CN114146129A - Traditional Chinese medicine composition for improving sleep, foot bath bag containing same and application - Google Patents
Traditional Chinese medicine composition for improving sleep, foot bath bag containing same and application Download PDFInfo
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- CN114146129A CN114146129A CN202010930007.9A CN202010930007A CN114146129A CN 114146129 A CN114146129 A CN 114146129A CN 202010930007 A CN202010930007 A CN 202010930007A CN 114146129 A CN114146129 A CN 114146129A
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/754—Evodia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/758—Zanthoxylum, e.g. pricklyash
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/06—Antiarrhythmics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
Abstract
The invention discloses a traditional Chinese medicine composition for improving sleep, which is mainly prepared from the following raw materials in parts by weight: 15-30 parts of rhizoma acori graminei, 10-30 parts of safflower, 15-30 parts of cassia twig, 15-30 parts of ligusticum wallichii, 15-30 parts of rhizoma atractylodis, 15-30 parts of fructus evodiae, 20-25 parts of asarum, 15-30 parts of angelica sinensis, 15-30 parts of folium artemisiae argyi, 15-25 parts of pepper and 15-25 parts of garden balsam stem. Also discloses a foot bath bag, which comprises the traditional Chinese medicine composition for improving sleep. The submicron powder footbath bag for improving sleep provided by the invention has a remarkable curative effect on insomnia treatment, and no relapse of patients in a treatment group is observed in a follow-up process; in addition, no adverse reaction and toxic or side effect are found in the process of verifying the curative effect, and the preparation is worthy of clinical popularization and application.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine health care, and particularly relates to a traditional Chinese medicine composition for improving sleep, a foot bath bag containing the traditional Chinese medicine composition and a preparation method of the foot bath bag.
Background
With the pace of modern life increasing, social competition increasing and work pressure increasing, people's spirit is in a highly stressed state for a long time, thereby causing the number of insomnia patients to increase year by year. According to WHO survey reports: by investigating more than twenty thousand basic-level patients in 14 countries, up to 27% of patients have sleep problems, with insomnia occurring at 32-35% in the united states and 10-14% in the united kingdom, and over 30% in our country. Sleep disorder has become a common phenomenon affecting health, has high incidence rate and poses serious threats to health and social life. Persistent sleep disorder is one of the risk factors and is also an early clinical symptom of schizophrenia and other psychiatric disorders. Long-term insomnia can cause the decline of memory function, attention function and planning function, seriously affect normal work and life, even cause psychological diseases, cause diseases of organs such as heart, brain and the like, and cause accidents.
At present, the treatment scheme of insomnia mainly comprises psychological adjustment, drug therapy, external treatment and the like, the western medicine for treating insomnia mainly comprises sedative hypnotic drugs, the drugs are frequently used for a long time and are easy to generate addiction and drug resistance of different degrees, and symptoms are easy to rebound after drug withdrawal, so the western medicine is not suitable for long-term treatment of intractable insomnia patients and is also not particularly suitable for old patients suffering from sleep apnea syndrome, serious liver and kidney function insufficiency and other diseases.
The traditional Chinese medicine foot bath is one of the traditional Chinese medicine therapies. The ancient medical books record the "toe-observing method" and "arch channel" of foot, and many acupoints on the foot can reach the meridians of various viscera such as liver meridian, spleen meridian, stomach meridian, gallbladder meridian, kidney meridian, etc. The feet are the second heart of the human body, and the circulation of the feet can be stimulated through the process of foot bath, and then various organs of the body are affected. The traditional Chinese medicine foot bath principle is that hot water is utilized to promote medicine to permeate into a human body, decocted traditional Chinese medicine is placed into a foot bath basin, foot skin and capillary vessels are expanded by means of water vapor, acupuncture points and reflecting areas are stimulated, and pharmacological effects of the whole body and local focus of a disease are promoted by absorbing stimulation of effective components of the traditional Chinese medicine, so that the effects of external treatment of internal diseases and lower treatment of upper diseases are achieved.
