Application of sphallerocarpus gracilis extract in preparation of medicine or healthy food for improving sleep quality

The preparation and purification of ginseng alcohol extract has solved the problems of dependence and side effects of chemical drug treatment for insomnia, and provided a safe and effective natural drug or health food to improve sleep quality. By increasing the levels of 5-hydroxytryptamine and γ-aminobutyric acid in the brain, it achieves higher safety and efficacy.

CN121154699APending Publication Date: 2025-12-19YUNNAN UNIVERSITY OF CHINESE MEDICINE
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Patent Information

Application Number
CN202511593311.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-11-03
Publication Date
2025-12-19

AI Technical Summary

Technical Problem

In existing technologies, chemical drug treatments for insomnia have the problems of dependence, drug resistance, and side effects, while there is insufficient in-depth research and application of natural plants in improving sleep quality.

Method used

By using extracts of Codonopsis pilosula, especially alcoholic extracts, through alcohol solvent extraction and purification steps such as petroleum ether, ethyl acetate, and n-butanol extraction, drugs or health foods that improve sleep quality can be prepared, thereby increasing the levels of 5-hydroxytryptamine and γ-aminobutyric acid in the brain.

Benefits of technology

The extract of Codonopsis pilosula can effectively shorten the sleep latency, prolong sleep time, and improve the sleep onset rate. Its mechanism of action is different from that of traditional sleeping pills, and it has higher safety and no potential toxic side effects of chemically synthesized drugs.

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Abstract

The invention discloses an application of an extract of sphallerocarpus gracilis (dried root of Crassulaceae plant Sedum aizoon L. Sedum aizoon L.) in preparation of a medicine or a healthy food for improving sleep quality. The extract is an alcohol extract of sphallerocarpus gracilis, is preferably extracted by an alcohol solvent (such as ethanol), and can be further obtained by fractional extraction and purification of petroleum ether, ethyl acetate and n-butyl alcohol. The extract can effectively shorten the sleep latency, prolong the sleep time and improve the sleep rate, and the action mechanism of the extract is related to the increase of the levels of 5-HT and GABA in the brain. The invention provides a new choice for developing natural and safe medicines for improving sleep.
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Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, specifically to the application of a ginseng extract in the preparation of drugs or health foods that improve sleep quality. Background Technology

[0002] Sleep is a vital physiological process for the human body, and good sleep is crucial for maintaining physical and mental health. With the accelerating pace of society and increasing life pressures, the incidence of sleep disorders such as insomnia is rising year by year, becoming a common problem affecting human health. Currently, the main treatments for insomnia both domestically and internationally rely on chemical and biological drugs. While these drugs can effectively improve some sleep indicators, their side effects, such as dependence, drug tolerance, memory loss, and daytime sleepiness, can disrupt the body's endocrine homeostasis and pose certain risks. In contrast, natural medicinal plants such as jujube seed, cypress seed, and polygala root have fewer side effects and can comprehensively improve circadian rhythm, sleep quality, and post-wake state, showing promising application prospects.

[0003] Therefore, developing sleep-improving drugs or health foods derived from natural plants that are safe and have few side effects has become a current research hotspot. *Sedum aizoon* is a plant belonging to the Crassulaceae family. Sedum aizoon The dried root of L. First recorded in "Diannan Materia Medica": "It is used to nourish the five internal organs, calm the mind, stop palpitations, and improve eyesight..." Current research on the natural plant Sedum aizoon focuses primarily on the application of its above-ground parts (whole herb) in hemostasis and anti-inflammation, while in-depth research and application of its root (Huangshen), especially its specific extracts, in improving sleep quality have not yet been reported. Summary of the Invention

[0004] To address the problems in the prior art, this invention provides an application of ginseng extract in the preparation of drugs or health foods that improve sleep quality.

[0005] Technical solution of the present invention To achieve the above objectives, the present invention adopts the following technical solution: First, the present invention provides the application of ginseng extract in the preparation of medicines or health foods that improve sleep quality, wherein the extract is an alcoholic extract of ginseng.

[0006] Huangshen is a plant of the Crassulaceae family called Sedum aizoon. Sedum aizoon The dried root of L. Its source plant is Sedum aizoon. Sedum aizoon L. is an important plant used for both food and medicine, and has a long history of use in Chinese folk medicine.

