Traditional Chinese medicine composition for improving dizziness and preparation method thereof

Abstract

The invention belongs to the technical field of medicine and health food, and provides a traditional Chinese medicine composition for improving dizziness, which is prepared from the following raw materials by weight: 30-35% of armillaria mellea sporocarp extract, 25-30% of kudzu vine root extract, 10-15% of mulberry leaf extract, 6-8% of hawthorn extract, and 20-25% of maltodextrin. The invention further discloses a specific preparation method of the traditional Chinese medicine composition, and the traditional Chinese medicine composition has the health-care function of improving dizziness; the food adopts medicinal and edible substances, has the advantages of being capable of replacing decoction to be rapidly absorbed, free of sugar, safe to eat, capable of being taken for a long time, good in taste, small in size, convenient to carry and the like, and overcomes the defects in the prior art.

Description

Technical Field

[0001] The invention belongs to the technical field of medicine and health food, in particular to a Chinese medicine composition for improving vertigo and a preparation method thereof. Background Art

[0002] Vertigo is a common clinical symptom, characterized by patients feeling the surrounding environment or their own body rotating or moving, often accompanied by headaches, tinnitus, nausea and other discomfort. Its pathogenesis is complex and may be closely related to factors such as dysfunction of the inner ear balance system, nervous system lesions, and poor blood circulation. Modern medicine mainly focuses on symptomatic treatment and etiological treatment for vertigo, but some common treatments are often accompanied by side effects and are not effective in some patients.

[0003] Traditional Chinese medicine has a long history of treating vertigo, emphasizing the improvement of symptoms by harmonizing yin and yang, unblocking meridians, and dispelling wind and cold. Although traditional Chinese medicine preparations have certain therapeutic effects, they often affect patient compliance due to problems such as taste, dosage, and absorption rate. In recent years, with the promotion of the concept of medicine and food being of the same origin, traditional Chinese medicine compositions that can have both health care and therapeutic functions have received increasing attention.

[0004] To this end, those skilled in the art have proposed a Chinese medicine composition and a preparation method thereof, aiming to improve the symptoms of vertigo. Summary of the invention

[0005] In order to solve the above technical problems, the present invention provides a Chinese medicine composition for improving vertigo and a preparation method thereof, so as to solve the problems raised in the background technology.

[0006] According to the first aspect of the present disclosure, a Chinese medicine composition for improving vertigo is proposed, which is made of the following raw materials by weight: 30-35% of Armillaria fruiting body extract, 25-30% of Pueraria extract, 10-15% of mulberry leaf extract, 6-8% of hawthorn extract, and 20-25% of maltodextrin.

[0007] Preferably, the composition is composed of the following raw materials by weight: 33.33% of Armillaria fruiting body extract, 26.67% of Pueraria root extract, 10% of mulberry leaf extract, 6.67% of hawthorn extract and 23.33% of maltodextrin.

[0008] According to the second aspect of the present disclosure, a method for preparing a Chinese medicine composition for improving vertigo is proposed, and the specific preparation steps are as follows:

[0009] S1. Weigh 1000 g of Armillaria mellea extract, 800 g of Pueraria root extract, 300 g of mulberry leaf extract, and 200 g of hawthorn extract respectively, put them into a mixer and mix them evenly;

[0010] S2. Weigh 1000 mL of 90% ethanol solution as a wetting agent, and slowly spray it on the surface of the fine powder of the composition while the mixer is running, and stir evenly;

[0011] S3, take 700g of maltodextrin and add 2000mL of water, stir evenly, heat to make a transparent liquid, cool to 50°C, slowly add to the above composition and stir evenly;

[0012] S4. If the humidity is insufficient, add 90% ethanol solution until the requirement is met, then use a 14-16 mesh nylon sieve to make wet granules using a granulator, dry at 50°C, and bag.

[0013] Preferably, the preparation process of the Armillaria mellea extract is as follows: take the Armillaria mellea fruiting body, wash, dry, and crush into coarse powder; the solid-liquid ratio is 1:20, the temperature is 100°C, add water and reflux to extract twice, the first time is 3 hours, and the second time is 2 hours; combine the extracts, and vacuum concentrate them at room temperature into a clear paste with a relative density of 1.10 to 1.20; the clear paste is precipitated with 3 to 4 times the amount of 95% mass fraction ethanol for 24 hours, and the precipitate is dissolved with 4 to 5 times the amount of mass fraction ≥80°C hot water, cooled and precipitated for 24 to 48 hours, the supernatant is taken, the water insoluble matter is filtered out, concentrated into a thick paste, vacuum dried at a temperature below 60°C, and crushed into fine powder.

[0014] Preferably, the preparation process of the kudzu root extract is as follows: take kudzu root, crush it into coarse powder, reflux extract it with 30% ethanol solution twice, each time for 2 hours, add 10 times the amount for the first time, and add 8 times the amount for the second time, combine the extracts, recover ethanol, concentrate the extracts to a clear paste with a relative density of 1.10 to 1.20 at room temperature, cool it, add ethanol to make the alcohol content 70%, and precipitate it for 12 hours to 24 hours; take the supernatant, recover ethanol, concentrate it into a thick paste, vacuum dry it at a temperature below 60°C, and crush it into fine powder.

[0015] Preferably, the preparation process of the mulberry leaf extract is as follows: take mulberry leaves, crush them into coarse powder, the solid-liquid ratio is 1:10, the temperature is 80°C to 90°C, reflux extraction is performed with 70% ethanol solution twice, each for 1 hour, the filtrate is combined, the ethanol is recovered, and vacuum concentration is performed at room temperature to a relative density of 1.10 to 1.20; 3 times the mass fraction of 95% ethanol is added to the concentrate, and precipitation is performed for 24 hours to 48 hours; the supernatant is taken, the ethanol is recovered, and concentrated into a thick paste, vacuum dried at a temperature below 60°C, and crushed into fine powder.

