Traditional Chinese medicine composition for treating Meniere's syndrome

Abstract

The invention relates to a traditional Chinese medicine composition for treating Meniere's syndrome, and belongs to the technical field of pharmacy, the traditional Chinese medicine composition comprises crepis phoenix, Chinese aralis, rhizoma polygonati, gastrodia elata, pseudo-ginseng, cleavers and hairyvein agrimony; in the preparation process of the traditional Chinese medicine composition, the raw material medicines are subjected to targeted treatment according to the performance of the raw material medicines in the formula, the Chinese aralis, the cleavers and the hairyvein agrimony contain volatile oil, the volatile oil is firstly extracted and then subjected to enzymolysis treatment, the compound enzyme is a mixture of cellulase, pectinase, saccharifying enzyme and amylase, and the compound enzyme is a mixture of cellulase, pectinase, saccharifying enzyme and amylase. Effective components in crepis phoenix, Chinese aralis, polygonatum kingianum, gastrodia elata, pseudo-ginseng, cleavers and hairyvein agrimony can be fully extracted, so that the curative effect is ensured; the core of compatibility of the traditional Chinese medicine composition is that multiple methods of nourishing liver and kidney, calming liver and suppressing yang, and reducing phlegm and activating blood are simultaneously carried out to jointly achieve the purpose of treating dizziness, and the traditional Chinese medicine composition has a curative effect on the dizziness symptom, namely the traditional Chinese medicine composition has a curative effect on Meniere syndrome.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of pharmacy, in particular to a traditional Chinese medicine composition for treating Meniere's syndrome. BACKGROUND

[0002] Meniere's syndrome, also known as Meniere's disease, is an inner ear disease characterized by endolymphatic hydrops. The etiology of Meniere's disease is not clear, but the occurrence of the disease is believed to be related to a variety of factors such as imbalance of endolymph production and absorption, immune response, inner ear ischemia, endolymphatic sac dysfunction, viral infection and heredity. Patients are mostly between 40 and 60 years old, and women are more susceptible than men. In terms of disease type, Meniere's disease is usually divided into single ear and bilateral ear, most of which initially occurs in single ear, but may occur in bilateral ear as the disease progresses. In addition, Meniere's disease is also divided into familial Meniere's disease and sporadic Meniere's disease according to the form of onset. Patients will have a series of clinical symptoms such as recurrent rotational vertigo, fluctuant sensorineural hearing loss, tinnitus and (or) fullness of the ear, etc.

[0003] Severe vertigo is accompanied by nausea, vomiting, pale face, cold sweat, decreased blood pressure, slow pulse and other autonomic nervous dysfunction symptoms. Vertigo is a motion or positional illusion, often manifested as a feeling of rotation, tilting and fluctuation, which is a very common and complex symptom that causes serious individual morbidity, healthcare burden and economic cost. Patients may feel that themselves or surrounding objects are rotating, moving, tilting, shaking or rising and falling, usually accompanied by nausea, vomiting, pale face, slow heartbeat and decreased blood pressure, etc. Meniere's syndrome belongs to the category of "dizziness" and "ear dizziness" in traditional Chinese medicine, and is differentiated into phlegm turbidity obstruction, liver yang hyperactivity, deficiency of qi and blood, and deficiency of kidney essence, etc. The treatment is mainly based on resolving phlegm and calming liver, tonifying qi and blood, and nourishing kidney essence, combined with acupuncture, nursing and other methods to improve symptoms. Resolving phlegm and calming liver plays a decisive role in the treatment of Meniere's syndrome. As a treasure trove of Chinese medicine resources, many Chinese herbal medicines have the effect of treating dizziness and have the characteristics of small side effects. Therefore, it is necessary to disclose a traditional Chinese medicine composition for treating Meniere's syndrome and dizziness symptoms, and to prepare a convenient Chinese medicine dosage form. It plays a therapeutic role on dizziness caused by related diseases. SUMMARY

[0004] In order to overcome the problems in the background art, the present application discloses a traditional Chinese medicine composition for treating Meniere's syndrome, which comprises Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine and Agrimonia pilosa. Among the traditional Chinese medicine combinations, the monarch drugs are Crepis phoenix Dunn and Aralia chinensis L. Crepis phoenix Dunn is neutral in nature, sweet and slightly bitter in taste, and has the effects of tonifying the liver and kidney, strengthening the spleen and promoting diuresis. For the symptom of dizziness, traditional Chinese medicine generally believes that it is related to the deficiency of the liver and kidney. Crepis phoenix Dunn directly supplements the root of the liver and kidney, solving the deep pathogenesis of dizziness. Aralia chinensis L. is neutral in nature, pungent, slightly bitter in taste, and has the functions of expelling wind and removing dampness, promoting blood circulation to relieve pain, and strengthening the spleen and promoting diuresis. Aralia chinensis L. assists Crepis phoenix Dunn to eliminate the pathological factors that may cause dizziness, such as phlegm-dampness, by removing wind-dampness pathogens in the body and strengthening the spleen. Aralia chinensis L. and Crepis phoenix Dunn work together synergistically to jointly lay the treatment foundation of "tonifying the liver and kidney, strengthening the spleen and removing dampness", targeting the "deficiency of root" problem of dizziness. The ministerial drugs are Gastrodia elata Blume, Panax notoginseng, Polygonatum sibiricum Redoute, Galium aparine L., and Agrimonia pilosa Ledeb. Gastrodia elata Blume is an important drug for calming the liver wind and stopping dizziness. In traditional Chinese medicine, there is a saying that "all dizziness and vertigo are attributed to the liver". Gastrodia elata Blume directly enters the liver meridian, can effectively calm the liver wind and inhibit the hyperactivity of liver yang, and is a "targeted drug" for treating dizziness and headache. Gastrodia elata Blume assists the monarch drugs to specifically solve the direct cause of dizziness, that is, "internal movement of liver wind". Panax notoginseng promotes blood circulation to remove blood stasis and dredges collaterals to relieve pain. For a long-term illness, there is often blood stasis. Dizziness patients often have problems with poor qi and blood circulation. Blood stasis blocking the clear orifices (head) can also cause dizziness. Panax notoginseng can remove blood stasis and dredge collaterals to ensure smooth qi and blood supply to the head. Polygonatum sibiricum Redoute supplements qi and nourishes yin, strengthens the spleen, moistens the lungs, and benefits the kidneys. Polygonatum sibiricum Redoute strongly assists the monarch drugs in "tonifying the liver and kidney" and helps to transform dampness by strengthening the spleen and qi to prevent the formation of phlegm-dampness. Agrimonia pilosa Ledeb is also known as "tuolicao" among the people, and has the functions of astringing to stop bleeding and tonifying deficiency (especially good at tonifying qi deficiency caused by overexertion). In this formula, the main function of Agrimonia pilosa Ledeb is to assist in tonifying deficiency and improving symptoms such as shortness of breath and fatigue caused by deficiency. Galium aparine L. has the effects of clearing heat and detoxifying, inducing diuresis for reducing swelling, and antibacterial and anti-inflammatory, and can be used as an assistant drug to clear heat and promote diuresis, and assist the monarch drugs to remove damp-heat pathogens in the patient's body. The core of the compatibility of the traditional Chinese medicine composition lies in the combined use of multiple methods such as "tonifying the liver and kidney, suppressing liver yang, resolving phlegm and promoting blood circulation", jointly achieving the purpose of treating the dizziness symptoms of Meniere's syndrome.

