CN111407851A

CN111407851A - Traditional Chinese medicine composition, preparation method and application thereof in preparation of anti-fatigue medicine

Info

Publication number: CN111407851A
Application number: CN202010476989.9A
Authority: CN
Inventors: 何述金; 何承东; 周代俊; 费翔; 欧阳习叶
Original assignee: Changsha Xinquan Xinlin Health Products Co ltd; HUNAN XINHUI PHARMACEUTICAL CO Ltd
Current assignee: Changsha Xinquan Xinlin Health Products Co ltd; HUNAN XINHUI PHARMACEUTICAL CO Ltd
Priority date: 2020-05-29
Filing date: 2020-05-29
Publication date: 2020-07-14

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition, a preparation method and application thereof in preparing an anti-fatigue medicine, wherein the traditional Chinese medicine composition comprises the following raw material components, by weight, 1-2 parts of ginseng, 5-7 parts of rhizoma polygonati preparata, 2-3 parts of raspberry, 2-3 parts of cherokee rose pulp, 3-4 parts of medlar, 3-4 parts of fructus ligustri lucidi preparata, 1-2 parts of semen cuscutae preparata, 2-4 parts of salvia miltiorrhiza and 2-4 parts of epimedium, wherein the weight content of polysaccharide is more than 10%, and the weight content of icariin is more than 0.04%. Raspberry, medlar, glossy privet fruit, dodder, epimedium and cherokee rose fruit are taken as ministerial drugs, and the effects of nourishing liver and kidney, building body and assisting monarch drugs in relieving physical fatigue are achieved. Rhizoma Polygonati and Saviae Miltiorrhizae radix are used as adjuvant drugs to achieve the effect of regulating qi and blood by invigorating qi, promoting blood circulation, and cooling blood.

Description

Traditional Chinese medicine composition, preparation method and application thereof in preparation of anti-fatigue medicine

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition, a preparation method and application thereof in preparing an anti-fatigue medicine.

Background

"fatigue" is the subjective feeling of people, and almost everyone has the experience of fatigue. It is not only a normal phenomenon after fatigue of healthy people, but also an important manifestation of various diseases. The traditional Chinese medicine has been known for fatigue for two thousand years. From the medical point of view, fatigue should be the earliest one in China's book of Huangdi's classic of medicine. In Huangdi's classic on medicine, the etiology, pathogenesis, prevention, health preservation and treatment of fatigue are explained and referred. The main causes of fatigue include: accumulation of fatigue substances, consumption of force sources, changes of central system, biochemical changes and local blood flow blockage. Fatigue belongs to the categories of consumptive disease and deficiency in traditional Chinese medicine, and viscera deficiency caused by various factors and yin and yang deficiency of qi and blood of five internal organs are basic pathogenesis of fatigue. Clinically, the symptoms are qi and blood deficiency, heart and spleen deficiency, liver stagnation and spleen deficiency, liver and kidney yin deficiency, spleen and kidney yang deficiency, and the like.

Chinese patent application CN201610050853.5 discloses a Chinese medicinal composition, which is prepared from maca, ginseng, hippocampus, cordyceps sinensis, wolfberry fruit, yam, cistanche deserticola, epimedium, dodder, schisandra chinensis, semen allii tuberosi, poria cocos, eucommia ulmoides, achyranthes bidentata, morinda officinalis, cynomorium songaricum, astragalus membranaceus, cinnamon bark, raspberry, dogwood, fennel, aspongopus and liquorice, wherein the effects of various substances are described in the specification.

CN 201611175051.3A health wine discloses a Chinese medicinal material raw material proportion, which comprises 5 parts of aweto, 5 parts of cistanche, 5 parts of cynomorium songaricum, 5 parts of epimedium, 8 parts of Chinese yam, 5 parts of morinda officinalis, 8 parts of astragalus membranaceus, 4 parts of prepared rehmannia root, 4 parts of dodder, 8 parts of sea-buckthorn, 4 parts of prepared fleece-flower root, 4 parts of raspberry, 8 parts of cortex acanthopanacis, 4 parts of cervus elaphus linnaeus, 7 parts of glossy privet fruit, 7 parts of dogwood, 7 parts of cinnamon, 7 parts of black sesame, 7 parts of cassia seed, 7 parts of hawthorn, 7 parts of Chinese date, 7 parts of polygonatum odoratum, 7 parts of platycodon grandiflorum, 7 parts of medlar, 7 parts of kudzuvine root, 7 parts of schisandra chinensis, 5 parts of angelica, 4 parts of eucommia ulmoides, 6 parts of acanthopanax, 6 parts of safflower, 6 parts of cherokee rose, 6 parts of semen allii tuberose, 6 parts. It has effects in invigorating kidney, nourishing yin, supporting yang, enhancing immunity, and relieving fatigue.