[0007] Preferably, the extract is prepared by the following method: taking the powder of Huangjian, extracting with an alcohol solvent, filtering to obtain an extract, concentrating the extract to an alcohol content of 35% to 40%, adding 1 to 1.5 times water to precipitate, filtering, concentrating the filtrate, and drying to obtain the alcohol extract.

[0008] Further preferably, the alcohol solvent is a methanol or ethanol aqueous solvent with a volume concentration of 75% to 80%. More preferably, it is ethanol, which is highly safe and suitable for use in pharmaceuticals and food.

[0009] Further preferably, when the alcohol solvent is extracted, 8 to 10 L of the alcohol solvent is added per kg of medicinal material.

[0010] Further preferably, the extraction method can be selected from immersion extraction, hot reflux extraction, ultrasonic extraction, or any combination of two thereof, and preferably hot reflux extraction to improve the extraction efficiency.

[0011] Further preferably, the standing precipitation time is 12 to 14 h, and the temperature is 2 to 8°C.

[0012] In a more preferred embodiment, the preparation method further comprises the following purification steps: dissolving the alcohol extract obtained above in water, then extracting with petroleum ether to remove fat-soluble impurities, collecting the aqueous phase; adding ethyl acetate to the aqueous phase to further remove moderately polar impurities, collecting the aqueous phase; and finally, adding n-butanol to the aqueous phase, the active ingredients in Huangjian that are related to improving sleep are mainly enriched in the n-butanol fraction, collecting the n-butanol fraction and concentrating under reduced pressure, and drying to obtain the Huangjian extract.

[0013] Further preferably, in the purification step, the amount of water used for dissolving the alcohol extract is 5 to 6 times the mass of the alcohol extract; the volume of petroleum ether, ethyl acetate, and n-butanol used for extraction is 0.5 to 1 times the volume of the water used for dissolving, respectively; and each solvent is extracted 3 to 4 times to ensure sufficient extraction and separation.

[0014] The drug can shorten the sleep latency, prolong the sleep time, and improve the sleep rate. The drug can increase the levels of 5-hydroxytryptamine (5-HT) and gamma-aminobutyric acid (GABA) in the brain.

[0015] Preferably, the drug further comprises a pharmaceutically acceptable pharmaceutical excipient.

[0016] Preferably, the pharmaceutically acceptable adjuvant includes any one of or a combination of at least two of a sustained-release agent, an excipient, a filler, a binder, a humectant, a disintegrant, an absorption enhancer, a surfactant, a lubricant, for example, a combination of a binder and an excipient, a combination of a binder and a flavoring agent, a combination of a binder and a filler, and the like, and any other combination can be selected, which will not be described herein.

[0017] Preferably, the pharmaceutical dosage form is a tablet, a capsule, a granule, an injection, an oral liquid, a pill, a paste, a suspension, a dispersion, a syrup, an aerosol, or a patch.

[0018] Finally, the present application provides use of the extract of Huangjian in preparation of a 5-hydroxytryptamine (5-HT) and gamma-aminobutyric acid (GABA) activator, wherein the extract of Huangjian is an n-butanol extract part obtained by sequentially extracting the Huangjian with petroleum ether, ethyl acetate, and n-butanol.

