step one: Preprocessing: remove impurities and clean all traditional Chinese medicine raw materials, slice Herba Epimedii, Rhizoma Polygonati, Radix Rehmanniae Preparata, Semen Trichosanthis and Fructus Lycii, crush Radix Astragali, Rhizoma Atractylodis Macrocephalae, Fructus Corni, Rhizoma Dioscoreae, Fructus Evodiae and Radix Ophiopogonis into coarse powder, crush Pericarpium Citri Reticulatae and Radix Glycyrrhizae Preparata into fine powder, and reserve them for use; Step two: Fractional extraction: Take Herba Epimedii, Rhizoma Polygonati, Radix Rehmanniae Preparata and Semen Trichosanthis, add 60% ethanol, reflux extraction, filter, combine the filtrate, and obtain fat-soluble extract; Take Radix Astragali, Rhizoma Atractylodis Macrocephalae, Fructus Corni, Rhizoma Dioscoreae, Fructus Evodiae and Radix Ophiopogonis, add water, first boil with strong fire, then simmer twice with weak fire, filter, combine the filtrate, and obtain water-soluble extract; Take Pericarpium Citri Reticulatae fine powder, extract Pericarpium Citri Reticulatae volatile oil by supercritical CO2 extraction method, and reserve it for use; Step three: Concentration and purification: concentrate the fat-soluble extract obtained in step two under reduced pressure to relative density 1.18-1.22 (58-62°C), and obtain fat-soluble concentrated paste; Filter the water-soluble extract obtained in step two by ceramic membrane with pore size of 100 nm to remove macromolecular impurities, then concentrate under reduced pressure to relative density 1.12-18 (58-62°C), and obtain water-soluble concentrated paste; Step four: Mixing and granulation: mix the fat-soluble concentrated paste and water-soluble concentrated paste obtained in step three uniformly, add Pericarpium Citri Reticulatae volatile oil obtained in step two, Radix Glycyrrhizae Preparata fine powder obtained in step one and dextrin 9-11 parts, stir uniformly to form soft material; Pass the soft material through a 16-mesh sieve to granulate, place it in a vacuum drying oven, turn over twice during the period to ensure uniform drying, and obtain dry granules; Pass the dry granules through a 20-mesh sieve to granulate, remove fine powder and large granules, and obtain uniform granules; Step five: capsule filling: fill the uniform granules obtained after granulation in step four into capsules, and each capsule contains 0.5 g.

3. The preparation method of the kidney-tonifying and spleen-nourishing traditional Chinese medicine composition according to claim 2, characterized in that: In step one, the thickness of Herba Epimedii, Rhizoma Polygonati, Radix Rehmanniae Preparata, Semen Trichosanthis and Fructus Lycii slices is 2-4 mm, the crushing of Radix Astragali, Rhizoma Atractylodis Macrocephalae, Fructus Corni, Rhizoma Dioscoreae, Fructus Evodiae and Radix Ophiopogonis into coarse powder is 15-25 mesh, and the crushing of Pericarpium Citri Reticulatae and Radix Glycyrrhizae Preparata into fine powder is 75-85 mesh.

4. The preparation method of the kidney-tonifying and spleen-nourishing traditional Chinese medicine composition according to claim 2, characterized in that: The reflux extraction in the second step is carried out twice, each time for 110-130 minutes, the amount of water added in the second step is 1:10 of the material liquid ratio, and the decoction is carried out twice with small fire, the first time for 90-110 minutes and the second time for 70-90 minutes; the extraction pressure in the second step is 30-32 MPa, the extraction temperature is 40-45℃, and the extraction time is 110-130 minutes.

5. The preparation method of the kidney-tonifying and spleen-nourishing traditional Chinese medicine composition according to claim 2, characterized in that: The temperature for drying the soft material in the fourth step is 58-62℃, and the time is 180-200 minutes.

6. The application of the yin-yang complementary and spleen-kidney harmonizing kidney-tonifying and spleen-nourishing traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is applied to the kidney and spleen tonifying aspect of yin and yang double tonifying and spleen and kidney same regulation.