CN 109745541A discloses a foot bath bag for insomnia patients and a preparation method thereof, wherein the foot bath bag is composed of 11 traditional Chinese medicine raw materials, and the crushing granularity is 60-80 meshes. CN 105943943A discloses a dendrobium officinale foot bath bag for improving sleep and promoting digestion, which is prepared from 36 traditional Chinese medicine raw materials by crushing into coarse powder and sieving with a 15-25 mesh sieve. CN 111388524A discloses a traditional Chinese medicine foot bath bag for inhibiting bacteria, diminishing inflammation, dredging channels, activating collaterals and improving sleep, which is composed of 5 traditional Chinese medicine raw materials, and the crushing particle size is 10-120 meshes.
The foot bath bag powder prepared by the patent has the crushing granularity range of 10-120 meshes, and the powder fineness is coarse powder, medium powder or fine powder. Under the condition of consistent water temperature and water quantity, the fineness difference of the medicinal material powder can generate different results on the extraction rate, transfer rate and yield of active ingredients in the medicinal material raw materials, and the exertion of the curative effect is directly influenced; in addition, the treatment range of the raw material formula is too wide and the pertinence is not strong, and the scientificity and rationality of the formula are not questioned.
Disclosure of Invention
The invention aims to overcome the defects in the prior art, and provides a traditional Chinese medicine composition for improving sleep, which has a scientific and reasonable formula; on the other hand, provides a foot bath bag containing the traditional Chinese medicine composition, a preparation method of the traditional Chinese medicine composition and application thereof. The traditional Chinese medicine composition and the foot bath bag comprising the same have incomparable advantages: (1) the grain size of the superfine powder is uniform and consistent; (2) the dissolution rate of the effective components is high, which is beneficial to improving the bioavailability and the efficacy of the medicine; (3) the utilization rate of the medicinal materials is high, and the resources of the Chinese medicinal materials are saved. The formula of the invention has the effects of clearing heat and soothing nerves, enriching blood and activating blood circulation, and removing blood stasis and promoting qi circulation, mainly treats diseases such as dysphoria, insomnia, palpitation and uneasiness, has obvious curative effect, and is worthy of clinical popularization and application. Therefore, the invention has wide market prospect.
In order to achieve the purpose, the invention provides the following technical scheme:
the invention provides a traditional Chinese medicine composition for improving sleep, which is mainly prepared from the following raw materials in parts by weight: 15-30 parts of rhizoma acori graminei, 10-30 parts of safflower, 15-30 parts of cassia twig, 15-30 parts of ligusticum wallichii, 15-30 parts of rhizoma atractylodis, 15-30 parts of fructus evodiae, 20-25 parts of asarum, 15-30 parts of angelica sinensis, 15-30 parts of folium artemisiae argyi, 15-25 parts of pepper and 15-25 parts of garden balsam stem.
Further, the traditional Chinese medicine composition for improving sleep is mainly prepared from the following raw materials in parts by weight: 20-25 parts of rhizoma acori graminei, 15-25 parts of safflower, 20-25 parts of cassia twig, 20-25 parts of ligusticum wallichii, 20-25 parts of rhizoma atractylodis, 20-25 parts of fructus evodiae, 20-25 parts of asarum, 20-25 parts of angelica sinensis, 20-25 parts of folium artemisiae argyi, 20-25 parts of pepper and 20-25 parts of garden balsam stem.
Preferably, the traditional Chinese medicine composition is an ultrafine powder mixture of raw materials, and the particle size of the ultrafine powder is not more than 75 μm. More preferably, the particle size of the ultrafine powder is 25 to 58 μm.
The invention provides a preparation method of the traditional Chinese medicine composition for improving sleep, and the traditional Chinese medicine composition is prepared by weighing the raw materials in parts by weight, drying, coarsely crushing, drying at low temperature, micronizing, uniformly mixing and sterilizing.
