CN104491310B - Anti-fatigue composition and its preparation method and application - Google Patents

Abstract

The invention discloses an anti-fatigue composition and its preparation method and application, belonging to the technical field of medicine. The active ingredients of the composition are prepared from the following raw materials in parts by weight: 10.0-20.0 parts of Acanthopanax, 8.0-18.0 parts of Cordyceps militaris, 5.0-23.0 parts of Chinese yam, 3.0-10.0 parts of Rosa laevigata, 3.0-10.0 parts of Ligustrum lucidum 10.0 servings. The anti-fatigue composition combines Acanthopanax militaris, Cordyceps militaris, Chinese yam, Rosaceae, and Ligustrum lucidum, uses Cordyceps militaris to nourish the kidneys, nourish the lungs, nourish the essence, and mainly nourish the innate qi, and is the king drug; Invigorate qi and invigorate the spleen, invigorate the kidney and calm the nerves, mainly nourish the acquired qi, and serve as ministerial medicine; use yam to nourish qi and nourish yin, and privet fruit to nourish the liver and kidney, which are used as adjuvant medicine; medicine. These several kinds of raw materials cooperate with each other, act synergistically, work together, and play the effect of anti-fatigue.

Description

Anti-fatigue composition and its preparation method and application

technical field

The invention relates to the technical field of medicine, in particular to an anti-fatigue composition and its preparation method and application.

Background technique

With the acceleration of the pace of social life, modern people have long been in an environment of intense work and high competitive pressure, which leads to emotional instability, fatigue, and a sub-healthy state.

Fatigue is divided into two types: physiological fatigue and pathological fatigue. Among them: Physiological fatigue can be relieved by normal rest, but pathological fatigue cannot be effectively relieved by rest, which seriously affects daily life and work, and is a great hidden danger to human health. Drugs or psychotherapy must be used. Give treatment.

If fatigue is not relieved for a long time, it will develop into chronic fatigue syndrome, which can even lead to sudden death in severe cases. The typical sudden death symptom is "death from overwork". Epidemiological surveys show that fatigue is more common in middle-aged people with higher education, especially in women, and it tends to spread to young people. It has become one of the major hidden dangers that threaten human health in the 21st century.

At present, most of the drugs used clinically for anti-fatigue are chemical drugs of central nervous system stimulants, which are addictive and dependent, which greatly limits their clinical application. Therefore, the development of pure natural health food with anti-fatigue effect and no side effects has extremely important practical and social significance.

Contents of the invention

Based on this, the purpose of the present invention is to overcome the defects of the prior art, to provide an anti-fatigue composition, which has a good anti-fatigue effect, and is completely composed of natural ingredients, without addiction and dependence, Advantages of less side effects.

To achieve the above object, the present invention takes the following technical solutions:

An anti-fatigue composition, the active ingredient of which is prepared from the following raw materials in parts by weight:

10.0-20.0 parts of Acanthopanax, 8.0-18.0 parts of Cordyceps militaris, 5.0-23.0 parts of Chinese yam, 3.0-10.0 parts of golden cherry, 3.0-10.0 parts of Ligustrum lucidum.

The anti-fatigue composition of the present invention is guided by the theory of traditional Chinese medicine. It is believed that the appearance of fatigue is closely related to the imbalance of the five internal organs. For example, the weakness of the limbs is mostly related to the spleen and stomach, the soreness of the waist and legs is mostly related to the kidneys, and the lack of strength is mostly related to the kidneys. It is related to the lungs, confusion is mostly related to the heart, and fatigue is mostly related to the liver. The whole life activities of a person depend entirely on "vital energy". Vitality is endowed innate (kidney) and nourished in acquired (spleen and stomach). It is the source of energy for the human body. The combination of vitality and different organs produces different functions. It will cause people's various functions to be in a depressed and inhibited state, which is also the root cause of fatigue. Therefore, the treatment of fatigue should not only benefit the five internal organs, but also cannot ignore the supplement of "Qi".

On the basis of the above research, in the present invention, Acanthopanax, Cordyceps militaris, Chinese yam, Fructus Rosa, and Fructus Ligustrum are matched, and the method of treating the disease is to nourish the kidney and nourish the lung, invigorate the spleen and replenish qi, and carry out according to the prescription principle of the monarch, minister and assistant envoy. Drug Compatibility. In the prescription, Cordyceps militaris nourishes the kidneys and lungs, nourishes the essence, and is the king drug for nourishing the innate qi; Acanthopanax senticosus nourishes the spleen, nourishes the kidney and calms the nerves, and is the subject medicine for nourishing the acquired qi; Invigorating the liver and kidney is an adjuvant drug; Fructus Rosa japonica solidifies essence and astringent intestines, and reconciles the properties of the medicine as an adjuvant drug. These several kinds of raw materials cooperate with each other, act synergistically, work together, and play the effect of anti-fatigue.