Disclosure of Invention

The invention aims to solve the technical problem of providing a traditional Chinese medicine composition, a preparation method and application thereof in preparing an anti-fatigue medicine.

The invention relates to a traditional Chinese medicine composition which comprises traditional Chinese medicine components and auxiliary materials, wherein the traditional Chinese medicine components comprise the following raw material components in parts by weight,

1-2 parts of ginseng, 5-7 parts of wine-processed sealwort, 2-3 parts of raspberry, 2-3 parts of cherokee rose pulp, 3-4 parts of medlar, 3-4 parts of wine-processed glossy privet fruit, 1-2 parts of fried dodder, 2-4 parts of salvia miltiorrhiza and 2-4 parts of epimedium, wherein the weight content of polysaccharide is more than 10 percent, and the weight content of icariin is more than 0.04 percent.

Preferably, the traditional Chinese medicine component consists of the following raw material components in parts by weight,

2 parts of ginseng, 6 parts of wine-processed rhizoma polygonati, 2 parts of raspberry, 3 parts of cherokee rose pulp, 3 parts of medlar, 3 parts of wine-processed glossy privet fruit, 2 parts of fried dodder, 3 parts of salvia miltiorrhiza and 3 parts of epimedium herb.

A Chinese medicinal composition is prepared by micronizing Ginseng radix; mixing rhizoma Polygonati preparata, Rubi fructus, fructus Rosae Laevigatae, fructus Lycii, fructus Ligustri Lucidi preparata, semen Cuscutae preparata, Saviae Miltiorrhizae radix and herba Epimedii to obtain mixture, sequentially adding 8-10 times and 6-8 times of water, soaking, heating to 80-100 deg.C, and vacuum-extracting; concentrating under reduced pressure, belt vacuum drying, and mixing the dried material with superfine pulverized Ginseng radix to obtain Chinese medicinal composition.

Preferably, the specific gravity of the drug solution after concentration under reduced pressure is 1.29.

Preferably, the vacuum concentration is carried out under the conditions of-0.03 to-0.06 Mpa of vacuum degree, 60 to 90 ℃ of temperature and 0.05 to 0.1Mpa of steam pressure.

Preferably, the belt type vacuum drying conditions comprise that the vacuum degree is-99 KPa, the frequency of a feeding pump is 8Hz, the transmission frequency is 16Hz, the material distribution frequency is 8Hz, the material distribution angle is 40 ℃, the temperature of a first zone is 105 ℃, the temperature of a second zone is 85 ℃, and the temperature of a cooling zone is 33-30 ℃.

Preferably, the dried substance and the ginseng after the superfine grinding are mixed, and then auxiliary materials are added, wherein the auxiliary materials are pregelatinized starch, lactose, silicon dioxide, microcrystalline cellulose and magnesium stearate, and the traditional Chinese medicine composition is obtained after dry granulation and treatment.

Preferably, the total weight of the dried material and the ginseng after the micronization is 2-8 times of the weight of the auxiliary materials.

Preferably, the auxiliary materials comprise, by weight, 4-5 parts of pregelatinized starch, 6-7 parts of lactose, 9-10 parts of silicon dioxide, 6-7 parts of microcrystalline cellulose and 0.3-0.8 part of magnesium stearate.

The invention provides application of a traditional Chinese medicine composition in preparing an anti-fatigue medicine.

In the composition of the present application,

ginseng: sweet, slightly bitter and warm, entering spleen, lung, heart and kidney meridians; has effects of invigorating primordial qi, restoring pulse, relieving depletion, invigorating spleen, benefiting lung, promoting fluid production, nourishing blood, tranquilizing mind, and improving intelligence.

