CN113908210B

CN113908210B - Traditional Chinese medicine anti-anxiety bag and preparation method thereof

Info

Publication number: CN113908210B
Application number: CN202111252478.XA
Authority: CN
Inventors: 田微; 赵玲; 陈新; 江维; 余洁; 廖承刚
Original assignee: Hubei Youbaike Biotechnology Co ltd
Current assignee: Hubei Youbaike Biotechnology Co ltd
Priority date: 2021-10-26
Filing date: 2021-10-26
Publication date: 2023-03-21
Anticipated expiration: 2041-10-26
Also published as: CN113908210A

Abstract

The invention discloses a traditional Chinese medicine anxiolytic bag and a preparation method thereof, the traditional Chinese medicine anxiolytic bag comprises at least one of an oral preparation and aromatherapy, and the oral preparation comprises the following components: clary sage, marjoram, cypress, mint, orange peel, ginseng, lycium ruthenicum and mulberry; the champignon comprises the following components: clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet and orange flower. Through the design of the raw material components of the oral preparation, the anxiolytic ability of the organism can be improved, and all the components are medicinal and edible homology sources, so that the medicinal effect is mild, natural, safe and free from toxic and side effects, and the oral preparation can be taken for a long time; through the design of the raw material components of the external aromatherapy, the nervous system can be regulated through the blood brain barrier, the anxiety feeling is reduced, and meanwhile, the environment of an anxiety patient is improved through volatile substances of the traditional Chinese medicine, so that the anti-anxiety effect is better, and each raw material component is natural, safe and free of toxic and side effects; the oral administration is combined with the external application, and the effect is better.

Description

Traditional Chinese medicine anti-anxiety bag and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine anti-anxiety bag and a preparation method thereof.

Background

With the improvement of living standard of people, mental diseases gradually occupy one of the leading diseases threatening the health of modern people. In the modern age with advanced technology, people feel stressed, and the anxiety is just like a popular vocabulary. Anxiety disorders also fall into different categories depending on the symptoms and the time of onset. Anxiety disorders can be broadly classified into the following: generalized anxiety disorder, social anxiety disorder, panic disorder, obsessive compulsive disorder, and post-traumatic stress disorder.

Currently, the anxiolytic drugs mainly used in clinical practice are: dinitrogen benzene

Class (BZD), non-benzodiazepines

And antidepressant drugs with anxiolytic effect, and the like, and the drugs have side effects with different degrees. The new anxiolytic drugs such as Saletide, etc. have high price and still have side effects. Therefore, the search for an anti-anxiety drug which is economical, has little side effect and is widely used is urgent. The traditional Chinese medicine has the advantages of low price, small side effect and the like, so that the traditional Chinese medicine has obvious advantages and application prospects in the aspect of treating anxiety disorder.

Disclosure of Invention

The invention mainly aims to provide a traditional Chinese medicine anti-anxiety package and a preparation method thereof, and aims to provide the anti-anxiety traditional Chinese medicine package with small side effect and low cost.

In order to achieve the above object, the present invention provides a traditional Chinese medicine anxiolytic bag, which comprises: at least one of an oral preparation and aromatherapy, wherein the oral preparation comprises the following components: clary sage, marjoram, cypress, mint, orange peel, ginseng, lycium ruthenicum and mulberry;

the aromatherapy comprises the following components: clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet and orange blossom.

Optionally, in the oral preparation, the parts by weight of the clary sage, marjoram, cypress, mint, orange peel, ginseng, lycium ruthenicum and mulberry correspond to: 1 to 50 parts, 1 to 60 parts, 1 to 50 parts, 2 to 100 parts and 2 to 100 parts.

Optionally, in the oral preparation, the parts by weight of the clary sage, marjoram, cypress, mint, orange peel, ginseng, lycium ruthenicum and mulberry correspond to: 10 to 30 parts, 20 to 30 parts, 10 to 30 parts, 15 to 35 parts, 20 to 40 parts, 10 to 30 parts, 30 to 70 parts and 40 to 70 parts.

Optionally, in the aromatherapy, the parts by weight of the clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet, and orange flower correspond to: 1 to 50 parts, 2 to 100 parts, 1 to 50 parts, 1 to 60 parts, 2 to 100 parts and 2 to 100 parts.

Optionally, in the aromatherapy, the parts by weight of the clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet, and orange flower correspond to: 10 to 30 parts, 30 to 60 parts, 20 to 40 parts, 15 to 35 parts, 20 to 40 parts, 30 to 50 parts, 30 to 60 parts, 30 to 70 parts and 20 to 80 parts.

Optionally, the dosage form of the oral preparation comprises any one of tablets, powders, granules, pills and paste.

Based on the above purpose, the invention also provides a preparation method of the traditional Chinese medicine anxiolytic bag, which comprises the following steps:

s10, preparing an oral preparation; and/or the presence of a gas in the atmosphere,

s20, preparing the aromatherapy.

Optionally, step S10 includes:

s11, uniformly mixing the raw material components of the oral preparation, extracting for 2-4 times, and then combining to obtain an extracting solution;

s12, concentrating and drying the obtained extracting solution to obtain a dry extract;

s13, crushing and sieving the dry extract to obtain extract powder, and preparing the extract powder into an oral preparation.