[0016] Preferably, the preparation process of the hawthorn extract is as follows: take hawthorn, crush it into coarse powder, use 70% ethanol solution, solid-liquid ratio 1:10, reflux extraction at 90°C twice, each time for 1.5 hours; combine the extracts, recover ethanol, and concentrate the extracts to a relative density of 1.10 to 1.20 at room temperature; add 3 times the mass fraction of 95% ethanol to the concentrate, and precipitate for 24 to 48 hours; take the supernatant, recover ethanol, concentrate it into a thick paste, vacuum dry it at a temperature below 60°C, and crush it into fine powder.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] 1. The present invention has the health care function of helping to improve vertigo, adopts medicine and food homologous substances, has a simple production process, can be quickly absorbed instead of decoctions, is sugar-free, can be taken for a long time, is safe to eat, tastes good, and is small in size and easy to carry.

[0019] 2. The composition of the present invention mainly uses wind-dispelling Chinese medicine; Armillaria replaces Gastrodia to relieve wind and stop spasm, and is used for dizziness, headache, and limb numbness caused by hypertension vertebral basilar artery insufficiency, Meniere's disease, and autonomic dysfunction; Pueraria root and mulberry leaf disperse wind-heat, and are used for dizziness, headache, red and swollen eyes, and blurred vision caused by wind-heat and lung heat; Hawthorn promotes qi and dissipates blood stasis, clears turbidity and reduces lipids, and is used for dizziness and unsteady standing caused by blood stasis. The components of the composition work together to improve the symptoms of dizziness. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 The effect of the extraction solid-liquid ratio on the yield of crude polysaccharides from Armillaria mellea.

[0021] Figure 2 The effect of extraction temperature on the yield of crude polysaccharides from Armillaria mellea.

[0022] Figure 3 The effect of extraction time on the yield of crude polysaccharides from Armillaria mellea.

[0023] Figure 4 The effect of ethanol concentration on the total flavonoids content in mulberry leaves.

[0024] Figure 5 The effect of temperature on the total flavonoids content in mulberry leaves.

[0025] Figure 6 The influence of solid-liquid ratio on the total flavonoids content of mulberry leaves.

[0026] Figure 7 The effect of extraction time on the total flavonoids content in mulberry leaves.

[0027] Figure 8 The effect of ethanol concentration on the total flavonoids content of hawthorn.

[0028] Fig. 9The effect of temperature on the total flavonoids content of hawthorn.

[0029] Fig.10 The effect of extraction time on the total flavonoids content of hawthorn.

[0030] Fig.11 The influence of the solid-liquid ratio on the total flavonoids content of hawthorn. DETAILED DESCRIPTION

[0031] The following embodiments of the present invention are described in further detail in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0032] As attached Figure 1 To Attachment Fig.11 As shown:

[0033] Embodiment 1: The present invention provides a Chinese medicine composition for improving vertigo and a preparation method thereof, which is made from the following raw materials by weight: 33.33% of Armillaria fruiting body extract, 26.67% of Pueraria extract, 10% of mulberry leaf extract, 6.67% of hawthorn extract, and 23.33% of maltodextrin.

[0034] According to the theory of traditional Chinese medicine and the principle of compatibility of monarch, minister, assistant and envoy in traditional Chinese medicine prescriptions, the fruiting body of Armillaria mellea (hazel mushroom) is sweet, neutral in nature, and belongs to the liver meridian. It can calm the liver, dispel wind and dredge meridians, strengthen tendons and bones, and is used as the monarch medicine for various types of vertigo, dizziness, headache, insomnia, and numbness of the limbs;

[0035] Pueraria root is sweet, pungent and cool in nature. It enters the spleen, stomach and lung meridians. It relieves muscle and fever, promotes the production of body fluid, clears rashes, and promotes blood circulation. It is used as a ministerial drug for dizziness, headache, and stiff neck and back pain caused by hypertension.

[0036] Mulberry leaves are sweet, bitter and cold in nature. They belong to the lung and liver meridians. They are used to dispel wind-heat, clear the lungs and moisten dryness, clear the liver and improve eyesight. They are used as adjuvants for wind-heat colds, lung heat and dry coughs, dizziness and headaches, and red and blurred eyes.

[0037] Hawthorn is sour, sweet and slightly warm in nature. It enters the spleen, stomach and liver meridians, helps digestion and invigorates the stomach, promotes qi and dissipates blood stasis, and is used for hyperlipidemia and improving microcirculation as a guiding drug. The combination of various drugs is used to help improve various symptoms such as dizziness, headache, insomnia, and numbness of the limbs.

[0038] 1. Research on the preparation process of Armillaria mellea extract

[0039] The Armillaria extract was extracted by hot water extraction;

[0040] 1.1 Determination of the content of crude polysaccharides from Armillaria mellea The content of crude polysaccharides from Armillaria mellea was determined according to the standard SN / T 4260-2015 "Determination of crude polysaccharides in plant-derived foods for export - phenol-sulfuric acid method";

[0041] 1.2 Effects of extraction temperature, solid-liquid ratio and time on the yield of crude polysaccharides from Armillaria mellea;

[0042] 1.2.1 Effect of extraction solid-liquid ratio on the yield of crude polysaccharides from Armillaria mellea

[0043] Effects of different solid-liquid ratios and boiling point temperatures on the yield of crude polysaccharides from Armillaria mellea for 5 hours. Figure 1 .

