Depression-relieving pill-based traditional Chinese medicine composition for treating insomnia and preparation method of depression-relieving pill-based traditional Chinese medicine composition

Abstract

The traditional Chinese medicine composition is prepared from the following medicines in parts by weight: 8 to 10 parts of radix bupleuri, 8 to 10 parts of radix angelicae sinensis, 8 to 10 parts of radix paeoniae alba, 6 to 8 parts of radix curcumae, 10 to 15 parts of fructus lycii, 5 to 8 parts of flos chrysanthemi, 5 to 8 parts of flos eriocauli, 10 to 15 parts of poria cocos, 5 to 8 parts of fructus ziziphi jujubae, 3 to 5 parts of radix polygalae, 5 to 8 parts of liquorice root and 8 to 10 parts of caulis polygoni multiflori. And 2-5 parts of xanthophyll. On the basis of the depression-relieving pill, the blood-cooling and eyesight-improving decoction is combined for increasing and decreasing the prescription, so that the medicinal composition is obtained, and the symptoms of asthenopia and liver depression and spleen deficiency can be effectively relieved and treated.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition for treating insomnia based on Jieyu pills and a preparation method thereof, belonging to the field of traditional Chinese medicine preparations. Background Art

[0002] With the development of science and the progress of society, as well as the widespread popularization and application of video terminals such as computers, televisions, and mobile phones, more and more people are engaged in close-up and fine eye work, and the situation of excessive eye use is becoming more and more serious, which causes a series of discomfort symptoms such as eye soreness, swelling, dryness, and tearing. These symptoms seriously affect people's physical and mental health and quality of life. In fact, this is a modern work style disease - visual fatigue. Visual fatigue is a complex syndrome of a series of symptoms. The main symptoms of patients with early visual fatigue are: eye: eye soreness, swelling, pain, photophobia and tearing, itchy and dry eyes, eye muscle spasm, etc.; vision: unclear vision at a distance or near, temporary vision loss, easy to make mistakes when reading text, blurred lines of text, foreign body sensation, etc. This stage In the early stage, some drugs are generally used to improve eye and vision problems, but people's working environment has not changed, resulting in general effects. After long-term treatment without effect, people experience headaches, dizziness, neck and shoulder pain, drowsiness, fatigue, restlessness, irritability, difficulty concentrating, and in severe cases, accompanied by numbness of the limbs, nausea, vomiting, heart attack, insomnia, memory loss and other problems. At this stage, it is generally believed that people suffer from depression, insomnia, menopausal disease, etc., and use corresponding treatment plans for treatment. In this process, the treatment of eyes and vision is generally ignored, resulting in poor effects. Therefore, it is of great significance to develop a drug that can simultaneously adjust eye and vision disease problems and treat insomnia caused by visual fatigue. Summary of the invention

[0003] The invention provides a traditional Chinese medicine composition for treating insomnia based on Jieyu Pills and a preparation method thereof, which solves the problems that the existing medicines for treating insomnia caused by visual fatigue focus on treating the symptoms of insomnia, ignore the treatment of eye diseases, and have poor overall effects.

[0004] In order to solve the above technical problems, the technical solution adopted by the present invention is:

[0005] A traditional Chinese medicine composition for treating insomnia based on Jieyu Pills is prepared from the following drugs in parts by weight:

[0006] 8-10 parts of bupleurum, 8-10 parts of angelica, 8-10 parts of white peony root, 6-8 parts of curcuma, 10-15 parts of wolfberry, 5-8 parts of chrysanthemum, 5-8 parts of schizonepeta tenuifolia, 10-15 parts of poria, 5-8 parts of jujube, 3-5 parts of polygala, 5-8 parts of liquorice, 8-10 parts of polyphylla, and 2-5 parts of lutein.

[0007] Further, preferably: prepared from the following drugs in parts by weight, 10g of bupleurum, 10g of angelica, 8g of white peony root, 6g of curcuma, 12g of wolfberry, 6g of chrysanthemum, 6g of herbaceous stalks, 15g of poria, 5g of jujube, 4g of polygala, 6g of licorice, 9g of polysaccharide, and 3g of lutein.