The invention further provides a preparation method of the traditional Chinese medicine composition for improving sleep, and the traditional Chinese medicine composition can be prepared by the following steps:
step 1, weighing raw materials of rhizoma acori graminei, safflower, cassia twig, ligusticum wallichii, rhizoma atractylodis, fructus evodiae, asarum, angelica sinensis, folium artemisiae argyi, pepper and garden balsam stem according to parts by weight, and drying at 35-50 ℃ for later use;
step 2, coarsely crushing the raw materials in the step 1, and sieving the crushed raw materials by a 24-50-mesh sieve to obtain coarse powder;
step 3, drying the coarse powder in the step 2 at a low temperature of-20 to-10 ℃, and carrying out superfine grinding to obtain superfine powder with the superfine powder grain diameter of not more than 75 microns, preferably 25 to 58 microns;
and 4, uniformly mixing the superfine powder obtained in the step 3, and sterilizing to obtain the traditional Chinese medicine composition.
In particular, the raw material composition of the present invention may be pulverized first and then mixed, or may be mixed first and then pulverized into powder, for example, into an ultrafine powder state.
In another aspect of the present invention, a foot bath bag is provided, which comprises the above traditional Chinese medicine composition for improving sleep.
In another aspect of the invention, the application of the traditional Chinese medicine composition for improving sleep in preparing the foot bath bag is provided.
Furthermore, the invention also provides application of the traditional Chinese medicine composition for improving sleep in preparation of medicines for treating dysphoria, insomnia, palpitation and restlessness.
The sources and the functions of the raw material medicaments are mainly as follows:
grassleaf sweelflag rhizome: is dried rhizome of Acrorus tatarinowii Schott of Araceae. The Chinese pharmacopoeia records: grassleaf sweelflag rhizome, rhizoma Acori Graminei, pungent, bitter and warm. It enters heart and stomach meridians. [ FUNCTIONS ] can induce resuscitation, eliminate phlegm, refresh mind, promote intelligence, eliminate dampness, and promote appetite. Can be used for treating coma, epilepsy, amnesia, insomnia, tinnitus, deafness, epigastric fullness, no hunger, vomiting and dysentery. Modern pharmacological research shows that the rhizoma acori graminei has a sedative effect, the decoction and the volatile oil of the rhizoma acori graminei can reduce spontaneous activity of mice and delay sleep time caused by sodium pentobarbital.
Safflower: is dried flower of Carthamus tinctorius L. The Chinese pharmacopoeia records: safflower, pungent in flavor and warm in nature. It enters heart and liver meridians. [ FUNCTIONS ] can promote blood circulation, dredge channels, dissipate blood stasis and relieve pain. Can be used for treating amenorrhea, dysmenorrhea, lochiorrhea, abdominal mass, thoracic obstruction, cardialgia, abdominal pain due to blood stasis, thoracic and hypochondriac pain, traumatic injury, and pyocutaneous disease with swelling and pain. Modern pharmacological research shows that hydroxysafflor yellow can protect nerves by weakening neurotoxicity of 6-hydroxydopamine Parkinson's disease rats.
Cassia twig: is dried twig of Cinnamomum cassia Presl of Lauraceae. The Chinese pharmacopoeia records: gui Zhi, [ sex and taste ] is pungent, sweet and warm. It enters heart, lung and bladder meridians. [ FUNCTIONS ] can induce sweat, dispel muscles, warm and dredge meridians, strengthen yang, regulate qi, and calm the adverse flow of qi. Can be used for treating wind-cold type common cold, abdominal psychroalgia, blood cold amenorrhea, arthralgia, phlegm retention, edema, palpitation, and galloping. Modern pharmacological studies show that, after a mouse is administered with cinnamaldehyde, the autonomous activity of the mouse is reduced, and the barbiturate drug action is increased [ Zhaojian one, pharmacological studies and clinical new use of cassia twig, Guangming traditional Chinese medicine, 2010, 25 (8): 1546-1547.].
