Traditional Chinese medicine foot washing composition for sleep disorder, preparation and preparation method

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine foot washing composition for sleep disorder, a preparation and a preparation method, the traditional Chinese medicine composition comprises the following components: 10-19 parts of angelica sinensis, 5-15 parts of safflower, 15-28 parts of folium artemisiae argyi, 3-12 parts of caulis spatholobi, 6-19 parts of radix cyathulae, 2-7 parts of lycopodium clavatum, 3-16 parts of cowherb seed, 9-17 parts of frankincense, 4-11 parts of myrrh and 5-13 parts of rhizoma zingiberis. The traditional Chinese medicine composition disclosed by the invention can be applied to preparation of a solid preparation for foot bath and can be used for improving sleep, and the formula is clinically optimized for many years, so that the traditional Chinese medicine composition has the effects of activating blood to promote menstruation, improving the circulation function, improving the oxygen saturation of a human body and improving the sleep quality.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine foot-washing composition, a preparation and a preparation method for treating sleep disorders. Background Art

[0002] Sleep is an important part of a person's life. Sleep is conducive to physical and mental recovery, while sleep disorders can cause sensory dysfunction, reduced daytime work ability, and lead to anxiety and depression. The plateau has a special natural environment, which is characterized by low pressure, low oxygen, dryness, coldness, strong winds, and strong ultraviolet rays. Among them, the low oxygen environment has the greatest impact on sleep.

[0003] Plateau-related sleep disorders mainly include acute mountain sickness, chronic mountain sickness, high-altitude cerebral degeneration, high-altitude insomnia, high-altitude sleep apnea, high-altitude Cheyne-Stokes respiration, and high-altitude rhythm disorders. A survey shows that about 70% of people have sleep disorders within 1 week of entering the plateau. Even after acclimatizing to the plateau for 3 months, 40% of people have sleep disorders. The incidence of plateau sleep disorders is significantly higher than that of people in the plains. In the harsh plateau environment, long-term lack of sleep can lead to a decline in judgment, command, decision-making and other abilities, and even the risk of comorbidities. Therefore, in addition to the currently recognized physical treatments such as acupuncture and transcranial magnetism, it is of great significance to find effective treatments to improve plateau sleep disorders. Summary of the invention

[0004] The main purpose of the present invention is to provide a Chinese medicine foot-washing composition, preparation and preparation method for sleep disorders, aiming to solve the problems pointed out in the above background technology.

[0005] In order to achieve the above object, the present invention provides the following technical solutions:

[0006] A Chinese medicine foot-washing composition for treating sleep disorders, comprising the following Chinese medicines in parts by weight:

[0007] 10-19 parts of angelica, 5-15 parts of safflower, 15-28 parts of wormwood, 3-12 parts of Millettia reticulata, 6-19 parts of Cyathula capitata, 2-7 parts of Lycopodiella ciliata, 3-16 parts of Vaccaria segetalis, 9-17 parts of frankincense, 4-11 parts of myrrh, and 5-13 parts of dried ginger.

[0008] Preferably, the Chinese medicine comprises the following parts by weight:

[0009] 12-18 parts of angelica, 7-14 parts of safflower, 19-24 parts of wormwood, 6-11 parts of Millettia reticulata, 8-15 parts of Cyathula capitata, 3-6 parts of Lycopodiella ciliata, 7-14 parts of Vaccaria segetalis, 12-14 parts of frankincense, 6-10 parts of myrrh, and 7-9 parts of dried ginger.

[0010] Preferably, the Chinese medicine comprises the following parts by weight:

[0011] 16 parts of angelica, 10 parts of safflower, 22 parts of wormwood, 7 parts of Millettia reticulata, 12 parts of Cyathula capitata, 6 parts of Lycopodiella ciliata, 10 parts of Vaccaria segetalis, 13 parts of frankincense, 6 parts of myrrh, and 8 parts of dried ginger.

[0012] Preferably, the wormwood is wormwood processed with vinegar; the fenugreek is stir-fried fenugreek; the frankincense is stir-fried frankincense; and the myrrh is myrrh processed with vinegar.

[0013] A traditional Chinese medicine foot-washing preparation for sleep disorders, which consists of an extract of the traditional Chinese medicine foot-washing composition for sleep disorders, an effervescent disintegrant and auxiliary materials.

