A traditional chinese medicine composition for regulating brain-gut axis

Abstract

The application discloses a traditional Chinese medicine composition for regulating a brain-gut axis, which is characterized by being prepared from raw medicinal materials in the following proportions by weight: 10-20 parts of marigold, 8-16 parts of day day flower, 6-12 parts of perilla, 4-8 parts of ophiopogon, 2-4 parts of polygonatum, 2-4 parts of dried tangerine or orange peel, 2-4 parts of anemarrhena, 2-4 parts of poria, and 2-4 parts of licorice. According to the mechanism of the brain-gut axis, the traditional Chinese medicine composition can safely and effectively treat diseases of multiple systems such as the digestive system, the nervous system and the endocrine system.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition, specifically a traditional Chinese medicine composition for regulating the brain-gut axis. Background Technology

[0002] The "brain-gut axis" is a bidirectional pathway connecting the central nervous system and the digestive system through a neuroendocrine-immune network. Brain-gut peptides are key effector molecules that exert hormonal effects in both the central nervous system and the gastrointestinal tract. These peptides can exert broad regulatory effects in both the gastrointestinal tract and the brain through autocrine, paracrine, and neurotransmitter mechanisms. This process involves the mutual intervention and regulation between the central nervous system and gastrointestinal function, also known as "brain-gut interaction."

[0003] The "brain-gut axis" involves various factors in the human body, including microorganisms, metabolites, and neuroactive peptides, and transmits information through neural pathways such as the sympathetic nervous system and the vagus nerve. Based on this, modern research suggests that a key pathogenesis of digestive system diseases is the disruption of the "brain-gut interaction," especially digestive system diseases accompanied by mental abnormalities. Changes in thinking and emotion lead to changes in visceral functions such as gastrointestinal sensation, gastrointestinal smooth muscle movement, and gastrointestinal mucosal gland secretion. Simultaneously, gastrointestinal activity can also have a reciprocal effect on the central nervous system, influencing the emotions, mental state, and even behavior it regulates.

[0004] In summary, abnormal distribution levels of brain-gut peptides are closely related to disorders of neuroendocrine-immune regulation and imbalances in the brain-gut interaction. The brain-gut axis connects the gastrointestinal tract and the central nervous system, creating physiological and pathological connections between them. Through the brain-gut interaction process, they can influence and regulate each other, which reasonably explains the interdependent and mutually restrictive mechanism in the occurrence and development of gastrointestinal diseases and nervous system diseases.

[0005] For example, in the neuroendocrine pathway, gut microbiota stimulates afferent neurons in the enteric nervous system, creating synaptic connections between the enteric and vagus nerves, thus facilitating information transmission and communication between the gut microbiota and the brain. Research indicates that gut microbiota dysbiosis may be a significant cause of insomnia. When the balance of gut microbiota is disrupted, its metabolic function and the levels of its metabolic products decrease, activating the body's "brain-gut axis," which in turn leads to shorter sleep duration than fragmented sleep, affecting sleep quality.

[0006] Currently, numerous traditional Chinese medicines (TCMs) are available for treating specific diseases of the digestive, nervous, and endocrine systems. However, no TCM has yet been found that treats diseases based on the "brain-gut axis" mechanism. Therefore, developing a TCM composition that comprehensively regulates multiple systems, including the digestive, nervous, and endocrine systems, by combining Western medical pathological mechanisms with TCM treatment methods has significant social and economic value. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for regulating the brain-gut axis, based on the mechanism of the "brain-gut axis", so as to achieve the purpose of safely and effectively treating diseases of multiple systems such as the digestive system, nervous system, and endocrine system.

[0008] To solve this technical problem, the present invention adopts the following technical solution:

[0009] A traditional Chinese medicine composition for regulating the brain-gut axis is prepared from the following raw medicinal materials: roselle, bitter orange, perilla, ophiopogon japonicus, polygonatum odoratum, tangerine peel, anemarrhena asphodeloides, poria cocos, and licorice.

[0010] Preferably, the traditional Chinese medicine composition for regulating the brain-gut axis consists of the following medicinal materials in parts by weight: 10-20 parts of roselle, 8-16 parts of bitter orange, 6-12 parts of perilla, 4-8 parts of ophiopogon japonicus, 2-4 parts of polygonatum odoratum, 2-4 parts of tangerine peel, 2-4 parts of anemarrhena asphodeloides, 2-4 parts of poria cocos, and 2-4 parts of licorice.

