A traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood and its application

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically disclosing a traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood, and its application. It consists of the following raw materials in parts by weight: 8-12 parts of Cistanche deserticola (processed with wine), 8-12 parts of stir-fried Ziziphus jujuba seeds, 4-6 parts of ginseng, 8-12 parts of stir-fried Atractylodes macrocephala, 10-14 parts of Poria cocos, 5-7 parts of licorice root, 5-7 parts of Angelica sinensis, 12-18 parts of Astragalus membranaceus, 10-14 parts of Scutellaria baicalensis, 5-7 parts of Coptis chinensis, 10-14 parts of Rehmannia glutinosa, 2-4 parts of cinnamon bark, and 10-14 parts of Phellodendron chinense. Compared with existing technologies, this invention's traditional Chinese medicine composition comprehensively replenishes qi and blood, strengthens the spleen and calms the mind, clears and drains excess fire, warms the kidneys and guides fire back to its source, and is balanced in its warming and cooling properties, replenishing without stagnation, clearing without coldness, and warming without dryness, thus effectively treating insomnia due to deficiency of heart and liver blood.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood, and its application. Background Technology

[0002] Insomnia is a common clinical sleep disorder. With increasing social pressure and a rapidly aging population, its incidence continues to rise, affecting a wide range of people globally and has been classified as a mental illness by modern medicine. This condition is often characterized by recurrent episodes and chronic persistence, directly leading to decreased nighttime sleep quality and significantly impacting daytime social functioning, such as reduced work efficiency, impaired cognition and alertness, and increased anxiety and depression. Modern medical treatment for insomnia primarily relies on sedative-hypnotic drugs, but long-term use carries risks such as dependence, drug tolerance, and cognitive impairment. Traditional Chinese medicine (TCM) treatment for insomnia, with its advantages of multi-target and holistic regulation, is gaining increasing attention. Therefore, actively exploring effective formulas and medications to provide effective intervention methods for insomnia patients is of great significance. While there are various TCM compositions for insomnia in the current technology, there are no TCM compositions specifically targeting insomnia caused by deficiency of heart and liver blood. Summary of the Invention

[0003] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood, and its application.

[0004] To achieve the above objectives, the present invention is implemented according to the following technical solution: The first technical solution provided by this invention is a traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood, which is composed of the following raw materials in parts by weight: 8-12 parts of Cistanche deserticola (processed with wine), 8-12 parts of stir-fried Ziziphus jujuba seeds, 4-6 parts of ginseng, 8-12 parts of stir-fried Atractylodes macrocephala, 10-14 parts of Poria cocos, 5-7 parts of licorice root, 5-7 parts of Angelica sinensis, 12-18 parts of Astragalus membranaceus, 10-14 parts of Scutellaria baicalensis, 5-7 parts of Coptis chinensis, 10-14 parts of Rehmannia glutinosa, 2-4 parts of cinnamon bark, and 10-14 parts of Phellodendron chinense.

[0005] Preferably, the traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood is composed of the following raw materials in parts by weight: 10 parts of Cistanche deserticola (processed with wine), 10 parts of stir-fried Ziziphus jujuba seeds, 5 parts of ginseng, 10 parts of stir-fried Atractylodes macrocephala, 12 parts of Poria cocos, 6 parts of licorice root, 6 parts of Angelica sinensis, 15 parts of Astragalus membranaceus, 12 parts of Scutellaria baicalensis, 6 parts of Coptis chinensis, 12 parts of Rehmannia glutinosa, 3 parts of cinnamon, and 12 parts of Phellodendron chinense.

[0006] The second technical solution provided by the present invention is the application of the above-mentioned traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood in the preparation of traditional Chinese medicine preparations for treating insomnia due to deficiency of heart and liver blood.

[0007] The third technical solution provided by the present invention is a traditional Chinese medicine preparation for treating insomnia due to deficiency of heart and liver blood, comprising an extract of the above-mentioned traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood; the preparation method of the extract is as follows: take each raw material according to the ratio, add water with a total weight of 30-60 times that of the raw materials and decoct for 1-2 hours, filter and collect the first filtrate and the first residue, add water with a total weight of 30-60 times that of the first residue and decoct for 1-2 hours, filter and collect the second filtrate, combine the first filtrate and the second filtrate, concentrate and dry to obtain the extract.

