A traditional Chinese medicine compound for treating or improving anxiety and application thereof

Abstract

The application provides a traditional Chinese medicine compound for treating or improving anxiety and application thereof, and relates to the technical field of Chinese herbal medicines. The traditional Chinese medicine compound takes Cortex Albiziae, Longan Arillus and Citrus Aurantium as monarchs, takes Hedychium Flavescens, Terminalia Chebula and Cyperus Rotundus as ministers, and takes Fructus Evonymi, Terminalia Chebula, Dictamnus Dasycarpus, Prunella Vulgaris, Radix Viola and Radix Glycyrrhizae as assistants. The combination of the medicines can regulate qi movement, tonify qi and blood, disperse stasis and clear evil toxin. The whole prescription can relieve depression, soothe liver and regulate qi, tonify heart and spleen, and activate blood and clear heat. The traditional Chinese medicine compound can effectively relieve anxiety of patients, improve sleep quality, and improve somatic symptoms and other anxiety manifestations of patients. The curative effect is remarkable, and the traditional Chinese medicine compound has great application potential in treating or improving anxiety and is worth promoting.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine compound for treating or improving anxiety disorders and its application. Background Technology

[0002] Anxiety disorder is one of the most common mental disorders, affecting approximately 40% of people at some point in their lives. The lifetime prevalence in the general population is about 15%, with women being 2-2.5 times more likely to be affected than men. Its high prevalence, high relapse rate, and serious complications have led the World Health Organization to list it as the ninth leading cause of disability related to health. Anxiety disorders mainly include the following six subtypes: generalized anxiety disorder, panic disorder, agoraphobia, specific phobia, social anxiety disorder, and separation anxiety disorder. Its etiology is complex, and its pathogenesis is not yet fully understood, involving both psychosomatic pathological processes. Western medicine treatment for anxiety disorders often combines psychotherapy and medication. First-line psychotherapy is cognitive behavioral therapy (CBT), which aims to modify erroneous cognitions and behaviors, aligning the patient's thinking with reality, thereby alleviating distress and reducing related symptoms. It has proven effective in treating anxiety disorders in adolescents. First-line treatment for anxiety disorders primarily involves selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), including paroxetine, fluoxetine, and sertraline. These medications have relatively mild side effects and are often used in the initial treatment of anxiety disorders. However, these drugs have a slow onset of action, often taking several weeks to become effective, and are prone to developing tolerance. After discontinuation, the condition is likely to relapse or even worsen. Other anti-anxiety medications, including benzodiazepines, tricyclic antidepressants, and multi-channel reuptake inhibitors, often have significant side effects, such as potential damage to liver and kidney function, cognitive impairment, and marked withdrawal reactions, leading to prolonged and recurring symptoms. Traditional Chinese medicine (TCM) offers significant advantages in treating anxiety disorders, playing a crucial role in mood regulation, immune control, and neuroprotection. It has fewer side effects, better efficacy, and can quickly alleviate anxiety and physical symptoms in patients with mild to moderate anxiety disorders by improving their overall health. When used in combination with Western medicine for severe anxiety disorders, it can reduce the side effects of Western medications and improve efficacy. Summary of the Invention

[0003] (a) Technical problems to be solved

[0004] In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine compound for treating or improving anxiety disorder and its pharmaceutical uses.

[0005] (II) Technical Solution

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] This invention provides a traditional Chinese medicine compound for treating or improving anxiety disorder, which is composed of the following Chinese medicinal materials in parts by weight: Albizia bark 10-40 parts, longan pulp 10-40 parts, citron 10-40 parts, turmeric 10-40 parts, salsa seed 10-40 parts, sparganium rhizome 10-40 parts, fraxinus bark 10-40 parts, chebula fruit 10-30 parts, dictamnus root bark 10-30 parts, prunella vulgaris 10-30 parts, gromwell root 10-30 parts, and licorice root 5-20 parts.

[0008] Furthermore, the traditional Chinese medicine compound is composed of the following medicinal materials in parts by weight: 20-30 parts of Albizia bark, 20-30 parts of longan pulp, 20-30 parts of citron, 15-25 parts of Curcuma zedoaria, 15-25 parts of Salvia miltiorrhiza, 15-25 parts of Sparganium stoloniferum, 15-25 parts of Fraxinus chinensis bark, 10-20 parts of Terminalia chebula, 10-20 parts of Dictamnus dasycarpus bark, 10-20 parts of Prunella vulgaris, 10-20 parts of Lithospermum erythrorhizon, and 5-15 parts of Glycyrrhiza uralensis.