[0011] More preferably, the traditional Chinese medicine composition for regulating the brain-gut axis consists of the following medicinal materials in parts by weight: 15 parts of roselle, 10 parts of bitter orange, 9 parts of perilla, 6 parts of ophiopogon japonicus, 3 parts of polygonatum odoratum, 3 parts of tangerine peel, 3 parts of anemarrhena asphodeloides, 3 parts of poria cocos, and 3 parts of licorice.

[0012] The dosage form of the traditional Chinese medicine composition for regulating the brain-gut axis is a decoction, and its preparation includes the following steps:

[0013] (1) After the drugs are weighed and mixed, they are put into a container;

[0014] (2) Add water to the container to soak, bring to a boil over high heat, then reduce to low heat and simmer to obtain the filtrate;

[0015] (3) Repeat step (2) and mix the two filtrates to obtain the decoction of the Chinese medicine composition.

[0016] A medicine for regulating the brain-gut axis, made from the traditional Chinese medicine composition or from the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0017] Preferably, the dosage form of the drug for regulating the brain-gut axis is a decoction, the preparation of which includes the following steps:

[0018] (1) After the drugs are weighed and mixed, they are put into a container;

[0019] (2) Add water to the container to soak, bring to a boil over high heat, then reduce to low heat and simmer to obtain the filtrate;

[0020] (3) Repeat step (2), mix the two filtrates, add decoction excipients, and the decoction of medicine is obtained.

[0021] Preferably, the dosage form of the drug for regulating the brain-gut axis is a powder, and its preparation includes the following steps:

[0022] (1) After the drugs are weighed and mixed, they are put into a container;

[0023] (2) Add water to the container to soak, bring to a boil over high heat, then reduce to low heat and simmer to obtain the filtrate;

[0024] (3) Repeat step (2) and mix the two filtrates to obtain the Chinese medicine liquid;

[0025] (4) Simmer the Chinese medicine liquid over a low flame to concentrate it into a paste, dry and pulverize it, and then add the granule excipients to obtain the medicine granules.

[0026] Preferably, the dosage form of the drug for regulating the brain-gut axis is a water pill, the preparation of which includes the following steps:

[0027] (1) Weigh out the perilla, ophiopogon japonicus, dried tangerine peel and licorice, mix them together and put them into a container;

[0028] (2) Add water to the container to soak, bring to a boil over high heat, then reduce to low heat and simmer to obtain the filtrate;

[0029] (3) Repeat step (2) and mix the two filtrates to obtain the Chinese medicine liquid;

[0030] (4) After weighing and combining the roselle, bitter orange, anemarrhena, polygonatum and poria, grind them into a fine powder of Chinese medicine to serve as the base for water pills.

[0031] (5) Mix the fine powder of Chinese medicine obtained in step (4) with the liquid Chinese medicine obtained in step (3), add the excipients for water pills, and make pills.

[0032] (6) After drying the pills, the water pills of the medicine are obtained.

[0033] The explanation of this formula is as follows:

[0034] Roselle is the main ingredient in this formula. It is cool in nature and sour in taste. It enters the stomach, liver and kidney meridians and has the effects of strengthening the stomach and promoting digestion, promoting body fluid and quenching thirst, clearing heat and removing fire, and promoting blood circulation and replenishing blood.

[0035] The bitter orange flower in the formula is sweet and slightly bitter in taste, and neutral in nature. It has the effects of regulating qi, relieving chest tightness, stimulating appetite, and stopping vomiting. The perilla flower is pungent and warm in taste, and enters the lung and spleen meridians. It has the effects of dispelling cold, regulating qi, and harmonizing the stomach. These two herbs assist the principal and chief herbs, and together they serve as auxiliary and ministerial herbs.

