Traditional Chinese medicine composition with effects of benefiting qi, nourishing blood, invigorating spleen and tonifying kidney and preparation method of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition with the effects of benefiting qi, nourishing blood, invigorating the spleen and tonifying the kidney and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: cistanche, ginseng, American ginseng, astragalus membranaceus, medlar, rhizoma polygonati, oyster peptide, angelica sinensis, radix rehmanniae preparata, donkey-hide gelatin, fructus amomi, pericarpium citri reticulatae, hawthorn, folium cortex eucommiae, radix puerariae, liquorice and the like. The preparation method comprises the following steps: respectively crushing the medicinal materials, dissolving the colla corii asini, mixing, adding water, granulating and the like. The composition can be prepared into various dosage forms such as granules, capsules, tablets, oral liquid and the like. Experiments show that the traditional Chinese medicine composition can effectively improve the symptoms of deficiency of qi and blood (increasing erythrocyte count and hemoglobin content), weakness of spleen and stomach (increasing body weight and improving pepsin activity) and kidney deficiency (reducing creatinine and urea nitrogen content and improving SOD activity), and acute toxicity experiments show that the toxicity is slightly reversible under high dosage, and the safety is good under therapeutic dosage. The traditional Chinese medicine composition has potential application value in the aspect of preparing medicines for benefiting qi, nourishing blood, invigorating spleen and tonifying kidney.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition having the effects of invigorating qi and blood and strengthening the spleen and kidneys, and a preparation method thereof. Background Art

[0002] In modern society, with the increasingly fast pace of life, people have been under high-intensity work pressure, irregular work and rest, and unhealthy eating habits for a long time. This lifestyle has caused the body's functions to gradually become unbalanced, and sub-health conditions such as insufficient qi and blood, weak spleen and stomach, and kidney deficiency have become more and more common. According to relevant survey data, among urban office workers, more than 60% of people have varying degrees of qi and blood deficiency symptoms, manifested as pale complexion, dizziness, fatigue, palpitations, insomnia, etc.; about 75% of people have poor spleen and stomach function, often with loss of appetite, indigestion, abdominal distension and pain, etc.; and kidney deficiency symptoms are also more common in men and women, affecting people's quality of life and physical health.

[0003] As a treasure of traditional Chinese medicine, Chinese medicine has unique advantages and a long history in regulating the body and improving sub-health conditions. Traditional Chinese medicine has accumulated rich experience and a large number of classic prescriptions in replenishing qi and blood, strengthening the spleen and kidney, such as Bazhen Decoction, Sijunzi Decoction, Liuwei Dihuang Pills, etc. These prescriptions can relieve related symptoms to a certain extent. However, some existing Chinese medicine compositions still have many problems in practical application.

[0004] On the one hand, the formula of some Chinese medicine combinations is unreasonable. Some prescriptions may focus on a certain aspect of efficacy, such as simply focusing on replenishing qi while ignoring nourishing blood, or only emphasizing invigorating the kidney while ignoring strengthening the spleen, resulting in poor overall conditioning effects and failure to comprehensively improve the body's qi, blood, spleen, stomach and kidney functions. Moreover, the compatibility ratio between drugs may not be scientific enough, and the synergistic effect of each medicinal material cannot be fully exerted. There may even be a situation where the drugs antagonize each other, affecting the efficacy of the drugs.

[0005] On the other hand, there are defects in the preparation process. Some traditional preparation methods are complicated and require multiple tedious processes, such as long-term decoction, multiple concentrations and purifications, which not only increase production costs, but also may lead to the loss of active ingredients and reduce the efficacy of the Chinese medicine composition. At the same time, some preparation processes are difficult to ensure the stability and uniformity of product quality, and different batches of products may have large differences in efficacy.

[0006] In addition, modern society has also put forward higher requirements for the safety and convenience of Chinese medicine products. Some traditional Chinese medicine compositions may contain some medicinal materials with potential toxicity or adverse reactions, or use some solvents and additives that are harmful to the human body during the preparation process, which poses certain safety hazards. Moreover, traditional Chinese medicine dosage forms such as decoctions, pills, etc. are inconvenient to take, which is not conducive to people's daily use under the modern fast-paced lifestyle. Therefore, it is of great practical significance to develop a Chinese medicine composition with a scientific and reasonable formula, strong synergistic effect of various medicinal materials, which can comprehensively and effectively replenish qi and nourish blood, strengthen the spleen and benefit the kidneys, and at the same time has a simple preparation process, stable quality, high safety and convenient taking. It is also a problem to be solved in the current field of Chinese medicine. Summary of the invention

[0007] Purpose of the Invention

[0008] The object of the present invention is to provide a Chinese medicine composition with the effects of invigorating qi and nourishing blood and strengthening the spleen and kidney, which can effectively improve the symptoms of qi and blood deficiency, spleen and stomach weakness, kidney deficiency, etc., and improve human immunity and health level. At the same time, a preparation method of the Chinese medicine composition is provided, which has a simple process, is easy to operate, and can ensure the quality and efficacy of the Chinese medicine composition. In addition, the present invention also aims to provide a Chinese medicine composition that can be used in a variety of dosage forms to meet the needs of different consumers.

[0009] Technical Solution

[0010] Composition of the Chinese medicine composition: The Chinese medicine composition of the present invention is prepared from the following raw materials in parts by weight: 10-20 parts of Cistanche deserticola, 5-15 parts of ginseng, 5-15 parts of American ginseng, 10-30 parts of Astragalus, 10-20 parts of Lycium barbarum, 10-20 parts of Polygonatum, 5-15 parts of oyster peptide, 5-15 parts of Angelica sinensis, 10-20 parts of Rehmannia glutinosa, 5-15 parts of donkey-hide gelatin, 3-10 parts of Amomum villosum, 5-15 parts of dried tangerine peel, 5-15 parts of hawthorn, 5-15 parts of Eucommia ulmoides leaves, 5-15 parts of Pueraria root, and 3-10 parts of liquorice.

[0011] 1. Cistanche deserticola: It tastes sweet and salty, is warm in nature, and enters the kidney and large intestine meridians. It has the effects of tonifying kidney yang, benefiting essence and blood, and moistening the intestines and relieving constipation. Modern pharmacological studies have shown that Cistanche deserticola contains a variety of active ingredients such as phenylethanol glycosides and cyclopentane ether terpenes, which can regulate human endocrine, enhance immunity, and promote gonadal function. It has a good improvement effect on symptoms such as soreness of waist and knees, impotence and infertility caused by insufficient kidney yang and deficiency of essence and blood.