[0008] Furthermore, preferably, the Chinese medicine composition is prepared from the raw powder or water or organic solvent extract of the raw material medicine as the active ingredient, and pharmaceutically acceptable excipients or auxiliary ingredients are added to form a commonly used pharmaceutical preparation.

[0009] Furthermore, preferably, the preparation is an oral liquid, granules, capsules or pills.

[0010] The preparation method of the Chinese medicine composition of the present invention comprises the following steps:

[0011] (1) Weigh the APIs except lutein according to the weight ratio;

[0012] (2) extracting the active ingredients of the drug using a suitable extraction solvent and concentrating the extract to obtain the drug extract;

[0013] (3) Add lutein and pharmaceutically acceptable excipients or auxiliary ingredients to prepare a commonly used pharmaceutical preparation.

[0014] The Chinese medicine composition of the invention is used in preparing medicine for treating insomnia caused by visual fatigue.

[0015] Beneficial effects of the present invention:

[0016] The present invention is based on Jieyu Pills, combined with Liangxue Mingmu Decoction to add and subtract ingredients to obtain the drug combination of the present invention, which can effectively relieve and treat the symptoms of visual fatigue combined with liver depression and spleen deficiency syndrome. Jieyu Pills are composed of 10 kinds of herbs and are a proprietary medicine. They were originally developed from classic Chinese medicine formulas for the treatment of emotional symptoms related to the menstrual cycle. Clinical studies have shown that Jieyu Pills are effective in treating depression and anxiety, including menopausal depression, postpartum depression, generalized anxiety disorder, psychosomatic diseases and insomnia, and can be a good treatment for physical and mental diseases caused by visual fatigue. Liangxue Mingmu Decoction is from Volume 6 of "Xingyuan Shengchun". It is mainly used to treat long-term dull and painful eyes, or unclear vision, and photophobia. It can effectively treat eye and vision diseases.

[0017] The pharmacology of the drug combination of the present invention is as follows:

[0018] Main medicine: Bupleurum, Angelica:

[0019] Bupleurum: It has the effects of soothing the liver and relieving depression, regulating qi, improving the blood circulation in the eyes, and relieving insomnia caused by visual fatigue. Angelica: It replenishes blood and regulates menstruation, calms the mind, and has a good effect on improving insomnia caused by blood deficiency. The combination of the two medicines can enhance the effect of Bupleurum in soothing the liver and relieving depression, while replenishing blood and nourishing the liver, improving insomnia caused by liver blood deficiency.

[0020] Assistant medicine: white peony root, turmeric, wolfberry fruit;

[0021] White Peony Root: nourishes blood and softens the liver, relieves muscle tension, and helps reduce visual fatigue; Curcuma Radix: has the functions of promoting qi and blood circulation, clearing away heat and detoxifying, can enhance the effect of Bupleurum Root on soothing the liver and relieving depression, and can also relieve insomnia caused by bad mood; Lycium Barbarum: nourishes the liver and kidneys, improves eyesight, and has a good effect in relieving visual fatigue.

[0022] Adjuvants: Chrysanthemum, Herba Codonopsis, Poria, and Cistanche deserticola

[0023] Chrysanthemum: Clears the liver and improves eyesight, relieves dry eyes caused by overuse. Herba Corydalis: Clears heat and improves eyesight, used to treat dry eyes and blurred vision. Chrysanthemum and Herba Corydalis can improve symptoms of visual fatigue, relieve eye pain, and thus help improve insomnia. Poria: Strengthens the spleen and eliminates dampness, calms the mind, and helps improve insomnia. Herba Polygoni Multiflori: Nourishes blood and calms the mind, and has a good effect on treating insomnia.

[0024] Drug:

[0025] Jujube: nourishes the spleen and stomach, nourishes blood and calms the mind, and harmonizes various medicines. Polygala: calms the mind and stabilizes the spirit, connects the heart and kidney, and has an auxiliary therapeutic effect on insomnia. Licorice: harmonizes the properties of the medicines, relieves the mutual restraint between the medicines, and enhances the efficacy of the medicines.

[0026] Lutein:

[0027] Lutein is a natural antioxidant that helps improve vision, reduce eye fatigue and protect retinal health.

