阅读说明：本技术 一种改善睡眠的中药组合物 (Traditional Chinese medicine composition for improving sleep ) 是由 屈战果 崔传锋 张英华 于 2018-11-22 设计创作，主要内容包括：本发明涉及一种改善睡眠的中药组合物,由包括以下重量配比的中药原料制备而成,珍珠8-12份,野菊花25-30份,槐米8-12份。本发明还提供了其制备方法及用途。本发明所制备的产品清爽适口,长期服用具有改善睡眠、增强免疫、祛斑等功效,本品所用原辅料均经有长期食用历史,使用安全。本品不同于失眠上销售的以激素为主要有效成分的保健品,长期服用无毒副作用。(The invention relates to a traditional Chinese medicine composition for improving sleep, which is prepared from the following traditional Chinese medicine raw materials in parts by weight, 8-12 parts of pearl, 25-30 parts of wild chrysanthemum flower and 8-12 parts of sophora flower bud. The invention also provides a preparation method and application thereof. The product prepared by the invention is fresh and palatable, has the effects of improving sleep, enhancing immunity, removing freckles and the like after being taken for a long time, and is safe to use due to the fact that raw and auxiliary materials used by the product have long-term eating history. The product is different from health products which are sold on insomnia and take hormone as main effective component, and has no toxic and side effects after long-term administration.)

1. The traditional Chinese medicine composition for improving sleep is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 8-12 parts of pearl, 25-30 parts of wild chrysanthemum flower and 8-12 parts of sophora flower bud.

2. The traditional Chinese medicine composition for improving sleep as claimed in claim 1, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10 parts of pearl, 30 parts of wild chrysanthemum flower and 10 parts of sophora flower bud.

3. The method for preparing a traditional Chinese medicine composition for improving sleep as claimed in claim 1 or 2, characterized by comprising the following steps:

(1) weighing pearl, wild chrysanthemum flower and sophora flower bud according to the proportion;

(2) pulverizing Margarita, performing enzymolysis to obtain Margarita enzymolysis solution, and drying to obtain Margarita enzymolysis powder;

(3) mixing flos Chrysanthemi Indici and flos Sophorae Immaturus, and extracting with water to obtain extractive solution;

(4) and (3) uniformly mixing the pearl enzymolysis powder obtained in the step (2) with the wild chrysanthemum flower and sophora flower bud extracting solution obtained in the step (3).

4. The method of claim 3, wherein: the enzyme used in the enzymolysis in the step (2) is papain and/or trypsin, and the total mass of the added enzyme is 3-5% of the pearl powder.

5. The method of claim 3, wherein: adding lactic acid to acidify pearl before adding enzyme, filtering to remove acid solution, and performing enzymolysis.

6. The method for preparing a traditional Chinese medicine composition for improving sleep as claimed in claim 1 or 2, characterized by comprising the following steps:

(1) weighing pearl, wild chrysanthemum flower and sophora flower bud according to the proportion;

(2) pulverizing Margarita, performing acidolysis to obtain Margarita acidolysis solution, concentrating, and drying to obtain Margarita acidolysis powder;

(3) mixing flos Chrysanthemi Indici and flos Sophorae Immaturus, and extracting with ethanol to obtain extractive solution;

(4) mixing the pearl acid hydrolysis powder, the wild chrysanthemum flower and the sophora flower bud extract uniformly.

7. The method of claim 6, wherein: the acid used in the acidolysis in the step (2) is hydrochloric acid, the concentration of the hydrochloric acid is 5-10mol/L, the addition amount of the hydrochloric acid is 80-120% of the mass of the pearl, the hydrochloric acid is gradually added and stirred, and the acidolysis time is 8-24 hours, so as to obtain initial acidolysis solution; heating the initial acidolysis solution to drive acid to Cl^-Reducing the ion concentration to 50% of the initial acidolysis solution, stopping heating, and drying to obtain Margarita hydrolysis powder.

