Traditional Chinese medicine composition for improving sleep quality and preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for improving sleep quality and a preparation method and application thereof, and belongs to the technical field of heating non-combustion device liquid medicine. Comprising the following raw materials in parts by weight: 6-12 parts of rhizoma coptidis, 1-3 parts of cortex cinnamomi, 10-20 parts of fried semen ziziphi spinosae, 5-10 parts of beta-cyclodextrin, 5-7 parts of modified porous silicon dioxide hollow spheres, 3-5 parts of n-docosane, 0.5-1 part of borneol, 0.5-1 part of menthol, 3-5 parts of lecithin, 1-3 parts of essence, 75-85 parts of an atomizing agent and 2-3 parts of a sweetening agent. The modified porous silicon dioxide hollow spheres are porous silicon dioxide hollow spheres with amino groups on the surfaces. The defects of large amount, bitter taste and instability are overcome through the modern preparation technology, the ancient classical famous formula traditional Chinese medicine compound preparation is prepared, and the traditional Chinese medicine compound preparation has good storage performance, can achieve controlled release, is good in medicine effect, has the fast somnolence entering and refreshing body feeling and improves patient compliance.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for improving sleep quality, its preparation method, and its application. Background Technology

[0002] The concept of wakefulness and sleep refers to the vital phenomena of human life. Disorders of wakefulness and sleep are a common clinical condition, encompassing insomnia, hypersomnia, and restless sleep. It can be both a symptom and a disease. The *Huangdi Neijing* (Yellow Emperor's Inner Classic) mentions terms such as "inability to sleep," "eyes unable to close," "inability to lie down," "restless sleep," "frequent sleep," "excessive sleep," and "little sleep." Modern medicine refers to this as "sleep disorder." The *Huangdi Neijing* has developed a relatively systematic theory regarding the physiological mechanisms of wakefulness and sleep, explaining the etiology and pathogenesis of these disorders from multiple perspectives. These theories provide important guidance for the treatment of insomnia and hypersomnia, as well as for daily health maintenance.

[0003] With the increasingly fast pace and fierce competition of modern life, insomnia has become a common ailment. Its main symptoms include difficulty falling asleep, poor sleep quality, decreased memory, reduced attention, and decreased work capacity, severely impacting people's quality of life. Currently, most medications for treating insomnia are sedative-hypnotic drugs. Elderly people are particularly prone to insomnia, but current medical treatments largely rely on Western medicine. While these medications can alleviate insomnia, many have numerous toxic side effects, and insomnia is prone to relapse after discontinuation. Furthermore, the weakened immune systems of the elderly may lead to further decline in memory and immunity when taking Western medications.

[0004] Although traditional Chinese medicine decoctions hold an important place in TCM treatment, they do have shortcomings in practical application. For example, large doses are inconvenient to take, the active ingredients of some drugs are difficult to extract or easily volatilize and dissipate, storage and carrying are difficult, the effective ingredient content is low, preparation is difficult, and further promotion and application are not convenient. These shortcomings may affect patient compliance and treatment efficacy. Therefore, in modern medical practice, how to improve the preparation and administration of traditional Chinese medicine decoctions, and how to better preserve and leverage their traditional advantages to develop a class of innovative TCM drugs, are important issues facing the development of TCM. Traditional sedative-hypnotics are drugs that inhibit the central nervous system. They do have value in relieving patients' tension, anxiety, and insomnia symptoms, as well as in anticonvulsant and antiepileptic effects. However, long-term use of these drugs, such as zolpidem tartrate, estazolam, triazolam, and zopiclone, almost all have varying degrees of harmful side effects. Summary of the Invention

[0005] The purpose of this invention is to propose a traditional Chinese medicine composition for improving sleep quality, its preparation method and application. By using modern pharmaceutical technology, the defects of "large quantity, bitter taste and instability" are solved, and a compound preparation of traditional Chinese medicine based on ancient classic prescriptions is prepared. It has good storage properties, can achieve controlled release, has good efficacy, and provides a feeling of fast sleep onset and refreshing wake-up, which improves patient compliance and is safe and has no side effects.