[0028] Soothing the liver and relieving depression: Bupleurum, Curcuma; Nourishing blood and calming the mind: Angelica, White Peony, Jujube, Polygonum multiflorum; Clearing the liver and improving eyesight: Chrysanthemum, Coix lacryma-jobi, Lycium barbarum; Strengthening the spleen and eliminating dampness: Poria; Harmonizing the medicinal properties: Licorice; Anti-oxidation and protecting eyesight: Lutein.

[0029] It is based on Jieyu Pills, which soothe the liver and relieve depression, and harmonize Qi. Wolfberry, chrysanthemum and other eyesight-improving herbs are added to improve the symptoms of visual fatigue. At the same time, combined with herbs that calm the mind and stabilize the spirit, they work together to treat insomnia caused by visual fatigue, while improving insomnia caused by visual fatigue and protecting and improving vision. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work. Figure 1 The figure shows the weight change results of rats in different experimental groups; Figure 2 The graph shows the changes in food intake of rats in different experimental groups. DETAILED DESCRIPTION

[0031] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] Example 1

[0033] A traditional Chinese medicine composition for treating insomnia based on Jieyu Pills is prepared from the following medicines in parts by weight: 100g of bupleurum, 100g of angelica, 80g of white peony root, 60g of curcuma, 120g of wolfberry, 60g of chrysanthemum, 60g of coix seed, 150g of tuckahoe, 50g of jujube, 40g of polygala, 60g of liquorice, 90g of polysaccharide, and 30g of lutein;

[0034] The preparation method comprises the following steps:

[0035] (1) Weigh the APIs except lutein according to the weight ratio;

[0036] (2) Add 10 times the amount of water for the first extraction and extract for 2 hours. Add 8 times the amount of water for the second extraction and extract for 2 hours. Combine the filtrates, concentrate to a volume of 1:1, cool, and obtain an extract for later use.

[0037] (3) The extract, lutein, sucrose powder and dextrin are mixed and granulated in a weight ratio of 1:2:1, and the granules are dried to obtain 1000 g of the product, which is then packaged.

[0038] Example 2

[0039] It is basically the same as Example 1, except that: a Chinese medicine composition for treating insomnia based on Jieyu Pills is prepared from the following drugs in parts by weight: 80g of Bupleurum, 80g of Angelica, 100g of White Peony, 80g of Curcuma, 100g of Lycium barbarum, 50g of Chrysanthemum, 80g of Coix lacryma-jobi, 100g of Poria, 80g of Jujube, 50g of Polygala, 50g of Licorice, 100g of Polygala, and 50g of Lutein.

[0040] Example 3

[0041] The invention is basically the same as Example 1, except that: a traditional Chinese medicine composition for treating insomnia based on Jieyu Pills is prepared from the following medicines in parts by weight: 90g of Bupleurum, 100g of Angelica, 90g of White Peony, 70g of Curcuma, 150g of Lycium barbarum, 80g of Chrysanthemum, 50g of Herba Codonopsis pilosulae, 110g of Poria, 60g of Jujube, 30g of Polygala, 70g of Licorice, 80g of Polygonum multiflorum, and 20g of Lutein.

[0042] Example 4

[0043] It is basically the same as Example 1, except that: a Chinese medicine composition for treating insomnia based on Jieyu Pills is prepared from the following drugs in parts by weight: 80g of Bupleurum, 90g of Angelica, 80g of White Peony, 80g of Curcuma, 100g of Lycium barbarum, 70g of Chrysanthemum, 70g of Coix lacryma-jobi, 130g of Poria, 70g of Jujube, 50g of Polygala, 80g of Licorice, 80g of Polygonum multiflorum, and 30g of lutein.

[0044] Animal Experimentation:

[0045] (1) Animals: 60 SPF SD male rats, 6-7 weeks old, weighing 200±20 g, were housed in an SPF animal room at a temperature of 22±2°C and a humidity of 30-40%. Each group of rats was fed with regular feed and had free access to water.

