Kidney-tonifying and body-building traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention provides a kidney-tonifying and body-building traditional Chinese medicine composition as well as a preparation method and application thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises the following components in parts by weight: 120-170 parts of cornu cervi pantotrichum, 40-60 parts of an American ginseng extract, 130-160 parts of an angelica sinensis extract and 35-60 parts of an astragalus membranaceus extract. Mixing an angelica sinensis raw material with water, decocting, filtering and drying to obtain an angelica sinensis extract; american ginseng and astragalus membranaceus are respectively mixed with an ethanol solution, extracted, filtered and dried to obtain an American ginseng extract and an astragalus membranaceus extract. According to the invention, the four components are reasonably matched, and the components are extracted by adopting a specific extraction method and have a synergistic effect, so that the effects of enhancing energy and immunity and improving an anti-fatigue function are achieved. The traditional Chinese medicine composition can be used for preparing medicines and / or health-care foods with the effects of resisting fatigue, enhancing immunity, invigorating the kidney and strengthening yang.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for invigorating the kidney and strengthening the body, and a preparation method and application thereof. Background Art

[0002] Traditional Chinese Medicine believes that the human body is primarily governed by yin and yang, qi, blood, and body fluids. An imbalance of yin and yang, a lack of qi and blood, and a deficiency of body fluids can disrupt normal physiological functions and mechanisms. Kidney Qi Deficiency: The kidneys store essence, which generates marrow, and marrow transforms into blood. Inadequate innate endowment, postnatal malnutrition, and excessive sexual activity can all lead to kidney deficiency. Kidney deficiency leads to a deficiency of essence, and a deficiency of essence leads to a deficiency of blood.

[0003] The main clinical symptoms of kidney yang deficiency include decreased sexual function, physical weakness, mental fatigue, soreness of the waist and legs, dizziness, frequent urination at night, forgetfulness and insomnia. The most important symptoms are decreased ability to sustain activity, fatigue, difficulty concentrating, memory loss, poor emotional stability, and mental fatigue. To alleviate these symptoms, research is underway into relatively safe Traditional Chinese Medicine (TCM) preparations.

[0004] Chinese invention patent CN105456972A discloses a tortoise and deer kidney-tonifying Chinese medicine composition, which is made from the following raw materials extracted with water and ethanol: epimedium, fenugreek, Morinda officinalis, Psoralea corylifolia, Polygala tenuifolia, Ziziphus jujuba seed, Poria cocos, Angelica sinensis, longan meat, Astragalus membranaceus, Atractylodes macrocephala, Zingiber officinale, jujube, licorice, costus root, dog kidney, red ginseng, deer antler glue, tortoise shell glue and cinnamon; the above-mentioned Chinese medicine composition can warm and tonify kidney yang, resist fatigue, anti-aging and enhance immunity.

[0005] Chinese invention patent CN110201048A discloses a Chinese herbal medicine composition for tonifying kidney and replenishing essence and its preparation method. The raw materials of the Chinese herbal medicine composition include 20-40 parts of angelica sinensis, 20-40 parts of white peony root, 20-40 parts of ginseng, 20-40 parts of epimedium, 30-60 parts of officinal meat, 20-40 parts of liquorice, 10-30 parts of leech, 80-220 parts of centipede, 20-40 parts of deer antler, and 20-40 parts of male antler. 20-40 parts of silkworm moth, 10-20 parts of nine-scented insect, 20-40 parts of pseudo-sea dragon, 150-550 parts of gecko, 30-60 parts of aconite, 15-30 parts of cinnamon bark, 10-30 parts of seahorse, 10-30 parts of deer antler, 40-80 parts of astragalus, 20-60 parts of asarum, 15-40 parts of actinolite, 15-40 parts of purple quartz, 40-80 parts of maca, 50-80 parts of euryale ferox, and 35-110 parts of yellow dog kidney. This invention only generally states that the Chinese medicine composition has the effects of nourishing the kidney and replenishing essence, warming the kidney and strengthening yang, and enhancing immunity, but the specific effects are unclear.