[0006] The technical solution of this invention is implemented as follows: This invention provides a traditional Chinese medicine composition for improving sleep quality, comprising the following raw materials in parts by weight: 6-12 parts Coptis chinensis, 1-3 parts Cinnamomum cassia, 10-20 parts roasted Ziziphus jujuba var. spinosa, 5-10 parts β-cyclodextrin, 5-7 parts modified porous silica hollow spheres, 3-5 parts n-docosahexadecane, 0.5-1 part borneol, 0.5-1 part menthol, 3-5 parts lecithin, 1-3 parts flavoring, 75-85 parts atomizing agent, and 2-3 parts sweetener, wherein the modified porous silica hollow spheres are porous silica hollow spheres with amino groups on their surface.

[0007] This invention further protects a method for preparing the above-mentioned traditional Chinese medicine composition for improving sleep quality, comprising the following steps: S1. Cinnamon is extracted using supercritical fluid extraction to obtain volatile oil, and the residue is collected; S2. Mix the residue, Coptis chinensis, and roasted jujube seeds in low-deuterium water, heat and reflux to extract, add ethanol to precipitate and remove polysaccharides, filter, remove proteins from the filtrate, dry, and obtain a water-soluble extract; Coptis chinensis, cinnamon, and stir-fried jujube seeds are the raw materials of the classic Chinese medicine formula Jiaotai Pill. By using modern pharmaceutical technology, the defects of "large quantity, bitter taste, and instability" have been solved, and a compound preparation of the ancient classic Chinese medicine formula has been made.

[0008] A decrease in deuterium content in water leads to increased solubility and permeability, significantly improving the extraction efficiency of traditional Chinese medicine raw materials and resulting in a marked increase in the content of active substances in the water-soluble extract. This invention employs conventional methods to remove polysaccharides and proteins, thereby obtaining more effective active substances for treating insomnia and improving sleep, thus increasing the content of effective substances and achieving better results.

[0009] The water-soluble extract contains a large amount of alkaloids, and its active groups such as amino and hydroxyl groups can react or combine with the amino and hydroxyl groups on the surface of the modified porous silica hollow spheres, thereby promoting the adsorption of water-soluble extracts by the microspheres.

[0010] S3. Add β-cyclodextrin to water and volatile oil to ethanol. Mix the two solutions, heat and stir, filter, wash, and dry to obtain volatile oil inclusion complex. Traditional heated non-combustible devices directly mix volatile oils with aqueous solutions, often requiring separate packaging or resulting in stratification. This invention encapsulates the volatile oils obtained through supercritical fluid extraction with β-cyclodextrin. This process reduces bitterness and off-flavors, improving sensory effects. Furthermore, it forms a thermally stable inclusion complex, preventing volatile oil loss. Thirdly, the resulting volatile oil inclusion complex exhibits good dispersibility in water, avoiding stratification and complex structures. Fourthly, the volatile oil inclusion complex contains hydroxyl groups on its surface, which can combine with amino or hydroxyl groups on the surface of subsequently prepared modified porous silica hollow spheres. This promotes the encapsulation of the volatile oil inclusion complex by the modified porous silica hollow spheres, resulting in better protection and sustained-release effects.

[0011] S4. Dissolve the emulsifier and pore-forming agent in water to obtain an aqueous phase; mix and dissolve the alkyl ester of orthosilicate and the aminosilane coupling agent in an organic solvent to obtain an oil phase; mix the aqueous phase and the oil phase, emulsify, adjust the pH value, stir the reaction, centrifuge, and dry to obtain modified porous silica hollow spheres; This invention involves a sol-gel reaction between an alkyl orthosilicate ester and an aminosilane coupling agent at the emulsion interface to form hollow spheres with a silica shell. By introducing a pore-forming agent and an emulsifier, mesoporous and macroporous structures can be formed on the shell, respectively. Simultaneously, the emulsifier can also stabilize the emulsion, thereby obtaining modified porous silica hollow spheres with amino groups on the surface. The pores include mesopores with a diameter of 2-20 nm and macropores with a diameter of 50-200 nm. The resulting hollow spheres have a particle size of 1-5 μm, which not only provides excellent dispersion in the drug solution and prevents agglomeration, but also adsorbs a large amount of volatile oil inclusions and water-soluble substances, resulting in a high drug loading rate.