[0014] Preferably, the extract of the traditional Chinese medicine foot-washing composition for sleep disorders is prepared by the following method:

[0015] S1. Mix the Chinese medicine composition evenly, soak it in water for 0.5-2h, the mass of water is 5-10 times of the Chinese medicine composition, and then decoct it twice, the decoction temperature is 80-120°C, and the decoction time for each time is 1.5 hours. After the two decoctions are completed, filter them separately, combine the two filtrates, filter them again, and concentrate them to obtain a concentrated solution;

[0016] S2. Add ethanol to the concentrated solution obtained in step S1 so that the ethanol content reaches 70-90%, then let it stand for 6-24 hours, filter and remove impurities, and concentrate the filtrate after impurities removal again to obtain an extract with a density of 1.1-1.5 g / ml, add a surfactant and spray dry to obtain a dry extract powder.

[0017] A method for preparing a traditional Chinese medicine foot-washing preparation for sleep disorders, prepared by the following method:

[0018] The dried extract powder is mixed with the effervescent disintegrant and auxiliary materials in proportion, and tabletted to obtain effervescent tablets.

[0019] Preferably, the ratio of the mass of the dry extract powder to the sum of the mass of the effervescent disintegrant and the excipients is 1:2.

[0020] The pharmacological activities of the above Chinese medicinal materials are as follows:

[0021] Mugwort: Contains volatile oils, flavonoids, phenylpropanoids, terpenes and other ingredients, and has multiple pharmacological effects such as antibacterial, antiviral, hemostatic, anti-tumor, antioxidant, analgesic, anti-inflammatory, and immunomodulatory.

[0022] Angelica: It has the effects of nourishing blood and activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It has a protective effect on myocardial ischemia, cerebral ischemia, and renal ischemia, and has anticoagulant, antiplatelet aggregation, and procoagulant effects. The active ingredient ferulic acid in Angelica also has antioxidant and free radical scavenging effects, and can protect membrane lipids from oxidation.

[0023] Safflower: It has the effects of promoting blood circulation, removing blood stasis, regulating menstruation and relieving pain. Safflower contains many chemical components, mainly flavonoids, alkaloids, organic acids, pigments, volatile oils, polysaccharides, etc. Safflower has the functions of regulating blood status, resisting hypoxia, resisting free radical damage, dilating blood vessels, and anti-inflammatory. It is widely used in the treatment of anemia, coronary heart disease, angina pectoris and other diseases.

[0024] Millettia reticulata: It has the effects of promoting blood circulation and replenishing blood, regulating menstruation and relieving pain, and relaxing muscles and tendons. At present, chemical components such as flavonoids, phenolic acids, sterols, terpenes, lignans, anthraquinones, etc. have been isolated from Millettia reticulata. It has the effects of protecting the cardiovascular and cerebrovascular system, anti-oxidation, anti-tumor, anti-virus, liver protection, and anti-inflammatory.

[0025] Sichuan Achyranthes bidentata: It has the effects of removing blood stasis, dredge meridians, unblocking joints, and promoting diuresis and relieving stranguria. The chemical components in Sichuan Achyranthes bidentata include sterols, polysaccharides, saponins, etc., which have the effects of regulating blood viscosity, improving microcirculation, delaying aging, anti-tumor and enhancing immunity.

[0026] Stretch mark grass: It contains rich types of alkaloids, has the functions of dispelling wind and dampness, relaxing muscles and activating blood circulation. Modern pharmacological research shows that it has anti-inflammatory, analgesic, antibacterial, and acetylcholinesterase activity inhibitory effects.

[0027] Frankincense and myrrh: Both are clinically used medicines for promoting blood circulation, dispersing blood stasis, reducing swelling and relieving pain. Both are resins of plants in the olive family. Their pharmacological activities are extensive, mainly concentrated in anti-inflammatory, analgesic, anti-tumor, effects on cardiovascular diseases and anti-thrombotic.

[0028] Dried ginger: It is a homologous Chinese medicine, whose chemical components mainly include volatile oils and gingerols. Gingerol has the effect of improving cardiovascular function.

[0029] Fenugreek: It has the function of stopping bleeding and relieving pain, and has the "three-way" function, namely, promoting lactation, promoting menstruation, and relieving stranguria. Traditional formulas include Fenugreek powder, which is used to treat symptoms such as stranguria with stones, stranguria with blood, and lower abdominal pain. It also contains volatile oils, flavonoid glycosides, cyclic peptides, saponins, etc., and has pharmacological effects such as anti-tumor, promoting milk secretion, antibacterial and anti-inflammatory, and antioxidant.