Ligusticum wallichii: is dried rhizome of Ligusticum chuanxiong Hort. belonging to Umbelliferae. The Chinese pharmacopoeia records: chuan Xiong (character and taste) is pungent and warm. It enters liver, gallbladder and pericardium meridians. [ FUNCTIONS ] can promote blood circulation, promote the circulation of qi, dispel wind, and relieve pain. Can be used for treating thoracic obstruction, cardialgia, stabbing pain in chest and hypochondrium, traumatic injury, menoxenia, amenorrhea, dysmenorrhea, abdominal mass, headache, and rheumatalgia. Clinical studies show that ligustrazine is used as the main active ingredient of ligusticum wallichii and is widely applied to ischemic cerebrovascular diseases, such as cerebral ischemia, cerebral thrombosis, cerebral embolism and the like.
Rhizoma atractylodis: is dried rhizome of Atractylodes lancea (Thunb.) or Atractylodes chinensis Koidz. The Chinese pharmacopoeia records: rhizoma Atractylodis, is pungent, bitter and warm. It enters spleen, stomach and liver meridians. [ FUNCTIONS ] can eliminate dampness , dispel wind and cold, and improve eyesight. Can be used for treating damp obstruction of middle warmer, abdominal distention, diarrhea, edema, tinea pedis atrophy 36484m, rheumatalgia, wind-cold type common cold, night blindness, dim eyesight, and astringency. Modern pharmacological studies show that the rhizoma atractylodis volatile oil has a sedative effect on frogs [ Zhao Aimei, pharmacological action research of rhizoma atractylodis, Guangming traditional Chinese medicine, 2009, 24 (1): 181-181.].
Evodia fruit: dried near-ripe fruit of rutaecarpa, Euodia rutaecarpa (Juss.) benth, var, officinalis (Dode) Huang or rutaecarpa pubescens rutaecarpa (Juss.) benth, var, bodinieri (Dode) Huang. The Chinese pharmacopoeia records: evodia rutaecarpa, [ PROPERTIES AND WESTERILIES ] is pungent, bitter and hot; has little toxicity. It enters liver, spleen, stomach and kidney meridians. [ FUNCTIONS ] can dispel cold, alleviate pain, check adverse rise of qi, arrest vomiting, strengthen yang and arrest diarrhea. Modern pharmacological research shows that the fructus evodiae has the effects of reducing blood pressure, resisting thrombus, sterilizing and the like.
Asarum: dried roots and rhizomes of Aristolochiaceae, Asarum heterotropoides Fr.Schmidt var. mandshuricum (Maxim.) Kitag., Asarum sieboldii Miq.var. seoulen Nakai, or Asarum sieboldii Miq. The Chinese pharmacopoeia records: asarum herb, herba asari, pungent in flavor and warm in nature. It enters heart, lung and kidney meridians. [ FUNCTIONS ] can relieve exterior syndrome, dispel cold, dispel wind, alleviate pain, dredge orifices, warm lung and resolve retained fluid. Can be used for treating common cold due to wind-cold, headache, toothache, nasal obstruction, nasal discharge, allergic rhinitis, nasosinusitis, rheumatic arthralgia, phlegm and fluid retention, and cough and asthma. Modern pharmacological studies show that the asarum volatile oil has a central inhibition effect similar to barbital, and can obviously reduce the times of autonomous activities of mice, [ Yuanqin, Sunjianfen, the analgesic action site and mechanism research of asarum, Shanghai journal of medicine, 2009, 43 (5): 72-75.].
Chinese angelica: is dried root of Angelica sinensis (Oliv.) Diels) belonging to family Umbelliferae. The Chinese pharmacopoeia records: dang Gui (sex and taste) is sweet, pungent and warm. It enters liver, heart and spleen meridians. [ FUNCTIONS ] can tonify blood, promote blood circulation, regulate menstruation, relieve pain, moisten intestines and relieve constipation. Can be used for treating blood deficiency, sallow complexion, giddiness, palpitation, menoxenia, amenorrhea, dysmenorrhea, asthenia cold, abdominal pain, rheumatalgia, traumatic injury, superficial infection, pyocutaneous disease, intestinal dryness, and constipation. Modern pharmacological studies show that angelica can prolong sleep caused by barbital.