[0044] The experimental results showed that the yield of crude polysaccharides from Hazel Mushroom was the highest when the solid-liquid ratio was 1:20. When the solid-liquid ratio was further increased, the yield of crude polysaccharides did not increase significantly.

[0045] 1.2.2 Effect of extraction temperature on the yield of crude polysaccharides from Armillaria mellea The effect of different temperatures and a solid-liquid ratio of 1:20 on the yield of crude polysaccharides from Armillaria mellea was observed when the extraction time was 5 hours. Figure 2 .

[0046] The experimental results show that the extraction temperature has a significant effect on the yield of crude polysaccharides. Under the extraction conditions of 100℃ and 85℃, the yield of crude polysaccharides can be increased by more than 60%.

[0047] 1.2.3 Effect of extraction time on the yield of crude polysaccharides from Armillaria mellea The effects of different extraction times, a solid-liquid ratio of 1:20, and boiling point temperature on the yield of crude polysaccharides from Armillaria mellea. Figure 3 .

[0048] The test results show that the optimal extraction time is 5 hours, and the yield of crude polysaccharides does not increase significantly when the extraction time is longer than 5 hours.

[0049] 1.2.4 Orthogonal experimental design and result analysis of the extraction rate of crude polysaccharides from Armillaria mellea. There are three factors that affect the yield of polysaccharides from Armillaria mellea, namely, the solid-liquid ratio, extraction temperature and extraction time. The experimental results are shown in Table 1.

[0050] Table 1 Orthogonal test results of the yield of crude polysaccharides from Armillaria mellea

[0051]

[0052] The analysis results show that the factors affecting the yield of crude polysaccharides from Armillaria mellea are in the following order: extraction temperature > solid-liquid ratio > extraction time. The best combination of factors is B3, A3, and C2, that is, extraction temperature: 100°C, extraction time: 5 hours, and solid-liquid ratio: 1:30. However, the solid-liquid ratio is not much different from 1:20. Considering cost savings, the solid-liquid ratio was finally set at 1:20.

[0053] 2. Research on the preparation process of Pueraria lobata extract Based on the technical requirements and preparation methods specified in the "Technical Requirements and Preparation Instructions for Pueraria lobata Extract", the optimal preparation process was summarized after data analysis.

[0054] 2.1 Determination of puerarin content in puerarin extract The puerarin content was determined according to the method specified in GB / T 22251-2008 “Determination of puerarin in health foods”.

[0055] 2.2 Orthogonal test design and result analysis of puerarin extraction rate Water, 30% ethanol, 50% ethanol and 80% ethanol were used as extraction solvents respectively. The extraction was carried out twice at 90℃~100℃ with heating reflux, each time for 2 hours. The amount was increased by 10 times for the first time and by 8 times for the second time. Ethanol was added to make the alcohol content of 60%, 70% and 80% respectively for alcohol precipitation. The effect on the puerarin content was analyzed. The analysis results are shown in Table 2.

[0056] Table 2 Puerarin extraction rate orthogonal test results

[0057]

[0058]

[0059] The analysis results show that the order of factors affecting the yield of puerarin is: extraction solvent > alcohol precipitation concentration, and the best factor combination is: A2, B2, that is, using 30% ethanol solution to extract twice, each time for 2 hours, the solid-liquid ratio is 10 times the first time and 8 times the second time, and the alcohol precipitation concentration of 70% is the best preparation process condition.

[0060] 3. Study on the preparation process of mulberry leaf extract Mulberry leaves mainly contain total flavonoids, alkaloids and polysaccharides and other effective ingredients, among which flavonoids have a large content, and flavonoids are easily soluble in solvents such as acetone, ethanol, methanol and ethyl acetate. The present invention uses ethanol as a solvent, and designs different extraction temperatures, different ethanol concentrations, and different extraction times to determine the optimal extraction conditions.

[0061] 3.1 Determination of total flavonoids in mulberry leaf extract The total flavonoids content in mulberry leaf extract was determined in accordance with the Technical Specifications for Inspection and Evaluation of Health Foods (2003 Edition) - Determination of total flavonoids in health foods.

[0062] 3.2 Effects of ethanol concentration, extraction temperature, solid-liquid ratio and extraction time on the total flavonoids content in mulberry leaves.

[0063] 3.2.1 Effect of ethanol concentration on the total flavonoids content in mulberry leaves.

[0064] The solid-liquid ratio was 1:10, the extraction temperature was 100°C, and the extraction time was 1 hour. Figure 4 .

[0065] The test results show that the extraction effects of 70% and 80% ethanol solutions in reflux extraction of total flavonoids from mulberry leaves are similar. In order to save costs, 70% ethanol concentration is the best.

[0066] 3.2.2 Effect of temperature on the total flavonoids content in mulberry leaves.

[0067] The solid-liquid ratio was 1:10, the ethanol concentration was 70%, and the extraction time was 1 hour. Figure 5 .

[0068] The test results show that the extraction effect of 70% ethanol solution in a water bath at 80℃~100℃ is better. The extraction at 80℃ is beneficial to save costs and is the best solution.

[0069] 3.2.3 Effect of solid-liquid ratio on the total flavonoid content of mulberry leaves The temperature was 80°C, the ethanol concentration was 70%, and the extraction time was 1 hour. Figure 6 .

[0070] The test results show that when using 70% ethanol solution at 80℃ reflux extraction, the best effects are achieved with a solid-liquid ratio of 1:10, 1:20, and 1:30. However, when the solid-liquid ratio is greater than 1:10, the content of total flavonoids in mulberry leaves increases slowly. Therefore, a solid-liquid ratio of 1:10 is the best option.