[0030] Compared with the prior art, the present invention has the following beneficial effects:

[0031] The present invention complies with the principle of "monarch, minister, assistant and envoy" of traditional Chinese medicine, wherein Artemisia argyi is the monarch, Angelica sinensis, safflower, Millettia reticulata, Cyathula officinalis are the ministers, Herba Lycopodii, Vaccariae segetalis, frankincense and myrrh are the adjuvants, and dried ginger is the envoy. This formula has been clinically optimized for many years and has the effects of promoting blood circulation, improving circulation function, increasing human oxygen saturation and enhancing sleep quality;

[0032] The effervescent tablets developed by the formula not only have the effects of the traditional Chinese medicine itself, but also have the advantages of being easy to store, easy to carry and easy to use;

[0033] The Chinese medicine preparations prepared in this way have good compliance, no dependence, and few side effects. They are not only beneficial to the improvement of sleep disorders (including plateau sleep disorders), but also beneficial to the prevention and treatment of diseases such as fatigue, diabetic peripheral neuropathy, hypertension, diarrhea, postoperative recovery, pain, stroke sequelae, and sub-health conditions. DETAILED DESCRIPTION

[0034] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] The present invention provides:

[0036] Example 1

[0037] A Chinese medicine foot-washing composition for treating sleep disorders, comprising the following Chinese medicines in parts by weight:

[0038] Angelica 10g, safflower 5g, mugwort 21g, Millettia reticulata 8g, Achyranthes bidentata 11g, Lycopodiella ciliata 7g, Vaccaria segetalis 15g, frankincense 12g, myrrh 11g, and dried ginger 5g.

[0039] The above-mentioned Chinese medicine foot-washing composition is prepared into an effervescent tablet by the following method:

[0040] S1. Mix the above Chinese medicine composition evenly, add 840g water and soak for 1.5h, decoct twice, the decoction temperature is 100°C, and the decoction time is 1.5 hours each time. After the two decoctions are completed, filter them separately, combine the two filtrates, filter them again, and concentrate them to obtain a concentrate;

[0041] S2, adding ethanol to the concentrated solution obtained in step S1 so that the ethanol content reaches 80%, then standing for 20 hours, filtering and removing impurities, and concentrating the filtrate after impurities removal again to obtain an extract with a density of 1.2 g / ml, adding a surfactant and spray drying to obtain a dry extract powder;

[0042] S3. Mix the dry extract powder with the effervescent disintegrant and the auxiliary materials, and compress the mixture into tablets to obtain effervescent tablets. The ratio of the mass of the dry extract powder to the sum of the mass of the effervescent disintegrant and the auxiliary materials is 1:2.

[0043] Example 2

[0044] A Chinese medicine foot-washing composition for treating sleep disorders, comprising the following Chinese medicines in parts by weight:

[0045] Angelica 18g, safflower 11g, mugwort 24g, Millettia reticulata 11g, Achyranthes bidentata 19g, Lycopodiella cuneata 6g, Vaccaria segetalis 15g, frankincense 12g, myrrh 6g, and dried ginger 7g.

[0046] The above-mentioned Chinese medicine foot-washing composition is prepared into an effervescent tablet by the following method:

[0047] S1. Mix the above Chinese medicine composition evenly, add 1032g of water and soak for 1.5h, decoct twice, the decoction temperature is 100°C, and the decoction time is 1.5 hours each time. After the two decoctions are completed, filter them separately, combine the two filtrates, filter them again, and concentrate them to obtain a concentrate;

[0048] S2, adding ethanol to the concentrated solution obtained in step S1 so that the ethanol content reaches 80%, then standing for 20 hours, filtering and removing impurities, and concentrating the filtrate after impurities removal again to obtain an extract with a density of 1.2 g / ml, adding a surfactant and spray drying to obtain a dry extract powder;

[0049] S3. Mix the dry extract powder with the effervescent disintegrant and the auxiliary materials, and compress the mixture into tablets to obtain effervescent tablets. The ratio of the mass of the dry extract powder to the sum of the mass of the effervescent disintegrant and the auxiliary materials is 1:2.

[0050] Example 3

[0051] A Chinese medicine foot-washing composition for treating sleep disorders, comprising the following Chinese medicines in parts by weight:

[0052] Angelica 10g, safflower 6g, mugwort 21g, Millettia reticulata 8g, Achyranthes bidentata 11g, Lycopodiella ciliata 6g, Vaccaria segetalis 16g, frankincense 17g, myrrh 4g, and dried ginger 13g.

