Composition for treating insomnia and improving sleep quality and preparation method thereof

Abstract

The invention is suitable for the technical field of functional food, and provides a composition for treating insomnia and improving sleep quality and a preparation method thereof, the composition is prepared from the following raw materials in parts by weight: 1-20 parts of lily, 1-20 parts of codonopsis pilosula, 1-20 parts of astragalus membranaceus, 1-20 parts of polygonatum kingianum, 1-12 parts of spina date seed extract, 0.02-0.2 part of melatonin and 0.03-0.6 part of vitamin B6. The preparation method comprises the following steps: mixing the lily, the codonopsis pilosula, the astragalus membranaceus and the rhizoma polygonati according to the formula ratio to obtain a mixture; mixing the obtained mixture with a solvent, extracting, combining extracting solutions, concentrating and drying to obtain an extract; and finally, uniformly mixing the obtained extract with the semen ziziphi spinosae extract, melatonin and vitamin B6 according to the formula ratio to obtain the composition for treating insomnia and improving sleep quality. The production process of the composition is optimized and screened, and the composition is accurate in preparation process parameter, scientific and stable in process, controllable in quality, moderate in cost and suitable for industrial mass production.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of functional food, and particularly relates to a composition for treating insomnia and improving sleep quality and a preparation method thereof. BACKGROUND

[0002] Insomnia refers to a subjective experience that is not satisfied with sleep time and / or sleep quality despite having suitable sleep opportunities and sleep environment, and affecting daytime function or causing physical discomfort. In the fast-paced modern life, sleep seems to have become a luxury. Reports show that the incidence of insomnia among Chinese adults in 2023 is as high as 38.2%, and the number of people with sleep disorders is as high as 510 million. This means that among every two adults, one is suffering from insomnia. Hypertension, diabetes, obesity, mental disorders, senile dementia and stroke are common diseases caused by insomnia. Of course, insomnia can also cause a series of problems such as decreased immunity, endocrine disorders and accelerated aging of the human body.

[0003] Currently, the western medicine treatment of insomnia mainly adopts "sedative and hypnotic therapy", mainly by taking sleeping pills. Sleeping pills mainly inhibit the central nervous system to make people fall asleep. Sleeping pills have clear specificity and the most rapid effect, but long-term use will produce dependence.

[0004] Traditional Chinese medicine has a deep understanding of insomnia and unique treatment methods. In traditional Chinese medicine theory, insomnia is called "not sleeping", which is mainly related to dysfunction of viscera, imbalance of qi and blood, and imbalance of yin and yang, mainly involving heart, liver, spleen and other viscera. Due to different constitutions, different types of diseases and different degrees of illness, the effect of traditional Chinese medicine treatment of insomnia is slower than that of western medicine.

[0005] Therefore, it is of important application value to develop a composition for treating insomnia and improving sleep quality, which can solve the problems of dependence of western medicine treatment and slow effect of traditional Chinese medicine treatment. SUMMARY

[0006] The purpose of the embodiment of the present application is to provide a composition for treating insomnia and improving sleep quality and a preparation method thereof, which aims to solve the problems proposed in the background.

[0007] The embodiment of the present application is implemented as follows: a composition for treating insomnia and improving sleep quality, raw materials are composed of the following ingredients by weight fraction: Baihe 1-20 parts, Dangshen 1-20 parts, Huangqi 1-20 parts, Huangjing 1-20 parts, Suanzaoren extract 1-12 parts, melatonin 0.02-0.2 parts and vitamin B6 0.03-0.6 parts.

[0008] Further technical solutions, the raw materials of the composition consist of the following ingredients by weight: Baihe 2-14 parts, Dangshen 3-15 parts, Huangqi 2-12 parts, Huangjing 2-11 parts, Suanzaoren extract 3-9 parts, melatonin 0.04-0.14 parts and vitamin B6 0.07-0.4 parts.

[0009] Further technical solutions, the raw materials of the composition consist of the following ingredients by weight: Baihe 4-8 parts, Dangshen 5-10 parts, Huangqi 4-7 parts, Huangjing 6-10 parts, Suanzaoren extract 4-7 parts, melatonin 0.07-0.11 parts and vitamin B6 0.1-0.3 parts.