Prescription: Cordyceps militaris (belonging to Hypocreales, Ergotaceae, Cordyceps genus, also known as Cordyceps militaris), sweet in taste, neutral in nature, and belongs to kidney and lung meridians. It has the effects of nourishing the kidney and nourishing the lung, nourishing the essence, stopping bleeding and resolving phlegm. For impotence and nocturnal emission, chronic cough with dyspnea due to deficiency, labor cough with phlegm and blood. The main components of Cordyceps militaris include nucleosides, polysaccharides, sugar alcohols and sterols. Modern pharmacological studies have shown that Cordyceps militaris can promote cellular immunity and inhibit humoral immunity, and promote bone marrow hematopoietic stem cells (CFU-3), erythroid progenitor cells (CFU-E BFU-E) and bone marrow fibroblast progenitor cells (CFU-E ) proliferation, as well as androgen-like effects. This prescription uses Cordyceps militaris as the monarch drug, aiming to exert its function of nourishing the kidney, nourishing the lung and nourishing the essence, nourishing the essence of the kidney to nourish the innate essence, and nourishing the lung qi to achieve the function of descending.

Acanthopanax (belonging to Umbelliferae, Araliaceae, Aralis genus), pungent in taste, slightly bitter, warm in nature, belongs to the spleen, kidney, and heart channels. It has the effects of nourishing qi, invigorating the spleen, invigorating the kidney and calming the nerves. For spleen and kidney yang deficiency, physical weakness and fatigue, loss of appetite, soreness of the waist and knees, insomnia and dreaminess. Modern medical research shows that eleutheroside, the main component of eleuthero, has similar effects to ginseng, can stimulate mental and physical vitality, increase endurance, agility and learning ability, prolong the load swimming time of rats, and The results of the mouse climbing rope test and activity energy all proved the anti-fatigue effect of eleutheroside. This prescription uses Acanthopanax acanthopanax as the ministerial drug, while exerting its effect of nourishing Qi and invigorating the spleen and nourishing acquired qi, at the same time, it uses the effect of nourishing the kidney and calming the nerves to improve the recovery function of the patient's body after exercise.

Chinese yam (the dry rhizome of Dioscorea opposita Thunb.), sweet in taste and flat in nature, returns to the spleen, lung and kidney channels. It has the effects of nourishing qi and nourishing yin, nourishing spleen and lung, nourishing kidney and strengthening essence. For insufficiency of the spleen, lack of food, loose stool, cough and asthma due to lung deficiency, nocturnal emission, frequent urination, deficiency of yin and quenching thirst. Modern pharmaceutical research shows that yam contains a variety of mucins, amylases, saponins, polysaccharides and dietary fiber, which can lower blood fat, help digestion, and enhance immune function.

Ligustrum lucidum (the dried ripe fruit of Ligustrum lucidum Ait.), sweet in the mouth, bitter in the mouth, cool in nature. Return liver, kidney channel. It has the effects of nourishing liver and kidney, improving eyesight and clearing deficiency and heat. Used for dizziness, premature graying of beard and hair, dim vision, yin deficiency and fever. The main components of Ligustrum lucidum are terpenoids, glycosides, organic acids and polysaccharides, among which oleanolic acid and Ligustrum lucidum polysaccharides are the main components of Ligustrum lucidum regulating the body's immune function.

In the present invention, yam and Ligustrum lucidum are used as adjuvant medicines, aiming at assisting the qi-tonifying effect of various medicines for monarchs and ministers, and at the same time assisting with nourishing yin and strengthening essence of yam and nourishing liver and clearing away heat of Ligustrum lucidum, so as to achieve both nourishment of qi and yin, and flattening of essence. purpose of the liver.

Fructus Rosa Rosa (belonging to Rosaceae, Rosaceae, Rosa), sweet in the mouth, slightly sour, astringent, flat in nature, returns kidney, bladder, large intestine meridian. It has the effects of solidifying essence and astringent intestines, reducing urination and stopping diarrhea. For slippery semen, enuresis, frequent urination, dysentery due to spleen deficiency, dyspnea and cough due to lung deficiency, spontaneous sweating and night sweating, metrorrhagia and vaginal discharge. In the prescription, Fructus Rosa Rosa Fructus is used as an envoy to harmonize the properties of the above-mentioned drugs by using its mild property while exerting its effect of strengthening essence and astringing intestines.