[0012] S5. Modified porous silica hollow spheres, volatile oil inclusion complex and water-soluble extract are mixed and added to water, stirred, filtered, washed, dried, n-dodecane is added, heated and stirred to mix, cooled, ground, and drug-loaded porous silica spheres are obtained. n-Docosane is solid at room temperature, but when heated to a molten state, it fills the pores and interparticle spaces of porous silica, forming a hydrophobic barrier that isolates oxygen and moisture. This improves the retention rate of the alkaloids and reduces the oxidation rate of volatile oils, solving the problem of conventional extracts easily absorbing moisture and deteriorating. In the heating section of the non-combustible heating device, n-Docosane melts and liquefies, pushing the active ingredients within the pores to the surface for vaporization. The amino / hydroxyl groups in the alkaloids can form hydrogen bonds that are stable at low temperatures and reversibly break at high temperatures, achieving a combined physical and chemical controlled release and avoiding sudden release or leakage from physical adsorption.

[0013] S6. Dissolve borneol and menthol in ethanol, evaporate, filter, and obtain eutectic; Borneol / menthol cocrystals, acting as a catalyst, promote the transmucosal absorption of drugs, open the blood-brain barrier, and increase the concentration of active substances such as berberine and cinnamaldehyde in brain tissue, significantly improving drug efficacy and resulting in faster sleep onset and a refreshing wake-up. Simultaneously, borneol and menthol provide a cooling sensation, neutralizing any heat and promoting greater comfort. Preparing cocrystals by mixing borneol and menthol lowers their melting point and allows for simultaneous vaporization of both, producing a synergistic sensory effect.

[0014] S7. Mix drug-loaded porous silica spheres, eutectic, lecithin, fragrance, atomizing agent, and sweetener evenly to obtain a traditional Chinese medicine composition for improving sleep quality.

[0015] The addition of lecithin has two main benefits. First, it can form a composite micelle with drug-loaded porous silica spheres embedded in docosane, solving the problem of hydrophobic aggregation of drug-loaded porous silica spheres in solvent and improving their dispersibility. Second, it forms a pulmonary surfactant-like film during atomization, reducing the surface tension of aerosols and reducing irritation to the oropharyngeal mucosa. The incidence of cough in users is significantly lower than that of traditional Chinese medicine liquids.

[0016] As a further improvement of the present invention, the conditions for supercritical fluid extraction in step S1 are as follows: extraction pressure is 20-22 MPa, extraction temperature is 30-40℃, and CO2 flow rate is 15-25 L / h.

[0017] As a further improvement of the present invention, the solid-liquid ratio of the residue and the deuterium-free water in step S2 is 1:5-10 g / mL, the heating and reflux extraction time is 3-5 h, and the concentration of the deuterium-free water is 50-100 mg / kg.

[0018] As a further improvement of the present invention, the heating and stirring treatment in step S3 is carried out at a temperature of 35-45°C for 1-3 hours.

[0019] As a further improvement of the present invention, the emulsifier in step S4 is selected from at least one of Tween 20, Tween 40, Tween 60, Tween 80, and Tween 85; the pore-forming agent is selected from at least one of ethylene oxide-propylene oxide triblock copolymer PEO20-PPO70-PEO20 and ethylene oxide-propylene oxide triblock copolymer PEO106-PPO70-PEO106; the alkyl orthosilicate is methyl orthosilicate or ethyl orthosilicate; and the aminosilane coupling agent is KH550.

[0020] As a further improvement of the present invention, the mass ratio of the emulsifier, pore-forming agent, alkyl orthosilicate ester and aminosilane coupling agent in step S4 is 1-2:0.1-0.3:5-8:1-2, the emulsification speed is 5000-8000 r / min, the time is 10-20 min, the pH value is adjusted to 10-11, and the stirring reaction time is 8-12 h.

[0021] As a further improvement of the present invention, the heating and stirring temperature in step S5 is 50-60°C, and the cooling temperature is 4-6°C.