[0005] To achieve the above purpose, the present invention is realized through the following technical solutions: The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 75 - 85 parts of Crepis phoenix Dunn, 75 - 85 parts of Aralia chinensis L., 15 - 25 parts of Polygonatum sibiricum Redoute, 15 - 25 parts of Gastrodia elata Blume, 15 - 25 parts of Panax notoginseng, 45 - 55 parts of Galium aparine L., 55 - 75 parts of Agrimonia pilosa Ledeb; the traditional Chinese medicine composition is specifically used for treating the dizziness symptoms of Meniere's syndrome.

[0006] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 85 parts of Crepis phoenix Dunn, 85 parts of Aralia chinensis L., 26 parts of Polygonatum sibiricum Redoute, 26 parts of Gastrodia elata Blume, 26 parts of Panax notoginseng, 45 - 55 parts of Galium aparine L., 75 parts of Agrimonia pilosa Ledeb.

[0007] Preferably, the traditional Chinese medicine composition is prepared into capsules for standby.

[0008] Preferably, the method for preparing the adhesive includes the following steps: (1) Preparation of medicinal slices: Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine, and Agrimonia pilosa were selected, washed, cut and dried to obtain medicinal slices of Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine and Agrimonia pilosa. (2) Grind the medicinal slices: Take the prescribed amount of Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine, and Agrimonia pilosa, grind them into powder and mix them for later use; (3) Extraction of volatile oil: Take the crushed and mixed Aralia elata, Galium aparine and Agrimonia pilosa slices, soak them in water for 2-3 hours, and then extract the volatile oil by steam distillation. Collect the volatile oil for later use. (4) Decoction: After the volatile oil is extracted, the dregs are mixed with the crushed slices of Polygonatum odoratum, Polygonatum sibiricum, Gastrodia elata and Panax notoginseng. After mixing, add 7-9 times the amount of water of the total amount of the slices and soak for 1.0-2.0 hours. Decoction is carried out for 2.5-3.5 hours. Filter to obtain filtrate. Add 3-4 times the amount of water of the dregs and decoct a second time for 1.0-2.0 hours. Filter to obtain filtrate for later use. (5) Enzymatic hydrolysis: Cool the filtrate to 30-40℃, add compound enzyme for enzymatic hydrolysis, and hydrolyze for 2-3 hours; (6) Alcohol precipitation: Add 60%-70% of the volume of the decoction to the enzymatically hydrolyzed decoction and mix. After mixing, let stand and refrigerate for 12-24 hours and then filter to obtain the filtrate. (7) Concentration: The filtrate is heated and concentrated into a thick paste. The thick paste is mixed with volatile oil, and then vacuum dried and pulverized into fine powder. (8) Preparation: The pulverized fine powder is sieved and filled into the capsule shell using a fully automatic capsule filling machine according to the specifications. After polishing, the capsule is obtained.

[0009] Preferably, in step (5), the complex enzyme is a mixture of cellulase, pectinase, saccharifying enzyme and amylase.

[0010] Preferably, the compound enzyme comprises the following parts by weight: 0.02-0.1 parts cellulase, 0.02-0.1 parts pectinase, 0.1-0.2 parts saccharifying enzyme, and 0.02-0.1 parts amylase.

[0011] Preferably, the capsules are in the form of 0.5g / capsule.

[0012] As a preferred option, the dosage of the capsules is 1-1.5g each time, twice a day, for 30 consecutive days as one course of treatment.

[0013] The beneficial effects of this invention are as follows: The traditional Chinese medicine composition for treating Meniere's syndrome includes *Aralia elata*, *Aralia elata*, *Polygonatum sibiricum*, *Gastrodia elata*, *Panax notoginseng*, *Galium affine*, and *Agrimonia pilosa*. In the preparation process of the traditional Chinese medicine composition, the raw materials are treated specifically according to their properties. *Aralia elata*, *Galium affine*, and *Agrimonia pilosa* contain volatile oils. These volatile oils are first extracted, followed by enzymatic hydrolysis. The complex enzyme is a mixture of cellulase, pectinase, saccharifying enzyme, and amylase, which can fully extract the effective components from *Aralia elata*, *Aralia elata*, *Polygonatum sibiricum*, *Gastrodia elata*, *Panax notoginseng*, *Galium affine*, and *Agrimonia pilosa* to ensure its efficacy. The core of the traditional Chinese medicine composition lies in the combined approach of "nourishing the liver and kidneys, calming the liver and suppressing yang, resolving phlegm and promoting blood circulation" to achieve the purpose of treating vertigo. Its effectiveness in treating vertigo symptoms proves its efficacy in treating Meniere's syndrome. Attached Figure Description