The above-mentioned pharmaceutical composition aims at alleviating fatigue, mainly to invigorate qi, taking into account congenital qi and acquired qi, as well as major organs such as kidney, spleen, liver and lung, and has the characteristics of reasonable compatibility and scientific composition. It has the effects of nourishing the kidney and nourishing the lung, invigorating the spleen and replenishing qi.

In one of the embodiments, the active ingredients of the composition are prepared from the following raw materials in parts by weight: 13-17 parts of Acanthopanax, 10-14 parts of Cordyceps militaris, 6-10 parts of Chinese yam, 2- 5 parts, 4-7 parts of Ligustrum lucidum.

The invention also discloses a preparation method of the above-mentioned anti-fatigue composition, which includes the following steps: weighing Acanthopanax, Cordyceps militaris, Chinese yam, Fructus Rosa and Ligustrum lucidum by weight, crushing after drying, and mixing, namely have to.

The invention also discloses a preparation method of the above-mentioned anti-fatigue composition, which includes the following steps: weighing Acanthopanax and Ligustrum lucidum by weight, adding 10-20ml of raw materials according to 1g, and the volume percentage is 35-65% Extract with ethanol at 60-80°C for 1-3 times, each time for 1-2 hours, and dry to obtain a dry extract; in addition, weigh Cordyceps militaris, Chinese yam and Rosa laevigata in parts by weight, and add 10-20ml according to 1g of raw materials extracted water at 70-90°C for 1-3 times, each time for 1-2 hours, and dried to obtain dry extract 2; mix the above-mentioned dry extract 1 and dry extract 2 evenly to obtain.

The invention also discloses an anti-fatigue preparation, which comprises the above-mentioned anti-fatigue composition as an active ingredient and a pharmaceutically acceptable carrier. The anti-fatigue composition can be prepared according to conventional production methods in the field of pharmacy, such as mixing the active ingredient with one or more carriers, and then making it into a desired dosage form.

In one of the embodiments, the dosage form of the anti-fatigue preparation is an orally disintegrating tablet, which includes the following ingredients:

The anti-fatigue composition is made into an orally disintegrating tablet that can quickly disintegrate in the oral cavity. Part of the active ingredients can be absorbed through the sublingual mucosa to achieve the purpose of rapid onset of action; the rest can be dispersed into fine particles before reaching the gastrointestinal tract. Particles, so it is distributed in a large area of the gastrointestinal tract, with more absorption points and high bioavailability.

In one of the embodiments, the filler is at least one of microcrystalline cellulose, lactose starch, lactose, precrossified starch and mannitol; the disintegrant is low-substituted hydroxypropylmethylcellulose , cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl starch and cross-linked sodium carboxymethylcellulose; the effervescent agent is sodium bicarbonate and tartaric acid, sodium bicarbonate and citric acid, carbonic acid At least one group of sodium bicarbonate and fumaric acid, sodium bicarbonate and vitamin C; the flavoring agent is at least one of menthol, peppermint oil, lemon flavor, cyclamate and aspartame; the lubricant The agent is at least one of magnesium stearate, magnesium lauryl sulfate and talcum powder; the glidant is at least one of micronized silica gel and talcum powder.

The key to preparing orally disintegrating tablets is to select appropriate excipients to ensure good fluidity and strong compressibility of the granules during tablet compression, and the disintegration speed of the compressed tablets is fast. In addition, it is also necessary to ensure that the prepared tablets have a good taste .

In the present invention, after screening based on solubility, tablet hardness, wetting time, water absorption, etc., at least one of microcrystalline cellulose, lactose starch, lactose, precrossified starch and mannitol is preferably used as a filler.

After the present invention takes water-absorbing swelling performance and water-absorbing rate as index screening, preferably low substituting group hydroxypropyl methylcellulose (L-HPC), cross-linked polyvinylpyrrolidone (PVPP), cross-linked carboxymethyl starch sodium (CCMS-Na ) and at least one of croscarmellose sodium (CMC-Na) as a disintegrant.

According to the taste test of volunteers, at least one of menthol, peppermint oil, lemon essence, cyclamate and aspartame is preferably used as a flavoring agent after masking its slight bitter taste.