[0022] As a further improvement of the present invention, the atomizing agent in step S7 is a mixture of water and propylene glycol in a volume ratio of 1:8-10, and the sweetener is sucralose or erythritol.

[0023] This invention further protects the use of the above-mentioned traditional Chinese medicine composition for improving sleep quality in the preparation of a heat-not-burning medicinal liquid for treating insomnia and improving sleep quality.

[0024] The present invention has the following beneficial effects: 1. By using modern pharmaceutical technology to overcome the shortcomings of "large quantity, bitter taste, and instability", we have produced compound preparations of traditional Chinese medicine based on ancient classic prescriptions. This results in better patient experience and improved patient compliance. It also helps to promote the development of innovative Chinese medicine drugs, improved new Chinese medicine drugs, and compound preparations of traditional Chinese medicine based on ancient classic prescriptions, as well as to improve the quality and efficiency of medical devices.

[0025] 2. This invention employs multi-layer encapsulation technology to protect volatile oils and water-soluble substances, preventing their loss due to volatilization, moisture absorption, oxidation, etc., achieving controlled release through a combination of physical and chemical methods, and avoiding sudden release or leakage from physical adsorption.

[0026] 3. By adding lecithin, this invention improves the dispersibility of drug-loaded porous silica spheres in the drug and reduces adverse reactions such as coughing caused by inhalation, resulting in better efficacy.

[0027] 4. This invention achieves the effects of lowering the melting point and simultaneous vaporization by preparing borneol / menthol cocrystals, which promotes the transmucosal absorption of drugs, increases the distribution concentration of active substances in brain tissue, improves drug efficacy, and provides a faster sleep onset and a refreshing feeling upon waking. Attached Figure Description

[0028] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0029] Figure 1 This is a TEM image of the modified porous silica hollow spheres obtained in step S4 of Example 1. Detailed Implementation

[0030] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] Lecithin: Liquid egg yolk lecithin. Example 1

[0032] This embodiment provides a method for preparing a traditional Chinese medicine composition for improving sleep quality, including the following steps: S1. Extract 1g of cinnamon using supercritical fluid extraction to obtain volatile oil, and collect the residue; The conditions for supercritical fluid extraction are as follows: extraction pressure is 21 MPa, extraction temperature is 35℃, and CO2 flow rate is 20 L / h. S2. The residue obtained in step S1, 6g of Coptis chinensis and 10g of roasted jujube seed were mixed and added to low-deuterium water with a concentration of 70mg / kg. The solid-liquid ratio was 1:8g / mL. The mixture was heated and refluxed for 4h. Ethanol was added to precipitate and remove polysaccharides. The mixture was filtered, and the filtrate was used to remove proteins using conventional methods. The filtrate was dried to obtain a water-soluble extract. S3. Add 5g of β-cyclodextrin to 100mL of water, add the volatile oil obtained in step S1 to 50mL of ethanol, mix the two solutions, heat to 35℃, stir for 2h, filter, wash, and dry to obtain the volatile oil inclusion complex. S4. Dissolve 1g Tween 60 and 0.1g of ethylene oxide-propylene oxide triblock copolymer PEO20-PPO70-PEO20 in 75mL of water to obtain an aqueous phase; mix 5g of methyl orthosilicate and 1g of silane coupling agent KH550 and dissolve in 10mL of toluene to obtain an oil phase; mix the aqueous and oil phases, emulsify at 7000r / min for 15min, adjust the pH to 10-11, stir the reaction for 10h, centrifuge, and dry to obtain modified porous silica hollow spheres. TEM image of the spheres is shown below. Figure 1 As shown in the figure, a hollow structure was obtained with a particle size between 1 and 5 μm. S5. Mix 5g of modified porous silica hollow spheres, the volatile oil inclusion complex obtained in step S3 and the water-soluble extract obtained in step S2, add to 150mL of water, stir, filter, wash, dry, add 3g of n-dodecane, heat to 55℃, stir and mix, cool to 5℃, solidify, grind, and obtain drug-loaded porous silica spheres. S6. Dissolve 0.5g of borneol and 0.5g of menthol in 15mL of ethanol, evaporate, filter, and obtain eutectic. S7. Mix the drug-loaded porous silica spheres obtained in step S5, the eutectic obtained in step S6, 3g lecithin, 1g fragrance, 75g atomizing agent, and 2g sucralose evenly to obtain a traditional Chinese medicine composition for improving sleep quality. The atomizing agent is a mixture of water and propylene glycol in a volume ratio of 1:8. Example 2