[0014] Figure 1 A bar chart showing the irritability rating; Figure 2 The irritability level is linearly rated; Figure 3 A bar chart showing the trend of weight change; Figure 4 A line graph showing the trend of weight change; Figure 5 A bar chart showing liver coefficients; Figure 6 Bar chart showing the effect of PXJN on balance beam walking in rats with liver yang hyperactivity type of ischemic vertigo (n=6). Figure 7 Linear graph showing the effect of PXJN on balance beam walking in rats with ischemic vertigo due to liver yang hyperactivity (n=6). Figure 8 Bar chart showing the effect of PXJN on serum IL-6 levels in rats with ischemic vertigo due to liver yang hyperactivity (n=6). Figure 9 This is a schematic diagram of the staining results. Detailed Implementation

[0015] To make the above objectives, technical solutions, and beneficial effects clearer and more explicit, the present invention will be specifically described below in conjunction with embodiments.

[0016] Example 1: (1) Preparation of medicinal slices: The following raw materials were selected, cleaned, cut and dried to obtain medicinal slices of Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine and Agrimonia pilosa, with the following weight parts: Wan Zhang Shen 75 parts, Aralia elata 75 parts, Polygonatum sibiricum 15 parts, Gastrodia elata 15 parts, Panax notoginseng 15 parts, Galium aparine 45 parts, Agrimonia pilosa 55 parts. (2) Grind the medicinal slices: Take the prescribed amount of Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine, and Agrimonia pilosa, grind them into powder and mix them for later use; (3) Extraction of volatile oil: Take the crushed and mixed Aralia elata, Galium aparine and Agrimonia pilosa slices, soak them in water for 2 hours, and then extract the volatile oil by steam distillation. Collect the volatile oil for later use. (4) Decoction: The dregs after volatile oil extraction are mixed with the crushed slices of Polygonatum odoratum, Polygonatum odoratum, Gastrodia elata and Panax notoginseng. After mixing, add 9 times the amount of water of the slices and soak for 1.0 hour. Decoction for 2.5 hours. Filter to obtain filtrate. Add 4 times the amount of water of the dregs and decoct a second time for 1.0 hour. Filter to obtain filtrate for later use. (5) Enzymatic hydrolysis: Cool the filtrate to 30°C, add the following parts by weight of compound enzyme for enzymatic hydrolysis, and hydrolyze for 2 hours. The parts by weight are: 0.02 parts of cellulase, 0.02 parts of pectinase, 0.1 parts of saccharifying enzyme, and 0.02 parts of amylase. (6) Alcohol precipitation: The decoction after enzymatic hydrolysis is mixed with 65% ethanol solution of the decoction volume, and after mixing, it is allowed to stand and refrigerated for 12 hours before filtering to obtain the filtrate. (7) Concentration: The filtrate is heated and concentrated into a thick paste. The thick paste is mixed with volatile oil, and then vacuum dried and pulverized into fine powder. (8) Preparation: The fine powder is sieved and filled into the capsule shell using a fully automatic capsule filling machine according to the specifications. After polishing, the capsule is obtained. The capsule is 0.5g / capsule. The dosage of the capsule is 2 capsules each time, twice a day, for 30 days as one course of treatment.

[0017] Example 2: (1) Preparation of medicinal slices: The following raw materials were selected, cleaned, cut and dried to obtain medicinal slices of Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine and Agrimonia pilosa, with the following weight parts: Wan Zhang Shen 85 parts, Aralia elata 85 parts, Polygonatum sibiricum 26 parts, Gastrodia elata 26 parts, Panax notoginseng 26 parts, Galium aparine 55 parts, Agrimonia pilosa 75 parts; (2) Grind the medicinal slices: Take the prescribed amount of Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine, and Agrimonia pilosa, grind them into powder and mix them for later use; (3) Extraction of volatile oil: Take the crushed and mixed Aralia elata, Galium aparine and Agrimonia pilosa slices, soak them in water for 3 hours, and then extract the volatile oil by steam distillation. Collect the volatile oil for later use. (4) Decoction: The dregs after volatile oil extraction are mixed with crushed slices of Polygonatum odoratum, Polygonatum odoratum, Gastrodia elata and Panax notoginseng. After mixing, add 7 times the amount of water of the total amount of the slices and soak for 2.0 hours. Decoction is carried out for 3.5 hours and filtered to obtain filtrate. The dregs are added to 3 times the amount of water of the total amount of the dregs and decocted a second time for 2.0 hours. Filter to obtain filtrate for later use. (5) Enzymatic hydrolysis: Cool the filtrate to 40°C, add the following parts by weight of compound enzyme for enzymatic hydrolysis, and hydrolyze for 3 hours. The parts by weight are: 0.1 parts of cellulase, 0.1 parts of pectinase, 0.2 parts of saccharifying enzyme, and 0.1 parts of amylase. (6) Alcohol precipitation: The decoction after enzymatic hydrolysis is mixed with 65% ethanol solution of the decoction volume, and after mixing, it is allowed to stand and refrigerated for 24 hours before filtering to obtain the filtrate. (7) Concentration: The filtrate is heated and concentrated into a thick paste. The thick paste is mixed with volatile oil, and then vacuum dried and pulverized into fine powder. (8) Preparation: The fine powder is sieved and filled into the capsule shell using a fully automatic capsule filling machine according to the specifications. After polishing, the capsule is obtained. The capsule is 0.5g / capsule. The dosage of the capsule is 3 capsules each time, twice a day, for 30 days as one course of treatment.