Optionally, in step S11, the extraction time of the extraction is 0.5 to 3 hours, and the mass of the extraction solvent is 5 to 15 times of the total mass of the raw materials; and/or the presence of a gas in the gas,

in the step S12, the drying temperature is 40-60 ℃, and the pressure is 0.01-0.10 MPa; and/or the presence of a gas in the gas,

in step S13, the sieving is to pass through a 100-300 mesh sieve.

Optionally, step S20 includes the steps of: the preparation method of the champignon comprises the following steps:

s21, uniformly mixing the raw material components of the aromatherapy, crushing, and extracting to obtain volatile oil;

s22, adsorbing the volatile oil by using mesoporous silica, stirring, and sealing to obtain the aromatherapy.

According to the technical scheme provided by the invention, the traditional Chinese medicine anxiolytic bag contains an oral preparation, or champignon, or both the oral preparation and the champignon, the internal environment of an organism can be regulated through the design of raw material components of the oral preparation, and the anxiolytic capability of the organism is improved through a blood brain barrier; the external aromatherapy acts on respiratory mucosa, and through the design of the raw material components of the external aromatherapy, on one hand, the nervous system can be regulated through a blood brain barrier to reduce anxiety feeling, and on the other hand, the environment of an anxiety patient is improved through volatile substances of traditional Chinese medicines, so that the anxiolytic effect is better, and each raw material component is natural, safe and free of toxic and side effects; the oral administration is combined with the external application, and the effect is better.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. The examples, in which specific conditions are not specified, were carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.

It should be noted that those who do not specify specific conditions in the examples were performed under the conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially. In addition, the meaning of "and/or" appearing throughout includes three juxtapositions, exemplified by "A and/or B" including either A or B or both A and B. In addition, technical solutions between the various embodiments may be combined with each other, but must be based on the realization of the capability of a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Class (BZD), non-benzodiazepines

And antidepressant drugs with anxiolytic effect, and the like, and the drugs have side effects with different degrees. The new anxiolytic drugs such as celecoxib and the like are high in price and still have side effects. Therefore, the search for an anti-anxiety drug which is economical, has little side effect and is widely used is urgent. The traditional Chinese medicine has the advantages of low price, small side effect and the like, so that the traditional Chinese medicine has obvious advantages and application prospects in the aspect of treating anxiety disorder.

In view of the above, the invention provides a traditional Chinese medicine anxiolytic bag, which comprises at least one of an oral preparation and aromatherapy, wherein the oral preparation comprises the following components: clary sage, marjoram, cypress, mint, orange peel, ginseng, lycium ruthenicum and mulberry;

the champignon comprises the following components: clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet and orange blossom.

In a first embodiment, the traditional Chinese medicine anxiolytic bag is externally applied with aromatherapy, wherein the aromatherapy comprises the following components: clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet and orange blossom.

The volatile components in clary sage mainly contain volatile oil, phenols, phenolic acid and derivatives thereof, such as: linalool, linalyl acetate, caryophyllene, alpha-terpineol, geraniol, neryl acetate, sclareol, germacrene and the like, salvia can be used for treating anxiety, stress, tension and depression mental diseases, can restore weak nervous systems and is commonly used for fatigue, neurasthenia, lassitude, stress and insomnia, and the anxiolytic effect of the salvia is mainly realized by acting on a DANERGIC signal to reduce the cortisol level in blood plasma and increase the concentration of 5-hydroxytryptamine (5-HT).

The origanum majorana mainly contains monoterpene, diterpene or flavonoid components, such as: the animal behavior tests show that the marjoram water-ethanol extract can effectively increase the exploration times and time of a light region in a light and dark box test (LDB) and shows an anxiolytic effect.

Cypress mainly contains (+) -Carrageenan, alpha-patchouli, furans, beta-selenene, alpha-selenene, sabinene, delta-limonene, beta-cubebene and bornyl acetate, and the protein and mRNA expression of brain-derived neurotrophic factor (BDNF) in hippocampus is effectively improved and promoted mainly by activating cAMP reaction element binding protein (CREB).

Mint, 3-octanol, limonene, linalool, menthone, menthol, carvone, menthyl acetate, eucalyptol, corticosterone (CORT) and hippocampal neurogenesis.

Orange peel, 2-methylamino-methyl benzoate, D-limonene, beta-myrcene, alpha-pinene, beta-pinene and linalyl acetate. Linalool in orange peel can inhibit the release of acetylcholine so as to change the ionic function of neuromuscular junction; linalyl acetate has anesthetic action.

The flos Caryophylli mainly contains eugenol, catecholamine, methyl eugenol, beta-caryophyllene, eugenol acetate and alpha-copaene. Wherein the eugenol and the methyl eugenol can play A role by regulating and controlling A SIRT1-MAO-A signal channel in A monoamine neurotransmitter 5-HT metabolic channel and influencing the content of COMT, ADH and AR metabolic enzymes in A catechol amine neurotransmitter metabolic channel and corresponding gene expression.

Perilla contains mainly linalyl acetate, linalool, alpha-terpineol, acetic acid, she Zhi, geraniol, 4-terpineol, neryl acetate, borneol, perillaldehyde, delta-3-carene, perillaldehyde induces specific protein expression mainly by enriching in and improving the cognitive function of a patient by generating a new hippocampal neural membrane structure.

The lavender mainly contains linalyl acetate, linalool, 4-terpineol, ocimene, beta-caryophyllene, alpha-terpineol, gamma-terpinene, carvone oxide, alpha-pinene oxide and limonene, parasympathetic nerve activity is increased, sympathetic nerve activity is reduced, and linalool and flavonoid compounds can increase the activity of GABA receptors.