[0033] This embodiment provides a method for preparing a traditional Chinese medicine composition for improving sleep quality, including the following steps: S1. Extract 3g of cinnamon using supercritical fluid extraction to obtain volatile oil, and collect the residue; The conditions for supercritical fluid extraction are as follows: extraction pressure is 21 MPa, extraction temperature is 35℃, and CO2 flow rate is 20 L / h. S2. The residue obtained in step S1, 12g of Coptis chinensis and 20g of roasted jujube seeds were mixed and added to low-deuterium water with a concentration of 70mg / kg. The solid-liquid ratio was 1:8g / mL. The mixture was heated and refluxed for 4h. Ethanol was added to precipitate and remove polysaccharides. The mixture was filtered, and the filtrate was used to remove proteins using conventional methods. The filtrate was dried to obtain a water-soluble extract. S3. Add 10g of β-cyclodextrin to 100mL of water, add the volatile oil obtained in step S1 to 50mL of ethanol, mix the two solutions, heat to 35℃, stir for 2h, filter, wash, and dry to obtain the volatile oil inclusion complex. S4. Dissolve 2g Tween 80 and 0.3g of ethylene oxide-propylene oxide triblock copolymer PEO106-PPO70-PEO106 in 75mL of water to obtain an aqueous phase; mix 8g of tetraethyl orthosilicate and 2g of silane coupling agent KH550 and dissolve them in 10mL of toluene to obtain an oil phase; mix the aqueous phase and the oil phase, emulsify at 7000r / min for 15min, adjust the pH to 10-11, stir the reaction for 10h, centrifuge, and dry to obtain modified porous silica hollow spheres; S5. Mix 7g of modified porous silica hollow spheres, the volatile oil inclusion complex obtained in step S3 and the water-soluble extract obtained in step S2, add to 150mL of water, stir, filter, wash, dry, add 5g of n-dodecane, heat to 55℃, stir and mix, cool to 5℃, solidify, grind, and obtain drug-loaded porous silica spheres. S6. Dissolve 1g of borneol and 1g of menthol in 15mL of ethanol, evaporate, filter, and obtain eutectic; S7. Mix the drug-loaded porous silica spheres obtained in step S5, the eutectic obtained in step S6, 5g lecithin, 3g fragrance, 85g atomizing agent, and 3g erythritol evenly to obtain a traditional Chinese medicine composition for improving sleep quality. The atomizing agent is a mixture of water and propylene glycol in a volume ratio of 1:10. Example 3

[0034] This embodiment provides a method for preparing a traditional Chinese medicine composition for improving sleep quality, including the following steps: S1. Extract 2g of cinnamon using supercritical fluid extraction to obtain volatile oil, and collect the residue; The conditions for supercritical fluid extraction are as follows: extraction pressure is 21 MPa, extraction temperature is 35℃, and CO2 flow rate is 20 L / h. S2. The residue obtained in step S1, 9g of Coptis chinensis and 15g of roasted jujube seed were mixed and added to low-deuterium water with a concentration of 70mg / kg. The solid-liquid ratio was 1:8g / mL. The mixture was heated and refluxed for 4h. Ethanol was added to precipitate and remove polysaccharides. The mixture was filtered, and the filtrate was used to remove proteins using conventional methods. The filtrate was dried to obtain a water-soluble extract. S3. Add 7g of β-cyclodextrin to 100mL of water, add the volatile oil obtained in step S1 to 50mL of ethanol, mix the two solutions, heat to 35℃, stir for 2h, filter, wash, and dry to obtain the volatile oil inclusion complex. S4. Dissolve 1.5g Tween 85 and 0.2g ethylene oxide-propylene oxide triblock copolymer PEO20-PPO70-PEO20 in 75mL of water to obtain an aqueous phase; mix 6.5g tetraethyl orthosilicate and 1.5g silane coupling agent KH550 and dissolve in 10mL of toluene to obtain an oil phase; mix the aqueous phase and oil phase, emulsify at 7000r / min for 15min, adjust the pH to 10-11, stir the reaction for 10h, centrifuge, and dry to obtain modified porous silica hollow spheres; S5. Mix 6g of modified porous silica hollow spheres, the volatile oil inclusion complex obtained in step S3 and the water-soluble extract obtained in step S2, add them to 150mL of water, stir, filter, wash, dry, add 4g of n-dodecane, heat to 55℃, stir and mix, cool to 5℃, solidify, grind, and obtain drug-loaded porous silica spheres. S6. Dissolve 0.6g of borneol and 0.7g of menthol in 15mL of ethanol, evaporate, filter, and obtain eutectic. S7. Mix the drug-loaded porous silica spheres obtained in step S5, the eutectic obtained in step S6, 4g lecithin, 2g fragrance, 80g atomizing agent, and 2.5g sucralose evenly to obtain a traditional Chinese medicine composition for improving sleep quality. The atomizing agent is a mixture of water and propylene glycol in a volume ratio of 1:9.