[0018] Example 3 (1) Preparation of medicinal slices: The following raw materials were selected, cleaned, cut and dried to obtain medicinal slices of Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine and Agrimonia pilosa, with the following weight parts: Wan Zhang Shen 80 parts, Aralia elata 80 parts, Polygonatum sibiricum 20 parts, Gastrodia elata 20 parts, Panax notoginseng 20 parts, Galium aparine 50 parts, Agrimonia pilosa 60 parts; (2) Grind the medicinal slices: Take the prescribed amount of Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine, and Agrimonia pilosa, grind them into powder and mix them for later use; (3) Extraction of volatile oil: Take the crushed and mixed Aralia elata, Galium aparine and Agrimonia pilosa slices, soak them in water for 2.5 hours, and then extract the volatile oil by steam distillation. Collect the volatile oil for later use. (4) Decoction: The dregs after volatile oil extraction are mixed with crushed Wan Zhang Shen, Huang Jing, Tian Ma, and San Qi slices. After mixing, add 8 times the amount of water of the slices and soak for 1.5 hours. Decoction for 3 hours and filter to obtain filtrate. Add 3.5 times the amount of water of the dregs and decoct a second time for 1.5 hours. Filter to obtain filtrate for later use. (5) Enzymatic hydrolysis: Cool the filtrate to 35°C, add the following parts by weight of compound enzyme for enzymatic hydrolysis, and hydrolyze for 2-3 hours. The parts by weight are: 0.05 parts of cellulase, 0.05 parts of pectinase, 0.15 parts of saccharifying enzyme, and 0.05 parts of amylase. Hydrolyze for 2.5 hours. (6) Alcohol precipitation: The decoction after enzymatic hydrolysis is mixed with 65% ethanol solution of the decoction volume, and after mixing, it is allowed to stand and refrigerated for 20 hours before filtering to obtain the filtrate. (7) Concentration: The filtrate is heated and concentrated into a thick paste. The thick paste is mixed with volatile oil, and then vacuum dried and pulverized into fine powder. (8)Preparation: The pulverized fine powder is sieved, and according to the specification requirements, the fine powder is filled into the capsule shell by a fully automatic capsule filling machine and polished to obtain the capsule preparation; the capsule preparation is 0.5 g per capsule, and the usage and dosage of the capsule preparation are: 2 capsules each time, 2 times a day, and continuous administration for 30 days is taken as 1 course of treatment.

[0019] Example 4: Rat experiment 1.1 Experimental animals Select 50 SPF-grade male SD rats at 6 - 8 weeks old, with a body weight of 180 ± 20 g, purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd., and the production license number is: SCXK(Beijing)2019 - 0008. The rats are raised in the Medical Experiment Center of China Academy of Chinese Medical Sciences, and the license number is: SYXK(Beijing)2021 - 0017. The experiment is maintained at a room temperature of 20 - 25 °C and a relative humidity of 45% - 65%. The rats are provided with sufficient drinking water and food. The experimental protocol and animal procedures have been approved by the Animal Experiment Welfare Review Committee of the Experiment Center of China Academy of Chinese Medical Sciences (ERCCACMS21 - 2306 - 02).

[0020] 1.2 Drugs and kits 1.3 Instruments Take out the drugs in the capsule preparations of Example 1, Example 2, and Example 3, weigh an appropriate amount of PXJN powder, and prepare suspensions with different doses (PXJN - H: 1250 mg / kg / d, PXJN - M: 625 mg / kg / d, PXJN - L: 312 mg / kg / d) with pure water.

[0021] 1.5 Preparation of Fuzhi Decoction Take the processed Radix Aconiti Lateralis Preparata slices (1500 g), soak them in 2 times the amount of water for 30 min, decoct them twice with 10 times the amount of water and 8 times the amount of water respectively, filter, and after combining the medicinal liquids, evaporate and concentrate to 7500 ml, obtaining a medicinal liquid with a mass concentration of 2 mg / ml (calculated based on crude drug).

[0022] 2. Experimental method 2.1 Preparation of the model of hyperactivity of liver yang type ischemic vertigo disease Administer Fuzhi Decoction to rats by gavage for 3 weeks, at a dose of 10 ml / kg / d by gavage for 3 weeks, equivalent to 2 g / kg / d of crude drug, to establish a rat model with hyperactivity of liver yang syndrome.

[0023] Rats in the sham-operated group and the model group (ischemic vertigo model) were fed a standard diet and were also given 10 ml / kg body weight of distilled water daily. Rats were first anesthetized with a freshly prepared 2% sodium pentobarbital solution according to their body weight, fixed in a supine position, and the neck skin was cut open with scissors. The muscles were bluntly dissected, and the right common carotid artery (CCA) was ligated with surgical sutures. The subclavian artery (SCA) was located along the common carotid artery and sutured. The temperature was maintained at 37 ℃ during the operation to create an ischemic vertigo model.

[0024] Based on previous experimental studies and a comprehensive review of literature, starting from the day of modeling, except for sham-operated rats, rats were rotated daily using a rotating instrument at a time of 15 minutes and a rotation speed of 70 r (based on previous experiments by the research group) to create a mechanical vertigo complex model.

[0025] This experiment established a combined model of liver yang hyperactivity, ischemic vertigo, and mechanical vertigo. Rats were anesthetized with 2% sodium pentobarbital solution (1 ml / kg) according to their body weight, then fixed in a supine position. The skin of the neck was cut, the muscles were bluntly dissected, and the exposed right common carotid artery was ligated with surgical sutures. The subclavian artery was then ligated along the common carotid artery with surgical sutures. The temperature was maintained at 37°C during the operation. Immediately after the model was established, the rats were administered a prepared 2 g·kg / d / Fuzi decoction via gavage to create a rat model of liver yang hyperactivity. After 7 days of gavage administration of Fuzi decoction, the rats were simultaneously administered PXJN continuously for 14 days, once daily, 1 ml / 100g. During the modeling period, except for the sham-operated group, the rats were rotated daily using a balance rotator at 70 rpm for 15 minutes to create a rat model of ischemic vertigo due to liver yang hyperactivity. After 14 days of PXJN intervention, the efficacy of PXJN on ischemic vertigo of the liver-yang hyperactivity type was evaluated by observing the general condition, irritability, liver coefficient, balance beam score and serum IL-6 content of rats.