[0036] The formula contains five herbs: Ophiopogon japonicus (Mai Dong), which is sweet, slightly bitter, and slightly cold in nature, and enters the heart, lung, and stomach meridians. It nourishes yin, generates fluids, moistens the lungs, and clears the heart. Polygonatum odoratum (Yu Zhu), which is sweet and slightly cold in nature, enters the lung and stomach meridians. It is sweet and moist, soft and nourishing, and does not cause greasiness or lingering of pathogens. It is especially good at nourishing the yin fluids of the lungs and stomach. Citrus reticulata (Chen Pi), which is bitter, pungent, and warm in nature, enters the lung and spleen meridians. It regulates qi, strengthens the spleen, dries dampness, and resolves phlegm. Anemarrhena asphodeloides (Zhi Mu), which is bitter, sweet, and cold in nature, enters the lung, stomach, and kidney meridians. It generates fluids, moistens dryness, clears heat, and purges fire. Poria cocos (Fu Ling), which is neutral, sweet, and bland in nature, enters the heart, spleen, lung, and kidney meridians. It promotes diuresis, eliminates dampness, strengthens the spleen, and calms the mind. These five herbs assist the principal and assistant herbs, serving as adjuvant herbs.

[0037] Licorice root in the formula is sweet and neutral in nature, and enters the heart, lung, spleen, and stomach meridians. It has the effect of harmonizing the various herbs and serves as the guiding herb.

[0038] The combination of the above-mentioned drugs is consistent with the syndrome, and the drugs correspond to the syndrome, resulting in a direct and significant therapeutic effect.

[0039] The positive effects of this invention are as follows:

[0040] Based on the principles of traditional Chinese medicine, this invention has the effects of tonifying the spleen and stomach, regulating qi and relieving pain. It has significant therapeutic effects on gastrointestinal diseases (symptoms such as bloating, pain, heartburn, hiccups, nausea and vomiting). This invention can also regulate intestinal flora, improve the metabolic function and metabolic product levels of intestinal flora, and restore the balance of the intestine.

[0041] Furthermore, based on the "brain-gut axis" mechanism, this invention can also activate the body's "brain-gut interaction" process, effectively improve sleep quality during the treatment of gastrointestinal diseases, and alleviate mental illnesses such as anxiety and depression. Detailed Implementation

[0042] To better understand and implement this invention, the invention will be further described below with reference to specific embodiments.

[0043] Experiment 1 investigates the effects of traditional Chinese medicine formulations on sleep and gut microbiota in mice.

[0044] Mice were randomly divided into three groups: a traditional Chinese medicine group, a diazepam group, and a control group. All mice were administered the medicine via gavage for 7 consecutive days. The traditional Chinese medicine group received the herbal formula (20 g / kg body weight) daily, the diazepam group received diazepam (3 mg / kg body weight) daily, and the control group received the same volume of purified water as the traditional Chinese medicine group daily.

[0045] The traditional Chinese medicine group described herein is administered daily as a decoction of the traditional Chinese medicine formula, the preparation of which includes the following steps:

[0046] (1) Take 15 parts of roselle, 10 parts of bitter orange, 9 parts of perilla, 6 parts of ophiopogon japonicus, 3 parts of polygonatum odoratum, 3 parts of dried tangerine peel, 3 parts of anemarrhena asphodeloides, 3 parts of poria cocos, and 3 parts of licorice. After weighing them together, put them into the container for decocting Chinese medicine.

[0047] (2) Add 500 ml of water to the container, soak for about half an hour, bring to a boil over high heat, then simmer over low heat for about half an hour to obtain the filtrate.

[0048] (3) Repeat step (2) and mix the two filtrates (about 300 ml) to obtain the decoction of the Chinese medicine composition.

[0049] The specific experiment is as follows:

[0050] (1) Subthreshold dose hypnotic test of sodium pentobarbital:

[0051] Before the formal experiment, a preliminary experiment was conducted to determine the maximum subthreshold dose of sodium pentobarbital at which the righting reflex of 80-90% of mice would not disappear, i.e., the subthreshold hypnotic dose of sodium pentobarbital (generally 16-30 mg / kg animal body weight, and determined to be 24 mg / kg animal body weight in the preliminary experiment).

[0052] Animals were given the drug once a day. 30 minutes after administration (the traditional Chinese medicine formula of this invention, diazepam, or purified water), each group of animals was intraperitoneally injected with the maximum subthreshold hypnotic dose of sodium pentobarbital, 24 mg / kg of animal body weight. The number of animals that fell asleep within 30 minutes (those whose righting reflex disappeared for more than 1 minute) was recorded. The results are shown in Table 1.

[0053] Table 1. Hypnotic Tests with Subthreshold Doses of Sodium Pentobarbital on Samples

[0054] control group 12 0 0 Traditional Chinese Medicine Group 12 4 33.3％* Diazepam Group 12 8 67％**

[0055] *,** indicates that compared with the control group, P<0.05, P<0.01.