8. The method of claim 6, wherein: the acidolysis step of the step (2) comprises the following steps:

(2-1) dropwise adding 5-10mol/L hydrochloric acid solution into the pearl powder while stirring until no pearl powder is precipitated, and performing suction filtration to obtain filter residue and acidolysis solution 1;

(2-2) adding 5-10mol/L hydrochloric acid solution which accounts for 80-120% of the mass of the filter residue into the filter residue obtained in the step (2-1), and refluxing under normal pressure until no suspended matter exists in the bottle; the flask was heated to drive the acid to Cl in solution^-The concentration is reduced by half; passing through anion exchange resin chromatographic column until the effluent is alkaline, and collecting the effluent as acidolysis solution 2; pouring the used anion exchange resin into a mesh bag, washing until the anion exchange resin is detected to be slightly blue by an indantrione method, and collecting washing liquid, namely acidolysis liquid 3;

(2-3) putting the acidolysis solution 1 into an ice water bath for recrystallization and rapid suction filtration to reduce Cl in the solution^-Concentration; passing the recrystallized liquid through anion exchange resin chromatographic column and cation exchange resin chromatographic column in sequence to remove Ca²⁺、Cl^-Performing ion treatment to obtain acidolysis solution 4;

(2-4) mixing the acidolysis solution 2, the acidolysis solution 3 and the acidolysis solution 4 to obtain the pearl acidolysis solution.

9. Use of the Chinese medicinal composition of claim 1 or 2 in the preparation of a health-care product preparation for improving sleep.

10. An oral liquid for improving sleep is characterized by comprising the following components: the sleep improvement traditional Chinese medicine composition of claim 1 or 2, wherein the sleep improvement traditional Chinese medicine composition comprises, by weight, 1 to 10 parts of the traditional Chinese medicine composition, 0.0005 to 0.01 part of the acid-base modifier, 0.001 to 10 parts of the flavoring agent, and 10 to 1000 parts of water.

Technical Field

The invention relates to a traditional Chinese medicine composition for improving sleep.

Background

With the acceleration of life rhythm, the pressure of people on the aspects of work and family is increased; the quality of sleep is reduced due to the change of living environment and the aggravation of noise, light and electric pollution, which is a common trouble for people. According to the results of foreign investigation, the prevalence rate of insomnia of young people is 10%, that of middle-aged people is 20%, and that of the elderly people over 65 years old is 35-50%. Insomnia is manifested by difficulty in falling asleep, too short depth or frequency of sleep, early awakening, insufficient or poor sleep time, etc. Insomnia often brings great pain and psychological burden to patients, and the abuse of insomnia drugs can damage bodies.

Disclosure of Invention

The invention relates to a traditional Chinese medicine composition for improving sleep, which is prepared from the following traditional Chinese medicine raw materials in parts by weight, 8-12 parts of pearl, 25-30 parts of wild chrysanthemum flower and 8-12 parts of sophora flower bud.

Preferably, the traditional Chinese medicine composition for improving sleep is prepared from the following traditional Chinese medicine raw materials in parts by weight, namely 10 parts of pearl, 30 parts of wild chrysanthemum flower and 10 parts of sophora flower bud.

The components are proportioned according to the parts by weight, and can be increased or reduced according to corresponding proportions during production, for example, the weight can be increased or reduced in units of kilograms or tons during large-scale production, but the proportion of the weight proportion of the medicinal materials among the components is unchanged.

The traditional Chinese medicine composition for improving sleep is prepared by processing the traditional Chinese medicine raw materials consisting of the formula through enzymolysis, hydrolysis, extraction or other methods.

In particular, the amount of the solvent to be used,

the invention also provides a preparation method (preparation method I) of the traditional Chinese medicine composition for improving sleep, which comprises the following steps:

(1) weighing pearl, wild chrysanthemum flower and sophora flower bud according to the proportion;

(2) pulverizing Margarita, performing enzymolysis to obtain Margarita enzymolysis solution, and drying to obtain Margarita enzymolysis powder;

(3) mixing flos Chrysanthemi Indici and flos Sophorae Immaturus, and extracting with water to obtain extractive solution;

(4) and (3) uniformly mixing the pearl enzymolysis powder obtained in the step (2) with the wild chrysanthemum flower and sophora flower bud extracting solution obtained in the step (3).