[0008] Furthermore, traditional Chinese medicine preparations for treating insomnia due to deficiency of heart and liver blood also contain pharmaceutically usable carriers or excipients.

[0009] Furthermore, the dosage form of the traditional Chinese medicine preparation is one of granules, tablets, pills, capsules, powders, mixtures, or oral liquids.

[0010] Preferably, the dosage form of the traditional Chinese medicine preparation is an oral liquid.

[0011] Compared with existing technologies, the herbal composition of this invention uses Cistanche deserticola (processed with wine) and stir-fried jujube seeds as the principal herbs, emphasizing both kidney tonification and essence replenishment, as well as heart nourishment and calming the mind; ginseng, astragalus, angelica, and rehmannia are used as assistant herbs to greatly replenish qi and blood; scutellaria, coptis, and phellodendron are used to clear heat from the upper, middle, and lower jiao; stir-fried atractylodes macrocephala and poria cocos strengthen the spleen and harmonize the middle jiao; and a trace amount of cinnamon guides fire back to its source and harmonizes the heart and kidneys. The entire formula integrates "tonification, clearing, warming, and strengthening," using both cold and hot herbs, and combining attack and tonification. Atractylodes macrocephala, poria cocos, and licorice are added to protect the spleen and stomach; the entire formula tonifies qi and blood, strengthens the spleen and calms the mind, clears and drains ministerial fire, warms the kidneys and guides fire back to its source, and is balanced in its cold and warm properties, tonifying without stagnation, clearing without coldness, and warming without dryness, thus treating insomnia due to deficiency of heart and liver blood. Attached Figure Description

[0012] Figure 1 The results of comparing the number of times mice crossed platforms and the latency period in the water maze experiment were as follows: A represents the number of times mice crossed platforms; B represents the latency period.

[0013] Figure 2 The results of comparing the total distance, simulated infrared crossings, central distance, central time, side distance, and side time in the mine experiment for mice in the normal group, model group, low-dose group of this traditional Chinese medicine compound, medium-dose group of this traditional Chinese medicine compound, high-dose group of this traditional Chinese medicine compound, and positive drug (eszopiclone) group are as follows: A is the total distance; B is the simulated infrared crossings; C is the central distance; D is the central time; E is the side distance; F is the side time.

[0014] Figure 3Comparison of sleep duration and sleep latency in righting test mice in normal group, model group, low-dose group of this traditional Chinese medicine compound, medium-dose group of this traditional Chinese medicine compound, high-dose group of this traditional Chinese medicine compound, and positive drug (eszopiclone) group: A is sleep duration; B is sleep latency.

[0015] Figure 4 The results of comparing the serum levels of NE, 5-HT, GABA, and GLU in mice in the normal group, model group, low-dose group of this traditional Chinese medicine compound, medium-dose group of this traditional Chinese medicine compound, high-dose group of this traditional Chinese medicine compound, and positive drug (eszopiclone) group are as follows: A is the NE level; B is the 5-HT level; C is the GABA level; D is the GLU level; and E is the DA level. Detailed Implementation

[0016] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. The specific embodiments described herein are for illustrative purposes only and are not intended to limit the invention.

[0017] Example: Preparation of a traditional Chinese medicine preparation for treating insomnia due to deficiency of heart and liver blood. This embodiment exemplarily provides a traditional Chinese medicine composition, using the following raw medicinal materials: 10 g of Cistanche deserticola (processed with wine), 10 g of stir-fried Ziziphus jujuba seeds, 5 g of ginseng, 10 g of stir-fried Atractylodes macrocephala, 12 g of Poria cocos, 6 g of licorice root slices, 6 g of Angelica sinensis, 15 g of Astragalus membranaceus, 12 g of Scutellaria baicalensis, 6 g of Coptis chinensis, 12 g of Rehmannia glutinosa, 3 g of cinnamon, and 12 g of Phellodendron chinense. All the above raw medicinal materials are from the pharmacy of this hospital. Take all the above raw medicinal materials, add 30 times the total weight of the raw materials to water and decoct for 1 hour. Filter and collect the first filtrate and the first residue. Add 30 times the total weight of the first residue to water and decoct for 2 hours. Filter and collect the second filtrate. Combine the first and second filtrates, and then concentrate to 3-7 times the total weight of the raw medicinal materials to obtain a traditional Chinese medicine preparation for treating insomnia due to deficiency of heart and liver blood.