[0056] As shown in Table 1, compared with the control group, the incidence of sleep in the mice in the traditional Chinese medicine group was significantly increased (P<0.05). The incidence of sleep in the mice in the diazepam group was significantly increased compared with the control group (P<0.01), and the incidence of sleep in the diazepam group was higher than that in the traditional Chinese medicine group.

[0057] (2) Sodium barbiturate sleep latency test:

[0058] Before the formal experiment, a preliminary experiment was conducted to determine the dosage of sodium barbital (generally 200-300 mg / kg animal body weight) that would allow 100% of the animals to fall asleep without causing excessive sleep time. The preliminary experiment determined the dosage to be 260 mg / kg animal body weight, and this dosage was used in the formal experiment.

[0059] Animals were given the drug once a day. 30 minutes after administration (the traditional Chinese medicine formula of this invention, diazepam, or purified water), each group of animals was intraperitoneally injected with sodium barbital at a dose of 260 mg / kg animal body weight, with an injection volume of 0.2 mL / 20 g animal body weight. The effect of the test sample on the sleep latency of sodium barbital was observed using the disappearance of the righting reflex as an indicator. The results are shown in Table 2.

[0060] Table 2. Sample sodium barbital sleep latency test (Mean ± SEM)

[0061] control group 57.4±4.2 Traditional Chinese Medicine Group 48.1±3.1* Diazepam Group 33.9±3.3**

[0062] * indicates that compared with the control group, P<0.05, P<0.01.

[0063] As shown in Table 2, compared with the control group, the sleep latency of mice in the traditional Chinese medicine group was significantly shortened (P<0.05). The sleep latency of mice in the diazepam group was also significantly shortened (P<0.01), and the sleep latency of mice in the diazepam group was shorter than that of the traditional Chinese medicine group.

[0064] The results of experiments (1) and (2) combined indicate that after mice were administered the sample by gavage for 7 consecutive days, both the "subthreshold dose of sodium pentobarbital for hypnosis" and the "sodium barbital for sleep latency" tests were positive. This demonstrates that although the traditional Chinese medicine formula of this invention cannot treat insomnia symptoms like the positive drug diazepam, it can significantly improve the sleep quality of mice.

[0065] (3) Intestinal microbiome testing:

[0066] After experiment (2), mouse feces from the control group and the traditional Chinese medicine group were collected and placed in conical flasks containing sterile water and glass beads. After shaking at 120 r / min for 30 min, the feces were spread on plates and cultured for counting. The number of Bifidobacterium, Lactobacillus, Bacteroides and Enterococcus were detected. The mixed bacterial count method was used, and each dilution was repeated 3 times. The number of each type of bacteria per gram of intestinal contents was calculated. The results are shown in Table 3.

[0067] Table 3. Effects of Traditional Chinese Medicine Formulas on Intestinal Microbiota in Animals Experimental for Improving Sleep (Viable Bacteria Count / ×10⁻⁶) 7 cfu·g -1 )

[0068] control group 12 4.6±0.8 7.9±1.6 5.2±0.9 6.6±1.1 Traditional Chinese Medicine Group 12 <![CDATA[8.2±1.0 ## ]]> <![CDATA[9.7±1.1 # ]]> 5.0±0.8 5.9±1.0

[0069] # , ## The results indicate that, compared with the control group, the traditional Chinese medicine group showed P<0.05 and P<0.01.

[0070] As shown in Table 3, compared with the control group, the number of Bifidobacteria and Lactobacillus in the intestinal flora of mice in the traditional Chinese medicine group was significantly increased (P < 0.05; P < 0.01). This indicates that the traditional Chinese medicine formula of the present invention has a significant effect on improving the intestinal flora of mice.

[0071] Experiment Example 2 investigates the effects of traditional Chinese medicine formulations on fecal condition and gut microbiota in animals.

[0072] (1) Experiment on the frequency and rate of loose stools in animals:

[0073] Animal grouping and model establishment: After 3 days of acclimatization, mice were randomly divided into a normal group and a model group. Mice in the model group were administered a mixed antibiotic (gentamicin sulfate + cephalexin capsules) via gavage to establish a diarrhea model due to dysbiosis. The criteria for successful model establishment were: dull fur, reduced food intake, curled-up behavior, reduced activity, sluggish response, slow movements, and noticeable staining at the anus. After successful model establishment, the model group mice were randomly divided into a model control group and a traditional Chinese medicine (TCM) treatment group, with 10 animals in each group. The TCM treatment group received 20 g / kg of the TCM formula, while the normal group and model control group received the same volume of purified water as the TCM treatment group.