The main components of violet comprise alkaloid, tannin, flavonoid, saponin, terpenoid and steroid, and can effectively improve the sleep quality and index of patients after treatment.

The main components of the neroli are limonene, coumarin, delta-3-carene, alpha-cadinene, linalool, trans-carveol, myrcene, caryophyllenol, cis-chrysanthenol, germacrene, D-4-alcohol and cis-calamene, and the limonene in the neroli reduces neurons in an active central nervous system through mediating a GABAergic pathway and antagonizes GABA receptors so as to generate an anxiolytic effect; coumarin increases GABA secretion of prefrontal cortex and hippocampus; linalool is a glutamate receptor antagonist that promotes glutamate release and modulates presynaptic inhibition, affecting acetylcholine release. Flavonoids, believed to be ligand receptors for GABA-A, act viabase:Sub>A mechanism similar to benzodiazepines

Quasi-drugs by addition with benzodiazepine

Contact of the receptor exerts an anxiolytic effect.

The external aromatherapy provided by the invention acts on respiratory mucosa, and through the design of the raw material components, on one hand, the aromatherapy can regulate a nervous system through a blood brain barrier and reduce anxiety feeling, and on the other hand, the environment of an anxiety patient can be improved through volatile substances of traditional Chinese medicines, such as linalool, linalyl acetate, alpha-terpineol and other volatile components with an anxiolytic effect, so that the anxiolytic effect is better, and each raw material component is natural, safe and free of toxic and side effects.

In a second embodiment, the traditional Chinese medicine anxiolytic kit is an oral formulation, wherein the oral formulation comprises the following components: clary sage, marjoram, cypress, mint, orange peel, ginseng, lycium ruthenicum and mulberry.

Cypress resin, light and astringent taste, mild nature; it enters lung, liver and spleen meridians; has effects in relieving fever, eliminating dampness, and relieving pain; mainly treats fever, headache and leucorrhea; it is externally used for treating traumatic hemorrhage.

Mint, pungent taste, cool in nature; entering lung and liver meridians; has effects of dispelling pathogenic wind heat, clearing head and eyes, relieving sore throat, promoting eruption, dispersing stagnated liver qi, and activating qi-flowing; the main treatment is as follows: wind-heat common cold, headache, sore throat, food stagnation and flatulence, aphtha, toothache, scabies, urticaria, initial epidemic febrile disease, rubella pruritus, stagnation of qi due to depression of the liver, chest distress and hypochondriac pain.

Orange peel, bitter and pungent in flavor, warm in nature; entering lung and spleen meridians; has the effects of regulating qi, strengthening spleen, eliminating dampness and phlegm. The main indications are as follows: a gastric and abdominal distention, poor appetite, vomiting and diarrhea, cough with profuse sputum.

Ginseng, sweet and slightly bitter in taste, slightly warm in nature; entering lung, spleen and heart meridians; has effects of invigorating primordial qi, invigorating spleen, benefiting lung, promoting fluid production, tranquilizing mind, and improving intelligence; the main treatment is as follows: can be used for treating qi deficiency, hypolipemic, spleen qi deficiency, middle-jiao sinking, lung deficiency, asthma, cough, short breath, asthenia, body fluid consumption, thirst, asthenia heat, diabetes, insomnia, amnesia, palpitation, blood deficiency, sallow complexion, sexual impotence, and cold womb.

Lycium ruthenicum Murr is sweet in taste and mild in nature; has effects of regulating immunity, resisting aging, and relieving fatigue.

Mulberries, sweet and sour in taste and cold in nature; enter the lung, liver, kidney and large intestine meridians; has effects in nourishing liver, invigorating kidney, promoting salivation, moisturizing intestine, blackening hair, improving eyesight, quenching thirst, removing toxic materials, and caring skin; the main treatment is as follows: can be used for treating yin and blood deficiency, dizziness, night sweat, thirst due to body fluid consumption, diabetes, intestinal dryness, and constipation.

It should be noted that anxiety disorder is accompanied by symptoms of anxiety, chest distress, and headache due to chronic heat transformation from stagnation of liver qi, failure of qi to circulate, liver fire flaming up, heat disturbing the heart, or failure to nourish heart due to anxiety, heart-spleen deficiency, qi-blood generation, or kidney-yin deficiency, and failure to astringe heart-yin deficiency.

The oral preparation provided by the invention takes cypress and mint as leads, and the two ingredients of the oral preparation enter liver channels, so that the oral preparation has the effects of soothing liver, relieving depression and easing pain, and can help anxiety patients to sooth liver, regulate qi, relieve depression and effectively relieve pain symptoms; the ginseng, the medlar and the orange peel are used for assisting in regulating the flow of qi, strengthening the spleen, tonifying the heart and the spleen, replenishing qi and blood, nourishing the heart, soothing the nerves and tranquilizing the mind; the mulberry has the effects of tonifying liver and kidney, nourishing brain and improving intelligence, and can effectively improve the immunity of the organism; the marjoram is sweet in taste, has the effects of relaxing nerves and relieving headache, improves the smell of the traditional Chinese medicine on one hand, gains the effect of resisting anxiety on the other hand, and comprehensively and effectively relieves symptoms such as insomnia, headache and the like caused by anxiety; the volatile components of the components such as the clary sage, the marjoram, the cypress, the mint, the orange peel and the like are mostly small molecular compounds, and the volatile components are combined with the volatile characteristics of the small molecular compounds, so that the small molecular compounds can easily permeate blood brain barriers to reach target organs (brains), and the drug effect can be fully exerted; in addition, all the raw material components in the oral preparation are medicinal and edible homology sources, the medicinal effect is mild and not irritant, the oral preparation is natural, safe and free of toxic and side effects, and the oral preparation can be taken for a long time and has an obvious effect. Therefore, the oral preparation provided by the invention has the advantages that through the design of the raw material components, the prepared oral preparation has appropriate smell and taste, is safe and free of side effect, and has an obvious anxiolytic effect.

