CN114869959B

CN114869959B - Application of traditional Chinese medicine composition in preparation of medicine for treating depression

Info

Publication number: CN114869959B
Application number: CN202210323414.2A
Authority: CN
Inventors: 牛景月; 吴维海; 田野; 王贵金; 李建勇; 纪玉哲; 王�琦
Original assignee: Hebei Ping'an Health Group Co ltd
Current assignee: Hebei Ping'an Health Group Co ltd
Priority date: 2020-08-24
Filing date: 2020-08-24
Publication date: 2023-04-28
Anticipated expiration: 2040-08-24
Also published as: CN114796380A; CN112057542B; CN114869958A; CN114869959A; CN114796380B; CN112057542A

Abstract

The invention discloses an application of a traditional Chinese medicine composition in preparing a medicine for treating depression, which is characterized in that the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 200-800 parts of dogwood fruit, 200-800 parts of shizandra berry, 100-500 parts of wild jujube seed, 100-500 parts of white paeony root, 100-500 parts of rehmannia root, 50-250 parts of lotus plumule, 100-500 parts of moutan bark, 100-400 parts of rhizoma anemarrhenae, 100-400 parts of radix bupleuri and 100-400 parts of fried gardenia. The invention utilizes the effects of the medicaments to produce synergistic effect, nourish yin and tonify kidney, clear heart and tranquilize, sooth liver and relieve depression, and is used for treating insomnia and forgetfulness, chest distress and palpitation, inappetence, mental absentmindedness and restlessness, dreaminess and easy awakening, listlessness, vexation and irritability, insomnia, dreaminess, heat, sweat, dizziness and tinnitus caused by dizziness and tinnitus and climacteric syndrome, thereby effectively treating insomnia, anxiety, depression and climacteric syndrome.

Description

Application of traditional Chinese medicine composition in preparation of medicine for treating depression

The invention relates to a Chinese medicinal composition for treating insomnia, anxiety, depression and climacteric syndrome and a preparation method thereof, which are classified as No. 202010855136.6 application of the invention of the year-8 and 24 application in 2020.

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome and a preparation method thereof.

Background

Insomnia is a common refractory disease clinically at present, and refers to sleep disorder syndrome in which sleep initiation and sleep maintenance are impaired, so that the sleep quality cannot meet the physiological needs of individuals and the daytime activity of patients is obviously influenced. Insomnia is a sleep disorder disease mainly comprising the problems of too short sleep time and reduced sleep quality caused by the factors of spirit, body, environment, medicines and the like, and the incidence rate of insomnia is in a trend of increasing year by year along with the acceleration of life rhythm, the gradual increase of social competition pressure and the change of life habits. Another study shows that insomnia patients are often accompanied by different degrees of depression anxiety and other bad moods besides serious sleep problems, long-term anxiety can cause depression, and depression is an affective disorder disease mainly characterized by chronic depression mood, and has attracted extensive attention worldwide. Patients suffering from insomnia are also prone to induce various psychological and somatic diseases, which seriously affect the daily work and life quality of the patients, and in addition, the clinic of climacteric syndrome is also marked by insomnia, anxiety and depression. Therefore, the treatment of insomnia has become a prominent medical and social problem to be solved urgently.

The clinical manifestations of insomnia generally include difficulty in falling asleep, not deep sleep, dreaminess, easy awakening, early awakening, difficulty in falling asleep after awakening, tiredness and sleepiness after sleeping, daytime sleepiness, etc. In addition to the symptoms described above, anxiety and fear are felt by patients suffering from anxiety insomnia, and in severe cases, the working efficiency or social function thereof may be affected. Patients with anxiety symptoms may also exhibit anxiety such as vexation and irritability, persistent anxiety, stress and irritability, fear, night fright and panic, or autonomic nervous system symptoms and somatic anxiety symptoms such as dry mouth and facial red, sweating, tension type headache, twitch and tremor.

Western medicine researches show that three main causes of insomnia are: 1. mental and disease factors: insomnia caused by negative psychology such as anxiety, vexation, pain, mood swings and the like is a state, overactive and short-term insomnia; in addition, mental diseases such as depression and mania can lead to chronic insomnia; 2. individual patients take hypnotics for a long time or in large quantity, the organism depends on the medicines, and once the medicines are stopped, the organism is extremely uneasy, so that insomnia is caused; 3. some patients have rhythmic insomnia related to work habits and living habits, such as time difference, shift and other reasons; still other patients are withdrawal symptoms due to sudden withdrawal from alcohol addiction, and some are food allergies. The pathogenesis of insomnia is closely related to the sleep-wake cycle. The well-known mechanism is that the thalamus comprises two regulation mechanisms of inducing sleep and arousal, the central nucleus of the brain stem and the solitary nucleus can induce sleep, and the covered basket-spot head inside the back of the brain bridge can play a role in maintaining arousal.

The traditional Chinese medicine considers that insomnia belongs to the category of insomnia, and the related records of insomnia, insomnia of eyes and insomnia, and insomnia are recorded in the Huangdi Nei Jing. In traditional Chinese medicine, insomnia is considered to be the syndrome of principal deficiency and secondary excess, and is mostly closely related to dysfunction of heart, liver, kidney, spleen and other organs, malnutrition or uneasiness of heart and mind. Because the insomnia patient has longer disease course, is easy to repeatedly attack and is difficult to quickly heal, the treatment of the insomnia patient is always one of the difficult problems faced by clinic. A large number of clinical practices in recent years prove that the traditional Chinese medicine has good clinical curative effect on insomnia, has unique advantages which Western medicine does not have, and can make patients obtain clinical benefit of 'half effort'.

From the medical condition of each big hospital, the clinic treatment of insomnia mainly depends on western medicines, but more and more defects are shown: some side effects are serious, and the patients are in a depression state and an anxiety state; in addition, western medicines are mainly used for symptomatic treatment, so that patients are easy to generate dependence and cannot recover fundamentally. Therefore, the traditional Chinese medicine has attracted great attention from medical workers for treating insomnia, anxiety, depression and climacteric syndrome.

Disclosure of Invention

The invention aims to solve the technical problems of providing a traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome and a preparation method thereof, and aims to overcome the defects of the traditional Chinese medicine composition for fundamentally treating insomnia, anxiety, depression and climacteric syndrome, such as the fact that western medicine treatment is still based on chemical medicine treatment, dependency is easy to generate, side effects are relatively large, anxiety and depression states of patients are even aggravated, and the traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome is accumulated for thousands of years by combining with rich clinical experience.