[0074] The traditional Chinese medicine group described herein is administered daily as a decoction of the traditional Chinese medicine formula, the preparation of which includes the following steps:

[0075] (1) Take 15 parts of roselle, 10 parts of bitter orange, 9 parts of perilla, 6 parts of ophiopogon japonicus, 3 parts of polygonatum odoratum, 3 parts of dried tangerine peel, 3 parts of anemarrhena asphodeloides, 3 parts of poria cocos, and 3 parts of licorice. After weighing them together, put them into the container for decocting Chinese medicine.

[0076] (2) Add 500 ml of water to the container, soak for about half an hour, bring to a boil over high heat, then simmer over low heat for about half an hour to obtain the filtrate.

[0077] (3) Repeat step (2) and mix the two filtrates (about 300 ml) to obtain the decoction of the Chinese medicine composition.

[0078] The number of loose stools for each mouse was recorded, and the loose stool rate (the ratio of loose stools to the total number of stools) was calculated. The results are shown in Table 4.

[0079] Table 4. Effects of Traditional Chinese Medicine Formulas on the Frequency and Rate of Loose Stools in Diarrhea-Induced Animals

[0080]

[0081]

[0082] ** indicates a comparison between the model control group and the normal group, P<0.01. # The comparison between the traditional Chinese medicine treatment group and the model control group showed a p-value of <0.05.

[0083] As shown in Table 4, compared with the normal group, the number and rate of loose stools in the model control group mice were significantly increased (P < 0.01), indicating that the constipation animal model was successfully established. Compared with the model control group, the rate of loose stools in the traditional Chinese medicine treatment group was significantly reduced (P < 0.05), but there was no statistically significant difference in the number of loose stools (P > 0.05). The above results indicate that the traditional Chinese medicine formula of this invention has a significant effect on improving the symptoms of diarrhea in animals.

[0084] (2) Intestinal microbiome detection:

[0085] After experiment (1), mouse feces were collected and placed in an Erlenmeyer flask containing sterile water and glass beads. The flask was shaken at 120 r / min for 30 min, then spread on agar plates and cultured for counting. The counts of Bifidobacterium, Lactobacillus, Bacteroides, and Enterococcus were detected. The mixed bacterial count method was used, with each dilution performed in triplicate. The number of each type of bacteria per gram of intestinal contents was calculated, and the results are shown in Table 5.

[0086] Table 5. Effects of Traditional Chinese Medicine Formulas on Animal Intestinal Microbiota (Viable Bacteria Count / ×10⁷ CFU·g⁻¹)

[0087] normal group 10 4.1±0.9 6.2±1.1 4.0±1.1 5.1±1.0 Model control group 10 2.8±0.9** 3.8±1.2** 5.3±1.4* 6.8±1.1** Traditional Chinese Medicine Treatment Group 10 <![CDATA[3.8±0.9 # ]]> <![CDATA[5.7±0.9 ## ]]> 5.0±1.2 <![CDATA[5.7±1.0 # ]]>

[0088] * indicates that the model control group was compared with the normal group, and P<0.05, P<0.01. # , ## The results showed that the traditional Chinese medicine treatment group was significantly different from the model control group (P<0.05, P<0.01).

[0089] Table 5 shows that, compared with the normal group, the number of Bifidobacteria and Lactobacillus in the intestinal flora of mice in the model control group was significantly reduced (P < 0.01), while the number of Bacteroides and Enterococci was significantly increased (P < 0.05; P < 0.01). Compared with the model control group, the number of Bifidobacteria and Lactobacillus in the intestinal flora of mice in the traditional Chinese medicine treatment group was significantly increased (P < 0.05; P < 0.01), while the number of Enterococci was significantly reduced (P < 0.05), but there was no significant effect on Bacteroides. The above results indicate that the traditional Chinese medicine formula of the present invention has a significant effect on improving the intestinal flora.

[0090] Experiment 3 explores the clinical efficacy of traditional Chinese medicine formulas in treating constipation in the elderly.

[0091] Methods: A total of 58 elderly patients with constipation were included, divided into a treatment group (n=30) and a control group (n=28). The control group did not receive any medication, while the treatment group received the traditional Chinese medicine formula of this invention. The treatment group received the decoction, granules, or pills of the traditional Chinese medicine formula of this invention daily.