[0010] Further technical solutions, the raw materials of the composition consist of the following ingredients by weight: Baihe 6 parts, Dangshen 8 parts, Huangqi 6 parts, Huangjing 8 parts, Suanzaoren extract 5 parts, melatonin 0.08 parts and vitamin B6 0.15 parts.

[0011] Further technical solutions, the Suanzaoren extract is prepared according to the following method: Step S1: Suanzaoren is crushed to pass through a 40-mesh sieve, heated extraction is carried out with distilled water, concentrated to a solution with a density of 1.25 g / ml, 8 times the volume of 95% ethanol is added, and the supernatant is dried under reduced pressure to obtain Suanzaoren crude extract; Step S2: The Suanzaoren crude extract obtained in step S1 is loaded onto a macroporous resin column, and gradient elution is carried out with ethanol aqueous solution with a volume fraction of 10-25% and 60-75%, respectively, the eluate of ethanol aqueous solution with a volume fraction of 60-75% is collected, and the Suanzaoren eluate is dried. Step S3: The Suanzaoren eluate obtained in step S2 is loaded onto a silica gel column, and elution is carried out using a mixture system of chloroform, methanol, water and ammonia water, wherein the volume ratio of chloroform:methanol:water:ammonia water is 86:11:3:0.1 and 82:15:3:0.1, respectively, the eluate eluted by the system with a volume ratio of 82:15:3:0.1 is collected, and the Suanzaoren extract is dried.

[0012] Further technical solutions, in the step S1, the conditions for heating extraction with distilled water are: the solid-liquid ratio is 1:8-20, and the extraction time is 1-3 h.

[0013] Further technical solutions, in the step S2, gradient elution is carried out with ethanol aqueous solution with a volume fraction of 18% and 67% in turn, and the eluate eluted by ethanol aqueous solution with a volume fraction of 67% is collected.

[0014] Another purpose of the embodiment of the present application is to provide a preparation method of a composition for treating insomnia and improving sleep quality, based on the composition described above, comprising the following steps: Step 1: mixing the formula amount of lily, dangshen, astragalus and polygonatum, to obtain a mixture; Step 2: mixing the obtained mixture with a solvent, extracting, combining the extract, and concentrating and drying to obtain an extract; Step 3: mixing the obtained extract with the formula amount of semen ziziphi spinosae extract, melatonin and vitamin B6, to obtain a composition for treating insomnia and improving sleep quality.

[0015] Further technical solutions, in the step 2, the solvent is water or an ethanol aqueous solution; The extraction conditions are: the solid-liquid mass ratio is 1:6-12, the extraction time is 0.5-3h, and the extraction times is 1-3 times.

[0016] The composition for treating insomnia and improving sleep quality and the preparation method thereof provided by the embodiment of the present application have the following beneficial effects: (1) The melatonin in the present application is synthesized by the brain gland-pineal gland in the human body, vitamin B6 exists in poultry, fish, potato and other starch vegetables and various green leaf vegetables, and other raw materials are all natural plants. The prepared composition has no toxic side effects, high safety, no dependence, and is suitable for long-term taking.

[0017] (2) The raw materials are reasonably matched to play a role in treating insomnia and improving sleep quality from the aspects of nourishing yin, tonifying blood, tonifying qi, generating fluid, stabilizing the surface, softening the liver, regulating the mind and protecting the nervous system. The scientific matching of raw materials not only pays attention to treating insomnia and improving sleep quality itself, but also strives to balance the nervous system of the patient, so as to achieve the purpose of self-healing.

[0018] (3) The production process of the composition is optimized and selected, fully considering the chemical properties, thermal stability, polarity and cost-effectiveness of the target compound. The preparation process parameters are accurate, the process is scientific and stable, the quality is controllable, the cost is moderate, and it is suitable for industrial production. DETAILED DESCRIPTION

[0019] In order to make the purpose, technical scheme and advantages of the present application more clear, the present application is further described in detail below combined with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application, and are not used to limit the present application.