[0018] Example 2: Animal pharmacodynamic experiment of a traditional Chinese medicine preparation for treating insomnia due to deficiency of heart and liver blood. Experimental materials Experimental animals: SPF grade C57BL / 6J male mice, weighing 18-22g, were used for experiments after one week of acclimatization.

[0019] Test drug: The traditional Chinese medicine compound decoction prepared in Example 1 of this invention. Positive control drug: Eszopiclone tablet suspension.

[0020] Modeling reagent: p-Chlorophenylalanine (PCPA), dissolved in DMSO and then prepared with physiological saline.

[0021] Main reagent kits: 5-hydroxytryptamine (5-HT), γ-aminobutyric acid (GABA), dopamine (DA), norepinephrine (NE), glutamate (Glu), ELISA detection kit.

[0022] Main instruments: Morris water maze system, open field test chamber, righting reflection test equipment, microplate reader, centrifuge, etc.

[0023] Experimental methods (1) Mice were randomly divided into 6 groups: blank group; model group; low-dose group; medium-dose group; high-dose group; and positive control group. Except for the blank group, all other groups of mice were given PCPA (300 mg / kg, for 3 consecutive days) via intraperitoneal injection to establish a chemical insomnia model. Starting from the day after model establishment, each group was given the drug by gavage once a day for 21 consecutive days. It should be noted that the dosage of the medium-dose and positive control groups was converted from human to mouse equivalent doses. Based on the dosage for a 70 kg adult, and according to the equivalent body surface area in "Methodology of Pharmacological Research of Traditional Chinese Medicine", the equivalent dose coefficient of 9.1 times that of the mouse to human body surface area was used as the medium dose and positive control dose of the traditional Chinese medicine. The dosages of the low-dose group and the high-dose group were 1 / 2 and 2 times that of the medium dose, respectively.

[0024] (2) Behavioral experiments ① Morris Water Maze Experiment: This experiment tested the spatial learning and memory abilities of mice over five consecutive days. Before the experiment, mice were gently placed into the pool along the wall and allowed to swim for 2 minutes to acclimatize. Video recording was used to ensure the mice had normal swimming ability. The acclimatization period was one day. At the start of training, mice were placed in the water from the center of each quadrant, facing away from the underwater platform. The order of quadrants they entered the pool varied each day. The time it took for the mouse to search for and climb onto the underwater platform was recorded as the escape latency. If a mouse failed to find the platform within 60 seconds, it was guided to the platform. The entire training lasted five days. On the sixth day, the underwater platform was removed, and the mouse entered the water from the quadrant opposite the platform. The number of times the mouse crossed the platform within 60 seconds and the latency period were recorded.

[0025] ② Open field test: Mice were acclimatized in the laboratory for 1 hour beforehand. At the start of the experiment, mice were placed sequentially at the center of a 50 cm × 50 cm open field box. The central area was defined as a 25 cm × 25 cm region near the center. The total distance traveled by the mouse during the test (5 min), the distance traveled to the center, the distance traveled to the edge, the time spent in the center, the time spent in the edge, and the number of times the mouse traversed the simulated infrared beam were recorded. After each mouse finished, the open field was cleaned with 75% alcohol to erase the information left by the previous mouse. After the alcohol had completely evaporated, this operation was repeated for the next batch of mice in the open field test.

[0026] ③ Righting reflex test: After intraperitoneal injection of sodium pentobarbital (40 mg / kg), mice were placed in a supine position to induce complete sleep, and then sleep signs were monitored. Sleep latency was defined as the time between the sodium pentobarbital injection and the delayed onset of the righting reflex. Sleep duration was defined as the time between the onset of the righting reflex and its recovery.