Rhizoma polygonati: sweet and neutral, entering spleen, lung and kidney meridians; has effects of invigorating qi, nourishing yin, invigorating spleen, moistening lung, and invigorating kidney, and can be used for treating deficiency of spleen-qi and stomach-qi, asthenia, essence and blood deficiency, soreness of waist and knees, etc.

Raspberry: sweet and sour, warm and entering liver, kidney and bladder meridians, and has the functions of tonifying kidney, controlling nocturnal emission, reducing urination, nourishing liver and improving eyesight.

Cherokee rose fruit: sour, sweet, astringent and neutral, enter kidney, bladder and large intestine meridians, and have the effects of securing essence, reducing urination, relieving metrorrhagia, arresting leucorrhea, astringing intestine and stopping diarrhea.

Medlar: sweet and neutral, entering liver and kidney meridians, has the effects of nourishing liver and kidney, replenishing vital essence and improving eyesight, and is used for consumptive disease and essence deficiency, soreness and weakness of waist and knees and the like.

Glossy privet fruit: sweet, bitter and cool, entering liver and kidney meridians, has the functions of nourishing liver and kidney, improving eyesight and blackening hair.

Dodder seed: pungent, sweet and leap enter liver, kidney and spleen meridians, and have the effects of tonifying liver and kidney, securing essence, reducing urination, preventing abortion, improving eyesight and stopping diarrhea.

Red sage root: bitter and slightly cold, enter heart and liver meridians, and have the effects of promoting blood circulation, removing blood stasis, dredging channels, relieving pain, clearing heart fire, relieving restlessness, cooling blood and resolving carbuncle.

Herba epimedii: pungent and sweet with warm property entering liver and kidney meridians, it has the actions of tonifying kidney yang, strengthening tendons and bones, and dispelling wind-damp.

The ginseng health-care wine has the beneficial effects that the ginseng is used as a monarch drug, so that the ginseng health-care wine can greatly tonify primordial qi, recover pulse, relieve depletion and relieve physical fatigue. Raspberry, medlar, glossy privet fruit, dodder, epimedium and cherokee rose fruit are taken as ministerial drugs, and the effects of nourishing liver and kidney, building body and assisting monarch drugs in relieving physical fatigue are achieved. Rhizoma Polygonati and Saviae Miltiorrhizae radix are used as adjuvant drugs to achieve the effect of regulating qi and blood by invigorating qi, promoting blood circulation, and cooling blood.

The invention improves the anti-fatigue effect by the following modes:

1. improving energy metabolism and glycogen storage;

2. removing redundant metabolites and playing a role in resisting fatigue;

3. has antifatigue effect by regulating immunity.

Drawings

FIG. 1 is a flow chart of the preparation of the present invention;

FIG. 2 is a ginseng thin-layer chromatogram identification map of the Chinese medicinal composition of the present invention. Wherein the content of the first and second substances,

a: ginseng control drug, B: ginsenoside Rb1 reference substance, ginsenoside Re reference substance, ginsenoside Rf reference substance and ginsenoside Rg1 reference substance mixed solution, C: traditional Chinese medicine composition 1, D: and (3) a traditional Chinese medicine composition 2.

FIG. 3 is a thin-layer identification spectrum of fructus Ligustri Lucidi of the Chinese medicinal composition; wherein, A: oleanolic acid control solution, C:

traditional Chinese medicine composition 1, D: and (3) a traditional Chinese medicine composition 2.

Detailed Description

Example 1

As shown in fig. 1, which is a flow chart of the preparation of the present application,

comprises the following raw material components in parts by weight,

The method comprises the following steps:

water extraction (8 kinds of medicine such as wine sealwort, epimedium herb and the like)

The extraction process comprises the following steps: firstly, adding a proper amount of drinking water into an extraction tank, putting the pretreated 8-medicine (rhizoma polygonati preparata, raspberry, cherokee rose pulp, medlar, wine glossy privet fruit, fried dodder, salvia miltiorrhiza and epimedium) clean decoction pieces into the extraction tank from a feed inlet, soaking for 30min, and adding drinking water to 10 times of the amount of the medicinal materials; introducing hot steam into the tank jacket, heating to 80 deg.C, opening vacuum valve, vacuumizing, extracting for 1.5 hr, closing steam valve and vacuum valve, breaking vacuum, and discharging the feed liquid; and (3) adding 8 times of water for the second time, heating to 80 ℃, opening a vacuum valve for vacuumizing, extracting for 1h, closing a steam valve and the vacuum valve, breaking vacuum, discharging feed liquid, filtering by a stainless steel filter, and storing in a storage tank.