[0009] Furthermore, the traditional Chinese medicine compound is composed of the following parts by weight of Chinese medicinal materials: 26 parts of Albizia bark, 22 parts of longan pulp, 28 parts of citron, 20 parts of Curcuma zedoaria, 18 parts of Sal alopecuroides, 18 parts of Sparganium stoloniferum, 16 parts of Fraxinus chinensis bark, 14 parts of Terminalia chebula, 14 parts of Dictamnus dasycarpus bark, 16 parts of Prunella vulgaris, 16 parts of Lithospermum erythrorhizon, and 9 parts of Glycyrrhiza uralensis.

[0010] This invention also provides the application of the above-mentioned traditional Chinese medicine compound in the preparation of a drug for treating or improving anxiety disorder. The drug is made from the above-mentioned proportions of traditional Chinese medicine materials by weight, supplemented with medically acceptable excipients, and prepared into any one of the following oral dosage forms: pills, tablets, powders, granules, oral liquids, capsules, lyophilized powders, and ointments, according to conventional preparation methods.

[0011] Albizia bark: The dried bark of the legume Albizia julibrissin Durazz. It has a sweet taste and neutral properties, entering the heart and liver meridians. Its functions and indications include relieving depression, harmonizing blood, calming the mind, and reducing swelling and abscesses. It is used to treat restlessness, depression, insomnia, lung abscesses, carbuncles, scrofula, and fractures.

[0012] Longan pulp, also known as dragon eye fruit, is the aril of the longan plant (Dimocarpus longan Lour.), belonging to the Sapindaceae family. It has a sweet taste and warm nature, and enters the heart and spleen meridians. It nourishes the heart and spleen, replenishes blood, and calms the mind. It is commonly used for qi and blood deficiency, palpitations, forgetfulness, insomnia, and anemia with sallow complexion.

[0013] Citron: The dried, ripe fruit of Citronella medica L. or Citronella civilsonii Tanaka, both belonging to the Rutaceae family. It is pungent, bitter, sour, and warm in nature, and enters the liver, spleen, and lung meridians. It soothes the liver and regulates qi, relieves chest tightness, and resolves phlegm. It is used for liver and stomach qi stagnation, chest and rib pain, abdominal distension, vomiting, belching, and cough with excessive phlegm.

[0014] Curcuma phaeocaulis Vai., the dried rhizome of the ginger family (Zingiberaceae), is a traditional Chinese medicine. It is pungent, bitter, and warm in nature, and enters the liver and spleen meridians. It has the effects of promoting blood circulation, regulating qi, eliminating stagnation, and relieving pain. Clinically, it is often used for conditions such as qi stagnation and blood stasis, and masses and accumulations.

[0015] Sal seeds: The dried, mature seeds of *Aesculus chinensis* Bge. var. *chekiangensis* (Hu et Fang) Fang or *Aesculus wilsonii* Rehd., belonging to the Aesculaceae family. They are sweet and warm in nature, and enter the liver and stomach meridians; they soothe the liver and regulate qi, harmonize the stomach and relieve pain; used for stagnation of liver and stomach qi, chest and abdominal distension, and stomach pain.

[0016] Bolboschoenus yagara (Ohwi) YC Yang & M.Zhan, a plant in the Cyperaceae family, is a dried tuber, also known as black sparganium. It has a bitter taste and neutral properties, and enters the liver and spleen meridians. It has the effects of promoting blood circulation, relieving stagnation, and alleviating pain. It is used to treat qi stagnation and blood stasis, abdominal distension and pain, amenorrhea, and traumatic injuries.

[0017] Fraxinus bark: The dried bark of the branches or trunk of *Fraxinus rhynchophylla* Hance, *Fraxinus chinensis* Roxb., *Fraxinus szaboana* Lingelsh, or *Fraxinus stylosa* Lingelsh, all belonging to the Oleaceae family. It has a bitter and astringent taste and is cold in nature. It possesses the functions of clearing heat and drying dampness, astringing and stopping dysentery, stopping leukorrhea, and improving eyesight. It is used for dysentery due to heat toxicity, leukorrhea, red and swollen eyes, and eye diseases such as corneal opacity.

[0018] Terminalia chebula: The dried, ripe fruit of Terminalia chebula Retz. or Terminalia chebula Retz. var. tomentella Kurt., belonging to the Combretaceae family. It tastes bitter, sour, and astringent; its nature is neutral; it enters the lung and large intestine meridians. It has the effects of astringing the intestines to stop diarrhea, astringing the lungs to stop cough, reducing internal heat and relieving sore throat. It is commonly used for chronic diarrhea and dysentery, hematochezia and rectal prolapse, lung deficiency with wheezing and coughing, persistent cough, sore throat and hoarseness.