Folium artemisiae argyi: is dried leaf of Artemisia argyi Levl. et Vant. The Chinese pharmacopoeia records: folium artemisiae argyi, property and taste, is pungent, bitter and warm; has little toxicity. It enters liver, spleen and kidney meridians. [ FUNCTIONS ] can warm channels to stop bleeding, dispel cold to relieve pain; externally used for eliminating dampness and relieving itching. Can be used for treating hematemesis, epistaxis, metrorrhagia, menorrhagia, fetal leakage, lower blood, lower abdomen psychroalgia, menoxenia, and infertility due to cold womb. A large number of pharmacological studies show that the folium Artemisiae Argyi extract has antibacterial, antiviral and tranquilizing effects.
Chinese prickly ash: is dried mature pericarp of Rutaceae plant green pepper Zanthoxylum schinifolium Sieb.et Zucc. or Zanthoxylum bungeanum Maxim. The Chinese pharmacopoeia records: zanthoxylum bungeanum, pungent and warm in nature and flavor. It enters spleen, stomach and kidney meridians. [ FUNCTIONS ] can warm the middle energizer to relieve pain, kill parasites to relieve itching. Can be used for treating abdominal psychroalgia, emesis, diarrhea, and abdominal pain due to parasitic infestation. Modern pharmacological research shows that the pepper extract has the functions of resisting bacteria, killing insects and resisting atherosclerosis.
Garden balsam stem: is dried aerial part of Ballon, Speranskia tuboculata (Bunge) of Euphorbiaceae. The whole plant with flowers and fruits is cut in summer and autumn and dried in the sun. [ PROPERTIES AND FLAVOUR ] pungent and warm. It enters liver and kidney meridians. [ FUNCTIONS AND INDICATIONS ] can dispel pathogenic wind, remove dampness, relax tendons, activate collaterals, remove blood stasis, and relieve swelling.
The invention has the advantages that: according to the principle of treatment based on syndrome differentiation, the theory of meridian conduction and visceral manifestation, and the principle of skin mucosa absorption and physical stimulation in western medicine, the Chinese medicinal preparation can directly penetrate into acupoints with the aid of drug potency and heat to exert the effect, and is the traditional Chinese medicine external treatment. The foot 60 has many points closely related to the zang-fu organs and meridians, and is the "second heart" of the human body. The formula has the following technical effects: the traditional Chinese medicine compatibility degree of the traditional Chinese medicine theory is followed, the pharmacological analysis of the modern traditional Chinese medicine and the relevant theory and clinical achievement of the modern medicine are combined, the ingredients are taken into consideration, no additive is added, and the traditional Chinese medicine is safe and nontoxic; the process adopts superfine pulverizing process, so that the active ingredients can be rapidly absorbed, and the drug effect and bioavailability can be effectively improved.
Drawings
The drawings illustrate specific embodiments of the invention.
Fig. 1 is a flow chart of the preparation of a sleep-improving footbath bag according to the present invention.
Detailed Description
The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention. It is intended that all modifications or alterations to the methods, procedures or conditions of the present invention be made without departing from the spirit and substance of the invention.
Example 1
Raw materials: 150g of rhizoma acori graminei, 100g of safflower, 150g of cassia twig, 150g of ligusticum wallichii, 150g of rhizoma atractylodis, 150g of fructus evodiae, 200g of asarum, 150g of angelica, 150g of folium artemisiae argyi, 150g of pepper and 150g of garden balsam stem.
The preparation method comprises the following steps:
firstly, weighing the raw materials of grassleaf sweelflag rhizome, safflower, cassia twig, Szechuan lovage rhizome, swordlike atractylodes rhizome, medcinal evodia fruit, manchurian wildginger, Chinese angelica, Chinese mugwort leaf, Chinese prickly ash and garden balsam stem according to the weight, drying at 35 ℃, carrying out coarse crushing, and sieving by a 50-mesh sieve to obtain mixture coarse powder; drying at-10 deg.C, micronizing, sieving with 500 mesh sieve to obtain superfine powder with particle diameter no greater than 25 μm, mixing, sterilizing, and packaging into non-woven fabric foot bath bag to obtain superfine powder mixture foot bath bag.
