Traditional Chinese medicine preparation for traditional Chinese medicine fumigation device and preparation method thereof

Abstract

This application discloses a traditional Chinese medicine preparation for use in a fumigation device and its preparation method, belonging to the field of traditional Chinese medicine preparation technology. The traditional Chinese medicine preparation for the fumigation device, by weight, comprises the following raw materials: Rehmannia glutinosa, Cornus officinalis, Dioscorea opposita, Poria cocos, Ziziphus jujuba var. spinosa, Lilium brownii, Ostrea gigas, Albizia julibrissin, Rosa rugosa, Mentha haplocalyx, Polygonum multiflorum, and Citrus medica. The preparation includes a compound essential oil and a traditional Chinese medicine granule carrier. The granule carrier is impregnated with the compound essential oil to obtain the preparation for the fumigation device. The mass ratio of the compound essential oil to the granule carrier is (5-8):100. By limiting the composition and ratio of the components of the traditional Chinese medicine preparation, synergistic effects between the drugs are achieved to improve insomnia, anxiety, depression, and other conditions. The compound essential oil and the granule carrier together form the preparation, avoiding the drawbacks of easy spillage and difficulty in transportation and storage associated with traditional Chinese medicine fumigation. This ensures the uniform and continuous release of effective components, preventing insufficient release of effective components in the later stages of fumigation.

Description

Technical Field

[0001] This application relates to a traditional Chinese medicine preparation for use in a traditional Chinese medicine fumigation device and its preparation method, belonging to the field of traditional Chinese medicine preparation technology. Background Technology

[0002] With the fast pace of modern life and increased mental stress, the incidence of psychosomatic disorders such as insomnia, anxiety, and depression is rising year by year, becoming a significant public health issue affecting the physical and mental health of the population. These disorders often manifest as difficulty falling asleep, sleep maintenance disorders, low mood, irritability, and poor concentration. Long-term, recurring episodes not only reduce quality of life but may also induce complications such as cardiovascular disease and endocrine disorders, causing dual harm to the patient's physical and mental health.

[0003] Currently, clinical and daily treatment solutions for insomnia, anxiety, and depression mainly fall into two categories: First, chemical drug treatment, such as sedative-hypnotics and anti-anxiety-depressants, can quickly relieve symptoms, but long-term use can easily lead to drug tolerance and dependence, and is accompanied by side effects such as dizziness, drowsiness, and memory loss, with poor safety. Second, physical therapy and psychological intervention, such as cognitive behavioral therapy, acupuncture, and massage, although without drug side effects, rely on professional operation, have long treatment cycles, and are slow to take effect, making it difficult to meet the public's need for convenient and immediate treatment. In recent years, with the gradual increase in people's awareness of traditional Chinese medicine health care, traditional Chinese medicine fumigation has gradually gained attention, resulting in corresponding developments in both theory and practice of traditional Chinese medicine fumigation, which is gradually being used in leisure and health care, rehabilitation and recuperation, and clinical treatment of mental illnesses.

[0004] Traditional Chinese medicine fumigation, also known as Chinese medicine steaming therapy, Chinese medicine steam bath therapy, drug penetration therapy, hot fog therapy, etc., organically combines the medicinal power and heat through fumigation and steaming. The warm stimulation of the medicinal steam raises the local temperature of the skin, dilates the skin capillaries, promotes the absorption of drugs by the body, promotes blood circulation, and enhances the body's disease resistance.

[0005] Existing traditional Chinese medicine fumigation methods mostly involve heating the herbal liquid for fumigation. For example, Chinese patent CN109528480A discloses a traditional Chinese medicine fumigation-type insomnia treatment chamber, which uses traditional Chinese medicine fumigation to treat insomnia and specifically discloses the setting of a herbal liquid heating device to generate herbal liquid steam for fumigation. However, the heated herbal liquid is prone to spillage, and this method is only suitable for fumigation with fixed devices in fixed positions, which is not convenient for moving the location. Secondly, the herbal liquid is not convenient to transport and store, which creates unfavorable factors for the promotion and use of fumigation. In addition, how to ensure the continuous and uniform release of effective ingredients during the fumigation process is a problem that deserves attention.

[0006] Therefore, the problem that needs to be solved is how to provide a traditional Chinese medicine preparation for fumigation devices that is easy to transport and store while also achieving continuous and uniform release of active ingredients. Summary of the Invention

[0007] To address the aforementioned issues, a traditional Chinese medicine preparation for use in a fumigation device and its preparation method are provided. By defining the composition and ratio of the components in the preparation, the synergistic effect between the drugs is enhanced to improve conditions such as insomnia, anxiety, and depression. The preparation is composed of compound essential oils and traditional Chinese medicine granule carriers, which avoids the drawbacks of traditional Chinese medicine liquid fumigation, such as easy spillage and difficulty in transportation and storage. The traditional Chinese medicine granule carriers carrying essential oils can uniformly and continuously release effective ingredients, avoiding insufficient release of effective ingredients in the later stages of fumigation.

[0008] According to one aspect of this application, a traditional Chinese medicine preparation for a fumigation device is provided, comprising, by weight, 20-24 parts of Rehmannia glutinosa, 10-14 parts of Cornus officinalis, 10-14 parts of Dioscorea opposita, 10-14 parts of Poria cocos, 13-17 parts of Ziziphus jujuba var. spinosa, 10-14 parts of Lilium brownii, 28-32 parts of Ostrea gigas, 10-14 parts of Albizia julibrissin, 6-9 parts of Rosa rugosa, 4-8 parts of Mentha haplocalyx, 13-17 parts of Polygonum multiflorum, and 7-11 parts of Citrus medica; the traditional Chinese medicine preparation comprises a compound essential oil and a traditional Chinese medicine granule carrier, wherein the traditional Chinese medicine granule carrier is impregnated with the compound essential oil to obtain the traditional Chinese medicine preparation for the fumigation device, and the mass ratio of the compound essential oil to the traditional Chinese medicine granule carrier is (5-8):100.