In order to solve the technical problems, the invention provides a traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome, which comprises the following components in parts by weight: 200-800 parts of dogwood fruit, 200-800 parts of shizandra berry, 100-500 parts of wild jujube seed, 100-500 parts of white paeony root, 100-500 parts of rehmannia root, 50-250 parts of lotus plumule, 100-500 parts of moutan bark, 100-400 parts of rhizoma anemarrhenae, 100-400 parts of radix bupleuri and 100-400 parts of fried gardenia.

In the traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome, the weight parts of the components can be preferably as follows: 300-700 parts of dogwood fruit, 300-700 parts of shizandra berry, 200-400 parts of wild jujube seed, 200-400 parts of white paeony root, 200-400 parts of rehmannia root, 100-200 parts of lotus plumule, 200-400 parts of moutan bark, 150-350 parts of rhizoma anemarrhenae, 150-350 parts of radix bupleuri and 150-350 parts of fried gardenia.

In the traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome, the weight parts of the components can be preferably as follows: 400-600 parts of dogwood fruit, 400-600 parts of shizandra berry, 200-350 parts of wild jujube seed, 200-350 parts of white paeony root, 200-350 parts of rehmannia root, 140-190 parts of lotus plumule, 200-350 parts of moutan bark, 150-300 parts of rhizoma anemarrhenae, 150-300 parts of radix bupleuri and 150-300 parts of fried gardenia.

In the traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome, the weight parts of the components can be preferably as follows: 400-500 parts of dogwood fruit, 400-500 parts of shizandra berry, 250-350 parts of wild jujube seed, 250-350 parts of white peony root, 250-350 parts of rehmannia root, 150-170 parts of lotus plumule, 250-350 parts of moutan bark, 150-250 parts of rhizoma anemarrhenae, 150-250 parts of radix bupleuri and 150-250 parts of fried gardenia.

The traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome can be prepared into any one of commonly used preparations.

The preparation which can be prepared by the traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome comprises tablets, capsules, granules, pills, mixture, syrup, decoction, powder, suppositories, gel, spray or injection.

The traditional Chinese medicine can be replaced by traditional Chinese medicines with the same or similar effects, the medicines can be processed according to national traditional Chinese medicine processing standards or Chinese medicine dictionary, for example, the wild jujube seed can be replaced by the stir-fried wild jujube seed, the bupleurum chinense can be replaced by the bupleurum chinense, the stir-fried gardenia can be replaced by the gardenia, and the drug effect after replacement can be better than the drug effect obtained by using the traditional Chinese medicine, but the traditional Chinese medicine belongs to the content of the invention.

In order to solve the technical problems, the invention provides a preparation method of a traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome, which comprises the following steps:

(1) 200-800 parts of pulp of dogwood fruit, 200-800 parts of shizandra berry, 100-500 parts of wild jujube seed, 100-500 parts of white paeony root, 100-500 parts of rehmannia root, 50-250 parts of lotus plumule, 100-500 parts of moutan bark, 100-400 parts of rhizoma anemarrhenae, 100-400 parts of radix bupleuri and 100-400 parts of fried gardenia for standby according to the proportion;

(2) adding 6-14 times of crude drug of water into pulp of dogwood fruit, schisandra chinensis, wild jujube seed, white peony root, moutan bark, bupleurum, fried gardenia, rehmannia root, rhizoma anemarrhenae and lotus plumule, heating and reflux-extracting for 0.5-5 hours, heating and reflux-extracting for 1-3 times, filtering, mixing the extracting solutions, and concentrating under reduced pressure at 40-90 ℃ until the density is 1.01-1.20 for standby;

(3) drying the concentrated solution obtained in the step (2) at 50-90 ℃, crushing the dried paste, adding auxiliary materials, and preparing the preparation.

In order to solve the technical problems, the invention also provides a preparation method of the traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome, which comprises the following steps:

(2) Taking pulp of dogwood fruit, schisandra chinensis, wild jujube seed, white peony root, moutan bark, bupleurum chinense and fried gardenia, adding 50-90% ethanol which is 6-14 times of the crude drug, heating and reflux-extracting for 0.5-5 hours, heating and reflux-extracting for 1-3 times, filtering, merging the extracting solutions, and concentrating the extracting solutions to the density of 1.01-1.20 at the temperature of 40-90 ℃ under reduced pressure for standby;

(3) adding 6-14 times of crude drug of rehmannia root, rhizoma anemarrhenae and lotus plumule into water, heating and reflux-extracting for 0.5-5 hours, heating and reflux-extracting for 1-3 times, filtering, combining the extracting solutions, concentrating the extracting solutions at 40-90 ℃ under reduced pressure to a density of 1.01-1.20, combining the concentrated solutions in the step (2), and continuously concentrating the concentrated solutions to a density of 1.05-1.15 for later use;

(4) drying the concentrated solution obtained in the step (3) at 50-90 ℃, crushing the dried paste, adding auxiliary materials, and preparing the preparation.

(2) Taking pulp of dogwood fruit, schisandra chinensis, wild jujube seed, white peony root, moutan bark, bupleurum, fried gardenia, rehmannia root, rhizoma anemarrhenae and lotus plumule, adding 50-90% ethanol which is 6-12 times of the crude drug, heating and reflux-extracting for 1-3 hours, heating and reflux-extracting for 1-3 times, filtering, merging the extracting solutions, and concentrating the extracting solutions at 50-90 ℃ under reduced pressure until the density is 1.05-1.20 for standby;

(2) pulverizing Corni fructus, fructus Schisandrae chinensis, radix Paeoniae alba and cortex moutan, and sieving to obtain powder;

(3) soaking rehmannia root, rhizoma anemarrhenae, lotus plumule, wild jujube seed, bupleurum chinense and fried gardenia in water with the dosage of 6-14 times of that of the raw materials for 0.5-1 hour, heating and reflux-extracting for 1-3 hours, heating and reflux-extracting for 1-3 times, filtering, merging the extracting solutions, concentrating the extracting solutions at 50-90 ℃ under reduced pressure until the density is 1.05-1.20, adding the powder in the step (2), and uniformly stirring for standby;

(4) Drying the thick paste obtained in the step (3) at 50-90 ℃, crushing the dried paste, adding auxiliary materials, and preparing the preparation.