In a third embodiment, the traditional Chinese medicine anxiolytic bag is an oral preparation and an external aromatherapy, and the oral preparation comprises the following components: clary sage, marjoram, cypress, mint, orange peel, ginseng, lycium ruthenicum and mulberry; the aromatherapy comprises the following components: clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet and orange blossom.

The anxiety-causing factors are multiple and complex, the single drug treatment form can cause the aversion of anxiety people to influence the treatment effect, in the embodiment, the oral administration is combined with the external use in diversified forms, the anxiety mood of the anxiety can be effectively relieved, and the effect on the aspect of anxiety resistance is remarkable.

It can be understood that, since this embodiment includes all the technical solutions of the first embodiment and the second embodiment, at least the beneficial effects of the first embodiment and the second embodiment are achieved, and details are not described herein.

According to the technical scheme provided by the invention, the traditional Chinese medicine anti-anxiety bag is an oral preparation, or aromatherapy, or both the oral preparation and the aromatherapy, the internal environment of an organism can be regulated through the design of raw material components of the oral preparation, the anti-anxiety capability of the organism is improved through a blood brain barrier, and the Chinese herbal medicine components in the oral preparation are both medicine-food homology sources, so that the medicine effect is mild and non-irritant, natural, safe and non-toxic, and the traditional Chinese medicine anti-anxiety bag can be taken for a long time and has an obvious effect; the external aromatherapy acts on respiratory mucosa, and through the design of the raw material components of the external aromatherapy, on one hand, the nervous system can be regulated through a blood brain barrier to reduce anxiety feeling, and on the other hand, the environment of an anxiety patient is improved through volatile substances of traditional Chinese medicines, so that the anxiolytic effect is better, and each raw material component is natural, safe and free of toxic and side effects; the oral administration is combined with the external application, and the effect is better.

In an embodiment of the oral preparation provided by the present invention, the parts by weight of salvia sclarea, marjoram, cypress, mint, orange peel, ginseng, lycium ruthenicum and mulberry correspond to: 1-50 parts, 1-60 parts, 1-50 parts, 2-100 parts and 2-100 parts, and under the mixture ratio range, the oral preparation has better anxiolytic effect.

In another preferred embodiment of the oral preparation provided by the present invention, the parts by weight of the clary sage, marjoram, cypress, mint, orange peel, ginseng, lycium ruthenicum and mulberry correspond to: 10 to 30 parts, 20 to 30 parts, 10 to 30 parts, 15 to 35 parts, 20 to 40 parts, 10 to 30 parts, 30 to 70 parts and 40 to 70 parts, and the oral preparation has excellent anxiolytic effect and good taste and smell in the mixture ratio.

The present invention does not limit the specific expression form of the oral preparation, and in this embodiment, the dosage form of the oral preparation includes any one of tablets, powders, granules, pills and pastes. It is understood that the components of the oral preparation further comprise pharmaceutically acceptable auxiliary materials, and the auxiliary materials can be flavoring agents and materials used in the preparation process, such as binding agents used in the preparation process of pills, wherein the binding agents can be honey or rice paste.

In an embodiment of the aromatherapy provided by the present invention, the parts by weight of the clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet, and orange blossom correspond to: 1-50 parts, 2-100 parts, 1-50 parts, 1-60 parts, 2-100 parts and 2-100 parts, and under the mixture ratio range, the anxiolytic effect of the external aromatherapy is better.

In another preferred embodiment of the aromatherapy provided by the present invention, the parts by weight of the clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet, and orange blossom correspond to: 10 to 30 parts, 30 to 60 parts, 20 to 40 parts, 15 to 35 parts, 20 to 40 parts, 30 to 50 parts, 30 to 60 parts, 30 to 70 parts and 20 to 80 parts, and the anti-anxiety effect of the aromatherapy is particularly good under the mixture ratio.

Further, the present invention also provides a preparation method of the above traditional Chinese medicine anxiolytic bag, in this embodiment, the preparation method comprises the following steps:

step S10, preparing an oral preparation; and/or the presence of a gas in the gas,

and S20, preparing the aroma.

In one embodiment, step S10 includes:

step S11, uniformly mixing the raw material components of the oral preparation, extracting for 2-4 times, and then combining to obtain an extracting solution;

wherein the extraction time is 0.5-3 h, and the mass of the extraction solvent is 5-15 times of the total mass of the raw materials. The extraction time is the total time of extraction 2 to 4 times, and the extraction solvent is the total mass of extraction 2 to 4 times.

wherein the drying temperature is 40-60 ℃, and the pressure is 0.01-0.10 MPa. Further, the drying temperature is preferably 50 ℃.