The invention also discloses a preparation method of the above-mentioned orally disintegrating tablet, comprising the following steps: weighing the anti-fatigue composition, filler, disintegrating agent, effervescent agent, corrective agent, lubricant and flow aid agent, passed through a 60-80 mesh sieve, and dried at 40°C-60°C, and then the anti-fatigue composition was mixed with filler, disintegrant, effervescent agent and flavoring agent in equal increments, and then Add lubricant and glidant, mix evenly, and directly compress the powder into tablets to obtain the product.

The invention also discloses a preparation method of the above-mentioned orally disintegrating tablet, comprising the following steps: weighing the anti-fatigue composition, filler, disintegrating agent, effervescent agent, corrective agent, lubricant and flow aid agent, passed through a 60-80 mesh sieve, and dried at 40°C-60°C, and then the anti-fatigue composition was mixed with filler, disintegrant, effervescent agent and flavoring agent in equal increments, and then Adding polyvinylpyrrolidone (PVP) ethanol solution, wet granulation, drying the obtained wet granules at 30°C to 50°C, sizing, adding lubricant and glidant, mixing evenly, and pressing to obtain the product.

Compared with the prior art, the present invention has the following beneficial effects:

In the anti-fatigue composition of the present invention, Acanthopanax militaris, Cordyceps militaris, Chinese yam, Fructus Rosa, and Ligustrum lucidum are combined, and Cordyceps militaris is used to nourish the kidneys, nourish the lungs, nourish the essence, and mainly nourish the innate qi, which is the monarch drug; Acanthopanax acanthopanax nourishes Qi and invigorates the spleen, invigorates the kidney and calms the nerves, and mainly nourishes the acquired Qi, which is used as a ministerial drug; Chinese yam is used to nourish Qi and nourish yin, Ligustrum lucidum nourishes the liver and kidney, and is used as an adjuvant drug; Rosa japonica is used to strengthen essence and astringent intestines, harmonize The medicinal property is to make medicine. These several kinds of raw materials cooperate with each other, act synergistically, work together, and play the effect of anti-fatigue.

Moreover, after mixing the various raw materials in a specific ratio, it has a very good anti-fatigue effect, can extend the swimming time of mice to 3.4 times, reduce the content of serum urea nitrogen by 18.3%, increase the content of liver glycogen by 2.3 times, and can It has a very good effect by reducing the increase in lactic acid in mice after exercise by 20.5%.

The anti-fatigue orally disintegrating tablet of the present invention does not require additional water to be taken, and can be rapidly disintegrated within 1 minute in the oral cavity only relying on saliva, and the dissolution rate of the active ingredients in the orally disintegrating tablet is greater than 75% within 25 minutes. %. It is not irritating to the oral mucosa, has a good taste and no gritty feeling, and is especially suitable for high-intensity mental workers.

The orally disintegrating tablet of the invention has a reasonable formula and a mature preparation process, and is suitable for industrial scale production.

detailed description

The present invention is described in detail below in conjunction with specific examples, but does not impose any limitation on the present invention.

Example 1

An anti-fatigue composition, the active ingredient of which is prepared from the following raw materials in parts by weight:

Acanthopanax 15g, Cordyceps militaris 12g, yam 8g, golden cherry 3g, privet privet 5g.

The specific preparation method of the above-mentioned anti-fatigue composition is as follows:

Weigh Acanthopanax and Ligustrum lucidum according to the prescription amount, add 50% ethanol (i.e. 200ml) according to the amount of 10ml solvent added to 1g of raw materials, extract 3 times at 70°C, each time for 2h, and dry to obtain Dry extract 1; In addition, weigh Cordyceps militaris, Chinese yam and Rosa chinensis according to the prescription amount, add water (ie 230ml) according to the amount of 1g of raw materials and 10ml of solvent, extract 3 times at 80°C, 1h each time, and dry until dry Extract: Mix the above two dry extracts evenly to obtain the anti-fatigue composition A.

Example 2

An anti-fatigue composition, the active ingredient of which is prepared from the following raw materials in parts by weight:

Acanthopanax 10g, Cordyceps militaris 18g, yam 5g, golden cherry 10g, Ligustrum lucidum 3g.

The specific preparation method of the above-mentioned anti-fatigue composition is as follows:

Acanthopanax, Cordyceps militaris, Chinese yam, Fructus Rosa and Ligustrum lucidum were weighed according to the prescription amount, dried, pulverized and mixed to obtain the anti-fatigue composition B.

Example 3

An anti-fatigue composition, the active ingredient of which is prepared from the following raw materials in parts by weight:

Acanthopanax 20g, Cordyceps militaris 8g, yam 23g, golden cherry 3g, privet privet 10g.