[0019] Dictamnus dasycarpus root bark: This is the dried root bark of Dictamnus dasycarpus Turcz., a plant in the Rutaceae family. It is cold in nature and bitter in taste, and enters the spleen, stomach, and bladder meridians. It has the effects of clearing heat and drying dampness, dispelling wind and detoxifying, and relieving itching. It is widely used for diseases such as damp-heat sores, eczema, and scabies.

[0020] Prunella vulgaris L., a plant in the Lamiaceae family, is a dried fruit spike. It has a bitter, pungent, and cold taste, and enters the liver and gallbladder meridians. It has the effects of clearing liver heat, improving eyesight, and reducing swelling and lumps. It is commonly used to treat red, swollen, and painful eyes, headaches, dizziness, scrofula, and goiter. In modern times, it is also used as an adjunct treatment for hypertension.

[0021] Purple gromwell root: The dried root of *Arnebia euchroma* (Royle) Johnst. or *Arnebia guttata* Bunge, belonging to the Boraginaceae family. It has a sweet and salty taste, and is cold in nature. It enters the heart and liver meridians. It has the functions of cooling the blood, promoting blood circulation, detoxifying, and relieving rashes. Therefore, it is effective for conditions such as excessive heat and toxicity in the blood, and measles and rashes with poor eruption.

[0022] Licorice: The dried root and rhizome of *Glycyrrhiza uralensis* Fisch., *Glycyrrhiza inflata* Bat., or *Glycyrrhiza glabra* L. (all belonging to the Fabaceae family). It has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasms and pain, and harmonizing other herbs. It is commonly used for spleen and stomach weakness, fatigue, palpitations, shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of other drugs.

[0023] (III) Beneficial Effects

[0024] Based on traditional Chinese medicine theory and following the principles of monarch-minister-assistant-guide drug combination, this invention presents a self-formulated Chinese herbal compound for treating or improving anxiety disorder. The compound consists of Albizia bark, longan pulp, citron, turmeric, salsa seed, sparganium rhizome, fraxinus bark, chebula fruit, dictamnus root bark, prunella vulgaris, gromwell root, and licorice root. In this formula, Albizia bark relieves depression and calms the mind, invigorates blood and reduces swelling; longan pulp benefits the heart and spleen, replenishes qi and blood, and calms the mind; citron soothes the liver, regulates qi, relieves chest congestion, and resolves phlegm, serving as the principal drug. Albizia bark primarily relieves depression and calms the mind, citron primarily soothes the liver and regulates qi, and longan pulp primarily replenishes qi and blood. The three drugs combined address both relieving depression and regulating qi, as well as replenishing qi and calming the mind. Curcuma zedoaria promotes qi circulation, breaks up blood stasis, eliminates stagnation, and relieves pain. Salvia miltiorrhiza regulates qi, relieves chest congestion, harmonizes the stomach, and relieves pain. Sparganium stoloniferum breaks up blood stasis, promotes qi circulation, eliminates stagnation, and relieves pain; these three herbs act as assistant herbs. Together, they assist the principal herb in regulating the body's qi, dispersing blood stasis and food stagnation, while also harmonizing stomach qi. Fraxinus rhynchophylla clears heat and dries dampness, relieves asthma and cough, and improves eyesight. Terminalia chebula astringes the intestines and lungs, reduces heat, and soothes the throat. Dictamnus dasycarpus dispels wind, dries dampness, clears heat, and detoxifies. Prunella vulgaris clears heat, improves eyesight, disperses nodules, and reduces swelling. Lithospermum erythrorhizon cools the blood, invigorates blood circulation, detoxifies, and promotes rash eruption. Glycyrrhiza uralensis tonifies heart qi, soothes the liver, relieves spasms, and harmonizes the other herbs. Together, these herbs regulate qi circulation, tonify qi and blood, dispel stagnation, and clear away toxins. The entire formula works to relieve depression and calm the mind, soothe the liver and regulate qi, tonify the heart and spleen, invigorate blood, and clear heat.

[0025] This invention's traditional Chinese medicine compound can increase the levels of monoamine neurotransmitters 5-HT, NE, and DA, decrease the levels of inflammatory factors TNF-α, IL-1β, and IL-6, and inhibit apoptosis of neurons in the prefrontal cortex. By regulating neurotransmitter balance and improving the inflammatory state, it alleviates anxiety-like behaviors and achieves the goal of treating anxiety disorders. Furthermore, the combination of this traditional Chinese medicine compound with paroxetine can effectively reduce patients' anxiety, improve sleep quality, and alleviate physical symptoms of anxiety. Its efficacy is significant, and its therapeutic effect is significantly superior to that of Western medicine alone. This invention's traditional Chinese medicine compound has great application potential in the treatment or improvement of anxiety disorders and is worthy of promotion. Attached Figure Description