[0019] The present application has the following advantages: The present application first discovers and confirms that the alcohol extract of Huangjian, especially the extract enriched in the n-butanol part, has an excellent effect of improving sleep quality, thereby providing a new direction and material basis for developing a new type of natural sleep aid product. The extract of the present application can effectively shorten the sleep latency, prolong the sleep time, and increase the sleep rate, as proved by animal experiments. The extract can play a role of central sedation and sleep improvement by increasing the levels of inhibitory neurotransmitter GABA and 5-HT related to sleep and emotion in the brain, and the mechanism of action is different from that of traditional sleeping pills, and is possibly safer. The raw material of the present application is derived from traditional Chinese medicinal materials, and the extraction process is simple, and safe solvents such as ethanol are used, thereby avoiding the potential toxic side effects and dependence risks of chemically synthesized drugs. The extraction and purification method provided by the present application has clear steps and definite parameters, and is easy to realize standardized production and quality control. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 Table 1 is the experimental results of the effects of the alcohol extract and the water extract of Huangjian on the sleep quality of mice (“*” represents P<0.05 compared with the normal group, “**” represents P<0.01 compared with the normal group, and “***” represents P<0.001 compared with the normal group); Figure 2 Table 2 is the experimental results of the effects of the alcohol extract of Huangjian and different extract parts thereof on the sleep quality of mice (“*” represents P<0.05 compared with the normal group, “**” represents P<0.01 compared with the normal group, and “***” represents P<0.001 compared with the normal group); Figure 3Figure 2 is a diagram of the moving distance and average moving speed of mice in the open field test with the Huangjian extract (n-butanol extraction part) ("*" indicates P<0.05 compared with the model group, "**" indicates P<0.01 compared with the model group, "***" indicates P<0.001 compared with the model group); Figure 4 Figure 4 is the result of the effect of the Huangjian extract (n-butanol extraction part) on the sleep latency and sleep time of mice ("*" indicates P<0.05 compared with the model group, "**" indicates P<0.01 compared with the model group, "***" indicates P<0.001 compared with the model group); Figure 5 Figure 5 is the level of 5-HT and the level of GABA in the hypothalamus of mice with the Huangjian extract (n-butanol extraction part) ("*" indicates P<0.05 compared with the model group, "**" indicates P<0.01 compared with the model group, "***" indicates P<0.001 compared with the model group). DETAILED DESCRIPTION

[0021] The present application will be further described in detail below with reference to the accompanying drawings and examples, but in no way limits the present application, any transformation or improvement based on the teaching of the present application falls within the protection scope of the present application.

[0022] The process, conditions, reagents, experimental methods, etc. for implementing the present application, except for the following specifically mentioned contents, are the general knowledge and common sense in the art, and the present application has no special limitation. The experimental methods not specified in the specific conditions in each example are usually according to the conventional conditions or according to the conditions suggested by the manufacturer.

[0023] Unless otherwise specified, the meanings of all professional terms and scientific terms used in the present specification are the same as those generally understood by the person skilled in the art to which the present application belongs. However, if there is a conflict, the present specification including the definition shall prevail.

[0024] The following are the main raw material sources in the examples: The Huangjian is collected from Wufeng Town (Center: 104.893827° 27.439132°, elevation: 1960.18m) of Zhenxiong County, Zhaotong City, Yunnan Province, and identified by the senior engineer Qiu Bin of Yunnan University of Chinese Medicine as the Sedum lineare of Crassulaceae Sedum aizoon L. roots.

[0025] Example 1 The Huangjian medicinal material was weighed, crushed to 20-30 mesh, extracted with 10 times the amount of 75% ethanol by continuous reflux for 2 times, 1.5 h each time, filtered with gauze, and the filtrates of the two times were combined. The filtrate was concentrated under reduced pressure to 40% alcohol content, allowed to cool, and 1 times the amount of distilled water was slowly added. Then the filtrate was allowed to stand at 4°C for 14 h. After the standing was completed, the precipitate was centrifuged and filtered (4°C, 3000 rpm, 10 min), and then the filtrate was concentrated under reduced pressure until the ethanol was completely removed, followed by freeze-drying to obtain the Huangjian extract.

[0026] Example 2 A portion of the Huangjian alcohol extract obtained in Example 1 was taken, 5 times the amount of distilled water was added, and it was stirred to dissolve or disperse completely. The obtained aqueous solution was transferred to a separatory funnel, extracted with petroleum ether once by volume, and then extracted 3 times by volume ratio 1:0.5, and the petroleum ether layer was discarded, and the water phase was collected. To the water phase, an equal volume of ethyl acetate was added and extracted 3 times, and the ethyl acetate layer was discarded, and the water phase was collected. Finally, an equal volume of n-butanol was added to the water phase and extracted 3 times, and all the n-butanol extracts were collected. The n-butanol liquid was concentrated under reduced pressure at 65°C to recover the solvent, dried, and the Huangjian extract was obtained.