[0027] (3) Sample collection and testing After the behavioral tests were completed, mouse serum was collected. The levels of 5-HT, GABA, DA, NE, and Glu in the serum were measured using the ELISA method strictly according to the kit instructions.

[0028] Experimental results The effect of this traditional Chinese medicine compound on cognitive function in sleep-deprived mice (water maze test). The comparison of the number of times mice crossed platforms in the water maze experiment and the comparison of latency time among the normal group, model group, low-dose group of this traditional Chinese medicine compound, medium-dose group of this traditional Chinese medicine compound, high-dose group of this traditional Chinese medicine compound, and positive drug (eszopiclone) group are as follows: Figure 1 As shown, by Figure 1 It was found that, compared with the normal group, the latency period of mice in the model control group was significantly prolonged and the number of platform crossings was significantly shortened (P<0.01), indicating that PCPA modeling successfully impaired the spatial learning and memory abilities of mice. Compared with the model group, the medium-dose group of this invention showed the most significant effect, with a significant increase in the number of platform crossings and a significant decrease in latency period (P<0.01), and the effect was superior to that of the positive control group. The above results indicate that the compound composition described in this invention has a significant therapeutic effect on spatial learning and memory impairment in PCPA-induced insomnia mice, and is superior to existing positive control drugs in improving cognitive dysfunction associated with insomnia, showing promise for development as a drug for treating insomnia with cognitive impairment.

[0029] The effects of this traditional Chinese medicine compound on spontaneous activities and anxiety-like behaviors (open field experiment) The comparison results of total distance traveled, simulated infrared crossing times, central distance traveled, central time traveled, and peripheral distance traveled and time traveled in the mining experiment were as follows among the normal group, model group, low-dose group of this traditional Chinese medicine compound, medium-dose group of this traditional Chinese medicine compound, high-dose group of this traditional Chinese medicine compound, and positive control drug (eszopiclone) group mice. Figure 2 As shown, by Figure 2It was found that, compared with the normal group, the total distance, central distance, edge distance, central time, and number of simulated infrared crossings of the model control group mice were significantly reduced, while the edge time was significantly increased (all P < 0.01 or P < 0.05). Compared with the model group, the total distance, central distance, edge distance, central time, and number of simulated infrared crossings of the medium-dose group of this invention were significantly increased, while the edge time was significantly reduced (all P < 0.01 or P < 0.05). The degree of improvement in the above indicators was better than that in the positive control group. The above results indicate that the compound composition of this invention has a significant therapeutic effect on anxiety-like behavior in PCPA-induced insomnia mice, and its anti-anxiety effect is superior to existing positive drugs, showing promise for development as a drug for treating insomnia with anxiety disorders.

[0030] The effect of this traditional Chinese medicine compound on the synergistic hypnotic effect of sodium pentobarbital (positiveing ​​experiment) The comparison results of sleep duration and sleep latency in the righting test of mice in the normal group, model group, low-dose group of this traditional Chinese medicine compound, medium-dose group of this traditional Chinese medicine compound, high-dose group of this traditional Chinese medicine compound, and positive drug (eszopiclone) group are as follows: Figure 3 As shown, by Figure 3 It was found that, compared with the normal group, the sleep duration of mice in the model control group was significantly shortened and the sleep latency was significantly prolonged (P<0.01). Compared with the model group, the sleep duration of mice in the medium-dose group and the positive drug group of this invention was significantly prolonged and the sleep latency was significantly shortened (P<0.01), and the effects of the two were comparable. The above results indicate that the compound composition of this invention has a significant therapeutic effect on PCPA-induced insomnia, and its sleep-improving effect is comparable to that of existing positive drugs, showing promise for development as a treatment for insomnia.