Preferably, the first and second electrodes are formed of a metal,

the enzyme used in the enzymolysis in the step (2) is papain and/or trypsin, and the total mass of the added enzyme is 3-5% of the total mass of the pearl powder; more preferably, carrying out enzymolysis for 3-24 hours under the conditions of pH6-8 and 40-60 ℃, heating the enzymolysis liquid to 90 ℃, preserving the temperature for 20 minutes, stopping the enzymolysis reaction, and carrying out spray drying on the enzymolysis liquid to obtain pearl enzymolysis powder; further preferably, the used enzyme is papain and trypsin in a mass ratio (1-3): (1-3) complex enzyme. More preferably, lactic acid is added to acidify the pearl before the enzyme is added, and the enzymatic hydrolysis process is carried out after the acid solution is removed by filtration.

In the water extraction in the step (3), the mass ratio of the traditional Chinese medicine raw materials (the total mass of the wild chrysanthemum flower and the sophora flower bud) to the water is 1: 5-1: 50; the water extraction temperature is 80-100 ℃, the water extraction time is 1-5h, the filtration is carried out, the repeated extraction is carried out for 1-3 times, the filtrates are combined, and the filtrate is decompressed and concentrated to 1/5-1/50 of the original volume.

The invention also provides another preparation method (preparation method II) of the traditional Chinese medicine composition for improving sleep, which comprises the following steps:

(1) weighing pearl, wild chrysanthemum flower and sophora flower bud according to the proportion;

(2) pulverizing Margarita, performing acidolysis to obtain Margarita acidolysis solution, concentrating, and drying to obtain Margarita acidolysis powder;

(3) mixing flos Chrysanthemi Indici and flos Sophorae Immaturus, and extracting with ethanol to obtain extractive solution;

(4) mixing the pearl acid hydrolysis powder, the wild chrysanthemum flower and the sophora flower bud extract uniformly.

Preferably, the first and second electrodes are formed of a metal,

the acid used in the acidolysis in the step (2) is hydrochloric acid, the concentration of the hydrochloric acid is 5-10mol/L, the addition amount of the hydrochloric acid is preferably 80-120% of the mass of the pearl, the hydrochloric acid is gradually added and stirred, and the acidolysis time is 8-24 hours, so as to obtain initial acidolysis solution; heating the initial acidolysis solution to drive acid to Cl^-Reducing ion concentration to 50% of the initial acidolysis solution, stopping heating, and drying to obtain MargaritaHydrolyzing powder; the drying is preferably spray drying;

more preferably, the acidolysis step of step (2) comprises:

(2-1) dropwise adding 5-10mol/L hydrochloric acid solution into the pearl powder while stirring until no pearl powder is precipitated, and performing suction filtration to obtain filter residue and acidolysis solution 1;

(2-2) adding 5-10mol/L hydrochloric acid solution which accounts for 80-120% of the mass of the filter residue into the filter residue obtained in the step (2-1), and refluxing under normal pressure until no suspended matter exists in the bottle; the flask was heated to drive the acid to Cl in solution^-The concentration is reduced by half; passing through anion exchange resin chromatographic column until the effluent is alkaline, and collecting the effluent as acidolysis solution 2; pouring the used anion exchange resin into a mesh bag, washing until the anion exchange resin is detected to be slightly blue by an indantrione method, and collecting washing liquid, namely acidolysis liquid 3;

(2-3) putting the acidolysis solution 1 into an ice water bath for recrystallization and rapid suction filtration to reduce Cl in the solution^-Concentration; passing the recrystallized liquid through anion exchange resin chromatographic column and cation exchange resin chromatographic column in sequence to remove Ca²⁺、Cl^-Performing ion treatment to obtain acidolysis solution 4;

(2-4) mixing the acidolysis solution 2, the acidolysis solution 3 and the acidolysis solution 4 to obtain the pearl acidolysis solution.