[0092] The preparation of the decoction includes the following steps:

[0093] (1) Take 15 parts of roselle, 10 parts of bitter orange, 9 parts of perilla, 6 parts of ophiopogon japonicus, 3 parts of polygonatum odoratum, 3 parts of dried tangerine peel, 3 parts of anemarrhena asphodeloides, 3 parts of poria cocos, and 3 parts of licorice. After weighing them together, put them into the container for decocting Chinese medicine.

[0094] (2) Add 500 ml of water to the container, soak for about half an hour, bring to a boil over high heat, then simmer over low heat for about half an hour to obtain the filtrate.

[0095] (3) Repeat step (2) and mix the two filtrates (about 300 ml). Add the decoction excipients to obtain the decoction of the medicine.

[0096] The dosage of the decoction is as follows: The above preparation amount is for one day. The patient should take 1 / 3 of the medicine each time (about 100 ml), divided into 3 doses per day, about half an hour after each meal.

[0097] The preparation of the powder includes the following steps:

[0098] (1) Take 15 parts of roselle, 10 parts of bitter orange, 9 parts of perilla, 6 parts of ophiopogon japonicus, 3 parts of polygonatum odoratum, 3 parts of dried tangerine peel, 3 parts of anemarrhena asphodeloides, 3 parts of poria cocos, and 3 parts of licorice. After weighing them together, put them into the container for decocting Chinese medicine.

[0099] (2) Add 500 ml of water to the container, soak for about half an hour, bring to a boil over high heat, then simmer over low heat for about half an hour to obtain the filtrate.

[0100] (3) Repeat step (2) and mix the two filtrates (about 300 ml) to obtain the Chinese medicine liquid;

[0101] (4) Simmer the Chinese medicine liquid over a low flame to concentrate it into a paste, put it in a drying oven at 60 degrees Celsius to dry, pulverize it after drying, add an appropriate amount of granule excipients (the amount of excipients should be based on the amount of 18g when mixed with the pulverized medicine powder) and process it to obtain the medicine granules.

[0102] The dosage of the powder is as follows: The above preparation amount is for one day. The patient should take 6 grams at a time, 3 times a day, about half an hour after each meal.

[0103] The preparation of water pills includes the following steps:

[0104] (1) Weigh out 9 parts of perilla, 6 parts of ophiopogon japonicus, 3 parts of dried tangerine peel and 3 parts of licorice, mix them together and put them into the container for decocting Chinese medicine.

[0105] (2) Add 500 ml of water to the container, soak for about half an hour, bring to a boil over high heat, then simmer over low heat for about half an hour to obtain the filtrate.

[0106] (3) Repeat step (2) and mix the two filtrates (about 300 ml) to obtain the Chinese medicine liquid. Simmer the Chinese medicine liquid over a low flame to concentrate it to about 30 ml.

[0107] (4) After weighing out 15 parts of roselle, 10 parts of bitter orange, 3 parts of anemarrhena, 3 parts of polygonatum and 3 parts of poria, mix and grind them into fine powder of Chinese medicine to serve as the base for water pills.

[0108] (5) Mix the fine powder of Chinese medicine obtained in step (4) with the liquid Chinese medicine obtained in step (3), add the excipients for water pills, and make pills.

[0109] (6) After drying the pills (so that each pill weighs about 18g), the water pill preparation of the medicine is obtained.

[0110] The dosage of the water pills is as follows: The above preparation amount is for one day. The patient takes 6 grams at a time, 3 times a day, about half an hour after each meal.

[0111] The scales (including weekly bowel movement frequency (SBM), Cleveland Criterion for Constipation (CCS), Symptom Checklist-Symptom Scale for Constipation (PAC-SYM), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS)) were assessed once before and once after treatment, and the clinical efficacy of the two groups was compared.

[0112] (1) Assessment of constipation: The test results are shown in Tables 6 and 7.

[0113] Table 6: Weekly Stool Frequency (SBM)

[0114] control group 28 2(2,3) 6(5,7) Treatment group 30 2(2,3) <![CDATA[4(3,5) # ]]>

[0115] # The difference between the treatment group and the control group after treatment is P<0.05.

[0116] As shown in Table 6, the number of bowel movements per week in the treatment group was significantly higher than that in the control group after treatment (P<0.05).