[0009] Specifically, this application uses a specific blend of traditional Chinese medicine components in a certain proportion. Rehmannia glutinosa and oyster shell are the principal herbs. Rehmannia glutinosa nourishes yin and blood, replenishes essence and marrow, and nourishes kidney yin to calm the five internal organs; oyster shell has a strong calming and yin-nourishing effect. Together, they are the principal herbs, directly addressing the core pathogenesis of "yin deficiency and restlessness of the mind," establishing the main effect of nourishing yin and calming the mind. Cornus officinalis, Dioscorea opposita, Ziziphus jujuba var. spinosa, Polygonum multiflorum, and Lilium brownii are the assistant herbs, assisting the principal herbs in enhancing their effects: Cornus officinalis and Dioscorea opposita nourish the liver and kidneys, benefit spleen yin, and strengthen the foundation of the internal organs; Ziziphus jujuba var. spinosa, Polygonum multiflorum, and Lilium brownii specifically nourish the heart and calm the mind, moisten dryness and relieve depression, enhancing the calming and stabilizing effect of the principal herbs, while also nourishing yin and moistening dryness, avoiding the damage to yin caused by strong sedative herbs. Citrus medica can also be used as an assistant herb. This formula soothes the liver, regulates qi, relieves depression, and broadens the chest. Poria cocos, Albizia julibrissin, Citrus medica, and Rosa rugosa are used as adjuvant herbs to treat concurrent symptoms and harmonize the properties of the herbs. Poria cocos strengthens the spleen, calms the mind, and promotes diuresis, preventing the nourishing yin herbs from hindering the spleen's function. Albizia julibrissin, Citrus medica, and Rosa rugosa soothe the liver, regulate qi, relieve depression, and invigorate blood, addressing the underlying cause of "emotional distress leading to restlessness." Rosa rugosa and Albizia julibrissin also have aromatic and orifice-opening effects, suitable for fumigation absorption. Citrus medica regulates qi and harmonizes the middle jiao, mitigating the nourishing properties of the other herbs. Peppermint disperses wind-heat, soothes the liver, promotes qi circulation, clears the head and eyes, and acts as a guiding herb, refreshing the mind and relieving headaches. This application follows the principles of traditional Chinese medicine's monarch-minister-adjuvant-guide formula, with each component working synergistically to improve insomnia, anxiety, and depression.

[0010] Optionally, the compound essential oil includes rose essential oil, bergamot essential oil, mimosa flower essential oil, and peppermint essential oil; the traditional Chinese medicine granule carrier is obtained by grinding and granulating Rehmannia glutinosa, Cornus officinalis, Dioscorea opposita, Poria cocos, Ziziphus jujuba var. spinosa, lily bulb, oyster shell, and Polygonum multiflorum vine.

[0011] Specifically, based on the characteristics of each medicinal material, this application divides them into two main categories: one exists in the form of essential oils, and the other exists in the form of traditional Chinese medicine granules. The active ingredients in the compound essential oils are the core fast-acting components of fumigation administration—small molecular weight, high volatility, and can rapidly diffuse with warm airflow, quickly absorbed through the respiratory mucosa and skin capillaries, and rapidly exert the effects of soothing the liver and relieving depression, and opening the orifices with aroma. The active ingredients in the traditional Chinese medicine granules are the long-acting basic components of fumigation. After granulation, a porous structure is formed, which can serve as an adsorption carrier for essential oils and can also slowly release its own active ingredients during warm fumigation, forming a "fast and slow combined" efficacy system with the fast-acting components of essential oils. This application adopts different forms according to the different characteristics of the components to retain the active ingredients to the greatest extent.

[0012] Optionally, the volume ratio of rose essential oil, bergamot essential oil, mimosa essential oil and peppermint essential oil in the compound essential oil is (2.5~3):(2~2.5):(2~2.5):(1.5~2).

[0013] Specifically, this application further limits the volume ratio of rose essential oil, bergamot essential oil, mimosa essential oil, and peppermint essential oil. Rose essential oil is the core antidepressant component, accounting for the highest proportion, which enhances the main effects of soothing the liver, relieving depression, and opening the mind with aroma. Bergamot and mimosa essential oils assist in relieving depression and calming the mind, accounting for the next highest proportion, and work synergistically with rose essential oil. Peppermint essential oil accounts for the lowest proportion and is only used as a guide and for aroma blending to prevent its pungent and cool aroma from overpowering the fragrance of other essential oils.

[0014] Optionally, the preparation method of the compound essential oil includes the following steps: S01 Remove impurities from roses, mimosa flowers, Buddha's hand, and mint, wash and dry them, then crush them for later use to obtain pre-treated Chinese medicinal materials; S02 Take the pretreated Chinese medicinal materials, add 8-10 times the amount of deionized water, and distill them in a steam distillation apparatus. The distillation time for rose and mimosa flowers is 3-4 hours, the distillation time for bergamot is 2-3 hours, and the distillation time for peppermint is 1-1.5 hours. The distillation temperature is 90-100℃, and the condensate temperature is 5-10℃. Collect the distillate, separate the oil and water, and let it stand for 2-4 hours to obtain the upper essential oil and the lower aqueous solution. S03 dried the obtained upper essential oil with anhydrous sodium sulfate for 24-36 hours, filtered to remove anhydrous sodium sulfate, and obtained rose essential oil, mimosa essential oil, bergamot essential oil and peppermint essential oil. S04: Mix rose essential oil, bergamot essential oil, mimosa essential oil and peppermint essential oil in the specified proportions, stir well, and obtain a compound essential oil.

[0015] Specifically, this application uses steam distillation to prepare essential oils and sets different distillation times according to different raw materials, which ensures the full extraction of essential oils from each raw material and avoids secondary volatilization of essential oils and increased energy consumption caused by excessively long distillation time.