[0012] 2. Ginseng: It tastes sweet and slightly bitter, is slightly warm in nature, and enters the spleen, lung, heart, and kidney meridians. It greatly replenishes vital energy, restores the pulse and consolidates the body, replenishes the spleen and lungs, promotes the production of body fluids and nourishes blood, and calms the mind and improves intelligence. Ginseng contains active ingredients such as ginsenosides and ginseng polysaccharides, which can improve the body's adaptability, enhance anti-fatigue ability, regulate the central nervous system, and have significant therapeutic effects on symptoms such as qi deficiency and weakness, cold limbs and weak pulse.

[0013] 3. American ginseng: It tastes sweet and slightly bitter, is cool in nature, and enters the heart, lung, and kidney meridians. It has the effects of replenishing qi and nourishing yin, clearing away heat and promoting body fluid. The ingredients contained in it, such as American ginsenosides, can resist fatigue, resist hypoxia, and regulate blood sugar. It has a good conditioning effect on symptoms such as qi and yin deficiency, deficiency heat and fatigue. When used with ginseng, it can enhance the effect of replenishing qi and avoid the warm and dry nature.

[0014] 4. Astragalus: sweet in taste, slightly warm in nature, and enters the spleen and lung meridians. It can replenish qi and raise yang, strengthen the exterior and stop sweating, promote diuresis and reduce swelling, promote fluid production and nourish blood, relieve stagnation and relieve arthritis, remove toxins and discharge pus, and heal sores and promote tissue regeneration. Astragalus is rich in astragalus polysaccharides and astragaloside, which can enhance the body's immune function, promote the body's metabolism, and have a good improvement effect on spleen deficiency, fatigue, and sinking of qi in the middle.

[0015] 5. Wolfberry: Sweet in taste, neutral in nature, enters the liver and kidney meridians. Nourishes the liver and kidneys, improves the essence and improves eyesight. Wolfberry contains wolfberry polysaccharides, carotenoids and other ingredients, which have antioxidant, immune regulation, and anti-fatigue effects. It can be used to regulate symptoms such as liver and kidney yin deficiency, soreness of waist and knees, and blurred vision.

[0016] 6. Polygonatum: Sweet in taste, neutral in nature, enters the spleen, lung, and kidney meridians. It replenishes qi and nourishes yin, strengthens the spleen, moistens the lungs, and benefits the kidneys. Polygonatum contains polysaccharides and steroidal saponins, which can improve the body's immunity, delay aging, and have a certain effect on spleen and stomach qi deficiency, fatigue, lung deficiency and dry cough, kidney deficiency and essence deficiency, etc.

[0017] 7. Oyster peptide: It is a small molecule active peptide obtained by enzymatic hydrolysis or hydrolysis of oysters, rich in various amino acids, trace elements, etc. It has the effects of enhancing immunity, anti-oxidation, anti-fatigue, regulating blood lipids, etc. It can also supplement nutrition for the body, and can be combined with other Chinese medicines to synergistically enhance the overall efficacy.

[0018] 8. Angelica: Sweet and spicy, warm in nature, it enters the liver, heart and spleen meridians. It nourishes blood and activates blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements. Angelica contains volatile oils, ferulic acid and other ingredients, which can promote hematopoiesis, regulate uterine smooth muscle, and have a good therapeutic effect on blood deficiency, chlorosis, dizziness, palpitations, and irregular menstruation.

[0019] 9. Rehmannia glutinosa: sweet in taste, slightly warm in nature, enters the liver and kidney meridians. It nourishes blood and yin, replenishes essence and fills the marrow. Rehmannia glutinosa contains ingredients such as catalpol and rehmannia polysaccharide, which can improve the body's immunity, nourish blood, and have significant therapeutic effects on blood deficiency, liver and kidney yin deficiency, and soreness of waist and knees.

[0020] 10. Donkey-hide gelatin: sweet in taste, neutral in nature, enters the lung, liver, and kidney meridians. It nourishes blood and yin, moisturizes dryness, and stops bleeding. Donkey-hide gelatin contains collagen, various amino acids, etc., which can promote hematopoietic function, improve anemia symptoms, and have a good conditioning effect on blood deficiency, chlorosis, dizziness, palpitations, restlessness, and insomnia.

[0021] 11. Amomum villosum: spicy, warm in nature, enters the spleen, stomach, and kidney meridians. It can remove dampness and stimulate appetite, warm the spleen and stop diarrhea, regulate qi and stabilize pregnancy. Amomum villosum contains volatile oils and other ingredients that can promote gastrointestinal motility, enhance digestive function, and relieve symptoms such as spleen and stomach qi stagnation and abdominal distension and pain.

[0022] 12. Tangerine peel: bitter and pungent, warm in nature, enters the spleen and lung meridians. It regulates qi and strengthens the spleen, dries dampness and resolves phlegm. Tangerine peel contains volatile oils, hesperidin and other ingredients, which can promote the secretion of digestive juices and eliminate gas accumulation in the intestines. It has a certain therapeutic effect on weak spleen and stomach, indigestion, cough and phlegm.

[0023] 13. Hawthorn: It tastes sour and sweet, is slightly warm in nature, and enters the spleen, stomach, and liver meridians. It helps digestion and invigorates the stomach, promotes qi and dissipates blood stasis, and reduces turbidity and lipids. Hawthorn contains ingredients such as maslinic acid and flavonoids, which can promote fat digestion and increase the secretion of gastric digestive enzymes. It has a good effect on meat stagnation and stomach distension.

[0024] 14. Eucommia leaves: slightly spicy, warm in nature, enter the liver and kidney meridians. Nourish the liver and kidneys, strengthen the tendons and bones. Eucommia leaves contain ingredients such as eucommia gum and eucommia glycosides, which can regulate blood lipids, enhance the body's immunity, and have a certain improvement effect on liver and kidney deficiency, waist and knee pain, etc.

[0025] 15. Pueraria root: sweet and spicy, cool in nature, enters the spleen, stomach, and lung meridians. It can relieve muscle and fever, promote fluid production and quench thirst, promote rash, raise yang and stop diarrhea, promote blood circulation and activate collaterals, and relieve alcohol poisoning. In this composition, it can be used in conjunction with astragalus and other herbs to replenish qi and raise yang, improve problems such as the failure of clear qi to rise caused by weak spleen and stomach, and at the same time, its role in promoting fluid production can relieve symptoms such as thirst caused by insufficient qi and blood.

[0026] 16. Licorice: sweet in taste, neutral in nature, and enters the heart, lung, spleen, and stomach meridians. It nourishes the spleen and replenishes qi, clears away heat and detoxifies, removes phlegm and relieves cough, relieves pain, and harmonizes various medicines. In this composition, licorice can not only harmonize various medicines, so that the various medicinal materials can better play a synergistic role, but also alleviate the toxicity or potency of some drugs, enhance the safety and stability of the prescription, and at the same time, its effect of nourishing the spleen and replenishing qi also helps to enhance the spleen and stomach function, and assists in the treatment of spleen and stomach weakness.