[0026] Figure 1 The results of TUNEL staining were used to detect apoptosis in the prefrontal cortex cells of mice in each group; Note: Compared with the control group, ## P<0.01, *P<0.05, **P<0.01 compared to the model group. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] Example 1

[0029] A traditional Chinese medicine compound for treating or improving anxiety disorder, the compound consisting of the following medicinal materials in parts by weight: Albizia bark 26 parts, longan pulp 22 parts, citron 28 parts, turmeric 20 parts, salsa seed 18 parts, sparganium rhizome 18 parts, fraxinus bark 16 parts, chebula fruit 14 parts, dictamnus root bark 14 parts, prunella vulgaris 16 parts, gromwell root 16 parts, and licorice root 9 parts.

[0030] The above-mentioned traditional Chinese medicine compound is used to prepare a drug for treating or improving anxiety disorder. The drug is made from the above-mentioned proportions of traditional Chinese medicinal materials by weight, supplemented with medically acceptable excipients, and prepared into any one of the following oral dosage forms: pills, tablets, powders, granules, oral liquids, capsules, lyophilized powders, and ointments, according to conventional preparation methods.

[0031] Example 2

[0032] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of traditional Chinese medicine materials: 12 parts of Albizia bark, 12 parts of longan pulp, 12 parts of citron, 10 parts of Curcuma zedoaria, 10 parts of Sal atractylodes, 10 parts of Sparganium rhizome, 10 parts of Fraxinus bark, 10 parts of Terminalia chebula, 10 parts of Dictamnus dasycarpus bark, 10 parts of Prunella vulgaris, 10 parts of Lithospermum erythrorhizon, and 6 parts of Glycyrrhiza uralensis.

[0033] Example 3

[0034] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of traditional Chinese medicine materials: 36 parts of Albizia bark, 34 parts of longan pulp, 32 parts of citron, 32 parts of Curcuma zedoaria, 32 parts of Sal atractylodes, 30 parts of Sparganium rhizome, 32 parts of Fraxinus bark, 26 parts of Terminalia chebula, 26 parts of Dictamnus dasycarpus bark, 24 parts of Prunella vulgaris, 26 parts of Lithospermum erythrorhizon, and 16 parts of Glycyrrhiza uralensis.

[0035] Example 4

[0036] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of traditional Chinese medicine materials: 14 parts of Albizia bark, 14 parts of longan pulp, 12 parts of citron, 12 parts of Curcuma zedoaria, 12 parts of Sal atractylodes, 12 parts of Sparganium rhizome, 12 parts of Fraxinus bark, 12 parts of Terminalia chebula, 12 parts of Dictamnus dasycarpus bark, 12 parts of Prunella vulgaris, 12 parts of Lithospermum erythrorhizon, and 8 parts of Glycyrrhiza uralensis.

[0037] Example 5

[0038] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of traditional Chinese medicine materials: Albizia bark 34 parts, longan pulp 32 parts, citron 32 parts, Curcuma zedoaria 30 parts, Sal atractylodes lancea 30 parts, Sparganium stoloniferum 28 parts, Fraxinus chinensis bark 28 parts, Terminalia chebula 22 parts, Dictamnus dasycarpus bark 24 parts, Prunella vulgaris 22 parts, Lithospermum erythrorhizon 24 parts, and Glycyrrhiza uralensis 16 parts.

[0039] Example 6

[0040] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of traditional Chinese medicine materials: 18 parts of Albizia bark, 18 parts of longan pulp, 16 parts of citron, 14 parts of Curcuma zedoaria, 14 parts of Sal atractylodes, 14 parts of Sparganium rhizome, 12 parts of Fraxinus bark, 10 parts of Terminalia chebula, 10 parts of Dictamnus dasycarpus bark, 10 parts of Prunella vulgaris, 10 parts of Lithospermum erythrorhizon, and 10 parts of Glycyrrhiza uralensis.

[0041] Example 7

[0042] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of traditional Chinese medicine materials: 20 parts of Albizia bark, 20 parts of longan pulp, 20 parts of citron, 15 parts of Curcuma zedoaria, 15 parts of Sal atractylodes, 15 parts of Sparganium rhizome, 15 parts of Fraxinus bark, 10 parts of Terminalia chebula, 10 parts of Dictamnus dasycarpus bark, 10 parts of Prunella vulgaris, 10-20 parts of Lithospermum erythrorhizon, and 5 parts of Glycyrrhiza uralensis.