[0006] Chinese invention patent CN118787676A discloses a medicinal composition for tonifying the kidney and strengthening yang, and resisting fatigue, and its preparation method. The composition includes ginseng, sika deer penis, red deer antler, sea cucumber, oyster, polygonatum, wolfberry, maca, yam, epimedium, Cistanche deserticola, Cordyceps militaris, Eucommia ulmoides, okra, silkworm pupae, dodder seed, Rosa laevigata fruit, Acanthopanax senticosus, Rhodiola rosea, royal jelly, pumpkin seed oil, lycopene, pyrroloquinoline quinone, taurine, gamma-aminobutyric acid, Artemisia africana, and Pelargonium angustifolia extract; the composition has the effects of tonifying the kidney and strengthening yang, and resisting fatigue, and is significantly effective for back pain, sore limbs, impotence and premature ejaculation, low libido, and memory loss.

[0007] Most existing traditional Chinese medicine preparations claiming kidney-tonifying, fatigue-relief, and immunity-boosting properties have complex formulations, ranging from nearly 10 ingredients to dozens. These complex formulations fail to leverage the synergistic effects of their components and may even exhibit antagonistic interactions. Furthermore, while some formulations exhibit some kidney-tonifying and body-strengthening effects, their effectiveness is limited. Therefore, further research into traditional Chinese medicine components is needed to develop a simpler, more effective traditional Chinese medicine composition. Summary of the Invention

[0008] In response to the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for tonifying the kidney and strengthening the body, as well as a preparation method and application thereof. The four ingredients, namely, deer antler, American ginseng extract, angelica extract and astragalus extract, are rationally matched. Each ingredient is extracted using a specific extraction method. The four ingredients work synergistically to significantly enhance energy and immunity, improve anti-fatigue resistance, and tonify the kidney and strengthen yang.

[0009] To achieve the above object, the technical solution adopted by the present invention is as follows: Firstly, the present invention provides a Chinese medicinal composition for tonifying the kidney and strengthening the body, comprising the following components: pilose antler, American ginseng extract, angelica extract and astragalus extract.

[0010] Preferably, the Chinese medicine composition comprises the following components in parts by weight: 120-170 parts of deer antler, 40-60 parts of American ginseng extract, 130-160 parts of angelica extract and 35-60 parts of astragalus extract.

[0011] Further preferably, the Chinese medicine composition comprises the following components in parts by weight: 150 parts of deer antler, 50 parts of American ginseng extract, 150 parts of angelica extract and 50 parts of astragalus extract.

[0012] Preferably, the preparation method of the angelica extract comprises the steps of: mixing the angelica raw material with water, decocting, filtering, and drying to obtain the angelica extract.

[0013] Further preferably, the preparation method of the angelica extract comprises the steps of: decocting the angelica raw material with 8-15 times the amount of water for 2-4 times, decocting for 0.5-2 hours each time, filtering, and drying to obtain the angelica extract.

[0014] More preferably, the preparation method of the angelica extract comprises the steps of: decocting the angelica raw material with 10 times the amount of water for 3 times, each decocting for 1 hour, filtering, and drying to obtain the angelica extract.

[0015] Preferably, the preparation method of the astragalus extract comprises the steps of: mixing the astragalus raw material with an ethanol solution having a volume concentration of 50%-65%, extracting, filtering, and drying to obtain the astragalus extract.

[0016] Further preferably, the preparation method of the astragalus extract comprises the steps of: extracting the astragalus raw material with 6-15 times the amount of 50%-65% volume concentration ethanol solution, extracting at a temperature of 70-80°C, extracting 2-4 times, each extraction for 0.5-2h, filtering, and drying to obtain the astragalus extract.

[0017] More preferably, the preparation method of the astragalus extract comprises the steps of: extracting the astragalus raw material with 10 times the amount of 60% volume concentration ethanol solution, extracting at 75°C, extracting three times, each extraction for 1 hour, filtering, and drying to obtain the astragalus extract.