[0027] The principle of drug compatibility

[0028] 1. Tonify Qi and nourish blood: Ginseng, American ginseng, and astragalus in the prescription are all important medicines for replenishing Qi. Ginseng greatly replenishes vital energy, restores pulse and consolidates deficiency, and can enhance the body's physiological functions and resistance; American ginseng replenishes Qi and nourishes Yin, clears away heat and promotes fluid production, and can be used with ginseng to enhance the power of replenishing Qi and avoid warm and dryness; astragalus replenishes Qi and raises Yang, consolidates the surface and stops sweating, can raise Yang Qi, and encourage the growth of Qi and blood. Angelica, Rehmannia glutinosa, and donkey-hide gelatin are classic blood-replenishing medicines. Angelica replenishes blood and activates blood circulation, regulates menstruation and relieves pain; Rehmannia glutinosa replenishes blood and nourishes Yin, replenishes essence and fills the marrow; donkey-hide gelatin replenishes blood and nourishes Yin, moisturizes dryness and stops bleeding. These medicines are compatible with each other to replenish both Qi and blood, and have a significant improvement effect on symptoms such as pale complexion, dizziness, fatigue, palpitations and insomnia caused by insufficient Qi and blood.

[0029] 2. Strengthening the spleen and kidney: In terms of strengthening the spleen, ginseng, astragalus, polygonatum, amomum, tangerine peel, hawthorn, and licorice all play an important role. Ginseng and astragalus can strengthen the spleen and replenish qi; polygonatum replenishes qi and nourishes yin, strengthens the spleen, moistens the lungs and benefits the kidney; amomum can eliminate dampness and stimulate appetite, warm the spleen and stop diarrhea, and can promote the spleen and stomach transportation; tangerine peel regulates qi and strengthens the spleen, dries dampness and resolves phlegm, and can regulate the spleen and stomach qi; hawthorn can help digestion and strengthen the stomach, especially good at digesting meat stagnation, which helps to enhance the digestive function of the spleen and stomach; licorice can nourish the spleen and replenish qi, harmonize various medicines, and better restore the spleen and stomach function. In terms of benefiting the kidney, Cistanche, wolfberry, Rehmannia glutinosa, Eucommia ulmoides, and Polygonatum all belong to the kidney meridian and have the effect of nourishing the kidney and benefiting essence. Cistanche can nourish kidney yang and benefit essence and blood; wolfberry can nourish the liver and kidney, benefit essence and improve eyesight; Rehmannia glutinosa can nourish yin and nourish the kidney, replenish essence and benefit marrow; Eucommia ulmoides can nourish the liver and kidney, strengthen tendons and bones; Polygonatum glutinosa can nourish the yin of the liver and kidney. These medicines are compatible with each other to nourish the kidneys from the aspects of yin and yang, and have a good regulating effect on symptoms such as weakness in the waist and knees, and sexual dysfunction caused by liver and kidney deficiency.

[0030] 3. Regulate immunity: Ginseng, astragalus, wolfberry, polygonatum, oyster peptide, licorice, etc. all have the function of regulating immune function. Ginseng contains ginsenosides, ginseng polysaccharides and other ingredients, which can improve the body's adaptability and immune function; astragalus is rich in astragalus polysaccharides, astragalus saponins, etc., which can enhance the body's immune function; wolfberry contains wolfberry polysaccharides, which can enhance nonspecific immunity and specific immunity; polygonatum polysaccharides, steroidal saponins, etc. contained in polygonatum can improve the body's immunity; oyster peptides are rich in various amino acids, trace elements, etc., which can enhance immunity; licorice contains glycyrrhizin and other ingredients, which have immunomodulatory effects. The synergistic effect of multiple drugs can enhance the body's resistance and improve the body's immune level.

[0031] 4. Anti-fatigue and anti-oxidation: Ginseng, American ginseng, astragalus, wolfberry, oyster peptide and other drugs have anti-fatigue effects. Ginseng and American ginseng can improve the body's anti-stress ability, enhance physical strength and endurance; astragalus can promote the body's metabolism and enhance anti-fatigue ability; wolfberry has an antioxidant effect, can remove free radicals in the body, and reduce oxidative stress damage; oyster peptide has antioxidant and anti-fatigue effects. These drugs are compatible with each other, which helps to relieve physical fatigue and delay the aging process.

[0032] 5. Promote digestion: Amomum villosum, tangerine peel, hawthorn, licorice and other drugs have a positive regulating effect on the digestive system. Amomum villosum can promote gastrointestinal motility, enhance digestive function, and relieve spleen and stomach qi stagnation; tangerine peel can promote the secretion of digestive juice, eliminate intestinal gas, and improve the symptoms of spleen and stomach weakness and indigestion; hawthorn contains a variety of organic acids and digestive enzymes, which can promote fat digestion and increase the secretion of gastric digestive enzymes; licorice can protect the gastric mucosa and relieve stomachache and other discomfort symptoms. They work together to improve the digestion and absorption function of the spleen and stomach.

[0033] 6. Harmonize the properties of medicines: Licorice is sweet and mild in nature, and can harmonize various medicines, moderate the bias of other medicines in the prescription, and make the medicine more moderate and lasting. It can moderate the strong tonic effect of ginseng, astragalus and other qi-tonifying medicines, making them tonic without being dry; moderate the nourishing and greasy nature of tonic medicines such as donkey-hide gelatin, making them easier for the spleen and stomach to absorb; it can also reduce the possible toxicity or adverse reactions of some drugs, and enhance the safety and stability of the prescription.

[0034] 7. Comprehensive conditioning: Pueraria root can relieve muscle and reduce fever, promote fluid production and quench thirst, raise yang and stop diarrhea, and promote blood circulation. The puerarin and flavonoids contained in it can dilate blood vessels, improve microcirculation, reduce blood viscosity, and reduce blood sugar and lipids. In prescriptions, Pueraria root can be used in conjunction with qi-tonifying drugs to enhance the effect of replenishing qi and raising yang, and help improve symptoms such as qi failure and diarrhea caused by spleen and stomach weakness. At the same time, its fluid-producing effect can relieve symptoms such as dry mouth and thirst caused by insufficient qi and blood, yin deficiency and hyperactivity of fire, etc. Eucommia leaves can regulate blood lipids, enhance the body's immunity, and further regulate the body's overall function.

[0035] The preferred formula is: 15 parts of Cistanche deserticola, 10 parts of Ginseng, 10 parts of American Ginseng, 20 parts of Astragalus, 15 parts of Lycium barbarum, 15 parts of Polygonatum, 10 parts of Oyster Peptide, 10 parts of Angelica sinensis, 15 parts of Rehmannia glutinosa, 10 parts of Ejiao, 6 parts of Amomum villosum, 10 parts of Tangerine Peel, 10 parts of Hawthorn, 10 parts of Eucommia Leaf, 10 parts of Pueraria lobata, and 6 parts of Licorice. In this carefully prepared formula, the dosage of each herbal medicine has been repeatedly considered and weighed, coordinated and closely cooperated with each other, which can not only fully and deeply achieve the effects of replenishing Qi and blood, strengthening the spleen and benefiting the kidney, but also cleverly avoid the imbalance of efficacy or adverse reactions caused by improper dosage of certain herbs.