Example 2
Raw materials: 300g of grassleaf sweelflag rhizome, 300g of safflower, 300g of cassia twig, 300g of szechuan lovage rhizome, 300g of rhizoma atractylodis, 300g of fructus evodiae, 250g of asarum, 300g of Chinese angelica, 300g of folium artemisiae argyi, 250g of pepper and 250g of garden balsam stem.
The preparation method comprises the following steps:
firstly, weighing the raw materials of grassleaf sweelflag rhizome, safflower, cassia twig, Szechuan lovage rhizome, swordlike atractylodes rhizome, medcinal evodia fruit, manchurian wildginger, Chinese angelica, Chinese mugwort leaf, Chinese prickly ash and garden balsam stem according to the weight, drying at 50 ℃, carrying out coarse crushing, and sieving by a 24-mesh sieve to obtain mixture coarse powder; drying at-20 deg.C, micronizing, sieving with 200 mesh sieve to obtain superfine powder with particle diameter no greater than 75 μm, mixing, sterilizing, and packaging into non-woven fabric foot bath bag to obtain superfine powder mixture foot bath bag.
Example 3
Raw materials: 250g of rhizoma acori graminei, 250g of safflower, 250g of cassia twig, 250g of ligusticum wallichii, 250g of rhizoma atractylodis, 250g of fructus evodiae, 250g of asarum, 250g of angelica, 250g of folium artemisiae argyi, 250g of pepper and 250g of garden balsam stem.
The preparation method comprises the following steps:
firstly, weighing the raw materials of grassleaf sweelflag rhizome, safflower, cassia twig, Szechuan lovage rhizome, swordlike atractylodes rhizome, medcinal evodia fruit, manchurian wildginger, Chinese angelica, Chinese mugwort leaf, Chinese prickly ash and garden balsam stem according to the weight, drying at 40 ℃, carrying out coarse crushing, and sieving by a 35-mesh sieve to obtain mixture coarse powder; drying at-15 deg.C, micronizing, sieving with 250 mesh sieve to obtain superfine powder with particle diameter no greater than 58 μm, mixing, sterilizing, and packaging into non-woven fabric foot bath bag to obtain superfine powder mixture foot bath bag.
Example 4
The quality of each of the footbath packs prepared in examples 1 to 3 was checked, and the results are shown in Table 1.
TABLE 1 foot bath bag quality test results
The following describes the application effect of the product:
clinical effect observation of superfine powder foot bath bag for improving sleep on insomnia treatment
1. Data and method
1.1 clinical data
The selected patients with gastritis who belong to the spleen-stomach damp-heat syndrome by traditional Chinese medicine differentiation totally comprise 100 cases, and the selected patients are respectively incorporated into a treatment group of 60 cases and a control group of 40 cases by adopting a random digital table according to the diagnosis sequence. The general data of sex, age, course of disease, etc. of two groups of patients have no obvious difference, P is more than 0.05, and the statistical significance is avoided, and the groups have comparability.
1.2 diagnostic criteria
Western diagnostic criteria: the insomnia diagnosis standard of 'Chinese adult insomnia diagnosis and treatment guideline' drawn up by the Chinese medical society neurological association sleep disorder group is referred. One of the following symptoms exists: difficulty falling asleep, sleep maintenance disorder, early awakening, decreased sleep quality or no sense of recovery after morning awakening in daily sleep; the symptoms still appear under the conditions of conditioned sleep and suitable sleep environment; patient complaints of at least one sleep-related daytime impairment of function: fatigue or general malaise; a decline in attention, attention maintenance, or memory; decreased learning, work, and/or social abilities; mood swings or irritability; thinking and sleeping in the daytime; decreased interest and energy; an increased tendency to error during work or driving; tension, headache, dizziness, or other somatic symptoms associated with loss of sleep; excessive attention to sleep; complaints of sleep disturbances occur at least 3 times per week and last for more than 1 month.