[0016] Optionally, the preparation method of the traditional Chinese medicine granule carrier includes the following steps: S1 Take Rehmannia glutinosa, Cornus officinalis, Dioscorea opposita, Poria cocos, Ziziphus jujuba var. spinosa, Lilium brownii, Ostrea gigas, and Polygonum multiflorum vine according to the weight proportions, dry them, pulverize them, and pass them through a 100-120 mesh sieve to remove the residue, and obtain the Chinese herbal medicine mixed powder; S2 mixes the Chinese herbal medicine powder and excipients evenly, sprays anhydrous ethanol vapor into it, and then adds a composite binder to obtain a soft material. The soft material is then made into round wet granules with a diameter of 3-5 mm. S3 involves vacuum drying the wet granules and then cooling them to room temperature to obtain a traditional Chinese medicine granule carrier.

[0017] Specifically, this application involves spraying anhydrous ethanol vapor after mixing the Chinese herbal medicine powder with excipients. On the one hand, this can act as a wetting agent to improve the cohesion between powder particles. At the same time, ethanol is volatile and will not remain in the particles, thus avoiding affecting the subsequent essential oil impregnation and component release. On the other hand, it can also activate the pore structure of the excipients and reduce the resistance to essential oil penetration.

[0018] Optionally, the amount of excipients added is 20-30% of the traditional Chinese medicine mixture powder; the excipients include porous starch and hydroxypropyl-β-cyclodextrin, and the mass ratio of porous starch to hydroxypropyl-β-cyclodextrin is (2-3):1.

[0019] Specifically, this application uses a specific ratio of porous starch and hydroxypropyl-β-cyclodextrin as excipients. Porous starch has a high specific surface area and porous structure, which can significantly increase the adsorption capacity of the compound essential oil on the particle carrier, while slowly releasing the adsorbed essential oil during fumigation. The combined effect of porous starch and hydroxypropyl-β-cyclodextrin enhances the carrying capacity of the carrier and is beneficial to the formability of the particles.

[0020] Optionally, the composite adhesive comprises 10-15% povidone ethanol solution and 0.5-0.8% sodium alginate aqueous solution, wherein the volume ratio of the povidone ethanol solution and the 0.5-0.8% sodium alginate aqueous solution is (1-1.5):1.

[0021] Specifically, this application uses a combination of povidone ethanol solution and sodium alginate aqueous solution to balance the mechanical strength and swelling properties of the particles. The povidone ethanol solution has strong binding force, which allows the particles to be well formed and not easily broken, making it suitable for the turning and airflow impact of the fumigation device. The sodium alginate aqueous solution has good swelling properties and will swell slightly in the warm and humid fumigation environment, opening the pores of the particle carrier. This is beneficial for both the release of essential oils and the dissolution of its own non-volatile components. The combination of the two can balance the strength and swelling properties of the particles.

[0022] Optionally, the mass of anhydrous ethanol in S2 is 1-3% of the mass of the mixed Chinese medicine powder; the vacuum drying temperature in S3 is 35-40℃, the vacuum degree is -0.06--0.08MPa, and the drying time is 2-2.5h.

[0023] According to another aspect of this application, a method for preparing the above-mentioned traditional Chinese medicine preparation for fumigation device is also provided, characterized by comprising the following steps: (1) A composite essential oil and traditional Chinese medicine granule carrier were prepared; (2) Preheat the carrier of Chinese medicine granules to 30~35℃, place it in a vacuum impregnation tank and impregnate it in compound essential oil, perform vacuum impregnation, and after the impregnation is completed, perform vacuum drying to obtain impregnated Chinese medicine granules. (3) Melt PEG-1500 at 45~48℃ to liquid state, and use a spray coating machine to spray and coat the impregnated Chinese medicine granules for 3~5 minutes, and cool to form a coating layer; (4) After irradiation sterilization, the product is packaged.

[0024] Specifically, this application uses vacuum impregnation, which can effectively increase the amount and uniformity of essential oil adsorption, allowing the essential oil to quickly and fully enter the particles and fill the pores of the particles, rather than being adsorbed on the surface of the particles. During fumigation, the release rate of essential oil is more stable, avoiding the initial sudden release of essential oil and the lack of oil to release later.

[0025] Specifically, this application also includes the step of coating Chinese herbal medicine granules with PEG-1500. When the fumigation device is working, it will generate a warm airflow. The warm environment will slowly soften the solid PEG-1500 coating layer, making the coating layer form tiny gaps. This allows the compound essential oils and non-volatile components inside the granules to be released slowly and evenly, achieving a long-lasting and stable fumigation effect. This can avoid the rapid volatilization of essential oils, excessively strong odor in the early stage of fumigation, and a sharp drop in efficacy in the later stage. Specifically, the solid PEG-1500 coating can isolate the particles from contact with the outside air and moisture, prevent the compound essential oil from being oxidized and deteriorated, prevent the carrier of traditional Chinese medicine particles from absorbing moisture and clumping, and greatly improve the storage stability of the preparation; at the same time, the coating can prevent the essential oil from being lost during transportation and packaging, and ensure the uniformity of drug loading in the preparation.

[0026] Optionally, in step (2), the vacuum impregnation includes evacuating to -0.06~-0.08MPa, maintaining for 15~20min, slowly releasing the vacuum, and standing in a constant temperature environment of 25~30℃ for 5~6h, gently turning it over once every 50~60min; the vacuum drying temperature is 30~35℃, the vacuum degree is -0.05~-0.07MPa, and the drying time is 30~40min; in step (3), the amount of PEG-1500 used is 5~10% of the mass of the Chinese medicine granule carrier.

[0027] Specifically, the irradiation sterilization is cobalt-60 irradiation sterilization, with a dose of 15~20kGy.

[0028] Optionally, the fumigation device is a fumigation cap, including a cap body, a medicine chamber, and a heating device; The hat body has a cavity to accommodate the user's head; The medicine compartment is located at the top and rear wall of the cavity to hold traditional Chinese medicine preparations; The heating device includes a heater and an atomizing device, the medicine chamber, the heater and the atomizing device are connected in sequence, and the atomizing device is provided with a fumigation port, which is connected to the cavity. The hat body is provided with a charging port, which is connected to the heating device; The fumigation port is equipped with a baffle to adjust its size; the top of the medicine chamber is equipped with a door for easy opening and closing.