[0026] 2.2 Observation Indicators (1) General situation (2) Observation and scoring of irritability level: Note: Generally, a model is considered successful if it is above level I. 2.3 Grouping and Administration After 3 days of acclimatization, rats were randomly divided into four groups based on their modeling performance: a blank control group (Sham), model group 1 (Fuzi decoction + surgery, Model 1), model group (surgery, Model 2), Gastrodia and Uncaria rhynchophylla (positive control, Tmgt), a high-dose PXJN group (PXJN-H), a medium-dose PXJN group (PXJN-M), and a low-dose PXJN group (PXJN-L), with six rats in each group. Fuzi decoction was administered by gavage for one week at a dose of 10 ml / kg / day, for a total of three weeks. The dosages for the three drugs were calculated using a body weight conversion method. The medium-dose PXJN was 625 mg / kg / day (clinical dose). A high-dose PXJN of 1250 mg / kg / day and a low-dose PXJN of 312 mg / kg / day were also established. The Tmgt dose was 3125 mg / kg / day (clinical dose). Administered once daily for 14 consecutive days.

[0027] 2.4 Changes in liver coefficient After euthanizing the rat by blood collection from the abdominal aorta, the liver was removed (in this experiment, only the liver was used), weighed, and the liver coefficient was calculated. Liver coefficient = [wet weight of organ / body weight of rat] x 100%.

[0028] 2.5 Balance Beam Measurement The balance beam scores of rats were observed at 0d, 7d and 14d after modeling. All rats were tested before 12:00 noon. Except for the sham-operated group, rats were subjected to mechanical rotation to induce vertigo before scoring.

[0029] Rats were placed on a balance beam apparatus and then placed inside a black wooden box to assess their ability to cross the beam. Performance was scored according to a scale designed in the literature, as shown in the table below: 2.6 Serum IL-6 level determination Fourteen days after drug administration, rats were anesthetized by intraperitoneal injection of 2% sodium pentobarbital solution (1 ml / kg). Arterial blood was collected from the abdominal aorta and placed in vacuum blood collection tubes. After standing at room temperature for 30 min, the blood was centrifuged at 3500 rpm for 10 min at 4℃, and the serum was collected, aliquoted, and stored at -80℃ for later use. The IL-6 content in rat serum was detected according to the steps of the ELISA kit.

[0030] 2.7 HE detection Whole brains of rats from each group were collected and fixed in 4% paraformaldehyde in preparation for HE staining. Paraffin embedding and sectioning were performed: sections were cut to the classic hippocampal position. The procedure involved fixation, washing, dehydration and clearing, paraffin embedding, sectioning, baking, and microscopic examination.

[0031] 2.8 Data Statistical Analysis IBM SPSS Statistics 26 software was used to analyze and process the experimental data. If the data conformed to a normal distribution and the variances were homogeneous, analysis of variance (ANOVA) was used for statistical analysis, followed by the LSD test. If the data did not conform to a normal distribution and the variances were unequal, nonparametric tests were performed. All data are expressed as mean ± standard deviation (s). p A value < 0.05 was considered statistically significant, and graphs were plotted using Graph Pad Prism 9 after analysis. 3. Experimental Results 3.1 Changes in irritability Fourteen days after modeling (7 days of drug administration), compared with the Sham group, there was no statistically significant difference in the irritability score of the Model 1 group rats, but there was an increasing trend; compared with the Model 1 group, there was no statistically significant difference in the irritability score of the Tmgt group and the PXJN-H, PXJN-M, and PXJN-L groups.

[0032] 21 days after modeling (14 days of drug administration), compared with the Sham group, the irritability score of the Model 1 group was significantly increased. p <0.05); compared with Model 1, the irritability score of rats in Model 2 group was significantly reduced ( p <0.05); Compared with Model 1 group, there was no statistically significant difference in irritability scores between the Tmgt group and the PXJN-H, PXJN-M, and PXJN-L groups, but a decreasing trend was observed. (See Tables II-VI) Figure 1 , Figure 2 ) Note: Compared with the blank group, # P <0.05, # P <0.01, ### P <0.001; compared with model group 1, * P <0.05,** P <0.01, *** P <0.001. Figure 1 , Figure 2 Bar charts and line graphs showing susceptibility ratings.

[0033] 3.2 Weight Changes Day 0 post-modeling, there was no statistically significant difference in body weight between the Model 1 group and the Sham group. p＞ 0.05); Compared with the Model 1 group, there was no statistically significant difference in body weight between the Tmgt group and the PXJN-H, PXJN-M, and PXJN-L groups ( p >0.05).

[0034] Seven days after modeling (day 0 of drug administration), there was no statistically significant difference in body weight between the Model 1 group and the Sham group; there were no statistically significant differences in body weight between the Tmgt group and the PXJN-H, PXJN-M, and PXJN-L groups compared with the Model 1 group. p >0.05).

[0035] Fourteen days after modeling (7 days of drug administration), there was no statistically significant difference in body weight between the Model 1 group and the Sham group. p >0.05); compared with the Model 1 group, the Tmgt group had a significantly higher body weight ( p＜ (0.05), there was no statistically significant difference in body weight among the PXJN-H, PXJN-M, and PXJN-L groups.

[0036] 21 days after modeling (7 days of drug administration), compared with the Sham group, the Model 1 group had a significantly lower body weight. p< 0.05); compared with Model 1 group, PXJN-H had a significantly higher body weight ( p< (0.05), there was no statistically significant difference in body weight between the Tmgt group and the PXJN-M and PXJN-L groups. (See Tables II-VII) Figure 3 , Figure 4 ) Note: Compared with the blank group, # P <0.05, # P <0.01, ### P <0.001; compared with model group 1, * P <0.05,** P <0.01, *** P <0.001. Figure 3 , Figure 4 The bar chart and line graph show the trend of rat body weight change.