[0117] Table 7 Comparison of Cleveland Cough Score (CCS) and Symptom Checklist-Symptom Scale for Constipation (PAC-SYM)

[0118]

[0119] # The difference between the treatment group and the control group after treatment is P<0.05.

[0120] As shown in Table 7, the CCS score and PAC-SYM score of the treatment group were significantly lower than those of the control group after treatment (P<0.05).

[0121] (2) Psychological state assessment: The results of the experiment are shown in Table 8.

[0122] Table 8 Comparison of Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS)

[0123]

[0124] # The difference between the treatment group and the control group after treatment is P<0.05.

[0125] As shown in Table 8, the SAS and SDS scores of the treatment group were significantly lower than those of the control group after treatment, and the differences were statistically significant (P<0.05).

[0126] The above results indicate that the traditional Chinese medicine formula of the present invention has significant improving effects on the human gastrointestinal system and nervous system.

Claims

1. A traditional Chinese medicine composition for regulating the brain-gut axis, characterized in that, It is composed of the following medicinal materials in parts by weight: 10-20 parts of roselle, 8-16 parts of bitter orange, 6-12 parts of perilla, 4-8 parts of ophiopogon japonicus, 2-4 parts of polygonatum odoratum, 2-4 parts of dried tangerine peel, 2-4 parts of anemarrhena asphodeloides, 2-4 parts of poria cocos, and 2-4 parts of licorice.

2. The traditional Chinese medicine composition for regulating the brain-gut axis as described in claim 1, characterized in that, It is composed of the following medicinal materials in parts by weight: 15 parts roselle, 10 parts bitter orange, 9 parts perilla, 6 parts ophiopogon japonicus, 3 parts polygonatum odoratum, 3 parts dried tangerine peel, 3 parts anemarrhena asphodeloides, 3 parts poria cocos, and 3 parts licorice.

3. The traditional Chinese medicine composition for regulating the brain-gut axis as described in claim 1 or 2, characterized in that, The dosage form of the traditional Chinese medicine composition is a decoction, and its preparation includes the following steps: (1) After the drugs are weighed and mixed, they are placed in a container; (2) Add water to the container to soak, bring to a boil over high heat, then simmer over low heat to obtain the filtrate; (3) Repeat step (2) and mix the two filtrates to obtain the decoction of the Chinese medicine composition.

4. A medicament for regulating the brain-gut axis, made from the traditional Chinese medicine composition of claim 1 or 2, or from the traditional Chinese medicine composition of claim 1 or 2 and pharmaceutically acceptable excipients.

5. The drug for regulating the brain-gut axis as described in claim 4, characterized in that, The drug is in the form of a decoction, and its preparation includes the following steps: (1) After the drugs are weighed and mixed, they are placed in a container; (2) Add water to the container to soak, bring to a boil over high heat, then simmer over low heat to obtain the filtrate; (3) Repeat step (2), mix the two filtrates, add decoction excipients, and the decoction of medicine is obtained.

6. The drug for regulating the brain-gut axis as described in claim 4, characterized in that, The drug is in the form of granules, and its preparation includes the following steps: (1) After the drugs are weighed and mixed, they are placed in a container; (2) Add water to the container to soak, bring to a boil over high heat, then simmer over low heat to obtain the filtrate; (3) Repeat step (2) and mix the two filtrates to obtain the Chinese medicine liquid; (4) The Chinese medicine liquid is simmered over low heat and concentrated into a paste. After drying and pulverizing, it is added with granule excipients to obtain the medicine granules.

7. The drug for regulating the brain-gut axis as described in claim 4, characterized in that, The drug is in the form of water pills, and its preparation includes the following steps: (1) Weigh out the perilla, ophiopogon japonicus, dried tangerine peel and licorice, mix them together and put them into a container; (2) Add water to the container to soak, bring to a boil over high heat, then simmer over low heat to obtain the filtrate; (3) Repeat step (2) and mix the two filtrates to obtain the Chinese medicine liquid; (4) After weighing the roselle, bitter orange, anemarrhena, polygonatum and poria, mix and grind them into fine powder of Chinese medicine, which will be used as the base of water pills. (5) Mix the fine powder of Chinese medicine obtained in step (4) with the liquid Chinese medicine obtained in step (3), add the excipients for water pills, and make pills. (6) After drying the pills, the water pills of the medicine are obtained.

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