[0046] After 7 days of adaptive feeding, rats were randomly divided into a normal group, a model group, a Jieyu Pill group, a Mingmu Dihuang Pill group and an Example 1 group according to their initial body weight, with 10 rats in each group and 5 rats in one cage. The normal group had free access to water and food without stimulation. The other three groups received various mild stimulations and drug gavage for 5 consecutive weeks. During the entire modeling and experimental process, the ethical guidelines for experimental animals were strictly implemented to minimize the suffering of the animals.

[0047] (2) Drug treatment:

[0048] The rats were gavaged 1 hour before modeling every day. According to the body weight conversion method, the dosage for an adult with an average body weight of 60 kg was converted into an equivalent drug dosage for rats (dose = adult dosage × 6.17 ÷ 60 kg), and the gavage volume was 1 ml / 100 g body weight.

[0049] Mingmu Dihuang Pills (honey pills): Dissolve Mingmu Dihuang Pills in deionized water to form a suspension and administer orally at a dosage of 1.23 g / kg / d.

[0050] Jieyu Pills group: Jieyu Pills were dissolved in deionized water to form a suspension, and the dosage was 1.23 g / kg / d by gavage;

[0051] Example 1 group: The particles prepared in Example 1 were dissolved in deionized water to form a suspension, and the dosage was 10.28 g / kg / d, which was administered orally every day.

[0052] The normal group and the model group were given an equal volume of deionized water.

[0053] (3) Modeling method

[0054] Modeling method of rats with visual fatigue and liver depression and spleen deficiency syndrome:

[0055] After one week of adaptive feeding, rats in all groups except the normal group were randomly exposed to LED light and any of the following three mild stresses every day, each continuously:

[0056] Tail clamp for 3 minutes: clamp the tail of the rat with a small long tail clamp for 3 minutes;

[0057] Noise: 75dB white noise stimulation for 4h;

[0058] Restraint for 3 hours: The rats were fixed in the restraint cylinder. The restraint was based on the premise of not affecting the normal circadian rhythm of the rats. The length of the restraint cylinder was adjusted to ensure that the animals were completely fixed without any damage. The rats were restricted from moving forward, backward and turning around, and the degree of restraint was set to avoid any sense of oppression and affecting their breathing and excretion.

[0059] LED lighting: 2000 Lux LED light irradiation, LED light eye intensity of 500-600 Lux, color temperature of 3300-3500 K, 4 hours, two 2-hour sessions, 1 hour rest. Specific modeling stress items and time arrangements are shown in Table 1.

[0060] Table 1 Modeling stress items and time

[0061] LED irradiation Clamp the tail for 3 minutes 85dB white noise 5h Bondage 3h Monday √ √ Tuesday √ √ Wednesday √ √ Thursday √ √ Friday √ √ Saturday √ √ Saturday √

[0062] (4) Observation of macroscopic characteristics of rats

[0063] Before daily administration, the rats' mental state, posture, fur color, activity, swaying, responsiveness to stimulation, color of palpebral fissure mucosa, feces and other general conditions were observed.

[0064] (5) Body weight and food intake

[0065] The rats were weighed one day before modeling. After modeling began, the weight of rats in each group was recorded every week (weekend 1, 2, 3, and 4) to monitor the weight changes of rats in each group.

[0066] After the modeling started, the food of each group was weighed and distributed to the rats at 8:00 a.m. every day. The remaining food of each group was weighed again at 8:00 a.m. the next day, and the weighed food was redistributed to the rats until the modeling was completed. The monitoring was continued for 6 weeks. The weekly food intake of the four groups of rats was calculated according to the formula: weekly food intake = weekly food intake (g) - weekly remaining food intake (g).

[0067] (6) Forced swimming test

[0068] After five weeks of modeling, a 50 cm high, 20 cm diameter, open top forced swimming bucket was used. The first day was the training period. Pure water (20-25°C) was added to the bucket to a height of 35 cm, and the rats were allowed to swim for 15 minutes as pre-experimental training. The second day was the formal experimental period. The rats were placed in a bucket filled with water and swam for 5 minutes. The time that each group of rats floated in the bucket (meaning that the animal's limbs floated on the water surface without activity or the limbs swam slightly to maintain its balance) within 5 minutes was recorded to evaluate the depressive behavior of each group of rats.