The process conditions are as follows: the equipment is clean and intact and runs normally; soaking time: 30 min; the temperature in the tank should be kept at 80-100 deg.C (boiling state) during extraction process; extraction time: 1.5h and 1 h; adding water: 10 times and 8 times of the total amount of the raw materials; mesh number of stainless steel screen: 100 meshes.

Double-effect concentration

The operation process is as follows: starting a vacuum pump, circulating water, starting a delivery pump, pumping 8 medicinal extracts such as rhizoma Polygonati preparata, herba Epimedii and the like into a double-effect energy-saving concentrator, opening a steam valve, carrying out reduced pressure concentration, discharging the concentrated liquid medicine with the specific gravity of about 1.29 (measured at 60 ℃), containing the liquid medicine in a clean area by using a turnover barrel, and weighing.

The process conditions are as follows: vacuum degree: -0.03 to-0.06 Mpa; temperature: 60-90 ℃. Steam pressure: 0.05 to 0.1 MPa. The specific gravity of the concentrated liquid medicine is as follows: 1.29.

vacuum drying and pulverizing

The operation process is as follows: slowly pouring the concentrated solution of 8 kinds of medicinal materials such as rhizoma Polygonati preparata, herba Epimedii, etc. into a belt type vacuum drier with vacuum degree of-99 KPa, feeding pump frequency of 8Hz, transmission frequency of 16Hz, material distribution frequency of 8Hz, material distribution angle of 40, temperature of 105 deg.C in the first region, temperature of 85 deg.C in the second region, and temperature of 33-30 deg.C in the cooling region. The dried material is automatically received by an automatic material receiving machine and is conveyed to an auxiliary crushing area for crushing, bagging, sealing, containing by a turnover barrel and conveying to a temporary storage room for storage.

The process conditions are as follows: the vacuum degree is-99 KPa, the frequency of a feeding pump is 8Hz, the transmission frequency is 16Hz, the material distribution frequency is 8Hz, the material distribution angle is 40, the temperature of a first area is 105 ℃, the temperature of a second area is 85 ℃, and the temperature of a cooling area is 33-30 ℃.

Superfine grinding

The operation process is as follows: pulverizing Ginseng radix slice with superfine pulverizer, bagging, sealing, and packaging with a turnover barrel.

The process conditions are as follows: low-temperature crushing temperature is-15 ℃; pulverizing for 3-5 min.

Fifthly, preparing capsules

The total weight of the dried substance and the ginseng after the superfine grinding after being mixed is 3 times of the weight of the auxiliary materials.

The auxiliary materials comprise, by weight, 4-5 parts of pregelatinized starch, 6-7 parts of lactose, 9-10 parts of silicon dioxide, 6-7 parts of microcrystalline cellulose and 0.3-0.8 part of magnesium stearate.

The preparation method comprises the steps of adding 8 medicinal extracts such as polygonatum sibiricum and the like, ginseng powder and a proper amount of pregelatinized starch, lactose, silicon dioxide, microcrystalline cellulose and magnesium stearate into an HF-2000 pyramid mixer for mixing for 15min, discharging and bagging after mixing, adding the mixture into a GZ L200-75L dry granulator for dry granulation, sieving the granules with a 16-mesh sieve, mixing with the rest silicon dioxide uniformly to facilitate capsule filling, and filling the granules in a turnover barrel with a plastic lining and a cover.

The process conditions are as follows: the equipment and the container are required to be cleaned and dried, and the equipment runs normally; the mixing time is 15min, the granulation pressure is 5Mpa, the vertical rotating speed is 18 r/min, the horizontal rotating speed is 48 r/min, the rotating speed of a compression roller is 13 r/min, the whole grain rotating speed is 120 r/min, and the mixture is sieved by a 16-mesh sieve.

Wherein the weight content of polysaccharide is more than 10%, and the weight content of icariin is more than 0.04%.