The specific preparation method of the above anti-fatigue composition refers to the preparation method in Example 1, and the anti-fatigue composition C is prepared.

Example 4

An anti-fatigue orally disintegrating tablet, the prescription is as follows:

The preparation method of the orally disintegrating tablet of the present embodiment is as follows:

Precisely weigh the prescription amount of anti-fatigue composition A, microcrystalline cellulose, lactose starch, sodium bicarbonate, tartaric acid, cross-linked polyvinylpyrrolidone, low-substituent hydroxypropylmethylcellulose, micronized silica gel, lemon essence, cyclamate and magnesium stearate, passed through a 80-mesh sieve, dried at 45°C, and mixed uniformly by equal volume addition method.

The above powder was directly compressed into tablets to obtain orally disintegrating tablet X, with an average tablet weight of about 250 mg.

Example 5

An anti-fatigue orally disintegrating tablet, the prescription is as follows:

The preparation method of the orally disintegrating tablet of the present embodiment is as follows:

Precisely weigh the prescribed amount of anti-fatigue composition B, mannitol, lactose starch, sodium bicarbonate, vitamin C, cross-linked polyvinylpyrrolidone, micropowder silica gel, lemon essence, aspartame and magnesium stearate, pass through 60 mesh Sieve, dry at 60°C, and mix evenly by equal volume addition method.

The above powder was directly compressed into tablets to obtain orally disintegrating tablet Y with an average tablet weight of about 400 mg.

Example 6

An anti-fatigue orally disintegrating tablet, the prescription is as follows:

The preparation method of the orally disintegrating tablet of the present embodiment is as follows:

Precisely weigh the prescription amount of anti-fatigue composition C, mannitol, microcrystalline cellulose, pregelatinized starch, sodium bicarbonate, fumaric acid, cross-linked polyvinylpyrrolidone, aspartame, and dry at 40°C. Pass through a 80-mesh sieve, and mix evenly using the equal-volume incremental method. Granulate with 2.0% PVP ethanol solution, dry at 40°C, spray lemon essence after granulation, add magnesium stearate, and compress into tablets to obtain orally disintegrating tablet Z, with an average tablet weight of about 500 mg.

Comparative example 1

This comparative example prepares a composition, which is basically the same as the anti-fatigue composition of Example 1, except that the composition of this comparative example is prepared from the following raw materials in parts by weight:

Acanthopanax 15g, yam 8g, golden cherry 3g, privet privet 5g.

Composition D was prepared according to the method of Example 1.

Comparative example 2

This comparative example prepares a composition, which is basically the same as the anti-fatigue composition of Example 1, except that the composition of this comparative example is prepared from the following raw materials in parts by weight:

Cordyceps militaris 12g, yam 8g, golden cherry 3g, privet privet 5g.

Composition E was prepared with reference to the method of Example 1.

Comparative example 3

This comparative example prepares a composition, which is basically the same as the anti-fatigue composition of Example 1, except that the composition of this comparative example is prepared from the following raw materials in parts by weight:

Cordyceps militaris 15g, Acanthopanax 12g.

Composition F was prepared according to the method of Example 1.

Comparative example 4

This comparative example prepares a kind of composition, is substantially identical with the composition of embodiment 1, and difference is that, the composition of this comparative example is prepared by the raw material of following weight part:

Acanthopanax 15g, Cistanche 12g, yam 8g, Rosa chinensis 3g, Ligustrum lucidum 5g.

Composition G was prepared according to the method of Example 1.

Comparative example 5

This comparative example prepares a kind of composition, is substantially identical with the composition of embodiment 1, and difference is that, the composition of this comparative example is prepared by the raw material of following weight part:

Acanthopanax 5g, Cordyceps militaris 5g, yam 25g, golden cherry 15g, privet privet 15g.

Composition H was prepared according to the method of Example 1.

Experimental example 1

Compositions A-H prepared above were subjected to experimental verification to investigate their effects.

1. Experimental drugs: the positive drugs are Biological Health Oral Liquid (source: Taiyangshen Group Co., Ltd., 021D1), compositions A-C prepared in Examples 1-3, and compositions D-G prepared in Comparative Examples 1-5.

2. Experimental animals: Male BALB/C mice (2011-0004) provided by the Experimental Animal Center of Jilin University were selected, clean animals, weighing 18-22 g, and randomly divided into groups according to body weight.