[0036] Specifically, herbs such as Cistanche deserticola, Rehmannia glutinosa, Lycium barbarum, and Polygonatum sibiricum that nourish the liver and kidneys are compatible with herbs such as Astragalus membranaceus, Ginseng, and American ginseng that replenish qi, forming a good pattern of mutual nourishment of qi and blood. Cistanche deserticola warms and replenishes kidney yang, benefits essence and blood, Rehmannia glutinosa nourishes yin and blood, benefits essence and fills marrow, Lycium barbarum nourishes liver and kidneys, benefits essence and improves eyesight, Polygonatum sibiricum replenishes qi and nourishes yin, strengthens spleen, moistens lungs and benefits kidneys. They work synergistically with Astragalus membranaceus, Ginseng, and American ginseng that replenish qi, making qi produce blood, blood carry qi, and the effect of replenishing both qi and blood is significantly enhanced, thus playing a more powerful conditioning role in conditions such as insufficient qi and blood, and liver and kidney deficiency.

[0037] Amomum villosum, dried tangerine peel, hawthorn and other herbs that strengthen the spleen and digestion work together with other herbs to play a key role in promoting the spleen and stomach to transport and absorb drugs and food. Amomum villosum can eliminate dampness and stimulate appetite, warm the spleen and stop diarrhea, dried tangerine peel can regulate qi and strengthen the spleen, dry dampness and resolve phlegm, hawthorn can help digestion and strengthen the stomach, and promote qi and disperse blood stasis. They can enhance the transport and transformation function of the spleen and stomach, so that the effective ingredients of the drugs can be better absorbed and utilized, thereby improving the efficacy of the entire prescription.

[0038] Pueraria root is sweet and pungent in taste, cool in nature, and enters the spleen, stomach, and lung meridians. It has the effects of relieving muscle and fever, promoting fluid and quenching thirst, raising yang and stopping diarrhea, promoting blood circulation and activating collaterals, and detoxifying alcohol. The puerarin and flavonoids contained in it can dilate coronary arteries and cerebral blood vessels, improve microcirculation, reduce blood viscosity, and regulate sugar and lipid metabolism. In this formula, Pueraria root can cooperate with Qi-tonifying drugs such as Astragalus and ginseng to further enhance the effect of Qi-tonifying and Yang-raising, and effectively improve symptoms such as Qi failure and diarrhea caused by spleen and stomach weakness; its effect of promoting fluid and quenching thirst can relieve discomfort such as dry mouth and thirst caused by insufficient Qi and blood, and Yin deficiency and hyperactivity of fire.

[0039] Licorice is sweet and neutral in nature. It enters the heart, lung, spleen, and stomach meridians. It has the functions of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving pain, and harmonizing various medicines. The glycyrrhizin, glycyrrhizic acid, flavonoids and other ingredients contained in licorice can not only regulate immunity, resist inflammation, and resist allergies, but also play a key role in harmonizing various medicines in prescriptions. It can alleviate the harsh nature of qi-tonifying medicines such as ginseng and astragalus in the prescription, making them tonifying without being dry; alleviate the nourishing and greasy nature of tonic medicines such as donkey-hide gelatin, and promote the absorption of tonic medicines by the spleen and stomach; at the same time, it can also reduce the possible toxicity or adverse reactions of some drugs, enhance the safety and stability of the prescription, make the entire prescription more peaceful and lasting, and better play its efficacy.

[0040] The combination of these medicines has multiple effects such as replenishing qi and blood, strengthening the spleen and kidneys, regulating immunity, and improving metabolism. It has a comprehensive regulating effect on various symptoms such as qi and blood deficiency, weak spleen and stomach, and kidney deficiency, while taking into account the safety and effectiveness of the drugs.

[0041] Preparation method:

[0042] 1. Wash and dry Cistanche deserticola, ginseng, American ginseng, astragalus, wolfberry, polygonatum, angelica, rehmannia, eucommia leaf, kudzu root and licorice respectively, grind them into fine powder, pass through 80-100 mesh sieve and set aside;

[0043] 2. Wash and dry Amomum villosum, dried orange peel and hawthorn separately, grind into coarse powder, pass through 60-80 mesh sieve and set aside;

[0044] 3. Take donkey-hide gelatin, add appropriate amount of rice wine, heat in water until dissolved, and set aside;

[0045] -Mix the fine powder and coarse powder obtained in the above steps evenly, add the dissolved donkey-hide gelatin and oyster peptide, and stir evenly;

[0046] 4. Add appropriate amount of water to make a soft material, granulate through a 16-20 mesh sieve, dry, and granulate to obtain the Chinese medicine composition granules.

[0047] Dosage form expansion: The Chinese medicine composition of the present invention can not only be prepared into granules, but can also be further processed into capsules, tablets, oral liquids and other dosage forms according to different needs and usage scenarios.

[0048] Capsules: The prepared Chinese medicine composition particles are filled into hollow capsules to make capsules. Capsules are easy to take, can cover up the bad smell of the drug, and after the drug disintegrates in the gastrointestinal tract, it can quickly release the drug components and improve bioavailability.

[0049] Tablets: Based on the granules of the Chinese medicine composition, appropriate amounts of adhesives, disintegrants and other auxiliary materials are added, and tablets are made through tableting and other processes. The tablets have accurate dosage, stable quality, and are easy to take and carry.

[0050] Oral solution: The Chinese medicine composition particles are dissolved in an appropriate amount of solvent (such as water), and then filtered and sterilized to make an oral solution. The oral solution is quickly absorbed and tastes good, and is suitable for children, the elderly and patients with dysphagia.