Sixthly, filling and polishing capsules

The operation process is as follows: adding the rhizoma polygonati compound capsules to be filled into granules into a hopper of a capsule filling machine, filling hollow capsules, starting the capsule filling machine, adjusting various parameters to ensure that the filling amount of the capsules is within a specified range, adding the filled capsules into the hopper of a polishing machine, starting the polishing machine, adjusting the rotating speed, and placing the polished capsules into a barrel which is internally lined with a plastic bag and is provided with a cover.

The process conditions are as follows: the equipment is clean and dry, and the operation is normal; the filling speed of the NJP-1200C type full-automatic capsule filling machine is 800-1200 granules/min, the capsule dividing negative pressure is negative 0.02-negative 0.03MPa, and the filling amount limit is as follows: (0.35 g. + -. 10%).

Experimental example 1

Ginseng powder identification test:

taking 2.10g and 2.24g of the product powder, adding 40ml of trichloromethane, heating and refluxing for 1 hour, removing trichloromethane liquid, volatilizing the solvent in the medicine residue, adding 0.5ml of water, stirring for moistening, adding 10ml of water-saturated n-butyl alcohol, carrying out ultrasonic treatment for 30 minutes, absorbing supernatant, adding 3 times of ammonia test solution, shaking uniformly, standing for layering, taking supernatant, evaporating to dryness, and adding 1ml of methanol to dissolve residues to obtain a test solution. Preparing 1g of ginseng reference medicinal material, and preparing a reference medicinal material solution by the same method. Adding methanol into ginsenoside Rb1, ginsenoside Re, ginsenoside Rf and ginsenoside Rg1 as reference solutions to obtain mixed solutions each containing 2mg of ginsenoside Rb1, ginsenoside Re, ginsenoside Rf and ginsenoside Rg1 in each 1 ml. Performing thin layer chromatography (general rule 0502) test, sucking 1-2 μ l of the above three solutions, respectively dropping on the same silica gel G thin layer plate, spreading with lower layer solution of chloroform-ethyl acetate-methanol-water (15: 40: 22: 10) at temperature below 10 deg.C as developing agent, taking out, air drying, spraying with 10% sulphuric acid ethanol solution, heating at 105 deg.C until the spots are clearly developed, and respectively placing under sunlight and ultraviolet lamp (365nm) for inspection. In the chromatogram of the test solution, spots or fluorescent spots with the same color are respectively displayed at the corresponding positions of the chromatogram of the reference solution and the chromatogram of the reference solution. As illustrated in fig. 2.

Salvia miltiorrhiza discrimination test

Taking 2.01g and 2.01g of the product powder, adding 5ml of ethanol, carrying out ultrasonic treatment for 15 minutes, centrifuging, and taking supernate as a test solution. Taking 1g of radix Salviae Miltiorrhizae as reference material, and making into reference material solution by the same method. And adding ethanol into tanshinone IIA reference substance and salvianolic acid B reference substance to obtain mixed solution containing 0.5mg and 1.5mg per 1ml as reference substance solution. Performing thin-layer chromatography (general rule 0502) test, sucking 5 μ l of each of the three solutions, respectively dropping on the same silica gel G thin-layer plate, forming into strip, developing to about 4cm with chloroform-toluene-ethyl acetate-methanol-formic acid (6: 4: 8: 1: 4) as developing agent, taking out, air drying, developing to about 8cm with petroleum ether (60-90 deg.C) -ethyl acetate (4: 1) as developing agent, taking out, air drying, and inspecting under sunlight and ultraviolet lamp (365 nm). In the result, in the chromatogram of the test sample, spots which do not show the same color are inspected under a fluorescent lamp at the positions corresponding to the chromatogram of the reference medicinal material and the chromatogram of the reference substance, one sample in the ultraviolet lamp inspection base shows fluorescence and light spots, and the method also needs to optimize the purification degree; as shown in fig. 3.

Experimental example 2

In the formula, rhizoma polygonati is used as a main component, the active ingredients of the rhizoma polygonati are used as content measurement indexes, and the health care function of the product is combined to relieve physical fatigue, so that the polysaccharide of the rhizoma polygonati is selected as the content measurement index; the epimedium is one of important components for relieving physical fatigue, and the content measurement index of the epimedium is icariin which is a main effective component for relieving the physical fatigue, so that the epimedium is selected as another content measurement index.