[0031] The effects of this traditional Chinese medicine compound on neurotransmitter and HPA axis hormone levels The comparison results of serum NE, 5-HT, GABA, and GLU levels in mice from the normal group, model group, low-dose group, medium-dose group, high-dose group, and positive drug (eszopiclone) group are shown in Figure 4. Figure 4The serum biochemical indicators showed that PCPA modeling successfully induced neuroendocrine system disorders in mice. Specifically, compared with the normal group, the levels of the inhibitory neurotransmitters 5-hydroxytryptamine (5-HT) and γ-aminobutyric acid (GABA) in the serum of the model control group mice were significantly decreased (P<0.01), while the levels of the excitatory neurotransmitters dopamine (DA), norepinephrine (NE), and glutamate (Glu) were significantly increased (P<0.01). After drug treatment intervention, each treatment group showed different degrees of regulatory effects. Among them, the low-dose group of this invention significantly increased the levels of 5-HT and GABA, and decreased the levels of Glu (P<0.01). The medium- and high-dose groups of this invention, as well as the positive control group, significantly increased the levels of 5-HT and GABA, and decreased the levels of DA, NE, and Glu (P<0.01). The above results indicate that the compound composition of the present invention can improve insomnia by regulating the balance of central inhibitory and excitatory neurotransmitters, and has the potential to be developed into a drug for treating insomnia accompanied by neuroendocrine disorders.

[0032] In summary, the traditional Chinese medicine composition of the present invention can treat insomnia due to deficiency of heart and liver blood.

[0033] The technical solutions of the present invention are not limited to the specific embodiments described above. Any technical modifications made in accordance with the technical solutions of the present invention fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood, characterized in that, It is composed of the following raw materials in parts by weight: 8-12 parts of Cistanche deserticola (processed with wine), 8-12 parts of stir-fried Ziziphus jujuba seeds, 4-6 parts of ginseng, 8-12 parts of stir-fried Atractylodes macrocephala, 10-14 parts of Poria cocos, 5-7 parts of licorice root, 5-7 parts of Angelica sinensis, 12-18 parts of Astragalus membranaceus, 10-14 parts of Scutellaria baicalensis, 5-7 parts of Coptis chinensis, 10-14 parts of Rehmannia glutinosa, 2-4 parts of cinnamon bark, and 10-14 parts of Phellodendron chinense.

2. The traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood according to claim 1, characterized in that, The raw materials are composed of the following parts by weight: 10 parts of Cistanche deserticola (processed with wine), 10 parts of stir-fried Ziziphus jujuba seeds, 5 parts of ginseng, 10 parts of stir-fried Atractylodes macrocephala, 12 parts of Poria cocos, 6 parts of licorice root, 6 parts of Angelica sinensis, 15 parts of Astragalus membranaceus, 12 parts of Scutellaria baicalensis, 6 parts of Coptis chinensis, 12 parts of Rehmannia glutinosa, 3 parts of cinnamon, and 12 parts of Phellodendron chinense.

3. The application of a traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood as described in claim 1 or 2 in the preparation of a traditional Chinese medicine preparation for treating insomnia due to deficiency of heart and liver blood.

4. A traditional Chinese medicine preparation for treating insomnia due to deficiency of heart and liver blood, characterized in that, An extract comprising the traditional Chinese medicine composition for treating insomnia due to deficiency of heart and liver blood as described in claim 1 or 2; the preparation method of the extract is as follows: take each raw material according to the ratio, add water of 30-60 times the total weight of the raw materials and decoct for 1-2 hours, filter and collect the first filtrate and the first residue, add water of 30-60 times the total weight of the first residue and decoct for 1-2 hours, filter and collect the second filtrate, combine the first filtrate and the second filtrate, concentrate and dry to obtain the extract.

5. The traditional Chinese medicine preparation for treating insomnia due to deficiency of heart and liver blood according to claim 4, characterized in that, It also includes pharmaceutically usable carriers or excipients.

6. The traditional Chinese medicine preparation for treating insomnia due to deficiency of heart and liver blood according to claim 5, characterized in that: The dosage form of the traditional Chinese medicine preparation is one of the following: granules, tablets, pills, capsules, powders, mixtures, or oral liquids.

7. The traditional Chinese medicine preparation for treating insomnia due to deficiency of heart and liver blood according to claim 6, characterized in that: The dosage form of the traditional Chinese medicine preparation is an oral liquid.

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