[0020] The specific implementation of the present application is described in detail below combined with specific embodiments.

[0021] An embodiment of the present application provides a composition for treating insomnia and improving sleep quality, and the raw materials are composed of the following ingredients by weight: Lily 1-20 parts, Dangshen 1-20 parts, Huangqi 1-20 parts, Huangjing 1-20 parts, Suanzaoren extract 1-12 parts, melatonin 0.02-0.2 parts, and vitamin B6 0.03-0.6 parts.

[0022] In the embodiments of the present application, lily is slightly cold in nature, sweet and slightly bitter in taste, and belongs to heart and lung channels. It has the effects of nourishing yin and moistening lung, clearing heart and calming mind. It can be used to treat restlessness, insomnia, and dreaminess caused by improper emotions.

[0023] Dangshen is flat in nature and sweet in taste, and belongs to spleen and lung channels. It has the effects of tonifying spleen and lung qi, tonifying blood, and producing saliva. Dangshen contains various active ingredients, including neuroprotective, sedative, and antioxidant ingredients, which have good protection for the nervous system of the human body.

[0024] Huangqi is slightly warm in nature and sweet in taste, and belongs to lung, spleen, liver, and kidney channels. It has the effects of tonifying qi, consolidating the exterior, and astringing sweat, and can be used to treat insomnia caused by qi deficiency.

[0025] Huangjing is flat in nature and sweet in taste, and belongs to spleen, lung, and kidney channels. It has the effects of tonifying lung, kidney, and spleen yin, tonifying spleen qi, and benefiting kidney essence. It can be used to treat symptoms such as lumbago and insomnia caused by kidney essence deficiency, liver and kidney deficiency, and deficiency of essence and blood.

[0026] Suanzaoren is flat in nature and sweet and sour in taste, and belongs to liver, gallbladder, and heart channels. It has the effects of nourishing blood, softening liver, calming mind, and stabilizing will. As a main drug for treating insomnia, Suanzaoren can be used together with other drugs for treating insomnia to enhance the pharmacological effect of treating insomnia. Suanzaoren has high safety and is suitable for long-term use.

[0027] As a preferred embodiment of the present application, the raw materials of the composition consist of the following ingredients by weight: Lily 2-14 parts, Dangshen 3-15 parts, Huangqi 2-12 parts, Huangjing 2-11 parts, Suanzaoren extract 3-9 parts, melatonin 0.04-0.14 parts, and vitamin B6 0.07-0.4 parts.

[0028] As a preferred embodiment of the present application, the raw materials of the composition consist of the following ingredients by weight: Lily 4-8 parts, Dangshen 5-10 parts, Huangqi 4-7 parts, Huangjing 6-10 parts, Suanzaoren extract 4-7 parts, melatonin 0.07-0.11 parts, and vitamin B6 0.1-0.3 parts.

[0029] As a preferred embodiment of the present application, the raw materials of the composition consist of the following ingredients by weight: Lily 6 parts, Dangshen 8 parts, Huangqi 6 parts, Huangjing 8 parts, Suanzaoren extract 5 parts, melatonin 0.08 parts, and vitamin B6 0.15 parts.

[0030] In a preferred embodiment of the present invention, the jujube seed extract is prepared according to the following method: Step S1: Crush the jujube seeds through a 40-mesh sieve, extract them with distilled water by heating, concentrate the solution to a density of 1.25 g / ml, add 8 times the volume of 95% ethanol, refrigerate and stand for 10 hours, and dry the supernatant under reduced pressure to obtain crude jujube seed extract. Step S2: The crude extract of jujube seed obtained in step S1 is loaded onto a macroporous resin column and eluted sequentially with ethanol aqueous solution of volume fractions of 10-25% and 60-75%. The eluent of ethanol aqueous solution of volume fraction of 60-75% is collected and dried to obtain jujube seed eluent. Step S3: Load the jujube seed eluate obtained in step S2 onto a silica gel column and elute using a mixture of chloroform, methanol, water, and ammonia, wherein the volume ratios of chloroform:methanol:water:ammonia are 86:11:3:0.1 and 82:15:3:0.1, respectively. Collect the eluent obtained from the system with a volume ratio of 82:15:3:0.1 and dry it to obtain the jujube seed extract.