And step S13, crushing and sieving the dry extract to obtain extract powder, and preparing the extract powder into an oral preparation.

Wherein the sieving is 100-300 mesh sieving, preferably 200 mesh sieving. It should be noted that, in this embodiment, the method for preparing the extract powder into various dosage forms is a conventional method, and details are not described herein.

The present invention does not limit the specific kind of the aromatherapy, and may be a common external aromatherapy, in this embodiment, in order to make the volatilization efficiency higher and thus the treatment effect better, in this embodiment, the aromatherapy is a nano aromatherapy, in this embodiment, step S20 includes:

step S21, uniformly mixing the raw material components of the aromatherapy, crushing, and extracting to obtain volatile oil;

the method for extracting volatile oil is conventional and will not be described herein.

And S22, adsorbing the volatile oil by using mesoporous silicon dioxide, stirring, and sealing to obtain the aromatherapy.

Wherein the mass ratio of the volatile oil to the mesoporous silica is 1:3 to 6. The stirring speed of the stirring is 30-80 r/min, and the stirring time is 3-8 min.

The following provides a specific embodiment of the preparation method of the traditional Chinese medicine anxiolytic bag provided by the invention:

(1) Uniformly mixing the raw material components of the oral preparation, extracting for 2-4 times, and then combining to obtain an extracting solution, wherein the extracting time is 0.5-3 h, and the mass of an extracting solvent is 5-15 times of the total mass of the raw materials; concentrating the obtained extracting solution, and then placing the concentrated extracting solution into a vacuum drying oven for drying to obtain a dry extract, wherein the drying temperature of the vacuum drying is 40-60 ℃, and the pressure is 0.01-0.10 MPa; and (2) crushing the dry extract, sieving the crushed dry extract by a sieve of 100-300 meshes to obtain extract powder, and preparing the extract powder into an oral preparation, wherein the oral preparation comprises any one of tablets, powder, granules, pills and paste.

(2) Uniformly mixing the raw material components of the aromatherapy, crushing, and extracting to obtain volatile oil; adsorbing the volatile oil by using mesoporous silica, stirring for 3-8 min at the speed of 30-80 r/min, and sealing by using an aluminum foil bag to obtain the aromatherapy, wherein the mass ratio of the volatile oil to the mesoporous silica is 1:3 to 6.

The technical solutions of the present invention are further described in detail with reference to the following specific examples, which should be understood as merely illustrative and not limitative.

Example 1

(1) The traditional Chinese medicine anxiolytic bag is an oral preparation.

(2) The oral preparation comprises the following components in parts by weight: 20 parts of clary sage, 30 parts of marjoram, 10 parts of cypress, 35 parts of mint, 40 parts of orange peel, 20 parts of ginseng, 60 parts of lycium ruthenicum and 60 parts of mulberry.

(3) Uniformly mixing the raw material components, extracting for 3 times, and then combining to obtain an extracting solution, wherein the extracting time is 2 hours, and the mass of an extracting solvent is 10 times of the total mass of the raw materials; concentrating the obtained extracting solution, and drying in a vacuum drying oven to obtain dry extract, wherein the drying temperature of vacuum drying is 50 ℃, and the pressure is 0.05MPa; pulverizing the dry extract, sieving with a 200 mesh sieve to obtain extract powder, and making the extract powder into granule, i.e. oral preparation.

Example 2

(1) The traditional Chinese medicine anti-anxiety bag is an oral preparation.

(2) The oral preparation comprises the following components in parts by weight: 50 parts of clary sage, 30 parts of marjoram, 1 part of cypress, 30 parts of mint, 1 part of orange peel, 40 parts of ginseng, 100 parts of lycium ruthenicum and 100 parts of mulberry.

(3) Uniformly mixing the raw material components, extracting for 4 times, and then combining to obtain an extracting solution, wherein the extraction time is 1h, and the mass of an extracting solvent is 5 times of the total mass of the raw materials; concentrating the obtained extracting solution, and drying in a vacuum drying oven to obtain dry extract, wherein the drying temperature of vacuum drying is 40 ℃, and the pressure is 0.10MPa; and (3) crushing the dry extract, sieving the crushed dry extract by a 100-mesh sieve to obtain extract powder, and preparing the extract powder into tablets, namely oral preparations.

Example 3

Except that the oral preparation replaced in the step (2) comprises the following components in parts by weight: 30 parts of clary sage, 2 parts of marjoram, 50 parts of cypress, 1 part of mint, 60 parts of orange peel, 1 part of ginseng, 70 parts of lycium ruthenicum mill and 50 parts of mulberry, and the rest steps are the same as the steps in the example 1.

Example 4

Except that the oral preparation replaced in the step (2) comprises the following components in parts by weight: 1 part of clary sage, 50 parts of marjoram, 20 parts of cypress, 50 parts of mint, 20 parts of orange peel, 50 parts of ginseng, 1 part of lycium ruthenicum mill and 2 parts of mulberry, and the rest steps are the same as those in example 1.

Example 5

(1) The traditional Chinese medicine anxiolytic bag is aromatherapy.

(2) The aromatherapy comprises the following components in parts by weight: 10 parts of clary sage, 30 parts of marjoram, 30 parts of cypress, 20 parts of mint, 40 parts of orange peel, 40 parts of clove, 40 parts of purple perilla, 60 parts of lavender, 70 parts of violet and 80 parts of orange flower.