The method for measuring the polysaccharide content comprises the following steps:

preparation of control solutions: taking a proper amount of anhydrous glucose reference substance, precisely weighing, and adding water to obtain a solution containing 0.32mg per 1 ml.

Preparation of standard curve 0.10ml, 0.20ml, 0.30ml, 0.40ml, 0.50ml and 0.60ml of reference solution are precisely measured and put into a 25ml test tube with a plug scale, water is added to make up to 2ml, 0.2% anthrone-sulfuric acid solution is slowly added into an ice water bath, shaking is carried out, boiling water bath is carried out for 10min, ice water bath is carried out for 15min, corresponding reagent is used as blank, ultraviolet-visible spectrophotometry is carried out, absorbance is measured at a wavelength of 582nm, the absorbance is used as ordinate, and glucose amount (mg) is used as abscissa, and the standard curve is drawn.

Preparation of test solution 0.5g of the content of the product is precisely weighed, placed into a centrifuge tube with a plug, 10ml of 90% ethanol is respectively used for ultrasonic extraction for 15min, centrifuged for 8 min (4000 rpm), the supernatant is poured out, the precipitate is washed by adding 10ml of corresponding solvent, and centrifuged. Dissolving the precipitate with appropriate amount of hot water, transferring to conical flask, adding 50ml of hot water, shaking for 30min, cooling to room temperature, filtering, transferring the supernatant to 100ml volumetric flask, washing the residue for 2-3 times, transferring the washing solution to volumetric flask, adding water to dilute to scale, shaking up, and using as sample determination solution. Precisely sucking 1ml of sample solution, placing the sample solution in a 10ml volumetric flask, adding water to the scale, sucking 1ml of the sample solution, measuring the absorbance by a method from the beginning of adding water to 2ml according to a preparation item of a standard curve, reading the weight (mg) of polysaccharide in the sample solution from the standard curve, and calculating to obtain the polysaccharide-polysaccharide test solution.

The product contains polysaccharide and anhydrous glucose (C) per 1g₆H₁₂O₆) Calculated by not less than 10 percent.

Experimental example 3

Content determination of icariin

Octadecylsilane chemically bonded silica is used as a filler in chromatographic conditions and system applicability tests; acetonitrile-water (25: 75) as mobile phase; the detection wavelength was 270 nm.

Preparation of control solution A proper amount of icariin control is precisely weighed, and added with methanol to obtain a solution containing 20 μ g of icariin per 1 ml.

Preparing a test solution, namely taking 1g of the product, precisely weighing, adding 20ml of 80% ethanol, weighing, ultrasonically treating for 60min, cooling to room temperature, complementing the reduced weight with 80% ethanol, shaking uniformly, filtering, taking 10ml to a water bath pot, drying by distillation, adding 10ml of water into residues, dissolving the residues into 10ml of water, adding the residues into a separating funnel, respectively shaking and extracting for 4 times by using ethyl acetate, 20ml each time, combining ethyl acetate solutions, drying by distillation in the water bath pot, dissolving the residues with 80% ethanol, transferring the residues into a 10ml measuring flask, adding 80% ethanol to dilute the residues to a scale, shaking uniformly, and filtering with a 0.45 mu m filter membrane to obtain the test solution.

The determination method comprises precisely sucking 10 μ l of each of the reference solution and the sample solution, injecting into liquid chromatograph, and determining.

The product contains icariin (C) calculated on dry basis₃₃H₄₀O₁₅) Not less than 0.04%.

Comparative example 1

The formulation of comparative example 1 consists of the following raw material components in parts by weight,

5 parts of ginseng, 15 parts of wine sealwort and 7 parts of epimedium; the rest is the same as example 1.

Experimental example 4 anti-fatigue test

The anti-fatigue health oral liquids prepared in the above example 1 and comparative example 1 were subjected to an anti-fatigue test.

First, experiment method

1. Experimental animals and groups: 20-24 g adult mice, each male and female half, are randomly grouped into 10 mice each group, and grow adaptively for 1 week. The anti-fatigue effect of the anti-fatigue health oral liquid is judged by the weight-bearing swimming time, the content of the hepatic glycogen and the content of the blood lactic acid respectively.