[0031] In a preferred embodiment of the present invention, in step S1, the conditions for heating and extracting distilled water are: a material-to-liquid ratio of 1:8-20 and an extraction time of 1-3 hours.

[0032] In a preferred embodiment of the present invention, in step S2, the mixture is sequentially eluted with an ethanol aqueous solution of 18% and 67% by volume, and the eluent obtained by eluting with the 67% ethanol aqueous solution is collected.

[0033] Another embodiment of the present invention provides a method for preparing a composition for treating insomnia and improving sleep quality, which, based on the above-described composition, includes the following steps: Step 1: Mix the prescribed amounts of lily bulbs, codonopsis, astragalus, and polygonatum to obtain a mixture; Step 2: Mix the obtained mixture with solvent, extract, combine the extracts, concentrate and dry to obtain the extract; Step 3: Mix the obtained extract with the prescribed amounts of jujube seed extract, melatonin, and vitamin B6 to obtain a composition for treating insomnia and improving sleep quality.

[0034] In a preferred embodiment of the present invention, in step 2, the solvent is water or an aqueous ethanol solution;

[0035] The extraction conditions are: material-to-liquid mass ratio of 1:6-12, extraction time of 0.5-3 hours, and extraction times of 1-3 times.

[0036] The following are several specific embodiments to verify the effectiveness of the present invention.

[0037] Example 1, the raw material composition is: 150g lily bulb, 100g codonopsis root, 100g astragalus root, 100g polygonatum rhizome, 15g jujube seed extract, 0.8g melatonin and 0.5g vitamin B6; The preparation method of jujube seed extract is as follows: Step S1: Crush the jujube seed into powder and pass it through a 40-mesh sieve. Heat and extract it with 8 times the amount of distilled water for 2 hours. Concentrate the powder to a solution with a density of 1.25 g / ml. Add 8 times the volume of 95% ethanol, refrigerate and let stand for 10 hours. Dry the supernatant under reduced pressure to obtain the crude extract of jujube seed. Step S2: Load the obtained crude extract of jujube seed onto a D-101 macroporous resin column and elute sequentially with 20% and 70% ethanol aqueous solution by volume fraction. Collect the eluent of 70% ethanol aqueous solution by volume fraction and dry it to obtain the jujube seed eluent. Step S3: Load the obtained jujube seed eluate onto a silica gel G column and elute using a mixture of chloroform, methanol, water, and ammonia, wherein the volume ratios of chloroform:methanol:water:ammonia are 86:11:3:0.1 and 82:15:3:0.1, respectively. Collect the eluent from the system with a volume ratio of 82:15:3:0.1 and dry it to obtain the jujube seed extract.

[0038] In preparing the composition, the prescribed amounts of lily bulb, codonopsis root, astragalus root, and polygonatum rhizome are mixed to obtain a mixture; the mixture is then added to 10 times the amount of water and heated to extract twice, 1 hour each time; the extracts are combined, concentrated, and dried to obtain the extract; the obtained extract is then mixed with the prescribed amounts of jujube seed extract, melatonin, and vitamin B6 to obtain the final product.

[0039] Example 2, the raw material composition is: 100g lily bulb, 90g codonopsis root, 80g astragalus root, 85g polygonatum rhizome, 35g jujube seed extract, 1g melatonin and 0.9g vitamin B6; The preparation method of jujube seed extract is as follows: Step S1: Crush the jujube seed and pass it through a 40-mesh sieve. Heat and extract with 10 times the amount of distilled water for 2.5 hours. Concentrate to a solution with a density of 1.25 g / ml. Add 8 times the volume of 95% ethanol. Refrigerate and let stand for 10 hours. Dry the supernatant under reduced pressure to obtain crude jujube seed extract. Step S2: Load the obtained crude extract of jujube seed onto an HPD-100 macroporous resin column and elute sequentially with 13% and 62% ethanol aqueous solution by volume fraction. Collect the eluent of 62% ethanol aqueous solution by volume fraction and dry it to obtain the jujube seed eluent. Step S3: Load the obtained jujube seed eluate onto a silica gel FCP column and elute using a mixture of chloroform, methanol, water, and ammonia, wherein the volume ratios of chloroform:methanol:water:ammonia are 86:11:3:0.1 and 82:15:3:0.1, respectively. Collect the eluent from the system with a volume ratio of 82:15:3:0.1 and dry it to obtain the jujube seed extract.