[0053] The above-mentioned Chinese medicine foot-washing composition is prepared into an effervescent tablet by the following method:

[0054] S1. Mix the above Chinese medicine composition evenly, add 896g of water and soak for 1.5h, decoct twice, the decoction temperature is 100°C, and the decoction time is 1.5 hours each time. After the two decoctions are completed, filter them separately, combine the two filtrates, filter them again, and concentrate them to obtain a concentrate;

[0055] S2, adding ethanol to the concentrated solution obtained in step S1 so that the ethanol content reaches 80%, then standing for 20 hours, filtering and removing impurities, and concentrating the filtrate after impurities removal again to obtain an extract with a density of 1.2 g / ml, adding a surfactant and spray drying to obtain a dry extract powder;

[0056] S3. Mix the dry extract powder with the effervescent disintegrant and the auxiliary materials, and compress the mixture into tablets to obtain effervescent tablets. The ratio of the mass of the dry extract powder to the sum of the mass of the effervescent disintegrant and the auxiliary materials is 1:2.

[0057] Example 4

[0058] A Chinese medicine foot-washing composition for treating sleep disorders, comprising the following Chinese medicines in parts by weight:

[0059] Angelica 12g, safflower 9g, mugwort 28g, Millettia reticulata 12g, Achyranthes bidentata 14g, Lycopodiella cuneata 6g, Vaccaria segetalis 4g, frankincense 13g, myrrh 7g, and dried ginger 11g.

[0060] The above-mentioned Chinese medicine foot-washing composition is prepared into an effervescent tablet by the following method:

[0061] S1. Mix the above Chinese medicine composition evenly, add 928g of water and soak for 1.5h, decoct twice, the decoction temperature is 100°C, and the decoction time is 1.5 hours each time. After the two decoctions are completed, filter them separately, combine the two filtrates, filter them again, and concentrate them to obtain a concentrate;

[0062] S2, adding ethanol to the concentrated solution obtained in step S1 so that the ethanol content reaches 80%, then standing for 20 hours, filtering and removing impurities, and concentrating the filtrate after impurities removal again to obtain an extract with a density of 1.2 g / ml, adding a surfactant and spray drying to obtain a dry extract powder;

[0063] S3. Mix the dry extract powder with the effervescent disintegrant and the auxiliary materials, and compress the mixture into tablets to obtain effervescent tablets. The ratio of the mass of the dry extract powder to the sum of the mass of the effervescent disintegrant and the auxiliary materials is 1:2.

[0064] Example 5

[0065] A Chinese medicine foot-washing composition for treating sleep disorders, comprising the following Chinese medicines in parts by weight:

[0066] Angelica 12g, safflower 7g, mugwort 20g, Millettia reticulata 6g, Achyranthes bidentata 15g, Lycopodiella ciliata 3g, Vaccaria segetalis 14g, frankincense 14g, myrrh 8g, and dried ginger 11g.

[0067] The above-mentioned Chinese medicine foot-washing composition is prepared into an effervescent tablet by the following method:

[0068] S1. Mix the above Chinese medicine composition evenly, add 880g water and soak for 1.5h, decoct twice, the decoction temperature is 100°C, and the decoction time is 1.5 hours each time. After the two decoctions are completed, filter them separately, combine the two filtrates and filter them again, and concentrate them to obtain a concentrate;

[0069] S2, adding ethanol to the concentrated solution obtained in step S1 so that the ethanol content reaches 80%, then standing for 20 hours, filtering and removing impurities, and concentrating the filtrate after impurities removal again to obtain an extract with a density of 1.2 g / ml, adding a surfactant and spray drying to obtain a dry extract powder;

[0070] S3. Mix the dry extract powder with the effervescent disintegrant and the auxiliary materials, and compress the mixture into tablets to obtain effervescent tablets. The ratio of the mass of the dry extract powder to the sum of the mass of the effervescent disintegrant and the auxiliary materials is 1:2.

[0071] Example 6

[0072] A Chinese medicine foot-washing composition for treating sleep disorders, comprising the following Chinese medicines in parts by weight:

[0073] 10 parts of angelica, 5 parts of safflower, 28 parts of wormwood, 12 parts of Millettia reticulata, 6 parts of Cyathula capitata, 2 parts of Lycopodiella ciliata, 3 parts of Vaccaria segetalis, 9 parts of frankincense, 4 parts of myrrh, and 5 parts of dried ginger.