[0027] Example 3 The Huangjian medicinal material was weighed, crushed to 20-30 mesh, extracted with 8 times the amount of 80% ethanol by continuous reflux for 3 times, 1.5 h each time, filtered with gauze, and the filtrates of the two times were combined. The filtrate was concentrated under reduced pressure to 35% alcohol content, allowed to cool, and 1.5 times the amount of distilled water was slowly added. Then the filtrate was allowed to stand at 8°C for 12 h. After the standing was completed, the precipitate was centrifuged and filtered (4°C, 3000 rpm, 10 min), and then the filtrate was concentrated under reduced pressure until the ethanol was completely removed, followed by freeze-drying to obtain the Huangjian extract.

[0028] Example 4 A portion of the Huangjian alcohol extract obtained in Example 1 was taken, 6 times the amount of distilled water was added, and it was stirred to dissolve or disperse completely. The obtained aqueous solution was transferred to a separatory funnel, extracted with petroleum ether once by volume, and then extracted 3 times by volume ratio 1:0.5, and the petroleum ether layer was discarded, and the water phase was collected. To the water phase, an equal volume of ethyl acetate was added and extracted 3 times, and the ethyl acetate layer was discarded, and the water phase was collected. Finally, an equal volume of n-butanol was added to the water phase and extracted 4 times, and all the n-butanol extracts were collected. The n-butanol liquid was concentrated under reduced pressure at 65°C to recover the solvent, dried, and the Huangjian extract was obtained.

[0029] Comparative Example 1 The prepared Huangjian medicine is crushed to 20-30 meshes, extracted with 10 times of pure water by continuous reflux extraction for 2 times, 1.5 h each time, filtered with gauze, and the filtrates of the two times are combined. The combined filtrate is concentrated under reduced pressure to a proper volume, 1 times of distilled water is slowly added after the filtrate is cooled, and then the filtrate is placed at 4°C for 14 h. After the placement is completed, the precipitate is centrifuged and filtered (4°C, 3000 r / min, 10 min), and then the filtrate is concentrated under reduced pressure to a proper volume and then freeze-dried to obtain the Huangjian water extract.

[0030] Comparative Example 2 The petroleum ether layer in Example 2 is concentrated and dried to obtain a petroleum ether extract.

[0031] Comparative Example 3 The ethyl acetate layer in Example 2 is concentrated and dried to obtain an ethyl acetate extract.

[0032] Comparative Example 4 The water phase part after the n-butanol extraction in Example 2 is concentrated and dried to obtain a polar extract.

[0033] Test Example 1 Pharmacodynamic experiment of sleep improvement effect 1. Experiment of influence of alcohol extract and water extract on sleep quality of mice 96 ICR species mice of 6-8 weeks old are taken, adaptively fed for 5 days, and then randomly divided into 8 groups according to the body weight, 12 mice in each group, which are normal group, positive group (diazepam 2 mg / kg), water extract low (3.9 g / kg), medium (7.8 g / kg), high (15.6 g / kg) dose groups prepared according to Comparative Example 1, alcohol extract low (3.9 g / kg), medium (7.8 g / kg), high (15.6 g / kg) dose groups prepared according to Example 1, the dose of the water extract and the alcohol extract is calculated by the crude drug amount, the normal group is given physiological saline by gavage, and the rest of the groups are given corresponding drugs by gavage, the volume of the drugs is 0.2 mL / 10 g, 1 time / d, and the drugs are continuously given for 8 d.

[0034] The pentobarbital sodium sleep time experiment of the mice is performed on the 7th day of the drug administration: the mice in each group start the experiment 30 min after the last gavage administration. The pre-experiment is performed to determine the pentobarbital sodium dose (55 mg / kg) that can make all the mice fall asleep, but not too long. The pentobarbital sodium solution (10 mL / kg BW) is absorbed according to the corresponding mouse weight, and the timing starts after the intraperitoneal injection. The pentobarbital sodium solution is injected to the mice in each group, and the sleep condition of the mice is observed with the disappearance of the righting reflex as the index, and the sleep latency and sleep time of each mouse are recorded.

[0035] The threshold hypnotic experiment of sodium pentobarbital was performed on the 8th day of administration: the test was performed 30 min after the last gavage of each group of mice. The maximum threshold dose of sodium pentobarbital (35 mg / kg) that made 80%-90% of mice not lose righting reflex was determined by pre-experiment. Sodium pentobarbital solution (10 mL / kg BW) was prepared according to the weight of the mice, and the timing started after intraperitoneal injection. Sodium pentobarbital solution was injected to each group of mice, and the disappearance of righting reflex was used as an indicator to observe the sleep of mice and record the number of mice in each group that entered sleep state within 30 min.