(2) pulverizing Corni fructus, fructus Schisandrae chinensis, semen Ziziphi Spinosae, radix Paeoniae alba, cortex moutan, bupleuri radix, fructus Gardeniae preparata, rehmanniae radix, rhizoma anemarrhenae, and plumula Nelumbinis into powder, and sieving;

(3) adding auxiliary materials into the powder obtained in the step (2) to prepare a preparation.

In order to solve the technical problems, the invention provides an application of a traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome in treating insomnia, anxiety, depression and climacteric syndrome.

Drawings

FIG. 1 is a graph showing the trend of body weight change among groups of animals administered to male rats for 12 weeks and 4 weeks during recovery.

FIG. 2 is a graph showing the trend of body weight change among groups of animals administered to female rats for 12 weeks and 4 weeks during recovery.

Detailed Description

The following examples are presented to illustrate the preparation of the medicaments of the present invention, but are not intended to limit the scope of the invention in any way.

Example 1

A traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome comprises, by weight, 300 parts of pulp of dogwood fruit, 300 parts of shizandra berry, 200 parts of wild jujube seed, 200 parts of white peony root, 200 parts of rehmannia root, 100 parts of lotus plumule, 200 parts of tree peony bark, 200 parts of rhizoma anemarrhenae, 200 parts of radix bupleuri and 200 parts of fried gardenia.

The preparation method comprises the following specific steps:

(1) reflux-extracting Corni fructus, fructus Schisandrae chinensis, semen Ziziphi Spinosae, radix Paeoniae alba, cortex moutan, bupleuri radix, and fructus Gardeniae preparata with 12 times of 80% ethanol for 2 hr, filtering, adding 12 times of 80% ethanol into the residue, reflux-extracting for 2 hr, filtering, mixing 2 times of extractive solutions, and concentrating under reduced pressure at 60deg.C to density of 1.08;

(2) reflux extracting rehmanniae radix, rhizoma anemarrhenae and plumula Nelumbinis with 12 times of water for 2 hr, filtering, collecting filtrate, adding 12 times of water, reflux extracting for 2 hr, filtering, mixing 2 times of extractive solutions, concentrating under reduced pressure at 60deg.C to density of 1.08, mixing the concentrated solutions of step (1), and concentrating to density of 1.10;

(3) Drying the concentrated solution obtained in the step (2) at 70 ℃, crushing the dry paste, adding auxiliary materials, and preparing the capsule.

Example 2

The preparation method comprises the following specific steps:

(3) Drying the concentrated solution in the step (2) at 70 ℃, crushing the dry paste, adding auxiliary materials, and preparing granules.

Example 3

A traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome comprises, by weight, 500 parts of pulp of dogwood fruit, 500 parts of shizandra berry, 300 parts of semen zizyphi spinosae, 300 parts of white peony root, 300 parts of rehmannia root, 150 parts of lotus plumule, 200 parts of cortex moutan, 200 parts of rhizoma anemarrhenae, 200 parts of radix bupleuri and 200 parts of fried gardenia.

The preparation method comprises the following specific steps:

(1) reflux-extracting Corni fructus, fructus Schisandrae chinensis, semen Ziziphi Spinosae, radix Paeoniae alba, cortex moutan, bupleuri radix, fructus Gardeniae preparata, rehmanniae radix, rhizoma anemarrhenae, and plumula Nelumbinis with 12 times of water for 2 hr, filtering, adding 12 times of water into the residue, reflux-extracting for 2 hr, filtering, mixing 2 times of extractive solutions, and concentrating under reduced pressure at 60deg.C to density of 1.08;

(2) drying the concentrated solution at 60deg.C, pulverizing the dried extract, adding adjuvants, and making into capsule.

Example 4

The preparation method comprises the following specific steps:

(2) drying the concentrated solution at 60deg.C, pulverizing the dried extract, adding adjuvants, and making into granule.

Example 5

The preparation method comprises the following specific steps:

(1) reflux-extracting Corni fructus, fructus Schisandrae chinensis, semen Ziziphi Spinosae, radix Paeoniae alba, cortex moutan, bupleuri radix, and fructus Gardeniae preparata with 10 times of 80% ethanol for 1.5 hr, filtering, adding 10 times of 80% ethanol, reflux-extracting the residue for 1.5 hr, filtering, mixing 2 times of extractive solutions, and concentrating under reduced pressure at 60deg.C to density of 1.06;

(2) Reflux extracting rehmanniae radix, rhizoma anemarrhenae and plumula Nelumbinis with 10 times of water for 1.5 hr, filtering, collecting filtrate, adding 10 times of water for reflux extraction for 1.5 hr, filtering, mixing 2 times of extractive solutions, concentrating under reduced pressure at 70deg.C to density of 1.06, mixing the concentrated solutions of step (1), and concentrating to density of 1.09;

(3) drying the concentrated solution obtained in the step (2) at 60 ℃, crushing the dry paste, adding auxiliary materials, and preparing the capsule.

Example 6

The preparation method comprises the following specific steps:

(3) drying the concentrated solution in the step (2) at 60 ℃, crushing the dry paste, adding auxiliary materials, and preparing granules.

Example 7

A traditional Chinese medicine composition for treating insomnia, anxiety, depression and climacteric syndrome comprises, by weight, 450 parts of cornus officinalis, 450 parts of schisandra chinensis, 300 parts of semen zizyphi spinosae, 300 parts of white peony root, 300 parts of rehmannia root, 160 parts of lotus plumule, 300 parts of cortex moutan, 230 parts of rhizoma anemarrhenae, 230 parts of radix bupleuri and 230 parts of fried gardenia.