[0069] (7) Blood preparation for SOD test: 2 ml of blood was collected from the common jugular vein and injected into a clean, dry test tube. The blood was centrifuged at 3600 rpm for 10 minutes to separate the serum and test it.

[0070] (8) Preparation of eye tissue slurry for SOD test: quickly remove the limiting ball, weigh on a precision balance, grind thoroughly in a micro grinder, centrifuge at 3000 rpm for 15 minutes, separate the supernatant, and test.

[0071] Experimental Results

[0072] (1) Macroscopic observation results of rats in each group

[0073] Before modeling, the rats in each group had full sperm, agile and powerful movements, sensitive reactions, smooth and shiny hair, ruddy skin, ruddy eye fissure mucosa, clean canthus, and moderately dry and spherical feces.

[0074] Normal group: rats were not subjected to any stress modeling treatment. After 4 weeks, except for the significant increase in body weight, other performances were the same as before modeling.

[0075] Model group: In the first week, the rats were in good spirits, responsive, lively and active. They struggled vigorously and resisted fiercely during gavage. The feces were moderately dry and spherical, and the hair was smooth and shiny. The rats resisted obviously when subjected to stimulation such as noise, and even jumped up and bit the speakers outside the cage. They were also hostile and alert to strange objects in the cage. When stimulated by tail clamping, the rats were irritable, jumping and biting violently. Rats resisted violently and were irritable when subjected to restraint stress. When captured, the rats kept biting and struggling; after being tied up, they kept biting the restraint belt and the restraint frame, trying to break free from the restraint belt. Generally, they broke free after a few minutes of restraint and needed to be fixed multiple times.

[0076] In the second week of modeling, the rats were in good spirits, their fur color darkened, their movements were agile but their activity level decreased. After modeling, they liked to curl up in the dark corner of the cage, their eyes showed discomfort, the number of blinks decreased slightly, their feces were moderately dry and spherical, and they did not resist the various modeling stimuli, but resisted various stimuli.

[0077] In the third week of modeling, the rats were in poor mental state, their hair was dry, their skin was dull, their movements were agile but their activity level was reduced, and the frequency and intensity of their resistance to various stimuli were significantly reduced. After the modeling, they preferred to curl up in the dark corner of the cage and avoid light. Their eyes showed discomfort and the number of blinks was significantly reduced. The rat feces were found to be softer with increased humidity through naked eye observation.

[0078] In the fourth week of modeling, the rats' mental state deteriorated significantly, their hair became dry and yellow, they were slow to react, lazy to move, liked to curl up and huddle, their eyes were dry, they rarely blinked, and they were not active in resisting various stimuli, or even did not resist. The feces became significantly softer, and some were shapeless.

[0079] In the fifth week of modeling, the rats had a poor mental state, were tired and sleepy, liked to curl up and gather together, had messy, dry and yellow hair, pale and dull skin color on the auricle and nose, pale mucous membrane of the eye fissure, obvious secretions in the canthus, weak voice, no arched back phenomenon, dry and wet feces, loose stools appeared. During the restraint stress process, the rats' resistance was weakened or even non-resistance, and no struggle occurred.

[0080] Mingmu Dihuang Pills Group:

[0081] In the first week, the rats were in good spirits, responsive, lively and active. They struggled vigorously and resisted fiercely during gavage. Their feces were moderately dry and spherical, and their hair was smooth and shiny. The rats resisted obviously when stimulated by noise, and even jumped up and bit the speakers outside the cage. They were also hostile and alert to strange objects in the cage. When stimulated by tail clamping, the rats were irritable, jumping and biting violently. Rats resisted violently and were irritable when subjected to restraint stress. When captured, the rats kept biting and struggling. After being tied up, they kept biting the restraint belt and the restraint frame, trying to break free from the restraint belt. Generally, they broke free after a few minutes of restraint and needed to be fixed multiple times.

[0082] In the second week of modeling, the rats were in good spirits, with no obvious changes in their fur. They were responsive but less active, and their resistance to gavage and grasping was slightly less than in the first week. Their feces were moderately dry and spherical. After the modeling, they liked to curl up in the dark corner of the cage and avoid light. They showed discomfort in their eyes and blinked less frequently, but their resistance to various modeling stimuli was still obvious.