[0071] 3.2.4 Effect of extraction time on the total flavonoids content of mulberry leaves The temperature was 80°C, the ethanol concentration was 70%, and the solid-liquid ratio was 1:10. The test results are shown in Figure 7 .

[0072] The experimental results show that when 70% ethanol solution is used for reflux extraction at 80℃ and the solid-liquid ratio is 1:10, the extraction time has no significant effect on the content of total flavonoids in mulberry leaves. Therefore, the preparation process of extracting twice, each time for 1 hour, is adopted.

[0073] 3.2.4 Orthogonal experimental design and result analysis of mulberry leaf extract There are four factors that affect the total flavonoids content of mulberry leaf extract, namely solvent selection, extraction temperature, solid-liquid ratio and extraction time. The analysis results are shown in Table 3.

[0074] Table 3 Results of orthogonal test of mulberry leaf extract

[0075]

[0076]

[0077] The analysis results show that the order of factors affecting the total flavonoids content of mulberry leaves is: solid-liquid ratio > extraction solvent > extraction temperature > extraction time, and the best combination of factors is: C3, A2, B3, D1, that is, a solid-liquid ratio of 1:20, ethanol concentration of 70%, extraction temperature: 80℃, and extraction time of 2 hours. Considering that the influence of solid-liquid ratios of 1:20 and 1:10 is smaller, in order to save costs, the best process conditions are finally selected: a solid-liquid ratio of 1:10, a temperature of 70℃~80℃, and 70% ethanol solution reflux extraction twice, each time for 1 hour.

[0078] 4. Study on the preparation process of hawthorn extract Hawthorn mainly contains total flavonoids, which are easily soluble in organic solvents such as acetone and ethanol. The present invention uses ethanol as solvent and designs different extraction temperatures, ethanol concentrations and extraction times to determine the optimal preparation process conditions.

[0079] 4.1 Determination of total flavonoids in hawthorn extract The total flavonoids content in hawthorn extract shall comply with the Determination of total flavonoids in health foods in the Technical Specifications for Inspection and Evaluation of Health Foods (2003 Edition).

[0080] 4.2 Effects of ethanol concentration, extraction temperature, solid-liquid ratio and extraction time on the total flavonoids content of hawthorn.

[0081] 4.2.1 Effect of ethanol concentration on the total flavonoids content of hawthorn.

[0082] The solid-liquid ratio was 1:20, the extraction temperature was 90°C, and the extraction time was 1 hour. Figure 8 .

[0083] The test results show that the ethanol concentration is basically unchanged from 40% to 50%, and gradually increases from 50% to 60%. When the concentration rises to 70%, the flavonoid extraction amount increases significantly and reaches the highest value. However, as the ethanol concentration continues to increase, the flavonoid extraction amount decreases, and 70% ethanol extracts the most flavonoids.

[0084] 4.2.2 Effect of temperature on the extraction of flavonoids from hawthorn The solid-liquid ratio was 1:20, the ethanol concentration was 70%, and the extraction time was 1 hour. Fig. 9 .

[0085] The test shows that when the temperature gradually rises from 50℃ to 80℃, the amount of flavonoids extracted also increases. This is because the solubility of flavonoids in ethanol increases with the increase of temperature. However, when the temperature is greater than 80℃, as the temperature further increases, the increase in the amount of flavonoids extracted is not so obvious and gradually tends to balance. In production, the maximum temperature for extracting flavonoids from hawthorn is preferably 80℃ to 90℃.

[0086] 4.2.3 Effect of extraction time on the extraction of total flavonoids from hawthorn The solid-liquid ratio was 1:20, the ethanol concentration was 70%, and the extraction temperature was 80°C. The experimental results are shown in Fig.10 .

[0087] The test results show that when the extraction time increases from 1 hour to 2 hours, the total flavonoids extraction amount increases sharply, but when the extraction time reaches 3 hours, the total flavonoids content does not change significantly. As time increases further, the total flavonoids extraction amount decreases instead. Therefore, an extraction time of 2 to 3 hours is optimal.

[0088] 4.2.4 Effect of solid-liquid ratio on the extraction of total flavonoids from hawthorn The ethanol concentration was 70%, the extraction temperature was 80°C, and the extraction time was 2 hours. Fig.11 .

[0089] The test results show that the solid-liquid ratio has little influence on the total flavonoids content of hawthorn. When the solid-liquid ratio is greater than 1:20, the extraction rate increases slowly. Therefore, a solid-liquid ratio of 1:20 is the best.

[0090] 4.2.5 Orthogonal experimental design and result analysis of hawthorn extract There are four factors that affect the total flavonoids content of hawthorn extract, namely solvent concentration, extraction temperature, solid-liquid ratio and extraction time. The analysis results are shown in Table 4.

[0091] Table 4 Results of orthogonal test of hawthorn extract

[0092]

[0093]

[0094] The analysis results show that the order of factors affecting the total flavonoids content of hawthorn is: extraction temperature > solvent concentration > extraction time > solid-liquid ratio, and the best factor combination is: B3, A3, D3, C3, that is, extraction temperature: 90℃, ethanol concentration 80%, extraction time 3 hours, solid-liquid ratio 1:30. Considering that the influencing factors between 70% and 80% ethanol concentration and each solid-liquid ratio are small, in order to save costs, the final choice is a solid-liquid ratio of 1:10, extraction temperature 90℃, 70% ethanol solution reflux extraction 2 times, each time 1.5 hours, the best process conditions.