The preparation method comprises the following specific steps:

(1) reflux-extracting Corni fructus, fructus Schisandrae chinensis, semen Ziziphi Spinosae, radix Paeoniae alba, cortex moutan, bupleuri radix, and fructus Gardeniae preparata with 70% ethanol of 10 times of the crude drug for 1.5 hr, filtering, adding 70% ethanol of 10 times of the crude drug into the residue, reflux-extracting for 1 hr, filtering, mixing 2 times of the extractive solutions, and concentrating under reduced pressure at 60deg.C to a density of 1.05;

(2) Reflux extracting rehmanniae radix, rhizoma anemarrhenae and plumula Nelumbinis with 10 times of water for 1.5 hr, filtering, collecting filtrate, adding 10 times of water for reflux extraction for 1 hr, filtering, mixing 2 times of extractive solutions, concentrating under reduced pressure at 60deg.C to density of 1.04, mixing the concentrated solutions of step (1), and concentrating to density of 1.09;

Example 8

The preparation method comprises the following specific steps:

Example 9

The preparation method comprises the following specific steps:

(1) reflux-extracting Corni fructus, fructus Schisandrae chinensis, semen Ziziphi Spinosae, radix Paeoniae alba, cortex moutan, bupleuri radix, fructus Gardeniae preparata, rehmanniae radix, rhizoma anemarrhenae, and plumula Nelumbinis with 80% ethanol of 10 times of crude drug for 1.5 hr, filtering, adding the residue with 80% ethanol of 10 times of crude drug, reflux-extracting for 1.5 hr, filtering, mixing 2 times of extractive solutions, and concentrating under reduced pressure at 60deg.C to density of 1.10;

(2) Drying the concentrated solution obtained in the step (1) at 60 ℃, crushing the dry paste, adding auxiliary materials, and preparing the capsule.

Example 10

The preparation method comprises the following specific steps:

(1) pulverizing Corni fructus, fructus Schisandrae chinensis, semen Ziziphi Spinosae, radix Paeoniae alba, cortex moutan, bupleuri radix, fructus Gardeniae preparata, rehmanniae radix, rhizoma anemarrhenae, and plumula Nelumbinis into powder, and sieving;

(2) adding adjuvants into the powder obtained in step (1), and making into capsule.

Example 11

The preparation method comprises the following specific steps:

(1) pulverizing Corni fructus, fructus Schisandrae chinensis, radix Paeoniae alba and cortex moutan, and sieving to obtain powder;

(2) Soaking rehmannia root, rhizoma anemarrhenae, lotus plumule, wild jujube seed, bupleurum chinense and fried gardenia in water with the dosage of 6-14 times of that of the raw materials for 0.5-1 hour, heating and reflux-extracting for 1-3 hours, heating and reflux-extracting for 1-3 times, filtering, merging the extracting solutions, concentrating the extracting solutions at 50-90 ℃ under reduced pressure until the density is 1.05-1.20, adding the powder in the step (1), and uniformly stirring for standby;

(3) drying the thick paste obtained in the step (2) at 60 ℃, crushing the dried paste, adding auxiliary materials, and preparing the granules.

The pharmacodynamics research of the traditional Chinese medicine composition comprises the following steps:

the traditional Chinese medicine composition improves sleep function test:

the purpose is as follows: ICR mice were used to study the effect of test samples on sleep time in mice due to sodium pentobarbital at threshold and sub-threshold doses for 7 days following gastric lavage.

The method comprises the following steps: 60 ICR mice qualified in quarantine are selected, 18-24 g of the ICR mice are divided into 5 groups randomly, and 12 ICR mice are selected from each group. The solvent control group is 0.5% CMC-Na, the positive drug (the depression relieving and nerve soothing granule) control group is 2.0g/kg, and the test sample (the traditional Chinese medicine composition) of the invention is 0.42g/kg, 0.84g/kg and 1.68g/kg respectively. The corresponding medicine is administrated by stomach irrigation, 1 time a day, and 7 days continuously. After the last administration for 1 hour, each group of mice was intraperitoneally injected with pentobarbital sodium at a subthreshold dose of 25mg/kg, and the number of each group of sleeping mice was recorded and the statistical differences of each group were compared with those of which the eversion and the extinction of the specular reflection were over 1min as the standard of falling asleep. After all mice recovered, a threshold dose of 40mg/kg of pentobarbital sodium was again intraperitoneally injected 48 hours later, the time from the completion of pentobarbital sodium injection to the disappearance of the specular reflection was taken as the sleep-in latency, the time from the disappearance of the specular reflection to the recovery time was taken as the sleep duration, the sleep latency and the sleep time of each mouse were recorded, and the statistical differences of the groups were compared.

Results: pentobarbital sodium subthreshold dose experiments: compared with the control group, the incidence of sleep of mice in all groups except the low-dose group of the test sample is obviously increased, and the difference has statistical significance (P < 0.05); pentobarbital sodium threshold dose experiment: compared with the control group, the positive medicine control group and the test sample have obviously shortened sleep latency (P <0.05, P < 0.01) and obviously prolonged sleep time (P <0.05, P < 0.01), and the low dose group has shorter latency and prolonged sleep time compared with the control group, but has no statistical significance. The results are shown in tables 1 and 2.

TABLE 1 Effect of Chinese medicinal composition on the sleep induction of mice by sub-threshold dose of sodium pentobarbital

Comparison to vehicle control: chi-square test, #p <0.05, #p <0.01

Table 2 effect of the Chinese medicinal composition on sleep induction in mice by threshold dose of sodium pentobarbital (x±s, n=12)

Comparison to vehicle control: t-test, p <0.05, p <0.01

Conclusion: the traditional Chinese medicine composition can increase the incidence rate of sleep of mice induced by the subthreshold dose of pentobarbital sodium and prolong the sleep time of the mice induced by the threshold dose of pentobarbital sodium. The traditional Chinese medicine composition is prompted to have the effect of improving the sleep of mice and has the effect of soothing the nerves.

Test of the inhibition effect of the traditional Chinese medicine composition on sweat gland secretion:

The purpose is as follows: the KM mice are continuously perfused for 7 days, and the influence of the test sample on the sweating effect of the mice caused by pilocarpine is studied.

The method comprises the following steps: 50 KM mice qualified in quarantine are taken, 18-24 g of the mice are divided into 6 groups randomly, and 8 mice are respectively selected from each group. The vehicle control group, the model control group and the positive drug control group (jieyu tranquillizing granule) are respectively 2.0g/kg, and the low, medium and high dosage groups of the test article (Chinese medicinal composition) are respectively 0.42g/kg, 0.84g/kg and 1.68g/kg. The corresponding drugs were administered by gavage for each group, except for the vehicle control group and model control group, which were administered with 0.5% cmc-Na, 1 time a day for 7 days. After the last administration for 1 hour, pilocarpine (0.035 g/kg) was injected into the abdominal cavity of each of the other groups except the vehicle control group, the sweating of each group of mice was observed for 15min, and the sweating was judged in stages, immediately after 15min, each group of mice was sacrificed, double hind limbs were taken, 10% formalin was fixed, 1 piece of each of the meat pads of the double plantar region was taken, dehydrated, embedded, sliced, and HE stained, and the occurrence rate of sweat gland lumen of each group of mice was calculated by microscopic examination, wherein the occurrence rate of sweat gland lumen cavitation = number of sweat gland lumen cavitation/(number of sweat gland lumen cavitation + number of sweat gland lumen cavitation) x 100%.