3. Experimental grouping: The administration dose of the administration group was 9 times the dose equivalent to the human body’s recommended dose converted to the mouse equivalent dose, that is, 2.69mg/10g body weight, the administration dose of the positive control group was 0.03ml/10g, and the administration dose of the blank was 0.03ml/10g. The control group had a normal diet, fed the same amount of test substance continuously for 30 days, and measured various indexes.

4. Experimental equipment: swimming box, lead wire, electronic balance, microplate reader, ultraviolet-visible spectrophotometer, centrifuge, homogenizer.

5. Experimental method:

5.1 Swimming test

30 minutes after the last administration of the mouse test substance, the base of the mouse's tail bears a lead wire of 3% of the mouse's body weight, and puts it into a swimming tank with a water temperature of 30°C and a water depth of 35cm. Before each batch of mice entered the water, the water temperature was adjusted to 30°C. A maximum of 6 mice were put in each time, and the time from the start of swimming to exhaustion was recorded with a stopwatch, which was the swimming time of the mice.

5.2 Determination of serum urea nitrogen

30 minutes after the last administration of the test substance to the mice, the mice were placed in water at a temperature of 30°C and swam for 90 minutes, the eyeballs were removed to obtain blood, and the serum was taken to determine its value.

5.3 Determination of liver glycogen

Thirty minutes after the last administration of the test substance to the mice, they were sacrificed immediately. The liver was rinsed with normal saline and blotted dry with filter paper. Accurately weighed 200 mg of the liver, added 4 mL of 5% trichloroacetic acid (TCA), homogenized each tube for 1 minute, poured the homogenate into a centrifuge tube, and centrifuged at 3000 rpm. After 15 minutes, transfer the supernatant to another tube. Add 4 mL of TCA to the pellet, homogenize for 1 minute, centrifuge again for 15 minutes, take the supernatant, combine it with the supernatant of the first centrifugation, and mix thoroughly. Take 1 mL of the supernatant and put it into a 10 mL centrifuge tube, add 4 mL of 95% ethanol to each tube, and mix well until there is no interface between the two liquids. Plug with clean stoppers and store upright overnight at room temperature. After precipitation was complete, the tube was centrifuged at 3000 rpm for 15 minutes. Carefully discard the supernatant and invert the tube for 10 minutes. Dissolve the glycogen with 2mL distilled water, and wash the glycogen on the tube wall when adding water to dissolve it completely.

Test tube blank: pipette 2 mL of distilled water into a clean centrifuge tube.

Standard tube: Put 0.5mL glucose standard solution (containing 100mg/dL glucose) and 1.5mL distilled water into the same centrifuge tube.

Determination: Add 10mL of anthrone reagent to each tube forcefully, and the liquid flow directly into the center of the tube to ensure thorough mixing. From the time the anthrone reagent is injected into the tube, place the tube in cold water. After reaching the temperature of the cold water, immerse it in a boiling water bath for 15 minutes, then move to the cold water bath and cool to room temperature. Transfer the liquid in the tube to a cuvette, measure the absorbance of the sample tube and the standard tube after zeroing with a reagent blank at a wavelength of 620nm. Liver glycogen content (expressed in mg/g liver) was converted based on liver weight.

5.4 Determination of blood lactic acid

30 minutes after the last administration of the test substance to the mice, put them into a swimming tank with a water temperature of 30°C and a water depth of 35 cm for 10 minutes and then take them out. Immediately collect 20 μL of tail blood, add it to a test tube containing 40 μL of hemolytic agent and mix well, A sensory analyzer was used to measure the blood lactate value. The same method was used to measure the blood lactate level before swimming and after swimming for 20 minutes.

6. Experimental results: Statistical analysis was performed on the experimental data.

The experimental results are as follows:

1) Swimming test: See the table below for the results.

Table 1: Experimental results of weight-bearing swimming time of mice ( )

From the above results, we can see that in the compositions A-C of Examples 1-3 of the present invention, the swimming time of the mice was longer than that of the blank group, indicating that the compositions have an anti-fatigue effect. And the composition A can extend the swimming time of mice to 3.4 times, which has a very good effect.

Although the swimming time of the mice in the compositions D-H of Comparative Examples 1-5 was better than that of the blank group, it was not as good as that of the A-C groups, indicating that the compositions D-H of Comparative Examples 1-5 also had anti-fatigue effects, but the effect was not as good as that of the A-C groups.

Although the swimming time of the mice in the positive group was better than that of the composition D-H group, and comparable to that of the composition C group, it was not as good as that of the composition A and B groups, indicating that the effect was better, but still not as good as that of the composition A and B.