[0036] The experimental data were statistically analyzed by SPSS 27.0 (IBM) software. GraphPad Prism 10.0 (GraphPad Software, Inc.) was used for statistical chart drawing. One-way ANOVA was used for comparison between groups, and Dunnet-t test was used for further analysis when there was a difference between groups. The results in the statistical table are expressed as mean ± standard error.

[0037] The experimental results are shown in Table 1 and Figure 1 The results show that the sleep latency of the alcohol extract group is shorter than that of the water extract group, the sleep time is longer than that of the water extract group, and the sleep rate is larger than that of the water extract group, indicating that the alcohol extract of Huangshen improves sleep quality better than the water extract of Huangshen.

[0038] Table 1 Number of mice in sleep in the comparison experiment of pharmacodynamics of water extract and alcohol extract of Huangshen

[0039] 2. Effect of Huangshen alcohol extract and its different extract fractions on sleep quality of mice Take 84 ICR mice of 6-8 weeks old, adaptively feed for 5 days, and then randomly divide them into 7 groups, namely normal group, positive group (diazepam 2 mg / kg), alcohol extract group prepared in Example 1 (crude drug 3.9 g / kg), petroleum ether extract group prepared in Comparative Example 2 (crude drug 3.9 g / kg), ethyl acetate extract group prepared in Comparative Example 3 (crude drug 3.9 g / kg), n-butanol extract group prepared in Example 2 (crude drug 3.9 g / kg), and polar extract group prepared in Comparative Example 4 (crude drug 3.9 g / kg), 12 mice in each group. The normal group was given physiological saline by gavage, and the other groups were given corresponding drugs by gavage, with a drug volume of 0.2 mL / 10 g, once a day, for 8 consecutive days.

[0040] The prolonged pentobarbital sodium mouse sleep time experiment was performed on the 7th day of administration: the test was started 30 min after the last gavage administration of each group of mice. First, the pre-experiment was performed to determine the pentobarbital sodium dose that made all mice fall asleep but did not make the sleep time too long (55 mg / kg). According to the mouse body weight, pentobarbital sodium solution (10 mL / kg BW) was absorbed, and the timing started after intraperitoneal injection. Each group of mice was injected with pentobarbital sodium solution, and the sleep of the mice was observed with the disappearance of the righting reflex as the index, and the sleep latency and sleep time of each mouse were recorded.

[0041] The subthreshold dose of pentobarbital sodium sleep experiment was performed on the 8th day of administration: the test was performed 30 min after the last gavage of each group of mice. First, the pre-experiment was performed to determine the maximum subthreshold dose of pentobarbital sodium that made 80% to 90% of the mice not disappear (35 mg / kg). According to the mouse body weight, pentobarbital sodium solution (10 mL / kg BW) was absorbed, and the timing started after intraperitoneal injection. Each group of mice was injected with pentobarbital sodium solution, and the sleep of the mice was observed with the disappearance of the righting reflex as the index, and the number of mice in each group that entered sleep within 30 min was recorded.

[0042] The data obtained in the experiment were statistically analyzed using SPSS 27.0 (IBM) software. GraphPad Prism 10.0 (GraphPad Software, Inc.) was used for statistical chart drawing. One-way ANOVA was used for comparison between groups, and Dunnet-t test was used for further analysis of groups with differences. The results in the statistical table are expressed as mean ± standard error.

[0043] The results are shown in Table 2 and Figure 2 The results showed that the n-butanol extract group had a shorter sleep latency, a longer sleep time, and a higher sleep rate compared with the petroleum ether extract group, the ethyl acetate extract group, the polar extract group, and the alcohol extract group. This indicated that the activity of the n-butanol extract fraction was significantly higher than that of the alcohol extract after extraction with petroleum ether, ethyl acetate, and n-butanol in turn, which indicated that the extraction method enriched the active substances that improved sleep quality.