Results: after pilocarpine is injected into the abdominal cavity, the sweating degree of all animals in the model control group is 3 grade, and the whole body hair is wet; the sweating of the test sample low-dose group animals is obviously reduced, 1 only the whole body sweats, 5 head, neck and four limbs sweats and 2 only the head and neck moistures are seen; the sweating of the middle dosage is obviously reduced, 5 of the head, the neck and the limbs sweat, and 3 of the head, the neck and the limbs are moist; the high-dose and positive drug groups obviously reduce the sweating, 3 animals sweat on the head, neck and nose, the sweat is not obvious, and 5 animals have no typical sweating signs; histopathology is seen as follows: the sweat gland bleb of the vehicle control group is serous gland, and the conduit is single-layer cubic epithelium; the gland secretion of the model control group is increased, the acinus is in a cavitation shape, and a small amount of serous fluid is visible in the lumen of the individual gland; the positive medicine control group and the test sample have obvious cavitation bubbles in the glandular epithelium of each dose, compared with the model control group, the cavitation bubble occurrence rate is obviously reduced (p < 0.01), and compared with the model control group, the test sample has fewer and smaller cavitation bubbles in the low dose group glandular bubble microscopic observation, the cavitation bubble occurrence rate is obviously reduced (p < 0.01). The results are shown in tables 3 and 4.

TABLE 3 visual inspection Standard for sweating test

Table 4 effect of Chinese medicinal composition on sweating effect of pilocarpine in mice (n=8)

Comparison with model control group p <0.05, p <0.01

Conclusion: the traditional Chinese medicine composition can obviously reduce the sweat degree of mice caused by pilocarpine, and has a certain inhibition effect on sympathetic excitation of sweat glands.

The traditional Chinese medicine composition of the invention is used for anti-fatigue test:

the purpose is as follows: the experiment adopts ICR mice, and the research of the influence of the traditional Chinese medicine composition on the swimming time of the mice is carried out in view of fatigue resistance.

The method comprises the following steps: 60 ICR mice qualified in quarantine are selected, 18-26 g of the ICR mice are divided into 5 groups randomly, and 12 ICR mice are selected from each group. The solvent control group is CMC-Na with concentration of 0.5%, the positive drug control group (jieyu tranquillizing granule) is 2.0g/kg, and the test sample (Chinese medicinal composition) is in low, medium and high dosage groups of 0.42g/kg, 0.84g/kg and 1.68g/kg. The corresponding medicine is administrated by stomach irrigation, 1 time a day, and 7 days continuously. After the last 1 hour of administration, the rat tail was loaded with 1.5g of lead wire (equivalent to 5-7% of body weight), and the rat was placed in a plastic box 40cm long, 25cm wide, 18cm deep in water and at a water temperature of 21.+ -. 1 ℃ for free swimming. When the mice swim in water until overfatigue is not caused, the nostrils are judged to be finished when the nostrils are just submerged in water, the time from the time of the mice entering water to the time of drowning is recorded as a fatigue resistance test index, and the statistical differences of the groups are compared. Mice fasted for 16h before swimming trials were performed.

Results: compared with the solvent control group, the positive control group and the high-dose group of the test sample can obviously increase the swimming time (p < 0.05) of the mice, and the low-dose group and the medium-dose group of the test sample have the tendency of increasing the swimming time, but have no statistical significance. And as the dose of the test agent increases, the swimming time of the mice gradually increases. The results are shown in Table 5.

Table 5 effect of the Chinese medicinal composition on swimming time of mice (x±s, n=12)

Comparison to vehicle control: t-test, p <0.05, p <0.01

Conclusion: the traditional Chinese medicine composition can increase the swimming time of the mice with load, and the traditional Chinese medicine composition has the anti-fatigue effect according to the index.

Test of the effects of the Chinese medicinal composition on spontaneous Activity of animals:

the purpose is as follows: the experiment adopts ICR mice to study the influence of the traditional Chinese medicine composition on spontaneous activities of the mice.

The method comprises the following steps: 60 ICR mice qualified in quarantine are selected, 18-22 g of the ICR mice are divided into 5 groups randomly, and 12 ICR mice are selected from each group. The solvent control group is 0.5% CMC-Na, the positive drug control group (jieyu tranquillizing granule) is 2.0g/kg, and the low, medium and high dosage groups of the test sample are 0.42 g/kg, 0.84g/kg and 1.68g/kg respectively. The corresponding medicine is administrated by stomach irrigation, 1 time a day, and 7 days continuously. And (3) placing the mice into a movable box 1 hour after the last administration, recording the familiar environment of each animal for 5 minutes before the experimental formally, and recording the total movement distance, average speed, total movement time, movement distance of surrounding areas, movement time of surrounding areas, movement speed of surrounding areas, total resting time, resting time of surrounding areas, resting time of a central area and resting time of surrounding areas of the mice within 10 minutes so as to evaluate the influence of the drugs on spontaneous activities of the animals.

Results: compared with a solvent control group, the total movement distance, average speed and total movement time of mice in each dosage group and the positive control group of the traditional Chinese medicine composition are not obviously different (p is more than 0.05), but have a tendency of reduction; compared with the solvent control group, the peripheral zone movement distance, the peripheral zone movement time, the peripheral zone movement speed and the peripheral zone resting time are not obviously different (p is more than 0.05); there was no significant difference (p > 0.05) in residence time in the central zone and in the peripheral zone for each dosing group compared to the vehicle control group, but the residence time in the peripheral zone was significantly longer than in the central zone. The results are shown in tables 6, 7 and 8.