[0029] The beneficial effects of this application include, but are not limited to: 1. The traditional Chinese medicine preparation for fumigation device according to this application, by limiting the composition and ratio of the components of the traditional Chinese medicine preparation, exerts a synergistic effect between drugs to improve insomnia, anxiety and depression; the traditional Chinese medicine preparation is composed of compound essential oil and traditional Chinese medicine granule carrier, which avoids the disadvantages of traditional Chinese medicine liquid fumigation being easy to spill and difficult to transport and store, and the traditional Chinese medicine granule carrier carrying essential oil can uniformly and continuously release effective ingredients, avoiding the situation of insufficient release of effective ingredients in the later stage of fumigation.

[0030] 2. According to the traditional Chinese medicine preparation for fumigation device of traditional Chinese medicine in this application, the types and amounts of adjuvants for traditional Chinese medicine granule carriers are limited. Povidone ethanol solution and sodium alginate aqueous solution are compounded, and porous starch and hydroxypropyl-β-cyclodextrin are compounded to ensure the pore structure of traditional Chinese medicine granule carriers, improve drug loading, and ensure mechanical strength and swelling properties.

[0031] 3. The traditional Chinese medicine preparation for fumigation device according to this application adopts vacuum impregnation and PEG-1500 coating. On the one hand, it increases the adsorption amount and adsorption uniformity of essential oil. On the other hand, the PEG-1500 coating prevents the compound essential oil from being oxidized and deteriorated, and prevents the traditional Chinese medicine granule carrier from absorbing moisture and clumping. This greatly improves the storage stability of the preparation and is also conducive to the slow and uniform release of effective ingredients during heating and fumigation.

[0032] 4. The preparation method of traditional Chinese medicine preparations for fumigation device according to this application is simpler and easier to promote and use on a large scale than the preparation method of decocting traditional Chinese medicine liquid for fumigation. Attached Figure Description

[0033] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings: Figure 1 This is a front cross-sectional view of the fumigation cap according to an embodiment of this application; List of components and reference numerals: 1. Cap body; 2. Cavity; 3. Medicine compartment; 4. Heater; 5. Atomizing device; 6. Fumigation port; 7. Charging port; 8. Baffle; 9. Door. Detailed Implementation

[0034] The present application is described in detail below with reference to the embodiments, but the present application is not limited to these embodiments.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of skill in the art. The reagents and raw materials used in this invention are readily available through conventional means, and unless otherwise specified, they shall be used in accordance with conventional methods in the art or as per the product instructions. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to the methods of this invention. The preferred embodiments and materials described in this patent are for illustrative purposes only.

[0036] Example 1 Preparation of a traditional Chinese medicine preparation for fumigation devices: (1) Take compound essential oil and Chinese medicine granule carrier, with a mass ratio of compound essential oil to Chinese medicine granule carrier of 5:100; (2) The carrier of Chinese medicine granules is preheated to 30°C and placed in a vacuum impregnation tank to be impregnated in compound essential oil. Vacuum impregnation includes drawing a vacuum to -0.06MPa, maintaining it for 15 minutes, slowly releasing the vacuum, and standing in a constant temperature environment of 25°C for 5 hours, gently turning it over once every 50 minutes. After impregnation, vacuum drying is carried out at a temperature of 30°C, a vacuum degree of -0.05MPa, and a drying time of 30 minutes to obtain impregnated Chinese medicine granules. (3) PEG-1500 was melted to liquid state at 45℃ and coated with a spray coating machine. The amount of PEG-1500 was 5% of the mass of the Chinese medicine granule carrier. The spraying time was 3 minutes. The coating layer was formed after cooling. (4) After sterilization by cobalt-60 irradiation, the product is packaged at a dose of 15 kGy.

[0037] Preparation of compound essential oils: S01 Remove impurities from 6 parts of rose petals, 10 parts of mimosa flowers, 7 parts of bergamot, and 4 parts of mint, wash and dry them, then crush them for later use to obtain pre-treated Chinese medicinal materials. S02 Take the pretreated Chinese medicinal materials, add 8 times the amount of deionized water, and distill them in a steam distillation apparatus. The distillation time for rose and mimosa flowers is 3 hours, the distillation time for Buddha's hand is 2 hours, and the distillation time for peppermint is 1 hour. The distillation temperature is 90℃, the condensate temperature is 5℃, the distillate is collected, the oil and water are separated, and the mixture is allowed to stand for 2 hours to obtain the upper essential oil and the lower aqueous solution. S03 dried the obtained upper essential oil with anhydrous sodium sulfate for 24 hours, filtered to remove anhydrous sodium sulfate, and obtained rose essential oil, mimosa essential oil, bergamot essential oil and peppermint essential oil. S04. Rose essential oil, bergamot essential oil, mimosa essential oil and peppermint essential oil are mixed in a volume ratio of 2.5:2:2:1.5 and stirred evenly to obtain a compound essential oil.

[0038] Preparation of Chinese medicine granule carriers: S1 Take 20 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 10 parts of Dioscorea opposita, 10 parts of Poria cocos, 13 parts of Ziziphus jujuba var. spinosa, 10 parts of Lilium brownii, 28 parts of Ostrea gigas, and 13 parts of Polygonum multiflorum vine according to the weight proportions. After drying, pulverize and pass through a 100-mesh sieve to remove the residue to obtain a mixed powder of Chinese medicine. S2 mixes the traditional Chinese medicine powder with excipients evenly, then sprays anhydrous ethanol vapor onto it. The mass of anhydrous ethanol is 1% of the mass of the traditional Chinese medicine powder. Then, a composite binder is added to obtain a soft material. The soft material is then formed into round, wet granules with a diameter of 3 mm. The amount of excipients added is 20% of the traditional Chinese medicine powder. The excipients include porous starch and hydroxypropyl-β-cyclodextrin, with a mass ratio of porous starch to hydroxypropyl-β-cyclodextrin of 2:1. The composite binder includes a 10% povidone ethanol solution and a 0.5% sodium alginate aqueous solution, with a volume ratio of povidone ethanol solution to sodium alginate aqueous solution of 1:1. S3 obtained traditional Chinese medicine granule carriers by vacuum drying the wet granules and then cooling them to room temperature. The vacuum drying temperature was 35℃, the vacuum degree was -0.06MPa, and the drying time was 2h.