The traditional Chinese medicine diagnosis standard is as follows: refer to the "diagnosis and treatment routine for internal diseases of traditional Chinese medicine". The main symptoms are: difficulty in falling asleep or easy to wake up, insomnia after waking up, and insomnia through night; syndrome of secondary complications: palpitation, amnesia, dizziness, lassitude, abdominal distension, loose stool, and lusterless complexion; tongue manifestation: pale tongue with thin coating and pulse: the pulse is thready and weak. One main symptom is present, and more than 3 secondary symptoms are present, and the diagnosis can be confirmed by referring to the tongue pulse.
1.3 inclusion criteria
Firstly, symptoms such as difficulty in falling asleep, sleep maintenance disorder, early awakening, sleep quality reduction or no recovery feeling after morning awakening in daily sleep appear in a month; ② accords with the diagnosis standard of traditional Chinese medicine dialectical analysis; age 18-60 years without limitation; fourthly, the testee agrees with the information and signs the relevant documents.
1.4 exclusion criteria
Finding that the standard is seriously not met after the inclusion; ② the study is not finished and other studies are participated in.
1.5 methods of treatment
Example 1 was used for treatment group 1, example 2 was used for treatment group 2, and example 3 was used for treatment group 3. The use method of the foot bath bag comprises the following steps: before sleeping every night, taking a foot bath bag (containing 200g of medicinal powder), putting the non-woven fabric inner packaging bag and the medicinal powder into a foot bath basin, adding 2L of boiling water, stirring, standing for 10min, adding cold water to adjust the water temperature to 40-45 ℃, putting both feet into the foot bath basin for soaking, wherein the liquid level is higher than the ankle, soaking for 30min each time, adding hot water in time after cooling slightly, and soaking and rubbing the feet with the feet until the lower limbs and the back slightly sweat. After the completion, the feet are wiped off in time, and the warm is kept. 1 pack/time, 1 time/d, 4 weeks as a treatment course. Control 1 employed a blank, namely: the foot bath bag is not added, and the foot is soaked by hot water only, and the specific method is the same as that of the treatment group. The control group 2 adopts Chinese medicinal therapy, and takes Ginseng radix spleen invigorating pill 3 g/pill, 1 pill/time, 2 times/d, and 4 weeks as a treatment course. Each group was compared for efficacy at the end of treatment 1 course. During the treatment period, other sedative drugs are not taken.
1.6 evaluation method of therapeutic Effect
And (3) healing: the sleep time is recovered to be normal, or the sleep time at night is more than 6h, the sleep is deep, and the spirit after waking is good;
the effect is shown: the sleep is obviously improved, the sleep time is increased by more than 3h, and the sleep depth is also increased;
the method has the following advantages: the symptoms are relieved, but the sleep time is increased by less than 3 hours;
and (4) invalidation: the insomnia is not obviously improved or aggravated after the treatment.
The total effective rate (%) - (cure + significant effect + effective) cases/group number × 100%.
1.7 statistical analysis
Analyzing and processing each data by adopting statistical software SPSS 22.0, and expressing the measurement data by adopting the mean value plus or minus standard deviation of a sample; the comparison among groups adopts t test; the comparison of the counting data and the inter-group rate adopts non-parameter test, and the difference is that P is less than 0.05, which has statistical significance.
1.8 results
The results are shown in Table 2.
TABLE 2 comparison of clinical efficacy of each group
The difference was statistically significant (P < 0.05).
1.9 conclusion
The submicron powder footbath bag for improving sleep provided by the invention has a remarkable curative effect on insomnia treatment, and no relapse of patients in a treatment group is observed in a follow-up process; in addition, no adverse reaction and toxic or side effect are found in the process of verifying the curative effect, and the preparation is worthy of clinical popularization and application.