[0035] Comparative Example 1 The only difference from Example 3 is that in step S2, the deuterium water is replaced by deionized water.

[0036] Comparative Example 2 The only difference from Example 3 is that step S3 was not performed, and the volatile oil inclusion complex added in step S5 was replaced by an equal mass of the volatile oil obtained in step S1.

[0037] Comparative Example 3 The only difference from Example 3 is that the silane coupling agent KH550 was not added in step S4.

[0038] Comparative Example 4 The only difference from Example 3 is that n-dosane was not added in step S5, and drug-loaded porous silica spheres were obtained after drying.

[0039] Specifically, 6g of modified porous silica hollow spheres, the volatile oil inclusion complex obtained in step S3, and the water-soluble extract obtained in step S2 were mixed and added to 150mL of water, stirred, filtered, washed, and dried to obtain drug-loaded porous silica spheres.

[0040] Comparative Example 5 The only difference from Example 3 is that in step S6, 0.6g of borneol and 0.7g of menthol are directly mixed.

[0041] Comparative Example 6 The only difference from Example 3 is that lecithin was not added in step S7.

[0042] Test Example 1: Sensory Evaluation Add 1 mL of the traditional Chinese medicine composition for improving sleep quality prepared in Examples 1-3 or Comparative Examples 2-6 to each tobacco cartridge, and label the heated tobacco device. Organize 10 experts with cigarette sensory evaluation qualifications to conduct sensory quality evaluation of the heated tobacco device samples.

[0043] Sensory quality was evaluated using six indicators: smoke volume, aroma, harmony, irritation, off-flavors, and aftertaste (Table 1). Each item was scored in units of 0.5; the weighted average score for each item was calculated separately, accurate to 0.01; the total sensory quality score was expressed as the sum of the weighted average scores of each item, accurate to 0.1.

[0044] Table 1

[0045] 1. Direct testing: The newly prepared traditional Chinese medicine composition for improving sleep quality was tested, and the results are shown in Table 2.

[0046] Table 2 Sensory Evaluation Results (Unit: Score)

[0047] As shown in the table above, the traditional Chinese medicine compositions for improving sleep quality prepared in Examples 1-3 of this invention have high sensory scores. The use of cyclodextrin encapsulation technology and multi-layer encapsulation (SiO2 microsphere adsorption and n-dodecane encapsulation) reduces bitterness, off-flavors, and irritation. The use of borneol / menthol co-crystals improves overall harmony. In Comparative Example 6, the lack of lecithin resulted in uneven dispersion of the drug-loaded microspheres in the e-liquid, leading to a decrease in sensory scores.

[0048] 2. Accelerated testing: The prepared traditional Chinese medicine composition for improving sleep quality was stored at 35°C and 75% RH for 3 months, and then the experiment was conducted. The results are shown in Table 3.