[0039] Example 2 Preparation of a traditional Chinese medicine preparation for fumigation devices: (1) Take compound essential oil and Chinese medicine granule carrier, with a mass ratio of compound essential oil to Chinese medicine granule carrier of 8:100; (2) The carrier of Chinese medicine granules is preheated to 35°C and placed in a vacuum impregnation tank to be impregnated in compound essential oil. Vacuum impregnation includes drawing a vacuum to -0.08MPa, maintaining it for 20 minutes, slowly releasing the vacuum, and standing in a constant temperature environment of 30°C for 6 hours, gently turning it once every 60 minutes. After impregnation, vacuum drying is carried out at a temperature of 35°C, a vacuum degree of -0.07MPa, and a drying time of 40 minutes to obtain impregnated Chinese medicine granules. (3) PEG-1500 was melted to liquid state at 48℃ and coated with the impregnated Chinese medicine granules using a spray coating machine. The amount of PEG-1500 was 10% of the mass of the Chinese medicine granule carrier. The spraying time was 5 minutes. The coating layer was formed after cooling. (4) After sterilization by cobalt-60 irradiation, the product is packaged at a dose of 20 kGy.

[0040] Preparation of compound essential oils: S01 Remove impurities from 9 parts of rose petals, 14 parts of mimosa flowers, 11 parts of Buddha's hand citron, and 8 parts of mint, wash and dry them, then crush them for later use to obtain pre-treated Chinese medicinal materials; S02 Take the pretreated Chinese medicinal materials, add 10 times the amount of deionized water, and distill them in a steam distillation apparatus. The distillation time for rose and mimosa flowers is 4 hours, the distillation time for Buddha's hand is 3 hours, and the distillation time for peppermint is 1.5 hours. The distillation temperature is 100℃, the condensate temperature is 10℃, the distillate is collected, the oil and water are separated, and the mixture is allowed to stand for 4 hours to obtain the upper essential oil and the lower aqueous solution. S03 dried the obtained upper essential oil with anhydrous sodium sulfate for 36 hours, filtered to remove anhydrous sodium sulfate, and obtained rose essential oil, mimosa essential oil, bergamot essential oil and peppermint essential oil. S04. Rose essential oil, bergamot essential oil, mimosa essential oil and peppermint essential oil are mixed in a volume ratio of 3:2.5:2.5:2 and stirred evenly to obtain a compound essential oil.

[0041] Preparation of Chinese medicine granule carriers: S1 Take 24 parts of Rehmannia glutinosa, 14 parts of Cornus officinalis, 14 parts of Dioscorea opposita, 14 parts of Poria cocos, 17 parts of Ziziphus jujuba var. spinosa, 14 parts of Lilium brownii, 32 parts of Ostrea gigas, and 17 parts of Polygonum multiflorum vine according to the weight proportions. After drying, pulverize and pass through a 120-mesh sieve to remove the residue to obtain a mixed powder of Chinese medicine. S2 mixes the traditional Chinese medicine powder with excipients evenly, then sprays anhydrous ethanol vapor onto it. The mass of anhydrous ethanol is 3% of the mass of the traditional Chinese medicine powder. Then, a composite binder is added to obtain a soft material. The soft material is then formed into round, wet granules with a diameter of 5 mm. The amount of excipients added is 30% of the traditional Chinese medicine powder. The excipients include porous starch and hydroxypropyl-β-cyclodextrin, with a mass ratio of 3:1. The composite binder includes a 15% povidone ethanol solution and a 0.8% sodium alginate aqueous solution, with a volume ratio of 1.5:1. S3 obtains traditional Chinese medicine granule carriers by vacuum drying the wet granules and then cooling them to room temperature. The vacuum drying temperature is 40℃, the vacuum degree is -0.08MPa, and the drying time is 2.5h.

[0042] Example 3 Preparation of a traditional Chinese medicine preparation for fumigation devices: (1) Take compound essential oil and Chinese medicine granule carrier, with a mass ratio of compound essential oil to Chinese medicine granule carrier of 7:100; (2) The carrier of Chinese medicine granules is preheated to 32°C and placed in a vacuum impregnation tank to be impregnated in compound essential oil. Vacuum impregnation includes drawing a vacuum to -0.07MPa, maintaining it for 18 minutes, slowly releasing the vacuum, and standing in a constant temperature environment of 27°C for 6 hours, gently turning it once every 60 minutes. After impregnation, vacuum drying is carried out at a temperature of 35°C, a vacuum degree of -0.06MPa, and a drying time of 35 minutes to obtain impregnated Chinese medicine granules. (3) PEG-1500 was melted to liquid state at 47℃ and coated with the impregnated Chinese medicine granules using a spray coating machine. The amount of PEG-1500 was 8% of the mass of the Chinese medicine granule carrier. The spraying time was 4 min. The coating layer was formed after cooling. (4) After sterilization by cobalt-60 irradiation, the product is packaged at a dose of 20 kGy.

[0043] Preparation of compound essential oils: S01 Remove impurities from 8 parts of rose petals, 12 parts of mimosa flowers, 9 parts of Buddha's hand citron, and 6 parts of mint, wash and dry them, then crush them for later use to obtain pre-treated Chinese medicinal materials; S02 Take the pretreated Chinese medicinal materials, add 9 times the amount of deionized water, and distill them in a steam distillation apparatus. The distillation time for rose and mimosa flowers is 3.5h, the distillation time for Buddha's hand is 2.5h, and the distillation time for peppermint is 1.5h. The distillation temperature is 90℃, the condensate temperature is 8℃, the distillate is collected, the oil and water are separated, and the mixture is allowed to stand for 3h to obtain the upper essential oil and the lower aqueous solution. S03 dried the obtained upper essential oil with anhydrous sodium sulfate for 30 hours, filtered to remove anhydrous sodium sulfate, and obtained rose essential oil, mimosa essential oil, bergamot essential oil and peppermint essential oil. S04. Rose essential oil, bergamot essential oil, mimosa essential oil and peppermint essential oil are mixed in a volume ratio of 3:2:2:2 and stirred evenly to obtain a compound essential oil.