[0043] Example 8

[0044] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of traditional Chinese medicine materials: 30 parts of Albizia bark, 30 parts of longan pulp, 30 parts of citron, 25 parts of Curcuma zedoaria, 25 parts of Sal atractylodes, 25 parts of Sparganium rhizome, 25 parts of Fraxinus bark, 20 parts of Terminalia chebula, 20 parts of Dictamnus dasycarpus bark, 20 parts of Prunella vulgaris, 20 parts of Lithospermum erythrorhizon, and 15 parts of Glycyrrhiza uralensis.

[0045] Example 9

[0046] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of traditional Chinese medicine materials: 22 parts of Albizia bark, 22 parts of longan pulp, 20 parts of citron, 16 parts of Curcuma zedoaria, 20 parts of Sal atractylodes, 18 parts of Sparganium rhizome, 16 parts of Fraxinus bark, 12 parts of Terminalia chebula, 12 parts of Dictamnus dasycarpus bark, 14 parts of Prunella vulgaris, 12 parts of Lithospermum erythrorhizon, and 8 parts of Glycyrrhiza uralensis.

[0047] Example 10

[0048] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of traditional Chinese medicine materials: 25 parts of Albizia bark, 25 parts of longan pulp, 25 parts of citron, 20 parts of Curcuma zedoaria, 20 parts of Sal atractylodes, 20 parts of Sparganium rhizome, 20 parts of Fraxinus bark, 15 parts of Terminalia chebula, 150 parts of Dictamnus dasycarpus bark, 15 parts of Prunella vulgaris, 15 parts of Lithospermum erythrorhizon, and 10 parts of Glycyrrhiza uralensis.

[0049] Test case

[0050] Study on the effects of the traditional Chinese medicine compound of this invention on a mouse model of anxiety disorder

[0051] 1. Materials and Methods

[0052] 1.1 Laboratory Animals

[0053] C57BL / 6J mice, weighing 18-22g, SPF grade, male, were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. They were acclimatized for one week before the experiment.

[0054] 1.2 Experimental Drugs

[0055] Comparative Chinese medicine: Jieyu Anshen Granules, 5g / sachet.

[0056] Comparative Western medicine: Fluoxetine hydrochloride capsules, 20mg (calculated as fluoxetine).

[0057] Preparation of the experimental drug: The following Chinese medicinal materials were weighed according to the following weight parts: 26 parts of Albizia bark, 22 parts of longan pulp, 28 parts of citron, 20 parts of Curcuma zedoaria, 18 parts of Sparganium fruit, 18 parts of Sparganium rhizome, 16 parts of Fraxinus bark, 14 parts of Terminalia chebula, 14 parts of Dictamnus dasycarpus bark, 16 parts of Prunella vulgaris, 16 parts of Lithospermum erythrorhizon, and 9 parts of Glycyrrhiza uralensis, each part by weight being 1g; after washing, they were decocted three times with 4 times their weight of purified water, and the decoctions were combined and concentrated under reduced pressure to a relative concentration of 1.2-1.3g / mL; after sterilization, the concentrated solution was placed in a freezer and rapidly frozen to below -50℃ for more than 6 hours, and then vacuum dried and sublimated to obtain the freeze-dried powder of the Chinese herbal compound of the present invention, with a yield of 32.7%.

[0058] 1.3 Establishment and grouping of anxiety disorder mouse model

[0059] Mice were randomly divided into 6 groups, including a blank control group (0.1 mL / 10 g saline) and a blank control group (0.1 mL / 10 g / ml saline). -1 Model group (physiological saline 0.1 mL·10 g) -1 The control group (using traditional Chinese medicine, Jieyu Anshen Granules, 2.5 g·kg) -1 ), Western medicine control group (fluoxetine hydrochloride capsules, 10 mg / kg) -1 ), High-dose group of traditional Chinese medicine compound (lyophilized powder of traditional Chinese medicine compound of this invention, 11.6g·kg -1 ), low-dose group of traditional Chinese medicine compound (lyophilized powder of traditional Chinese medicine compound of this invention, 5.8g·kg -1 Except for the control group, mice in all other groups underwent chronic restraint for 6 consecutive hours from 9:00 to 15:00 daily. The method involved placing the mice in a specially designed restraint device with pre-drilled ventilation holes at the top and sides to maintain airflow. The mice were secured in the restraint device via a base, allowing for head movement but preventing them from turning. The mice's condition was monitored closely during restraint to prevent suffocation or other fatalities. During restraint, the control group mice were deprived of food and water. This regimen lasted for 4 weeks, with appropriate medications administered to each group 30 minutes before each restraint procedure.

[0060] 1.4 Behavioral Testing

[0061] In the fourth week of the experiment, behavioral tests were conducted. For each test, six mice were randomly selected from each group, and only one behavioral test was performed each day.