[0074] The above-mentioned Chinese medicine foot-washing composition is prepared into an effervescent tablet by the following method:

[0075] S1. Mix the above Chinese medicine composition evenly, add 672g of water and soak for 1.5h, decoct twice, the decoction temperature is 100°C, and the decoction time is 1.5 hours each time. After the two decoctions are completed, filter them separately, combine the two filtrates, filter them again, and concentrate them to obtain a concentrate;

[0076] S2, adding ethanol to the concentrated solution obtained in step S1 so that the ethanol content reaches 80%, then standing for 20 hours, filtering and removing impurities, and concentrating the filtrate after impurities removal again to obtain an extract with a density of 1.2 g / ml, adding a surfactant and spray drying to obtain a dry extract powder;

[0077] S3. Mix the dry extract powder with the effervescent disintegrant and the auxiliary materials, and compress the mixture into tablets to obtain effervescent tablets. The ratio of the mass of the dry extract powder to the sum of the mass of the effervescent disintegrant and the auxiliary materials is 1:2.

[0078] Example 7

[0079] A Chinese medicine foot-washing composition for treating sleep disorders, comprising the following Chinese medicines in parts by weight:

[0080] Angelica 12g, safflower 14g, mugwort 19g, Millettia reticulata 10g, Achyranthes bidentata 8g, Lycopodiella cuneata 6g, Vaccaria segetalis 7g, frankincense 16g, myrrh 10g, and dried ginger 9g.

[0081] The above-mentioned Chinese medicine foot-washing composition is prepared into an effervescent tablet by the following method:

[0082] S1. Mix the above Chinese medicine composition evenly, add 888g of water and soak for 1.5h, decoct twice, the decoction temperature is 100°C, and the decoction time is 1.5 hours each time. After the two decoctions are completed, filter them separately, combine the two filtrates, filter them again, and concentrate them to obtain a concentrate;

[0083] S2, adding ethanol to the concentrated solution obtained in step S1 so that the ethanol content reaches 80%, then standing for 20 hours, filtering and removing impurities, and concentrating the filtrate after impurities removal again to obtain an extract with a density of 1.2 g / ml, adding a surfactant and spray drying to obtain a dry extract powder;

[0084] S3. Mix the dry extract powder with the effervescent disintegrant and the auxiliary materials, and compress the mixture into tablets to obtain effervescent tablets. The ratio of the mass of the dry extract powder to the sum of the mass of the effervescent disintegrant and the auxiliary materials is 1:2.

[0085] Example 8

[0086] A Chinese medicine foot-washing composition for treating sleep disorders, comprising the following Chinese medicines in parts by weight:

[0087] Angelica 16g, safflower 10g, mugwort 22g, Millettia reticulata 7g, Achyranthes bidentata 12g, Lycopodiella ciliata 6g, Vaccaria segetalis 10g, frankincense 13g, myrrh 6g, and dried ginger 8g.

[0088] S1. Mix the above Chinese medicine composition evenly, add 880g water and soak for 1.5h, decoct twice, the decoction temperature is 100°C, and the decoction time is 1.5 hours each time. After the two decoctions are completed, filter them separately, combine the two filtrates and filter them again, and concentrate them to obtain a concentrate;

[0089] S2, adding ethanol to the concentrated solution obtained in step S1 so that the ethanol content reaches 80%, then standing for 20 hours, filtering and removing impurities, and concentrating the filtrate after impurities removal again to obtain an extract with a density of 1.2 g / ml, adding a surfactant and spray drying to obtain a dry extract powder;

[0090] S3. Mix the dry extract powder with the effervescent disintegrant and the auxiliary materials, and compress the mixture into tablets to obtain effervescent tablets. The ratio of the mass of the dry extract powder to the sum of the mass of the effervescent disintegrant and the auxiliary materials is 1:2.