[0044] Preparation of Chinese medicine granule carriers: S1 Take 22 parts of Rehmannia glutinosa, 12 parts of Cornus officinalis, 12 parts of Dioscorea opposita, 12 parts of Poria cocos, 15 parts of Ziziphus jujuba var. spinosa, 12 parts of Lilium brownii, 30 parts of Ostrea gigas, and 15 parts of Polygonum multiflorum vine according to the weight proportions. After drying, pulverize and pass through a 100-mesh sieve to remove the residue to obtain a mixed powder of Chinese medicine. S2 mixes the traditional Chinese medicine powder with excipients evenly, then sprays anhydrous ethanol vapor onto it. The mass of anhydrous ethanol is 2% of the mass of the traditional Chinese medicine powder. Then, a composite binder is added to obtain a soft material. The soft material is then formed into round, wet granules with a diameter of 4 mm. The amount of excipients added is 25% of the traditional Chinese medicine powder. The excipients include porous starch and hydroxypropyl-β-cyclodextrin, with a mass ratio of porous starch to hydroxypropyl-β-cyclodextrin of 2.5:1. The composite binder includes a 15% povidone ethanol solution and a 0.5% sodium alginate aqueous solution, with a volume ratio of povidone ethanol solution to sodium alginate aqueous solution of 1.5:1. S3 obtains traditional Chinese medicine granule carriers by vacuum drying the wet granules and then cooling them to room temperature. The vacuum drying temperature is 40℃, the vacuum degree is -0.08MPa, and the drying time is 2.5h.

[0045] Example 4 The difference between Example 4 and Example 3 is that the volume ratio of rose essential oil, bergamot essential oil, mimosa essential oil and peppermint essential oil in the compound essential oil is 1:1:1:1, while the rest are the same.

[0046] Example 5 The difference between Example 5 and Example 3 is that a single rose essential oil is used instead of the compound essential oil, while the rest are the same.

[0047] Example 6 The difference between Example 6 and Example 3 is that the auxiliary material is single starch and the binder is 10% starch paste, while the rest are the same.

[0048] Example 7 The difference between Example 7 and Example 3 is that Example 7 does not include the PEG-1500 coating step; all other steps are the same.

[0049] Comparative Example 1 The difference between Comparative Example 1 and Example 3 is that oysters and jujube seeds are not included, Rehmannia glutinosa is 52 parts, Polygonum multiflorum vine is 30 parts, and the rest are the same.

[0050] Comparative Example 2 Comparative Example 2: The medicinal materials were added to 10 times the amount of water according to the components and weights of Example 3, and decocted for 2 hours to obtain the Chinese medicine liquid.

[0051] Comparative Example 3 The difference between Comparative Example 3 and Example 3 is that the herbal powder obtained in S1 is used to adsorb the compound essential oil, while the rest are the same.

[0052] Experimental Example 1 Equal masses of the preparations obtained from Examples 1-4, 6-7 and Comparative Examples 1-3 were placed in a fumigation device, and the temperature was set to 45°C. The fumigation exhaust gas was collected at 0 min, 30 min, 60 min, 90 min and 120 min respectively. The menthol content was detected by GC. The test results are shown in Table 1.

[0053] Table 1 Release performance test results

[0054] The embodiments of this application show high peak and late-stage release amounts, with Embodiment 3 being the best embodiment. Embodiment 6 changed the excipients and binders, resulting in a reduction in the adsorption of essential oils and a decrease in both peak and late-stage release amounts. Embodiment 7 lacked PEG-1500 coating, leading to excessively rapid initial release, rapid decay at 60 minutes, and a significant decrease in release amount at 120 minutes. In Comparative Example 2, the herbal solution lacked a solid-phase carrier for adsorption, resulting in rapid evaporation of the essential oils and almost no release at 120 minutes. Comparative Example 3 used a mixed herbal powder to adsorb the essential oils, exhibiting poor adsorption stability, easy and rapid desorption of the essential oils, high initial release amount, and low late-stage release amount.

[0055] Experimental Example 2 Experimental animals: SPF-grade Kunming mice, weighing 20±2g, half male and half female, 30 mice per group, were selected and acclimatized for 1 week (room temperature 22±2℃, humidity 55±5%, circadian rhythm 12h / 12h, free access to food and water), and individuals with abnormal physical conditions were excluded.

[0056] Model establishment: A combined insomnia and anxiety model was established using intraperitoneal injection of p-chlorophenylalanine (PCPA) combined with restraint stress. PCPA 300 mg / kg was injected intraperitoneally daily for days 1-2. Starting on day 3, restraint stress was applied for 2 hours daily (the restraint device was a breathable plastic cylinder, restricting movement without compressing organs) for 3 consecutive days. Successful model establishment was defined as a 30% or greater increase in spontaneous activity and a 50% or greater extension of sleep latency compared to the normal group.

[0057] Administration method: 10g of each formulation of Examples 3, 4, 5 and each comparative example was administered to each group. Mice were placed in a closed fumigation chamber (volume 10L). The formulation was heated by a constant temperature heating device to generate drug vapor. The fumigation temperature was 40±2℃. Mice were placed in the fumigation chamber for 40 minutes at 9 am every day for 7 consecutive days. The blank control group was only introduced with the same amount of air at the same temperature and humidity, without the formulation.

[0058] Testing indicators and judgment criteria: a. Sleep latency and sleep duration: 30 minutes after the last fumigation, mice were injected intraperitoneally with sodium pentobarbital (40 mg / kg). The time from the completion of the injection to the disappearance of the righting reflex (sleep latency) and the time from the disappearance of the righting reflex to its recovery (sleep duration) were recorded and the average values ​​were calculated. b. Forced swimming test: 2 hours after the last fumigation, mice were placed in a transparent cylindrical barrel (20cm in diameter, 50cm in height, and 30cm in depth) filled with water at 25±1℃. The immobility time of the mice within 6 minutes was recorded (floating or slight struggling without obvious displacement was considered immobility). The average value was calculated, and the test results are shown in Table 2.