[0062] ① Novelty Environment Feeding Inhibition Experiment: Before the experiment, mice were fasted (but allowed water) for 24 hours. Two identical food pellets were placed in the center of a rectangular test box. After placing the mice facing the box wall in one corner of the test box, the timing was started, and the latency period for the mice to begin feeding was recorded. The detection time was 5 minutes.

[0063] ② Light-dark chamber experiment: At the beginning of the experiment, the mice were placed in the light chamber, and the latency to enter the dark, the number of times the mice passed through the light chamber, and the time spent in the light chamber were recorded. The detection time was 5 minutes.

[0064] ③ Elevated Cross Maze Test: After mice have adapted to an open area for 5 minutes, they are placed in an elevated cross maze near the center, facing the open arms. The time and number of times the mice enter the open and closed arms are measured, and the ratio of time to number of times the mice enter the open arms within 5 minutes is calculated. The elevated cross maze test is conducted under low-intensity light.

[0065] 1.5 Physiological Indicator Detection

[0066] After the behavioral experiment, 6 mice from each group were randomly selected and euthanized. Brain tissue was dissected, a portion of which was fixed in 4% paraformaldehyde, and the other portion was weighed and mixed with pre-cooled (4°C) physiological saline at a ratio of 1:9 (v:v). The mixture was homogenized, centrifuged, and the supernatant was collected and stored at -20°C for later use.

[0067] TUNEL staining was used to detect apoptosis of prefrontal cortical cells in each group of mice; ELISA was used to detect the levels of inflammatory factors TNF-α, IL-6, IL-1β and monoamine neurotransmitters 5-HT, NE, and DA in brain homogenates, and the detection procedures were performed according to the ELISA instructions.

[0068] 1.6 Data Statistics and Analysis

[0069] Statistical analysis was performed using GraphPad Prism 8.0 software. One-way ANOVA was used for data between groups, and Bonferroni post-hoc tests were used for further pairwise comparisons. Experimental data are expressed as mean ± standard deviation, and P < 0.05 was considered statistically significant.

[0070] 2 Results

[0071] 2.1 Effects of the herbal compound of this invention on the behavior of anxiety disorder model mice

[0072] As shown in Table 1, compared with the blank group, the feeding latency and dark latency of the model group mice were significantly increased (P<0.01), while the number of times the mice entered the light room, the time spent in the light room, the ratio of time to open arm entry, and the ratio of times to enter the open arm entry were significantly decreased (P<0.01), indicating that the anxiety model was successfully established. Compared with the model, the high and low doses of the traditional Chinese medicine compound significantly reduced the feeding latency and dark latency of the model mice (P<0.05, P<0.01), increased the swimming and tail-suspending immobility time of the model mice (P<0.05, P<0.01), and increased the number of times the mice entered the light room, the time spent in the light room, the ratio of time to open arm entry, and the ratio of times to enter the open arm entry (P<0.05 or P<0.01), indicating that the traditional Chinese medicine compound of the present invention has the effect of improving anxiety-like behavior in mice. The high-dose group had an effect comparable to that of the Western medicine control group and was significantly better than that of the traditional Chinese medicine control group.

[0073] Table 1. Effects of the traditional Chinese medicine compound of this invention on anxiety behavior in model mice.

[0074]

[0075] Note: Compared with the blank group, ## P < 0.01; * P < 0.05; ** P < 0.01 compared with the model group.

[0076] 2.2 Effects of the herbal compound of this invention on inflammatory factors in brain homogenate of anxiety disorder model mice

[0077] As shown in Table 2, compared with the blank group, the levels of TNF-α, IL-1β, and IL-6 in the brain homogenate of the model group mice were significantly increased (P<0.01). Compared with the model, the high-dose and low-dose traditional Chinese medicine compound significantly reduced the levels of TNF-α, IL-1β, and IL-6 in the brain homogenate of the model mice (P<0.05, P<0.01), indicating that the traditional Chinese medicine compound of the present invention can effectively reduce the expression level of inflammatory factors in the brain homogenate of anxiety model mice. The high-dose group had an effect comparable to that of the Western medicine control group and was significantly better than that of the traditional Chinese medicine control group.

[0078] Table 2. Effects of the traditional Chinese medicine compound of this invention on inflammatory factors in the brain tissue of anxiety model mice.

[0079]

[0080] Note: Compared with the blank group, ## P < 0.01; * P < 0.05; ** P < 0.01 compared with the model group.