[0095] Embodiment 2: The present invention also provides a method for preparing a Chinese medicine composition for improving vertigo. 1000 g of Armillaria mellea extract, 800 g of Pueraria root extract, 300 g of mulberry leaf extract, and 200 g of hawthorn extract are weighed respectively and mixed evenly; another 700 g of maltodextrin is stirred evenly with 2000 mL of cold water, heated to make a paste as a binder, and then 85% to 95% edible alcohol is used as a wetting agent, and wet granules are made with a 14 to 16 mesh nylon sieve, dried at 50°C to 60°C to a moisture content of ≤5.0% (mass ratio), and bagged, 3 g per bag, to make 1000 bags.

[0096] 5.2 Effective ingredients and test results of Chinese medicine combination preparations

[0097] 5.2.1 Crude polysaccharides: According to the method for determining the content of crude polysaccharides in health foods in the "Test Method for Effective Ingredients of Health Foods (2002)", the preparation of the present invention contains 12136 mg of crude polysaccharides per 100 g.

[0098] 5.2.2 Puerarin: According to the method specified in GB / T 22251-2008 “Determination of Puerarin in Health Foods”, the preparation of the present invention contains 925.6 mg of puerarin per 100 g.

[0099] The effective components determined by the invention are: crude polysaccharide and puerarin.

[0100] 1. Preparation of honey fungus extract: Take honey fungus fruiting bodies, wash, dry, and crush into coarse powder; the solid-liquid ratio is 1:20, the temperature is 100°C, add water and reflux to extract twice, the first time is 3 hours, and the second time is 2 hours; combine the extracts, and vacuum concentrate to a clear paste with a relative density of 1.10-1.20 (room temperature); the clear paste is precipitated with 3-4 times the amount of 95% (mass fraction) ethanol for 24 hours, and the precipitate is dissolved with 4-5 times the amount (mass fraction) of hot water ≥80°C, cooled and precipitated for 24-48 hours, the supernatant is taken, the water insoluble matter is filtered out, concentrated into a thick paste, vacuum dried at a temperature below 60°C, and crushed into fine powder.

[0101] 2. Preparation of Pueraria root extract: Take Pueraria root, crush it into coarse powder, and reflux extract it with 30% ethanol solution twice, each time for 2 hours, add 10 times the amount for the first time, and add 8 times the amount for the second time, combine the extracts, recover ethanol, and concentrate the extract to a clear paste with a relative density of 1.10-1.20 (room temperature), cool it, add ethanol to make the alcohol content 70%, and precipitate it for 12 hours to 24 hours; take the supernatant, recover ethanol, concentrate it into a thick paste, vacuum dry it at a temperature below 60°C, and crush it into fine powder.

[0102] 3. Preparation of mulberry leaf extract: Take mulberry leaves, crush them into coarse powder, the solid-liquid ratio is 1:10, the temperature is 80℃~90℃, reflux extract with 70% ethanol solution twice, each for 1 hour, combine the filtrate, recover the ethanol, and vacuum concentrate to a relative density of 1.10~1.20 (room temperature); add 3 times the amount (mass fraction) of 95% ethanol to the concentrate, precipitate for 24 hours to 48 hours; take the supernatant, recover the ethanol, concentrate it into a thick paste, vacuum dry it at a temperature below 60℃, and crush it into fine powder.

[0103] 4. Preparation of hawthorn extract: Take hawthorn, crush it into coarse powder, use 70% ethanol solution, solid-liquid ratio 1:10, reflux extraction at 90℃ twice, each time for 1.5 hours; combine the extracts, recover ethanol, and concentrate the extracts to a relative density of 1.10-1.20 (room temperature); add 3 times the amount (mass fraction) of 95% ethanol to the concentrate, and precipitate for 24 hours to 48 hours; take the supernatant, recover ethanol, concentrate it into a thick paste, vacuum dry it at a temperature below 60℃, and crush it into fine powder.

[0104] A large number of experiments have proved that Armillaria mycelium and fermentation liquid have sedative, anticonvulsant, cardiovascular and cerebrovascular disease treatment effects, and have no toxic side effects. Other literature studies have shown that Armillaria mycelium polysaccharide AMP-1 can enhance the glucose tolerance of normal mice, and both AMP-1 and AMP-2 can inhibit the increase of blood sugar in alloxan diabetic mice. AMP-2 can significantly reduce the blood sugar of alloxan diabetic mice. AMP-1 and AMP-2 (gavage dose of 10g kg -1 ·d -1 ) had no toxic effect on the test mice, and the internal organs were normal and intact. After continuous ig administration of Armillaria mellea polysaccharide to mice for 4 days, no mice died of drug poisoning, and the internal organs were normal and intact, with no adverse reactions.

[0105] The acute toxicity and genotoxicity of mulberry leaf water extract were investigated by acute toxicity test in mice, Salmonella typhimurium test (Ames test), chromosome aberration test in Chinese hamster lung fibroblasts (CHL) and micronucleus test in mouse bone marrow polychromatic erythrocytes. Results No death occurred in mice after oral administration of 40 g / kg of mulberry leaf water extract, and there was no significant difference in body weight between the control group and the normal control group (P>0.05). The results of Ames test, CHL cell chromosome aberration test and mouse micronucleus test were all negative. Conclusion Under the experimental conditions, the maximum oral administration dose of mulberry leaf water extract in mice was 40 g / kg, and no genotoxicity was shown.