[0059] Table 2 Results of mouse experiments

[0060] In Example 3 of this application, the sleep latency was significantly shortened compared to the blank control group, while the sleep time and the time spent motionless during forced swimming were significantly prolonged. This demonstrates that the sustained-release and long-term release of the active ingredient allows mice to continuously receive the effective dose during fumigation, maximizing the sedative and anti-anxiety effects. Example 4 changed the ratio of the compound essential oil, and Example 5 used a single rose essential oil, which altered the interactions between the drugs, resulting in poor efficacy. Comparative Example 1 changed the medicinal materials in the carrier of the traditional Chinese medicine granules, altering the balance of the principal, assistant, and adjuvant herbs in traditional Chinese medicine, losing the synergistic effect between the drugs, and thus reducing efficacy. Comparative Example 2 used a liquid traditional Chinese medicine, which caused the active ingredient to evaporate rapidly, resulting in lower actual absorption by the mice and reduced efficacy. Comparative Example 3 directly used a mixed powder of traditional Chinese medicine, which had poor carrier adsorption and uneven release of the active ingredient, thus affecting efficacy.

[0061] Experimental Example 3 Volunteer selection: 120 volunteers aged 18-60 with mild insomnia and anxiety were selected, meeting the following criteria: PSQI score 7-15 (mild insomnia), HAMA score 14-21 (mild anxiety), HAMD score 17-24 (mild depression); those with severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, pregnant and lactating women, those allergic to the ingredients of this preparation, and those who have taken sedative and tranquilizing drugs in the past month were excluded.

[0062] Grouping and Administration: Participants were randomly assigned to an experimental group (using the formulation from Example 3) and a control group (grouped according to the corresponding ratio, with 30 participants in each group; there were no statistically significant differences in male-to-female ratio, age distribution, or baseline scale scores, P>0.05). One hour before bedtime each day, participants used a standardized head fumigation device, adding 5g of the corresponding formulation, and fumigated for 30 minutes (fumigation distance 20-30cm from the skin, temperature 40±2℃) for 14 consecutive days. During the trial period, participants were prohibited from taking other sedative, anti-anxiety, or depressive medications or health supplements, and maintained a regular sleep schedule.

[0063] Evaluation methods and judgment criteria: The scores of various indicators of clinical patients before and after 14 days of treatment were assessed using the Traditional Chinese Medicine Syndrome Scale, and the efficacy index was calculated. The formula is: Efficacy Index (n) = [(Pre-treatment score - Post-treatment score) / Pre-treatment score] × 100%. Based on the efficacy index, evaluation criteria were established, as shown in Table 3. Based on these criteria, the effectiveness rate of treating anxiety disorders in each group was further calculated, and the results are shown in Table 4.

[0064] Table 3 Evaluation Criteria for Therapeutic Effect Index

[0065] Table 4. Effectiveness of treating insomnia and anxiety

[0066] The herbal fumigation preparation prepared in this invention significantly improves mild insomnia and anxiety symptoms in human clinical trials, demonstrating high efficacy, good safety, and convenient administration. Comparative Example 1 lacked the required herbal ingredients, resulting in a lack of synergistic effects; Comparative Example 3 lacked granulation technology, leading to insufficient effective dose absorption and thus a lower efficacy rate; in Comparative Example 2, the efficacy rate was only 66.67%, with 10 participants showing no effect. This was due to the rapid volatilization of the active ingredients and the short fumigation period, meaning the body could not receive a sufficient effective dose during the 30-minute fumigation process, resulting in the worst clinical outcome.

[0067] like Figure 1 As shown, the fumigation device of this application is a fumigation cap, including a cap body 1, a medicine chamber 3 and a heating device; The hat body 1 has a cavity 2 inside to accommodate the user's head; Specifically, the hat body includes an outer insulation layer, a middle heat insulation layer, and an inner fumigation layer. The outer insulation layer prevents heat loss and improves thermal efficiency; the middle heat insulation layer ensures that heat is conducted inward to avoid overheating on the outside; the inner fumigation layer comes into contact with the skin of the human head, is breathable, moisturizing, and heat-resistant, and facilitates the passage of medicinal vapors.

[0068] Medicine compartment 3 is located at the top and rear wall of cavity 2 to contain traditional Chinese medicine preparations; The heating device includes a heater 4 and an atomizing device 5. The medicine chamber 3, the heater 4 and the atomizing device 5 are connected in sequence. The atomizing device 5 is provided with a fumigation port 6, which is connected to the cavity 2. Specifically, the medicine tank, heater, and atomizing device are located on the top and back of the cap, corresponding to the top and back of the user's head.

[0069] The hat body 1 is provided with a charging port 7, which is connected to the heating device; The fumigation port 6 is equipped with a baffle 8 to adjust the size of the fumigation port 6; the top of the medicine chamber 3 is equipped with a chamber door 9 for easy opening and closing.

[0070] Specifically, the atomizing device can deliver steam into the cavity; Specifically, the heating device heats the traditional Chinese medicine preparation in the medicine chamber 3, and the steam carrying the effective ingredients of the traditional Chinese medicine is sprayed out from the fumigation port 6 and directly enters the cavity 2 to act on the user's head.

[0071] The above description is merely an embodiment of this application, and the scope of protection of this application is not limited to these specific embodiments, but is determined by the claims of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the technical concept and principles of this application should be included within the scope of protection of this application.

Claims

1. A traditional Chinese medicine preparation for use in a fumigation device, characterized in that, The raw materials, by weight, include 20-24 parts of Rehmannia glutinosa, 10-14 parts of Cornus officinalis, 10-14 parts of Dioscorea opposita, 10-14 parts of Poria cocos, 13-17 parts of Ziziphus jujuba var. spinosa, 10-14 parts of Lilium brownii, 28-32 parts of Ostrea gigas, 10-14 parts of Albizia julibrissin, 6-9 parts of Rosa rugosa, 4-8 parts of Mentha haplocalyx, 13-17 parts of Polygonum multiflorum, and 7-11 parts of Citrus medica. The traditional Chinese medicine preparation includes a compound essential oil and a traditional Chinese medicine granule carrier. The traditional Chinese medicine granule carrier is impregnated with the compound essential oil to obtain the traditional Chinese medicine preparation for fumigation devices. The mass ratio of the compound essential oil to the traditional Chinese medicine granule carrier is (5-8):

100.