[0040] In preparing the composition, the prescribed amounts of lily bulb, codonopsis root, astragalus root, and polygonatum rhizome are mixed to obtain a mixture; the mixture is then added to 8 times the amount of 50% ethanol, and extracted twice by reflux heating, 1.5 hours each time. The extracts are combined, concentrated, and dried to obtain the extract; the obtained extract is then mixed with the prescribed amounts of jujube seed extract, melatonin, and vitamin B6 to obtain the final product.

[0041] Example 3, the raw material composition is: 60g lily bulb, 80g codonopsis root, 60g astragalus root, 80g polygonatum rhizome, 50g jujube seed extract, 0.8g melatonin and 1.5g vitamin B6.

[0042] The preparation method of jujube seed extract is as follows: Step S1: Crush the jujube seed and pass it through a 40-mesh sieve. Heat and extract it with 15 times the amount of distilled water for 2 hours. Concentrate it to a solution with a density of 1.25 g / ml. Add 8 times the volume of 95% ethanol, refrigerate and let it stand for 10 hours. Dry the supernatant under reduced pressure to obtain the crude extract of jujube seed. Step S2: Load the obtained crude extract of jujube seed onto an HP-20 macroporous resin column and elute sequentially with 18% and 67% ethanol aqueous solution by volume fraction. Collect the eluent of 67% ethanol aqueous solution by volume fraction and dry it to obtain the jujube seed eluent. Step S3: Load the obtained jujube seed eluate onto a silica gel G column and elute using a mixture of chloroform, methanol, water, and ammonia, wherein the volume ratios of chloroform:methanol:water:ammonia are 86:11:3:0.1 and 82:15:3:0.1, respectively. Collect the eluent from the system with a volume ratio of 82:15:3:0.1 and dry it to obtain the jujube seed extract.

[0043] In preparing the composition, the prescribed amounts of lily bulb, codonopsis root, astragalus root, and polygonatum rhizome are mixed to obtain a mixture; the mixture is then added to 10 times the amount of 60% ethanol, and extracted twice by reflux heating, 1 hour each time. The extracts are combined, concentrated, and dried to obtain the extract; the obtained extract is then mixed with the prescribed amounts of jujube seed extract, melatonin, and vitamin B6 to obtain the final product.

[0044] Comparative Example 1 differs from Example 3 in that step S3 was not performed. Specifically: Step S1: Crush the jujube kernels and pass them through a 40-mesh sieve. Heat and extract with 15 times the amount of distilled water for 2 hours. Concentrate the solution to a density of 1.25 g / ml. Add 8 times the volume of 95% ethanol. Refrigerate and let stand for 10 hours. Dry the supernatant under reduced pressure to obtain the crude extract of jujube kernels.

[0045] Step S2: Load the obtained crude extract of jujube seed onto an HP-20 macroporous resin column and elute sequentially with 18% and 67% ethanol aqueous solution by volume fraction. Collect the eluent of 67% ethanol aqueous solution by volume fraction and dry it to obtain the jujube seed eluent. Comparative Example 2 differs from Example 3 in that it does not contain Polygonatum sibiricum in its raw material composition.

[0046] The specific raw material composition is as follows: Lily bulb 60g, Codonopsis pilosula 80g, Astragalus membranaceus 60g, Ziziphus jujuba var. spinosa extract 50g, melatonin 0.8g and vitamin B6 1.5g.

[0047] Comparative Example 3 differs from Example 3 in that it does not contain Astragalus membranaceus in its raw material composition.