[0083] The third week of modeling: other changes were not obvious in the third week;

[0084] The fourth week of modeling: The overall condition of the rats improved, the reaction was more sensitive, the activity increased compared with the model group, the feces became softer but still formed. The symptoms of eye discomfort were alleviated, and the number of blinks increased.

[0085] The fifth week of modeling: compared with the model group, the condition was significantly improved: the mental state was good, the fur was shiny and slightly messy, the canthus was clean, the symptoms of eye discomfort disappeared, various autonomous activities were normal, the feces were moderately dry and spherical, and there was obvious resistance to various stimuli.

[0086] Jieyu Pills Group: In the first week, the rats were in good spirits, responsive, lively and active. They struggled vigorously and resisted fiercely during gavage. The feces were moderately dry and spherical, and the hair was smooth and shiny. The rats resisted obviously when subjected to stimulation such as noise, and even jumped up and bit the speakers outside the cage. They were also hostile and alert to strange objects in the cage. When stimulated by tail clamping, the rats were irritable, jumping and biting violently. The rats resisted violently and were irritable when subjected to restraint stress. When captured, the rats kept biting and struggling; after being tied up, they kept biting the restraint belt and the restraint frame, trying to break free from the restraint belt. Generally, they broke free after a few minutes of restraint and needed to be fixed multiple times.

[0087] In the second week of modeling, the rats were in good spirits, with no obvious changes in their fur. They were responsive but less active, and their resistance to gavage and grasping was slightly less than in the first week. Their feces were moderately dry and spherical. After the modeling, they liked to curl up in the dark corner of the cage and avoid light. They showed discomfort in their eyes and blinked less frequently, but their resistance to various modeling stimuli was still obvious.

[0088] The third week of modeling: other changes were not obvious in the third week;

[0089] The fourth week of modeling: The overall condition of the rats improved, the reactions were more sensitive, the activity increased compared with the model group, the feces became softer but still formed, the symptoms of eye discomfort were alleviated, and the number of blinks increased.

[0090] The fifth week of modeling: compared with the model group, the condition was significantly improved: the mental state was good, the fur was shiny and slightly messy, the canthus was clean, the symptoms of eye discomfort still existed, various autonomous activities were normal, the feces were moderately dry and spherical, and there was obvious resistance to various stimuli.

[0091] Embodiment 1 group:

[0092] In the first week, the rats were in good spirits, responsive, lively and active. They struggled vigorously and resisted fiercely during gavage. Their feces were moderately dry and spherical, and their hair was smooth and shiny. The rats resisted obviously when stimulated by noise, and even jumped up and bit the speakers outside the cage. They were also hostile and alert to strange objects in the cage. When stimulated by tail clamping, the rats were irritable, jumping and biting violently. Rats resisted violently and were irritable when subjected to restraint stress. When captured, the rats kept biting and struggling. After being tied up, they kept biting the restraint belt and the restraint frame, trying to break free from the restraint belt. Generally, they broke free after a few minutes of restraint and needed to be fixed multiple times.

[0093] In the second week of modeling, the rats were in good spirits, with no obvious changes in their fur. They were responsive but less active, and their resistance to gavage and grasping was slightly less than in the first week. Their feces were moderately dry and spherical. After the modeling, they liked to curl up in the dark corner of the cage and avoid light. They showed discomfort in their eyes and blinked less frequently, but their resistance to various modeling stimuli was still obvious.

[0094] The third week of modeling: other changes were not obvious in the third week;

[0095] The fourth week of modeling: The overall condition of the rats improved, the reactions were more sensitive, the activity increased compared with the model group, the feces became softer but still formed, and the eye discomfort symptoms disappeared.

[0096] The fifth week of modeling: compared with the model group, the conditions were significantly improved: good mental state, shiny fur, clean eye canthus, bright eyes, normal blinking, normal autonomous activities, moderate dryness and wetness of feces and spherical shape, strong resistance to various stimuli, and increased weight compared with the fourth week.