[0044] Table 2 Number of mice in sleep comparison experiment of Huangshen alcohol extract and its different extract fractions

[0045] Test Example 2 Mechanism of Action ICR male mice aged 6-8 weeks were randomly divided into groups according to statistics after adaptive feeding for 7 days. Each group contained 12 mice. The mice were divided into a blank group, a model group, a positive group (diazepam 2 mg / kg), a low, medium and high dose group of the extract of Huangqin (n-butanol extract part) prepared in Example 2 (in the amount of crude drugs, the dosages were: low 1.95 g / kg, medium 3.9 g / kg, and high 7.8 g / kg), and a medium dose of the extract of Huangqin (n-butanol extract part) plus sugar administration group (the sugar administration group was to exclude whether the bitter and astringent taste of Huangqin affected the mice). Except for the normal group, the mice in the other groups were stimulated in a random manner once a day for 2 weeks. The stimulation methods included fasting for 24 h, wet bedding for 24 h, fasting for 24 h, mouse cage inclined at 45° for 24 h, 4℃ ice water swimming for 5 min, tail clamping for 1 min, and binding for 2 h. Different methods were performed once every 2 days. Starting from the 15th day, the normal group was intraperitoneally injected with normal saline every morning, and the mice in the other groups were injected with p-chlorophenylalanine (PCPA 350 mg / kg) for 2 consecutive days. Starting from the 17th day, the normal group and the model group were administered with normal saline by gavage, and the mice in the other groups were administered with the corresponding drugs by gavage. The administration volume was 0.2 ml / 10 g, once a day, and the administration was continuously performed for 8 days. The open field test was performed on the 7th day of continuous administration, i.e. 30 min after the last administration on the 7th day, the mice were placed in the center of the open field reaction box, and the total movement distance and average moving speed of the mice within 5 min were collected by using a mouse open field activity test system. The experiment was performed in a quiet and stable light environment. After the experiment of each mouse, the inner wall and bottom surface of the square box were wiped with 75% ethanol to prevent leaving odors and excrement, etc. Subsequently, the data were analyzed by using animal behavior analysis software. The pentobarbital sodium sleep test was performed on the 8th day of continuous administration, i.e. 30 min after the last gavage on the 8th day, the mice were intraperitoneally injected with pentobarbital sodium solution (55 mg / kg, which was the dose determined in the pre-experiment to make the mice fall asleep completely, but not too long). The injection volume was 10 ml / kg, and the timing started after the injection. The mice in each group were injected with pentobarbital sodium solution, and the disappearance of the righting reflex was taken as the index. The sleep latency and sleep time of each mouse were recorded. 30 min after the last gavage on the 9th day of continuous administration, the mice were intraperitoneally injected with 2% pentobarbital sodium (40 mg / kg, prepared with 0.9% sodium chloride solution) for anesthesia. The brain tissue of the mice was dissected on ice, the hypothalamus of the mice was separated, and the mice hypothalamus was ground according to the ratio of hypothalamus (g): PBS (ml)=1:9. The centrifugation was performed at 4℃ and 5000 r for 10 min, and the supernatant was extracted. The levels of 5-HT and GABA in the mouse hypothalamus were measured by using an enzyme-linked immunosorbent assay kit.

[0046] The experimental data were statistically analyzed by SPSS 27.0 (IBM) software. GraphPad Prism 10.0 (GraphPad Software, Inc.) was used for statistical graphing. One-way ANOVA was used for comparison between groups, and Dunnet-t test was used for further analysis of groups with differences. The results in the statistical table are expressed as mean ± standard error.

[0047] 1. The results of the open field experiment are shown in Figure 3 Compared with the normal group, the activity distance and average speed of the model group mice were significantly increased (P<0.05, P<0.05); compared with the model group, the activity distance and average speed of the positive group mice were significantly reduced (P<0.01, P<0.01); compared with the model group, the activity distance of the low, medium and high dose groups of Huangshen extract (n-butanol extraction part) and the medium dose group with sugar administration was significantly reduced (P<0.01, P<0.001, P<0.001, P<0.001), and the average speed was significantly reduced (P<0.01, P<0.001, P<0.001, P<0.001). The results showed that Huangshen extract had a sedative effect.