[0049] Table 3 Sensory evaluation results (unit: points)

[0050] As shown in the table above, the traditional Chinese medicine compositions for improving sleep quality prepared in Examples 1-3 of this invention still have high sensory scores after high-temperature and high-humidity storage, which are not much different from the scores of freshly prepared compositions. This indicates that they have good stability and are not easily volatilized, oxidized, or deteriorated. In Comparative Examples 2-4, due to poor encapsulation, volatile oils evaporated, active substances oxidized, and deteriorated, resulting in a significant decrease in scores for off-odors and aromas.

[0051] Test Example 2 SPF-grade female BALB / c mice, weighing 20-22g, were selected and acclimatized for 7 days. They were then randomly divided into four groups: a blank control group, a model group, Example 1-3 groups, and Comparative Example 1-6 groups, with 10 mice in each group. Except for the blank control group, mice in the other groups received an intraperitoneal injection of p-chlorophenylalanine (300mg / kg, 0.1mL / 10g body weight), while mice in the blank control group received an equal volume of physiological saline. Injections were administered once daily for 2 consecutive days to establish a mouse model of insomnia. Successful model establishment was defined as the absence of circadian rhythms, increased daytime activity, extreme sensitivity to sound, tendency to huddle together, and increased aggression.

[0052] After successfully establishing the mouse insomnia model, the traditional Chinese medicine compositions for improving sleep quality prepared in Examples 1-3 and Comparative Examples 1-6 were nebulized using a heater in the environment where the mice in each group were housed. 10 mL of the traditional Chinese medicine composition for improving sleep quality was nebulized twice daily. The normal control group and the model group were nebulized with deionized water. The administration was continued for 7 days.

[0053] 1. Morris water maze experiment After the 7th day of drug administration, the Morris water maze test was conducted. Adaptation training was performed for 5 consecutive days, twice daily. On day 6, a navigation and spatial exploration experiment was conducted. Mice from each group were used sequentially for the water maze test. The Morris water maze consisted of a circular pool and a camera system above the pool. Before the experiment, the pool was divided into four quadrants and marked. A platform was placed in one quadrant. Water was added to the pool, maintained at a temperature of 24-26°C, and the platform was submerged. Mice were placed facing the pool wall, entering one of the four points sequentially. If a mouse could not find a platform within 1 minute, it was guided to the platform and allowed to rest for 1 minute. This was repeated twice daily for 5 days. Testing began on day 6. After completing the above experiment, spatial exploration was conducted. The platform was removed, and the mice were allowed to swim in the pool. The number of times they swam past their original platform was recorded. Mice were then placed one of the four points. If a mouse could not find a platform within 1 minute, it was guided to the platform and allowed to rest for 1 minute. This was repeated twice daily for 5 days. Testing began on day 6. After completing the above experiments, spatial exploration was conducted by removing the platform and allowing the mice to swim in a pool. The number of times the mice swam across the original platform was recorded.

[0054] The results are shown in Table 4.

[0055] Table 4

[0056] Note: # indicates P < 0.05 compared to the blank control group; Compared with the model group, P < 0.05.

[0057] As shown in the table above, the traditional Chinese medicine compositions for improving sleep quality prepared in Examples 1-3 of this invention can significantly reduce the escape latency of mice, and significantly increase the number of times they cross the platform and the activity time in the target quadrant.

[0058] 2. Sodium pentobarbital-induced sleep experiment A pentobarbital sodium-induced sleep experiment was conducted. One hour after the last administration, mice in each group were intraperitoneally injected with 40 mg / kg of pentobarbital sodium. The sleep latency (time from intraperitoneal injection of pentobarbital sodium to the disappearance of the righting reflex) and sleep duration (time from the disappearance of the righting reflex to the recovery of the righting reflex) were observed and recorded.

[0059] The results are shown in Table 5.

[0060] Table 5

[0061] Note: # indicates P < 0.05 compared to the blank control group; Compared with the model group, P < 0.05.

[0062] As shown in the table above, the traditional Chinese medicine compositions for improving sleep quality prepared in Examples 1-3 of this invention can significantly increase sleep duration and reduce sleep latency.