2) Determination of serum urea nitrogen: see the table below for the results.

Table 2: Experimental results of serum urea nitrogen content in mice ( )

From the above results, we can see that the serum urea nitrogen content of the mice in the compositions A-C of Examples 1-3 of the present invention are all lower than those of the blank group, indicating that the compositions have an anti-fatigue effect. And composition A can reduce the serum urea nitrogen content of mice by 18.3%, which has a very good effect.

Although the serum urea nitrogen content of the mice in the compositions D-H of Comparative Examples 1-5 was lower than that of the blank group, it was not as good as that of the A-C groups, indicating that the compositions D-H of Comparative Examples 1-5 also had anti-fatigue effects, but the effect was not as good as that of the A-C groups .

Although the serum urea nitrogen content of the mice in the positive group was lower than that of the composition D-H group and equivalent to that of the composition C group, it was still higher than that of the composition A and B groups, indicating that the effect was better, but still not as good as that of the composition A and B groups .

3) Determination of liver glycogen: Please see the table below for the results.

Table 3: Experimental results of mouse liver glycogen content ( )

From the above results, we can see that the liver glycogen content of mice in the compositions A-C of Examples 1-3 of the present invention is higher than that of the blank group, indicating that the composition has an anti-fatigue effect. And composition A can increase the liver glycogen content of mice by 2.3 times, which has a very good effect.

Although the mouse liver glycogen content of the composition D-H of comparative examples 1-5 is higher than that of the blank group, it is not as good as that of the A-C group, indicating that the composition D-H of the comparative examples 1-5 also has anti-fatigue effect, but its effect is not as good as that of the A-C group .

Although the mouse liver glycogen content of the positive group was higher than that of the composition D-H group, it was still lower than that of the composition A-C group, indicating that the effect was better, but still not as good as that of the composition A-C group.

4) Determination of blood lactic acid: see the table below for the results.

Table 4: Experimental results of 10 minutes of swimming in each group on the blood lactic acid value of mice ( )

From the above results, we can see that in the compositions A-C of Examples 1-3 of the present invention, the increase in lactic acid of mice after exercise is smaller than that of the blank group, indicating that the composition has an anti-fatigue effect. And the composition B can reduce the increase rate of lactic acid in mice by 20.5%, which has a very good effect.

Although the lactic acid increase multiple of the composition D-H of Comparative Examples 1-5 is lower than that of the blank group, it is not as good as that of the A-C group, indicating that the composition D-H of Comparative Examples 1-5 also has anti-fatigue effect, but its effect is not as good as that of the A-C group.

Although the increase in lactic acid of mice in the positive group was lower than that of the composition D-H group and comparable to that of the composition C group, it was still higher than that of the composition A and B groups, indicating that the effect was better, but still not as good as that of the composition A and B groups .

4 Conclusion

Oral administration of the composition prepared in Examples 1-3 to mice for 30 days can significantly prolong the swimming time of mice, significantly reduce the serum urea nitrogen of mice after exercise, significantly increase the speed of blood lactic acid clearance of mice after exercise, and significantly improve Mouse liver glycogen content. According to the provisions of "Health Food Functional Evaluation Procedure and Test Method", the health product of the present invention has anti-fatigue effect.

And, as can be seen from the experimental results, the present invention can alleviate the occurrence of fatigue and accelerate the elimination of fatigue, improve the condition of the body, reduce serum urea nitrogen and accelerate the removal of blood lactic acid, increase liver glycogen content, and the effect is remarkable, is Ideal product against fatigue.

Experimental example 2

The orally disintegrating tablet X-Z prepared above was subjected to experimental verification to investigate its effect.

1. Determination of disintegration time in vitro

Take a 5mL test tube as a container, add 2mL of distilled water as a medium, place the test tube in a water bath at a temperature of 37°C, put the orally disintegrating tablet prepared in Example 3-6 into the tube and start timing until the tablet The time for complete disintegration into granules is the disintegration time, and the whole process is measured statically. Each group measured 10 tablets, the specific results are shown in the table below, and the average disintegration time was calculated.

Table 5: In vitro disintegration time

From the above results, we can see that the in vitro disintegration time is 50.74±5.50s, 49.10±5.92s, 46.63±4.39s, all disintegrate rapidly within 1 minute, and have the characteristics of good disintegration effect.

2. Determination of oral disintegration time

Select 6 healthy volunteers, take the orally disintegrating tablets X-Z prepared in Examples 4-6, put them into the mouths of the volunteers, and start recording the time for the orally disintegrating tablets to completely disintegrate in the oral cavity. 10 tablets were measured for each group, and the specific results are shown in the table below, and the average oral disintegration time was calculated.