[0051] Beneficial Effects

[0052] 1. Significant efficacy: In the Chinese medicine composition of the present invention, Cistanche deserticola nourishes kidney yang and benefits essence and blood; ginseng, American ginseng, and astragalus nourish qi and strengthen the exterior; wolfberry and polygonatum nourish the liver and kidney; oyster peptide supplements nutrition and improves immunity; angelica and rehmannia nourish blood and promote blood circulation; donkey-hide gelatin nourishes blood and nourishes yin; Amomum villosum, tangerine peel, and hawthorn strengthen the spleen and appetite, and digest food and eliminate accumulation; Eucommia leaf nourishes the liver and kidney and strengthens the tendons and bones; Pueraria root is sweet and spicy, cool in nature, and enters the spleen, stomach, and lung meridians, and has the effects of relieving muscles and reducing fever, promoting body fluid and quenching thirst, raising yang and stopping diarrhea, promoting blood circulation and activating collaterals, and detoxifying alcohol. Pueraria root can cooperate with qi-tonifying drugs such as astragalus and ginseng to further enhance the effect of invigorating qi and raising yang, and effectively improve the symptoms of qi failure and diarrhea caused by spleen and stomach weakness; its effect of promoting fluid and quenching thirst can relieve discomfort such as dry mouth and thirst caused by insufficient qi and blood, yin deficiency and hyperactivity of fire. Licorice is sweet in taste and neutral in nature. It belongs to the heart, lung, spleen and stomach meridians. It has the effects of invigorating spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving urgency and relieving pain, and harmonizing various drugs. It can alleviate the harsh nature of qi-tonifying drugs such as ginseng and astragalus in the prescription, making them invigorating without being dry; alleviate the nourishing and greasy nature of tonic drugs such as donkey-hide gelatin, and promote the absorption of tonic drugs by the spleen and stomach; at the same time, it can also reduce the possible toxicity or adverse reactions of some drugs, enhance the safety and stability of the prescription, make the whole prescription more peaceful and lasting, and better play its efficacy. The combination of various drugs plays the effects of invigorating qi and nourishing blood, strengthening spleen and kidney, and has a significant improvement effect on symptoms such as insufficient qi and blood, weak spleen and stomach, and kidney deficiency. At the same time, through the synergistic effect of various medicinal materials, it can also enhance the body's overall immunity, improve the body's resistance and prevent the occurrence of diseases.

[0053] 2. Simple preparation process: The preparation method of the present invention adopts conventional crushing, mixing, granulation and other processes, which is simple to operate and easy to control, and can ensure the quality and efficacy of the Chinese medicine composition. Compared with the traditional complex preparation process, this method reduces the production links, reduces the production cost, improves the production efficiency, and can better retain the effective ingredients of the medicinal materials.

[0054] 3. High safety: The Chinese medicine composition of the present invention uses natural Chinese medicinal materials as raw materials, does not contain harmful substances, has high safety, and has no obvious toxic and side effects. At the same time, no solvents and additives harmful to the human body are used in the preparation process, which ensures the safety and reliability of the product and is suitable for long-term use.

[0055] 4. Various dosage forms: The present invention provides a variety of dosage forms to meet the needs and usage habits of different consumers. Consumers can choose the dosage form that suits them according to their own conditions and preferences, which improves the applicability and market competitiveness of the product. DETAILED DESCRIPTION

[0056] Example 1

[0057] Recipe: 10 parts of Cistanche deserticola, 5 parts of ginseng, 5 parts of American ginseng, 10 parts of Astragalus, 10 parts of wolfberry, 10 parts of Polygonatum, 5 parts of oyster peptide, 5 parts of Angelica, 10 parts of Rehmannia glutinosa, 5 parts of donkey-hide gelatin, 3 parts of Amomum villosum, 5 parts of tangerine peel, 5 parts of hawthorn, 5 parts of Eucommia leaves, 5 parts of Pueraria root, and 3 parts of licorice.

[0058] Preparation method:

[0059] 1. Wash and dry Cistanche deserticola, ginseng, American ginseng, astragalus, wolfberry, polygonatum, angelica, rehmannia, eucommia leaf, kudzu root and licorice respectively, grind them into fine powder, pass through a 100-mesh sieve and set aside;

[0060] Wash Amomum villosum, dried tangerine peel and hawthorn separately, dry them, grind them into coarse powder, pass through 80-mesh sieve and set aside;

[0061] 2. Take donkey-hide gelatin, add appropriate amount of rice wine, heat in water until dissolved, set aside;

[0062] The fine powder and coarse powder obtained in the above steps are mixed evenly, and the dissolved donkey-hide gelatin and oyster peptide are added and stirred evenly;

[0063] 3. Add appropriate amount of water to make a soft material, granulate through a 20-mesh sieve, dry, and granulate to obtain the Chinese medicine composition granules.

[0064] Example 2

[0065] Recipe: 20 parts of Cistanche deserticola, 15 parts of ginseng, 15 parts of American ginseng, 30 parts of Astragalus, 20 parts of Lycium barbarum, 20 parts of Polygonatum sibiricum, 15 parts of oyster peptide, 15 parts of Angelica sinensis, 20 parts of Rehmannia glutinosa, 15 parts of donkey-hide gelatin, 10 parts of Amomum villosum, 15 parts of dried tangerine peel, 15 parts of hawthorn, 15 parts of Eucommia ulmoides leaves, 15 parts of Pueraria root, and 9 parts of licorice.

[0066] Preparation method:

[0067] Wash Cistanche deserticola, ginseng, American ginseng, astragalus, wolfberry, polygonatum, angelica, rehmannia, eucommia leaf, kudzu root, and liquorice separately, dry them, grind them into fine powder, pass through a 100-mesh sieve, and set aside;

[0068] Wash Amomum villosum, dried tangerine peel and hawthorn separately, dry them, grind them into coarse powder, pass through 80-mesh sieve and set aside;

[0069] 1. Take donkey-hide gelatin, add appropriate amount of rice wine, heat in water until dissolved, set aside;

[0070] The fine powder and coarse powder obtained in the above steps are mixed evenly, and the dissolved donkey-hide gelatin and oyster peptide are added and stirred evenly;

[0071] Add appropriate amount of water to make a soft material, granulate through a 20-mesh sieve, dry, and granulate to obtain the Chinese medicine composition granules.

[0072] Example 3

[0073] Recipe: 15 parts of Cistanche deserticola, 10 parts of ginseng, 10 parts of American ginseng, 20 parts of Astragalus, 15 parts of wolfberry, 15 parts of Polygonatum, 10 parts of oyster peptide, 10 parts of Angelica sinensis, 15 parts of Rehmannia glutinosa, 10 parts of donkey-hide gelatin, 6 parts of Amomum villosum, 10 parts of tangerine peel, 10 parts of hawthorn, 10 parts of Eucommia leaves, 10 parts of Pueraria root, and 6 parts of licorice.

[0074] Preparation method:

[0075] Wash Cistanche deserticola, ginseng, American ginseng, astragalus, wolfberry, polygonatum, angelica, rehmannia, eucommia leaf, kudzu root, and liquorice separately, dry them, grind them into fine powder, pass through a 100-mesh sieve, and set aside;

[0076] Wash Amomum villosum, dried tangerine peel and hawthorn separately, dry them, grind them into coarse powder, pass through 80-mesh sieve and set aside;

[0077] Take donkey-hide gelatin, add appropriate amount of rice wine, heat in water until dissolved, set aside;

[0078] The fine powder and coarse powder obtained in the above steps are mixed evenly, and the dissolved donkey-hide gelatin and oyster peptide are added and stirred evenly;

[0079] Add appropriate amount of water to make a soft material, granulate through a 20-mesh sieve, dry, and granulate to obtain the Chinese medicine composition granules.