2. The traditional Chinese medicine preparation for fumigation device according to claim 1, characterized in that, The compound essential oil includes rose essential oil, bergamot essential oil, mimosa flower essential oil, and peppermint essential oil; the traditional Chinese medicine granule carrier is obtained by grinding and granulating Rehmannia glutinosa, Cornus officinalis, Dioscorea opposita, Poria cocos, Ziziphus jujuba var. spinosa, lily bulb, oyster shell, and Polygonum multiflorum vine.

3. The traditional Chinese medicine preparation for fumigation device according to claim 2, characterized in that, The volume ratio of rose essential oil, bergamot essential oil, mimosa essential oil and peppermint essential oil in the compound essential oil is (2.5~3):(2~2.5):(2~2.5):(1.5~2).

4. The traditional Chinese medicine preparation for fumigation device according to claim 3, characterized in that, The preparation method of the compound essential oil includes the following steps: S01 Remove impurities from roses, mimosa flowers, Buddha's hand, and mint, wash and dry them, then crush them for later use to obtain pre-treated Chinese medicinal materials; S02 Take the pretreated Chinese medicinal materials, add 8-10 times the amount of deionized water, and distill them in a steam distillation apparatus. The distillation time for rose and mimosa flowers is 3-4 hours, the distillation time for bergamot is 2-3 hours, and the distillation time for peppermint is 1-1.5 hours. The distillation temperature is 90-100℃, and the condensate temperature is 5-10℃. Collect the distillate, separate the oil and water, and let it stand for 2-4 hours to obtain the upper essential oil and the lower aqueous solution. S03 dried the obtained upper essential oil with anhydrous sodium sulfate for 24-36 hours, filtered to remove anhydrous sodium sulfate, and obtained rose essential oil, mimosa essential oil, bergamot essential oil and peppermint essential oil. S04: Mix rose essential oil, bergamot essential oil, mimosa essential oil and peppermint essential oil in the specified proportions, stir well, and obtain a compound essential oil.

5. The traditional Chinese medicine preparation for fumigation device according to claim 2, characterized in that, The preparation method of the traditional Chinese medicine granule carrier includes the following steps: S1 Take Rehmannia glutinosa, Cornus officinalis, Dioscorea opposita, Poria cocos, Ziziphus jujuba var. spinosa, Lilium brownii, Ostrea gigas, and Polygonum multiflorum vine according to the weight proportions, dry them, pulverize them, and pass them through a 100-120 mesh sieve to remove the residue, and obtain the Chinese herbal medicine mixed powder; S2 mixes the Chinese herbal medicine powder and excipients evenly, sprays anhydrous ethanol vapor into it, and then adds a composite binder to obtain a soft material. The soft material is then made into round wet granules with a diameter of 3-5 mm. S3 involves vacuum drying the wet granules and then cooling them to room temperature to obtain a traditional Chinese medicine granule carrier.

6. The traditional Chinese medicine preparation for fumigation device according to claim 5, characterized in that, The amount of excipients added is 20-30% of the mixed powder of traditional Chinese medicine; the excipients include porous starch and hydroxypropyl-β-cyclodextrin, and the mass ratio of porous starch to hydroxypropyl-β-cyclodextrin is (2-3):1; the composite binder includes 10-15% povidone ethanol solution and 0.5-0.8% sodium alginate aqueous solution, and the volume ratio of povidone ethanol solution to 0.5-0.8% sodium alginate aqueous solution is (1-1.5):

1.

7. The traditional Chinese medicine preparation for fumigation device according to claim 5, characterized in that, In S2, the mass of anhydrous ethanol is 1-3% of the mass of the mixed Chinese medicine powder; in S3, the vacuum drying temperature is 35-40℃, the vacuum degree is -0.06--0.08MPa, and the drying time is 2-2.5h.

8. The method for preparing a traditional Chinese medicine preparation for a fumigation device according to any one of claims 1 to 7, characterized in that, Includes the following steps: (1) A composite essential oil and traditional Chinese medicine granule carrier were prepared; (2) Preheat the carrier of Chinese medicine granules to 30~35℃, place it in a vacuum impregnation tank and impregnate it in compound essential oil, perform vacuum impregnation, and after the impregnation is completed, perform vacuum drying to obtain impregnated Chinese medicine granules. (3) Melt PEG-1500 at 45~48℃ to liquid state, and use a spray coating machine to spray and coat the impregnated Chinese medicine granules for 3~5 minutes, and cool to form a coating layer; (4) After irradiation sterilization, the product is packaged.

9. The method for preparing a traditional Chinese medicine preparation for a fumigation device according to claim 8, characterized in that, In step (2), the vacuum impregnation includes evacuating to -0.06~-0.08MPa, maintaining for 15~20min, slowly releasing the vacuum, and standing in a constant temperature environment of 25~30℃ for 5~6h, gently turning it over once every 50~60min; the vacuum drying temperature is 30~35℃, the vacuum degree is -0.05~-0.07MPa, and the drying time is 30~40min; in step (3), the amount of PEG-1500 used is 5~10% of the mass of the Chinese medicine granule carrier.

10. The method for preparing a traditional Chinese medicine preparation for a fumigation device according to claim 8, characterized in that, The fumigation device is a fumigation cap, including a cap body, a medicine chamber, and a heating device; The hat body has a cavity to accommodate the user's head; The medicine compartment is located at the top and rear wall of the cavity to hold traditional Chinese medicine preparations; The heating device includes a heater and an atomizing device, the medicine chamber, the heater and the atomizing device are connected in sequence, and the atomizing device is provided with a fumigation port, which is connected to the cavity. The hat body is provided with a charging port, which is connected to the heating device; The fumigation port is equipped with a baffle to adjust its size; the top of the medicine chamber is equipped with a door for easy opening and closing.

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