[0106] Acute toxicity and long-term toxicity tests of total flavonoids of Pueraria root have shown that the LD50 of intraperitoneal injection is 5.97 (5.46-6.48) g / kg, and the LD50 of oral gavage is 10.11 (9.41-10.8) g / kg. Long-term toxicity to rats: The animals were given total flavonoids of Pueraria root orally at doses of 2.50, 1.66 and 0.83 g / kg, once a day, for 90 consecutive days; the animals were generally in good condition, and except for a slight effect on the body weight and total white blood cell count of male animals at high and medium doses, there was no significant effect on platelets, hemoglobin, liver and kidney function, and pathological histology of major organs. Long-term use of this product may not produce cumulative toxicity.

[0107] Studies have shown that hawthorn leaf water extract was subjected to pollutant mutagenicity detection (Ames test), mouse bone marrow micronucleus test and mouse sperm aberration test, and no mutagenicity, embryotoxicity or obvious teratogenic potential was found in hawthorn leaf water extract.

[0108] Mice were gavaged with the extract of Crataegus pinnatifida for 72 hours, and the LD50 was (44.6±4) g (calculated as crude drug). According to data reports, the oral LD50 of medicinal hawthorn for mice is 18.5 g. Therefore, Crataegus pinnatifida is much less toxic than medicinal hawthorn. Jin Xueping conducted acute toxicity experiments and maximum safe tolerable dose experiments on mice with 5 different groups of extracts of apple leaves. The results showed that no mouse deaths were found in the concentrations of groups A, C, E, and F at 2.6 g / ml, and the maximum safe tolerable dose multiple was 132, which was considered safe and non-toxic. The mortality rate of group D was 80%, and further experiments determined that its median lethal dose was 2.1 g / ml, indicating that the alkaloids dissolved in acid water after ethanol extraction were toxic; Pan Ying et al. conducted acute toxicity experiments and maximum safe tolerable dose experiments on total flavonoids of Crataegus pinnatifida, and the results showed that the maximum tolerable dose of total flavonoids of Crataegus pinnatifida was 168 g / kg, which is equivalent to the daily oral dose of crude drugs for adults (33.3 g·kg -1 ·d -1 ) (based on the average content of total flavonoids in the fruit of the herbal medicine Crataegus chinensis), and is considered safe and non-toxic.

[0109] Example 3: The Chinese medicine composition of Example 2 was measured by spectrophotometry and HPLC, wherein:

[0110] Armillaria crude polysaccharide: 1) Sample processing:

[0111] a. Sample extraction: Weigh 2.0 g of sample, place in a 100 mL volumetric flask, add 80 mL of water, heat in a boiling water bath for 2 hours, cool to room temperature, add water to the scale, mix well and filter, discard the initial filtrate, and collect the remaining filtrate for precipitation of polysaccharides.

[0112] b. Precipitation of crude polysaccharide: Accurately pipette 5.0 mL of the final filtrate of item (a) into a 50 mL centrifuge tube, add 20 mL of anhydrous ethanol, mix for 5 minutes, centrifuge at 3000 r / min for 5 minutes, and discard the supernatant. Wash the residue with a few milliliters of 80% (volume fraction) ethanol solution, discard the supernatant after centrifugation, and repeat the operation 3 to 4 times. Dissolve the residue in water and make it up to 5.0 mL, mix it, and then precipitate the glucan.

[0113] c. Precipitate dextran: Accurately pipette 2.0 mL of the final solution in item (b) into a 20 mL centrifuge tube, add 2.0 mL of 100 g / L sodium hydroxide solution and 2.0 mL of copper reagent solution, boil in a boiling water bath for 2 min, cool, centrifuge at 3000 r / min for 5 min, and discard the supernatant. Wash the residue with a few milliliters of washing solution, discard the supernatant after centrifugation, repeat the operation 3 times, dissolve the residue with 2.0 mL of 10% (volume fraction) sulfuric acid solution and transfer to a 50 mL volumetric flask, dilute to the mark with water, and mix well. This solution is the sample test solution.

[0114] 2) Standard curve drawing: Accurately weigh 0, 0.10, 0.20, 0.40, 0.60, 0.80, 1.00 mL of the standard dextran solution (equivalent to 0, 0.01, 0.02, 0.04, 0.06, 0.08, 0.10 mg of dextran) and place them in 25 mL colorimetric tubes, accurately add water to 2.0 mL, add 1.0 mL of 50 g / L phenol solution, mix well on a rotary mixer, carefully add 10.0 mL of concentrated sulfuric acid, mix well on a rotary mixer, boil in a boiling water bath for 2 min, cool and use a spectrophotometer at a wavelength of 485 nm with the reagent blank solution as the reference and a 1 cm colorimetric dish to measure the absorbance value. Draw a standard curve with the dextran concentration as the horizontal axis and the absorbance value as the vertical axis.

[0115] 3) Sample determination: Accurately pipette 2.0 mL of sample determination solution, place in a 25 mL colorimetric tube, add 1.0 mL of 50 g / L phenol solution, mix well on a rotary mixer, carefully add 10.0 mL of concentrated sulfuric acid, mix well on a rotary mixer, boil in a boiling water bath for 2 min, cool to room temperature, and use a spectrophotometer at a wavelength of 485 nm, with the reagent blank as a reference, and a 1 cm colorimetric dish to determine the absorbance value. Find the glucan content from the standard curve, calculate the crude polysaccharide content in the sample, and perform a sample blank test at the same time.