Table 6 effect of the Chinese medicinal composition on the overall activity of mice (x±s, n=12)

Compared with vehicle control group, t-test, p <0.05, p <0.01

TABLE 7 influence of Chinese medicinal composition on the activity of peripheral zone of mice (X.+ -. S, n=12)

Compared with vehicle control group, t-test, p <0.05, p <0.01

Table 8 influence of the Chinese medicinal composition on the residence time in the central and peripheral regions of mice (X.+ -. S, n=12)

Compared with the residence time of the central zone of the corresponding group, t-test, p <0.05, p <0.01

Conclusion: the traditional Chinese medicine composition has no obvious influence on spontaneous activities of mice, and the total movement tends to be reduced along with the increase of the dosage of the medicine.

Acute toxicity test:

the purpose is as follows: the animals were observed for acute toxic response following oral administration of the Chinese medicinal composition.

The method comprises the following steps: 40 healthy mice which are qualified in quarantine are taken, the healthy mice are divided into 2 groups randomly, 20 mice in each group are fasted and not forbidden for 12 hours, wherein 1 group is orally administered with a test solution, the administration volume is 40ml/kg body weight, the administration is twice per day for 1 day, 19.2g/kg each time, and the total dosage is 38.4g/kg when the two administrations are separated from each other for 6 hours. The other group was orally administered with an equal amount (volume) of distilled water as a negative control. After administration, the animals were observed for fecal, skin, mucosal, respiratory, heartbeat and activity conditions within 14 days, if there were abnormalities recorded in time, and if there were dead animals for necropsy. Daily food intake was weighed, animals were weighed before administration, at one week of administration and at the end of the trial, and after the end of the observation period, surviving animals were sacrificed and subjected to gross dissection and, if necessary, pathological histology.

Results: 2 times of gastric lavage administration in a day, when the dosage is 38.4g crude drug/kg/day (corresponding to 559.7 times of clinical dosage of adult), the mice are continuously observed for two weeks, no death occurs, and the food intake and the weight within 14 days are not significantly different from those of a negative control group; no obvious toxic reaction condition exists in the skin, mucous membrane, respiration, heartbeat and activity, and no death occurs. The results are shown in tables 9, 10 and 11.

TABLE 9 acute toxicity test results of Chinese medicinal compositions

Table 10 results of weight change in acute toxicity test of Chinese medicinal composition

Table 11 results of food intake in acute toxicity test of Chinese medicinal composition

Conclusion: the oral acute toxicity of the traditional Chinese medicine composition is basically nontoxic.

Long-term toxicity test:

the purpose is as follows: the SD rats are observed to be continuously irrigated with stomach for 12 weeks, the toxic reaction and the severity of the toxic reaction to organisms are provided for the traditional Chinese medicine composition, the reversibility of target organs and damage of the toxic reaction is provided, the dosage of the non-toxic reaction is determined, and animal experimental data is provided for clinical research and application.

The method comprises the following steps: 80 SD rats qualified in quarantine are 4-5 weeks old, the weight of the SD rats is 160.7-220.3 g at the end of body weight quarantine, the SD rats are half-bred in a male-female mode, the SD rats are adaptively bred for 4 days before the test, the SD rats are randomly divided into 4 groups according to sex and weight during the test, a solvent control group, a low, medium and high dose group of test products are adopted, and 20 animals in each group are bred in a female-male mode and a male-female mode in a cage. The test sample is respectively administered with 2.0 g/kg, 4.0 g/kg, 8.0g/kg of suspension of the traditional Chinese medicine composition, and the vehicle control group is administered with 0.5% of sodium carboxymethylcellulose suspension, and the animals are completely administrated by stomach irrigation, wherein the stomach irrigation volume is 2mL/100g of body weight, 1 time per day, 6 days per week, rest 1 day, and continuous administration for 12 weeks. Animals were observed daily for physical signs of appearance, behavioral activity, and body weight and food intake were measured once a week during dosing. After 12 weeks of continuous administration, sorting according to animal numbers, selecting 12 animals (male and female halves) with smaller animal numbers in each group, taking abdominal cavity injection anesthesia by using 1.5mL/kg of 3% pentobarbital sodium after fasted for about 16 hours, taking abdominal aorta blood to observe changes of animal hematology indexes and blood biochemical indexes, then carrying out general dissection, weighing heart, liver, spleen, kidney, adrenal gland, thymus, testis, epididymis, uterus, ovary and brain and calculating organ coefficients including a brain specific coefficient (heart weight/brain weight) and a viscera body specific coefficient (heart weight/body weight/100, namely the relative weight of the viscera per 100g of body weight); histopathological examination was performed on the following organs: brain (brain, cerebellum, brain stem), spinal cord (neck, chest, waist segment), pituitary gland, thymus, thyroid, esophagus, stomach, large and small intestine, liver, kidney, adrenal gland, spleen, pancreas, trachea, lung, heart, aorta, testis, epididymis, ovary, uterus, prostate (male), breast (female), sciatic nerve, bladder, bone marrow, mesenteric lymph node, and other abnormal tissues found by system dissection. The remaining animals were observed for 4 weeks, and after the observation period was completed, the remaining animals were dissected and killed, and the above-mentioned indexes were detected.

Results: the oral suspension is administrated, the administration dosage is 8g, 4g and 2g/kg (which is equivalent to 116.6/58.3/29.2 times of clinical dosage), and 12-period experiments of the gastric lavage administration of the tested drug to SD rats show that the weights of male animals in low, medium and high dosage groups are reduced to different degrees, the stopping and recovery are carried out for 1-2 weeks, and the weight of female animals in high dosage groups is reduced; the feeding amount of the low-dose group male animals is reduced in the 4 th, 5 th, 8 th and 10 th weeks, the feeding amount of the medium-dose group male animals is reduced in the 7 th to 9/11 th weeks, and the feeding amount of the high-dose group male animals is reduced in the 4 th to 12 th weeks; the WBC count of the low dose group is reduced, the LY percentage is increased, the RBC count of the medium dose group is reduced, the MCV is obviously increased, the RBC count, the MCHC and the EO of the high dose group are reduced, the RET percentage, the MCV and the MCH are increased, the RET percentage of the low dose group is reduced after the drug withdrawal is recovered for 4 weeks, the RET percentage of the medium dose group is reduced, the EO percentage is increased, and other hematology indexes are not obviously abnormal; the Total Bilirubin (TBIL) of the high-dose group is obviously increased, the blood chlorine (Cl-) is obviously reduced, and the blood biochemical indexes of each dose group are not obviously abnormal in the recovery period of stopping the drug; the liver and body ratio coefficients of the low-dose group female animals are obviously increased, the liver weight, the body ratio and the brain and brain ratio coefficients of the medium-dose group and high-dose group male animals are obviously increased, the heart weight and the body ratio coefficients of the high-dose group male animals are reduced, the kidney, brain, testis and epididymis body ratio coefficients are increased, the brain weight of the high-dose group female animals is reduced, and the brain and heart ratio coefficients of the heart and the kidney are obviously increased. After 4 weeks of drug withdrawal recovery, the weight of ovaries of the female animals in the low, medium and high dose groups is obviously reduced, the ratio of the ovaries to the viscera and the brain of the male animals in the low and medium dose groups is obviously reduced, and no abnormality is found in the systematic section and the histopathological examination. The pharmaceutical composition has no difference to the general condition, weight, hematology index, blood biochemical index, main organ weight coefficient of rats of each dosing group compared with the comparison group; no abnormality was seen in the system section and no abnormality was seen in the pathology examination. The data results are shown in fig. 1 and 2; table 12, table 13 and table 14.