2. The dosage method and dosage of the anti-fatigue health oral liquid are that the anti-fatigue health oral liquid A, B, C and the experimental group D are set for experiments, the dosage is (1g of raw medicinal materials/(kg. D)), a blank control group (intragastric distilled water) is set for oral intragastric administration, the intragastric administration amount is 0.2m L/(only. D), and the oral administration is continuously fed for 30D.

3. Weight-bearing swimming time experiment: 30min after the last administration of the test sample, 5% of the lead skin by mass was bound to the root of the mouse tail, and the mouse was placed in water at about 25 ℃ for swimming, and the time from swimming to death was recorded.

4. Liver glycogen content determination, namely, 30min after the last sample giving, killing a mouse, taking a liver, rinsing the liver by using normal saline, sucking water, accurately weighing 100mg, adding 8m L% trichloroacetic acid, homogenizing for 1min, then placing homogenate into a 10m L centrifuge tube, centrifuging for 15min at 3000r/min, taking 1m L of supernatant into a 10m L centrifuge tube, adding 4m L% ethanol, oscillating until no interface exists between the two liquids, standing overnight at room temperature to extract glycogen, centrifuging for 15min at 3000r/min after complete precipitation, discarding supernatant, fully dissolving the glycogen by using 2m L distilled water, uniformly mixing 0.5m L mg/m L glucose standard solution and 1.5m L distilled water, using an anthrone method to measure absorbance at the wavelength of 620nm, and calculating the glycogen content according to the following formula:

liver glycogen content/(mg/100 g) ═ AS/A0 × 0.5 × V_{Extract liquid}/m_{Liver tissue}×100×0.9

Wherein As is the absorbance of the sample tube, A0 is the absorbance of the standard tube, 0.5mg is 0.5m, namely the glucose content in the glucose standard solution of L m, V extract is 8m L, m liver tissue is 0.1g, 100g is 100g, and 0.9 is the conversion coefficient for converting glucose into glycogen.

5. Blood lactic acid content determination, blood sampling is carried out 30min after the last sample giving, blood sampling is carried out immediately after swimming for 10min in water with the water temperature of about 30 ℃ under the condition of no load, the blood sampling is carried out 3 times after the last sample giving, 20 mu L of whole blood is accurately sucked, the bottom of a 5m L test tube filled with 0.48m L1% sodium fluoride solution in advance is added, 1.5m L protein precipitator (formed by mixing 10% sodium tungstate, 0.33 mol/L sulfuric acid and distilled water according to the volume ratio of 1: 28) is added, the mixture is fully oscillated and mixed evenly, the mixture is centrifuged for 10min at 3000r/min, and the supernatant is taken for blood lactic acid content determination, wherein the operation is as follows:

respectively setting a measuring tube, a standard tube and a blank tube, adding 0.5m L supernatant into the measuring tube, respectively adding 0.1m L4% of copper sulfate solution and 3m L% of concentrated sulfuric acid into the standard tube and the blank tube in the same volume of lactic acid standard solution and precipitant-sodium fluoride mixed solution (the protein precipitant and the sodium fluoride solution are mixed according to the volume ratio of 3: 1), fully mixing the tubes, boiling in a water bath for 5min, taking out, cooling in an ice water bath for 10min, adding 0.1m L1.5.5% of p-hydroxybiphenyl into each tube, 0.1m L, shaking uniformly, placing in a 30 ℃ water bath for 30min, shaking for 1 time every 10min, taking out, boiling in a water bath for 90s, taking out, cooling to room temperature, measuring absorbance at the wavelength of 560nm, adjusting to zero in the blank tube, and calculating the blood lactic acid content, the area under the blood lactic acid curve and the blood lactic acid recovery rate according to the following formulas.