[0116] Puerarin: 1) Sample treatment: Accurately weigh 0.50g-1.00g of sample (accurate to 0.001g), add appropriate amount of water to dissolve, and ultrasonicate in an ultrasonic cleaner for 20 minutes. After cooling to room temperature, dilute to 10mL with water, mix well, and centrifuge at 4000r / min for 5min. Take 1mL of supernatant and apply it to a macroporous adsorption resin chromatography column, elute impurities with about 40mL of water at 1mL / min, and then elute puerarin with 50mL of 70% methanol. Place the eluate in a boiling water bath and evaporate it to near dryness, dissolve it with 70% methanol and dilute to 1mL, and filter it through a 0.45μm filter membrane for high performance liquid chromatography.

[0117] 2) Liquid chromatography reference conditions: Chromatographic column: ODS C18, 250 mm×4.6 mm, 5 μm; Mobile phase: methanol+36% acetic acid+water=25+3+72; Flow rate: 0.6 mL / min; Detection wavelength: 247 nm; Injection volume: 10 μL.

[0118] The effective ingredient contents of the traditional Chinese medicine composition are as follows: crude polysaccharide: 121.36 mg / g; puerarin: 9.26 mg / g.

[0119] The animal modeling test was conducted on the Chinese medicinal composition for improving vertigo function described in Example 2, which proved that the Chinese medicinal composition of the present invention has the effect of improving vertigo.

[0120] Experimental example: 1. Materials and instruments

[0121] 1.1 Animals: 100 Kunming mice, male, weighing 20-22 g; 50 guinea pigs, both male and female, weighing 230-260 g, all provided by the Experimental Animal Center of Jilin University;

[0122] 1.2 Drugs The composition of the present invention (Armillaria officinalis, hawthorn and kudzu root granules); Gastrodia elata capsules (produced by Kunming Pharmaceutical Group Co., Ltd.);

[0123] 1.3 Instruments: Three-way maze for experiment (Shanghai Haodun Industry & Trade Co., Ltd.); platform experiment apparatus (modified by connecting Shanghai-made electric stimulator to platform); rotator (modified by 681-type magnetic heating stirrer from Shanghai Nanhui Telecommunications Equipment Factory).

[0124] 2. Experimental methods and results

[0125] 2.1 Effect of the composition of the present invention on toxic dizziness reaction in guinea pigs

[0126] Fifty guinea pigs were randomly divided into five groups: model group (normal saline), control group (Gastrodia elata capsule, 1.00 g kg -1 ), high, medium and low dose groups of the composition of the present invention (1.0, 0.5, 0.25 g / kg). The drug was administered once a day for 14 consecutive days. One hour after the last administration, 20 μL of chloroform was quickly injected into the external auditory canal of the guinea pig at 4 to 5 mm. The animals were carefully observed for 20, 40 and 60 minutes thereafter, with the number of nystagmus and head shaking times of the animals as observation indicators, and each observation time was 1 minute. The experimental results are shown in Table 5.

[0127] Table 5 Effect of the composition of the present invention on toxic dizziness reaction in guinea pigs

[0128]

[0129]

[0130] Note: Compared with the model group, *P<0.05, **P<0.01

[0131] It can be seen that the three dosage groups of the composition of the present invention can reduce the number of head shaking and nystagmus at different times in guinea pigs with poisonous dizziness (P<0.05 or P<0.01).

[0132] 2.2 Anti-vertigo effect of the composition of the present invention on mice

[0133] 2.2.1 Maze experiment

[0134] Take 50 healthy mice and randomly divide them into 5 groups: normal control group (normal saline), positive control group (Gastrodia elata capsule, 1.0g / kg), low, medium and high groups of the composition of the present invention (1.0, 0.5, 0.25g / kg), gavage, once a day, for 3 consecutive days. The experimental mice are continuously trained to escape electric shock reflex in the jumping platform instrument, and 3 consecutive trainings are 1 time, and 1 training is performed in the morning and afternoon every day to consolidate their reflexes for 3 consecutive days to establish a stable and firm escape electric shock reflex. After 3 days, the drug is administered 1h before the test. After 1 training, except for the normal group, the mice are rotated at a constant speed of 50r / min on the rotating instrument for 10min and stopped suddenly, and the mice are immediately placed in the jumping platform instrument, the power is turned on, and the time taken for the mice to successfully escape the electric shock and jump onto the platform is recorded.

[0135] 2.2.2 Jumping platform experiment

[0136] The grouping, training, drug administration and stun-inducing methods of mice were the same as those of the maze experiment, and the time required for the mice to jump onto the platform for the first time without falling after receiving the electric shock was recorded. The experimental results are shown in Table 6.

[0137] Table 6 Anti-vertigo effect of the composition of the present invention on mice

[0138]

[0139] Note: Compared with the normal control group, **P<0.01.

[0140] 2.2.3 Food intake measurement After the experiment, the mice were fed a fixed amount of food, the activity of the mice was observed, and the food intake of each group of mice within 3 hours was recorded. The experimental results are shown in Table 7.

[0141] Table 7 Effect of the composition of the present invention on the food intake of mice

[0142]

[0143] As can be seen from the above, each dose group and the positive group of the composition of the present invention can significantly shorten the escape time of mice in the maze, and the difference is statistically significant compared with the blank control group (P<0.01); each dose group and the positive group of the composition of the present invention can significantly shorten the time for mice to successfully jump onto the platform, and the difference is statistically significant compared with the blank control group (P<0.01), and the effect of the composition of the present invention is dose-dependent. As can be seen from Table 15, each dose group and the positive group of the composition of the present invention can increase the activity of dizzy mice and increase the food intake of mice to varying degrees.