Table 12 influence of the administration of the Chinese medicinal composition on food intake of Male SD rats (g/M, mean.+ -. SD) for 12 weeks and 4 weeks of recovery period

Remarks: p <0.05, < p <0.01 compared to vehicle control.

Table 13 Effect of the Chinese medicinal composition on food intake of female SD rats (g/M, mean.+ -. SD) for 12 weeks and 4 weeks of recovery period

Table 14 effects of 12 weeks of administration of the chinese medicinal composition on biochemical indicators of blood in rats (n=12, mean±sd)

Remarks: the number of samples in the dose group in the delta test article n=11; p <0.05, P <0.01 compared to vehicle control.

Conclusion: the traditional Chinese medicine composition is basically safe to use under the experimental condition, and the traditional Chinese medicine composition is safe and reliable to use under the specified dosage.

Clinical trials of the traditional Chinese medicine composition in the invention:

the purpose is as follows: the clinical effects of the test samples on insomnia, anxiety, depression and climacteric syndrome are studied by adopting a random grouping method.

The method comprises the following steps: the clinical number of 127 persons is randomly divided into 2 groups, the control group of 63 persons and the test group of 64 persons. Positive medicine (depression relieving and nerve soothing granule) control group and test sample (traditional Chinese medicine composition) test group. Patients were followed and the patient dictation was recorded according to the scoring criteria of table 15.

Table 15 clinical efficacy scoring criteria

Table 16 statistical scoring results of clinical efficacy

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Conclusion: the traditional Chinese medicine composition has better clinical curative effect than the control medicine, has quicker curative effect according to the oral result of patients and has no adverse reaction.

Typical cases of clinical application of the traditional Chinese medicine composition of the invention:

case 1: sometimes in utero, women, age 48, and patients have frequent insomnia in recent years. Symptoms such as baking heat, sweating, losing eyes, dreaminess, hypomnesis, tinnitus and the like are repeated in the last 4 months. A red tongue with a pale tongue coating and a thready and rapid pulse. The traditional Chinese medicine composition of the embodiment 1 of the invention is taken for 3 weeks, the symptoms such as baking heat, sweating, insomnia and the like are relieved, tinnitus disappears, the symptoms completely disappear after the traditional Chinese medicine composition is taken for 2 weeks, and no recurrence is seen in follow-up half a year.

Case 2: yellow to a certain age, female, 47 years old, 5 am hot sweats from 4 months ago, sleep quality is reduced, the morning is dry and bitter, the mood is restless and irritable at ordinary times, and people often make a uproar with something else, the complexion is flushed, memory is reduced, the tongue is red, the tongue coating is white, and the pulse is thin and rapid. After taking the traditional Chinese medicine composition of the embodiment 2 of the invention for 3 weeks, the re-diagnosis is carried out, the night sweating of the patient is obviously reduced, the dry mouth and bitter taste of the patient are eliminated, the red face is faded, the memory is still poor, the sleep is bad, the taking is continued for 2 weeks, the re-diagnosis is carried out, the symptoms of baking heat and sweating are eliminated, and the patient self-states that: the mood is not depressed before, the user often dances on squares and friends, the user sleeps more stably at night than before, the whole mind state is better, and the user can continuously take the composition for 2 weeks to heal the composition.

Case 3: if a man is in a certain state, 58 years old, the man suffers from insomnia for more than 2 years, has difficulty in falling asleep, and has sleeping time of less than 4 hours every night, the man wakes up with a little sound at night, and has no need of picking up during the daytime and is faint and sinking in the severe cases. The administration of various western medicines can be relieved to a certain extent but cannot be radically cured. After taking the medicine of the example 4 for 4 weeks, the clinical symptoms of the patient completely disappear, the average sleep time is more than 7 hours per night, and no relapse occurs in 2 years of visit.

Case 4: li Mou female, 37 years old, has a disease of chlordiazepoxide for more than 2 years. The marital problem causes symptoms of unstable emotion, dysphoria, palpitation, night sleep difficulty, inappetence, dizziness and headache in severe cases, and frequent administration of western medicines for hypnotic is not ideal. After 4 weeks of administration of the drug of this example 5, the clinical symptoms completely disappeared and the patient had 8 hours of sleep time per night with no recurrence following one year.

Case 5: han Mou A, 52 years old, suffers from generalized anxiety for 1 year, is difficult to fall asleep, worry, easy to anger, tension tremble, poor memory, limb cramp, frequent cold and fever, weakness, constipation, frequent urination and urgent urination. The effect of the western medicine alprazolam is not ideal when the western medicine alprazolam is taken frequently. The clinical symptoms completely disappear after 5 weeks of taking the medicine of the example 6, and the patient sleeps for 7 hours every night without relapse after follow-up for one year.

Case 6: a woman, 50 years old, suffers from generalized anxiety for 2 years, worries about easy crying and trembling, fear of darkness, deep sleep, poor memory, trembling of sound, chest pain, dyspnea. The effect of the alprazolam and fluoxetine is not ideal by alternately taking western medicines. The clinical symptoms completely disappear after 6 weeks of administration of the medicament of the embodiment 7, and the patient sleeps for 6 hours every night without relapse after follow-up for one year.