[0037] 3.3 Changes in liver coefficient The liver coefficients of rats in each group are as follows (see Tables II-VIII). Figure 5 There were no statistically significant differences among the groups. p >0.05), compared to the Sham group, the liver coefficient of Model 1 showed a decreasing trend. 3.4 Balance Beam Walking Experiment Before administration, there were no statistically significant differences among the groups.

[0038] Seven days after administration, compared with the Sham group, the Model 1 group had a significantly higher balance beam score. p< 0.05); Compared with Model 1, there was no statistically significant difference in the balance beam scores between the Tmgt group and the PXJN-H, PXJN-M, and PXJN-L groups ( p >0.05), but there is a clear downward trend.

[0039] 14 days after administration, the balance beam score of the Model 1 group was significantly different from that of the Sham group. p <0.05); compared with Model 1, the balance beam scores of the Tmgt group and the PXJN-H and PXJN-M groups were significantly reduced ( p< 0.05), there was no statistically significant difference in balance beam scores between the PXJN-L group and the PXJN-L group. p >0.05). (See Table II-IX, Figure 6 , Figure 7 ) Note: Compared with the blank group, # P <0.05, # P <0.01, ### P <0.001; compared with model group 1, * P <0.05, ** P <0.01, *** P <0.001. Figure 6 , Figure 7 Bar and line graphs showing the effect of PXJN on balance beam walking in rats with liver yang hyperactivity type of ischemic vertigo (n=6).

[0040] 3.5 Effects of the capsules in Examples 1, 2, and 3 on serum IL-6 levels in rats with ischemic vertigo due to liver yang hyperactivity. Compared with the Sham group, the IL-6 levels in the Model1 and Model2 groups showed an increasing trend; compared with the Model1 group, the IL-6 levels in the Tmgt group and the PXJN-H group showed a decreasing trend. These results indicate that PXJN has a tendency to improve IL-6 levels in rats with ischemic vertigo due to liver yang hyperactivity. (Tables II-X) Figure 8 ) Note: Compared with the blank group, # P <0.05, # P<0.01, ### P <0.001; compared with model group 1, * P <0.05,** P <0.01, *** P <0.001. Figure 8 The bar chart shows the effect of PXJN on serum IL-6 levels in rats with ischemic vertigo due to liver yang hyperactivity (n=6).

[0041] 3.6 HE staining Microscopic observation of the classic hippocampal tissue in rats with ischemic vertigo due to liver yang hyperactivity revealed that the hippocampal tissue structure of the Sham group was relatively intact and clear, with tightly and regularly arranged nerve cells, normal cell structure, full cell bodies, and no apoptotic or necrotic cells or inflammation. Compared with Sham, the hippocampal tissue structure of the Model1 group was more severely damaged, with irregularly arranged nerve cells and the presence of necrotic cells. PXJN and Tmgt could improve hippocampal tissue cells to varying degrees, inhibit inflammation, reduce the number of necrotic cells, and improve hippocampal damage in rats. Figure 9 The results of HE staining are shown (n=3, 400×). A rat model of ischemic vertigo with liver yang hyperactivity and a rat model of ischemic vertigo were established to evaluate the therapeutic effects and potential mechanisms of action of the capsules in Examples 1, 2, and 3; the material basis of the capsules in Examples 1, 2, and 3 was analyzed; and Western blotting was used to study the polarization and mechanism of action of the intestinal absorption liquid of the capsules in Examples 1, 2, and 3 in LPS-induced inflammatory damage to Bv-2 cells.

[0042] PXJN has the effect of improving motor function in rats with ischemic vertigo caused by liver yang hyperactivity; PXJN-H may have anti-inflammatory effects by reducing the content of IL-6 in rat serum; PXJN has neuroprotective effects; PXJN may reduce inflammatory response and improve post-inflammation damage caused by ischemic vertigo caused by liver yang hyperactivity by regulating cellular inflammatory pathways; therefore, the capsules in Examples 1, 2, and 3 are effective in treating vertigo and other related symptoms in rats caused by "liver yang hyperactivity".

[0043] Example 5: Clinical Trial Validation Since the rat experiment in Example 4 proved that the capsules of Example 1, Example 2 and Example 3 are effective in treating dizziness and other related symptoms in rats caused by "liver yang hyperactivity" and have no obvious toxic side effects, a clinical trial is now being conducted.

[0044] 1.1 General Information One hundred and twenty patients with vertigo admitted to the Department of Neurology of a hospital from February 2023 to August 2024 were selected as the study subjects and randomly divided into a treatment group and a control group, with sixty patients in each group.

[0045] The treatment group consisted of 29 males and 31 females, aged 23 to 78 years, with a mean age of (47.77 ± 11.23) years; the duration of illness ranged from 1 month to 6 years, with a mean duration of illness of 3.9 years.

[0046] The control group consisted of 27 males and 33 females, aged 27–80 years (mean age 46.11 ± 10.17 years), with a disease duration of 1 month to 7 years (mean duration 3.1 years). There were no statistically significant differences between the two groups in terms of gender, age, disease severity, and disease duration (P > 0.05).

[0047] 1.2 Diagnostic and Syndrome Differentiation Criteria The Western medicine diagnostic criteria were based on the clinical diagnostic criteria in the 2006 Chinese PCI Expert Consensus. The traditional Chinese medicine diagnostic criteria were based on the relevant standards in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine" and the diagnostic criteria for vertigo of the liver yang hyperactivity type in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases." Symptoms included: dizziness, vertigo, and a feeling of spinning, with a subjective sensation of head and body swaying. In mild cases, the symptoms stopped when the eyes were closed; in severe cases, the symptoms felt like being on a boat or in a car, with a spinning sensation that made it difficult to stand. Other symptoms included nausea, vomiting, sweating, dry mouth and thirst, headache, head distension, flushed face, irritability, insomnia with vivid dreams, red tongue, thin yellow coating, and wiry pulse.

