CN110755585A

CN110755585A - Prescription composition of traditional Chinese medicine foot bath agent for treating chronic insomnia and preparation method thereof

Info

Publication number: CN110755585A
Application number: CN201911035086.0A
Authority: CN
Inventors: 李廷利; 李尔逊
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-10-29
Filing date: 2019-10-29
Publication date: 2020-02-07
Anticipated expiration: 2039-10-29
Also published as: CN110755585B

Abstract

The prescription composition of a traditional Chinese medicine foot bath agent for treating chronic insomnia and a preparation method thereof relate to the prescription composition of a traditional Chinese medicine foot bath agent and a preparation method thereof. The traditional Chinese medicine foot bath agent solves the problems that the traditional Chinese medicine foot bath agent for treating chronic insomnia is low and unstable in curative effect, too simple and rough in preparation process, less in dissolution of effective components and the like. The Chinese medicinal foot bath agent is prepared from rhizoma Pinelliae, Prunellae Spica, rhizoma Zingiberis recens, pericarpium Citri Tangerinae and Coicis semen. The preparation method of the traditional Chinese medicine foot bath agent comprises the following steps: accurately weighing raw materials; the medicinal materials in the formula are dried properly; mixing, pulverizing, and sieving. The method 2 comprises the following steps: accurately weighing raw materials; the medicinal materials in the formula are dried properly; mixing, micronizing, and sieving. The prescription of the traditional Chinese medicine foot bath agent has the advantages of ingenious conception, unique prescription and cheap and easily-obtained medicinal materials. The preparation process has reasonable design, advanced processing technology and high dissolution rate of effective components.

Description

Prescription composition of traditional Chinese medicine foot bath agent for treating chronic insomnia and preparation method thereof

Technical Field

The invention relates to a prescription composition of a traditional Chinese medicine foot bath agent for treating chronic insomnia and a preparation method thereof.

Background

With the acceleration of modern life rhythm, the number of insomnia patients is increasing, and according to statistics, the incidence of insomnia in European and American countries reaches 20% -30%, and the incidence of insomnia in China is about 25%. The hazards of insomnia are as follows:

1. the insomniacs have poor spirit which can influence work and life, particularly have great influence on work requiring fine operation, and even the drivers can not concentrate the spirit when driving because of poor sleep so as to cause traffic accidents;

2. the long-term insomnia can affect the mood of a person, and anxiety and depression are easy to occur, and suicide tendency is caused in severe cases;

3. the long-term insomnia may cause the resistance of the human body to be reduced, and diseases such as hypertension, diabetes and the like are easy to suffer.

Attention should be paid to insomnia, and the purpose of better rest can be achieved by improving sleep, so that the working efficiency can be improved, and the social function can be improved.

Modern medicine clinically treats insomnia by using sedative hypnotic drugs. Sedative hypnotics are drugs that inhibit the central nervous system causing sedative and hypnotic effects. It has use value in relieving the symptoms of stress, anxiety and insomnia, convulsion, epilepsy resistance and the like of patients, but the tolerance, the habituation and the addiction can be caused almost by taking the medicine for a long time.

As early as thousands of years ago, the traditional Chinese medicine places great importance on the exercise and maintenance of feet, and uses foot soaking massage (pedicure) to prevent and treat diseases. The traditional Chinese medicine health-care theory relates to feet bath in four seasons: washing feet in spring, and opening yang to relieve exhaustion; washing feet in summer, and removing summer heat; washing feet in autumn, moistening lung and intestines; the record of foot washing in winter and the wet burning in the Dentian is the visual summarization of the traditional Chinese medicine pedicure function. The foot bath with traditional Chinese medicines can dredge channels and collaterals, promote blood circulation, remove blood stasis, dredge collaterals, relieve pain, stimulate acupuncture points of the sole of a foot and increase the running conditions of channels and collaterals of the sole of the foot. The thenar has many health-care points, and the functions of the viscera can be adjusted through the treatment of warming and activating the channels, promoting blood circulation and removing blood stasis by traditional Chinese medicines. Modern researches show that the way of treating insomnia by soaking feet with traditional Chinese medicines is to regulate human brain and central nerve through foot reflex zones so as to eliminate insomnia.