Calculate the average disintegration time. The results are shown in Table 6, and the oral disintegration time was 50.22±3.11s.

Table 6: Oral Disintegration Time

From the above results, we can see that the disintegration time is 51.46±4.32s, 50.20±5.18s, 47.16±4.06s, all disintegrate rapidly within 1 minute, and have the characteristics of good disintegration effect. Moreover, the volunteers reported that the orally disintegrating tablet has no irritation to the oral mucosa, has a good taste, and has no gritty feeling.

The above-mentioned embodiments only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but should not be construed as limiting the patent scope of the present invention. It should be pointed out that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.

Claims (8)

1. a kind of anti-Fatigue Composition, it is characterised in that the active ingredient of the composition is prepared by the raw material of following parts by weight Form：

13-17 parts of wilsonii, 10-14 parts of Cordyceps militaris, 6-10 parts of Chinese yam, 2-5 parts of the fruit of Cherokee rose, 4-7 parts of the fruit of glossy privet.

2. the preparation method of the anti-Fatigue Composition described in claim 1, it is characterised in that comprise the following steps：By weight Wilsonii, Cordyceps militaris, Chinese yam, the fruit of Cherokee rose and the fruit of glossy privet are weighed, crushed after being dried, mixing is produced.

3. the preparation method of the anti-Fatigue Composition described in claim 1, it is characterised in that comprise the following steps：By weight Wilsonii and the fruit of glossy privet are weighed, the ethanol that 10~20ml concentration expressed in percentage by volumes are 35-65%, 60-80 DEG C are added according to 1g raw materials Extract 1-3 times, 1~2h, dries to obtain dry extract one every time；Separately Cordyceps militaris, Chinese yam and the fruit of Cherokee rose are weighed by weight, it is former according to 1g Material adds 10~20ml water, and 70-90 DEG C is extracted 1-3 times, and 1~2h, dries to obtain dry extract two every time；By the above-mentioned He of dry extract one Dry extract two is well mixed, and is produced.

4. a kind of antifatigue preparation, it is characterised in that including the antifatigue combination described in the claim 1 as active component Thing, and pharmaceutically acceptable carrier.

5. antifatigue preparation according to claim 4, it is characterised in that the formulation of the preparation is oral disintegrating tablet, including Following component：

6. antifatigue preparation according to claim 5, it is characterised in that the filler is microcrystalline cellulose, lactose At least one of starch, lactose, pre-paying starch and mannitol；The disintegrant is low substituent hydroxypropyl fiber At least one of element, PVPP, crosslinked carboxymethyl fecula sodium and Ac-Di-Sol；The bubble Agent is risen in sodium acid carbonate and tartaric acid, sodium acid carbonate and citric acid, sodium acid carbonate and fumaric acid, sodium acid carbonate and vitamin C At least one set；The flavouring is at least one of menthol, peppermint oil dementholized, lemon extract, honey element and Aspartame； The lubricant is at least one of magnesium stearate, Stepanol MG and talcum powder；The glidant be superfine silica gel powder, At least one of talcum powder.

7. the preparation method of the oral disintegrating tablet described in a kind of any one of claim 5-6, it is characterised in that comprise the following steps：Press Parts by weight weigh anti-Fatigue Composition, filler, disintegrant, effervescent agent, flavouring, lubricant and glidant, and 60-80 is crossed respectively Mesh sieve, in 40 DEG C of -60 DEG C of drying, then by anti-Fatigue Composition respectively with filler, disintegrant, effervescent agent and flavouring with etc. Measure method of progressively increasing to be well mixed, add lubricant and glidant, be well mixed, direct powder compression is produced.

8. the preparation method of the oral disintegrating tablet described in a kind of any one of claim 5-6, it is characterised in that comprise the following steps：Press Parts by weight weigh anti-Fatigue Composition, filler, disintegrant, effervescent agent, flavouring, lubricant and glidant, and 60-80 is crossed respectively Mesh sieve, in 40 DEG C of -60 DEG C of drying, then by anti-Fatigue Composition respectively with filler, disintegrant, effervescent agent and flavouring with etc. Measure method of progressively increasing to be well mixed, add the ethanol solution of polyvinylpyrrolidone, wet granulation, by obtained wet granular at 30 DEG C ~50 DEG C of drying, whole grain adds lubricant and glidant, is well mixed, and compacting is produced.