[0091] Selecting experimental subjects

[0092] The experimental subjects were 680 adults living at an altitude of more than 3,800 meters. The age range of the experimental subjects was between 20 and 60 years old. All the experimental subjects were patients with sleep disorders. The main manifestations of sleep disorders are as follows:

[0093] 1. Short sleep time: The sleep time at night is short, no more than 5.5 hours;

[0094] 2. Difficulty falling asleep: The time it takes to fall asleep each time exceeds 30 minutes;

[0095] 3. Frequent waking up at night: Frequently waking up more than 2 times at night;

[0096] 4. Poor sleep quality: Still easily tired after falling asleep, inability to concentrate during the day and memory impairment;

[0097] 5. Abnormal sleep: dreaming, talking in sleep, or even sleepwalking frequently during sleep;

[0098] The presence of any one of the above five symptoms can be considered a sleep disorder, which meets the requirements for experimental subjects in this experiment;

[0099] In addition, the subjects in this experiment excluded patients with systemic diseases such as heart, lung, and spleen.

[0100] Experimental evaluation criteria

[0101] The evaluation criteria in this experiment were all judged by the patient's subjective method, including:

[0102] 1. Cure: The patient's symptoms completely disappear;

[0103] 2. Obvious effect: most of the patient's symptoms disappear;

[0104] 3. Mild effect: a small number of symptoms of the patient disappear;

[0105] 4. Ineffective: All symptoms of the patient still exist.

[0106] Experimental standards

[0107] In order to explore the effects of the compositions produced by various Chinese medicine ratios on the experimental subjects, the effervescent tablets prepared in Examples 1-8 only changed the ratios of the components of the Chinese medicines, and the materials and other adjustments for preparing the effervescent tablets were set to a unified standard, specifically:

[0108] The added water is uniformly set to 8 times of the weight of the traditional Chinese medicine composition, the soaking time in water is set to 1.5 hours, the temperature of the two decoctions is uniformly set to 100°C, the density of the concentrated extract is 1.2g / ml, the added surfactant is sodium dodecyl sulfate, the wormwood leaf in the traditional Chinese medicine composition is wormwood leaf made with vinegar, the fenugreek root is stir-fried fenugreek root, the frankincense is stir-fried frankincense, and the myrrh is myrrh made with vinegar. The auxiliary materials for preparing the effervescent tablet include a binder, a filler, and a lubricant, the binder is hydroxypropyl methylcellulose, the filler is starch, the lubricant is magnesium stearate, and the disintegrant is a mixture of sodium bicarbonate, sodium carbonate and citric acid.

[0109] Experimental methods

[0110] 640 subjects out of 680 experimental subjects were evenly divided into 8 groups as experimental groups, and the 8 experimental groups were respectively distributed with 8 groups of effervescent tablets prepared in Examples 1-8. The specific method of use was as follows: before going to bed every night, three effervescent tablets were mixed with 3L warm water, each effervescent tablet weighing 3g, and then the feet were soaked in this warm water. The remaining 40 subjects were set as the control group, and the subjects in the control group directly soaked their feet in warm water. The foot soaking time and warm water temperature of the experimental subjects in the experimental group and the control group were exactly the same. The performance of the 680 experimental subjects after 1 week and 2 weeks were recorded respectively, and the experimental results were recorded.

[0111] Experimental Results

[0112] The experimental results of the experimental group and the control group after 1 week are shown in Table 1 below:

[0113] Table 1: Experimental results of the experimental group and the control group after 1 week

[0114] cure Obvious effect Slight effect invalid Example 1 26 29 12 13 Example 2 29 32 11 8 Example 3 30 27 13 10 Example 4 22 35 7 16 Example 5 26 32 10 12 Example 6 31 26 9 14 Example 7 30 24 14 12 Example 8 36 31 10 3 Control group 0 0 2 38

[0115] The experimental results of the experimental group and the control group after 2 weeks are shown in Table 1 below:

[0116] Table 2: Experimental results of the experimental group and the control group after 2 weeks

[0117] cure Obvious effect Slight effect invalid Example 1 27 28 12 13 Example 2 29 32 11 8 Example 3 32 25 15 8 Example 4 22 37 9 12 Example 5 30 30 15 5 Example 6 32 27 11 10 Example 7 30 27 15 8 Example 8 36 31 11 2 Control group 0 1 4 35

[0118] Experimental results analysis

[0119] It can be seen from the data in Table 1 above that the effective rates (the effective rates include the sum of cure, obvious effect and slight effect accounting for the total proportion of experimental subjects) of the experimental group subjects after using the effervescent tablets prepared in Examples 1-8 of the present invention for 1 week were 83.75%, 90%, 87.5%, 80%, 85%, 82.5%, 85% and 96.25%, respectively. According to the data in Table 2 above, the effective rates of the experimental group subjects after using the effervescent tablets prepared in Examples 1-8 of the present invention for 2 weeks were 83.75%, 90%, 90%, 85%, 93.75%, 87.5%, 90% and 97.5%, respectively, while the effective rates of the control group after using ordinary warm water for 1 week and 2 weeks were 5% and 12.5%, respectively. It can be clearly seen that the effervescent tablets prepared by the Chinese medicine combination of the present invention can effectively alleviate or even cure the sleep disorder of patients on the plateau after foot soaking.