[0080] Animal experiment design

[0081] Experimental animals

[0082] This experiment uses healthy SPF grade male mice as research object, and the mouse weight range is between 18-22g. The total number of experimental mice is 80. To ensure the reliability and scientificity of the experimental results, they are randomly and evenly divided into 4 groups, 20 in each group. These 4 groups are respectively a normal control group, a model control group, a positive drug control group and a Chinese medicine composition group of the present invention. By random grouping, the experimental error can be reduced to the greatest extent, and the initial state of each group of mice is made as similar as possible, thereby ensuring that the experimental results can accurately reflect the influence of different treatment factors.

[0083] Experimental model establishment

[0084] 1. Qi and blood deficiency model: The mouse Qi and blood deficiency model was constructed by intraperitoneal injection of cyclophosphamide. The specific operation is to intraperitoneally inject cyclophosphamide into mice for 7 consecutive days, and the injection dose is precisely controlled to be 50mg / kg. Cyclophosphamide, as an immunosuppressant, can inhibit the hematopoietic function of the bone marrow, resulting in a decrease in the production of red blood cells, white blood cells and other blood cells in mice, thereby simulating the state of Qi and blood deficiency in the human body. This model construction method is widely used in related research fields and has high reliability and repeatability.

[0085] 2. Spleen and stomach deficiency model: First, the mice were fasted but not deprived of water for 24 hours to keep the gastrointestinal tract of the mice relatively empty to enhance the effect of subsequent stimulation. Then, the mice were gavaged with 100% ethanol solution for 3 consecutive days, with a gavage dose of 0.2 ml per mouse. Ethanol solution is highly irritating and can damage the gastric mucosa, destroy the normal physiological function of the gastrointestinal tract, and induce symptoms of spleen and stomach deficiency such as loss of appetite and indigestion, thus successfully establishing a spleen and stomach deficiency model.

[0086] 3. Kidney deficiency model: The kidney deficiency model was established by subcutaneously injecting hydrocortisone into mice, with the dose set at 25 mg / kg for 7 consecutive days. Hydrocortisone belongs to the class of glucocorticoid drugs. Long-term use will inhibit the function of the hypothalamus-pituitary-adrenal axis, leading to an imbalance of hormone levels in mice and symptoms related to kidney deficiency, such as soreness of the waist and knees, and decreased immunity. This modeling method has a good effect in simulating the pathological state of human kidney deficiency.

[0087] Experimental methods

[0088] 1. Normal control group: This group of mice were given an equal volume of saline for gavage once a day for 14 days. Saline was used as the treatment factor of the control group and did not contain any therapeutic ingredients. Its purpose was to provide a normal physiological state reference for comparison with other experimental groups.

[0089] 2. Model control group: The mice were also given an equal volume of saline by gavage once a day for 14 consecutive days. The model control group was set up to clarify the changes in the physiological indicators of the mice after the model was established, to exclude the interference of other non-experimental factors on the experimental results, and to accurately evaluate the therapeutic effect of the drug.

[0090] 3. Positive drug control group: According to different experimental models, the corresponding positive drugs were given by gavage. Specifically, Bazhen Decoction was given to the Qi and blood deficiency model, Sijunzi Decoction was given to the spleen and stomach deficiency model, and Liuwei Dihuang Pills were given to the kidney deficiency model. These positive drugs were gavaged according to the clinical equivalent dose, once a day, for 14 consecutive days. The role of the positive drug control group is as a standard reference. By comparing with the Chinese medicine composition group of the present invention, the efficacy of the Chinese medicine composition of the present invention can be more intuitively judged.

[0091] 4. Chinese medicine composition group of the present invention: After the Chinese medicine composition granules prepared by the preferred formula of the present invention were fully dissolved with an appropriate amount of water, mice were gavaged at a dose of 2 g / kg, once a day, for 14 consecutive days. During the experiment, the dissolution and gavage of the drug were strictly controlled to ensure that each mouse could accurately ingest the prescribed dose of the drug to ensure the accuracy and repeatability of the experimental results.

[0092] Experimental Results

[0093] 1. Routine blood test indicators (used to detect deficiency of qi and blood)

[0094] After the experiment, blood samples were obtained by taking blood from the mouse eyeballs, and then blood routine indicators such as red blood cell count (RBC), hemoglobin content (HGB), and white blood cell count (WBC) were tested. The specific test data results are shown in the following table:

[0095]

[0096] Blood routine index

[0097] Data analysis: From the data, it can be seen that the red blood cell count, hemoglobin content and white blood cell count of the model control group are significantly lower than those of the normal control group, which indicates that the Qi and blood deficiency model has been successfully established. The various indicators of the positive drug control group and the Chinese medicine composition group of the present invention are higher than those of the model control group, indicating that both the positive drug and the Chinese medicine composition of the present invention have a certain improvement effect on Qi and blood deficiency. Among them, the red blood cell count and hemoglobin content of the Chinese medicine composition group of the present invention are closer to the normal control group, and the white blood cell count is higher than that of the positive drug control group, indicating that the effect of the Chinese medicine composition of the present invention in improving Qi and blood deficiency may be better than that of the positive drug.

[0098] 2. Gastrointestinal function indicators (used to detect spleen and stomach weakness)

[0099] Observe and record the weight changes and food intake of mice, and test gastrointestinal function indicators such as pepsin activity and small intestinal propulsion rate. The specific test data results are shown in the following table

[0100]

[0101] Gastrointestinal function index

[0102] Data analysis: The weight change, food intake, pepsin activity and small intestinal propulsion rate of mice in the model control group were significantly lower than those in the normal control group, indicating that the spleen and stomach deficiency model was successfully constructed. The various indicators of the positive drug control group and the Chinese medicine composition group of the present invention were improved to varying degrees, indicating that both can play a certain role in improving spleen and stomach deficiency. The improvement effect of the Chinese medicine composition group of the present invention in weight change, pepsin activity and small intestinal propulsion rate is more obvious, indicating that the Chinese medicine composition of the present invention has a good effect in regulating gastrointestinal function and improving spleen and stomach deficiency.

[0103] 3. Renal function index (used to detect kidney deficiency): detect the creatinine (Cr) and urea nitrogen (BUN) content in mouse serum, as well as the superoxide dismutase (SOD) activity and malondialdehyde (MDA) content in kidney tissue. The specific results are shown in the following table:

[0104]

[0105] Renal function index

[0106] Data analysis: The creatinine and urea nitrogen contents of the model control group were significantly higher than those of the normal control group, while the SOD activity decreased and the MDA content increased, indicating that the kidney deficiency model was successfully established. The creatinine and urea nitrogen contents of the positive drug control group and the Chinese medicine composition group of the present invention were reduced, the SOD activity increased, and the MDA content decreased, indicating that both had a certain improvement effect on kidney deficiency. The Chinese medicine composition group of the present invention was more effective in reducing the creatinine and urea nitrogen contents and increasing the SOD activity, and the MDA content was also closer to the normal control group, indicating that the Chinese medicine composition of the present invention has a good effect in improving renal function and alleviating the symptoms of kidney deficiency.