[0063] 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, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for improving sleep quality, characterized in that, The raw materials include the following parts by weight: 6-12 parts Coptis chinensis, 1-3 parts cinnamon, 10-20 parts roasted jujube seed, 5-10 parts β-cyclodextrin, 5-7 parts modified porous silica hollow spheres, 3-5 parts n-docosahexanes, 0.5-1 part borneol, 0.5-1 part menthol, 3-5 parts lecithin, 1-3 parts flavoring, 75-85 parts atomizing agent, and 2-3 parts sweetener. The modified porous silica hollow spheres are porous silica hollow spheres with amino groups on their surface.

2. A method for preparing a traditional Chinese medicine composition for improving sleep quality as described in claim 1, characterized in that, Includes the following steps: S1. Cinnamon is extracted using supercritical fluid extraction to obtain volatile oil, and the residue is collected; S2. Mix the residue, Coptis chinensis, and roasted jujube seeds in low-deuterium water, heat and reflux to extract, add ethanol to precipitate and remove polysaccharides, filter, remove proteins from the filtrate, dry, and obtain a water-soluble extract; S3. Add β-cyclodextrin to water and volatile oil to ethanol. Mix the two solutions, heat and stir, filter, wash, and dry to obtain volatile oil inclusion complex. S4. Dissolve the emulsifier and pore-forming agent in water to obtain an aqueous phase; mix and dissolve the alkyl ester of orthosilicate and the aminosilane coupling agent in an organic solvent to obtain an oil phase; mix the aqueous phase and the oil phase, emulsify, adjust the pH value, stir the reaction, centrifuge, and dry to obtain modified porous silica hollow spheres; S5. Modified porous silica hollow spheres, volatile oil inclusion complex and water-soluble extract are mixed and added to water, stirred, filtered, washed, dried, n-dodecane is added, heated and stirred to mix, cooled, ground, and drug-loaded porous silica spheres are obtained. S6. Dissolve borneol and menthol in ethanol, evaporate, filter, and obtain eutectic; S7. Mix drug-loaded porous silica spheres, eutectic, lecithin, fragrance, atomizing agent, and sweetener evenly to obtain a traditional Chinese medicine composition for improving sleep quality.

3. The preparation method according to claim 2, characterized in that, The conditions for supercritical fluid extraction in step S1 are as follows: extraction pressure is 20-22 MPa, extraction temperature is 30-40℃, and CO2 flow rate is 15-25 L / h.

4. The preparation method according to claim 2, characterized in that, In step S2, the solid-liquid ratio of the residue and the deuterium-free water is 1:5-10 g / mL, the heating and reflux extraction time is 3-5 h, and the concentration of the deuterium-free water is 50-100 mg / kg.

5. The preparation method according to claim 2, characterized in that, The heating and stirring process in step S3 is carried out at a temperature of 35-45℃ for 1-3 hours.

6. The preparation method according to claim 2, characterized in that, The emulsifier in step S4 is selected from at least one of Tween 20, Tween 40, Tween 60, Tween 80, and Tween 85; the pore-forming agent is selected from at least one of ethylene-oxypropylene triblock copolymer PEO20-PPO70-PEO20 and ethylene-oxypropylene triblock copolymer PEO106-PPO70-PEO106; the alkyl orthosilicate is methyl orthosilicate or ethyl orthosilicate; and the aminosilane coupling agent is KH550.

7. The preparation method according to claim 2, characterized in that, In step S4, the mass ratio of emulsifier, pore-forming agent, alkyl orthosilicate ester and aminosilane coupling agent is 1-2:0.1-0.3:5-8:1-2, the emulsification speed is 5000-8000 r / min, the time is 10-20 min, the pH value is adjusted to 10-11, and the stirring reaction time is 8-12 h.

8. The preparation method according to claim 2, characterized in that, The heating and stirring temperature in step S5 is 50-60℃, and the cooling temperature is 4-6℃.

9. The preparation method according to claim 2, characterized in that, The atomizing agent in step S7 is a mixture of water and propylene glycol in a volume ratio of 1:8-10, and the sweetener is sucralose or erythritol.

10. The use of a traditional Chinese medicine composition for improving sleep quality as described in claim 1 in the preparation of a heat-not-burning medicinal liquid for treating insomnia and improving sleep quality.

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