[0120] In addition, from the experimental data of the comparative experimental groups for 1 week and 2 weeks, it can be seen that the effervescent tablets formed by the Chinese medicine combination of the present invention take effect on patients quickly and can show obvious effects within 1 week. The effervescent tablets prepared from the Chinese medicine composition with the ratio in Example 8 have the best effect on the treatment of plateau sleep in patients among all experimental groups.

[0121] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicinal foot-washing composition for sleep disorders, characterized in that: The invention comprises the following Chinese medicines in parts by weight: 10-19 parts of angelica, 5-15 parts of safflower, 15-28 parts of wormwood, 3-12 parts of Millettia reticulata, 6-19 parts of Cyathula capitata, 2-7 parts of Lycopodiella ciliata, 3-16 parts of Vaccaria segetalis, 9-17 parts of frankincense, 4-11 parts of myrrh, and 5-13 parts of dried ginger.

2. The Chinese medicinal foot-washing composition for sleep disorders according to claim 1, characterized in that: The invention comprises the following Chinese medicines in parts by weight: 12-18 parts of angelica, 7-14 parts of safflower, 19-24 parts of wormwood, 6-11 parts of Millettia reticulata, 8-15 parts of Cyathula capitata, 3-6 parts of Lycopodiella ciliata, 7-14 parts of Vaccaria segetalis, 12-14 parts of frankincense, 6-10 parts of myrrh, and 7-9 parts of dried ginger.

3. The Chinese medicinal foot-washing composition for sleep disorders according to claim 1, characterized in that: The invention comprises the following Chinese medicines in parts by weight: 16 parts of angelica, 10 parts of safflower, 22 parts of wormwood, 7 parts of Millettia reticulata, 12 parts of Cyathula capitata, 6 parts of Lycopodiella ciliata, 10 parts of Vaccaria segetalis, 13 parts of frankincense, 6 parts of myrrh, and 8 parts of dried ginger.

4. The Chinese medicinal foot-washing composition for sleep disorders according to claim 1, characterized in that: The mugwort is mugwort prepared with vinegar; the fenugreek is fried fenugreek; the frankincense is fried frankincense; and the myrrh is myrrh prepared with vinegar.

5. A Chinese medicine foot-washing preparation for sleep disorders, characterized in that: The traditional Chinese medicine foot washing preparation is composed of an extract of the traditional Chinese medicine foot washing composition for sleep disorders according to any one of claims 1 to 4, an effervescent disintegrant and auxiliary materials.

6. The Chinese medicinal foot-washing preparation for sleep disorders according to claim 5, characterized in that: The extract of the traditional Chinese medicine foot-washing composition for sleep disorders is prepared by the following method: S1. Mix the Chinese medicine composition evenly, soak it in water for 0.5-2h, the mass of water is 5-10 times of the Chinese medicine composition, and then decoct it twice, the decoction temperature is 80-120°C, and the decoction time for each time is 1.5 hours. After the two decoctions are completed, filter them separately, combine the two filtrates, filter them again, and concentrate them to obtain a concentrated solution; S2. Add ethanol to the concentrated solution obtained in step S1 so that the ethanol content reaches 70-90%, then let it stand for 6-24 hours, filter and remove impurities, and concentrate the filtrate after impurities removal again to obtain an extract with a density of 1.1-1.5 g / ml, add a surfactant and spray dry to obtain a dry extract powder.

7. A method for preparing the Chinese medicine foot-washing preparation for sleep disorders as claimed in any one of claims 4 to 5, characterized in that: Prepared by the following method: The dried extract powder is mixed with the effervescent disintegrant and auxiliary materials in proportion, and tabletted to obtain effervescent tablets.

8. The method of using a traditional Chinese medicine foot-washing preparation for sleep disorders according to claim 7, characterized in that: The ratio of the mass of the dry extract powder to the sum of the mass of the effervescent disintegrant and the auxiliary materials is 1:2.