[0048] The specific raw material composition is as follows: Lily bulb 60g, Codonopsis pilosula 80g, Polygonatum sibiricum 80g, Ziziphus jujuba var. spinosa extract 50g, melatonin 0.8g and vitamin B6 1.5g.

[0049] Comparative Example 4 differs from Example 3 in that it does not contain Codonopsis pilosula in its raw material composition.

[0050] The specific raw material composition is as follows: Lily bulb 60g, Astragalus membranaceus 60g, Polygonatum sibiricum 80g, Ziziphus jujuba var. spinosa extract 50g, melatonin 0.8g and vitamin B6 1.5g.

[0051] Experiment Example 1: Effects on spontaneous activity in mice; The experimental method is as follows: Kunming mice were randomly divided into 6 groups of 10 mice each, based on their body weight: a blank control group (0.3% CMC), Example 3 group (5 mg / kg), Comparative Example 1 group (5 mg / kg), Comparative Example 2 group (5 mg / kg), Comparative Example 3 group (5 mg / kg), and Comparative Example 4 group (5 mg / kg). Five minutes after gavage administration, the mice were placed in a spontaneous activity recorder for 1 minute to acclimatize, and the number of spontaneous movements was recorded over 5 minutes. The experiment was conducted in a quiet environment at room temperature, starting at 8:00 AM.

[0052] Experimental results: In Example 3, the mice exhibited behavioral responses such as decreased excitability, slowed movement, reduced activity, lethargy, and closed eyes. Compared with the blank control group, Example 3 significantly reduced spontaneous activity in the mice, demonstrating a marked sedative effect. Specific data are shown in Table 1 below.

[0053] Table 1. Statistical Table of Exercise Activity Counts

[0054] Note: Activity count ratio = Number of activities in the experimental group / Number of activities in the blank control group * 100%.

[0055] Experimental Example 2: Effect of subthreshold doses of sodium pentobarbital on hypnotic effects; The experimental method is as follows: Kunming mice were randomly divided into 6 groups of 10 mice each, based on body weight: a blank control group (0.3% CMC), Example 3 group (5 mg / kg), Comparative Example 1 group (5 mg / kg), Comparative Example 2 group (5 mg / kg), Comparative Example 3 group (5 mg / kg), and Comparative Example 4 group (5 mg / kg). Twenty minutes after gavage administration, 25 mg / kg of sodium pentobarbital was injected intraperitoneally. Mice that lost their righting reflex for more than one minute within 15 minutes of pentobarbital administration were defined as sleeping mice. The number of sleeping mice was observed, and the sleep rate was calculated. The experiment was conducted in a quiet, room-temperature environment, starting at 8:00 AM.

[0056] Experimental results: Gavage administration of the 3rd group (5 mg / kg) significantly increased the number of mice falling asleep induced by subthreshold doses of sodium pentobarbital. Specific data are shown in Table 2 below.

[0057] Table 2. Statistics on Sleep Attention Rate

[0058] Experimental Example 3: Effect of sodium pentobarbital on sleep duration; The experimental method is as follows: Kunming mice were randomly divided into 6 groups of 10 mice each, based on their body weight: a blank control group (0.3% CMC), Example 3 group (5 mg / kg), Comparative Example 1 group (5 mg / kg), Comparative Example 2 group (5 mg / kg), Comparative Example 3 group (5 mg / kg), and Comparative Example 4 group (5 mg / kg). Twenty minutes after gavage administration, sodium pentobarbital (40 mg / kg) was administered intraperitoneally. The disappearance of the righting reflex was used as the indicator of sleep onset. The time from the disappearance to the restoration of the righting reflex was defined as sleep time. The experiment was conducted in a quiet, room-temperature environment, starting at 8:00 AM.

[0059] Experimental results: Gavage administration of the 3rd group (5 mg / kg) to mice could prolong the sleep time induced by sodium pentobarbital 40 mg / kg. Specific data are shown in Table 3 below.