[0018] Then, the present invention provides a method for preparing the above-mentioned Chinese medicine composition, comprising the steps of: (1) After sterilization, the antler is crushed to obtain antler powder; (2) Preparation of American ginseng extract: Mixing American ginseng raw material with ethanol solution for extraction, filtering, and drying the filtrate to obtain American ginseng extract; (3) Preparing the angelica extract: mixing the angelica raw material with water, boiling, filtering, and drying to obtain the angelica extract; (4) Preparation of Astragalus extract: Mixing the Astragalus raw material with a 50%-65% volume concentration ethanol solution, extracting, filtering, and drying to obtain the Astragalus extract; (5) Deer antler powder, American ginseng extract, Chinese angelica extract and astragalus extract are mixed to obtain a Chinese medicine composition.

[0019] Preferably, in step (1), the particle size of the antler powder is 60-100 mesh; more preferably 80 mesh.

[0020] Preferably, in step (1), the sterilization is Co60 irradiation sterilization.

[0021] Preferably, step (2) is specifically as follows: the American ginseng raw material is mixed with 8-12 times the amount of 68%-75% volume concentration of ethanol solution and extracted 2-4 times, the temperature of each extraction is 70-80°C, each extraction is 1-3h, filtering, and drying the filtrate to obtain the American ginseng extract.

[0022] Further preferably, step (2) is specifically as follows: the American ginseng raw material is mixed with 10 times the amount of 70% volume concentration ethanol solution and extracted three times, the temperature of each extraction is 75°C, each extraction is 2 hours, filtering, and drying the filtrate to obtain the American ginseng extract.

[0023] Preferably, step (3) is specifically as follows: decocting the angelica raw material with 8-15 times the amount of water for 2-4 times, decocting for 0.5-2 hours each time, filtering, and drying to obtain the angelica extract.

[0024] Further preferably, step (3) is specifically as follows: decocting the angelica raw material with 10 times the amount of water for 3 times, each decocting for 1 hour, filtering, and drying to obtain the angelica extract.

[0025] Preferably, step (4) is specifically as follows: extracting the astragalus raw material with 6-15 times the amount of 50%-65% volume concentration ethanol solution, extracting at a temperature of 70-80°C, extracting 2-4 times, each extraction time of 0.5-2h, filtering, and drying to obtain the astragalus extract.

[0026] Further preferably, step (4) is specifically as follows: extracting the Astragalus raw material with 10 times the amount of 60% volume concentration ethanol solution, the extraction temperature is 75°C, extracting 3 times, each extraction time is 1 hour, filtering, and drying to obtain the Astragalus extract.

[0027] Furthermore, the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of medicines and / or health foods having the effects of resisting fatigue, enhancing immunity, tonifying the kidney and strengthening yang.

[0028] Furthermore, the present invention provides a health food with the effects of resisting fatigue, enhancing immunity, tonifying the kidney and strengthening yang, comprising the above-mentioned Chinese medicine composition.

[0029] Finally, the present invention provides a medicine with the effects of resisting fatigue, enhancing immunity, tonifying the kidney and strengthening yang, comprising the components: the above-mentioned Chinese medicine composition.

[0030] Preferably, the drug may further include a pharmaceutical carrier. The pharmaceutical carrier may be solid, liquid, or gaseous. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate, and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil, and water. Examples of gaseous carriers include carbon dioxide and nitrogen.

[0031] When preparing compositions for oral dosage forms, any convenient pharmaceutical medium can be used. For example, water, ethanol, oils, alcohols, flavoring agents, preservatives, colorants, and the like can be used to form oral liquid formulations, such as suspensions and solutions; while carriers, such as starches, sugars, microcrystalline cellulose, diluents, granulating agents, emulsifiers, lubricants, binders, and disintegrants can be used to form oral solid formulations, such as powders, capsules, and tablets. Tablets and capsules are preferred oral dosage units using solid pharmaceutical carriers due to their ease of administration. Tablets can be coated using standard aqueous or nonaqueous techniques.