[0097] (2) Weight changes

[0098] The changes in body weight of rats in each group at different time points are shown in the table and figure below

[0099] The changes in body weight of rats in each group at different time points (as shown in Table 2, Figure 1): Compared with the blank group, the body weight of the model group had no significant changes before modeling and 1 and 2 weeks after modeling; at the end of the third week, the body weight of the model group was significantly lower than that of the normal group (P < 0.05); at the end of the fourth and fifth weeks, the body weight of the model group decreased significantly (P < 0.01). Compared with the model group, the body weight of the rats in the Mingmu Dihuang Pill group had no significant changes before modeling and at the end of the first, second and third weeks; at the end of the fourth and fifth weeks, the drug effect began to appear, and the body weight of the Xiaoyao Powder group increased significantly (P < 0.05); compared with the model group, the body weight of the Jieyu Pill group had no significant changes before modeling and at the end of the first and second weeks; at the end of the third, fourth and fifth weeks, the body weight of the Jieyu Pill group increased significantly (P < 0.05); compared with the model group, the body weight of the Example 1 group had no significant changes before modeling and at the end of the first and second weeks; at the end of the third week, the body weight of the Example 1 group increased significantly (P < 0.05), and at the end of the fourth and fifth weeks, the body weight of the Example 1 group increased significantly (P < 0.01).

[0100] Table 2 Statistical results of body weight changes of rats in each group at different time points

[0101] Before modeling / g Week 1 / g Week 2 / g Week 3 / g Week 4 / g Week 5 / g Blank Group 205.32±8.63 252.02±5.67 268.06±6.32 293.60±4.32 336.39±6.05 358.24±5.24 Model Group 204.68±6.08 254.14±6.08 262.85±5.36 265.29±3.69* 266.91±4.27** 270.80±6.24** Mingmu Dihuang Pills 205.89±7.12 255.36±5.23 264.27±4.39 285.37±5.01 302.28±6.37# 326.47±4.69# Jieyu Pills Group 203.36±5.89 251.89±6.05 265.06±4.38 282.64±3.09# 294.54±5.63# 324.63±4.15# Example 1 Group 204.67±8.26 255.37±3.25 268.23±3.67 289.01±5.07# 321.90±4.09## 346.21±4.35##

[0102] Note: Compared with the blank group: *P<0.05, **P<0.01, compared with the model group: #P<0.05, ##P<0.01.

[0103] (3) Changes in food intake of rats in each group at different time points (as shown in Table 3, Figure 2 ): Compared with the blank group, the food intake of the model group did not change significantly in the first and second weeks, and there was no statistical significance (P>0.05); in the third, fourth and fifth weeks, the food intake of the model group decreased significantly compared with the normal group (P<0.01). Compared with the model group, the food intake of the rats in the Mingmu Dihuang Pill group did not change significantly in the first and second weeks; the drug effect began to appear in the fourth week, and the food intake increased significantly in the third, fourth and fifth weeks (P<0.05); compared with the model group, the food intake of the Jieyu Pill group did not change significantly in the first and second weeks; in the third week, the food intake increased significantly (P<0.01); in the fourth and fifth weeks, the food intake increased significantly (P<0.05); compared with the model group, the food intake of the Example 1 group did not change significantly in the first and second weeks; in the third, fourth and fifth weeks, the food intake increased significantly (P<0.01).

[0104] Table 3 Statistical results of body weight changes of rats in each group at different time points

[0105]

[0106]

[0107] Note: Compared with the blank group: *P<0.05, **P<0.01, compared with the model group: #P<0.05, ##P<0.01.

[0108] (4) Results of the forced swimming test

[0109] Comparison of the immobility time within 5 minutes of forced swimming in rats of each group (as shown in Table 4): Compared with the normal group, the immobility time within 5 minutes of forced swimming in rats of the model group was significantly increased (P < 0.01). Compared with the model group, the Mingmu Dihuang Pills group and the Jieyu Pills group could significantly reduce the immobility time within 5 minutes of forced swimming in rats (P < 0.05); Example 1 could significantly reduce the immobility time within 5 minutes of forced swimming in rats (P < 0.01).