(3) Mixing the above raw materials, pulverizing, and extracting to obtain volatile oil; adsorbing the volatile oil by using mesoporous silica, stirring for 5min at the speed of 60r/min, and sealing by using an aluminum foil bag to obtain the nano aromatherapy, wherein the mass ratio of the volatile oil to the mesoporous silica is 1:4.

example 6

(1) The traditional Chinese medicine anxiolytic bag is aromatherapy.

(2) The aromatherapy comprises the following components in parts by weight: 1 part of clary sage, 50 parts of marjoram, 20 parts of cypress, 1 part of mint, 40 parts of orange peel, 1 part of clove, 40 parts of purple perilla, 2 parts of lavender, 30 parts of violet and 100 parts of orange flower.

(3) Uniformly mixing the raw material components, crushing, and extracting to obtain volatile oil; adsorbing the volatile oil by using mesoporous silica, stirring for 8min at the speed of 30r/min, and sealing by using an aluminum foil bag to obtain the nano aromatherapy, wherein the mass ratio of the volatile oil to the mesoporous silica is 1:3.

example 7

Except that the champignon in the step (2) is replaced by the champignon, and the champignon comprises the following components in parts by weight: 50 parts of clary sage, 2 parts of marjoram, 50 parts of cypress, 50 parts of mint, 1 part of orange peel, 30 parts of clove, 60 parts of purple perilla, 70 parts of lavender, 100 parts of violet and 2 parts of orange flower, and the rest steps are the same as the example 5.

Example 8

Except that the champignon in the step (2) is replaced by the champignon, and the champignon comprises the following components in parts by weight: 20 parts of clary sage, 100 parts of marjoram, 1 part of cypress, 25 parts of mint, 60 parts of orange peel, 60 parts of clove, 1 part of perilla, 100 parts of lavender, 20 parts of violet and 50 parts of orange flower, and the rest steps are the same as the steps in the example 5.

Example 9

(1) The traditional Chinese medicine anxiolytic bag comprises an oral preparation and an external aromatherapy.

(2) The oral preparation comprises the following components in parts by weight: 20 parts of clary sage, 20 parts of marjoram, 10 parts of cypress, 25 parts of mint, 30 parts of orange peel, 20 parts of ginseng, 50 parts of lycium ruthenicum and 70 parts of mulberry. Uniformly mixing the raw material components, extracting for 2 times, and then combining to obtain an extracting solution, wherein the extracting time is 3 hours, and the mass of an extracting solvent is 15 times of the total mass of the raw materials; concentrating the obtained extracting solution, and drying in a vacuum drying oven to obtain dry extract, wherein the drying temperature of vacuum drying is 60 ℃, and the pressure is 0.01MPa; and (3) crushing the dry extract, sieving the crushed dry extract by a 300-mesh sieve to obtain extract powder, and preparing the extract powder into pills, namely the oral preparation.

(3) The aromatherapy comprises the following components in parts by weight: 10 parts of clary sage, 30 parts of marjoram, 20 parts of cypress, 30 parts of mint, 20 parts of orange peel, 30 parts of clove, 20 parts of purple perilla, 60 parts of lavender, 50 parts of violet and 30 parts of orange flower. Uniformly mixing the raw material components, crushing, and extracting to obtain volatile oil; adsorbing the volatile oil by using mesoporous silica, stirring for 3 at 80r/min, and sealing by using an aluminum foil bag to obtain the nano aromatherapy, wherein the mass ratio of the volatile oil to the mesoporous silica is 1:6.

comparative example 1

The procedure was the same as in example 1 except that the oral preparation did not accelerate the formation of salvia.

Comparative example 2

The procedure was the same as in example 1 except that peppermint was not added to the oral formulation.

Comparative example 3

The procedure was the same as in example 5 except that marjoram was not added to the aroma.

Comparative example 4

The procedure was the same as in example 5 except that cedar was not added to the aroma.

1. The anti-anxiety effect behavioral experiments of the traditional Chinese medicine anti-anxiety packages prepared in examples 1 to 9 and comparative examples 1 to 4 were carried out, and the method and results thereof are as follows:

1. laboratory animal

Healthy male BALB/C mice weighing 18-22g were selected.

2. Apparatus and device

ZH-YLS-1 small animal spontaneous activity recorder, YLS-17B mouse light and dark box, ZH-DSG elevated plus maze, ST80C type illuminometer, and Xeye animal behavior video analysis system V3.20 version.

3. Animal experiment grouping

After adaptive feeding of 60 healthy male BALB/C mice for 5 days, randomly dividing the mice into 6 groups, wherein each group comprises 10 mice, namely a control group (distilled water), the oral preparation (low dose, medium dose and high dose) prepared in example 1, the nano aromatherapy prepared in example 5, and the traditional Chinese medicine anxiolytic bag comprising the oral preparation and the aromatherapy prepared in example 9; the breeding temperature is 22 ℃ +/-1 ℃.

Wherein, the low dosage refers to an oral preparation prepared by the total mass of the raw materials for feeding every time being 2g, the medium dosage refers to an oral preparation prepared by the total mass of the raw materials for feeding every time being 5g, and the high dosage refers to an oral preparation prepared by the total mass of the raw materials for feeding every time being 10 g; mice were fed three times a day for 21 consecutive days. The aromatherapy in the examples 5 and 9 is a nano aromatherapy prepared from 210g of the total mass of the raw materials, and the mice are allowed to continuously take the aromatherapy for 21 days; the oral formulation of example 9 was fed at a medium dose in the same manner as in example 1. The total mass of the raw materials herein refers to the total mass of the prescription.