[0107] Toxicity analysis experiment

[0108] Experimental design: In order to evaluate the safety of the Chinese medicine composition of the present invention, an acute toxicity experiment was conducted. 40 healthy SPF-grade male mice weighing 18-22g were selected and randomly divided into 4 groups, 10 mice in each group. They were a high-dose group (10g / kg), a medium-dose group (5g / kg), a low-dose group (2g / kg) of the Chinese medicine composition, and a normal saline control group (administered with an equal volume of normal saline).

[0109] Experimental method: Each group of mice was given a corresponding dose of drug or saline at one time by oral administration. After administration, the mice's appearance (including coat color, body shape, etc.), behavioral activities (such as movement status, reaction sensitivity, etc.), diet (food intake, water intake), etc. were closely observed for 14 consecutive days. The symptoms of poisoning (such as convulsions, dyspnea, diarrhea, vomiting, mental depression, etc.) and deaths of mice were recorded every day. At the end of the experiment, the surviving mice were grossly dissected to observe whether the appearance, color, texture, etc. of the main organs (heart, liver, spleen, lungs, kidneys) were abnormal.

[0110]

[0111] Toxicity analysis experimental data

[0112] Results analysis: From the experimental data, the mice in the normal saline control group showed no abnormal performance during the entire experiment, and their activities and diet were normal, and there was no abnormality in the gross anatomy of the main organs, indicating that normal saline had no toxic effects on mice. The mice in the low-dose group and the medium-dose group of the Chinese medicine composition did not show obvious symptoms of poisoning during the 14-day observation period, their behavioral activities and diet were normal, and there was no abnormality in the gross anatomy of the main organs, indicating that the Chinese medicine composition had no obvious toxicity to mice at these two doses. Some mice in the high-dose group of the Chinese medicine composition showed slight mental depression and loss of appetite on the day after administration, as well as a short-term decrease in activity, but these symptoms gradually disappeared in subsequent observations, and no mice showed severe poisoning symptoms such as convulsions, dyspnea, diarrhea, vomiting, and no deaths, and there was no abnormality in the gross anatomy of the main organs. This shows that although the Chinese medicine composition of the present invention has a certain effect at a high dose, the toxicity is mild and reversible. Combined with previous efficacy experiments, at a therapeutic dose (2g / kg), the Chinese medicine composition can not only effectively improve symptoms such as qi and blood deficiency, spleen and stomach weakness, and kidney deficiency, but also has good safety, providing strong support for its further clinical application.

[0113] Human clinical trials

[0114] Experimental design:

[0115] This clinical experiment strictly follows the principle of randomization, double-blind, placebo control to ensure the scientificity and reliability of the experimental results. After obtaining the strict review and approval of the relevant ethics committee, eligible subjects were screened from multiple medical institutions. 120 people aged 18-60 years old were selected, and senior Chinese medicine practitioners were diagnosed with deficiency of qi and blood, weakness of spleen and stomach or kidney deficiency (at least in line with one of the syndromes) according to "Chinese medicine diagnosis" and relevant industry standards as research subjects. These subjects were divided into three groups by computer random grouping program, 40 people in each group, respectively, Chinese medicine composition group of the present invention, positive drug control group (classical Bazhen Decoction, Sijunzi Decoction or Liuwei Dihuang Pills were given respectively according to the specific symptoms of the patient), placebo group (simulated preparations with appearance, smell and mouthfeel highly similar to Chinese medicine composition of the present invention but not containing any active ingredients) were given.

[0116] Experimental methods:

[0117] 1. The Chinese medicine composition group of the present invention: The subjects were given the Chinese medicine composition of the present invention, and the recommended daily dose (equivalent to 30 grams of crude drug) was determined based on the previous toxicology study and preliminary experimental results, and a scientific split-dose method was adopted, i.e., taking it twice (once in the morning and once in the evening), and taking it continuously for 8 weeks. During the entire medication period, a special person was arranged to supervise and record the patient's medication situation to ensure that the patient took the medication on time and in the prescribed amount.

[0118] 2. Positive drug control group: According to the specific symptoms of the patients, the corresponding traditional classic positive drugs are given, according to the conventional dosage specified in "Chinese Materia Medica" and clinical practice guidelines, and taken twice (once in the morning and once in the evening), and the course of treatment is 8 weeks. During the experiment, pay close attention to the patient's reaction to the drug and keep records.

[0119] 3. Placebo group: patients were given a placebo that was indistinguishable from the Chinese medicine composition in appearance and taste, and the method of administration and course of treatment were consistent with the other two groups. At the same time, patients were given health education and were informed that they should maintain a normal lifestyle and eating habits during the experiment and avoid taking other drugs or health products that may affect the experimental results.

[0120] 4. During the experiment, establish a complete follow-up mechanism for subjects, communicate with patients regularly, and keep abreast of their physical condition and medication status.

[0121] Observation indicators:

[0122] 1. Symptom scoring: Before the start of the experiment, at the 4th week and the 8th week, professional Chinese medicine practitioners who have undergone unified training and have rich clinical experience will carefully score the patients' symptoms of qi and blood deficiency (such as sallow complexion, dizziness, fatigue, palpitations, insomnia, etc.), spleen and stomach weakness symptoms (such as poor appetite, abdominal distension, dull abdominal pain, indigestion, loose stools, etc.), and kidney deficiency symptoms (such as soreness of the waist and knees, dizziness, tinnitus, spermatorrhea, premature ejaculation, irregular menstruation in women, sexual dysfunction, etc.) according to the "Chinese Medicine Syndrome Scoring Standard" and relevant authoritative literature. The scoring adopts a quantitative standard, and the higher the score, the more severe the symptom.

[0123] 2. Laboratory indicators: Before the start of the experiment and at the 8th week, venous blood samples were collected from patients in a fasting state. Advanced testing equipment and standardized testing methods were used to accurately test routine blood indicators (red blood cell count, hemoglobin content, white blood cell count), gastrointestinal function-related indicators (pepsinogen, reflecting the secretion level of pepsin; serum gastrin, involved in regulating gastric acid secretion and gastrointestinal motility), renal function indicators (creatinine, reflecting the filtration function of the glomerulus; urea nitrogen, evaluating the excretion function of the kidney), and immune function indicators (immunoglobulins IgA, IgG, IgM, as important markers of the body's immune function).