[0060] Table 3 Sleep Duration Statistics

[0061] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A composition for treating insomnia and improving sleep quality, characterized by comprising, The raw materials of the composition are composed of the following ingredients by weight: Baihe 1-20 parts, Dangshen 1-20 parts, Huangqi 1-20 parts, Huangjing 1-20 parts, Suanzaoren extract 1-12 parts, melatonin 0.02-0.2 parts and vitamin B6 0.03-0.6 parts.

2. The composition for treating insomnia and improving sleep quality according to claim 1, wherein The raw materials of the composition are composed of the following ingredients by weight: Baihe 2-14 parts, Dangshen 3-15 parts, Huangqi 2-12 parts, Huangjing 2-11 parts, Suanzaoren extract 3-9 parts, melatonin 0.04-0.14 parts and vitamin B6 0.07-0.4 parts.

3. The composition for treating insomnia and improving sleep quality according to claim 2, wherein The raw materials of the composition are composed of the following ingredients by weight: Baihe 4-8 parts, Dangshen 5-10 parts, Huangqi 4-7 parts, Huangjing 6-10 parts, Suanzaoren extract 4-7 parts, melatonin 0.07-0.11 parts and vitamin B6 0.1-0.3 parts.

4. The composition for treating insomnia and improving sleep quality according to claim 3, wherein The raw materials of the composition are composed of the following ingredients by weight: Baihe 6 parts, Dangshen 8 parts, Huangqi 6 parts, Huangjing 8 parts, Suanzaoren extract 5 parts, melatonin 0.08 parts and vitamin B6 0.15 parts.

5. The composition for treating insomnia and improving sleep quality according to claim 1, wherein The Suanzaoren extract is prepared by the following method: Step S1: Suanzaoren is crushed to pass through a 40-mesh sieve, heated extraction is performed with distilled water, concentrated to a solution with a density of 1.25 g / ml, 8 times the volume of 95% ethanol is added, and the supernatant is dried under reduced pressure to obtain a Suanzaoren crude extract; Step S2: The Suanzaoren crude extract obtained in step S1 is loaded onto a macroporous resin column, and gradient elution is performed with ethanol aqueous solutions with volume fractions of 10-25% and 60-75%, respectively, the eluate with a volume fraction of 60-75% ethanol aqueous solution is collected, and the Suanzaoren eluate is dried; Step S3: The Suanzaoren eluate obtained in step S2 is loaded onto a silica gel column, and elution is performed using a mixture system of chloroform, methanol, water and ammonia water, wherein the volume ratio of chloroform:methanol:water:ammonia water is 86:11:3:0.1 and 82:15:3:0.1, respectively, the eluate eluted by the system with a volume ratio of 82:15:3:0.1 is collected, and the Suanzaoren extract is dried.

6. The composition for treating insomnia and improving sleep quality according to claim 5, wherein In the step S1, the conditions for heating extraction with distilled water are as follows: the solid-liquid ratio is 1:8-20, and the extraction time is 1-3 h.

7. The composition for treating insomnia and improving sleep quality according to claim 5, wherein In the step S2, gradient elution is performed with ethanol aqueous solutions with volume fractions of 18% and 67%, respectively, and the eluate eluted by the ethanol aqueous solution with a volume fraction of 67% is collected.

8. A method for the preparation of a composition for the treatment of insomnia and for the improvement of sleep quality, based on the composition for the treatment of insomnia and for the improvement of sleep quality according to any one of claims 1 to 7, characterized in that, The following steps are included: Step 1: Mix Baihe, Dangshen, Huangqi and Huangjing in the formula amount to obtain a mixture; Step 2: Mix the obtained mixture with a solvent, extract, combine the extract, and concentrate and dry to obtain an extract; Step 3: Mix the obtained extract with Suanzaoren extract, melatonin and vitamin B6 in the formula amount to obtain a composition for treating insomnia and improving sleep quality.

9. The method for preparing the composition for treating insomnia and improving sleep quality according to claim 8, characterized in that, In the step 2, the solvent is water or an ethanol aqueous solution; The extraction conditions are as follows: the solid-liquid mass ratio is 1:6-12, the extraction time is 0.5-3 h, and the extraction is performed 1-3 times.

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