[0081] 2.3 Effects of the relapse of the traditional Chinese medicine in this invention on monoamine neurotransmitters in the brain homogenate of anxiety disorder model mice

[0082] As shown in Table 3, compared with the blank group, the levels of 5-HT, NE, and DA in the brain homogenate of model mice were significantly reduced (P<0.01). Compared with the model, the high-dose and low-dose traditional Chinese medicine compound significantly increased the levels of 5-HT, NE, and DA in the brain homogenate of model mice (P<0.05, P<0.01), indicating that the traditional Chinese medicine compound of the present invention can effectively improve the expression level of monoamine neurotransmitters in the brain homogenate of anxiety model mice. The high-dose group had an effect comparable to that of the Western medicine control group and was significantly better than that of the traditional Chinese medicine control group.

[0083] Table 3. Effects of the traditional Chinese medicine compound of this invention on monoamine neurotransmitters in brain homogenate of anxiety model mice.

[0084]

[0085] Note: Compared with the blank group, ## P < 0.01; * P < 0.05; ** P < 0.01 compared with the model group.

[0086] 2.4 Effects of the relapse of the traditional Chinese medicine in this invention on apoptosis of prefrontal neurons in a mouse model of anxiety disorder

[0087] TUNEL staining was used to detect the apoptotic status of prefrontal cortex cells in each group of mice. Apoptotic cells showed red fluorescence, and the fluorescence intensity was positively correlated with the degree of apoptosis. Figure 1 It can be seen that, compared with the blank group, the prefrontal cortex neurons of the model group mice showed significant apoptotic characteristics (P<0.01); compared with the model, the high-dose and low-dose Chinese herbal compound can significantly reduce the apoptosis level of prefrontal cortex neurons in the model mice (P<0.05, P<0.01), suggesting that the Chinese herbal compound of the present invention can effectively inhibit the occurrence of prefrontal neuronal apoptosis in anxiety model mice, and the high-dose group has a more prominent inhibitory effect.

[0088] 3. Conclusion

[0089] This experiment successfully established a mouse model of anxiety disorder using the chronic restraint stress method. Administration of the traditional Chinese medicine compound of this invention significantly improved anxiety-like behaviors in the model mice. Studies have shown that the pathogenesis of anxiety disorder is closely related to neurotransmitter imbalance and inflammatory response. In this experiment, compared with the control group, the levels of inflammatory factors TNF-α, IL-1β, and IL-6 in the brain homogenate of the model mice were significantly increased, while the levels of monoamine neurotransmitters 5-HT, NE, and DA in the brain homogenate were significantly decreased, consistent with existing research reports. Administration of the traditional Chinese medicine compound of this invention significantly reduced the levels of inflammatory factors TNF-α, IL-1β, and IL-6 in the brain homogenate of the model mice and significantly increased the levels of monoamine neurotransmitters 5-HT, NE, and DA in the homogenate. Further experimental results showed that the traditional Chinese medicine compound of this invention has a significant inhibitory effect on neuronal apoptosis in the prefrontal cortex of the model mice; and the above effects are comparable to fluoxetine and significantly superior to Jieyu Anshen granules. The traditional Chinese medicine compound of this invention holds promise for further development and application as a drug for the treatment or improvement of anxiety disorder.

[0090] Application examples

[0091] Clinical observation of the efficacy of the traditional Chinese medicine compound of this invention on anxiety disorder.

[0092] 1. Materials and Methods

[0093] 1.1 General Information

[0094] One hundred and fourteen patients with generalized anxiety disorder (GAD) admitted between January 2024 and September 2025 were selected as the study subjects and randomly divided into a control group and an observation group, with 52 patients in each group. The control group consisted of 16 males and 36 females, aged 20–60 years (mean 32.44 ± 8.19 years), with a disease duration of 8–36 months (mean 12.06 ± 3.22 months). The observation group consisted of 18 males and 34 females, aged 20–60 years (mean 33.09 ± 7.13 years), with a disease duration of 6–36 months (mean 12.79 ± 4.11 months). There were no statistically significant differences in general characteristics between the two groups (P > 0.05), indicating comparability.

[0095] Inclusion criteria: ① Meeting the criteria in the "Guidelines for the Diagnosis and Treatment of Generalized Anxiety Disorder in Primary Care (2021)" and diagnosed with generalized anxiety disorder; ② Age ≥ 18 years; ③ Duration of illness ≥ 6 months; ④ Hamilton Anxiety Scale (HAMA) score ≥ 14 points; ⑤ No use of anti-anxiety or other psychotropic medications in the past month; ⑥ Normal cognitive and communication abilities; ⑦ Informed consent from the patient and their family.

[0096] Exclusion criteria: ① Comorbid mental illnesses such as bipolar disorder or schizophrenia; ② Comorbid severe systemic diseases; ③ Allergy to the drugs used in this study; ④ Comorbid severe cardiovascular or cerebrovascular diseases; ⑤ Comorbid severe physical diseases; ⑥ Alcohol or drug dependence; ⑦ Pregnant or lactating women; ⑧ Withdrawal from the study midway.