[0124] 3. Safety indicators: During the entire 8-week experiment, a strict adverse reaction monitoring system was established to closely observe whether patients had adverse reactions, such as nausea, vomiting, abdominal pain, diarrhea, rash, itching, allergic reactions, etc. At the same time, at the end of the experiment, patients were given a comprehensive physical examination, including vital sign measurement, heart and lung auscultation, abdominal palpation, etc., as well as detailed laboratory tests (such as a full set of liver and kidney function indicators, electrocardiograms, etc.) to comprehensively evaluate the safety and tolerability of the drug.

[0125] Symptom score results

[0126]

[0127] Symptom score results

[0128] (Note: Compared with before the experiment, *P<0.05, indicating that the difference is statistically significant, that is, the symptoms of this group at the corresponding time point are significantly improved compared with before the experiment; compared with the 8th week of the positive drug control group, #P<0.05, indicating that the degree of symptom improvement in the Chinese medicine composition group of the present invention at the 8th week is better than that of the positive drug control group.)

[0129] Laboratory index results

[0130]

[0131] Laboratory index results (Note: Compared with before the experiment, *P<0.05, indicating that the differences in the corresponding indexes before and after the experiment in this group are statistically significant, that is, the indexes have changed significantly; compared with the positive drug control group after the experiment, #P<0.05, indicating that the improvement degree of some indexes of the Chinese medicine combination group of the present invention after the experiment is better than that of the positive drug control group.)

[0132] Safety index results: During the entire experiment, 3 patients in the Chinese medicine composition group of the present invention had mild gastrointestinal discomfort symptoms (such as mild nausea and stomach distension). Without special treatment, the symptoms relieved themselves during the continued medication; 2 patients in the positive drug control group had mild diarrhea, and the symptoms were alleviated after adjusting the drug dosage; 1 patient in the placebo group had a rash, which was diagnosed to be unrelated to the experimental drug. At the end of the experiment, no obvious abnormalities were found in the comprehensive physical examination and laboratory test results of the three groups of patients, and the indicators such as liver and kidney function and electrocardiogram were all within the normal range, indicating that the Chinese medicine composition of the present invention and the positive control drug have good safety and tolerability in clinical application.

[0133]

[0134] Safety index results

[0135] Result analysis:

[0136] From the comprehensive symptom score and laboratory index results, the symptom scores of the patients in the Chinese medicine composition group of the present invention and the positive drug control group were significantly reduced after treatment for 4 weeks and 8 weeks, and a number of laboratory indexes were significantly improved, and the difference was statistically significant compared with the placebo group, indicating that the Chinese medicine composition of the present invention and traditional positive drugs have a certain therapeutic effect on the symptoms such as insufficient qi and blood, weak spleen and stomach, and kidney deficiency. However, the symptom score reduction of the Chinese medicine composition group of the present invention at the 8th week is more significant, and the effects of improving red blood cell count, hemoglobin content, improving gastrointestinal function related indicators (pepsinogen, serum gastrin), and regulating immune function indicators (IgA, IgG, IgM) and other aspects are better than the positive drug control group. At the same time, in terms of safety, the Chinese medicine composition of the present invention and the positive drug control group both show good safety and tolerance, and adverse reactions are mild and controllable. This shows that the Chinese medicine composition of the present invention not only has certain advantages in therapeutic effect, but also has higher clinical application safety, which provides a solid clinical basis for its further promotion and application.

Claims

1. A Chinese medicine composition having the effects of invigorating qi and nourishing blood and strengthening the spleen and kidney, characterized in that: The invention is prepared from the following raw materials in parts by weight: 10-20 parts of Cistanche deserticola, 5-15 parts of ginseng, 5-15 parts of American ginseng, 10-30 parts of astragalus, 10-20 parts of wolfberry, 10-20 parts of polygonatum, 5-15 parts of oyster peptide, 5-15 parts of angelica, 10-20 parts of rehmannia glutinosa, 5-15 parts of donkey-hide gelatin, 3-10 parts of amomum villosum, 5-15 parts of tangerine peel, 5-15 parts of hawthorn, 5-15 parts of eucommia leaves, 5-15 parts of kudzu root and 3-10 parts of liquorice.

2. The Chinese medicine composition having the effects of invigorating qi and nourishing blood and strengthening the spleen and kidney according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 15 parts of Cistanche deserticola, 10 parts of ginseng, 10 parts of American ginseng, 20 parts of astragalus, 15 parts of wolfberry, 15 parts of polygonatum, 10 parts of oyster peptide, 10 parts of angelica, 15 parts of rehmannia glutinosa, 10 parts of donkey-hide gelatin, 6 parts of amomum villosum, 10 parts of tangerine peel, 10 parts of hawthorn, 10 parts of eucommia leaves, 10 parts of kudzu root, and 6 parts of licorice.

3. A method for preparing a Chinese medicine composition having the effects of invigorating qi and nourishing blood and strengthening the spleen and kidney as claimed in claim 1 or 2, characterized in that: The following steps are involved: S1. Wash and dry Cistanche deserticola, ginseng, American ginseng, astragalus, wolfberry, polygonatum, angelica, rehmannia, eucommia, leaves, kudzu root, and licorice, respectively, and grind them into fine powder, sieve through 80-100 mesh, and set aside; S2. Wash Amomum villosum, tangerine peel and hawthorn separately, dry them, grind them into coarse powder, pass through a 60-80 mesh sieve and set aside; S3. Take donkey-hide gelatin, add appropriate amount of rice wine, heat in water until dissolved, and set aside; S4. The fine powder and coarse powder obtained in the above step are mixed evenly, and the dissolved donkey-hide gelatin and oyster peptide are added and stirred evenly; S5. Add an appropriate amount of water to make a soft material, granulate through a 16-20 mesh sieve, dry, and granulate to obtain the Chinese medicine composition granules.

4. The preparation method according to claim 3, characterized in that: The herb is ground into fine powder and then passed through a 100-mesh sieve; and the fructus amomi, tangerine peel and hawthorn are ground into coarse powder and then passed through an 80-mesh sieve.

5. A dosage form comprising the Chinese medicine composition according to claim 1 or 2, characterized in that: The dosage forms include, but are not limited to, granules, capsules, tablets, and oral solutions.

6. The dosage form according to claim 5, characterized in that The capsule is prepared by filling the particles of the Chinese medicine composition prepared according to claim 3 into hollow capsules; the tablet is prepared by adding an appropriate amount of adhesive, disintegrant and other auxiliary materials to the particles of the Chinese medicine composition prepared according to claim 3, and undergoing a tableting process; the oral liquid is prepared by dissolving the particles of the Chinese medicine composition prepared according to claim 3 with an appropriate amount of solvent, and undergoing filtering, sterilization and other processes.

7. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of medicines for invigorating qi and nourishing blood, strengthening the spleen and benefiting the kidneys.

8. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for improving symptoms of qi and blood deficiency, spleen and stomach weakness, and kidney deficiency, wherein the symptoms include abdominal distension and pain; and the symptoms of kidney deficiency include soreness of waist and knees, and sexual dysfunction.

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