At present, the traditional Chinese medicine foot bath agent for treating chronic insomnia has the problems of low and unstable curative effect, too simple and rough preparation process, less dissolution of effective components and the like.

Disclosure of Invention

The invention aims to solve the problems that the traditional Chinese medicine foot bath preparation for treating chronic insomnia is low and unstable in curative effect, too simple and rough in preparation process, less in dissolution of effective components and the like, and provides a prescription composition of the traditional Chinese medicine foot bath preparation for treating chronic insomnia and a preparation method thereof.

The traditional Chinese medicine foot bath agent for treating chronic insomnia is prepared from 30-80 parts by weight of raw pinellia ternate, 30-80 parts by weight of selfheal, 20-70 parts by weight of ginger, 20-70 parts by weight of dried orange peel and 20-70 parts by weight of coix seed, or comprises 20-50 parts by weight of raw pinellia ternate, 20-50 parts by weight of selfheal, 10-40 parts by weight of ginger, 10-40 parts by weight of dried orange peel and 10-40 parts by weight of coix seed, or comprises 40 parts by weight of raw pinellia ternate, 40 parts by weight of selfheal, 30 parts by weight of ginger, 30 parts by weight of dried orange peel and 30 parts by weight of coix seed.

The preparation method of the traditional Chinese medicine foot bath agent for treating chronic insomnia comprises the following steps: the method comprises the following steps: selecting 30-80 parts of raw pinellia ternate, 30-80 parts of selfheal, 20-70 parts of ginger, 20-70 parts of dried orange peel and 20-70 parts of coix seed according to the weight part ratio, drying, respectively crushing, sieving and fully mixing to finish the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia. The method 2 comprises the following steps: selecting 30-80 parts of raw pinellia ternate, 30-80 parts of selfheal, 20-70 parts of ginger, 20-70 parts of dried orange peel and 20-70 parts of coix seed according to parts by weight, drying, respectively carrying out superfine grinding, and fully mixing to complete the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia.

The preparation method of the traditional Chinese medicine foot bath agent for treating chronic insomnia comprises the following steps: the method comprises the following steps: selecting 40 parts of unprocessed pinellia tuber, 40 parts of common selfheal fruit-spike, 30 parts of ginger, 30 parts of dried orange peel and 30 parts of coix seed according to parts by weight, drying, respectively crushing, sieving and fully mixing to finish the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia. The method 2 comprises the following steps: selecting 40 parts of unprocessed pinellia tuber, 40 parts of common selfheal fruit-spike, 30 parts of ginger, 30 parts of dried orange peel and 30 parts of coix seed according to the weight part ratio, drying, respectively carrying out superfine grinding, and fully mixing to finish the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia.

According to the traditional Chinese medicine, the causes of insomnia are yin-yang imbalance, yang does not enter yin, heart spirit fails to nourish, and heart spirit is uneasy due to emotional depression, internal damage of diet, after illness, age, insufficient natural endowment, heart deficiency and timidity. Raw pinellia in the prescription has the efficacies of harmonizing yin and yang, harmonizing stomach and lowering adverse qi, and the like, so the raw pinellia is a monarch drug. The selfheal has the effects of clearing liver fire and dissipating stagnation, strengthens the function of the unprocessed pinellia tuber for harmonizing yin and yang, can dissipate stagnation and is used as a ministerial drug; the ginger is used for warming middle energizer and arresting vomiting, the dried orange peel is used for regulating qi and strengthening spleen, eliminating dampness and phlegm and the coix seed is used for strengthening spleen and strengthening middle energizer. The medicines are combined to play the effects of harmonizing yin and yang, guiding yang into yin, calming heart and soothing nerves.