In the alcohol extraction in the step (3), the mass ratio of the traditional Chinese medicine raw materials (the total mass of the wild chrysanthemum flower and the sophora flower bud) to the alcohol is 1: 10-1: 50; extracting with alcohol at 50-80 ℃ for 1-4 h repeatedly for 1-3 times, mixing filtrates, and concentrating the filtrate under reduced pressure to 1/5-1/50; the alcohol is preferably ethanol (the volume fraction of ethanol may be 50% to 90%).

The invention also provides application of the traditional Chinese medicine composition in preparing a health-care product preparation for improving sleep.

The health product preparation comprises the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

In the health product preparation, the weight percentage of the traditional Chinese medicine composition can be 0.1-99.9%, and the balance is pharmaceutically acceptable auxiliary materials.

The dosage form of the health product preparation can be any dosage form which can be used as a health product, and the dosage forms comprise: tablets, capsules, oral liquids, sprays, drops, granules, pills, powders, ointments and the like; preferably oral liquid, tablet, granule, pill, powder, and unguent; most preferred is oral liquid. The tablet can be in the form of common tablet, chewable tablet, buccal tablet, etc.

The pharmaceutically acceptable auxiliary materials are selected from one or more of fillers, pH regulators, suspending agents, stabilizers, flavoring agents, coloring agents, preservatives, antioxidants, osmotic pressure regulators, fillers, disintegrating agents, lubricants, wetting agents, other pharmaceutically acceptable carriers and the like.

The acid-base regulator is selected from citric acid (citric acid monohydrate, anhydrous citric acid), malic acid, vitamin C, tartaric acid, sorbic acid, tartaric acid, lactic acid, phosphoric acid, acetic acid, hydrochloric acid, caproic acid and fumaric acid; one or more of sodium citrate, potassium sorbate, sodium hydroxide, sodium carbonate, sodium bicarbonate, potassium carbonate and potassium bicarbonate.

The flavoring agent is one or more selected from glucose, sucrose, fructose, maltose, starch sugar, stevioside, glycyrrhizin, aspartame, saccharin sodium, sucralose, neotame, and mogroside.

The filler is selected from one or more of cellulose, mannitol, lactose and other similar fillers.

The disintegrant is selected from one or more of starch, polyvinylpyrrolidone and starch derivatives, such as sodium starch glycolate.

The lubricant is selected from one or more of talcum powder, magnesium stearate and polyethylene glycol.

The wetting agent is selected from sodium dodecyl sulfate and the like.

The other pharmaceutically acceptable carriers are selected from mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, thioglycolic acid, methionine, disodium EDTA, calcium sodium EDTA, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, dextran, glycine, starch, lactose, mannitol, silicon derivatives, alginate, gelatin, glycerol, tween 80, agar, calcium carbonate, calcium bicarbonate, surfactant, cyclodextrin, kaolin, calcium stearate and the like.

The health product preparation of the invention determines the usage amount according to the condition of a patient when in use, and can be taken three times a day, 1-20 doses each time, such as 1-20 tablets or granules or bottles.

The invention also provides an oral liquid for improving sleep, which comprises the following components: the traditional Chinese medicine composition for improving sleep comprises, by weight, 1-10 parts of an acid-base regulator, 0.0005-0.01 part of a flavoring agent, 0.001-10 parts of a flavoring agent and 10-1000 parts of water.

The preparation method of the oral liquid for improving sleep comprises the following steps: mixing the above components, filtering, bottling, and sterilizing.

The product prepared by the invention is fresh and palatable, has the effects of improving sleep, enhancing immunity, removing freckles and the like after being taken for a long time, and is safe to use due to the fact that raw and auxiliary materials used by the product have long-term eating history. The product is different from health products which are sold on insomnia and take hormone as main effective component, and has no toxic and side effects after long-term administration.

Detailed Description

The invention is further illustrated by the following examples, which are not intended to limit the claims.