4. Body weight gain determination

The weight of the mice was weighed with an electronic balance at the start of the experiment and at the end of the study, and the weight gain of the mice during the experiment was calculated.

Body weight gain (g) = body weight at end of experiment (g) -body weight before experiment (g)

5. Mouse light and dark box

Based on natural aversion and preference of animals to light, in an LDB experiment, the light of a bright box is brighter, a contradiction psychology which is feared and attracted to exploration of mice is generated, and the dark box is relatively safe, so that the contradiction psychology causes anxiety state of the mice. The anxiolytic can increase the light exploration of the mouse and overcome the fear of the mouse to the light to a certain extent, and is particularly characterized by increasing three indexes of the latency period, the box-passing times and the total time of the left-box detention. The mouse light and dark box is composed of a polypropylene experiment box, the length, the width and the height are respectively 44cm, 21cm and 21cm, and the mouse light and dark box is divided into a light box and a dark box, wherein the light box accounts for 1/2 of the total volume, the dark box accounts for 1/2 of the total volume, and a small hole is formed between the light box and the dark box and can be freely penetrated by a mouse.

6. Elevated cross maze

EPM is a commonly used classical model in animal model evaluation systems for "anxiety disorders". The model utilizes the nature that animals want to explore unknown new environment, and produces the horror after discovering that the animals are in the open arm of high overhang, and the two can cause the stress reaction of psychological contradiction, well simulate the clinical anxiety disorder. The selective preference of the animals for the open arms suspended at high altitude in the experiment is inversely related to the anxiety degree of the animals, namely, the increase of the time for entering the open arms and the increase of the times can indicate that the anxiety disorder degree of the animals is reduced. If the retention time of the experimental animal in the open arm is prolonged and the number of times of entering the open arm is increased after the administration of the anxiolytic drug, the anxiolytic drug is suggested to have anxiolytic effect.

The mouse elevated cross maze consists of four arms and a central area, wherein the four arms are two opposite open arms (open arm, the length multiplied by the width is 30cm multiplied by 6cm respectively); two opposing closed arms (length x width x height, respectively, 30cm x 6cm x 15 cm), and a central region connecting four arms (5 cm x 5 cm) (i.e., open arm-central platform-open arm or closed arm-central platform-closed arm, which are perpendicular to each other in a "ten" (plus) shape). Short baffles of 1cm height around the edges of the open arms, which are intended to prevent the animals from inadvertently sliding down the maze during the experiment. The maze is made of organic glass with the thickness of 0.5cm, and except that the bottom plates and the central areas of the four arms are black, the rest parts are colorless and transparent. The organic glass part is integrally fixed on a bracket (consisting of a black cross-shaped wooden frame with equal length and width and a stainless steel liftable base), so that the labyrinth bottom plate is adjusted to be 50cm away from the ground of a laboratory. And the camera is connected with analysis software above the center of the maze, and tracks and records the activity condition of the mouse in the maze.

7. Test results

The effects on the body weight of the mice, the results of the mouse light and dark boxes, and the results of the elevated plus maze test are shown in tables 1, 2, and 3, respectively.

TABLE 1 Effect of groups on mouse body weight

As can be seen from Table 1, the mice in each group had smooth skin and hair, good mental status and no adverse reaction. Compared with the control group, the weight growth values of the mice in the high, medium and low dose groups of example 1 and the groups of examples 5 and 9 have no significant difference (p is more than 0.05), which indicates that the animals do not influence the growth no matter the mice are orally taken or externally used.

Table 2 mouse light and dark box test results

As can be seen from Table 2, the light box latency of the high, medium and low dose groups of example 1 and the mice of examples 5 and 9 was significantly increased (p < 0.01 or p < 0.05), the total light box retention time was significantly increased (p < 0.01 or p < 0.05), and the dark box latency was significantly decreased (p < 0.01 or p < 0.05) compared to the control group, indicating that the drug group was effective in anti-anxiety by oral administration and external application.

TABLE 3 elevated Cross maze test results

As can be seen from Table 3, there was no significant difference in the total number of open arm and closed arm activities (p > 0.05) in each group of mice, and the administration did not affect the normal behavioral activities of the mice. Compared with the control group, the mice in the high, medium and low dose groups of example 1 and the mice in the examples 5, 8 and 9 have obviously increased time and frequency of entering the open arm (p is less than 0.01 or p is less than 0.05), and the time and frequency percentage of entering the open arm are obviously increased (p is less than 0.01 or p is less than 0.05), which indicates that the oral administration and the external administration of the drug group can effectively resist anxiety.

2. The traditional Chinese medicine anxiolytic packages prepared in the examples and comparative examples were tested as follows:

the test consisted of 260 volunteers, half each male and female, aged 15-50 years, all suffered from anxiety, randomized into 13 groups, treatment: the oral preparations prepared in examples 1-4 and comparative examples 1 and 2, each time 5g (referring to the weight of the extract powder), 3 times a day, each time after breakfast, lunch and supper, 3 weeks as a treatment course, and after 5 treatment courses, the treatment effect is counted; the nano aromatherapy prepared in examples 5 to 8 and comparative examples 3 and 4 was administered for 21 days, the total mass of the raw material components in the nano aromatherapy was 200g, and the curative effect was counted; in example 9, the administration manner of the nano aromatherapy article is the same as that of example 5 except that the amount of the oral preparation is 3g at a time, and the rest is the same as that of example 1.