[0032] Tablets containing the Chinese herbal compositions or extracts of the present invention can be prepared by compression or molding, optionally with one or more auxiliary ingredients or adjuvants. Compressed tablets can be prepared by compressing the active ingredient in a free-flowing form (such as a powder or granules) in a suitable machine, optionally mixed with a binder, lubricant, inert diluent, surfactant, or dispersant. Molded tablets can be molded in a suitable machine from a powdered mixture of the compound moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of the active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of the active ingredient. For example, a formulation intended for oral administration to humans may contain about 0.5 mg to about 5 g of the active drug, mixed with an appropriate and convenient carrier material, which may comprise about 5% to 95% of the total composition. Unit dosage forms typically contain about 1 mg to about 2 g of the active ingredient, typically 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg, or 1000 mg.

[0033] Pharmaceutical compositions suitable for parenteral administration of the present invention can be prepared as aqueous solutions or suspensions of the active compound. Suitable surfactants, such as hydroxypropylcellulose, can be included. Dispersions can also be prepared in glycerol, liquid polyethylene glycol, and oil mixtures thereof. In addition, preservatives can be added to prevent the harmful growth of microorganisms.

[0034] Medicine of the present invention can be the form that is suitable for topical use, for example aerosol, emulsifiable paste, ointment, lotion, powder or analogue.In addition, composition can be that suitable form is used for transdermal drug delivery device.Can use Chinese medicine composition of the present invention, prepare these prescriptions by conventional processing method.For example, by mixing hydrophilic material and water, and the compound of about 5wt% to about 10wt%, preparation has emulsifiable paste or ointment of required consistency.

[0035] The medicament of the present invention can be in a form suitable for rectal administration, wherein the carrier is a solid. It is best to prepare the mixture into unit dose suppositories. Suitable carriers include cocoa butter and other materials commonly used in the art. Suppositories can be prepared by first forming a composition containing a softened or melted carrier, followed by cooling and shaping in a mold.

[0036] In addition to the aforementioned carrier components, the pharmaceutical preparations may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, binders, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. Furthermore, other excipients, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, colorants, and flavoring agents, may be added to render the preparation isotonic with the blood of the intended recipient. The components comprising the Chinese medicine composition of the present invention may also be prepared in powder or concentrated liquid form.

[0037] Preferably, the dosage form of the drug is not limited to pills, capsules, granules, oral liquids, powders, tablets, lozenges, ointments and other dosage forms, and suitable drug carriers in the art can be selected for different dosage forms.

[0038] In the present invention, the velvet antler is sika deer antler, and there is no significant difference in the technical effect between different types of velvet antler.

[0039] In the present invention, the American ginseng raw material is not limited to American ginseng medicinal materials and American ginseng decoction pieces.

[0040] In the present invention, the angelica raw material is not limited to angelica Chinese medicinal materials and angelica decoction pieces.

[0041] In the present invention, the astragalus raw material is not limited to astragalus Chinese medicinal materials and astragalus decoction slices.

[0042] In the Chinese medicine composition of the present invention, deer antler nourishes the kidneys and replenishes essence, and is responsible for bone and marrow production; when kidney essence is full, it transforms into bone marrow, nourishes the bones, makes the bones strong and powerful, makes the limbs move lightly and vigorously, and makes the mind agile and quick-thinking. Angelica sinensis nourishes blood and regulates the liver, moistens the tendons and veins, replenishes liver blood, and nourishes the fascia, resulting in flexible and powerful movements. American ginseng replenishes qi and nourishes yin, clears heat and promotes fluid production, and has the effects of replenishing qi and blood, promoting fluid production and quenching thirst. Astragalus has the effects of replenishing qi and raising yang, promoting fluid production and nourishing blood. The four ingredients are used together to nourish the kidneys and strengthen qi, nourish yin and promote fluid production, nourish blood and regulate the liver, complementing each other and achieving the effect of nourishing the body and relieving physical fatigue.

[0043] Compared with the prior art, the present invention has the following beneficial effects: 1. The present invention selects four ingredients, namely, deer antler, American ginseng extract, angelica extract and astragalus extract, and rationally combines them. The ingredients synergize and cooperate with each other to significantly enhance energy and immunity and improve anti-fatigue function. The composition of the present invention has a simple formula and a clear composition.

[0044] 2. The angelica extract of the present invention is obtained by decoction in water, and is rich in polysaccharides and has a high level of active substances; astragalus and American ginseng are extracted using an ethanol solution of a specific concentration and are rich in various saponin components; while maintaining the activity of high effective ingredients, each extract interacts with deer antler, can enhance the body's yang energy, nourish the kidneys and strengthen yang, significantly reduce fatigue, and improve energy and immunity. DETAILED DESCRIPTION

[0045] The following non-limiting examples are provided to enable those skilled in the art to more fully understand the present invention, but are not intended to limit the present invention in any way. The following are merely illustrative of the scope of the present invention, and those skilled in the art may make various changes and modifications to the present invention based on the disclosed content, which should also fall within the scope of the present invention.

[0046] When numerical ranges are given in the examples, it should be understood that, unless otherwise specified herein, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the invention belongs.

[0047] The present invention is further described below by way of specific examples. Unless otherwise specified, the various chemical reagents used in the examples of the present invention were obtained through conventional commercial channels.

[0048] Example 1 A Chinese medicinal composition for tonifying the kidney and strengthening the body comprises, by weight, 150 parts of deer antler, 50 parts of American ginseng extract, 150 parts of angelica extract, and 50 parts of astragalus extract. The components are uniformly mixed to obtain the Chinese medicinal composition.

[0049] The velvet antler is sika deer antler powder: the sika deer antler is sterilized by Co60 irradiation, crushed and passed through an 80-mesh sieve to obtain the sika deer antler powder.

[0050] The preparation method of American ginseng extract is as follows: American ginseng slices are mixed with 10 times the amount of 70% volume concentration ethanol solution and extracted three times, the temperature of each extraction is 75°C, each extraction is 2 hours, filtering, and drying the filtrate to obtain American ginseng extract.

[0051] The preparation method of the angelica extract is as follows: decocting the angelica slices with 10 times the amount of water for 3 times, decocting for 1 hour each time, filtering, and drying to obtain the angelica extract.

[0052] The preparation method of the astragalus extract is as follows: extracting the astragalus slices with 10 times the amount of 60% volume concentration ethanol solution, the extraction temperature is 75°C, extracting 3 times, each extraction time is 1 hour, filtering, and drying to obtain the astragalus extract.

[0053] Example 2 The difference from Example 1 is that the ratios of the components in the Chinese medicine composition are different.

[0054] A Chinese herbal composition for invigorating the kidney and strengthening the body comprises, by weight, 120 parts of deer antler, 60 parts of American ginseng extract, 160 parts of angelica extract, and 35 parts of astragalus extract. The remaining ingredients are the same as those in Example 1.

[0055] Example 3 The difference from Example 1 is that the ratios of the components in the Chinese medicine composition are different.

[0056] A Chinese herbal composition for invigorating the kidney and strengthening the body comprises the following components by weight: 170 parts of deer antler, 40 parts of American ginseng extract, 130 parts of angelica extract, and 60 parts of astragalus extract. The remaining ingredients are the same as those in Example 1.

[0057] Example 4 The difference from Example 1 is that the preparation method of the Chinese medicine composition is different.

[0058] (1) The sika deer antler was sterilized by Co60 irradiation and then crushed through an 80-mesh sieve to obtain sika deer antler powder.

[0059] (2) The preparation method of American ginseng extract is as follows: American ginseng slices are mixed with 8 times the amount of 75% volume concentration ethanol solution and extracted twice, each extraction temperature is 80℃, each extraction time is 3 hours, filtered, and the filtrate is dried to obtain American ginseng extract.

[0060] (3) The preparation method of angelica extract is as follows: decocting angelica slices with 8 times the amount of water twice, each decocting for 2 hours, filtering, and drying to obtain angelica extract.

[0061] (4) The preparation method of Astragalus extract is as follows: extract the Astragalus slices with 15 times the amount of 50% volume concentration ethanol solution, the extraction temperature is 80℃, the extraction is performed 4 times, each extraction time is 0.5h, filtered, and dried to obtain the Astragalus extract.

[0062] (5) Sika deer antler powder, American ginseng extract, Chinese angelica extract and astragalus extract are mixed to obtain a traditional Chinese medicine composition.

[0063] Example 5 The difference from Example 1 is that the preparation method of the Chinese medicine composition is different.

[0064] (1) The sika deer antler was sterilized by Co60 irradiation and then crushed through an 80-mesh sieve to obtain sika deer antler powder.

[0065] (2) The preparation method of American ginseng extract is as follows: American ginseng slices are mixed with 12 times the amount of 68% volume concentration ethanol solution and extracted 4 times, each extraction temperature is 70℃, each extraction is 1 hour, filtered, and the filtrate is dried to obtain American ginseng extract.

[0066] (3) The preparation method of angelica extract is as follows: decocting angelica slices with 15 times the amount of water for 4 times, each time for 0.5 h, filtering, and drying to obtain angelica extract.

[0067] (4) The preparation method of Astragalus extract is as follows: extract the Astragalus slices with 6 times the volume of 65% ethanol solution, the extraction temperature is 70℃, the extraction is performed twice, each extraction is 2 hours, the Astragalus extract is obtained by filtering and drying.

[0068] (5) Sika deer antler powder, American ginseng extract, Chinese angelica extract and astragalus extract are mixed to obtain a traditional Chinese medicine composition.

[0069] Comparative Example 1 The difference from Example 1 is that the angelica extract is not contained.

[0070] The Chinese medicine composition comprises the following components in parts by weight: 150 parts of pilose antler, 50 parts of American ginseng extract and 50 parts of astragalus extract. The components are mixed evenly to obtain the Chinese medicine composition.

[0071] Comparative Example 2 The difference from Example 1 is that only 150 parts of the angelica extract is used, and the remaining ingredients are 240 parts of microcrystalline cellulose and 10 parts of magnesium stearate as auxiliary materials. The angelica extract and the auxiliary materials are mixed to obtain a traditional Chinese medicine composition.

[0072] Comparative Example 3 Different from Example 1, the Chinese medicine composition further contains Schisandra chinensis powder and Polygonatum sibiricum powder.

[0073] The Chinese medicine composition comprises, by weight, 150 parts of deer antler, 50 parts of American ginseng extract, 150 parts of angelica extract, 50 parts of astragalus extract, 50 parts of schisandra chinensis powder (80 mesh particle size), and polygonatum powder. The components are uniformly mixed to obtain the Chinese medicine composition.

[0074] Comparative Example 4 The difference from Example 1 is that the antler is replaced by epimedium, and the powder particle size is 80 mesh.

[0075] The Chinese medicine composition comprises the following components in parts by weight: 150 parts of epimedium, 50 parts of American ginseng extract, 150 parts of angelica extract, and 50 parts of astragalus extract. The components are mixed evenly to obtain the Chinese medicine composition.

[0076] Comparative Example 5 Different from Example 1, the ratio of each component in the traditional Chinese medicine composition is different.

[0077] The traditional Chinese medicine composition, the components by weight are: 200 parts of pilose antler, 80 parts of American ginseng extract, 100 parts of angelica sinensis extract and 20 parts of astragalus membranaceus extract. Each component is mixed evenly to obtain the traditional Chinese medicine composition.

[0078] Comparative Example 6 Different from Example 1, the preparation method of the angelica sinensis extract is different.

[0079] The preparation method of the angelica sinensis extract is: the angelica sinensis cut pieces are refluxed and extracted 3 times with 10 times the amount of 95% ethanol at 55 - 60 °C for 1 hour each time, filtered, and dried to obtain the angelica sinensis extract.

[0080] The rest are the same as in Example 1.

[0081] Experiment: Detection of the function of relieving physical fatigue Experimental animals: SPF - grade male KM mice, weighing 18 g - 22 g, provided by the Breeding and Research Laboratory of the Institute of Laboratory Animals, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (Animal License No.: SCXK(Sichuan)2013 - 15). Feeding conditions: Barrier - level animal house (License No.: SYXK(Sichuan)2013 - 011).

[0082] Experimental method: After adaptive feeding, 240 KM mice are divided into two index - determination groups: the first group is used for the load - bearing swimming experiment, and the second group is used for the serum urea nitrogen determination experiment. Each index - determination group respectively includes a blank control group, Example 1 - Example 5 groups, and Comparative Example 1 - Comparative Example 6 groups, with 10 animals in each group.

[0083] In each group experiment, the dose of the test substance (traditional Chinese medicine composition) is 0.90 g / kg.bw (equivalent to 30 times the recommended human intake). By gavage, the animals in the blank control group are gavaged with an equal amount of pure water once a day. The drinking water is pure water. Throughout the test process, the animals freely eat and drink water, the room temperature is 21 °C - 22 °C, and the relative humidity is 50% - 53%.

[0084] After continuous gavage for 30 days, the following experiments are carried out respectively.

[0085] I. Load - bearing swimming experiment 30 minutes after the last administration of the test substance, the mice with a 5% body - weight lead sheet loaded at the tail root are placed in a swimming box to swim. The water depth in the box is not less than 30 cm, the water temperature is 25 °C ± 1 °C, and record the time from the start of swimming to death of the mice (load - bearing swimming time).

[0086] The load - bearing swimming time (s) of each group of mice is shown in Table 1.

[0087] Table 1

[0088] In Table 1, & Compared with the blank control group, there is a significant difference. & P < 0.05; # It means that the comparative example group has significant difference compared with the example 1 group. # P<0.05.

[0089] As can be seen from Table 1, the Chinese medicine composition of the present invention containing four kinds of Chinese medicinal ingredients has a significantly longer weighted swimming time for mice than the blank control group, indicating that the Chinese medicine composition of the present invention has a significantly improved anti-fatigue effect; In addition, the Chinese medicine composition of the present invention is significantly prolonged compared with the comparative examples 1 and 2 in which the ingredients are deleted, and even the improvement effect of the swimming time is better than the sum of the comparative examples 1 and 2. This shows that when the Chinese medicinal ingredients are used separately, there is no synergistic effect between the components. Only when the four ingredients are present at the same time, the components interact with each other, bringing about an unexpected synergistic effect. The Chinese medicine composition of the present invention is compared with the comparative example 3 with an additional component and the comparative example 4 with the replacement of the epimedium component which also has anti-fatigue effect. The weighted swimming time is significantly prolonged, which shows that only under the action of the four ingredients described in the present invention can the significant anti-fatigue effect be achieved. The Chinese medicine composition of the present invention is also significantly prolonged compared with the comparative example 5 and the comparative example 6 with a changed preparation method. Therefore, the component ratio of the non-present invention and the specific lifting method of the non-present invention affect the performance of the active ingredients and only have a certain effect on the anti-fatigue effect.

[0090] 2. Serum urea nitrogen determination experiment Serum urea nitrogen determination: 30 minutes after the last administration of the test substance, the mice were placed in 30°C water and swam without weight for 90 minutes. After resting for 60 minutes, 0.5 mL of eye blood was collected. After the blood coagulated, serum was collected and the serum urea nitrogen content was determined using the diacetyl monoxime method.

[0091] The serum urea nitrogen content (mmol / L) of mice in each group is shown in Table 2.

[0092] Table 2

[0093] In Table 2, & Compared with the blank control group, there is a significant difference. & P < 0.05; # indicates that there is a significant difference between the comparative example group and the example 1 group. # P<0.05.

[0094] Under normal circumstances, the body's serum urea nitrogen content is relatively stable. However, when the body exercises vigorously or continuously for a long time, when glycogen and fat metabolism can no longer meet the body's energy needs, the body needs to rely on protein decomposition for energy. Urea nitrogen is a nitrogen-containing compound other than protein that is synthesized in the liver from ammonia and carbon dioxide and transported to the kidneys through the blood for excretion from the body. An increase in serum urea nitrogen levels indicates that the body's aerobic metabolic capacity is reduced and the degree of exercise fatigue is increased. As can be seen from Table 2, the Chinese medicine composition containing 4 Chinese medicinal ingredients of the present invention can significantly reduce the serum urea nitrogen content of mice, reduce the degree of exercise fatigue, and has a better anti-fatigue effect compared with the comparative example. This shows that when the Chinese medicine composition is deleted, added or replaced with ingredients, or the dosage ratio and extraction method of each component are changed, although there is a certain effect of reducing the urea nitrogen content, the effect of reducing urea nitrogen is limited, and the significant anti-fatigue effect described in the present invention cannot be achieved.

[0095] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for tonifying the kidney and strengthening the body, characterized in that: The invention comprises the following ingredients: deer antler, American ginseng extract, angelica extract and astragalus extract.

2. The Chinese medicine composition according to claim 1, characterized in that The invention comprises the following components in parts by weight: 120-170 parts of pilose antler, 40-60 parts of American ginseng extract, 130-160 parts of angelica extract and 35-60 parts of astragalus extract.

3. The Chinese medicine composition according to claim 2, characterized in that The invention comprises the following components in parts by weight: 150 parts of pilose antler, 50 parts of American ginseng extract, 150 parts of angelica extract and 50 parts of astragalus extract.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that The preparation method of the angelica extract comprises the steps of: mixing the angelica raw material with water, decocting, filtering, and drying to obtain the angelica extract.

5. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that The preparation method of the astragalus extract comprises the following steps: mixing the astragalus raw material with an ethanol solution having a volume concentration of 50%-65%, extracting, filtering, and drying to obtain the astragalus extract.

6. The method for preparing the Chinese medicine composition according to any one of claims 1 to 5, characterized in that: Including steps: (1) After sterilization, the antler is crushed to obtain antler powder; (2) Preparation of American ginseng extract: Mixing American ginseng raw material with ethanol solution for extraction, filtering, and drying the filtrate to obtain American ginseng extract; (3) Preparing the angelica extract: mixing the angelica raw material with water, boiling, filtering, and drying to obtain the angelica extract; (4) Preparation of Astragalus extract: Mixing the Astragalus raw material with a 50%-65% volume concentration ethanol solution, extracting, filtering, and drying to obtain the Astragalus extract; (5) Deer antler powder, American ginseng extract, Chinese angelica extract and astragalus extract are mixed to obtain a Chinese medicine composition.

7. The preparation method according to claim 6, characterized in that In step (1), the particle size of the velvet antler powder is 60-100 mesh; in step (1), the sterilization is Co60 irradiation sterilization.

8. The preparation method according to claim 6, characterized in that Step (2) is specifically as follows: the American ginseng raw material is mixed with 8-12 times the amount of 68%-75% volume concentration of ethanol solution and extracted 2-4 times, the temperature of each extraction is 70-80 ° C, each extraction time is 1-3 hours, filtering, and drying the filtrate to obtain the American ginseng extract; Step (3) is specifically as follows: decocting the angelica raw material with 8-15 times the amount of water for 2-4 times, decocting for 0.5-2 hours each time, filtering, and drying to obtain the angelica extract; Step (4) is specifically as follows: extracting the astragalus raw material with 6-15 times the amount of 50-65% volume concentration ethanol solution, extracting at a temperature of 70-80° C., extracting 2-4 times, each extraction for 0.5-2 hours, filtering, and drying to obtain the astragalus extract.

9. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine composition prepared by the preparation method according to any one of claims 6 to 8 in the preparation of medicines and / or health foods having anti-fatigue, immunity-enhancing, kidney-tonifying and yang-strengthening effects.

10. A medicine with the effects of anti-fatigue, enhancing immunity, tonifying the kidney and strengthening yang, characterized in that: The invention comprises components: the traditional Chinese medicine composition according to any one of claims 1 to 5 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 6 to 8.

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