[0144] From the above experiments, it can be seen that the composition of the present invention can reduce the number of head swings and nystagmus of guinea pigs with poisonous vertigo, and the composition of the present invention can significantly shorten the escape time of mice in the maze, significantly shorten the escape time of mice jumping onto the platform, and enhance the activity of mice, which proves that it also has a positive pharmacodynamic effect on the mouse vertigo model. In short, the composition of the present invention can enhance the activity of dizzy mice and improve the adaptability of the body to environmental changes.

[0145] Additionally, in order to provide a concise description of exemplary embodiments, all features of an actual embodiment (ie, those features that are not relevant to the best mode presently contemplated for carrying out the invention or those that are not relevant to implementing the invention) may not be described.

[0146] It should be understood that in the development of any actual implementation, as in any engineering or design project, numerous implementation-specific decisions may be made. Such a development effort may be complex and time-consuming, but for those of ordinary skill having the benefit of this disclosure, without undue experimentation, the development effort will be a routine task of design, fabrication, and production.

[0147] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the spirit and scope of the technical solutions of the present invention, which should all be included in the scope of the claims of the present invention.

Claims

1. A Chinese medicine composition for improving vertigo, characterized in that: The invention is prepared from the following raw materials by weight: 30-35% of honey fungus fruiting body extract, 25-30% of kudzu root extract, 10-15% of mulberry leaf extract, 6-8% of hawthorn extract and 20-25% of maltodextrin.

2. A Chinese medicine composition for improving vertigo as claimed in claim 1, characterized in that: The invention is composed of the following raw materials by weight: 33.33% of Armillaria mellea fruiting body extract, 26.67% of Pueraria root extract, 10% of mulberry leaf extract, 6.67% of hawthorn extract and 23.33% of maltodextrin.

3. A method for preparing a Chinese medicine composition for improving vertigo, using a Chinese medicine composition for improving vertigo as described in any one of claims 1-2, characterized in that: The specific preparation steps are: S1. Weigh 1000 g of Armillaria mellea extract, 800 g of Pueraria root extract, 300 g of mulberry leaf extract, and 200 g of hawthorn extract respectively, put them into a mixer and mix them evenly; S2. Weigh 1000 mL of 90% ethanol solution as a wetting agent, and slowly spray it on the surface of the fine powder of the composition while the mixer is running, and stir evenly; S3, take 700g of maltodextrin and add 2000mL of water, stir evenly, heat to make a transparent liquid, cool to 50°C, slowly add to the above composition and stir evenly; S4. If the humidity is insufficient, add 90% ethanol solution until the requirement is met, then use a 14-16 mesh nylon sieve to make wet granules using a granulator, dry at 50°C, and bag.

4. A method for preparing a Chinese medicine composition for improving vertigo as claimed in claim 3, characterized in that: The preparation process of the honey fungus extract is as follows: taking honey fungus fruiting bodies, washing, drying, and crushing into coarse powder; with a solid-liquid ratio of 1:20, the temperature is 100°C, adding water for reflux extraction twice, the first time for 3 hours, and the second time for 2 hours; combining the extracts, vacuum concentrating at room temperature to form a clear paste with a relative density of 1.10-1.20; using 3-4 times the amount of 95% by mass ethanol to precipitate the clear paste for 24 hours, using 4-5 times the amount of hot water with a mass fraction of ≥80°C to dissolve the precipitate, cooling and then precipitating for 24-48 hours, taking the supernatant, filtering out water-insoluble matter, concentrating into a thick paste, vacuum drying at a temperature below 60°C, and crushing into fine powder to obtain the extract.

5. A method for preparing a Chinese medicine composition for improving vertigo as claimed in claim 3, characterized in that: The preparation process of the kudzu root extract is as follows: taking kudzu root, crushing it into coarse powder, refluxing and extracting it with a 30% ethanol solution for 2 times, each time for 2 hours, adding 10 times the amount for the first time and 8 times the amount for the second time, combining the extracts, recovering ethanol, concentrating the extracts to a clear paste with a relative density of 1.10 to 1.20 at room temperature, cooling, adding ethanol to make the alcohol content 70%, and precipitating for 12 to 24 hours; taking the supernatant, recovering ethanol, concentrating it into a thick paste, vacuum drying it at a temperature below 60°C, and crushing it into fine powder to obtain the extract.

6. A method for preparing a Chinese medicine composition for improving vertigo as claimed in claim 1, characterized in that: The preparation process of the mulberry leaf extract is as follows: taking mulberry leaves, crushing them into coarse powder, with a solid-liquid ratio of 1:10, the temperature is 80°C to 90°C, refluxing extraction with 70% ethanol solution for 1 hour each, combining the filtrates, recovering ethanol, and vacuum concentrating to a relative density of 1.10 to 1.20 at room temperature; adding 3 times the mass fraction of 95% ethanol to the concentrated solution, and precipitating for 24 to 48 hours; taking the supernatant, recovering ethanol, concentrating it into a thick paste, vacuum drying at a temperature below 60°C, and crushing it into fine powder to obtain the extract.

7. A Chinese medicine composition for improving vertigo and a preparation method thereof as claimed in claim 1, characterized in that: The preparation process of the hawthorn extract is as follows: taking hawthorn, crushing it into coarse powder, using 70% ethanol solution, with a solid-liquid ratio of 1:10, and refluxing extraction at 90°C for two times, each time for 1.5 hours; combining the extracts, recovering ethanol, and concentrating the extracts to a relative density of 1.10-1.20 at room temperature; adding 3 times the mass fraction of 95% ethanol to the concentrate, and precipitating for 24 hours to 48 hours; taking the supernatant, recovering ethanol, concentrating it into a thick paste, vacuum drying it at a temperature below 60°C, and crushing it into fine powder to obtain the extract.

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