Claims (10)
1. A traditional Chinese medicine composition for improving sleep is characterized by being mainly prepared from the following raw materials in parts by weight: 15-30 parts of rhizoma acori graminei, 10-30 parts of safflower, 15-30 parts of cassia twig, 15-30 parts of ligusticum wallichii, 15-30 parts of rhizoma atractylodis, 15-30 parts of fructus evodiae, 20-25 parts of asarum, 15-30 parts of angelica sinensis, 15-30 parts of folium artemisiae argyi, 15-25 parts of pepper and 15-25 parts of garden balsam stem.
2. The traditional Chinese medicine composition for improving sleep as claimed in claim 1, which is mainly prepared from the following raw materials in parts by weight: 20-25 parts of rhizoma acori graminei, 15-25 parts of safflower, 20-25 parts of cassia twig, 20-25 parts of ligusticum wallichii, 20-25 parts of rhizoma atractylodis, 20-25 parts of fructus evodiae, 20-25 parts of asarum, 20-25 parts of angelica sinensis, 20-25 parts of folium artemisiae argyi, 20-25 parts of pepper and 20-25 parts of garden balsam stem.
3. The traditional Chinese medicine composition for improving sleep as claimed in claim 1 or 2, wherein the traditional Chinese medicine composition is an ultra-micro powder mixture of raw materials, and the particle size of the ultra-micro powder is not more than 75 μm.
4. The traditional Chinese medicine composition for improving sleep as claimed in claim 3, wherein the particle size of the ultrafine powder is 25 μm to 58 μm.
5. The method for preparing a traditional Chinese medicine composition for improving sleep as claimed in any one of claims 1 to 4, wherein the traditional Chinese medicine composition is prepared by weighing the raw materials in parts by weight, drying, coarse grinding, low-temperature drying, ultra-fine grinding, mixing, and sterilizing.
6. The method for preparing a traditional Chinese medicine composition for improving sleep as claimed in claim 5, wherein the traditional Chinese medicine composition is prepared by the following steps:
step 1, weighing raw materials of rhizoma acori graminei, safflower, cassia twig, ligusticum wallichii, rhizoma atractylodis, fructus evodiae, asarum, angelica sinensis, folium artemisiae argyi, pepper and garden balsam stem according to parts by weight, and drying at 35-50 ℃ for later use;
step 2, coarsely crushing the raw materials in the step 1, and sieving the crushed raw materials by a 24-50-mesh sieve to obtain coarse powder;
step 3, drying the coarse powder in the step 2 at a low temperature of-20 to-10 ℃, carrying out superfine grinding and sieving to obtain superfine powder with the particle size of not more than 75 mu m;
and 4, uniformly mixing the superfine powder obtained in the step 3, and sterilizing to obtain the traditional Chinese medicine composition.
7. The method for preparing a Chinese medicinal composition for improving sleep as claimed in claim 6, wherein the ultrafine pulverization is carried out, and the sieved ultrafine powder with a particle size of 25 μm to 58 μm is obtained.
8. A foot bath pack comprising the traditional Chinese medicine composition for improving sleep of any one of claims 1 to 4.
9. Use of the traditional Chinese medicine composition for improving sleep of any one of claims 1 to 4 in the preparation of a foot bath bag.
10. Use of the Chinese medicinal composition for improving sleep as claimed in any one of claims 1 to 4 in the preparation of a medicament for treating dysphoria, insomnia, palpitation, and restlessness.
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| CN111166859A (en) * | 2019-12-31 | 2020-05-19 | 深圳市淘莎店网络科技有限公司 | Foot bath powder and preparation method thereof |
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| CN111166859A (en) * | 2019-12-31 | 2020-05-19 | 深圳市淘莎店网络科技有限公司 | Foot bath powder and preparation method thereof |
Non-Patent Citations (1)
| Title |
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| AZG168: "治失眠偏方：中药泡脚治失眠偏方", 《HTTPS://WWW.AZG168.CN/PIANFANG/192658.HTML》 * |
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