Blood lactic acid content/(mg/L) ═ A assay tube/A standard tube × 100 × 10

Area under the blood lactic acid curve 5 × (blood lactic acid value before swimming + 0min after 3 × swimming + 20min after 2 × swimming)

Rate of recovery from blood lactic acid/(mg/(L. min)) ═ (0 min blood lactic acid value after swimming-20 min blood lactic acid value after swimming)/(20 min-0 min)

Second, experimental results

Table 1: influence table of anti-fatigue health oral liquid on anti-fatigue of mice

Group of	Swimming time/s	Liver glycogen content/(mg/100 g)
			Blank control group	270.1±20.6	180.9±16.8
EXAMPLE 1 group	1980.3±56.2	1184.3±45.8
			Comparative example 1 group	1535.6±35.9	980.7±35.9

Table 2: influence table of anti-fatigue health oral liquid on anti-fatigue of mice

Group of	Area under blood lactic acid curve	Blood lactic acid recovery rate/(mg/(L. min))
			Blank control group	73.58±13.8	0.012±0.0034
EXAMPLE 1 group	28.75±6.71	0.0192±0.0074
			Comparative example 1 group	56.32±7.98	0.0141±0.0098

Note: p <0.05, significant difference; the difference was very significant with p < 0.01.

As shown in the table 1-2, the swimming time of the traditional Chinese medicine composition is longer than that of a blank control group, the liver glycogen content is also obviously higher than that of the blank control group, the area under the blood lactic acid curve is smaller than that of the blank control group, and the recovery rate is higher than that of the control group, so that the swimming time of a mouse taking the traditional Chinese medicine composition under load is obviously prolonged, the liver glycogen content is obviously increased, and the blood lactic acid content is obviously reduced after swimming, therefore, the traditional Chinese medicine composition has the function of relieving physical fatigue and has the best anti-fatigue effect.

Claims

1. A traditional Chinese medicine composition is characterized by comprising traditional Chinese medicine components and auxiliary materials, wherein the traditional Chinese medicine components comprise the following raw material components in parts by weight,

2. The traditional Chinese medicine composition as claimed in claim 1, wherein the traditional Chinese medicine component comprises the following raw material components in parts by weight,

3. A method for preparing the Chinese medicinal composition as claimed in claim 1 or 2, wherein ginseng is subjected to micronization; mixing rhizoma Polygonati preparata, Rubi fructus, fructus Rosae Laevigatae, fructus Lycii, fructus Ligustri Lucidi preparata, semen Cuscutae preparata, Saviae Miltiorrhizae radix and herba Epimedii to obtain mixture, sequentially adding 8-10 times and 6-8 times of water, soaking, heating to 80-100 deg.C, and vacuum-extracting; concentrating under reduced pressure, belt vacuum drying, and mixing the dried material with superfine pulverized Ginseng radix to obtain Chinese medicinal composition.

4. The process according to claim 3, wherein the specific gravity of the liquid medicine after the concentration under reduced pressure is 1.29.

5. The method according to claim 3, wherein the concentration under reduced pressure is carried out under a vacuum degree of-0.03 to-0.06 MPa, a temperature of 60 to 90 ℃ and a steam pressure of 0.05 to 0.1 MPa.

6. The process according to claim 3, wherein the conditions of the belt-type vacuum drying are a degree of vacuum of-99 KPa, a frequency of a feed pump of 8Hz, a driving frequency of 16Hz, a frequency of distribution of 8Hz, a distribution angle of 40 degrees, a temperature of 105 ℃ in the first zone, a temperature of 85 ℃ in the second zone, and a temperature of 33 ℃ to 30 ℃ in the cooling zone.

7. The method for preparing a Chinese medicinal composition according to any one of claims 3 to 6, wherein the dried material and the ultra-finely pulverized ginseng are mixed, and then the auxiliary materials, which are pregelatinized starch, lactose, silicon dioxide, microcrystalline cellulose and magnesium stearate, are added, and the dry granulation and the treatment are carried out to obtain the Chinese medicinal composition.

8. The preparation method according to claim 7, wherein the total weight of the dried material and the ultra-fine pulverized ginseng after mixing is 2 to 8 times the weight of the supplementary material.

9. The preparation method according to claim 7, wherein the auxiliary materials comprise 4-5 parts of pregelatinized starch, 6-7 parts of lactose, 9-10 parts of silicon dioxide, 6-7 parts of microcrystalline cellulose and 0.3-0.8 part of magnesium stearate by weight.

10. Use of the Chinese medicinal composition of claim 1 or 2 in the preparation of an anti-fatigue medicament.