[0048] 2. The results of the pentobarbital sodium sleep time extension experiment are shown in Figure 4 Compared with the normal group, the sleep latency of the model group mice was significantly shortened, and the sleep time was significantly prolonged (p<0.05, p<0.01); compared with the model group, the sleep latency of the positive group mice was significantly shortened, and the sleep time was significantly prolonged (p<0.001, p<0.001); compared with the model group, the sleep latency of the low, medium and high dose groups of Huangshen extract (n-butanol extraction part) and the medium dose group with sugar administration was significantly shortened (P<0.01, P<0.001, P<0.001, P<0.001), and the sleep time was significantly prolonged (P<0.05, P<0.001, P<0.001, P<0.001). There was no significant difference in sleep latency and sleep time between the medium dose group of Huangshen extract (n-butanol extraction part) and the medium dose group with sugar administration, indicating that the bitter and astringent taste of Huangshen did not affect the mice. The above results showed that Huangshen extract could synergize with pentobarbital sodium to exert a sedative effect.

[0049] 3. The effect on neurotransmitters in the brain of mice is shown in Figure 5Compared with the normal group, the levels of 5-HT and GABA in the hypothalamus of the model group were significantly decreased (P<0.01, P<0.05); compared with the model group, the levels of 5-HT and GABA in the hypothalamus of the positive group were significantly increased (P<0.01, P<0.05), the levels of GABA in the hypothalamus of the low, medium and high dose groups of the Xanthium extract (n-butanol extraction part) and the medium dose group of the Xanthium extract (n-butanol extraction part) plus sugar were significantly increased (P<0.001, P<0.001, P<0.001, P<0.01), and the levels of 5-HT in the hypothalamus of the low, medium and high dose groups of the Xanthium extract (n-butanol extraction part) were significantly increased (P<0.05, P<0.05, P<0.05, P<0.05). The results show that the Xanthium extract can increase the inhibitory neurotransmitter in the brain of the mice and improve the sleep quality of the mice.

[0050] Finally, it should be noted that: the above examples are only used to illustrate the technical solutions of the present application, but not to limit it; although the present application has been described in detail with reference to the foregoing examples, those skilled in the art should understand that: it can still modify the technical solutions recorded in the foregoing examples, or make equivalent replacement for part of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. Use of a Scutellaria baicalensis Georgi extract in the preparation of a drug or health food for improving sleep quality, characterized in that, The extract is an alcohol extract of the Huangjian.

2. Use according to claim 1, characterized in that, The Huangjian extract is prepared by the following method: Huangjian is pulverized, extracted with an alcohol solvent, filtered to obtain an extract, the extract is concentrated to an alcohol content of 35-40%, 1-1.5 times water is added and allowed to stand to precipitate, filtered, the filtrate is concentrated, dried, and the alcohol extract is obtained.

3. Use according to claim 2, characterized in that, The alcohol solvent is a methanol or ethanol aqueous solvent with a volume concentration of 75-80%.

4. Use according to claim 2, characterized in that, The alcohol solvent extraction is performed by adding 8-10 L of alcohol solvent per kg of medicinal material.

5. The use according to claim 2, characterized in that, The extraction method can be selected from immersion extraction, hot reflux extraction, ultrasonic extraction, or any two combinations thereof.

6. Use according to claim 2, characterized in that, The preparation method further comprises the following purification steps: the alcohol extract is dissolved in water, extracted with petroleum ether, the aqueous phase portion is collected, extracted with ethyl acetate, the aqueous phase portion is collected, extracted with n-butanol, the n-butanol portion is collected, and concentrated under reduced pressure to obtain the Huangjian extract.

7. Use according to claim 6, characterized in that, The amount of water used to dissolve the alcohol extract is 5-6 times the mass of the alcohol extract, the volume of petroleum ether, ethyl acetate, and n-butanol used for extraction is 0.5-1 times the volume of the water used for dissolution, and each solvent is extracted 3-4 times.

8. Use according to any one of claims 1 to 6, characterized in that, The drug can shorten sleep latency, prolong sleep time, and improve sleep rate.

9. Use according to any one of claims 1 to 6, characterized in that, The drug increases the levels of 5-HT and GABA in the brain.

10. Use of a Scutellaria baicalensis extract for the preparation of 5-hydroxytryptamine and gamma-aminobutyric acid activators, characterized in that, The Huangjian extract is an alcohol extract of Huangjian, and the n-butanol extraction portion obtained after sequential extraction with petroleum ether, ethyl acetate, and n-butanol.