[0110] Table 4 Statistical results of immobility time within 5 min of forced swimming in each group of rats

[0111] Immobility time within 5 minutes / s Blank Group 92.25±9.26 Model Group 109.09±10.12** Mingmu Dihuang Pills 101.82±11.04 Jieyu Pills Group 98.36±9.25# Example 1 Group 95.69±10.61##

[0112] Note: Compared with the blank group: *P<0.05, **P<0.01, compared with the model group: #P<0.05, ##P<0.01.

[0113] (5) SOD measurement results

[0114] Table 5 Results of SOD activity determination in serum and eye tissue homogenate of rats in each group

[0115]

[0116] Note: Compared with the blank group: *P<0.05, **P<0.01, compared with the model group: #P<0.05, ##P<0.01.

[0117] Compared with the blank group, the SOD activities in serum and eye tissue homogenate of the model group were significantly lower than those of the blank group (P<0.01); compared with the model group, the serum SOD activity of the Mingmu Dihuang Pills group was significantly higher than that of the model group, and the SOD activity in eye tissue homogenate was not significantly significant; compared with the model group, the serum SOD activity of the Jieyu Pills group was not significantly significant, and the SOD activity in eye tissue homogenate was significantly higher than that of the model group (P<0.05); compared with the model group, the SOD activities in serum and eye tissue homogenate of the Example 1 group were significantly higher than those of the model group (P<0.01).

[0118] A rat model of visual fatigue combined with liver depression and spleen deficiency was constructed by adopting a 5-week chronic unpredictable mild stress model. Through animal macroscopic characterization, behavioral experiments, SOD activity determination and other tests, the animal model of visual fatigue combined with liver depression and spleen deficiency type insomnia was successfully replicated.

[0119] By using Jieyu Pills, Mingmu Dihuang Pills and the medicine of the present invention to conduct comparative experiments, it can be found that Jieyu Pills and Mingmu Dihuang Pills have certain therapeutic effects on rats with visual fatigue combined with liver depression and spleen deficiency symptoms, and the medicine of the present invention can significantly improve the treatment of insomnia rats with visual fatigue combined with liver depression and spleen deficiency symptoms, and is a traditional Chinese medicine for treating visual fatigue combined with liver depression and spleen deficiency.

[0120] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating insomnia based on Jieyu Pills, characterized in that: According to weight parts, it is prepared from the following drugs: 8-10 parts of bupleurum, 8-10 parts of angelica, 8-10 parts of white peony root, 6-8 parts of curcuma, 10-15 parts of wolfberry, 5-8 parts of chrysanthemum, 5-8 parts of schizonepeta tenuifolia, 10-15 parts of poria, 5-8 parts of jujube, 3-5 parts of polygala, 5-8 parts of liquorice, 8-10 parts of polyphylla, and 2-5 parts of lutein.

2. The Chinese medicine composition according to claim 1, characterized in that: It is prepared from the following medicines by weight: 10g of bupleurum, 10g of angelica, 8g of white peony root, 6g of curcuma, 12g of wolfberry, 6g of chrysanthemum, 6g of herbaceous stalk, 15g of poria, 5g of jujube, 4g of polygala, 6g of liquorice, 9g of polysaccharide, and 3g of lutein.

3. The Chinese medicine composition for treating diabetic neurovascular coupling injury according to claim 1 or 2, characterized in that: The Chinese medicine composition is prepared from the raw powder or water or organic solvent extract of the raw medicine as active ingredients, and pharmaceutically acceptable excipients or auxiliary ingredients are added to form a commonly used pharmaceutical preparation.

4. The Chinese medicine composition according to claim 3, characterized in that: The preparation is oral liquid, granules, capsules and pills.

5. A method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: It includes the following steps: (1) Weigh the APIs except lutein according to the weight ratio; (2) extracting the active ingredients of the drug using a suitable extraction solvent and concentrating the extract to obtain the drug extract; (3) Add lutein and pharmaceutically acceptable excipients or auxiliary ingredients to prepare a commonly used pharmaceutical preparation.

6. Use of the Chinese medicine composition according to claim 1 in preparing a medicine for treating insomnia caused by visual fatigue.

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