The traditional Chinese medicine foot bath agent formula for treating chronic insomnia is a traditional Chinese medicine foot bath agent formula which is prepared by selecting traditional Chinese medicines with the effects of balancing yin and yang, harmonizing stomach and soothing nerves based on the theory of yin-yang balance generated by sleep and insomnia in the traditional Chinese medicine theory and the traditional meridian theory that the three yin and three yang meridians of foot converge and is based on the traditional Chinese medicine compound formula principle and has the effect of treating chronic insomnia. Compared with the traditional Chinese medicine foot bath agent prescription for treating chronic insomnia, the invention has the advantages of unique theoretical basis, strict prescription compatibility, precise and appropriate medicinal material selection and definite and stable curative effect. The traditional Chinese medicine foot bath agent for treating chronic insomnia disclosed by the invention has the effects of regulating yin and yang, harmonizing stomach and soothing nerves, is suitable for treating chronic insomnia caused by various reasons, and has a good sleeping effect proved by clinical application.

The preparation method of the traditional Chinese medicine foot bath agent for treating chronic insomnia has the advantages of easily available raw materials, simple process, high dissolution rate of effective components and low cost; the traditional Chinese medicine foot bath agent for treating chronic insomnia prepared by the two preparation methods has the function of treating chronic insomnia.

Detailed Description

The technical solution of the present invention is not limited to the following specific embodiments, but includes any combination of the specific embodiments.

The first embodiment is as follows: the formula of the traditional Chinese medicine foot bath agent for treating chronic insomnia comprises, by weight, 30-80 parts of raw pinellia ternate, 30-80 parts of selfheal, 20-70 parts of ginger, 20-70 parts of dried orange peel and 20-70 parts of coix seed.

The traditional Chinese medicine decoction pieces used in the prescription of the traditional Chinese medicine foot bath agent for treating chronic insomnia in the embodiment are composed of raw pinellia ternate, selfheal, ginger, dried orange peel and coix seed.

The raw pinellia tuber in the embodiment has the effects of harmonizing yin and yang, tonifying qi and lifting yang, harmonizing stomach and lowering adverse qi, eliminating dampness and phlegm, relieving distension and fullness and dissipating stagnation; the selfheal has the effects of clearing liver fire and dispersing stagnation; the ginger has the effects of sweating, relieving exterior syndrome, warming middle-jiao and arresting vomiting; the dried orange peel has the effects of regulating qi, strengthening spleen, eliminating dampness and phlegm; the coix seed has the effects of inducing diuresis to alleviate edema, invigorating spleen and reinforcing middle warmer.

The second embodiment is as follows: the first difference between the embodiment and the specific embodiment is that the traditional Chinese medicine foot bath agent for treating chronic insomnia is prepared from 20-50 parts by weight of raw pinellia ternate, 20-50 parts by weight of selfheal, 10-40 parts by weight of ginger, 10-40 parts by weight of dried orange peel and 10-40 parts by weight of coix seed. The rest is the same as the first embodiment.

The third concrete implementation mode: the first difference between the embodiment and the specific embodiment is that the prescription of the traditional Chinese medicine foot bath agent for treating chronic insomnia is composed of 40 parts by weight of unprocessed pinellia tuber, 40 parts by weight of common selfheal fruit-spike, 30 parts by weight of ginger, 30 parts by weight of dried orange peel and 30 parts by weight of coix seed. The rest is the same as the first embodiment.

The fourth concrete implementation mode: the method for preparing the traditional Chinese medicine foot bath agent for treating chronic insomnia according to the embodiment comprises the following steps: selecting 30-80 parts of raw pinellia ternate, 30-80 parts of selfheal, 20-70 parts of ginger, 20-70 parts of dried orange peel and 20-70 parts of coix seed according to the weight part ratio, drying, respectively crushing, sieving and fully mixing to finish the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia.