[0048] 1.3 Inclusion Criteria The patient meets the diagnostic criteria for vertigo and is diagnosed with the liver yang hyperactivity type; the age of onset is 18-75 years old; and the patient fully cooperates with the treatment.

[0049] 1.4 Exclusion Criteria ① Patients with fresh cerebral infarction, based on imaging examinations (such as cranial MRI, CT); ② Patients with abnormal liver and kidney function; ③ Patients with vertigo due to other causes, such as cervical spondylosis, anemia, otogenic vertigo, benign paroxysmal positional vertigo, etc.; ④ Patients allergic to cinnarizine and the study drug; ⑤ Patients with bleeding tendencies; ⑥ Patients with mental disorders, or women who are breastfeeding or pregnant; ⑦ Patients using other vertigo medications not specified in the study. Other factors such as the location and severity of dizziness, tongue and pulse examination, pre-treatment symptom scores, and cerebral blood flow imaging showed no statistically significant differences (P>0.05).

[0050] 1.5 Treatment Methods The control group received flunarizine hydrochloride capsules (Xi'an Janssen Pharmaceutical Co., Ltd., National Drug Approval Number H1093003), 5 mg, once nightly. The treatment group received capsules prepared according to Examples 1, 2, and 3, 0.5 g, 3 capsules, 3 times daily. The treatment course for both groups was three months.

[0051] Observation indicators: ① Transcranial Doppler ultrasound (TCD) examination: Each patient underwent a transcranial Doppler ultrasound (TCD) examination before and after treatment. The instrument used was a CRS-900 TCD scanner manufactured by Mindray Medical International Limited (Mindray Medical International Limited), mainly detecting the bilateral basilar arteries (BA) and vertebral arteries (VA). ② Hemorheological parameters: Hemorheological parameters were measured in both groups of patients before and after treatment. ③ Frequency and duration of vertigo attacks: The frequency and duration of vertigo attacks were compared between the two groups of patients before and after treatment. ④ Safety evaluation indicators: Liver and kidney function tests, blood, urine, and stool routine tests, and electrocardiograms were performed on both groups of patients before and after treatment.

[0052] 1.6 Efficacy Criteria Efficacy evaluation criteria: Determined according to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines". Cure: Complete relief of basic symptoms such as dizziness, and normalization of transcranial Doppler (TCD). Significantly Effective: Reduced severity of dizziness, milder accompanying symptoms, reduced frequency of attacks by 2 / 3, and TCD improvement of over 60%. Effective: Reduced frequency, severity, and duration of clinical symptoms such as dizziness by 1 / 3, and TCD improvement of over 40%. Ineffective: No reduction in dizziness severity, less than 1 / 3 reduction in dizziness duration, or worsening of dizziness, no significant improvement in physical signs, TCD improvement of less than 40%, or progression to cerebral infarction. Total effective rate = Cure rate + Significantly Effective rate + Effective rate.

[0053] 1.7 Statistical Analysis SPSS 15.0 statistical software was used for data processing. Quantitative data were presented as follows: "This indicates that a t-test is used, and the chi-square test is used for count data." 2 The test was performed, with P < 0.05 considered statistically significant.

[0054] 2. Results 2.1 Comparison of duration and frequency of dizziness The differences between the two groups before and after treatment were statistically significant (P<0.05). The treatment group showed a more significant improvement in the duration of vertigo (P<0.05), and also a greater reduction in the frequency of vertigo attacks compared to the control group (P<0.05). See Table 1. Note: Compared with the control group, * P <0.05.

[0055] 2.2 Comparison of therapeutic effects After treatment, the total effective rate in the treatment group was 90%, while the total effective rate in the control group was 75%, and the difference was statistically significant (P<0.05). See Table 2.

[0056] Note: Compared with the control group, * P <0.05.

[0057] 2.3 Comparison of blood rheology After treatment, all indicators in both groups of patients showed significant decreases compared to before treatment, with statistically significant differences (P<0.05). Furthermore, among patients after treatment, the decreases were more pronounced in the treatment group than in the control group, with statistically significant differences (P<0.05). See Table 3. Note: Compared with the pre-treatment level in this group * P <0.05, compared with the control group, △P<0.05.

[0058] 2.4 TCD Comparison Comparison of TCD results before and after treatment revealed that cerebral blood flow velocity increased in both groups after treatment compared to before treatment, with statistically significant differences (P<0.05). Furthermore, inter-group comparisons after treatment showed that the increase in blood flow velocity was more pronounced in the treatment group than in the control group, with a statistically significant difference (P<0.05). See Table 4. Note: Compared with the pre-treatment level in this group * P <0.05, compared with the control group, △P<0.05.

[0060] 2.5 Safety Testing The patient's various indicators (liver and kidney function, blood routine, urine and stool routine) were all normal after treatment.

[0061] In summary, vertigo has been recorded in traditional Chinese medicine for a long time. The causes of vertigo can be broadly categorized into liver yang hyperactivity, qi and blood deficiency, phlegm obstruction, wind-evil disturbance, kidney essence deficiency, and blood stasis. Clinically, the syndrome of deficiency in the root and excess in the branch is quite common. Especially in modern society, with high work and life pressures and frequent emotional imbalances, liver qi stagnation, qi stagnation transforming into fire, disturbs the head and eyes, thus patients with liver yang hyperactivity type vertigo are more common. In the capsule formulations of Examples 1, 2, and 3, Aralia elata has the effects of clearing liver heat, strengthening the spleen and regulating the stomach; *Gynostemma pentaphyllum*, also known as *Gynostemma pentaphyllum*, has the effects of clearing heat, tonifying the kidney and replenishing essence, and strengthening the spleen; *Galium aparine* clears heat and detoxifies, and invigorates blood circulation; *Agrimonia pilosa* stops bleeding, invigorates blood circulation, and tonifies the spleen and replenishes qi; *Panax notoginseng* removes blood stasis, stops bleeding, and invigorates blood circulation; *Gastrodia elata* has the effects of calming the liver and suppressing yang, relieving wind and stopping spasms; and *Polygonatum sibiricum* nourishes yin and moistens the lungs. The above-mentioned herbs nourish the liver and kidneys, calm the liver and subdue yang, enter the liver, lung, kidney, spleen and stomach meridians, comprehensively regulate the functions of the whole body organs, promote blood circulation and remove blood stasis, promote blood circulation and stop bleeding, reduce inflammation and promote diuresis, effectively regulate vasomotor function, improve cerebral ischemia and hypoxia, resist vasoactive mediators, relieve vasospasm, improve microcirculation, protect nerve cell function, relieve inflammatory response, and improve symptoms such as dizziness.