Case 7: zhang Mou men, 31 years old, had depression for 6 months, had severe criminal duties, were negatively and often had suicidal thoughts, had difficulty falling asleep, had weight loss, had a spelt of being disappointed. The Western medicine is not ideal, clinical symptoms completely disappear after the medicine of the embodiment 8 is taken for 8 weeks, and the patient falls asleep for 7 hours every night without relapse after follow-up for one year.

Case 8: chestnut, male, 47 years old, had 1 year depression, wakefulness, sleep inadequacy, anxiety, suspicion, physical exertion evident, weight loss. The clinical symptoms are all disappeared after the medicine of the embodiment 8 is taken for 6 weeks, and the patient falls asleep for 6 hours every night without recrudescence after follow-up for one year.

Case 9: zhao is a female, 49 years old, and the patients have irregular menstrual cycles and less menstrual flow in recent years. Symptoms such as baking heat, sweating, losing eyes, dreaminess, hypomnesis, tinnitus and the like are repeated in the last 4 months. A red tongue with a pale tongue coating and a thready and rapid pulse. After taking the medicine of the example 9 for 2 weeks, the patient was re-diagnosed, hong Re, sweats, insomnia were relieved, tinnitus was disappeared, and after taking the medicine for 3 weeks, clinical symptoms were all disappeared.

Case 10: when a woman is in the middle of the age of 52 years, the patient stops menstruation for 2 years, and the person is hot and sweats from 5 hours before 4 months, the sleep quality is reduced, the person is dry and bitter in mouth in the morning, and the person is often noisy with other people, flushed in the face, memory is reduced, red tongue, white coating and thready and rapid pulse. After taking the medicine of the embodiment 10 for 3 weeks, the patient is re-diagnosed, hong Re, sweats and symptoms are relieved, sleep is good, mood is improved obviously, clinical symptoms are all disappeared after taking the medicine for 4 weeks, and no recurrence is caused in one year of follow-up.

Case 11: the symptoms of a certain Qiao, a woman, 40 years old, irregular menstruation, less menstruation, disharmony of sexual life, insomnia, dreaminess, hypomnesis, hong Re, sweat, hypodynamia and the like of a patient repeatedly occur, and dependence is generated when western medicines are frequently taken for hypnotic. After taking the medicine of the example 11 for 3 weeks, menstruation returns to normal, clinical symptoms completely disappear, and no relapse occurs in one year of follow-up.

Claims

1. The application of the traditional Chinese medicine composition in preparing the medicine for treating depression is characterized in that the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 300-700 parts of dogwood fruit, 300-700 parts of shizandra berry, 200-400 parts of wild jujube seed, 200-400 parts of white paeony root, 200-400 parts of rehmannia root, 100-200 parts of lotus plumule, 200-400 parts of moutan bark, 150-350 parts of rhizoma anemarrhenae, 150-350 parts of radix bupleuri and 150-350 parts of fried gardenia.

2. The application of claim 1, wherein the traditional Chinese medicine raw materials are in parts by weight: 400-600 parts of dogwood fruit, 400-600 parts of shizandra berry, 200-350 parts of wild jujube seed, 200-350 parts of white paeony root, 200-350 parts of rehmannia root, 140-190 parts of lotus plumule, 200-350 parts of moutan bark, 150-300 parts of rhizoma anemarrhenae, 150-300 parts of radix bupleuri and 150-300 parts of fried gardenia.

3. The application of claim 1, wherein the traditional Chinese medicine raw materials are in parts by weight: 400-500 parts of dogwood fruit, 400-500 parts of shizandra berry, 250-350 parts of wild jujube seed, 250-350 parts of white peony root, 250-350 parts of rehmannia root, 150-170 parts of lotus plumule, 250-350 parts of moutan bark, 150-250 parts of rhizoma anemarrhenae, 150-250 parts of radix bupleuri and 150-250 parts of fried gardenia.

4. The use according to any one of claims 1 to 3, wherein the Chinese medicinal composition is prepared into any one of commonly used preparations, such as tablets, capsules, granules, pills, mixtures, syrups, soft extracts, powders, suppositories, gels, sprays, or injections.

5. The use according to any one of claims 1 to 3, wherein the Chinese medicinal composition is prepared by a preparation method comprising the steps of:

(1) Weighing the raw materials according to the proportion for standby;

(3) drying the concentrated solution obtained in the step (2) at 50-90 ℃, crushing the dried paste, and adding auxiliary materials to prepare the preparation.

6. The use according to any one of claims 1 to 3, wherein the Chinese medicinal composition is prepared by a preparation method comprising the steps of:

(1) weighing the raw materials according to the proportion for standby;

(3) reflux extracting rehmannia root, anemarrhena rhizome and lotus plumule with 6-14 times of water for 0.5-5 hr, filtering to obtain filtrate, reflux extracting the residue with 6-14 times of water for 0.5-5 hr, reflux extracting for 1-3 times, filtering, merging the extracting solutions, decompressing and concentrating at 40-90 deg.c to 1.01-1.20, merging the concentrated solutions in the step (2), concentrating to 1.05-1.15;

(4) Drying the concentrated solution in the step (3) at 50-90 ℃, crushing the dried paste, and adding auxiliary materials to prepare the preparation.

7. The use according to any one of claims 1 to 3, wherein the Chinese medicinal composition is prepared by a preparation method comprising the steps of:

(1) weighing the raw materials according to the proportion for standby;

(2) taking pulp of dogwood fruit, schisandra chinensis, wild jujube seed, white peony root, moutan bark, bupleurum, fried gardenia, rehmannia root, rhizoma anemarrhenae and lotus plumule, adding 50-90% ethanol which is 6-12 times of crude drug, heating and reflux-extracting for 1-3 hours, heating and reflux-extracting for 1-3 times, filtering, merging the extracting solutions, and concentrating the extracting solutions under reduced pressure at 50-80 ℃ until the density is 1.05-1.20 for later use;

8. The use according to any one of claims 1 to 3, wherein the Chinese medicinal composition is prepared by a preparation method comprising the steps of:

(1) weighing the raw materials according to the proportion for standby;

9. The use according to any one of claims 1 to 3, wherein the Chinese medicinal composition is prepared by a preparation method comprising the steps of:

(1) weighing the raw materials according to the proportion for standby;

(3) adding auxiliary materials into the powder in the step (2) to prepare the preparation.