The fifth concrete implementation mode: the method for preparing the traditional Chinese medicine foot bath agent for treating chronic insomnia according to the embodiment comprises the following steps: selecting 30-80 parts of raw pinellia ternate, 30-80 parts of selfheal, 20-70 parts of ginger, 20-70 parts of dried orange peel and 20-70 parts of coix seed according to parts by weight, drying, respectively carrying out superfine grinding, and fully mixing to complete the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia.

The sixth specific implementation mode: the method for preparing the traditional Chinese medicine foot bath agent for treating chronic insomnia according to the embodiment comprises the following steps: the traditional Chinese medicine foot bath agent for treating chronic insomnia is prepared by drying 20-50 parts by weight of raw pinellia ternate, 20-50 parts by weight of selfheal, 10-40 parts by weight of ginger, 10-40 parts by weight of dried orange peel and 10-40 parts by weight of coix seed, respectively crushing, sieving and fully mixing.

The seventh embodiment: the method for preparing the traditional Chinese medicine foot bath agent for treating chronic insomnia according to the embodiment comprises the following steps: the traditional Chinese medicine foot bath agent for treating chronic insomnia is prepared by drying 20-50 parts by weight of raw pinellia ternate, 20-50 parts by weight of selfheal, 10-40 parts by weight of ginger, 10-40 parts by weight of dried orange peel and 10-40 parts by weight of coix seed, respectively carrying out superfine grinding, sieving and fully mixing.

The specific implementation mode is eight: the method for preparing the traditional Chinese medicine foot bath agent for treating chronic insomnia according to the embodiment comprises the following steps: selecting 40 parts of unprocessed pinellia tuber, 40 parts of common selfheal fruit-spike, 30 parts of ginger, 30 parts of dried orange peel and 30 parts of coix seed according to parts by weight, drying, respectively crushing, sieving and fully mixing to finish the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia.

The specific implementation method nine: the method for preparing the traditional Chinese medicine foot bath agent for treating chronic insomnia according to the embodiment comprises the following steps: selecting 40 parts of unprocessed pinellia tuber, 40 parts of common selfheal fruit-spike, 30 parts of ginger, 30 parts of dried orange peel and 30 parts of coix seed according to parts by weight, drying, respectively carrying out superfine grinding, sieving and fully mixing to finish the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia.

In the quality control of the traditional Chinese medicine foot bath agent for treating chronic insomnia prepared in the embodiment, a qualitative identification method for crude pinellia ternate, selfheal, ginger, dried orange peel and coix seed medicinal materials in the obtained five crushed medicinal materials is as follows:

a. taking a proper amount of sample, adding 10ml of methanol, heating and refluxing for 30 minutes, filtering, and volatilizing the filtrate to 0.5ml to be used as a test solution. And adding 70% methanol into arginine control, alanine control, valine control, and leucine control to obtain mixed solutions each containing 1mg per 1ml as control solutions. Performing thin-layer chromatography (general rule 0502) test, sucking 5 μ l of sample solution and 1 μ l of control solution, respectively dropping on the same silica gel G thin-layer plate, developing with n-butanol-glacial acetic acid-water (8: 3: 1) as developing agent, taking out, air drying, spraying ninhydrin test solution, and heating at 105 deg.C until the spots are clearly developed. Spots of the same color appear in the chromatogram of the test solution at positions corresponding to those in the chromatogram of the control solution.

b. Taking a proper amount of a sample, adding 30ml of 70% ethanol, carrying out ultrasonic treatment for 30 minutes, filtering, evaporating filtrate to dryness, and adding 5ml of ethanol into residues to dissolve the residues to obtain a sample solution. Adding ethanol into rosmarinic acid control to obtain solution containing 0.1mg per 1ml as control solution. Performing thin layer chromatography (general rule 0502) test, sucking 2 μ l of sample solution and 5 μ l of control solution, respectively dropping on the same silica gel G thin layer plate, developing with cyclohexane-ethyl acetate-isopropanol-formic acid (15: 3: 3.5: 0.5) as developing agent, taking out, air drying, and inspecting under ultraviolet lamp (365 nm). The test chromatogram shows fluorescent spots of the same color at the positions corresponding to those of the control chromatogram.

c. Taking a proper amount of sample, adding 20ml of ethyl acetate, carrying out ultrasonic treatment for 10 minutes, filtering, evaporating filtrate to dryness, and adding 1ml of ethyl acetate into residues to dissolve the residues to obtain a sample solution. Adding methanol into 6-gingerol control to obtain a solution containing 0.5mg per 1ml as control solution. Performing thin-layer chromatography (general rule 0502) test, sucking 6 mul of a test solution to be tested and 4 mul of a reference solution, respectively dropping the test solution and the reference solution on the same silica gel G thin-layer plate, developing by taking petroleum ether (60-90 ℃) and trichloromethane-ethyl acetate (2: 1: 1) as developing agents, taking out, airing, spraying a vanillin sulfuric acid test solution, and heating at 105 ℃ until spots are clearly developed. Spots of the same color appear in the chromatogram of the test solution at positions corresponding to those in the chromatogram of the control solution.

d. Taking a proper amount of sample, adding 10ml of methanol, heating and refluxing for 20 minutes, filtering, taking 5ml of filtrate, and concentrating to 1ml to be used as a test solution. Adding methanol into hesperidin control to obtain saturated solution as control solution. Performing thin layer chromatography (general rule 0502) test, sucking 2 μ l of the above two solutions, respectively dropping on the same silica gel G thin layer plate prepared with 0.5% sodium hydroxide solution, spreading to about 3cm with ethyl acetate-methanol-water (100: 17: 13) as developing agent, taking out, air drying, spreading to about 8cm with upper layer solution of toluene-ethyl acetate-formic acid-water (20: 10: 1: 1) as developing agent, taking out, air drying, spraying with aluminum trichloride test solution, and inspecting under ultraviolet lamp (365 nm). The test chromatogram shows fluorescent spots of the same color at the positions corresponding to those of the control chromatogram.

e. Taking a proper amount of a sample, adding 30ml of petroleum ether (60-90 ℃), carrying out ultrasonic treatment for 30 minutes, filtering, and taking a filtrate as a test solution. And adding petroleum ether (60-90 deg.C) into the semen Coicis oil control extract to obtain a solution containing 2mg of semen Coicis oil per 1ml as control extract solution. Performing thin layer chromatography (general rule 0502) test, sucking 2ul of the two solutions, respectively dropping on the same silica gel G thin layer plate, developing with petroleum ether (60-90 deg.C) -diethyl ether-glacial acetic acid (83: 17: 1) as developing agent, taking out, air drying, spraying with 5% vanillin sulfuric acid solution, and heating at 105 deg.C until the spots are clearly developed. Spots of the same color appear in the chromatogram of the test solution at positions corresponding to those in the chromatogram of the control solution.

In the embodiment, the contents of rosmarinic acid and glycerol trioleate in the traditional Chinese medicine foot bath agent for treating chronic insomnia are measured by adopting a high performance liquid chromatography:

1. determination of rosmarinic acid

Octadecylsilane chemically bonded silica is used as a filler in chromatographic conditions and system applicability tests; methanol-0.1% trifluoroacetic acid solution (42: 58) is used as a mobile phase; the detection wavelength was 330 nm. The number of theoretical plates should not be less than 6000 calculated according to the peak of rosmarinic acid.

Preparation of reference solution A proper amount of rosmarinic acid reference is precisely weighed, and diluted ethanol is added to make into solution containing 0.5mg per 1 ml.

Preparing test solution by weighing about 0.5g of the powder (sieved by a second sieve), precisely weighing, placing in a conical flask with a plug, precisely adding 50ml of dilute ethanol, performing ultrasonic treatment (power of 90W and frequency of 59 kHz) for 30 minutes, cooling, weighing again, supplementing the weight loss by dilute ethanol, shaking up, filtering, and taking the subsequent filtrate.

The determination method comprises precisely sucking 5 μ l of each of the reference solution and the sample solution, injecting into liquid chromatograph, and determining.

The product contains rosmarinic acid (C18H 16O 8) not less than 0.20% by dry product.

2. Measurement of Glycerol trioleate

Octadecylsilane chemically bonded silica is used as a filler in chromatographic conditions and system applicability tests; acetonitrile-dichloromethane (65: 35) is used as a mobile phase; detection by an evaporative light scattering detector. The number of theoretical plates should not be less than 5000 as calculated by the triolein peak. Preparation of control solution A proper amount of triolein control is precisely weighed, and mobile phase is added to make into solution containing 0.14mg per 1 ml.

Preparation of test solution about 0.6g of the product powder (screened by a third sieve) is taken, precisely weighed, placed in a conical flask with a plug, precisely added with 50ml of mobile phase, weighed, soaked for 2 hours, ultrasonically treated (with the power of 300W and the frequency of 50 kHz) for 30 minutes, cooled, weighed again, supplemented with the lost weight of the mobile phase, shaken evenly, filtered, and the subsequent filtrate is taken, thus obtaining the test solution.

The determination method precisely absorbs 5 mu l and 10 mu 1 of reference solution and 5-10 mu 1 of test solution respectively, injects the solutions into a liquid chromatograph, determines, and calculates by an external standard two-point method logarithmic equation to obtain the final product.

The product contains glycerol trioleate (C57H 104O 6) not less than 0.50% calculated on dry basis.

Experiment:

test animals: ICR mice are male, and have the weight of 18-22 g (SPF grade, provided by the experimental animal center of the university of traditional Chinese medicine in Heilongjiang. license number SCXK 2013-.

And (3) preparing a test sample: the invention relates to a traditional Chinese medicine foot bath agent for treating chronic insomnia, which is prepared by two processes: the sample obtained by the preparation method in the eighth embodiment is test sample No. 1, and the sample obtained by the preparation method in the ninth embodiment is test sample No. 2. 200g of each of the No. 1 and No. 2 samples to be tested are accurately weighed and respectively placed in 2000ml containers, a proper amount of water is added, the mixture is decocted for 30 minutes and filtered while the mixture is hot, and the filtrate is reserved. Adding appropriate amount of water into the filter residue, decocting for 30 minutes, filtering while hot, and mixing the two filtrates for use.

Control sample and preparation:

① reference sample I, which is prepared by removing Coicis semen from the prescription of the preparation method of the detailed embodiment, and comprises 40 parts of rhizoma Pinelliae, 40 parts of Prunellae Spica, 30 parts of rhizoma Zingiberis recens and 30 parts of pericarpium Citri Tangerinae.

② reference sample II, which is prepared by removing Coicis semen and pericarpium Citri Tangerinae from the prescription of the preparation method of the detailed embodiment, and only comprises 40 parts of rhizoma Pinelliae, 40 parts of XIAGUCAO and 30 parts of rhizoma Zingiberis recens.

③ control sample III, except Coicis semen, pericarpium Citri Tangerinae and rhizoma Zingiberis recens in the preparation method of the detailed embodiment, is composed of 40 parts of rhizoma Pinelliae and 40 parts of XIAGUCAO.

④ reference sample IV, which is prepared by removing Coicis semen, pericarpium Citri Tangerinae and rhizoma Zingiberis recens from the prescription of the preparation method of the detailed embodiment, and only comprises 40 parts of rhizoma Pinelliae.

The above control samples were prepared according to the preparation method of the ninth embodiment.

Administration dose: and calculating according to a surface area folding algorithm of the moving object, namely using the mouse = the medicine quantity for human use × 0.0026, and using the rat = the medicine quantity for human use × 0.018.

1. The traditional Chinese medicine foot bath agent for treating chronic insomnia influences the sleep time and sleep latency of mice caused by suprathreshold dose of sodium pentobarbital.

After the experimental animals are adapted to the environment for 7 days, the experimental animals are randomly divided into a blank control group, a model control group, a test sample No. 1 group, a test sample No. 2 group and control samples No. I, No. II, No. III and No. IV groups, and each group contains 20 animals. The experimental animals of the test sample No. 1 group, test sample No. 2 group and control samples No. I, No. II, No. III and No. IV group are respectively placed in a special glass jar (the filtrate just soaks the ankle of the mouse) in which 100ml of filtrate (32 +/-3 ℃) of the test sample No. 1 or test sample No. 2 or control samples No. I, No. II, No. III and No. IV is placed in advance, 1 time every day, 30 minutes every time and 15 days continuously. The experimental animals of the blank control group and the model control group were only placed in water at the same temperature. Except for the blank group of experimental animals, each group of experimental animals is given pentobarbital sodium at a dose of 50 mg/kg through an intraperitoneal injection way 30 minutes after the last foot soaking, the disappearance time and the recovery time of the mouse turning positive reflex are observed, and the sleeping duration and the sleeping latency of the mouse are recorded. The results are shown in tables 1 and 2.

TABLE 1 influence of Chinese medicinal foot bath on sleep time and sleep latency of suprathreshold dose of pentobarbital sodium-induced mice (±)s，n=20)

Note: comparison with blank control: p is less than or equal to 0.05; p is less than or equal to 0.01.

The experimental result shows that compared with a blank control group, the sleep latency of the experimental animals of only the model control group and the test sample No. 2 group is obviously shortened, and the experimental animals have significant difference (A)pLess than or equal to 0.05). In terms of sleep time, the sleep time of the experimental animals in the model control group, experimental samples No. 1 and No. 2 and control samples No. I, No. II, No. III and No. IV is obviously prolonged, and the experimental animals have extremely obvious or significant difference (thepLess than or equal to 0.05 orpLess than or equal to 0.01). The experimental animals of test sample No. 2 group had significantly higher sleep latency and sleep time than the other groups between the test sample and the control sample. The experimental animals in the control sample group all had significantly lower sleep times than the sample group.

2. The traditional Chinese medicine foot bath agent for treating chronic insomnia disclosed by the invention has an influence on the sleep percentage of mice induced by a subthreshold dose of pentobarbital sodium.

After the experimental animals are adapted to the environment for 7 days, the experimental animals are randomly divided into a blank control group, a model control group, a test sample No. 1 group, a test sample No. 2 group and control samples No. I, No. II, No. III and No. IV groups, and each group contains 20 animals. The experimental animals of the test sample No. 1 group and the test sample No. 2 group and the control samples No. I, No. II, No. III and No. IV group are respectively placed in a special glass jar (the filtrate just soaks the ankle of the mouse) in which 100ml of the filtrate (32 +/-3 ℃) of the test sample No. 1 or the test sample No. 2 or the control samples No. I, No. II, No. III and No. IV group is placed in advance, 1 time every day, 30 minutes every time and 15 days continuously. The experimental animals of the blank control group and the model control group were only placed in water at the same temperature. Except for the blank group of experimental animals, each group of experimental animals is given pentobarbital sodium at the dose of 10 mg/kg 30 minutes after the last foot soaking through an intraperitoneal injection way, the sleeping time of the experimental animals is taken as an observation index, the number of mice falling asleep within 30min is recorded, and the sleeping percentage of each group is calculated. The results are shown in Table 2.

TABLE 2 Effect of Chinese medicinal foot bath on percentage of sleep in mice induced by subthreshold dose of sodium pentobarbital (±) -s，n=20)

The experimental results show that compared with the blank control group, the sleep incidence rate of the experimental animals of the model control group, the tested samples No. 1 and No. 2 and the control samples No. I and No. II is obviously increased and has extremely obvious or significant difference (A)pLess than or equal to 0.05 orpLess than or equal to 0.01). The incidence of sleep between test and control samples was significantly higher in the experimental animals of test sample No. 2 than in the other groups. The control sample group had significantly lower incidence of experimental animal sleep than the sample group.

Clinical experiments of the traditional Chinese medicine foot bath agent for treating chronic insomnia prepared by the two preparation methods of the invention:

analysis of observed cases: 120 patients were out-patient in all cases. 80 women account for 66.6 percent of the total weight of the composition. 40 male cases. Accounting for 33.3 percent. The age is 40-65 years old. 40 patients with insomnia history of 0.5-1 year account for 33.3%, 60 patients with insomnia history of 2-5 years account for 50.0%, and 20 patients with insomnia history of more than 5 years account for 16.6%.

The clinical observation method comprises the following steps: the sample obtained by the preparation method in the embodiment nine of the invention is a test sample (wrapped by a plurality of layers of gauze). Before a patient is asleep, placing a test sample into a container, adding a certain amount of water, decocting for 30 minutes, putting the decoction into a foot bath basin, soaking feet of the patient for 30 minutes when the temperature is proper, and soaking for 1 time every day for 15 days continuously.

3. The clinical observation results are as follows: after the treatment course is finished, 110 cases of people with improved self-sleep account for 91.6%, and 10 cases of people without improved self-sleep account for 8.3%.

The clinical observation results are as follows: the sample obtained by the preparation method in the embodiment mode nine of the invention is a tested sample and has the function of obviously improving the sleep of the insomnia patients.

Claims

1. The traditional Chinese medicine foot bath agent for treating chronic insomnia is characterized by comprising 30-80 parts by weight of raw pinellia ternate, 30-80 parts by weight of selfheal, 20-70 parts by weight of ginger, 20-70 parts by weight of dried orange peel and 20-70 parts by weight of coix seed.

2. The prescription of a traditional Chinese medicine foot bath agent for treating chronic insomnia according to claim 1 is characterized by comprising, by weight, 20-50 parts of raw pinellia ternate, 20-50 parts of selfheal, 10-40 parts of ginger, 10-40 parts of dried orange peel and 10-40 parts of coix seed.

3. The prescription of a traditional Chinese medicine foot bath agent for treating chronic insomnia according to claim 1 is characterized by comprising 40 parts of raw pinellia tuber, 40 parts of common selfheal fruit-spike, 30 parts of ginger, 30 parts of tangerine peel and 30 parts of coix seed according to the parts by weight.

4. The method for preparing the prescription composition of the traditional Chinese medicine foot bath preparation for treating the chronic insomnia as claimed in claim 1 is characterized in that the prescription composition method for preparing the traditional Chinese medicine foot bath preparation for treating the chronic insomnia is carried out according to the following steps: selecting 30-80 parts of raw pinellia ternate, 30-80 parts of selfheal, 20-70 parts of ginger, 20-70 parts of dried orange peel and 20-70 parts of semen coicis according to the weight part ratio, drying, respectively crushing, sieving and fully mixing to finish the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia;

the method 2 comprises the following steps: selecting 30-80 parts of raw pinellia ternate, 30-80 parts of selfheal, 20-70 parts of ginger, 20-70 parts of dried orange peel and 20-70 parts of coix seed according to parts by weight, drying, respectively carrying out superfine grinding, and fully mixing to complete the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia.

5. The method for preparing the prescription of the traditional Chinese medicine foot bath agent for treating chronic insomnia as claimed in claim 4, wherein the prescription comprises the following components: selecting 40 parts of unprocessed pinellia tuber, 40 parts of common selfheal fruit-spike, 30 parts of ginger, 30 parts of dried orange peel and 30 parts of coix seed according to parts by weight, drying, respectively crushing, sieving and fully mixing to finish the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia.

6. The method for preparing the prescription of the traditional Chinese medicine foot bath agent for treating chronic insomnia as claimed in claim 4, wherein the prescription comprises the following components: selecting 40 parts of unprocessed pinellia tuber, 40 parts of common selfheal fruit-spike, 30 parts of ginger, 30 parts of dried orange peel and 30 parts of coix seed according to the weight part ratio, drying, respectively carrying out superfine grinding, and fully mixing to finish the preparation of the traditional Chinese medicine foot bath agent for treating chronic insomnia.