[0062] TCD and hemorheology are indicators reflecting hemodynamics and flow status. Increased blood viscosity suggests poor blood flow and impaired cerebral circulation. TCD testing can assess blood flow in the vertebral and basilar arteries. This study shows that when using the capsules of Examples 1, 2, and 3 to treat vertigo of the liver-yang hyperactivity type, the frequency and duration of attacks improved compared to before treatment. Hemorheological parameters and TCD results also improved. There were statistically significant differences between the two groups after treatment. The capsules of Examples 1, 2, and 3 were significantly effective in improving vertigo symptoms.

[0063] Finally, it should be noted that the above preferred 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 through the above preferred embodiments, those skilled in the art should understand that various changes can be made to it in form and detail without departing from the scope defined by the claims of the present invention.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a formulation for treating Meniere's syndrome, characterized in that, The traditional Chinese medicine composition includes the following raw materials in parts by weight: 75-85 parts of *Wan Zhang Shen*, 75-85 parts of *Aralia elata*, 15-25 parts of *Polygonatum sibiricum*, 15-25 parts of *Gastrodia elata*, 15-25 parts of *Panax notoginseng*, 45-55 parts of *Galium affine*, and 55-75 parts of *Agrimonia pilosa*. The traditional Chinese medicine composition is specifically designed to treat the dizziness symptoms of Meniere's disease.

2. The application of the traditional Chinese medicine composition according to claim 1 in the preparation of a formulation for treating Meniere's syndrome, characterized in that: The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 85 parts of *Wan Zhang Shen*, 85 parts of *Aralia elata*, 26 parts of *Polygonatum sibiricum*, 26 parts of *Gastrodia elata*, 26 parts of *Panax notoginseng*, 45-55 parts of *Galium affine*, and 75 parts of *Agrimonia pilosa*.

3. The application of the traditional Chinese medicine composition according to claim 1 in the preparation of a formulation for treating Meniere's syndrome, characterized in that: The traditional Chinese medicine composition is prepared into capsules for later use.

4. The application of the traditional Chinese medicine composition according to claim 3 in the preparation of a formulation for treating Meniere's syndrome, characterized in that: The method for preparing the capsules includes the following steps: (1) Preparation of medicinal slices: Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine, and Agrimonia pilosa were selected, washed, cut and dried to obtain medicinal slices of Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine and Agrimonia pilosa. (2) Grind the medicinal slices: Take the prescribed amount of Wan Zhang Shen, Aralia elata, Polygonatum sibiricum, Gastrodia elata, Panax notoginseng, Galium aparine, and Agrimonia pilosa, grind them into powder and mix them for later use; (3) Extraction of volatile oil: Take the crushed and mixed Aralia elata, Galium aparine and Agrimonia pilosa slices, soak them in water for 2-3 hours, and then extract the volatile oil by steam distillation. Collect the volatile oil for later use. (4) Decoction: After the volatile oil is extracted, the dregs are mixed with the crushed slices of Polygonatum odoratum, Polygonatum sibiricum, Gastrodia elata and Panax notoginseng. After mixing, add 7-9 times the amount of water of the total amount of the slices and soak for 1.0-2.0 hours. Decoction is carried out for 2.5-3.5 hours. Filter to obtain filtrate. Add 3-4 times the amount of water of the dregs and decoct a second time for 1.0-2.0 hours. Filter to obtain filtrate for later use. (5) Enzymatic hydrolysis: Cool the filtrate to 30-40℃, add compound enzyme for enzymatic hydrolysis, and hydrolyze for 2-3 hours; (6) Alcohol precipitation: Add 60%-70% of the volume of the decoction to the enzymatically hydrolyzed decoction and mix. After mixing, let stand and refrigerate for 12-24 hours and then filter to obtain the filtrate. (7) Concentration: The filtrate is heated and concentrated into a thick paste. The thick paste is mixed with volatile oil, and then vacuum dried and pulverized into fine powder. (8) Preparation: The pulverized fine powder is sieved and filled into the capsule shell using a fully automatic capsule filling machine according to the specifications. After polishing, the capsule is obtained.

5. The application of the traditional Chinese medicine composition according to claim 4 in the preparation of a formulation for treating Meniere's syndrome, characterized in that: In step (5), the complex enzyme is a mixture of cellulase, pectinase, saccharifying enzyme and amylase.

6. The application of the traditional Chinese medicine composition according to claim 5 in the preparation of a formulation for treating Meniere's syndrome, characterized in that: The complex enzyme comprises the following parts by weight: Cellulase 0.02-0.1 parts, pectinase 0.02-0.1 parts, saccharifying enzyme 0.1-0.2 parts, amylase 0.02-0.1 parts.

7. The application of the traditional Chinese medicine composition according to claim 4 in the preparation of a formulation for treating Meniere's syndrome, characterized in that: The capsules are available in a specification of 0.5g / capsule.

8. The application of the traditional Chinese medicine composition according to claim 4 in the preparation of a formulation for treating Meniere's syndrome, characterized in that: The dosage and administration of the capsules are as follows: 1-1.5g each time, twice a day, for 30 consecutive days as one course of treatment.

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