[0097] 1.2 Methods

[0098] The control group received oral paroxetine, 20 mg once daily, taken in the morning.

[0099] The observation group received oral administration of the compound herbal decoction of this invention, once a day, in addition to the treatment given to the control group. The decoction was prepared using conventional methods, with 400mL of liquid taken twice daily, morning and evening. The formula consists of: Albizia bark 26g, longan pulp 22g, citron 28g, turmeric 20g, Spatholobus suberectus 18g, Sparganium stoloniferum 18g, Fraxinus chinensis bark 16g, Terminalia chebula 14g, Dictamnus dasycarpus bark 14g, Prunella vulgaris 16g, Lithospermum erythrorhizon 16g, and Glycyrrhiza uralensis 9g.

[0100] Both groups received continuous treatment for 2 months.

[0101] 1.3 Efficacy Evaluation Criteria

[0102] Clinical cure: HAMA score decreased by 80-100% after treatment;

[0103] Significant effect: HAMA score decreased by 50-79% after treatment;

[0104] Effective: HAMA score decreased by 30-49% after treatment;

[0105] Ineffective: HAMA score reduction of 0-29% after treatment.

[0106] Overall effective rate = (Number of clinically cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases × 100%

[0107] 1.4 Observation Indicators

[0108] The Hamilton Anxiety Rating Scale (HAMA) and the Pittsburgh Sleep Quality Index (PSQI) were used to assess patients’ anxiety levels and sleep quality before and after treatment.

[0109] 1.5 Statistical Methods

[0110] SPSS 18.0 statistical software was used. Quantitative data were expressed as mean ± standard deviation. Independent samples t-tests were used between groups, and paired samples t-tests were used within groups. Count data were expressed as percentages (%). Chi-square tests were used for comparisons between groups. 2 The test showed that P < 0.05 was statistically significant.

[0111] 2 Results

[0112] 2.1 Comparison of clinical efficacy between the two groups

[0113] The results are shown in Table 4. The total effective rate of treatment in the observation group was 92.30%, while that in the control group was 76.92%. The difference between the two groups was statistically significant (P<0.05).

[0114] Table 4 Comparison of clinical efficacy between the two groups [n(%)]

[0115]

[0116] 2.2 Comparison of HAMA and PSQI scores before and after treatment in the two groups of patients

[0117] Compared with before treatment, the HAMA and PSQI scores of both groups decreased significantly after treatment (P<0.01); after treatment, the HAMD score of the observation group was significantly lower than that of the control group (P<0.05), and the PSQI score was significantly lower than that of the control group (P<0.01).

[0118] Table 4 Comparison of HAMA and PSQI scores before and after treatment in the two groups of patients.

[0119]

[0120] Note: Compared with the group before treatment, ** P < 0.01; compared with the control group, # P < 0.05, ## P < 0.01

[0121] 3 Discussion

[0122] Based on the above results, the total effective rate in the treatment group was significantly higher than that in the control group. After two months of treatment, the HAMA and PSQI scores in the treatment group were significantly lower than those in the control group. These results indicate that the traditional Chinese medicine compound of this invention, combined with paroxetine, can effectively reduce patients' anxiety, improve sleep quality, and alleviate physical symptoms related to anxiety. Its efficacy is significant, and its therapeutic effect is significantly superior to that of Western medicine alone. The traditional Chinese medicine compound of this invention has great application potential in the treatment or improvement of anxiety disorders and is worthy of promotion.

[0123] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating or improving anxiety disorders, characterized in that, The traditional Chinese medicine composition consists of the following parts by weight of medicinal materials: 26 parts of Albizia bark, 22 parts of longan pulp, 28 parts of citron, 20 parts of Curcuma zedoaria, 18 parts of Sal alopecuroides, 18 parts of Sparganium stoloniferum, 16 parts of Fraxinus chinensis bark, 14 parts of Terminalia chebula, 14 parts of Dictamnus dasycarpus bark, 16 parts of Prunella vulgaris, 16 parts of Lithospermum erythrorhizon, and 9 parts of Glycyrrhiza uralensis.

2. The use of the traditional Chinese medicine composition as described in claim 1 in the preparation of a medicament for treating or improving anxiety disorders, characterized in that, The drug is made from the above-mentioned proportions of Chinese medicinal herbs by weight, supplemented with medically acceptable excipients, and prepared according to conventional preparation methods into any one of the following oral dosage forms: pills, tablets, powders, granules, oral liquids, capsules, freeze-dried powders, and ointments.

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