Evaluation was performed according to the International health organization for diagnostic criteria for anxiety disorders (ICD-10): the patient presents the following elements comprised by the primary symptoms of anxiety:

(a) Panic (unfortunate distress in the future, feeling "restlessness," difficulty concentrating on, etc.);

(b) Exercise stress (restlessness, tension headache, tremor, inability to relax);

(c) Hyperactivity of vegetative nerve (heaviness of the head and feet, sweating, tachycardia or tachypnea, epigastric discomfort, dizziness, dry mouth, etc.).

And (3) curing: the above 3 elements are all lightened or disappeared; the method is effective; any 2 of the above elements are reduced or eliminated; invalid; none of the above 3 elements was reduced or eliminated.

TABLE 4 drug efficacy test data

As can be seen from Table 4, the treatment effects of the examples 1 to 9 on anxiety are better than those of the comparative examples 1 to 4, so that the compatibility of the traditional Chinese medicines in the formula of the invention achieves better anti-anxiety effect, and the lack of one of the traditional Chinese medicines can reduce the anti-anxiety effect; in addition, the effective rate (the number of cure cases + the number of effective cases) of the anxiety disorder treatment in the example 9 is higher than that of other examples, which shows that the anti-anxiety bag provided by the invention can achieve the best anti-anxiety effect by matching the external aromatherapy and the internal aromatherapy; in addition, as can be seen from comparative example 1 and examples 2 to 4, the anti-anxiety effect is better when the addition amount of each component of the oral preparation is within the preferable range of the present invention, and as can be seen from comparative example 5 and examples 6 to 8, the anti-anxiety effect is better when the addition amount of each component of the aromatherapy is within the preferable range of the present invention.

The above is only a preferred embodiment of the present invention, and it is not intended to limit the scope of the invention, and various modifications and changes will occur to those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention shall be included in the scope of the present invention.

Claims

1. The traditional Chinese medicine anxiolytic bag is characterized by comprising an oral preparation and aromatherapy, wherein the oral preparation is prepared from the following raw materials: clary sage, marjoram, cypress, mint, orange peel, ginseng, lycium ruthenicum and mulberry; in the oral preparation, the weight parts of the clary sage, the marjoram, the cypress, the mint, the orange peel, the ginseng, the lycium ruthenicum and the mulberry correspond to that: 1 to 50 parts, 1 to 60 parts, 1 to 50 parts, 2 to 100 parts and 2 to 100 parts; the preparation method of the oral preparation comprises the following steps:

s11, uniformly mixing the raw material components of the oral preparation, extracting 2~4 times, and then combining to obtain an extracting solution;

s13, crushing and sieving the dry extract to obtain extract powder, and preparing the extract powder into an oral preparation;

the champignon is prepared from the following raw materials: clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet and orange blossom; in the aromatherapy, the parts by weight of the clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet and orange flower are as follows: 1 to 50 parts, 2 to 100 parts, 1 to 50 parts, 1 to 60 parts, 2 to 100 parts and 2 to 100 parts; the preparation method of the champignon comprises the following steps:

s22, adsorbing the volatile oil by using mesoporous silicon dioxide, stirring, and sealing to obtain the aromatherapy.

2. The traditional Chinese medicine anxiolytic bag according to claim 1, wherein the oral preparation comprises, in parts by weight, salvia sclarea, marjoram, cypress, mint, orange peel, ginseng, lycium ruthenicum and mulberry fruit: 10 to 30 parts, 20 to 30 parts, 10 to 30 parts, 15 to 35 parts, 20 to 40 parts, 10 to 30 parts, 30 to 70 parts and 40 to 70 parts.

3. The traditional Chinese medicine anxiolytic bag of claim 1, wherein in the aromatherapy, the parts by weight of the clary sage, marjoram, cypress, mint, orange peel, clove, perilla, lavender, violet, and orange blossom correspond to: 10 to 30 parts, 30 to 60 parts, 20 to 40 parts, 15 to 35 parts, 20 to 40 parts, 30 to 50 parts, 30 to 60 parts, 30 to 70 parts and 20 to 80 parts.

4. The traditional Chinese medicine anxiolytic kit according to claim 1, wherein a dosage form of the oral preparation includes any one of a tablet, a powder, a granule, a pill, and an ointment.

5. A method for preparing the traditional Chinese medicine anxiolytic kit according to any one of claims 1 to 4, comprising the following steps:

s10, preparing an oral preparation;

s20, preparing the champignon.

6. The method for preparing the traditional Chinese medicine anxiolytic kit according to claim 5, wherein the step S10 includes:

7. The preparation method of the traditional Chinese medicine anxiolytic bag according to claim 6, wherein in step S11, the extraction time is 0.5 to 3 hours, and the mass of the extraction solvent is 5 to 15 times of the total mass of the raw materials; and/or the presence of a gas in the gas,

in the step S12, the drying temperature is 40 to 60 ℃, and the pressure is 0.01 to 0.10MPa; and/or the presence of a gas in the atmosphere,

in the step S13, the sieving is performed by sieving with a sieve of 100 to 300 meshes.

8. The method for preparing the traditional Chinese medicine anxiolytic kit according to claim 5, wherein the step S20 includes the steps of: the preparation method of the champignon comprises the following steps: